EP1574200B1 - Eine sterile Verbindung herstellender Perforationsverbinder - Google Patents

Eine sterile Verbindung herstellender Perforationsverbinder Download PDF

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Publication number
EP1574200B1
EP1574200B1 EP20050356039 EP05356039A EP1574200B1 EP 1574200 B1 EP1574200 B1 EP 1574200B1 EP 20050356039 EP20050356039 EP 20050356039 EP 05356039 A EP05356039 A EP 05356039A EP 1574200 B1 EP1574200 B1 EP 1574200B1
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EP
European Patent Office
Prior art keywords
sleeve
foil
needle
stroke
connector
Prior art date
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Active
Application number
EP20050356039
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English (en)
French (fr)
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EP1574200A1 (de
Inventor
Alain Orlu
Pierre-André Commaret
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P2A Medical
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P2A Medical
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Publication date
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Publication of EP1574200A1 publication Critical patent/EP1574200A1/de
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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
    • A61J1/14Details; 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

Definitions

  • the present invention relates to perforating connectors for connecting a first container and a second container for the passage of a fluid between the two containers.
  • the containers may be tubes, flasks, flexible walled pouches, having a mouth closed by a cover that a hollow needle can cross.
  • the invention relates more particularly to such a connector provided with a hollow needle for fluid passage, the needle being adapted to pierce a first cap of the first container and a second cap of the second container, for the passage of fluid through the channel axis of the needle between the two containers.
  • Such perforating connectors have already been designed, comprising a hollow needle for fluid passage, and with a needle support body sealingly attached around an intermediate portion of the needle and allowing a first and a second section of the needle to pass through. end of the needle for the passage of the lids of the containers.
  • a connector further comprising a first tubular receptacle surrounding the first end portion of the needle, closed by a first cover, and shaped to receive a first container to be connected, and comprising a second tubular receptacle surrounding the second end portion of the needle, closed by a second cap, and shaped to receive a second container to be connected.
  • the covers are movable axially towards one another by sliding, while the needle is mounted on an inner body which slides freely with respect to one and the other of the covers. By relative approximation of the caps, they are pierced by the respective ends of the needle.
  • the needle is thus confined in a sealed enclosure which protects it from all risks of pollution until the needle simultaneously pierces the wall of the sealed enclosure and the lids of the containers to be connected. It is thus possible, in practice, to disinfect, locally, before drilling, the external surfaces of the sealed enclosure wall and the lids of the containers that will be pierced by the needle, minimizing the risks of particle entrainment. pollutants during drilling.
  • Such a perforating connector structure requires simultaneously placing the two receptacles to be connected on either side of the covers. Otherwise, there is a risk that the needle, which is not held axially, pierces too early one of the opercules not yet covered with a container, and sterility would then no longer ensured, and the user could get hurt.
  • the problem proposed by the invention is, in such a perforating connector, to prevent any risk of inadvertent drilling of the sealed enclosure wall before positioning the containers, drilling which would not only produce the pollution of the needle, but also cause a major risk of injury to the operating personnel.
  • the invention also seeks to facilitate the handling of the perforating connector, in particular to ensure the drilling with the aid of simple axial translation movements.
  • the invention incorporates the general structure of a perforating connector comprising a hollow fluid passage needle, a needle support body sealingly attached around an intermediate portion of the needle and leaving a first end portion and a second end portion of the needle protruding, a first tubular receptacle surrounding the first end portion of the needle and shaped to receive a first element to be connected, a second receptacle tubular surrounding the second end portion of the needle and shaped to receive a second element to be connected, a first seal closing the first tubular receptacle, a second seal closing the second tubular receptacle, the first seal being axially displaceable relative to the body needle holder according to a first piercing stroke between an initial position away from the body and the needle and an end position close to the body and in which the needle passes through the first cap and its end protrudes outwardly of the connector, the second cap being axially movable relative to the needle support body in a second piercing stroke between a
