EP1574200B1 - Connector of the perforating type performing a sterile connection - Google Patents

Connector of the perforating type performing a sterile connection 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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Application number
EP20050356039
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German (de)
French (fr)
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EP1574200A1 (en
Inventor
Alain Orlu
Pierre-André Commaret
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P2A Medical
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P2A Medical
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    • 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

Abstract

The connector has an external coaxial gripping sleeve arranged for axially moving a body (2) and a gate (9) towards another gate (6) according to a drill stroke, and the gate (9) towards the body and the gate (6) according to another drill stroke. The body supporting a needle (1) includes an annular rib that is engaged in a bore of the sleeve to authorize the axial movement of the sleeve around the body.

Description

La présente invention concerne les connecteurs perforants, permettant de connecter entre eux un premier récipient et un second récipient pour le passage d'un fluide entre les deux récipients. Les récipients peuvent être des tubes, des flacons, des poches à paroi flexible, ayant une embouchure obturée par un opercule qu'une aiguille creuse peut traverser.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.

L'invention concerne plus spécialement un tel connecteur muni d'une aiguille creuse de passage de fluide, l'aiguille étant adaptée pour percer un premier opercule du premier récipient et un second opercule du second récipient, pour le passage du fluide à travers le canal axial de l'aiguille entre les deux récipients.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.

On a déjà conçu de tels connecteurs perforants, comprenant une aiguille creuse de passage de fluide, et avec un corps support d'aiguille fixé de façon étanche autour d'un tronçon intermédiaire de l'aiguille et laissant dépasser un premier et un second tronçon d'extrémité de l'aiguille pour le passage des opercules des récipients.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.

Les extrémités de l'aiguille sont agressives, et constituent un danger pour le personnel qui manipule le connecteur. De tels connecteurs perforants nécessitent en outre de prévoir une protection de l'aiguille contre les contaminations, pour assurer la stérilité avant usage. Pour cela, les documents WO 03/082398 A et US 2003/0199846 A1 décrivent un connecteur comprenant en outre un premier réceptacle tubulaire entourant le premier tronçon d'extrémité de l'aiguille, obturé par un premier opercule, et conformé pour recevoir un premier récipient à connecter, et comprenant un second réceptacle tubulaire entourant le second tronçon d'extrémité de l'aiguille, obturé par un second opercule, et conformé pour recevoir un second récipient à connecter. Les opercules sont déplaçables axialement l'un vers l'autre par coulissement, tandis que l'aiguille est montée sur un corps intérieur qui coulisse librement vis-à-vis de l'un et l'autre des opercules. Par rapprochement relatif des opercules, ceux-ci sont percés par les extrémités respectives de l'aiguille.The ends of the needle are aggressive, and pose a danger to the personnel handling the connector. Such piercing connectors also require the protection of the needle against contaminations to ensure sterility before use. For this, the documents WO 03/082398 A and US 2003/0199846 A1 disclose 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.

L'aiguille est ainsi confinée dans une enceinte étanche qui la protège de tous risques de pollution jusqu'au moment où l'aiguille perce simultanément la paroi de l'enceinte étanche et les opercules des récipients à connecter. Il est ainsi possible, en pratique, de désinfecter, localement, avant le perçage, les surfaces externes de la paroi d'enceinte étanche et des opercules des récipients qui vont être percés par l'aiguille, minimisant les risques d'un entraînement de particules polluantes pendant le perçage.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.

Une telle structure de connecteur perforant nécessite de placer simultanément les deux récipients à relier de part et d'autre des opercules. A défaut, il y a un risque que l'aiguille, qui n'est pas tenue axialement, perfore trop tôt l'un des opercules non encore recouvert d'un récipient, et la stérilité ne serait alors plus assurée, et l'utilisateur pourrait se blesser.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.

Le problème proposé par l'invention est, dans un tel connecteur perforant, d'empêcher tous risques de perçage intempestif de la paroi d'enceinte étanche avant positionnement des récipients, perçage qui non seulement produirait la pollution de l'aiguille, mais aussi entraînerait un risque majeur de blessure du personnel d'utilisation.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.

Il faut en particulier éviter un risque de perçage de l'enceinte étanche par l'aiguille en l'absence d'un récipient à connecter.In particular, it is necessary to avoid a risk of piercing the sealed enclosure by the needle in the absence of a container to be connected.

