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

• US 6,996,951 B2
• Filed: 09/17/2003
• Issued: 02/14/2006
• 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: Sacca, Giuseppe, Pool, Scott L., York, Walter A., Smith, Steven L., Walter, William V., Sperko, William A., Gharbian, Noel, Young, H. Theodore, Wu, Nicholas Chung-Hui, Mclonis, Mark R., Turner, Robert E., Ray, William B., Harvey, Douglas G., Barney, Ward, Sakaguchi, Thomas R., Peara, Christopher D., Sandberg, Sharilyn J.
• Primary Examiner(s): HUYNH, LOUIS K
• Application Number:
  US10/664,643
• Publication Number:
  US 20040068960A1
• Time in Patent Office: 881 Days
• Field of Search: 534/12, 534/25, 534/26, 534/69, 534/77, 493/189, 493/190, 493/210, 493/212, 493/213, 206/219, 206/220, 206/221, 604/85, 604/87, 604/410
• US Class Current: 53/425
• 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 forming a flexible container, the method comprising the steps of:

providing a flexible, transparent front sheet;

providing a flexible, vapor impermeable rear sheet;

heating the front and rear sheets in a first localized area to fuse together the heated portions of the adjoining surfaces, thereby forming a permanent seal around a portion of a common peripheral edge of said front and rear sheets, the permanent seal having at least one gap having an opening spaced from the permanent seal for providing a channel between said front and rear sheets; and

providing at least one sacrificial port interposed between the front and rear sheets and in communication with the channel for aseptically filling the container, the at least one sacrificial port attached to the front and rear sheets by a second seal at the opening of the at least one gap.

2. The method according to claim 1 further comprising the step of heating the front and rear sheets in a second localized area to fuse together the heated portions of the adjoining surfaces, thereby forming a peelable seal extending between two sides of the common peripheral edge, the peelable seal separably joining the front and rear sheets to thereby form a first compartment for containing a first composition and a second compartment for containing a second composition.

3. The method according to claim 2, further comprising the step of providing a second sacrificial port interposed between the front and rear sheets, the at least one and second sacrificial ports in communication with the first and second compartments, respectively.

4. The method according to claim 3 further comprising the steps of:

aseptically filling the first compartment with a first composition through a respective sacrificial port; and

aseptically filling the second compartment with a second composition through a respective sacrificial port.

5. The method according to claim 4 further comprising the step of completing the permanent seal along the container'"'"'s common peripheral edge and removing the sacrificial ports from the container, whereby container formation is completed without being subject to a sterilization step after the compartment filling step.

6. The method according to claim 5, further comprising the step of providing an isolator having a sterile environment, the ambient atmosphere within the isolator maintained in a sterile condition, wherein the first compartment and the second compartment are aseptically filled with pre-sterilized first composition and pre-sterilized second composition in the sterile environment inside the isolator.

7. The method according to claim 6 further comprising the step of sterilizing said container before the first aseptic compartment filling step.

8. The method according to claim 5, wherein said peelable seal is formed by maintaining the heat seal temperature in the range of from 245°

F. to 265°

F. while applying a pressure in the range of from about 230 psi to about 340 psi for a time in the range of from about 1.5 seconds to about 2.5 seconds.

9. A method for forming a flexible container, the method comprising the steps of:

providing a flexible, transparent front sheet;

providing a flexible, vapor impermeable rear sheet;

heating the front and rear sheets in a first localized area to fuse together the heated portions of the adjoining surfaces, thereby forming a permanent seal around a portion of a common peripheral edge of said front and rear sheets, the permanent seal having at least one gap having an opening spaced from the permanent seal for providing a channel between said front and rear sheets;

providing at least one sacrificial port interposed between the front and rear sheets and in communication with the channel for aseptically filling the container, the at least one sacrificial port attached to the front and rear sheets by a second seal at the opening of the at least one gap; and

providing at least one outlet port interposed between the front and rear sheets and attached to the front and rear sheets by the permanent seal.

10. The method as recited in claim 9, further comprising the step of removing the at least one sacrificial port.

11. A method for forming a flexible container, the method comprising the steps of:

providing a flexible, transparent front sheet comprising a polypropylene-polyethylene co-polymer blended with styrene ethylene-butylene styrene elastomer;

providing a flexible, vapor impermeable rear sheet;

heating the front and rear sheets in a first localized area to fuse together the heated portions of the adjoining surfaces, thereby forming a permanent seal around a portion of a common peripheral edge of said front and rear sheets, the permanent seal having at least one gap having an opening spaced from the permanent seal for providing a channel between said front and rear sheets; and

providing at least one sacrificial port interposed between the front and rear sheets and in communication with the channel for filling the container, the at least one sacrificial port attached to the front and rear sheets by a second seal at the opening of the at least one gap.

12. The method according to claim 11 further comprising the step of heating the front and rear sheets in a second localized area to fuse together the heated portions of the adjoining surfaces, thereby forming a peelable seal extending between two sides of the common peripheral edge, the peelable seal separably joining the front and rear sheets to thereby form a first compartment for containing a first component and a second compartment for containing a second component.

13. The method according to claim 12, wherein the flexible, vapor impermeable rear sheet comprises a multi-layer laminate formed by the steps of:

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

providing an intermediate layer of aluminum foil; and

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

14. The method according to claim 13, further comprising the step of providing a second sacrificial port interposed between the front and rear sheets, the at least one sacrificial port and the second sacrificial port in communication with the first and the second compartments, respectively.

15. The method according to claim 14, further comprising the step of completing the permanent seal along the container'"'"'s common peripheral edge and removing the sacrificial ports from the container, whereby container formation is completed without being subject to sterilization step.

16. The method according to claim 15, wherein said peelable seal is formed by maintaining the heat seal temperature in the range from 245°

F. to 265°

F. while applying a pressure in the range of from about 230 psi to about 340 psi for a time in the fange from about 1.5 seconds to about 2.5 seconds.