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NZ758147B2 - Integrated vascular access device and anchor pad - Google Patents
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NZ758147B2 - Integrated vascular access device and anchor pad - Google Patents

Integrated vascular access device and anchor pad Download PDF

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Publication number
NZ758147B2
NZ758147B2 NZ758147A NZ75814718A NZ758147B2 NZ 758147 B2 NZ758147 B2 NZ 758147B2 NZ 758147 A NZ758147 A NZ 758147A NZ 75814718 A NZ75814718 A NZ 75814718A NZ 758147 B2 NZ758147 B2 NZ 758147B2
Authority
NZ
New Zealand
Prior art keywords
catheter
anchor
anchor pad
window
stabilization platform
Prior art date
Application number
NZ758147A
Other versions
NZ758147A (en
Inventor
Jonathan Karl Burkholz
Original Assignee
Becton Dickinson And Company
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US15/481,716 external-priority patent/US10905847B2/en
Application filed by Becton Dickinson And Company filed Critical Becton Dickinson And Company
Publication of NZ758147A publication Critical patent/NZ758147A/en
Publication of NZ758147B2 publication Critical patent/NZ758147B2/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • A61M2025/0246Holding devices, e.g. on the body fixed on the skin having a cover for covering the holding means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • A61M2025/0253Holding devices, e.g. on the body where the catheter is attached by straps, bands or the like secured by adhesives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • A61M2025/0266Holding devices, e.g. on the body using pads, patches, tapes or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • A61M2025/0266Holding devices, e.g. on the body using pads, patches, tapes or the like
    • A61M2025/0273Holding devices, e.g. on the body using pads, patches, tapes or the like having slits to place the pad around a catheter puncturing site
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body

Abstract

anchor system, comprising: a catheter assembly, comprising a catheter hub, a stabilization platform extending from the catheter hub, and a catheter that extends from the catheter hub; and an anchor pad having an upper surface and a bottom surface opposite the upper surface, the bottom surface forming an adhesive surface, the anchor pad including a connected portion that is coupled to the stabilization platform and a fold portion that extends distally from the connected portion, the fold portion being folded back overtop the stabilization platform prior to insertion of the catheter such that the bottom surface along the fold portion is oriented upwardly, and wherein, after insertion of the catheter, the fold portion is configured to unfold onto skin surrounding an insertion site of the catheter, the anchor pad also including a window that is oriented to cause the insertion site to be positioned within the window when the fold portion is unfolded onto the skin surrounding the insertion site thereby to provide securement of the catheter assembly in a controlled, efficient and safe manner. ming an adhesive surface, the anchor pad including a connected portion that is coupled to the stabilization platform and a fold portion that extends distally from the connected portion, the fold portion being folded back overtop the stabilization platform prior to insertion of the catheter such that the bottom surface along the fold portion is oriented upwardly, and wherein, after insertion of the catheter, the fold portion is configured to unfold onto skin surrounding an insertion site of the catheter, the anchor pad also including a window that is oriented to cause the insertion site to be positioned within the window when the fold portion is unfolded onto the skin surrounding the insertion site thereby to provide securement of the catheter assembly in a controlled, efficient and safe manner.

