Flexible multiple compartment medical container with preferentially rupturable seals

• US 5,928,213 A
• Filed: 11/12/1997
• Issued: 07/27/1999
• Est. Priority Date: 05/13/1996
• Status: Expired due to Term

• 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., Barney, Ward W.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): Cho, David J.
• Application Number:
  US08/967,687
• Time in Patent Office: 622 Days
• Field of Search: 604/82, 604/85, 604/87, 604/89-91, 604/408-410, 604/416, 604/56, 206/219, 206/221, 206/568, 206/438, 383/38, 383/39, 383/41, 383/111, 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: A61J 2200/76 for fluid level
• 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 66/1122 Single lap to lap joints, i.e. overlap joints B29C66/45, B29C66/472, B29C66/52272 take precedence
• 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 66/53262 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: B29C 66/72343 for liquids
• CPC Class Codes: B29C 66/73793 soluble, e.g. water-soluble
• CPC Class Codes: B29C 66/8322 Joining or pressing tools reciprocating along one axis
• CPC Class Codes: B29K 2009/06 : SB polymers, i.e. butadiene-styrene polymers
• CPC Class Codes: B29K 2023/0625 : LLDPE, i.e. linear low density polyethylene
• CPC Class Codes: B29K 2023/0633 : LDPE, i.e. low density polyethylene
• CPC Class Codes: B29K 2023/0641 : MDPE, i.e. medium density polyethylene
• CPC Class Codes: B29K 2023/065 : HDPE, i.e. high density polyethylene
• CPC Class Codes: B29K 2023/08 : Copolymers of ethylene B29K2023/16 takes precedence
• CPC Class Codes: B29K 2023/083 : EVA, i.e. ethylene vinyl acetate copolymer
• CPC Class Codes: B29K 2023/086 : EVOH, i.e. ethylene vinyl alcohol copolymer
• CPC Class Codes: B29K 2023/14 : Copolymers of polypropylene B29K2023/16 takes precedence
• CPC Class Codes: B29K 2067/003 : PET, i.e. poylethylene terephthalate
• 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 2160/20 : with structural provision for thickness of contents
• CPC Class Codes: B32B 27/08 : of synthetic resin
• 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 mixing together of diluents and medicaments. The container incorporates multiple compartments, separated by preferentially peelable seals, in which the diluents and medicaments are stored. The container is constructed of thermoplastic materials having high oxygen and moisture barrier properties which allows the container to be stored for extended periods of time without degrading the contents. The peelable seals are ruptured by manipulation of the container to thereby mix the contents together for delivery through standard IV arrangement to a patient. The seals are constructed such that the seal between the diluent and medicament compartments is preferentially ruptured such that a liquid medicament and a diluent are always mixed before the combined solution is accessible for administration. The container is fillable with a single component liquid medicament which may be susceptible to sloshing or turbulence. Turbulence is minimized by eliminating the internal gaseous head space by initially forming the head space with a low molecular weight gas such as helium. The helium is allowed to diffuse into the atmosphere and the head space collapses as a result.

Claims

1. A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising:

a flexible rear sheet;

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

a first preferentially peelable seal separably joining the front and rear sheets to delineate and define a compartment containing a diluent;

a second preferentially peelable seal separably joining the front and rear sheets to delineate and define a compartment containing a medicament; and

wherein the first and second preferentially peelable seals are rupturable in response to hydraulic pressure developed by manipulating the container, each seal configured with a respective different rupture characteristic, such that the first preferentially peelable seal ruptures before the second preferentially peelable seal regardless of whether the hydraulic pressure is developed in the diluent compartment or the medicament compartment.

2. A flexible container as defined in claim 1, wherein the first and second preferentially peelable seals are substantially rectangular in shape and extend between two sides of the common peripheral edge of the container.

3. A flexible container as defined in claim 1, wherein the first and second preferentially peelable seals are each characterized by a seal width, and wherein the seal width of the first preferentially peelable seal is less than that of the second preferentially peelable seal.

4. A flexible container as defined in claim 3, wherein the second preferentially peelable seal extends between two sides of the common peripheral edge to form thereby an outlet compartment such that the medicament compartment is intermediate the outlet compartment and the diluent compartment.