Selon l'invention, on cherche également à faciliter la manipulation du connecteur perforant, notamment afin d'assurer le perçage avec l'aide de mouvements simples de translation axiale.According to the invention, it also seeks to facilitate the handling of the perforating connector, in particular to ensure the drilling with the aid of simple axial translation movements.

Pour atteindre ces buts ainsi que d'autres, l'invention reprend la structure générale d'un connecteur perforant comprenant une aiguille creuse de passage de fluide, un corps support d'aiguille fixé de façon étanche autour d'un tronçon intermédiaire de l'aiguille et laissant dépasser un premier tronçon d'extrémité et un second tronçon d'extrémité de l'aiguille, un premier réceptacle tubulaire entourant le premier tronçon d'extrémité de l'aiguille et conformé pour recevoir un premier élément à connecter, un second réceptacle tubulaire entourant le second tronçon d'extrémité de l'aiguille et conformé pour recevoir un second élément à connecter, un premier opercule obturant le premier réceptacle tubulaire, un second opercule obturant le second réceptacle tubulaire, le premier opercule étant déplaçable axialement par rapport au corps support d'aiguille selon une première course de perçage entre une position initiale à l'écart du corps et de l'aiguille et une position finale rapprochée du corps et dans laquelle l'aiguille traverse le premier opercule et son extrémité dépasse vers l'extérieur du connecteur, le second opercule étant déplaçable axialement par rapport au corps support d'aiguille selon une seconde course de perçage entre une position initiale à l'écart du corps et de l'aiguille et une position finale rapprochée du corps et dans laquelle l'aiguille traverse le second opercule et son extrémité dépasse vers l'extérieur du connecteur.To achieve these and other objects, 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 initial position away from the body and the needle and a final position close to the body and in which the needle passes through the second cap and its end protrudes outwardly of the connector.

Selon l'invention, le connecteur perforant comprend un manchon de préhension externe coaxial agencé pour déplacer axialement le corps et le second opercule vers le premier opercule selon la première course de perçage, puis pour déplacer axialement le second opercule vers le corps et vers le premier opercule selon la seconde course de perçage.According to the invention, 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.

L'utilisateur peut ainsi maîtriser les mouvements relatifs produisant le perçage de l'un et l'autre des opercules, et peut en particulier inhiber de manière certaine le perçage du second opercule pendant le perçage du premier opercule, et il peut n'entreprendre le perçage du second opercule qu'après s'être assuré de la présence du second récipient à connecter.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.

En pratique, selon un mode de réalisation avantageux de l'invention, le manchon de préhension est relié au corps et au second opercule par des liaisons mécaniques particulières permettant les mouvements et entraînements ci-dessus. Ainsi :

  • le manchon comprend des moyens d'engagement unilatéral pour que le manchon pousse axialement le corps et le second opercule vers le premier opercule lorsque le manchon effectue un déplacement axial selon une distance égale à la première course de perçage en direction du corps, et pour que le manchon se dégage axialement du corps et du second opercule lorsque le manchon effectue une course de recul inverse selon une distance égale à la première course de perçage à l'écart du premier opercule,
  • le manchon comprend des moyens d'engagement anti-retour pour que le manchon autorise le maintien du second opercule en position fixe par rapport au corps pendant la course de recul inverse du manchon, puis pour que le manchon entraîné le second opercule de sa position initiale vers sa position finale lorsque le manchon effectue une seconde course de perçage en direction du premier opercule.
In practice, according to an advantageous embodiment of the invention, the gripping sleeve is connected to the body and to the second seal by special mechanical connections allowing the movements and drives above. So :
  • the sleeve comprises unilateral engagement means for the sleeve to axially push the body and the second seal towards the first seal when the sleeve makes an axial displacement at a distance equal to the first piercing stroke towards the body, and so that the sleeve disengages axially from the body and the second cap when the sleeve performs an inverse recoil stroke at a distance equal to the first piercing stroke away from the first cap,
  • the sleeve comprises non-return engagement means for the sleeve to allow the second cap to be held in a fixed position relative to the body during the reverse stroke of the sleeve, and then for the sleeve to drive the second cap from its initial position. towards its final position when the sleeve performs a second drilling stroke towards the first seal.

