EP1150639B1 - Connecting device between a container and its contents and ready-to-use assembly comprising same - Google Patents

Connecting device between a container and its contents and ready-to-use assembly comprising same Download PDF

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Publication number
EP1150639B1
EP1150639B1 EP20000903770 EP00903770A EP1150639B1 EP 1150639 B1 EP1150639 B1 EP 1150639B1 EP 20000903770 EP20000903770 EP 20000903770 EP 00903770 A EP00903770 A EP 00903770A EP 1150639 B1 EP1150639 B1 EP 1150639B1
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EP
European Patent Office
Prior art keywords
piston
sleeve
position
characterized
device according
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.)
Not-in-force
Application number
EP20000903770
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German (de)
French (fr)
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EP1150639A1 (en
Inventor
Antoine Aneas
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biodome
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Biodome
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Publication date
Priority to FR9901755 priority Critical
Priority to FR9901755A priority patent/FR2789369B1/en
Application filed by Biodome filed Critical Biodome
Priority to PCT/FR2000/000315 priority patent/WO2000047159A1/en
Publication of EP1150639A1 publication Critical patent/EP1150639A1/en
Application granted granted Critical
Publication of EP1150639B1 publication Critical patent/EP1150639B1/en
Application status is Not-in-force legal-status Critical
Anticipated expiration 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
    • A61J1/2089Containers or vials which are to be joined to each other in order to mix their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, 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
    • A61J1/20Arrangements 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
    • A61J1/2048Connecting means
    • A61J1/2051Connecting means having tap means, e.g. tap means activated by sliding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers 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
    • A61J1/2048Connecting means
    • A61J1/2055Connecting means having gripping means

Abstract

The invention concerns a device comprising a base plate (10) mounted on the container (2) and a sleeve (14) forming an inner bore (A), and a plunger capable of sliding in said bore (A), between a first released position relatively to the cap (5) of the container (2) and a second position called transfer position, wherein a hollow needle (21) borne by the plunger (20) passes through the cap (5). The base plate (10) is provided with at least an elastic spout (15) retaining the plunger (20) in transfer position, said spout projecting, from the sleeve (14), towards the bore (A) inside and capable of co-operating with an outer radial flap (24) of the plunger (20).

Description

L'invention a trait à un dispositif de connexion entre un récipient fermé et un contenant. The invention relates to a connection device between a closed recipient and a container. L'invention a également trait à un ensemble prêt à l'emploi comprenant, entre autres, un récipient fermé et un dispositif de connexion du type précité. The invention also relates to a set ready for use comprising, inter alia, a closed container and a connecting device of the aforementioned type.

Dans le domaine du conditionnement de médicaments, il est connu de stocker un composant d'une préparation pharmaceutique, tel que par exemple son principe actif, dans un récipient fermé par un bouchon en matériau relativement mou, par exemple en élastomère. In the field of drug packaging, it is known to store a component of a pharmaceutical preparation, such as for example its active ingredient, in a container closed by a plug of a relatively soft material, for example elastomer. Un liquide peut être introduit dans ce récipient après perforation du bouchon pour dissoudre ou mettre en suspension le composant contenu dans le récipient, ceci afin d'obtenir une préparation, notamment un médicament ou un vaccin, sous forme liquide et prête à être administrée aux patients. A liquid may be introduced into the container after penetration of the cap to dissolve or suspend the component within the container, in order to obtain a preparation including a medicament or a vaccine in liquid form and ready to be administered to patients .

Par les documents WO-A-90/03 536 et WO-A-97/10 156, on connaít des dispositifs de connexion comprenant chacun une embase adaptée pour coiffer le col d'un récipient et se prolongeant par une collerette ou douille formant un alésage interne, alors qu'un piston est monté coulissant dans cet alésage. By WO-A-90/03536 and WO-A-97/10156 discloses connection devices each having a base adapted to cover the neck of a container and being extended by a collar or sleeve forming a inner bore, while a piston is slidably mounted in this bore. Le piston est prévu pour être poussé vers une position de transfert dans laquelle une aiguille creuse portée par le piston traverse le bouchon du récipient. The piston is adapted to be pushed to a transfer position in which a hollow needle borne by the piston passes through the stopper of the container. Ces dispositifs connus autorisent des mouvements axiaux du piston lorsqu'il a été déplacé jusqu'en position de transfert, ce qui pourrait conduire à des fuites et ne permet pas de contrôler efficacement le volume mort du récipient, c'est-à-dire la quantité de liquide qui ne peut pas en être soutirée. These known devices allow axial movements of the piston when it has been moved until transfer position, which could lead to leaks and does not allow to effectively control the void volume of the container, that is to say the amount of liquid that can not be withdrawn.

