EP1006981B1 - Connecting device, in particular between a receptacle with a stopper capable of being perforated and a syringe - Google Patents

Connecting device, in particular between a receptacle with a stopper capable of being perforated and a syringe Download PDF

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Publication number
EP1006981B1
EP1006981B1 EP19970942082 EP97942082A EP1006981B1 EP 1006981 B1 EP1006981 B1 EP 1006981B1 EP 19970942082 EP19970942082 EP 19970942082 EP 97942082 A EP97942082 A EP 97942082A EP 1006981 B1 EP1006981 B1 EP 1006981B1
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EP
European Patent Office
Prior art keywords
means
perforating
receptacle
stopper
position
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP19970942082
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German (de)
French (fr)
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EP1006981A1 (en
Inventor
Antoine Aneas
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Biodome
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Biodome
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Publication date
Priority to FR9611965 priority Critical
Priority to FR9611965A priority patent/FR2753624B1/en
Application filed by Biodome filed Critical Biodome
Priority to PCT/FR1997/001676 priority patent/WO1998013006A1/en
Publication of EP1006981A1 publication Critical patent/EP1006981A1/en
Application granted granted Critical
Publication of EP1006981B1 publication Critical patent/EP1006981B1/en
Anticipated expiration legal-status Critical
Application status is Expired - Lifetime legal-status Critical

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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
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/1412Containers with closing means, e.g. caps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • 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
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • 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
    • A61J1/2068Venting means
    • A61J1/2075Venting means for external venting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • 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
    • A61J1/2079Filtering means
    • A61J1/2082Filtering means for gas filtration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • 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
    • A61J1/2079Filtering means
    • A61J1/2086Filtering means for fluid filtration

Abstract

The invention concerns a connecting device (1) between a first receptacle (2), and a second receptacle (4) comprising a muff joint (4a), said device comprising means (5) for perforating a stopper, including a faucet (6) and a filtering chamber (7) isolated from outside by a filter (8), two independent channels (9, 10) being provided in the perforating means (5) for communicating the inside of the first receptacle (2) with the faucet (6) and the filtering chamber (7) respectively, said device further comprising means (11) for displacing with guidance the perforating means (5), means for fastening (13) the skirt (12) on the neck (2a), a plunger (15) mounted in the internal bore (12a) on which the perforating means (5) are fixed, for sliding by simple pressure, and means (16) for definitively stopping the plunger (15).

Description

La présente invention concerne de manière générale la connexion entre, d'un côté un premier récipient comprenant un col obturé par un bouchon perforable visco-élastique, et de l'autre côté un deuxième récipient comprenant un embout mâle. The present invention relates generally to the connection between, on one side a first container comprising a neck obturated by a visco-elastic pierceable stopper, and on the other side a second container comprising a male endpiece.

Plus particulièrement, mais à titre non exclusif, la présente invention sera introduite, définie et décrite par référence à la connexion entre, d'un côté un premier récipient constitué par un flacon rigide, par exemple en verre, dont le col est obturé de manière étanche par un bouchon en caoutchouc perforable, et de l'autre côté un deuxième récipient, toujours rigide, constitué par une seringue, comportant elle-même de manière traditionnelle un corps tubulaire rigide se terminant par un embout mâle, du type "luer lock" par exemple, et un piston monté de manière étanche et coulissante à l'intérieur du corps tubulaire. More particularly, but not exclusively, the present invention will be introduced, defined and described with reference to the connection between, on one side a first container consisting of a rigid bottle, e.g. of glass, whose neck is closed so sealed by a pierceable rubber stopper, and the other side a second container, always rigid, consisting of a syringe, having itself a traditional manner a rigid tubular body terminating in a male end, of the type "luer lock" for example, and a sealingly and slidably mounted piston inside the tubular body. Une connexion telle que définie précédemment est en particulier requise lorsqu'il s'agit de préparer une solution ou suspension médicamenteuse à partir d'un principe actif sous forme de poudre ou de lyophilisat, contenu par le premier récipient, à savoir le flacon, et d'un milieu liquide, par exemple une solution, contenue dans le deuxième récipient, c'est-à-dire dans la seringue. Such a connection as defined above is particularly required in the case of preparing a drug solution or suspension from an active principle in form of powder or lyophilisate, contained by the first container, namely the bottle, and a liquid medium, e.g., a solution contained in the second container, that is to say into the syringe. En pareil cas, de manière générale, les opérations suivantes sont mises en oeuvre : In such cases, in general, the following steps are implemented:

