EP1365725A1 - Device for connection between a vessel and a container and a ready-to-use assembly comprising same - Google Patents

Device for connection between a vessel and a container and a ready-to-use assembly comprising same

Info

Publication number
EP1365725A1
EP1365725A1 EP02714279A EP02714279A EP1365725A1 EP 1365725 A1 EP1365725 A1 EP 1365725A1 EP 02714279 A EP02714279 A EP 02714279A EP 02714279 A EP02714279 A EP 02714279A EP 1365725 A1 EP1365725 A1 EP 1365725A1
Authority
EP
European Patent Office
Prior art keywords
sleeve
needle
piston
container
section
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP02714279A
Other languages
German (de)
French (fr)
Other versions
EP1365725B1 (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 SAS
Original Assignee
Biodome SAS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biodome SAS filed Critical Biodome SAS
Publication of EP1365725A1 publication Critical patent/EP1365725A1/en
Application granted granted Critical
Publication of EP1365725B1 publication Critical patent/EP1365725B1/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/2013—Piercing means having two piercing ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2055—Connecting means having gripping means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068—Venting means
    • A61J1/2072—Venting means for internal venting

Definitions

  • CONNECTION DEVICE BETWEEN A CONTAINER AND A CONTAINER AND READY-TO-USE ASSEMBLY COMPRISING SUCH A DEVICE
  • the invention relates to a connection device between a closed container and a container.
  • the invention also relates to a ready-to-use assembly comprising, inter alia, a closed container and a connection device of the aforementioned type.
  • a component of a pharmaceutical preparation such as for example its active principle
  • a container closed by a stopper of relatively soft material for example made of elastomer.
  • a liquid can be introduced into this container after puncturing the stopper to dissolve or suspend the component contained in this container, this in order to obtain a preparation, in particular a medicament or a vaccine, in liquid form and ready to be administered to the patient .
  • WO-A-98/13 006 discloses a connection device comprising a base adapted to cover the neck of a container and being extended by a flange or sleeve forming an internal bore while a piston is slidably mounted in this bore.
  • the piston carries snap teeth distributed around its axis and intended to cooperate with an annular blank of the flange. This device gives satisfaction for the connection of a syringe provided with a luer tip.
  • the invention therefore aims to propose a device for connection of the aforementioned type in which the base and the piston have particularly simple structures, while the piston is effectively guided in translation relative to the base and effectively maintained in the transfer position, including in the case of use with a double-pointed needle.
  • the invention relates to a device in which the needle of the piston is of non-circular external cross section, while a sleeve formed by the base is of internal cross section also non-circular the external sections of the needle and internal of the sleeve being such that a sliding of the needle in the sleeve is possible, without the possibility of rotation of the needle.
  • the edge of the sleeve opposite the container stopper is provided with stop means capable of cooperating with complementary means provided on the piston for its locking in the transfer position.
  • the structure of the piston can be eminently simplified compared to the devices of the state of the art since the shape of the needle which it carries or which it includes allows guiding in translation in the sleeve, without possibility of rotation.
  • the sliding without possibility of rotation guarantees an adequate positioning of the stop means provided on the upper edge of the sleeve and -complementary means provided on the piston.
  • the piston of the device of the invention is easy to mold, while its cost price in material is very attractive and the geometry of the device facilitates the movement of the piston, its released position to its transfer position.
  • the needle is of oval external cross section, while the sleeve is also of oval internal cross section.
  • the needle can be of polygonal external cross section, while the sleeve is of cross section internal polygonal, with the same number of sides as the external section of the needle.
  • the device incorporates one or more of the following characteristics:
  • the stop means provided on the edge of the sleeve include elastically deformable hooks
  • the complementary means provided on the piston include bearing surfaces formed on a one-piece flange with the needle, the needle and the flange constituting together the piston.
  • the flange is advantageously provided with openings for the passage of the hooks.
  • the hooks can each be provided with a nose capable of being nested with a return bordering one of the bearing surfaces provided on the flange. It can also be provided that the hooks project radially outward relative to the sleeve.
  • the base comprises a second sleeve disposed radially outside the aforementioned sleeve, the second sleeve being able to cooperate with a cap for isolating the piston from the ambient atmosphere.
  • Rigidification ribs can be arranged between these sleeves.
  • These means may comprise at least one relief in relief formed on the external surface of the needle and at least one protruding relief extending from the internal radial surface of the sleeve, in the direction of a central axis. of the bore, the protruding relief being able to be engaged in the hollow relief to maintain the piston in the released position relative to the container cap.
  • the invention also relates to a ready-to-use assembly
  • a ready-to-use assembly comprising a closed container containing a product, in particular a pharmaceutical preparation, this container being provided with a neck whose opening is closed by a plug, and a connection device such as previously described mounted on this container.
  • a connection device such as previously described mounted on this container.
  • FIG. 1 is an exploded side view of a ready-to-use assembly according to the invention and of a bottle intended to cooperate with this assembly;
  • FIG. 2 is an axial section of the connection device belonging to the assembly of Figure 1, mounted on the container in storage configuration;
  • FIG. 3 is a section along line III-III in Figure 2;
  • - Figure 4 is an enlarged view of detail IV in Figure 2;
  • - Figure 5 is a perspective view, partially broken away, of the connection device before mounting on the container;
  • FIG. 6 is a view similar to Figure 2, at the start of a connection operation of the container with the flexible bottle shown in Figure 1; _ "
  • Figure 7 is a view similar to Figure 2, while the bottle is connected to the container of the assembly of Figure 1 and
  • Figure 8 is a section similar to Figure 3, for a device according to a second embodiment of the invention.
  • the device 1 according to the invention shown in Figures 1 to 6 has a dual function. It ensures, on the one hand, the inviolability of a container 2, for example a glass bottle, containing a product not shown and previously closed or capped.
  • the device 1 also makes it possible to ensure or establish a sealed connection between the interior of the container 2 and the interior of another container, such as a rigid or semi-rigid plastic bottle 3 containing a liquid intended to dissolve or suspend the product contained in the container 2.
  • the container could also be formed by a glass bottle.
  • the bottle 2 has a neck 4, the opening 4a of which is sealed off by a stopper 5 made of a relatively soft material, for example an elastomer, preferably rubber.
  • a capsule can be arranged around the plug 5 and an external annular part 4b_ of the neck 4.
  • the plug 5 has a substantially cylindrical central part 5a suitable for a flexible and watertight fitting interior of the opening 4a and a flattened part 5b, supported on the part 4h and possibly covered by the capsule.
  • the device 1 comprises a base 10 produced by injection of plastic material, for example polyethylene and or polypropylene, and intended to be mounted around the elements 4 and 5.
  • the base 10 forms a sleeve 11 generally cylindrical and centered on an axis XX 1 , which is an axis of symmetry of the elements 2, 4 and 5 in the mounted configuration shown in FIG. 2.