Par le document WO-A-98/13 006, on connaít un dispositif adapté, en particulier, à la connexion entre un récipient avec bouchon perforable et une seringue, dans lequel des dents sont distribuées autour de l'axe du piston et prévues pour être rappelées de manière centrifuge ou centripète pour coopérer avec un flan d'arrêt prévu sur une embase. By WO-A-98/13 006 discloses a device adapted in particular to the connection between a container with a pierceable stopper and syringe, wherein the teeth are distributed around the axis of the piston and adapted to be recalled centrifugally or centripetally for engagement with a stop provided on a base blank. Ce dispositif permet un verrouillage du piston tante que l'effort de déplacement auquel il est soumis n'est pas trop important. This device allows a locking of the moving piston aunt effort which it is subjected is not too important. Cependant, dans certaines conditions, les dents pourraient être déformées de façon plastique, ce qui pourrait permettre un arrachement du piston dans une direction d'extraction. However, under certain conditions, the teeth might be deformed plastically, which could allow a pullout of the piston in an extraction direction.

Par le document WO-A-98/32411, on connaít un dispositif de connexion dans lequel un piston solidaire d'une aiguille est pourvu d'une patte destinée à s'engager dans un renfoncement ménagé dans l'épaisseur d'une embase. From WO-A-98/32411 discloses a connection device in which a piston integral with a needle is provided with a tab for engaging in a recess formed in the thickness of a base. Le jonc qui borde ce renfoncement se déforme essentiellement parallèlement à la direction de déplacement du piston et à une faible largeur selon une direction radiale, ce qui ne permet pas d'assurer un maintient efficace du piston en position de transfert. The ring that borders the recess essentially parallel to deform the piston travel direction and a small width in a radial direction, which does not ensure an effective maintains the piston in the transfer position.

C'est à ces inconvénients qu'entend plus particulièrement remédier l'invention, en proposant un dispositif de connexion perfectionné dans lequel il est obtenu un verrouillage particulièrement efficace du piston en position de transfert. It is these drawbacks more particularly to remedy the invention, by providing an improved connection device wherein it is obtained a particularly effective locking of the piston in the transfer position.

Dans cet esprit, l'invention concerne un dispositif du type précité dans lequel l'embase est pourvue d'au moins un bec élastiquement déformable vers l'extérieur de la douille, ce bec faisant saillie, à partir de la douille, vers l'intérieur de l'alésage pour la retenue du piston en position de transfert et étant apte à être chassé radialement vers l'extérieur de la douille par une patte radiale externe du piston, pendant le déplacement du piston de sa position dégagée à sa position de transfert, et à immobiliser cette patte et ce piston en position de transfert. With this in mind, the invention relates to a device of the aforementioned type wherein the base is provided with at least one elastically deformable spout outwardly of the sleeve, this mouthpiece protruding from the sleeve towards the within the bore for retaining the piston in the transfer position and being capable of being driven radially outwardly of the sleeve by an external radial tab of the plunger, during movement of the piston from its disengaged position to its transfer position and to immobilize said lug and said piston in the transfer position.

Grâce à l'invention, le bec élastique garantit un verrouillage efficace du piston en position de transfert. Thanks to the invention, the elastic nose ensures efficient locking of the plunger in transfer position. Ce verrouillage est d'autant plus efficace que plusieurs becs sont avantageusement prévus, ces becs pouvant être régulièrement répartis autour de l'axe central du dispositif. This locking is all the more effective than several nozzles are advantageously provided, these nozzles being regularly distributed around the central axis of the device.

Selon un premier aspect avantageux de l'invention, le bec est pourvu, sur une face radiale externe, d'un talon apte à coopérer avec une bague de verrouillage en position de retenue du piston, cette bague étant apte à coulisser autour de la douille. According to a first advantageous aspect of the invention, the mouthpiece is provided on an outer radial face, with a heel adapted to cooperate with a locking ring for retaining the piston position, this ring being able to slide around the sleeve . Cette bague permet de conférer au bec de retenue une rigidité suffisante pour résister efficacement à un effort de déplacement du piston à partir de la position de transfert. This ring makes it possible to give the spout retaining sufficient rigidity to effectively resist a movement of the piston force from the transfer position. Cette bague est avantageusement pourvue d'une collerette radiale externe de verrouillage en translation dans une position de coopération avec le bec. This ring is advantageously provided with an external radial flange translational locking in a cooperative position with the spout.

Selon un autre aspect avantageux de l'invention, le dispositif comprend des moyens de verrouillage en rotation du piston et/ou de la bague de verrouillage. According to another advantageous aspect of the invention, the device comprises rotating means for locking the piston and / or the locking ring. Ces moyens comprennent avantageusement des nervures longitudinales ménagées sur la face interne et/ou la face externe de la douille et aptes à coopérer avec des reliefs correspondants prévus sur la surface radiale externe du piston et/ou sur la surface radiale interne de la bague. These means advantageously comprise longitudinal ribs on the inner face and / or the outer face of the sleeve and able to collaborate with corresponding reliefs provided on the external radial surface of the piston and / or on the inner radial surface of the ring.