  • le premier récipient (flacon) étant activé, et le second récipient (seringue) étant rempli avec le milieu liquide, on perfore le bouchon avec un moyen de perforation approprié, appartenant ou non à la seringue, pour établir une communication entre les deux récipients, the first container (vial) being activated, and the second container (syringe) is filled with the liquid medium, it perforates the stopper with a suitable punching means, inside or outside the syringe, for establishing communication between the two containers,
  • on introduit le milieu liquide du second récipient (seringue) à l'intérieur du premier récipient (flacon), pour mélanger le milieu liquide et le principe actif en poudre ou lyophilisat, la seringue étant dans ce cas disposée au dessus du flacon, introducing the liquid medium from the second container (syringe) into the first container (vial), for mixing the liquid medium and the active ingredient in powder or lyophilisate, the syringe being in this case disposed above the flask,
  • la dissolution ou mise en suspension étant complète à l'intérieur du premier récipient (flacon), on retourne l'ensemble constitué par le flacon et la seringue connectés l'un à l'autre par l'intermédiaire du moyen de perforation, pour disposer le premier récipient au-dessus du second récipient, dissolving or suspending being complete within the first container (vial), one returns the group consisting of the vial and the syringe connected to the other through the perforation means, to dispose the first container above the second container,
  • et en tirant le piston de la seringue, on extrait la suspension ou solution du principe actif, du premier récipient pour l'introduire dans le second récipient, and by pulling the plunger of the syringe, extracting the solution or suspension of the active ingredient from the first container for introduction into the second container,
  • dès lors la seringue comportant la suspension ou solution du principe actif est prête à être utilisée, éventuellement après mise en place d'une aiguille d'injection sur l'embout mâle de ladite seringue. therefore the syringe with the suspension or solution of active principle is ready for use, optionally after introduction of an injection needle on the male end of said syringe.

Aux fins de connecter deux récipients tels que définis et exemplifiés précédemment, conformément au document EP-A-0 126 718, on a déjà proposé un dispositif de transfert avec perforation du bouchon comportant : For the purpose of connecting two containers as defined and exemplified above, according to EP-A-0126718, it has been proposed a transfer device with perforation of the stopper comprising:

  • d'une part un embout femelle de jonction étanche, par exemple un cône du type "luer lock", de jonction étanche avec l'embout mâle du deuxième récipient, et d'autre part une chambre de filtration isolée par rapport à l'extérieur par un filtre, par exemple un filtre absolu permettant de stériliser tout flux gazeux ou liquide le traversant dans un sens ou dans l'autre, firstly a sealed connection socket, for example a cone type "luer lock" tight junction with the male end of the second container, and secondly a filtering chamber isolated from outside by a filter, for example a HEPA filter for sterilizing all gaseous or liquid flow through it in one direction or the other,
  • deux canaux indépendants ménagés dans ledit moyen de perforation pour établir une communication entre l'intérieur du premier récipient et respectivement l'embout femelle et la chambre de filtration, dans la position où le moyen de perforation perfore le bouchon, de manière étanche par rapport à l'extérieur. two independent channels in said perforating means for establishing a communication between the interior of the first container and respectively the socket and the filtration chamber, in the position where the perforating means perforates the stopper, sealed with respect to outside.

Ce dispositif de connexion comprend en outre des moyens de déplacement avec guidage du moyen de perforation, constitués au moins par une collerette ménageant un alésage interne ; The connection device further comprises means for displacing with guidance the perforating means, constituted at least by a collar providing an inner bore;

  • des moyens d'accrochage de la collerette sur le col du premier récipient, pour aboutir à une position accrochée dans laquelle l'alésage interne débouche sur le bouchon ; hooking means of the collar on the neck of the first container, leading to an engaged position in which the internal bore opens out on the stopper;
  • des moyens d'étanchéité de l'alésage interne par rapport à l'extérieur, dans la position accrochée de la collerette ; sealing means of the internal bore with respect to the outside, in the hooked position of the collar;
  • un piston sur lequel est fixé ou auquel appartient le moyen de perforation, ceci pour coulisser par simple poussée, d'une position inactivée dans laquelle l'extrémité perforante est à l'écart du bouchon, à une position perforante ou de perforation dans laquelle cette même extrémité perforante a traversé le bouchon, a piston on which is fixed or to which belongs the perforation means, this to slide by simple push, an inactivated position wherein the piercing end is away from the stopper, to a perforating position or perforation in which the even perforating end has traversed the stopper,

