EP0757553B1 - Distributeur fait d'une seule piece pour l'administration sans contamination de medicaments (cytostatiques) - Google Patents

Distributeur fait d'une seule piece pour l'administration sans contamination de medicaments (cytostatiques) Download PDF

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Publication number
EP0757553B1
EP0757553B1 EP95917950A EP95917950A EP0757553B1 EP 0757553 B1 EP0757553 B1 EP 0757553B1 EP 95917950 A EP95917950 A EP 95917950A EP 95917950 A EP95917950 A EP 95917950A EP 0757553 B1 EP0757553 B1 EP 0757553B1
Authority
EP
European Patent Office
Prior art keywords
dispensing device
container
coupling member
piece
piece dispensing
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
EP95917950A
Other languages
German (de)
English (en)
Other versions
EP0757553A1 (fr
Inventor
Harry Leibitzki
Marina Menz
Norbert Neubauer
Sebastian Vogt
Gerhard Wienzek
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.)
Menz Marina
Primed Halberstadt Medizintechnik GmbH
Original Assignee
Menz Marina
Primed Halberstadt Medizintechnik GmbH
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=27206544&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP0757553(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from DE9407022U external-priority patent/DE9407022U1/de
Priority claimed from DE19944422960 external-priority patent/DE4422960C2/de
Priority claimed from DE19944433669 external-priority patent/DE4433669C2/de
Application filed by Menz Marina, Primed Halberstadt Medizintechnik GmbH filed Critical Menz Marina
Publication of EP0757553A1 publication Critical patent/EP0757553A1/fr
Application granted granted Critical
Publication of EP0757553B1 publication Critical patent/EP0757553B1/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
    • A61J1/14—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
    • A61J1/2048—Connecting means
    • A61J1/2058—Connecting means having multiple connecting 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
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents

Definitions

  • the invention relates to a one-piece application device for contamination-free Administration of drugs (cytostatics), in particular used in outpatient treatment.
  • drugs cytostatics
  • the connector described in EP 0 363 770 consists essentially of a tubular coupling part and a this final shut-off device.
  • Coupling part consisting of a hollow piercing mandrel and one itself then insertable into a tubular connector of a container hollow part together by an externally detachable Shut-off device is completed.
  • are also off US Pat. No. 4,675,020 and EP 0 028 198 connectors are known, but they are also known do not correct the contamination problem in the desired manner and beyond, like the others described Solutions, just connecting two with pharmaceutical Allow solutions of filled containers. This implies that this Solutions are not, or only partially applicable, e.g. if the Dissolution of a preparation, for example, requires two solvents.
  • the invention has for its object an application device for Compound containing medication (cytostatics) Administration instruments indicate the contamination of the Environment of the drug container during its connection up towards disposal without major technical outlay guaranteed.
  • Compound containing medication cytostatics
  • Administration instruments indicate the contamination of the Environment of the drug container during its connection up towards disposal without major technical outlay guaranteed.
  • the object of the invention is achieved by the features of claim 1 solved.
  • the invention provides an application device Available, especially for outpatient treatments Application comes and no high demands on the medical technology personnel in their use and this by Exposes contamination problems.
  • FIG. 1 shows an application device which consists of a coupling part 1 exists, which includes a spike 2.
  • This coupling part is inseparable from a hose connection 3, 31 with a flexible, When using the arrangement for the first time, only fill it with a gas.
  • Container 4 cannot be removed by gluing or Weld connected.
  • shut-off valve 5 is provided inside the hose connection.
  • the flexible container 4 one, also inextricably linked to it hose-like drain 6.
  • the drain 6 is another mechanical Shut-off valve 7 arranged integrated.
  • Connection tubes to the patient e.g. also usual Catheter, connectable.
  • the coupling part 1 in turn consists of a Pot-shaped, inelastic hollow body 11, which has an inner receiving profile 12 has.
  • the hollow body 11 is advantageously also not shown elastic sealant lined.
  • the admission profile 12 is tapered inwards and has barbed surfaces 13.
  • a drug cytostatics
  • the bottleneck of the coupling part 1 can be included, is indicated schematically in Fig. 3 Medicament container 100 inserted into the coupling part 1 and pressed on.
  • the relative height is the depth of penetration of the piercing mandrel 2 to the barb surfaces 13 so that when the Spike 2 penetrated the puncture base of the medicament container 100 has, the barb surfaces 13 immediately in corresponding Engage the mating surfaces of the bottle neck of the drug container 100 and thus inseparably connect it to the coupling part 1. This ensures that during the connection and the subsequent infusion to be carried out by neither the medical personnel still the environment with leaking from the drug container Aerosols or similar be contaminated.
  • a mechanically operated Shut-off valve 5 the way to, e.g. air-filled, sterile, flexible Container 4 released.
  • the air can enter the drug container 100 pressed and then the required, metered amount of aspirated or drained liquid drug in the container 4 become. Only then is the route of the drug to the patient the hose-like drain 6 through the mechanical shut-off valve 7 openable, released.
  • FIG. 1 A further embodiment of the invention is shown in FIG differs from the embodiment according to FIG. 1 by a different design of the hose connector 31 along a line X-X differs.
  • the two hose connections 32 each provided with a coupling part 1, which is analogous to that shown in FIG. 1 are described.
  • This version is used in particular Administration of drugs (cytostatics) in solid form, such as Powders are available.
  • the procedure is as follows: First, the first coupling part 1 with a container that a corresponding solvent and then the second Coupling part 1 with a container containing the drug to be dissolved includes connected.
  • shut-off valve 51 After opening the shut-off valve 51 one arrives Predeterminable amount of the solvent in the flexible container 4, at The shut-off valves 7 and 5 are in the closed position Shutoff valve 51 closed and the shutoff valve 5 opened to the To clear the way to the container with the drug to be dissolved (cytostatics), the flexible container 4 is pressurized. To the dissolved medicament can be placed in the container 4 get back. The shut-off valves 5 and 51 are closed Position transferred and the administration of the dissolved drug can be done analogously, as described in Fig. 1. Of course 2 can also be used for dosed mixing of two liquid drugs, the container on the first and second coupling part 1 can be connected.
  • FIG. 3 shows a particularly advantageous application device according to the invention, which consists of a coupling part 1, which also contains a piercing mandrel 2.
  • This coupling part 1 is inseparably connected by means of a hose connection 31 to a flexible, self-supporting container 41 filled with a gas by gluing or welding.
  • a mechanically actuated shut-off valve 5 is provided within the hose connection.
  • the aforementioned container 41 carries, analogously to FIG. 1, a hose-like drain 6, which is also inseparably connected to it, within which a further mechanical shut-off valve 7 is integrated.
  • a second hose connection 32 branches off from the hose connection 31 and is also non-detachably connected thereto, to which a check valve 52 is connected as a mechanical shut-off valve, which has a blocking effect against the direction of the flexible container 41.
  • the check valve 52 is provided with a connecting piece 521 for receiving a conical connecting piece 9.
  • This connection piece 521 is preferably designed as a Luer lock connection, which is used in particular for receiving a conical outlet end of a conventional syringe.
  • an analog shut-off valve 5 can be provided between the check valve 52 and the hose connection 31.
  • the Luer lock connection is preferably designed such that it engages in the check valve itself in such a way that it causes the same to open when connected to the conical syringe outlet end 9.
  • the proposed embodiment is used in particular for the administration of medicaments (cytostatics) which are available in solid form, such as powders.
  • the procedure is as follows: first, the container 100, which contains the medicament to be dissolved, is connected to the coupling part 1 by pressing in the direction of the arrow. The path to the hose connection 31 is kept closed by the shut-off valve 5.
  • a syringe which can be filled, usually with saline solution, is variable, depending on the amount to be dissolved, of the drug present in solid form, with its conical outlet end 9 with the Luer lock connection 521, the nonreturn valve 52 being opened.
  • the solvent can now be introduced into the flexible, self-supporting container 41 filled with a gas, preferably air.
  • the syringe is removed, the check valve 52 ensuring the contamination-free closure to the outside. If the syringe or other storage container for the solvent remains in the connected position, a further shut-off valve 5 must be provided between the check valve 52 and the hose connection 31, which would have to be closed after the solvent has been introduced into the container 41.
  • shut-off valve 5 Only then is the first shut-off valve 5 to the coupling part 1 opened, the defined, predetermined amount of the solvent pressed into the container with the drug to be dissolved, and the solution passed into the container 41 after dissolution.
  • the drug container 100 remains inseparably and sealingly connected to the part 1, the first shut-off valve 5 is closed. It is within the scope of the invention to design the shut-off valve 5 as a three-way valve which is introduced into the container 41 immediately before the hose connection 31 occurs.
  • the released medicinal product is released to the patient by opening the shut-off valve 7.
  • FIG. 4 shows a coupling part 1, partly in section, in more detail shown.
  • all of the designated parts are: piercing mandrel 2, Hollow body 11, receiving profile 12 and a connector 8, preferably made of plastic, in one piece trained, i.e. the spike 2 is also an integral part of the Coupling part 1.
  • the entire coupling part 1 as Manufacture uniform molded part.
  • the essence of the invention is not to the number of those described Connections limited. In any case, it is essential that a flexible container 4, 41 filled with a gas is used, the one with at least two connecting lines that can be optionally opened and closed to defined coupling means or in the direction the drug delivery is provided.
  • the entire Application device that already with a gas (preferably air) filled containers includes to be provided in sterilized form.

