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

• US 6,764,567 B2
• Filed: 08/28/2002
• Issued: 07/20/2004
• Est. Priority Date: 05/13/1996
• Status: Expired due to Term

• Current Assignee: B. Braun Medical
• Original Assignee: B. Braun Medical
• Inventors: Smith, Steven L., Sperko, William A., Turner, Robert E., Ray, William B.
• Primary Examiner(s): Purvis, Sue A.
• Application Number:
  US10/233,213
• Publication Number:
  US 20030000632A1
• Time in Patent Office: 692 Days
• Field of Search: 156/229, 156/146, 156/147, 156/69, 156/308--30, 222/95, 493/193, 493/194, 493/213, 383/3, 604/408, 604/410, 604/412, 604/416, 206/219, 206/221, 428/35.4, 428/426, 428/34.1, 428/412
• 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 1/2024 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 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 and having an outlet port formed along the common peripheral edge for emptying stored contents; and

expanding the volume enclosure by introducing a pressurized fluid through a sacrificial port and 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, the sacrificial port being separable from the flexible container subsequent to the expanding step.

4. 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.

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

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

3. The method as recited in claim 2 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.

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

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

b. providing a flexible rear sheet constructed from a vapor impermeable layer;

c. sealing the front sheet and the rear sheet together along a common peripheral edge to form a volume enclosure having a first volume capacity;

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

e. determining whether to expand the volume enclosure to a second volume capacity or leaving the volume enclosure to its first volume capacity;

f. where volume expansion is desired, expanding the volume enclosure by introducing a pressurized fluid into the volume enclosure to permanently stretch at least one of the front or the rear sheets to thereby increase the capacity of the volume enclosure.

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

8. The method as recited in claim 6 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.

9. The method as recited in claim 8 wherein the step of maintaining 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.

10. The method as recited in claim 9, 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.

11. The method as recited in claim 7 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.

12. The method as recited in claim 11, and further comprising the step of maintaining the permanently stretched volume enclosure inflated.

13. 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,

providing an outlet port formed along the common peripheral edge for emptying stored contents;

connecting the common peripheral edge with a peelable seal to divide the volume enclosure into a first volume enclosure and a second volume enclosure;

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

14. The method as recited in claim 13 wherein the pressurized fluid is a gas.

15. The method as recited in claim 13 wherein the step of expanding comprises the steps of:

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

maintaining the peelable seal substantially against the common plane, and

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

16. The method as recited in claim 13 wherein the step of expanding comprises inflating the first or the second volume enclosure with a pressurized gas to permanently stretch both the front and the rear sheets of the first or the second volume enclosure.

17. The method as recited in claim 13 wherein the stretched volume enclosure supports a volume capacity of at least 1.5 times the original volume.