Description

lNTEGRATED VASCULAR ACCESS DEVICE AND ANCHQR FAB BACKGROUND 0F "Fl-ll}: lNVlEZNTlON [@991] A clinician may insert a vascular access device into vasculature of a patient to infuse fluid and/or draw blood. The vascular access device may first penetrate skin of the patient at an insertion site, and when the vascular access device is properly placed within the vasculature, the clinician may apply a skin ve at the insertion site to secure the vascular access device. in order to apply the shin adhesive at the insertion site, the clinician may hold the inserted. vascular access device in one hand and use another hand to open an adhesive container and apply the shin adhesive, After applying the skin adhesive to the insertion site, the clinician may hold the vascular access device while the skin adhesive dries. Securing the vascular access device via the skin adhesive may thus he a ult and messy s that may result in dislodgenient of the vascular access , ineffective application of the shin adhesive through ation. of too much or too little oi" the skin ve, or adhering of the skin adhesive tn a hand or glove of the clinician. Accordingly, there is a need in the art for devices, s, and methods that provide securenient of the vascular access device in a controlled, ef ‘icient and safe manner, BRllEF SUM MARY 0F ’"l‘l-llii lN‘v’lENTltilN The t disclosure relates generally to devices, systems, and associated methods to secure and stabilize a vascular access device inserted into a hlood vessel of a patient, in some embodiments, an anchor system to secure the vascular access device to the patient may include an anchor pad, which may e a lower surface, an upper surface, and a window extending through the anchor pad. in some embodiments, the lower surface may include an adhesive layer to adhere the anchor pad to skin of the patient, In some ments, the window may provide access to the skin of the patient for ation of a topical shin adhesive at an insertion site of the vascular access device, the insertion site being disposed within the window, [tltltlSl in some embodiments, the vascular access device may include a stabilization rm. in some ments, the stabilization rm may extend from a body of the vascular access device. For example, the vascnla? access device may include a peripheral intravenous (IV) catheter, which may include a catheter huh. in some embodiments, the stabilization platform may extend outwardly from the catheter hub. in some embodiments, the stabilization platform may include a first wing and/or a second wing in some embodiments, the first and second wings may extend outwardly in te directions from the body of the. vascular access device or the catheter hub. [@994] in some embodiments, the anchor pad may extend distally from the stabilization platform. in some ments, the anchor pad and the stabilization platform may be integrated, in further detail, in some ments, the anchor pad may be coupled to the stabilization platform. in some embodiments, the anchor pad may he coupled to a bottom or top surface of the stabilization platform. in some ments, the skin adhesive may be disposed within the window to secure the vascular access device in place at the insertion site. in some embodiments, the window may enclose the insertion site, which may facilitate controlled and contained application of the shin adhesive at the insertion site, In further detail, the skin adhesive may contact the anchor pad and/or the skin of the patient within the window. In some embodiments, the skin adhesive may be ted or discouraged from contacting skin of the patient outside of the window, reducing a likelihood of a messy application of the skin adhesive. in some embodiments, the skin adhesive may provide localized stabilization of the vascular access device at the insertion site and/or may provide a seal around the vascular access device at the insertion site, which may prevent infection. The skin adhesive may also increase indweli time for the vascular access device. in some embodiments, the anchor pad may include a release liner that may cover the adhesive layer and may be removed prior to adhering the anchor pad to the skin of the patient. In some ments, an entirety of the ve layer may be adhered to the skin of the patient at approximately the same time. in some embodiments, portions of the adhesive layer may be adhered to the skin of the patient at different times. For example. a portion of the adhesive layer configured to be disposed between the skin and the stabilization platform may be adhered to the skin prior to a fold portion of the anchor pad. in these and other embodiments, a n of the release liner corresponding to the toidable portion may he removed at a same time as or after a portion of the release liner corresponding to the portion of the adhesive layer configured to be disposed between the skin and, the stabilization platform. lilililti] in some embodiments, the anchor pad may he i‘oldahle. For example, prior to inserting the vascular access device into the patient at the insertion site, the anchor pad may he folded such that a fold portion of the anchor pad is disposed in a first or proximal on. The fold portion may correspond to a portion of the adhesive layer. Alter inserting the vascular access device into the t at the insertion site, the anchor pad may he unfolded such that the. fold portion is disposed in a second or distal on in which the portion of the adhesive layer contacts the skin of the patient. [illlllfl in some embodiments, a method of securing the vascular access device may include providing the ar access devic which may include the stabilization rm. in some ments, the method may e coupling the vascular access device to the anchor WO 86980 pad. In some embodiments, the method may include inserting the vascular access device into the patient at the ion site. in some embodiments, the method may include adhering the anchor pad to the skin of the patient via the adhesive layer. in some embodiments, the method may include applying the skin adhesive at the insertion site and/or proximate the insertion site within the window after the vascular access device is inserted at the insertion site and after the anchor pad is adhered to the skin of the patient. In some embodiments, adhering the anchor pad to the skin of the patient via. the adhesive layer may include ng the release liner covering the adhesive layer.
