EP0727200B1 - Système et procédé de connexion pour poches - Google Patents

Système et procédé de connexion pour poches Download PDF

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Publication number
EP0727200B1
EP0727200B1 EP95101987A EP95101987A EP0727200B1 EP 0727200 B1 EP0727200 B1 EP 0727200B1 EP 95101987 A EP95101987 A EP 95101987A EP 95101987 A EP95101987 A EP 95101987A EP 0727200 B1 EP0727200 B1 EP 0727200B1
Authority
EP
European Patent Office
Prior art keywords
pouch
bag
tubing
sterile
unit
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP95101987A
Other languages
German (de)
English (en)
Other versions
EP0727200A1 (fr
Inventor
Agilio E. Macabasco
Renato R. Salumbides
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Pall Corp
Original Assignee
Pall Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Pall Corp filed Critical Pall Corp
Priority to AT95101987T priority Critical patent/ATE167388T1/de
Priority to DE69503031T priority patent/DE69503031T2/de
Priority to EP95101987A priority patent/EP0727200B1/fr
Publication of EP0727200A1 publication Critical patent/EP0727200A1/fr
Application granted granted Critical
Publication of EP0727200B1 publication Critical patent/EP0727200B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports

Definitions

  • the present invention generally relates to the field of blood bag systems, and specifically relates to the field of sterile docking multiple blood bag systems.
  • Plastic bag systems for the collection, processing, and storage of blood and blood components are well known and have been used for thirty or more years.
  • plastic films were used to make bags that ultimately replaced glass bottles
  • many of the plastic blood bag systems were "open” in the sense that there existed the chance of contamination as blood or separated blood components were moved into or out of the system.
  • the plastic bag system was a single bag having attached to it one or more tubings and ports for adding or removing bag contents.
  • Blood bags most often are manufactured from plastics such as polyvinylester polyvinyl acetates, polyolefin, polyvinylchloride homopolymer films, and the like. These materials tend to have a high water vapor transmission rate such that the bag has to be in an aluminium foil pouch to assure a longer shelf life of any solution contained in the bag. Not only do solutions contained within the bags become dehydrated, but the condensation on the outside of the bags resulting from the vapor transmission promotes bacteria growth.
  • plastics such as polyvinylester polyvinyl acetates, polyolefin, polyvinylchloride homopolymer films, and the like. These materials tend to have a high water vapor transmission rate such that the bag has to be in an aluminium foil pouch to assure a longer shelf life of any solution contained in the bag. Not only do solutions contained within the bags become dehydrated, but the condensation on the outside of the bags resulting from the vapor transmission promotes bacteria growth.
  • a dockable bag system comprising a sealed pouch manufactured from a vapor transmission resistant material; a bag system including at least one bag unit and a length of tubing connected thereto, contained within said pouch; at least one external tube fitting attached to and protruding from the pouch and having a length of tubing extending therethrough, the terminal end of the extended tubing being sealed; wherein the bag unit is suitable for sterile docking to at least one additional bag system including at least one bag unit by joining the extended tubing to the additional bag system.
  • a method for providing fluid communication between a plurality of plastic bag units comprising placing at least a first plastic bag unit having an amount of sterile solution contained therein and a length of tubing connected to the unit in a pouch manufactured from a vapor transmission resistant material, wherein a portion of the tubing extends exteriorly from the pouch through at least one external tube fitting attached to the pouch, the terminal end of the extended tubing being sealed; sealing the pouch; sterile docking a bag system including at least one additional bag unit to the extended tubing; and sterile transferring an amount of the sterile solution from the first plastic bag unit into the bag system.
