Flexible medical container with selectively enlargeable compartments and method for making same

• US 6,468,377 B1
• Filed: 02/10/1999
• Issued: 10/22/2002
• 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., Sperko, William A., Turner, Robert E., Ray, William B.
• Primary Examiner(s): Crispino, Richard
• Assistant Examiner(s): Purvis, Sue A.
• Application Number:
  US09/247,997
• Time in Patent Office: 1,350 Days
• Field of Search: 156/147, 156/145, 156/229, 156/146, 428/35.4, 428/34.1
• US Class Current: 156/229
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1475 Inlet or outlet ports
• CPC Class Codes: A61J 1/16 Holders for containers
• 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 2793/0027 Cutting off
• CPC Class Codes: B29C 2793/009 after shaping
• 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 65/18 using heated tools
• CPC Class Codes: B29C 65/76 Making non-permanent or releasable joints
• 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 66/7234 : comprising a barrier layer
• CPC Class Codes: B29C 66/72341 : for gases
• CPC Class Codes: B29C 66/72343 : for liquids
• CPC Class Codes: B29C 66/80 : General aspects of machine operations or constructions and parts thereof
• 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 2023/06 : PE, i.e. 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 2023/10 : Polymers of propylene
• CPC Class Codes: B29K 2023/12 : PP, i.e. polypropylene
• 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 2027/08 : PVDC, i.e. polyvinylidene chloride
• CPC Class Codes: B29K 2027/12 : containing fluorine
• CPC Class Codes: B29K 2067/00 : Use of polyesters or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2067/003 : PET, i.e. poylethylene terephthalate
• CPC Class Codes: B29K 2101/12 : Thermoplastic materials
• CPC Class Codes: B29K 2105/0085 : Copolymers
• CPC Class Codes: B29K 2105/0088 : Blends of polymers
• CPC Class Codes: B29K 2305/02 : Aluminium
• CPC Class Codes: B29K 2705/02 : Aluminium
• CPC Class Codes: B29L 2009/00 : Layered products
• CPC Class Codes: B29L 2009/003 : comprising a metal layer
• CPC Class Codes: B29L 2031/7148 : Blood bags, medical bags
• CPC Class Codes: B31B 2155/00 : Flexible containers made from webs
• CPC Class Codes: B31B 2155/002 : by joining superimposed webs, e.g. with separate bottom webs
• CPC Class Codes: B31B 2170/20 : having multi-layered walls, e.g. laminated or lined
• CPC Class Codes: B31B 2241/00 : Making bags or boxes intended for a specific use
• CPC Class Codes: B31B 70/844 : Applying rigid valves, spouts, or filling tubes
• CPC Class Codes: B32B 15/08 : of synthetic resin
• 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: B65B 55/16 : by irradiation
• 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 23/142 : at least partially crystalline copolymers of propene with other 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
• CPC Class Codes: Y10T 428/13 : Hollow or container type article [e.g., tube, vase, etc.]
• CPC Class Codes: Y10T 428/1341 : Contains vapor or gas barrier, polymer derived from vinyl chloride or vinylidene chloride, or polymer containing a vinyl alcohol unit

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 method for increasing the capacity of a flexible container for storage and administration, the method comprising the steps of:

providing a pair of flexible planar sheets;

joining the flexible planar sheets together to thereby provide a flexible container having a flexible planar front sheet opposing a flexible planar rear sheet along a common plane, the front sheet being sealably attached to the flexible rear sheet along a common peripheral edge to form a volume enclosure;

expanding the volume enclosure by introducing a pressurized fluid into the volume enclosure to permanently stretch at least one of the front or rear sheets to thereby increase the capacity of the volume enclosure; and

wherein the step of expanding comprises the steps of;

maintaining the rear sheet and the common peripheral edge substantially against the common plane; and

inflating the volume enclosure with a pressurized gas to permanently stretch a portion of the front sheet outwardly from the common plane.

