EP1574200A1 - Eine sterile Verbindung herstellender Perforationsverbinder - Google Patents

Eine sterile Verbindung herstellender Perforationsverbinder Download PDF

Info

Publication number
EP1574200A1
EP1574200A1 EP20050356039 EP05356039A EP1574200A1 EP 1574200 A1 EP1574200 A1 EP 1574200A1 EP 20050356039 EP20050356039 EP 20050356039 EP 05356039 A EP05356039 A EP 05356039A EP 1574200 A1 EP1574200 A1 EP 1574200A1
Authority
EP
European Patent Office
Prior art keywords
sleeve
cap
needle
stroke
connector
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.)
Granted
Application number
EP20050356039
Other languages
English (en)
French (fr)
Other versions
EP1574200B1 (de
Inventor
Alain Orlu
Pierre-André Commaret
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.)
P2A Medical
Original Assignee
P2A Medical
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 P2A Medical filed Critical P2A Medical
Publication of EP1574200A1 publication Critical patent/EP1574200A1/de
Application granted granted Critical
Publication of EP1574200B1 publication Critical patent/EP1574200B1/de
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61J1/14—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
    • 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
    • A61J1/2051—Connecting means having tap means, e.g. tap means activated by sliding

Definitions

  • the present invention relates to perforating connectors, allowing to connect between them 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, with a mouth closed by a seal that a hollow needle can cross.
  • the invention more specifically relates to such a connector provided with a hollow needle for fluid passage, the needle being adapted to pierce a first lid of the first container and a second lid of the second container, for the passage of the fluid through the axial channel of the needle between the two containers.
  • Such piercing connectors have already been designed, including a needle hollow fluid passage, and with a needle support body fixed so tight around an intermediate portion of the needle and leaving first and second end sections of the needle for the passage of lids of the containers.
  • the needle is thus confined in a sealed enclosure which protects it from all risks of pollution until the needle pierces the wall simultaneously the sealed enclosure and the lids of the containers to be connected. It is so possible, in practice, to disinfect, locally, before drilling, the surfaces external walls of the sealed enclosure wall and the lids of the containers that will be pierced by the needle, minimizing the risk of particle entrainment pollutants during drilling.
  • Such a perforating connector structure requires placing simultaneously the two containers to be connected on both sides of the covers. AT defect, 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 be more assured, and the user could get hurt.
  • the problem proposed by the invention is, in such a connector perforating, prevent any risk of inadvertent drilling of the enclosure wall sealed before positioning the containers, piercing which would not only produce pollution of the needle, but also would entail a major risk of injury to the user staff.
  • a perforating connector comprising a hollow needle of fluid passage, a needle support body sealingly attached around a intermediate section of the needle and leaving a first section end and a second end portion of the needle, a first receptacle tubular surrounding the first end portion of the needle and shaped to receive a first element to be connected, a second tubular receptacle 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 operculum being axially displaceable relative to the needle support body according to a first piercing stroke between an initial position away from the body and the needle and a final position close to the body and in which the needle crosses the first seal and its end protrudes outward from the connector, the second cap being movable axially relative to the body needle holder according to a second piercing stroke from an initial
  • the perforating connector comprises a sleeve of coaxial external grip arranged to axially move the body and the second operculum towards the first seal according to the first piercing stroke, then for axially move the second seal towards the body and towards the first seal according to the second piercing stroke.
  • the user can thus control the relative movements producing the piercing one and the other of the lids, and may in particular inhibit some piercing of the second cap during the drilling of the first cap, and he can only begin piercing the second lid after having made sure of the presence of the second container to be connected.
  • Means of anti-return engagement of the sleeve on the second such a cap may for example be such that the second bore comprises a intermediate annular rib with transverse sawtooth profile having a first right face and a second oblique face, cooperating with the second operculum to allow its movement towards the first operculum and for prohibit his movement back 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 means of waterproof sliding.
  • the first cylinder can constitute said first receptacle tubular.
  • the second cap can be mounted on a second cylinder which slides in the sleeve and which slides on the body with interposition of waterproof sliding means.
  • the second cylinder can 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 operculum in the vicinity of the second end of the muff.
  • a connector perforating device comprises a hollow needle 1 with an axial channel 1 a of fluid passage, a needle support body 2 which surrounds and is fixed so sealed to an intermediate portion of the needle 1, and which allows to pass a first end section 3 and a second end section 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 operculum 6. In this way, initial position or transport position illustrated in Figure 1, the first section end 3 of the needle 1 remains confined in a first cavity 7 limited by the first operculum 6, by the first tubular receptacle 5 and the body 2.
  • a second tubular receptacle 8 surrounds the second section end 4 of the needle 1 and is closed by a second operculum 9.
  • the second section 4 end of the needle 1 is confined in a second cavity 10 limited by the second operculum 9, by 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 vial.
  • the assembly formed by the first cap 6 and the first receptacle tubular 5 can slide on the body 2, so that the first seal 6 is axially displaceable relative to the body 2 needle support according to a first C1 piercing stroke:
  • the first piercing stroke C1 is defined as being the axial translational movement of the first cap 6 from a position initial embodiment, illustrated in FIG. 1, in which the first lid 6 is away from the body 2 and the needle 1, to a final position, illustrated in FIG. which the first operculum 6 is close to the body 2, the needle 1 passes through the first cap 6 and its end 3a protrudes outwardly of the connector.
  • the assembly formed by the second operculum 9 and the second tubular receptacle 8 can slide on the body 2, so that the second opercule 9 is axially displaceable relative to the body 2 needle support in a second drilling stroke C2 ( Figure 3).
  • the second race of drilling C2 is defined as the axial translation movement of the second opercule 9 from an initial position, illustrated in FIGS. 1 to 3, in which the second cap 9 is away from the body 2 and the needle 1, to a position end, illustrated in FIG. 4, in which the second cap 9 is brought closer to the body 2, the needle 1 passes through the second operculum 9 and its end 4a protrudes towards the outside of the connector.
  • the two lids 6 and 9 are movable independently of one of the other towards and away from the body 2.
  • the first cap 6 is thus mounted on a first receptacle tubular 5 itself in the form of a first cylinder which slides on the body 2 with 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 receptacle tubular 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 ribs rings provided on the body 2.
  • An outer coaxial sleeve 11 is provided to constitute a means of gripping for axially moving the body 2 towards the first operculum 6 according to a distance equal to the first piercing stroke C1 by causing the second operculum 9, then to axially move the second cap 9 to the body 2 and towards the first cap 6 according to the second piercing stroke C2.
  • the sleeve 11 comprises for this means unilateral engagement means to axially push the body 2 towards the first lid 6, so that the sleeve 11 performs the first drilling stroke towards the body 2, that is to say the illustrated run from Figure 1 to Figure 2.
  • the first cap 6 is in axial support against a first container, so that it undergoes a relative movement towards the body 2 according to said first piercing stroke.
  • the means of unilateral engagement allow the sleeve 11 to reverse reversing stroke of the first piercing stroke, out of the way of the first operculum 6, that is to say, to move from the position of FIG. position of Figure 3.
  • the second operculum 9 is in axial support against a second container, 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 sleeve 11 comprises a first bore 12 of larger diameter, provided in a section of first end 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 according to a race appropriately equal to the first piercing stroke C1.
  • the annular rib 15 abuts on one or the other of the shoulders 13 or 14.
  • the sleeve 11 comprises a second bore of larger diameter 16, provided in a section of second end 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 for 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 face 21 oblique.
  • the second tubular receptacle 8 in the form of a second cylinder slides in the sleeve 11.
  • the first cylinder exceeds outside the sleeve 11, so that the first cap 6 presents a first external face 6a accessible for disinfection.
  • the second cylinder 8 is engaged in the sleeve 11 while having the second operculum 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 shown in Figure 1: the first cylindrical tubular receptacle 5 is away from the body 2 and protrudes outside the sleeve 11, the first end portion 3 of the needle 1 being confined in the first cavity 7 set back from the first lid 6.
  • 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 section 4 of the needle 1 is then confined in the second cavity 10.
  • the lid or cap of a first container is engaged against the first operculum 6, and the perforating connector is pushed by its sleeve 11 against the first bottle, that is to say downwards in Figure 1.
  • the shoulder 18 also causes the second operculum 9 in the same race, in the same movement as the body 2, the needle 1 thus remaining always set back from the second lid 9.
  • the sleeve 11 is then brought back in a recoil stroke, as illustrated in FIG. 3.
  • the second operculum 9 selected in axial support against the operculum or cap of a second container, lets pass the intermediate rib 19, thanks to the asymmetrical shape of the rib and to a elastic radial deformation of the rib 19 and / or the operculum 9, and engage under the right face 20 of this 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)
  • Prostheses (AREA)
  • Separation Using Semi-Permeable Membranes (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
EP20050356039 2004-03-10 2005-03-02 Eine sterile Verbindung herstellender Perforationsverbinder Not-in-force EP1574200B1 (de)

