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EP1721595B1 - Récipient pour délivrer des liquides médicaux - Google Patents

Récipient pour délivrer des liquides médicaux Download PDF

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Publication number
EP1721595B1
EP1721595B1 EP05010458.7A EP05010458A EP1721595B1 EP 1721595 B1 EP1721595 B1 EP 1721595B1 EP 05010458 A EP05010458 A EP 05010458A EP 1721595 B1 EP1721595 B1 EP 1721595B1
Authority
EP
European Patent Office
Prior art keywords
bag
valve
container
breakable seal
connector
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.)
Active
Application number
EP05010458.7A
Other languages
German (de)
English (en)
Other versions
EP1721595A1 (fr
EP1721595B2 (fr
Inventor
Matthias Wesseler
Martin Dr. Renken
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.)
B Braun Avitum AG
Original Assignee
B Braun Avitum AG
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
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Application filed by B Braun Avitum AG filed Critical B Braun Avitum AG
Priority to EP05010458.7A priority Critical patent/EP1721595B2/fr
Publication of EP1721595A1 publication Critical patent/EP1721595A1/fr
Application granted granted Critical
Publication of EP1721595B1 publication Critical patent/EP1721595B1/fr
Publication of EP1721595B2 publication Critical patent/EP1721595B2/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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

Definitions

  • the invention relates to a container for the provision of medical fluids according to the preamble of claim 1.
  • Such a container is out US 4,516,977 A known, wherein on a tubular connecting piece a pierceable membrane is provided, which is kept sterile by a cap or a removable protective strip before use.
  • Patent Abstracts of Japan Bd2003, No. 12, 5 shows a valve inserted on the circumference of a hose, through which a connecting line can be inserted transversely into the hose, which is connected to a bag for medical fluid.
  • two ports are each welded from a flexible tube in the edge region of the foil bag and provided at the free end with a protective cap which is screwed onto the Luer thread at the free end of the tube.
  • a tamper-evident crucible is formed, which can be opened by kinking the tube.
  • the flexible hose is compressed by a clamp.
  • Tubing welding is a difficult process to control in the manufacture of such a bag because capillary welding can easily occur between the two film layers of the bag when welding the tube.
  • the detachable flexible hose is also costly.
  • the hose must be made relatively thick-walled, so that a sufficient stability when inserting a plug required for welding is present.
  • the internal, sterile-tight tamper-evident closure complicates the validated sterilization of the connection area.
  • the space within the Luer-Lock cone between the tamper-evident closure and the outer protective cap is not sterilized during the sterilization process because it is not in contact with the sterilized solution to which the physical / microbiological process validation refers. Therefore, an additional transfer bag is usually required.
  • the invention has the object of providing a container of the type described in such a way that at low cost in the manufacture also handling is simplified.
  • the designed as a removal connector port is provided near the free end with a valve device and at the outer end with the originality-crushing seal.
  • the valve is after breaking the breaker seal by a connection device, such as the tubular approach of a Luer-Lock (male), on a hose or the like operable.
  • the tamper-evident closure delimits the connection or connection area on the outside and is connected to the front side of the removal connector, the sterility of the connection area is ensured and a repacking bag for maintaining the sterility of the connection area can be dispensed with. Due to the external quality seal, which is not covered by any protective cap, the usability state is immediately recognizable. By the valve means results in a shut-off possibility on the bag to separate the partially filled bag from a flushing system, without a separate terminal is required.
  • Fig. 1 shows a bag 1 in a front view, Fig. 1a in a side view and Fig. 1b in a view from below.
  • the bag 1 consists of two films along each other along their edge 1a are welded.
  • two extraction connectors 2 are welded at a distance from each other in the edge region 1 a.
  • Fig. 2 shows an enlarged view of a section of a removal connector in the view of Fig. 1 and Fig. 2a shows a 90 ° offset section through the removal connector in the view of Fig. 1 a.
  • the two removal connectors 2 have in the connection area 2a a polygonal, in particular diamond-shaped cross-section, which can be pressed flat during welding in the edge region 1a of the bag 1, so that a welding of the removal connector with the bag films without a core is possible, the Einschwei A flexible hose is required.
  • the thin-walled polygonal region 2a of the removal connector 2 merges into a thicker-walled middle region 2b, which in this exemplary embodiment results in a stiff tubular cross-section.