Selon un autre aspect avantageux de l'invention, en position dégagée par rapport au bouchon, le piston est solidaire de la douille par au moins une languette sécable. According to another advantageous aspect of the invention, in the disengaged position relative to the cap, the piston is integral with the sleeve by at least one breakable tongue. En outre, l'embase et le piston sont avantageusement formés en une seule pièce monobloc par injection de matière plastique. In addition, the base and the plunger are advantageously formed in a single piece by plastic injection. Ceci facilite le positionnement du piston par rapport à l'embase dans la mesure où ce positionnement découle directement de la méthode de fabrication et où il n'est pas nécessaire de prévoir une étape de montage correspondant à l'insertion du piston dans l'embase. This facilitates the positioning of the piston relative to the base insofar as this positioning arises directly from the method of manufacture and where it is not necessary to provide a mounting step corresponding to the insertion of the piston in the base . De plus, le caractère monobloc de l'embase et du piston garantit que le piston ne risque pas de coulisser dans l'alésage, notamment sous l'effet de vibrations ou d'accélérations brusques lors du transport du dispositif. In addition, the one-piece nature of the base and the piston ensures that the piston does not risk to slide in the bore, in particular under the effect of vibrations or sudden accelerations during transport of the device. Ainsi, la pointe d'une aiguille portée par le piston est maintenue, de façon certaine, à l'intérieur de l'alésage, de sorte qu'elle ne risque pas de dépasser de l'embase au point de marquer ou de perforer un bouchon lors de la mise en place du dispositif sur le récipient. Thus, the tip of a needle carried by the piston is maintained with certainty, within the bore, so that it can not exceed the base to the point of marking or perforating a plug when setting up the device on the container. Avec les dispositifs connus, un tel risque ne pouvait pas être complètement éliminé, y compris lors de l'utilisation de bourrelets de maintien du piston. With the known devices, such a risk could not be completely eliminated, including when using the piston retention beads.

Selon un autre aspect avantageux de l'invention, une coiffe de protection de l'alésage et du piston est pourvue, sur une face interne, d'un organe de transmission d'un effort de poussée pour le déplacement du piston de la première position vers la seconde position. According to another advantageous aspect of the invention, a protective cap of the bore and the piston is provided on an inner face of a member for transmitting a thrust force for moving the piston from the first position to the second position. Ainsi, la coiffe de protection sert d'organe de manoeuvre du piston. Thus, the protective cap serves as the piston actuator.

Selon un autre aspect avantageux de l'invention, la douille comprend, au voisinage de son bord libre, des moyens de blocage du contenant par coopération de formes, notamment des lumières de verrouillage à baïonnette aptes à coopérer avec au moins une patte du contenant. According to another advantageous aspect of the invention, the sleeve comprises, near its free edge, locking means of the container by cooperation of forms, including bayonet locking lights capable of cooperating with at least one lug of the container.

Selon un autre aspect avantageux, l'embase comprend une surface cylindrique définissant une jupe qui s'étend autour du col du récipient et porte des dents d'accrochage, cette jupe comprenant au moins une ouverture d'accès au bec et/ou à certaines dents d'accrochage depuis l'extérieur. According to another advantageous aspect, the base comprises a cylindrical surface defining a skirt that extends around the container neck and bears hooking teeth, said skirt comprising at least one access opening to the spout and / or certain hooking teeth from the outside. Ces ouvertures sont particulièrement utiles pour un moulage efficace du ou des becs et des dents correspondantes. These openings are particularly useful for efficient molding or nozzles and corresponding tooth.

L'invention concerne également un ensemble prêt à l'emploi comprenant un récipient fermé contenant un produit, notamment une préparation pharmaceutique, ce récipient étant pourvu d'un col dont l'ouverture est obturée par un bouchon, et un dispositif de connexion tel que précédemment décrit monté sur le récipient. The invention also relates to an assembly ready for use comprising a closed container containing a product, particularly a pharmaceutical preparation, said container being provided with a neck whose opening is closed by a stopper, and a connection device such as described above mounted on the container. Un tel ensemble permet de conserver de façon stérile un composant d'un médicament ou d'un vaccin, notamment son principe actif, et de le préparer en temps utile par mélange avec un liquide, alors que son piston est efficacement maintenu en position. Such an assembly allows to maintain sterile a component of a medicament or vaccine, particular active ingredient, and preparing in good time by mixing with a liquid, while its piston is effectively held in position.

L'invention sera mieux comprise et d'autres avantages de celle-ci apparaítront plus clairement à la lumière de la description qui va suivre d'un mode de réalisation d'un dispositif de connexion conforme à son principe, donnée uniquement à titre d'exemple et faite en référence aux dessins annexés dans lesquels : The invention will be better understood and other advantages thereof will appear more clearly in the light of the following description of an embodiment of a connection device according to its principle, given solely by way of example and with reference to the accompanying drawings in which:

  • la figure 1 est une vue éclatée de côté d'un ensemble prêt à l'emploi conforme à l'invention ; Figure 1 is an exploded side view of a ready-to-use according to the invention;
  • la figure 2 est une coupe transversale selon la ligne II-II à la figure 1 ; FIG 2 is a cross section along line II-II in Figure 1;
  • la figure 3 est une coupe brisée selon la ligne III-III à la figure 2, on y a également indiqué en II-II le plan de coupe de la figure 2 ; Figure 3 is a broken section along line III-III in Figure 2, there is also indicated by II-II the sectional plane of Figure 2;
  • la figure 4 est une coupe analogue à la figure 3 lors d'une première étape de mise en oeuvre du dispositif et Figure 4 is a section similar to Figure 3 in a first implementation step of the device and
  • la figure 5 est une coupe analogue à la figure 3 lors d'une seconde étape de mise en oeuvre du dispositif. Figure 5 is a section similar to Figure 3 during a second stage of implementation of the device.

