AU632058B2

AU632058B2 - Wedge-shaped port for flexible containers

Info

Publication number: AU632058B2
Application number: AU39576/89A
Authority: AU
Inventors: Bradley H. Buchanan; Robert A. Miller; R. Daniel Webster
Original assignee: Clintec Nutrition Co
Current assignee: Clintec Nutrition Co
Priority date: 1988-08-31
Filing date: 1989-08-15
Publication date: 1992-12-17
Anticipated expiration: 2009-08-15
Also published as: DE68905977T2; CA1335372C; DE68905977D1; IL91381A0; AU3957689A; ZA896688B; ES2041380T3; EP0356955A1; EP0356955B1; ATE88082T1; JPH02167167A

Abstract

A wedge-shaped access port (18) for a flexible container (10) which is formed of at least one or more sheets of material (12) which are sealed together about the edges (14) to form a cavity (16). The wedge-shaped port (18) is sealed to the container (10) so that a base (22) of the wedge is exterior to the cavity (16) and a thin edge of the wedge is located inside the cavity (16). An orifice (20) in the port (18) provides a passageway from the base (22) of the wedge to the cavity (16). The wedge shape of the port (18) allows sealing of the port (18) to container (10) with minimal stress or thinning of material at the seal between the port (18) and the container (10).

Description

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6 32 0!G5 8 Form PATENTS ACT 1952 COMPLETE SPECIFICATION

(ORIGINAL)

FOR OFFICE USE Short Thil: Int. CI: Application Number: Lodged: _:Complets Specification-i-Lodged: Ac'.9pted: Lapsed: Published: Priority: Reiated Ait: TO BE COMPLETED BY APPLICANT Name of Applicant: Address of Applicant: Actual Inventor: Address for Service: NB International Technologies 55 Avenue Nestle, 1800 Vevey, Switzerland Robert A. Miller R. Daniel Webster Bradley H. Buchanan Peter Maxwell Associates, Blaxland House, 5-7 Ross Street, NORTH PARRAMATTA. N.S.W. 2151 Complete Specification for the invention entitled: WEDGE-SHAPED PORT FOR FLEXIBLE CONTAINERS The following statement is L, full description of this Invention, Including the best method of performing it known to me:- Note: The description. Is to be typed In double Wnicng, plca "yp face, In an area not exceeding 250 mm In depth~ and 160 mm In width, onl tough whit* papef of good qualltv and It Is to be Insetted Inside this form.

1416OM-L 141 84177-L Printd bY Q L. THOMsm. Acftg Cnowswalth Govcrumint Prfrar, Cazzbwra i la The inventi:- generally relates to ports for containers and more specifically relates to wedge-shaped ports for flexible containers.

It is common medical practice to provide fluids to a patient either intravenously or enterally as a method of 10 treating a patient for various medical conditions.

Frequently, the fluids to be administered to a patient are contained in a flexible container. One method of forming a flexible container is to seal two sheets of flexible material about the periphery of the sheets to create a cavity. A port is frequently placed between the sheets during the sealing process to create a communication between the cavity and t'e exterior of the container to provide a means of introducing fluid into or aispensing fluid from the container. In many cases, a length of flexible tubing is typically attached to this port so that a needle or enteral feeding tube can then be attached to the other end of the tube to administer the fluid to the patient.

-I Generally speaking, fluids that are administered to a patient must be sterile. Therefore, it is very important that a hermiatic seal is created between the port and the container. Certain medical solutions that are administered to patients such as high concentrations of dextrose, amino acids, lipid emulsions, or enteral diets are also oxygen sensitive. Therefore, in those cases, it is also very important that the container and the port are manufactured from materials that reduce permeability of the container, or as an alternative, an overwrap is placed 0 over the container at the time of manufacture to reduce o 0 permeability of the container.

o 00i o •Typically fluids to be administered to a patient are added i to a flexible container through the use of an access port into the container. A separate port is frequently provided to administer the fluid to the patient. In the past, these ports have been typically formed by placing a tube in between the sheets of the container as the container is manufactured. The tubes are sealed to both sheets of the container during manufacture. Since the tubes have a cylindrical shape and the sheets are basically flat, stresses and thinning occur in the sheets as the sheets are sealed about each tubular port. One means of reducing the stresses created by sealing a tubular port to the sheets of a flexible container is to design the port to have an lenticular rather than cylindrical configuration.