In some embodiments, the method. may include, prior to ing the vascular access device into the patient at the insertion site, g the anchor pad such that the fold portion of the anchor pad is ed in the first or proximal position. in these and other embodiments, the method may e removing a release liner covering a portion of the adhesive layer ponding to the fold portion of the anchor pad. In some embodiments, the method may include, after inserting the catheter assembly into the t at the insertion site, unfolding the anchor pad such that the fold portion is ed in the second or distal position in which the portion of the adhesive layer contacts skin of the patient" BRIEF DESCRIPTlON OF THE SEVERAL VIEWS OF Tl-lE FlGURES {hill}?! in order that the manner in which the above—recited and other features and advantages of the invention will he readily understood, a more particular description of the devices, systems, and associated methods to secure and stabilize a vascular access device briefly described above will be rendered by reference to specific embodiments thereof, which are illustrated in figures 14. Understanding that these Figures depict only typical embodiments and are not, therefore, to be considered to be limiting of its scope, the invention will he described and ned with addititmal specificity and detail through the use of the accompanying s in which: ] Figure l is an upper perspective View of an example anchor system secured to a patient, according to some embodiments; [Willi Figure 2A is an upper perspective View of the anchor system of Figure 1 prior to insertion into a blood vessel of the patient, ing to some embodiments; Figure IZB is an upper perspective View of the anchor system of Figure l inserted into the blood vessel of the patient, illustrating a release liner partially removed, according to some ments; Figure 2C is a bottom View of an example anchor pad of the anchor system of Figure l, according to some embodiments; Figure 3 is an upper perspective View of the anchor system of Figure 1, illustrating an ex ample slot, according to some embodiments; and [MRS] liiigure 4 is a bioclt diagram of an example method of securing a catheter, according to some embodiments.
DETAll_,lED DESCRlPTlQN 0F Til-iii INVENTIQN it will be readily understood that the components of the present invention, as generally described and illustrated in the Figures in the present disclosure, could be arranged and designed in a Wide variety of different configurations. Thus, the following more detailed description of the ments, ented in Figures 1-4, is not intended to limit the scope of the invention, as claimed, but is merely representative of some embodiments of the invention. [0&7] Referring to Figure i, an example anchor system it) for securing a catheter assembly 12 to a patient is illustrated. lt is understood, however. that the anchor system it) may be utilized in connection with other vascular access devices, including, but not d to, fluid supply and drainage lines, feeding tubes, chest tubes, scopes, connectors, adaptors, electrical wires and. cables, and the like, any of which may be secured to the patient by the anchor system [Milli] in some embodiments, the anchor system l0 may include an anchor pad l4, which may include various shapes and sizes. in some embodiments, the anchor pad 14 may include a lower e, an upper surface to, and a window 18 extending through the anchor pad in some embodiments, the anchor system it) may include the catheter assembly 12. in some embodiments, the catheter assembly l2 may include a catheter hub 20 configured to house a catheter 22, An introdueer needle is lly ed h the catheter 22 such that a tip of the needle extends beyond a tip of the catheter 22, insertion of the needle into a blood vessel of the patient es an opening into the blood yessel through which the tip of the catheter 22 is ed. Once the catheter 22 is inserted into the blood vessel of the t, the introducer needle is removed from a lumen of the catheter 22 to permit infusion or withdrawal via the catheter 22. in some embodiments, the anchor system it) may secure or stabilize the catheter ’22 within the blood vessel of the patient, as illustrated in Figure l. [(3629] in some embodiments, the catheter ly l2 may include a stabilization platform 24. in some embodiments, the stabilization platform 24 may extend outwardly from the catheter hub 20. in some embodiments, the stabilization platform 24 may include a first wing 26a. and/or a second wing 26b. in some embodiments, the first wing 26a and/or second wing 26b may extend outwardly in opposite directions from the er hub 29. in some embodiments, the stabilization platform 24 may be configured to rest on the skin 28 of the patient when the catheter 22 is inserted at the insertion site in a fluid delivery configuration, as illustrated in Figure l, in some embodiments, the stabilization platform 24 may support one or more digits of the clinician. as the clinician. inserts the catheter 23 at the insertion site and/or moves the catheter assembly l2 from an insertion configuration, illustrated in Figures 2A and 2B, to the fluid delivery configuration, rated in Figure l. in some embodiments, the clinician may pinch or grip the stabilization platform 24.