Le dispositif 1 conforme à l'invention a une double fonction. The device 1 according to the invention has a dual function. Il assure d'une part l'inviolabilité d'un récipient 2, par exemple un flacon en verre, contenant un produit non représenté et préalablement fermé ou bouché. It serves firstly the inviolability of a container 2, for example a glass vial, containing a not shown and previously closed or blocked product. Ce produit peut être une poudre destinée à former un vaccin buvable. This product can be a powder to form an oral vaccine. Il peut s'agir de tout autre type de préparation pharmaceutique, en particulier de tout type de médicament. It can be any other type of pharmaceutical preparation, especially any type of medication. Le dispositif 1 permet d'autre part d'assurer ou d'établir une connexion étanche entre l'intérieur du récipient 2 et l'intérieur d'un autre contenant 3, tel qu'une seringue contenant un liquide destiné à mettre en solution ou en suspension le produit contenu dans le récipient 2. A la place d'une seringue, le contenant 3 pourrait être formé par une poche souple ou un autre flacon en verre. The device 1 allows the other hand to ensure or establish a sealed connection between the interior of container 2 and within another container 3, such as a syringe containing a liquid intended to be dissolved or suspending the product contained in the container 2. instead of a syringe, the container 3 could be formed by a flexible pouch or other glass vial.

Le récipient 2 comporte un col 4, dont l'ouverture 4 a est obturée de façon étanche par un bouchon 5 réalisé en un matériau relativement mou, par exemple en élastomère et notamment en caoutchouc. The container 2 comprises a neck 4, the opening 4a is tightly sealed by 5-directed stopper of a relatively soft material, for example elastomer and in particular rubber. Le col 4 comporte un bourrelet annulaire externe 4 b sur lequel est sertie une capsule 6 qui recouvre également une partie périphérique du bouchon 5 et qui est pourvue d'une ouverture centrale 6 a à travers laquelle il est possible de perforer le bouchon 5. Le bouchon 5 comporte une partie centrale sensiblement cylindrique 5 a , adaptée à un emmanchement souple et étanche à l'intérieur de l'ouverture 4 a , et une partie externe 5 b , aplatie, épaulée sur le bourrelet 4 a , et recouverte par la capsule 6. The neck 4 comprises an outer annular bead 4 b on which is crimped a cap 6 which also covers a peripheral portion of the cap 5 and which is provided with a central opening 6a through which it is possible to perforate the stopper 5. The plug 5 has a substantially cylindrical central portion 5a adapted to a flexible and tight fit within the opening 4a, and an outer part 5b, flattened, supported on the flange 4a, and covered with the capsule 6.

Le dispositif 1 est essentiellement formé de deux pièces réalisées par injection de matière plastique, par exemple de polyéthylène, de polypropylène, de polyamide ou d'ABS (polyacrylonitryle/butadiène/styrène), à savoir un élément de base ou embase 10 destiné à être monté autour des éléments 3 à 6, et une coiffe 30. The device 1 consists essentially of two parts made of plastic material by injection, for example polyethylene, polypropylene, polyamide or ABS (polyacrylonitryle / butadiene / styrene), namely a base member or base 10 to be mounted around the elements 3 to 6, and a cap 30.

L'élément de base 10 comprend plusieurs dents d'accrochage 11 prévues pour être disposées autour du bourrelet 4 b , à la façon représentée à la figure 3. Ces dents sont définies en partie inférieure d'une jupe cylindrique 12 entourant le col 4. L'élément 10 comprend une paroi 13 d'appui sur la partie supérieure de la capsule 6, cette paroi étant pourvue d'un évidement central 13 a bordé par une douille cylindrique 14, concentrique à la jupe 12 et s'étendant à l'opposé de la paroi 13 par rapport à cette jupe. The base member 10 comprises a plurality of hooking teeth 11 intended to be arranged around the bead 4b in the manner shown in Figure 3. These teeth are defined in the lower part with a cylindrical skirt 12 surrounding the neck 4. the element 10 comprises a wall 13 bearing on the upper part of the cap 6, this wall being provided with a central recess 13 is bordered by a cylindrical sleeve 14, concentric with the skirt 12 and extending the opposite the wall 13 relative to the skirt.

On note XX' l'axe central du dispositif 1 qui est, en particulier, l'axe de la jupe 12 et de la douille 14. La douille 14 s'étend jusqu'au contact de la capsule 6 et définit un alésage A centré sur l'axe XX'. It is noted XX 'the central axis of the device 1 which is, in particular, the axis of the skirt 12 and the sleeve 14. The sleeve 14 extends to contact the capsule 6 and defines a bore centered A on the axis XX '.

