EP1293190B1 - Transfereinheit bestend aus einem Flacon, einer Ampulle, und einer Vorrichtung zum bidirektionalen Übertragen einer in dem Flacon enthaltenen Flüssigkeit in die Ampulle - Google Patents

Transfereinheit bestend aus einem Flacon, einer Ampulle, und einer Vorrichtung zum bidirektionalen Übertragen einer in dem Flacon enthaltenen Flüssigkeit in die Ampulle Download PDF

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Publication number
EP1293190B1
EP1293190B1 EP20020292139 EP02292139A EP1293190B1 EP 1293190 B1 EP1293190 B1 EP 1293190B1 EP 20020292139 EP20020292139 EP 20020292139 EP 02292139 A EP02292139 A EP 02292139A EP 1293190 B1 EP1293190 B1 EP 1293190B1
Authority
EP
European Patent Office
Prior art keywords
piston
needle
carpule
cartridge
bottle
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
EP20020292139
Other languages
English (en)
French (fr)
Other versions
EP1293190A1 (de
Inventor
Jean-Pascal Delay
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.)
Sedat SAS
Original Assignee
Sedat SAS
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 Sedat SAS filed Critical Sedat SAS
Publication of EP1293190A1 publication Critical patent/EP1293190A1/de
Application granted granted Critical
Publication of EP1293190B1 publication Critical patent/EP1293190B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089Containers or vials which are to be joined to each other in order to mix their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06Ampoules or carpules
    • A61J1/062Carpules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/201Piercing means having one piercing end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/2013Piercing means having two piercing ends
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2051Connecting means having tap means, e.g. tap means activated by sliding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2065Connecting means having aligning and guiding means