Un tel dispositif autorise tout mouvement relatif non contrôlé, entre les deux récipients en cours de connexion ou connectés, de telle sorte qu'il est difficile de maítriser avec précision la quantité de milieu liquide ou liquide, introduite dans le premier récipient ou extraite de ce dernier, par l'intermédiaire du mouvement relatif entre le piston et le corps tubulaire de la seringue (deuxième récipient) par exemple. Such a device allows any uncontrolled relative movement between the two containers being connection or connected, so that it is difficult to control accurately the amount of liquid or liquid medium introduced into the first container or derived from this last, through the relative movement between the piston and the tubular body of the syringe (second vessel), for example.

La présente invention a donc pour objet une solution permettant de mieux contrôler le mouvement relatif entre le premier récipient et le second récipient, lorsqu'ils sont connectés, de manière en particulier à minimiser et à rendre constant le volume mort, c'est-à-dire du liquide qui ne peut être soutiré du premier récipient, après connexion des deux récipients. The present invention therefore relates to a solution for better control of the relative movement between the first container and the second container, when connected, in particular so as to minimize and make constant the dead volume, that is to -dire liquid which can not be withdrawn from the first container after connection of the two containers.

Conformément à la présente invention, le dispositif de connexion comprend en outre : According to the present invention, the connection device further comprises:

  • des moyens d'arrêt du piston, définitivement dans la position perforante, ces moyens comportant un organe d'encliquetage disposé sur ou du côté du piston, et un organe complémentaire d'arrêt, disposé sur ou du côté de la collerette, l'organe d'encliquetage comportant une pluralité de dents distribuées autour de l'axe du psiton, élastiques pur être rappelées de manière centrifuge ou centripète, l'organe complémentaire d'arrêt consistant en un flanc annulaire contre lequel se bloquent desdites dents. means for stopping the piston, permanently in the perforating position, these means comprising a locking member arranged on or on the piston side, and a complementary stop member disposed on or next to the flange, the member ratchet having a plurality of teeth distributed about the axis of psiton elastic pure be recalled centrifugally or centripetally, the complementary stop member consisting of an annular flank against which said teeth are blocked.

La présente invention fait référence au dessin annexé, dans lequel : The present invention refers to the accompanying drawing, wherein:

  • la figure 1 représente, en coupe transversale, un dispositif de connexion conforme à la présente invention, en position accrochée et verrouillée sur un premier récipient, et dans la position inactivée du piston comportant le moyen de perforation ; 1 shows, in cross section, a connecting device according to the present invention, in the latched and locked position of a first container and in the inactivated position of the piston having the perforating means; sur cette figure, le dispositif de connexion est également représenté avec son capuchon, maintenant une étanchéité de l'intérieur du dispositif de connexion par rapport à l'extérieur, in this figure, the connection device is also shown with its cap, maintaining a sealing of the interior of the connecting device relative to the outside,
  • la représentation de la figure 2 diffère de celle de la figure 1, en ce que le capuchon a été retiré, et le second récipient est embouché sur le moyen de perforation, dans la position inactivée de ce dernier, representation of Figure 2 differs from that of Figure 1, in that the cap was removed, and the second container is mouthed to the perforation means in the inactivated position of the latter,
  • la représentation de la figure 3 diffère de celle de la figure 2, en ce que le piston et son moyen de perforation sont dans la position activée, ou perforante, avec introduction du liquide contenu par le deuxième récipient dans le premier récipient, dans cet exemple en appuyant sur le piston de la seringue constituant le second récipient, the representation of Figure 3 differs from Figure 2 in that the piston and the perforation means are in the activated position, or perforating, with introduction of the liquid contained by the second container into the first container, in this example by pressing the plunger of the syringe constituting the second container,
  • la représentation de la figure 4 diffère de celle de la figure 3, en ce que l'ensemble des deux récipients connectés est retourné, et le liquide contenu dans le premier récipient est soutiré dans le second récipient, en tirant sur le piston de la seringue par exemple. the representation of Figure 4 differs from Figure 3 in that the set of two connected containers is returned, and the liquid contained in the first container is drawn into the second container, by pulling the plunger of the syringe for example.