Dans sa partie 14 a la plus proche du bouchon 5, la douille 14 est équipée de deux becs 15 et 15' faisant saillie radialement vers l'intérieur de l'alésage A. Compte tenu du matériau plastique utilisé pour le moulage de l'élément 10, ces becs présentent une souplesse telle qu'ils peuvent être déformés élastiquement, comme représenté par la flèche F à la figure 3. In its portion 14 has closest to the plug 5, the bushing 14 is equipped with two nozzles 15 and 15 'projecting radially inwardly of the bore A. In view of the plastic material used for molding of the element 10, these nozzles have a flexibility such that they can be elastically deformed, as shown by the arrow F in Figure 3.

Comme il apparaít plus clairement à la figure 2, les becs 15 et 15' sont diamétralement opposés. As shown more clearly in Figure 2, the nozzles 15 and 15 'are diametrically opposed. Cependant, d'autres répartitions peuvent être envisagées, de même qu'un nombre de différent de becs de retenue. However, other distributions can be considered, as well as a number of different retaining noses.

A l'intérieur de l'alésage A est disposé un piston 20 formant une aiguille creuse 21 apte à perforer le bouchon 5 dans sa partie centrale. Inside the bore is arranged a piston 20 forming a hollow needle 21 adapted to perforate the stopper 5 in its central part. Le piston 20 est relié à la douille 14 par des languettes 22 qui sont au nombre de trois et régulièrement réparties à la périphérie du piston 20. Ainsi, le piston 20 est monobloc avec l'embase 10 jusqu'à la rupture des languettes 22. The piston 20 is connected to the sleeve 14 by tabs 22 which are three in number and regularly distributed on the periphery of the piston 20. Thus, the piston 20 is integral with the base 10 up to the rupture tabs 22.

Le piston 20 forme également une chemise 23 de réception du nez 3a de la seringue 3. Le diamètre intérieur de la chemise 23 est choisi suffisamment faible pour que les seules seringues pouvant être introduites à l'intérieur de cette chemise correspondent à une fabrication spéciale dédiée à cet usage. The piston 20 also forms a jacket 23 for receiving the nose 3a of the syringe 3. The inside diameter of the jacket 23 is selected sufficiently low so that the only needle insertable within the sleeve correspond to a special dedicated manufacturing for this purpose.

Le piston 20 porte deux pattes 24 s'étendant radialement vers l'extérieur au niveau de la zone de transition 25 entre l'aiguille 21 et la chemise 23. The piston 20 has two lugs 24 extending radially outwardly at the transition zone 25 between the needle 21 and the jacket 23.

Sur sa surface radiale interne, la douille 14 porte trois nervures longitudinales 16 qui coopèrent avec les côtés des pattes 24 pour éviter une rotation du piston 20 autour de l'axe XX'. On its inner radial surface, the socket 14 has three longitudinal ribs 16 which cooperate with the sides of the lugs 24 to prevent rotation of piston 20 about the axis XX '.

La coiffe 30 est formée d'une partie amovible 31, entourant le bord libre 14 b de la douille 14, et d'une bague 32 disposée autour de la douille 14, les parties 31 et 32 étant reliées par une zone sécable 33. The cap 30 is formed of a removable part 31 surrounding the free edge 14b of the sleeve 14, and a ring 32 disposed around the sleeve 14, the parts 31 and 32 being connected by a breakable zone 33.

A proximité de son bord libre 14 b , la douille 14 est pourvue d'un jonc externe 14 c prévu pour pénétrer dans une gorge périphérique interne 32 c de la bague 32. Ce jonc et cette gorge permettent de maintenir en position la coiffe 30 par rapport à l'élément 10 dans la position de stockage des figures 1 à 3. Le dispositif 1 peut être conservé dans cette position, pendant plusieurs mois, sur le flacon 2 avant utilisation. Near its free edge 14 b, the sleeve 14 is provided with an external rim 14 c provided to penetrate into an inner peripheral groove 32 c of the ring 32. This ring groove and this can maintain in position the cap 30 by relative to the element 10 in the storage position of figures 1 to 3. the device 1 can be kept in this position for several months on the bottle 2 before use.

Sur sa face interne 31 a , la partie 31 est équipée d'une extension 34 dont la forme est adaptée pour qu'elle puisse s'engager partiellement dans la chemine 23. Cette extension a, en coupe transversale, une forme de croix, car elle est formée de deux nervures sensiblement orthogonales 34 a et 34 b se croisant au niveau de l'axe XX'. On its inner face 31a, the part 31 is equipped with an extension 34 whose shape is adapted to enable it to engage partially in the chimney 23. This extension has, in cross section, a cross shape, because it is formed of two substantially orthogonal ribs 34 a and 34 b intersecting at the axis XX '. Dans la position de la figure 3, le positionnement de l'extension 34, et notamment sa profondeur d'enfoncement dans la chemise 23, est déterminé par la coopération du jonc 14 c et de la gorge 32 c . In the position of Figure 3, the positioning of the extension 34, including its depth of insertion into the jacket 23, is determined by the cooperation of the ring 14c and the groove 32 c.

