Sacrificial port for filling flexible, multiple-compartment drug container

• US 6,165,161 A
• Filed: 11/10/1998
• Issued: 12/26/2000
• 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, Pool, Scott L., York, Walter A., Young, H. Theodore, Harvey, Douglas G.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): Cho, David J.
• Application Number:
  US09/189,473
• Time in Patent Office: 777 Days
• Field of Search: 604/408, 604/409, 604/411, 604/412, 604/415, 604/416, 53/410, 53/452, 53/455, 53/425, 53/133.2
• US Class Current: 604/408
• 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 is folded-over along the line of one of the seals and also includes a locking tab and retaining slot to secure the bag in a folded-over condition.

Claims

1. A sacrificial port adapted for insertion between the front and rear film sheets defining a medical container, the sacrificial port comprising:

a generally tubular, hollow filling barrel;

a tapered heat seal flange, the flange including a central orifice, the orifice communicating with the tubular filling barrel, the filling barrel terminating at the flange orifice at a first end;

a first grasping flange disposed along the length of the filling barrel, the first grasping flange extending from the barrel in a direction orthogonal to the barrel'"'"'s central axis; and

a second grasping flange disposed along the length of the barrel and spaced-apart along the length of the barrel from the first grasping flange, the second grasping flange extending outwardly from the barrel and parallel to the first grasping flange.

2. The sacrificial port according to claim 1, further comprising a cap adapted to fit within and close off a second end of the filling barrel opposite the first end connected to the heat seal flange.

3. The sacrificial port according to claim 2, wherein the cap includes upper and lower grasping flanges, the lower grasping flanges configured to engage the second end of the filling tube as the cap is inserted therein so as to limit the caps depth of insertion.

4. The sacrificial port according to claim 3, the filling barrel having inner and outer diameters, the inner and outer diameters configured to be substantially the same as those of a drug vial, the filling barrel adaptable to be engaged and filled by conventional drug vial filling apparatus.

5. The sacrificial port according to claim 4, wherein the filling barrel'"'"'s outer diameter ranges from about 11.5 mm to about 12.5 mm.

6. The sacrificial port according to claim 5, wherein the filling barrel'"'"'s inner diameter ranges from about 10.00 mm to about 10.75 mm.

7. In a flexible container adapted for administration of IV solutions, flexible container formed from a flexible front sheet and a flexible rear sheet, the front and rear sheet sealed together at a common peripheral edge so as to define a volume enclosure therebetween, an aseptic filling system adapted to permit aseptic filling of the volume enclosure, the aseptic filling system including at least one sacrificial port interposed between the container front and rear sheets and in communication with the volume enclosure, the container 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 so as to form a channel from the sacrificial port to the volume enclosure, the sacrificial port and channel defining an aseptic filling path.

8. The aseptic filling system according to claim 7, the sacrificial port comprising generally tubular, hollow filling barrel, the filling barrel having inner and outer diameters, the inner and outer diameters configured to be substantially the same as those of a drug vial, the filling barrel adaptable to be engaged by conventional drug vial filling apparatus.

9. The aseptic filling system according to claim 8, the sacrificial port further comprising:

a first grasping flange disposed along the length of the filling barrel, the first grasping flange extending from the barrel in a direction orthogonal to the barrel'"'"'s central axis; and

a second grasping flange disposed along the length of the barrel and spaced-apart along the length of the barrel from the first grasping flange, the second grasping flange extending outwardly from the barrel and parallel to the first grasping flange.

10. The aseptic filling system according to claim 9, wherein the filling barrel'"'"'s grasping flanges are oriented to permit the at least one sacrificial port and, thus, the container to be grasped and manipulated by a robotic filling apparatus.

11. The aseptic filling system according to claim 10, wherein the first localized area, including the channel and the at least one sacrificial port, is adapted to be removed from the container once the volume enclosure has been aseptically filled.

12. A method for aseptically filling 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 sheet sealed together at a common peripheral edge so as to define a volume enclosure therebetween, the method comprising the steps of:

providing at least one sacrificial port;

interposing the at least one sacrificial port between the front and rear sheets of the container and in communication with the volume enclosure; and

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 region in a portion of the container extending between two sides of the common peripheral edge, the permanent seal region being laterally spaced-away from the at least one sacrificial port, the lateral spacing forming a channel from the at least one sacrificial port to the volume enclosure, the sacrificial port and channel defining an aseptic filling path.

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

aseptically filling the volume enclosure through the sacrificial port;

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

removing a substantial portion of the permanent seal region, including the sacrificial port, from the container, whereby container formation is completed without being subject to a sterilization step after the volume enclosure is filled.

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

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

16. The method according to claim 15, wherein the sacrificial port is configured as a generally tubular, hollow filling barrel, the filling barrel having inner and outer diameters, the inner and outer diameters configured to be substantially the same as those of a drug vial, the filling barrel adaptable to be engaged and filled by conventional drug vial filling apparatus.

17. The method according to claim 16, the sacrificial port further comprising:

a first grasping flange disposed along the length of the filling barrel, the first grasping flange extending from the barrel in a direction orthogonal to the barrel'"'"'s central axis; and

a second grasping flange disposed along the length of the barrel and spaced-apart along the length of the barrel from the first grasping flange, the second grasping flange extending outwardly from the barrel and parallel to the first grasping flange.

18. The method according to claim 17, wherein the first and second grasping flanges are oriented such that the sacrificial port and, thus, the container, may be grasped and manipulated by robotic filling apparatus.