Conformément aux figures 1 et 2, le dispositif de connexion décrit ci-après permet de connecter de manière étanche par rapport à l'extérieur, et notamment en préservant des conditions pré-établies de stérilité : According to Figures 1 and 2, the connection device described below is used to connect sealingly with respect to the outside, and in particular preserving the sterility of pre-established conditions:

  • d'un côté, un premier récipient 2 par exemple un flacon en verre, comprenant un col 2a avec un bourrelet annulaire 2b, obturé par un bouchon 3 en matériau visco-élastique (caoutchouc), perforable, et comportant lui-même une partie épaulée 3b reposant à plat sur le bourrelet annulaire 2b du premier récipient ; on one side, a first container 2, for example a glass vial, comprising a neck with an annular bead 2a 2b, closed by a cap 3 made of viscoelastic material (rubber), perforable, and itself comprising a stepped portion 3b resting flat on the annular bead 2b of the first container; par hypothèse et en utilisation, ce flacon contient dans des conditions d'étanchéité (notamment par rapport à tout liquide extérieur), et de stérilité, une poudre ou lyophilisat d'un principe actif par exemple, by hypothesis and in use, this vial contains in sealing conditions (particularly with respect to any external liquid), and sterility, a powder or lyophilisate of an active ingredient for example,
  • et de l'autre côté un deuxième récipient, comprenant un embout mâle 4a, constitué par exemple par une seringue traditionnelle, comportant un corps tubulaire 4b, un cône du type "luer lock", rapporté sur une extrémité du corps tubulaire 4b, formant l'embout mâle précité, et un piston 21 permettant à volonté de remplir ou vider la seringue. and on the other side a second container comprising a male end 4a, constituted for example by a conventional syringe comprising a tubular body 4b, a cone type "luer lock" attached to one end of the tubular body 4b, forming abovementioned male end, and a piston 21 allowing will fill or empty the syringe.

Le dispositif de connexion proprement dit, conforme à l'invention, permettant de relier les deux récipients exemplifiés précédemment, par perforation du bouchon 3, comprend de manière générale : The connection device itself, according to the invention, for connecting the two containers exemplified above, by perforation of the stopper 3, comprises in general:

  • un moyen 5 de perforation du bouchon, a means 5 for perforating the stopper,
  • des moyens 11 de déplacement avec guidage du moyen de perforation précité, constitués au moins par une collerette 12 et un piston 15 sur lequel est monté ou auquel appartient le moyen de perforation 5, means 11 for guiding movement with the aforesaid punching means, constituted at least by a collar 12 and a piston 15 on which is mounted or to which belongs the perforation means 5,
  • des moyens d'accrochage 13 de la collerette 12 sur le col 2a du premier récipient, hooking means 13 of the collar 12 of the neck 2a of the first container,
  • des moyens d'étanchéité 14 de l'intérieur de la collerette 12, par rapport à l'extérieur, mettant en oeuvre les caractéristiques visco-élastiques de la partie supérieure du bouchon 3, sealing means 14 from the inside of the collar 12, with respect to the outside, employing the visco-elastic characteristics of the upper stopper 3,
  • et des moyens d'arrêt 16 définitifs du piston 15 dans la position perforante ou de perforation, représentée par exemple aux figures 3 et 4. and stop means 16 definitive of the piston 15 in the perforating position or perforation, shown for example in Figures 3 and 4.