Lorsqu'il est nécessaire de procéder au mélange des contenus de la seringue 23 et du récipient 2, on exerce sur la partie 31 de la coiffe 30, un effort, représenté par la flèche E à la figure 3, qui a pour effet de faire porter des épaulements 34 c des nervures 34 a et 34 b contre le bord libre de la chemise 23, tout en chassant la gorge 32 c par rapport au jonc 14 c . When it is necessary to mix the contents of the syringe 23 and the container 2, is exerted on the portion 31 of the cap 30, a force represented by the arrow E in Figure 3, which has the effect of wear shoulders 34 c of the ribs 34 a and 34 b against the free edge of the jacket 23, while driving the groove 32 c relative to the rim 14 c. La bague 32 se déplace alors le long de la douille 14 en direction de la paroi 13. L'effort transmis par l'extension 34 à la chemise 23 a pour effet de sectionner les languettes 22 et de pousser le piston 20 vers l'ouverture centrale 6 a de la capsule 6, de telle sorte que la pointe effilée 21 a de l'aiguille 21 pénètre dans le flacon 2 à travers le bouchon 5. L'effort E est maintenu jusqu'à ce que la bague 32 soit reçue dans un espace annulaire 17 défini entre la partie supérieure de la jupe 12 et la partie inférieure 14 a de la douille 14. Ce déplacement de la bague 32 correspond à un déplacement du piston 20 tel que la zone de transition 25 entre l'aiguille 21 et la chemise 23 est disposée au voisinage immédiat de la surface supérieure de la capsule 6. The ring 32 then moves along the sleeve 14 towards the wall 13. The force transmitted by the extension 34 to the jacket 23 has the effect of severing the tabs 22 and urging the piston 20 toward the opening Central 6a of the cartridge 6, so that the tapered tip 21a of the needle 21 penetrates the vial 2 through the cap 5. the E effort is maintained until the ring 32 is received in an annular space 17 defined between the upper part of the skirt 12 and the lower portion 14 a of the sleeve 14. This movement of the ring 32 corresponds to a displacement of the piston 20 such that the transition zone 25 between the needle 21 and the jacket 23 is disposed adjacent to the upper surface of the cartridge 6.

Ce déplacement du piston 20 a pour effet de faire engager les pattes 24 et 24' respectivement en arrière des becs 15 et 15', ces becs étant chassés radialement, vers l'extérieur de la douille 14, par des pattes 24 et 24' lors du mouvement d'avance du piston 20. Ceci est possible car la face avant 15 a du bec 15 visible aux figures 3 à 5 est inclinée par rapport à l'axe XX'. This movement of the piston 20 has the effect of engaging tabs 24 and 24 'respectively behind the catches 15 and 15', these noses being expelled radially outwardly from the sleeve 14 by tabs 24 and 24 'at the piston forward movement 20. This is possible because the front face 15 a of spout 15 visible in figures 3 to 5 is inclined relative to the axis XX '. On est alors dans la position de la figure 4 où la bague 32 exerce sur un talon 15 b situé sur une surface arrière ou radiale externe 15 c du bec 15 un effort centripète qui maintient le bec 15 dans une position de verrouillage efficace de la patte 24. Le bec 15' qui est identique fonctionne de la même manière. It is then in the position of Figure 4 where the ring 32 exerts on a shoulder 15 b on a rear surface or radially outer 15 c of the spout 15, a centripetal force which keeps the spout 15 in an effective locking position of the tab 24. the spout 15 'which is identical works the same way.

Afin de garantir un positionnement constant de la bague 32 à l'intérieur du volume 17, cette bague est pourvue d'une collerette externe 32 d apte à s'engager sous un rebord rentrant supérieur 12 a de la jupe 12 prévu sur un secteur angulaire au niveau du bec 15. Un rebord rentrant analogue 12' a est prévu au niveau du bec 15'. To ensure a constant positioning of the ring 32 within the volume 17, this ring is provided with an external collar 32 of adapted to engage in a re-entrant rim top 12 a of the skirt 12 provided over an angular sector at the spout 15. A similar re-entrant rim 12 'is provided at the nozzle 15'.

Ainsi, la bague 32 est fermement maintenue dans une position telle qu'elle empêche une déformation élastique du bec 15 qui pourrait permettre un mouvement des pattes 24 dans un sens d'éloignement par rapport au bouchon 5. Le fonctionnement est analogue au niveau du bec 15'. Thus, the ring 32 is firmly held in a position such as to prevent an elastic deformation of the spout 15 which might permit movement of the tabs 24 in a direction away relative to the plug 5. The operation is similar to the level of the spout 15 '.

Au niveau de sa partie 14 a , la douille 14 est pourvue de nervures externes 14 e prévues pour s'engager dans des encoches correspondantes 32 e ménagées sur la surface radiale interne de la bague 32. Ainsi, dans la position de la figure 4, la bague 32 est immobilisée en rotation autour de l'axe XX'. At its portion 14 a, the sleeve 14 is provided with external ribs 14 e provided to engage corresponding slots 32 e formed on the inner radial surface of the ring 32. Thus, in the position of Figure 4, the ring 32 is immobilized in rotation about the axis XX '. Il est alors possible d'exercer sur la partie 31 de la coiffe 30 un couple C permettant de rompre la partie sécable 33 de façon à retirer cette partie 31, alors que la bague 32 demeure en position de verrouillage des becs 15 et 15'. It is then possible to exert on the part 31 of the cap 30 a torque C to break the breakable portion 33 so as to remove this portion 31, while the ring 32 remains in the locking position of the slats 15 and 15 '.

