Transport and sterilization carrier for flexible, multiple compartment drug container

• US 6,198,106 B1
• Filed: 11/10/1998
• Issued: 03/06/2001
• 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: Gharibian, Noel, Sacca, Giuseppe, York, Walter A., Young, H. Theodore, Harvey, Douglas G., Sakaguchi, Thomas R., Barney, Ward W., Smith, Steven L., Pool, Scott L.
• Primary Examiner(s): Polutta, Mark O.
• Assistant Examiner(s): Cho, David J.
• Application Number:
  US09/189,530
• Time in Patent Office: 847 Days
• Field of Search: 604/408, 604/409, 604/416, 53/54, 535/43, 534/95, 534/49, 96/6, 96/46, 961/93, 962/66, 206/5.1, 206/363, 250/453.11, 250/454.11
• US Class Current: 250/453.11
• 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 mixing together of diluents and medicaments. The container incorporates multiple compartments, separated by 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 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 to provide a non-linear resistance characteristic to hydraulic pressure, which causes the seal to peel open completely along its length. The container also includes a locking tab and retaining slot to secure the bag in a folded-over condition.

Claims

1. A transport carrier adapted for sterilization by application of E-beam radiation, the transport carrier comprising:

a generally rectangular container tray, the tray enclosing a volume and including an upper peripheral edge bent-over outwardly to form a horizontally oriented peripheral lip;

a rail cartridge for supporting a multiplicity of containers, the rail cartridge configured to be received within the volume of the tray; and

a sealable film lid affixed to the horizontally oriented peripheral lip to thereby cover the tray to form a transportable sterile containment isolator for transporting and sterilizing empty containers.

2. The transport carrier according to claim 1, wherein the sealable film lid is constructed with dimensions along the film lid to be positioned on the peripheral lip such that the film lid edge is inset from an outer edge of the peripheral lip around the entire lip periphery.

3. The transport carrier according to claim 2, wherein the sealable film lid is heat sealed to the peripheral lip of the tray.

4. The transport carrier according to claim 3, wherein the film lid heat seal extends beyond the edge of the film lid and overlaps the film lid edge and the tray'"'"'s peripheral lip, such that the entire periphery of the film lid is heat sealed to the container'"'"'s peripheral lip.

5. The transport carrier according to claim 1, wherein the container tray further comprises first and second opposing pockets formed in the centers of the opposing short sides of the tray and extending outwardly from the plane of the short sides, the pockets extending downwardly from the peripheral lip to form first and second opposing recesses for receiving the rail cartridge.

6. The transport carrier according to claim 5, wherein the rail cartridge includes means for engaging sacrificial ports of empty medical containers, such that a plurality of empty containers may be engaged and supported by the cartridge.

7. The transport carrier according to claim 6, wherein the sacrificial port engagement means comprises a plurality of spaced-apart rails defining slots therebetween, the sacrificial ports of medical containers inserted into the slots, the slots including horizontally oriented flanges disposed along the length of each slot, the flanges engaging mating flanges on the sacrificial ports to support the ports thereby.

8. The transport carrier according to claim 7, wherein the rail cartridge further comprises a spacer plate, the spacer plate affixed to the plurality of spaced-apart rails, the spacer plate including means for grasping and manipulating the rail cartridge without contacting medical containers loaded thereon.

9. The transport carrier according to claim 8, the rail cartridge configured to be inserted into the container tray, the rail cartridge having first and second ends adapted to be received into the container trays opposing pockets.

10. A method for sterilizing a flexible container adapted for administration of IV solutions, the flexible container formed from a flexible front sheet and a flexible rear sheet, the front and rear sheets sealed together at a common peripheral edge so as to define a volume enclosure therebetween, at least one sacrificial port being interposed between the front and rear sheets and in communication with the volume enclosure, the front and rear sheets heated in a first localized area to fuse together the heated portions of the adjoining surfaces, thereby forming a permanent seal in a portion of the container extending between two sides of the common peripheral edge and laterally spaced-away from the at least one sacrificial port, the permanent seal defining a channel from the sacrificial port to the volume enclosure, the method comprising the steps of:

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

loading a multiplicity of containers onto the rail cartridge;

placing the loaded rail cartridge within a body portion of the transport carrier;

sealing the transport carrier to thereby enclose the body portion; and

exposing the sealed transport carrier and containers within to an e-beam radiation source, the e-beam radiation source sterilizing the containers against biological contamination.

