EP1721595B2 - Récipient pour délivrer des liquides médicaux - Google Patents

Récipient pour délivrer des liquides médicaux Download PDF

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Publication number
EP1721595B2
EP1721595B2 EP05010458.7A EP05010458A EP1721595B2 EP 1721595 B2 EP1721595 B2 EP 1721595B2 EP 05010458 A EP05010458 A EP 05010458A EP 1721595 B2 EP1721595 B2 EP 1721595B2
Authority
EP
European Patent Office
Prior art keywords
bag
valve
breakable seal
container
welded
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
EP05010458.7A
Other languages
German (de)
English (en)
Other versions
EP1721595A1 (fr
EP1721595B1 (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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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=35064581&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP1721595(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
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
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

Definitions

  • the invention relates to a container for providing medical fluids according to the preamble of claim 1.
  • Patent Abstracts of Japan Vol2003, No. 12, 5 shows a valve inserted on the circumference of a hose line, through which a connecting line can be inserted transversely into the hose line and connected to a bag for medical fluid.
  • two ports each consisting of a flexible hose are welded into the edge area 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 hose.
  • a tamper-evident break seal is formed inside the hose, which can be opened by kinking the hose. To shut off the port, the flexible hose is compressed by a clamp.
  • the welding of the hose is a difficult process to control in the production of such a bag because capillaries can easily develop between the two film layers of the bag when the hose is welded in.
  • the clampable flexible hose is also expensive.
  • the hose must be made relatively thick-walled so that there is sufficient stability when inserting a plug required for welding.
  • the internal sterile-tight tamper-evident closure makes the validated sterilization of the connection area difficult.
  • the space within the Luer-Lock cone between the tamper-evident closure and the outer protective cap is not sterilized during the sterilization process, as it is not in contact with the sterilized solution to which the physical / microbiological process validation relates. Therefore, an additional bag is usually required.
  • the invention is based on the object of designing a container of the type specified at the outset in such a way that handling is also simplified with low manufacturing costs.
  • the port which is designed as a removal connector, is provided with a valve device near the free end and with the tamper-evident break seal at the outer end. After the break seal has been broken, the valve can preferably be actuated by a connection device, for example the tubular attachment of a Luer lock (male), on a hose or the like.
  • a connection device for example the tubular attachment of a Luer lock (male), on a hose or the like.
  • the tamper-evident closure delimits the connection area on the outside and is connected to the face of the removal connector, the sterility of the connection area is guaranteed and an outer bag to maintain the sterility of the connection area can be omitted. Thanks to the quality break seal on the outside, which is not covered by any protective cap, the usability status is immediately recognizable.
  • the valve device enables the bag to be shut off in order to separate the partially filled bag from a rinsing system without the need for a separate clamp.
  • Fig. 1 shows a bag 1 in a front view, Fig. 1a in a side view and Figure 1b in a view from below.
  • the bag 1 consists of two foils which are welded to one another along their edge 1a.
  • two removal connectors 2 are welded into the edge area 1 a at a distance from one another.
  • Fig. 2 shows an enlarged view of a section of a removal connector in the view of FIG Figures 1 and 2a shows a section offset by 90 ° through the removal connector in the view of FIG Fig. 1 a.
  • the two removal connectors 2 have a polygonal, in particular diamond-shaped, cross-section in the connection area 2a, which can be pressed flat when being welded into the edge area 1a of the bag 1, so that the removal connector can be welded to the bag films without a core -outside a flexible hose is required.
  • the thin-walled polygonal region 2a of the removal connector 2 merges into a thick-walled central region 2b, which in this exemplary embodiment results in a stiff tubular cross-section.
  • 2c designates a connecting sleeve with a groove on the end face, into which an axially protruding flange of a disk-shaped end part 2d is inserted or in a fluid-tight manner is shrink-wrapped.
  • This disc-shaped end part 2d has in the middle a tube extension 2e with a smaller diameter, in which a valve 3 is inserted and which has a Luer thread on the outer circumference.
  • a break seal 4 in the form of a disk is molded or welded onto the outer end face of this pipe extension 2e.
  • the valve 3 consists of an elastomer disc which - like Fig. 5 shows - starting from a thicker peripheral edge is thinner inward and in the thin central area with a z. B. is provided with a needle pierced hole 3a. If this disk made of flexible plastic is acted upon by the pipe socket La of a Luer lock male L, the hole widens in the middle, as Figure 5b shows, and releases the flow for the liquid in the bag. In the relaxed state of the valve disk 3, on the other hand, no liquid is let through, provided the pressure of the liquid is not too high. When the Luer-Lock L is tightened, the valve disc 3 is expanded to release the flow.
