EP1239808A1 - Device for connection between a vessel and a container and ready-to-use assembly comprising same - Google Patents
Device for connection between a vessel and a container and ready-to-use assembly comprising sameInfo
- Publication number
- EP1239808A1 EP1239808A1 EP01978541A EP01978541A EP1239808A1 EP 1239808 A1 EP1239808 A1 EP 1239808A1 EP 01978541 A EP01978541 A EP 01978541A EP 01978541 A EP01978541 A EP 01978541A EP 1239808 A1 EP1239808 A1 EP 1239808A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- valve
- container
- piston
- sleeve
- closed
- 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.)
- Withdrawn
Links
- 239000012530 fluid Substances 0.000 claims abstract description 5
- 230000000694 effects Effects 0.000 claims description 7
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 4
- 230000002093 peripheral effect Effects 0.000 claims description 3
- 239000007788 liquid Substances 0.000 description 18
- 229920001971 elastomer Polymers 0.000 description 6
- 239000003814 drug Substances 0.000 description 5
- 239000000806 elastomer Substances 0.000 description 4
- 230000000474 nursing effect Effects 0.000 description 4
- 230000006835 compression Effects 0.000 description 3
- 238000007906 compression Methods 0.000 description 3
- 230000002209 hydrophobic effect Effects 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 231100000331 toxic Toxicity 0.000 description 3
- 230000002588 toxic effect Effects 0.000 description 3
- 206010028980 Neoplasm Diseases 0.000 description 2
- 201000011510 cancer Diseases 0.000 description 2
- 239000002775 capsule Substances 0.000 description 2
- 238000002512 chemotherapy Methods 0.000 description 2
- 231100000433 cytotoxic Toxicity 0.000 description 2
- 230000001472 cytotoxic effect Effects 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 238000002955 isolation Methods 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- -1 polyethylene Polymers 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 239000007779 soft material Substances 0.000 description 2
- 239000000725 suspension Substances 0.000 description 2
- 229960005486 vaccine Drugs 0.000 description 2
- 239000004698 Polyethylene Substances 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 238000004026 adhesive bonding Methods 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000006355 external stress Effects 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 230000010354 integration Effects 0.000 description 1
- 230000002452 interceptive effect Effects 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 239000002991 molded plastic Substances 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 230000002040 relaxant effect Effects 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 230000035882 stress Effects 0.000 description 1
- 238000013022 venting Methods 0.000 description 1
- 238000003466 welding Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2096—Combination of a vial and a syringe for transferring or mixing 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
- A61J1/1412—Containers with closing means, e.g. caps
-
- 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
- A61J1/202—Separating means
- A61J1/2037—Separating means having valve 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
- A61J1/2075—Venting means for external venting
-
- 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
- A61J1/2079—Filtering means
- A61J1/2082—Filtering means for gas filtration
Definitions
- 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 the 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-97/10156 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 a needle intended to pass through the cap of the container in a so-called transfer position.
- This device is satisfactory and in particular allows the connection of a syringe provided with a luer tip.
- certain products used for example, in the context of chemotherapy for the treatment of cancer and incorporating molecules of the cytotoxic type are packaged in containers which do not necessarily correspond to a dose to be administered at once to a patient.
- the nursing staff must therefore carry out a multi-dosage of the product in question, that is to say an administration in several times. Due to their toxic nature, these products must be handled with the greatest care and in conditions avoiding exposing the nursing staff.
- the invention aims to solve these problems by proposing a new connection device which allows effective isolation of the interior volume of the container from the ambient atmosphere after the piston has been brought into a position of perforation of the container cap and this , without using an add-on valve capable of generating leaks and / or hampering the handling of the device.
- the invention relates to a device of the aforementioned type, the piston of which is equipped with a valve for controlling the flow of a fluid to or from the interior volume of the container, this valve being integrated into a part of the piston. provided for the connection of a container with the needle of this piston.
- the valve which forms a check valve return, is permanently in place on the piston and does not risk detaching it inappropriately, hence limiting the risk of leakage. Due to its integration into the part of the piston provided for the connection of the container, this valve does not appreciably modify the dimensions of the piston, which is advantageous with regard to the overall dimensions of the device.
- the device incorporates one or more of the following characteristics:
- the valve comprises a one-piece valve body with the piston and a valve trapped in this body.
- the body advantageously forms an internal shoulder capable of receiving in abutment a surface or a bearing part of the valve.
- This internal shoulder serves to limit movement of the valve and to close the liquid flow channel (s) inside the valve.
- the shoulder can penetrate superficially in a bearing part provided on the valve.