Zl in some embodiments, the anchor pad l4 may extend distally from the. stabilization platform 24. in some embodiments, the anchor pad 14 and the stabilization platform 24 may be integrated. in further , in some embodiments, the anchor pad 14 may be d to the stabilization platform ‘24. in some embodiments, the anchor pad l4 may be coupled, to any surface of the stabilization platform 24. in a preferred embodiment, the anchor pad l4 may be d to a bottom surface of the stabilization platform 24, as illustrated in Figures i—3. In some embodiments, the anchor pad 14 maybe coupled to a top surface of the stabilization platform 24. ln some embodiments, the anchor pad. 14 may fully or partially cover the top or bottom surface of the stabilization rm 24-. The anchor pad 14- may be coupled to the stabilization platform 24 in any number of ways, such as, for example, adhesive, ultrasonic welding, heat staking, insert molding, etc. in some embodiments, the window l8 may provide access to skin 28 of the patient for application of a topical skin adhesive 30 at an insertion site of the er assembly 12, the insertion site being disposed within the window 18. in some embodiments, the skin adhesive 30 may be disposed within the window 18 to secure the catheter assembly l2 in place at the ion site. in some embodimenta the window l8 may enclose the insertion site, which may facilitate controlled and contained application of the skin ve 30 at the insertion site. in further detail, the shin adhesive 36 may contact the skin 28 of the patient within the window l8 and/or a portion of the anehor pad 14 proximate the window 18, but may be prevented or discouraged from contacting the skin 28 of the t outside of the. window 18 and/or beyond an outer edge of the anchor pad, reducing a likelihood of a. messy application of the skin adhesive 30. in some embodiments, the skin ve 30 may provide localized stabilization of the catheter assembly 2 at the insertion site and/or may provide a seal around the catheter assembly l2 at the insertion site, which may t infection. The. skin adhesive 30 may also increase an indwell time for the catheter assembly l2. in some embodiments, the shin adhesive and/or the integrated anchor pad l4 and catheter assembly 12 may increase a force necessary to dislodge the catheter assembly 12 at the insertion site. in some embodiments, the eatl'teter assembly l2 may be ed into the patient prior to application of the shin adhesive 30 to the insertion site. Given the dit‘t‘ieultly and usability nges of holding the catheter assembly 112 in position while ng the skin adhesive 30 to the insertion site, it may be advantageous to e a means of seenrement of the catheter assembly 12, such as the integrated anchor pad l4, prior to application of the skin adhesive 30.
Thus, in some embodiments, insertion of the catheter assembly l2 and placement of the anchor pad l4 on the skin of the patient in an ed position, as illustrated in Figure l, may oecnr prior to application of the skin adhesive 30. The. anchor pad 14 coupled to the eatl'teter assembly 12 and at least a fold portion 29 adhered to the slrin 28 of the patient via an adhesive layer may facilitate greater control and accuracy in placement of the shin adhesive 39 at the ii‘isertion site, reduc‘ an amount of sltin adhesive 30 required, reduce a likelihood of a messy application of the shin adhesive 30, and reduce a rislt of the catheter assembly l2 becoming dislodged due to unintentional movement during application of the sltin adhesive 36. Further, the anchor pad 14 coupled to the catheter assembly 12 and d to the skin 28 of the patient may eliminate a need for the ian to hold the. catheter assembly 12 while the shin adltiesive 30 dries, which may reduce a likelihood of the skin adhesive 30 g to a hand or glove of the clinician.