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One problem with each of the examples described above, however, is that thinning and stressing of the sheets continues to occur as the flat sheets are turced to seal about a curved port. As long as the material used to create the container is fairly elastic and capable of withstanding stresses, then it is possible to develop an adequate seal between a curved port and a flat sheet.

However, in many cases, it is desired to use materials which are relatively inelastic or are very thin and thus more susceptible to stress fractures at the location of the seal of the material to the curved port.

i:o o ft b oo boo 0 11" Li In view of the foregoing, it is an object of the invention to provide a port having relatively flat surfaces for sedling to a flexible container.

It is another object of the invention to provide a port which has relatively low oxygen permeability.

It is a further object of the invention to provide a port for a flexible container which is relatively easy and inexpensive to manufacture.

It is yet a further object of the invention to provide a port for sealing engagement with a flexible container which minimizes stresses and thinning of the container at the location of sealing between the container and the port.

It is also an object of the invention to provide a plurality of ports for use with a flexible container to provide at least one port for filling the container and at least one other port for dispensing fluids from the container.

In accordance with one broad aspect of the invention there is provided a container formed of at least one sheet of material and having a seal operatively formed between two edges of said material to form a cavity for housing a fluid comprising: a wedge-shaped port in sealed engagement with Srv said edges of the container, said port having a base and first and second opposing discrete sides which extend from said base, said first and second sides extending from Sopposite lateral edges of said base, said sides defining two intersecting planes, said intersecting planes describing an I. acute angle, said port having an orifice extending through said base to provide continuous fluid communication between inside and outside of said cavity, said port being disposed i ialong said edges of said container so that a periphery of said port is inside the cavity while an outer surface of said base is outside of the container, a vertex of the acute angle Sdefined by said intersecting planes being positioned within i the said cavity, said orifice being so constructed and arranged that a member inserted through said orifice does not 25 penetrate said seal, said port including third and fourth sides attached on opposite lateral edges of said base, said third and fourth sides having portions that are outwardly bent and that extend beyond said first and second sides so as CO aoa S 0 si ot sisd h avt hl note ufc fsi i 3 baei usd fth otieavrexo h ct nl r- i -4ato form triangular legs whose edges are sealed to said material, said third and fourth sides being tapered in conformity with said acute angle defined by said intersecting planes.

According to a further aspect of the invention there is provided a container formed of at least one sheet of material and having a seal formed between two edges of said material to form a cavity comprising: a wedge-shaped po't in sealed I ;engagement with said edges of container, said port having a 10 thick base and two opposing sides which taper to a relatively thin edge, said port having an orifice extending from said t, base to said edge to provide continuous fluid communication Sbetween inside and outside of said cavity, said port being disposed along said edges so that said edge is inside the 15 cavity and said base is outside the container, said orifice being so constructed and arranged that a member inserted through said orifice does not penetrate said seal.

According to a further aspect of the invention there is provided a container formed of at least one sheet of material i 20 and having a seal operatively formed between two edges of said material to form a cavity for housing a fluid comprising: a port in communication with said container, said port having a wedge shape with at least one orifice therethrough, said port including a base and first and second oppositely disposed substantially flat sides extending /PLI therefrom, said first and second sides defining intersecting planes that define said wedge shape, said intersecting planes -4bdefining an acute angle, the orifice extending through the base, said port further including third and fourth opposing sides extending from the base, said port being located between said material along said seal and in sealed engagement with said material, said port being disposed in said container such that at least portiont of said first and second sides are disposed in said cavity of said container and said base is outside of said cavity, a vertex of said acute angle defined by said intersecting planes being positioned with said cavity, said orifice extending through said port and so constructed and arranged that a member a inserted through said orifice does not penetrate said seal, said third and fourth sides being tapered in conformity with t said acute angle defined by said intersecting planes, said V 15 third and fourth sides having portions outwardly bent and extending to form triangular legs.

According to a still further aspect of the invention there is provided a port comprising: a substantially rectangular member with at least one openiaig; a tubular conduit operatively extending in registry from said opening in said rectangular member; two sides having outwardly flaring triangular portions attached to opposite lateral edges of said rectangular member, the outwardly flaring portions being tapered to aefine a wedge with an acute angle that opens toward said rectangular member; and two other y sides attached on other opposite lateral edges of the c3 i i i: S ij a

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-4crectangular member and along a portion of a periphery of said triangular sides to provide a wedge, the four sides and the rectangular member defining a body which surround said conduit, said conduit providing a continuous fluid communication between inside and outside of a cavity formed in a container comprising at least one sheet of material by forming a seal between two edges of said material, said conduit being so constructed and arranged that a member inserted through said conduit does not penetrate said seal.