  • a method for connecting a plurality of plastic bag units comprising placing at least a first plastic bag unit and a length of tubing connected to the unit in a pouch manufactured from a vapor transmission resistant material, wherein a portion of the tubing extends exteriorly from the pouch through at least one external tube fitting attached to the pouch, the terminal end of the extended tubing being sealed; sealing the pouch; positioning a bag system including at least one additional bag unit for connection to the extended tubing wherein the extended tubing is suitable for sterile docking; and connecting the bag system to the extended tubing.
  • the fitting is sonic welded in place in the aperture to form a hermetic seal.
  • the tube fitting may have an internal diameter sufficient to permit passage therethrough of the tubing contained within the pouch and connected to the bag unit contained therein. The protruding tubing then may be used for docking with other bag units.
  • the plastic bags are blood bags that form part of a blood bag system. More specifically, the plastic bag system may be a blood bag system, having at least one blood bag unit and an amount of flexible tubing, and the plastic bag unit is a blood bag unit that contains a solution including anticoagulant, saline, and the like for use in conjunction with collected blood.
  • FIGURE 1 is a perspective view of an embodiment of the present invention.
  • FIGURE 2 is a front cutaway view of an embodiment of the present invention.
  • FIGURE 3 is a detail cross-section of a fitting used in an embodiment of the present invention.
  • FIGURE 4 is a perspective view of an exemplary configuration using an embodiment of the present invention.
  • the present invention is a system 100 for sterile docking plastic bags 110 contained within a vapor transmission containment pouch.
  • the system 100 is used for sterile docking multiple blood bag units 110, at least one of such units 110 being contained within the inventive system 100.
  • FIGURE 1 shows a perspective view of one embodiment of the present system 100.
  • the system 100 includes a pouch 102 of sufficient size and dimensions to hold a bag unit (110 of FIGURE 2).
  • the illustrated pouch 102 is sealed at all edges such that the contents of the pouch are maintained in an air-tight environment.
  • the pouch 102 is manufactured from a material that may be sterilized, either by heat (e.g., autoclave), chemical, radiation, or other standard methods known and used in the art.
  • the material preferably is vapor transmission resistant; that is, the material does not transmit water, in vapor form, to outside of the pouch from inside the pouch.
  • the moisture transmission value of the pouch material is zero or as close to zero as possible.
  • the pouch 102 is manufactured using an aluminum foil laminate, which has a known water transmission rate of zero.
  • the pouch 102 is constructed from a laminate that includes an outer layer of a polyester film, a middle layer of annealed aluminum foil, an inner layer of polyethyelene or polypropylene, and an intermediate tie layer of polyethylene copolymer of FDA approved adhesive.
  • the intermediate tie layer may be an extrusion laminated seal layer.
  • Foil material is commercially available from several suppliers, including American National Co., Mt. Vernon, Ohio.
  • the inventive system 100 further includes an aperture 104 or other opening in the pouch 102 through which a tube fitting 106 protrudes.
  • the aperture 104 may be located either in one of the walls of the pouch 102 (as illustrated in FIGURE 1), or may be formed at one of the pouch 102 seams.
  • the aperture 104 is positioned in one of the pouch 102 walls and proximal one end of the pouch 102. The position of the aperture 104 may depend on such variables as the position of the bag unit 110 within the pouch 102, the amount of tubing 108 to be threaded through the fitting 106, and other manufacturing and assembly considerations.
  • the plastic bag unit 110 contained within the pouch 102 preferably is sterilizable. Standard sterilizing methods, such as heat, chemical, radiation, and the like, may be used on the bag units 110 prior to insertion of the bag units 110 inside the pouch 102. Presterilization of the bag units 110 may further extend the shelf-life of the bag 110 contents.
  • the system 100 includes a plastic bag 110 contained within the pouch 102.
  • the plastic bag 110 may be a blood bag, manufactured from standard materials used in the blood bag industry. Such bags 110 are commercially available from Miles Inc., Covina, California.
  • the bag 110 may contain a solution for transfer to another system 100, a blood collection system, another plastic bag, and the like.