In some embodiments, an outer edge of the window 18 may be spaced apart from the outer edge of the anchor pad 14. in further detail, in some embodiments, the window 18 may be inset. from the outer edge of the anchor pad l4. in some embodiments, the catheter assembly 12 may extend through a middle portion of the window 18. in some embodiments, the skin adhesive 39 may include crylate or another suitable glue or g material. in some ments, cyanoaerylate may include liquid monomers and may polymerize on contact with the skin, creating a flexible and/or semi-rigid layer. in these and other embodiments, liquid crylate may be applied at the insertion site within the window l8 and may cure to a solid form within a period of seconds. [titlZS] Referring now to Figures ZA—ZD, in some embodiments, the lower e 34- may include the adhesive layer 3’2 to adhere the anchor pad 14 to skin ’28 of the patient. in some embodimentst the adhesive layer 32 may include any type or form of adhesive that is suitable. for use with the methods and embodiments discussed. in the present disclosure. In some embodiments, the adhesive layer 32 may he a spray—on ve, adhesive film, or any other type of adhesive application. in some embodiments the adhesive layer 32. may be formed of or include a r-based pressure sensitive adhesive. For example, when a polymer—based pressure sensitive adhesive is used in the ve layer 32. a bond may formed between the adhesive layer 32 and the shin 28 of the t by applying light press are between anchor pad l4 and the skin 28. in some embodiments, the adhesive layer 32 may include a slight liquid carrier that facilitates bonding with the skin 28. in some embodiments, the adhesive layer 32 may include a single-use glue. such that the adhesive layer 32 loses its adhesive properties once removed from the sltin 28. in some embodiments, the adhesive layer 32 may include an antimicrobial agent to aid in maintaining ity of the insertion site. in some embodiments, the adhesive layer 32, may include a multiple-use glue. which may allow the anchor pad 14 to be applied repeatedly {W29} in some embodiments, the anchor pad l4 may include a release liner 36 that may cover the adhesive layer 32, and may he removed prior to adhering the anchor pad l4- to the shin 28 of the patient. in some embodiments, the release liner 36 may include any material or combination of materials that permit temporary bonding between the release liner 36 and the adhesive layer 32. [liliSll] in some ments, an entirety of the adhesive layer 32. may be adhered to the skin of the patient at approximately a same time. in some embodiments, portions of the adhesive layer 32 may be adhered to the skin 28 of the patient at different times. For example, a portion of the ve layer 32 ured to he disposed between the skin 28 and the stabilization platform 24 may he adhered to the skin 28 prior to the fold portion 29 of the anchor pad 14. in these and other embodiments, a portion of the release liner corresponding to the fold portion 29 may be removed at a same time as or after a portion of the release liner 36 corresponding to the portion of the adhesive layer 32 configured to be disposed n the skin 28 and the stahilization platform 24. 2018/021207 [Mill] As illustrated. in Figure 2C, in some ments, the release liner 36 may be divided into multiple pieces or s tctions to ease attachment of the anchor pad l4 to the skin 28 of the patient. in some embodiments, the release liner 36 may include a first n 37 corresponding to the portion of the adhesive layer 32 configured to be ed between the skin 28 and. the stabilization platform 24. in some embodiments, the release liner 36 may include a second section 39 corresponding to the fold portion 29, in some embodiments, the first and second sections 37, 39 may be removed separately. in some embodiments, the second section 39 may include a slit or slot 41, which may allow for the second section 39 to be removed in a distal direction after the catheter assembly 12 is inserted into the patient at the insertion site. {9932] in some embodiments, the release liner 35 may include an aperture corresponding to the window 18 or the release liner 36 may cover the window l8. in some embodiments, the release liner 36 may include paper, plastic, or another suitable material. in some embodiments, the release liner 36 may include one or more crobial agents. [@933] in some embodiments, the release liner 36 may be removed from the ve layer 32 by pulling in a distal direction on the release liner 36, which may reduce a risk of dislodging the catheter 22, in some embodiments, the release liner 36 may include one or more pull—tabs 40 to facilitate l of the release liner 36 from the adhesive layer 32. in some embodiments, the pull-tabs 4-0 may be designed in a variety of configurations and need not be. ed along a line of the anchor pad 14.