  • the sleeve 11 is connected to an annular part 12 provided with a rod 13 with a pointed profile intended to penetrate superficially on the upper or exposed surface 5c of the plug 5.
  • the annular part 12 is extended, opposite the sleeve 11, by several elastic tabs 14 each provided with a spout 15 capable of cooperating with the external surface of the neck 4, in view an elastic snap-fitting of the base 10 on the neck.
  • a second sleeve 16 which extends in the direction of the axis XX 'and has an oval internal section as shown in FIG. 3.
  • the sleeves 11 and 16 are connected by stiffening ribs 17 ensuring adequate positioning and rigidity of the sleeve 16.
  • the internal volume of the sleeve 16 constitutes a bore A inside which a piston 20 formed can slide a molded plastic part.
  • the piston 20 comprises a hollow needle 21 with a double point provided with two channels 21a, 21b and capable of perforating the plug 5.
  • the piston 20 also comprises a flange 22, integral with the needle 21 and provided with two openings 22a and 22b. As also appears from FIG. 3, the needle 21 has an oval external section.
  • 21c the external radial surface of the needle 21, we note 16c the internal radial surface of the sleeve 16.
  • the surfaces 16c and 21c are such that a sliding of the needle 21, that is to say of the piston 20, in bore A is possible.
  • the non-circular character around the axis XX 'of the surfaces 16c and 21c is such that the piston 20 can slide in the bore A without the possibility of rotation around the axis XX' relative to the sleeve 16.
  • Two elastic hooks 16a and 16b are provided at the upper edge 16d of the sleeve 16, that is to say of the edge of this sleeve opposite the plug 5. These hooks extend near the two parts of the lower sleeve radius of curvature.
  • the hooks 16a and 16b are configured to be able to penetrate into the openings 22a and 22b in order to snap onto the retaining surfaces 22d and 22e provided in the flange 22. It is noted that the openings 22a and 22b are ⁇ each provided with an edge 22 £ converging towards the end 21d of the needle 21 opposite the stopper 5. Furthermore, the hooks 16a and 16b are provided with truncated edges 16 £ converging opposite the part 12.
  • the cooperation of the edges 16 £ and 22f has the effect of tightening the hooks 16 in the direction of the axis XX 'when the flange 22 comes to bear against these hooks, this allowing the hooks 16a and 16b to pass through the openings 22a and 22b before expands radially outwards again, so that the hooks 16a and 16b come to bear on the surfaces 22d and 22a.
  • the hooks 16a and 16b are each provided with a nose 16n, respectively 16p, directed towards the part 12. Furthermore, the flange 22 is equipped with returns 22n and 22p which respectively border the surfaces 22d and 22a.
  • the noses 16n and 16p. come to bear against surfaces 22d and 22c, behind returns 22n and 22p. Any risk of relative sliding of the hooks 16a and 16b relative to the flange 22 is thus avoided because such sliding is prevented by the bearing of the noses 16n and 16p. against returns 22n and 22p.
  • the sleeve 16 is provided of an internal rod 16g projecting from the surface 16c in the direction of the axis XX '. Furthermore, the surface 21c of the needle 21 is provided with a groove 21g in which the rod 16g can be engaged. When the rod 16g is engaged in the groove 21g, the needle 21, that is to say the piston -20, is immobilized in translation- in the bore A.
  • the rod 16g and the groove 21g can be replaced by other reliefs which can extend over only part of the circumference of the surfaces 16c and 21c.
  • An outer casing 30 is provided to be mounted around the base 10 and the piston 20 on the container 2.
  • the casing 30 comprises a ring 31 intended to immobilize the tabs 14 in position around the neck 4, in accordance with the teaching WO-A-97/10 technique 156.
  • the ring 31 is connected by a breakable section 32 to a cap 33 which isolates the base 10 and the piston 20 from the ambient atmosphere as long as the breakable section has not been broken. It is noted that the cap 33 is designed to come into abutment against the external radial surface of the sleeve 11.
  • a lubricant can be applied discontinuously to the internal surface of the cap 33 to facilitate its removal relative to the base 10.
  • This lubricant could be applied around the sleeve 11, also discontinuously, that is to say by not forming a complete circumference around the axis XX '.
  • the operation is as follows: When it is necessary to make a liquid penetrate inside the container 2, the cap 33 is removed by rupture of the section 32, as shown by the arrows R and F_ in FIG. 6. It is then possible to exert on the piston 1 an effort F 2 directed towards the stopper 5 in order to pierce the latter thanks to the needle 21.
  • the effort F 2 can be exerted by means of the bottle 3 including a stopper 5 'is first engaged on the exposed end 21d of the needle 21, the plug 5' can then be taken in hand by the user to exert on the base 22 the force F 2 , which has the effect of driving the rod 16g out of the groove 21g and then allowing the needle 21 to move forward in the direction of the plug 5 which it then crosses.
  • the hooks 16a and 16b penetrate into the openings 22a and 22b, being deformed thanks to the cooperation of the edges 16 £ and 22 £.
  • the hooks 16a and 16b then come to lock on the surfaces 22d and 22c of the flange 22, so that the piston 20 is snapped into the transfer position on the sleeve 16.
  • the sleeve 16 is kept rigid by virtue of the ribs 17 which ensure the recovery of any transverse forces.
  • the hooks 16a and 16b are obtained without the use of a complex mold, two openings 12a and 12b being provided in part 12 for the passage of drawers for forming these hooks in the mold for manufacturing the base 10.
  • the base 10 is a single piece which comprises the elements 11 to 17.
  • the constituent elements of the device 1 of the invention are therefore particularly simple and of very attractive cost price.
  • the sliding of the needle 21 in the sleeve 16 allows correct alignment of the hooks provided in the upper part of the sleeve and the corresponding hooking means provided on the collar of the piston.
  • the invention has been shown with two hooks 16a and 16b formed at the parts of the sleeve 16 of smaller radius of curvature. According to a variant not shown of the invention, these hooks could be formed at the parts of the greatest radius of curvature of this sleeve, that is to say of the parts shown respectively upwards and downwards in the figure. 3. In this case, the position of the openings 22a and 22b and the surfaces 22d and 22c of the collar 22 with respect to needle 21 is adapted accordingly.
  • the number of hooks of the device of the invention is not limited to two; a hook is enough for it to immobilize the piston in the transfer position. Alternatively, a number of hooks greater than or equal to three may be provided.
  • the invention has been shown with a monobloc piston. It is also applicable to the case where the piston is formed of an assembly comprising a needle and an attached flange.

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Hematology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Supplying Of Containers To The Packaging Station (AREA)
  • Cartons (AREA)
  • Quick-Acting Or Multi-Walled Pipe Joints (AREA)
  • Auxiliary Devices For And Details Of Packaging Control (AREA)
  • Load-Engaging Elements For Cranes (AREA)

Abstract

The invention relates to a connecting device (1) comprising a base (10) which can be mounted on the vessel (2) and consisting of a sleeve (16) which forms an inner bore and a plunger (20) adapted to slide in the bore between a first released position relative to a cap of the vessel and a so-called transfer position, wherein the hollow needle (21) thereof passes through the cap. The needle (21) is provided with a non-circular external transverse section while the sleeve (16) is provided with a non-circular internal transverse section. The external section of the needle (21) and the internal section of the sleeve (16) are such that the needle can slide in the sleeve, without rotating therein. The edge (16d) of the sleeve opposite the cap is provided with stop means (16a, 16b) which can co-operate with complementary means (22d, 22e) which are disposed on the plunger (20) for locking the plunger in said transfer position.