2. The method as recited in claim 1 wherein the pressurized fluid is a gas.

3. The method as recited in claim 1 wherein the step of expanding comprises inflating the volume enclosure with a pressurized gas to permanently stretch both the front and the rear sheets.

4. The method as recited in claim 3 wherein the stretched volume enclosure supports a volume capacity of at least two times the provided container.

5. A method for constructing a flexible container for combined storage and administration, the method comprising the steps of:

providing a substantially transparent front sheet constructed from a planar layer comprising a polymer;

providing a flexible rear sheet constructed from a vapor impermeable layer,

sealing the front sheet and the rear sheet together along a common peripheral edge to form a volume enclosure;

providing a port supported by the common peripheral edge, and fluidly connected with the volume enclosure;

expanding the volume enclosure by introducing a pressurized fluid into the volume enclosure to permanently stretch at least one of the front or rear sheets to thereby increase the capacity of the volume enclosure; and

wherein the step of expanding comprises the steps of;

maintaining the rear sheet and the common peripheral edge against a substantially planar surface; and

inflating the volume enclosure with a pressurized gas.

6. The method as recited in claim 5 wherein the pressurized fluid used to permanently stretch both the front and the rear shoots is a gas.

7. The method as recited in claim 5 wherein the step of maintain the rear sheet and the common peripheral edge comprises:

providing a multi-piece tool configured for receiving the volume enclosure, the tool including a lower tool portion and an opposing upper tool portion, the lower tool portion having a lower planer surface and the upper tool portion having an upper concave surface with a planar edge being configured for capturing the common peripheral edge against the lower planer surface; and

placing the container within the tool wherein the rear sheet contacts the planar surface of the lower tool portion and the front sheet faces the concave surface.

8. The method as recited in claim 5 wherein the step of inflating includes removably coupling pressurized gas to the port, the gas having an inlet pressure of from about 15 to about 25 psi, the pressurized gas inflating the volume enclosure with sufficient pressure to stretch the front sheet outwardly against the concave surface of the tool, wherein the gas is maintained at the inlet pressure for a period of about 15 seconds.

9. The method as recited in claim 5 wherein the step of expanding comprises the steps of:

providing a multi-piece tool configured for receiving the volume enclosure, the tool including a lower tool portion and an opposing upper tool portion, the lower tool portion having a lower concave region with a lower planar edge and the upper tool portion having an upper concave region with an upper planar edge, the lower and upper planer edges being opposed and configured for capturing the common peripheral edge;

placing the container within the tool wherein the rear sheet faces the upper concave region and the front sheet faces the lower concave region; and

inflating the volume enclosure with a pressurized gas at an inlet pressure of from about 15 to about 25 psi to permanently stretch the front and rear sheets outwardly against the respective concave regions of the tool, the gas maintained at the inlet pressure for a period of about 15 seconds.

10. The method as recited in claim 7, and further comprising the step of maintaining the permanently stretched volume enclosure inflated.

11. A method for forming a flexible container for combined storage and administration, the method comprising the steps of:

providing a substantially transparent front sheet constructed from a flexible planar layer of a polymer film;

providing a flexible and vapor impermeable rear sheet constructed from a planer multi-layer laminate;

sealing the front sheet and the rear sheet together along a common peripheral edge so as to define a volume enclosure;

providing a first sacrificial port supported by the common peripheral edge and fluidly connected to the volume enclosure;

providing a second sacrificial port supported by the common peripheral edge and fluidly connected to the volume enclosure, the second sacrificial port being spaced apart from the first sacrificial port along a first side of the common peripheral edge;

providing a outlet port fluidly connected to the volume enclosure, the outlet port being supported by a second side of the common peripheral edge;

supporting the volume enclosure in a tool having a first concave region for receiving at least a portion of the front sheet and an opposing second concave region for receiving at least a portion of the rear sheet, the first concave region defining a greater volume than the second concave region;

expanding the volume enclosure with a pressurized gas to stretch the front sheet and the rear sheet against the respective concave regions of the tool; and

relieving the pressurized gas from within the volume enclosure;

wherein the front and rear sheets are permanently stretched to thereby increase the volume capacity of the container.