Le nez 3 a de la seringue 3 est alors introduit dans la chemise 23, comme représenté à la figure 5, en utilisant une ou plusieurs pattes 3 b prévues au niveau d'une douille de base 3 c de la seringue 3 pour pénétrer chacune dans une lumière de verrouillage à baïonnette 14 f prévue à proximité du bord libre 14 b du la douille 14. Cette construction particulière permet un verrouillage efficace de la seringue 3 par rapport au dispositif 1 lors des opérations de transit du liquide de la seringue vers le flacon et de récupération de la préparation dans la seringue. The nose 3a of the syringe 3 is then introduced into the jacket 23, as shown in Figure 5, using one or more tabs 3b provided at a base sleeve 3 c of the syringe 3 to penetrate into each a bayonet locking aperture 14 f provided near the free edge 14 b of the socket 14. This particular construction allows an efficient locking of the syringe 3 relative to the device 1 during transit of the liquid from the syringe to the vial operations and recovery of the mixture into the syringe.

La douille 12 est pourvue, au niveau du bec 15, d'une ouverture 18 qui permet à un tiroir mobile de conformer la partie arrière du bec 15 et le rebord rentrant 12 a de la jupe 12 lors du moulage. The bushing 12 is provided at the nozzle 15, an opening 18 which allows a mobile drawer to conform the rear portion of the spout 15 and the re-entrant rim 12a of the skirt 12 during molding. Les dents 11 peuvent être obtenues lors du moulage de l'élément 10 par des tiroirs pénétrant jusqu'au bas de la jupe 12 à travers des ouvertures 13 b prévues dans la paroi 13. Compte tenu de la géométrie et de l'emplacement des becs 15, ceci n'est pas possible pour les dents 11 situées dans le même secteur angulaire que les becs 15 et 15'. The teeth 11 can be obtained during the molding of the element 10 by penetrating drawers to the bottom of the skirt 12 through openings 13 b provided in the wall 13. Due to the geometry and location of the spouts 15 this is not possible for the teeth 11 located in the same angular sector as the catches 15 and 15 '. Une ouverture 19 est prévue dans la jupe 12, au-dessous de l'ouverture 18, pour permettre le passage d'un tiroir mobile de conformation de la dent 11 correspondante lors du moulage du dispositif 1. Bien entendu des ouvertures correspondantes sont prévues dans le secteur angulaire correspondant au bec 15'. An opening 19 is provided in the skirt 12, below the opening 18, to allow passage of a mobile drawer conformation of the corresponding tooth 11 during molding of the device 1. Of course the corresponding openings are provided in the angular sector corresponding to the spout 15 '.

La structure particulière des becs 15 et 15' et leur coopération avec la bague 32 garantissent un verrouillage efficace du piston 20 dans la position de transfert des figures 4 et 5. On comprend aisément que le nombre et la répartition des becs 15, 15' ou équivalent dépendent d'un choix de conception à la portée de l'homme du métier, en fonction de la force de verrouillage recherchée et de la rigidité des matériaux utilisés. The particular structure of the slats 15 and 15 'and their cooperation with the ring 32 guarantee an effective locking of the piston 20 in the transfer position of Figures 4 and 5. It is readily understood that the number and distribution of the nozzles 15, 15' or equivalent depend on a design choice within the reach of the skilled person depending on the desired clamping force and rigidity of the materials used.

L'invention présente l'avantage particulier qu'elle est adaptable à des flacons conditionnés de façon classique avec un bouchon et une capsule sertie 6, ce qui permet sa mise en oeuvre après conditionnement d'une partie des médicaments sur une chaíne classique. The invention has the particular advantage that it is adaptable to bottles packaged in conventional manner with a plug and a crimped cap 6, allowing its implementation after preparation of some of the drugs over a conventional chain.

L'invention est applicable indépendamment du mode de fixation de l'élément ou embase 10 sur le récipient 2 et, de façon générale, elle peut être utilisée dans tout dispositif de connexion comprenant un piston mobile à l'intérieur d'un alésage d'une embase montée sur un récipient. The invention is applicable regardless of the mode of fixation of the element or base 10 of the container 2 and, in general, it can be used in any connection device comprising a piston movable within a bore of a base mounted on a vessel.