According to yet another aspect of the invention there is provided a port for a container formed of at least one 4: sheet of material and having a seal operatively formed between two edges of said material to form a cavity for i tit housing a fluid, comprising: a body that substantially S 15 encloses a space, first and second faces describing first and second sides of the said port, third and fourth faces iK describing third and fourth sides of said port, said third i and fourth sides being tapered so as to impart a wedge shape to said port, and said first and second sides defining intersecting planes in accordance with said wedge shape, a rectangular member positioned and secured to form a top of said body, the rectangular member including at least one port opening, said third and fourth sides having portions extending beyond said rectangular member to define two extending triangular members; and a conduit extending from said port opening in a direction opposite said extending triangular members, said conduit providing continuous fluid communication between inside and outside of the cavity formed in the container and so constructed and arranged that a member inserted therethrough does not penetrate said seal.

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FIG. 1 is invention FIG. 2 is including FIG. 3 is removable an isometric drawing of one embodiment of the as sealed within a container; an isometric view of a wedge-shaped port a flap; an isometric view of a port including a cover; o 40 t I o FIG. 4 is an isometric view of a port in which the material forming the container extends beyond the base of the port; FIG. 5 is a top view, partially broken away, of a wedge-shaped port having a breakable seal surrounding the base of the wedge; FIG. 6 is an isometric view of a "U-shaped" embodiment of the port of the subject invention; FIG. 7 is an embodiment of the invention containing a plurality of orifices in a wedge-shaped port; and FIG. 8 illustrates an embodiment of the invention in which opposite sides of a wedge-shaped port may flex outwardly.

r Referring now to FIG. 1, a flexible container 10 is formed of at least one sheet of flexible material 12. The container is sealed about the edges 14 of the material to form a cavity 16 within the container. A wedge shaped port 18 is located at the bottom of the container. The wedge shaped port has at least one orifice therethrough. The wedge includes a base 22 and first and second oppositely disposed substantially flat sides 24 and 26 extending therefrom, The first and second sides form a generally acute angle 28 which creates a relatively thin edge 30 along the top of the wedge. In a preferred embodiment of the invention, the port is located between the first and second sheets of material 14 and 16 along a seal line 32. The port is disposed in the container such that the acute angle 28 is located within the cavity of the container in the base 22 is located outside of the cavity.

o oo 0 0 0 0 Lti In a preferred embodiment of the invention, at least one sheet of the container may extend downwardly from the base of the wedge to form a flap 34 to cover the orifice 20 at the base 22. The flap may be r:,,evably sealed to the base 22 of the wedge 18. In the embodiment illustrated in FIG.

2, flap 36 may include a first portion 38 which covers the base of the wedge 22 and a second portion 40 which can be folded up over a side 24 of the wedge 18. In many embodiments of the invention, it is desirable for the flap to be temporarily sealed to the base of the wedge in order to maintain cleanliness or sterility of the orifice or to control permeability. In such embodiments, when a user wishes to insert a tube into the port to either add or remove fluid from the container, the user can simply peal back the flap from the port im'ciately prior to insertion of the tube. In other embodiments, the cover may be formed of an elastomeric resealable material.

In another embodiment of the invention, it may be desirable to permanently seal flap 34 as illustrated in FIG. 1 (or flap 36 as illustrated in FIG. 2) to the base or side wall of the wedge-shaped port. In this embodiment, the flap forms a penetratable membrane which can be ruptured by the user through the use of a spiked tube or needle.

7 In yet another embodiment of the invention, the port 18 ma) include a removable cover 42 as illustrated in FIG.

3. As can be seen in the figure, the removable cover 42 covers the base 22 of the wedge 18 and third and fourth side walls 44 and 46 of the wedge. In one embodiment of the invention, the removable cover can include an adhesive coating to create a temporary bond between the cover and the base of the wedge. This insures that the removable cover will stay on the wedge-shaped port until the user wishes to remove the cover to either introduce fluids or remove fluids from the container.

