AU2023203963B2

AU2023203963B2 - Catheter insertion tray with integrated instructions

Info

Publication number: AU2023203963B2
Application number: AU2023203963A
Authority: AU
Inventors: John GOHDE; David Hughett; Russell RIESCHER
Original assignee: CR Bard Inc
Current assignee: CR Bard Inc
Priority date: 2017-04-13
Filing date: 2023-06-23
Publication date: 2025-06-26
Anticipated expiration: 2037-04-14
Also published as: JP2020518322A; CA3058887A1; AU2017409008B2; EP3609561A1; KR20190132698A; KR20230026519A; MX2024012003A; ZA201906629B; CN110913938B; KR102622098B1; SA519410281B1; BR112019021090A2; EP3609561A4; WO2018190865A1; AU2017409008A1; JP7013481B2; CN110913938A; MX2019012210A; AU2023203963A1

Abstract

#$%^&*AU2023203963B220250626.pdf##### ABSTRACT An improved medical procedure or catheterization tray included in an improved medical procedure or catheterization package. The improved medical procedure or catheterization tray is intuitively arranged and includes instructions printed thereon to improve the medical procedure or catheterization implementation and results. In one example, a catheterization package and catheterization tray has a layout and/or arrangement of components that may help reduce CAUTI rates by facilitating ease of use and aiding in proper aseptic technique during insertion. The medical procedure or catheterization package and/or medical procedure or catheterization tray may include various implements, compartments, and components necessary and/or helpful to the medical procedure or catheterization, including, for example, improved swabs and an improved compartment for holding the swabs. 20 23 20 39 63 2 3 Ju n 20 23 ABSTRACT An improved medical procedure or catheterization tray included in an improved medical 2023203963 23 Jun 2023 procedure or catheterization package. The improved medical procedure or catheterization tray is intuitively arranged and includes instructions printed thereon to improve the medical procedure or catheterization implementation and results. In one example, a catheterization package and catheterization tray has a layout and/or arrangement of components that may help reduce CAUTI rates by facilitating ease of use and aiding in proper aseptic technique during insertion. The medical procedure or catheterization package and/or medical procedure or catheterization tray may include various implements, compartments, and components necessary and/or helpful to the medical procedure or catheterization, including, for example, improved swabs and an improved compartment for holding the swabs. ABSTRACT An improved medical procedure or catheterization tray included in an improved medical 2023203963 23 Jun 2023 procedure or catheterization package. The improved medical procedure or catheterization tray is intuitively arranged and includes instructions printed thereon to improve the medical procedure or catheterization implementation and results. In one example, a catheterization package and catheterization tray has a layout and/or arrangement of components that may help reduce CAUTI rates by facilitating ease of use and aiding in proper aseptic technique during insertion. The medical procedure or catheterization package and/or medical procedure or catheterization tray may include various implements, compartments, and components necessary and/or helpful to the medical procedure or catheterization, including, for example, improved swabs and an improved compartment for holding the swabs.

Description

CATHETER INSERTIONTRAY TRAYWITH WITHINTEGRATED INTEGRATED INSTRUCTIONS 07 May 2025 2023203963 07 May 2025

CATHETER INSERTION INSTRUCTIONS PRIORITY PRIORITY

[0001]

[0001] This application is a divisional application of Australian patent application no. This application is a divisional application of Australian patent application no.

2017409008,which 2017409008, which is the is the Australian Australian national national phase phase of PCT/US2017/027628, of PCT/US2017/027628, filed 14filed 14 April April 2017, which claims priority to claims the benefit of Patent Application No. 15/487,297 filed 13 2017, which claims priority to claims the benefit of Patent Application No. 15/487,297 filed 13

April 2017, April 2017, which whichisisaacontinuation-in-part continuation-in-partofof U.S. U.S.Patent PatentApplication ApplicationNo. No. 15/029,613, 15/029,613, filed filed 2023203963

April 14, April 14, 2016, 2016,which which is aisU.S. a U.S. national national stage stage of International of International Patent Patent Application Application No. No. PCT/US2014/060963, PCT/US2014/060963, filedfiled October October 16, 2014, 16, 2014, which which claims claims the benefit the benefit of U.S.of U.S. Provisional Provisional

Patent Application Patent ApplicationNo. No. 61/891,496, 61/891,496, filed filed October October 16, 2013, 16, 2013, andProvisional and U.S. U.S. Provisional Patent Patent Application No. Application No.62/015,206, 62/015,206, filed filed JuneJune 20, 2014, 20, 2014, the disclosures the disclosures of eachofofeach whichofare which are incorporated herein incorporated herein by by reference reference in their in their entirety. entirety.

BACKGROUND BACKGROUND

[0002]

[0002] Urinary drainage Urinary drainagesystems systemsareareconventionally conventionally used used in in hospitals hospitals andand health health care care

facilities facilities when when ititis is necessary necessaryto tofacilitate, facilitate,control, control,monitor monitor urination urination of patients, of patients, anditwhen and when is it is necessary to collect urine from a patient. These urinary drainage systems permit the patient to necessary to collect urine from a patient. These urinary drainage systems permit the patient to

remainin remain in bed, bed, without without having to use having to use aa bedpan or be bedpan or be moved to use moved to use aa bathroom. Urinarydrainage bathroom. Urinary drainage systems may systems may include include a catheter a catheter (e.g., (e.g., a urinary a urinary catheter, catheter, such such as an as an intermittent intermittent catheter or catheter a or a Foley catheter), Foley catheter), aa collection collection container/bag container/bag (e.g., (e.g.,a abag bagmade of aa polymeric made of materialoror PVC polymeric material PVC film), film), aa urine urine meter, meter, tubing connectingthe tubing connecting theFoley Foleycatheter cathetertotothe thecollection collectioncontainer/bag container/bagoror urine meter, urine meter, and/or and/orother otherequipment. equipment.In In operation, operation, thethe patient patient is is firstcatheterized, first catheterized, and andthe the catheter is connected catheter is connected to to the the drainage drainage container/bag container/bag and/orand/or urinethrough urine meter meter through a length a length of tubing of tubing

(e.g., (e.g., drainage tubing).TheThe drainage tubing). urine urine drains drains through through the catheter, the catheter, the tubing, the tubing, and then and then finally finally into into

the collection the collection container/bag container/bag and/or and/or urine urinemeter. meter.The The urine urinemay may be be moved fromthe moved from thecatheter catheterinto into the collection bag solely due to gravitational forces. On average, a patient produces about 80- the collection bag solely due to gravitational forces. On average, a patient produces about 80-

90 mLofofurine 90 mL urinein in 11 hour. hour. Summary Summary

[0003]

[0003] Accuratemonitoring Accurate monitoringof ofurine urine helps helps thethe cliniciandetect clinician detectirregularities irregularities in in urine urine flow rateororvolume flow rate volume that that cancan signal signal to the to the clinician clinician that that the patient the patient is suffering is suffering certain certain problems. problems.

However,urine However, urineoutput outputcannot cannot be be accurately accurately measured measured if the if the drainage drainage system system attached attached to to the the Foley catheter is not reliable, or if the Foley catheter and drainage system are not properly used. Foley catheter is not reliable, or if the Foley catheter and drainage system are not properly used.

Further, hospitals Further, hospitals are are using using increasingly increasingly lower-profile lower-profile beds in order beds in order to to reduce the number reduce the number ofof

injuries injuries sustained sustained from falls. With from falls. the adoption With the adoption of of lower lowerprofile profile beds, beds,the theamount amountof of height height available to allow allow the the tubing tubingtotodrain drainisisdecreased. decreased.Drainage Drainage tubing usedused in hospitals and and 07 May 2025 2023203963 07 May 2025 available to tubing in hospitals associated associated venting venting systems systems have also undergone have also undergone changes/revisions. changes/revisions. Changes in venting Changes in venting combined with combined with increasingly increasingly lower lower profile profile hospital hospital bedsbeds have have created created suboptimal suboptimal drainage drainage performance.For performance. Forexample, example, urine urine has has been been observed observed poolingpooling in the tubing. in the tubing. This prevents This prevents accurate accurate urine urine output output and and flow rate measurements, flow rate whicharearecritical measurements, which critical for for many patients. many patients.

[0004]

[0004] Currently, the Currently, the second-most common second-most common form form of Hospital of Hospital Acquired Acquired Infection Infection (HAI) (HAI) 2023203963

is is catheter-associated urinary catheter-associated urinary tract tract infection infection (CAUTI). (CAUTI). Hospitals Hospitals are interested are interested in ways to in cutways to cut

their CAUTI their ratesbybyconforming CAUTI rates conformingto to a strictaseptic a strict aseptic technique techniqueas as aa standard standard of of care. care. However, However,

there are there are many factorsthat many factors that influence influence aa hospital's hospital's ability ability to tomeet meet the the standard standard of of care. care. These These

factors factors include health care include health care practitioner/nurse practitioner/nurse experience experienceand andtraining, training,patient patientfactors factors(e.g., (e.g., general health,weight, general health, weight,andand anatomy), anatomy), environmental environmental factors, factors, and tray and tray layout as layout well asas well as contents contents

and instructions/indicators. AAcatheterization and instructions/indicators. catheterizationpackage package and/or and/or catheterization catheterization tray with tray with

components optimized components optimized to the to the procedure procedure and and an intuitive an intuitive layout layout can increase can increase compliance compliance to to aseptic aseptic technique, technique, potentially potentiallyreducing reducing CAUTI rates. CAUTI rates.

[0005]

[0005] There is a need in the healthcare field for a more reliable, safe, and easy method There is a need in the healthcare field for a more reliable, safe, and easy method

for insertinga acatheter, for inserting catheter,such such as aasurinary a urinary catheter, catheter, for example for example an indwelling an indwelling or intermittent or intermittent

catheter, intoaapatient. catheter, into patient.More More particularly, particularly, there there is a is a need need to provide to provide a catheterization a catheterization package package

and/or and/or aa catheterization catheterization tray tray (e.g., (e.g.,a aFoley Foley catheter catheter tray) tray)that thatimproves improves and standardizes the and standardizes the process for inserting a urinary catheter, such as an indwelling Foley catheter, into a patient process for inserting a urinary catheter, such as an indwelling Foley catheter, into a patient

[0006]

[0006] The present disclosure may provide a catheterization package, catheter tray, and The present disclosure may provide a catheterization package, catheter tray, and

drainage system configured to better meet patients' needs, improve reliability and ease of use, drainage system configured to better meet patients' needs, improve reliability and ease of use,

reduce incidents reduce incidents ofofCAUTI, CAUTI, improve improve safety, safety, or address or address other other issuesissues described described above above and and elsewhere herein. elsewhere herein.

[0006A]

[0006A] Any discussion of documents, acts, materials, devices, articles or the like which Any discussion of documents, acts, materials, devices, articles or the like which

has been included in the present specification is not to be taken as an admission that any or all has been included in the present specification is not to be taken as an admission that any or all

of of these these matters matters form form part part of of the theprior priorart base art or or base were common were general knowledge common general knowledgeininthe thefield field relevant to the present disclosure as it existed before the priority date of each of the appended relevant to the present disclosure as it existed before the priority date of each of the appended

claims. claims.

SUMMARY SUMMARY

2

[0007] Embodiments of,of, andand enhancements for, for, packages, systems, trays, assemblies, 07 May 2025 2023203963 07 May 2025

[0007] Embodiments enhancements packages, systems, trays, assemblies,

devices, methods, devices, methods, etc.etc. usedused for medical for medical treatment treatment generallygenerally and catheterization, and catheterization, in particular, in particular,

are describedherein. are described herein.

[0007A]

[0007A] Throughoutthis Throughout thisspecification specificationthethe word word "comprise", "comprise", or variations or variations such assuch as "comprises" or"comprising", "comprises" or "comprising",will willbebeunderstood understood to to imply imply the the inclusion inclusion of aofstated a stated element, element,

integer integer or or step, step, or or group of elements, group of elements,integers integersororsteps, steps, but but not notthe theexclusion exclusionofofany any other other 2023203963

element, integeror or element, integer step, step, or or group group of elements, of elements, integers integers or steps. or steps.

[0008]

[0008] Theobjectives The objectives described describedherein hereincan canbebemet metbybyproviding providing an an improved improved medical medical

procedurepackage procedure packageand/or and/ortray tray(e.g., (e.g., an an improved improvedcatheterization catheterizationpackage packageand/or and/orananimproved improved catheterization catheterization tray). tray). The improvedmedical The improved medical procedure procedure package package may include may include the improved the improved

medicalprocedure medical proceduretray traytherein, therein, and and the the medical medical procedure tray may procedure tray beintuitively may be intuitively arranged arranged and and

may include may include instructions instructions or or procedural procedural indicators indicators to to improve improve the themedical medicalprocedure procedure implementation andresults. implementation and results. The medicalprocedure The medical procedurepackage package and/or and/or medical medical procedure procedure tray tray may may

include include various various implements andcomponents implements and components necessary necessary and/or and/or helpful helpful to to themedical the medical procedure. procedure.

For example, For example,ananimproved improved catheterization catheterization package package may may include include an improved an improved catheterization catheterization

tray, povidone tray, iodine swabs povidone iodine swabsoror swabsticks swabsticksthat that allow allow for for greater greater coverage andsaturation, coverage and saturation, hand hand

sanitizer sanitizer with with improved efficacy and improved efficacy andthat that enables enablessingle-handed single-handedusage, usage,tubing tubing thatbreaks that breaksupup the surface tension of the fluid in order to improve drainage, and/or other components described the surface tension of the fluid in order to improve drainage, and/or other components described

herein. herein.

[0008A]

[0008A] In In one one embodiment thereisisprovided embodiment there provideda acatheterization catheterizationpackage packageincluding including aa catheterization tray,comprising: catheterization tray, comprising: aa main mainsection sectionconfigured configuredto to accommodate accommodate at least at least a portion a portion of a Foley of a Foley catheter catheter

drainage system; drainage system; aa first first side side section configured section configured to to accommodate accommodate a container a container of lubricant; of lubricant;

aa second secondside side section section separated separated from from the side the first firstsection side section bysection by a side a side partition, section partition, the second side section including an inclined surface; the second side section including an inclined surface;

aa continuous continuousmain mainsection sectionpartition partitionseparating separatingthe themain main section section from from the the first first side side

section andthethesecond section and second sideside section; section; and and

aa cover configuredtotobebepositioned cover configured positionedover overa adrainage drainagebagbag andand drainage drainage tubing tubing of the of the

Foley catheter Foley catheter drainage system, the drainage system, the cover cover configured configuredtoto fit fit within within the the main main section, section, and and which which

is is folded to form folded to forma aretainer retainer to to hold hold a syringe a syringe of sterile of sterile water. water.

2023203963 07 May 2025

[0009]

[0009] According toto various According variousembodiments, embodiments, the the present present disclosure disclosure provides provides a a catheterization packageand catheterization package and catheterization catheterization tray tray having having a layout a layout and/orand/or arrangement arrangement of of components thatmay components that may help help reduce reduce CAUTI CAUTI ratesrates by facilitating by facilitating ease ease of of useuse andand aiding aiding in in proper proper

aseptic aseptic technique technique during insertion. The during insertion. present disclosure The present disclosure also also provides methods ofof provides methods

catheterization catheterization and useofofa acatheterization and use catheterizationpackage package and/or and/or catheterization catheterization traytray that that may may 2023203963

facilitate easier and more sterile catheterization to help reduce CAUTI rates. Further, the present facilitate easier and more sterile catheterization to help reduce CAUTI rates. Further, the present

disclosure disclosure provides a system provides a that may system that improvedrainage may improve drainage performance, performance, which which in turn: in turn: (1)(1) helps helps

to eliminate to fluid in eliminate fluid in the the drain drain tubing, tubing, and and (2) (2) increases increases the the accuracy of urine accuracy of urine measurements measurements (e.g., (e.g.,measurements of output measurements of output and andflow). flow).

[0010]

[0010] In some In embodiments, some embodiments, a catheterization a catheterization package package is provided is provided including including a catheterization a catheterization

tray and tray and aa sterile sterile wrap wraparound aroundthethecatheterization catheterizationtray. tray. The Thecatheterization catheterization tray tray can caninclude include catheterization instructions imprinted catheterization instructions imprinteddirectly directlyononthe thecatheterization catheterizationtray. tray.The The catheterization catheterization tray tray cancan

also include also include aa first first section, section,aasecond second section, section, and a third and a third section, section, wherein in one wherein in oneorormore morepartitions partitionscan can separate separate atat leastthethe least third third section section fromfrom the first the first and second and second sections.sections. The first The first section can section can hold a drainage hold a drainage

system, the second system, the secondsection sectioncancan hold hold a container a container containing containing lubricant, lubricant, andthird and the the third section section can ahold a can hold

swab inananinclined swab in inclinedposition. position.The Theabsorbent absorbent head head of the of the swabswab can angle can angle downwardly downwardly intoofa well into a well the of the

third section third section and an elongate and an elongatemember member of the of the swabswab can angle can angle upwardly upwardly for gripping for gripping and removal and removal of the of the swab. swab.

[0011]

[0011] In such In suchembodiments, embodiments,the the catheterization catheterization package package can further can further includeinclude a pericare a pericare kit, a kit, a belly band, belly band, and anda apackaging packaging label. label. TheThe peri-care peri-care kit kit cancan be packaged be packaged withcatheterization with the the catheterization tray tray but but outside thesterile outside the sterile wrap. wrap.OneOne example example of a suitable of a suitable peri-care peri-care kit is kit is disclosed disclosed in PCT Application in PCT Application

PublicationNo. Publication No.WOWO 2016/126555, 2016/126555, the disclosure the disclosure ofiswhich of which is incorporated incorporated herein by herein by in reference reference its in its entirety. The entirety. The belly belly band canbe band can beoutside outsidethe the sterile sterile wrap holdingthe wrap holding thesterile sterile wrap in aa folded wrap in folded configuration configuration

aroundthe around thecatheterization catheterizationtray. tray. The Thepackaging packaging label label cancan be outside be outside the the sterile sterile wrap wrap for for identifying identifying the the catheterization package. catheterization package.

3A 3A

[0012] In such such embodiments, embodiments,the the third section of catheterization the catheterization package can 2023203963 23 Jun 2023

[0012] In third section of the package can

include aa swab include swabcompartment, compartment, an overflow an overflow compartment, compartment, and a corner and a corner storagestorage compartment compartment

holding aa specimen holding specimencontainer. container.TheThe swabswab compartment compartment can include can include the wellthe andwell and a a channel channel configured to hold the swab. The channel can include at least two snap-in tabs to hold the swab configured to hold the swab. The channel can include at least two snap-in tabs to hold the swab

in the channel under the snap-in tabs, wherein each longitudinal side of the channel includes at in the channel under the snap-in tabs, wherein each longitudinal side of the channel includes at

least one least one of of the the at atleast leasttwo twosnap-in snap-intabs. tabs.The The channel can be channel can be further further configured to convey configured to conveyaa 2023203963

fluid to the well when the swab is absent from the channel and the fluid is poured in the channel. fluid to the well when the swab is absent from the channel and the fluid is poured in the channel.

The overflow The overflowcompartment compartmentcan can be fluidly be fluidly connected connected to the to the well well through through thethe channel. channel.

[0013]

[0013] In such In such embodiments, theone embodiments, the oneorormore more partitionsofofthe partitions the catheterization catheterization package package

separating the third section from the first and second sections can further separate the second separating the third section from the first and second sections can further separate the second

section from the first section. Second section-separating partitions of the one or more partitions section from the first section. Second section-separating partitions of the one or more partitions

can have can have aa maximum maximum height height equal equal to atoheight a height of of thethe catheterizationtray, catheterization tray, wherein whereina abottom bottomofof the second the section can second section can be be elevated elevatedabove abovea abottom bottomof of thecatheterization the catheterizationtray. tray. Alternatively, Alternatively, the second the secondsection-separating section-separatingpartitions partitions of of the the one one or or more morepartitions partitionscan canhave havea maximum a maximum height less than the height of the catheterization tray, wherein the bottom of the second section height less than the height of the catheterization tray, wherein the bottom of the second section

and the bottom of the catheterization tray are substantially co-planar. and the bottom of the catheterization tray are substantially co-planar.

[0014]

[0014] In some In someembodiments, embodiments, a medical-procedure a medical-procedure package package is provided is provided including including a a tray with medical-procedure instructions imprinted directly on the tray, at least some of which tray with medical-procedure instructions imprinted directly on the tray, at least some of which

instructions are instructions are revealed revealed in in step stepwith with steps stepsof ofthe themedical medical procedure. Thetray procedure. The tray can caninclude includeaa first section, a second section, and a third section, wherein one or more partitions separate at first section, a second section, and a third section, wherein one or more partitions separate at

least the third section from the first and second sections. The tray can further include a drainage least the third section from the first and second sections. The tray can further include a drainage

system, a container containing a lubricant, and one or more swabs. The first section can include system, a container containing a lubricant, and one or more swabs. The first section can include

at least the drainage system, the second section can include at least the container containing the at least the drainage system, the second section can include at least the container containing the

lubricant, and the third section includes at least the one or more swabs. lubricant, and the third section includes at least the one or more swabs.

[0015]

[0015] In such In such embodiments, embodiments,thethe medical-procedure medical-procedure package package can further can further includeinclude a a specimen container. specimen container. The Thethird third section section can can include include aa swab swabcompartment, compartment,an an overflow overflow

compartment,and compartment, anda acorner comerstorage storagecompartment compartment including including the the specimen specimen container. container. The The swab swab compartmentcancan compartment include include a wellandand a well one one or or more more channels channels configured configured to respectively to respectively hold hold thethe

one or one or more moreswabs swabswith withsnap-in snap-intabs tabsininthe theone oneorormore morechannels. channels.TheThe one one or more or more channels channels

can also can also be be angled with respect angled with respect to to aa bottom of the bottom of the tray tray such such that thata ahandle handleend end of ofeach each swab swab of of

the one or more swabs held under the snap-in tabs is elevated with respect to an absorbent-head the one or more swabs held under the snap-in tabs is elevated with respect to an absorbent-head

end when end whenthe theabsorbent-head absorbent-head endend is in is in thethe well.The The well. overflow overflow compartment compartment can be can be fluidly fluidly

-4-

Jun 2023 connectedto connected to the the well well through the one through the or more one or channels, wherein more channels, whereinthe theone oneorormore morechannels channelscan can be further be further configured configured to to convey convey aa fluid fluid poured poured therein therein to tothe thewell wellwhen when the the one one or or more swabs more swabs

are removed are fromthe removed from theone oneorormore more channels. channels.

2023203963 23

[0016]

[0016] In such In such embodiments, themedical-procedure embodiments, the medical-procedure package package cancan further further include include a a third third

section-separating partition of the one or more partitions at a well-end of the swab compartment section-separating partition of the one or more partitions at a well-end of the swab compartment

directly separating directly separating the the well well from the second from the secondsection. section. Alternatively, Alternatively,a awell-end well-endof of theswab the swab 2023203963

compartment can share with the tray an inner wall of the tray. compartment can share with the tray an inner wall of the tray.

[0017]

[0017] In such In such embodiments, embodiments,thethe one one or more or more partitions partitions ofmedical-procedure of the the medical-procedure package separating the third section from the first and second sections can further separate the package separating the third section from the first and second sections can further separate the

secondsection second section from fromthe thefirst first section. section. Second section-separating partitions Second section-separating partitions of of the theone one or ormore more

partitions can partitions can have a maximum have a height maximum height equal equal to to a height a height of of thethe tray,wherein tray, wherein a bottom a bottom of the of the

secondsection second section can can be be elevated elevated above abovea abottom bottomofofthe thetray. tray. Alternatively, Alternatively, the the second secondsection- section- separating partitions separating partitions of of the the one one or or more partitions can more partitions can have have aa maximum maximum height height lessless than than thethe

height of height of the the tray, tray, wherein the bottom wherein the bottomofofthe thesecond secondsection sectionandand thethe bottom bottom of the of the traytray are are

substantially co-planar. substantially co-planar.

[0018]

[0018] In some In someembodiments, embodiments, a catheterization a catheterization package package is provided is provided including including a tray a tray

with instructions for a catheterization procedure imprinted directly on the tray, at least some of with instructions for a catheterization procedure imprinted directly on the tray, at least some of

whichinstructions which instructions are are revealed revealed in in step step with with steps steps of of the the catheterization catheterization procedure. Thetray procedure. The tray can include a first section, a second section, and a third section, wherein one or more partitions can include a first section, a second section, and a third section, wherein one or more partitions

separate at least the third section from the first and second sections. The tray can further include separate at least the third section from the first and second sections. The tray can further include

a drainage system, a container containing a lubricant, a syringe of sterile liquid, such as water a drainage system, a container containing a lubricant, a syringe of sterile liquid, such as water

or, in some instances, saline, and a skin-preparation kit. The first section can include at least or, in some instances, saline, and a skin-preparation kit. The first section can include at least

the drainage the system, which drainage system, whichdrainage drainagesystem systemcan caninclude includea aFoley Foleycatheter, catheter,drainage drainagetubing, tubing, and and a drainage bag. The second section can include at least the container containing the lubricant. a drainage bag. The second section can include at least the container containing the lubricant.

The first section can include the syringe of the sterile liquid, such as sterile water, which syringe The first section can include the syringe of the sterile liquid, such as sterile water, which syringe

can be configured for inflating a balloon of the Foley catheter with the sterile water. According can be configured for inflating a balloon of the Foley catheter with the sterile water. According

to certain to certain embodiments, thewater embodiments, the watersyringe syringecan canbebeconnected connected to to theinflation the inflationport portofofthe the Foley Foley catheter during catheter during manufacture ofthe manufacture of the assembly. assembly.Providing Providing a pre-connected a pre-connected syringe syringe to to thethe Foley Foley

catheter can catheter help minimize can help minimizethe thenumber number of steps of steps required required to to catheterize catheterize a patient.TheThe a patient. third third

section can section can include include at at least least the the skin-preparation kit, which skin-preparation kit, kit can which kit include aa package can include packageofofanan antiseptic and antiseptic and one one or or more swabs. more swabs.

-5-

[0019] In such such embodiments, embodiments,the thecatheterization catheterization package can further further include include aa 2023203963 23 Jun 2023

[0019] In package can

specimencontainer specimen containerand anda alabel labelfor forthe thespecimen specimen container. container. The The third third section section can can include include a a swabcompartment, swab compartment,an an overflow overflow compartment, compartment, and and a corner a corner storage storage compartment compartment including including the the

specimencontainer. specimen container.TheThe swab swab compartment compartment can include can include a well a well and one and one channels or more or more channels configured to configured to respectively respectively hold hold the the one oneorormore moreswabs swabs with with snap-in snap-in tabs tabs in in thethe oneone or more or more

channels. The channels. Theoverflow overflow compartment compartment can can be fluidly be fluidly connected connected to the to the wellwell through through the the one one or or 2023203963

morechannels, more channels,wherein whereinthethe oneone or more or more channels channels canfurther can be be further configured configured to convey to convey the the antiseptic poured antiseptic poured therein therein to tothe thewell wellwhen when the the one one or or more more swabs are removed swabs are removedfrom from theoneone the oror

morechannels. more channels.TheThe package package of the of the antiseptic antiseptic cancan be be placed placed over over thethe swab swab compartment, compartment, the the overflowcompartment, overflow compartment, thecorner the cornerstorage storagecompartment, compartment, orcombination or a a combination thereof. thereof.

[0020]

[0020] In such In such embodiments, embodiments,thethe catheterizationpackage catheterization package can can further further include include a third a third

directly separating directly separating the the well well from the second from the secondsection. section. Alternatively, Alternatively,a awell-end well-endof of theswab the swab compartment can share with the tray an inner wall of the tray. compartment can share with the tray an inner wall of the tray.

[0021]

[0021] In such In embodiments,the such embodiments, theone oneorormore more partitionsofofthe partitions the catheterization catheterization package package

can have can havea amaximum maximum height height equalequal to a to a height height oftray, of the the tray, wherein wherein a bottom a bottom of the of the second second

section can be elevated above a bottom of the tray. Alternatively, the second section-separating section can be elevated above a bottom of the tray. Alternatively, the second section-separating

partitions of partitions ofthe theone oneor ormore more partitions partitionscan canhave haveaamaximum heightless maximum height lessthan thanthe the height height of of the the

tray, wherein the bottom of the second section and the bottom of the tray are substantially co- tray, wherein the bottom of the second section and the bottom of the tray are substantially co-

planar. planar.

[0022]

[0022] In such In embodiments,thethecatheterization such embodiments, catheterizationpackage packagecancan further further include include a sterile a sterile

wrap, a peri-care kit, a belly band, and a packaging label. The sterile wrap can be in a folded wrap, a peri-care kit, a belly band, and a packaging label. The sterile wrap can be in a folded

configuration around the tray. The peri-care kit can be packaged with the catheterization tray configuration around the tray. The peri-care kit can be packaged with the catheterization tray

but outside the sterile wrap. The belly band can be outside the sterile wrap holding the sterile but outside the sterile wrap. The belly band can be outside the sterile wrap holding the sterile

wrapinin the wrap the folded foldedconfiguration configurationaround around thethe catheterization catheterization tray.TheThe tray. belly belly bandband can can also also include instructions include instructions regarding howtotoorient regarding how orientthe thetray tray prior prior to to opening openingthe thesterile sterile wrap. The wrap. The

packaging label can be outside the sterile wrap for identifying the catheterization package. In packaging label can be outside the sterile wrap for identifying the catheterization package. In

addition, the addition, the packaging packaginglabel labelcancan include include information information emphasizing emphasizing key features key features of the of the catheterization package in a way that is easy to read quickly. catheterization package in a way that is easy to read quickly.

-6-

[0023] In some someembodiments, embodiments, a catheterization package comprises a catheterization 2023203963 23 Jun 2023

[0023] In a catheterization package comprises a catheterization

tray including tray including a a first firstcompartment holding aa drainage compartment holding drainagesystem; system;a asecond secondcompartment compartment holding holding

a syringe; a syringe; aa third thirdcompartment holdinga aswab compartment holding swabininananinclined inclinedposition positionsuch suchthat thatananabsorbent absorbent head of head of the the swab swabisis biased biased downwardly downwardly into into a well a well of of thethird the thirdcompartment compartmentand and an elongate an elongate

member member of of thethe swab swab angles angles upwardly upwardly for easier for easier gripping gripping and removal; and removal; and catheterization and catheterization

instructions or instructions or procedural procedural indicators indicatorsimprinted imprinteddirectly directlyon on thethe catheterization catheterization tray. tray. The The 2023203963

catheterization package catheterization mayalso package may also include include aa sterile sterile wrap wrap (e.g., (e.g.,a CSR a CSRwrap) wrap) wrapped aroundthe wrapped around the catheterization tray. catheterization tray. The absorbent head The absorbent headofofthe the swab swabmay may be be formed formed of absorbent of absorbent foam, foam, and and the elongate the elongate member member ofof theswab the swabmay may have have a generally a generally rectangular rectangular cross cross section section with with rounded rounded

edges. TheThe edges. catheterization catheterization package package may include may also also include a peri-care a peri-care kit packaged kit packaged with the with the catheterization tray at a location outside the sterile wrap. The catheterization package may also catheterization tray at a location outside the sterile wrap. The catheterization package may also

include aa belly include belly band bandoutside outsidethethe sterilewrap, sterile wrap, thethe belly belly band band including including an instruction an instruction or or procedural indicator regarding how to orient the catheterization tray prior to opening the sterile procedural indicator regarding how to orient the catheterization tray prior to opening the sterile

wrap. Additionally, wrap. Additionally,the thecatheterization catheterizationpackage packagemaymay include include a packaging a packaging label label outside outside the the sterile wrap, wherein the packaging label includes at least three sides folded into a different sterile wrap, wherein the packaging label includes at least three sides folded into a different

plane from the top portion of the label that are visible when viewing the catheterization package plane from the top portion of the label that are visible when viewing the catheterization package

from one from oneorormore more sides sides of of thethe catheterizationpackage, catheterization package, and/or and/or wherein wherein the the packaging packaging label label

includes information includes information features features (e.g., (e.g., information information squares) squares) that thateach each emphasize emphasize aa key key feature feature of of the catheterization the catheterization package package in in aa way that isiseasy way that easyto toread readquickly. quickly. The The catheterization catheterizationpackage package

may include an outer sealed container or bag (e.g., a plastic, transparent bag) around the other may include an outer sealed container or bag (e.g., a plastic, transparent bag) around the other

componentstotomaintain components maintainsterility sterility during shipping and during shipping and storage. storage.

[0024]

[0024] In some In embodiments, some embodiments, a medical a medical procedure procedure package package comprises comprises three three or or more more compartments holding compartments holding implements implements useful useful for for performance performance of of the the medical medical procedure procedure and and instructions/procedural indicators imprinted or included directly on the medical procedure tray instructions/procedural indicators imprinted or included directly on the medical procedure tray

directing aa user directing user how to carry how to carry out out steps steps of of the the medical medicalprocedure, procedure,wherein whereinthethe threeor ormore three more compartmentsof of compartments thethe medical medical procedure procedure tray, tray, the instructions/procedural the instructions/procedural indicators, indicators, and and implements are implements are arranged arranged in in an an arrangement arrangementsuch suchthat thatthe themedical medicalprocedure procedureproceeds proceeds intuitively from intuitively from step stepto tostep stepbased basedon onthe thearrangement. arrangement. The The arrangement mayinclude arrangement may includestacking stacking various components various or implements components or implements(e.g., (e.g., 22 toto 2020implements/components implements/components or or 4 10 4 to to 10 implements/components) implements/components) on top on top of each of each other other in the in the order order that that they they aretotobebeused are used(e.g., (e.g., with with componentsororimplements components implementsto to bebe usedbefore used beforeother othercomponents componentsor or implements implements being being positioned positioned

on top on top of of the the other other components orimplements components or implementstotobebeused usedlater). later).

-7-

[0025] In some someembodiments, embodiments, a method of treating a patient comprises providing a 2023203963 23 Jun 2023

[0025] In a method of treating a patient comprises providing a

medical procedure medical proceduretray tray including includingthree three or or more compartments more compartments including including implements implements useful useful for for

performanceofofthe performance the medical medicalprocedure procedureand andinstructions/procedural instructions/proceduralindicators indicators imprinted imprinted directly directly on the medical procedure tray directing a user how to carry out steps of the medical procedure. on the medical procedure tray directing a user how to carry out steps of the medical procedure.

The method The methodmaymay also also include include performing performing the the medical medical procedure procedure on a on a patient patient whilewhile following following

the instructions/procedural the instructions/procedural indicators indicatorsimprinted imprinted on on the themedical medical procedure tray. Three procedure tray. or more Three or more 2023203963

compartmentsof of compartments thethe medical medical procedure procedure tray,tray, the the instructions/procedural instructions/procedural indicators, indicators, and/or and/or

implementsare implements arearranged arrangedsuch suchthat thatthe the medical medicalprocedure procedureproceeds proceedsintuitively intuitivelyfrom fromstep stepto to step step based on based on how howthey theyare arearranged arrangedon/in on/inthe themedical medicalprocedure procedure tray. tray.

[0026]

[0026] In some In embodiments, some embodiments, a method a method of catheterizing of catheterizing a patientcomprises a patient comprises providing providing

a catheterization package having a catheterization tray including a first compartment holding a a catheterization package having a catheterization tray including a first compartment holding a

drainage system drainage systemincluding includinga acatheter; catheter;a asecond secondcompartment compartment holding holding a swab a swab in an in an inclined inclined

position such that position such that and and absorbent absorbenthead headofofthe theswab swab is is biased biased downwardly downwardly into into a a well well of of the the second compartment second compartmentand andananelongate elongatemember memberof of thethe swab swab angles angles upwardly; upwardly; pouring pouring an an antiseptic solution into the well such that the absorbent head is in contact with the antiseptic antiseptic solution into the well such that the absorbent head is in contact with the antiseptic

solution, using the swab to cleanse the patient in a region to be catheterized, and inserting a solution, using the swab to cleanse the patient in a region to be catheterized, and inserting a

portion of portion of aa catheter catheter into intoa aurethra urethraofof thethepatient. A Asealed patient. sealedcontainer containeroror bag bagmay may be be disposed disposed

aroundthe around the catheterization catheterization tray, tray,and and the themethod mayinclude method may includeunsealing unsealingthe thesealed sealedcontainer containeroror bag. A Asterile bag. sterilewrap wrapmaymay be wrapped be wrapped around around the catheterization the catheterization tray, tray, andmethod and the the method may may include unwrapping include unwrappingthe thesterile sterile wrap wrapprior prior to to pouring pouring an an antiseptic antiseptic solution solution into into the thewell. well. The The

catheterization package may also include a peri-care kit located outside of the sterile wrap, and catheterization package may also include a peri-care kit located outside of the sterile wrap, and

the method the may method may include include using using thethe peri-carekitkittotocleanse peri-care cleansea aportion portionofofthe the patient's patient's perineum perineum

prior to unwrapping the sterile wrap. A belly band may be positioned outside the sterile wrap, prior to unwrapping the sterile wrap. A belly band may be positioned outside the sterile wrap,

the belly the belly band bandmay may include include an instruction/procedural an instruction/procedural indicator indicator or instructions/procedural or instructions/procedural

indicators regarding how to properly orient the catheterization tray prior to opening the sterile indicators regarding how to properly orient the catheterization tray prior to opening the sterile

wrap, and wrap, and the the method methodmay may include include orientingthe orienting thetray trayaccording accordingtotothe the instruction(s)/procedural instruction(s)/procedural indicator(s) prior to unwrapping the sterile wrap. indicator(s) prior to unwrapping the sterile wrap.

[0027]

[0027] In some In someembodiments, embodiments, a method a method of manufacturing of manufacturing a catheterization a catheterization package package

comprises providing comprises providing aa catheterization catheterization tray tray including including aa first first compartment, compartment, aa second second compartment,a athird compartment, third compartment compartment having having an an inclinedportion inclined portionofofthe the bottom bottomofofthe the compartment compartment

with channels with channelsforforholding holding a swab, a swab, and catheterization and catheterization instructions/procedural instructions/procedural indicators indicators

imprinted directly imprinted directly ononthe thecatheterization catheterizationtray; tray; wherein whereinthethe firstcompartment, first compartment, the the second second

-8-

compartment,and andthethethird thirdcompartment compartmentare are each at leastpartially partiallyseparated separatedfrom fromeach eachother other 2023203963 23 Jun 2023

compartment, each at least

by partitions. by partitions. The The method method may include may also also include positioning positioning a drainage a drainage system insystem in the first the first compartment,a asyringe compartment, syringeininthe the second secondcompartment, compartment,andand a swab a swab in the in the thirdcompartment third compartment suchsuch

that an that an absorbent absorbent head of the head of the swab is biased swab is biased downwardly intoa awell downwardly into wellofofthe the third third compartment compartment

and an and an elongate elongatemember memberof of thethe swab swab angles angles upwardly upwardly for easier for easier gripping gripping and removal. and removal. The The methodmay method may furtherinclude further includewrapping wrappingthethe catheterizationtray catheterization trayininaa sterile sterile wrap wrap and and positioning positioning 2023203963

a belly a belly band bandaround arounda portion a portion of the of the sterile sterile wrap, wrap, the the bellybelly band band including including an an instruction/procedural indicator or instructions/procedural indicators regarding how to properly instruction/procedural indicator or instructions/procedural indicators regarding how to properly

orient the catheterization tray prior to opening the sterile wrap. In addition, the method may orient the catheterization tray prior to opening the sterile wrap. In addition, the method may

include adding a peri-care kit to the catheterization tray outside the belly band and sterile wrap, include adding a peri-care kit to the catheterization tray outside the belly band and sterile wrap,

the peri-care kit including a baggy with a zipper holding cleansing towelettes, hand sanitizer, the peri-care kit including a baggy with a zipper holding cleansing towelettes, hand sanitizer,

and instructions/procedural and instructions/procedural indicators indicators for for cleansing cleansingthe thepatient. patient. TheThe method method may include may include

adding aa document adding document ofof detailedcatheterization detailed catheterizationinstructions instructions and/or and/or procedural procedural indicators indicators to to the the catheterization package. catheterization Also, the package. Also, the method mayinclude method may includeplacing placinga apackaging packaging labelonontop label topofofthe the catheterization package, the packaging label including at least three side portions folded from catheterization package, the packaging label including at least three side portions folded from

the top the portion, and/or top portion, placing aa packaging and/or placing packaginglabel labelonontop topofofthethecatheterization catheterizationpackage, package,thethe packaginglabel packaging label including includingananinformation informationfeature featureororinformation informationfeatures featuresthat that each each emphasize emphasize one or more key features of the catheterization package in a way that is easy to read quickly. one or more key features of the catheterization package in a way that is easy to read quickly.

The information The informationfeature featureororinformation information features features maymay beinformation be an an information squaresquare or multiple or multiple

information squares. information squares. The Themethod methodmaymay alsoalso include include sealing sealing (e.g.,bybyheat (e.g., heatsealing) sealing) aa transparent transparent

plastic bag around the catheterization package. plastic bag around the catheterization package.

[0028]

[0028] In some embodiments, In some embodiments,a catheterization a catheterization system system includes includes aa container container for for securing components securing componentsfor fora acatheterization catheterization procedure. procedure. The Thecontainer containerhas hasananouter outershell shell defining defining

a general a general shape of the shape of the container container and a plurality and a plurality of ofcompartments withinthe compartments within the outer outer shell. shell. Each Each of the of the plurality pluralityof ofcompartments is separated compartments is separated from oneoror more from one moreadjacent adjacentcompartments compartments of the of the

plurality of plurality ofcompartments byone compartments by oneorormore morepartitions. partitions. The Theplurality plurality of of compartments compartments include include a a first compartment first sizedandand compartment sized configured configured to contain to contain a catheter a catheter assembly assembly and oneand one or more or more secondarycompartments secondary compartments separated separated from from the the first first compartment compartment by one by the the or onemore or more partitions. partitions.

At least At least one one of of the the one one or or more secondarycompartments more secondary compartments includes includes at at leastone least onepartial partial partition partition (e.g., a partition that includes a reduced height portion) of the one or more partitions. (e.g., a partition that includes a reduced height portion) of the one or more partitions.

[0029]

[0029] In some In embodiments, some embodiments, a catheterizationsystem a catheterization systemfor forperforming performinga acatheterization catheterization procedureisis provided. procedure provided. The Thecatheterization catheterizationsystem systemincludes includes a catheterizationtray a catheterization traythat that has has anan

-9-

outer shell defining a general shape of the container and a plurality of compartments within the 2023203963 23 Jun 2023

outer shell defining a general shape of the container and a plurality of compartments within the

outer shell. outer shell. Each Eachofofthe theplurality plurality of of compartments compartments is is separated separated from from one one or more or more adjacent adjacent

compartmentsof of compartments theplurality the pluralityofofcompartments compartments by one by one or more or more partitions. partitions. The plurality The plurality of of compartmentsmay compartments may include include a firstcompartment a first compartment containing containing a catheterassembly a catheter assemblyandand oneone or or more more

secondarycompartments secondary compartments separated separated from from the the first first compartment compartment by one by the the or onemore or more partitions. partitions.

At least At least one one of ofthe the one oneorormore more secondary secondary compartments compartments may include may include at leastatone least one partial partial 2023203963

partition (e.g., a partition that includes a reduced height portion) of the one or more partitions. partition (e.g., a partition that includes a reduced height portion) of the one or more partitions.

Additionally, the Additionally, the catheterization catheterization system systemincludes includesoneone or or more more swabsswabs located located in a second in a second

compartmentofofthe compartment theone oneorormore more secondary secondary compartments. compartments.

DRAWINGS DRAWINGS

[0030]

[0030] The disclosed The disclosed embodiments embodiments of,of, andenhancements and enhancements for,for, packages, packages, trays,devices, trays, devices, systems and systems andmethods methods can can be better be better understood understood with reference with reference to the to the following following drawings. drawings.

Portions of the Portions of the material material in in this thispatent patentdocument are subject document are subject to to copyright copyright protection protection under under the the

copyright laws copyright laws of of the the United States and United States and of of other other countries. countries. The Theowner ownerofofthe thecopyright copyrightrights rights has no has no objection objection to to the the facsimile facsimile reproduction reproduction by by anyone ofthe anyone of the patent patent document documentororthe thepatent patent disclosure, as disclosure, as ititappears appearsin inthe theUnited United States StatesPatent Patentand and Trademark Officepublicly Trademark Office publiclyavailable available file or records, but otherwise reserves all copyright rights whatsoever. file or records, but otherwise reserves all copyright rights whatsoever.

[0031]

[0031] FIG. 11 shows FIG. shows a top a top view view of a of a medical medical procedure procedure tray including tray including integrated integrated

instructions/procedural indicators in the form of a catheterization tray. instructions/procedural indicators in the form of a catheterization tray.

[0032]

[0032] FIG. 22 shows FIG. showsa atop, top, front front (or (or proximal), proximal), right right perspective perspective view of the view of the medical medical procedure tray of FIG. 1. procedure tray of FIG. 1.

[0033]

[0033] FIG. 33 shows FIG. showsa aright right side side elevation elevation view of the view of the medical proceduretray medical procedure trayofofFIG. FIG. 1. 1.

[0034]

[0034] FIG. 44 shows FIG. showsa aback back (or(or distal)side distal) sideelevation elevationview viewofofthe themedical medicalprocedure procedure tray of FIG. 1. tray of FIG. 1.

[0035]

[0035] FIG. 55 shows FIG. showsaatop top view viewofofanother anothermedical medicalprocedure proceduretray trayincluding includingintegrated integrated instructions/procedural indicators in the form of a catheterization tray that is larger than the instructions/procedural indicators in the form of a catheterization tray that is larger than the

tray in FIG. 1. tray in FIG. 1.

-10-

Jun 2023

[0036]

[0036] FIG. 6A FIG. 6Ashows shows a top a top view view of aofswab a swab or swabstick or swabstick that that may may be be included included in a in a catheterization package and/or tray. catheterization package and/or tray.