Definitions

  • the needle ensuring the communication between the cartridge and the bottle is carried by a pierceable shuttle initially free to slide axially relative to the body.
  • the object of the invention is to propose a transfer device whose operating sequence is simplified.
  • the subject of the invention is a bidirectional transfer device, of the aforementioned type, characterized in that the hollow needle is integral with the body and is axially fixed relative to the body.
  • the transfer device 10 shown in FIG. 1 is generally cylindrical in shape of the X-X axis. It is adapted to ensure the bidirectional transfer of a fluid between a cartridge 12, visible in Figures 2 and 4, and a bottle 14, visible in these figures.
  • the device 10 essentially comprises a body 16 having, at a lower end, means 18 for attaching the bottle, a mobile support member 20 for supporting the body of the cartridge, this equipment being adapted to slide relative to the body 16 and a spacer 22 forming a pusher adapted to bear on the piston of the cartridge 12.
  • the device further comprises a hollow needle 24 integral with the body 16. In Figure 2, the latter is shown away from the body 16 to be visible.
  • the cartridge 12 is intended to perform an injection after having been extracted from the transfer device and equipped with an injection needle and an actuating pusher. It comprises a cylindrical tank 25 having, at the front, a narrowed neck closed by a pierceable lid 26. The lid 26 is adapted to be perforated by an injection needle mounted on the cartridge for injection.
  • the carpule further comprises a perforable piston 27 sliding axially inside the reservoir 25. Initially, the cartridge contains a solvent.
  • the bottle 14 comprises a glass body having a neck closed by a perforable lid 28.
  • the neck has a peripheral rim defining a shoulder 29.
  • the bottle 14 contains a lyophilizate to be dissolved in the solvent contained in the carpule.
  • the body 16 generally has a tubular shape. It has, at its lower end, a cap 30 defining a housing 31 for receiving the bottle 14.
  • the housing 31 is defined by a cylindrical wall 32 closed by a bowl 34 for receiving the neck of the bottle 14.
  • the bowl 34 is delimited laterally by a cylindrical wall 36 of smaller diameter than the cylindrical wall 32. It is closed by a transverse wall 37 forming a bottom.
  • the bowl is connected to the cylindrical wall 32 by a frustoconical section 38.
  • projections 40 On the inner surface of the cylindrical wall 32 are provided projections 40 to ensure axial retention of the bottle by resilient engagement of the projections behind the neck of the bottle.
  • the bottom 37 of the bowl is traversed axially by the transfer needle 24.
  • This needle is retained by a collar 42 projecting out of the housing 30.
  • the collar 42 provides an axial connection of the body 16 and the needle 24.
  • the needle 24 has a first end 24A projecting inside the housing 30. This end is adapted to perforate the lid 28 closing the bottle 14.
  • the needle 24 extends on the other side of the bottom 37 over most of the length of the body 16. It has on this side of the bottom 37 a 24B perforation end of the piston of the cartridge.
  • the body 16 has a tubular trunk 50 extending the cylindrical wall 32 of the cap.
  • the tubular trunk 50 surrounds the side wall 36. Between the cylindrical wall 36 and the lower end of the tubular trunk 50 is defined an annular space 52.
  • the tubular trunk 50 has longitudinal lumens and windows ensuring the elastic interlocking of protrusions provided on the movable retaining member 20 of the carpule and on the spacer 22.
  • the spacer 22 has, at a lower end, a base 60 in the form of a bell adapted to engage around the bowl 34. At its other free end, it has a profile 62 for hooking and bearing on the piston of the carpule.
  • the spacer 22 has a cylindrical wall 64 axially surrounding the needle 24.
  • the outer diameter of the cylindrical wall 64 is smaller than the inner diameter of the tank of the carpule, to allow the spacer to enter the carpule .
  • the base 60 is integral with the end of the cylindrical wall 64.
  • This base has a peripheral skirt 66 adapted to be received in the annular space 52.
  • This skirt is connected to the cylindrical wall 64 by a ring 68.
  • the skirt 66 externally has two diametrically opposed snap protrusions 70. These projections are adapted to be received, as shown in Figure 3, in two windows 72 formed in the tubular trunk 50 of the body. These windows 72 are arranged away from the cap 30.
  • Two identical windows 74 are formed in the vicinity of the cap 29 and are adapted to receive the latching projections 70 after displacement of the spacer 22 along the needle 24 towards the bottle 14.
  • the attachment and support profile 62 of the pierceable piston of the carpule comprises a threaded end 75 extending axially in the extension of the cylindrical wall 64.
  • This threaded end has a outer diameter reduced and has an external thread adapted to cooperate with a thread formed in a threaded recess of the pierceable piston 27 of the cartridge.
  • a shoulder 76 is provided at the end of the cylindrical wall 64 to ensure the connection of this wall 64 to the tip 75. This shoulder also allows the support of the piston of the cartridge.
  • the end piece 75 is extended inside the cylindrical body by a collar 77.
  • the endpiece 75 and the collar 77 internally define a passage 78 for guiding the needle 24 and in particular its end section completed by the perforation end 24B.