Description

DISPOSITIF DE CONNEXION ENTRE UN RECIPIENT ET UN CONTENANT ET ENSEMBLE PRET A L'EMPLOI COMPRENANT UN TEL DISPOSITIF CONNECTION DEVICE BETWEEN A CONTAINER AND A CONTAINER AND READY-TO-USE ASSEMBLY COMPRISING SUCH A DEVICE
L'invention a trait à un dispositif de connexion entre un récipient fermé et un contenant. 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 relates to a connection device between a closed container and a container. The invention also relates to a ready-to-use assembly comprising, inter alia, a closed container and a connection device of the aforementioned type.
Dans le domaine du conditionnement des 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 de matériau relativement mou, par exemple en élastomère. Un liquide peut être introduit dans ce récipient après perforation du bouchon pour dissoudre ou mettre en suspension le composant contenu dans ce récipient, ceci afin d'obtenir une préparation, notamment un médicament ou un vaccin, sous forme liquide et prêt à être administré au patient.In the field of packaging of medicaments, it is known to store a component of a pharmaceutical preparation, such as for example its active principle, in a container closed by a stopper of relatively soft material, for example made of elastomer. A liquid can be introduced into this container after puncturing the stopper to dissolve or suspend the component contained in this container, this in order to obtain a preparation, in particular a medicament or a vaccine, in liquid form and ready to be administered to the patient .
Par WO-A-98/13 006, on connaît un dispositif de connexion comprenant 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. Le piston porte des dents d' encliquetage distribuées autour de son axe et prévues pour coopérer avec un flan annulaire de la collerette. Ce dispositif donne satisfaction pour le raccordement d'une seringue pourvue d 'un embout luer.WO-A-98/13 006 discloses a connection device comprising a base adapted to cover the neck of a container and being extended by a flange or sleeve forming an internal bore while a piston is slidably mounted in this bore. The piston carries snap teeth distributed around its axis and intended to cooperate with an annular blank of the flange. This device gives satisfaction for the connection of a syringe provided with a luer tip.
Cependant, il est parfois nécessaire de raccorder un récipient à un contenant autre qu'une seringue, auquel cas le transfert de liquide entre le récipient et le contenant, ou réciproquement, a lieu par gravité. Dans ce cas, une aiguille à double pointe avec des canaux de section relativement importante doit utilisée. Compte tenu du volume de cette aiguille, l'effort de réaction du bouchon, qui tend à la repousser hors du récipient, est important, au point qu'un système à encliquetage tel que connu de WO-A-98/13006 ne serait pas forcément suffisant.However, it is sometimes necessary to connect a container to a container other than a syringe, in which case the transfer of liquid between the container and the container, or vice versa, takes place by gravity. In this case, a double-pointed needle with channels of relatively large cross-section should be used. Given the volume of this needle, the reaction force of the stopper, which tends to push it out of the container, is large, to the point that a snap-in system as known from WO-A-98/13006 would not be necessarily enough.
L'invention vise donc à proposer un dispositif de connexion du type précité dans lequel l'embase et le piston ont des structures particulièrement simples, alors que le piston est efficacement guidé en translation par rapport à l'embase et efficacement maintenu en position de transfert, y compris dans le cas d'une utilisation avec une aiguille à double pointe.The invention therefore aims to propose a device for connection of the aforementioned type in which the base and the piston have particularly simple structures, while the piston is effectively guided in translation relative to the base and effectively maintained in the transfer position, including in the case of use with a double-pointed needle.
Dans cet esprit, l'invention concerne un dispositif dans lequel l'aiguille du piston est à section transversale externe non circulaire, alors qu'un manchon formé par l'embase est à section transversale interne également non circulaire les sections externe de l'aiguille et interne du manchon étant telles qu'un coulissement de l'aiguille dans le manchon est possible, sans possibilité de rotation de l'aiguille. En outre, le bord du manchon opposé au bouchon du récipient est pourvu de moyens d'arrêt aptes à coopérer avec des moyens complémentaires prévus sur le piston pour son verrouillage en position de transfert.In this spirit, the invention relates to a device in which the needle of the piston is of non-circular external cross section, while a sleeve formed by the base is of internal cross section also non-circular the external sections of the needle and internal of the sleeve being such that a sliding of the needle in the sleeve is possible, without the possibility of rotation of the needle. In addition, the edge of the sleeve opposite the container stopper is provided with stop means capable of cooperating with complementary means provided on the piston for its locking in the transfer position.
Grâce à l'invention, la structure du piston peut être éminemment simplifiée par rapport aux dispositifs de l'état de la technique puisque la forme de l'aiguille qu'il porte ou qu'il comprend permet un guidage en translation dans le manchon, sans possibilité de rotation. Le coulissement sans possibilité de rotation garantit un positionnement adéquat des moyens d'arrêt prévus sur le bord supérieur du manchon et des moyens -complémentaires prévus sur le .piston.Thanks to the invention, the structure of the piston can be eminently simplified compared to the devices of the state of the art since the shape of the needle which it carries or which it includes allows guiding in translation in the sleeve, without possibility of rotation. The sliding without possibility of rotation guarantees an adequate positioning of the stop means provided on the upper edge of the sleeve and -complementary means provided on the piston.
Compte tenu de sa structure particulièrement simple et de son faible volume, le piston du dispositif de l'invention est aisé à mouler, alors que son prix de revient en matière est très attractif et que la géométrie du dispositif facilite le mouvement du piston, de sa position dégagée à sa position de transfert.Given its particularly simple structure and its small volume, the piston of the device of the invention is easy to mold, while its cost price in material is very attractive and the geometry of the device facilitates the movement of the piston, its released position to its transfer position.