[0037]

[0037] FIG. 6B FIG. 6Bshows showsa aside sideperspective perspectiveview viewofofthe theswab swabororswabstick swabstick inin FIG.6A.6A. FIG.

2023203963 23

[0038]

[0038] FIG. 6C FIG. 6Cshows showsan an endend view view of the of the swab swab or swabstick or swabstick in FIG. in FIG. 6A to6A to the show show the cross-sectional shape cross-sectional shape of of the the elongate elongate member member ororstick. stick. 2023203963

[0039]

[0039] FIG. 7A FIG. 7Ashows shows a top a top view view of aofswab a swab or swabstick or swabstick that that may may be be included included in a in a catheterization package and/or tray. catheterization package and/or tray.

[0040]

[0040] FIG. 7B FIG. 7Bshows showsa aside sideperspective perspectiveview viewofofthe theswab swabororswabstick swabstick inin FIG.7A.7A. FIG.

[0041]

[0041] FIG. 7C FIG. 7Cshows showsan an endend view view of the of the swab swab or swabstick or swabstick in FIG. in FIG. 7A to7A to the show show the cross-sectional shape of the elongate member or stick, the cross-sectional shape being different cross-sectional shape of the elongate member or stick, the cross-sectional shape being different

from that from that shown shownininFIG. FIG.6C. 6C.

[0042]

[0042] FIG. 88 shows FIG. showsa atop top view viewofofaaswab swabcompartment compartmentand and small small storage storage or overflow or overflow

compartmentof of compartment a catheterizationtray a catheterization trayincluding includingswabs swabs or or swabsticks swabsticks similar similar to the to the swab swab or or swabstick shown swabstick shownininFIGS. FIGS.7A-7C, 7A-7C, wherein wherein one one swabswab or swabstick or swabstick is rotated is rotated approximately approximately 90° 90° to release to release ititfrom fromthe thesecurement securement features featuresof ofthe theswab swab compartment. compartment.

[0043]

[0043] FIG. 99 shows FIG. showsaatop top view viewofofaa catheterization catheterization package sealed in package sealed in aa sealed sealed bag bag and and

having aa packaging having packaginglabel labelwith withinformation information squares squares on on a top a top andand two two sides sides thereof, thereof, the the sides sides

providing for providing for easy easyviewing viewing even even if the if the catheterization catheterization package package were were in a of in a stack stack of other other catheterization packages. catheterization packages.

[0044]

[0044] FIG. 10 FIG. 10 shows showsa atop, top, front front perspective perspective view viewof of another anothercatheterization catheterization package package

(different from that shown in FIG. 9) sealed in a sealed bag and having a packaging label with (different from that shown in FIG. 9) sealed in a sealed bag and having a packaging label with

information squares information squaresonona atop topand andtwotwo sides sides thereof thereof (one (one side side of of which which is visible),thethesides is visible), sides providing for providing for easy easyviewing viewing even even if the if the catheterization catheterization package package were were in a of in a stack stack of other other catheterization packages. catheterization packages.

[0045]

[0045] FIG. 11 FIG. 11 shows showsa atop topview view of of thethe catheterizationpackage catheterization package of of FIG. FIG. 9 outside 9 outside of of the sealed bag, but still having the same packaging label thereon. the sealed bag, but still having the same packaging label thereon.

[0046]

[0046] FIG. 12 shows a top, flattened view of the packaging label of the catheterization FIG. 12 shows a top, flattened view of the packaging label of the catheterization

packageofofFIG. package FIG.1010including includinglines lines added addedtoto show showwhere wherethethe sidesmay sides may be be folded folded when when placed placed

-11-

over other components of a catheterization package prior to sealing the catheterization package 2023203963 23 Jun 2023

over other components of a catheterization package prior to sealing the catheterization package

in a sealed bag. in a sealed bag.

[0047]

[0047] FIG. 1313shows FIG. shows a view a top top view of a catheterization of a catheterization packagepackage (e.g., the (e.g., either either the catheterization package catheterization of FIG. package of FIG. 99ororFIG. FIG.10) 10)after afterthe the sealed sealed bag bagand andpackaging packaging label label have have

been removed, been removed,and andshowing showing detailed detailed instructions/proceduralindicators instructions/procedural indicatorsdocument documentor or directions directions

for use for use (DFU) document (DFU) document thereon. thereon. 2023203963

[0048]

[0048] FIG. 14A FIG. 14A shows showsa page a page of document of a a document of detailed of detailed catheterization catheterization instructions/procedural indicators instructions/procedural indicators or or directions directionsfor foruse use(DFU) (DFU) document that may document that maybebeincluded included in a catheterization package. in a catheterization package.

[0049]

[0049] FIG. 14B FIG. 14Bshows shows another another page page of theofdocument the document of detailed of detailed catheterization catheterization

instructions/procedural indicators instructions/procedural indicators or ordirections directionsfor useuse(DFU) for (DFU) document ofFIG. document of FIG. 14A. 14 A.

[0050]

[0050] FIG. 14C FIG. 14Cshows shows another another page page of theofdocument the document of detailed of detailed catheterization catheterization

[0051]

[0051] FIG. 14D FIG. 14Dshows shows another another page page of theofdocument the document of detailed of detailed catheterization catheterization

[0052]

[0052] FIG. 15A FIG. 15Ashows shows a frontside a front sideofofaapatient patient education education information informationsheet/pamphlet sheet/pamphlet that may be included in a catheterization package. that may be included in a catheterization package.

[0053]

[0053] FIG. 15B FIG. 15Bshows showsa aback backside sideofofthe the patient patient education education information sheet/pamphlet information sheet/pamphlet

of FIG. of 15 A. FIG. 15A.

[0054]

[0054] FIG. 16 FIG. 16 shows showsa atop topview viewofofthe the catheterization catheterization package ofFIG. package of FIG. 1313 without withoutthe the detailed instructions/procedural detailed instructions/procedural indicators indicators document document orordirections directionsfor foruse use(DFU) (DFU) document, document,

and showing a label or insert sheet thereon. and showing a label or insert sheet thereon.

[0055]

[0055] FIG. 1717shows FIG. shows a top a top view view of aof a catheterization catheterization package package (e.g., (e.g., similar similar to to the the catheterization package catheterization of FIG. package of FIG. 16) 16)without withoutthe thelabel label oror insert insert sheet, sheet, and and showing showing a aperineal perineal care or peri-care kit/packet thereon. care or peri-care kit/packet thereon.

[0056]

[0056] FIG. 1818shows FIG. shows a top a top view view of aof a catheterization catheterization package package (e.g., (e.g., similar similar to to the the catheterization package catheterization ofFIG. package of FIG.16) 16)without withoutthethelabel labelororinsert insertsheet, sheet, and andshowing showing another, another,

different perineal care or peri-care kit/packet thereon. different perineal care or peri-care kit/packet thereon.

-12-

10057] FIG. 19 19 shows showsa aseparated separatedview viewofofthe thecomponents componentsof of theperineal perinealcare care(or (or peri- peri- 2023203963 23 Jun 2023

[0057] FIG. the

care) kit or packet of FIG. 18. care) kit or packet of FIG. 18.

[0058]

[0058] FIG. 20 FIG. 20shows shows a top a top view view of aof a catheterization catheterization package package (e.g., (e.g., similar similar to to the the catheterization package catheterization of FIG. package of FIG. 1717ororFIG. FIG.18) 18)without withoutthe theperineal perinealcare care(or (orperi-care) peri-care) kit kit or or packet, and packet, showinga abelly and showing belly band bandincluding includinginstructions/procedural instructions/proceduralindicators indicators thereon. thereon. 2023203963

[0059]

[0059] FIG. 2121shows FIG. shows a top a top view view of aof a catheterization catheterization package package (e.g., (e.g., similar similar to to the the catheterization package catheterization of FIG. package of 20 or FIG. 20 or FIG. 21) without FIG. 21) without the the belly belly band, band, and showingthe and showing thesterile sterile wrap only partially folded/wrapped around a catheterization tray. wrap only partially folded/wrapped around a catheterization tray.

[0060]

[0060] FIG. 22 FIG. 22shows showsa top a topview view of of thethe catheterizationpackage catheterization package of FIG. of FIG. 22 with 22 with the the sterile wrap sterile completelyunfolded wrap completely unfolded but but remaining remaining underneath underneath the catheterization the catheterization tray, tray, and and showingthe showing thecontents contents of of the the catheterization catheterization tray traybefore beforeany anycomponents havebeen components have beenremoved removedor,or,

during manufacture/packaging, after all the components to be within the sterile wrap have been during manufacture/packaging, after all the components to be within the sterile wrap have been

placed therein. placed therein.

[0061]

[0061] FIG. 23 FIG. 23shows shows a top a top view view of the of the catheterization catheterization package package of FIG. of FIG. 23 awith 23 with a package of sterile gloves partially unfolded and sitting on top of the catheterization tray. package of sterile gloves partially unfolded and sitting on top of the catheterization tray.

[0062]

[0062] FIG. 24 FIG. 24 shows showsa atop topview viewofofthe thecatheterization catheterization package ofFIG. package of FIG. 24 24without withoutthe the packageofofsterile package sterile gloves, gloves, and and revealing revealing aa pad/drape (representative of pad/drape (representative of aawaterproof waterproof underpad underpad

and/or a fenestrated drape) sitting on top of the catheterization tray. and/or a fenestrated drape) sitting on top of the catheterization tray.

[0063]

[0063] FIG. 25 FIG. 25 shows showsa top a topview view of of thethe catheterizationpackage catheterization package of FIG. of FIG. 25 with 25 with the the pad/drape moved pad/drape off the moved off the swab swabcompartment, compartment,and andrevealing revealinga apacket packetofofpovidone-iodine povidone-iodine solution sitting solution sitting ininthe theswab compartmentandand swab compartment extending extending overover the the small small storage storage or overflow or overflow

compartment of the catheterization tray. compartment of the catheterization tray.

[0064]

[0064] FIG. 26 FIG. 26 shows showsa atop topview viewofofthe thecatheterization catheterization package ofFIG. package of FIG.26 26without withoutthe the povidone-iodinesolution, povidone-iodine solution, and and revealing revealing the the swabs or swabsticks swabs or in the swabsticks in the swab swab compartment with compartment with

the proximal the endsofofthe proximal ends the sticks sticks extending overthe extending over the small small storage storage or or overflow overflowcompartment compartmentof of the catheterization tray. the catheterization tray.

[0065]

[0065] FIG. 27 FIG. 27shows showsa top a topview view of of thethe catheterizationpackage catheterization package of FIG. of FIG. 27 with 27 with the the syringe of sterile liquid attached to the inflation port of the catheter. syringe of sterile liquid attached to the inflation port of the catheter.

-13-

[0066] FIG. 28 shows a top view of the catheterization package of FIG. 28 with a distal 2023203963 23 Jun 2023

[0066] FIG. 28 shows a top view of the catheterization package of FIG. 28 with a distal

portion of portion of the the catheter catheter positioned positioned in in the the syringe syringe or or catheter catheter compartment andthethesyringe compartment and syringeofof lubricating jelly adjacent to syringe or catheter compartment ready to dispense the lubricating lubricating jelly adjacent to syringe or catheter compartment ready to dispense the lubricating

jelly on top of the distal region or distal end of the catheter. jelly on top of the distal region or distal end of the catheter.

[0067]

[0067] FIG. 29 FIG. 29shows showsa atoptopview view of of thethe catheterizationpackage catheterization package of of FIG. FIG. 29 after 29 after thethe

catheter has catheter has been removed been removed from from thethe tray tray andand inserted inserted in in a patient,with a patient, with thethe drainage drainage tubing tubing 2023203963

extending in the direction of the patient. extending in the direction of the patient.

[0068]

[0068] FIG. 30A is a top view of a catheterization system; FIG. 30A is a top view of a catheterization system;

[0069]

[0069] FIG. SOB is a top view of a catheterization tray of the catheterization system of FIG. 30B is a top view of a catheterization tray of the catheterization system of

FIG. 30A, FIG. 30A,which whichisiswrapped wrappedin in a awrap; wrap;

[0070]

[0070] FIG. 31A is an isometric view of a catheterization tray with contents thereof; FIG. 31A is an isometric view of a catheterization tray with contents thereof;

[0071]

[0071] FIG. 31B FIG. 3 IBisis an an isometric isometric view of the view of the catheterization catheterizationtray trayofof FIG. 31A FIG. 31Awith withsome some

of the of the contents contents thereof thereofremoved therefrom; removed therefrom;

[0072]

[0072] FIG. 31C FIG. 31Cisis aa back back isometric isometric view viewofofthe the catheterization catheterization tray tray of ofFIG. FIG. 31 A; 31A;

[0073]

[0073] FIG. 32 FIG. 32isis aa top top view viewofofthe thecatheterization catheterizationtray tray of ofFIG. FIG.31A 31A with with allall of of the the

contents thereof contents thereof removed therefrom; removed therefrom;

[0074]

[0074] FIG. 33 is a top view of a catheterization system; FIG. 33 is a top view of a catheterization system;

[0075]

[0075] FIG. 34 is a top view of a fenestrated drape; FIG. 34 is a top view of a fenestrated drape;

[0076]

[0076] FIG. 35 FIG. 35 is is an an isometric isometric view of aa swab; view of swab;

[0077]

[0077] FIG. 36A FIG. 36Aisis an an isometric isometric view viewofofaa catheterization catheterization system; system;

[0078]

[0078] FIG. 36B FIG. 36Bisisananisometric isometricview viewof of a catheterizationtray a catheterization trayofofthe thecatheterization catheterization system of system of FIG. FIG. 36A; 3 6A;

[0079]

[0079] FIG. 37A FIG. 37Aisis an an isometric isometric view viewofofaa catheterization catheterization system; system;

[0080]

[0080] FIG. 37B is an isometric view of a partially unfolded catheterization tray of the FIG. 37B is an isometric view of a partially unfolded catheterization tray of the

catheterization system catheterization system of of FIG. FIG. 37A; and 37A; and

-14-

[0081] FIG. 37Cis is a partial isometric viewview of theof the unfolded catheterization tray of the 2023203963 23 Jun 2023

[0081] FIG. 37C a partial isometric unfolded catheterization tray of the

catheterization system catheterization system of of FIG. FIG. 37A. 37A.

[0082]

[0082] FIG. 38A FIG. 38Ashows shows a view a view of of another another medical-procedure medical-procedure tray tray in accordance in accordance with with some embodiments. some embodiments.

[0083]

[0083] FIG. 38B FIG. 38Bshows shows another another view view of of thethe medical-procedure medical-procedure traytray of of FIG. FIG. 3 8 A. 38A. 2023203963

[0084]

[0084] FIG. 38C FIG. 38C shows showsanother anotherview viewofofthe themedical-procedure medical-procedure tray tray of of FIG. FIG. 38A 38A together with a cover. together with a cover.

[0085]

[0085] FIG. 38D shows FIG. 38D showsanother anotherview viewofofthe themedical-procedure medical-procedure tray tray of of FIG. FIG. 38A 38A together with a cover. together with a cover.

[0086]

[0086] FIG. 39A FIG. 39Ashows shows a view a view of of another another medical-procedure medical-procedure tray tray in accordance in accordance with with some embodiments. some embodiments.

[0087]

[0087] FIG. 39B FIG. 39Bshows shows another another view view of of thethe medical-procedure medical-procedure traytray of of FIG. FIG. 39A. 39A.

[0088]

[0088] FIG. 39C FIG. 39Cshows shows a view a view of a of a medical-procedure medical-procedure tray including tray including a number a number of of retainers ininaafirst retainers configuration first in accordance configuration with in accordance some with someembodiments. embodiments.

[0089]

[0089] FIG. 39D FIG. 39Dshows shows a view a view of a of a medical-procedure medical-procedure tray including tray including a number a number of of retainers inina asecond retainers second configuration configuration in inaccordance accordance with with some embodiments. some embodiments.

[0090]

[0090] FIG. 40A FIG. 40Ashows shows a view a view of of another another medical-procedure medical-procedure tray tray in accordance in accordance with with some embodiments. some embodiments.

[0091]

[0091] FIG. 40B FIG. 40Bshows shows another another view view of of thethe medical-procedure medical-procedure traytray of of FIG. FIG. 40A. 40A.

[0092]

[0092] FIG. 41A FIG. 41Ashows shows a view a view of of another another medical-procedure medical-procedure tray tray in accordance in accordance with with some embodiments. some embodiments.

[0093]

[0093] FIG. 41B FIG. 41Bshows shows another another view view of of thethe medical-procedure medical-procedure traytray of of FIG. FIG. 41 A. 41A.

[0094]

[0094] FIG. 41C FIG. 41Cshows shows another another view view of of thethe medical-procedure medical-procedure traytray of of FIG. FIG. 41 A. 41A.

[0095]

[0095] FIG. 42A FIG. 42Ashows shows a view a view of of another another medical-procedure medical-procedure tray tray in accordance in accordance with with some embodiments. some embodiments.

-15-

Jun 2023

[0096]

[0096] FIGS. 42B FIGS. 42Bandand 42C42C showshow otherother viewsviews of theofmedical-procedure the medical-procedure tray oftray FIG.of FIG. 42A. 42A.

[0097]

[0097] FIG. 43 FIG. 43 shows showsa view a view of of another another medical-procedure medical-procedure tray tray in accordance in accordance with with 2023203963 23

some embodiments. some embodiments.

[0098]

[0098] FIG. 44A FIG. 44Ashows shows a view a view of aof a removable removable retainer retainer on a on a partition partition or a or a side side of a of a 2023203963

medical-procedure trayinin accordance medical-procedure tray accordancewith withsome some embodiments. embodiments.

[0099]

[0099] FIG. 44B FIG. 44Bshows showsanother another view view of of a removable a removable retainer retainer on on a partitionororaa side a partition side of of a medical-procedure a medical-proceduretray traywith with a concealed a concealed tabinstructions tab of of instructions in accordance in accordance with with some some embodiments. embodiments.

[0100]

[0100] FIG. 44C FIG. 44Cshows shows another another view view of of a removable a removable retainer retainer on on a partitionororaa side a partition side of of a medical-procedure a medical-proceduretray tray with with a revealed a revealed tabinstructions tab of of instructions in accordance in accordance with with some some embodiments. embodiments.

[0101]

[0101] FIG. 45 FIG. 45 shows showsa view a view of of an an appendage-type appendage-type retainer retainer on a on a side side of a of a medical- medical-

proceduretray procedure tray in in accordance withsome accordance with someembodiments. embodiments.

[0102]

[0102] Whilethe While theinvention inventionis issusceptible susceptibleto tovarious various modifications modifications and and alternative alternative

forms, specific forms, specific embodiments thereofhave embodiments thereof havebeen beenshown shown by by wayway of example of example in drawings in the the drawings and and are herein described in detail. It should be understood, however, that the description herein of are herein described in detail. It should be understood, however, that the description herein of

specific embodiments is not intended to limit the invention to the particular forms disclosed, specific embodiments is not intended to limit the invention to the particular forms disclosed,

but rather the intention is to cover all modifications, equivalents, and alternatives falling within but rather the intention is to cover all modifications, equivalents, and alternatives falling within

the spirit and scope of the invention as defined by the appended claims. the spirit and scope of the invention as defined by the appended claims.

DESCRIPTION DESCRIPTION

[0103]

[0103] The following The followingdescription description and andaccompanying accompanying figures,which figures, which describe describe andand show show

certain embodiments, certain aremade embodiments, are made to demonstrate, to demonstrate, in a in a non-limiting non-limiting manner, manner, several several possible possible

configurations ofofmedical configurations medicalprocedure procedure packages, packages, medical medical procedure procedure trays, catheterization trays, catheterization

packages, catheterization packages, catheterization trays, trays, and and associated associated components, assemblies, and components, assemblies, andsystems, systems,etc. etc. and and various methods various ofmanufacturing methods of manufacturingand andmethods methods of of using using these these according according to to variousaspects various aspectsand and features of the present disclosure. features of the present disclosure.

[0104]

[0104] Various packages,kits, Various packages, kits, trays, trays, systems, systems, assemblies, assemblies, devices, devices, and andmethods methods are are

described herein, described herein, including including those those used in various used in various medical procedures(including, medical procedures (including, for for example, example,

-16-

Jun 2023 catheterization procedures). catheterization While procedures). While specific specific embodiments embodiments are described are described hereinherein by way by of way of example, the example, the embodiments embodimentsandand examples examples described described are are not not intended intended to betolimiting. be limiting. Accordingly,while Accordingly, whileaspects aspectsof of thethe invention invention may may be described, be described, for example, for example, inofterms in terms of catheterization packages, catheterization trays, catheterization procedures, etc. disclosure is not catheterization packages, catheterization trays, catheterization procedures, etc. disclosure is not 2023203963 23

limited to catheterization-related packages, trays, systems/assemblies, procedures, etc. Rather, limited to catheterization-related packages, trays, systems/assemblies, procedures, etc. Rather,

the inventive the inventive principles principles associated associated with with the the embodiments describedherein, embodiments described herein,may maybebe applied applied to to 2023203963

other embodiments other and embodiments and other other types types of of packages, packages, trays,systems/assemblies, trays, systems/assemblies, devices,methods, devices, methods, etc. etc.

[0105]

[0105] According to According to various various embodiments, embodiments,the theobjectives objectives described described above aboveandand elsewhereherein elsewhere hereinmay maybebeaccomplished accomplished by by providing providing an improved an improved medical medical procedure procedure package package

or kit including a medical procedure tray, for example, with a more intuitive or better organized or kit including a medical procedure tray, for example, with a more intuitive or better organized

layout, instructions/procedural layout, instructions/procedural indicators indicatorsincluded included on on the thetray, etc. tray, ForForexample, etc. example,an animproved improved

catheterization package catheterization or kit package or kit may be provided may be providedtotoimprove improveease easeofofuse, use,improve improve adherence adherence to to proper techniques, reduce the likelihood of infection, etc. proper techniques, reduce the likelihood of infection, etc.

[0106]

[0106] In accordance In withvarious accordance with variousembodiments, embodiments,thethe medical medical procedure procedure package package may may include aa medical include medicalprocedure proceduretray traytherein. therein. The The medical medical procedure procedure package package mayinclude may also also include any other any other components componentsnecessary necessary or or helpfultotothe helpful themedical medicalprocedure. procedure. TheThe medical medical procedure procedure

tray(s) contemplated tray(s) herein may contemplated herein maybebea asingle singlelevel leveltray trayororhave havemultiple multiplelevels. levels. The The medical medical

proceduretray(s) procedure tray(s) may mayhave havea avariety varietyofofshapes shapesand andsizes. sizes. For Forexample, example, a medical a medical procedure procedure

tray may tray mayhave have a generally a generally or approximately or approximately rectangular, rectangular, square, square, circular, circular, oval, oval, triangle, triangle,

hexagonal, polygon, hexagonal, polygon,or orother other shape. shape. As a As a non-limiting non-limiting example, example, a generally a generally rectangular rectangular

medical procedure medical proceduretray traymay mayhave have a length a length in in therange the rangefrom from 7 inches 7 inches to to 2020 inches,a width inches, a width in in

the range from 4 inches to 12 inches, and a height in the range from 1 inch to 4 inches. In one the range from 4 inches to 12 inches, and a height in the range from 1 inch to 4 inches. In one

embodiment, a generally rectangular medical procedure tray (e.g., a catheterization tray similar embodiment, a generally rectangular medical procedure tray (e.g., a catheterization tray similar

to that to that shown shownininFIGS. FIGS. 1-4)1-4) may may have have a length a length of approximately of approximately 11 ainches, 11 inches, a width of width of approximately8.5 approximately 8.5inches, inches,and anda height a height of of approximately approximately 2 inches. 2 inches. In oneInembodiment, one embodiment, a a generally rectangular medical procedure tray (e.g., similar to the tray shown in FIGS. 5, 31A- generally rectangular medical procedure tray (e.g., similar to the tray shown in FIGS. 5, 31A-

31C, &&32) 31C, 32)may mayhave havea alength lengthofofapproximately approximately1414inches, inches,a awidth widthofofapproximately approximately8.5 8.5inches, inches, and aa height and height of of approximately 2.5 inches. approximately 2.5 inches.

[0107]

[0107] Themedical The medicalprocedure procedure tray(s) tray(s) maymay also also include include multiple multiple sections sections having having a a variety of variety of shapes shapes and andsizes, sizes, any anyofofwhich whichsections sectionscancan optionally optionally form form a compartment. a compartment. A A section of the medical procedure tray can be designated for one or more particular uses (e.g., section of the medical procedure tray can be designated for one or more particular uses (e.g.,

-17-

Jun 2023 well for well for iodine, iodine, section section for for storage, storage, etc.), etc.),whereas whereas a a compartment can compartment can be be a section a section at at least least

partially and partially and up to wholly up to whollyseparated separatedfrom from oneone or more or more otherother sections, sections, compartments, compartments, or a or a combinationthereof combination thereofbybya aphysical physicalfeature featuresuch suchasasone oneorormore more partitions.TheThe partitions. partitionscan partitions can be formed be formedfrom fromthethemedical medical procedure procedure traytray itself itself (e.g.,formed (e.g., formed during during an an injection injection molding molding 2023203963 23

process), and process), andopposing opposing faces faces of partitions of the the partitions canunequal can be be unequal in ifheight in height if separating separating

compartments from compartments fromother other sections sections or or compartments compartmentshaving havingbottoms bottomsofofhigher higherororlower lower 2023203963

elevations. Partitions elevations. Partitions can can be be separately separatelyformed formed from a same from a material as same material as the the medical procedure medical procedure

tray or tray or aa different different material material than thanthe themedical medicalprocedure procedure tray. tray. The partitions The partitions can be can also also be transiently formed transiently fromany formed from anyone oneorormore moreof of theother the othercomponents components necessary necessary or helpful or helpful to the to the

medical procedure medical procedure- -until until the the any any one oneoror more moreofofthe theother othercomponents componentsareare removed removed fromfrom the the medical procedure medical proceduretray. tray.ForFor example, example, withwith respect respect to components to components necessary necessary or helpful or helpful to to catheterization, the one or more partitions can be transiently formed from a specimen or sample catheterization, the one or more partitions can be transiently formed from a specimen or sample

container, instructions/procedural container, instructions/procedural indicators, indicators, or other components or other components necessary necessary or helpful or helpful to to catheterization described catheterization herein. Like described herein. Likethe thesections, sections, the the compartments compartments cancan have have a variety a variety of of shapes and sizes (e.g., the compartments may be of any of the shapes described for the medical shapes and sizes (e.g., the compartments may be of any of the shapes described for the medical

procedure tray itself or of other shapes). procedure tray itself or of other shapes).

[0108]

[0108] In accordance In withvarious accordance with variousembodiments, embodiments,thethe medical medical procedure procedure package package may may be aa catheterization be catheterization package packagethat thatincludes includesoneone or or more more catheterization catheterization trays trays therein. therein. For For example,aa catheterization example, catheterization package mayinclude package may includeananimproved improved catheterization catheterization tray tray with with a more a more

intuitive or intuitive or better betterorganized organized layout layout and/or and/or instructions/procedural instructions/procedural indicators indicators included included on on the the

tray. While tray. variousfeatures While various features are are described described below belowininterms termsofofaa catheterization catheterization package and/or package and/or

catheterization tray, catheterization tray, the the features features described mayalso described may alsobebeincluded included in in or or applied applied to medical to medical

procedurepackages procedure packagesand/or and/ortrays traysused usedfor forprocedures proceduresother otherthan thancatheterization. catheterization.

[0109]

[0109] The catheterization The catheterization package mayinclude package may includeanyany components components necessary necessary or helpful or helpful

to catheterization. to Somecomponents catheterization. Some components helpful helpful to catheterization to catheterization that that maymay be included be included in in the the catheterization package include a drainage system, a drainage/collection bag, drainage tubing, catheterization package include a drainage system, a drainage/collection bag, drainage tubing,

a catheter (e.g., a Foley catheter), a drainage outlet, a stabilization device (e.g., C. R. Bard, a catheter (e.g., a Foley catheter), a drainage outlet, a stabilization device (e.g., C. R. Bard,

Inc.'s StatLock® Foley stabilization device), a urine meter, swabs or swabsticks, prepping balls Inc.'s StatLock® Foley stabilization device), a urine meter, swabs or swabsticks, prepping balls

(e.g., absorbent cotton balls), forceps, a specimen or sample container, a label that can be filled (e.g., absorbent cotton balls), forceps, a specimen or sample container, a label that can be filled

out with details regarding the sample and adhered to the specimen or sample container, a packet out with details regarding the sample and adhered to the specimen or sample container, a packet

or container or container of of an anantiseptic antiseptic skin skin cleanser cleanser(e.g., (e.g., aa packet packetororcontainer containerofofpovidone-iodine povidone-iodine solution), a packet or container of lubricant (e.g., a syringe of lubricating jelly), a syringe of solution), a packet or container of lubricant (e.g., a syringe of lubricating jelly), a syringe of

-18-

sterile liquid (e.g., a lOcc syringe of sterile water for inflating the retention balloon of the Foley 2023203963 23 Jun 2023

sterile liquid (e.g., a 10cc syringe of sterile water for inflating the retention balloon of the Foley

catheter), a fenestrated drape to place on patient, an underpad to place under the buttocks of a catheter), a fenestrated drape to place on patient, an underpad to place under the buttocks of a

patient (e.g., a waterproof absorbent underpad), gloves (e.g., a package of rubber gloves, latex patient (e.g., a waterproof absorbent underpad), gloves (e.g., a package of rubber gloves, latex

gloves, latex-free gloves, latex-free gloves), gloves), aa sterile sterilewrap wrap (e.g., (e.g.,a aCSR CSR wrap), wrap), aa belly belly band band(e.g., (e.g., to to hold hold the the

sterile wrap in a folded configuration), a perineal care packet, hand sanitizer (e.g., antiseptic sterile wrap in a folded configuration), a perineal care packet, hand sanitizer (e.g., antiseptic

gel hand gel handrinse), rinse), moist moisttowelettes towelettes(e.g., (e.g.,a package a package of castile of castile soap towelettes), soap towelettes), 2023203963

instructions/procedural indicators instructions/procedural indicators (e.g., (e.g., instruction instruction sheet sheet for for health healthcare careprovider provider and/or and/or

instruction pamphlet instruction pamphletforforpatient), patient),a checklist a checklist of safety of safety considerations/steps, considerations/steps, a patient a patient

information chart, an insert sheet, a packaging label, an outer container (e.g., a sealed bag), information chart, an insert sheet, a packaging label, an outer container (e.g., a sealed bag),

and/or other and/or other components. components.TheThe components components included included in thein the catheterization catheterization package package may be may be included in included in one or more one or compartments more compartments of of thethecatheterization catheterizationtray, tray, in in aa separate separatepackage package or or bag bag

(e.g., a package outside the tray), or in a second catheterization tray. (e.g., a package outside the tray), or in a second catheterization tray.

[0110]

[0110] The catheterization The catheterization tray(s) tray(s)may be labeled may be labeled with with step-wise step-wise instructions/procedural indicators instructions/procedural indicators arranged arranged in logical in logical locations locations on theontray(s). the tray(s). The The catheterization tray(s) catheterization tray(s)may may have a layout have a layout and design that and design that makes the catheterization makes the catheterization procedure procedure moreintuitive. more intuitive. A A single-level single-level catheterization catheterization tray tray having having a generally a generally rectangular rectangular shape, shape,

including multiple including multiple compartments compartments of of varying varying shapes, shapes, including including step-wise step-wise instructions/procedural indicators, instructions/procedural indicators, and and having an improved having an improvedlayout layoutisisshown, shown, forfor example, example, in in FIGS. 1-4 FIGS. 1-4and anddescribed describedbelow. below.Other Other similar similar single-level single-level catheterizationtrays catheterization traysare areshown shownin in

FIGS. 5,5, 31A-31C, FIGS. 31A-31C,& & 32 32 as as well. well.

[0111]

[0111] Accordingtotovarious According variousembodiments embodimentsand and as shown, as shown, for example, for example, in FIGS. in FIGS. 1-5, 1-5, the catheterization the catheterizationtray traymay may include: include:a amain main compartment 1; aa syringe compartment 1; syringe or or catheter cathetercompartment compartment

2; aa swab 2; compartment swab compartment 3; 3; a small a small storage storage or or overflow overflow compartment compartment 4; and4;a and a comer corner storage storage

compartment 5. The tray also includes stiffening ribs (e.g., stiffening ribs 20 shown in FIG. 2; compartment 5. The tray also includes stiffening ribs (e.g., stiffening ribs 20 shown in FIG. 2;

see also see also stiffening stiffeningribs ribs205 205inin FIGS. FIGS.31A-31C), whichhelp 31A-31C), which helptoto strengthen strengthen the the tray tray and and keep the keep the

tray from tray bendingwhen from bending whenheld, held,e.g., e.g., when whenheld heldbybyone onehand. hand.

[0112]

[0112] Withreference With referencetotoFIGS. FIGS.1, 1,2, 2,andand 5, 5, thethe main main compartment compartment 1 islargest 1 is the the largest compartment in the tray and may contain any number of items for the catheterization procedure, compartment in the tray and may contain any number of items for the catheterization procedure,

for example, for example, aa drainage drainagesystem, system,a acollection collectionbag, bag,aadrape, drape, ananunderpad, underpad,ananinflation inflationsyringe, syringe, and/or gloves. and/or gloves. AAdrainage drainagesystem system thatmay that may be be included included in in thethe catheterizationpackage catheterization package and/or and/or

in the in the main maincompartment compartment 1 may 1 may include, include, for example, for example, a drainage/collection a drainage/collection bag, drainage bag, drainage

tubing, a catheter (e.g., a Foley catheter), a drainage outlet, a urine meter, and/or other drainage tubing, a catheter (e.g., a Foley catheter), a drainage outlet, a urine meter, and/or other drainage

-19-

system components. components.TheThe drainage system components may be pre-connected and stored in the 2023203963 23 Jun 2023

system drainage system components may be pre-connected and stored in the

catheterization package catheterization in aa pre-connected package in pre-connectedstate, state, or or the the drainage system components drainage system componentsmaymay be be stored as stored as separate separate components to be components to be assembled/connected assembled/connected later. later.

[0113]

[0113] The drainage The drainagesystem systemand andtubing tubingincluded includedininthe thecatheterization catheterization package packagemay maybebe configured and configured andarranged arrangedinin aa way waythat that helps helps improve improvedrainage drainageofofurine urinethrough throughthe thesystem systemand and tubing. For tubing. For example, example,the thetubing tubingororother other components components of of thedrainage the drainagesystem system maymay be designed be designed 2023203963

to break to break up up the the surface surface tension tension of of the thefluid fluidinin order to to order improve improvedrainage. drainage.The The drainage drainage tubing tubing

maybebeshort may shortto to accommodate accommodate lower lower bedbed profiles profiles or or maymay havehave an adjustable an adjustable length length for for various various

size beds. size Thetubing beds. The tubing or or other other drainage drainage system system components components may may have have a(e.g., a coating coating a (e.g., a lubricious coating) thereon to facilitate drainage therethrough. Optionally, the tubing or other lubricious coating) thereon to facilitate drainage therethrough. Optionally, the tubing or other

drainage system drainage systemcomponents components may may include include a superhydrophobic a superhydrophobic pattern pattern thereon thereon to facilitate to facilitate

drainage. drainage.

[0114]

[0114] Additionally, there Additionally, there are are aa range range of ofsuitable suitable durometers durometersofofthe thetubing tubingororother other drainage system drainage systemcomponents. components. However, However, for components for components thatbemay that may be in coiled coiled the in the(e.g., tray tray (e.g., drainage tubing drainage tubing and/or and/orthe the catheter), catheter), it it isisdesirable desirabletotohave havea atubing tubingdurometer durometer that that does does not not

tend to tend to hold hold aa set setshape shape at atroom room temperature. For example, temperature. For example,one onecan canexperiment experiment with with different different

durometerstoto ensure durometers ensurethat that the the durometer durometerultimately ultimatelyused usedfor forcoiled coiledcomponents components does does notnot tend tend

to leave to leave the the component component inina acoiled coiledshape shapewhen when removed removed from from the and the tray trayput andtoput to It use. use.is It is desirable, for desirable, for example, togive example, to givethe thedrainage drainage tubing tubing a durometer a durometer such that, such that, despite despite being being

packagedininthe packaged the main maincompartment compartmentin in a coiledstate, a coiled state, when whenconnected connected to to a patient,the a patient, the drainage drainage tubing does not remain coiled, but tends to straighten out to facilitate drainage. The drainage tubing does not remain coiled, but tends to straighten out to facilitate drainage. The drainage

tubing can tubing can be be made madeofofpolyvinyl polyvinylchloride chloride(PVC), (PVC), silicone, silicone, latex,Teflon, latex, Teflon,ororanother anotherpolymer polymer material. material.

[0115]

[0115] As shown As shownininFIG. FIG.1,1,sides sides8 8and and9 9ofofthe thetray tray form formtwo twoorthogonal orthogonalinner innerwalls walls of the of the main main compartment compartment 1 1and andform form a a cornerofofthe corner themain maincompartment compartment 1 where 1 where the the sides sides 8 and 8 and

9 intersect 9 intersect each each other. other. TwoTwo additional, additional, interior interior partitions partitions 10 and 10 and 12 separate 12 separate the the main main compartment1 from compartment 1 from other other compartments. compartments. The twoThe two interior interior partitions partitions 10include 10 and 12 and 12 include reduced height reduced heightportions portions 1414and and1616(with (withreduced reducedheights heightscompared compared withwith the the tray's tray's full-height full-height

partitions, inner walls, or sides). partitions, inner walls, or sides).

-20-

Jun 2023

[0116]

[0116] Also, the Also, the main compartment main compartment 1 includes 1 includes interiorfillets interior fillets 18 18 at atthe thecomers cornersformed formed

betweenthe between thefloor floor of of the the main main compartment compartment 1 1and andits itsinner inner walls. walls. Such Suchfillets fillets 18 18 may reinforce may reinforce

the comers the corners of of the the main main compartment compartment 1.1.

2023203963 23

[0117]

[0117] As shown, As shown,for forexample, example,ininFIGS. FIGS.1, 1,2,2,and and5,5, the the main maincompartment compartmentof of thethe tray tray

mayinclude may includeinstructions/procedural instructions/proceduralindicators indicatorsand/or and/orother otherinformation information integrated integrated thereon. thereon.

For example, For example,the themain maincompartment compartment may may include include a logo a logo or trademark or trademark name written name written thereon, thereon, 2023203963

e.g., "SureStep™ e.g., "SureStepM Foley Foley Tray Tray System" System" and and "BARD." The "BARD." The main main compartment compartment may may also, also, or or alternatively, include instructions/procedural indicators related to the catheterization printed or alternatively, include instructions/procedural indicators related to the catheterization printed or

otherwise included otherwise included thereon. For example, thereon. For example, the the main maincompartment compartmentmaymay include include instructions/procedural indicators for how instructions/procedural to catheterize how to catheterize aa patient patient or or instructions/procedural instructions/procedural indicators for indicators for steps steps to to take take after after catheterization. catheterization. Optionally, Optionally,the themain main compartment compartment may may include instructions/procedural include instructions/procedural indicators indicators for forproper proper Foley Foley care care and and maintenance. maintenance. AsAs shown, shown,

for example, for in FIGS. example, in FIGS.1 1and and5,5,the theinstructions/procedural instructions/proceduralindicators indicatorsintegrated integratedononthe themain main compartmentmaymay compartment include include instructions/procedural instructions/procedural indicators indicators stating, stating, "(1) "(1) Secure Secure Foley Foley withwith

StatLock®", "(2) StatLock®", "(2)position positionbag bag below below bladder", bladder", "secure "secure tubingtubing to sheets to sheets with "(3) with clip", clip", "(3) documentinsertion document insertiondate", date","(4) "(4)maintain maintainredred sealperper seal hospital hospital policy","(5) policy", "(5)assess assess need need for for

catheter routinely." catheter Theinstructions/procedural routinely." The instructions/proceduralindicators indicatorsororother otherinformation information maymay be be in in upper case letters, in bold, or otherwise called out for greater visibility to ensure the clinician upper case letters, in bold, or otherwise called out for greater visibility to ensure the clinician

reads the reads the instructions/procedural instructions/procedural indicators indicators ororother other information, information. Optionally, Optionally,

instructions/procedural indicators instructions/procedural maymaybebeprinted indicators printedoror otherwise otherwise included included on on the main the main

compartmenttotoremind compartment remind thehealth the healthcare careprovider/clinician provider/clinicianto to instruct instruct the the patient patientregarding regardinghow how

to properly care for and maintain the catheter after catheterization. The instructions/procedural to properly care for and maintain the catheter after catheterization. The instructions/procedural

indicators may indicators maybebewritten written to to help help the the health health care care provider/clinician provider/clinician remember remember to coverto cover important instructions that should be given to the patient. important instructions that should be given to the patient.

[0118]

[0118] The syringe The syringe or or catheter catheter compartment compartment 2 has an 2 has an elongated elongated shape shape and and spans spans approximately an entire length of the tray. Partitions and the inner walls of the tray contribute approximately an entire length of the tray. Partitions and the inner walls of the tray contribute

to form to the syringe form the syringeororcatheter catheter compartment compartment2. 2. Partition Partition 12 spans 12 spans between between opposing opposing inner inner walls of walls of the the tray trayand andseparates separatesthe thesyringe syringeoror catheter compartment catheter compartment22from from other othercompartments compartments

- namely, - namely,from fromthe themain main compartment compartment 1 and1 from and from the compartment the swab swab compartment 3. Theorsyringe 3. The syringe or catheter compartment catheter compartment 2 2isissized sized and andshaped shapedtotocontain containone oneorormore moresyringes syringes(e.g., (e.g., aa syringe syringe of of lubricating jelly and a syringe of sterile liquid to inflate the retention balloon) and/or a catheter, lubricating jelly and a syringe of sterile liquid to inflate the retention balloon) and/or a catheter,

such as such as aa Foley Foleycatheter. catheter. For Forexample, example, a syringe a syringe of of lubricating lubricating jellyand jelly and a syringe a syringe of of lOcc 10cc

-21-

Jun 2023 sterile water may be packaged in the syringe or catheter compartment 2, but the end user (e.g., sterile water may be packaged in the syringe or catheter compartment 2, but the end user (e.g.,

a clinician) may remove the syringes at the time of catheterization and place the catheter in the a clinician) may remove the syringes at the time of catheterization and place the catheter in the

syringe or catheter compartment 2 prior to insertion into a patient (e.g., to facilitate lubrication syringe or catheter compartment 2 prior to insertion into a patient (e.g., to facilitate lubrication

of the catheter). of the catheter). 2023203963 23

[0119]

[0119] A portion of the partition 12 separates the catheter compartment 2 from the main A portion of the partition 12 separates the catheter compartment 2 from the main

compartment 1. Some of the partition 12 has a full height (e.g., extends as high as the sides of compartment 1. Some of the partition 12 has a full height (e.g., extends as high as the sides of 2023203963

the tray), the tray),but butthe thepartition partition1212also includes also includesreduced reducedheight heightportions portions 16 16 and and 22 22 (which haveaa (which have

reduced height relative to the full height of the partition 12, inner walls, or sides of the tray). reduced height relative to the full height of the partition 12, inner walls, or sides of the tray).

Reducedheight Reduced heightportion portion1616ofofthe thepartition partition1212may mayactact asasa abreak breakororopening opening in in thethe partition, partition,

whichmay which mayplace placethe thesyringe syringeororcatheter cathetercompartment compartment 2 influid 2 in fluidcommunication communicationwithwith the the main main

compartment1 and compartment 1 and viceversa. vice versa.Along Along reduced reduced height height portion portion 16, 16, the the partition partition 12 12 maymay formform a a small step small step between thesyringe between the syringeororcatheter catheter compartment compartment 2 and 2 and thethe main main compartment compartment 1, e.g., 1, e.g.,

as shown as shown ininFIGS. FIGS.2 2andand 6 (seealso 6 (see alsoFIGS. FIGS. 31A-31C). 31A-31C). Themay The step stepalso maybealso be formed formed by the by the maincompartment main compartment 1 having 1 having a lower/deeper a lower/deeper floor floor thanfloor than the the floor of theof the syringe syringe or catheter or catheter

compartment compartment 2,2,e.g., e.g., as as shown inFIGS. shown in FIGS.2 2and (seealso and6 6(see alsoFIGS. FIGS.31A-31C). 31A-31C).

[0120]

[0120] In FIGS. 1 and 2, another reduced height portion of the partition, i.e., reduced In FIGS. 1 and 2, another reduced height portion of the partition, i.e., reduced

height portion height portion 22, 22, separates separatesthe thesyringe syringeororcatheter compartment catheter compartment 22 from from the the swab swab compartment compartment

3. Reduced height portion 22 of the partition 12 has a partial or reduced height relative to the 3. Reduced height portion 22 of the partition 12 has a partial or reduced height relative to the

full height of the inner walls or the sides of the tray. FIG. 5 shows an alternate arrangement of full height of the inner walls or the sides of the tray. FIG. 5 shows an alternate arrangement of

reduced height reduced heightportions portions16, 16,wherein wherein both both reduced reduced height height portions portions 16 located 16 are are located alongalong the the partition between partition between the the syringe syringe or or catheter cathetercompartment andthe compartment and the main maincompartment compartment (i.e.,there (i.e., there is is no reduced no reducedheight heightportion portion22 22 between between the syringe the syringe or catheter or catheter compartment compartment and the and swabthe swab compartment).Other compartment). Other arrangements arrangements and configurations and configurations arepossible. are also also possible. If syringes If syringes are are packagedororincluded packaged includedininsyringe syringeororcatheter catheter compartment compartment 2, 2, thereduced the reduced height height portions portions (e.g., (e.g.,

reduced height portions 16 and 22) help facilitate easy removal of the syringes from the syringe reduced height portions 16 and 22) help facilitate easy removal of the syringes from the syringe

or catheter compartment 2 by providing more open space for the end user to reach into the tray or catheter compartment 2 by providing more open space for the end user to reach into the tray

and grasp onto the syringes. This makes removal of the syringes easier than if the partition 12 and grasp onto the syringes. This makes removal of the syringes easier than if the partition 12

did not have any reduced height portions and the clinician had to try to grasp the syringes within did not have any reduced height portions and the clinician had to try to grasp the syringes within

a narrower a region. narrower region.