  • the present invention is particularly suited for sterile docking of the plastic bag 110 to another sterile system.
  • the bag 110 of the illustrated system may include a port 112, attached to the bag 110, that has an attached amount of tubing 108 that extends from the contents of the bag 110 to outside the system 100.
  • a standard frangible valve 120 may be positioned within the port to control flow of fluid from the bag 110 to outside of the system 100 via the tubing 108.
  • a bushing 114 is attached to the bag port 112 and extends at least partially through the aperture 104.
  • the bushing 114 may extend beyond the fitting 106, and acts as a conduit for the tubing 108.
  • the tubing 108 extends directly from the bag 110 through the fitting 106 without the guidance of a bushing 114.
  • the tubing fitting 106 includes a main body portion 116 and a foot portion 118.
  • the fitting body 116 is inserted through the aperture 104 from the inside of the pouch 102 such that the body 116 protrudes from within the pouch 102 and the foot portion 118 abuts against the inner pouch surface adjacent the aperture 104.
  • the fitting 106 may then be welded or otherwise attached to the pouch 102.
  • the fitting body 116 includes a pair of flanges 120 that extend around the circumference of the inner side of the body 116.
  • the flanges function to grip the bushing 114, or tubing 108 when no bushing 114 is present, to further secure the bushing 114 or tubing 108 in position within the fitting 106.
  • the fitting 106 is sonically welded to the pouch 102 to form a hermetic seal.
  • the fitting 106 is attached within the aperture 104 by chemical, RF, or other methods known and available to those skilled in the art, Preferably, any method that produces a hermetic seal may be used to secure the fitting 106 to the pouch 102.
  • the terminal end of tubing 108 that extends outside of the pouch 102 is sealed.
  • the seal is an RF seal, but the manner and type of seal may depend on the specific materials from which the tubing is manufactured. It is desirable that the terminal end of the tubing 108 be sealed or otherwise closed to prevent uncontrolled loss of solution from the bag 110 and to prevent introduction of contaminants into the bag 110.
  • the portion of the tubing 108 that extends outside of the pouch 102 is connected to tubing 132 from another system 130.
  • the system 130 may include a blood bag system, as illustrated in FIGURE 4, another single blood bag unit 110 similar to that shown in FIGURE 2, or the like.
  • sterile docking is accomplished using a sterile docking device, such as that commercially available from DuPont, Wilmington, Delaware. Using that exemplary device, the two tubings 108 and 132 to be joined are positioned in the docking device (not shown). The device cuts the tubing ends. The opened ends then are joined automatically, typically using a heat process.
  • the frangible valve 112 may be opened to permit fluid flow from the bag 110 to the sterile docked system 130. That device is described in further detail in U.S. Patent No. 4,507,119, the relevant portions of which are incorporated herein by reference. Another sterile docking device is described in U.S. Patent No. 4,157,123, and which relevant portions thereof also are incorporated herein by reference.
  • a single blood bag unit 110 is sealed within the pouch 102.
  • the pouch 102 includes two or more bags, each of which may be interconnected via tubing, or may have separate lengths of tubing extending outside of the pouch 102.
  • a previously sterilized plasma collection bag, including a tubing harness, and containing a sterilized solution for long-term storage is placed in the pouch 102.
  • the foil pouch 102 includes an aperture 104 punched into one pouch wall approximately 5 cm from the top edge of the pouch 102.
  • a flanged fitting 106 preferably manufactured from polyethylene or polypropylene is positioned within the aperture 104 and sonically welded into position.
  • the blood bag 110 includes a frangible valve closure 120, to which is connected a length of PVC tubing.
  • the tubing is not less than 12 inches in length. The exact length of tubing may be longer, depending on the type of sterile docking device being used. That tubing 108 is threaded through the flanged fitting 106 from inside the bag 110 such that it extends at least about 1 cm above the fitting 106.
  • the system 100 now is ready to for long-term storage and/or sterile docking with another blood bag system.