Selon un premier mode de réalisation de l'invention, on peut prévoir que l'aiguille est à section transversale externe ovale, alors que le manchon est à section transversale interne ovale également.According to a first embodiment of the invention, it can be provided that the needle is of oval external cross section, while the sleeve is also of oval internal cross section.
Selon un autre mode de réalisation de l'invention, l'aiguille peut être à section transversale externe polygonale, alors que le manchon est à section transversale interne polygonale, avec le même nombre de côtés que la section externe de l'aiguille.According to another embodiment of the invention, the needle can be of polygonal external cross section, while the sleeve is of cross section internal polygonal, with the same number of sides as the external section of the needle.
Selon les aspects avantageux de l'invention, le dispositif incorpore une ou plusieurs des caractéristiques suivantes :According to the advantageous aspects of the invention, the device incorporates one or more of the following characteristics:
- Les moyens d ' arrêt prévus sur le bord du manchon comprennent des crochets élastiquement déformables, alors que les moyens complémentaires prévus sur le piston comprennent des surfaces d'appui ménagées sur une collerette monobloc avec l'aiguille, l'aiguille et la collerette constituant ensemble le piston. Dans ce cas, la collerette est avantageusement pourvue d'ouvertures de passage des crochets..Les crochets peuvent être pourvus chacun d'un nez apte à être imbriqué avec un retour bordant 1 ' une des surfaces d'appui ménagées sur la collerette. On peut en outre prévoir que les crochets font saillie radialement vers l'extérieur par rapport au manchon.- The stop means provided on the edge of the sleeve include elastically deformable hooks, while the complementary means provided on the piston include bearing surfaces formed on a one-piece flange with the needle, the needle and the flange constituting together the piston. In this case, the flange is advantageously provided with openings for the passage of the hooks. The hooks can each be provided with a nose capable of being nested with a return bordering one of the bearing surfaces provided on the flange. It can also be provided that the hooks project radially outward relative to the sleeve.
L'embase comprend un second manchon disposé radialement à l'extérieur du manchon précité, le second manchon étant apte à coopérer avec une coiffe d'isolation du piston par rapport à l'atmosphère ambiante. Des nervures de rigidification peuvent être disposées entre ces manchons.The base comprises a second sleeve disposed radially outside the aforementioned sleeve, the second sleeve being able to cooperate with a cap for isolating the piston from the ambient atmosphere. Rigidification ribs can be arranged between these sleeves.
- Il est prévu des moyens d'arrêt provisoire du piston dans la position dégagée de l'aiguille. Ces moyens peuvent comprendre au moins un relief en creux ménagét-s-ur la surface externe de l'aiguille et au moins un relief en saillie s 'étendant, à partir de la surface radiale interne du manchon, en direction d'un axe central de l'alésage, le relief en saillie étant apte à être engagée dans le relief en creux pour maintenir le piston en position dégagée par rapport au bouchon du récipient .- Provision is made for temporary stop of the piston in the released position of the needle. These means may comprise at least one relief in relief formed on the external surface of the needle and at least one protruding relief extending from the internal radial surface of the sleeve, in the direction of a central axis. of the bore, the protruding relief being able to be engaged in the hollow relief to maintain the piston in the released position relative to the container cap.
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 ce récipient . 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, la manoeuvre de cet ensemble prêt à l'emploi étant particulièrement aisée.The invention also relates to a ready-to-use assembly comprising a closed container containing a product, in particular a pharmaceutical preparation, this container being provided with a neck whose opening is closed by a plug, and a connection device such as previously described mounted on this container. Such an assembly allows sterile storage of a component of a drug or of a vaccine, in particular its active principle, and to prepare it in good time by mixing with a liquid, the operation of this ready-to-use assembly being particularly easy.
L'invention sera mieux comprise et d'autres avantages de celle-ci apparaîtront plus clairement à la lumière de la description qui va suivre de deux modes 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 : - la figure 1 est une vue éclatée de côté d'un ensemble prêt à l'emploi conforme à l'invention et d'un flacon prévu pour coopérer avec cet ensemble ;The invention will be better understood and other advantages thereof will appear more clearly in the light of the following description of two embodiments of a connection device in accordance with its principle, given solely by way of example and made with reference to the accompanying drawings in which: - Figure 1 is an exploded side view of a ready-to-use assembly according to the invention and of a bottle intended to cooperate with this assembly;
- la figure 2 est une coupe axiale du dispositif de connexion appartenant à l'ensemble de la figure 1, monté sur le récipient en configuration de stockage ;- Figure 2 is an axial section of the connection device belonging to the assembly of Figure 1, mounted on the container in storage configuration;
- la figure 3 est une coupe selon la ligne III-III à la figure 2 ;- Figure 3 is a section along line III-III in Figure 2;
- la figure 4 est une vue à plus grande échelle du détail IV à la figure 2 ; - la figure 5 est une vue en perspective, avec arrachement partiel, du dispositif de connexion avant son montage sur le récipient ;- Figure 4 is an enlarged view of detail IV in Figure 2; - Figure 5 is a perspective view, partially broken away, of the connection device before mounting on the container;
- la figure 6 est une vue analogue à la figure 2 , au début d'une opération de raccordement du récipient avec le flacon souple représentée à la figure 1 ; _„- Figure 6 is a view similar to Figure 2, at the start of a connection operation of the container with the flexible bottle shown in Figure 1; _ "
- la figure 7 est une vue analogue à la figure 2, alors que le flacon est connectée au récipient de l'ensemble de la figure 1 et- Figure 7 is a view similar to Figure 2, while the bottle is connected to the container of the assembly of Figure 1 and
- la figure 8 est une coupe analogue à la figure 3, pour un dispositif conforme à un second mode de réalisation de l'invention.- Figure 8 is a section similar to Figure 3, for a device according to a second embodiment of the invention.