[0121]

[0121] As shown, As shown,for forexample, example,ininFIGS. FIGS.1 and 1 and 5, 5, thesyringe the syringeororcatheter cathetercompartment compartment of the of the tray tray may mayalso also include include instructions/procedural instructions/procedural indicators indicators and/or and/or otherother information information

integrated thereon. integrated For example, thereon. For example,the thesyringe syringeororcatheter catheter compartment compartment may may optionally optionally include include

-22-

instructions/procedural indicators indicators related relatedto tothe thecatheterization written thereon. thereon.As Asshown in 2023203963 23 Jun 2023

instructions/procedural catheterization written shown in

FIGS. 1 1and FIGS. and5, 5,thetheinstructions/procedural instructions/proceduralindicators indicatorsintegrated integratedon on thethe syringe syringe or catheter or catheter

compartmentmaymay compartment include include instructions/procedural instructions/procedural indicators indicators stating"Dispense stating "Dispense & Lube & Lube FoleyFoley

here" (alternatively, here" (alternatively, this this instruction instruction may simplysaysay may simply "Lube "Lube Foley," Foley," "Dispense "Dispense Lube,"Lube," or or somethingsimilar), something similar),"retract "retractgenitalia genitalia(non-dominant (non-dominant hand)", hand)", "prep "prep patientpatient with with swabs swabs (dominanthand)", (dominant hand)","insert "insert catheter catheter & inflate balloon & inflate balloon (dominant hand)."AsAs (dominant hand)." shown shown in FIGS. in FIGS. 1 1 2023203963

and 55 and and andasasstated stated above, above,the theinstructions/procedural instructions/procedural indicators indicators may mayinform informthethehealth healthcare care provider which provider whichhand hand to to useuse for for a given a given step, step, e.g., e.g., dominant dominant or non-dominant or non-dominant hand. hand. The The instructions/procedural indicators or other information may be in upper case letters, in bold, or instructions/procedural indicators or other information may be in upper case letters, in bold, or

otherwise called otherwise called out outforfor greater greater visibilityto to visibility ensure ensure the clinician the clinician reads reads the the instructions/procedural indicators or other information. instructions/procedural indicators or other information.

[0122]

[0122] Note that Note that the thesides sidesof the of the catheterization catheterization traytray may include may also also include instructions/procedural indicators or instructions/procedural indicators other information or other information thereon. thereon. ForFor example, example, as shown as shown in in FIGS. 1,1, 2, FIGS. 2, and 5, side and 5, side 66 may include an may include an instruction/procedural instruction/procedural indicator indicator 47 to "open 47 to iodine," "open iodine,"

while side 77 may while side include an may include an instruction/procedural instruction/procedural indicator indicator 49 49 to to "attach "attachwater water syringe." syringe." The The

instructions/procedural indicators or other information may be in upper case letters, in bold, or instructions/procedural indicators or other information may be in upper case letters, in bold, or

[0123]

[0123] As shown As shownininFIGS. FIGS.3 3and and4,4,the thebase base5555ofofthe thesyringe syringeor or catheter catheter compartment compartment

2 may 2 maybebeoffset offset from fromthe thebases basesofofall all other other compartments. compartments. InIn otherwords, other words,thethebase base 55 55 of of the the

syringe or catheter compartment 2 may be not as deep or separated from the top of the tray as, syringe or catheter compartment 2 may be not as deep or separated from the top of the tray as,

for example, for the base example, the base 57 57 of of the the main maincompartment compartment1. 1. As As the the basebase 55 offset 55 is is offset from from thethe bases bases

of the of the other other compartments, thebottom/floor compartments, the bottom/floorofofthe thesyringe syringeororcatheter cathetercompartment compartmentis is offset offset

from bottoms/floors from bottom s/floorsofofthe the other other compartments, compartments,including including being being offset offset from from thethe bottom/floor bottom/floor

of the of the main compartment1. 1. main compartment

[0124]

[0124] The swab The swabcompartment compartment 3 spans 3 spans alongalong a portion a portion of tray's of the the tray's inner inner wallwall along along

side 66 of side of the the tray; tray;that portion that ofof portion thethe inner wallwall inner forms a side forms of the a side swab of the compartment swab compartment3.3. The The

swabcompartment swab compartment 3 may 3 may contain contain various various items, items, for for example, example, swabs swabs or swabsticks or swabsticks andor and one one or more antiseptics such as iodine (e.g., an iodophor such as povidone-iodine, tincture of iodine, more antiseptics such as iodine (e.g., an iodophor such as povidone-iodine, tincture of iodine,

aqueous iodine, etc.). Portions of partition 10 and partition 12 extend along two other sides of aqueous iodine, etc.). Portions of partition 10 and partition 12 extend along two other sides of

the swab the compartment swab compartment 3 forming 3 forming twotwo other other sides sides of of thethe swab swab compartment compartment 3, separate 3, and and separate the the swabcompartment swab compartment 3 from 3 from thethe main main compartment compartment 1 and1 the andsyringe the syringe or catheter or catheter compartment compartment 2, 2,

-23-

23 Jun 2023

respectively. Also, respectively. Also, the the small small storage storage or or overflow overflowcompartment compartment 4 extends 4 extends along along a fourth a fourth side side

of the of the swab compartment swab compartment 3. 3.In In one one embodiment embodiment as shown, as shown, for example, for example, in FIGS. in FIGS. 1 and 12,and the2, the partition 10 partition has aa full 10 has full height height where whereit itseparates separatesthetheswab swab compartment compartment 3 from3 the from the main main compartment 1, while the partition 12 has a reduced height (i.e., at reduced height portion 22) compartment 1, while the partition 12 has a reduced height (i.e., at reduced height portion 22)

that separates that separates the the swab compartment swab compartment 3 from 3 from the the syringe syringe or catheter or catheter compartment compartment 2. In 2.oneIn one embodiment embodiment as as shown, shown, forfor example, example, in FIG. in FIG. 5, the 5, the partition1010andand partition thepartition the partition1212both bothhave have 2023203963

2023203963

a full a fullheight heightwhether whether they they separate separatethe theswab swab compartment compartment 3 3from fromthe themain maincompartment compartment 1 1 and and the syringe the syringe or or catheter cathetercompartment 2. compartment 2.

[0125]

[0125] The swab The swabcompartment compartment 3 an 3 has hasangled an angled bottom/floor bottom/floor that spans that spans between between the the small storage small storage or or overflow compartment overflow compartment 4 and 4 and thesyringe the syringeororcatheter cathetercompartment compartment 2 and 2 and hashas a a downward downward slope slope therebetween therebetween (i.e., (i.e., thethe bottom/floor bottom/floor of the of the swab swab compartment compartment 3 near 3 near the the catheter compartment catheter compartment 2 2isis lower lowerthan thannear nearthe thestorage storage compartment compartment4).4). As As such, such, fluid fluid poured poured

into the swab into compartment swab compartment maymay flowflow in a in a direction direction toward toward the catheter the catheter compartment compartment 2 and 2 and pool in pool in the the lowest/deepest portion or lowest/deepest portion or well well 24 24 ofofthe the swab swabcompartment compartmentnearnear the the partition partition 12 12 (e.g., adjacent (e.g., adjacent reduced heightportion reduced height portion2222in inFIGS. FIGS. 1 and 1 and 2) where 2) where it separates it separates the the swab swab compartment3 3from compartment from thecatheter the cathetercompartment compartment 2. Fillets 2. Fillets maymay be be included included in the in the comers corners of of thethe swabcompartment swab compartment 3 similar 3 similar totofillets fillets 18 18 in in the the main main compartment compartment 1,1,e.g., e.g., as as shown in FIGS. shown in FIGS.11 and 2. and 2.

[0126]

[0126] FIG. 88 shows FIG. showsa alarger largerview viewofofthe theswab swabcompartment compartment 3 and 3 and the the adjacent adjacent small small

storage or storage or overflow compartment4 4with overflow compartment withswabs swabs or or swabsticks swabsticks contained contained in in thethe swab swab

compartment3. 3.Near compartment Near the the small small storage storage or overflow or overflow compartment compartment 4, the 4,bottom/floor the bottom/floor of the of the swabcompartment swab compartment 3 may 3 may be be supported supported by another by another partition partition 30 30 (shown (shown on on FIG. FIG. 2) that 2) that separates separates

the small storage the storage or oroverflow overflow compartment compartment 4 4from fromthe theswab swabcompartment compartment 3. Also, 3. Also, thethe partition partition

30 may 30 mayextend extendupward upward (from (from the the bottom/floor bottom/floor of the of the small small storage storage or overflow or overflow compartment compartment

4) only 4) to the only to the bottom/floor of the bottom/floor of the swab compartment swab compartment 3, 3, leaving leaving thebottom/floor the bottom/floor of of thetheswab swab compartment3 3unobstructed compartment unobstructed near near thesmall the smallstorage storageororoverflow overflowcompartment compartment 4 (as 4 (as such,swabs such, swabs or swabsticks or swabsticks with witha alonger longerstick/stem stick/stemmaymay extend extend over over a portion a portion ofsmall of the the small storage storage or or overflowcompartment overflow compartment 4 from 4 from thethe bottom/floor bottom/floor of of swab swab compartment compartment 3 as 3shown, as shown, for example, for example,

in FIG. in 8). This FIG. 8). This design design or or arrangement arrangementalso alsoallows allowssmall smallstorage storageororoverflow overflow compartment compartment 4 4 to act to act as asan anoverflow overflow well well in in case casetoo toomuch much fluid/iodine fluid/iodine is ispoured poured into intoswab swab compartment compartment 3.3.

[0127]

[0127] The swab The swabcompartment compartment 3 includes 3 includes one one or more or more channels channels 28 extending 28 extending at at least least partially along partially along the the region region between the small between the small storage storage or or overflow overflowcompartment compartment 4 and 4 and wellwell 24 24

-24-

located at at aa bottom/floor bottom/floor of of the the swab compartment3. 3. On On a side of the swab compartment 3 2023203963 23 Jun 2023

located swab compartment a side of the swab compartment 3

near the near the catheter catheter compartment compartment 2,2,the thechannels channels28 28 extend extend to and to and are are in fluid in fluid communication communication

with the lowest/deepest portion of the well 24 adjacent the partition 12, such that liquid poured with the lowest/deepest portion of the well 24 adjacent the partition 12, such that liquid poured

into the into the channel(s) channel(s)28 28 can canflow flow downward throughthe downward through thechannel(s) channel(s)2828along alongthe thedownward downward slope slope

and pool and pool in in the the lowest/deepest portion of lowest/deepest portion of the the well well 24. Thechannel(s) 24. The channel(s)2828may maybe be designed designed to to hold an hold an elongated elongated device device (e.g., (e.g., swabs swabs or or swabsticks) swabsticks) and each channel and each channel 28 28may maybebeseparated separatedbyby 2023203963

one or one or more morebarriers barriers 26 26toto help help space spacethe theelongate elongatedevices devices(e.g., (e.g., swabs swabsororswabsticks) swabsticks)apart. apart. Channel(s) 28 may also include undercutting or snap-in features 32 (e.g., snap-in tabs) that may Channel(s) 28 may also include undercutting or snap-in features 32 (e.g., snap-in tabs) that may

help secure help secure elongated devices, such elongated devices, such as as swabs, swabbingsticks, swabs, swabbing sticks, or or swabsticks swabsticks in in the the channel(s) channel(s)

28. 28.

[0128]

[0128] As shown, As shown,for forexample, example,ininFIGS. FIGS.1,1,5,5, and and8,8, the the swab swabcompartment compartmentof of thethe tray tray

mayalso may alsoinclude include instructions/procedural instructions/procedural indicators indicators and/or and/or other other information information integrated integrated

thereon. For thereon. Forexample, example, thethe swab swab compartment compartment (e.g.,(e.g., on oneonofone of barriers barriers 26)optionally 26) may may optionally include instructions/procedural include instructions/procedural indicators indicators related related to to the the catheterization catheterization printed printed or or otherwise otherwise

included thereon. included thereon. As As shown shown in FIGS. in FIGS. 1, 5,8, and 1, 5, and the 8, the instructions/procedural instructions/procedural indicators indicators

integrated on integrated the swab on the swabcompartment compartmentmay may include include an instruction/procedural an instruction/procedural indicator indicator stating stating

"pour iodine here." The instructions/procedural indicators or other information may be in upper "pour iodine here." The instructions/procedural indicators or other information may be in upper

case letters, in bold, or otherwise called out for greater visibility to ensure the clinician reads case letters, in bold, or otherwise called out for greater visibility to ensure the clinician reads

the instructions/procedural indicators or other information. the instructions/procedural indicators or other information.

[0129]

[0129] Oneorormore One moreswabs swabs or or swabsticks swabsticks (e.g.,swab (e.g., swab or or swabstick swabstick 34 34 shown shown in FIGS. in FIGS.

6A-8) may 6A-8) maybebepackaged packaged in in theswab the swab compartment compartment 3 and3 held and held in channels in channels 28 (e.g., 28 (e.g., as shown as shown in in FIG. 8). FIG. 8). The Theswabs swabsororswabsticks swabsticksmay maybe be speciallydesigned specially designed to to fitin fit in swab swabcompartment compartment 3 and 3 and

to be to be held in channels 28. Swab channels 28. Swabcompartment compartment 3 may 3 may also include also include iodine iodine or povidone-iodine or povidone-iodine

solution. The iodine or povidone-iodine solution may be packaged in its own container, packet, solution. The iodine or povidone-iodine solution may be packaged in its own container, packet,

or syringe or syringe in in the the swab swabcompartment compartment 3, e.g., 3, e.g., povidone-iodine povidone-iodine packet packet 52 shown 52 shown in FIG.in26. FIG. 26. Alternatively, the Alternatively, the iodine or povidone-iodine iodine or povidone-iodinesolution solutionmay may be be stored stored and/or and/or sealed sealed in swab in swab

compartment 3 in direct contact with the swab(s) or swabstick(s) 34 (e.g., packaged/sealed such compartment 3 in direct contact with the swab(s) or swabstick(s) 34 (e.g., packaged/sealed such

that it is in contact with a portion of the bottom/floor of swab compartment 3). that it is in contact with a portion of the bottom/floor of swab compartment 3).

[0130]

[0130] FIGS. 6A-6C FIGS. 6A-6C show show one one embodiment embodiment of or of swab swab or swabstick swabstick 34 with34anwith an elongate elongate

member member or or stick/stem3838having stick/stem having more more rounded rounded sidessides (e.g., (e.g., in in cross-section) cross-section) than than thethe swab swab or or swabstick 34 swabstick shown in 34 shown in FIGS. FIGS. 7A-7C. 7A-7C.FIGS. FIGS. 7A-7C 7A-7C show show one embodiment one embodiment of swaboforswab or swabstick 34 swabstick 34with withananelongate elongatemember member or stick/stem or stick/stem 38 38 having having lessless rounded rounded or more or more angular angular

-25-

sides than than the the swab or swabstick 34 shown shownininFIGS. FIGS.6A-6C. 6A-6C. SwabSwab or swabstick 34,shown as shown 2023203963 23 Jun 2023

sides swab or swabstick 34 or swabstick 34, as

in FIGS. in 6A-7C,isisrepresentative FIGS. 6A-7C, representative of of other other possible possible swabs or swabsticks swabs or swabsticks that that may beincluded. may be included. Swabororswabstick Swab swabstick3434includes includesananabsorbent absorbenthead head3636and andananelongate elongatemember member or stick/stem or stick/stem 38.38.

Absorbenthead Absorbent head3636 is is designed designed to to allow allow forfor greater greater saturationin incleansing saturation cleansing solution solution (e.g.,inin (e.g.,

iodine or povidone-iodine solution) and for greater contact with the surface area of the region iodine or povidone-iodine solution) and for greater contact with the surface area of the region

to be to cleansed. Absorbent be cleansed. Absorbent head head 36 36 may may be formed be formed from various from various materials, materials, including including foam, foam, 2023203963

rayon (e.g., puffs of rayon or a spiral of rayon), cotton, other materials, and/or a combination rayon (e.g., puffs of rayon or a spiral of rayon), cotton, other materials, and/or a combination

of one of or more one or of these more of these materials. To improve materials. To improvesaturation saturationofofthe the absorbent absorbenthead, head, the the absorbent absorbent head 3636isisdesirably head desirablymade madeof of a material a material that that readily readily absorbs absorbs and and distributes distributes the the cleansing cleansing

solution. Any material that absorbs a significant percentage of its weight in cleansing solution solution. Any material that absorbs a significant percentage of its weight in cleansing solution

is desirable for use in the absorbent head, especially if it also releases a large percentage of is desirable for use in the absorbent head, especially if it also releases a large percentage of

absorbed cleansing solution, i.e., it is desirable to use a material that absorbs a large amount of absorbed cleansing solution, i.e., it is desirable to use a material that absorbs a large amount of

cleaning solution and also releases a large amount of cleaning solution when used on the patient cleaning solution and also releases a large amount of cleaning solution when used on the patient

for cleaning. for It has cleaning. It been found has been foundthat thatforming formingthetheabsorbent absorbent head head 36 36 of foam of foam (as opposed (as opposed to to rayon or rayon or other other materials) materials) provides providesthe theabsorbent absorbenthead head 36 36 with with improved improved absorption absorption of andof and saturation with saturation cleansing solution. with cleansing solution. Further, Further, aafoam foamabsorbent absorbent head head readily readily releases releases a large a large

amountofofthe amount thecleansing cleansingsolution solutionwhen when put put in contact in contact withwith the region the region ofpatient of the the patient to beto be cleansed and cleansed and when whencompressed compressed slightly slightly against against thetheregion regionbeing being cleansed.ThisThis cleansed. ready ready release release

of cleansing of solution makes cleansing solution cleansingthe makes cleansing theregion regionofofthe the patient patient easier easier and and allows allows the the end end user user

to be more gentle when cleansing the patient. If absorbent head 36 is made entirely or partially to be more gentle when cleansing the patient. If absorbent head 36 is made entirely or partially

of foam, of the foam foam, the foammay maybebeopen-cell open-cellfoam, foam, closed-cellfoam, closed-cell foam, polyurethane polyurethane foam, foam, highhigh density density

foam, latex foam, latex foam, honeygold foam, honey goldfoam, foam,ororother othertypes types of of foam. Theabsorbent foam. The absorbenthead headmaymay be be heated heated

such that it bonds to the elongate member or stick (e.g., the foam may be heated to bond to the such that it bonds to the elongate member or stick (e.g., the foam may be heated to bond to the

stick), or other means of attachment may be used, e.g., using an adhesive. stick), or other means of attachment may be used, e.g., using an adhesive.

[0131]

[0131] Preferably the Preferably the foam or other foam or other material(s) material(s) selected selected for for the theabsorbent absorbent head head do do not not

degradeororatatleast degrade least resist resist degrading degradingwhen whenin in contact contact with with the the cleansing cleansing solution. solution. In oneIn one embodiment,thetheswabs embodiment, swabs or swabsticks or swabsticks may may be stored be stored in contact in contact with iodine with iodine or a povidone- or a povidone-

iodine solution, so they are already saturated when they are first accessed in the catheterization iodine solution, so they are already saturated when they are first accessed in the catheterization

package. For package. Forexample, example, a seal a seal may may be placed be placed in or in or swab over over compartment swab compartment 3 that 3 that holds a holds a cleansing solution cleansing solution in in contact contact with with the the absorbent head(s) of absorbent head(s) of the the swab(s) swab(s) or or swabstick(s) swabstick(s) while while preventing leaks preventing leaks until until the the seal seal is is removed. When removed. When packaged packaged and stored and stored in contact in contact with with the the cleansing solution, it is vital that the absorbent head not degrade over time. Honey gold foam, cleansing solution, it is vital that the absorbent head not degrade over time. Honey gold foam,

-26-

Jun 2023 for example, is sufficiently resistant to degradation when in contact with an iodine or povidone- for example, is sufficiently resistant to degradation when in contact with an iodine or povidone-

iodine solution. iodine solution.

[0132]

[0132] Absorbenthead Absorbent head3636may maybebe ofof a avariety variety of of sizes sizes and and shapes. shapes. Preferably, Preferably, the thefoam foam

2023203963 23

is shaped in such a way as to provide for greater contact with the surface area of the region to is shaped in such a way as to provide for greater contact with the surface area of the region to

be cleansed. be cleansed. For Forexample, example,thethe absorbent absorbent head head 36 may 36 may be shaped be shaped suchthe such that thatdistal the distal end orend or distal region (e.g., regions that come into contact with the patient), are substantially larger than distal region (e.g., regions that come into contact with the patient), are substantially larger than 2023203963

regions that are less likely to come into contact with the patient (e.g., the proximal end or where regions that are less likely to come into contact with the patient (e.g., the proximal end or where

the absorbent the absorbent head 36 attaches head 36 attaches to to the theelongate elongatemember or stick member or stick 38). 38). This This provides provides more more surface surface

area in the patient-contacting end of the absorbent head and makes cleansing the patient quicker area in the patient-contacting end of the absorbent head and makes cleansing the patient quicker

and easier. Further, with the distal region of the absorbent head being larger, the majority of and easier. Further, with the distal region of the absorbent head being larger, the majority of

the iodine is absorbed into the area that contacts the patient (in contrast, when the largest region the iodine is absorbed into the area that contacts the patient (in contrast, when the largest region

of the absorbent head is not at or near the distal end, much of the iodine is wastefully absorbed of the absorbent head is not at or near the distal end, much of the iodine is wastefully absorbed

into aa location into location that that does does not not contact contact or or cleanse cleanse the the patient). patient). The absorbenthead The absorbent head3636may may be be shapedasas shown shaped shownininFIGS. FIGS. 6A-7B 6A-7B and be and may may be wider wider than than it it is thick. is thick. The absorbent The absorbent head head 36 36 could also could also be be shaped shapedtotobebegenerally generallyororapproximately approximately circular, circular, rectangular,or or rectangular, trapezoidal. trapezoidal.

Optionally, the Optionally, the shape shapeofofabsorbent absorbent head head 36 be 36 may may be generally generally or approximately or approximately conical, conical, pyramidal, tear drop, ovoid, or triangular in shape (with the larger base end positioned at the pyramidal, tear drop, ovoid, or triangular in shape (with the larger base end positioned at the

distal tip of the swab or swabstick), or may be another shape. If generally pyramidal in shape, distal tip of the swab or swabstick), or may be another shape. If generally pyramidal in shape,

the base the of the base of the pyramidal shapemay pyramidal shape maybe be generally generally triangular,square, triangular, square,pentagonal, pentagonal,hexagonal, hexagonal, etc. Even etc. Evenif ifotherwise otherwise generally generally conical, conical, pyramidal, pyramidal, or another or another shape,shape, the edges the edges of the of the absorbent head at the distal end may be curved or tapered (e.g., as the distal edges are curved absorbent head at the distal end may be curved or tapered (e.g., as the distal edges are curved

in FIGS.6A-7B). in Further,the FIGS.6A-7B). Further, thedistal distal end end of of the the elongate elongate member orstick member or stick 38 mayalso 38 may also be be curved curved (e.g., the distal end may be semi-circular rather than flat across the top or distal-most edge), as (e.g., the distal end may be semi-circular rather than flat across the top or distal-most edge), as

curves are less likely to harm patient when cleansing with a swab or swabstick. curves are less likely to harm patient when cleansing with a swab or swabstick.

[0133]

[0133] In one In embodiment,the one embodiment, thelength lengthofofthe the absorbent absorbenthead headmay maybebe between between 0.50.5 andand 2 2 inches (in inches (in one one embodiment, the length embodiment, the length may maybebeapproximately approximately1 1inch), inch),the the width width of of the the absorbent absorbent

head at head at its itswidest widestmay may be be between 0.5 and between 0.5 and 22 inches inches (in (in one one embodiment, thewidth embodiment, the widthatatits its widest widest

maybebeapproximately may approximately 1 inch) 1 inch) andand the the width width of the of the absorbent absorbent head head at narrowest at its its narrowest may may be be between0.1 between 0.1 and and11 inches inches (in (in one one embodiment, thewidth embodiment, the widthatatits its narrowest narrowest may beapproximately may be approximately V2 of ½ ofan an inch). inch). Further, Further, ifif the the absorbent absorbent head headisis not not generally generally conical conical oror pyramidal pyramidalininshape shape (i.e., such that its width and thickness are the same all around), it may have a thickness less (i.e., such that its width and thickness are the same all around), it may have a thickness less

-27-

than its its width, width, e.g., e.g.,a athickness thicknessbetween between 0.1 0.1 and 1 inches (in one embodiment,thethethickness thickness 2023203963 23 Jun 2023

than and 1 inches (in one embodiment,

maybebeapproximately may approximately 3/8ofofananinch). 3/8 inch).

[0134]

[0134] In one In one embodiment, theelongate embodiment, the elongatemember memberor or stick3838may stick may have have a lengthbetween a length between 2 and 2 and 77 inches inches (e.g., (e.g., the the elongate elongate member orstick member or stick 38 38 may mayhave havea length a lengthbetween between 3.53.5 andand 4.54.5

inches, or a length of approximately 4.25 inches). The length of penetration of the stick 38 into inches, or a length of approximately 4.25 inches). The length of penetration of the stick 38 into

the absorbent the absorbent head head3636(i.e., (i.e., the the length length the the stick stick38 38that thatextends extendsdistally distallybeyond beyond the the proximal proximal 2023203963

end ofofthe end theabsorbent absorbenthead) head) maymay be between be between 0.25 inches 0.25 inches and(e.g., and 1 inch 1 inchthe(e.g., theoflength length of penetration may penetration maybebeapproximately approximately 0.5 0.5 inches). inches). It preferable It is is preferable to to ensure ensure that that thethe length length of of penetration is within a good range relative to the overall length of the absorbent head. If the penetration is within a good range relative to the overall length of the absorbent head. If the

stick 38 extends too far into the absorbent head 36, the patient's skin may be too easily damaged stick 38 extends too far into the absorbent head 36, the patient's skin may be too easily damaged

by the stick 38 (e.g., it may be more likely to scrape against the patient during cleansing, and by the stick 38 (e.g., it may be more likely to scrape against the patient during cleansing, and

maynot may notbe bepadded paddedbybyenough enough foam). foam). Whereas, Whereas, if the if the stick stick 38 38 does does notnot extend extend farfar enough enough intointo

the absorbent head 36, the absorbent head 36 will lack structure and flop around (especially if the absorbent head 36, the absorbent head 36 will lack structure and flop around (especially if

saturated with saturated liquid), which with liquid), which makes it harder makes it harder for for the the end user to end user to guide the absorbent guide the absorbent head headofof the swab or swabstick and effectively cleanse the patient. Ideally, the length of penetration of the swab or swabstick and effectively cleanse the patient. Ideally, the length of penetration of

the stick the stick 38 38 will will extend extend between 35 and between 35 and70% 70%of of thelength the lengthofofthe theabsorbent absorbenthead head 36 36 (e.g.,the (e.g., the length of length of penetration penetration may maybebeabout about50%50% of the of the length length of of thethe absorbent absorbent head). head). The elongate The elongate

member member or or stick3838 stick maymay be formed be formed from various from various materials, materials, including including a plastic a plastic or polymer or polymer

material. material.

[0135]

[0135] The elongate member or stick 38 may have a variety of different cross-sectional The elongate member or stick 38 may have a variety of different cross-sectional

sizes and sizes shapes. For and shapes. Forexample, example,thetheswab swab or or swabstick swabstick may may be biased be biased to betorelatively be relatively flatflat or or have a generally rectangular cross-section (or a rectangular-like cross-section but with rounded have a generally rectangular cross-section (or a rectangular-like cross-section but with rounded

edges as edges as shown, shown,for for example exampleininFIG. FIG.6C, 6C,ororwith withcut cutoff offedges edgesasasshown, shown,for forexample, example,ininFIG. FIG. 7C), so 7C), so it it is is easier easier to to hold. Theelongate hold. The elongatemember member or stick or stick 38 shown 38 shown in FIGS. in FIGS. 6A-6C 6A-6C has has rounded edges, but has a roughly rectangular shape otherwise. This is a shape that is easier to rounded edges, but has a roughly rectangular shape otherwise. This is a shape that is easier to

hold and manipulate while cleaning a patient than a stick with a circular cross-section. Further, hold and manipulate while cleaning a patient than a stick with a circular cross-section. Further,

this and similar cross-sectional shapes for the elongate member or stick 38 make it possible for this and similar cross-sectional shapes for the elongate member or stick 38 make it possible for

the swabs the or swabsticks swabs or swabsticks to to snap snap into into the the tray trayor orbebeheld heldunder underfeatures 3232toto features prevent movement prevent movement

of the of the swabs or swabsticks swabs or swabsticks during duringshipping shippingororbefore beforeuse. use. ToToremove remove a swab a swab or swabstick or swabstick of of this cross-section, this cross-section, one one can simplytwist can simply twist the the elongate elongatemember member or stick or stick 38 38 in ainclockwise a clockwise or or counter clockwise counter clockwisedirection directionand andthe thefeatures features 32 32easily easily release release the the swab swabororswabstick swabstickfor foruse. use. For example, For example,FIG. FIG.8 8shows shows twotwo swabs swabs or swabsticks or swabsticks that that are snapped are snapped or held or held in place in place underunder

-28-

the features features 32, and also also shows showsone oneswab swab or swabstick thatthat has has beenbeen twisted such such that the 2023203963 23 Jun 2023

the 32, and or swabstick twisted that the

features 32 features no longer 32 no longerhold holdthe theswabstick swabstickororprevent prevent itsitsremoval. removal. ThisThis makes makes the swabs the swabs or or swabsticks very swabsticks verysecure secureininthe theswab swabcompartment compartment 3 during 3 during shipping shipping and before and before use,also use, but but also makesremoval makes removalofofthe theswabs swabsor or swabsticks swabsticks at at thetime the timeofofcatheterization catheterization very very simple simpleand andeasy. easy.

[0136]

[0136] In one In embodiment,ififthe one embodiment, theelongate elongatemember member or stick or stick is is ofof a agenerally generallyflattened flattened (e.g., generally (e.g., generallyrectangular) rectangular)shape, shape,the thewidth width or ordiameter diameter of of the the elongate elongate member member ororstick stick 38 38 2023203963

maybebebetween may betweenapproximately approximately 1/8 1/8 of of an an inch inch andand 3/43/4 of of an an inch inch (e.g., the (e.g., the width widthmay maybebeabout about 1/4 of an inch), whereas the thickness may be between 1/16 of an inch and 1/2 of an inch (e.g., 1/4 of an inch), whereas the thickness may be between 1/16 of an inch and 1/2 of an inch (e.g.,

the thickness the thickness may beapproximately may be approximately1/81/8 of of an an inch).If If inch). thethe elongate elongate member member or stick or stick is aof is of a generally circular cross-section or is generally cylindrical in shape, the diameter of the elongate generally circular cross-section or is generally cylindrical in shape, the diameter of the elongate

member member oror stick3838may stick maybe be between between 1/8 1/8 of an of an inch inch andand 1/2 1/2 of an of an inch inch (e.g.,the (e.g., thediameter diametermaymay be about 1/4 of an inch). be about 1/4 of an inch).

[0137]

[0137] The swabs or swabsticks are loaded into the tray and held in such a way that the The swabs or swabsticks are loaded into the tray and held in such a way that the

absorbent head absorbent head3636is isininthethelowest/deepest lowest/deepest portion portion or well or well 24the 24 of of bottom the bottom of theof the swab swab compartment 3 such that they are exposed to the iodine that pools in the lowest/deepest portion compartment 3 such that they are exposed to the iodine that pools in the lowest/deepest portion

or well or 24 of well 24 ofthe the bottom bottomofofthe theswab swab compartment compartment 3 and3 easily and easily saturate saturate with with the iodine the iodine or or povidone-iodinesolution. povidone-iodine solution. However, However,thethe elongate elongate member member or stick or stick 38 may 38 may be loaded be loaded into into the the tray and tray held in and held in such such aa way waythat that the the elongate elongate member memberor or stick3838 stick is is notitself not itself exposed exposedtotothe the iodine or iodine or povidone-iodine solution. povidone-iodine solution.

[0138]

[0138] The small The small storage storage or or overflow compartment overflow compartment 4 spans 4 spans along along a portionofofthe a portion thetray's tray's side 6, side 6, which formsananinner which forms inner wall wall of of thethe tray tray andand a side a side of the of the small small storage storage or overflow or overflow

compartment4.4.Three compartment Three other other sidesofofthe sides thesmall smallstorage storageororoverflow overflowcompartment compartment 4 are 4 are formed formed

by partial-height partitions that separate the small storage or overflow compartment 4 from the by partial-height partitions that separate the small storage or overflow compartment 4 from the

maincompartment main compartment1, 1, swab swab compartment compartment 3, corner 3, and and corner compartment compartment 5. compartments 5. These These compartments maysurround may surroundthe thesmall smallstorage storageororoverflow overflowcompartment compartment 4 on4 three on three sides sides thereof. thereof. The The small small

storage or storage or overflow compartment overflow compartment 4 4 may may actact as as anan overflow overflow well well to to collectany collect anyfluid fluidthat that might might overflowfrom overflow fromthe theswab swabcompartment. compartment. Optionally, Optionally, the the small small storage storage or or overflow overflow compartment compartment

4 may store or hold one or more items useful for catheterization. 4 may store or hold one or more items useful for catheterization.

[0139]

[0139] As shown, As shown, for for example, example, in in FIGS. FIGS. 1 1 and and5,5,the the small small storage storage or or overflow overflow compartmentof of compartment thethe tray tray maymay also also include include instructions/procedural instructions/procedural indicators indicators and/orand/or other other information integrated information integrated thereon. thereon. For For example, example,the thesmall smallstorage storageor or overflow overflowcompartment compartmentmaymay

-29-

23 Jun 2023

optionally include instructions/procedural indicators related to the catheterization printed or optionally include instructions/procedural indicators related to the catheterization printed or

otherwise included otherwise includedthereon. thereon.AsAs shown shown in FIGS. in FIGS. 1 and1 5, and the5,information the information integrated integrated on theon the small storage small storage or overflow compartment or overflow compartmentmay may include include a reminder a reminder thatthat thethe health health care care

provider/clinician should provider/clinician should"refer "refertotodirections directionsforfor useuse for for complete complete instructions." instructions." The The instructions/procedural indicators or other information may be in upper case letters, in bold, or instructions/procedural indicators or other information may be in upper case letters, in bold, or

otherwise called otherwise called out outforfor greater greater visibilityto to visibility ensure ensure the clinician the clinician reads reads the the 2023203963

2023203963

instructions/procedural indicators or other information. instructions/procedural indicators or other information.

[0140]

[0140] The corner The comerstorage storage compartment compartment 5 spans 5 spans along along portions portions of of thethe tray'sside tray's side 66 and and side 9, side 9,which which form sides and form sides and a a comer corner of of the thecorner cornerstorage storagecompartment 5. Two compartment 5. Twoother othersides sidesofof the comer the corner storage storage compartment compartment 5 5may may be be formed formed by partial-height by partial-height partitionsthat partitions thatseparate separatethe the corner storage corner storage compartment compartment5 5from from thethe main main compartment compartment 1 (e.g., 1 (e.g., reduced reduced height height portion portion 14) 14) and small and small storage storage or or overflow overflow compartment compartment 4. These compartments 4. These compartmentssurround surroundthe the corner corner storage compartment storage compartment 5 5onon two two sidesthereof. sides thereof.

[0141]

[0141] The bottom/floor The bottom/floorofofthethecorner corner storage storage compartment compartment 5 may 5bemay be non-planar; non-planar;

namely, the namely, the bottom/floor bottom/floormay mayhave havea anon-planar, non-planar,rounded, rounded, or or partiallycylindrical partially cylindrical shape. shape. This This shape may shape maybebeparticularly particularly useful useful for for holding holding aa specimen specimenororsample samplecontainer. container.Corner Corner storage storage

compartmentmaymay compartment store store or or hold hold various various implements implements useful useful for catheterization. for catheterization. For For example, example,

corner storage compartment may hold a label that can be filled out by a clinician on a first side corner storage compartment may hold a label that can be filled out by a clinician on a first side

and adhered and adheredto to aa specimen specimenororsample samplecontainer containeronona asecond secondside. side. The Thesecond second sidemaymay side already already

include an include an adhesive thereon; the adhesive thereon; the adhesive adhesive may be covered may be coveredbybyaaremovable removablecover cover sheetthat sheet thatmay may be removed be removedat atthethetime time of of adhering. adhering. The The corner corner storage storage compartment compartment may alsomay also ainclude include a specimenororsample specimen samplecontainer container54. 54.

[0142]

[0142] In one In one embodiment, embodiment,at at least least some some of the of the compartments compartments may bemay be insealed sealed a in a manner that manner that prevents prevents contamination contamination thereof. thereof, In In one one embodiment, embodiment,at atleast leastone oneofofthethe compartmentsmay compartments may be be unsealed unsealed independently independently of at of at leastone least oneother othercompartment. compartment.ForFor example, example,

a user a user may first unseal may first unsealthe themain main compartment, leaving other compartment, leaving other compartments compartmentssealed. sealed.After Afterusing using items contained items contained in in the the main maincompartment, compartment,thethe user user may may unseal unseal another another compartment compartment and and use use items contained items contained in in that that compartment. compartment.

[0143]

[0143] In one In one embodiment, embodiment, a auser user may mayunseal unsealthe theswab swabcompartment compartment 3 prior 3 prior to to unsealing the unsealing the syringe syringe or or catheter catheter compartment compartment 2 orthethemain 2 or main compartment compartment 1. user 1. The Themay user may pour iodine pour iodine or or another anotherantiseptic antiseptic solution solution into into the the swab compartment swab compartment andand maymay use use the swab the swab

-30-

compartmentforforapplying applying theantiseptic antisepticsolution solutiononto ontoswabs, swabs,andand then use thethe iodine soaked 2023203963 23 Jun 2023

compartment the then use iodine soaked

swabstoto cleanse swabs cleanse the the patient. patient. AAuser usermay may then then unseal unseal thethe syringe syringe or or cathetercompartment catheter compartment 2 2 and dispense and dispenselubricant lubricant therein therein prior prior to to unsealing unsealing the the main compartment main compartment 1. 1. A user A user may may then then unseal the unseal the main maincompartment compartment1 to1 access to access the the catheter. catheter. The shape The shape andofsize and size the of the catheter catheter

compartment facilitate lubrication of the catheter (e.g., a tip of the catheter can rotate within compartment facilitate lubrication of the catheter (e.g., a tip of the catheter can rotate within

the elongated shape of the catheter compartment and collect lubricant on its surface during the the elongated shape of the catheter compartment and collect lubricant on its surface during the 2023203963

rotation). The rotation). catheter may The catheter maybebelubricated lubricatedininthe the syringe syringeororcatheter catheter compartment compartment 2 and 2 and then then

inserted into the patient's urethra. inserted into the patient's urethra.

[0144]

[0144] Accordingtotovarious According variousembodiments, embodiments,and and as shown as shown in FIGS. in FIGS. 1, 2 5, 1, 2 and andand5, as and as discussed above, discussed above,thethetray traymaymay have have ordered, ordered, stepwise stepwise instructions/procedural instructions/procedural indicators indicators

thereon for a suitable or preferred catheter insertion technique. thereon for a suitable or preferred catheter insertion technique.

[0145]

[0145] Other aspects Other aspects or or features features of of the the catheterization catheterization package(s) package(s) and catheterization and catheterization

tray(s) are tray(s) arealso alsodescribed describedbelow below in inthe thecontext contextof ofnon-limiting non-limitingprocedures procedures or ormethods of using methods of using

the catheterization the catheterization package packageandand catheterization catheterization tray, tray, and and in context in the the context of methods of methods of of manufacturingororpackaging manufacturing packaginga acatheterization catheterization package. package. The Theaspects aspectsororfeatures features described described below below

maybebeincorporated may incorporatedinto intothe the various various embodiments embodiments already already discussed discussed above. above. The The arrangement arrangement

of components of components andand how how they they are accessed are accessed is partisofpart the of the overall overall intuitive intuitive design design of the of the catheterization package, catheterization i.e., components package, i.e., andfeatures components and featuresare arearranged arrangedinina alogical logicalmanner manner that that

flows from flows fromstep stepto tostep step to to make make the catheterization the catheterization procedure procedure more intuitive more intuitive and and make make completingthe completing theprocedure procedureeasier easierand/or and/orquicker. quicker.Step-by-step Step-by-step ordering ordering of of thethe components components in in the catheterization the catheterizationpackage package helps helps aa user/clinician user/cliniciantoto logically know logically knowwhat whatstep stepcomes comes next. next. For For

example, a first item may be revealed in the package, then once the first item is used, a second example, a first item may be revealed in the package, then once the first item is used, a second

item that was underneath the first item is revealed, the second item being next logical item for item that was underneath the first item is revealed, the second item being next logical item for

use in use in the the catheterization catheterization procedure. procedure. Once Once thethe second second itemitem is used, is used, a third a third item item that that was was underneaththe underneath the second seconditem itemmay maybebe revealed,thethethird revealed, thirditem itembeing beingthe thenext nextlogical logical item item for for use use

in the catheterization procedure, and so on. in the catheterization procedure, and so on.

[0146]

[0146] The catheterization The catheterization package(s) and catheterization package(s) and catheterization tray(s) tray(s)described describedherein hereinmay may

be used be used in in many different ways. many different ways. A Anon-limiting non-limiting method method of use of use is is described described below. below. However, However,

clinicians may clinicians varythe may vary thesteps stepsororprocedures procedures described described herein, herein, may may reorder reorder the steps, the steps, may may perform additional perform additional steps steps beyond beyond those those described, described, and/or and/or may mayomit omit certain certain steps steps as as circumstancesand circumstances andaapatient's patient's unique unique needs mayrequire. needs may require. Further, Further, the the description description below canbe below can be

-31-

considered aa description description of of an an overall overall procedure procedure with with many steps or or can can be be considered consideredaa series series 2023203963 23 Jun 2023

considered many steps

of individual methods or procedures each including only a subset of the steps described. of individual methods or procedures each including only a subset of the steps described.

[0147]

[0147] First, aacatheterization First, catheterizationpackage package as asshown, shown, for for example, in FIGS. example, in FIGS. 99 and and 1010may may be provided be provided(e.g., (e.g., aa health health care careprovider/clinician provider/clinician may mayobtain obtain or or select select thethe catheterization catheterization

packagefrom package fromshelf shelfororthrough through a purchase, a purchase, or or maymay place place the catheterization the catheterization package package in in the the hospital room hospital wherethe room where thepatient patient is is waiting waiting for for catheterization.) catheterization.)As As can can be be seen seen in inFIGS. FIGS. 99 and and 2023203963

10, the catheterization package may be sealed, e.g., by an outer container 60 (e.g., a sealed bag) 10, the catheterization package may be sealed, e.g., by an outer container 60 (e.g., a sealed bag)

surroundingthe surrounding theother othercontents contentsofofthe thecatheterization catheterization package, package,such suchthat thatthe thecontents contentsremain remain sterile and properly contained. Just inside the sealed bag (or other external container), a paper sterile and properly contained. Just inside the sealed bag (or other external container), a paper

or cardboard or packaginglabel cardboard packaging label6262may maybebeincluded included inin thecatheterization the catheterization package. package.The The external external

container 60 (or sealed bag) may be transparent, or at least partially transparent, such that a container 60 (or sealed bag) may be transparent, or at least partially transparent, such that a

clinician may see the label 62 or portions of the label. The label 62 may include sides 64 that clinician may see the label 62 or portions of the label. The label 62 may include sides 64 that

are foldable are such that foldable such that they extend down they extend downthethesides sidesofofthe thecatheterization catheterizationpackage. package.TheThe label label

mayinclude may includeone, one,two, two,three, three, or or four four sides. sides. For Forexample, example,FIGS. FIGS.11 11 andand 12 each 12 each showshow a label a label

62 that a large top portion 66, and 3 smaller sides or side portions 64 foldable to a different 62 that a large top portion 66, and 3 smaller sides or side portions 64 foldable to a different

plane from plane fromthe the plane plane in in which whichthe thelarge large top top portion portion 66 66 resides. resides. Lines Lines on on FIG. FIG.1212show show where where

the folds the folds may bemade may be madeto to form form thethe sides sides or or sideportions. side portions.In Inoneone embodiment, embodiment, the label the label has has four sides or side portions 64 instead of three. four sides or side portions 64 instead of three.

[0148]

[0148] Thepackaging The packaging label62 62 label may may include include instructions instructions and and or or information other other information thereon. For thereon. Forexample, example,thethelabel label6262maymay include include initialinstructions initial instructionsfor forcatheterization. catheterization. The The label 62 may include a logo, trademark, or product name printed or otherwise included thereon, label 62 may include a logo, trademark, or product name printed or otherwise included thereon,

e.g., "SureStep™Foley e.g., Tray "SureStep Foley Tray System", System", "Lubri-sil® "Lubri-sil® I.C.Complete I.C. Complete Care ®H Care®", , and/or and/or "BARD." "BARD." The The label 62 may also, or alternatively, include instructions related to the catheterization written label 62 may also, or alternatively, include instructions related to the catheterization written

thereon. For thereon. Forexample, example,thethe labelmaymay label include include instruction(s) instruction(s) 40 40 to to verify verify whether whether the the patient patient

meets the meets the CDC CDC guidelines guidelines forfor indwelling indwelling urethral urethral catheter catheter use, use, as as shown shown in the in the bottom bottom left left quadrant of the top portion 66 of the labels 62 in FIGS. 9-12. The label may include a checklist quadrant of the top portion 66 of the labels 62 in FIGS. 9-12. The label may include a checklist

41 to verify the different factors that qualify a patient for indwelling urethral catheter use under 41 to verify the different factors that qualify a patient for indwelling urethral catheter use under

the CDC guidelines, e.g., as also shown in the bottom left quadrant of the top portion 66 of the the CDC guidelines, e.g., as also shown in the bottom left quadrant of the top portion 66 of the

labels 62 labels 62 shown inFIGS. shown in FIGS.9-12. 9-12.TheThe label label 62 62 maymay alsoalso include include a listofofcomponents a list components 42 the 42 of of the catheterization package as shown on the right side the top portion 66 of the labels 62 in FIGS. catheterization package as shown on the right side the top portion 66 of the labels 62 in FIGS.