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  • Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Supplying Of Containers To The Packaging Station (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packages (AREA)

Claims (13)

  1. Système à sac raccordable, comprenant :
    A) une poche (102) formée en un matériau résistant à la transmission de vapeur,
    B) au moins un élément à sac (110) scellé hermétiquement dans la poche, l'élément à sac ayant une quantité prédéterminée de tube (108) qui lui est raccordée, et
    C) au moins un raccord (106) de tube externe fixé à la poche et dépassant de celle-ci et ayant une quantité de tube qui dépasse, l'extrémité terminale du tube étant scellée,
    D) le raccordement stérile de l'élément à sac étant autorisé par raccordement de l'extrémité terminale coupée du tube à une autre unité à sac.
  2. Système selon la revendication 1, dans lequel le raccord de tube est soudé par ultrasons à la poche.
  3. Système selon la revendication 1, dans lequel au moins un élément à sac contient une certaine quantité de solution stérile.
  4. Système selon la revendication 1, dans lequel le raccord de tube est scellé hermétiquement sur la poche.
  5. Système selon la revendication 1, dans lequel le matériau résistant à la transmission de vapeur est une feuille d'aluminium.
  6. Système selon la revendication 1, dans lequel le système à sac est un système à sac sanguin.
  7. Système selon la revendication 1, dans lequel l'élément de sac est un élément de sac sanguin.
  8. Système selon la revendication 1, dans lequel le raccord comprend au moins une bride dans le raccord pour la fixation du tube à l'intérieur.
  9. Procédé de raccordement stérile de plusieurs éléments à sac de matière plastique (110), comprenant :
    A) la disposition d'un système à sac qui comprend :
    une poche (102) fabriquée en un matériau résistant à la transmission de vapeur,
    au moins un élément à sac (110) contenant une certaine quantité de solution stérile et une quantité prédéterminée de tube raccordée à l'élément à sac, scellée hermétiquement dans la poche, et
    au moins un raccord (106) pour un tube externe, fixé à une première extrémité de la poche et ayant une quantité de tube introduite dans le raccord et passant dans celui-ci, l'extrémité terminale du tube étant scellée, et
    B) le transfert stérile d'une quantité de solution stérile de l'élément à sac par le tube à un réceptacle par raccordement de l'extrémité terminale coupée du tube au réceptacle.
  10. Procédé selon la revendication 9, comprenant en outre, avant le transfert stérile, une étape de soudage par ultrasons du raccord de à la poche.
  11. Procédé selon la revendication 9, comprenant en outre, avant le transfert stérile, une étape de traitement thermique du système de raccordement stérile d'une manière suffisante pour qu'une soudure hermétique soit formée entre le tube et le raccord de tube.
  12. Procédé selon la revendication 9, qui comprend un procédé de raccordement stérile de plusieurs systèmes à sac sanguin.
EP95101987A 1995-02-14 1995-02-14 Système et procédé de connexion pour poches Expired - Lifetime EP0727200B1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
AT95101987T ATE167388T1 (de) 1995-02-14 1995-02-14 Verbindungssystem und verfahren für beutel
DE69503031T DE69503031T2 (de) 1995-02-14 1995-02-14 Verbindungssystem und Verfahren für Beutel
EP95101987A EP0727200B1 (fr) 1995-02-14 1995-02-14 Système et procédé de connexion pour poches

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP95101987A EP0727200B1 (fr) 1995-02-14 1995-02-14 Système et procédé de connexion pour poches

Publications (2)

Publication Number Publication Date
EP0727200A1 EP0727200A1 (fr) 1996-08-21
EP0727200B1 true EP0727200B1 (fr) 1998-06-17

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ID=8218978

Family Applications (1)

Application Number Title Priority Date Filing Date
EP95101987A Expired - Lifetime EP0727200B1 (fr) 1995-02-14 1995-02-14 Système et procédé de connexion pour poches

Country Status (3)

Country Link
EP (1) EP0727200B1 (fr)
AT (1) ATE167388T1 (fr)
DE (1) DE69503031T2 (fr)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3906418A1 (de) * 1989-03-01 1990-09-13 Fresenius Ag Enterale ernaehrungsanordnung und verfahren zur herstellung einer enteral einsetzbaren ernaehrungsanordnung
DE4213681C2 (de) * 1992-04-25 1996-03-14 Drk Plasma Verarbeitungsgesell Blutbeutelanordnung mit Schutzbeutel
IT227703Y1 (it) * 1992-12-16 1997-12-15 S I F Ra Societa Italiana Farm Confezione di un gruppo monouso per l'infusione di un liquido medicale nel corpo di un paziente.

Also Published As

Publication number Publication date
EP0727200A1 (fr) 1996-08-21
DE69503031T2 (de) 1998-12-03
DE69503031D1 (de) 1998-07-23
ATE167388T1 (de) 1998-07-15

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