Le dispositif 1 conforme à l'invention représenté aux figures 1 à 6 a une double fonction. 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. 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, tel qu'un flacon en matière plastique rigide ou semi-rigide 3 contenant un liquide destiné à mettre en solution ou en suspension le produit contenu dans le récipient 2. Le contenant pourrait également être formé par un flacon en verre .The device 1 according to the invention shown in Figures 1 to 6 has a dual function. It ensures, on the one hand, the inviolability of a container 2, for example a glass bottle, containing a product not shown and previously closed or capped. The device 1 also makes it possible to ensure or establish a sealed connection between the interior of the container 2 and the interior of another container, such as a rigid or semi-rigid plastic bottle 3 containing a liquid intended to dissolve or suspend the product contained in the container 2. The container could also be formed by a glass bottle.
Le flacon 2 comporte un col 4 dont 1 ' ouverture 4a est obturée de façon étanche par un bouchon 5 réalisé dans un matériau relativement mou, par exemple un élastomère, de préférence en caoutchouc . Selon une variante non représentée de l'invention, une capsule peut être disposée autour du bouchon 5 et d'une partie annulaire externe 4b_ du col 4. Le bouchon 5 comporte une partie centrale 5a sensiblement cylindrique adaptée à un emmanchement souple et étanche à l'intérieur de l'ouverture 4a et une partie 5b aplatie, épaulée sur la partie 4h et éventuellement recouverte par la capsule .The bottle 2 has a neck 4, the opening 4a of which is sealed off by a stopper 5 made of a relatively soft material, for example an elastomer, preferably rubber. According to a variant not shown of the invention, a capsule can be arranged around the plug 5 and an external annular part 4b_ of the neck 4. The plug 5 has a substantially cylindrical central part 5a suitable for a flexible and watertight fitting interior of the opening 4a and a flattened part 5b, supported on the part 4h and possibly covered by the capsule.
Le dispositif 1 comprend une embase 10 réalisée par injection de matière plastique, par exemple de polyéthylène et ou de polypropylène, et destinée à être monté autour des éléments 4 et 5. L'embase 10 forme un manchon 11 globalement cylindrique et centré sur un axe X-X1, qui est un axe de symétrie des éléments 2, 4 et 5 en configuration montée représentée à la figure 2. Le manchon 11 est relié à une partie annulaire 12 pourvue d'un jonc 13 à profil en pointe destiné à pénétrer superficiellement sur la surface supérieure ou exposée 5c du bouchon 5. La partie annulaire 12 se prolonge, à l'opposé du manchon 11, par plusieurs pattes élastiques 14 pourvues chacune d'un bec 15 apte à coopérer avec la surface externe du col 4, en vue d'un encliquetage élastique de l'embase 10 sur le col.The device 1 comprises a base 10 produced by injection of plastic material, for example polyethylene and or polypropylene, and intended to be mounted around the elements 4 and 5. The base 10 forms a sleeve 11 generally cylindrical and centered on an axis XX 1 , which is an axis of symmetry of the elements 2, 4 and 5 in the mounted configuration shown in FIG. 2. The sleeve 11 is connected to an annular part 12 provided with a rod 13 with a pointed profile intended to penetrate superficially on the upper or exposed surface 5c of the plug 5. The annular part 12 is extended, opposite the sleeve 11, by several elastic tabs 14 each provided with a spout 15 capable of cooperating with the external surface of the neck 4, in view an elastic snap-fitting of the base 10 on the neck.
A l'intérieur du manchon 11 est formé un second manchon 16 qui s'étend selon la direction de l'axe X-X' et a une section interne ovale ainsi que cela ressort de la figure 3. Les manchons 11 et 16 sont reliés par des nervures 17 de rigidification assurant un positionnement et une rigidité adéquats du manchon 16.Inside the sleeve 11 is formed a second sleeve 16 which extends in the direction of the axis XX 'and has an oval internal section as shown in FIG. 3. The sleeves 11 and 16 are connected by stiffening ribs 17 ensuring adequate positioning and rigidity of the sleeve 16.
Le volume intérieur du manchon 16 constitue un alésage A à l'intérieur duquel peut coulisser un piston 20 formé d'une pièce en matière plastique moulée. Le piston 20 comprend une aiguille creuse 21 à double pointe pourvue de deux canaux 21a, 21b et apte à perforer le bouchon 5. Le piston 20 comprend également une collerette 22, monobloc avec l'aiguille 21 et pourvue de deux ouvertures 22a et 22b. Comme il ressort également de la figure 3, l'aiguille 21 est à section externe ovale.The internal volume of the sleeve 16 constitutes a bore A inside which a piston 20 formed can slide a molded plastic part. The piston 20 comprises a hollow needle 21 with a double point provided with two channels 21a, 21b and capable of perforating the plug 5. The piston 20 also comprises a flange 22, integral with the needle 21 and provided with two openings 22a and 22b. As also appears from FIG. 3, the needle 21 has an oval external section.
On note 21c la surface radiale externe de l'aiguille 21, on note 16c la surface radiale interne du manchon 16. Les surfaces 16c et 21c sont telles qu'un coulissement de l'aiguille 21, c'est-à-dire du piston 20, dans l'alésage A est possible. Le caractère non circulaire autour de l'axe X- X' des surfaces 16c et 21c est tel que le piston 20 peut coulisser dans l'alésage A sans possibilité de rotation autour de l'axe X-X' par rapport au manchon 16.We note 21c the external radial surface of the needle 21, we note 16c the internal radial surface of the sleeve 16. The surfaces 16c and 21c are such that a sliding of the needle 21, that is to say of the piston 20, in bore A is possible. The non-circular character around the axis XX 'of the surfaces 16c and 21c is such that the piston 20 can slide in the bore A without the possibility of rotation around the axis XX' relative to the sleeve 16.
Deux crochets élastiques 16a et 16b sont prévus au niveau du bord supérieur 16d du manchon 16, c'est-à-dire du bord de ce manchon opposé au bouchon 5. Ces crochets s'étendent à proximité des deux parties du manchon de plus faible rayon de courbure.Two elastic hooks 16a and 16b are provided at the upper edge 16d of the sleeve 16, that is to say of the edge of this sleeve opposite the plug 5. These hooks extend near the two parts of the lower sleeve radius of curvature.