9-12. The instructions or other information may be in upper case letters, in bold, or otherwise 9-12. The instructions or other information may be in upper case letters, in bold, or otherwise

-32-

called out out for forgreater greatervisibility visibility totoensure ensurethethe clinician reads the the instructions or other 2023203963 23 Jun 2023

called clinician reads instructions or other

information. information.

[0149]

[0149] The packaging The packaginglabel label6262maymay also also include include key key information information or variables or variables called called

out in out in aa simplified simplified and easy-to-read manner. and easy-to-read manner.ForFor example, example, visual visual identifiers,squares, identifiers, squares,other other shapes, and/or shapes, and/or other other features features may be included may be includedthat that each each have haveananindicator indicatorof ofone onekey keypiece pieceofof information or variable called out and easy to read. In FIGS. 9-12, the labels 62 are shown as information or variable called out and easy to read. In FIGS. 9-12, the labels 62 are shown as 2023203963

including information including informationsquares squares 44 that 44 that each each includes includes an indicator an indicator of one of key one piecekey of piece of information about information aboutthe the catheterization catheterization package. Informationsquares package. Information squares4444 essentiallyisolate essentially isolate and and feature particular feature particular information about the information about the catheterization catheterization tray tray from from aa range rangeofofpossibilities possibilities or or variables. Various variables. Variousfeatures featuresororvariables variablesmay maybe be called called out, out, including:(1)(1) including: whether whether the the traytray

includes aa drainage includes drainage bag bagororaaurine urinemeter, meter,(2) (2) the the French Frenchsize sizeofofthe thecatheter, catheter, (3) (3) the the type of type of

catheter included, (4) the substrate type of materials used in the catheter or other components, catheter included, (4) the substrate type of materials used in the catheter or other components,

e.g., latex e.g., latex or or latex-free, latex-free,(5) (5)special specialcomponents or features, components or features, e.g., e.g., inclusion inclusion of of aa StatLock® StatLock®

securement device, inclusion of special infection control coating, or other features. This calling securement device, inclusion of special infection control coating, or other features. This calling

out of particular variables, separated from everything else, allows the health care provider to out of particular variables, separated from everything else, allows the health care provider to

see what see whatisis in in the the catheterization catheterization package or tray package or tray at at aa glance. glance. Accordingly, Accordingly,thethehealth healthcare care provider can provider can quickly quicklydetermine determinewhat what thethe keykey distinguishing distinguishing elements elements of catheterization of the the catheterization packageorortray package trayare. are. For Forexample, example, if the if the catheterizationpackage catheterization package shown shown in FIG. in FIG. 9 and 9the and the catheterization package catheterization in FIG. package in 10 were FIG. 10 wereboth bothstored storedononthe thesame sameshelf, shelf,a ahealth healthcare care provider provider could quickly could quickly tell tell the the major major differences differences between the catheterization between the catheterization packages just by packages just by looking looking at the at the information information squares squares 44. Onecan 44. One canreadily readilytell tell from the information from the information squares squares44 44inin FIG. FIG.99 that the catheterization package in FIG. 9 includes an 18 French sized catheter, a drainage bag, that the catheterization package in FIG. 9 includes an 18 French sized catheter, a drainage bag,

Bard's StatLock®, and is a non-latex catheter. One can readily tell from the information squares Bard's StatLock®, and is a non-latex catheter. One can readily tell from the information squares

44 in FIG. 10 that the catheterization package in FIG. 10 includes a 16 French sized catheter, 44 in FIG. 10 that the catheterization package in FIG. 10 includes a 16 French sized catheter,

a drainage a drainage bag, bag, and Bard's StatLock® and Bard's StatLock®.

[0150]

[0150] Further, the packaging label 62 may be designed to be visible in multiple planes. Further, the packaging label 62 may be designed to be visible in multiple planes.

The label may be designed to fold at the edges of the catheterization package such that the label The label may be designed to fold at the edges of the catheterization package such that the label

(or a portion of the label) forms sides or side portions that are visible when the catheterization (or a portion of the label) forms sides or side portions that are visible when the catheterization

package is viewed from the sides, in addition to being visible from the top. In FIGS. 9-12, the package is viewed from the sides, in addition to being visible from the top. In FIGS. 9-12, the

labels 62 labels 62 are are designed designedsuch such that that information information squares squares 44 visible 44 are are visible fromtoptheof top from the the of the catheterization package, catheterization and at package, and at least least two two sides sides of of the the tray. tray. Optionally, Optionally, the the label labelmay may also also be be

designed such that information squares 44 appear on all the sides of the catheterization package designed such that information squares 44 appear on all the sides of the catheterization package

-33-

(e.g., on three sides or four sides). Accordingly, anyway you stock the catheterization package, 2023203963 23 Jun 2023

(e.g., on three sides or four sides). Accordingly, anyway you stock the catheterization package,

you can see the label. Further, multiple catheterization packages may be stacked on top of each you can see the label. Further, multiple catheterization packages may be stacked on top of each

other, but other, because ofofthe but because theinformation informationsquares squares on on one one or more or more sides sides ofcatheterization of the the catheterization package, aa clinician package, clinician can can still still quickly quickly tell tellfrom from the the sides sides of of the the packages in the packages in stack which the stack which

catheterization package from the stack is the one desired for a particular patient. catheterization package from the stack is the one desired for a particular patient.

[0151]

[0151] The catheterization The catheterization package packagemay maybebe selectedbased selected based on on thethe information information squares squares 2023203963

44, e.g., 44, e.g., after afterreviewing reviewing the the information information squares squares 44. Afterproviding/obtaining/selecting 44. After providing/obtaining/selectingthe the catheterization package, catheterization the user package, the user may openthe may open thecontainer container(e.g., (e.g., the the sealed sealed bag) and remove bag) and removeitit from around from aroundthe theremainder remainderofofthe thecatheterization catheterization package. package.After Afterthe thecontainer container(or (orsealed sealedbag) bag) has been has been removed removedthetheremainder remainder of of thethe catheterizationpackage catheterization package looks, looks, forfor example, example, as as shown shown

in FIG. 11. in FIG. 11.

[0152]

[0152] The user The user may maythen thenremove remove thethe label6262andand label setset it itaside asidetotoreveal reveal other other componentsthat components thatwere wereunderneath underneath thethe label62.62.ForFor label example, example, when when the label the label is removed is removed from from

the catheterization the catheterization packages shownininFIGS. packages shown FIGS.9-11, 9-11,detailed detailedinstructions instructionsfor for catheterization catheterization or or the directions the directions for for use use document 68ofofthe document 68 the catheterization catheterization package packageorortray tray may maybeberevealed revealedasas shown, for shown, for example, example, inin FIG. FIG.13.13.Detailed Detailed instructionsand/or instructions and/orinformation informationononsafety safety considerations are considerations are thereby therebyone oneof of thethe firstitems first itemsaccessed accessed in the in the catheterization catheterization package. package.

Providing detailed instructions up front allows the user/clinician/health care provider to review Providing detailed instructions up front allows the user/clinician/health care provider to review

the entire procedure in advance of any other steps and before breaking the sterile field formed the entire procedure in advance of any other steps and before breaking the sterile field formed

by the by the CSR CSR wrap wrap around around the catheterization the catheterization tray.tray. This helps This helps the procedure the procedure to run to run more more efficiently and safely. Pages of detailed instructions may be seen on various pages of document efficiently and safely. Pages of detailed instructions may be seen on various pages of document

68 in 68 in FIGS. FIGS. 14A-14D. Anyone 14A-14D. Any oneorormore moreofofthe the steps steps contained contained in inFIGS. FIGS.14A-14D 14A-14D may be may be

performedasasaa catheterization performed catheterization method orprocedure. method or procedure.

[0153]

[0153] Additionally, there Additionally, there may may also also be associated be associated patient patient education education information information

whether attached to the detailed instructions or separately placed in the catheterization package. whether attached to the detailed instructions or separately placed in the catheterization package.

The patient education information may be used by a health care provider to instruct the patient The patient education information may be used by a health care provider to instruct the patient

on care of the indwelling catheter and may, ultimately, be given to the patient for reference. on care of the indwelling catheter and may, ultimately, be given to the patient for reference.

FIGS.15A FIGS. 15Aandand 15B15B showshow an example an example of patient of patient education education information information thatbemay that may be included included

on aa patient on patient sheet/pamphlet 70 in sheet/pamphlet 70 in the the catheterization catheterization tray. tray. FIG. 15Ashows FIG. 15A showsa afirst first side side of of the the

patient education patient information sheet education information sheet 70 70inin English, English, whereas whereasFIG. FIG.15B15B shows shows a second a second side side of of the patient education information sheet 70 in Spanish. the patient education information sheet 70 in Spanish.

-34-

Jun 2023

[0154]

[0154] Underneath thedetailed Underneath the detailed instructions instructions or directions or directions for for use document, use document, the the catheterization package catheterization packagemay may include include a checklist a checklist of safety of safety considerations/steps, considerations/steps, a patient a patient

information chart, information chart, ororananinsert insertsheet sheet including including safety safety consideration/steps consideration/steps and aand a patient patient

information chart information chart combined combinedon on thethe same same insert insert sheet. sheet. FIG.FIG. 16 shows 16 shows an insert an insert sheet sheet 72 on 72 on 2023203963 23

whichpatient which patient information informationcan canbeberecorded recordedororcharted chartedand andincluding including safetyinformation. safety information.This This insert sheet insert sheet 72 72 may be accessed may be accessedafter after the the detailed detailed instructions instructionsare areremoved from the removed from the package. package. 2023203963

It may be beneficial to have an insert sheet 72 in this location to do one last safety check prior It may be beneficial to have an insert sheet 72 in this location to do one last safety check prior

to treating to treatingthe thepatient patientand andtotohave haveimportant important patient patientinformation information at athand. hand. The insert sheet The insert sheet 72 72

may be configured as a sticker label, e.g., the insert sheet 72 may include a backing that protects may be configured as a sticker label, e.g., the insert sheet 72 may include a backing that protects

a sticker adhesive, and when the backing is removed, the insert sheet 72 may be stuck to a file a sticker adhesive, and when the backing is removed, the insert sheet 72 may be stuck to a file

or chart associated with the patient. or chart associated with the patient.

[0155]

[0155] After removing After removingthe thedetailed detailedinstructions instructions6868and andthetheinsert insertsheet sheet7272from from thethe

catheterization package, a perineal care (or peri-care) packet or kit 74 is revealed, as shown in catheterization package, a perineal care (or peri-care) packet or kit 74 is revealed, as shown in

FIGS. 17 and 18, and may be accessed. A peri-care kit is helpful to provide an initial cleaning FIGS. 17 and 18, and may be accessed. A peri-care kit is helpful to provide an initial cleaning

of the of the area area where the catheterization where the catheterization takes takes place place prior prior to to using an iodine using an iodine solution solution to to further further cleanse and sanitize the area. This is especially true for patients who are very dirty and must cleanse and sanitize the area. This is especially true for patients who are very dirty and must

have an initial cleaning before the iodine solution will be most effective. The peri-care kit may have an initial cleaning before the iodine solution will be most effective. The peri-care kit may

include any items helpful for an initial cleaning of the patient's perineum or for perineum care include any items helpful for an initial cleaning of the patient's perineum or for perineum care

in general. in Forexample, general. For example,asasshown shown in FIGS. in FIGS. 18 19, 18 and and the 19, peri-care the peri-care kit may kit may include include hand hand sanitizer 76 (e.g., antiseptic gel hand rinse) for the health care provider to sanitize his/her hands, sanitizer 76 (e.g., antiseptic gel hand rinse) for the health care provider to sanitize his/her hands,

moist towelettes moist towelettes7878(e.g., (e.g.,a apackage package of castile of castile soap soap towelettes), towelettes), instructions/procedural instructions/procedural

indicators 8080(e.g., indicators (e.g., instructions/procedural instructions/proceduralindicators indicators for for health health care care provider provider and/or and/or instructions for instructions forpatient). patient).The Thehand hand sanitizer sanitizermay maybe bedesigned designed to tohave haveimproved efficacy and/or improved efficacy and/or

to enable to enable single-handed usage. single-handed usage.

[0156]

[0156] As shown As shownininFIGS. FIGS. 17-19, 17-19, thethe items items of of thethe peri-care peri-care kitmay kit may be be included included in ain a bag 82 bag 82 (e.g., (e.g., aazip ziplock baggy) lock baggy)ororother package other packagetotokeep keepthe theitems/components items/components together. together. In In one one

embodiment,the embodiment, thebag bagtype typeused usedisisa abaggy baggyincluding includinga azipper zipper84. 84.ItIthas hasbeen beenfound foundsuch sucha abag bag type is easier to open with gloves on rather than, for example, a bag without a zipper or a bag type is easier to open with gloves on rather than, for example, a bag without a zipper or a bag

that must be opened by tearing. However, a bag with perforations on the bag instead of a zipper that must be opened by tearing. However, a bag with perforations on the bag instead of a zipper

or zip-lock or zip-lock feature feature isisalso contemplated, also contemplated,asassuch suchmay may be be cheaper cheaper to to manufacture. manufacture.

[0157]

[0157] Peri-care instructions/procedural Peri-care instructions/procedural indicators indicators 80 80 are areshown in FIGS. shown in 17-19. The FIGS. 17-19. The instructions 80 instructions mayinform 80 may informa ahealth healthcare careprovider provider to:to:"1. "1.Wash Wash hands hands and gloves," and don don gloves," "2. "2.

-35-

Explain procedure to patient and open Peri-Care kit," "3. Use the provided packet of towel ettes 2023203963 23 Jun 2023

Explain procedure to patient and open Peri-Care kit," "3. Use the provided packet of towelettes

to cleanse to cleanse the thepatient's patient'speri-urethral area," peri-urethral and and area," "Remove gloves "Remove and gloves andperform performhand hand hygiene hygiene with with

provided alcohol hand sanitizer gel." Other instructions/procedural indicators are also possible. provided alcohol hand sanitizer gel." Other instructions/procedural indicators are also possible.

The method The methodmay may include include performing performing somesome or all or all of the of the four four stepsrecited steps recitedabove aboveasassteps stepsononthe the instructions. instructions.

[0158]

[0158] The method The methodmaymay proceed proceed in three in three main main stages, stages, i.e., i.e., (A) (A) the initial the initial peri-care peri-care 2023203963

stage, (B) stage, (B) the the catheterization catheterizationstage, and stage, and(C) (C)the thecatheter care catheter andandmaintenance care maintenance stage. stage. Each of Each of

these stages is denoted on the instructions/procedural indicators and/or other materials with a these stages is denoted on the instructions/procedural indicators and/or other materials with a

large "A" large "A" "B" "B"oror"C" "C"totosignify signifythe thedifferent differentmain mainstages. stages.As As cancan be seen be seen on peri-care on the the peri-care instructions 80, instructions 80, there is aa large there is "A" atat the large "A" the top top ofofthe theinstructions/procedural instructions/proceduralindicators indicatorstoto indicate the first stage. As discussed elsewhere herein, the belly band 46 includes a large "B" indicate the first stage. As discussed elsewhere herein, the belly band 46 includes a large "B"

to indicate the second stage, and the main compartment 1 of the catheterization tray includes a to indicate the second stage, and the main compartment 1 of the catheterization tray includes a

large "C" to indicate the third stage. large "C" to indicate the third stage.

[0159]

[0159] After removing After removingand andusing usingthetheperi-care peri-carekit, kit, aa belly belly band/indicator band/indicator wrapper wrapper4646 maybeberevealed may revealedasasshown shownininFIG. (seealso FIG.2020(see alsoindicator indicatorwrapper wrapper140140ininFIG. FIG.30B). SOB).TheThe belly belly

band46 band 46may maycircumvent circumvent thethe trayininatat least tray least one one direction. direction. The The belly belly band 46 may band 46 mayhelp helptoto keep keep the CSR the wrapintact CSR wrap intactand andmaintain maintainthe thesterile sterile barrier. barrier. The The belly belly band 46 may band 46 mayalso alsohelp helpto to keep keep all the contents inside the tray, so the items do not move around. all the contents inside the tray, so the items do not move around.

[0160]

[0160] The belly The bellyband/indicator band/indicator wrapper wrapper 46 include 46 may may include instructions/procedural instructions/procedural

indicators and/or indicators and/or other other information information thereon. For example, thereon. For example,asasshown showninin FIG.2020 FIG. (seealso (see alsoFIG. FIG. SOB), the 30B), the belly belly band bandmay may include include an an instruction/procedural instruction/procedural indicator indicator tellingthethehealth telling healthcare care provider how provider howtotoorient orient the the tray tray relative relative to tothe thepatient. patient.For Forexample, example, the the belly belly band maysay, band may say, "orient toward insertion site" and have an arrow pointing to the end of the catheterization tray "orient toward insertion site" and have an arrow pointing to the end of the catheterization tray

that should be positioned closest to the patient's perineum and urinary tract. This ensures that that should be positioned closest to the patient's perineum and urinary tract. This ensures that

the tray is properly positioned for most logical and intuitive use when the CSR wrap is opened. the tray is properly positioned for most logical and intuitive use when the CSR wrap is opened.

[0161]

[0161] Further, as Further, as shown in FIG. shown in FIG. 20 (see also 20 (see also indicator indicator wrapper 140inin FIG. wrapper 140 FIG.30B), SOB),the the belly band belly band4646 maymay include include instructions/procedural instructions/procedural indicators indicators to "utilize to "utilize proper proper aseptic aseptic

technique," "(1) technique," "(1) Open CSR Open CSR Wrap," Wrap," "(2) "(2) DonDon Sterile Sterile Gloves," Gloves," "(3) "(3) Place Place Underpad," Underpad," "(4)"(4) Place Place

Fenestrated Drape," Fenestrated Drape,"andand (5) (5) "Follow "Follow Tray Instructions. Tray Instructions. These instructions/procedural These instructions/procedural

indicators include a large "B" at the top to signify that these instructions/procedural indicators indicators include a large "B" at the top to signify that these instructions/procedural indicators

are part are part of of the the second stage or second stage or catheterization catheterization stage. stage. The Theinstructions/procedural instructions/proceduralindicators indicators

-36-

inform the the health health care care provider provider to to open open the the CSR CSRwrap wrap andand perform other steps onceonce the the CSR CSR 2023203963 23 Jun 2023

inform perform other steps

wrap is opened. Providing this information before breaking the sterile barrier gives the health wrap is opened. Providing this information before breaking the sterile barrier gives the health

care provider a preview of the procedure, and ensures he/she is prepared when the sterile barrier care provider a preview of the procedure, and ensures he/she is prepared when the sterile barrier

is broken is by opening broken by openingthe theCSR CSR wrap. wrap. Optionally, Optionally, a label a label or sticker or sticker maymay be used be used instead instead of a of a belly-band, which belly-band, mayprovide which may provide thesame the same information information as as thethe bellyband belly band described described herein. herein.

[0162]

[0162] Oncethe Once thetray tray is is oriented oriented and and the the health health care care provider provider has has read read the the belly belly band band 2023203963

instructions/procedural indicators, the next step is to open and/or remove the belly band. After instructions/procedural indicators, the next step is to open and/or remove the belly band. After

removingthe removing thebelly belly band, band, the the sterile sterile wrap wrap 56 56 (e.g., (e.g.,CSR CSR wrap) maybebeopened. wrap) may opened.FIG. FIG. 21 21 shows shows

the catheterization tray with three corners of the sterile wrap 56 unfolded to represent unfolding the catheterization tray with three corners of the sterile wrap 56 unfolded to represent unfolding

the sterile wrap 56. Note that until the belly band and sterile wrap are opened, the sterile barrier the sterile wrap 56. Note that until the belly band and sterile wrap are opened, the sterile barrier

of the catheterization tray and its components is not broken. This maintains the sterile barrier of the catheterization tray and its components is not broken. This maintains the sterile barrier

while the while the initial initial peri-care peri-care stage stage is iscompleted and while completed and whilethe thetray trayisis properly properlypositioned positionedand and oriented for catheterization. By leaving the sterile barrier intact during the initial steps of the oriented for catheterization. By leaving the sterile barrier intact during the initial steps of the

method, there are fewer opportunities for contamination and the resulting patient infection. method, there are fewer opportunities for contamination and the resulting patient infection.

[0163]

[0163] If the catheterization tray is oriented as directed by the belly band 46, when the If the catheterization tray is oriented as directed by the belly band 46, when the

sterile wrap sterile 56 (e.g., wrap 56 (e.g., CSR CSRwrap) wrap) is is opened, opened, the the traytray is properly is properly oriented oriented for logical for logical and and convenient use of the catheterization tray and its components. The tray is arranged and ordered convenient use of the catheterization tray and its components. The tray is arranged and ordered

for logical step-by-step use as described herein. The initial view of the tray after opening the for logical step-by-step use as described herein. The initial view of the tray after opening the

sterile wrap sterile wrap 56 entirely isis shown 56 entirely in FIG. shown in FIG. 22. 22. (A(Abreakaway breakaway lineline is used is used to to indicate indicate thatthethe that

actual edges actual edges of of the the sterile sterilewrap wrap5656extend extendbeyond beyond the thebreakaway edgesshown breakaway edges shownininFIGS. FIGS.22-29.) 22-29.) Notethat Note that the the sterile sterile wrap wrap 56 56 may remainunderneath may remain underneath thecatheterization the catheterizationtray traytoto form forma asterile sterile field for catheterization. The tray shown in FIG. 22 and the other figures are right-hand biased field for catheterization. The tray shown in FIG. 22 and the other figures are right-hand biased

to make to useeasier make use easier for for aa right-handed health care right-handed health care provider provider when standingnear when standing nearthe thelower loweredge edge of the of the catheterization catheterization tray traywith withthe thesyringe syringe or orcatheter cathetercompartment positionedfurthest compartment positioned furthest from from the health care provider (i.e., if the band points toward the genitalia between the legs, the right- the health care provider (i.e., if the band points toward the genitalia between the legs, the right-

handed user stands on the side closest to the patient's right leg). Alternatively, a catheterization handed user stands on the side closest to the patient's right leg). Alternatively, a catheterization

tray may be left-hand biased (e.g., essentially a mirror image of the tray shown in FIGS. 22-29 tray may be left-hand biased (e.g., essentially a mirror image of the tray shown in FIGS. 22-29

with the mirror placed along the tray's side 7 or along the syringe or catheter compartment). with the mirror placed along the tray's side 7 or along the syringe or catheter compartment).

[0164]

[0164] As instructed on the belly band 46, after first opening the CSR wrap, the health As instructed on the belly band 46, after first opening the CSR wrap, the health

care provider care next dons provider next dons the the sterile sterile gloves gloves provided in the provided in the tray. tray. As shownininFIG. As shown FIG.22, 22,the thetop top item in item in the the tray tray after afterthe theCSR CSR wrap is opened wrap is openedisis aa package package5858ofofsterile sterile gloves gloves (note (note that that the the

cuff end cuff of the end of the gloves gloves may beindicated may be indicatedononthe thepackage package58). 58).TheThe sterilegloves sterile glovesmay may be be made made

-37-

Jun 2023 of any of any material materialknown known to suitable, to be be suitable, e.g., e.g., latex, latex, rubber, rubber, or latex-free or latex-free materials). materials). This This placement of the gloves on top of the tray under the sterile wrap helps the health care provider placement of the gloves on top of the tray under the sterile wrap helps the health care provider

to intuitively to intuitively know he/sheshould know he/she shoulddondon thethe gloves gloves before before proceeding proceeding further further (because (because it is it is intuitive, it may be unnecessary to refer back to the instructions/procedural indicators on the intuitive, it may be unnecessary to refer back to the instructions/procedural indicators on the 2023203963 23

belly band belly band 46). 46). The packageofofgloves The package gloves5858may maybebeopened openedby by folding folding thecuff the cuffdown downtoto bebeclosest closest to the to the health health care careprovider provider and and then then opening the package opening the like aa book, package like as shown book, as inFIG. shown in FIG.23. 23. IfIf 2023203963

openedininthis opened this intuitive, intuitive, logical logical way, the left way, the left hand handglove gloveisispositioned positionedon on thethe health health care care

provider's left side and the right hand glove is positioned on the health care provider's right side provider's left side and the right hand glove is positioned on the health care provider's right side

for easy for easy donning ofthe donning of the gloves. gloves. AAsymbol symbolor or other other indicatormay indicator may be be included included on on the the package package

58 to identify the left and right hand gloves as shown, for example, in FIG. 23. 58 to identify the left and right hand gloves as shown, for example, in FIG. 23.

[0165]

[0165] As instructed As instructed on on the the belly belly band band46, 46,after afterdonning donningthethegloves, gloves,thethehealth healthcare care provider places provider places ananunderpad underpad under under thethe patient's patient's buttocks.As shown buttocks. As shown in 24, in FIG. FIG.once 24,the once the packageofofgloves package glovesisis removed removedfrom from thethe tray,the tray, theunderpad underpadandand fenestrateddrape fenestrated drape areare revealed. revealed.

The folded The folded pad/drape pad/drape8686shown shownin in FIG.2424 FIG. isisrepresentative representativeof: of: (1) (1) aa waterproof waterproof underpad, and underpad, and

(2) aa separate (2) separate fenestrated fenestrated drape. drape. TheThe underpad underpad may ahave may have a waterproof waterproof side andside and a a liquid liquid absorbent side. If so, the absorbent side is placed up under the patient, and the waterproof side absorbent side. If so, the absorbent side is placed up under the patient, and the waterproof side

(or plastic side) is placed down. As instructed on the belly band 46, after placing the underpad, (or plastic side) is placed down. As instructed on the belly band 46, after placing the underpad,

the health care provider places the fenestrated drape on the patient such that the genitalia are the health care provider places the fenestrated drape on the patient such that the genitalia are

visible through visible the central through the central opening openingininthethefenestrated fenestrateddrape. drape.Although Although the underpad the underpad and and fenestrated drape are not shown in FIG. 24 as distinct pieces, they are both included in the area fenestrated drape are not shown in FIG. 24 as distinct pieces, they are both included in the area

of the pad/drape 86, and are arranged such that the underpad is on top of the fenestrated drape of the pad/drape 86, and are arranged such that the underpad is on top of the fenestrated drape

(i.e., because (i.e., becausethe theunderpad is placed underpad is placed first, first,which which reveals revealsthe thefenestrated fenestrateddrape drape for forplacement placement

thereafter). The fenestrated drape is logically located and folded such that it is intuitive to open thereafter). The fenestrated drape is logically located and folded such that it is intuitive to open

the drape away from clinician, which is preferable for how the drape is best used. the drape away from clinician, which is preferable for how the drape is best used.

[0166]

[0166] As instructed on the belly band 46, after placing the fenestrated drape, the health As instructed on the belly band 46, after placing the fenestrated drape, the health

care provider care follows the provider follows the instructions/procedural instructions/procedural indicators indicators and/or takes the and/or takes the steps steps written written on on

the catheterization the catheterization tray trayitself. AsAsshown itself. shown in in FIG. FIG. 25, 25, removal of the removal of the underpad andfenestrated underpad and fenestrated drape reveals drape reveals aa package ofantiseptic package of antiseptic solution solution 52 (e.g., povidone-iodine 52 (e.g., povidone-iodine solution). solution). (Note that (Note that

FIG. 25 FIG. 25 shows showsthe thefenestrated fenestrateddrape drapemoved moved from from overover the the swabswab compartment compartment 3 into3 the intomain the main compartment compartment 1. 1.Moving Moving the the drape drape in this in this wayway or placing or placing the the fenestrated fenestrated drape drape on the on the patient patient

will reveal will reveal the the antiseptic antiseptic solution solution in in the the swab swabcompartment.) compartment.) Further, Further, the first the first

instruction/procedural indicator 47 on the tray (i.e., "(1) Open Iodine"; although, variations on instruction/procedural indicator 47 on the tray (i.e., "(1) Open Iodine"; although, variations on

-38-

this instruction or other instructions are possible) is visible on the left side of the tray (which is 2023203963 23 Jun 2023

this instruction or other instructions are possible) is visible on the left side of the tray (which is

also the side closest to the patient and the region to be catheterized, if oriented as instructed by also the side closest to the patient and the region to be catheterized, if oriented as instructed by

the belly band 46). Placement of the first instruction 47 on the left is logical because people the belly band 46). Placement of the first instruction 47 on the left is logical because people

read English from left to right, and beginning instructions on the left is intuitive (although in read English from left to right, and beginning instructions on the left is intuitive (although in

countries that do not read left to right, this might be adjusted). Also the instruction/procedural countries that do not read left to right, this might be adjusted). Also the instruction/procedural

indicator is indicator is located close to located close to the the antiseptic antiseptic or or iodine solution 52 iodine solution 52 inin the thetray, tray, which whichmakes makes 2023203963

following the instruction/procedural indicator easier and more intuitive. following the instruction/procedural indicator easier and more intuitive.

[0167]

[0167] Assumingthetheclinician Assuming clinicianisis right-handed, right-handed, and andhas hasoriented orientedthe thetray tray as as instructed instructed by the belly band 46, the antiseptic or iodine solution 52 is automatically positioned closest to by the belly band 46, the antiseptic or iodine solution 52 is automatically positioned closest to

patient. (However, patient. asdiscussed (However, as discussedabove, above,another anotherarrangement arrangementis is possiblewhere possible where thethe trayisisleft- tray left- handed biased (e.g., essentially a mirror image of the tray in the figures) such that a left-handed handed biased (e.g., essentially a mirror image of the tray in the figures) such that a left-handed

user positioning the tray as instructed by the belly band would also automatically position the user positioning the tray as instructed by the belly band would also automatically position the

antiseptic or iodine solution closest to the patient (e.g., with the left-handed clinician standing antiseptic or iodine solution closest to the patient (e.g., with the left-handed clinician standing

on an on an opposite opposite side side of of the the tray trayfrom from where where aa right-handed clinician would right-handed clinician stand or would stand or on on the the side side closest to the patient's left leg).) Positioning the antiseptic or iodine solution (and the swab closest to the patient's left leg).) Positioning the antiseptic or iodine solution (and the swab

compartment)closest compartment) closesttotothe thepatient patientisispreferable preferablefor forthe theuse useofofthe thetray. tray. Having Having thethe swab swab

compartment3 and compartment 3 and wellwell of iodine of iodine solution solution closest closest to patient to the the patient is beneficial, is beneficial, because because it it prevents dragging prevents draggingoror moving movingswabs swabs saturated saturated with with thethe antisepticororiodine antiseptic iodinesolution solutionacross acrossthe the tray (which tray mightdrip (which might drip on on other other components componentsofofthe thetray, tray, if if moved overthem). moved over them).

[0168]

[0168] FIG. 26 FIG. 26shows showsthethe catheterizationtray catheterization trayafter afterremoval removalof of thethe povidone-iodine povidone-iodine

solution. Note that removal of the packet of antiseptic or iodine solution 52 reveals the swabs solution. Note that removal of the packet of antiseptic or iodine solution 52 reveals the swabs

or swabsticks 34 and the second instruction/procedural indicator 48 on the tray. This intuitively or swabsticks 34 and the second instruction/procedural indicator 48 on the tray. This intuitively

leads the health care provider to logically follow the second instruction 48 after picking up the leads the health care provider to logically follow the second instruction 48 after picking up the

packet of packet of antiseptic antiseptic or or iodine iodine solution. solution. The secondinstruction The second instruction 48 48ononthe thetray trayisis in in the the swab swab

compartment3 3andand compartment says says "(2)Pour "(2) Pour Iodine Iodine Here Here -->"—>" andand points points to the to the lowest/deepest lowest/deepest point point or or well of well of the the swab compartment swab compartment 3 (although, 3 (although, variations variations of of thisinstruction this instruction oror other other instructions instructions are possible). If antiseptic or iodine solution is poured on the barriers or channels of the swab are possible). If antiseptic or iodine solution is poured on the barriers or channels of the swab

compartment 3, the incline ensures the solution will flow to the lowest/deepest point or well. compartment 3, the incline ensures the solution will flow to the lowest/deepest point or well.

[0169]

[0169] Oncethe Once thehealth health care care provider providerhas haspoured pouredthe theantiseptic antiseptic or or iodine iodine solution solution into into the well the well of of the theswab swab compartment compartment 3 3such suchthat that the the absorbent heads of absorbent heads of the the swabs begin absorbing swabs begin absorbing the antiseptic or iodine solution, the health care provider may then attach the syringe of sterile the antiseptic or iodine solution, the health care provider may then attach the syringe of sterile

liquid 88 to the inflation port of the catheter 92 (e.g., a Foley catheter) as is instructed by the liquid 88 to the inflation port of the catheter 92 (e.g., a Foley catheter) as is instructed by the

-39-

Jun 2023 third instruction/procedural indicator 49. The third instruction 49 is logically located on side third instruction/procedural indicator 49. The third instruction 49 is logically located on side

7 of the tray not far from the well of the swab compartment where the health care provider has 7 of the tray not far from the well of the swab compartment where the health care provider has

just poured the antiseptic or iodine solution, and near the syringe of sterile liquid to be used in just poured the antiseptic or iodine solution, and near the syringe of sterile liquid to be used in

the third the third instruction. instruction. The third instruction The third instruction 49 states "(3) 49 states "(3) Attach WaterSyringe" Attach Water Syringe"(although, (although, 2023203963 23

variations on this instruction or other instructions/procedural indicators are possible). FIG. 27 variations on this instruction or other instructions/procedural indicators are possible). FIG. 27

shows the syringe of sterile liquid or water 88 after it has been attached to the inflation port of shows the syringe of sterile liquid or water 88 after it has been attached to the inflation port of 2023203963

the catheter 92. the catheter 92.

[0170]

[0170] Oncethe Once thesyringe syringeofofsterile sterile liquid liquid 88 is removed 88 is fromthethesyringe removed from syringe or or catheter catheter

compartment,the compartment, thefourth fourthinstruction/procedural instruction/procedural indicator indicator 50 50 is is revealed revealed (which was previously (which was previously obscured by the syringe of sterile liquid). The fourth instruction 50 may inform the health care obscured by the syringe of sterile liquid). The fourth instruction 50 may inform the health care

provider to provider to "(4) "(4) Lube Catheter"oror"(4) Lube Catheter" "(4)Dispense Dispense& & Lube Lube Foley Foley Here" Here" or something or something similarsimilar

(again, variations on this instruction or other instructions/procedural indicators are possible). (again, variations on this instruction or other instructions/procedural indicators are possible).

Indeed, lubricating the catheter is the next step taken by the health care provider. To do so, the Indeed, lubricating the catheter is the next step taken by the health care provider. To do so, the

health care health care provider provider removes removesthethesyringe syringeofof lubricatingjelly lubricating jelly89, 89,which whichremoval removal reveals reveals the the

fifth, sixth, and seventh instructions/procedural indicators that were previously obscured by the fifth, sixth, and seventh instructions/procedural indicators that were previously obscured by the

syringe of lubricating jelly 89. In accordance with the present disclosure, the lubricating jelly syringe of lubricating jelly 89. In accordance with the present disclosure, the lubricating jelly

can be provided in other suitable containers well-known to those of ordinary skill in the art, can be provided in other suitable containers well-known to those of ordinary skill in the art,

with non-limiting with non-limitingexamples examples including including a bellows, a bellows, an ampoule, an ampoule, or like. or the the like. The health The health care care provider can then lubricate the catheter in any way desired. In one embodiment, the health care provider can then lubricate the catheter in any way desired. In one embodiment, the health care

provider can provider can remove removethe theplastic plastic wrap 90(shown wrap 90 (shownininFIGS. FIGS.2727andand 28) 28) from from over over thethe catheter9292 catheter

(which can (which canbebea aFoley Foley catheter)andand catheter) move move a portion a portion of catheter of the the catheter 92 into 92 into the syringe the syringe or or catheter compartment catheter compartment 2,2,e.g., e.g., asasshown shownin in FIG. FIG. 28.28. Placing Placing the distal the distal end end 94the 94 of of Foley the Foley catheter 92 catheter 92 in in the the syringe syringeororcatheter cathetercompartment compartment 2 helps 2 helps to line to line the the catheter catheter 92for 92 up up for lubrication and lubrication catheterization. For and catheterization. example,asasshown For example, shownin in FIG. FIG. 28,28, with with thethe distalend distal end9494of of the catheter 92 positioned near the left-most side of the syringe or catheter compartment 2, the the catheter 92 positioned near the left-most side of the syringe or catheter compartment 2, the

distal end distal 94 ofofthe end 94 thecatheter catheter9292isispositioned positionedvery very near near the the patient patient and and the region the region to beto be catheterized (assuming catheterized the tray (assuming the tray has has been beenoriented oriented asas directed directed by by the the belly belly band band 46). 46). Further, Further, the distal tip of the catheter 92 is positioned such that it essentially points at the region to be the distal tip of the catheter 92 is positioned such that it essentially points at the region to be

catheterized such catheterized that the such that the health health care care provider provider may simplylift may simply lift the the catheter catheter 92 and move 92 and moveititaa short distance in the direction it is pointing to begin insertion of the catheter 92 into the patient. short distance in the direction it is pointing to begin insertion of the catheter 92 into the patient.

Oncethe Once thecatheter catheter9292isispositioned positionedininthe thesyringe syringeororcatheter cathetercompartment compartment 2, the 2, the useruser may may dispense the dispense the lubricating lubricating jelly jellyfrom from the the syringe syringe 89 89 into into the the syringe syringe or or catheter cathetercompartment compartment 22

onto a distal portion of the catheter 92 (e.g., the syringe may be dispensed on the left side of onto a distal portion of the catheter 92 (e.g., the syringe may be dispensed on the left side of

-40-

the syringe syringe or or catheter catheter compartment near thepatient patientand andthetheregion region to to bebe catheterized),and and 2023203963 23 Jun 2023

the compartment near the catheterized),

twist the catheter 92 in the lubricating jelly to ensure it is properly lubricated. twist the catheter 92 in the lubricating jelly to ensure it is properly lubricated.

[0171]

[0171] Whilethe While theabove above lubrication lubrication method method is beneficial is beneficial for for the the reasons reasons discussed discussed

above, other above, other methods methodsofoflubricating lubricating the the catheter catheter 92 92 are are also also possible. possible. In Inone one embodiment, the embodiment, the

health care health care provider provider may dispensethe may dispense thelubricating lubricating jelly jelly onto onto aa portion portion of of the thesterile/CSR sterile/CSRwrap wrap

aroundthe around the tray tray and andput putthe theend endofofthe thecatheter catheterininthe thelubricating lubricatingjelly jelly to to lubricate. lubricate. In In one one 2023203963

embodiment,thetheuser embodiment, usermaymay dispense dispense the the lubricating lubricating jellydirectly jelly directlyinto intothe thesyringe syringeororcatheter catheter compartment2 2before compartment before moving moving the the catheter catheter 92 from 92 from mainmain compartment compartment 1, and 1, andmove then thenthe move the distal portion of the catheter 92 into the lubricating jelly. distal portion of the catheter 92 into the lubricating jelly.

[0172]

[0172] After lubricating the catheter 92, the health care provider may leave the catheter After lubricating the catheter 92, the health care provider may leave the catheter

92 temporarily 92 temporarilyininthe thesyringe syringeandand catheter catheter compartment compartment 2 while 2 while he/shehe/she uses his/her uses his/her non- non dominanthand dominant handtotoretract retract the the genitalia, genitalia, and and uses uses his/her his/herdominant dominant hand to prepare hand to prepare and and sanitize sanitize the patient with the swabs or swabsticks saturated with antiseptic or iodine solution. The swabs the patient with the swabs or swabsticks saturated with antiseptic or iodine solution. The swabs

or swabsticks or swabsticks (e.g., (e.g., swabs or swabsticks swabs or swabsticks3434with with absorbent absorbent head head 36 and 36 and stickstick 38 discussed 38 discussed

above) may above) maybebetwisted twistedeither eitherclockwise clockwise or or counterclockwise counterclockwise to easily to easily release release them them fromfrom the the channels of channels of the the swab compartment swab compartment asas discussedabove. discussed above.Preferably Preferably each each swab swab or swabstick or swabstick will will

be used for one swipe on the patient only. For female patients, one may cleanse the patient by: be used for one swipe on the patient only. For female patients, one may cleanse the patient by:

(1) using (1) using aa downward strokewith downward stroke withone oneswab swab or or swabstick swabstick to to cleanse cleanse theright the rightlabia labiaminora minoraand and discard the discard the swab or swabstick, swab or swabstick, (2) (2) using using aa downward strokewith downward stroke withanother anotherswab swaboror swabstick swabstick to to

cleanse the cleanse the left leftlabia labiaminora minora and and discard discard the the swab or swabstick, swab or swabstick, and (3) using and (3) using a a third third swab or swab or

swabstick to swabstick to cleanse cleanse the the middle middlearea areabetween betweenthethe labiaminora. labia minora. For For malemale patients, patients, one one may may cleanse the cleanse the patient patient with with aa swab swabororswabstick swabstickusing usinga circular a circularmotion motion startingatatthe starting theurethral urethral meatusand meatus andworking working outward. outward. After After propping prepping and and sanitizing sanitizing thethe patient patient in in thisway, this way,the thehealth health care provider uses his/her dominant hand to insert the catheter into the patient's bladder (urine care provider uses his/her dominant hand to insert the catheter into the patient's bladder (urine

becomesvisible becomes visibleinin the the tubing tubing when whenthe thecatheter catheterenters entersthe the bladder, bladder, but but two twoadditional additional inches inches beyondthis beyond this point point should shouldbebeinserted insertedto to allow allowthe the retention retention balloon balloon to to enter enter the the bladder), bladder), and and

inflate the retention balloon in the bladder by injecting the sterile liquid from the syringe of inflate the retention balloon in the bladder by injecting the sterile liquid from the syringe of

sterile liquid sterile liquid88 88 into intothe thecatheter catheter92 92 through through the the inflation inflation port. port. Indeed, these are Indeed, these are the the steps steps instructed on the tray in the fifth step, sixth step, and seventh step, which state, respectively, instructed on the tray in the fifth step, sixth step, and seventh step, which state, respectively,

"(5) Retract "(5) Retract Genitalia Genitalia(Non-Dominant (Non-Dominant Hand)", Hand)", "(6) "(6) Prep Prep Patient Patientwith with Swabs Swabs (Dominant (Dominant

Hand)", and Hand)", and"(7) "(7)Insert Insert Catheter Catheter&&Inflate InflateBalloon Balloon(Dominant (Dominant Hand)." Hand)." Variations Variations on on these these instructions/procedural indicators instructions/procedural indicators or or other otherinstructions/procedural instructions/proceduralindicators indicatorsarearepossible. possible.

-41-

Once inflated, the health care provider may gently pull the catheter until the inflated balloon is 2023203963 23 Jun 2023

Once inflated, the health care provider may gently pull the catheter until the inflated balloon is

snug against snug against the the bladder neck. These bladder neck. Thesesteps stepscomplete complete thecatheterization the catheterizationstage stageororstage stage "B" "B"ofof the procedure. the procedure.

[0173]

[0173] FIG. 29 FIG. 29 shows showshow how thethe tray tray may may look look immediately immediately afterafter the the catheter catheter has has beenbeen

properly placed in the patient. Note that the drainage tubing 95 easily follows the catheter 92 properly placed in the patient. Note that the drainage tubing 95 easily follows the catheter 92

towardthe toward the patient patient and and out out of ofthe the tray. tray. AAfolded foldedurine urinecollection collectionbag bag9696isispositioned positionedininthe the 2023203963

maincompartment main compartment 1 in 1 in FIG. FIG. 29 29 andand maymay be packaged be packaged pre-connected pre-connected to thetotubing the tubing 95, catheter 95, catheter

92, and/or 92, and/or other other components ofthe components of the catheter catheter assembly. assembly. Urine collection bag Urine collection bag 96 96 may be unfolded may be unfolded and hung below the patient to collect urine as it drains from the patient. and hung below the patient to collect urine as it drains from the patient.

[0174]

[0174] After catheterization of the patient (i.e., after the catheter has been inserted and After catheterization of the patient (i.e., after the catheter has been inserted and

the retention the retention balloon inflated in balloon inflated in the the patient's patient's bladder), bladder), additional additional steps steps may be taken. may be taken. For For example,inin stage example, stage "C" "C"ororthe theCare Careand andMaintenance Maintenance stage, stage, the the health health care care provider provider may:may: (1) (1) secure the Foley catheter to the patient (e.g., using a StatLock® device), (2) position the urine secure the Foley catheter to the patient (e.g., using a StatLock® device), (2) position the urine

bag and/or bag and/or urine urine meter meterbelow belowthe thepatient's patient's bladder bladder (e.g., (e.g., hang hang the the bag on aa hanger bag on hanger on onthe the bed bed rail at the foot of the bed) and secure the tubing to the bed sheets (e.g., with a clip) in such a rail at the foot of the bed) and secure the tubing to the bed sheets (e.g., with a clip) in such a

waythat way that the the tubing tubing is is not not kinked, kinked, (3) (3) document the insertion document the insertion date date by by indicating indicating time time and and date date

of catheter of catheter insertion insertion on on a a label label and/or and/or chart chart (e.g., (e.g.,the thelabel/sheet 7272shown label/sheet shown in in FIG. 16) and FIG. 16) and document the procedure according to hospital protocol, (4) maintain the catheter (e.g., if it has document the procedure according to hospital protocol, (4) maintain the catheter (e.g., if it has

a sterile red seal, then maintain the red seal), (5) re-assess the need for the indwelling catheter a sterile red seal, then maintain the red seal), (5) re-assess the need for the indwelling catheter

routinely evaluate routinely evaluate whether whetherthethe catheter catheter becomes becomes unnecessary, unnecessary, (6) other (6) and/or and/orcare other or care or maintenancesteps. maintenance steps.