11. The method according to claim 10, further comprising:

introducing the e-beam sterilized sealed transport carrier into a UV decontamination chamber;

decontaminating the exterior surfaces of the transport carrier by application of UV radiation; and

introducing the decontaminated transport carrier into an isolator having a sterile environment without reexposing the carrier to ambient atmosphere.

12. The method according to claim 11, further comprising the steps of:

removing the sterilized containers from the transport carrier;

aseptically filling the volume enclosure through the sacrificial port;

completing the permanent seal along the container'"'"'s common peripheral edge so as to interrupt communication between the sacrificial port and the volume enclosure; and

removing the sacrificial port from the container, whereby container formation is completed without being subject to a sterilization step after the volume enclosure is filled.

13. The method according to claim 12, wherein the volume enclosure is aseptically filled through the sacrificial port with a diluent liquid.

14. The method according to claim 12, wherein the volume enclosure is aseptically filled through the sacrificial port with a medicament.

15. The method according to claim 12 the transport carrier further comprising:

a generally rectangular container tray defining a body portion, enclosing a volume, the body portion including an upper peripheral edge, the edge bent-over outwardly to form a horizontally oriented peripheral lip; and

a flexible film sealably affixed to the horizontally oriented peripheral lip and extending over the body portion to thereby cover the container volume and form a transportable sterile containment isolator for transporting and sterilizing said containers.

16. The method according to claim 15, wherein the film is sealably affixed onto the peripheral lip such that a film peripheral edge in any direction is inset from a corresponding outer edge of the peripheral lip, around the entire lip periphery.

17. The method according to claim 16, wherein the film is heat sealably affixed to the peripheral lip of the tray, the film heat seal extending beyond the edges of the film and overlapping the film edges and the carrier'"'"'s peripheral lip such that the entire peripheral edge of the film is heat sealed to the container'"'"'s peripheral lip.

18. A transport carrier configured to contain a multiplicity of flexible containers adapted for administration of IV solutions, the containers formed from flexible, thermoplastic front and rear sheets sealed together along a common peripheral edge so as to define a volume enclosure therebetween, each container including at least one sacrificial port interposed between the front and rear sheets and in communication with the volume enclosure, the transport carrier comprising:

a generally rectangular container tray defining a body portion and enclosing a volume, the body portion having four sides, a bottom and an upper peripheral edge circumscribing an open top, the upper peripheral edge bent-over outwardly to form a horizontally oriented peripheral lip;

a rail cartridge for supporting a multiplicity of containers, the rail cartridge configured to be received within the volume of the body portion; and

a film lid sealably affixed to the horizontally oriented peripheral lip to thereby cover the open top and form a containment isolator for transporting and sterilizing said containers.

19. The transport carrier according to claim 18, wherein the container body portion further comprises first and second opposing pockets formed in the centers of two opposing sides of the body portion and extending outwardly from the plane of the sides, the pockets extending downwardly from the plane of the peripheral lip to thereby form first and second opposing recesses for receiving the rail cartridge.

20. The transport carrier according to claim 19, wherein the rail cartridge comprises a plurality of laterally spaced-apart elongated rails, each rail comprising horizontally oriented flanges along the length of each rail, the flanges of adjacent rails opposing and spaced-apart from one another so as to define a slot therebetween, a medical container being inserted into a slot by its sacrificial port, the slots receiving the sacrificial ports and the rail flanges engaging mating flanges on the sacrificial ports to thereby confine and support the ports.

21. The transport carrier according to claim 20, the rail cartridge configured to be inserted into the container volume, the rail cartridge having first and second ends adapted to be received into the container'"'"'s first and second opposing recesses.

22. The transport carrier according to claim 21, wherein the rail cartridge further comprises a spacer plate, the spacer plate affixed to the plurality of spaced-apart rails, the spacer plate maintaining a separation distance between spaced-apart rails sufficient to receive a sacrificial port inserted therebetween, the spacer plate including means for grasping and manipulating the rail cartridge without allowing contact with medical containers loaded thereon.

23. The transport carrier according to claim 22 wherein the transport carrier and a multiplicity of medical containers contained within are sterilized by application of e-beam radiation, the film lid and container body portion allowing passage of e-beam radiation into the enclosed volume, the container body portion and film lid preventing subsequent contamination of enclosed medical containers.