Par exemple, les moyens d'engagement unilatéral du manchon peuvent comprendre des moyens d'engagement unilatéral sur le corps, à savoir :

  • un premier alésage de plus grand diamètre, prévu sur le manchon selon un premier tronçon d'extrémité, limité par un premier épaulement et un second épaulement,
  • une nervure annulaire de plus grand diamètre, prévue sur le corps, engagée dans le premier alésage du manchon pour autoriser un déplacement axial relatif du manchon autour du corps selon une course appropriée égale à la première course de perçage entre deux positions limites où la nervure annulaire est en butée sur l'un ou l'autre des épaulements.
For example, the unilateral engagement means of the sleeve may comprise unilateral engagement means on the body, namely:
  • a first bore of larger diameter, provided on the sleeve according to a first end section, bounded by a first shoulder and a second shoulder,
  • an annular rib of greater diameter, provided on the body, engaged in the first bore of the sleeve to allow relative axial displacement of the sleeve around the body in a suitable stroke equal to the first drilling stroke between two limit positions where the annular rib is abutting on one or the other of the shoulders.

D'autre part, les moyens d'engagement unilatéral du manchon peuvent comprendre des moyens d'engagement unilatéral sur le second opercule, à savoir :

  • un second alésage de plus grand diamètre, prévu dans le manchon selon un second tronçon d'extrémité, limité par un premier épaulement et un second épaulement,
  • le second opercule étant engagé dans le second alésage pour se déplacer selon une course axiale appropriée égale à la seconde course de perçage.
On the other hand, the unilateral engagement means of the sleeve may comprise unilateral engagement means on the second seal, namely:
  • a second bore of larger diameter, provided in the sleeve according to a second end section, bounded by a first shoulder and a second shoulder,
  • the second cap being engaged in the second bore to move along an appropriate axial stroke equal to the second piercing stroke.

Les moyens d'engagement antiretour du manchon sur le second opercule peuvent par exemple être tels que le second alésage comprenne une nervure annulaire intermédiaire à profil transversal en dent de scie ayant une première face droite et une seconde face oblique, coopérant avec le second opercule pour autoriser son déplacement en direction du premier opercule et pour interdire son déplacement de retour en direction inverse.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.

Pour assurer un mouvement aisé et régulier des opercules dans le sens axial, on prévoit de préférence des moyens pour assurer leur guidage. Par exemple, le premier opercule est monté sur un premier cylindre qui coulisse dans le manchon et qui coulisse sur le corps avec interposition de moyens de coulissement étanche. Le premier cylindre peut constituer ledit premier réceptacle tubulaire.To ensure easy and regular movement of the caps in the axial direction, means are preferably provided to ensure their guiding. For example, 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.

Egalement, pour les mêmes raisons, le second opercule peut être monté sur un second cylindre qui coulisse dans le manchon et qui coulisse sur le corps avec interposition de moyens de coulissement étanche. Le second cylindre peut constituer ledit second réceptacle tubulaire.Also, for the same reasons, 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.

Il est préférable de laisser accessibles depuis l'extérieur les faces externes des deux opercules, pour assurer leur désinfection avant les opérations de perçage. Pour cela, en position initiale, le premier cylindre peut avantageusement dépasser hors du manchon, tandis que le second cylindre peut être engagé avec le second opercule au voisinage de la seconde extrémité du manchon.It is preferable to leave accessible from the outside the outer faces of the two lids, to ensure their disinfection before drilling operations. For this, in the initial position, 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.

D'autres objets, caractéristiques et avantages de la présente invention ressortiront de la description suivante de modes de réalisation particuliers, faite en relation avec les figures jointes, parmi lesquelles :

  • la figure 1 est une vue de côté en coupe longitudinale d'un connecteur perforant selon un mode de réalisation de la présente invention, en position initiale ou position de transport ;
  • la figure 2 est une vue de côté en coupe du connecteur de la figure 1, après la première course de perforation ayant conduit à la perforation du premier opercule ;
  • la figure 3 est une vue de côté en coupe du connecteur de la figure 1, après une course de recul inverse ; et
  • la figure 4 est une vue de côté en coupe du connecteur de la figure 1, après la seconde course de perçage.
Other objects, features and advantages of the present invention will become apparent from the following description of particular embodiments, with reference to the accompanying drawings, in which:
  • Figure 1 is a longitudinal sectional side view of a perforating connector according to an embodiment of the present invention, in initial position or transport position;
  • FIG. 2 is a sectional side view of the connector of FIG. 1, after the first perforation stroke having led to the perforation of the first seal;
  • Figure 3 is a sectional side view of the connector of Figure 1, after an inverse recoil stroke; and
  • Figure 4 is a sectional side view of the connector of Figure 1, after the second piercing stroke.