[0175]

[0175] Stage "C" and associated instructions/procedural indicators are identified in the Stage "C" and associated instructions/procedural indicators are identified in the

maincompartment main compartmentof of thethe catheterizationtray catheterization trayasas shown shownininFIGS. FIGS.1, 1,2,2,and and5.5. For Forexample, example, the the

stage "C" stage "C" instructions/procedural instructions/procedural indicators indicators may include: "(1) may include: "(1) Secure Secure Foley Foleywith withStatLock®", StatLock®", "(2) position bag below bladder", "secure tubing to sheets with clip", "(3) document insertion "(2) position bag below bladder", "secure tubing to sheets with clip", "(3) document insertion

date", "(4) date", "(4) maintain red seal maintain red seal per per hospital hospital policy", policy", "(5) "(5) assess assess need needfor forcatheter catheterroutinely." routinely." Variations ononthese Variations these instructions/procedural instructions/procedural indicators indicators or instructions/procedural or other other instructions/procedural indicators are indicators are possible. possible. Urine samplesmay Urine samples maybe be taken taken as as instructed instructed in in FIG. FIG. 14D. 14D. Ultimately, Ultimately,

the catheter the catheter may be removed may be removedasasinstructed instructedinin FIG. FIG. 14C. 14C.

[0176]

[0176] The catheterization The catheterization package(s) package(s)andand catheterization catheterization tray(s) tray(s) described described herein herein

madebebemanufactured/packaged made manufactured/packaged in different in different ways. ways. For For example, example, a manufacturer a manufacturer or vendor or vendor of of

-42-

catheterization packages mayvary varythe thesteps stepsororprocedures proceduresdescribed described herein,maymay reorder thethe 2023203963 23 Jun 2023

catheterization packages may herein, reorder

steps, may steps, performadditional may perform additionalsteps steps beyond beyondthose thosedescribed, described,and/or and/ormay may omit omit certain certain stepsasas steps

circumstances and circumstances and unique uniqueneeds needsmaymay require. require. Further, Further, any features, any features, components, components,

arrangements,designs, arrangements, designs,ordering ordering of components, of components, etc. described etc. described above features above (e.g., (e.g., features or or arrangementsthat arrangements thatmake make using using thethe catheterizationpackage catheterization package more more intuitive intuitive or logical) or logical) maymay be be addedto added to or or included in the included in the catheterization catheterizationpackage package during during manufacturing, e.g., in manufacturing, e.g., in aamethod of method of 2023203963

manufacturing/packaging. However, manufacturing/packaging. However, non-limiting, non-limiting, methods methods of manufacture/packaging of manufacture/packaging are are described below. The steps described herein may be done in order as described or out of order. described below. The steps described herein may be done in order as described or out of order.

[0177]

[0177] In one In one embodiment, embodiment, a catheterization a catheterization package package is manufactured/packaged is manufactured/packaged by by providing a catheterization tray (e.g., a catheterization tray similar to or including features of providing a catheterization tray (e.g., a catheterization tray similar to or including features of

those shown those shownininFIGS. FIGS.1-5 1-5and anddescribed describedabove). above).TheThe tray tray maymay be purchased be purchased or formed or formed by by the the manufacturerofofthe manufacturer thecatheterization catheterization package. package. IfIfmanufactured, manufactured,thethetray traymay may be be formed formed using using

an injection an injection molding processororother molding process othersuitable suitableprocesses. processes.Instructions/procedural Instructions/proceduralindicators indicators maybebeintegrated may integratedon, on,printed, printed, ororotherwise otherwiseincluded includedon on thethe trayas asdescribed tray described above above and and as as shown,for shown, for example, example,ininFIGS. FIGS.1,1,2,2, and and 5. 5.

[0178]

[0178] Various components Various components (e.g.,any (e.g., anyofofthe the components componentsdiscussed discussed above above or or elsewhere elsewhere

herein) may herein) beadded may be addedtotothe thetray. tray. InInone oneembodiment, embodiment, a pre-connected a pre-connected drainage drainage system system may may be added be addedto/included to/includedininthe the tray, tray, e.g., e.g.,ininthe themain main compartment compartment 1 1asasshown shownin in FIG. FIG. 26.26. The The

drainage system drainage systemmay may include include a drainage/collection a drainage/collection bag bag 96,96, drainage drainage tubing tubing 95, 95, a catheter a catheter 92 92 (e.g., a Foley catheter), a drainage outlet, a urine meter, or other drainage components. Swabs (e.g., a Foley catheter), a drainage outlet, a urine meter, or other drainage components. Swabs

or swabsticks or swabsticks 3434may maybe be added added to/included to/included in the in the tray, tray, e.g.,ininthe e.g., theswab swab compartment compartment 3 as 3 as shownininFIG. shown FIG.8 8ororFIG. FIG.26. 26.A A specimen specimen or sample or sample container container 54 and 54 and a label a label thatthat cancan be be filled filled

out with out with details detailsregarding regarding the thesample sample and and adhered to the adhered to the specimen or sample specimen or samplecontainer containermay maybebe addedto/included added to/included in in the the tray, tray, e.g., e.g.,inin thethecorner storage corner compartment storage compartment 5 as shown in FIG. shown in FIG.26. 26. A packet or container of an antiseptic skin cleanser 52 (e.g., a packet or container of povidone- A packet or container of an antiseptic skin cleanser 52 (e.g., a packet or container of povidone-

iodine solution) iodine solution) may be added may be addedto/included to/includedininthe the tray, tray, e.g., e.g.,ininthe theswab swabcompartment compartment 33 on ontop top of the swabsticks 34 as shown in FIG. 25. A packet or container of lubricant 89 (e.g., a syringe of the swabsticks 34 as shown in FIG. 25. A packet or container of lubricant 89 (e.g., a syringe

of lubricating of lubricating jelly) jelly) may beadded may be addedto/included to/included in in thethe tray,e.g., tray, e.g.,ininthe thesyringe syringeororcatheter catheter compartment compartment 2 asshown 2 as shown in FIG. in FIG. 26. 26. A syringe A syringe of sterile of sterile liquid liquid 88 (e.g., 88 (e.g., a lOcc a 10cc syringe syringe of of sterile water for inflating the retention balloon of the Foley catheter) may be added to/included sterile water for inflating the retention balloon of the Foley catheter) may be added to/included

in the tray, e.g., in the syringe or catheter compartment 2 on top of or partially on top of the in the tray, e.g., in the syringe or catheter compartment 2 on top of or partially on top of the

syringe of syringe of lubricating lubricating jelly jelly89 89 as as shown in FIG. shown in FIG. 26. 26. A Afenestrated fenestrateddrape drapeto toplace placeonon patient patient

-43-

maybebeadded addedto/included to/includedininthe thetray, tray, e.g., e.g.,on ontop topof ofother othercomponents, components, and and may spanportions portions 2023203963 23 Jun 2023

may may span

of more of than one more than onecompartment compartmentas as shown shown in FIG in FIG 24. 24. An underpad An underpad to place to place under under the buttocks the buttocks

of a patient (e.g., a waterproof absorbent underpad) may be added to/included in the tray, e.g., of a patient (e.g., a waterproof absorbent underpad) may be added to/included in the tray, e.g.,

on top on top of of the the fenestrated fenestrated drape drape or or other other components, andmay components, and mayspan span portionsofofmore portions more than than oneone

compartment.BothBoth compartment. the the underpad underpad and fenestrated and fenestrated drape drape are are represented represented in the figures in the figures by by pad/drape 86. Gloves (e.g., a package 58 of rubber gloves, latex gloves, latex-free gloves) may pad/drape 86. Gloves (e.g., a package 58 of rubber gloves, latex gloves, latex-free gloves) may 2023203963

be added be addedto/included to/includedininthe thetray, tray, e.g., e.g., on on top top of of the the underpad or other underpad or other components componentsandand maymay

span portions span portions of of more than one more than onecompartment compartmentas as shown shown in FIG. in FIG. 22. 22.

[0179]

[0179] The tray The tray and and components componentsmaymay be sterilized,andand be sterilized, a sterilewrap a sterile wrap5656(e.g., (e.g., aa CSR CSR wrap) may wrap) maybebefolded foldedororwrapped wrapped around around the the catheterization catheterization tray tray as as shown shown in FIGS. in FIGS. 20-21. 20-21. A A belly band 46 (e.g., to hold the sterile wrap in a folded configuration and help to keep all the belly band 46 (e.g., to hold the sterile wrap in a folded configuration and help to keep all the

contents inside contents inside the the tray, tray,sosothe theitems itemsdo donot notmove move around) maybebeincluded around) may includedaround around thesterile the sterile wrap 56 as shown in FIG. 20. A perineal care (or peri-care) packet or kit 74 (e.g., as shown in wrap 56 as shown in FIG. 20. A perineal care (or peri-care) packet or kit 74 (e.g., as shown in

FIGS.17-19) FIGS. 17-19)may maybe be added added to/included to/included in the in the catheterization catheterization package, package, e.g., e.g., placed placed over over thethe

belly band belly 46 and/or band 46 and/or sterile sterile wrap wrap 56 56 as as shown in FIGS. shown in 17 and FIGS. 17 and18. 18. The Theperineal perinealcare carepacket packetoror kit 74 may include hand sanitizer 76 (e.g., antiseptic gel hand rinse), moist towelettes 78 (e.g., kit 74 may include hand sanitizer 76 (e.g., antiseptic gel hand rinse), moist towelettes 78 (e.g.,

a package of castile soap towelettes), instructions 80 (e.g., instruction for health care provider a package of castile soap towelettes), instructions 80 (e.g., instruction for health care provider

and/or instructions for patient), and/or other components (see e.g., FIG. 19). An insert sheet or and/or instructions for patient), and/or other components (see e.g., FIG. 19). An insert sheet or

label 72 with instructions or other information may be added to/included in the catheterization label 72 with instructions or other information may be added to/included in the catheterization

package, e.g., an insert sheet or label 72 with a checklist of safety considerations/steps and/or package, e.g., an insert sheet or label 72 with a checklist of safety considerations/steps and/or

a patient a patient information information chart chart may be included may be included on ontop top of of the the perineal perineal care care packet packet or or kit kitasasshown shown

in FIG. in FIG. 16. 16. A detailed instructions A detailed instructionsdocument (e.g., asasshown document (e.g., shown in inFIGS. FIGS. 14A-14D) and/orpatient 14A-14D) and/or patient educational information educational information(e.g., (e.g., as as shown in FIGS. shown in FIGS.15A 15Aandand 15B) 15B) may may be added be added to/included to/included in in the catheterization the catheterization package, e.g., a directions package, e.g., directions for for use (DFU)document use (DFU) document 68 and/or 68 and/or a patient a patient

educational pamphlet educational pamphlet7070may may be be included included on top on top of the of the insert insert sheet sheet as as shown shown in FIG. in FIG. 13. 13. A A packaginglabel packaging label 62 62 (e.g., (e.g., aa packaging label as packaging label as described described above and shown above and shownininFIGS. FIGS.9-12) 9-12)maymay be added be addedto/included to/includedininthe the catheterization catheterization package, package, e.g., e.g., on top of on top of all all the the other other components components

and with edges folding down to cover the sides of the catheterization tray. The catheterization and with edges folding down to cover the sides of the catheterization tray. The catheterization

packagemay package maybebesterilized sterilizedand andsealed, sealed, e.g., e.g., in in sealed sealed container container or orbag bag 60 60 as as shown in FIGS. shown in FIGS. 99 and 10. and 10. Other Othercomponents components useful useful to to catheterizationororcare catheterization caremay mayalso alsobebeincluded. included.

[0180]

[0180] In one In one embodiment, embodiment, a catheterization a catheterization system system may may include include a ureteral a ureteral catheter catheter

assemblyand/or assembly and/ormaterials materialsororsupplies supplies(e.g., (e.g., catheterization catheterization elements or components, elements or components,such suchasas

-44-

Jun 2023 sanitizer liquid, lubricant, inflation liquid, gloves, etc.) suitable or necessary for a ureteral sanitizer liquid, lubricant, inflation liquid, gloves, etc.) suitable or necessary for a ureteral

catheterization procedure. catheterization For instance, procedure. For instance, the the catheterization catheterization system system may mayinclude includea a catheterization tray catheterization tray that that has has multiple compartments multiple compartments forfor housing housing and/or and/or securing securing a ureteral a ureteral

catheter assembly (e.g., an assembly including a Foley catheter) as well as other sterile and/or catheter assembly (e.g., an assembly including a Foley catheter) as well as other sterile and/or 2023203963 23

non-sterile catheterization non-sterile catheterization elements, elements,including includinganyany of those of those discussed discussed above. above, Sterile Sterile catheterization elements may be housed in the catheterization tray in a manner that the sterile catheterization elements may be housed in the catheterization tray in a manner that the sterile 2023203963

elements remain elements remainuncontaminated uncontaminatedby by non-sterile non-sterile catheterizationelements. catheterization elements.

[0181]

[0181] The catheterization The catheterization tray tray may include one may include oneorormore morevisual, visual,procedural proceduralindicators indicators or instructions or instructions that that may aid aa user may aid userduring duringthe thecatheterization catheterizationprocedure. procedure.ForFor instance, instance, thethe

procedural indicators may aid the user in orienting the catheterization tray (and catheterization procedural indicators may aid the user in orienting the catheterization tray (and catheterization

components or elements thereof) relative to a patient, such that the catheterization components components or elements thereof) relative to a patient, such that the catheterization components

and/or elements and/or elementsmay maybe be positioned positioned at at predictable predictable andand suitable suitable or or desirable desirable locations locations and/or and/or

orientations relative to orientations relative to the user and/or the user and/ortotothe thepatient. patient. Additionally Additionally or alternatively, or alternatively, thethe

procedural indicators procedural indicators may mayaid aidthe theuser userininsequencing sequencinguseuse of of thethe catheterizationcomponents catheterization components and/or removal thereof from the catheterization tray. and/or removal thereof from the catheterization tray.

[0182]

[0182] As mentioned As mentionedabove, above, thethe catheterization catheterization trayandand tray system system including including suchsuch tray tray

mayfacilitate may facilitate aseptic aseptic techniques techniques during during aa catheterization catheterization procedure. In one procedure. In oneembodiment, embodiment,as as shownininFIG. shown FIG.30A, 30A, catheterization catheterization system system 100 100 includes includes container container 110 (e.g., 110 (e.g., a sealed a sealed bag), bag),

which may which mayhermetically hermeticallyseal sealor orcontain contain thethe catheterizationtray catheterization trayand andcatheterization catheterization components.ForFor components. instance, instance, thethe container container 110 110 may facilitate may facilitate maintaining maintaining sterility sterility of sterile of sterile

catheterization components. catheterization components. ForFor example, example, the the container container 110bemay 110 may be a plastic a plastic bag (e.g., bag (e.g., a a polyethylenebag). polyethylene bag). Moreover, Moreover,thethe container container 110110 maymay include include a peelable a peelable sideside 111,111, which which may may be detached be detachedfrom froma anon-peelable non-peelableside side112112totoform form an an opening opening in the in the container container 110110 (container (container

60 above 60 abovemay mayhave have similar similar featuresand features andproperties); properties);the thecontents contentslocated locatedinin the the container container 110 110 maybeberemoved may removed through through thethe opening. opening.

[0183]

[0183] In one In embodiment,thethecatheterization one embodiment, catheterizationtray trayand andatatleast least some someofofthe thecontents contents thereof (i.e., catheterization components) may be at least partially surrounded or enveloped by thereof (i.e., catheterization components) may be at least partially surrounded or enveloped by

an identification an identification cover cover 120. In one 120. In oneembodiment, embodiment,thethe packaging packaging label label or identification or identification cover cover

120 (e.g., 120 (e.g., similar similar to to packaging label 62 packaging label 62discussed discussedabove) above) maymay include include onemore one or or more visualvisual

identifiers including key information or variables, such as visual identifiers 121, 122, 123 (e.g., identifiers including key information or variables, such as visual identifiers 121, 122, 123 (e.g.,

these can these can be be similar similarto tothe information the informationsquares squaresdiscussed discussedabove), above),which which may may provide indication provide indication

related to the type and/or contents of the catheterization system 100. related to the type and/or contents of the catheterization system 100.

-45-

[0184] For example, example,the the packaging packaginglabel labelororidentification identification cover 120 may maybebefabricated fabricated 2023203963 23 Jun 2023

[0184] For cover 120

from a sheet-like material, such as paper, cardboard, plastic (e.g., plastic film), etc. The visual from a sheet-like material, such as paper, cardboard, plastic (e.g., plastic film), etc. The visual

identifiers 121, identifiers 121, 122, 122, 123 123 may beconfigured may be configuredtotoconvey convey sufficientinformation sufficient information forfor thethe user user to to

identify the identify specific type the specific of the type of the catheterization catheterization system system100100 and/or and/or contents contents thereof. thereof. For For instance, the visual identifier 121 may identify the size of the catheter (e.g., 16 French, etc.). instance, the visual identifier 121 may identify the size of the catheter (e.g., 16 French, etc.).

In one In one example, example,the thevisual visualidentifier identifier122 122may may indicate indicate that that thethe catheterization catheterization system system 100 100 2023203963

includes a urine meter (which may be attached to the catheter), and/or the visual identifier 123 includes a urine meter (which may be attached to the catheter), and/or the visual identifier 123

may indicate that the catheterization system 100 includes a catheter stabilization device (e.g., may indicate that the catheterization system 100 includes a catheter stabilization device (e.g.,

STATLOCK). STATLOCK).

[0185]

[0185] The visual The visual identifiers identifiers 121, 121, 122, 122, 123 maybebevisually 123 may visuallyseparated separatedororisolated isolated one one from another. from another. For Forexample, example,the thevisual visual identifiers identifiers 121, 121, 122, 122, 123 123 may include aa generally may include generally square square

or rectangular perimeter outline that may delimit or define the outer contours thereof. In other or rectangular perimeter outline that may delimit or define the outer contours thereof. In other

words, the identifying words, the identifying information informationofofthe thevisual visual identifiers identifiers 121, 121, 122, 122, 123 123 may maybebe contained contained

within the within the generally generally rectangular rectangular outlines outlines of of the the visual visual identifiers identifiers 121, 121, 122, 122, 123. Hence,for 123. Hence, for instance, the instance, the user usermaymay easily easily and/or and/or quickly quickly locate locate the pertinent the pertinent information information of the of the identification cover identification 120, to cover 120, to identify identify and/or and/or select select the the particular particular catheterization catheterization system 100 system 100

suitable for the procedure. suitable for the procedure.

[0186]

[0186] One, some, or all of the visual identifiers 121, 122, 123 may include any visible One, some, or all of the visual identifiers 121, 122, 123 may include any visible

indications or indications or information informationthat thatmay may inform inform the the useruser about about specifics specifics of catheterization of the the catheterization system 100. system 100.ForFor example, example, the visual the visual identifiers identifiers 121,121, 122, 122, 123 include 123 may may include text, images, text, images,

symbols, etc. symbols, etc. Moreover, Moreover,the thevisual visualidentifiers identifiers 121, 121, 122, 122, 123 123 and/or and/or portions portions thereof thereof may have may have

any suitable any suitable color color or multiple colors, or multiple colors, which may aid which may aidthe theuser userininidentifying identifying and/or and/or distinguishing among distinguishing thevisual among the visual identifiers identifiers 121, 121, 122, 122, 123. In one 123. In one embodiment, embodiment,atatleast leastone oneofof the visual identifiers 121, 122, 123 may have a different color than others. the visual identifiers 121, 122, 123 may have a different color than others.

[0187]

[0187] It should It be appreciated should be appreciated that that the the particular particular contour contour shape, shape, size, size, thickness, thickness, or or combinationsthereof, combinations thereof, which whichsurrounds surrounds or or contains contains thethe identifying identifying information information of the of the visual visual

identifiers 121, identifiers 121, 122, 123 may 122, 123 mayvary varyfrom from oneone embodiment embodiment to thetonext. the next. Asthe As such, such, the visual visual identifiers 121, identifiers 122, 123 121, 122, 123maymay havehave generally generally circular, circular, triangular, triangular, or polygonal or polygonal shapes.shapes.

Furthermore,the Furthermore, theidentification identification cover cover 120 120may mayinclude include anyany number number of suitable of suitable materials materials thatthat

maycarry may carrythe the visual visual identifiers identifiers121, 121,122, 122,123 123may may vary vary from oneembodiment from one embodimentto to another.ForFor another.

instance, the instance, the visual visual identifiers identifiers 121, 121, 122, 122,123123 may may be printed, be printed, embossed, embossed, or otherwise or otherwise

transferred onto the identification cover 120. transferred onto the identification cover 120.

-46-

[0188] The identification identification cover 120 may mayinclude includeany anynumber number of visual identifiers.InIn 2023203963 23 Jun 2023

[0188] The cover 120 of visual identifiers.

other words, other words, the the visual visual identifiers identifiers 121, 122, 123 121, 122, 123 may maybebe located located at at anyany number number of suitable of suitable

locations on locations on the theidentification identification cover cover120120 and/or and/or may may be duplicated. be duplicated. For example, For example, the the identification cover identification cover 120 120 may includevisual may include visualidentifiers identifiers 121, 122, 123 121, 122, 123 on on aa major majorface facethereof thereof and on and on aa minor minorface facethereof. thereof. InInone oneembodiment, embodiment,thethe visual visual identifiers121, identifiers 121,122, 122,123 123may may be be located on one, some, or all visible sides of the catheterization system 100 (e.g., one, some, or located on one, some, or all visible sides of the catheterization system 100 (e.g., one, some, or 2023203963

all of the visual identifiers 121, 122, 123 may be visible from any side of the catheterization all of the visual identifiers 121, 122, 123 may be visible from any side of the catheterization

system 100 system 100during duringstorage storagethereof). thereof).

[0189]

[0189] The identification The identification cover 120may cover 120 maybeberemovable removable fromfrom the catheterization the catheterization tray. tray.

For instance, For instance, the the identification identificationcover cover 120 120 may be generally may be generally detached detachedfrom fromthe thecatheterization catheterization tray (e.g., the identification cover 120 may lie on the catheterization tray and may be secured tray (e.g., the identification cover 120 may lie on the catheterization tray and may be secured

relative totothe relative thecatheterization catheterizationtray by by tray thethe container 110). container Furthermore, 110). Furthermore,asasshown shown in inFIG. FIG. 30B, 30B,

removing theidentification removingthe identification cover mayexpose cover may exposethe thecatheterization catheterizationtray, tray, which maybebewrapped which may wrapped by or by or into into aa central central supply supply room (CSR)sterile room (CSR) sterile wrap wrap130. 130.Accordingly, Accordingly, thethe CSRCSR sterile sterile wrapwrap 130 may at least temporarily secure components in the catheterization tray. 130 may at least temporarily secure components in the catheterization tray.

[0190]

[0190] The CSR The CSRsterile sterile wrap 130 may wrap 130 may be be unwrapped unwrapped and andremoved removedfrom fromthe the catheterization tray catheterization tray and and may be used may be usedduring duringthe thecatheterization catheterization procedure. procedure.ForFor example, example, thethe

CSR sterile wrap 130 may be placed near and/or under the patient to provide at least a partially CSR sterile wrap 130 may be placed near and/or under the patient to provide at least a partially

sterile environment sterile nearthe environment near thesite site of of the the catheterization catheterization procedure, procedure, thereby therebyreducing reducingrisk riskofof infections associated infections associated with the catheterization with the catheterization procedure. TheCSR procedure. The CSR sterile sterile wrap wrap 130 130 may may be be substantially opaque, substantially opaque, such suchthat thatthethecontents contents of the of the catheterization catheterization tray tray and/or and/or locations locations

catheterization components catheterization areobscured components are obscuredor or notnot be be visibletotothetheuser. visible user.Optionally, Optionally, thethe CSRCSR

sterile wrap 130 may be translucent or transparent, such that the user may view and/or visually sterile wrap 130 may be translucent or transparent, such that the user may view and/or visually

identify catheterization components contained in the catheterization tray. identify catheterization components contained in the catheterization tray.

[0191]

[0191] The catheterization system 100 may include a belly band or directional indicator The catheterization system 100 may include a belly band or directional indicator

wrapper140, wrapper 140,which whichmay may provide provide an an indication indication of of relativepositioning relative positioningand/or and/ororientation orientation of of the the

componentsininthe components thecatheterization catheterization tray, tray, which maynot which may notbe bevisible visible to to the the user. user. For For example, example, the the

belly band belly or indicator band or indicator wrapper 140 may wrapper 140 mayinclude includea adirection directionarrow arrow141 141that thatmay maybebealigned alignedbyby the user to point toward the catheter insertion site, which may orient the catheterization tray the user to point toward the catheter insertion site, which may orient the catheterization tray

and catheterization and catheterization components components therein therein relativetotothethepatient. relative patient.ForFor instance, instance, orienting orienting thethe

catheterization tray catheterization tray in in aa manner that aligns manner that aligns the the direction direction arrow arrow141 141in inthethedirection directionofofthethe insertion site insertion sitemay position the may position the catheterization catheterization components and/orelements components and/or elements at at leastpartially least partially

-47-

sequentially, such that the catheterization elements and/or components to be used earlier in the 2023203963 23 Jun 2023

sequentially, such that the catheterization elements and/or components to be used earlier in the

procedureare procedure are located located closer closer to to the the patient patientthan thanthe thecatheterization catheterizationcomponents components intended intended to to be be

used later in the procedure. used later in the procedure.

[0192]

[0192] In addition, In addition, the the belly belly band or indicator band or indicator wrapper wrapper140140maymay include include a warning a warning

indicator 142 to alert the user to proper aseptic technique for the catheterization procedure. For indicator 142 to alert the user to proper aseptic technique for the catheterization procedure. For

example,the example, the warning warningindicator indicator142 142may may includeoneone include or or more more specificelements specific elements identifying identifying the the 2023203963

particular steps particular steps suitable suitableor ornecessary necessary for for proper proper aseptic aseptic procedure. In one procedure. In oneembodiment, embodiment,thethe

warning indicator warning indicator 142 142 identifies identifies onemore one or or of more the of the following following steps: steps: (1) open (1) CSR open CSR sterile wrap sterile wrap

130; (2) don sterile gloves; (3) place underpad; (4) place fenestrated drape; or (5) follow steps 130; (2) don sterile gloves; (3) place underpad; (4) place fenestrated drape; or (5) follow steps

identified by procedure indicators located inside the catheterization tray. identified by procedure indicators located inside the catheterization tray.

[0193]

[0193] Whilethe While theindicator indicator wrapper wrapper140 140maymay wrap wrap around around the sterile the CSR CSR sterile wrap wrap 130, 130, this disclosure this disclosure is isnot notsosolimited. limited.For Forexample, example, aa sticker stickeror oran anadhesive adhesive label labelmay may be be attached attached

to the CSR sterile wrap and may include the same or similar indicators as the indicator wrapper to the CSR sterile wrap and may include the same or similar indicators as the indicator wrapper

140. Alternatively or additionally, the indicators may be placed directly onto the CSR sterile 140. Alternatively or additionally, the indicators may be placed directly onto the CSR sterile

wrap 130 (e.g., may be printed, embossed, or otherwise transferred thereto). wrap 130 (e.g., may be printed, embossed, or otherwise transferred thereto).

[0194]

[0194] After the After the CSR sterile wrap CSR sterile wrap 130 130 is is removed or unwrapped removed or unwrapped from from the the catheterization tray, catheterization tray, the the contents of the contents of the catheterization catheterization tray tray may maybe be exposed. exposed. FIG. FIG. 31A 31A illustrates a catheterization tray 200 of the catheterization system 100. The catheterization tray illustrates a catheterization tray 200 of the catheterization system 100. The catheterization tray

200 may 200 mayinclude include multiple multiple compartments compartments thatsecure that may may secure orvarious or house house various catheterization catheterization

components.TheThe components. shape shape and and sizesize of the of the catheterization catheterization tray tray 200 200 maymay be defined be defined by sides by the the sides thereof. For thereof. For instance, instance, sides sides 201, 201, 202, 202, 203, 203, and 204 may and 204 maydefine defineananapproximately approximately rectangular rectangular

outer shell or exterior perimeter of the catheterization tray 200. outer shell or exterior perimeter of the catheterization tray 200.

[0195]

[0195] The catheterization The catheterization tray tray 200 maybe be 200 may molded molded (e.g., (e.g., injection injection molded, molded,

thermoformed)ororstamped thermoformed) stamped (e.g.,from (e.g., froma aplastic plasticmaterial). material). Hence, Hence,the thesides sides 201, 201, 202, 202, 203, 203, and and 204 may 204 maybebeformed formed from from a sheetdikematerial. a sheet-like material.One One or or more more of of thethe sides201, sides 201,202, 202,203, 203,oror204 204 may include stiffening ribs 205, which may provide rigidity and/or stiffness to the sides 201, may include stiffening ribs 205, which may provide rigidity and/or stiffness to the sides 201,

202, 203, 202, 203, 204. 204. The Thestiffening stiffeningribs ribs 205 205 may mayhave have an an approximately approximately tapered tapered shape shape and/or and/or may may protrude outward protrude outwardfrom from thethe respective respective sides sides 201, 201, 202,202, 203,203, or 204. or 204. More specifically, More specifically, for for example,lower example, lowerportions portionsofofthe thestiffening stiffening ribs ribs 205 205 (portions (portions closer closer to to the the bottom/floor of the bottom/floor of the

catheterization tray catheterization tray200) 200) may protrude out may protrude out of of the the respective respective sides sides 201, 201, 202, 202, 203, 203, or or 204 204 more more

than the than the upper upperportions portionsofofthethestiffening stiffeningribs ribs205205 (portions (portions closer closer to the to the opening opening of of the the

-48-

catheterization tray 200). At least a portion of one, some, or all of the stiffening ribs 205 may 2023203963 23 Jun 2023

catheterization tray 200). At least a portion of one, some, or all of the stiffening ribs 205 may

have a partially conical shape. have a partially conical shape.

[0196]

[0196] The catheterization The catheterization tray tray 200 200 may includeaa swab may include swabcompartment compartment 210, 210, which which may may include one include one or or more moreswabs swabs 150150 therein. therein. Additionally Additionally or alternatively, or alternatively, thethe compartment compartment 210 210 mayinclude may includeaacleansing/sanitizing cleansing/sanitizing solution solution or or sanitizer sanitizerpacket packet 160, 160,which which may containone may contain oneoror moresanitizing more sanitizingagents agentsor orcleansing/sanitizing cleansing/sanitizingsolutions solutions (e.g.,containing (e.g., containing povidone-iodine povidone-iodine 2023203963

solution). The solution). The compartment compartment210210 maymay be positioned be positioned near near andleast and at at least partially partially defined defined by by thethe

side 201 of the catheterization tray 200. In some instances, the exterior of the sanitizer packet side 201 of the catheterization tray 200. In some instances, the exterior of the sanitizer packet

160 may 160 maybebenon-sterile. non-sterile. Hence, Hence,the thecleansing/sanitizing cleansing/sanitizingsolution solutionororsanitizer sanitizer packet 160 may packet 160 may be placed inside another packaging or a bag, which may have a sterile exterior that may prevent be placed inside another packaging or a bag, which may have a sterile exterior that may prevent

or reduce or contaminationofofother reduce contamination othercatheterization catheterizationcomponents components in the in the catheterization catheterization tray tray 200200

from the unsterilized packet 160 of cleansing solution or sanitizer. The plastic bag may include from the unsterilized packet 160 of cleansing solution or sanitizer. The plastic bag may include

a zipper a zipper or or similar similarmechanism that may mechanism that maybebeoperated operatedbybythetheuser usertotoopen openand andaccess accessthe thepacket packet 160 and/or 160 and/or other other components componentstherein. therein.

[0197]

[0197] Catheterization instructions Catheterization instructions may mayinclude includeimages images and and description description of various of various

steps or acts taken during the catheterization procedure. In some instances, instructions also steps or acts taken during the catheterization procedure. In some instances, instructions also

may identify specific step or act numbers, thereby suggesting a particular sequence of steps or may identify specific step or act numbers, thereby suggesting a particular sequence of steps or

acts for the catheterization procedure. Catheterization instructions, which may be non-sterile, acts for the catheterization procedure. Catheterization instructions, which may be non-sterile,

may be placed into a sterile container, such as a plastic bag, thereby isolating or separating the may be placed into a sterile container, such as a plastic bag, thereby isolating or separating the

non-sterile instructions from sterile catheterization components in the catheterization tray 200. non-sterile instructions from sterile catheterization components in the catheterization tray 200.

Also, in some examples, the catheterization system may include multiple sets of catheterization Also, in some examples, the catheterization system may include multiple sets of catheterization

instructions, which instructions, mayimprove which may improve compliance compliance with with aseptic aseptic catheterization catheterization procedures. procedures. For For example,catheterization example, catheterization instructions instructions may couldbebeattached may could attachedororadhered adhered to to (e.g., asas aa sticker) (e.g., sticker) inside the sterile plastic bag and/or to another catheterization element or component (e.g., to inside the sterile plastic bag and/or to another catheterization element or component (e.g., to

the sterile the sterile container container with with the sanitizer packet the sanitizer 160), to packet 160), to an an exterior exterior sleeve sleeve or or portion portion ofofthe the catheterization system, etc. catheterization system, etc.

[0198]

[0198] The compartment The compartment210 210 may may be be configured configured to contained to contained sanitizing sanitizing substance substance

(e.g., liquid), (e.g., which liquid), whichmay may be be dispensed in the dispensed in the compartment 210from compartment 210 from thethe sanitizerpacket sanitizer packet160. 160. For example, For example,asasdescribed describedbelow below in more in more detail, detail, the the compartment compartment 210have 210 may may have a a slanted slanted bottom/floor, such that the cleansing or antiseptic solution (e.g., povidone-iodine solution) or bottom/floor, such that the cleansing or antiseptic solution (e.g., povidone-iodine solution) or

sanitizer from sanitizer from the the packet packet 160 160 may pool near may pool near and/or and/or at at aa lowermost lowermostcorner comer between betweena a bottom/floor and bottom/floor andaa side side (e.g., (e.g., partition partition211) 211)ofof thethecompartment compartment 210. Furthermore,tips 210. Furthermore, tips of of the the

-49-

swabs150 150may maybe be located at at or or near thelowermost lowermost comer between the bottom/floor and the 2023203963 23 Jun 2023

swabs located near the corner between the bottom/floor and the

side of the compartment 210, such that the tips of the swabs 150 are positioned in the dispensed side of the compartment 210, such that the tips of the swabs 150 are positioned in the dispensed

sanitizing liquid. sanitizing liquid.

[0199]

[0199] The compartment The compartment 210210 maymay beleast be at at least partiallydefined partially definedbybya aportion portionofofthe theside side 201 or inner wall thereof, the partition 211, by a partition 212, and by the slanted bottom/floor. 201 or inner wall thereof, the partition 211, by a partition 212, and by the slanted bottom/floor.

For instance, For instance, the the lowermost portion of lowermost portion of the the compartment 210may compartment 210 may be be located located at at thecorner the corneredge edge 2023203963

formedbybyand formed andbetween betweenthethe partition211 partition 211and andthe theslanted slantedbottom/floor. bottom/floor.Hence, Hence, positioning positioning the the

tips/absorbent heads tips/absorbent of the heads of the swabs swabs150 150near nearthe theslanted slantedbottom/floor bottom/floorand/or and/ornear nearthe thepartition partition 211 of 211 of the the compartment compartment 210 210 maymay locate locate the the tips/absorbent tips/absorbent heads heads of the of the swabs swabs 150oratnear 150 at or near the lowermost the portionofofthe lowermost portion the compartment compartment 210. 210.

[0200]

[0200] As described above, the catheterization tray 200 may be oriented relative to the As described above, the catheterization tray 200 may be oriented relative to the

patient in patient in aa manner that places manner that places the the side side 201 and the 201 and the compartment compartment210210 closer closer to to thethe insertion insertion

site than site the side than the side203 203of of the the catheterization catheterization traytray 200. 200. In words, In other other orienting words, orienting the the catheterization tray 200 based on the direction arrow of the directional indicator wrapper (while catheterization tray 200 based on the direction arrow of the directional indicator wrapper (while

the contents the contents and and compartments compartments ofof thecatheterization the catheterization tray tray 200 are concealed 200 are concealedor or covered coveredbybythe the CSRsterile CSR sterile wrap wrap130 130(FIG. (FIG.30B) 30B) maymay place place the the sideside 201 201 and compartment and the the compartment 210thenear 210 near the insertion site. In some instances, the insertion site may be first sterilized with the swabs 150 insertion site. In some instances, the insertion site may be first sterilized with the swabs 150

that may that may bebesaturated saturatedwith withthethe sanitizingliquid sanitizing liquidfrom from the the sanitizer sanitizer packet packet 160.160. As As such, such, positioning the positioning the compartment 210together compartment 210 togetherwith withthe theswabs swabs150 150and andsanitizer sanitizerpacket packet160 160near nearthe the insertion site may reduce spillage of the sanitizer liquid (e.g., onto one or more catheterization insertion site may reduce spillage of the sanitizer liquid (e.g., onto one or more catheterization

componentsininthe components thecatheterization catheterization tray tray 200) 200) and/or and/or contamination of the contamination of the swabs 150, which swabs 150, whichmay may lead to contamination of the insertion site. lead to contamination of the insertion site.

[0201]

[0201] As described As describedbelow belowininmore more detail,thethecompartment detail, compartment 210 210 may ahave may have a slanted slanted

bottom/floor. For bottom/floor. Forinstance, instance,ananupper upper edge edge (or (or surface), surface), such such as upper as an an upper edge edge 206 of206 the of the catheterization tray catheterization tray200 200 may lie in may lie inan animaginary imaginary plane plane that that may be approximately may be approximatelyparallel parallel to to aa support surface that may support the catheterization tray 200 (e.g., surface of the patient's bed). support surface that may support the catheterization tray 200 (e.g., surface of the patient's bed).

The slanted The slanted bottom/floor bottom/floorof of the the compartment compartment210210 maymay havehave a non-parallel a non-parallel orientation orientation relative relative

to the imaginary plane of the upper edge 206 and/or to the support surface. to the imaginary plane of the upper edge 206 and/or to the support surface.

[0202]

[0202] Furthermore,the Furthermore, thebottom/floor bottom/floorof of thecompartment the compartment 210bemay 210 may be non-parallel non-parallel

relative totobottoms/floors relative bottoms/floors of of one one or or more other compartments more other compartments in in thecatheterization the catheterizationtray tray200. 200. For example, For example,thethecatheterization catheterizationtray tray 200200 may may beonset be set theon the support support surface,surface, such such that that

-50-

Jun 2023 bottom s/floors of bottoms/floors of one one or or more compartments more compartments support support and/or and/or orient orient thecatheterization the catheterizationtray tray 200 200 on the on the support support surface. surface. Hence, Hence,asasdescribed describedabove, above,the thebottom/floor bottom/floorofofthe thecompartment compartment210 210

may have a non-parallel orientation relative to the support surface. may have a non-parallel orientation relative to the support surface.

2023203963 23

[0203]

[0203] The catheterization The catheterization tray tray200 200 may may include include a a side sidecompartment 220. For compartment 220. Forexample, example, the compartment the compartment 220 220may may extend extend along along substantiallyananentire substantially entireside sideororlength lengthofofthe the catheterization tray catheterization tray200 200 (e.g., (e.g.,thethe compartment compartment 220 220 may extendbetween may extend betweenthe thesides sides201 201and and203 203 2023203963

and/or may and/or bepartially may be partially defined defined thereby). Hence, in thereby). Hence, in some someinstances, instances, one one side side of of the the compartment220220 compartment maymay be defined be defined by abyside a side such such as by as by thethe side side 204. 204.

[0204]

[0204] The compartment The compartment220 220maymay contain contain any any number number of suitable of suitable elements elements or or componentsof of components thethe catheterizationkit. catheterization kit.ForFor example, example, the compartment the compartment 220 may220 may acontain contain a syringe 170 syringe 170with withliquid liquidthat thatmay maybebe used used forfor inflating inflating a balloon a balloon of of thethe catheter catheter (described (described

below) and/or below) and/oraa syringe syringe 180 180 that that may contain lubricant. may contain lubricant. As such, the As such, the width width of of the thecompartment compartment

220 may 220 maybebesufficient sufficient to to accommodate accommodate thethe syringes syringes 170, 170, 180. 180. In some In some instances, instances, thethe syringes syringes

170, 180 170, 180 may maybebeoriented orientedlengthwise lengthwisealong alongthe thecompartment compartment 220, 220, and and may may lie ainsingle lie in a single row, row,

one in front of the other therein. one in front of the other therein.

[0205]

[0205] The catheterization The catheterization tray tray 200 mayinclude 200 may includeone oneorormore more cutouts cutouts or or recesses recesses in in a a partition 221, partition 221,which which may separate the may separate the compartment 220from compartment 220 from anan adjacentcompartment(s) adjacent compartment(s) (e.g., (e.g.,

from aa catheter from catheter compartment 230).For compartment 230). Forexample, example, oneone or or more more recesses recesses in in thepartition the partition221 221may may have top have top edges edges thereof thereof located located below the upper below the upper edge edge206 206ofofthe the catheterization catheterization tray tray 200. 200. More More

specifically, in some instances, the recesses may provide access to one or more of the syringes specifically, in some instances, the recesses may provide access to one or more of the syringes

170, 180 170, 180 from fromthe the compartment compartment 230. 230. Hence, Hence, a user a user of the of the catheterization catheterization kitkit may may remove remove the the syringe 170 syringe 170 and/or and/or syringe syringe 180 180by byreaching reachinginto into the the compartment compartment 230,ininlieu 230, lieuofofor or in in addition addition

to reaching to reaching into into the the compartment 220. compartment 220.

[0206]

[0206] In one In one embodiment, thesyringes embodiment, the syringes170 170and and180180 may may be be differently differently sized.Hence, sized. Hence, in one in embodiment,atatleast one embodiment, leastaaportion portion of ofthe the compartment compartment 220220 maymay be narrower be narrower than than another another

portion thereof, portion thereof,toto accommodate syringes 170, accommodate syringes 170, 180 180ofofdifferent different sizes. sizes. For Forexample, example, compartment210210 compartment maymay include include a narrowing a narrowing protrusion protrusion 222, 222, whichwhich may extend may extend into into the the space space of the of the compartment 220,thereby compartment 220, therebynarrowing narrowing a portion a portion of of thethe compartment compartment 220. 220. For instance, For instance,

the syringe the 170 may syringe 170 mayhave havea asmaller smallerdiameter diameter or or peripheralsize peripheral sizethan thanthe thesyringe syringe180. 180.Hence, Hence, the narrowing the protrusion 222 narrowing protrusion 222may maynarrow narrow thethe width width of of thethe (s)ofofthe (s) thecompartment compartment220220 maymay be be

-51-

sufficiently wide to accommodate accommodate thethe syringe 180 180 (e.g., thethe narrowing protrusion 222 may 2023203963 23 Jun 2023

sufficiently wide to syringe (e.g., narrowing protrusion 222 may

prevent or prevent or limit limit lateral lateralmovement of the movement of the syringe syringe 170 in the 170 in the compartment 220). compartment 220).

[0207]

[0207] As mentioned As mentioned above, above, the the catheterization catheterization tray tray 200 200 may may include include the ormain the main or catheter compartment catheter compartment 230. The compartment 230. The compartment230 230may mayhave haveananapproximately approximatelyrectangular rectangular shape. For shape. Forexample, example, thethe compartment compartment 230the 230 and andshape the thereof shape thereof may be may be atpartially at least least partially defined by the side 203, at least a portion of the side 202, and by partitions 212, 221. While in defined by the side 203, at least a portion of the side 202, and by partitions 212, 221. While in 2023203963

one embodiment one embodiment thethe compartment compartment 230have 230 may maya have a generally generally rectangular rectangular shape, shape, it it should should be be appreciated that appreciated that the the shape shape of ofthe thecompartment 230 may compartment 230 mayvary varyfrom fromoneone embodiment embodiment to the to the next. next.

[0208]

[0208] In any In any event, event, the the compartment compartment 230230 maymay be sized be sized (e.g., (e.g., perimeter perimeter dimensions dimensions

and depth), and depth), shaped, shaped, or or otherwise configuredto otherwise configured to contain contain or or house house aa catheter catheter assembly 190.For assembly 190. For instance, the catheter assembly 190 may include a catheter 191 that may be connected to a urine instance, the catheter assembly 190 may include a catheter 191 that may be connected to a urine

collection bag collection and/or urine bag and/or urine meter meter192. 192.In In some some instances, instances, the the compartment compartment 230mayalso 230 also may contain or contain or house housea aSTATLOCK STATLOCK 193, may 193, which which may secure at secure least a at least aofportion portion of the the catheter catheter assembly190 assembly 190during duringthe thecatheterization catheterization procedure. procedure.

[0209]

[0209] The compartment The compartment230230 may may have have an approximately an approximately flat flat or or planar planar bottom/floor, bottom/floor,

as described as described below in more below in detail. For more detail. example,the For example, the bottom/floor bottom/floorof of the the compartment 230maymay compartment 230

support the support the catheterization catheterization tray tray 200 on the 200 on the support support surface. surface. Hence, Hence,ininone oneembodiment, embodiment, the the bottom/floor ofofthe bottom/floor thecompartment compartment210 210 may ahave may have a non-parallel non-parallel orientation orientation relativerelative to the to the bottom/floor of bottom/floor of the the compartment 230. compartment 230.