Figure 2A illustrates the ated anchor pad 14 and catheter assembly 12 prior to inserting the catheter assembly l2 into the patient at the insertion site. The tip of the introducer needle 38 extends beyond a tip of the catheter 22 prior to and during the insertion of the catheter assembly l2. As mentioned, in some embodiments, the anchor pad 14 may be fold-able. in some embodiments, prior to ing the catheter assembly 12 into the patient at the insertion site, the airichor pad l4 may be folded such that the fold portion 29 of the anchor pad 14- is disposed in a first or proximal position, illustrated in Figure 2A. in some embodiments, after inserting the vascular access device into the patient at the insertion site, the anchor pad 14 may he unfolded such that the fold portion 29 is disposed in a second or distal position in which a portion of the adhesive layer 32 corresponding to the fold portion 29 contacts the Skill 28, as illustrated in Figure l.
The adhesive layer 2‘2, may cover all or a portion of the lower surface 34 or" the anchor pad 14. in some emhodiments, a particular portion of the lower surface 34 configured. to be disposed between the bottom e of the stabilization platform 24 and the slain 28 may not include the adhesive layer 3’2. in some embodiments, the particular portion of the lower surface 34 configured to he disposed between the bottom surface of the stabilization platform 24 and the skin 28 may include the adhesive layer 32, which may allow the particular portion to be secured to the skin 28 prior to unfolding the anchor pad l4. in some ments, the release liner 26 may he d along a. fold line 42, which may allow the first section 37 to he d at a ent time as or before a remaining portion of the adhesive layer 32. in some embodiments, the window 18 may provide access to the skin 28 of the patient for application of the skin adhesive 30 and/or a cleaning or disinfection agent at the. insertion site of the catheter assembly l2. in some embodiments, the ng agent may he disposed within the window 18 and may contact the skin 28 of the patient within the window 18. in some ments, the cleaning agent may be prevented or discouraged from contacting the skin 28 of the patient outside of the window 18 and/or beyond an outer edge of the anchor pad 14. in some embodiments, the skin adhesive and/or the cleaning agent may he wiclted or pulled 2018/021207 into the anchor pad 14 from the window 18 but may not contact the skin '28 beyond, the outer edge of the. anchor pad 14. in some ments, a material of the anchor pad l4 may absorb a portion of the shin adhesive 39 and/or the cleaning agent and prevent spreading of the skin adhesive 30 and/or cleaning agent beyond the outer edge of the anchor pad 14. In some embodiments, the skin adhesive 30 and/or the cleaning agent may be contained within the window iii. in some embodiments, the anchor pad 14 may e any suitable medical grade rnateriall in some ments, in addition to the adhesive layer 3'2, the anchor pad l4 may e a cloth layer and/'or a foam layer, In some embodiments, the cloth layer may include the upper e 16. In some embodiments, the foam layer may include the upper surface in. In some embodiments, the cloth layer may he non-woven or woven. in some embodiments, the anchor pad l4 may include one or more antimicrobial agents? which may he applied in a film or otherwise.
Referring now to Figure 3, in some embodiments, the anchor pad 14 may include a, slit or slot 44 that may extend from the window iii to an exterior of the anchor pad l4. in some embodiments, the slot 44 may facilitate or ease insertion of the catheter assembly 12 into the patient prior to unfolding the anchor pad .14 such that the fold portion 29 of the anchor pad 14 is moved from the first position to the second, position to be adhered to the skin 28 of the patient, Figures l—3 rate. a peripheral lV catheter r to the ED NEXIVATM Closed {V Catheter (Becton, Dickinson and Company). l-lowever, it is understood that the anchor system l0 may be ed in connection with various types of catheter assemblies and vascular access devices. The anchor system l0 may be utilized in connection with, for example, peripheral lV catheters, central venous catheters (CK/Cs)" peripherally inserted central catheters (PlCCs), hernodialysis catheters, arterial catheters, integrated lV catheters, non~integrated lV catheters, etc. The anchor system it) may also be ed in connection with ED SAP-T- lNTll‘leTM Closed lV Catheter (Becton, Dickinson and Company).