Dans le mode de réalisation illustré sur les figures, un connecteur perforant selon l'invention comprend une aiguille creuse 1 à canal axial 1 a de passage de fluide, un corps support d'aiguille 2 qui entoure et est fixé de façon étanche à un tronçon intermédiaire de l'aiguille 1, et qui laisse dépasser un premier tronçon d'extrémité 3 et un second tronçon d'extrémité 4 de l'aiguille 1.In the embodiment illustrated in the figures, a perforating connector according to the invention 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.

Le premier tronçon d'extrémité 3 de l'aiguille 1 est entouré par un premier réceptacle tubulaire 5 obturé par un premier opercule 6. De la sorte, en position initiale ou position de transport illustrée sur la figure 1, le premier tronçon d'extrémité 3 de l'aiguille 1 reste confiné dans une première cavité 7 limitée par le premier opercule 6, par le premier réceptacle tubulaire 5 et par le corps 2.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.

De même, un second réceptacle tubulaire 8 entoure le second tronçon d'extrémité 4 de l'aiguille 1 et est obturé par un second opercule 9. De la sorte, en position initiale ou position de transport illustrée sur la figure 1, le second tronçon d'extrémité 4 de l'aiguille 1 est confiné dans une seconde cavité 10 limitée par le second opercule 9, par le second réceptacle tubulaire 8 et par le corps 2.Similarly, 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.

Le premier réceptacle tubulaire 5 est conformé pour être accouplé à un premier récipient à connecter, par exemple en étant appliqué axialement contre un opercule ou bouchon d'un premier flacon.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.

De même, le second réceptacle tubulaire 8 est conformé pour être accouplé à un second récipient à connecter; par exemple en étant appliqué axialement contre un second opercule ou bouchon d'un second flacon.Similarly, 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.

L'ensemble formé par le premier opercule 6 et le premier réceptacle tubulaire 5 peut coulisser sur le corps 2, de sorte que le premier opercule 6 soit déplaçable axialement par rapport au corps 2 support d'aiguille selon une première course de perçage C1 : la première course de perçage C1 est définie comme étant le mouvement de translation axiale du premier opercule 6 depuis une position initiale, illustrée sur la figure 1, dans laquelle le premier opercule 6 est à l'écart du corps 2 et de l'aiguille 1, jusqu'à une position finale, illustrée sur la figure 2, dans laquelle le premier opercule 6 est rapproché du corps 2, l'aiguille 1 traverse le premier opercule 6 et son extrémité 3a dépasse vers l'extérieur du connecteur.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.

De même, l'ensemble formé par le second opercule 9 et le second réceptacle tubulaire 8 peut coulisser sur le corps 2, de façon que le second opercule 9 soit déplaçable axialement par rapport au corps 2 support d'aiguille selon une seconde course de perçage C2 (Figure 3). La seconde course de perçage C2 est définie comme étant le mouvement de translation axiale du second opercule 9 depuis une position initiale, illustrée sur les figures 1 à 3, dans laquelle le second opercule 9 est à l'écart du corps 2 et de l'aiguille 1, jusqu'à une position finale, illustrée sur la figure 4, dans laquelle le second opercule 9 est rapproché du corps 2, l'aiguille 1 traverse le second opercule 9 et son extrémité 4a dépasse vers l'extérieur du connecteur.Similarly, 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.

Les deux opercules 6 et 9 sont déplaçables indépendamment l'un de l'autre vers et à l'écart du corps 2.The two lids 6 and 9 are movable independently of each other to and away from the body 2.

Le premier opercule 6 est ainsi monté sur un premier réceptacle tubulaire 5 lui-même en forme de premier cylindre qui coulisse sur le corps 2 avec interposition de premiers moyens de coulissement étanches 5a, par exemple une pluralité de nervures annulaires prévues sur le corps 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.

De même, le second opercule 9 est monté sur un second réceptacle tubulaire 8 en forme de cylindre qui coulisse sur le corps 2 avec interposition de moyens de coulissement étanches 8a, par exemple une pluralité de nervures annulaires prévues sur le corps 2.Similarly, 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.