Applications Claiming Priority (2)

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

Publications (2)

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

Family

ID=34814576

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20050356039 Not-in-force EP1574200B1 (de) 2004-03-10 2005-03-02 Eine sterile Verbindung herstellender Perforationsverbinder

Country Status (6)

Country Link
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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EP2090278A1 (de) * 2008-02-18 2009-08-19 P2A Medical Deckelsystem zur Übertragung
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EP2090278A1 (de) * 2008-02-18 2009-08-19 P2A Medical Deckelsystem zur Übertragung
FR2927533A1 (fr) * 2008-02-18 2009-08-21 P2A Medical Soc Par Actions Si Capuchon de transfert securise
WO2014053430A1 (de) * 2012-10-01 2014-04-10 Medac Gesellschaft für klinische Spezialpräparate mbH Transfervorrichtung zur entnahme oder übergabe eines fluids
US10058482B2 (en) 2012-10-01 2018-08-28 Medac Gesellschaft Fur Klinische Spezialpraparate Mbh Transfer device for tapping or delivering a fluid
WO2015160522A1 (en) * 2014-04-15 2015-10-22 Advanced Scientifics, Inc. Aseptic connector
US9186493B2 (en) 2014-04-15 2015-11-17 Advanced Scientific, Inc. Aseptic connector
US10111809B2 (en) 2014-04-15 2018-10-30 Advanced Scientifics, Inc. Aseptic connector and method
US11191700B2 (en) 2014-04-15 2021-12-07 Advanced Scientifics, Inc. Aseptic connector

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EP1574200B1 (de) 2006-11-02
ATE344000T1 (de) 2006-11-15
FR2867396B1 (fr) 2006-12-22
US20050203481A1 (en) 2005-09-15
US7297140B2 (en) 2007-11-20
DE602005000215T2 (de) 2007-08-30
CA2500562A1 (fr) 2005-09-10
DE602005000215D1 (de) 2006-12-14
FR2867396A1 (fr) 2005-09-16

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