US3554256A - Flexible intravenous container - Google Patents

Flexible intravenous container Download PDF

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US3554256A
US3554256A US3554256DA US3554256A US 3554256 A US3554256 A US 3554256A US 3554256D A US3554256D A US 3554256DA US 3554256 A US3554256 A US 3554256A
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bag
connector
container
additive
ends
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Douglas W Anderson
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DAVE CHAMPMAN GOLDSMITH AND YAMA
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DAVE CHAMPMAN GOLDSMITH AND YAMA
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/1475Inlet or outlet ports

Abstract

A container for packaging and feeding intravenous fluids includes a flexible tubular container member having sealed ends and an outlet connector disposed midway between the ends of the container for interconnecting with an intravenous tube. The ends of the container member are adapted to be attached to a support so that the container member can be folded over and its ends attached to the support, whereby the outlet is disposed at the bottom of the container member. At least one other connector is located near one end of the container member to permit an additive to be added to the contents of the container.

Description

United States Patent 1,603,001 10/1926 Carter a corporation in trust of Delaware FLEXIBLE INTRAVENOUS CONTAINER 11 Claims, 4 Drawing Figs.

US. Cl, 150/8, 128/214, 128/272, 150/1, 222/105 Int. Cl A61m 5/14 Field ofSearch 150/1, 8;

128/(Bag Digest), 272, 214, 227, 232, (inquired); 229/53, 62; 222/105, 173

References Cited UNITED STATES PATENTS l28/227UX Primary Examiner-Donald F. Norton Attorney-Fidler, Bradley, Patnaude & Lazo ABSTRACT: A container for packaging and feeding intravenous fluids includes a flexible tubular container member having sealed ends and an outlet connector disposed midway between the ends of the container for interconnecting with an intravenous tube. The ends of the container member are adapted to be attached to a support so that the container member can be folded over and its ends attached to the support, whereby the outlet is disposed at the bottom of the container member. At least one other connector is located near one end of the container member to permit an additive to be added to the contents of the container.

. FLEXIBLE INTRAVENOUS CONTAINER BACKGROUND OF THE INVENTION The present invention relates to new and improved in? travenous containers, and-it more particularly relates to an intravenous system for adding medications or-other ingredients to the contents of a flexible-plastic intravenouscontainer'for packaging and feedingits contents to a patient.

When an intravenous fluid, such as a saline solution, is to be administered from an intravenous bottle to a patient, it frequently becomes necessarytoadd a medication, such as a vitamin supplement, to the intravenous solution. For example, in adding'a vitamin supplement to a saline solution in an intravenous bottle, a small quantity of saline solution is injected with a suitable instrument,'such as a hypodermic syringe, into a sterilized vial of the powdered vitamin supplement to dissolve it in the saline solution. The vitamin-saline solution can then be transferred from the vial to the intravenous bottle by means of the syringe. Therefore, it would be desirable to have a more simple and direct system for adding a medication to the contents of an intravenous container.

Therefore, it is the principle object of the present invention to provide a new and improved intravenous container.

Another object of the present invention is to provide a new and improved system for adding a medication to an intravenous fluid.

SUMMARY OF THE INVENTION Briefly, the above and further objects of the present invention may be realized in accordance with the present invention by providing a flexible intravenous container having a flexible tubular container member which has each of its ends aseptically sealed together to provide a sealed package for an intravenous fluid and which hasan outlet connector at a point midway between its ends to connect an intravenous tube in fluid communication with the container membenThe ends of the container member are adapted to be attached to a support stand so that the container member can be folded over at its midpoint and its ends can be readily. attached to the support stand whereby the outlet connector is disposed at the bottom of the container. At least one additive connector is provided near one of its ends so thata medication container can be interconnected with the container member. Where the medication to be added is in powdered form, such as 'a'vitamin supplement', andthe intravenous fluid is a saline solution, a vial containing the vitamin supplement'can be interconnected to theadditive'connector so that an attendant can squeeze the flexible container member to force a small quantity of the saline solution into the medication container to mix withthe powdered vitamin. Upon releasing the container member, the vitamin-saline solution is drawn from the vial into the container member as a result of the suction which is created by the container member.