  • 2c is a connection sleeve with a groove on the front side, in which an axially projecting flange of a disk-shaped end part 2d is inserted or welded in a fluid-tight manner.
  • This disk-shaped end part 2d has in the middle a smaller diameter pipe socket 2e, in which a valve 3 is inserted and which has a luer thread on the outer circumference.
  • a crushing seal 4 is formed or welded in the form of a disc.
  • the valve 3 consists of an elastomeric disc, which - like Fig. 5 shows - starting from a thicker peripheral edge becomes thinner inside and in the thin central region with a z. B. pierced with a needle hole 3a is provided. If this disc of flexible plastic from the pipe socket La of a Luer-Lock-male L is applied, then the hole widens in the middle, such as Fig. 5b shows, and releases the flow for the liquid in the bag. In the relaxed state of the valve disc 3, however, no liquid is allowed to pass, unless the pressure of the liquid is too high. By tightening the Luer-Lock L, the valve disc 3 is widened to release the flow.
  • connection device can be designed so that the valve disc 3 closes again by slightly loosening the Luer-Lock L, such as Fig. 5c in the enlarged view of the valve shows without the hose S is completely detached from the bag. In this way, a switchability of the valve is achieved without a connection hose S is released from the removal connector 2.
  • the valve 3 made of an elastomer disc fulfills several functions. In addition to the valve function, which can be switched by pressure of the Luer-Lock-male, there is a radial guidance and sealing of the cone tip of the Luer-Lock-male.
  • the wall of the Luer-Lock-female on the removal connector or the Luer thread on the pipe socket 2e can not be made exactly conical standard for injection molding technical reasons because of the outer crushing crucible 4 and the necessary demolding of réellekems.
  • the concave shape of the valve disc 3 serves as a guide and hydraulic sealing of the pipe socket La of the Luer lock male.
  • valve for water vapor is permeable through the hole 3a in the middle of the valve disc 3, so that during sterilization, the sterility of a present between the valve 3 and crucible 4 Konnetechnischsraumes 5 is ensured.
  • the Konnetechnischsraum 5 in the pipe socket 2e of the removal connector 2 is through the hole 3a in the valve disc within the solution space, which is closed by the crushing seal 4 and is bounded by the foil bag 1 and the removal connector 2.
  • Fig. 3 to 5 show a further embodiment, wherein the same reference numerals are used for the same or corresponding elements.
  • two removal connectors 20 are welded into the film 1b of the bag on the front side of the bag 1, wherein the removal connector 20, the in Fig. 4 has reproduced cross-sectional shape.
  • an outwardly projecting portion 20b is formed on a round or oval flange portion 20a, which in the sectional view of Fig. 4 approximately perpendicular to each other having wall sections, wherein at the downwardly inclined wall portion 20c of the pipe socket 2e of the removal connector 2 ( Fig. 2 ) is formed, which receives the valve disc 3.
  • This pipe neck 2e is how Fig. 3b in a side view of the bag shows obliquely inclined downwards.
  • Fig. 3 denotes a filling connector, which is welded in the same way via a flange portion 30 a with the film 1 b of the bag 1.
  • 30b is a shutter disc referred to, which is welded to the filling connector 30 and closes it.
  • Fig. 5 shows the extraction connector 20 in the provision, wherein a connection hose S with a luer lock male L to be connected to the bag.
  • the crushing seal 4 is first aborted from the pipe neck 2e, with no liquid emerging through the closed position of the valve disk 3 reproduced in an enlarged view.
  • Fig. 5b shows screwed the female thread Lb Luer-Lock on the pipe socket 2e, wherein the pipe socket La penetrates into the pipe socket 2e.
  • the pipe socket La deforms the valve disk 3 such that the small opening 3a is expanded in the relaxed state, as shown in the enlarged view in FIG Fig. 5b shows. In this state, the valve 3 is opened and liquid can flow out into the connection hose S.
  • the diameter of the disc-shaped crushing crucible 4 is advantageously larger than the outer diameter of the tube extension 2e. As a result, the removal of the refractive seal is facilitated and it is the usability state easily recognizable by this relatively large-scale refractive seal.
  • valve disc 3 instead of the reproduced valve disc 3, another embodiment of a valve can be provided, which is adjustable from the outside through the protruding tubular extension La of a Luer-Lock in the open position and automatically or by the pressure of the liquid in the bag is moved back into the closed position.
  • the described embodiment in the form of the valve disc 3 forms a particularly inexpensive solution.
  • the inventive design of a removal connector can for different containers, such.
  • vials, bottles and the like are used and is not limited to a rinsing solution bag, in which two of the described removal connectors 2, 20 are provided at a distance of about 20 to 40 mm from each other to a circulation of the rinsing solution through the bag. 1 to enable.