Les crochets 16a et 16b sont configurés pour pouvoir pénétrer dans les ouvertures 22a et 22b afin de s ' encliqueter sur des surfaces 22d et 22e de retenue prévues dans la collerette 22. On note que- les ouvertures 22a et 22b sont ^chacune pourvues d'un bord 22£ convergent en direction de l'extrémité 21d de l'aiguille 21 opposée au bouchon 5. Par ailleurs, les crochets 16a et 16b sont pourvus de bords tronqués 16£ convergents à l'opposé de la partie 12. Ainsi, la coopération des bords 16£ et 22f a pour effet de resserrer les crochets 16 en direction de l'axe X-X' lorsque la collerette 22 vient en appui contre ces crochets, ceci permettant aux crochets 16a et 16b de traverser les ouvertures 22a et 22b avant de s ' expandre radialement à nouveau vers l'extérieur, de telle sorte que les crochets 16a et 16b viennent en appui sur les surfaces 22d et 22a.The hooks 16a and 16b are configured to be able to penetrate into the openings 22a and 22b in order to snap onto the retaining surfaces 22d and 22e provided in the flange 22. It is noted that the openings 22a and 22b are ^ each provided with an edge 22 £ converging towards the end 21d of the needle 21 opposite the stopper 5. Furthermore, the hooks 16a and 16b are provided with truncated edges 16 £ converging opposite the part 12. Thus, the cooperation of the edges 16 £ and 22f has the effect of tightening the hooks 16 in the direction of the axis XX 'when the flange 22 comes to bear against these hooks, this allowing the hooks 16a and 16b to pass through the openings 22a and 22b before expands radially outwards again, so that the hooks 16a and 16b come to bear on the surfaces 22d and 22a.
Lorsque les crochets 16a et 16b sont en appui sur les surfaces 22d et 22c, le piston 20 est efficacement maintenu en position de transfert de fluide vers ou à partir du volume intérieur du récipient 2, cette position étant représentée à la figure 7.When the hooks 16a and 16b are supported on the surfaces 22d and 22c, the piston 20 is effectively held in the fluid transfer position to or from the interior volume of the container 2, this position being shown in FIG. 7.
Comme il ressort plus particulièrement de la figure 6, les crochets 16a et 16b sont chacun pourvu d'un nez 16n, respectivement 16p, dirigé vers la partie 12. Par ailleurs, la collerette 22 est équipée de retours 22n et 22p qui bordent respectivement les surfaces 22d et 22a. Ainsi, lorsque les crochets 16 et 16b sont engagés dans les ouvertures 22a et 22b, les nez 16n et 16p. viennent en appui contre les surfaces 22d et 22c, en arrière des retours 22n et 22p. Tout risque de glissement relatif des crochets 16a et 16b par rapport à la collerette 22 est ainsi évité car un tel glissement est empêché par la portée des nez 16n et 16p. contre les retours 22n et 22p.As can be seen more particularly from FIG. 6, the hooks 16a and 16b are each provided with a nose 16n, respectively 16p, directed towards the part 12. Furthermore, the flange 22 is equipped with returns 22n and 22p which respectively border the surfaces 22d and 22a. Thus, when the hooks 16 and 16b are engaged in the openings 22a and 22b, the noses 16n and 16p. come to bear against surfaces 22d and 22c, behind returns 22n and 22p. Any risk of relative sliding of the hooks 16a and 16b relative to the flange 22 is thus avoided because such sliding is prevented by the bearing of the noses 16n and 16p. against returns 22n and 22p.
Pour garantir un maintient du piston 20 en configuration de stockage du dispositif 1, c'est-à-dire dans une configuration dans laquelle l'aiguille 21 est à distance du bouchon 5 comme représenté aux figures 1 à 6, le manchon 16 est pourvu d'un jonc interne 16g faisant saillie à partir de la surface 16c en direction de l'axe X-X'. Par ailleurs, la surface 21c de l'aiguille 21 est pourvue d'une gorge 21g dans laquelle peut être engagé le jonc 16g. Lorsque le jonc 16g est engagé dans la gorge 21g, l'aiguille 21, c'est-à- dire le piston -20, est immobilisé en translation- dans 1 ' alésage A.To ensure that the piston 20 is maintained in the storage configuration of the device 1, that is to say in a configuration in which the needle 21 is at a distance from the plug 5 as shown in FIGS. 1 to 6, the sleeve 16 is provided of an internal rod 16g projecting from the surface 16c in the direction of the axis XX '. Furthermore, the surface 21c of the needle 21 is provided with a groove 21g in which the rod 16g can be engaged. When the rod 16g is engaged in the groove 21g, the needle 21, that is to say the piston -20, is immobilized in translation- in the bore A.
Selon des variantes non représentées de l'invention, le jonc 16g et la gorge 21g peuvent être remplacés par d'autres reliefs qui peuvent s'étendre sur une partie seulement de la circonférence des surfaces 16c et 21c.According to variants not shown of the invention, the rod 16g and the groove 21g can be replaced by other reliefs which can extend over only part of the circumference of the surfaces 16c and 21c.
Une enveloppe externe 30 est prévue pour être montée autour de l'embase 10 et du piston 20 sur le récipient 2. L'enveloppe 30 comprend une bague 31 prévue pour immobiliser les pattes 14 en position autour du col 4, conformément à l'enseignement technique de WO-A-97/10 156. La bague 31 est reliée par une section sécable 32 à une coiffe 33 qui isole l'embase 10 et le piston 20 de l'atmosphère ambiante tant que la section sécable n'a pas été rompue. On note que la coiffe 33 est prévue pour venir en appui contre la surface radiale externe du manchon 11. Un lubrifiant peut être appliqué de façon discontinue sur la surface interne de la coiffe 33 pour faciliter son retrait par rapport à l'embase 10. Ce lubrifiant pourrait être appliqué autour du manchon 11, également de façon discontinue, c'est-à-dire en ne formant pas une circonférence complète autour de l'axe X-X'. Le fonctionnement est le suivant : Lorsqu'il convient de faire pénétrer un liquide à l'intérieur du récipient 2, la coiffe 33 est retirée par rupture de la section 32, comme représenté par les flèches R et F_ à la figure 6. Il est alors possible d'exercer sur le piston 1 un effort F2 dirigé vers le bouchon 5 afin de transpercer celui-ci grâce à l'aiguille 21. En pratique, l'effort F2 peut être exercé au moyen du flacon 3 dont un bouchon 5' est tout d'abord engagé sur l'extrémité exposée 21d de l'aiguille 21, le bouchon 5' pouvant alors être pris en mains par l'utilisateur pour exercer sur l'embase 22 l'effort F2, ce qui a pour effet de chasser le jonc 16g de la gorge 21g puis de permettre le mouvement d'avance de l'aiguille 21 en direction du bouchon 5 qu'elle traverse alors.An outer casing 30 is provided to be mounted around the base 10 and the piston 20 on the container 2. The casing 30 comprises a ring 31 intended to immobilize the tabs 14 in position around the neck 4, in accordance with the teaching WO-A-97/10 technique 156. The ring 31 is connected by a breakable section 32 to a cap 33 which isolates the base 10 and the piston 20 from the ambient atmosphere as long as the breakable section has not been broken. It is noted that the cap 33 is designed to come into abutment against the external radial surface of the sleeve 11. A lubricant can be applied discontinuously to the internal surface of the cap 33 to facilitate its removal relative to the base 10. This lubricant could be applied around the sleeve 11, also discontinuously, that is to say by not forming a complete circumference around the axis XX '. The operation is as follows: When it is necessary to make a liquid penetrate inside the container 2, the cap 33 is removed by rupture of the section 32, as shown by the arrows R and F_ in FIG. 6. It is then possible to exert on the piston 1 an effort F 2 directed towards the stopper 5 in order to pierce the latter thanks to the needle 21. In practice, the effort F 2 can be exerted by means of the bottle 3 including a stopper 5 'is first engaged on the exposed end 21d of the needle 21, the plug 5' can then be taken in hand by the user to exert on the base 22 the force F 2 , which has the effect of driving the rod 16g out of the groove 21g and then allowing the needle 21 to move forward in the direction of the plug 5 which it then crosses.