The intravenous container of the present invention is not bulky to use, and thus it can be easily handled and mounted on a support stand. Moreover, the inventive container can be readily hung onthe stand'before the medication is added to the contents of thecontainer; Due to the-unique constructionv of the container, it can be completely emptied, and it does not DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION Referring now to the drawings, and more particularly to FIG. 1 thereof, there is shown a flexible intravenous container 10 which embodies the principles of the present invention and which-is mounted on a support stand 12. The container 10 includes a sealed, flexible bag 14 which containsan intravenous fluid and which is hung by its apertured ends 16 and 18 from a hook 20 on the stand :12. Inordertornount the container 10 on the stand l2,'fIrst the end l8-is slipped over the end of. the hook 20, and then the bag 14 is folded over and its other end 16 is slipped over the end ofthe hook'20. As shown in FIG. I, an outlet connector 22 at the bottom of the bag 14 is adapted to receive a tube connector24-of an intravenous tube 26 to connect it in fluid communication with the inside of the bag. In order to add a medication to the intravenous fluid in the bag 14, a vial (not shown) containing a medication can be interconnected to one of a pair of additive connector assemblies 28 and.31 which are located near therespective ends16 and 18 of the bag 14. The connector assembly 28 can accommodate a vial (not shown) which'has a male connector and which is commonly known as a Travenol package. The connector assembly 31 can be used with a vial (not shown) which has a female connector and is commonly known as a Squibb package.

In use, a medication vial is interconnected .with one of the connector assemblies, such as the connector assembly 28. If

the medication. in the vial. is .in powdered form, the bag 14 is compressed bythe attendant to force a small quantity of the intravenous fluid into the vial to dissolve the powdered medication contained therein. After shaking the vial to dissolve the powder, as a result of the suction produced when the bag 14 is released, the medication solution is transferred from the vial to the bag 14 to mix with the remaining fluid contained therein. If the medication is in liquid-form, the -bag.l4 is first squeezed, and then the vialis interconnected with .oneof the additive connectors of the bag 14 sov that'when the bag 14 is released, the medicationis drawn-into the bag.

Referring now to FIGS. 2and 3 of the drawings, the bag 14 is aseamless, extruded plastic tube which .iscomposed of a thin plastic film, such as a three-ply film composed of polyethylene at the-outer layers'and mylar at the middle layer. However, it is to be understood that the bag 14 couldalso be formed in different manners, such as by formingthe bag of two sheets of thin'plastic film which are heat sealed together alongtheir sidemarginal edges. One of theends 16 and 'l 8.of the tubular bag .l4is heatwelded together to fonn-a container, and the other end is -left.open to till the container withan .intravenous fluid. The bag l4is filled .to alevelwhichds slightly below the additive connector assemblies 28 and 31 when the intravenous container l0'is mounted on thestand 12.as show n in FIG. 1. Afterfilling, the open end may then be closed .by

require an air vent since the container is composed of'aflexiblematerial.Furthermore, the container of thepresent invention is easily and inexpensively manufactured by in line.

techniques so that it can bemadeas a disposable item. BRIEF DESCRIPTION OF THE DRAWINGS heat welding to complete the package. Each of the :ends ;16

and 18 has a centrally disposed hole 33 for receivingatheihook 20 on the-stand 12.