[0210]

[0210] As mentioned As mentionedabove, above,the thecompartment compartment 230230 may may have have an approximately an approximately

rectangular shape. rectangular Furthermore,the shape. Furthermore, the compartment compartment 230 230 maymay have have rounded rounded or chamfered or chamfered interior interior

corners 231 corners 231between between the the inner inner walls walls that that define define the perimeter the perimeter of theof the compartment compartment 230. 230. Additionally or alternatively, the upper portions of the inner walls and/or partitions may have Additionally or alternatively, the upper portions of the inner walls and/or partitions may have

one or more chamfers or fillets 232, which may extend at least partially along their respective one or more chamfers or fillets 232, which may extend at least partially along their respective

lengths. lengths.

[0211]

[0211] The catheterization The catheterization tray tray 200 200 also also may mayinclude include an an auxiliary auxiliary compartment compartment 240 240 that may that containoror house may contain houseananauxiliary auxiliarycontainer container195 195(e.g., (e.g., aa specimen specimenororsample sample container). container).

For instance, For instance, the the auxiliary auxiliarycontainer container 195 195 may be approximately may be approximatelycylindrical cylindricaland andmay may include include a a cap. Furthermore, cap. Furthermore,the thecompartment compartment240 240 may may be shaped, be shaped, sized,sized, and configured and configured to secure to secure the the auxiliary container auxiliary container 195 therein. In 195 therein. In one embodiment,thethelength one embodiment, lengthofofthe thecompartment compartment240 240 may may be similar be similar to to the thelength lengthof ofthe theauxiliary auxiliarycontainer 195 container 195(e.g., thethe (e.g., compartment compartment240 240may may include include

-52-

a small small clearance clearance or or may mayhave have an an interference fitfitwith withthe theauxiliary auxiliarycontainer container195). 195).In In oneone 2023203963 23 Jun 2023

a interference

embodiment,thethebottom/floor embodiment, bottom/floor of of thecompartment the compartment 240 240 may may be be semi-cylindrical semi-cylindrical or generally or generally

arcuate and arcuate mayapproximately and may approximately follow follow thethe general general cylindricalshape cylindrical shapeofofthe theauxiliary auxiliarycontainer container 195. Hence, 195. Hence,for forinstance, instance, the the bottom/floor bottom/floor of of the the compartment 240may compartment 240 mayat at leastpartially least partially wrap wrap

around the auxiliary container 195. around the auxiliary container 195.

[0212]

[0212] For example, For example,asasshown shownininFIG. FIG.31B, 3 IB,thethecompartment compartment 240 240 may may have have a partially a partially 2023203963

roundedbottom/floor rounded bottom/floor241. 241.The The compartment compartment 240 240 may may be separated be separated from from the compartment the compartment 210 210 in the in catheterization tray the catheterization tray 200. Forinstance, 200. For instance,the thecatheterization catheterizationtray tray200 200maymay include include an an overflowcavity overflow cavity 250 250located locatedbetween betweenthethecompartment compartment 240 240 and compartment and the the compartment 210. 210. In one In one embodiment, the embodiment, the overflow overflowcavity cavity 250 250maymay formform a recess a recess or depression or depression between between the the compartment 210 compartment 210and andthe the compartment compartment240. 240.ForFor example, example, thethe overflow overflow cavity250 cavity 250may may prevent ororlimit prevent limitoverflow overflowof of thethe sanitizing sanitizing liquid liquid dispensed dispensed into into the compartment the compartment 210. 210. Moreover, theuser Moreover,the usermay maytaptap excess excess sanitizing sanitizing liquidfrom liquid from thethe tipsofof tips theswabs the swabs 150150 intointo thethe

overflow cavity 250, before applying the sanitizing liquid at or near the insertion site. overflow cavity 250, before applying the sanitizing liquid at or near the insertion site.

[0213]

[0213] The slanted The slanted bottom/floor bottom/floor213 213 of of the thecompartment compartment 210 may be 210 may beelevated elevated or or stepped above stepped abovethetheoverflow overflow cavity cavity 250.250. For example, For example, the slanted the slanted bottom/floor bottom/floor 213 may 213 may terminate at terminate at aa fillet filletor or radius 214214 radius thatthat maymay extend from extend thethe from slanted bottom/floor slanted 213213 bottom/floor downward downward

towardthe toward the overflow overflowcavity cavity250 250ororananedge edge thereof.TheThe thereof. radius radius 214214 may may provide provide a transition a transition

betweenthe between theslanted slanted bottom/floor bottom/floor213 213and andatatleast least aa portion portion of of the the overflow overflow cavity cavity 250 250 located located

belowthe below theslanted slantedbottom/floor bottom/floor213. 213.In any In any event, event, the the slanted slanted bottom/floor bottom/floor 213slant 213 may may slant downward downward andand away away fromfrom the the overflow overflow cavity cavity 250.250.

[0214]

[0214] As mentioned As mentioned above, above, sanitizing sanitizing liquid liquid may may be dispensed be dispensed at the at the lowermost lowermost

portion 215 portion 215 ofofthe thecompartment compartment210 210 (e.g., (e.g., at or at or near near thethe lowermost lowermost portion portion ofslanted of the the slanted bottom/floor 213). bottom/floor 213). Furthermore, Furthermore, sanitizing sanitizing liquid liquid dispensed dispensed in the in the compartment compartment 210 210 may may generally flow generally flow toward towardand and pool pool at at thethe lowermost lowermost portion portion 215 215 of compartment of the the compartment 210. In210. In addition, the addition, the tips tips 151 151 of of the the swabs 150 may swabs 150 maybebeset setororpositioned positionedininthe thesanitizing sanitizing liquid. liquid. As As such, the such, the user usermay may remove the swabs remove the swabs150 150from fromthe thecompartment compartment210210 andand apply apply sanitizing sanitizing liquid liquid

at the insertion site without further acts. at the insertion site without further acts.

[0215]

[0215] The swabs The swabs 150 150may maybe be securedininthe secured thecompartment compartment 210210 in in a manner a manner that that

positions the positions the tip(s) tip(s) ororabsorbent absorbent head(s) head(s) 151 151 in sanitizing in the the sanitizing liquid liquid dispense dispense in the in the compartment210. compartment 210.ForFor example, example, one, one, some, some, or or each each of of thethe swabs swabs 150150 maymay include include an elongated an elongated

-53-

stem/stick 152 152 and anda atip/absorbent tip/absorbenthead head151151attached attached to to thethe stem/stick 152. Moreover, the 2023203963 23 Jun 2023

stem/stick stem/stick 152. Moreover, the

compartment210 compartment 210 may may include include channels channels 216216 that that maymay house house and and secure secure the the elongated elongated stem/stick stem/stick

152 of 152 of the the swabs swabs150. 150.Hence, Hence, thethe stems/sticks stems/sticks 152152 of the of the swabs swabs 150 150 may may be be secured secured in the in the channels 216 channels 216ofofthe the compartment compartment 210. 210.

[0216]

[0216] The channels The channels216 216maymay include include one one or more or more retention retention features features (e.g.,(e.g., detents, detents,

overhangs), which overhangs), whichmay may secure secure thethe stems/sticks152152 stems/sticks therein.ForFor therein. example, example, the the stems stems 152 152 may may 2023203963

have approximately have approximatelyrectangular rectangular or or generally generally rectangular rectangular cross-sectional cross-sectional shapes. shapes. WhenWhen the the stems/sticks 152 stems/sticks 152 are are oriented oriented along alongthe the longer longerside sideofofthe the rectangular rectangular cross-sectional cross-sectional shapes shapes thereof, the thereof, the retention retentionfeatures featuresmay may secure secure the the elongated stem 152 elongated stem 152inin the the channels channels216. 216.Also, Also, rotating or twisting the swabs 150 in the channels 216 (e.g., such that the shorter side of the rotating or twisting the swabs 150 in the channels 216 (e.g., such that the shorter side of the

rectangular cross-sectional rectangular cross-sectional shapes shapes of of the the stems stems 152 maybebeoriented 152 may orientedtoto lie lie within within the the channels channels

216) may 216) maydisengage disengagethethestems stems152152 from from thethe channels channels 216. 216.

[0217]

[0217] In other In other words, words, spacing spacing between theretention between the retention features features of of the the channels channels 216 216 may may

be less than the width of the longer side of the rectangular cross-sectional shape of the elongated be less than the width of the longer side of the rectangular cross-sectional shape of the elongated

stem 152, stem 152, such suchthat thatthe theretention retentionfeatures featuresmay mayrestrain restrainthe theelongated elongated stem/stick stem/stick 152152 in the in the

channels 216. channels 216. Moreover, Moreover,thethe spacing spacing between between the the retention retention features features may may be greater be greater thanthan the the length of the shorter side of the rectangular cross-sectional shape of the elongated stem/stick length of the shorter side of the rectangular cross-sectional shape of the elongated stem/stick

152. Accordingly, 152. Accordingly,twisting twistingororrotating rotating the the swabs swabs150 150within withinthe thechannels channels216216 maymay allow allow the the elongated stem/stick 152 to pass between the retention features of the channels 216 in order to elongated stem/stick 152 to pass between the retention features of the channels 216 in order to

removethe remove theelongated elongatedstem/stick stem/stick152 152therefrom. therefrom.

[0218]

[0218] The catheterization tray 200 (as well as the catheterization trays shown in FIGS. The catheterization tray 200 (as well as the catheterization trays shown in FIGS.

1-5) may 1-5) maybebefabricated fabricatedininanyany number number of suitable of suitable ways ways andany and with with any of number number of suitable suitable manufacturingtechniques. manufacturing techniques.As As mentioned mentioned above, above, the catheterization the catheterization tray(s) tray(s) may may be injection be injection

molded,thermoformed, molded, thermoformed,or or otherwise otherwise mass-produced. mass-produced. For instance, For instance, the catheterization the catheterization tray(s) tray(s)

maybebefabricated may fabricatedfrom froma asheet sheetofofplastic plastic material material that that may be processed may be processedbybycompressing compressingandand

heating the sheet into the suitable configuration, as described herein. As such, one or more of heating the sheet into the suitable configuration, as described herein. As such, one or more of

the sides of the catheterization tray(s) may comprise a relatively thin plastic material (e.g., the sides of the catheterization tray(s) may comprise a relatively thin plastic material (e.g.,

0.005 inch, 0.005 inch, 0.010 0.010 inch, inch, 0.020 0.020inch, inch, 0.050 0.050inch, inch,0.catheterization 0.catheterization system system100 100inch, inch,etc.). etc.). AsAs described above, described above, the the catheterization catheterization tray(s) tray(s) may include stiffening may include stiffening ribs ribs on on one or more one or moresides sides thereof, which may provide rigidity to such sides. thereof, which may provide rigidity to such sides.

-54-

[0219] The catheterization catheterization tray(s) tray(s) may includestiffening stiffening ribs ribs as as described described herein herein on on 2023203963 23 Jun 2023

[0219] The may include

one or one or more morepartitions partitionsthat thatdivide dividethe theinterior interiorspace spaceofofthe thecatheterization catheterizationtray(s) tray(s)into into the the compartmentsdescribed compartments described herein.Also, herein. Also, as as described described below below in more in more detail, detail, thethe partitions(e.g., partitions (e.g., the partition 221) may include folded or dual layers of sheet material. The stiffening ribs may the partition 221) may include folded or dual layers of sheet material. The stiffening ribs may

protrude away protrude awayfrom fromthethecompartments compartments (e.g., (e.g., awayaway from from the compartment the compartment 210, compartment 210, compartment

220, compartment 220, compartment230) 230) and and intothethespace into spacebetween between thethe layersofofthe layers thesheet sheetmaterial. material. 2023203963

[0220]

[0220] As described As describedabove, above,in in thethe compartments, compartments, the inside the inside comers corners and/orand/or edges edges formed between the bottom/floor and inner walls, sides, and/or partitions may include fillets or formed between the bottom/floor and inner walls, sides, and/or partitions may include fillets or

chamfers. For chamfers. Forexample, example, such such filletsor orchamfers fillets chamfers maymay reduce reduce stress stress at the at the inside inside comers corners or or edges of edges ofthe the compartments. compartments. Accordingly, Accordingly, the fillets the fillets and/or and/or chamfers chamfers formed formed at the at the inside inside

corners and/or corners and/or edges edgesofofthe thecompartments compartmentsmaymay reduce reduce or prevent or prevent breakage breakage or failure or failure of of the the sheet material that forms the catheterization tray 200. sheet material that forms the catheterization tray 200.

[0221]

[0221] The bottom/floor The bottom/floor ofofthe thecompartment compartment 230 230 may may be be substantially substantially flat. flat. Additionally or Additionally or alternatively, alternatively, the thebottom/floor bottom/floorof ofthe thecompartment 230 may compartment 230 mayhave havea aprotruding protruding landing 232 landing 232 and andaarecessed recessedportion portion233. 233. For Forexample, example, thethe recessed recessed portion portion 233 233 maymay be lower be lower

or farther or farther away from the away from the upper upperedge edge206 206ofofthe thecatheterization catheterizationtray tray 200 200 than thanthe the landing landing232. 232. Furthermore,the Furthermore, therecessed recessedportion portion233 233maymay at least at least partiallyororcompletely partially completely wrap wrap around around the the landing 232. landing 232. AsAs such, such, forfor instance,thethe instance, recessed recessed portion portion 233233 may may accommodate accommodate at leastata least a portion of portion of the the catheter, catheter,which which may wraparound may wrap aroundthe thelanding landing232. 232.

[0222]

[0222] As described As describedabove, above,the thecatheterization catheterizationtray tray 200 200may maybe be placed placed on aonsupport a support surface, such as a surface of the patient's bed. For example, as shown in FIG. 31C the recessed surface, such as a surface of the patient's bed. For example, as shown in FIG. 31C the recessed

portion 233 of the compartment 230 may form a protrusion on the exterior of the catheterization portion 233 of the compartment 230 may form a protrusion on the exterior of the catheterization

tray 200, while the landing 232 may form a recesses on the exterior of the catheterization tray tray 200, while the landing 232 may form a recesses on the exterior of the catheterization tray

200. AsAssuch, 200. such,the theexterior exterior surface surface of of the the recessed portion 233 recessed portion mayprovide 233 may provideororform form a surface a surface

that may that orient and/or may orient and/or support support the the catheterization catheterization tray tray200 200 on on the the support support surface. surface. Moreover, Moreover,

in one in embodiment, one embodiment, thethe exteriorsurface exterior surfaceof of therecessed the recessed portion portion 233233 may may be approximately be approximately

parallel to the imaginary plane of the upper edge 206. parallel to the imaginary plane of the upper edge 206.

[0223]

[0223] Also, as Also, as mentioned mentionedabove, above,thethechannels channels 216216 of the of the compartment compartment 210bemay 210 may be generally parallel generally parallel to to the the slanted slanted bottom/floor bottom/floor 213 andslanted 213 and slantedorornon-parallel non-parallel relative relative to to the the

support surface. support surface. The channels216 The channels 216ofofthe the compartment compartment210 210 may may have have a non-parallel a non-parallel orientation orientation

relative to the exterior surface of the recessed portion 233. For instance, on the exterior of the relative to the exterior surface of the recessed portion 233. For instance, on the exterior of the

-55-

catheterization tray tray 200, the channels channels216216 maymay protrude outward awaythefrom the slanted 2023203963 23 Jun 2023

catheterization 200, the protrude outward away from slanted

bottom/floor 213. bottom/floor 213.

[0224]

[0224] A compartment A compartmentof of thethecatheterization catheterizationtray tray(e.g., (e.g., compartment 210)orora aportion compartment 210) portion thereof may carry the sanitizing or cleansing liquid (e.g., povidone-iodine solution) therein. thereof may carry the sanitizing or cleansing liquid (e.g., povidone-iodine solution) therein.

For example, For example,atat least least aa portion portion of ofthe thecompartment maycarry compartment may carrythe thesanitizing sanitizing liquid liquid and and may be may be

sealed by sealed a peelable by a peelable cover. Assuch, cover. As such, during duringthe the catheterization catheterization procedure, procedure, the the user user may avoid may avoid 2023203963

pouring aa sanitizing pouring sanitizing liquid liquid out out ofofaapacket packet(e.g., (e.g., into into the the catheterization catheterization tray), tray), which may which may

prevent or prevent or reduce reducespillage spillageofofthethesanitizing sanitizingliquid. liquid.TheThe swabs swabs may may be be at partially at least least partially submergedininthe submerged thesanitizing sanitizingliquid liquidand/or and/oratatleast least partially partially sealed sealed together together therewith therewith by bythe the peelable cover. peelable Alternatively or cover. Alternatively or additionally, additionally, the the swabs maybebelocated swabs may locatedininanother another compartment of the catheterization tray. compartment of the catheterization tray.

[0225]

[0225] As described As described above, above,partitions partitions of of the thecatheterization catheterizationtray 200 tray may 200 maybe beformed formed by by

two layers two layers of of aa sheet sheet material. material. AtAtleast least some someofofthe thepartitions partitions may mayhave have space space between between the the layers of the sheet material. For example, the partition 221 may include a first layer 221a and layers of the sheet material. For example, the partition 221 may include a first layer 221a and

a second layer 221b spaced apart from each other (e.g., the first layer 221a may define or form a second layer 221b spaced apart from each other (e.g., the first layer 221a may define or form

the perimeter the perimeter of ofthe the compartment compartment 230, 230, and and the the second second layerlayer 221b 221b may define may define or form or theform the perimeter of perimeter of the the compartment 220. compartment 220.

[0226]

[0226] The stiffening ribs 205 on the first layer 221a of the partition 221 may protrude The stiffening ribs 205 on the first layer 221a of the partition 221 may protrude

outward, away outward, awayfrom from thethe compartment compartment 230into 230 and andthe intospace the space betweenbetween theand the first first and second second layers 221a, layers 221a, 221b. Thestiffening 221b. The stiffening ribs ribs205 205 on onthe thesecond second layer layer221b 221bmay may also also protrude protrude outward, outward,

away from away fromthe thecompartment compartment 220220 and and toward toward the outer the outer perimeter perimeter or periphery or periphery of of the the catheterization tray catheterization 200. tray 200. In In any event, as any event, described above, as described above, the the compartments of the compartments of the catheterization tray catheterization tray 200 mayhave 200 may haveindents indentsthat thatcorrespond correspond to to thethe protrusions protrusions formed formed on on the the exterior portions of the catheterization tray 200 by the stiffening ribs 205. exterior portions of the catheterization tray 200 by the stiffening ribs 205.

[0227]

[0227] The catheterization tray 200 may include one or more instructions or procedural The catheterization tray 200 may include one or more instructions or procedural

indicators that may assist a user during a catheterization procedure. For instance, as illustrated indicators that may assist a user during a catheterization procedure. For instance, as illustrated

in FIG. in FIG. 32, 32, the the catheterization catheterizationtray 200 tray 200may may include include indicators indicators301-307, 301-307, which maybebeprinted which may printed on the catheterization tray 200. For example, a first indicator 301 may indicate to the user to on the catheterization tray 200. For example, a first indicator 301 may indicate to the user to

open the open the package packagecontaining containingsanitizing sanitizingliquid, liquid, and and aa second secondindicator indicator 302 302may mayindicate indicatetotothe the user to user to pour pourthe thesanitizing sanitizingliquid liquidinto intothethe compartment compartment 210, during 210, during the catheterization the catheterization

procedure. procedure.

-56-

[0228] A third indicator 303 may indicate to the user to attach to the catheter the syringe 2023203963 23 Jun 2023

[0228] A third indicator 303 may indicate to the user to attach to the catheter the syringe

containing liquid for inflating the catheter balloon. In one embodiment, a fourth indicator 304 containing liquid for inflating the catheter balloon. In one embodiment, a fourth indicator 304

may indicate to the user to dispense lubricant and/or may identify or suggest a location in the may indicate to the user to dispense lubricant and/or may identify or suggest a location in the

compartment220220 compartment forfor dispensing dispensing lubricant.Also, lubricant. Also, indicators indicators 305-307 305-307 may may identify identify additional additional

or alternative steps to take during the catheterization procedure (e.g., retract genitalia (with or alternative steps to take during the catheterization procedure (e.g., retract genitalia (with

non-dominanthand), non-dominant hand),prepare prepare patient patient with with swabs swabs (with (with dominant dominant hand),hand), insertinsert catheter catheter and and 2023203963

inflate balloon inflate balloon (with (with dominant hand)). dominant hand)).

[0229]

[0229] Thecatheterization The catheterization tray tray 200 200may may include include an an enlarged enlarged or bolded or bolded printprint of of the the indicators 301-307 for improved visibility. Further, other enlarged instructions/indicators may indicators 301-307 for improved visibility. Further, other enlarged instructions/indicators may

be printed be printed on on the the bottom/floor bottom/floor of of the the compartment 230,asasshown compartment 230, shownininFIG. FIG.32.32.TheThe presence presence of of the indicators the indicators 301-307 on the 301-307 on the catheterization catheterization tray tray 200 200 may obviate or may obviate or reduce reducethe the necessity necessity for for printed handouts or similar instructions. printed handouts or similar instructions.

[0230]

[0230] In one In one embodiment, embodiment, as as shown shown in FIG. in FIG. 33, 33, a catheterization a catheterization system system 100a 100a may may include one include oneorormore more procedural procedural indicators indicators 260a260a on a on CSRasterile CSR sterile wrapExcept wrap 130a. 130a. asExcept as otherwise described otherwise describedherein, herein, the the catheterization catheterization system 100aand system 100a andits its elements elements and andcomponents components maybebesimilar may similarto to or or the the same as catheterization same as catheterization system 100 (FIGS. system 100 (FIGS. 30A-32) 30A-32)andand itsrespective its respective elements and elements andcomponents. components. For example For example the catheterization the catheterization system system 100a may100a maythe include include the catheterization tray catheterization tray 200 200 and catheterization elements and catheterization and/orcomponents elements and/or components described described above above in in connectionwith connection withthe the catheterization catheterization tray tray 200 200 above. above.

[0231]

[0231] In one In embodiment, the one embodiment, the CSR CSRsterile sterile wrap wrap 130a 130amay mayinclude includeone oneorormore more procedural indicators procedural indicators 260a 260athat that may mayassist assista auser userduring duringthe thecatheterization catheterizationprocedure. procedure.ForFor example,one example, oneorormore moreof of theprocedural the procedural indicators indicators 260a 260a maymay be individually be individually isolated isolated and/or and/or

delimited, or otherwise visually enclosed by a perimeter outline. In particular, isolating each delimited, or otherwise visually enclosed by a perimeter outline. In particular, isolating each

of the procedural indicators 260a may draw or focus user's attention thereto and may facilitate of the procedural indicators 260a may draw or focus user's attention thereto and may facilitate

identification thereof. identification Theprocedural thereof. The procedural indicators indicators 260a 260a may contain may contain similarsimilar or the or the same same information as information as indicators indicators 301-307 (FIG. 32). 301-307 (FIG. 32).

[0232]

[0232] In one In one embodiment, embodiment,thethe catheterizationtray catheterization traymay may include include a fenestrated a fenestrated drape, drape,

whichmay which may partiallycover partially coverthethepatient patientand andmaymay facilitateinsertion facilitate insertionofofthe thecatheter. catheter.FIG. FIG. 34 34 illustrates a fenestrated drape 270. The fenestrated drape 270 may have a generally rectangular illustrates a fenestrated drape 270. The fenestrated drape 270 may have a generally rectangular

shape. Moreover, shape. Moreover,thethefenestrated fenestrateddrape drape270270 maymay include include perforations perforations 271.271. In particular, In particular, thethe

perforations 271 perforations maygenerally 271 may generallyform form a shape a shape of of a cutout a cutout in in thefenestrated the fenestrateddrape drape270, 270,which which

-57-

maybebeformed formed therein by by tearing a portion of the fenestrated drape 270 delimited by theby the 2023203963 23 Jun 2023

may therein tearing a portion of the fenestrated drape 270 delimited

perforations 271. In one embodiment, the central portion of the fenestrated drape 270 is already perforations 271. In one embodiment, the central portion of the fenestrated drape 270 is already

opened, i.e., the central material inside the area circumscribed by perforations 271 is removed opened, i.e., the central material inside the area circumscribed by perforations 271 is removed

prior to packaging the fenestrated drape 270. prior to packaging the fenestrated drape 270.

[0233]

[0233] The shape The shapedefined definedbybythe theperforations perforations271 271ororthe theshape shapeofofthe thecentral centralopening opening maybebesuitable may suitablefor foraccessing accessingthe thegenitalia genitaliaofofthe the patient patient for for performing performingthe thecatheterization catheterization 2023203963

procedureafter procedure after covering covering the the patient patient with with the the fenestrated fenestrated drape drape 270. Also, in 270. Also, in some someinstances, instances, the fenestrated the fenestrated drape drape 270 270 may include side may include side cutouts cutouts 272. For instance, 272. For instance, the the side sidecutouts cutouts272 272may may

be generally be generally V-shaped. V-shaped.InInone oneembodiment, embodiment, the the sideside cutouts cutouts 272 272 may may facilitate facilitate placement placement of of the fenestrated drape 270 about the legs of the patient. the fenestrated drape 270 about the legs of the patient.

[0234]

[0234] As mentioned As mentionedabove, above,thethe catheterizationsystem catheterization system maymay include include various various

components that may facilitate the catheterization procedure, such as swabs that may facilitate components that may facilitate the catheterization procedure, such as swabs that may facilitate

sanitizing area near or at the site of the catheterization. FIG. 35 illustrates a swab 150. For sanitizing area near or at the site of the catheterization. FIG. 35 illustrates a swab 150. For

example, the example, the swabs swabs 150 150may mayinclude includethe theelongated elongatedmember memberor or stem/stick152152 stem/stick andand thethe

tip/absorbent head 151 attached thereto. tip/absorbent head 151 attached thereto.

[0235]

[0235] The tip/absorbent The tip/absorbent head head151151maymay havehave a generally a generally rounded rounded outward outward or or distal distal portion and portion anda atapered tapered proximal proximal portion portion (e.g., (e.g., tapering tapering toward toward the proximal the proximal end end of the of the tip/absorbent head tip/absorbent head 151 and toward 151 and toward the theelongated elongatedstem/stick stem/stick 152). 152). ForFor example, example, thethe

tip/absorbent head 151 may be narrower at the proximal end of than at the distal portion (i.e., tip/absorbent head 151 may be narrower at the proximal end of than at the distal portion (i.e.,

the distal the distalportion portionmay may be be generally generally flared flaredand and front frontedge edgethereof thereofmay may be be generally generally rounded). rounded).

[0236]

[0236] The tip/absorbent The tip/absorbent head head 151 151may mayinclude includeanyany suitablematerial, suitable material,which whichmay may vary vary

from one from oneembodiment embodimentto to thethe next.TheThe next. tip/absorbent tip/absorbent head head 151151 maymay include include or comprise or comprise liquid liquid

absorbing material, absorbing material,which which may may absorb absorb sanitizing sanitizing liquid liquid and subsequently and subsequently dispense dispense the the sanitizing liquid onto and/or near the site of catheterization. For instance, the tip/absorbent sanitizing liquid onto and/or near the site of catheterization. For instance, the tip/absorbent

head 151 head 151 may maycomprise comprise a suitablefoam, a suitable foam,sponge, sponge, cotton,etc. cotton, etc.

[0237]

[0237] The tip/absorbent The tip/absorbent head head151 151maymay be attached be attached to the to the elongated elongated stem/stick stem/stick 152 152 with any with any number numberofofsuitable suitablemechanisms, mechanisms, which which may may vary vary from from one embodiment one embodiment to the to the next. next. For example, For example,the thetip/absorbent tip/absorbent head head151 151may maybebe attachedtotothe attached theelongated elongatedstem/stick stem/stick152 152with with an adhesive, an adhesive, may maybebeultrasonically ultrasonically welded weldedtotothe the stem/stick stem/stick 152, 152, etc. etc. The The elongated elongatedstem stem152 152 mayenter may enterinto intothe thetip/absorbent tip/absorbenthead head151151 topredetermined to a a predetermined depth, depth, whichwhich may facilitate may facilitate

suitably securing suitably securing together together the the tip/absorbent tip/absorbent head head 151 and the 151 and the elongated elongated stem/stick stem/stick 152, 152, while while

-58-

Jun 2023 leaving a sufficient portion of the tip/absorbent head 151 beyond the elongated stem/stick 152 leaving a sufficient portion of the tip/absorbent head 151 beyond the elongated stem/stick 152

(e.g., in a manner that avoids contacting and/or injuring or hurting the patient with the elongated (e.g., in a manner that avoids contacting and/or injuring or hurting the patient with the elongated

stem/stick 152 during application of the sanitizing liquid at the insertion site. For instance, stem/stick 152 during application of the sanitizing liquid at the insertion site. For instance,

after being after secured toto the being secured the elongated elongatedstem/stick stem/stick152, 152,thethe tip/absorbent tip/absorbent head head 151 151 may may have have 2023203963 23

sufficient flexibility and sufficient resilience and/or stiffness, such that the tip may substantially sufficient flexibility and sufficient resilience and/or stiffness, such that the tip may substantially

remainunbent remain unbentafter afterabsorption absorption of the of the sanitizing sanitizing liquid liquid and and may resiliently may resiliently bend bend during during 2023203963

application of the sanitizing liquid at the insertion site. application of the sanitizing liquid at the insertion site.

[0238]

[0238] As described As described above, above, ininsome some examples, examples, the the catheter catheter assembly assembly in in the the catheterization tray may be oriented generally parallel to the support surface that supports the catheterization tray may be oriented generally parallel to the support surface that supports the

catheterization tray. catheterization Thecatheter tray. The catheterassembly assembly in the in the catheterization catheterization traytray may may be generally be generally

oriented vertically oriented vertically or perpendicularly to or perpendicularly to the the support supportsurface. surface.FIGS. FIGS. 36A-36B 36A-36B illustrate illustrate a a catheterization system 100a that includes a catheterization tray 200a, which secures a catheter catheterization system 100a that includes a catheterization tray 200a, which secures a catheter

assembly and/orone assemblyand/or oneorormore more components components or elements or elements for catheterization for catheterization procedures. procedures. Except Except

as described as herein, the described herein, the catheterization catheterizationsystem system 100a 100a and its elements and its elements and componentsmaymay and components be be similar to similar to or orthe thesame samecatheterization catheterizationsystem system100 100 (FIGS. (FIGS. 30A) and its 30A) and its elements elements or or components. components.

For instance, For instance, except exceptasasdescribed describedherein, herein,thethecatheterization catheterizationtray tray200a 200a andand catheterization catheterization

elements and elements andcomponents components contained contained in catheterization in the the catheterization traytray 200a200a may may be be similar similar to theto the catheterization tray catheterization tray200 200(FIGS. (FIGS. 31A-32) and catheterization 31A-32) and catheterization elements or components elements or contained components contained

therein. therein.

[0239]

[0239] For example, For example,asasshown shownin in FIG. FIG. 36A, 36A, thethe catheterization catheterization tray200a tray 200a maymay havehave a a generally rectangular generally shape, which rectangular shape, maybebedefined which may definedbyby sides201a-204a. sides 201a-204a. The The sides sides 201a-204a 201a-204a

maybebeapproximately may approximately planar, planar, hence, hence, may may definedefine a box-like a box-like structure structure or periphery or periphery of the of the catheterization tray catheterization tray 200a. The catheterization 200a. The catheterization tray tray 200a also may 200a also includea atop may include topcompartment compartment 210athat 210a that may maycontain containinstructions instructionsand/or and/oroneone or or more more catheterization catheterization components. components. In oneIn one embodiment,the embodiment, thetop topcompartment compartment 210a 210a may may be defined be defined by partitions by partitions 21 212a 211a, la, 212a and and a a bottom bottom

213a. In 213a. In one one embodiment, embodiment, thepartitions the partitions 211a, 21 la, 212a, 212a, and/or and/or the the bottom 213amay bottom 213a maybeberemovable removable from the catheterization tray 200a. from the catheterization tray 200a.

[0240]

[0240] In one In one embodiment, embodiment, removal removal of the of the partitions partitions 211a, 211a, 212a, 212a, and/or and/or the the bottom bottom

213a may 213a mayprovide provideaccess access to to additionalcatheterization additional catheterization components componentscontained containedin in thethe

catheterization tray catheterization tray 200a. For example, 200a. For example,asasshown shownin in FIG. FIG. 36B, 36B, after after removing removing the the partitions partitions

21 la, 212a, 211a, 212a, and and the the bottom 213a(FIG. bottom 213a (FIG.36A), 3 6 A),a acenter centercompartment compartment 220a 220a of the of the catheterization catheterization

tray 200a tray maybebeexposed 200a may exposed and/or and/or accessible accessible to to theuser. the user.ForFor instance,the instance, thecompartment compartment220a220a

-59-

mayhouse houseororcontain containcatheter catheterassembly assembly190. 190.In Inoneone embodiment, the the compartment 210a may 2023203963 23 Jun 2023

may embodiment, compartment 210a may

be separated be separated from fromadjacent adjacentcompartments compartmentsby by one one or more or more partitions partitions (e.g.,by by (e.g., partitions221a, partitions 221a, 222a). As 222a). As mentioned mentionedabove, above, the the catheter catheter assembly assembly 190 190 in in the thecompartment compartment 210a 210a may be may be

oriented approximately vertically relative to the support surface (e.g., when the catheterization oriented approximately vertically relative to the support surface (e.g., when the catheterization

tray 200a is placed on the support surface, such as a surface of the patient's bed). tray 200a is placed on the support surface, such as a surface of the patient's bed).

[0241]

[0241] In one embodiment, In one embodiment,thethepartitions partitions 221a, 221a, 222a 222amay may separate separate thethe center center 2023203963

compartment220a compartment 220a from from adjacent adjacent compartments compartments 230a,230a, 240a.240a. Compartments Compartments 230a240a 230a and/or and/or 240a mayhouse may houseororcontain contain various various catheterizationelements catheterization elements or or components components for procedure, for procedure, whichwhich

maybebesimilar may similartotoororthe the same sameasascatheterization catheterizationcomponents components described described above above in connection in connection

with catheterization with catheterization tray tray 200 (FIGS.31A-32). 200 (FIGS. 31A-32).In some In some instances, instances, the the partitions partitions 221 221 and/or and/or

222a may 222a maybeberemovable removable fromfrom the catheterization the catheterization traytray 200a, 200a, which which may facilitate may facilitate removal removal of of catheterization elements catheterization elements or or components fromthe components from thecatheterization catheterizationtray tray 200a. 200a.

[0242]

[0242] Thecatheterization The catheterization tray tray 200a maybebeconstructed 200a may constructedofofany anysuitable suitable material. material. For For example, the catheterization tray 200a may be constructed of thick sheet-like material or panels example, the catheterization tray 200a may be constructed of thick sheet-like material or panels

(e.g., plastic (e.g., plasticmaterial). material).For For instance, instance,thickness thickness of ofthe thepanels panels may be in may be in one oneorormore moreofof the the

following ranges: about 0.1 inches to about 0.2 inches; about 0.15 inches to about 0.3 inches; following ranges: about 0.1 inches to about 0.2 inches; about 0.15 inches to about 0.3 inches;

about 0.25 about 0.25 inches inches to to about about 0.5 0.5 inches. inches. It It should should be be appreciated, appreciated,however, however, panel panel thickness thickness may may

be less than 0.1 inches or greater than 0.5 inches. Moreover, the catheterization tray 200a may be less than 0.1 inches or greater than 0.5 inches. Moreover, the catheterization tray 200a may

be reused be reusedafter afterthe thecatheterization catheterizationprocedure procedure (e.g.,thethecatheterization (e.g., catheterizationtray tray200a 200a may may be be sanitized and/or repacked for reuse). sanitized and/or repacked for reuse).

[0243]

[0243] In one In one embodiment, embodiment,thethecatheterization catheterization tray tray may maybe be at least at least partially partially

disassembled(e.g., disassembled (e.g., in in addition addition to to or or in in lieu lieu of of removing partitions). FIG. removing partitions). FIG.37A 37A illustratesaa illustrates

catheterization system catheterization 100bthat system 100b thatmaymay include include a catheterization a catheterization tray tray 200b,200b, whichwhich may be may be unfolded to unfolded to access access contents contents therein. therein. As As mentioned above,the mentioned above, thecatheterization catheterization system 100bmay system 100b may include aa catheterization include catheterization tray tray 200b that may 200b that bewrapped may be wrappedin in a CSR a CSR sterile sterile wrap wrap 130b, 130b, which which

maybebeunwrapped may unwrapped to access to access the the catheterization catheterization traytray 200b. 200b. For instance, For instance, initially initially a flap a flap or or portion 131b portion 131b ofofthe the CSR CSRsterile sterile wrap wrap130b 130bmaymay be unfolded be unfolded toward toward the patient the patient (e.g., (e.g., thereby thereby

covering the support surface with the sterile portion 13 lb of the CSR sterile wrap 130b. covering the support surface with the sterile portion 131b of the CSR sterile wrap 130b.

[0244]

[0244] In one In one embodiment, embodiment,thethe CSRCSR sterile sterile wrapwrap 130b 130b may include may include a pocket a pocket 132b, 132b, which may which maybebeexposed exposed when when the the CSR CSR sterile sterile wrapwrap 130b 130b is unwrapped is unwrapped to expose to expose the the catheterization tray catheterization tray 200b. 200b. In In one one embodiment, embodiment, during after during and/or and/or theafter the catheterization catheterization

-60-

procedure, used used items items or or trash trash may be placed placedin in the the pocket 132b. Subsequently, Subsequently,the thetrash trashmay may 2023203963 23 Jun 2023

procedure, may be pocket 132b.

be disposed be disposed together together with with the the CSR CSRsterile sterile wrap wrap130b. 130b.

[0245]

[0245] A drape A drape(e.g., (e.g., the the fenestrated fenestrated drape drape 270) 270) may maybebe attached attached to to thethe CSRCSR sterile sterile

wrap130b, wrap 130b,such suchthat that after after the theunwrapping the CSR unwrapping the CSRsterile sterile wrap 130b,the wrap 130b, the drape drape is is exposed and exposed and

maybeberemoved may removed from from thethe CSRCSR sterile sterile wrap wrap 130b 130b and and usedused in the in the catheterization catheterization procedure. procedure. In In one embodiment, one embodiment, thethe fenestrateddrape fenestrated drape 270 270 maymay be attached be attached to the to the CSR CSR sterile sterile wrapwrap 130b 130b in in 2023203963

any suitable any suitable manner, whichmay manner, which may vary vary from from one one embodiment embodiment to thetonext. the next. In oneInexample, one example, the the fenestrated drape fenestrated drape 270 maybebeattached 270 may attachedtotothe the CSR CSR sterilewrap sterile wrap130b 130bwith with lightadhesive, light adhesive,tape, tape, tabs, etc. tabs, etc.

[0246]

[0246] As mentioned As mentionedabove, above, the the catheterization catheterization tray tray200b 200b may be exposed may be exposedafter after unwrappingthe unwrapping theCSR CSR sterilewrap sterile wrap130b. 130b.TheThe catheterizationtray catheterization tray200b 200bmay may include include oneone or or more more

identifiers 260b, identifiers 260b, which mayidentify which may identifyoror suggest suggestananorder orderofofstep step and/or and/or use use of ofcatheterization catheterization componentsininthe components thecatheterization catheterization procedure procedure(e.g., (e.g., the the identifiers identifiersmay maybe be on on one one or or more more outer outer

surfaces of the catheterization tray 200b). For example, the identifiers 260b may be located on surfaces of the catheterization tray 200b). For example, the identifiers 260b may be located on

the top the top surface surfaceofofthethecatheterization catheterizationtray tray 200b 200b and indicate and may may indicate further further steps insteps the in the catheterization procedure. catheterization procedure. According to one According to oneembodiment, embodiment,a top a top panel panel 201b201b of of the the catheterization tray catheterization tray200b 200b may be opened may be openedtotounfold unfoldthe the catheterization catheterization tray tray 200b 200b and access the and access the

catheterization components in the catheterization tray 200b. catheterization components in the catheterization tray 200b.

[0247]

[0247] As shown in FIG. 37B, after opening the catheterization tray 200b, the user may As shown in FIG. 37B, after opening the catheterization tray 200b, the user may

access the access the compartment compartment 210b, 210b,which whichmaymay contain contain the the catheter catheter assembly assembly 190 190 for for the the catheterization procedure. catheterization Forinstance, procedure. For instance, the the top top panel panel201b 201btogether togetherwith witha side a sidepanel panel202b 202b (connected thereto) (connected thereto) may maybebeunfolded unfoldedaway away from from panels panels 203b, 203b, 204b, 204b, 205b. 205b. More More specifically, specifically,

the side the side panels panels 203b, 203b,204b, 204b,stiffening stiffeningribs ribs205b 205bmaymay partially partially define define the the periphery periphery of of the the compartment210b. compartment 210b.Unfolding Unfolding the the side side panel panel 202b 202b and and the the toptop panel panel 201b 201b from from the the sideside panels panels

203b, 204b, 203b, 204b, 205b 205bmay may provide provide access access toto thecompartment the compartment 210b 210b through through a side a side (from (from which which the the side panel side panel 202b wasunfolded) 202b was unfolded)and andthrough through thethe top top (where (where thethe toptop panel panel 201b 201b was was removed). removed).

In one In embodiment,thetheside one embodiment, sidepanel panel202b 202b and and thethe toppanel top panel 201b 201b maymay be unfolded be unfolded in a in a general general

direction that is opposite to or away from the insertion site (e.g., in a manner that would not direction that is opposite to or away from the insertion site (e.g., in a manner that would not

interfere with the catheterization procedure). interfere with the catheterization procedure).

[0248]

[0248] Moreover,ononthetheinterior Moreover, interiorsurface surfaceofofthe thepanel panel201b, 201b, thethe catheterization catheterization tray tray

200b may include additional or alternative catheterization components, such as the syringe 170 200b may include additional or alternative catheterization components, such as the syringe 170

-61-

and swabs swabs150. 150.Such Such catheterizationcomponents components may may be attached or secured to top the top panel 2023203963 23 Jun 2023

and catheterization be attached or secured to the panel

201b and/or 201b and/ortoto the the side side panel panel 202b. 202b. For Forexample, example, thethe syringe syringe 170170 maymay be secured be secured to top to the the top panel 201b panel 201b with withone oneorormore morestraps straps220b. 220b.Furthermore, Furthermore,in in some some instances, instances, thetheswabs swabs 150150 maymay

be secured be secured to to the the top top panel panel 201b 201bwithin withinone oneorormore more pockets pockets 230b. 230b. It should It should be appreciated be appreciated

that, the catheterization components (such as the syringe 170, swabs 150, etc.) may be attached that, the catheterization components (such as the syringe 170, swabs 150, etc.) may be attached

or secured or secured to to the the top top panel panel201b 201bininanyany number number of suitable of suitable waysways and any and with withnumber any number of of 2023203963

suitable mechanisms suitable (e.g., adhesive, mechanisms (e.g., adhesive, tabs, tabs, etc.). etc.).In Inany any event, event,the thecatheterization catheterizationcomponents components

secured on secured on the the interior interior of of the the top top panel 201b and/or panel 201b and/orside sidepanel panel202b 202bmaymay be accessible be accessible and and

removabletherefrom removable therefromafter afterunfolding unfoldingthereof thereofaway awayfrom from thethe sidepanels side panels203b, 203b,204b, 204b, 205b. 205b.

[0249]

[0249] Moreover,the Moreover, theside sidepanel panel202b 202band/or and/or thethe toptop panel panel 201b 201b may may include include one one or or moreprocedural more proceduralindicators indicators260b 260bnear nearone oneorormore more corresponding corresponding catheterization catheterization components. components.

For example, For example,procedural proceduralindicators indicators260b 260bmaymay identify identify thethe catheterizationcomponents catheterization components withwith a a number thatmay numberthat may correspond correspond withwith a suggested a suggested number number of a in of a step step in a suggested a suggested sequence sequence of of steps for steps for the the catheterization catheterization procedure. Also,the procedure. Also, thecatheterization catheterization components componentsandand correspondingprocedural corresponding proceduralindicators indicators260b 260bmaymay be be arranged arranged in ainsequential a sequential manner, manner, such such that that

the indicators the indicators with with higher higher numbers and corresponding numbers and correspondingcatheterization catheterization components are components are

generally positioned generally positionedincreasingly increasinglyfarther fartherfrom from the the insertion insertion site.site. In words, In other other words, the the catheterization components that are used earlier in the catheterization procedure may be closer catheterization components that are used earlier in the catheterization procedure may be closer

to the to the insertion insertion site, site, while whilethethecatheterization catheterization components components thatused that are are later usedinlater the in the catheterization procedure catheterization arelocated procedure are locatedfarther fartheraway away fromfrom the insertion the insertion site site (based (based on theon the orientation of the catheterization tray 200b). orientation of the catheterization tray 200b).

[0250]

[0250] In one In one embodiment, thecatheterization embodiment, the catheterization tray tray 200b 200b may include aa horizontal may include horizontal panel panel

207b, which 207b, whichmay maybe be connected connected to and to and extend extend from from the panel the side side panel 204b (e.g., 204b (e.g., the horizontal the horizontal

panel 207b panel 207b may maybebefolded foldedinto intothe thecompartment compartment 210b 210b and/or and/or may may be approximately be approximately parallel parallel to to the support surface supporting the catheterization tray 200b). In some instances, the horizontal the support surface supporting the catheterization tray 200b). In some instances, the horizontal

panel 207b panel 207bmay maysupport supportand/or and/orsecure secureoneone or or more more catheterization catheterization components. components. For For example, example,

the horizontal the horizontal panel panel 207b 207bmaymay secure secure a pouch a pouch 180blubricant 180b with with lubricant that that may be may be removed removed therefrom and therefrom andused usedininthe the catheterization catheterization procedure. procedure.