Lors de ce mouvement, les crochets 16a et 16b pénètrent dans les ouvertures 22a et 22b, en étant déformées grâce à la coopération des bords 16£ et 22£. Les crochets 16a- et 16b viennent alors se verrouiller sur les surfaces 22d et 22c de la collerette 22, de telle sorte que le piston 20 est encli- queté en position de transfert sur le manchon 16.During this movement, the hooks 16a and 16b penetrate into the openings 22a and 22b, being deformed thanks to the cooperation of the edges 16 £ and 22 £. The hooks 16a and 16b then come to lock on the surfaces 22d and 22c of the flange 22, so that the piston 20 is snapped into the transfer position on the sleeve 16.
Tout glissement des crochets 16a et 16b par rapport à la collerette 22, sous l'effet d'un effort tendant à extraire l'aiguille 21 du récipient 2, est empêché par l'imbrication des nez 16n et 16p derrière les retours 22n et 22p.Any sliding of the hooks 16a and 16b relative to the collar 22, under the effect of an effort tending to extract the needle 21 from the container 2, is prevented by the interlocking of the noses 16n and 16p behind the returns 22n and 22p .
Lors du mouvement de pénétration de l'aiguille 21 dans le bouchon 5, le manchon 16 est maintenu rigide grâce aux nervures 17 qui assurent une reprise des efforts transversaux éventuels.During the movement of penetration of the needle 21 into the plug 5, the sleeve 16 is kept rigid by virtue of the ribs 17 which ensure the recovery of any transverse forces.
Lorsqu'une quantité suffisante du liquide a été intro- duite dans le récipient 2, il est possible d'agiter celui-ci pour mélanger le liquide au produit originellement présent dans le récipient 2 afin d'obtenir la solution ou la suspension recherchée. Il est alors possible de retourner l'ensemble formé des éléments 1 à 3 pour faire passer cette solution ou cette suspension dans le flacon 3 en vue de son utilisation.When enough liquid has been introduced taken in container 2, it is possible to stir it to mix the liquid with the product originally present in container 2 in order to obtain the desired solution or suspension. It is then possible to return the assembly formed of the elements 1 to 3 in order to pass this solution or this suspension through the bottle 3 for use.
Les crochets 16a et 16b sont obtenus sans utilisation de moule complexe, deux ouvertures 12a et 12b étant prévues dans la partie 12 pour le passage de tiroirs de formation de ces crochets dans le moule de fabrication de l'embase 10.The hooks 16a and 16b are obtained without the use of a complex mold, two openings 12a and 12b being provided in part 12 for the passage of drawers for forming these hooks in the mold for manufacturing the base 10.
L'embase 10 est une pièce monobloc qui comprend les éléments 11 à 17. Les éléments constitutifs du dispositif 1 de l'invention sont donc particulièrement simples et de prix de revient très attractifs.The base 10 is a single piece which comprises the elements 11 to 17. The constituent elements of the device 1 of the invention are therefore particularly simple and of very attractive cost price.
Dans le second mode de réalisation représenté à la figure 8, les éléments analogues à ceux du premier mode de réalisation portent des références identiques. Ce mode de réalisation diffère du précédent en ce que l'aiguille 21 est à section radiale externe polygonale alors que le manchon 16 est à section interne polygonale, avec le même nombre de côtés et la même répartition géométrique de ces côtés, ce qui permet un coulissement de l'aiguille 21 dans le manchon 16, selon un axe X-X1, sans possibilité de rotation autour de cet axe. - — -In the second embodiment shown in Figure 8, elements similar to those of the first embodiment bear identical references. This embodiment differs from the previous one in that the needle 21 is of polygonal external radial section while the sleeve 16 is of polygonal internal section, with the same number of sides and the same geometric distribution of these sides, which allows a sliding of the needle 21 in the sleeve 16, along an axis XX 1 , without the possibility of rotation about this axis. - - -
Quel que soit le mode de réalisation de l'invention, le coulissement de l'aiguille 21 dans le manchon 16 permet un alignement correct des crochets prévus en partie supérieure du manchon et des moyens d'accrochage correspondant prévus sur la collerette du piston.Whatever the embodiment of the invention, the sliding of the needle 21 in the sleeve 16 allows correct alignment of the hooks provided in the upper part of the sleeve and the corresponding hooking means provided on the collar of the piston.
L'invention a été représenté avec deux crochets 16a et 16b formés au niveau des parties du manchon 16 de plus petit rayon de courbure. Selon une variante non représentée de l'invention, ces crochets pourraient être ménagés au niveau des parties de plus grand rayon de courbure de ce manchon, c'est-à-dire des parties représentées respectivement vers le haut et vers le bas de la figure 3. Dans ce cas, la position des ouvertures 22a et 22b et des surfaces 22d et 22c de la collerette 22 par rapport à l'aiguille 21 est adaptée en conséquence. En outre, le nombre de crochets du dispositif de l'invention n'est pas limité à deux ; il suffit d'un crochet pour que celui-ci immobilise le piston dans la position de transfert. En variante, un nombre de crochets supérieur ou égal à trois peut être prévu.The invention has been shown with two hooks 16a and 16b formed at the parts of the sleeve 16 of smaller radius of curvature. According to a variant not shown of the invention, these hooks could be formed at the parts of the greatest radius of curvature of this sleeve, that is to say of the parts shown respectively upwards and downwards in the figure. 3. In this case, the position of the openings 22a and 22b and the surfaces 22d and 22c of the collar 22 with respect to needle 21 is adapted accordingly. In addition, the number of hooks of the device of the invention is not limited to two; a hook is enough for it to immobilize the piston in the transfer position. Alternatively, a number of hooks greater than or equal to three may be provided.
L'invention a été représentée avec un piston monobloc. Elle est également applicable au cas où le piston est formé d'un assemblage comprenant une aiguille et une collerette rapportée. The invention has been shown with a monobloc piston. It is also applicable to the case where the piston is formed of an assembly comprising a needle and an attached flange.