Claims (11)

  1. Device for connecting a closed receptacle (2) and a container (3), the said closed receptacle comprising a neck (4) the opening (4a) of which is sealed by a stopper (5), the said connecting device comprising:
    a base unit (10), which can be mounted on the said receptacle and which comprises a sleeve (14) forming an internal bore (A),
    a piston (20) able to slide in the said bore, between a first position clear of the said stopper (5) and a second position, known as the transfer position, in which a hollow needle (21) carried by the said piston passes through the said stopper,
    characterized in that the said base unit (10) is provided with at least one spur (15, 15') that is elastically deformable (F) towards the outside of the said sleeve (14), the said spur protruding, from the said sleeve (14), towards the inside of the said bore (A) to retain the said piston in the transfer position and being capable of being driven radially towards the outside of the said sleeve by an external radial tab (24) of the said piston (20), as the said piston moves between the said first and second positions, and of immobilizing the said tab and the said piston in the transfer position.
  2. Device according to Claim 1, characterized in that the said spur (15, 15') is provided, on an external radial face (15c), with a heel (15b) able to collaborate with a ring (32) for locking the said piston (20) in the retained position, the said ring being able to slide around the said sleeve (14).
  3. Device according to Claim 2, characterized in that the said ring (32) is provided with an external radial flange (32d) for locking in terms of translation in a position of collaboration with the said spur.
  4. Device according to one of the preceding claims, characterized in that it comprises means (16, 24, 14e, 32e) of locking the said piston (20) and/or the said ring (32) in terms of rotation about a central axis (XX') of the said bore (A).
  5. Device according to Claim 4, characterized in that the said means of locking in terms of rotation comprise longitudinal ribs (16, 14e) formed on the internal face and/or the external face of the said sleeve (14) and able to collaborate with corresponding reliefs (24, 32c) provided on the external radial surface of the said piston (24) and/or on the internal radial surface of the said ring (32).
  6. Device according to one of the preceding claims, characterized in that, in the said position clear of the said stopper (5), the said piston (20) is secured to the said sleeve (14) by at least one frangible tag (22).
  7. Device according to one of the preceding claims, characterized in that the said base unit (11-19) and the said piston (20) are formed as a one-piece part (10) by the injection moulding of plastic.
  8. Device according to one of the preceding claims, characterized in that it comprises a cap (30) protecting the said bore (A) and the said piston (20), the said cap being provided, on an internal face, with a member (34) for transmitting a thrusting force (E) for moving the said piston (20) from the said first position towards the said second position.
  9. Device according to one of the preceding claims, characterized in that the said sleeve (14) comprises, near its free edge (14b), means of immobilizing the said container (3) through the collaboration of shapes, particularly bayonet-type locking slots (14f) able to collaborate with at least one lug (3b) of the said container.
  10. Device according to one of the preceding claims, characterized in that the said base unit (10) comprises a skirt (12) which extends around the said neck (4) of the said receptacle (2) and carries catching teeth (11), the said skirt comprising at least one opening (18, 19) for access to the said spur (15) and/or to certain catching teeth (11) from the outside.
  11. Ready-to-use assembly comprising a closed receptacle (2) containing a product, particularly a pharmaceutical preparation, the said receptacle being provided with a neck the opening of which is sealed by a stopper (5), and a connecting device (10-34) according to any one of the preceding claims, mounted on the said receptacle.
EP20000903770 1999-02-10 2000-02-09 Connecting device between a container and its contents and ready-to-use assembly comprising same Not-in-force EP1150639B1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
FR9901755 1999-02-10
FR9901755A FR2789369B1 (en) 1999-02-10 1999-02-10 Connecting arrangement between a container and a container together and ready to use such a device comprising
PCT/FR2000/000315 WO2000047159A1 (en) 1999-02-10 2000-02-09 Connecting device between a container and its contents and ready-to-use assembly comprising same

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EP1150639A1 EP1150639A1 (en) 2001-11-07
EP1150639B1 true EP1150639B1 (en) 2002-09-04

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EP (1) EP1150639B1 (en)
JP (1) JP2002536120A (en)
CN (1) CN1337869A (en)
AT (1) AT223189T (en)
AU (1) AU761028B2 (en)
BR (1) BR0008118B1 (en)
CA (1) CA2360196A1 (en)
DE (1) DE60000409T2 (en)
DK (1) DK1150639T3 (en)
ES (1) ES2182776T3 (en)
FR (1) FR2789369B1 (en)
HU (1) HU0105369A3 (en)
MX (1) MXPA01008138A (en)
PL (1) PL350089A1 (en)
PT (1) PT1150639E (en)
RU (1) RU2229871C2 (en)
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AU2554800A (en) 2000-08-29
RU2229871C2 (en) 2004-06-10
TR200102307T2 (en) 2002-01-21
AU761028B2 (en) 2003-05-29
CA2360196A1 (en) 2000-08-17
DE60000409T2 (en) 2003-04-17
FR2789369A1 (en) 2000-08-11
HU0105369A3 (en) 2003-01-28
BR0008118B1 (en) 2009-08-11
PT1150639E (en) 2003-01-31
WO2000047159A1 (en) 2000-08-17
JP2002536120A (en) 2002-10-29
US6478788B1 (en) 2002-11-12
FR2789369B1 (en) 2001-04-27
CN1337869A (en) 2002-02-27
DK1150639T3 (en) 2002-12-23
HU0105369A2 (en) 2002-05-29
PL350089A1 (en) 2002-11-04
ZA200105728B (en) 2002-03-01
BR0008118A (en) 2001-11-13
MXPA01008138A (en) 2003-07-21
AT223189T (en) 2002-09-15
EP1150639A1 (en) 2001-11-07
DE60000409D1 (en) 2002-10-10
ES2182776T3 (en) 2003-03-16

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