Referring now to Figure 4, in some embodiments, a method 50 of securing a catheter may begin at block 52.. At blocl: 52, a catheter assembly may he provided. in some embodiments, the catheter assembly may include a stabilization platform. The catheter assembly, catheter, and stabilization platform. may include or correspond to the catheter assembly l2, the catheter 22, and the stabilization platform 24, respectively, discussed with t to any of Figures l--3. Block 531 may be followed by block 54.
At block 54., an anchor pad may be d to the catheter assembly, The anchor pad may include or correspond to the anchor pad l4 discussed with respect to any of the previous Figures l-3. Block 54- may be followed by block 56. [tltMZ] At block 56, the er assembly may be inserted into a patient at an insertion site. In some embodiments, once a distal tip of the catheter of the catheter assembly is ly placed into a blood vessel of the patient and an introducer needle is withdrawn from the blood vessel and the distal tip, the catheter may be left. in place to provide intravenous access to the patient. Block 56 may be ed by block 58 At block 58. the anchor pad may be adhered or ed. to the skin of the patient via an adhesive layer disposed on a lower surface of the anchor pad. In some embodiments, adhering the anchor pad via the adhesive layer may include unfolding the anchor pad and/or securing a n of the anchor pad surrounding a window to the skin of the patient. The adhesive layer may correspond to the adhesive layer 32 discussed with respect to any of the previous s l-3. Block 58 may he tollowed by block 60. [fillet-4i] At block 60, a skin adhesive may he applied at the insertion site and/or proximate the. insertion. site within the window. In some embodiments, the skin adhesive may he wicked or pulled into the anchor pad from the window. in these and other ments, the skin adhesive may not contact the skin beyond an outer edge or perimeter of the anchor pad. in some embodiments, a material of the anchor pad may absorb the skin adhesive to prevent spreading of the skin adhesive beyond the. outer edge of the anchor pad. For example, the anchor pad may include one or more of the following: a cloth layer, a foam layer, and another absorbing layer. in some embodiments, the cloth layer may be non-woven or woven. in some embodiments, the anchor pad. may help limit spread of the skin adhesive beyond, the outer edge of the anchor pad but may not completely prevent the skin adhesive from contacting the skin of the patient beyond the outer edge of the anchor pad. in some embodiments, the skin adhesive may be d after the catheter is inserted at the insertion site and the anchor pad is adhered to the skin of the patient. The skin adhesive may correspond to the skin adhesive 30 discussed with t to any of the us Figures l-El. Block 60 may he followed by block 62. [tillélfi] At block: 62, a securement dressing may be applied over top of the anchor pad and the catheter assembly. in some embodiments. the securement ng may include an antimicrobial agent, such as. for example, TEGADERMTM or CHLORASHIELDTM. ’i] Although illustrated as discrete hlocks, various blocks may be d into additional blocks, combined into fewer s, or eliminated, depending, on the desired implementation. rmore, the order of the blocks may he changed. Also, additional blocks may be added. in some embodiments, the method. may include, prior to inserting the vascular access device into the patient at the. insertion site, folding the anchor pad such that a fold portion of the anchor pad is disposed in a first position. in these and other embodiments, the method may include removing a release liner covering a portion of the ve layer corresponding to the fold portion of the anchor pad. in some embodiments, the method may include, after inserting the catheter assembly into the patient, at the insertion site, unfolding the anchor pad such that the fold n is ed in a second position in which the portion of the adhesive layer contacts skin of the patient, [95}47] The. present invention may be embodied in other specific forms without departing from its ures, methods, or other essential characteristics as broadly described herein and claimed hereinafter, The described embodiments and examples are to he considered in all respects only as illustrative, and not restrictive. The scope of the invention is, therefore, indicated by the appended claims, rather than by the foregoing description, All changes that come within the meaning and range of equivalency of the claims are to he embraced within their scope.