As shown'in FIGS. .2 and 3, the outlet connector22. is heat welded to the bag 14 midway betweentheends .16 and 48in line withtheholes 33 therein. The connector22 isstubulanin shape and is heat welded over a hole 35in.the bag:l4.,A,n axial hole 37in the connector 22.isaligned-with the hole 35,.andan annular Iflange 39 surrounding the :hole 37 is heat. welded to the outer surface of bag 14. A protective cap :41 isdisposed over andconforrns to the shape of the outer endof the connector .22 and'has an annular flange43 vwhichabuts-theflai' ge 39 andsurrounds the open. end of the-.capAI for removing it from the connector 22. The cap 41 includes :a centrally disposed depending portion 45 which extends into the hole 37 to seal the connector 22. An internal annular groove 47 receives a complementary-shaped annular bead or ridge 49 surrounding the end of the depending member 45 to lock the cap 41 on the connector 22. The depending member 45 abuts a membrane portion 52 which is integrally formed in the connector 22 and extends across and blocks the hole 37. The membrane 52 permits the cap 41 to be removed while the bag 14 is mounted on the support 12 since the membrane 52 provides a second aseptic seal which prevents the fluid from leaving the bag 14. When the cap 41 is removed from the connector 22, the complementary-shaped connector 24 of the intravenous tube 26 may be inserted into the connector 22. The tube connector 24 on the vial includes a cutting edge (not shown) to pierce the membrane 52. The ruptured membrane serves the purpose of sealing the tube connector 24 in the outlet connector 22. The tube connector 24 includes a complementary-shaped annular ridge (not shown) which slips into the internal annular groove 47 of the connector 22 to interlock it with the tube connector 24, whereby when the bag 14 is compressed, the tube connector 24 is not forced out of engagement with the connector 22.

The connector 22 is composed of a plastic material, such as linear polyethene. The protective cap 41 may be formed of vinyl or a vinyl compound such as ethylvinylacetate acid by E. I. duPont de Nemours & Co., under the name, E. V. A. The connector member 22 is injection molded directly into the cap 41 so that the cap 41 is aseptically seals the connector 22. A process for such an injection molding process is disclosed in detail in my copending US. application, Ser. No. 763,097, filed on Sept. 27, 1968, entitled Aseptic Connector and Closure Assembly.

The connector assembly 28 includes a connector 54, which is substantially identical to the connector 22, and a protective cap 56 which fits over the connector member 54 and is substantially identical to the protective cap 41. The connector member 54 has an axial hole 58 which is aligned with a hole 60 located near and in line with the hole 33 in the end 16 of the bag 14. The connector 54 is thus adapted to interconnect with a connector (not shown) of a medication vial in the same manner as the connector 22 interconnects with the tube connector 24.

The connector assembly 31 comprises a connector 62 which has a protective cap 64 disposed over and conforming to the surface of the outer end of the connector 62. The connector 62 is tubular in shape and has an axial hole 66 extending therethrough in alignment with a hole 68 which is located near and in alignment with the hole 33 in the end 18 of the bag 14. The connector 62 includes an annular flange 71 which is heat welded to the bag 14. The outer end 73 of the connector 62 is cut on a bias to provide a cutting edge to pierce a diaphragm or membrane (not shown) on a medication vial when the two containers are interconnected.

The cap 64 includes a centrally disposed depending portion 75 which extends into the open end 73 to seal the connector 62. The connector 62 further includes an annular flange 77 which is disposed adjacent the annular flange 62 to permit the cap 64 to be removed from the connector 62. On the inside of the connector 62 opposite the outer annular flange 77 is an annular ridge or bead 79 which fits into a complementaryshaped annular groove 81 in the outer edge of the connector 62 adjacent the annular flange 71 to lock the cap 64 on the connector 62 and to receive a complementary-shaped annular bead (not shown) on the connector of the medication vial. An enlarged portion 83 of the cap 64 adjacent the bead 79 receives an annular boss or collar 83 which provides a stop member for the connector of the medication bottle.

The connector assembly 31 may be formed of the same material and in the same manner as the outlet connector 22 and its cap 41 so that an aseptic and hermetic seal is formed between the cap 64 and the connector 62.

