Flexible multi-compartment container with peelable seals and method for making same

• US 6,846,305 B2
• Filed: 03/29/2002
• Issued: 01/25/2005
• Est. Priority Date: 05/13/1996
• Status: Expired due to Fees

• Current Assignee: B Braun Medical Incorporated (B. Braun Holding GmbH & Co. KG)
• Original Assignee: B Braun Medical Incorporated (B. Braun Holding GmbH & Co. KG)
• Inventors: Smith, Steven L., Sacca, Giuseppe, Pool, Scott L., York, Walter A., Walter, William V., Gharbian, Noel, Young, H. Theodore, Wu, Nicholas Chung-Hui, Mclonis, Mark R., Harvey, Douglas G., Barney, Ward, Sakaguchi, Thomas R., Peara, Christopher D., Sandberg, Sharilyn J.
• Primary Examiner(s): Bianco, Patricia
• Application Number:
  US10/112,325
• Publication Number:
  US 20030047467A1
• Time in Patent Office: 1,033 Days
• Field of Search: 604/4.01, 604/6.15, 604/403, 604407-410, 604/415, 604/416, 604/257, 604/262, 128/DIG.24, 206/219, 206/221, 206/438, 2065141-5149, 206525- 26, 206/828, 206/62.11, 206 6221- 6222, 156/308.2, 156/308.4, 156325-328, 383/210, 383/211, 383/113, 383 38- 40, 383/42, 383 78- 80, 383/88, 383/93, 383/94, 383/105, 383/109, 383/41, 383/112, 383/116, 383/118, 383/121, 383123-125, 600/573, 600/575, 600/580, 220/23.91, 220500-502, 220/505, 220/523, 220/526, 220/527, 220/530, 222/92, 222/94, 222/129, 222/145.1, 222/206, 222/210, 222/211, 222/215, 428/412, 428/426
• US Class Current: 604/410
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1475 Inlet or outlet ports
• CPC Class Codes: A61J 1/2024 having peelable seals
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: B29C 49/0005 characterised by the material
• CPC Class Codes: B29C 49/0691 using sheet like material, e.g. sheet blow-moulding from joined sheets
• CPC Class Codes: B29C 65/00 Joining or sealing of preformed parts , e.g. welding of plastics materials; Apparatus therefor general aspects of processes or apparatus for joining preformed parts B29C66/00; using porous material formed by internal pressure generated therein for joining preformed parts B29C44/1228, B29C44/326
• CPC Class Codes: B29C 65/02 by heating, with or without pressure
• CPC Class Codes: B29C 65/08 using ultrasonic vibrations non-plastics element to plastics elements B29C65/645
• CPC Class Codes: B29C 65/18 using heated tools
• CPC Class Codes: B29C 66/112 Single lapped joints
• CPC Class Codes: B29C 66/1122 Single lap to lap joints, i.e. overlap joints B29C66/45, B29C66/472, B29C66/52272 take precedence
• CPC Class Codes: B29C 66/131 Single flanged joints, i.e. one of the parts to be joined being rigid and flanged in the joint area
• CPC Class Codes: B29C 66/133 Fin-type joints, the parts to be joined being flexible the parts to be joined being rigid B29C66/1312
• CPC Class Codes: B29C 66/242 said joint lines being closed, i.e. forming closed contours
• CPC Class Codes: B29C 66/53262 Enclosing spouts between the walls of bags, e.g. of medical bags
• CPC Class Codes: B29C 66/71 characterised by the composition of the plastics material of the parts to be joined welding bar compositions B29C65/125
• CPC Class Codes: B29C 66/72321 consisting of metals or their alloys
• CPC Class Codes: B29C 66/72341 for gases
• CPC Class Codes: B29K 2009/06 : SB polymers, i.e. butadiene-styrene polymers
• CPC Class Codes: B29K 2021/003 : Thermoplastic elastomers
• CPC Class Codes: B29K 2023/16 : EPM, i.e. ethylene-propylene copolymers; EPDM, i.e. ethylene-propylene-diene copolymers; EPT, i.e. ethylene-propylene terpolymers
• CPC Class Codes: B29K 2025/08 : Copolymers of styrene, e.g. AS or SAN, i.e. acrylonitrile styrene B29K2055/02 takes precedence
• CPC Class Codes: B29K 2705/02 : Aluminium
• CPC Class Codes: B29L 2009/00 : Layered products
• CPC Class Codes: B29L 2031/7148 : Blood bags, medical bags
• CPC Class Codes: B31B 2160/10 : rectangular and flat, i.e. without structural provision for thickness of contents
• CPC Class Codes: B32B 2307/41 : Opaque
• CPC Class Codes: B32B 2439/80 : Medical packaging
• CPC Class Codes: B32B 27/08 : of synthetic resin
• CPC Class Codes: B32B 27/32 : comprising polyolefins comprising vinyl (co)polymers or acrylic (co)polymers B32B27/30
• CPC Class Codes: B65D 75/5861 : Spouts B65D75/5811, B65D75/5822 take precedence
• CPC Class Codes: B65D 81/3266 : separated by a common rupturable seal, a clip or other removable fastening device
• CPC Class Codes: C08L 23/0815 : Copolymers of ethene with aliphatic 1-olefins
• CPC Class Codes: C08L 23/16 : Elastomeric ethene-propene or ethene-propene-diene copolymers, e.g. EPR and EPDM rubbers
• CPC Class Codes: C08L 2666/02 : Organic macromolecular compounds, natural resins, waxes or and bituminous materials
• CPC Class Codes: C08L 2666/04 : Macromolecular compounds according to groups C08L7/00 - C08L49/00, or C08L55/00 - C08L57/00; Derivatives thereof
• CPC Class Codes: C08L 2666/06 : Homopolymers or copolymers of unsaturated hydrocarbons; Derivatives thereof
• CPC Class Codes: C08L 2666/24 : Graft or block copolymers according to groups C08L51/00, C08L53/00 or C08L55/02; Derivatives thereof
• CPC Class Codes: C08L 53/00 : Compositions of block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 53/02 : of vinyl-aromatic monomers and conjugated dienes
• CPC Class Codes: C08L 53/025 : modified