  • the perforating connector comprises a coaxial external gripping sleeve arranged to axially move the body and the second cap towards the first cap according to the first piercing stroke, then to axially moving the second cap towards the body and towards the first cap according to the second piercing stroke.
  • the user can thus control the relative movements producing the piercing of one and the other of the covers, and can in particular definitely inhibit the piercing of the second cap during the piercing of the first cap, and it can not undertake the piercing the second cap after having made sure of the presence of the second container to be connected.
  • the non-return engagement means of the sleeve on the second seal may, for example, be such that the second bore comprises an intermediate annular rib with a sawtooth transverse profile having a first right face and a second oblique face, cooperating with the second seal for authorize its movement towards the first seal and to prohibit its return movement in the opposite direction.
  • the first cap is mounted on a first cylinder which slides in the sleeve and which slides on the body with the interposition of sealing means.
  • the first cylinder may constitute said first tubular receptacle.
  • the second cap can be mounted on a second cylinder which slides in the sleeve and which slides on the body with the interposition of sealing means.
  • the second cylinder may constitute said second tubular receptacle.
  • the first cylinder can advantageously protrude out of the sleeve, while the second cylinder can be engaged with the second seal in the vicinity of the second end of the sleeve.
  • a perforating connector comprises a hollow needle 1 with an axial channel 1a of fluid passage, a needle support body 2 which surrounds and is attached in a sealed manner to a section intermediate needle 1, and which allows to exceed a first end portion 3 and a second end portion 4 of the needle 1.
  • the first end portion 3 of the needle 1 is surrounded by a first tubular receptacle 5 closed by a first cap 6. In this way, in the initial position or the transport position illustrated in FIG. 1, the first end section 3 of the needle 1 remains confined in a first cavity 7 limited by the first lid 6, the first tubular receptacle 5 and the body 2.
  • a second tubular receptacle 8 surrounds the second end section 4 of the needle 1 and is closed off by a second cap 9. In this way, in the initial position or the transport position illustrated in FIG. 4 end of the needle 1 is confined in a second cavity 10 limited by the second cap 9, the second tubular receptacle 8 and the body 2.
  • the first tubular receptacle 5 is shaped to be coupled to a first container to be connected, for example by being applied axially against a lid or cap of a first bottle.
  • the second tubular receptacle 8 is shaped to be coupled to a second container to be connected; for example by being applied axially against a second cap or cap of a second bottle.
  • the assembly formed by the first cap 6 and the first tubular receptacle 5 can slide on the body 2, so that the first cap 6 is axially displaceable relative to the body 2 needle support in a first drilling hole C1:
  • the first piercing stroke C1 is defined as the axial translational movement of the first cap 6 from an initial position, illustrated in Figure 1, wherein the first cap 6 is away from the body 2 and the needle 1, to a final position, illustrated in Figure 2, wherein the first seal 6 is close to the body 2, the needle 1 through the first cap 6 and its end 3a protrudes outwardly of the connector.
  • the assembly formed by the second cap 9 and the second tubular receptacle 8 can slide on the body 2, so that the second cap 9 is axially movable relative to the body 2 needle support in a second piercing stroke C2 ( Figure 3).
  • the second drilling stroke C2 is defined as the axial translation movement of the second 9 from an initial position, illustrated in Figures 1 to 3, wherein the second cap 9 is away from the body 2 and the needle 1, to a final position, illustrated in Figure 4, in which the second operculum 9 is close to the body 2, the needle 1 through the second cap 9 and its end 4a protrudes outwardly of the connector.
  • the two lids 6 and 9 are movable independently of each other to and away from the body 2.
  • the first cap 6 is thus mounted on a first tubular receptacle 5 itself in the form of a first cylinder which slides on the body 2 with the interposition of first sealed sliding means 5a, for example a plurality of annular ribs provided on the body 2.
