EP1345566B1 - Rekonstitutionsvorrichtung, insbesondere zum mischen von substanzen auf dem gebiet der medizin - Google Patents

Rekonstitutionsvorrichtung, insbesondere zum mischen von substanzen auf dem gebiet der medizin Download PDF

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Publication number
EP1345566B1
EP1345566B1 EP01999342A EP01999342A EP1345566B1 EP 1345566 B1 EP1345566 B1 EP 1345566B1 EP 01999342 A EP01999342 A EP 01999342A EP 01999342 A EP01999342 A EP 01999342A EP 1345566 B1 EP1345566 B1 EP 1345566B1
Authority
EP
European Patent Office
Prior art keywords
socket
needle
end piece
holding
flask
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
EP01999342A
Other languages
English (en)
French (fr)
Other versions
EP1345566A1 (de
Inventor
Jean Curutcharry
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.)
Technoflex SA
Original Assignee
Technoflex SA
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 Technoflex SA filed Critical Technoflex SA
Publication of EP1345566A1 publication Critical patent/EP1345566A1/de
Application granted granted Critical
Publication of EP1345566B1 publication Critical patent/EP1345566B1/de
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
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • 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
    • 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/2013—Piercing means having two piercing ends

Definitions

  • the present invention relates to the mixing of one substance with another, particularly in the medical field for example for the reconstitution of a drug with a diluent.
  • the invention relates to the device, commonly called reconstitution device, intended to operate such a mixture.
  • a diluent which may be for example a dextrose solution, a saline solution or even water.
  • these medicaments must be mixed with a diluent contained in a flexible pouch provided for this purpose with an injection tubing comprising a tip made of a material, such as latex for example, which can be pierced by a needle, the passage formed by the latter closing of itself from the withdrawal of the needle.
  • a diluent contained in a flexible pouch provided for this purpose with an injection tubing comprising a tip made of a material, such as latex for example, which can be pierced by a needle, the passage formed by the latter closing of itself from the withdrawal of the needle.
  • the communication between the medicine vial and the flexible bag is provided by means of a reconstitution device consisting of a hollow needle pointed at its two ends and projecting into two open cylindrical sockets arranged head to tail and shaped to receive, one, the mouth of the vial with its latex cap for example and the other, the tip of the injection tubing of the flexible bag.
  • the reconstitution device is taken out of its sterile package, the needle, on the vial side, of the device is fully engaged through the stopper, then the other needle is also inserted fully into the container. end of the flexible bag, the communication between the latter and the vial thus being provided via the reconstitution device.
  • EP-A-1,034,772 discloses such a reconstitution device according to the preamble of claim 1.
  • Such a system has the disadvantage of the need to separately store soft bags, vials and reconstitution devices.
  • the purpose of the present invention is to simplify this system and make it more economical by combining the reconstitution device and the flexible bag as soon as it is manufactured by pre-positioning said device, and packaging the device + bag assembly in a package unique sterile.
  • the subject of the invention is a reconstitution device, in particular for the mixture of substances in the medical field, according to claim 1.
  • the device comprises a hollow needle, pointed at its two ends and fixed on a support defining two coaxial sleeves enveloping each end of the needle and loaded to receive, one, the plug mouth of a vial and the other, the tip of an injection port of a pocket flexible, so that, by perforation of said cap and tip, communicating the vial and the flexible bag via said needle, characterized in that said sleeve, flexible bag side, comprises positioning and retaining means giving a first stable position wherein the device is secured to the bag without the needle is in contact with the tip and a second stable position, corresponding to piercing of the tip by the needle.