Abstract

A flexible container is provided for the storage and administration of medical solutions. The container incorporates a transparent front sheet made from a planar layer of a polymer and an opposing rear sheet. The rear sheet is made from a planar laminate layer. The front and rear sheets are sealed together along a common peripheral edge to form a volume enclosure. The volume enclosure is constructed of materials having high oxygen and moisture barrier properties which allows the container thermoplastic to be stored for extended periods of time without degrading the contents. The volume enclosure is then inflated with a pressurized gas to permanently stretch the front and rear sheets outwardly and to thereby increase the volume capacity of the container. An alternative embodiment of the container incorporates multiple compartments, separated by peelable seals, for containing a diluent and a medicament. The seals are ruptured by manipulation of the container to thereby mix the contents together for delivery through standard IV arrangement to a patient.

Claims

1. A flexible container comprising:

a flexible front sheet;

a flexible rear sheet sealed to the front sheet along a common peripheral edge;

a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a first compartment;

a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby a second compartment and a third compartment, said second compartment is intermediate the first and third compartments, wherein the peelable seals are rupturable by hydraulic pressure against the seal caused by manipulation of the container;

an opaque high-barrier protective film separably sealed to the front sheet, the covering sized to extend over one of the compartments, whereby the opaque high-barrier protective film contacts only a portion of the surface of the associated compartment, the strength of attachment of the high-barrier protective film being directly proportional to the area of surface contact;

a locking tab integrally formed and extending from an edge of the container; and

a mating receptacle integrally formed with an extending from the same edge of the container as said locking tab, wherein the container is folded-over adjacent the first peelable seal thereby moving the locking tab into position for engagement with the mating receptacle for securing the container in a folded-over condition.

2. A flexible container as defined in claim 1, wherein the front sheet comprises a polypropylene-polyethylene co-polymer blended with styrene ethylene-butylene styrene elastomer in about an 80%/20% wt/wt ratio.

3. A flexible container as defined in claim 2, wherein the rear sheet comprises a multi-layer laminate including:

an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene ethylene-butylene styrene elastomer in about an 80%/20% wt/wt ratio interfacing with the front sheet;

an intermediate layer of aluminum foil; and

an outer thermoplastic layer having a higher melting point than said inner layer.

4. A flexible container as defined in claim 3, wherein the opaque, high-barrier protective covering comprises:

an opaque, peelable, multi-layer laminate including;

a modified ethylenevinylacetate polymer layer comprising an inwardly facing surface of said laminate;

a polyester polymer layer, having a higher melting temperature than said modified ethylenevinylacetate polymer layer comprising an outwardly facing surface of said laminate; and

an aluminum foil layer intermediate the modified ethylenevinylacetate and polyester layers.

5. A flexible container as defined in claim 1, wherein the opaque, high-barrier protective film is peelably affixed over the associated compartment by a patterned heat seal head, the patterned heat seal head defining a regular array of raised, generally circular, non-contact areas.