5. A flexible container as defined in claim 4, wherein the medicament is a liquid.

6. A flexible container as defined in claim 1, wherein the first preferentially peelable seal spans the two sides of the common peripheral edge and is formed as a compound curve, and wherein the second preferentially peelable seal spans the two sides of the common peripheral edge and is substantially rectangular in shape.

7. A flexible container as defined in claim 6, wherein the first and second preferentially peelable seals are each characterized by a width dimension, and wherein the width dimension of the first preferentially peelable seal is substantially smaller than the width dimension of the second preferentially peelable seal.

8. A flexible container as defined in claim 7, wherein the compound curvature of the first preferentially peelable seal defines at least one stress riser characterized by an inflection point having a convex contour oriented in the direction of the diluent compartment.

9. A flexible container as defined in claim 8, wherein the compound curvature of the first preferentially peelable seal further comprises at least a second stress riser characterized by an inflection point having a convex contour oriented in the direction of the medicament compartment.

10. A flexible container as defined in claim 9, wherein the first peelable seal preferentially initiates rupture at an inflection point of a stress riser oriented in the direction of the compartment from which hydraulic pressure is developed.

11. A flexible container as defined in claim 10, wherein the compound curves of the first preferentially peelable seal have a radius of curvature of from about 1/8 inch to about 1/2 inch.

12. A flexible container as defined in claim 11, wherein the radius of curvature is about 1/4 inch.

13. A flexible container as defined in claim 12, wherein the first preferentially peelable seal has a width dimension of from about 1/16 inches to about 3/16 inches.

14. A flexible container as defined in claim 13, wherein the first preferentially peelable seal has a width of about 1/8 inches or 3 millimeters.

15. A flexible container as defined in claim 14, wherein the second preferentially peelable seal has a width of from about 3/16 inches to about 5/16 inches.

16. A flexible container as defined in claim 5 or claim 15, wherein the peelable seals are constructed to provide a uniform burst characteristic to hydraulic pressure against the seal caused by manipulation of the container, the uniform burst characteristic causing the seal to peel-open at a predetermined applied pressure uniform to within ±

2 psi.

17. A flexible container as defined in claim 5, wherein the first preferentially peelable seal has a width dimension of from about 3 millimeters to about 7 millimeters, and wherein the second preferentially peelable seal has a width dimension of from about 7 millimeters to about 12 millimeters.

18. A flexible container as defined in claim 17, wherein the first preferentially peelable seal has a width dimension of about 6 millimeters, and wherein the second preferentially peelable seal has a width dimension of about 10 millimeters.

19. A flexible container for separately storing and mixing liquid diluent and medicament, the container comprising:

a multi-layer laminate rear sheet including an inner layer of a polypropylene-polyethylene copolymer 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 copolymer blended with styrene ethylene-butylene styrene elastomer interfacing with the rear sheet, the front sheet sealed to the rear sheet along a common peripheral edge;

at least two preferentially peelable seals commonly extending from at least one side of the common peripheral edge and separably joining the front and rear sheets to define at least a first compartment containing a liquid medicament; and

a third peelable seal extending between the at least two preferentially peelable seals and joining together their ends opposite the ends extending from the container peripheral edge, the third peelable seal formed parallel to and spaced-away from a second container peripheral edge, the two preferentially peelable seals and the third peelable seal configured to define a compartment containing a liquid diluent, an outlet area and a channel configured to provide fluid communication therebetween.

21. A flexible container as defined in claim 19, wherein the at least two preferentially peelable seals comprise a first preferentially peelable seal disposed between the medicament compartment and the diluent compartment, and a second preferentially peelable seal disposed between the medicament compartment and the outlet area.

20. A flexible container for separately storing and mixing liquid diluent and medicament, the container comprising:

a multi-layer laminate rear sheet including an inner layer of a polypropylene-polyethylene copolymer 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 copolymer blended with styrene ethylene-butylene styrene elastomer interfacing with the rear sheet, the front sheet sealed to the rear sheet along a common peripheral edge; and

first and second preferentially peelable seals extending between two parallel sides of the common peripheral edge and separably joining the front and rear sheets to define at least a first compartment containing a liquid medicament, the first and second preferentially peelable seals being rupturable in response to hydraulic pressure developed by manipulating the container, each seal configured with a respective different rupture characteristic such that the first preferentially peelable seal ruptures before the second preferentially peelable seal regardless of whether or not the hydraulic pressure is developed in the medicament compartment.