  • the second cap 9 is mounted on a second tubular receptacle 8 in the form of a cylinder which slides on the body 2 with the interposition of sealed sliding means 8a, for example a plurality of annular ribs provided on the body 2.
  • a coaxial outer sleeve 11 is provided to form a gripping means for axially displacing the body 2 towards the first cap 6 at a distance equal to the first piercing stroke C1 by driving the second cap 9, then to move the second cap axially 9 to the body 2 and to the first cover 6 according to the second piercing stroke C2.
  • the sleeve 11 comprises for this unilateral engagement means for axially pushing the body 2 towards the first cap 6, so that the sleeve 11 performs the first drilling stroke towards the body 2, that is to say the illustrated in FIG. 1 to FIG. 2.
  • the first cap 6 bears axially against a first container, so that it undergoes a relative movement towards the body 2 according to said first stroke piercing.
  • the unilateral engagement means allow the sleeve 11 to perform an inverse recoil stroke of the first piercing race, away from the first cap 6 that is to say to move from the position of Figure 2 in the position of FIG. 3.
  • the second cap 9 is in axial abutment against a second receptacle, and non-return engagement means of the sleeve 11 hold the second cap 9 in a fixed position relative to the body 2 allowing its sliding in the sleeve 11.
  • the unilateral engagement means again allow the axial displacement of the sleeve 11 in the direction of the first cap 6, according to a second drilling stroke passing from the position of Figure 3 to the position of the FIG. 4, during which the sleeve axially drives the second cap 9 from its initial position to its final position for its drilling by the needle 1.
  • the sleeve 11 comprises a first bore 12 of larger diameter, provided in a first end portion of the sleeve 11, and limited by a first shoulder 13 and a second shoulder 14.
  • the body 2 comprises an annular rib 15 of larger diameter, engaged in the first bore 12 of the sleeve 11 to allow the relative axial displacement of the sleeve 11 around the body 2 in a suitable stroke equal to the first drilling stroke C1.
  • the annular rib 15 abuts on one or other of the shoulders 13 or 14.
  • the sleeve 11 comprises a second bore of larger diameter 16, provided in a second end section of the sleeve 11, and limited by a third shoulder 17 and a fourth shoulder 18.
  • the second cap 9 remains engaged in the second bore 16 to move in an appropriate axial stroke equal to the second piercing stroke C2.
  • the second bore 16 comprises an intermediate annular rib 19 having a sawtooth transverse profile having a first right face and a second oblique face 21.
  • first tubular receptacle 5 in the form of a first cylinder, slides in the sleeve 11.
  • second tubular receptacle 8 in the form of a second cylinder, slides in the sleeve 11.
  • the first cylinder protrudes out of the sleeve 11, so that the first seal 6 has a first outer face 6a accessible for disinfection.
  • the second cylinder 8 is engaged in the sleeve 11 while having the second cap 9 in the vicinity of the second end of the sleeve 11, so that the outer face 9a of the second cap 9 is also accessible by the user for disinfection.
  • the connector is in the state illustrated in FIG. 1: the first tubular receptacle in the form of a cylinder 5 is away from the body 2 and protrudes outside the sleeve 11, the first end section 3 of the needle 1 being confined in the first recess 7 recessed from the first operculum 6.
  • the second tubular receptacle 8 is engaged in the sleeve 11 in the vicinity of its second end, the second operculum 9 being engaged between the fourth shoulder 18 and the intermediate rib 19, and being away from the body 2.
  • the second end portion 4 of the needle 1 is then confined in the second cavity 10.
  • the cap or cap of a first container is engaged against the first cap 6, and the perforating connector is pushed by its sleeve 11 against the first vial, c 1, which is then resting on the annular rib 15 of the body 2 by the shoulder 14, pushes the body 2 and the needle 1 downwards, causing the first cap 6 and the cap or plug of the first container to be pierced by the first end portion 3 of the needle 1.
  • the shoulder 18 also drives the second cap 9 in the same stroke, according to the same movement as the body 2, the needle 1 thus remaining always set back from the second operculum 9.
  • the sleeve 11 is then brought back in a recoil stroke, as illustrated in FIG. 3.
  • the second cap 9 held in axial abutment against the cap or cap of a second container, allows the rib to pass through. intermediate 19, thanks to the asymmetrical shape of the rib and elastic radial deformation of the rib 19 and / or the cover 9, and is engaged under the right side 20 of the intermediate rib 19.