Landscapes

  • 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)
  • External Artificial Organs (AREA)
  • Bag Frames (AREA)

Claims (6)

  1. Récipient pour délivrer des liquides médicaux, en particulier, poche pour une solution de rinçage pour la dialyse,
    dans lequel est relié au récipient de façon étanche aux fluides, un orifice qui présente un système de raccordement à une extrémité libre,
    caractérisé en ce que le système de raccordement est fermé à la distribution par un sceau, et
    en ce que l'orifice est conçu comme un connecteur de prélèvement (2, 20) qui est fermé à l'extrémité extérieure par le sceau (4), le connecteur de prélèvement étant doté, entre le sceau (4) et la liaison avec le récipient (1), d'un système de soupape (3), le système de soupape (3) pouvant être actionné après avoir cassé le sceau (4) par un système de raccordement (La) qui peut être relié au connecteur de prélèvement (2, 20).
  2. Récipient selon la revendication 1, dans lequel le système de soupape est conçu comme un disque de soupape (3) en un matériau flexible qui présente une épaisseur diminuant radialement de l'extérieur vers l'intérieur et qui présente au milieu une petite ouverture (3a) par laquelle du liquide ne sort pas mais qui peut être élargie par le passage du liquide.
  3. Récipient selon l'une des revendications 1 et 2, dans lequel le sceau (4) est formé ou soudé sur la face frontale extérieure d'un raccord (2e) du connecteur de prélèvement (2, 20).
  4. Récipient selon la revendication 3, dans lequel le sceau (4) est de forme circulaire, présentant un diamètre supérieur à celui du raccord (2e).
  5. Récipient selon l'une des revendications 1 à 4, dans lequel le connecteur de prélèvement (2) présente dans la zone de liaison avec une poche en feuille (1), une section polygonale flexible (2a) et est soudé dans la zone périphérique (1a) de la poche en feuille, entre deux feuilles.
  6. Récipient selon l'une des revendications 1 à 4, dans lequel le connecteur de prélèvement (20) présente dans la zone de liaison avec une poche en feuille, une zone de bride (20a) qui est soudée à une feuille (1b) de la poche (1) qui présente une ouverture de passage.
EP05010458.7A 2005-05-13 2005-05-13 Récipient pour délivrer des liquides médicaux Active EP1721595B2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP05010458.7A EP1721595B2 (fr) 2005-05-13 2005-05-13 Récipient pour délivrer des liquides médicaux

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP05010458.7A EP1721595B2 (fr) 2005-05-13 2005-05-13 Récipient pour délivrer des liquides médicaux

Publications (3)

Publication Number Publication Date
EP1721595A1 EP1721595A1 (fr) 2006-11-15
EP1721595B1 true EP1721595B1 (fr) 2013-07-10
EP1721595B2 EP1721595B2 (fr) 2021-08-11

Family

ID=35064581

Family Applications (1)

Application Number Title Priority Date Filing Date
EP05010458.7A Active EP1721595B2 (fr) 2005-05-13 2005-05-13 Récipient pour délivrer des liquides médicaux

Country Status (1)

Country Link
EP (1) EP1721595B2 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210187495A1 (en) * 2017-06-22 2021-06-24 Texas Heart Institute Multi-compartment biological fluid storage device

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3305365C2 (de) 1983-02-17 1989-06-29 Fresenius AG, 6380 Bad Homburg Aufbewahrungsbeutel
US5509433A (en) † 1993-10-13 1996-04-23 Paradis; Joseph R. Control of fluid flow
DE19728775C2 (de) † 1997-07-05 2002-01-31 Fresenius Ag Originalitätsverschluß für medizinische Flüssigkeiten enthaltende Verpackungen
DE29916170U1 (de) * 1999-09-14 1999-12-30 Fresenius Medical Care Deutschland GmbH, 61352 Bad Homburg Einsatzstück für medizinische Folienbeutel
DE10030474C1 (de) † 2000-06-21 2002-02-21 Fresenius Kabi De Gmbh Konnektor für medizinische Flüssigkeiten enthaltende Verpackungen sowie Verpackung für medizinische Flüssigkeiten
JP4118598B2 (ja) * 2002-05-17 2008-07-16 フカイ工業株式会社 シール弁および注射器接続ポート
US6994699B2 (en) † 2002-06-12 2006-02-07 Baxter International Inc. Port, a container and a method for accessing a port
DE10348016B4 (de) † 2003-10-15 2007-05-03 Fresenius Kabi Deutschland Gmbh Konnektor für medizinische Flüssigkeiten enthaltende Verpackungen und Verpackung für medizinische Flüssigkeiten

Also Published As

Publication number Publication date
EP1721595A1 (fr) 2006-11-15
EP1721595B2 (fr) 2021-08-11

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