Le moyen 5 de perforation comporte, comme représenté la figure 1, une partie centrale ou axiale 5b se terminant par une extrémité perforante 5a, un collet 5c permettant la fixation des moyens de perforation sur le piston défini ci-après, dans lequel une ouverture circonférentielle 5d est ménagée, et un embout femelle 6, prolongeant la partie axiale 5b, et permettant d'assurer une jonction étanche avec l'embout mâle 4a du deuxième récipient (seringue). The means 5 for perforating comprises, as shown in Figure 1, a central or axial portion 5b terminating in a perforating end 5a, an 5c collar for fixing the perforation means on the defined piston below, wherein a circumferential opening 5d is formed, and a socket 6, extending the axial part 5b, and to ensure a seal with the spigot 4a of the second container (syringe). Au niveau du moyen de perforation 5, à l'opposé de l'extrémité perforante 5a ci-après, une chambre de filtration 7 est ménagée entre un embrèvement prévu dans le piston 15, défini ci-après, et un filtre 8, maintenu serré entre le collet 5c et un épaulement correspondant prévu sur le piston 15, et isolant ladite chambre par rapport à l'extérieur. At the perforation means 5, opposite the perforating end 5a below, a filter chamber 7 is arranged between a recess provided in the piston 15, as defined below, and a filter 8, held clamped between the flange 5c and a corresponding shoulder on the piston 15, and isolating said chamber from the outside. L'embout femelle 6, disposé du côté opposé à l'extrémité perforante 5a, comporte un filtre 20 pour la filtration de tout liquide le traversant dans un sens ou dans l'autre. The female end 6, arranged on the side opposite the perforating end 5a, includes a filter 20 for filtering any liquid traversing it in one direction or the other. Deux canaux 9 et 10, indépendants, sont ménagés dans la partie axiale 5b du moyen de perforation 5, pour établir une communication entre l'intérieur du premier récipient 2 et respectivement l'embout femelle 6 et la chambre de filtration 7, dans la position perforante ou de perforation, représentée aux figures 2 à 4 par exemple, dans laquelle le moyen 5 de perforation perfore le bouchon 4, en l'ayant traversé complètement par son extrémité perforante 5a. Two channels 9 and 10, independent, are formed in the axial part 5b of the perforating means 5 for establishing a communication between the interior of first container 2 and the female end respectively 6 and the filtering chamber 7, in the position perforating or piercing, shown in figures 2 to 4, for example, wherein the perforation means 5 perforates the cap 4, by having completely crossed by its perforating end 5a.

Les moyens 11 de déplacement avec guidage du moyen de perforation 5 sont constitués par la coopération de la collerette 12 tubulaire, ménageant un alésage interne 12a, et du piston 15 monté dans l'alésage interne 12a, sur lequel est fixé ou monté le moyen de perforation 5. La collerette 12 est obtenue de manière monobloc avec les moyens d'accrochage 13, par exemple en matière plastique, et comme représenté sur la figure 1 peut s'étendre vers le haut, au-delà de l'extrémité libre de l'embout femelle 6, afin d'empêcher un actionnement accidentel du piston par les doigts de l'utilisateur. The means 11 for movement with the guide 5 of the perforation means are constituted by the cooperation of the tubular collar 12, leaving an internal bore 12a, and the piston 15 mounted in the internal bore 12a, on which is fixed or mounted the means perforation 5. the flange 12 is obtained integrally with the attachment means 13, for example of plastics material, and as shown in Figure 1 may extend upwards beyond the free end of the female end 6, in order to prevent accidental actuation of the piston by the fingers of the user. Par ailleurs, elle est munie d'une capsule formant moyens d'accrochage 13, susceptible de s'encliqueter par rapport et sous le rebord annulaire 2b du récipient 2, au contact du col 2a, et ceci grâce à une élasticité radiale lui permettant de rappeler le bord inférieur circonférentiel en position centripète. Furthermore, it is provided with a capsule-forming hooking means 13, susceptible to snap over and under the annular rim 2b of the receptacle 2 in contact with the neck 2a, and this thanks to a radial elasticity allowing it to recall the lower circumferential edge in centripetal position. En pratique, cette capsule d'accrochage 13 est constituée par une pluralité de dents d'accrochage, formant ensemble la capsule définie précédemment, et disposant chacune de l'élasticité radiale précitée. In practice, this attachment cap 13 is constituted by a plurality of hooking teeth, together forming the capsule defined above, and with each of the aforementioned radial elasticity. Dans la position accrochée représentée aux figures 1 à 4, l'alésage interne 12a débouche sur le bouchon 3, et plus particulièrement sa partie supérieure accessible à l'extrémité perforante Sa du moyen de perforation 5. Des moyens d'étanchéité 14 de l'alésage interne 12a, par rapport à l'extérieur, et utilisant les propriétés visco-élastiques du bouchon 3, sont construits de manière monobloc également avec la collerette 12 ; In the hooked position shown in Figures 1 to 4, the inner bore 12a opens out on the stopper 3, and more particularly its upper part accessible to the perforating end Sa of the perforation means 5. Sealing means 14 of the internal bore 12a, with respect to the exterior, and using the visco-elastic properties of the plug 3, are constructed integrally with the collar 12 also; ces moyens consistent notamment en une nervure circonférentielle continue, relativement dure et pénétrant au moins partiellement dans le matériau relativement mou du bouchon 3. these means consist in particular in a continuous circumferential rib, relatively hard and penetrating at least partly into the relatively soft material of the plug 3.