Claims

RFVENDTCΑTTONS RFVENDTCΑTTONS
1. Dispositif de connexion (1) entre un récipient fermé (2) et un contenant (3) , ledit récipient fermé comprenant un col (4) dont l'ouverture est obturée par un bouchon (5), ledit dispositif de connexion comprenant :1. Connection device (1) between a closed container (2) and a container (3), said closed container comprising a neck (4), the opening of which is closed by a plug (5), said connection device comprising:
- une embase (10) apte à être montée sur ledit récipient et comportant un manchon (16) formant un alésage interne (A) et un piston (20) apte à coulisser dans ledit alésage, entre une première position dégagée par rapport audit bouchon et une seconde position, dite de transfert, dans laquelle une aiguille (21) creuse, appartenant audit piston, traverse ledit bouchon, caractérisé en ce que ladite aiguille est à section transversale externe non circulaire, alors que ledit manchon est à section transversale interne non circulaire, les sections externe de ladite aiguille et interne dudit manchon étant telles qu'un coulissement de ladite aiguille dans ledit manchon est possible, sans possibilité de rotation de ladite aiguille dans ledit manchon, et en ce qu'un borda base (10) capable of being mounted on said container and comprising a sleeve (16) forming an internal bore (A) and a piston (20) capable of sliding in said bore, between a first position released with respect to said plug and a second position, called the transfer position, in which a hollow needle (21) belonging to said piston passes through said plug, characterized in that said needle is of non-circular external cross-section, while said sleeve is of non-circular internal cross-section , the external sections of said needle and internal of said sleeve being such that a sliding of said needle in said sleeve is possible, without the possibility of rotation of said needle in said sleeve, and in that an edge
(16d) dudit manchon opposé audit bouchon est pourvu de moyens d'arrêt (16a, 16b) aptes à coopérer avec des moyens complémentaires (22d, 22c) prévus sur ledit piston pour le verrouillage en position de transfert dudit piston.(16d) of said sleeve opposite said cap is provided with stop means (16a, 16b) capable of cooperating with complementary means (22d, 22c) provided on said piston for locking in the transfer position of said piston.
2. Dispositif selon la revendication 1, caractérisé en ce que ladite aiguille (21) est à section transversale externe ovale alors que ledit manchon (16) est à section transversale interne ovale.2. Device according to claim 1, characterized in that said needle (21) is of oval external cross section while said sleeve (16) is of oval internal cross section.
3. Dispositif selon la revendication 1, caractérisé en ce que ladite aiguille (21) est à section transversale externe polygonale alors que ledit manchon (16) est à section transversale interne polygonale, avec le même nombre de côtes que ladite section externe de ladite aiguille.3. Device according to claim 1, characterized in that said needle (21) is of polygonal external cross section while said sleeve (16) is of polygonal internal cross section, with the same number of ribs as said external section of said needle .
4. Dispositif selon l'une des revendications précédentes, caractérisé en ce que lesdits moyens d'arrêt prévus sur ledit bord (16d) dudit manchon comprennent des crochets (16a, 16b) élastiquement déformables alors que lesdits moyens complémentaires prévus sur ledit piston (20) comprennent des surfaces d'appui (22d, 22c) ménagées sur une collerette (22) monobloc avec ladite aiguille (21) , ladite aiguille et ladite collerette constituant ensemble ledit piston.4. Device according to one of the preceding claims, characterized in that said stop means provided on said edge (16d) of said sleeve comprise elastically deformable hooks (16a, 16b) while said complementary means provided on said piston (20) comprise bearing surfaces (22d, 22c) formed on a flange (22) integral with said needle (21), said needle and said collar constituting said piston together.
5. Dispositif selon la revendication 4, caractérisé en ce que ladite collerette (22) est pourvue d'ouvertures (22a, 22b) de passage desdits crochets (16a, 16b) . 5. Device according to claim 4, characterized in that said collar (22) is provided with openings (22a, 22b) for passage of said hooks (16a, 16b).
6. Dispositif selon l'une des revendications 4 ou 5, caractérisé en ce que lesdits crochets (16a, 16b) sont chacun pourvus d'un nez (16n, 16p) apte à être imbriqué avec un retour (22n, 22p bordant l'une des surfaces d'appui (22d, 22c) ménagées sur ladite collerette (22) . 6. Device according to one of claims 4 or 5, characterized in that said hooks (16a, 16b) are each provided with a nose (16n, 16p) capable of being nested with a return (22n, 22p bordering the one of the bearing surfaces (22d, 22c) formed on said flange (22).
7. Dispositif selon l'une des revendications 4 à 6, caractérisé en ce que lesdits crochets (16a, 16b) font saillie radialement vers l'extérieur par rapport audit manchon (16) .7. Device according to one of claims 4 to 6, characterized in that said hooks (16a, 16b) project radially outwards relative to said sleeve (16).
8. Dispositif selon l'une des revendications précédentes, caractérisé en ce que ladite embase (10) comprend un second manchon (11) disposé radialement à l'extérieur dudit manchon (16), ledit second manchon étant apte à coopérer avec une coiffe (33) d'isolation dudit piston (20) par rapport à l'atmosphère ambiante. 8. Device according to one of the preceding claims, characterized in that said base (10) comprises a second sleeve (11) disposed radially outside said sleeve (16), said second sleeve being able to cooperate with a cap ( 33) for isolating said piston (20) from the ambient atmosphere.
9. Dispositif selon la revendication 8, caractér-i é en ce qu'il comprend des nervures de rigidification (17) reliant lesdits manchons (11, 16).9. Device according to claim 8, characterized in that it comprises stiffening ribs (17) connecting said sleeves (11, 16).
10. Dispositif selon l'une des revendications précédentes, caractérisé en ce qu'il comprend des moyens (16g, 21g) d'arrêt provisoire dudit piston (20) dans ladite position dégagée .10. Device according to one of the preceding claims, characterized in that it comprises means (16g, 21g) temporarily stopping said piston (20) in said released position.
11. Dispositif selon la revendication 10, caractérisé en ce que lesdits moyens comprennent au moins un relief creux (21g) ménagé sur la surface externe (21c) de ladite aiguille (21) et au moins un relief en saillie (16g) s 'étendant, à partir de la surface radiale interne (16c) dudit manchon (16), en direction d'un axe central (X-X1) dudit alésage (A) , ledit relief en saillie étant apte à être engagée dans ledit relief en creux et à maintenir ledit piston (20) dans ladite première position.11. Device according to claim 10, characterized in that said means comprise at least one hollow relief (21g) formed on the external surface (21c) of said needle (21) and at least one projecting relief (16g) extending , from the internal radial surface (16c) of said sleeve (16), in the direction of a central axis (XX 1 ) of said bore (A), said projecting relief being able to be engaged in said recessed relief and to maintain said piston (20) in said first position.
12. Ensemble prêt à 1 ' emploi comprenant un récipient fermé (2) contenant un produit, notamment une préparation pharmaceutique, ledit récipient étant pourvu d'un col (4) dont l'ouverture est obturée par un bouchon (5), et un dispositif de connexion (1) selon l'une des revendications précédentes, monté sur ledit récipient. 12. Ready-to-use assembly comprising a closed container (2) containing a product, in particular a pharmaceutical preparation, said container being provided with a neck (4) the opening of which is closed by a plug (5), and a connection device (1) according to one of the preceding claims, mounted on said container.
1/61/6
2/6 2/6
3/6 3/6
Fig.8 4/6Fig.8 4/6
5/6 5/6
EP02714279A 2001-03-07 2002-03-05 Device for connection between a vessel and a container and a ready-to-use assembly comprising same Expired - Lifetime EP1365725B1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR0103125A FR2821827B1 (en) 2001-03-07 2001-03-07 CONNECTION DEVICE BETWEEN A CONTAINER AND A CONTAINER AND READY-TO-USE ASSEMBLY COMPRISING SUCH A DEVICE
FR0103125 2001-03-07
PCT/FR2002/000793 WO2002069881A1 (en) 2001-03-07 2002-03-05 Device for connection between a vessel and a container and a ready-to-use assembly comprising same

Publications (2)

Publication Number Publication Date
EP1365725A1 true EP1365725A1 (en) 2003-12-03
EP1365725B1 EP1365725B1 (en) 2005-09-14

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EP02714279A Expired - Lifetime EP1365725B1 (en) 2001-03-07 2002-03-05 Device for connection between a vessel and a container and a ready-to-use assembly comprising same

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US (1) US20020128629A1 (en)
EP (1) EP1365725B1 (en)
JP (1) JP2004527289A (en)
KR (1) KR20040015061A (en)
CN (1) CN100335021C (en)
AT (1) ATE304342T1 (en)
AU (1) AU2002246197B2 (en)
BR (1) BR0207330A (en)
CA (1) CA2437589A1 (en)
DE (1) DE60206139T2 (en)
ES (1) ES2249567T3 (en)
FR (1) FR2821827B1 (en)
HU (1) HUP0303446A2 (en)
MX (1) MXPA03007617A (en)
PL (1) PL363976A1 (en)
RU (1) RU2003129658A (en)
WO (1) WO2002069881A1 (en)
ZA (1) ZA200305907B (en)

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CN100335021C (en) 2007-09-05
ZA200305907B (en) 2004-06-29
PL363976A1 (en) 2004-11-29
RU2003129658A (en) 2005-04-10
MXPA03007617A (en) 2003-12-04
BR0207330A (en) 2004-02-10
KR20040015061A (en) 2004-02-18
ATE304342T1 (en) 2005-09-15
US20020128629A1 (en) 2002-09-12
ES2249567T3 (en) 2006-04-01
DE60206139D1 (en) 2005-10-20
FR2821827A1 (en) 2002-09-13
AU2002246197B2 (en) 2005-10-20
EP1365725B1 (en) 2005-09-14
JP2004527289A (en) 2004-09-09
WO2002069881A1 (en) 2002-09-12
FR2821827B1 (en) 2003-06-13
CA2437589A1 (en) 2002-09-12
CN1494407A (en) 2004-05-05
HUP0303446A2 (en) 2004-03-01
DE60206139T2 (en) 2006-06-22

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