- the valve comprises a valve which is resiliently deformable at least in a direction parallel to the direction of movement of the piston in the bore.
- the valve is provided with longitudinal grooves forming, in cooperation with the internal surface of the valve body, fluid circulation channels from or to the interior volume of the container.
- the valve advantageously comprises a peripheral groove separating two blocks in which are formed longitudinal grooves.
- the valve includes two end sections of larger diameter than the nominal diameter of an intermediate section formed between the end sections.
- the groove or the intermediate section can deform under the effect of a compressive force undergone by the valve.
- the valve is symmetrical with respect to its transverse median plane.
- the valve comprises a valve body provided with means for connecting the container, this valve body being able to accommodate a part of the container intended to interact with a valve flap.
- the body is advantageously adapted to receive a male luer tip belonging to the container, this tip allowing the valve to be operated by exerting on it a force directed towards the piston.
- a protective cap and isolation of the piston from the ambient atmosphere is able to be mounted on the base by protecting and isolating the valve, regardless of the position of the piston. Thanks to this aspect of the invention, the cap can be put in place before and after a first use of the device, in particular in order to protect it for later use in the case of a multi-dosage.
- 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.
- FIG. 1 is an exploded side view of a ready-to-use assembly according to the invention and a syringe provided to cooperate with this assembly;
- FIG. 1 is an axial section of the device mounted on the assembly of Figure 1, in storage configuration
- FIG. 3 is a view similar to Figure 2 during the introduction of a liquid into the container by means a syringe;
- FIG. 4 is a view similar to Figure 3 while the container has been inverted and the syringe has been withdrawn;
- FIG. 5 is a perspective view with partial cutaway of the piston of the device of Figures 1 to 4;
- FIG. 6 is a longitudinal section of the piston of a device according to a second embodiment of the invention, in the blocked configuration of the valve it incorporates;
- FIG. 7 is a view similar to Figure 6 while the valve is on and
- Figure 8 is a view similar to Figure 5 for the piston of Figures 6 and 7.
- the device 1 has a double function. On the one hand, it ensures the inviolability of a container 2, for example a glass bottle, containing a product which is not shown and which has previously been closed or capped.
- This product which can be a powder containing the active principle of a drug, such as cytotoxic molecules used for the treatment of cancer within the framework of chemotherapy. It can be any other type of pharmaceutical preparation.
- 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 syringe 3 containing a liquid intended to dissolve or suspension of the product contained in container 2.
- the container could be formed by a flexible bag or another glass vial.
- 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 comprises a central part 5a which is substantially cylindrical, suitable for a flexible and watertight fitting. inside the opening 4a and a flattened part 5b, supported on the part 4b 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, intended to be mounted around the elements 4 and 5.
- the base 10 comprises a sleeve 11 generally cylindrical and centered on the axis XX 'of symmetry of the elements 2, 4 and 5.
- the sleeve 11 is connected to an annular part 12 provided with a rod 13 with a pointed profile intended to penetrate superficially in the upper or exposed surface 5ç_ of the plug 5.
- the part 12 is extended, opposite the sleeve 11 by several elastic tabs 14 each provided with a spout 15 adapted to cooperate with the external surface of the neck 4, for an elastic snap-fitting of the base 10 on the neck.
- the internal volume of the sleeve constitutes a bore A inside which a piston 20 can slide, which essentially consists of two pieces of molded plastic.
- the first part 21 forms a hollow needle 22 provided with two channels 22a and 22b and capable of perforating the plug 5, passing through a central opening 12a of the annular part 12, when the piston 20 is moved until contact with the plug 5.
- the channel 22a is connected to a central chamber 23 of cylindrical shape while the channel 22b is connected to an annular chamber 24 in which is placed a hydrophobic filter 25.
- the chamber 24 is defined between the part 21 and a second part 26 also forming part of the piston 20 and immobilized on the part 21 by any suitable means, in particular by welding or gluing.
- the part 26 comprises an annular skirt 26a which surrounds the part 21, this skirt 26a being able to slide against the internal surface 11a of the sleeve 11.
- the internal surface of the sleeve 11 and the external surface of the skirt 26a can be shaped so that they form guide grooves in translation of the piston 20 inside the bore A.
- the part 26 also includes a central part 26b which defines, in cooperation with the part 21, the chamber 24 and in which are pierced vents 26ç_ for venting the chamber 24.
- the part 26 also comprises, opposite the skirt 26a with respect to the part 26b, a sleeve 26d integral with the rest of the part 26 and centered on the axis XX '.
- a generally cylindrical valve 27 is disposed in the interior volume of the sleeve 26b.
- This valve 27 is made of a relatively flexible material such as an elastomer, for example rubber.