Un manchon 11 externe coaxial est prévu pour constituer un moyen de préhension permettant de déplacer axialement le corps 2 vers le premier opercule 6 selon une distance égale à la première course de perçage C1 en entraînant le second opercule 9, puis pour déplacer axialement le second opercule 9 vers le corps 2 et vers le premier opercule 6 selon la seconde course de perçage C2.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.

Le manchon 11 comporte pour cela des moyens d'engagement unilatéral pour pousser axialement le corps 2 vers le premier opercule 6, de sorte que le manchon 11 effectue la première course de perçage en direction du corps 2, c'est-à-dire la course illustrée de la figure 1 vers la figure 2. Pendant cette première course de perçage, le premier opercule 6 est en appui axial contre un premier récipient, de sorte qu'il subit un mouvement relatif de rapprochement vers le corps 2 selon ladite première course de perçage.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. During this first piercing stroke, 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.

Ensuite, les moyens d'engagement unilatéral autorisent le manchon 11 à effectuer une course de recul inverse de la première course de perçage, à l'écart du premier opercule 6 c'est-à-dire pour passer de la position de la figure 2 à la position de la figure 3. Pendant cette course de recul, le second opercule 9 est en appui axial contre un second récipient, et des moyens d'engagement anti-retour du manchon 11 maintiennent le second opercule 9 en position fixe par rapport au corps 2 en autorisant son coulissement dans le manchon 11.Then, 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. During this recoil stroke, 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.

Ensuite, les moyens d'engagement unilatéral autorisent à nouveau le déplacement axial du manchon 11 en direction du premier opercule 6, selon une seconde course de perçage passant de la position de la figure 3 à la position de la figure 4, course pendant laquelle le manchon entraîne axialement le second opercule 9 de sa position initiale vers sa position finale pour son perçage par l'aiguille 1.Then, 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.

Pour permettre ces différents mouvements, le manchon 11 comprend un premier alésage 12 de plus grand diamètre, prévu dans un tronçon de première extrémité du manchon 11, et limité par un premier épaulement 13 et un second épaulement 14. Le corps 2 comprend une nervure annulaire 15 de plus grand diamètre, engagée dans le premier alésage 12 du manchon 11 pour autoriser le déplacement axial relatif du manchon 11 autour du corps 2 selon une course appropriée égale à la première course de perçage C1. Dans les positions limites de la course, la nervure annulaire 15 est en butée sur l'un ou l'autre des épaulements 13 ou 14.To allow these different movements, 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. In the limit positions of the race, the annular rib 15 abuts on one or other of the shoulders 13 or 14.

Ensuite, toujours pour permettre ces mouvements, le manchon 11 comprend un second alésage de plus grand diamètre 16, prévu dans un tronçon de seconde extrémité du manchon 11, et limité par un troisième épaulement 17 et un quatrième épaulement 18.Then, again to allow these movements, 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.

Le second opercule 9 reste engagé dans le second alésage 16 pour se déplacer selon une course axiale appropriée égale à la seconde course de perçage C2.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.

Le second alésage 16 comprend une nervure annulaire intermédiaire 19 à profil transversal en dent de scie ayant une première face 20 droite et une seconde face 21 oblique.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.

Comme on le voit sur les figures, le premier réceptacle tubulaire 5, en forme de premier cylindre, coulisse dans le manchon 11. De même, le second réceptacle tubulaire 8, en forme de second cylindre, coulisse dans le manchon 11.As can be seen in the figures, the first tubular receptacle 5, in the form of a first cylinder, slides in the sleeve 11. Similarly, the second tubular receptacle 8, in the form of a second cylinder, slides in the sleeve 11.

En position initiale, illustrée sur la figure 1, le premier cylindre dépasse hors du manchon 11, de sorte que le premier opercule 6 présente une première face externe 6a accessible pour la désinfection. De même, dans cette même position initiale, le second cylindre 8 est engagé dans le manchon 11 tout en ayant le second opercule 9 au voisinage de la seconde extrémité du manchon 11, de sorte que la face externe 9a du second opercule 9 est également accessible par l'utilisateur pour la désinfection.In the initial position, illustrated in Figure 1, the first cylinder protrudes out of the sleeve 11, so that the first seal 6 has a first outer face 6a accessible for disinfection. Similarly, in this same initial position, 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.

Lors de l'utilisation, le fonctionnement du connecteur perforant selon l'invention est expliqué ci-après.In use, the operation of the perforating connector according to the invention is explained below.