Referring now to FIG. 4, there is shown a cross-sectional view of another intravenous container 90 in accordance with the present invention. The container is similar to the container 10, but the container 90 is formed of a single sheet 92 of flexible plastic material which is folded over longitudinally and heat welded together at a seam 94 and which has the connector assemblies, such as a connector assembly 96, heat welded to its outer surface opposite to the seam 94. In order to permit the empty container 90 to occupy a minimum amount of space, a pair of V-shaped bellow-type gussets 98 in the form of pleats or folds extend along each side of the container 90. When the container 90 is filled, the gussets 98 unfold to increase the capacity of the container 90 accordingly.

While the present invention has been described in connection with particular embodiments thereof, it will be understood that those skilled in the art may make many changes and modifications without departing from the true spirit and scope of this invention, and accordingly all such changes and modifications which fall within the true spirit and scope of this invention are intended to be covered in the appended claims.

I claim:

1. A container for use in packaging and feeding intravenous fluids, comprising:

a substantially tubular, elongated bag formed of a thin walled, impervious plastic material and folded over at approximately its midpoint, said bag having a pair of overlapping ends; an outlet connector sealably attached to said bag at its midpoint opposite the overlapping ends of the folded bag;

means provided near the ends of said bag for hanging said bag on a support with said connector positioned on the lowest point on said bag; and

whereby a fluid contained in said bag may be fed under the force of gravity through said connector.

2. A container as set forth in claim 1 wherein:

said bag is hermetically sealed at both ends; and

said connector is located approximately half way between said ends.

3. A container as set forth in claim 1 further comprising an additive connector sealably attached to said bag near one end thereof.

4. A container as set forth in claim 1 wherein said outlet connector comprises an outlet connector member having an aperture extending therethrough and an imperforate cap to seal said connector member.

5. A container for use in packaging and feeding intravenous fluids, comprising:

a substantially tubular, elongated bag formed of a thinwalled, impervious plastic;

an outlet connector sealably attached to said bag intermediate the ends of said bag;

means provided near the ends of said bag for hanging said bag on a support with said connector positioned at the lowest point of said bag;

an additive connector sealably attached to said bag near one end thereof;

a second additive connector sealably attached to said bag near the other end thereof; and

whereby a fluid contained in said bag may be fed under the force of gravity through said connector.

6. A container as set forth in claim 5 wherein:

said first additive connector comprises an additive connector member having an aperture extending therethrough and an imperforate cap to sea] said additive connector member, and said additive connector member of said first additive connector is molded of plastic and includes a membrane extending across said aperture in said connector member and said imperforate cap of said first additive connector having a portion depending into the additive connector member aperture and abutting said membrane; and

said second additive connector comprises an additive connector member having an aperture extending therethrough and an imperforate cap to seal the last-mentioned additive connector member, the additive connector member of said second additive connector being molded of plastic and having a cutting edge, the last-mentioned connector member further including means defining an annular groove and the last-mentioned cap including an annular bead disposed in said groove and an outwardly extending flange on said cap opposite said bead.

7. A container for use in packaging and feeding intravenous fluids, comprising:

a substantially tubular, elongated bag formed of a thinwalled, impervious plastic;

an outlet connector sealably attached to said bag intermediate the ends of said bag; means provided near the ends of said bag for hanging said bag on a support with said connector positioned at the 1 9. A container as set forth in claim 8 wherein said sidewalls and said gussets are formed of a single sheet of plastic film sealed together along a scam in the other of said sidewalls.

10. A container for use in packaging and feeding intravenous fluids, comprising;

a substantially tubular, elongated bag formed of a thinwalled, impervious plastic;

an outlet connector sealably attached to said bag intermediate the ends of said bag; means provided near the ends of said bag for hanging said bag on a support with said connector positioned at the lowest point on said bag;

said outlet connector comprising an outlet connectoi' member having an aperture extending therethrough and an imperforate cap to seal said connector member, said outlet connector member being molded of plastic and in cluding a membrane extending across said aperture iri said connector member, said imperforate cap having a portion depending into the outlet connector aperture and abutting said membrane; and

whereby a fluid contained in said bag may be fed under the force of gravity through said connector.