22. A flexible container as defined in claim 20 or 21, wherein the first preferentially peelable seal is formed as a compound curve, and wherein the second preferentially peelable seal is substantially rectangular.

23. A flexible container as defined in claim 22, wherein the first and second preferentially peelable seals are each characterized by a width dimension, and wherein the width dimension of the first preferentially peelable seal is substantially smaller than the width dimension of the second preferentially peelable seal.

24. A flexible container as defined in claim 23, wherein the compound curvature of the first preferentially peelable seal defines at least one stress riser characterized by an inflection point having a convex contour oriented in the direction of the diluent compartment.

25. A flexible container as defined in claim 24, wherein the compound curvature of the first preferentially peelable seal further comprises at least a second stress riser characterized by an inflection point having a convex contour oriented in the direction of the medicament compartment.

26. A flexible container as defined in claim 25, wherein the first preferentially peelable seal preferentially initiates rupture at an inflection point of a stress riser oriented in the direction of the compartment from which hydraulic pressure is developed.

27. A flexible container as defined in claim 26, wherein the compound curves of the first preferentially peelable seal have a radius of curvature of from about 1/8 inch to about 1/2 inch.

28. A flexible container as defined in claim 27, wherein the first preferentially peelable seal has a width dimension of from about 1/16 inches to about 3/16 inches.

29. A flexible container as defined in claim 28, wherein the second preferentially peelable seal has a width of from about 3/16 inches to about 5/16 inches.

30. A flexible container as defined in claim 29, further comprising a fourth peelable seal disposed in the outlet area and extending between two parallel sides of the container'"'"'s common peripheral edge, the fourth seal separably joining the front and rear sheets to define an outlet compartment separate from the outlet area.

31. A flexible container as defined in claim 29, wherein the fluid communication channel formed between the diluent compartment and outlet area transfers hydraulic pressure developed in the diluent compartment to the outlet area such that hydraulic pressure on the first preferentially peelable seal and the second preferentially peelable seal is substantially equalized.

32. A flexible container as defined in claim 31, wherein the peelable seals are constructed to provide a uniform burst characteristic to hydraulic pressure against the seal caused by manipulation of the container, the uniform burst characteristic causing the seal to peel-open at a predetermined applied pressure uniform to within ±

2 psi.

33. A flexible container for combined storage and administration of liquid medicaments comprising:

a flexible rear sheet;

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

a peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to define an outlet compartment and a compartment containing a liquid medicament, wherein the medicament compartment is substantially completely filled with liquid medicament such that there is no gaseous head space in the compartment; and

means, integral to the container, for establishing a meniscus above the liquid medicament when the container is accessed for VI administration.

34. A flexible container as defined in claim 33, wherein the peelable seal is 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-open at a predetermined applied pressure uniform to within ±

2 psi.

35. A flexible container as defined in claim 34, wherein the outlet compartment contains a volume of air, said volume of air forming a meniscus above the liquid medicament upon rupture of the peelable seal caused by manipulation of the container.

36. A flexible container as defined in claim 35, wherein the flexible front sheet is constructed of a single layer film of a polypropylene-polyethylene copolymer blended with styrene ethylene-butylene styrene elastomer.

37. A flexible container as defined in claim 36, wherein the flexible rear sheet is constructed of a single layer film of a polypropylene-polyethylene copolymer blended with styrene ethylene-butylene styrene elastomer.

38. A flexible container as defined in claim 36, wherein the flexible rear sheet is constructed of a multi-layer laminate including an inner layer of a polypropylene-polyethylene copolymer blended with styrene ethylene-butylene styrene elastomer, said inner layer interfacing with the flexible front sheet.

39. A flexible container as defined in claim 38, the multi-layer laminate rear sheet further including an opaque high-barrier intermediate layer and an outer high temperature resistant mold release layer.

40. A flexible container as defined in claim 39, wherein the polypropylene-polyethylene copolymer of the front and rear sheets is blended with styrene ethylene-butylene styrene elastomer in an about 80%/20% wt/wt ratio.