Pour le transport, le connecteur est dans l'état illustré sur la figure 1 : le premier réceptacle tubulaire en forme de cylindre 5 est à l'écart du corps 2 et dépasse à l'extérieur du manchon 11, le premier tronçon d'extrémité 3 de l'aiguille 1 étant confiné dans la première cavité 7 en retrait du premier opercule 6. Le second réceptacle tubulaire 8 est engagé dans le manchon 11 au voisinage de sa seconde extrémité, le second opercule 9 étant engagé entre le quatrième épaulement 18 et la nervure intermédiaire 19, et étant à l'écart du corps 2. Le second tronçon d'extrémité 4 de l'aiguille 1 est alors confiné dans la seconde cavité 10.For transport, 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.

Après nettoyage des deux surfaces externes 6a et 9a des opercules respectifs 6 et 9, on engage l'opercule ou bouchon d'un premier récipient contre le premier opercule 6, et on pousse le connecteur perforant par son manchon 11 contre le premier flacon, c'est-à-dire vers le bas sur la figure 1. Le manchon 11, qui est alors en appui sur la nervure annulaire 15 du corps 2 par l'épaulement 14, pousse le corps 2 et l'aiguille 1 vers le bas, provoquant le perçage du premier opercule 6 et de l'opercule ou bouchon du premier récipient par le premier tronçon d'extrémité 3 de l'aiguille 1. On notera que l'épaulement 18 entraîne également le second opercule 9 dans la même course, selon le même mouvement que le corps 2, l'aiguille 1 restant ainsi toujours en retrait du second opercule 9.After cleaning the two outer surfaces 6a and 9a of the respective lids 6 and 9, 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. It will be noted that 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.

On ramène ensuite le manchon 11 selon une course de recul, comme illustré sur la figure 3. Au cours de cette course, le second opercule 9, retenu en appui axial contre l'opercule ou bouchon d'un second récipient, laisse passer la nervure intermédiaire 19, grâce à la forme dissymétrique de la nervure et à une déformation radiale élastique de la nervure 19 et/ou de l'opercule 9, et vient s'engager sous la face droite 20 de cette nervure intermédiaire 19.The sleeve 11 is then brought back in a recoil stroke, as illustrated in FIG. 3. During this run, 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.

Ensuite, un second mouvement axial du manchon 11 vers le bas entraîne le second opercule 9 vers le bas, tandis que le corps 2 reste immobile en appui par sa nervure 15 contre le premier réceptacle tubulaire 5 qui lui-même est en appui sur le premier flacon. On produit alors le perçage du second opercule 9. Simultanément, le second récipient, qui est en appui contre le second opercule 9, voit son opercule ou bouchon percé par l'aiguille 1.Then, a second axial movement of the sleeve 11 downwardly drives the second cap 9 downwards, while the body 2 remains stationary bearing its rib 15 against the first tubular receptacle 5 which itself bears on the first bottle. The piercing of the second cap 9 is then produced. Simultaneously, the second receptacle, which bears against the second cap 9, sees its cap or cap pierced by the needle 1.

On comprend que, à aucun moment, l'atmosphère intérieure de l'aiguille n'a été mise en contact avec l'atmosphère extérieure, et la connexion a été réalisée dans les meilleures conditions de stérilisation. En outre, le perçage des opercules, s'est effectué de manière non simultanée par des actions volontaires successives de l'utilisateur sur le manchon 11, excluant le risque d'un perçage intempestif.It is understood that, at no time, the inner atmosphere of the needle has been brought into contact with the outside atmosphere, and the connection has been made under the best conditions of sterilization. In addition, the piercing of the covers, was performed non-simultaneous manner by successive voluntary actions of the user on the sleeve 11, excluding the risk of inadvertent drilling.

La présente invention n'est pas limitée aux modes de réalisation qui ont été explicitement décrits, mais elle en inclut les diverses variantes et généralisations contenues dans le domaine des revendications ci-après.The present invention is not limited to the embodiments which have been explicitly described, but it includes the various variants and generalizations thereof within the scope of the claims below.