11. A container according to claim 10, wherein said outlet connector member is molded directly into said cap to asepti cally seal said connector member with said cap, said outle t connector member further includes means defining an annular groove, said cap including an annular bead disposed in said groove and an outwardly extending flange on said cap.

Claims (11)

1. A container for use in packaging and feeding intravenous fluids, comprising: a substantially tubular, elongated bag formed of a thin walled, impervious plastic material and folded over at approximately its midpoint, said bag having a pair of overlapping ends; an outlet connector sealably attached to said bag at its midpoint opposite the overlapping ends of the folded bag; means provided near the ends of said bag for hanging said bag on a support with said connector positioned on the lowest point on said bag; and whereby a fluid contained in said bag may be fed under the force of gravity through said connector.
2. A container as set forth in claim 1 wherein: said bag is hermetically sealed at both ends; and said connector is located approximately half way between said ends.
3. A container as set forth in claim 1 further comprising an additive connector sealably attached to said bag near one end thereof.
4. A container as set forth in claim 1 wherein said outlet connector comprises an outlet connector member having an aperture extending therethrough and an imperforate cap to seal said conNector member.
5. A container for use in packaging and feeding intravenous fluids, comprising: a substantially tubular, elongated bag formed of a thin-walled, impervious plastic; an outlet connector sealably attached to said bag intermediate the ends of said bag; means provided near the ends of said bag for hanging said bag on a support with said connector positioned at the lowest point of said bag; an additive connector sealably attached to said bag near one end thereof; a second additive connector sealably attached to said bag near the other end thereof; and whereby a fluid contained in said bag may be fed under the force of gravity through said connector.
6. A container as set forth in claim 5 wherein: said first additive connector comprises an additive connector member having an aperture extending therethrough and an imperforate cap to seal said additive connector member, and said additive connector member of said first additive connector is molded of plastic and includes a membrane extending across said aperture in said connector member and said imperforate cap of said first additive connector having a portion depending into the additive connector member aperture and abutting said membrane; and said second additive connector comprises an additive connector member having an aperture extending therethrough and an imperforate cap to seal the last-mentioned additive connector member, the additive connector member of said second additive connector being molded of plastic and having a cutting edge, the last-mentioned connector member further including means defining an annular groove and the last-mentioned cap including an annular bead disposed in said groove and an outwardly extending flange on said cap opposite said bead.
7. A container for use in packaging and feeding intravenous fluids, comprising: a substantially tubular, elongated bag formed of a thin-walled, impervious plastic; an outlet connector sealably attached to said bag intermediate the ends of said bag; means provided near the ends of said bag for hanging said bag on a support with said connector positioned at the lowest point of said bag; a first generally rectangular sidewall; a second generally rectangular sidewall; first and second inwardly folded gussets respectively connected between said first and second sidewalls; said outlet connector being attached to one of said sidewalls; and whereby a fluid contained in said bag may be fed under the force of gravity through said connector.
8. A container as set forth in claim 7 further comprising an additive connector attached to said one of said sidewalls near one end of said bag.
9. A container as set forth in claim 8 wherein said sidewalls and said gussets are formed of a single sheet of plastic film sealed together along a seam in the other of said sidewalls.
10. A container for use in packaging and feeding intravenous fluids, comprising; a substantially tubular, elongated bag formed of a thin-walled, impervious plastic; an outlet connector sealably attached to said bag intermediate the ends of said bag; means provided near the ends of said bag for hanging said bag on a support with said connector positioned at the lowest point on said bag; said outlet connector comprising an outlet connector member having an aperture extending therethrough and an imperforate cap to seal said connector member, said outlet connector member being molded of plastic and including a membrane extending across said aperture in said connector member, said imperforate cap having a portion depending into the outlet connector aperture and abutting said membrane; and whereby a fluid contained in said bag may be fed under the force of gravity through said connector.
11. A container according to claim 10, wherein said outlet connector member is molded directly into said cap to aseptically seal said connector member with said cap, said outlet connector member further iNcludes means defining an annular groove, said cap including an annular bead disposed in said groove and an outwardly extending flange on said cap.
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