In another embodiment of the invention as illustrated in FIG. 4, the container may include extensions 48 and which extend beyond the base of the wedge-shaped port from each side 24 and 26 of the wedge. It may be desirable to include such extensions 48 and 50 to provide protection for a spike or needle which may be inserted into the port. It may also be desirable to include such extensions on both sides of the wedge to create a sealed enclosure 52 about the base of the wedge as illustrated in FIG. The side walls 24 and 26 may be generally solid walls as illustrated in FIG. 1 or may be generally "U-shapcd" walls as illustrated in FIG. 6. The size and thickness of the side walls will, of course, vary depending on the size of the container and the application for which the container is being used. However, generally speaking, it is desirable that the third and fourth side walls 44 and 46 be somewhat thicker than the first and second side walls 24 ano 26 when it is desired to minimize oxygen ingress I- Iinto the cavity of the container. In the preferred embodiment of the invention, the first and second walls will generally be from 0.001 to 1.0 inches thick and the third and fourth walls will generally be from 0.001 to inches thick.

The acute angle 28 may likewise vary depending on the use and size of the container or the size of any spiking device that may be used with the container. In general, however, it is preferable that the acute angle range from 1 to 89 degrees.

I The wedge-shaped port can be formed from a variety of materials. In general, the main requirement for the material from which the port is formed is that it is capable of forming a hermatic seal with the material from which the container is made. In many embodiments, it is preferable that the port be formed from a material which has low permeability to oxygen and is sterilizable using standard sterilization techniques. Some of the preferred materials to use for the port are polyethylene, polypropylene or polyolefin or any of the materials listed above blended with ethylene vinyl alcohol, polyvinylidene chloride, or nylon. In one embodiment of the invention, it may be desirable to provide a metalized coating on the third and fourth walls 44 and 46 of the port to further reduce permeability of those walls.

'i In another embodiment of the invention, the orifice 20 may include a membrane 58 which extends across the entire orifice as illustrated in FIG. 1 to form a piercable seal. The membrane creates a barrier between the cavity of the container and the exterior to inaintain the cleanliness (or sterility) of the contents of the container prior to use. The membrane also prevents the flu.' from leaking from the container.

In still yet another embodiment of the invention, the wedge-shaped port may includP multiple orifices 54 and 56 as illustrated in FIG. 7. In another embodiment of the invention each orifice may include a conduit 60 which extends beyond the base of the orifice 54 as also illustrated in FIG. 7. The conduit may serve several purposes, for instance, the conduit may support a spike inserted in the port. The conduit may also provide a location for attaching a piercable medication membrane or sterility cover. The conduit may also be useful for attaching flexible tubing to the port.

As can be seen in FIG. 3, in one embodiment of the invention the first and second sides 24 and 26 may extend beyond the third and fourth sides 44 and 46 to create a channel 62 on either side of the wedge shaped port. This channel may be useful as a means for conveying the wedge-shaped port during manufacture of the container.

7 I II I, -11- Referring now to FIG. 8, in another embodiment of the invention the first and second side walls 24 and 26 may be in parallel juxtaposition with each other. As a spike is inserted into the orifice 54 of the port, the side walls 24 and 26 will flex outwardly. This embodiment is desirable to promote complete drainage of fluid from the container because the outward flexure of the side walls also causes the walls of the container to separate from one another to allow fluid to more readily flow into the port.

Although the invention has been described and illustrated in detail, it is to be clearly understood that the same is by way of illustration and example only, and is not to be taken by way of limitation; the spirit and scope of this invention being limited only by the terms of the appended claims.