  • the flask face of the device may be conventional and include a conventional socket for receiving a conventional flask.
  • the invention also relates to the assembly consisting of a flexible bag provided with at least one nozzle injection nozzle prepositioned in said first retaining position in the bushing of the reconstitution device.
  • the device of the invention therefore has substantial advantages, particularly in terms of ease of management and use.
  • the reconstitution device shown at 1 in Figure 1 comprises a hollow needle 2 passing through a circular support 3 extended towards each pointed end of the needle, a cylindrical sleeve.
  • One of the sleeves (4) is intended to accommodate (FIGS. 2 and 3) the end piece 5 of an injection tubing 6 of a flexible bag 7.
  • the other sleeve 8 arranged head to tail relative to the sleeve 4, has a larger diameter to receive the mouth provided with a plug 9 ( Figure 3) of a vial 10 of drug for example.
  • the sleeve 8 has an internal diameter adapted to the vial 10 and is closed during non-use by a plug B for security purposes.
  • the length of the bushing 8 is slightly greater than that of the projecting part of the needle 2.
  • the sleeve 4 is very substantially longer than the protruding part of the needle 2 in order to receive (FIG. 2) the entire endpiece 5 in an area remote from the pointed end of said needle.
  • the internal diameter of the bushing 4 corresponds to the external diameter of the nozzle 5, the wall of which is made of elastic material.
  • the tip 5 is of conventional structure of a material such as latex allowing its piercing through the needle 2, the passage hole closing itself after removal of the needle, as well as the material of the plug 9.
  • the sleeve 4 is internally provided with a slight annular bead 11, discontinuous as shown or not, however, at a distance from this bead 11 corresponding to the length of the nozzle 5 are provided one or several small internal projections, for example two protrusions 12 diametrically opposite, shaped at the end of two tongues 13 cut in the wall of the sleeve 4.
  • the device 1 is monobloc and made for example by molding a suitable plastic material.
  • FIG. 2 shows the device 1 pre-positioned on the injection tubing 6, in the standby position.
  • the device 1 is in its first stable position, the tip 5 having been engaged in the sleeve 4 by force to overcome, thanks to the elasticity of the tip, the inlet bead 11, the tip 5 being introduced completely and being stopped in this first position by the two abutment projections 12.
  • the tip of the needle 2 is kept at a distance from the tip 5 and the device 1 is integral with the flexible pouch 7.
  • the assembly can therefore be handled, packaged in a sterile flexible packaging , stored and managed as a single object.
  • the pocket 7 When using the pocket 7, that is to say when it is desired to mix the contents of the vial 10, with a dilution liquid for example contained in the pocket.
  • the device 1 is first placed on the tubing 6 in the position of Figure 2 (standby position). Then, the vial 10 is introduced through its plug 9 into the sleeve 8 so as to pierce the plug. Finally, the device 1-vial assembly 10 is pressed towards the pocket 7 in order to pierce the tip 5 by the needle.
  • the two containers 7 and 10 are then in communication via the needle 2 and the tubing 6.
  • the device of the invention has the advantage of allowing the removal of the entire device 1-vial 10 of the nozzle 5 after the reconstitution operation.
  • the operator is faced with a pocket 7 in which he can, via the tubing 6, make an additional injection if necessary.
  • the separation between the pocket 7 and the set 1-10 is desirable for optimized treatment of hospital waste.
  • the invention is obviously not limited to the embodiment shown and described above but covers all variants, particularly with regard to the means 11, 12 of positioning-locking of the tip 5 in his first position.
  • the bush 8 may optionally be provided internally in the known manner with one or more projections, three for example, as shown at 15 in the figures, for resiliently retain in the correct insertion position the plug 9 of the vial, and externally also in the known manner, one or more projections, three for example, as shown at 16 to retain the plug B.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Mixers Of The Rotary Stirring Type (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Claims (5)