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)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Claims (7)

  1. Appareil monobloc pour application de médicaments (cytostatiques) sans risque de contamination,
    comprenant au moins une pièce de raccord (1) pour établir une liaison solidaire avec un récipient (100) contenant un médicament, la pièce de raccord (1) étant dotée d'une tige de perforation (2) et de surfaces de barbes (13) pour y fixer le récipient avec le médicament,
    la dite pièce de raccord (1) étant solidairement reliée par un raccord flexible (3, 31 ;32, 31 ) à un récipient (4; 41) rempli de gaz
    le dit récipient (4; 41) étant solidairement raccordé à une pièce d'écoulement (6) et
    dans les dits raccords flexibles (3, 31 ; 32, 31, 6) étant intégré un robinet d'arrêt mécanique (5 ; 51 ; 7).
  2. Appareil d'application monobloc selon la revendication 1, il est caractérisé en ce que le raccord flexible (31) débouchant sur le récipient souple (4 ;41), que l'on peut remplir de gaz, est relié solidairement à deux raccords flexibles (32) dont chacun est doté d'un robinet d'arrêt mécanique (5 ;51 ;52) ; au moins un des raccords flexibles (32) est pourvu d'une pièce de raccord (1).
  3. Appareil d'application monobloc selon les revendications 1 et 2, il est caractérisé en ce que la pièce de raccord (1) est constituée d'un corps creux rigide (11) en forme de pot entourant la tige de perforation (2) et présentant à l'intérieur un profil de réception (12) permettant le branchement solidaire d'un récipient (100) contentant le médicament ; la distance relative qui sépare la pointe de la tige de perforation (2) et les surfaces à barbes (13) du profil de réception (12) étant choisie de sorte que l'effet d'accrochage causé par les surfaces à barbes (13) se produise immédiatement après la perforation de la paroi du récipient contenant le médicament, par la tige .
  4. Appareil d'application monobloc selon la revendication 3, il est caractérisé en ce que la pièce de raccord (1) constituée essentiellement du corps creux (11), du profil de réception (12), d'un raccord (8) et d'une tige de perforation (2) sont fabriqués dans une seule pièce et dans le même matériau.
  5. Appareil d'application monobloc selon la revendication 1, il est caractérisé en ce que le récipient (4) est constitué par un récipient (41) qui, au dépit de sa souplesse, conserve sa forme.
  6. Appareil d'application monobloc selon les revendications 2 ou 5, il est caractérisé en ce qu'au moins un robinet d'arrêt mécanique disposé sur le côté remplissage du récipient (4 ; 41) est conçu comme un clapet de retenue (52) comprenant un raccord tubulair (521) sur lequel on peut brancher une piéce de raccord conique (9) pour additionner le solvant dont la quantité peut varier d'une application à l'autre.
  7. Appareil d'application monobloc selon la revendication 6, il est caractérisé en ce que le raccord tubulair (521) est du type Luer-Lock lequel permet d'ouvrir par rotation le clapet de retenue (52).
EP95917950A 1994-04-28 1995-04-25 Distributeur fait d'une seule piece pour l'administration sans contamination de medicaments (cytostatiques) Expired - Lifetime EP0757553B1 (fr)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
DE9407022U DE9407022U1 (de) 1994-04-28 1994-04-28 Konnektor zur kontaminationsfreien Verabreichung von Arzneimitteln (Zytostatika)
DE9407022U 1994-04-28
DE19944422960 DE4422960C2 (de) 1994-04-28 1994-06-29 Einstückige Appliziervorrichtung zur kontaminationsfreien Verabreichung von Arzneimitteln, insbesondere Zytostatika
DE4422960 1994-06-29
DE19944433669 DE4433669C2 (de) 1994-04-28 1994-09-21 Einstückige Appliziervorrichtung zur kontaminationsfreien Verabreichung von in fester Ausgangsform vorliegenden Arzneimitteln, insbesondere Zytostatika
DE4433669 1994-09-21
PCT/EP1995/001547 WO1995029661A1 (fr) 1994-04-28 1995-04-25 Distributeur fait d'une seule piece pour l'administration sans contamination de medicaments (cytostatiques)