Le piston 15 comporte une âme transversale 15a comportant un orifice épaulé 15b permettant le passage de la partie axiale 5b du moyen de perforation 5, avec retenue axiale dudit moyen. The piston 15 comprises a transverse web 15a having a stepped hole 15b allowing passage of the axial part 5b of the perforating means 5 with said axial retaining means. Comme dit précédemment, le moyen de perforation 5 est par ailleurs retenu de manière étanche par son collet 5c, sur l'épaulement défini par l'embrèvement de la chambre de filtration 7. En étant bloqué en rotation par rapport à la collerette 12 par les moyens définis ci-après, le piston 15, monté dans l'alésage interne 12a, peut coulisser par simple poussée axiale, d'une position inactivée (Cf. figures 1 et 2) dans laquelle l'extrémité perforante 5a est à l'écart du bouchon 3, et une position perforante (Cf. figures 3 et 4), dans laquelle l'extrémité perforante 5a a complètement traversée le bouchon 3. Les moyens de blocage 19 en rotation du piston 15 par rapport à la collerette 12 sont obtenus en ménageant, du côté de la collerette 12 sur sa surface interne, huit rainures parallèles à l'axe du dispositif, réparties sur le pourtour de ladite collerette, et du côté du piston huit nervures correspondantes, non représentées, susceptibles de s'engager resp As said earlier, the perforation means 5 is also retained in sealed manner by its collar 5c, on the shoulder defined by the recess of the filter chamber 7. By being prevented from rotating relative to the collar 12 by means defined below the piston 15, mounted in the internal bore 12a, is slidable by simple axial thrust, an inactivated position (see figures 1 and 2) in which the perforating end 5a is aloof the cap 3, and a perforating position (see figures 3 and 4) in which the perforating end 5a has completely traversed the cap 3. the locking means 19 by rotation of the piston 15 relative to the flange 12 are obtained by arranging on the side of the collar 12 on its inner surface, eight grooves parallel to the axis of the device, distributed over the circumference of said flange, and the piston side eight corresponding ribs, not shown, capable of engaging respectively ectivement dans les rainures précitées. ectively in the aforementioned grooves.

Les moyens 16 d'arrêt définitif du piston 15 et par conséquent les moyens de perforation 5, dans la position perforante, dans laquelle l'extrémité perforante du moyen 5 a complètement traversé le bouchon 3, comportent : The means 16 definitive withdrawal of the piston 15 and consequently the perforating means 5, in the perforating position in which the perforating end of the means 5 has completely traversed the stopper 3, comprises:

  • un ou plusieurs organes d'encliquetage 17, appartenant au piston 5, constitués par des dents distribuées autour de l'axe du piston 15, élastiques pour être rappelées de manière centrifuge ou centripète ; one or more latching members 17 belonging to the piston 5, constituted by teeth distributed around the axis of the piston 15, elastic to be recalled centrifugally or centripetally; ces organes d'encliquetage 17 forment ensemble une couronne concentrique avec l'axe du piston 15, à l'intérieur de la collerette 15c assurant le coulissement du piston dans l'alésage interne 12a, these detents 17 together form a ring concentric with the axis of piston 15, within the flange 15c ensuring sliding of the piston 12a in the inner bore,
  • et un ou plusieurs organes complémentaires d'arrêt 18, disposés sur la collerette 12, consistant par exemple en un flanc annulaire 18, contre lequel ou sous lequel se bloquent les dents 17, lorsque le piston 15 est déplacé vers le bouchon 3. and one or more complementary members stop 18 disposed on the collar 12, for example consisting of an annular edge 18, against which or by which lock the teeth 17 when the piston 15 is moved toward the plug 3.