  1. Vorrichtung insbesondere für die Bildung eines Gemischs aus Substanzen im medizinischen Gebiet, des Typs, der eine Hohlnadel (2) umfasst, die an ihren zwei Enden spitz zuläuft und an einem Träger (3) befestigt ist, der zwei koaxiale Hülsen definiert, die die beiden Enden der Nadel umgeben und wovon eine (8) die mit einem Stopfen (9) versehene Mündung eines Fläschchens (10) aufnehmen soll und die andere (4) das Endstück (5) eines Einspritzrohrstutzens (6) eines nachgiebigen Beutels (7) aufnehmen soll, derart, dass durch Perforation des Stopfens (9) und des Endstücks (5) über die Nadel (2) eine Verbindung zwischen dem Fläschchen (10) und dem nachgiebigen Beutel (7) hergestellt wird, wobei die Vorrichtung einteilig ausgebildet ist, wobei die Hülse (4) auf Seiten des nachgiebigen Beutels (7) Mittel zum Positionieren und Halten der Hülse am Endstück umfasst, wobei diese Mittel einen ununterbrochenen oder unterbrochenen Wulst (11) umfassen, der nach innen in die Nähe der Einlassöffnung der Hülse (4) vorsteht,
    wobei die Vorrichtung dadurch gekennzeichnet ist, dass die Positionierungs- und Haltemittel außerdem einen oder mehrere Vorsprünge (12) umfassen, die elastisch einziehbar sind und in der Hülse (4) angeordnet sind, wobei sich die Vorsprünge (12) in einem Abstand von der Einlassöffnung der Hülse (4), der der Länge des Endstücks (5) entspricht, befinden, und dass
    - die Mittel den Eingriff der Hülse (4) am Endstück (5) in einer ersten stabilen Position ermöglichen, in der die Vorrichtung (1) mit dem Beutel (7) fest verbunden ist, ohne dass die Nadel (2) mit dem Endstück (5) in Kontakt ist, und die Hülse (4) am Endstück (5) gleitend angebracht ist, derart, dass sie sich durch einfaches Eintreiben der Vorrichtung (1) in das Endstück (5) von der ersten Position in eine zweite stabile Position bewegt, was einem Durchstechen des Endstücks (5) durch die Nadel (2) entspricht.
  2. Vorrichtung nach Anspruch 1, dadurch gekennzeichnet, dass sie Mittel (11, 12) zum Positionieren und Halten der Hülse (4) an dem Endstück (5) in der zweiten Position umfasst.
  3. Vorrichtung nach Anspruch 2, dadurch gekennzeichnet, dass die Hülse (8) auf Seiten des Fläschchens (10) innen mit einem oder mehreren Vorsprüngen (15) versehen ist, um den Stopfen (B) des Fläschchens in einer korrekten Eintreibposition elastisch zu halten.
  4. Vorrichtung nach Anspruch 2 oder 3, dadurch gekennzeichnet, dass die Hülse (8) auf Seiten des Fläschchens (10) außen mit einem oder mehreren Vorsprüngen (16) versehen ist, um einen Stopfen (9) zu Sicherheitszwecken zu halten.
  5. Baueinheit, die aus einem nachgiebigen Beutel (7) gebildet ist, der mit wenigstens einem Einspritzrohrstutzen (6) versehen ist, der ein Endstück (5) aufweist, das im Voraus zwischen den Mitteln (11, 12) zum Positionieren und Halten der Hülse (4) der Vorrichtung nach einem der Ansprüche 1 bis 4 positioniert ist.
EP01999342A 2000-12-06 2001-12-06 Rekonstitutionsvorrichtung, insbesondere zum mischen von substanzen auf dem gebiet der medizin Expired - Lifetime EP1345566B1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR0015823 2000-12-06
FR0015823A FR2817465B1 (fr) 2000-12-06 2000-12-06 Dispositif de reconstitution notamment pour le melange de substances dans le domaine medical
PCT/FR2001/003853 WO2002045649A1 (fr) 2000-12-06 2001-12-06 Dispositif de reconstitution notamment pour le melange de substances dans le domaine medical

Publications (2)