Publications (2)

Publication Number Publication Date
EP0757553A1 EP0757553A1 (fr) 1997-02-12
EP0757553B1 true EP0757553B1 (fr) 2000-08-02

Family

ID=27206544

Family Applications (1)

Application Number Title Priority Date Filing Date
EP95917950A Expired - Lifetime EP0757553B1 (fr) 1994-04-28 1995-04-25 Distributeur fait d'une seule piece pour l'administration sans contamination de medicaments (cytostatiques)

Country Status (6)

Country Link
US (1) US5899877A (fr)
EP (1) EP0757553B1 (fr)
AT (1) ATE195071T1 (fr)
CA (1) CA2188953A1 (fr)
FI (1) FI964252A0 (fr)
WO (1) WO1995029661A1 (fr)

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US7842377B2 (en) 2003-08-08 2010-11-30 Boston Scientific Scimed, Inc. Porous polymeric particle comprising polyvinyl alcohol and having interior to surface porosity-gradient
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US7311861B2 (en) * 2004-06-01 2007-12-25 Boston Scientific Scimed, Inc. Embolization
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US8101197B2 (en) 2005-12-19 2012-01-24 Stryker Corporation Forming coils
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US7947368B2 (en) 2005-12-21 2011-05-24 Boston Scientific Scimed, Inc. Block copolymer particles
BRPI0714879A2 (pt) * 2006-07-21 2013-02-26 Polimoom Medical Packaging As dispositivo de conector e mÉtodo para mistura estÉril
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US9084864B1 (en) 2010-03-04 2015-07-21 Barthel LLC Adaptor for breathing tube and method
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Also Published As

Publication number Publication date
ATE195071T1 (de) 2000-08-15
FI964252A (fi) 1996-10-22
US5899877A (en) 1999-05-04
EP0757553A1 (fr) 1997-02-12
FI964252A0 (fi) 1996-10-22
WO1995029661A1 (fr) 1995-11-09
CA2188953A1 (fr) 1995-11-09

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