6. A flexible container for combined storage and administration, the container comprising:

a flexible front sheet;

a flexible rear sheet sealed to the front sheet at a common peripheral edge;

a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a first compartment; and

a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby a second compartment and a third compartment, the second compartment being intermediate the first compartment and the third compartment, wherein the peelable seals are constructed to provide a uniform resistance characteristic to hydraulic pressure against the seal caused by manipulation of the container, the uniform resistance characteristic causing the seal to peel at an applied pressure in the range of from about 3 to about 5 lbs per square inch.

7. A flexible container as defined in claim 6, wherein the front sheet comprises a single layer film constructed of a polypropylene-polyethylene co-polymer blended with styrene-ethylene butylene styrene elastomer.

8. A flexible container as defined in claim 7, wherein the polypropylene-polyethylene co-polymer is blended with styrene ethylene-butylene styrene elastomer in about an 80%/20% wt/wt ratio.

9. A flexible container as defined in claim 6, wherein the rear sheet comprises a multi-layer laminate including:

an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene ethylene-butylene styrene elastomer in about an 80%/20% wt/wt ratio interfacing with the front sheet;

an intermediate layer of aluminum foil; and

an outer thermo-plastic layer having a higher melting point than said inner layer.

10. A flexible container as defined in claim 6, wherein the first and second peelable seals comprise:

a first longitudinal portion extending between two parallel sides of the common peripheral edge;

a second longitudinal portion extending between two parallel sides of the common peripheral edge; and

a transverse portion adjacent one of the two parallel sides of the common peripheral edge, the transverse portion joining the first and second longitudinal portions at one end thereof, to form thereby a U shape.

11. A flexible container as defined in claim 10, wherein the transverse portion is formed with its entire length partially overlapping the second compartment.

12. A flexible container as defined in claim 6, wherein the first and second peelable seals each comprise a generally rectangular longitudinal seal portion extending between the two sides of the common peripheral edge.

13. A flexible container as defined in claim 6, wherein the container is folded-over adjacent the first peelable seal such that the folded-over container'"'"'s outwardly facing surface comprises the multi-layer laminate rear sheet, the flexible container further comprising means for securing the container in a folded-over condition.

14. A flexible container as defined in claim 13, wherein the means for securing the container in a folded-over condition comprises:

a locking tab integrally formed with and extending from a side of the container; and

a slot integrally formed with and extending from the same side of the container as the tab, wherein the tab and slot are moved into position for mutual engagement when the container is folded-over adjacent the first peelable seal to thereby secure the container in a folded-over condition.

15. A flexible container for combined storage and administration, the container comprising:

a flexible rear sheet;

a flexible front sheet sealed to the rear sheet along a common peripheral edge;

a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a first compartment;

a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby a second compartment and a third compartment, said second compartment is intermediate the first compartment and the third compartment; and

a third peelable seal extending between the two sides of the common peripheral edge and separably joining, the front and rear sheets to form thereby a sacrificial moisture vapor barrier compartment which is intermediate the first compartment and the second compartment.

16. A flexible container as defined in claim 15, wherein the container is folded-over adjacent the first peelable seal, the flexible container further comprising means for securing the container in a folded-over condition.

17. A flexible container as defined in claim 16, wherein the means for securing the container in a folded-over condition comprises:

a locking tab integrally formed with and extending from a side of the container; and

a slot integrally formed with and extending from the same side of the container as the tab, wherein the tab and slot are moved into position for mutual engagement when the container is folded-over adjacent the first peelable seal to thereby secure the container in a folded-over condition.

18. A flexible container as defined in claim 15, wherein the peelable seals are constructed to provide a uniform resistance characteristic to hydraulic pressure against the seal caused by manipulation of the container, the uniform resistance characteristic causing the seal to peel at an applied pressure in the range of three to five pounds per square inch.

19. A flexible container as defined in claim 18, wherein the first and second peelable seals comprise:

a first longitudinal portion extending between two parallel sides of the common peripheral edge;

a second longitudinal portion extending between two parallel sides of the common peripheral edge; and

a transverse portion adjacent one of the two parallel sides of the common peripheral edge, the transverse portion joining the first and second longitudinal portions at one end thereof, to form thereby a U shape.

20. A flexible container as defined in claim 18, wherein the transverse portion is formed with its entire length partially overlapping the second compartment.

21. A flexible container as defined in claim 18, wherein the first and second peelable seals each comprise a generally rectangular longitudinal seal portion extending between the two sides of the common peripheral edge.