Publication Number Publication Date
EP1345566A1 EP1345566A1 (de) 2003-09-24
EP1345566B1 true EP1345566B1 (de) 2006-06-07

Family

ID=8857302

Family Applications (1)

Application Number Title Priority Date Filing Date
EP01999342A Expired - Lifetime EP1345566B1 (de) 2000-12-06 2001-12-06 Rekonstitutionsvorrichtung, insbesondere zum mischen von substanzen auf dem gebiet der medizin

Country Status (7)

Country Link
US (1) US7442189B2 (de)
EP (1) EP1345566B1 (de)
AT (1) ATE328567T1 (de)
AU (1) AU2002216186A1 (de)
DE (1) DE60120475T2 (de)
FR (1) FR2817465B1 (de)
WO (1) WO2002045649A1 (de)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2819418B1 (fr) * 2001-01-17 2003-03-14 Technoflex Sa Set de transfert notamment pour l'administration d'un melange de liquides a des fins medicales
ES2397833T3 (es) 2003-03-05 2013-03-11 Csl Behring Gmbh Dispositivo de transferencia
DE502004005171D1 (de) 2003-03-06 2007-11-22 Csl Behring Gmbh Transfervorrichtung, insbesondere für medizinische Fluids
ATE447923T1 (de) * 2006-02-16 2009-11-15 Hoffmann La Roche System und vorrichtung zum entnehmen von pharmazeutika
CA2704933A1 (en) 2007-08-21 2009-02-26 Yukon Medical, Llc Vial access and injection system
WO2009146088A1 (en) 2008-04-01 2009-12-03 Yukon Medical, Llc Dual container fluid transfer device
USD655017S1 (en) 2010-06-17 2012-02-28 Yukon Medical, Llc Shroud
USD681230S1 (en) 2011-09-08 2013-04-30 Yukon Medical, Llc Shroud
CA2877506A1 (en) * 2012-02-13 2013-08-22 Chongqing Lummy Pharmaceutical Co., Ltd. Doser having two needles
USD769444S1 (en) 2012-06-28 2016-10-18 Yukon Medical, Llc Adapter device
GB201318315D0 (en) * 2013-10-16 2013-11-27 Sab Miller Plc Dispensing apparatus
CN104385568B (zh) * 2014-09-17 2016-08-10 长沙市中一制药机械有限公司 一种直线式批量组装医用药包材的方法及设备
CN105342850B (zh) * 2015-11-13 2019-10-18 重庆莱美药业股份有限公司 单针混药器、硬双接口及输液软袋
US10874789B2 (en) 2015-12-03 2020-12-29 Drexel University Medical fluid delivery system

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3872867A (en) * 1971-06-02 1975-03-25 Upjohn Co Wet-dry additive assembly

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4759756A (en) * 1984-09-14 1988-07-26 Baxter Travenol Laboratories, Inc. Reconstitution device
US5653698A (en) * 1995-01-13 1997-08-05 Sanofi Winthrop, Inc. Coupling systems for saftey cannula
US6022339A (en) * 1998-09-15 2000-02-08 Baxter International Inc. Sliding reconstitution device for a diluent container
FR2790749B1 (fr) * 1999-03-10 2001-05-18 Maco Pharma Sa Dispositif de transfert d'une substance contenue dans un flacon dans une poche de solute

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3872867A (en) * 1971-06-02 1975-03-25 Upjohn Co Wet-dry additive assembly

Also Published As

Publication number Publication date
US20040015148A1 (en) 2004-01-22
AU2002216186A1 (en) 2002-06-18
WO2002045649A1 (fr) 2002-06-13
ATE328567T1 (de) 2006-06-15
FR2817465A1 (fr) 2002-06-07
DE60120475T2 (de) 2007-01-04
DE60120475D1 (de) 2006-07-20
US7442189B2 (en) 2008-10-28
FR2817465B1 (fr) 2003-04-25
EP1345566A1 (de) 2003-09-24

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