Claims (8)

  1. Perforating connector, comprising a hollow fluid passage needle (1), a needle support body (2) fixed in a sealed manner around an intermediate section of the needle (1) and allowing a first end section (3) and a second end section (4) of the needle (1) to project, a first tubular receptacle (5) around the first end section (3) of the needle (1) and conformed to receive a first element to be connected, a second tubular receptacle (8) around the second end section (4) of the needle (1) and conformed to receive a second element to be connected, a first foil (6) closing the first tubular receptacle (5), a second foil (9) closing the second tubular receptacle (8), the first foil (6) being movable axially relative to the needle support body (2) over a first piercing stroke (C1) between an initial position away from the body (2) and the needle (1) and a final position close to the body (2) in which the needle (1) passes through the first foil (6) and its end (3a) projects toward the exterior of the connector, this second foil (9) being movable axially relative to the needle support body (2) over a second piercing stroke (C2) between an initial position away from the body (2) and the needle (1) and a final position close to the body (2) in which the needle (1) passes through the second foil (9) and its end (4a) projects toward the exterior of the connector, characterized in that the perforating connector comprises a coaxial external holding sleeve (11) adapted for moving the body (2) and the second foil (9) axially toward the first foil (6) over the first piercing stroke (C1), and then for moving the second foil (9) axially toward the body (2) and toward the first foil (6) over the second piercing stroke (C2).
  2. Connector according to claim 1, characterized in that :
    - the sleeve (11) comprises unilateral engagement means (15, 18) to enable the sleeve (11) to push the body (2) and the second foil (9) axially toward the first foil (6) when the sleeve (11) moves axially over a distance equal to the first piercing stroke (C1) in the direction of the body (2), and for the sleeve (11) to be disengaged axially from the body (2) and the second foil (9) when the sleeve (11) effects a return stroke in the opposite direction away from the first foil (6) and over a distance equal to the first piercing stroke (C1),
    - the sleeve comprises non-return engagement means (19-21), in order for the sleeve (11) to allow the second foil (9) to be retained in a fixed position relative to the body (2) during the return stroke in the opposite direction of the sleeve (11), and for the sleeve (11) to entrain the second foil (9) axially from its initial position toward its final position when the sleeve (11) effects a second piercing stroke (C2) in the direction of the first foil (6).
  3. Connector according to claim 2, characterized in that the unilateral engagement means (15) of the sleeve (11) comprise :
    - a first larger diameter bore (12) on a first end section of the sleeve (11) delimited by a first shoulder (13) and a second shoulder (14),
    - a larger diameter annular rib (15) on the body (2), engaged in the first bore (12) of the sleeve (11) to allow relative axial movement of the sleeve (11) around the body (2) over an appropriate stroke equal to the first piercing stroke (C1) between two limiting positions in which the annular rib (15) is abutted against one or the other of the shoulders (13, 14).
  4. Connector according to any one of claims 2 or 3, characterized in that the unilateral engagement means (18) of the sleeve (11) comprise :
    - a larger diameter second bore (16) in a second end section of the sleeve (11) delimited by a first shoulder (17) and a second shoulder (18),
    - the second foil (9) being engaged in the second bore (16) to move over an appropriate axial stroke equal to the second piercing stroke (C2).
  5. Connector according to claim 4, characterized in that the second bore (16) comprises an annular intermediate rib (19) having a sawtooth transverse profile with a non-inclined first face (20) and an inclined second face (21), and cooperating with the second foil (9) to allow it to move in the direction of the first foil and to prevent any return movement thereof in the opposite direction.
  6. Connector according to any one of claims 1 to 5, characterized in that the first foil (6) is mounted on a first tubular receptacle (5) in the form of a first cylinder that slides in the sleeve (11) and slides on the body (2) with sealed sliding means (5a) between them.
  7. Connector according to any one of claims 1 to 6, characterized in that the second foil (9) is mounted on a second tubular receptacle (8) in the form of a second cylinder that slides in the sleeve (11) and slides on the body (2) with sealed sliding means (8a) between them.
  8. Connector according to any one of claims 6 or 7, characterized in that, in an initial position, the first cylinder (5) projects out of the sleeve (11), and the second cylinder (8) is engaged with the second foil (9) in the vicinity of the second end of the sleeve (11) to leave the external faces (6a, 9a) of the foils (6, 9) accessible from the outside.
EP20050356039 2004-03-10 2005-03-02 Connector of the perforating type performing a sterile connection Active EP1574200B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0402568A FR2867396B1 (en) 2004-03-10 2004-03-10 PERFORATING PERFORMER WITH STERILE CONNECTION
FR0402568 2004-03-10

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EP1574200A1 EP1574200A1 (en) 2005-09-14
EP1574200B1 true EP1574200B1 (en) 2006-11-02

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

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

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