[0251]

[0251] In one In one embodiment, embodiment,thethe side side panel panel 204b204b and horizontal and horizontal panelpanel 207b 207b may be may be unfolded away unfolded awayfrom from thethe side side panels panels 203b203b and 205b, and 205b, as shown as shown in FIG.in37C. FIG.For37C. For instance, instance,

unfolding the unfolding the side side panel panel 204b 204bmay mayprovide provide access access into into thecompartment the compartment 210b. 210b. Furthermore, Furthermore,

one or one or more morecatheterization catheterization components components may may be attached be attached to the to the side side panel panel 204b 204b and/or and/or to the to the

-62-

interior side side of of the the horizontal horizontal panel panel 207b, on the the interior interior surface surface thereof. For example examplethethe 2023203963 23 Jun 2023

interior 207b, on thereof. For

sanitizer packet 160 may be attached to the horizontal panel 207b and/or to the side panel 204b sanitizer packet 160 may be attached to the horizontal panel 207b and/or to the side panel 204b

(e.g., with (e.g., with light lightadhesive). adhesive). Also, the the catheterization catheterization tray 200b mayinclude 200b may includeindicator indicator260b 260b identifying the step or particular order or place in the sequence of the catheterization procedure identifying the step or particular order or place in the sequence of the catheterization procedure

where the sanitizer where the sanitizer packet packet 160 maybebeused. 160 may used.

[0252]

[0252] As described As describedabove, above,the thecatheterization catheterizationsystem systemmaymay include include a catheterization a catheterization 2023203963

tray wrapped tray into aa sterile wrapped into sterilewrap, wrap,which which may be used may be used during duringthe the catheterization catheterization procedure. The procedure. The

catheterization system catheterization mayinclude system may include oneone or more or more catheterization catheterization components components packaged packaged by by and/or secured in a sterile wrap (e.g., directly in the sterile wrap without the catheterization and/or secured in a sterile wrap (e.g., directly in the sterile wrap without the catheterization

tray). Such tray). Such catheterization catheterization system systemmay mayreduce reduce waste waste or or materials materials thatarearethrown that thrown away away after after

the catheterization procedure. For instance, after completing the catheterization material, the the catheterization procedure. For instance, after completing the catheterization material, the

sterile wrap sterile wrap may be disposed may be disposed and/or and/or composted compostedtotoreduce reducelong long term term waste waste fromfrom the the catheterization system. catheterization system.

[0253]

[0253] Followingononthe Following theforegoing, foregoing, FIGS. FIGS.38A, 38A,39A, 39A,40A, 40A, 41 A, 41A, 42A, 42A, and and 43A 43A provide provide

medical-proceduretrays medical-procedure traysforfor medical-procedure medical-procedure packages packages (e.g., catheterization (e.g., catheterization trays trays for for catheterization packages) catheterization in accordance packages) in accordancewith with some some alternative alternative embodiments embodiments to previously to previously

described medical-procedure described medical-procedure trays. trays. For expository For expository expediency, expediency, features features of alternative of alternative

embodiments embodiments shared shared with with medical-procedure medical-procedure traystrays previously previously described described in detail in detail aboveabove will will not be not described in be described in similar similar detail detailbelow. It should below. It should be be understood that description understood that description for for each of each of

the shared the features is shared features is incorporated incorporated by by reference, reference, as as appropriate, appropriate, by by the the shared shared feature's feature'sname name

whendescribing when describingalternative alternativeembodiments. embodiments.For For additional additional expository expository expediency, expediency, not not every every feature of feature of alternative alternativeembodiments sharedwith embodiments shared withpreviously previouslydescribed describedmedical-procedure medical-procedure trays trays

will be further described. Instead, it should be understood that shared visual elements between will be further described. Instead, it should be understood that shared visual elements between

the alternative the alternative embodiments andthethepreviously embodiments and previously described described medical-procedure medical-procedure traystrays represent represent

shared features shared features between betweenthe thealternative alternative embodiments embodimentsand and the the previously previously described described medical- medical-

proceduretrays. procedure trays. Thus, Thus, thethe shared shared visual visual elements elements provide provide a basisa for basis for incorporating incorporating by by reference, as reference, as appropriate, appropriate, description description for foreach eachof of thethe shared shared features features for for the alternative the alternative

embodiments. For embodiments. Forexample, example,FIGS. FIGS.2 2and and38A38A provide provide medical-proceduretrays medical-procedure traysincluding including stiffening ribs. (See stiffening ribs. stiffening ribs (See stiffening ribs 20 20 of of FIG. FIG. 22 and andthe thedescription descriptiontherefor.) therefor.) While While thethe

stiffening ribs stiffening ribs of of the the alternative alternativeembodiment embodiment ofofFIG. FIG.38A38A are are not not expressly expressly described, described, the the description for description for the the stiffening stiffening ribs ribs isisincorporated incorporated by by reference reference in in view ofthe view of the shared sharedvisual visual elements representing the stiffening ribs. elements representing the stiffening ribs.

-63-

Jun 2023

[0254]

[0254] FIG. 38A FIG. 38Ashows shows a view a view of of another another medical-procedure medical-procedure traytray 38003800 in accordance in accordance

with some with someembodiments. embodiments. FIG. FIG. 38B 38B showsshows another another view view of theofmedical-procedure the medical-procedure tray of tray 3800 3800 of FIG. 38A. FIG. 3 8 A.FIG. FIG. 38C38C shows shows another another view view of the of the medical-procedure medical-procedure tray tray 3800 of 3800 of FIG. FIG. 38A 38A together with together with a a cover cover 3801. FIG.38D 3801. FIG. 38Dshows shows another another view view of the of the medical-procedure medical-procedure traytray 3801 3801 2023203963 23

of FIG. of 38Atogether FIG. 38A togetherwith withthe the cover cover3801. 3801.

[0255]

[0255] The medical-procedure The medical-proceduretray tray3800 3800ofofFIGS. FIGS.38A, 38A, 38B, 38B, 38C, 38C, andand 38D38D can can include include 2023203963

a first a firstsection section3810, 3810,aasecond second section section 3820, 3820, and a third and a third section section 3830. Asdescribed 3830. As describedherein, herein,aa section of section of a a medical-procedure traycan medical-procedure tray canbebedesignated designated forfor one one or or more more particular particular uses uses (e.g., (e.g.,

well foriodine, well for iodine,section sectionforforstorage, storage,etc.), etc.),andand a section a section cancan beleast be at at least partially partially and and up toup to wholly wholly

separated from separated from one oneorormore moreother othersections sectionsbybyone oneorormore morephysical physicalfeatures features(e.g., (e.g., one or more one or more

partitions), thereby partitions), thereby forming a compartment forming a compartment foroneone for or or more more particular particular uses. uses. As shown, As shown, the the medical-proceduretray medical-procedure tray3800 3800includes includesa afirst first partition partition3842 3842formed formed from from the the medical-procedure medical-procedure

tray 3800 itself. The first partition 3842 or at least a first section-facing face of the first partition tray 3800 itself. The first partition 3842 or at least a first section-facing face of the first partition

3842 (see FIG. 3842(see FIG. 38A) 3 8 A)has hasa afirst first height height /?/ equal to h equal to aa height height of of the the medical-procedure tray 3800 medical-procedure tray 3800 at at at atleast leastananend endof ofthe medical-procedure the medical-procedure tray tray 3800 3800 including including the the second section 3820. second section 3820. The The first partition 3842 or at least the first section-facing face of the first partition 3842 (see FIG. first partition 3842 or at least the first section-facing face of the first partition 3842 (see FIG.

3 8 A) has a second height /?? less than the first height at at least an end of the medical-procedure 38A) has a second height h less than the first height at at least an end of the medical-procedure

tray 3800 opposite the second section 3820. In view of the first partition 3842, the first section tray 3800 opposite the second section 3820. In view of the first partition 3842, the first section

3810can 3810 canbebeconsidered considereda first a firstcompartment compartment38103810 at least at least partially partially separated separated from from the the third third

section 3830 section 3830and andwholly wholly separated separated fromfrom the second the second section section 3820. 3820. As further As further shown, shown, the the medical-proceduretray medical-procedure tray3800 3800 includes includes a second a second partition partition 3844 3844 formedformed from from the the medical- medical-

procedure tray 3800 itself. The second partition 3844 or at least a third section-facing face of procedure tray 3800 itself. The second partition 3844 or at least a third section-facing face of

the second the second partition partition 3844 (see FIG. 3844 (see FIG. 38A 38Aoror38B) 38B) hashas a firstheight a first heightequal equaltotothe theheight heightofofthe the medical-procedure tray 3800. In view of the first partition 3842 and the second partition 3844, medical-procedure tray 3800. In view of the first partition 3842 and the second partition 3844,

the second the section 3820 second section canbe 3820 can be considered considereda asecond secondcompartment compartment 3820 3820 wholly wholly separated separated from from

the first section 3810 and the third section 3830. Further in view of the first partition 3842 and the first section 3810 and the third section 3830. Further in view of the first partition 3842 and

the second the partition 3844, second partition 3844, the the third third section section3830 3830 can can be be considered a third considered a third compartment 3830 compartment 3830

at least at leastpartially partiallyseparated separatedfrom fromthe thefirst firstsection 3810 section 3810and andwholly wholly separated separated from the second from the second section 3820. section 3820.

[0256]

[0256] As with As withpreviously previouslydescribed describedmedical-procedure medical-procedure trays, trays, thethe medical-procedure medical-procedure

tray 3800 tray 3800can caninclude include medical-procedure medical-procedure instructions instructions imprinted imprinted directly directly on theonmedical- the medical- proceduretray procedure tray 3800, 3800, at at least least some of which some of whichinstructions instructions can can be be revealed revealedin in step step with with steps steps of of

-64-

the medical procedure. When Whenthethe medical-procedure traytray 3800 is incorporated intointo a medical- 2023203963 23 Jun 2023

the medical procedure. medical-procedure 3800 is incorporated a medical-

procedurepackage procedure packagewith withcontents contentsfor forthe themedical medicalprocedure procedure (e.g.,aadrainage (e.g., drainagesystem systemincluding including a catheter, a catheter, aa container container ofoflubricant, lubricant, aa syringe syringeofofwater, water,a askin-preparation skin-preparation kit,etc. kit, etc.forfora a catheterization procedure), catheterization procedure), step-wise step-wiseremoval removal of contents of the the contents can reveal can reveal the step-wise the step-wise

instructions for instructions forthe themedical medical procedure procedure imprinted on the imprinted on the medical-procedure tray3800. medical-procedure tray 3800.

[0257]

[0257] With respect to the first section or compartment 3810, the first section 3810 can With respect to the first section or compartment 3810, the first section 3810 can 2023203963

be configured be configuredtotoaccommodate accommodate a first a first set contents set of of contents for afor a medical medical procedure. procedure. In some In some embodiments, the medical procedure is a catheterization procedure and the first set of contents embodiments, the medical procedure is a catheterization procedure and the first set of contents

can include, but is not limited to, a drainage system including a catheter (e.g., a Foley catheter), can include, but is not limited to, a drainage system including a catheter (e.g., a Foley catheter),

drainage tubing, and a drainage bag. The first set of contents can further include a syringe of drainage tubing, and a drainage bag. The first set of contents can further include a syringe of

sterile water sterile water for forinflating inflatinga balloon such a balloon suchasas a balloon ofofa Foley a balloon catheter. a Foley When catheter. When the the medical- medical-

proceduretray procedure tray 3800 3800isis incorporated incorporatedinto into aa medical-procedure medical-procedurepackage, package, thethe firstsection first section3810 3810 can include the first set of contents. For a visual reference, the medical-procedure tray 3800 of can include the first set of contents. For a visual reference, the medical-procedure tray 3800 of

FIGS. 38A, FIGS. 38A,38B, 38B,38C, 38C, andand 38D 38D is shown is shown with with a syringe a syringe of sterile of sterile waterwater 3892.3892. As in As shown shown in FIGS. 38A FIGS. 38Aand and38B, 38B, thethe syringe syringe ofof sterile water sterile water3892 3892can canbebesimply simplyplaced placedalongside alongside an an inner inner

wall of wall of the the medical-procedure medical-proceduretray tray3800 3800 or or fitfitinto intoposition positionalongside alongsidethe theinner innerwall wallwith witha a loose-fit interference fit at both end of the syringe of sterile water 3892. As shown in FIGS. loose-fit interference fit at both end of the syringe of sterile water 3892. As shown in FIGS.

38Cand 38C and38D, 38D,thethesyringe syringeofofsterile sterile water water 3892 3892can canstill still be be placed alongside the placed alongside the inner inner wall of wall of

the medical-procedure the medical-proceduretray tray3800; 3800;however, however, the the syringe syringe of sterile of sterile water water 3892 3892 can can be further be further

placed within a folded portion or retainer 3803 of the cover 3801. placed within a folded portion or retainer 3803 of the cover 3801.

10258]

[0258] Referring to Referring to FIG. FIG.38C 38Candand 38D,38D, the medical-procedure the medical-procedure tray is3800 tray 3800 is shown shown together with the cover 3801 such as the packaging label 62 described in reference to FIGS. 11 together with the cover 3801 such as the packaging label 62 described in reference to FIGS. 11

and 12, and 12, the the identification identification cover cover 120 120described describedininreference referencetotoFIG. FIG. 30A, 30A, or aorcombination a combination thereof. As further shown, the cover 3801 can be folded to form the retainer 3803 for retaining thereof. As further shown, the cover 3801 can be folded to form the retainer 3803 for retaining

certain contents certain contents of of the themedical-procedure packageininthe medical-procedure package the first first section section 3810. 3810. For example,the For example, the retainer 3803 can be configured for keeping the syringe of sterile water 3892 in the first section retainer 3803 can be configured for keeping the syringe of sterile water 3892 in the first section

3810apart 3810 apart from fromcertain certainother othercontents contentsofofthe themedical-procedure medical-procedure package package in the in the firstsection first section 3810. Other 3810. Otherportions portionsof of thecover the cover 3801 3801 can can be folded be folded to form to form otherother retainers retainers for retaining for retaining

contents of contents of the the medical-procedure package medical-procedure package in in theappropriate the appropriatesections. sections.As As shown, shown, the the cover cover

3801 can be configured to fit within the first section 3810 of the medical-procedure tray 3800; 3801 can be configured to fit within the first section 3810 of the medical-procedure tray 3800;

however, the cover 3801 can be alternatively configured to fit within the first section 3810 and however, the cover 3801 can be alternatively configured to fit within the first section 3810 and

additional sections (e.g., the second section 3820, the third section 3830, etc.) of the medical- additional sections (e.g., the second section 3820, the third section 3830, etc.) of the medical-

-65-

proceduretray tray 3800 3800oror portions portions thereof. thereof. The Thecover cover3801 3801can canbebealternatively alternativelyconfigured configuredtotofit fit 2023203963 23 Jun 2023

procedure

over the over the medical-procedure medical-proceduretray tray4100 4100ininany anyofofthe theforegoing foregoing configurations configurations up up to to thewhole the whole medical-procedure tray4100 medical-procedure tray 4100excepting excepting foldedororotherwise folded otherwise shaped shaped portions portions of of thethecover cover 3801 3801

formingretainers forming retainers for for retaining retaining contents contents of of the the medical-procedure packageininthetheappropriate medical-procedure package appropriate sections. sections.

[0259]

[0259] Withrespect With respecttoto the the second secondsection sectionororcompartment compartment 3820, 3820, the second the second section section 2023203963

3820can 3820 canbebeconfigured configuredtotoaccommodate accommodate a second a second setcontents set of of contents for the for the medical medical procedure. procedure.

In some In embodiments, some embodiments, thethe medical medical procedure procedure is catheterization is a a catheterizationprocedure procedureandand thesecond the second setset

of contents can include, but is not limited to, a container containing lubricant (e.g., lubricant of contents can include, but is not limited to, a container containing lubricant (e.g., lubricant

for aa Foley for catheter). When Foley catheter). themedical-procedure When the medical-procedure tray tray 3800 3800 is incorporated is incorporated into into a medical- a medical-

procedure package, the second section 3820 can include the second set of contents. For a visual procedure package, the second section 3820 can include the second set of contents. For a visual

reference, the reference, the medical-procedure tray 3800 medical-procedure tray 3800ofofFIGS. FIGS.38A38A andand 38B 38B is shown is shown with with a container a container

of lubricant 3894. of lubricant 3894.

[0260]

[0260] Insofar as Insofar as configuration configuration of ofthe the second secondsection sectionororcompartment compartment 3820 3820 for for the the second set second set of of contents, contents, the the second secondsection section3820 3820cancan be be configured configured asretainer as a a retainer to to retainoror retain

otherwise secure otherwise securethe thesecond second setset of of contents contents (e.g., (e.g., thethe container container of lubricant of lubricant 3894) 3894) whilewhile

simultaneouslyproviding simultaneously providingopen open access access forfor easy easy removal removal of the of the second second setcontents. set of of contents. The The secondpartition second partition 3844 formedfrom 3844 formed from thethe medical-procedure medical-procedure traytray 38003800 can have can have the previously the previously

described first height (e.g., equal to the height of the medical-procedure tray 3800) at the third described first height (e.g., equal to the height of the medical-procedure tray 3800) at the third

section-facing face section-facing face of of the the second partition 3844 second partition (see FIG. 3844 (see 38Aoror38B); FIG. 38A 38B);however, however,thethe second second

partition 3844 partition 3844 can further have can further have aa second second height heightat at aa second secondsection-facing section-facing face face of of the the second second partition 3844. partition Thesecond 3844. The second height height at at thesecond the second section-facing section-facing face face of of thethe second second partition partition

3844 can be less than the first height at the third section-facing face of the second partition 3844 can be less than the first height at the third section-facing face of the second partition

3844, which, in turn, serves to elevate a bottom 3822 of the second section 3820 above a bottom 3844, which, in turn, serves to elevate a bottom 3822 of the second section 3820 above a bottom

3812 of the first section 3810 or the tray 3800 (see FIG. 38B). Again, for a visual reference, 3812 of the first section 3810 or the tray 3800 (see FIG. 38B). Again, for a visual reference,

the medical-procedure the tray 3800 medical-procedure tray 3800of ofFIGS. FIGS.38A 38Aand and38B 38B is is shown shown with with thethe containerofoflubricant container lubricant 3894. The 3894. Thecontainer container of of lubricant3894 lubricant 3894 cancan be be fitfit intoposition into positionalongside alongsideananinner inner wall wall (or(or a a protrusion thereof) protrusion thereof) of of the the medical-procedure tray3800 medical-procedure tray 3800shared shared with with thethe second second section section 3820 3820

and the second section-facing face of the second partition 3844 with a loose-fit interference fit and the second section-facing face of the second partition 3844 with a loose-fit interference fit

on both sides of the container of lubricant 3894, at both ends of the container of lubricant 3894, on both sides of the container of lubricant 3894, at both ends of the container of lubricant 3894,

or aa combination or combinationthereof. thereof. TheThe bottom bottom 38223822 of second of the the second section section 3820 elevated 3820 elevated above above the the

-66-

bottom3812 3812ofofthe thefirst first section section 3810 3810ororthe the tray tray 3800 3800provides providesfor forthe theopen openaccess accessforforeasy easy 2023203963 23 Jun 2023

bottom

removal of the second set of contents. removal of the second set of contents.

[0261]

[0261] Withrespect With respectto to the the third third section section or or compartment 3830,thethethird compartment 3830, thirdsection section3830 3830 can be can be configured configuredto to accommodate accommodate a third a third setofofcontents set contentsfor forthe the medical medicalprocedure. procedure.In Insome some embodiments, the medical procedure is a catheterization procedure and the third set of contents embodiments, the medical procedure is a catheterization procedure and the third set of contents

can include, but is not limited to, a specimen container, optionally, a label for the specimen can include, but is not limited to, a specimen container, optionally, a label for the specimen 2023203963

container, and a skin-preparation kit including a packet of antiseptic (e.g., an iodophor such as container, and a skin-preparation kit including a packet of antiseptic (e.g., an iodophor such as

povidone-iodine, tincture povidone-iodine, tincture of of iodine, iodine, aqueous iodine, etc.) aqueous iodine, etc.) and and one or more one or moreswabs. swabs.When When the the medical-proceduretray medical-procedure tray3800 3800 is incorporated is incorporated intointo a medical-procedure a medical-procedure package, package, the the third third section 3830 section can include 3830 can include the the third third set set of ofcontents. contents. The The medical-procedure tray 3800 medical-procedure tray 3800ofofFIGS. FIGS. 38Aand 38A and38B 38B is is shown shown without without the the specimen specimen container container orskin or the the skin preparation preparation kit; kit; however, however,

FIGS. 8,8, 26, FIGS. 26, and and 27 27 provide providevisual visual references references for for inclusion inclusion of of the theone one or ormore more swabs 34 in swabs 34 in the the medical-procedure tray3800, medical-proceduretray 3800, FIGS. FIGS. 25-29 25-29 provide provide visualvisual references references for inclusion for inclusion of the of the specimencontainer specimen container5454in inthethemedical-procedure medical-procedure traytray 3800, 3800, and 25 and FIG. FIG. 25 provides provides a a visual visual reference for inclusion of the packet of antiseptic 52 in the medical-procedure tray 3800. reference for inclusion of the packet of antiseptic 52 in the medical-procedure tray 3800.

[0262]

[0262] Insofar as configuration of the third section or compartment 3830 for the third Insofar as configuration of the third section or compartment 3830 for the third

set of set of contents, contents, the the third third section section 3830 can be 3830 can beconfigured configuredwith withoneone or or more more additional additional sub-sub

sections or sections or sub-compartments. sub-compartments. As As shown shown in FIGS. in FIGS. 38A38B, 38A and andthe 38B, onethe or one moreoradditional more additional sub-sections oror sub-compartments sub-sections sub-compartments can include aa swab can include swab compartment compartment3832, 3832,an an overflow overflow

compartment3834, compartment 3834, andand a corner a corner storage storage compartment compartment 3836. 3836. The compartment The swab swab compartment 3832, in3832, in turn, can turn, can include include aa well well 3831 and one 3831 and oneoror more morechannels, channels,one onechannel channel of of which which is is indicated indicated as as

channel 3833. channel 3833. The The well3831 well 3831 cancan be be positioned positioned at base at a a base of of thethesecond second partition3844, partition 3844,which which separates the separates the second second section section 3820 from the 3820 from the third third section section3830 3830 as as shown in FIGS. shown in 38Aand FIGS. 38A and38B. 38B. The well 3831 can be further positioned at a base of the one or more channels, thereby adjoining The well 3831 can be further positioned at a base of the one or more channels, thereby adjoining

each channel each channelofofthe theoneone or or more more channels channels at a at a well-end well-end thereof. thereof. The The well well 3831 can 3831 be can be configured to configured to contain contain aa fluid fluid such such asas the the antiseptic antiseptic of of the the medical-procedure package medical-procedure package when when

pouredtherein. poured therein.

[0263]

[0263] The one The oneorormore more channels channels can can be configured be configured to respectively to respectively hold hold the or the one one or moreswabs more swabsofofthe theskin-preparation skin-preparationkit kitfor for subsequent subsequentuse usewith withthe theantiseptic antiseptic of of the the packet of packet of

antiseptic. Each antiseptic. channelofofthe Each channel the one oneorormore morechannels channels cancan be be configured configured to hold to hold a respective a respective

swabofofthe swab theone oneorormore more swabs swabs optionally optionally under under at least at least one one snap-in snap-in feature feature or snap-in or snap-in tab tab positioned along a length or a longitudinal side of the channel. Any two or more snap-in tabs, positioned along a length or a longitudinal side of the channel. Any two or more snap-in tabs,

-67-

such as as any anythree threeorormore more snap-in tabs, and, for for example, any or four or snap-in more snap-in tabs 2023203963 23 Jun 2023

such snap-in tabs, and, example, any four more tabs

positioned along positioned along aa length length or or longitudinal longitudinal sides sides of of aa channel can be channel can be staggered staggeredwith withrespect respecttoto each other. each other. As As shown shownbetween between FIGS. FIGS. 38A 38A and 38B, and 38B, each each channel channel of theofone theor one or more more channels channels

can include three staggered snap-in tabs along the longitudinal sides thereof. (See also FIG. 8 can include three staggered snap-in tabs along the longitudinal sides thereof. (See also FIG. 8

and the and the description descriptiontherefor.) therefor.) Each Each channel channel of the of the onemore one or or channels more channels can be can be further further configured with configured withananincline inclineororananangle angle with with respect respect to the to the bottom bottom 3812 3812 of theoftray the 3800. tray 3800. 2023203963

Furthermore,each Furthermore, eachchannel channelofofthe theone oneorormore morechannels channelscancan bebe configured configured with with a deltaorordelta a delta delta shape at the well-end thereof adjoining the well 3831. With such a configuration, a handle end shape at the well-end thereof adjoining the well 3831. With such a configuration, a handle end

of a swab held under the snap-in tabs of a channel can be elevated with respect to an absorbent- of a swab held under the snap-in tabs of a channel can be elevated with respect to an absorbent-

head end head endofofthe the swab swabwhen when thethe absorbent-head absorbent-head end end is positioned is positioned in accommodating in an an accommodating delta delta therefor. As therefor. As such, such, an an absorbent absorbenthead headofofa aswab swabcancan angle angle downwardly downwardly into into the well the well 3831 3831 of of the swab the compartment swab compartment 3832 3832 of of thethe thirdsection third section3830 3830and andananelongate elongatemember member of the of the swab swab can can angle upwardly angle upwardlyforforgripping gripping andand removal removal at anatappropriate an appropriate step step of unboxing of unboxing the medical- the medical-

procedurepackage procedure packagecontaining containingthe thetray tray3800 3800and andthe theswab. swab.

[0264]

[0264] Theoverflow The overflowcompartment compartment 3834 3834 can can be positioned be positioned at an at an endend of of thethe oneone or or more more

channels opposite channels opposite the the well well 3831. Theoverflow 3831. The overflowcompartment compartment 38343834 canfluidly can be be fluidly connected connected to to the well the well 3831 3831through through thethe one one or more or more channels, channels, each channel each channel of whichof which can can be be further further configured to convey a fluid (e.g., the antiseptic of the skin-preparation kit) along its length configured to convey a fluid (e.g., the antiseptic of the skin-preparation kit) along its length

whenthe when thefluid fluid isis poured pouredtherein thereinororthereon. thereon. Should Should a medical a medical procedure procedure require require additional additional

antiseptic for skin preparation or the like, the additional antiseptic can be safely added to the antiseptic for skin preparation or the like, the additional antiseptic can be safely added to the

well 3831 well 3831 with withassurance assurancethat thatany anyvolume volumeof of antisepticexceeding antiseptic exceeding a totalvolume a total volumeof of thetheswab swab compartment3832 compartment 3832 (e.g.,a acombined (e.g., combined volume volume of the of the wellwell 38313831 andone and the the or onemore or more channels) channels)

can spill can spill into intothe theoverflow overflowcompartment 3834via compartment 3834 viathe theone oneorormore morechannels. channels.

[0265]

[0265] Withrespect With respect to to the the corner corner storage storage compartment 3836,the compartment 3836, thecorner comerstorage storagecan canbe be positioned between positioned betweenthe theoverflow overflowcompartment compartment 38343834 and and an an inner inner wall wall of theoftray the tray 3800,3800, and, and, thereby share thereby share the the inner inner wall wall of of the the tray tray 3800. Thecorner 3800. The comerstorage storagecompartment compartment 38363836 can can be be configured to configured to accommodate thespecimen accommodate the specimencontainer containerofofthe themedical-procedure medical-procedurepackage. package. Furthermore,while Furthermore, whilethe themedical-procedure medical-procedure package package can can include include the the packet packet of antiseptic of antiseptic in in or or over the over the swab swabcompartment compartment 3832 3832 and and the overflow the overflow compartment compartment 3834 as3834 shownasinshown in FIG. FIG. 25, 25, the corner the corner storage storage compartment compartment 3836 3836 can can be further be further configured configured to accommodate to accommodate at leastata least a portion of portion of the the packet packet of of antiseptic. antiseptic. In In such such aa configuration, configuration, the the packet packetofofantiseptic antiseptic can can be be placed in placed in or or over over the the swab swabcompartment compartment 3832, 3832, the overflow the overflow compartment compartment 3834, 3834, the the corner comer

-68-

storage compartment 3836, orora acombination combinationthereof thereofinina amedical-procedure medical-procedurepackage package 2023203963 23 Jun 2023

storage compartment 3836,

containing the tray 3800. containing the tray 3800.

[0266]

[0266] FIG. 39A FIG. 39Ashows shows a view a view of of another another medical-procedure medical-procedure traytray 39003900 in accordance in accordance

with some with someembodiments. embodiments. FIG. FIG. 39B 39B showsshows another another view view of theofmedical-procedure the medical-procedure tray of tray 3900 3900 of FIG. 39A. FIG. 3 9A. 2023203963

[0267]

[0267] The medical-procedure The medical-procedure tray tray 3900A 3900AofofFIGS. FIGS. 39A39A and and 39B have 39B can can ahave a configuration similar configuration similar to to the themedical-procedure tray 3800 medical-procedure tray described in 3800 described in reference reference to to FIGS. 38A, FIGS. 38A,

38B, 38C, 38B, 38C,and and38D. 38D. As such, As such, the 3900A the tray tray 3900A can likewise can likewise include include a first a first section section or or first first compartment compartment 3910, 3910, a second a second section section or or second second compartment compartment 3920,3920, and aand a third third section section of third of third

compartment3930, compartment 3930, each each of of which which can can be configured be configured to accommodate to accommodate andcontents and hold hold contents for a for a medical procedure. medical procedure.However, However, as shown, as shown, the first the first section section 3910 3910 of the of the tray tray 3900A 3900A can have can have a a different configuration different configuration than the first than the first section section 3810 of the 3810 of the tray tray 3800. 3800. For Forexample, example, thethe first first

section 3810 section of the 3810 of the tray tray 3800 of FIGS. 3800 of 38A,38B, FIGS. 38A, 38B,38C, 38C, andand 38D38D has has moremore of a of a square-shaped square-shaped

footprint, whereas footprint, whereas the the first firstsection 3910 section 3910of ofthe tray the 3900A tray 3900Aof ofFIGS. FIGS. 39A and 39B 39A and 39Bhas hasmore moreofof

a rectangle-shaped footprint. This results from sides of the tray 3 900A about the first section a rectangle-shaped footprint. This results from sides of the tray 3900A about the first section

3910(e.g., 3910 (e.g., aa side side of of the thetray tray3900A adjacent aa syringe 3900A adjacent syringe of of sterile sterile water water 3892 and an 3892 and an opposite opposite side thereof) side thereof) being longer than being longer thansimilar similarsides sides ofofthe thetray tray 3800 3800about about thethe firstsection first section3810. 3810. Configuringthe Configuring thefirst first section section 3910 in this 3910 in this way allows for way allows for aa comparatively comparativelylarger largercapacity capacityfor for comparativelymore comparatively morecontents contentsofofthe themedical-procedure medical-procedure package package including including the the tray tray 3 900A. 3900A.

[0268]

[0268] Not only Not only can can the the first first section section 3910 of the 3910 of the tray tray 3900A havea adifferent 3900A have different configuration than the first section 3810 of the tray 3800, but one or more partitions of the tray configuration than the first section 3810 of the tray 3800, but one or more partitions of the tray

3900Acancanhave 3900A have a different a different configuration configuration than than thethe oneone or more or more partitions partitions of the of the traytray 3800. 3800.

While not shown While not shownin inFIGS. FIGS. 39A 39A and the and 39B, 39B,different the different configuration configuration can include can include a a disproportionally or disproportionally or proportionally proportionally shorter shorter height height for for the the one one oror more morepartitions partitionsofofthe thetray tray 3900Acompared 3900A compared to the to the oneone or or more more partitions partitions of of thethe tray3800, tray 3800,which which oneone or more or more partitions partitions

can have can have aa height height (e.g., (e.g., aamaximum height)equal maximum height) equaltotoaaheight heightof of the the tray. tray. For an example For an exampleofofaa disproportionally shorter disproportionally shorter height, height, a afirst firstpartition partition3942 3942 of the of the tray tray 3900A3900A cana can have have a disproportionally shorter disproportionally shorter height height than than the thefirst first partition partition 3842 ofthe 3842 of the tray tray 3800, 3800,wherein wherein an an analogous first height hi of the first partition 3942 can be shorter than the first height hi of the analogous first height h of the first partition 3942 can be shorter than the first height h of the

first partition first partition3842, 3842,and andwherein wherein an an analogous analogous second heighthhiofofthe secondheight thefirst first partition partition 3942 3942 can can

be substantially the same as the second height hi of the first partition 3842. FIG. 4 IB provides be substantially the same as the second height h of the first partition 3842. FIG. 41B provides

a visual a visual reference reference for for such sucha adisproportionally disproportionallyshorter shorter height height forfor thethe first first partition3942 partition 3942

-69-

compared to the first partition 3842 with the understanding that the first partition 3942 of the 2023203963 23 Jun 2023

compared to the first partition 3842 with the understanding that the first partition 3942 of the

tray 3900A tray continuestotothe 3900A continues the inner inner wall wall of of the the tray tray3900A as shown 3900A as in FIGS shown in FIGS39A 39A andand 39B. 39B. For For an example an exampleofofa aproportionally proportionallyshorter shorterheight, height, aa second secondpartition partition 3944 3944ofofthe the tray tray 3900A 3900Acan can have a proportionally shorter height than the second partition 3844 of the tray 3800. FIG. 41B have a proportionally shorter height than the second partition 3844 of the tray 3800. FIG. 41B

also provides a visual reference for such a proportionally shorter height for the second partition also provides a visual reference for such a proportionally shorter height for the second partition

3944 compared to the second partition 3844. Configuring the one or more partitions of the tray 3944 compared to the second partition 3844. Configuring the one or more partitions of the tray 2023203963

3900Atotobe be 3900A disproportionally disproportionally or proportionally or proportionally shorter shorter in height in height than than theorone the one moreor more partitions of the tray 3800 allows for a bottom of the second section 3920 to be lower than the partitions of the tray 3800 allows for a bottom of the second section 3920 to be lower than the

bottom3822 bottom 3822ofofthe thesecond secondsection section3820 3820ofof thetray the tray3800 3800while whilestill still providing providing open openaccess accessfor for easy removal of the container of lubricant 3894. For example, the bottom of the second section easy removal of the container of lubricant 3894. For example, the bottom of the second section

3920can 3920 canbebesubstantially substantially co-planar co-planar with with aa bottom bottomofofthe the first first section section 3910 3910 or or aa bottom of the bottom of the

tray 3900A. tray FIG.41B 3900A. FIG. 41Bagain againprovides providesa avisual visualreference referencefor for such such aa bottom of the bottom of the second section second section

3920ofofthe 3920 the tray tray 33900A 900Awith withthe theunderstanding understanding thatthe that thefirst first partition partition 3942 of the 3942 of the tray tray 33900A 900A continues to continues to the the inner innerwall wallof ofthethe tray 3900A tray 3900Aasas shown shown in inFIGS FIGS 39A and 39B. 39A and 39B.The Theembodiment embodiment of the of the co-planar co-planar bottom of the bottom of the second section 3920 second section 3920ofofthe the tray tray 3900A 3 900Aand andthat thatofofthe theelevated elevated bottom 3822 of the tray 3800 provide open access for easy removal of the container of lubricant bottom 3822 of the tray 3800 provide open access for easy removal of the container of lubricant

3894inin that 3894 that both both embodiments embodiments do not do not havehave the container the container of lubricant of lubricant 3894 3894 ensconced ensconced too too deeply in a second-section well. deeply in a second-section well.

[0269]

[0269] Whileembodiments While embodimentsare are disclosed disclosed for for an elevated an elevated second-section second-section bottom bottom of a of a tray (e.g., the elevated bottom 3822 of the second section 3820 of the tray 3800) and a second- tray (e.g., the elevated bottom 3822 of the second section 3820 of the tray 3800) and a second-

section bottom section co-planarwith bottom co-planar witha abottom bottomof of thetray the tray(e.g., (e.g., the the co-planar co-planar bottom bottomofofthe thesecond second section 3920 section of the 3920 of the tray tray 33900A), 900A), it it should should be be understood that aa bottom understood that of any bottom of compartment any compartment ofof

any medical-procedure any medical-proceduretray traydisclosed disclosedherein hereincan canvary varyinin elevation elevation from fromaabottom bottomofofthe thetray tray in in accordancewith accordance withthat that described described for for the the trays trays 3800 3800 and 3900A. and 3900A.

[0270]

[0270] FIG. 39C FIG. 39Cshows showsa aview view of of a a medical-procedure medical-procedure tray tray 3900B 3900B including including a number a number

of retainers of retainersin ina afirst configuration first in accordance configuration with in accordance some with someembodiments. embodiments.

[0271]

[0271] The medical-procedure The medical-proceduretray tray3900B 3900Bof of FIG.39C39C FIG. cancan have have a configuration a configuration similar similar

to the to the medical-procedure tray 3900A medical-procedure tray 3900Adescribed described in in referencetotoFIGS. reference FIGS.39A39A and and 39B.39B. As such, As such,

the tray the tray 3900B canlikewise 3900B can likewiseinclude includea afirst first section section 3910, 3910,aasecond secondsection section3920, 3920,andand a third a third

section 3930, section 3930, each each of of which can be which can be configured to accommodate configured to accommodate andand hold hold contents contents fora amedical for medical procedure. However, procedure. However,as as shown, shown, the the firstsection first section3910 3910 of of thethetray tray3900B 3900B cancan have have a different a different

configuration than the first section 3910 of the tray 3900A. For example, the first section 3910 configuration than the first section 3910 of the tray 3900A. For example, the first section 3910

-70-

Jun 2023 of the tray 3900B of FIG. 39C can have a number of retainers, one retainer of which is indicated of the tray 3900B of FIG. 39C can have a number of retainers, one retainer of which is indicated

as retainer 3912. In contrast, the first section 3910 of the tray 3900A of FIGS. 39A and 39B is as retainer 3912. In contrast, the first section 3910 of the tray 3900A of FIGS. 39A and 39B is

shownwithout shown withoutthe thenumber numberof of retainers;however, retainers; however,ititshould shouldbebeunderstood understood thatthe that thetray tray3900A, 3900A, as well as well as as any tray provided any tray herein, can provided herein, can optionally optionally include include one one or or more moreretainers retainers of of any anytype type 2023203963 23

provided herein. provided herein. The Thenumber number of retainers of retainers in in thethe firstsection first section3910 3910ofofthe thetray tray3900B 3900Bcancan be be configured for retaining certain contents of the medical-procedure package in the first section configured for retaining certain contents of the medical-procedure package in the first section 2023203963

3910. For example, the number of retainers can be configured for keeping the syringe of sterile 3910. For example, the number of retainers can be configured for keeping the syringe of sterile

water 3892 in the first section 3910 apart from certain other contents of the medical-procedure water 3892 in the first section 3910 apart from certain other contents of the medical-procedure

package in the first section 3910. Any of a number of different types of retainers (e.g., column package in the first section 3910. Any of a number of different types of retainers (e.g., column

or tapered column-type retainers, rack-type retainers, tab-type retainers, removable retainers, or tapered column-type retainers, rack-type retainers, tab-type retainers, removable retainers,

etc.) can be formed, and any of a number of retainers (e.g., 1, 2, 3, 4, or 5 or more retainers) etc.) can be formed, and any of a number of retainers (e.g., 1, 2, 3, 4, or 5 or more retainers)

can be can be formed formed--some someofofwhich which retainerscan retainers canbebeformed formed from from thethe tray3900B tray 3900B itself.AsAs itself. shown, shown,

in FIG. 39C, the first section 3910 of the tray 3900B can include at least 3 tapered column-type in FIG. 39C, the first section 3910 of the tray 3900B can include at least 3 tapered column-type

retainers equidistant from the side of the tray 3900B adjacent the syringe of sterile water 3892. retainers equidistant from the side of the tray 3900B adjacent the syringe of sterile water 3892.

[0272]

[0272] FIG. 39D FIG. 39Dshows shows a view a view of of a a medical-procedure medical-procedure tray tray 3900C 3900C including including a number a number

of retainers of retainersin ina asecond secondconfiguration configurationin inaccordance accordance with with some embodiments. some embodiments.

[0273]

[0273] The medical-procedure The medical-procedure tray tray 3900C of FIG. 3900C of FIG. 39D 39Dcan canhave have a configuration a configuration

similar to similar to the themedical-procedure tray 3900B medical-procedure tray describedininreference 3900B described referencetoto FIG. FIG. 39C. 39C.AsAs such,thethe such,

tray 3900C can likewise include a first section 3910, a second section 3920, and a third section tray 3900C can likewise include a first section 3910, a second section 3920, and a third section

3930, each 3930, eachofofwhich whichcancan be configured be configured to accommodate to accommodate and holdand hold contents contents for a for a medical medical procedure. However, procedure. However,as as shown, shown, the the firstsection first section3910 3910 of of thethetray tray3900C 3900C cancan have have a different a different

configuration than the first section 3910 of the tray 3900B. For example, the first section 3910 configuration than the first section 3910 of the tray 3900B. For example, the first section 3910

of the of the tray tray3900C of FIG. 3900C of 39Dcan FIG. 39D cansimilarly similarly have haveatat least least 33 tapered tapered column-type retainers, one column-type retainers, one

retainer of retainer of which is indicated which is indicated as as retainer retainer 3912, 3912, and another retainer and another retainer of of which is indicated which is indicated as as retainer 3913. However, in contrast to the at least 3 tapered column-type retainers equidistantly retainer 3913. However, in contrast to the at least 3 tapered column-type retainers equidistantly

spaced from the side of the tray 3900B, at least one retainer (e.g., the retainer 3913) of the at spaced from the side of the tray 3900B, at least one retainer (e.g., the retainer 3913) of the at

least 33 tapered least tapered column-type retainers of column-type retainers of the thetray tray3900C 3900C can can be be offset offsetfrom from the the others othersas asshown shown

by the by the dotted dotted line. line. Such Sucha adifferent different configuration configurationcan canfurther furtherrestrict restrict degrees of freedom degrees of of freedom of

certain contents certain contents (e.g., (e.g.,the thesyringe syringeofofsterile water sterile 3892) water ofofthethe 3892) medical-procedure medical-procedure package in package in

the first the firstsection section3910. 3910. As such, such As such, suchaadifferent different configuration configuration can can further further keep keepsuch suchcertain certain contents in contents in the the first firstsection section3910 3910 apart apart from from certain certain other other contents contents of of the the medical-procedure medical-procedure

package in the first section 3910. package in the first section 3910.

-71-

Jun 2023

[0274]

[0274] FIG. 40A FIG. 40Ashows shows a view a view of of another another medical-procedure medical-procedure traytray 40004000 in accordance in accordance

with some with someembodiments. embodiments. FIG. FIG. 40B 40B showsshows another another view view of theofmedical-procedure the medical-procedure tray of tray 4000 4000 of FIG. 40A. FIG. 40A.

2023203963 23

[0275]

[0275] The medical-procedure The medical-procedure tray tray4000 4000ofofFIGS. FIGS.40A 40A and and 40B can have 40B can have aa configuration similar configuration similar to tothe themedical-procedure medical-procedure tray tray 3900A describedin 3900A described in reference reference to to FIGS. FIGS. 39A 39A

and 39B. As such, the tray 4000 can likewise include a first section or first compartment 4010, and 39B. As such, the tray 4000 can likewise include a first section or first compartment 4010, 2023203963

a second a section or second section or second compartment second compartment 4020, 4020, andand a thirdsection a third sectionororthird third compartment compartment 4030, 4030,

each of each of which whichcan canbebeconfigured configuredtotoaccommodate accommodateand and hold hold contents contents for afor a medical medical procedure. procedure.

However,asasshown, However, shown,the thesecond secondsection section4020 4020ofofthe thetray tray 4000 4000can canhave haveaadifferent different configuration configuration

than the than the second section 3920 second section 3920ofofthe the tray tray 33900A. 900A.For Forexample, example, thethe second second section section 4020 4020 of the of the

tray 4000 tray can be 4000 can be an an extended extendedsection section extending extendinginto into the the first first section section4010, 4010,whereas whereas the the second second

section 3920 section ofthe 3920 of the tray tray 3900A 3900Aterminates terminatesat ata acommon common partition partition to both to both the the second second section section

3920and 3920 andthe thethird thirdsection section3930 3930ofofthe thetray tray3900A, 3900A, namely namely at the at the first first partition3942. partition 3942.The The extendedsecond extended secondsection section4020 4020ofofthe the tray tray 4000 can be 4000 can be formed fromananextended formed from extendedsecond secondpartition partition 4044 extending into the first section 4010 and terminating at a third partition 4046 in the first 4044 extending into the first section 4010 and terminating at a third partition 4046 in the first

section 4010 of the tray 4000. In addition, a first partition 4042 separating the third section section 4010 of the tray 4000. In addition, a first partition 4042 separating the third section

4030from 4030 fromthe thefirst first section section 4010 4010cancanterminate terminate at at a medial a medial portion portion of the of the extended extended second second

partition 4044 partition instead of 4044 instead of at at an an inner inner wall wall ofofthe the tray tray 4000. 4000.With With the the second second section section 4020 4020

configured as configured as an an extended extendedsection, section, the the extended extendedsecond secondsection section4020 4020cancan accommodate accommodate more more contents, larger contents, larger contents, contents,or orboth bothasasneeded needed for fora amedical medical procedure. As shown, procedure. As shown,the theextended extended secondsection second section 4020 4020includes includesaa larger larger container container of of lubricant lubricant4094 4094 compared to the compared to the container container of of lubricant 3894 lubricant shownininFIGS. 3894 shown FIGS.39A 39A andand 39B. 39B.

[0276]

[0276] FIG. 41A FIG. 41Ashows shows a view a view of of another another medical-procedure medical-procedure traytray 41004100 in accordance in accordance

with some with someembodiments. embodiments. FIG. FIG. 41B 4shows IB shows another another view view of theofmedical-procedure the medical-procedure tray of tray 4100 4100 of FIG. 41A. FIG. 41 A.FIG. FIG.41C41C shows shows a third a third view view of the of the medical-procedure medical-procedure traytray 41004100 of FIG. of FIG. 41A.41 A.