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  • 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)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Prostheses (AREA)
  • Separation Using Semi-Permeable Membranes (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (8)

  1. Perforationsverbinder, umfassend eine Hohlnadel (1) für den Durchfluss eines Fluids, einen Lagerkörper (2) für die Nadel, in dem ein mittlerer Abschnitt der Nadel (1) abdichtend befestigt ist und über den ein erster Endabschnitt (3) und ein zweiter Endabschnitt (4) der Nadel (1) vorsteht, ein erstes rohrförmiges Gehäuse (5), das den ersten Endabschnitt (3) der Nadel (1) einschließt und so ausgebildet ist, daß es ein erstes anzuschließendes Element aufnehmen kann, ein zweites rohrförmiges Gehäuse (8), das den zweiten Endabschnitt (4) der Nadel (1) einschließt und so ausgebildet ist, daß es ein zweites anzuschließendes Element aufnehmen kann, einen ersten Deckel (6), der das erste rohrförmige Gehäuse (5) abschließt, einen zweiten Deckel (9), der das zweite rohrförmige Gehäuse (8) abschließt, wobei der erste Deckel (6) relativ zu dem Lagerkörper (2) für die Nadel über einen ersten Perforationshub (C1) in axialer Richtung verschiebbar ist zwischen einer von dem Lagerkörper (2) und der Nadel (1) entfernten Ausgangsstellung und einer an den Lagerkörper (2) angenäherten Endstellung, in der die Nadel (1) den ersten Deckel (6) durchstößt und mit ihrem Endabschnitt (3a) über den Verbinder nach außen vorsteht, und wobei der zweite Deckel (9) relativ zu dem Lagerkörper (2) für die Nadel über einen zweiten Perforationshub (C2) in axialer Richtung verschiebbar ist zwischen einer von dem Lagerkörper (2) und der Nadel (1) entfernten Ausgangsstellung und einer an den Lagerkörper (2) angenäherten Endstellung, in der die Nadel (1) den zweiten Deckel (9) durchstößt und mit ihrem Endabschnitt (4a) über den Verbinder nach außen vorsteht, dadurch gekennzeichnet, daß der Perforationsverbinder eine äußere, koaxiale Griffinuffe (11) aufweist, die dazu dient, den Lagerkörper (2) und den zweiten Deckel (9) um den ersten Perforationshub (C1) in Richtung auf den ersten Deckel (6) zu verschieben, um danach den zweiten Deckel (9) um den zweiten Perforationshub (C2) in Richtung auf den Lagerkörper (2) und den ersten Deckel (6) zu verschieben.
  2. Perforationsverbinder nach Anspruch 1, dadurch gekennzeichnet, daß
    - die Muffe (11) einseitig wirkende Eingriffsmittel (15, 18) aufweist, die so ausgebildet sind, daß die Muffe (11) den Lagerkörper (2) und den zweiten Deckel (9) in Richtung auf den ersten Deckel (6) axial vorstößt, wenn die Muffe (11) eine Axialverschiebung um einen Abstand durchführt, der mit dem ersten Perforationshub (C1) in Richtung des Lagerkörpers (2) übereinstimmt, und daß sich die Muffe (11) von dem Lagerkörper (2) und dem zweiten Deckel (9) in axialer Richtung entfernt, wenn die Muffe (11) in umgekehrter Richtung einen Rückhub um einen Abstand durchführt, der mit dem ersten Perforationshub (C1) von dem ersten Deckel (6) weg übereinstimmt,
    - die Muffe einen Rückhub verhindernde Eingriffsmittel (19-21) aufweist, die so ausgebildet sind, daß die Muffe (11) während ihres Rückhubs in der umgekehrten Richtung ein Festhalten des zweiten Deckels (9) in seiner relativ zum Lagerkörper (2) fixierten Stellung gewährleistet, und daß anschließend die Muffe (11) den zweiten Deckel (9) aus seiner Ausgangsstellung in Richtung seiner Endstellung axial verschiebt, wenn die Muffe (11) einen zweiten Perforationshub (C2) in Richtung auf den ersten Deckel (6) durchführt.
  3. Perforationsverbinder nach Anspruch 2, dadurch gekennzeichnet, daß die einseitig wirkenden Eingriffsmittel (15) der Muffe (11) aufweisen:
    - eine erste Bohrung (12) größeren Durchmessers, die in der Muffe (11) an einem ersten Endabschnitt ausgebildet und von einer ersten Schulter (13) und einer zweiten Schulter (14) begrenzt ist,
    - einen ringförmigen Bund (15) größeren Durchmesseres, der an dem Lagerkörper (2) ausgebildet ist und in die erste Bohrung (12) der Muffe (11) eingreift, um eine Axialverschiebung der Muffe (11) relativ zu dem Lagerkörper (2) über einen Hub zu ermöglichen, der geeignet und gleich dem ersten Perforationshub (C1) zwischen zwei Endstellungen ist, in denen der ringförmige Bund (15) an der einen oder der anderen der beiden Schultern (13, 14) anliegt.
  4. Perforationsverbinder nach einem der Ansprüche 2 oder 3, dadurch gekennzeichnet, daß die einseitig wirkenden Eingriffsmittel (18) der Muffe (11) aufweisen:
    - eine zweite Bohrung (16) größeren Durchmessers, die in der Muffe (11) an einem zweiten Endabschnitt ausgebildet und von einer ersten Schulter (17) und einer zweiten Schulter (18) begrenzt ist,
    - wobei der zweite Deckel (9) in die zweite Bohrung (16) so eingreift, so daß er über einen Axialhub verschiebbar ist, der mit dem zweiten Perforationshub (C2) übereinstimmt.
  5. Perforationsverbinder nach Anspruch 4, dadurch gekennzeichnet, daß die zweite Bohrung (16) einen ringförmigen Zwischenbund (19) mit dem Querschnittsprofil eines Sägezahnes aufweist, das eine erste, gerade Fläche (20) und eine zweite, schräge Fläche (21) aufweist und das mit dem zweiten Deckel (9) so zusammenwirkt, daß dieser in Richtung des ersten Deckels verschiebbar ist und seine Rückverschiebung in der entgegengesetzten Richtung verhindert wird.
  6. Perforationsverbinder nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, daß der erste Deckel (6) an einem ersten rohrförmigen Gehäuse (5) in Form eines ersten Zylinders angebracht ist, der in der Muffe (11) verschiebbar und auf dem Lagerkörper (2) unter Zwischenschaltung von dichtenden Gleitelementen (5a) verschiebbar ist.
  7. Perforationsverbinder nach einem der Ansprüche 1 bis 6, dadurch gekennzeichnet, daß der zweite Deckel (9) an einem zweiten rohrförmigen Gehäuse (8) in Form eines zweiten Zylinders angebracht ist, der in der Muffe (11) verschiebbar und auf dem Lagerkörper (2) unter Zwischenschaltung von dichtenden Gleitelementen (8a) verschiebbar ist.
  8. Perforationsverbinder nach einem der Ansprüche 6 oder 7, dadurch gekennzeichnet, daß in der Ausgangsstellung der erste Zylinder (5) über die Muffe (11) vorsteht und der zweite Zylinder (8) mit dem zweiten Deckel (9) in der Nähe des zweiten Endes der Muffe (11) in Eingriff ist, so daß die Außenflächen (6a, 9a) der Deckel (6, 9) von außen zugänglich sind.
EP20050356039 2004-03-10 2005-03-02 Eine sterile Verbindung herstellender Perforationsverbinder Active EP1574200B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0402568 2004-03-10
FR0402568A FR2867396B1 (fr) 2004-03-10 2004-03-10 Performeur perforant a connexion sterile

Publications (2)

Publication Number Publication Date
EP1574200A1 EP1574200A1 (de) 2005-09-14
EP1574200B1 true EP1574200B1 (de) 2006-11-02

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US (1) US7297140B2 (de)
EP (1) EP1574200B1 (de)
AT (1) ATE344000T1 (de)
CA (1) CA2500562A1 (de)
DE (1) DE602005000215T2 (de)
FR (1) FR2867396B1 (de)

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ATE344000T1 (de) 2006-11-15
DE602005000215T2 (de) 2007-08-30
FR2867396B1 (fr) 2006-12-22
FR2867396A1 (fr) 2005-09-16
EP1574200A1 (de) 2005-09-14
US7297140B2 (en) 2007-11-20
US20050203481A1 (en) 2005-09-15
DE602005000215D1 (de) 2006-12-14
CA2500562A1 (fr) 2005-09-10

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