Le capuchon 21 est monté sur la collerette 12, de manière étanche, pour contenir l'embout femelle 6 et les autres parties internes du dispositif, à savoir le piston 15 et le moyen de perforation 5, de manière isolée par rapport à l'extérieur, ceci en fermant de manière étanche la partie interne de la collerette 12, opposée au bouchon 3. Cette étanchéité est obtenue en particulier grâce à une succession de lamelles circonférentielles 19a ménagées sur la surface externe de la collerette 12, et sur lesquelles se bloque le capuchon 21. The cap 21 is mounted on the flange 12 in a sealed manner, to hold the socket 6 and the other internal parts of the device, namely the piston 15 and the perforation means 5 so insulated from outside This closing sealingly the internal portion of the flange 12 remote from the cap 3. This seal is achieved in particular thanks to a succession of circumferential sipes 19a formed on the external surface of the collar 12, on which the blocks are cap 21.

Par "étanchéité", on entend une étanchéité par rapport au moins aux liquides, et permettant en particulier de maintenir des conditions de stérilité à l'intérieur du dispositif de connexion. By "seal" means a seal with respect at least to liquids, and in particular in order to maintain sterile conditions within the connecting device.

Par ailleurs, le dispositif de connexion selon l'invention est fixé de manière définitive sur le premier récipient 2. A cette fin, il intègre des moyens 22 de verrouillage définitif du dispositif sur le premier récipient 2, bloquant les moyens d'accrochage 13 dans leur position accrochée sur le col 2a du récipient 2. Ces moyens de verrouillage consistent en particulier en une bague externe, construite de manière monobloc avec le capuchon 21, mais séparée de ce dernier par une ligne d'affaiblissement 30 permettant de séparer le capuchon du dispositif de connexion. Furthermore, the connecting device according to the invention is permanently fixed on the first container 2. To this end, it includes means 22 for final locking of the device on the first container 2, blocking the fastening means 13 in their position fastened on the neck 2a of container 2. These locking means consist in particular in an outer ring constructed integrally with the cap 21, but separated therefrom by a weakening line 30 for separating the cap from the connection device.

Le fonctionnement du dispositif de connexion 1 selon la présente invention se déduit des représentations des figures 2 à 4, explicitées par référence à l'énumératif des figures, et au deuxième paragraphe de la présente description. The operation of the connection device 1 according to the present invention is deduced from the representations of Figures 2 to 4, explained with reference to the enumerated figures, and the second paragraph of the present description.

Un dispositif tel que précédemment décrit présente en outre différents avantages importants : A device as described above also has several important advantages:

  • il est à usage unique, puisqu'en particulier les moyens 16 d'arrêt définitif du piston 15 excluent une autre réutilisation, it is for single use, since in particular the means 16 definitive withdrawal of the piston 15 excludes another reuse,
  • il assure une sécurité d'utilisation totale, l'utilisateur ne pouvant à aucun moment toucher l'extrémité perforante 5a du moyen de perforation 5, avec ses doigts, puisqu'en particulier le déplacement et guidage du piston 15 ne nécessitent aucune autre intervention que sa poussée par l'embout mâle de la seringue, it ensures a total security use, the user may at any time touching the perforating end 5a of the perforating means 5 with his fingers, since in particular the moving and guiding the piston 15 do not require any intervention other than its pushed by the male connector of the syringe,
  • l'utilisateur n'a aucun besoin fonctionnel de toucher le piston 15 et/ou le moyen de perforation 5 avec ses doigts, et en particulier il n'existe aucun risque de blessure accidentelle. the user has no functional need to touch the piston 15 and / or perforation means 5 with his fingers, and in particular there is no risk of accidental injury.