[0277]

[0277] The medical-procedure The medical-procedure tray4100 tray 4100 of of FIGS. FIGS. 41A,41 A, 41B, 41B, andcan and 41C 41C can include include a a first section first section 4110, 4110, a a second section 4120, second section 4120,and anda third a thirdsection section4130, 4130, each each of which of which can can be be configured to configured to accommodate accommodate andand hold hold contents contents for for a medical a medical procedure. procedure. As described As described herein, herein,

a section a section of of aamedical-procedure tray can medical-procedure tray can be be designated designated for for one one or or more moreparticular particular uses, uses, and and a a

section can be at least partially (e.g., the second section 4120) and up to wholly (e.g., the third section can be at least partially (e.g., the second section 4120) and up to wholly (e.g., the third

section 4130) separated from one or more other sections by one or more physical features (e.g., section 4130) separated from one or more other sections by one or more physical features (e.g.,

one or one or more morepartitions), partitions), thereby formingaacompartment thereby forming compartmentforfor oneone or or more more particular particular uses. uses. As As

-72-

Jun 2023 shown,the shown, thetray tray4100 4100 includes includes a first a first partition4142 partition 4142 and and a second a second partition partition 4144 4144 wholly wholly

separating the separating the third third section section4130 4130 from the first from the first section section4110 4110 and and the the second section 4120. second section In 4120. In

addition, the addition, the second partition 4144 second partition partially separates 4144 partially separates the the second section 4120 second section fromthe 4120 from thefirst first section 4110. section Likethe 4110. Like the medical-procedure medical-procedure tray3800 tray 3800 of of FIGS. FIGS. 38A38A and and 38B,38B, the first the first partition partition 2023203963 23

4142 of the tray 4100 - or at least a first section-facing face of the first partition 4142 - can 4142 of the tray 4100 - or at least a first section-facing face of the first partition 4142 - can

have aa first have heighthih and first height and aa second second height {see FIG. height h (see FIG. 41B), and the 41B), and the second secondpartition partition 4144 4144 -- or or 2023203963

at least the third section-facing face of the second partition 4144 - can have a first height (not at least the third section-facing face of the second partition 4144 can have a first height (not

shown). Unlike the tray 3800 of FIGS. 38A and 38B, the first height of the first partition 4142 shown). Unlike the tray 3800 of FIGS. 38A and 38B, the first height of the first partition 4142

and the first height of the second partition 4144 are, as shown, less than a height of the medical- and the first height of the second partition 4144 are, as shown, less than a height of the medical-

procedure tray 4100. In addition, a second section-facing face of the second partition 4144 can procedure tray 4100. In addition, a second section-facing face of the second partition 4144 can

have a height equal to the height of the third section-facing face of the second partition 4144 have a height equal to the height of the third section-facing face of the second partition 4144

makinga abottom making bottomofofthe thesecond secondsection section4120 4120 co-planar co-planar with with a bottom a bottom of the of the firstsection first section4110 4110 or the or the tray 4100. (See tray4100. (See FIG. FIG. 4IB.) 41B.)

[0278]

[0278] With respect to the first section 4110 of the tray 4100, the first section 4110 can With respect to the first section 4110 of the tray 4100, the first section 4110 can

be configured be configuredtotoaccommodate accommodate a first a first set contents set of of contents for afor a medical medical procedure procedure such as such a as a catheterization procedure. As previously described, the first set of contents can include, but is catheterization procedure. As previously described, the first set of contents can include, but is

not limited to, the drainage system including the catheter (e.g., the Foley catheter), the drainage not limited to, the drainage system including the catheter (e.g., the Foley catheter), the drainage

tubing, the drainage bag, and the syringe of sterile water 3892 for inflating the balloon of the tubing, the drainage bag, and the syringe of sterile water 3892 for inflating the balloon of the

Foley catheter. Foley catheter. For Foraa visual visual reference, reference, the the syringe syringe of of sterile sterilewater water3892 3892 isisshown shown mounted mounted inin

or on a retainer (e.g., a rack-type retainer) of the first section 4110 of a different type than the or on a retainer (e.g., a rack-type retainer) of the first section 4110 of a different type than the

retainers (e.g., tapered column-type retainers) described in reference to trays 3900B and 3900C retainers (e.g., tapered column-type retainers) described in reference to trays 3900B and 3900C

respectively of respectively of FIGS. 39Cand FIGS. 39C and39D. 39D.Like Like thethe number number of retainers of retainers of of trays trays 3900B 3900B and and 3900C, 3900C,

the retainer the retainer for for the the syringe syringe of of sterile sterilewater water 3892 can be 3892 can be formed formedofofthethetray tray4100 4100 itselfand itself and configured to keep the syringe of sterile water 3892 in the first section 4110 apart from other configured to keep the syringe of sterile water 3892 in the first section 4110 apart from other

contents of contents of the the medical-procedure medical-procedurepackage package in in thethe firstsection first section4110. 4110.TheThe syringe syringe of sterile of sterile

water 3892 can simply lay in the retainer or rack, or the syringe of sterile water 3892 can be fit water 3892 can simply lay in the retainer or rack, or the syringe of sterile water 3892 can be fit

into the retainer or rack with a loose-fit interference fit about the syringe of sterile water 3892. into the retainer or rack with a loose-fit interference fit about the syringe of sterile water 3892.

[0279]

[0279] Withrespect With respecttoto the the second secondsection section4120 4120of of thetray the tray4100, 4100,thethe second second section section

4120can 4120 canbebeconfigured configuredtotoaccommodate accommodate a second a second set ofset of contents contents for medical for the the medical procedure procedure

such as such as the the catheterization catheterizationprocedure. procedure. As previously described, As previously described, the the second second set set of of contents contents can can

include, but is not limited to, the container containing lubricant (e.g., lubricant for the Foley include, but is not limited to, the container containing lubricant (e.g., lubricant for the Foley

catheter) such as a syringe of lubricant 4194. For a visual reference, the syringe of lubricant catheter) such as a syringe of lubricant 4194. For a visual reference, the syringe of lubricant

-73-

4194 is shown mounted in or on a retainer 4114 (e.g., a rack-type retainer) like that described 2023203963 23 Jun 2023

4194 is shown mounted in or on a retainer 4114 (e.g., a rack-type retainer) like that described

in reference to the retainer in the first section 4110 for the syringe of sterile water 3892. The in reference to the retainer in the first section 4110 for the syringe of sterile water 3892. The

syringe of lubricant 4194 can simply lay in the retainer or rack 4194, or the syringe of lubricant syringe of lubricant 4194 can simply lay in the retainer or rack 4194, or the syringe of lubricant

4194 can be fit into the retainer or rack 4194 with a loose-fit interference fit about the syringe 4194 can be fit into the retainer or rack 4194 with a loose-fit interference fit about the syringe

of lubricant 4194. of lubricant 4194.

[0280]

[0280] The retainer 4194 and the retainer for the syringe of sterile water 3892 can have The retainer 4194 and the retainer for the syringe of sterile water 3892 can have 2023203963

the same the or different same or different dimensions asrequired dimensions as requiredbybythe thesize size of ofthe the syringe syringe of of lubricant lubricant 4194 and 4194 and

the size the size of ofthe thesyringe syringeof ofsterile water sterile 3892 water required 3892 bybythethe required medical procedure. medical procedure.When the size When the size of the syringe of lubricant 4194 and the size of the syringe of sterile water 3892 are the same, of the syringe of lubricant 4194 and the size of the syringe of sterile water 3892 are the same,

the retainers or racks therefor can have the same dimensions, and the syringe of lubricant 4194 the retainers or racks therefor can have the same dimensions, and the syringe of lubricant 4194

and the and the syringe syringe of of sterile sterile water water 3892 canbebeswapped 3892 can swapped with with respect respect to to their their placement placement in the in the

medical-procedurepackage, medical-procedure package,forforexample, example, to to betterorchestrate better orchestratesteps steps of of the the medical procedure. medical procedure.

Therefore, the Therefore, the second section 4120 second section is not 4120 is not limited limitedto toaccommodating andholding accommodating and holdingthe thesyringe syringeofof lubricant 4194, lubricant andthe 4194, and thefirst first section section 4110 is not 4110 is not limited limited to to accommodating accommodating and and holding holding the the syringe of syringe of sterile sterile water water3892. 3892. The The second section 4120 second section can be 4120 can be configured configuredto to accommodate accommodate andand

hold the hold the syringe syringeofofsterile sterilewater water3892, 3892, andand the the first first section section 41104110 canconfigured can be be configured to to accommodate accommodate thethe syringe syringe of of lubricant4194 lubricant 4194 - even - even if if thethesize sizeofofthe thesyringe syringeofoflubricant lubricant 4194 4194 and the size of the syringe of sterile water 3892 are different. and the size of the syringe of sterile water 3892 are different.

[0281]

[0281] Withrespect With respectto to the the third third section section 4130, 4130, the the third third section section 4130 4130 includes a swab includes a swab compartment4132, compartment 4132, an an overflow overflow compartment compartment 4134, 4134, and a and a comer corner storagestorage compartment compartment 4136 4136 configured as described herein to accommodate a third set of contents for the medical procedure configured as described herein to accommodate a third set of contents for the medical procedure

such as such as the the catheterization catheterization procedure. Aspreviously procedure. As previouslydescribed, described,the thethird thirdset set of ofcontents contents can can include, but is include, is not not limited limited to, to,the thespecimen container, optionally, specimen container, optionally, the the label labelfor forthe thespecimen specimen

container, and the skin-preparation kit including the packet of antiseptic (e.g., an iodophor such container, and the skin-preparation kit including the packet of antiseptic (e.g., an iodophor such

as povidone-iodine, as tincture of povidone-iodine, tincture of iodine, iodine, aqueous iodine, etc.) aqueous iodine, etc.)and and the the one one or or more swabs. The more swabs. The medical-proceduretray medical-procedure tray4100 4100 of of FIGS. FIGS. 41A,41A, 41B, 41B, andis41C and 41C is without shown shown without the the specimen specimen container or the skin preparation kit for which the third section 4130 is configured; however, container or the skin preparation kit for which the third section 4130 is configured; however,

FIGS. 8,8, 26, FIGS. 26, and and 27 27 provide providevisual visual references references for for inclusion inclusion of of the theone one or ormore more swabs 34 in swabs 34 in the the swabcompartment swab compartment 4132, 4132, FIGS. FIGS. 25-29 25-29 provide provide visual visual references references for for inclusion inclusion of the of the specimen specimen

container 54 container 54 in in the the corner corner storage storage compartment 4136,and compartment 4136, andFIG. FIG.2525provides provides a visualreference a visual reference for inclusion for inclusion of of the the packet packet of of antiseptic antiseptic52 52ininthe themedical-procedure medical-procedure tray tray 4100 over the 4100 over the swab swab compartment4132 compartment 4132 andand thethe overflow overflow compartment compartment 4134.4134.

-74-

23 Jun 2023

[0282]

[0282] Advertingto Adverting to FIG. FIG. 41C, 41C,the the medical-procedure medical-proceduretray tray4100 4100isisshown shown togetherwith together with a cover a cover 4101 4101such suchasasthe thepackaging packaging label62 62 label described described in in reference reference to to FIGS. FIGS. 11 and 11 and 12, 12, the the identification cover identification 120 described cover 120 describedinin reference referencetoto FIG. FIG.30A, 30A,or or a combination a combination thereof. thereof. As As shown,the shown, thecover cover4101 4101cancanbebe configured configured to to fitfitover overthe thewhole whole medical-procedure medical-procedure traytray 4100; 4100;

however,the however, thecover cover4101 4101cancan be be alternativelyconfigured alternatively configuredtotofit fitover overaaportion portion ofofthe the medical- medical- proceduretray procedure tray 4100, 4100,the theportion portionincluding includingany anyoneone or or more more sections sections selected selected fromfrom the first the first 2023203963

2023203963

section 4110, section the second 4110, the secondsection section4120, 4120,andand thethe thirdsection third section4130. 4130.The The cover cover 4101 4101 can becan be alternatively configured alternatively configured to to fit fitwithin withinthe themedical-procedure medical-procedure tray tray 4100 4100 in in any any of of the the foregoing foregoing

configurations such configurations suchasaswithin withinthethewhole whole medical-procedure medical-procedure tray or tray 4100 4100 or a portion a portion of the of the medical-proceduretray medical-procedure tray4100. (See, 4100.(See, forfor example, example, cover cover 3801 3801 of FIGS. of FIGS. 38C 38C and andAs38D.) 38D.) As further shown, the tray 4100 can be configured with an optional support 4102 in the first section further shown, the tray 4100 can be configured with an optional support 4102 in the first section

4110of 4110 ofthe the tray tray 4100. Thesupport 4100. The support4102 4102cancanprevent prevent caving caving of of thethecover cover 4101 4101 andand damage damage to to the contents the of the contents of the tray tray 4100 thereunderwhen 4100 thereunder whenoneone or or more more medical-procedure medical-procedure packages packages are are stacked on stacked on the the medical-procedure medical-procedurepackage package including including thethe medical-procedure medical-procedure traytray 4100 4100 and and the the cover 4101. cover 4101. The Thesupport supportcancanbebeconfigured configured with with a height a height substantiallyequal substantially equaltotoaa height height of of the the tray 4100 tray anda awidth 4100 and widthsufficient sufficientto to withstand withstandthe theweight weightofofa astack stackofofone oneorormore more medical- medical-

procedurepackages procedure packagesstacked stackedthereon. thereon.

[0283]

[0283] FIG. 42A FIG. 42Ashows shows a view a view of of another another medical-procedure medical-procedure traytray 42004200 in accordance in accordance

with some with someembodiments. embodiments. FIG. FIG. 42B 42B showsshows another another view view of theofmedical-procedure the medical-procedure tray of tray 4200 4200 of FIG. 42A. FIG. 42A.

[0284]

[0284] The medical-procedure The medical-procedure tray 4200 tray 4200ofofFIGS. FIGS.42A 42A and and 42B can have 42B can have aa configuration similar configuration similar to to the the medical-procedure tray 4100 medical-procedure tray 4100 described describedinin reference reference to to FIGS. FIGS.41A 41A and 41B. and 41B.AsAs such, such, thethe tray4200 tray 4200 cancan likewise likewise include include a first a first section4210, section 4210, a second a second section section

4220, and 4220, anda athird third section section 4230, 4230,each eachofofwhich whichcancan be be configured configured to accommodate to accommodate and and hold hold contents for contents for aa medical procedure. The medical procedure. The firstsection first section4210, 4210,for forexample, example,cancan be be configured configured to to accommodate accommodate thethe previously previously described described first first setset ofof contentsforforthe contents thecatheterization catheterizationprocedure procedure including the including the drainage drainage system systemincluding includingthethecatheter catheter(e.g., (e.g., the the Foley Foleycatheter), catheter), the the drainage drainage tubing, the drainage bag, and the syringe of sterile water 3892 for inflating the balloon of the tubing, the drainage bag, and the syringe of sterile water 3892 for inflating the balloon of the

Foley catheter. Foley catheter. For For aa visual visual reference, reference, the the syringe syringe of of sterile sterilewater water3892 3892 isisshown shown mounted mounted inin

or on or on aa rack-type rack-typeretainer retainerofofthe thefirst first section section 4210. 4210.In In addition, addition, thethe firstsection first sectioncancan be be configured with configured withananoptional optionalsupport support4202A 4202A to prevent to prevent caving caving of a of a cover cover placed placed thereon thereon or or thereover as thereover as described described herein. herein. The Thesecond second section section 4220, 4220, for for example, example, canconfigured can be be configured to to

-75-

23 Jun 2023

accommodate accommodate thethe previously previously described described second second setset of of contentsfor contents forthe thecatheterization catheterization procedure procedure including the container containing lubricant (e.g., lubricant for the Foley catheter) such as a including the container containing lubricant (e.g., lubricant for the Foley catheter) such as a

syringe of syringe of lubricant lubricant 4194. 4194. ForFor a visual a visual reference, reference, thethe syringe syringe of of lubricant lubricant 4194 4194 is shown is shown

mounted in or on a rack-type retainer 4214 in the second section 4220. The third section 4230, mounted in or on a rack-type retainer 4214 in the second section 4220. The third section 4230,

for example, for canbebeconfigured example, can configured with with a swab a swab compartment compartment 4232, 4232, an an overflow overflow compartment compartment

4234, and 4234, and aa corner comer storage storage compartment compartment 4236 4236 configured configured as as described described herein herein to to accommodate accommodate 2023203963

2023203963

the previously the described third previously described third set set of of contents contents for for the the catheterization catheterizationprocedure procedure including including the the

specimen container, optionally, the label for the specimen container, and the skin-preparation specimen container, optionally, the label for the specimen container, and the skin-preparation

kit including kit including the the packet of antiseptic packet of antiseptic (e.g., (e.g.,ananiodophor iodophor such such as as povidone-iodine, tincture of povidone-iodine, tincture of iodine, aqueous iodine, iodine, etc.) aqueous iodine, etc.)and and the theone one or ormore more swabs. swabs.

[0285]

[0285] Withrespect With respectto to the the third third section section 4230, however,the 4230, however, thethird third section section 4230 4230ofofthe the tray 4200 can have a different configuration than, for example, the third section of any one tray tray 4200 can have a different configuration than, for example, the third section of any one tray

of the trays 3800, 3900A-C, 4000, and 4100 in that at least the orientation of the third section of the trays 3800, 3900A-C, 4000, and 4100 in that at least the orientation of the third section

4230ofofthe 4230 thetray tray 4200 4200isisininaareversed reversedorientation orientationwith withrespect respecttotoany anyoneone trayof of tray theother the other foregoing trays. For example, the orientation of the third section 3830 of the tray 3800 is such foregoing trays. For example, the orientation of the third section 3830 of the tray 3800 is such

that the that the well well 3831 of the 3831 of the swab swabcompartment compartment38323832 or a or a well-end well-end of third of the the third section section 38303830 is is adjacent the adjacent the second section 3820 second section 3820ofofthe thetray tray 3800. 3800. InInsuch suchananorientation, orientation,the the corner comerstorage storage compartment compartment 3836 3836 shares shares with with thethe tray tray 3800 3800 an inner an inner wallwall of the of the tray tray 3800. 3800. In contrast, In contrast, thethe

reversed orientation of the third section 4230 of the tray 4200 is such that the well (not shown) reversed orientation of the third section 4230 of the tray 4200 is such that the well (not shown)

of the swab compartment 4232 or a well-end of the third section 4230 shares with the tray 4200 of the swab compartment 4232 or a well-end of the third section 4230 shares with the tray 4200

an inner an inner wall wall of of the thetray tray4200. 4200. In In such such an an orientation, orientation,the thecorner cornerstorage compartment storage compartment 4236 is 4236 is

adjacent the adjacent the second secondsection section4220 4220ofofthe thetray tray4200. 4200.AnyAny onemore one or or more of theof the trays trays provided provided

herein including herein including any anyone oneorormore moreofof thetrays the traysselected selectedfrom fromthethetrays trays3800, 3800,3900A-C, 3900A-C, 4000, 4000,

and 4100 can be configured with a third section in the reverse orientation. and 4100 can be configured with a third section in the reverse orientation.

[0286]

[0286] Advertingto Adverting to FIG. FIG. 42B, 42B,the the medical-procedure medical-proceduretray tray4200 4200isisshown shown togetherwith together with a cover a cover 4201 4201such suchasasthe thepackaging packaging label62 62 label described described in in reference reference to to FIGS. FIGS. 11 and 11 and 12, 12, the the identification cover identification 120 described cover 120 describedinin reference referencetotoFIG. FIG.30A, 30A,or or a combination a combination thereof. thereof. As As shown,the shown, the cover cover4201 4201cancanbebe configured configured to to fitfitover overthe thewhole whole medical-procedure medical-procedure traytray 4200; 4200;

however,the however, thecover cover4201 4201cancan be be alternativelyconfigured alternatively configuredtotofit fitover overaaportion portion ofofthe the medical- medical- proceduretray procedure tray 4200, 4200,the theportion portionincluding includingany anyoneone or or more more sections sections selected selected fromfrom the first the first

section 4210, section the second 4210, the secondsection section4220, 4220,andand thethe thirdsection third section4230. 4230.The The cover cover 4201 4201 can becan be alternatively configured alternatively configured to to fit fitwithin withinthe themedical-procedure medical-procedure tray tray 4200 4200 in in any any of of the the foregoing foregoing

-76-

Jun 2023 configurations such configurations suchasaswithin withinthethewhole whole medical-procedure medical-procedure tray or tray 4200 4200 or a portion a portion of the of the medical-proceduretray medical-procedure tray4200. (See, 4200.(See, forfor example, example, cover cover 3801 3801 of FIGS. of FIGS. 38C 38C and andAs38D.) 38D.) As further shown, further the tray shown, the tray 4200 4200can canbebeconfigured configured with with an optional an optional support support 4202B 4202B in theinfirst the first section 4110 of the tray 4100, which support 4202B is shown in a different location of the first section 4110 of the tray 4100, which support 4202B is shown in a different location of the first 2023203963 23

section 4110 section than the 4110 than the optional optional support support 4202A 4202A ofofFIG. FIG.42A. 42 A.TheThe optional optional supports supports 4202A 4202A and and 4202Bcan 4202B canvary vary in in locationin inininaccordance location accordance with with packaging packaging and stacking and stacking needs.needs. Again, Again, a a 2023203963

support such support such as as the the support support4202B 4202Bcancan prevent prevent caving caving of the of the cover cover 42014201 and damage and damage to the to the contents of contents of the thetray tray4200 4200thereunder thereunderwhen when one or more one or medical-procedurepackages more medical-procedure packages arestacked are stacked on the on the medical-procedure medical-procedurepackage package including including the the medical-procedure medical-procedure tray tray 4200 4200 andcover and the the cover 4201. Each 4201. Eachsupport supportofofthe the supports supports 4202A 4202Aand and4202B 4202Bcancan be be configured configured witha height with a height substantially equal to a height of the tray 4200 and a width sufficient to withstand the weight substantially equal to a height of the tray 4200 and a width sufficient to withstand the weight

of aa stack of stack of ofone one or ormore more medical-procedure packagesstacked medical-procedure packages stacked thereon. thereon.

[0287]

[0287] FIG. 43 FIG. 43 shows showsa view a view of of another another medical-procedure medical-procedure tray tray 4300 4300 in accordance in accordance

with some with some embodiments. embodiments.

[0288]

[0288] The medical-procedure The medical-proceduretray tray4300 4300ofofFIG. FIG.4343can canhave have a a configurationsimilar configuration similartoto the medical-procedure the tray4200 medical-procedure tray 4200described describedininreference referencetotoFIGS. FIGS.42A42A and and 42B.42B. As such, As such, the the tray 4300 can likewise include a first section 4310, a second section 4320, and a third section tray 4300 can likewise include a first section 4310, a second section 4320, and a third section

4330inin the 4330 the reverse reverse orientation orientation described described in in reference reference to to tray tray 4200. Eachofofthe 4200. Each thefirst first section section 4310, the 4310, the second secondsection section 4320, 4320,and andthe thethird third section section 4330 4330can canbebeconfigured configuredtotoaccommodate accommodate and hold and holdcontents contentsfor fora amedical medical procedure. procedure. The first The first section section 4310, 4310, for example, for example, can be can be configured to accommodate the previously described first set of contents for the catheterization configured to accommodate the previously described first set of contents for the catheterization

procedureincluding procedure includingthe thedrainage drainagesystem systemincluding including thecatheter the catheter(e.g., (e.g., the the Foley Foleycatheter), catheter), the the

drainage tubing, the drainage bag, and the syringe of sterile water for inflating the balloon of drainage tubing, the drainage bag, and the syringe of sterile water for inflating the balloon of

the Foley the catheter. While Foley catheter. notshown, While not shown,the thefirst first section section 4310 can be 4310 can be configured configuredwith witha atab-type tab-type retainer to retain or otherwise secure the syringe of sterile water. The second section 4320, for retainer to retain or otherwise secure the syringe of sterile water. The second section 4320, for

example,can example, canbebeconfigured configuredtotoaccommodate accommodate the previously the previously described described second second set ofset of contents contents

for the catheterization procedure including the container containing lubricant (e.g., lubricant for the catheterization procedure including the container containing lubricant (e.g., lubricant

for the Foley catheter), which container of lubricant can be retained or otherwise secured in the for the Foley catheter), which container of lubricant can be retained or otherwise secured in the

secondsection second section 4320 4320byby a tab-type a tab-type retainer4314 retainer 4314 in in thethe second second section section 4320. 4320. The reverse- The reverse-

orientation third orientation thirdsection section4330, 4330,for forexample, example,can canbe beconfigured configured with with aaswab swab compartment 4332, compartment 4332,

an overflow an overflow compartment compartment4334, 4334,and anda acorner cornerstorage storagecompartment compartment 4336 4336 configured configured as as described herein described hereintotoaccommodate accommodate the previously the previously described described third third set of set of contents contents for the for the

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Jun 2023 catheterization procedure catheterization includingthethespecimen procedure including specimen container, container, optionally, optionally, the label the label for for the the specimencontainer, specimen container,and andthe theskin-preparation skin-preparationkitkitincluding includingthethepacket packet of of antiseptic(e.g., antiseptic (e.g., anan iodophor such as povidone-iodine, tincture of iodine, aqueous iodine, etc.) and the one or more iodophor such as povidone-iodine, tincture of iodine, aqueous iodine, etc.) and the one or more

swabs. Like swabs. Likethe thetray tray 4200 4200ofofFIGS. FIGS. 42A42A and and 42B, 42B, the comer the corner storage storage compartment compartment 4336 is 4336 is 2023203963 23

adjacent the second section 4320 of the tray 4300; however, the second section 4320 of the tray adjacent the second section 4320 of the tray 4300; however, the second section 4320 of the tray

4300extends 4300 extendsfrom froman an inner inner wall wall of of thethefirst firstsection section 4310 4310ofofthe thetray tray4300 4300allallthe theway waytotoanan 2023203963

inner wall inner on an wall on an opposite opposite side side of of the the tray tray 4300 shared by 4300 shared by the the third third section section 4330, whereasthe 4330, whereas the secondsection second section 4220 4220ofofthe the tray tray 4200 does not. 4200 does not. That Thatbeing beingsaid, said, the the second section 4220 second section of the 4220 of the

tray 4200 tray can be 4200 can be configured configuredtotolikewise likewiseextend extendfrom fromananinner innerwall wallofofthe thefirst first section section 4210 of 4210 of

the tray the tray 4200 all the 4200 all the way to an way to an inner inner wall on an wall on an opposite opposite side side of of the the tray tray 4200 sharedbybythe 4200 shared the third section 4230. third section 4230.

[0289]

[0289] FIG. 44A FIG. 44Ashows shows a view a view of of a removable a removable retainer retainer 4412 4412 on on a partitionorora aside a partition sideofof a medical-procedure a medical-proceduretray trayininaccordance accordance with with some some embodiments. embodiments. FIG. FIG. 44B 44B shows shows another another viewof view ofthe the removable removableretainer retainer4412 4412ononthe thepartition partition or or the the side side of ofthe themedical-procedure tray medical-procedure tray

with aa concealed with concealed tab tab of of instructions instructions in in accordance with some accordance with someembodiments. embodiments.FIG.FIG. 44C 44C showsshows

another view another viewofofthe theremovable removable retainerononthethepartition retainer partitionororthe theside side of of the the medical-procedure medical-procedure tray with tray with aa revealed revealed tab tab of ofinstructions instructionsinin accordance accordancewith withsome some embodiments. embodiments.

[0290]

[0290] Anymedical-procedure Any medical-procedure trayprovided tray provided hereincancanoptionally herein optionallyinclude includeany anynumber number of retainers of any type selected from at least column or tapered column-type retainers, rack- of retainers of any type selected from at least column or tapered column-type retainers, rack-

type retainers, type retainers, and and tab-type tab-type retainers retainers for forretaining retainingcertain certaincontents contentsof ofthe themedical-procedure medical-procedure

packageininthe package the appropriate appropriatesections. sections. For Forexample, example,thethe tray3900A tray 3900A can can include include three three tapered tapered

column-typeretainers column-type retainersproviding providing thethe tray tray 3900B 3900B in which in which the tapered the three three tapered column-type column-type

retainers retain retainers retain or or otherwise otherwise keep the syringe keep the syringe of of sterile sterile water water 3892 in the 3892 in the first first section section 3910 3910

apart from apart other contents from other contents of of the the medical-procedure packageincluding medical-procedure package includingthe theother othercontents contents in in the the

first section 3810. {See FIG. 39C and the retainer 3912 in the first section 3910 retaining the first section 3810. (See FIG. 39C and the retainer 3912 in the first section 3910 retaining the

syringe 3892.) syringe 3892.) Furthermore, Furthermore, any any medical-procedure medical-procedure tray provided tray provided herein herein can can optionally optionally

include one include one oror more moreappendage-type appendage-type retainers retainers forfor retaining retaining certain certain contents contents of of thethe medical- medical-

procedure package procedure package in in the the appropriate appropriate sections. sections. For For example, as shown example, as shown inin FIG. FIG. 4545anan appendage-type retainer 4512 can include a clip section 4593 for clipping the syringe of sterile appendage-type retainer 4512 can include a clip section 4593 for clipping the syringe of sterile

water 3892 water 3892(or (orthe the container container of oflubricant lubricant 3894) 3894) to to the the appendage-type appendage-typeretainer retainer4512, 4512,and andthethe appendage-typeretainer appendage-type retainer4512 4512 can can include include an appending an appending belt or belt straporsection strap 4514 section for 4514 for appending the clip section 4593 to either the tray (e.g., a side of the tray as shown) or a cover appending the clip section 4593 to either the tray (e.g., a side of the tray as shown) or a cover

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(e.g., an an underside of the cover) therefor. therefor. Instructions Instructions for for one oneorormore moresteps stepsofof a medical 2023203963 23 Jun 2023

(e.g., underside of the cover) a medical

procedure can be printed on or imprinted in a visible surface of the belt or strap section 4514. procedure can be printed on or imprinted in a visible surface of the belt or strap section 4514.

[0291]

[0291] Whetherorornot Whether notaa medical-procedure medical-proceduretray trayincludes includesany anyofofthe the foregoing foregoing retainers retainers (e.g., the (e.g., the column column orortapered taperedcolumn-type column-type retainers, retainers, the the rack-type rack-type retainers, retainers, the tab-type the tab-type

retainers, and retainers, and the the appendage-type retainers), the appendage-type retainers), the medical-procedure medical-proceduretray traycancan include include oneone or or moreremovable more removable retainers.AnAn retainers. example example ofremovable of a a removable retainer retainer is is thetheremovable removable retainer retainer 4412 4412 2023203963

of FIGS. of 44A,44B, FIGS. 44A, 44B,and and44C, 44C,which which is is configured configured toto keepthethesyringe keep syringeofofsterile sterile water water 3892 and 3892 and

the container the of lubricant container of lubricant 3894 apart from 3894 apart fromother othercontents contentsofofthe the medical-procedure medical-procedure package. package.

However, However, ititshould shouldbebeunderstood understood that that removable removable retainers retainers areare notnot limited limited to to thethe removable removable

retainer 4412. retainer For example, 4412. For example,a aremovable removable retainercan retainer canbebeconfigured configured toto retainonly retain onlythe thesyringe syringe of sterile water 3892 or only the container of lubricant 3894. Furthermore, a removable retainer of sterile water 3892 or only the container of lubricant 3894. Furthermore, a removable retainer

can be can be configured configured to to retain retain other other contents contentsof ofthe themedical-procedure medical-procedure package in the package in the appropriate appropriate

sections therefor. sections therefor.

[0292]

[0292] As shown As shownininFIGS. FIGS.44A, 44A,44B, 44B,andand 44C, 44C, a removable a removable retainersuch retainer suchasasthe the removableretainer removable retainer4412 4412cancan include include a clip a clip such such as clip as clip 44144414 for removably for removably attaching attaching the the removableretainer removable retainertotoa apartition partitionorora aside sideofofa amedical-procedure medical-procedure tray. tray. The can The clip clipbecan be configured to clip the removable retainer onto a partition or a side of a medical-procedure tray configured to clip the removable retainer onto a partition or a side of a medical-procedure tray

such that the removable retainer is either inside the medical-procedure tray (e.g., as packaged) such that the removable retainer is either inside the medical-procedure tray (e.g., as packaged)

or outside or outside the the medical-procedure tray (e.g., medical-procedure tray (e.g.,when when in inuse useduring during aamedical medical procedure). procedure). The clip The clip

can be can be configured configuredtotoclip clipthe theremovable removable retainer retainer ontoonto a partition a partition or aorside a side of aof a medical- medical-

proceduretray procedure tray with witha aclip clipforce forcesufficient sufficient to to restrict restrict slideable slideable movement movement ofofthe theremovable removable retainer along the side or the partition of a medical-procedure tray. Alternatively, the clip can retainer along the side or the partition of a medical-procedure tray. Alternatively, the clip can

be configured be configured to to allow allow such slideable slideable movement. When movement. When thethe clipisisconfigured clip configuredtoto allow allow slideable slideable movement movement of of thethe removable removable retainer retainer along along a partition a partition or or a side a side of of a medical-procedure a medical-procedure tray, tray,

less clip less clip force force or oranother another captivating captivating means other than means other than clip clip force force can can be used to be used to captivate captivate or or otherwise hold otherwise hold the the removable removableretainer retainerononthe thepartition partition or or the the side side of ofaamedical-procedure tray medical-procedure tray

until the removable retainer is deliberately removed. until the removable retainer is deliberately removed.

[0293]

[0293] Theslideable The slideable movement movement of the of the removable removable retainer retainer canused can be be to used to reveal reveal or or conceal instructions conceal instructions for for one one or or more steps of more steps of aa medical procedure.AsAs medical procedure. shown shown in FIG. in FIG. 44B,44B, a a removableretainer removable retainersuch suchasasthe theremovable removable retainer retainer 4412 4412 can can be packaged be packaged on an on an inside inside of a of a medical-proceduretray medical-procedure trayconcealing concealinga afolded-down folded-down tab tab of the of the instructions instructions forthetheone for oneor ormore more steps of steps of the the medical procedure.While medical procedure. While thethe folded-down folded-down tabthe tab of ofinstructions the instructions is shown is shown in in

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FIGS. 44B 44Band and44C44C on on an outside of the medical-procedure tray, thethe tray cancan be be alternatively 2023203963 23 Jun 2023

FIGS. an outside of the medical-procedure tray, tray alternatively

configured with configured withthe the folded-down folded-down tabofofthe tab theinstructions instructionsononthe theinside inside of of the the tray. tray. Regardless Regardless of the of the outside outside oror the theinside insideconfiguration configurationofofthethefolded-down folded-down tab tab of instructions, of the the instructions, the the removableretainer removable retainercan canbe beslid slid aside aside as as shown in FIG. shown in FIG. 44B 44Btotoreveal revealthe theinstructions instructions shown showninin FIG. 44C, which instructions can be printed or imprinted on the tab. The instructions can again FIG. 44C, which instructions can be printed or imprinted on the tab. The instructions can again

be concealed be concealedbybypushing pushingthethetab tabofofthe theinstructions instructions in in toward towardthe theinside inside or or the the outside outside of of the the 2023203963

tray and tray sliding the and sliding the removable retainer thereover. removable retainer thereover. Concealing Concealingthetheinstructions instructionsininthe thefolded- folded- downtab down tabcan canreduce reduceananamount amount of information of information a health a health carecare provider provider needs needs to know to know to to only only the information the immediatelyneeded information immediately needed to to perform perform one one or more or more immediate immediate steps steps of theofmedical the medical procedure. This procedure. Thiscan, can, in in turn, turn, reduce reduce errors errorsin inthe themedical medicalprocedure. procedure. Furthermore, the folded- Furthermore, the folded-

downtab down tabofofthe theinstructions instructions can can further further conceal conceal sharp sharpedges edgesofofthe thetab tabthat that might mightotherwise otherwise compromise sterile packaging if left in an unfolded or extended position. compromise sterile packaging if left in an unfolded or extended position.

[0294]

[0294] Again, the removable Again, the removableretainer retainer 4412 4412ofofFIGS. FIGS.44A, 44A,44B, 44B, andand 44C44C is an is an example example

of aa removable of retainer configured removable retainer configured to to keep keep the the syringe syringe of of sterile sterile water water 3892 3892 and and the the container container

of lubricant of lubricant 3894 apart from 3894 apart from other other contents contents ofofthe the medical-procedure medical-procedurepackage. package. As shown As shown in in FIGS. 44A, FIGS. 44A,44B, 44B,andand 44C, 44C, thethe removable removable retainer retainer 44124412 can include can include another, another, wider wider clip clip (e.g., (e.g.,

wider than clip 4414) configured with a first clip section 4493 for clipping the syringe of sterile wider than clip 4414) configured with a first clip section 4493 for clipping the syringe of sterile

water 3892 water 3892and andaa second secondclip clip section section 4495 for the 4495 for the container containerof oflubricant 3894. lubricant 3894.Depending upon Depending upon

dimensionsofofthe dimensions thesyringe syringeofofsterile sterile water 3892and water 3892 andthe thecontainer containerofoflubricant lubricant3894, 3894,the thefirst first clip section clip section4493 4493 and and the the second second clip clip section section4495 4495 can can have have the the same dimensionsasaseach same dimensions eachother other or different or differentdimensions dimensions from eachother. from each other. Regardless, Regardless,the the syringe syringe of of sterile sterile water water 3892 3892 and and the the

container of container of lubricant lubricant 3894 3894 can can be be arranged in the arranged in the removable retainer 4412 removable retainer in step 4412 in step with with one or one or

moresteps more steps of of aa medical procedure. For medical procedure. Forexample, example, instructionsfor instructions forthe theone oneorormore moresteps stepsofofthe the medical procedure medical proceduremight might recommend recommend connecting connecting the syringe the syringe of sterile of sterile waterwater 3892 3892 to a to a Foley Foley

catheter in a first step, and the instructions might recommend lubricating the Foley catheter in catheter in a first step, and the instructions might recommend lubricating the Foley catheter in

a second step. a second step.

[0295]

[0295] Whilethe While theinvention inventionhas hasbeen been described described in in terms terms of particular of particular variations variations andand

illustrative figures, those of ordinary skill in the art will recognize that the invention is not illustrative figures, those of ordinary skill in the art will recognize that the invention is not

limited to limited to the thevariations variationsororfigures described. figures described.InInaddition, addition,where wheremethods methods and and steps steps described described

above indicate certain events occurring in certain order, those of ordinary skill in the art will above indicate certain events occurring in certain order, those of ordinary skill in the art will

recognize that the ordering of certain steps may be modified and that such modifications are in recognize that the ordering of certain steps may be modified and that such modifications are in

accordancewith accordance withthe thevariations variationsofofthe theinvention. invention.Additionally, Additionally, certain certain of of thethe steps steps maymay be be

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performedconcurrently concurrentlyininaaparallel parallel process process when possible, as as well well as as performed sequentially 2023203963 23 Jun 2023

performed when possible, performed sequentially

as described as above. Therefore, described above. Therefore,totothe theextent extentthere thereare arevariations variations of of the the invention, invention, which whichare are within the spirit of the disclosure or equivalent to the inventions found in the claims, it is the within the spirit of the disclosure or equivalent to the inventions found in the claims, it is the

intent that this patent will cover those variations as well. intent that this patent will cover those variations as well. 2023203963

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Claims

Claims: 07 May 2025 2023203963 07 May 2025 Claims:

1. 1. A catheterization package including a catheterization tray, comprising: A catheterization package including a catheterization tray, comprising:

aa main section configured main section configuredtotoaccommodate accommodate at least at least a portion a portion ofFoley of a a Foley catheter catheter

drainage system; drainage system;

aa first first side side section configured section configured to to accommodate accommodate a container a container of lubricant; of lubricant;

aa second sidesection second side section separated separated fromfrom the first the first sideside section section by a by sidea section side section partition, partition,

the second side section including an inclined surface; the second side section including an inclined surface; 2023203963

aa continuous continuous main main section section partition partition separating separating thesection the main main from section fromside the first the first side section andthethesecond section and second sideside section; section; and and

aa cover cover configured to be configured to be positioned positioned over a drainage over a bag and drainage bag and drainage drainagetubing tubingof of the the Foley catheter Foley catheter drainage drainagesystem, system,thethecover cover configured configured to fit to fit within within thethe main main

section, andwhich section, and whichis is folded folded to form to form a retainer a retainer to hold to hold a syringe a syringe of sterile of sterile water.water.

2. 2. The catheterization The catheterization package packageaccording accordingtotoclaim claim1,1,further furthercomprising comprisinginstructions instructions printed on a bottom surface of the main section, the first side section, and the second side section. printed on a bottom surface of the main section, the first side section, and the second side section.

3. 3. The catheterization The catheterization package packageaccording accordingtotoclaim claim1 1ororclaim claim 2, 2, wherein wherein thethe second second

side section further side section further comprises comprises aawell wellatata alower lowerendend of of thethe inclined inclined surface, surface, andand an overflow an overflow

compartment adjacentananupper compartment adjacent upper end end of of theinclined the inclinedsurface. surface.

4. 4. The catheterization The catheterization package accordingtotoclaim package according claim3,3,wherein whereinthe thesecond secondside sidesection section further further comprises a specimen comprises a containercompartment specimen container compartment adjacent adjacent thethe overflow overflow compartment. compartment.

5. 5. The catheterization The catheterization package accordingtotoany package according anyone oneofofthe the preceding precedingclaims, claims, wherein wherein the inclined surface includes a plurality of channels, each of the plurality of channels including the inclined surface includes a plurality of channels, each of the plurality of channels including

one or more one or snap-intabs. more snap-in tabs.

6. 6. The catheterization package according to claim 5, wherein the plurality of channels The catheterization package according to claim 5, wherein the plurality of channels

are configured to secure a plurality of swabs, each of the plurality of swabs including an elongated are configured to secure a plurality of swabs, each of the plurality of swabs including an elongated

stem and stem andan anabsorbent absorbenthead, head,the theelongate elongatestem stemsecured securedvia viathe theone oneorormore moresnap-in snap-intabs. tabs.

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7. The catheterization catheterization package packageaccording accordingtotoclaim claim6,6,wherein wherein a distalportion portionofofthe the 07 May 2025 2023203963 07 May 2025

7. The a distal

absorbent headis absorbent head is wider than aa proximal wider than portion of proximal portion of the the absorbent absorbent head, head, the the proximal portion being proximal portion being

secured to or integrated with the elongated stem. secured to or integrated with the elongated stem.

8. 8. Thecatheterization The catheterization package accordingtotoclaim package according claim6,6, wherein whereinthe theone oneoror more moresnap-in snap-in tabs extend tabs fromboth extend from bothsides sidesofofeach eachchannel channel of of thethe pluralityofofchannels plurality channels and and areare longitudinally longitudinally

offset. offset. 2023203963

9. 9. The catheterization The catheterization package packageaccording accordingtotoclaim claim8,8,wherein wherein thethe a snap-in a snap-in tabtab on on a a first first side side of of the the channel channel isislongitudinally longitudinally positioned positioned between between a second a second andsnap-in and a third a thirdtab snap-in on a tab on a

second side of the channel. second side of the channel.

10. 10. The The catheterization catheterization package package according according to claim to claim 9, wherein 9, wherein the first, the first, second, second, and and third snap-in tabs are longitudinally aligned with respect to each of the plurality of channels. third snap-in tabs are longitudinally aligned with respect to each of the plurality of channels.

11. 11. TheThe catheterizationpackage catheterization packageofofany anyone oneofofthe thepreceding precedingclaims, claims, wherein whereinthe the container of lubricant and the container of sterile water are syringes. container of lubricant and the container of sterile water are syringes.

12. 12. The The catheterization catheterization package package according according to one to any anyof one ofpreceding the the preceding claims, claims, further further

comprisinga asterile comprising sterile wrap removably wrap removably folded folded around around contents contents of the of the catheterization catheterization package, package, the the

sterile wrap sterile havinga afolded wrap having folded configuration configuration and and an unfolded an unfolded configuration, configuration, the sterile the sterile wrap wrap maintained in the folded configuration by a belly band, wherein the belly band includes orientation maintained in the folded configuration by a belly band, wherein the belly band includes orientation

instructions. instructions.

13. 13. The The catheterization catheterization package package according according to claim to claim 12, wherein 12, wherein the belly the belly band band further further

comprises instructions comprises instructions for for use use of the of the catheterization catheterization package. package.

14 The catheterization 14 The catheterization package package according according to claim to claim 13, wherein 13, wherein a paira of pairsterile of sterile gloves gloves

are are accessible accessible after after removal of the removal of the belly belly band and transitioning band and transitioning the the sterile sterilewrap wrap from the folded from the folded configuration to the unfolded configuration. configuration to the unfolded configuration.

15. 15. The The catheterization catheterization package package according according to claim to claim 14, wherein 14, wherein a packaging a packaging label islabel is positioned over positioned overthe thesterile sterile wrap wrapin in thethe folded folded configuration, configuration, the packaging the packaging label label including including

information squares information squares on top on the the surface top surface and atand at two least leastside twosurfaces. side surfaces.

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16. TheThe catheterizationpackage packageaccording accordingtotoclaim claim15, 15,wherein whereina sealed a sealedbagbag is is 07 May 2025 2023203963 07 May 2025

16. catheterization

positioned around the catheterization tray and the packaging label such that the at least two side positioned around the catheterization tray and the packaging label such that the at least two side

surfaces are disposed surfaces are disposedorthogonal orthogonaltotothethetoptopsurface surface of of thethe packaging packaging label, label, thereby thereby providing providing

visibility of the packaging label in multiple planes. visibility of the packaging label in multiple planes.

17. 17. The The catheterization catheterization package package according according to claim to claim 16, further 16, further comprising comprising a perineal a perineal

care packetpositioned care packet positioned between between the sterile the sterile wrap wrap in theinfolded the folded configuration configuration and the packaging and the packaging label, label, 2023203963

whereinthe wherein the perineal perineal care care packet includes one packet includes or more one or itemsin more items in aa sealed sealed baggy. baggy.

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