Claims

2. A container as claimed in claim 1 wherein at least one -13- ii "I S -q side of said material extends beyond said base of said port to form a flap to cover said orifice at said base.
3. A container as claimed in claim 2 wherein said flap is removably sealed to said base of said port.
4. A container as claimed in claim 2 wherein said flap is permanently sealed to said base of said port. A container as claimed in claim 1 wherein said two sides of said material extend beyond said base.
6. A container as claimed in claim 1 wherein said first and second sides are each generally shaped.
7. A container as claimed in claim 1 wherein said port further includes multiple orifices which individually form passageways from said base to said acute angle.
8. A container as claimed in claim 1 wherein said port is formed from a material having low permeability to oxygen.
9. A container as claimed in claim 8 wherein said port is formed of a material selected from the group consisting of polyethylene, polypropylene or polyolefin. A container formed of at least one sheet of material and having a se,'l formed between two edges of said material to form a cavity comprising: a wedge-shaped port in sealed engagement with said edges of container, said port having a thick base and two opposing sides which taper to a relatively thin edge, said port having an orifice extending from said base to said edge to provide continuous fluid communication between inside and outside of said cavity, said port being disposed along said edges so that said edge is inside the cavity and said base is outside the container, said orifice 14 being so constructed and arranged that a member inserted through said orifice does not penetrate said seal.
11. A container formed of at least one eheet of material and having a seal operatively formed between two edges of said material to form a cavity for housing a fluid ji comprising: a port in communication with said container, ji said port having a wedge shape with at least one orifice therethrough, said port including a base and first and second j oppositely disposed substantially flat sides extending I therefrom, said first and second sides defining intersecting j planes that define said wedge shape, said intersecting planes defining an acute angle, the orifice extending through the base, said port further including third and fourth opposing .sides extending from the base, said port being located between said material along said seal and in sealed i: engagement with said material, said port being disposed in said container such that at least portions of said first and second sides are disposed in said cavity of said container and said base is outside of said cavity, a vertex of said acute angle defined by said intersecting planes being positioned with said cavity, said orifice extending through said port and so constructed and arranged that a member inserted through said orifice does not penetrate said seal, said third and fourth sides being tapered in conformity with said acute angle defined by said intersecting planes, said third and fourth sides having portions outwardly bent and extending to form triangular legs. j i i :B 4 S i
12. A container as claimed in claim 11 wherein said third and fourth sides are thicker than said first and second sides.
13. A container as claimed in claim 12 wherein said first and second sides are from 0.001 to 1.0 inches thick and said third and fourth sides are from 0.001 to 1.0 inches thick.
14. A container as claimed in claim 11 wherein said acute angle ranges from 1 to 89 degrees. A container as claimed in claim 11 wherein said orifice includes a membrane to form a piercable seal across said orifice.
16. A container as claimed in claim 11 further including at least one conduit extending beyond said base from at least one of said orifices.
17. A container as claimed in claim 11 wherein said first and second opposing sides extend beyond said third and fourth sides.
18. A container as claimed in claim 17 wherein said first and second opposing sides flex outwardly when a spike is inserted into said cavity through said orifice.
19. A container as claimed in claim 17 further comprising: a removable cover surrounding said base and said third and fourth sides of said wedge. A container as claimed in claim 19 wherein said removable cover is formed from a material having low permeability.
21. A container as claimed in claim 11 wherein said third and fourth sides have outer surfaces with a metallized ,II I *4 1441 1t 4 44 11 -16- coating to control permeability of the port.
22. A container as claimed in claim 11 wherein at least one side of said material extends beyond said base of said wedge to form a flap to cover said orifice at said base.
23. A container as claimed in claim 22 wherein said third and fourth sides have outer surfaces with a metallized coating for controlling the permeability of the port.
24. A container as claimed in claim 11 which further includes a removable cover which cover-; said base. A container as claimed in claim 24 wherein said removable cover further covers said third and fourth sides.
26. A container as claimed in claim 25 wherein said removable cover includes an adhesive coating for removable attachment of said cover to said bas;.
27. A container as claimed in claim 25 whirei-, said removable cover is formed of an elastomeric resealable I material.
28. A port comprising: a substantially rectangular member with at least one opening; a tubular conduit operatively extending in registry from said opening in said rectangular member; two sides having outwardly flaring triangular portions attached to opposite lateral edges of said rectangular member, the outwardly flaring portions being tapered to define a wedge with an acute angle that opens toward said rectangular member; and two other sides attached on other opposite lateral edges of the rectangular member and along a portion of a periphery of said triangular sides to provide a wedge, the four sides and the rectangular member II i r- 17 defining a body which surrounds said conduit, said conduit providing a continuous fluid communication between inside and outside of a cavity formed in a container comprising at least one sheet of material by forming a seal between two edges of said material, said conduit being so constructed and arranged that a member inserted through said conduit does not penetrate said seal.
29. A port for a container formed of at least one sheet of material and .aving a seal operatively formed between two edges of said material to form a cavity for housing a fluid, comprising: a body that substantially encloses a space, first and second faces describing first and second sides of the said port, third and fourth faces describing third and fourth I| osides of said port, said third and fourth sides being tapered so as to impart a wedge shape to said port, and said first and second sides defining intersecting planes in accordance with said wedge shape, a rectangular member positioned and I* secured to form a top of said body, the rectangular member S' including at least one port opening, said third and fourth sides having portions extending beyond said rectangular member to define two extending triangular members; and a conduit extending from said port opening in a direction opposite said extending triangular members, said conduit providing continuous fluid communication between inside and outside of a cavity formed in the container and so constructed and arranged that a member inserted therethrough does not penetrate said seal. -18- A container substantially as hereinbefore described with reference to the accompanying drawings. DATED this 6th day of July, 1992. NB INTERNATIONAL TECHNOLOGIES Patent Attorneys for the Applicant: PETER MAXWELL ASSOCIATES. ;e I I 4 II