Claims (7)

  1. Device (1) for connection between, on the one hand, a first receptacle (2) comprising a neck (2a) obturated by a visco-elastic stopper (3) capable of being perforated, and, on the other hand, a second receptacle (4) comprising a muff joint (male element) (4a), said device comprising a means (5) for perforating the stopper, comprising on the side opposite the perforating end (5a) of said perforating means, on the one hand, a faucet (female element) (6) for tight join with the muff joint (4a) of the second receptacle (4), and, on the other hand, a filtering chamber (7) isolated with respect to the outside by a filter (8), two independent channels (9, 10) being made in the perforating means (5) for establishing communication between the inside of the first receptacle (2) and the faucet (6) and the filtering chamber (7) respectively, in,the position where the perforating means (5) perforates the stopper (4), said device further comprising means (11) for displacing with guidance the perforating means (5), constituted at least by a skirt (12) making an internal bore (12a), means (13) for fastening the skirt (12) on the neck (2a) of the first receptacle (2) in a fastened position in which the internal bore (12a) opens out on the stopper (3), with means (14) for sealing the internal bore (12a) with respect to the outside, a plunger (15) on which is fixed the perforating means (5), to slide by simple pressure from an inactive position in which the perforated end (5a) is spaced apart from the stopper (3), and a perforating position in which said perforating end (5a) has traversed the stopper (3), characterized in that the device further comprises means (16) for definitively stopping the plunger (15) in the perforating position, comprising a member (17) for clipping on the plunger, and a complementary stop member (18) on the skirt, the clipping member comprising a plurality of teeth (17) distributed about the axis of the plunger (15), which are elastic in order to be returned centrifugally or centripetally, and the complementary stop member consisting of an annular flank (18) against which said teeth (17) are blocked.
  2. Device according to Claim 1, characterized in that means (19) for blocking in rotation are arranged between the plunger (15) and the skirt (12).
  3. Device according to Claim 1, characterized in that the second receptacle (4) is a syringe, and the faucet is a "luer lock" cone (4a).
  4. Device according to Claim 1, characterized in that the filter (8) has a porosity ensuring a sterile filtration of all gaseous or liquid flow traversing it.
  5. Device according to Claim 1, characterized in that it comprises a cap (21) mounted on the start (12) to contain the faucet (6), arranged to hermetically close that part of the skirt (12) opposite the stopper (3).
  6. Device according to Claim 1, characterized in that it comprises means (22) for definitively locking on the first receptacle (2), blocking the fastening means (13) in their position fastened on the neck (2a) of the recipient.
  7. Device according to Claim 1, characterized in that the faucet (6) comprises a filter (20) for filtering any liquid traversing it.
EP19970942082 1996-09-25 1997-09-24 Connecting device, in particular between a receptacle with a stopper capable of being perforated and a syringe Expired - Lifetime EP1006981B1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
FR9611965 1996-09-25
FR9611965A FR2753624B1 (en) 1996-09-25 1996-09-25 Connection device, in particular between a container with a pierceable stopper and syringe
PCT/FR1997/001676 WO1998013006A1 (en) 1996-09-25 1997-09-24 Connecting device, in particular between a receptacle with a stopper capable of being perforated and a syringe

Publications (2)

Publication Number Publication Date
EP1006981A1 EP1006981A1 (en) 2000-06-14
EP1006981B1 true EP1006981B1 (en) 2001-11-14

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US (1) US6070623A (en)
EP (1) EP1006981B1 (en)
JP (1) JP3340749B2 (en)
CN (1) CN1133411C (en)
AT (1) AT208597T (en)
BR (1) BR9712102A (en)
CA (1) CA2263370C (en)
DE (2) DE69708333T2 (en)
DK (1) DK1006981T3 (en)
ES (1) ES2163196T3 (en)
FR (1) FR2753624B1 (en)
PT (1) PT1006981E (en)
RU (1) RU2190385C2 (en)
WO (1) WO1998013006A1 (en)

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DK1006981T3 (en) 2002-03-25
AT208597T (en) 2001-11-15
CN1237892A (en) 1999-12-08
CA2263370A1 (en) 1998-04-02
AU723566B2 (en) 2000-08-31
EP1006981A1 (en) 2000-06-14
RU2190385C2 (en) 2002-10-10
US6070623A (en) 2000-06-06
FR2753624B1 (en) 1999-04-16
DE69708333D1 (en) 2001-12-20
ES2163196T3 (en) 2002-01-16
PT1006981E (en) 2002-04-29
BR9712102A (en) 1999-08-31
WO1998013006A1 (en) 1998-04-02
JP2001505083A (en) 2001-04-17
CN1133411C (en) 2004-01-07
CA2263370C (en) 2004-01-20
FR2753624A1 (en) 1998-03-27
JP3340749B2 (en) 2002-11-05
DE69708333T2 (en) 2002-05-23
AU4388597A (en) 1998-04-17

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