  • This connection device can be designed so that the valve disc 3 closes again by slightly loosening the Luer lock L, as Figure 5c shows in the enlarged representation of the valve without the hose S being completely detached from the bag. In this way, the valve can be switched without a connecting hose S being detached from the extraction connector 2.
  • the valve 3 made of an elastomer disc fulfills several functions. In addition to the valve function, which can be switched by pressing 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 extraction connector or of the Luer thread on the pipe socket 2e cannot be made exactly conical in accordance with the standards due to the external break seal 4 and the required demolding of the inner core.
  • the concave shape of the valve disk 3 serves as a guide and hydraulic seal for the pipe socket La of the Luer lock male.
  • the valve is permeable to water vapor through the hole 3a in the middle of the valve disk 3, so that the sterility of a connection space 5 present between valve 3 and break seal 4 is guaranteed during sterilization.
  • the connection space 5 in the pipe socket 2e of the removal connector 2 lies through the hole 3a in the valve disc within the solution space, which is closed by the break seal 4 and delimited by the foil bag 1 and the removal connector 2.
  • FIGS 3 to 5 show a further embodiment, the same reference symbols being used for identical or corresponding elements.
  • two removal connectors 20 are welded into the film 1b of the bag on the front side of the bag 1, the removal connector 20 being the same as shown in FIG Fig. 4 has reproduced cross-sectional shape.
  • an outwardly protruding area 20b is formed on a round or oval flange area 20a, which in the sectional view of FIG Fig. 4 has wall sections lying approximately perpendicular to one another, wherein on the downwardly inclined wall section 20c the pipe socket 2e of the removal connector 2 ( Fig. 2 ) is formed, which receives the valve disc 3.
  • This pipe socket 2e is how Figure 3b shows in a side view of the bag, inclined obliquely downward.
  • a hole corresponding to the circumferential shape of the flange area 20a is punched into the front film 1b and the removal connector 20 is inserted so that the flange area 20a rests against the inside of the film 1b.
  • the film 1b is then welded to the flange area 20a.
  • Fig. 3 denotes a filling connector which is welded in the same way to the film 1b of the bag 1 via a flange region 30a.
  • a closure disk is designated by 30b, which is welded to the filling connector 30 and closes it.
  • Fig. 5 shows the removal connector 20 in readiness, wherein a connection hose S with a Luer lock male L is to be connected to the bag.
  • the break seal 4 is first broken off from the pipe socket 2e, with no liquid escaping due to the closed position of the valve disc 3 shown in an enlarged view.
  • Figure 5b shows, the internally threaded socket Lb of the Luer lock screwed onto the pipe socket 2e, the pipe socket La penetrating into the pipe socket 2e.
  • the pipe socket La deforms the valve disk 3 in such a way that the opening 3a, which is small in the relaxed state, is widened, as shown in the enlarged view in FIG Figure 5b indicates.
  • valve 3 is open and liquid can flow out into the connection hose S. If the socket Lb of the Luer lock is then released from the removal connector 20 or its pipe attachment 2e while the bag 1 is still about half full with liquid, for example, the elastic material of the valve disc 3 relaxes again, whereby the opening 3a in the thin area of the valve disc closes so far that no liquid escapes like this Figure 5c indicates.
  • the diameter of the disc-shaped break seal 4 is greater than the outer diameter of the pipe socket 2e. This makes it easier to remove the break seal and the usability status can be easily recognized by this relatively large break seal.
  • valve disk 3 instead of the reproduced valve disk 3, another embodiment of a valve can be provided, which can be adjusted from the outside through the protruding tubular extension La of a Luer lock into the open position and automatically or through the pressure of the liquid in the bag back into the Closed position is moved.
  • the embodiment described in the form of the valve disk 3 forms a particularly inexpensive solution.
  • a manually switchable valve on the extraction connector for example a valve with a rotatable tap, but such a design is expensive to manufacture.
  • the port is also possible to design the port to be kinkable, with a film hinge being able to facilitate kinking and the port remaining in the kinked position, for example by means of a clamping or latching device.
  • the central area of the removal connector 2 is designed with thin walls so that it can be bent. Even with such a configuration of a valve device by kinking, complete sterilization of the solution space between break seal 4 and bag 1 is guaranteed.
  • the inventive design of a removal connector can be used for different containers such.
  • B. vials, bottles and the like can be used and is not limited to a rinsing solution bag in which two of the described extraction connectors 2, 20 are provided at a distance of about 20 to 40 mm from each other in order to allow the rinsing solution to circulate 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 (4)