12. The method as recited in claim 11 wherein the step of providing a front sheet comprises providing a layer of a polypropylene-polyethylene co-polymer blended with a tyrene ethylene-butylene styrene thermoplastic elastomer.

13. The method as recited in claim 12 wherein the wherein the step of providing a rear sheet comprises providing:

an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene ethylene-butylene styrene thermoplastic elastomer, the inner layer opposing the front sheet;

an intermediate layer of an aluminum foil; and

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

14. The method as recited in claim 13, and further comprising the steps of:

filling the permanently stretched volume enclosure with a gas;

capping the sacrificial ports; and

capping the outlet port to maintain the container in an expanded configuration.

15. The method as recited in claim 14, and further comprising the steps of:

providing a transport carrier including a rail cartridge configured to receive and support a plurality of the containers, the rail cartridge engaging the containers by their respective sacrificial ports;

loading a plurality of containers onto the rail cartridge;

placing the loaded rail cartridge into the transport carrier;

sealing the transport carrier against environmental contamination; and

sterilizing the sealed transport carrier and loaded containers by application of a radiation beam.

16. The method as recited in claim 15, and further comprising the steps of:

removing each of the sacrificial ports; and

completing the seal along the first side of the common peripheral edge inwardly from the sacrificial ports, whereby formation of the container is completed.

17. The method as recited in claim 13 wherein the step of expanding the volume enclosure comprises permanently elongating the front and rear sheets to increase the volume capacity of the pre-enlarged container at least 2 times.

18. The method as recited in claim 17 wherein the step of expanding the volume enclosure comprises inflating the volume enclosure within the tool to a pressure of between approximately 15 and 25 psi.

19. The method as recited in claim 18 wherein the pressurized gas is compressed air.

20. A method for forming a flexible container for combined storage and administration, the method comprising the steps of:

providing a flexible and substantially transparent front sheet constructed from a planar layer of a polymer;

providing a flexible and vapor impermeable rear sheet constructed from a planer multi-layer laminate;

sealing the front sheet and the rear sheet together along a portion of a common peripheral edge so as to define a volume enclosure;

heating the front and rear sheets in a first localized area to fuse the front and rear sheets together along the heated first localized area, thereby forming a first peelable seal extending between a first side of the common peripheral edge and an opposing second side of the peripheral edge, the first peelable seal separably joining the front and rear sheets to thereby form a first compartment within the volume enclosure for containing a diluent;

providing a first sacrificial port interposed between the front and rear sheets and in fluid communication with the first compartment,

expanding a portion of the volume enclosure forming the first compartment to permanently stretch the front sheet and the rear sheet and to thereby increase the volume capacity of the first compartment.

21. The method as recited in claim 20 and further comprising the steps of:

heating the front and rear sheets in a second localized area to fuse the front and rear sheets together along the heated second localized area, thereby forming a second peelable seal extending between the first side and the opposing second side of the common peripheral edge, the second peelable seal separably joining the front and rear sheets to thereby form a second compartment for containing a medicament and an outlet compartment, the second compartment being between the first compartment and the outlet compartment;

providing a second sacrificial port interposed between the front and rear sheets and in communication with the second compartment; and

providing an outlet port interposed between the front and rear sheets and in communication with the outlet compartment.

22. The method as recited in claim 21 wherein the step of providing a front sheet comprises providing a layer of a polypropylene-polyethylene co-polymer blended with a styrene ethylene-butylene styrene thermoplastic elastomer.

23. The method as recited in claim 22 wherein the step of providing a rear sheet comprises providing a multi-layer laminate having:

an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene ethylene-butylene styrene thermoplastic elastomer, the inner layer opposing the front sheet;

an intermediate layer of an aluminum foil; and

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

24. The method as recited in claim 23 wherein the step of inflating comprises inflating the volume enclosure within the tool to a pressure of between approximately 15 and 25 psi for between approximately 10 and 25 seconds.