  • the dimensions of the needle 24 and the various components of the spacer 22 are such that, when the spacer 22 is in its initial position, with the latching projections 70 received in the windows 72 (FIGS. 3 and 4), the perforation end 24B of the needle is disposed inside the passage 78.
  • the mobile unit 20 for supporting and moving the reservoir of the carpule comprises a carpule holder 80 and a cap 82 screwed onto the carpule support. Between these is delimited a housing 84 of axial immobilization of the reservoir 25 of the carpule.
  • the carpule support 80 has a tubular section 86 whose inside diameter corresponds to the outside diameter of the tank 25 of the carpule.
  • This tubular section has on its outer surface a thread adapted to cooperate with a complementary thread formed at the end of the cap 82.
  • the latter has a cylindrical side wall 88 in which is partially received the tubular portion 86 of the carpule support.
  • This side wall 88 is closed by a transverse wall 90 forming a bearing surface for the hand.
  • the cylindrical section has a ring 91 forming a shoulder for the support of the rear end of the tank.
  • the ring 91 is extended by a peripheral lip 92 surrounding the cylindrical wall 64 of the spacer to ensure axial guidance of the moving element 20 with respect to the spacer 22.
  • the support 80 has an outer skirt 94 surrounding the tubular section 86 between the threading for the connection of the cap 82 and the end of the section 86 equipped with the lip 92.
  • This skirt 94 externally has a first pair of protrusions. snapping 98 diametrically opposed and adapted to be initially received in two windows 100 formed near the upper end of the tubular portion of the body.
  • another pair of diametrically opposed projections 104 are provided externally to the free end of the skirt 94. These are received in diametrically opposite longitudinal slots 106 extending substantially along the length of the tubular trunk 50 from the body.
  • the device is initially in the storage state shown in FIG. 3. In this state, no vial or cartridge is placed in the device.
  • the carpule 12 is first put in place in the moving assembly 20, as illustrated in FIG. 4.
  • the cap 82 is unscrewed from the carpule holder 80.
  • the carpule is then introduced with its rear end engaged in the space delimited by the cylindrical section 86.
  • the pierceable piston 27 is screwed onto the endpiece 75 of the spacer. In this position, the rear end of the cartridge bears against the ring 91 of the cartridge holder 80.
  • the cap 82 is then screwed onto the cartridge holder 80. This screwing is performed until the transverse wall 90 of the cap bears on the front end of the cartridge, so that the reservoir 25 of the carpule is secured axially relative to the moving assembly 20.
  • the bottle 14 is then engaged in the housing 30, as illustrated in FIG. 4.
  • the bottle 14 is retained in the housing 30 by the elastic engagement projections 40 applied against the shoulder 29.
  • the perforable seal 28 is perforated by the transfer needle 24 from its end 24A.
  • the moving assembly 20 is caused to move along the body.
  • the detent projections 98 emerge from the windows 100, thus allowing the mobile assembly 20 to slide inside the tubular trunk 50 of the body.
  • the perforated piston of the cartridge is held in abutment on the spacer 22 and is thus immobilized relative to the body.
  • the body of the carpule being displaced by the sliding of the moving element 20, a relative displacement between the piston and the cartridge body occurs, the piston gradually sinking into the body.
  • the liquid contained in the carpule is then ejected through the needle 24 into the bottle 14.
  • the projections 104 received in the longitudinal slots 106 provide a guide in translation and immobilization in rotation of the moving element relative to the body.
  • the detent projections 98 are also received in the slots 106.
  • the device is slightly shaken to ensure dissolution of the lyophilisate in the solvent initially contained in the carpule.
  • the device is completely returned.
  • the bottle 14 is above the carpule.
  • the end 24A of the needle is in the lower part of the vial allowing suction extraction of most of the contained mixture.
  • the suction is ensured by the moving equipment 20 which is brought away from the bottle 14.
  • the body 16 is held in one hand while the cap 90 is pulled in the direction of the needle.
  • the piston 27 traversed by the needle 24 is held immobilized relative to the body by the engagement of the latching projections 70 in the windows 74.
  • the mobile assembly 20 which is secured to the cylindrical reservoir 25 moves inside the body in the direction of the needle 24, so that the piston moves relative to the cylindrical reservoir, thereby creating a depression in the carpule, which causes the recall of the mixture contained in the bottle 14.
  • the displacement of the moving element 20 is interrupted when the detent tongues 98 reach the upper end of the longitudinal slots 106.
  • the presence of the projections 98 and stop stops formed by the ends of the slots 106 makes it possible to avoid that the moving element 20 is too far from the body, thus avoiding any risk of accidental disengagement of the piston 27 from the tank 25.
  • the cap 82 is finally disassembled and the carpule is extracted from the moving equipment. This cartridge is then used to make an injection after it has been equipped with an injection needle and a push rod screwed into the pierceable piston.