  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, qui est fermé à la distribution par un sceau (4),
    dans lequel l'orifice est conçu comme un connecteur de prélèvement (2, 20) qui est fermé à l'extrémité extérieure par le sceau (4), dans lequel le connecteur de prélèvement est doté, entre le sceau (4) et la liaison avec le récipient (1), d'un système de soupape (3),
    dans lequel le système de soupape (3) peut être actionné après avoir cassé le sceau (4) par un système de raccordement (La) qui peut être relié au connecteur de prélèvement (2, 20) et dans lequel le sceau (4) est formé ou soudé sur la face frontale extérieure d'un raccord (2e) du connecteur de prélèvement (2, 20) qui présente un filetage Luer sur la circonférence extérieure et dans lequel est inséré le système de soupape (3) et qui forme ainsi le système de raccordement de l'orifice qui est fermé à la distribution par le sceau (4) formé ou soudé, caractérisé en ce que le sceau (4) est de forme circulaire, présentant un diamètre supérieur à celui du raccord (2e).
  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 quelconque des revendications 1 à 2, 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.
  4. Récipient selon l'une quelconque des revendications 1 à 2, 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 Expired - Lifetime 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 EP1721595B1 (fr) 2013-07-10
EP1721595B2 true EP1721595B2 (fr) 2021-08-11

Family

ID=35064581

Family Applications (1)

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

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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

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5509433A (en) † 1993-10-13 1996-04-23 Paradis; Joseph R. Control of fluid flow
DE19728775A1 (de) † 1997-07-05 1999-01-21 Fresenius Ag Originalitätsverschluß für medizinische Flüssigkeiten enthaltende Verpackungen
DE10030474C1 (de) † 2000-06-21 2002-02-21 Fresenius Kabi De Gmbh Konnektor für medizinische Flüssigkeiten enthaltende Verpackungen sowie Verpackung für medizinische Flüssigkeiten
US20030233083A1 (en) † 2002-06-12 2003-12-18 Vincent Houwaert Port, a container and a method for accessing a port
WO2005037362A1 (fr) † 2003-10-15 2005-04-28 Fresenius Kabi Deutschland Gmbh Connecteur pour conditionnements contenant des liquides medicaux, et conditionnement pour liquides medicaux

Family Cites Families (3)

* 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
DE29916170U1 (de) * 1999-09-14 1999-12-30 Fresenius Medical Care Deutschland GmbH, 61352 Bad Homburg Einsatzstück für medizinische Folienbeutel
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

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5509433A (en) † 1993-10-13 1996-04-23 Paradis; Joseph R. Control of fluid flow
DE19728775A1 (de) † 1997-07-05 1999-01-21 Fresenius Ag Originalitätsverschluß für medizinische Flüssigkeiten enthaltende Verpackungen
DE10030474C1 (de) † 2000-06-21 2002-02-21 Fresenius Kabi De Gmbh Konnektor für medizinische Flüssigkeiten enthaltende Verpackungen sowie Verpackung für medizinische Flüssigkeiten
US20030233083A1 (en) † 2002-06-12 2003-12-18 Vincent Houwaert Port, a container and a method for accessing a port
WO2005037362A1 (fr) † 2003-10-15 2005-04-28 Fresenius Kabi Deutschland Gmbh Connecteur pour conditionnements contenant des liquides medicaux, et conditionnement pour liquides medicaux

Also Published As

Publication number Publication date
EP1721595A1 (fr) 2006-11-15
EP1721595B1 (fr) 2013-07-10

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