Claims (19)

1. An anchor, comprising: an assembly comprising a stabilization platform and a catheter that extends distally beyond the stabilization platform; and an anchor pad having an upper surface and a bottom surface te the upper surface, the bottom surface g an adhesive surface, the anchor pad including a ted portion that is d to the stabilization platform and a fold portion that extends distally from the connected portion, wherein the fold portion is folded along a line that extends through a window, the fold portion being folded back overtop the stabilization platform such that the bottom e along the fold portion is oriented upwardly, wherein the window is oriented to cause an insertion site of the catheter to be positioned within the window when the fold portion is unfolded onto skin surrounding the insertion site.
2. The anchor of claim 1, wherein the connected portion of the anchor pad is coupled to a top e or a bottom of the stabilization platform.
3. The anchor of claim 1 or claim 2 wherein the window is inset from an outer edge of the anchor pad.
4. The anchor system of any one of the preceding claims, wherein the fold portion is folded along a fold line, the fold line being positioned at a distal end of the stabilization platform.
5. The anchor system of any one of the ing claims, wherein the assembly comprises a catheter assembly.
6. The anchor system of any one of the preceding claims, further comprising a skin adhesive that is configured to be applied to the ion site via the window to thereby secure the catheter.
7. An anchor system, comprising: an anchor of any one of claims 1 to 6; a catheter assembly, comprising a catheter hub; wherein the ization platform extends from the catheter hub and the catheter extends from the catheter hub, wherein, prior to insertion of the catheter, the fold portion is folded back overtop the stabilization platform such that the bottom surface along the fold portion is oriented upwardly, wherein, after insertion of the catheter, the fold portion is ured to unfold onto skin surrounding an ion site of the catheter.
8. The anchor system of claim 7, wherein the stabilization platform comprises a first wing and a second wing, wherein the first and second wings extend dly in opposite directions from the catheter hub.
9. The anchor system of claim 7 or claim 8, wherein an outer edge of the window is spaced apart from an outer edge of the anchor pad.
10. The anchor system of any one of claims 7 to 9, wherein the upper surface of the connected portion is coupled to a bottom surface of the stabilization platform.
11. The anchor system of any one of claims 7 to 10, wherein the lower e of the connected portion is coupled to a top surface of the stabilization platform.
12. The anchor system of any one of claims 7 to 11, n the fold portion is folded along a fold line, the fold line being positioned at a distal end of the stabilization platform.
13. The anchor system of any one of claims 7 to 12, further comprising a release liner adhered to the adhesive surface.
14. The anchor system of claim 13, wherein the release liner includes a first section that is adhered to the adhesive surface along the connection portion and a second section that is adhered to the adhesive surface along the folded n.
15. The anchor system of claim 14, n the second section extends to a fold line along which the fold portion is folded.
16. The anchor system of claim 14 or claim 15, wherein the second section includes one or more pull tabs.
17. The anchor system of any one of claims 7 to 16, wherein the second section es a slit or slot.
18. The anchor system of any one of claims 7 to 17, wherein the anchor pad is formed of a cloth or foam material that is configured to absorb a skin adhesive that is applied within the window.
19. The anchor system of any one of claims 7 to 18, wherein the window extends proximally to the stabilization platform.
NZ758147A 2017-04-07 2018-03-06 Integrated vascular access device and anchor pad NZ758147B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US15/481,716 2017-04-07
US15/481,716 US10905847B2 (en) 2017-04-07 2017-04-07 Integrated vascular access device and anchor pad
PCT/US2018/021207 WO2018186980A1 (en) 2017-04-07 2018-03-06 Integrated vascular access device and anchor pad

Publications (2)

Publication Number Publication Date
NZ758147A NZ758147A (en) 2021-03-26
NZ758147B2 true NZ758147B2 (en) 2021-06-29

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