Claims (4)

  1. Übertragungsgerät, umfassend eine Flasche (14), die mit einem perforierbaren Stopfen (28) versehen ist, eine Karpule (12), die einen zylindrischen Behälter (25) umfasst, in dem ein perforierbarer Kolben (27) gleitet, und eine Vorrichtung zur bidirektionalen Übertragung einer Flüssigkeit zwischen der Flasche (14) und der Karpule (12), wobei die Vorrichtung umfasst:
    - einen Körper (16), der Mittel (18) zum Einhaken der Flasche (14) umfasst;
    - eine hohle Nadel (24), die ein erstes Ende (24B) zum Perforieren des Kolbens (27) der Karpule und ein zweites Ende (24A) aufweist, das für die Perforierung des Stopfens (28) der Flasche ausgelegt ist;
    - ein bewegliche Einrichtung (20), die bezüglich des Körpers (16) in der Richtung der Achse der Nadel (24) beweglich ist, wobei diese bewegliche Einrichtung (20) Mittel zur axialen festen Verbindung des Behälters (25) der Karpule gemäß der Richtung der Achse der Nadel (24) umfasst; und
    - ein Zwischenstück (22), das zwischen den Körper (16) und den perforierbaren Kolben (27) der Karpule eingesetzt ist, wobei dieses Zwischenstück (22) einen Stoppanschlag für den perforierbaren Kolben (27) bezüglich des Körpers (16) bildet,
    dadurch gekennzeichnet, dass die hohle Nadel (24) mit dem Körper (16) fest verbunden ist und axial bezüglich des Körpers (16) feststehend ist.
  2. Übertragungsgerät nach Anspruch 1, dadurch gekennzeichnet, dass das Zwischenstück (22) bezüglich des Körpers (16) zwischen einer Anfangsstellung, in der es den perforierbaren Kolben (27) in einem Abstand von dem ersten Ende (24B) der Nadel hält, und einer Endstellung beweglich ist, in der die Nadel (24) durch den perforierbaren Kolben (27) eingesteckt ist.
  3. Übertragungsgerät nach Anspruch 1 oder 2, dadurch gekennzeichnet, dass die bewegliche Einrichtung (20) und der Körper (16) Mittel (98, 106) zur Begrenzung der Bewegung der beweglichen Einrichtung (20) bezüglich des Körpers (16) in der Richtung des Auszugs des perforierbaren Kolbens (27) aus dem zylindrischen Behälter umfassen.
  4. Übertragungsgerät nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass die bewegliche Einrichtung (20) und der Körper (16) Mittel (104, 106) zur Führung in Translation und zur Blockierung in Drehung in Bezug aufeinander umfassen.
EP20020292139 2001-09-17 2002-08-29 Transfereinheit bestend aus einem Flacon, einer Ampulle, und einer Vorrichtung zum bidirektionalen Übertragen einer in dem Flacon enthaltenen Flüssigkeit in die Ampulle Expired - Lifetime EP1293190B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0112007 2001-09-17
FR0112007A FR2829691B1 (fr) 2001-09-17 2001-09-17 Dispositif de transfert bidirectionnel d'un liquide entre un flacon et une carpule

Publications (2)

Publication Number Publication Date
EP1293190A1 EP1293190A1 (de) 2003-03-19
EP1293190B1 true EP1293190B1 (de) 2006-10-25

Family

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Application Number Title Priority Date Filing Date
EP20020292139 Expired - Lifetime EP1293190B1 (de) 2001-09-17 2002-08-29 Transfereinheit bestend aus einem Flacon, einer Ampulle, und einer Vorrichtung zum bidirektionalen Übertragen einer in dem Flacon enthaltenen Flüssigkeit in die Ampulle

Country Status (7)

Country Link
US (1) US6752180B2 (de)
EP (1) EP1293190B1 (de)
JP (2) JP4790198B2 (de)
AT (1) ATE343362T1 (de)
DE (1) DE60215598T2 (de)
ES (1) ES2275821T3 (de)
FR (1) FR2829691B1 (de)

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DE60215598D1 (de) 2006-12-07
ES2275821T3 (es) 2007-06-16
DE60215598T2 (de) 2007-08-30
FR2829691B1 (fr) 2004-07-09
JP2009279424A (ja) 2009-12-03
EP1293190A1 (de) 2003-03-19
US20030055376A1 (en) 2003-03-20
JP4790198B2 (ja) 2011-10-12
ATE343362T1 (de) 2006-11-15
FR2829691A1 (fr) 2003-03-21
US6752180B2 (en) 2004-06-22
JP2003111842A (ja) 2003-04-15

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