22. A flexible container for separately storing and mixing multiple products, the container comprising:

a multi-layer laminate rear sheet including an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene ethylene-butylene styrene elastomer, an opaque high-barrier intermediate layer, and an outer high temperature resistant mold release layer;

a flexible front sheet constructed of a single layer film of a polypropylene-polyethylene co-polymer blended with styrene ethylene-butylene styrene elastomer in an about 80%/20% wt/wt ratio interfacing with the rear sheet, the front sheet sealed to the rear sheet along a common peripheral edge;

at least two peelable seals extending between two parallel sides of the common peripheral edge and separably joining the front and rear sheets to define at least three compartments in the container including a first compartment containing a first product and a second compartment containing a second product; and

an opaque high-barrier protective film separately sealed to a clear high-barrier laminate film, the opaque film sized to extend over the high-barrier laminate film and the high-barrier laminate film sized to extend over the second compartment.

23. A flexible container as defined in claim 22, wherein the container is folded-over adjacent the first peelable seal such that the folded-over container'"'"'s outwardly facing surface comprises the multi-layer laminate rear sheet, the flexible container further comprising means for securing the container in a folded-over condition.

24. A flexible container as defined in claim 23, wherein the means for securing the container in a folded-over condition comprises:

a locking tab integrally formed with and extending from a side of the container; and

a slot integrally formed with and extending from the same side of the container as the tab, wherein the tab and slot are moved into position for mutual engagement when the container is folded-over adjacent the first peelable seal to thereby secure the container in a folded-over condition.

25. A flexible container as defined in claim 22, wherein the second product is a powdered antibiotic.

26. A flexible container as defined in claim 22, wherein the peelable seals are constructed to provide a uniform resistance characteristic to hydraulic pressure against the seal caused by manipulation of the container, the uniform resistance characteristic causing the seal to peel at an applied pressure in the range of three to five pounds per square inch.

27. A flexible container for combined storage and administration of multiple products, the flexible container comprising:

a final configuration comprising;

a flexible rear sheet;

a flexible front sheet sealed to the rear sheet along at least a portion of a common peripheral edge;

a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a first compartment containing a first product, the first peelable seal being peelable to separate the joined front and rear sheets at the first peelable seal;

a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a second compartment containing a second product;

the second compartment being intermediate the outlet compartment and the first compartment and the second peelable seal being peelable to separate the joined front and rear sheets at the second peelable seal;

an opaque high-barrier protective film peelably affixed to the front sheet and sized to extend over at least a portion of the second compartment; and

a first configuration comprising;

a first sacrificial port attached to the flexible front sheet and flexible rear sheet and in fluid communication along a first fluid path with the first compartment for filling the first compartment with the first product; and

a second sacrificial port attached to the flexible front sheet and flexible rear sheet and in fluid communication along a second fluid path with the second compartment for filling the second compartment with the second product; and

wherein at least a portion of the first sacrificial port and at least a portion of the second sacrificial port are separated from the flexible front sheet and flexible rear sheet and the first fluid path and the second fluid path are sealed to produce the final configuration.

28. The flexible container as defined in claim 27, wherein the front sheet comprises a polypropylene-polyethylene co-polymer blended with styrene ethylene-butylene styrene elastomer.

29. The flexible container as defined in claim 28, wherein the polypropylene-polyethylene co-polymer is blended with styrene ethylene-butylene styrene elastomer in an about 80%/20% wt/wt ratio.

30. The flexible container as defined in claim 27, wherein the rear sheet comprises a multi-layer laminate including:

an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene ethylene-butylene styrene elastomer in about an 80%/20% wt/wt ratio interfacing with the front sheet;

an intermediate layer of aluminum foil; and

an outer thermoplastic layer having a higher melting point than said inner layer.

31. The flexible container as defined in claim 27, wherein the opaque, high-barrier protective covering comprises:

an opaque, peelable, multi-layer laminate including;

a modified ethylenevinylacetate polymer layer comprising the inwardly facing surface of said laminate;

a polyester polymer layer, having a higher melting temperature than said modified ethylenevinylacetate polymer layer comprising the outwardly facing surface of said laminate; and

an aluminum foil layer intermediate the modified ethylenevinylacetate and polyester layers.

32. The flexible container as defined in claim 27, further comprising a clear high-barrier laminate film peelably affixed to the front sheet and sized to extend over a substantial portion of the second compartment and wherein the opaque high-barrier protective film is peelably affixed to the clear high-barrier laminate film.