- the sleeve 27 comprises two blocks 27a and 27b separated by a part 27ç_ of smaller diameter than that of the blocks 27a and 27b.
- a peripheral groove 27d is provided between the blocks 27a and 27b at the part 27ç_. The groove 27d can be deformed in the event of axial compression of the valve 27.
- the valve 27 is symmetrical with respect to its transverse median plane P which is perpendicular to the axis XX ′ and passes through the middle of the groove 27d, so that the valve can be mounted in both directions in the sleeve 26d. This facilitates the mounting of the valve 27 in the piston 20 since no particular identification must be carried out before the installation of the valve in the sleeve.
- the external radial surfaces of the blocks 27a and 27b are provided with longitudinal grooves 27e which are generally parallel to the axis XX '.
- the valve 27 is also provided, at its ends, with two heads 27f and 27g, the head 27g of which rests against the part 21 at the level of the chamber 23.
- the heads 27f and 27g have diameters smaller than those of the blocks 27a and 27b , so that shoulders 27h and 27i are created between these blocks and these heads.
- the inner surface of the sleeve 26e also has a shoulder 26f_ against which the shoulder 27h of the valve 27 can bear.
- the dimensions of the sleeve 26d and of the valve 27 are chosen such that, in the absence of external stresses, the shoulder 27h of the valve 27 is in abutment against the shoulder 26f of the sleeve 26d, as shown in FIGS. 2, 4 and 5. Under these conditions, the grooves 27e of the block 27 are closed by the shoulder 26f and the valve V formed by elements 26f and 27 is not passable.
- 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-97/10156 technique.
- 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 until the breakable section has been broken. It is noted that the height h of the cap 33 is sufficient for it also to cover the valve V without interfering with it.
- 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 and the piston 20 is moved to its transfer position of FIG. 3 where the needle 22 passes through the stopper 5. Next, the luer nozzle 3a of the syringe 3 is introduced into the sleeve 26d of the valve V, while a nut 3b is screwed onto an external flange 26g of the sleeve 26d.
- the sleeve 26d constitutes a female luer tip for the tip 3a.
- Tightening the nut 3d has the effect of advancing the tip 3a in the direction of the part 21 of the piston 20, which results in a compression force F ⁇ on the valve 27, so that its shoulder 27h is far from the shoulder 26f.
- a circulation of liquid can thus take place through a central notch 27_ the head 27f then through the grooves 27e of the block 27a in the direction of the groove 27d where the flow is distributed between the grooves 27e of the block 27b before the flow is not distributed again around the head 27g and does not penetrate, through the central notch 27k of this head into the chamber 23.
- the valve V is then on. From the chamber 25, the liquid can be injected inside the container 2.
- lugs 21a of the part 21 which are provided with spouts 21b cooperate with the edge 12b of the opening 12a to immobilize the piston in position transfer, in accordance with the technical teaching of WO-A- 98/13 006.
- the channel 22b, the chamber 24 and the vents 26c allow the air to be evacuated, without the risk of creating an overpressure inside the container 2 during the introduction of the liquid into the container 2. This limits the risk of splashing, in particular during the withdrawal of the end piece 3a relative to the sleeve 26d.
- the device 101 of this embodiment comprises a piston 120 formed of two parts 121 and 126 assembled so rigid and waterproof and defining between them.
- the part 121 also forms a hollow needle 122 of which a first channel 122a is connected to a central chamber 123 while its second channel 122b is connected to the chamber 124.
- vents 126c are provided in the part 126 for the chamber 124, as is a sleeve 126d integral with the rest of the part 126.
- the sleeve 126d is centered on an axis XX 'which is also the central axis of the parts 121 and 122 and the sliding axis of the piston 120 in a bore of a base not shown, of the type of the base 10 of the first embodiment.
- a valve 127 made of elastomer and provided with two heads 127f and 127g of the type of heads 27f and 27g of the first embodiment.
- the valve 127 has two sections 1271 and 127m of diameter d x larger than the diameter d 2 than an intermediate section 127m formed between sections 1271. and 127m.
- the sleeve 126d is provided with an internal shoulder 126f with a point-shaped section, the internal diameter d 3 of the sleeve 126d at the level of the shoulder 126f . being smaller than the diameter d 1 # so that the shoulder 126f can come to bear and penetrate superficially into the section 1211 of the valve 127, which ensures a sealed support of the valve 127 against the shoulder 126f_.
- the internal dimensions of the sleeve 126d and the dimensions of the valve 127 are chosen so that, in the absence of stress, the valve has the configuration shown in FIG. 6.
- the male luer nozzle 103a of a container 103 is introduced into the sleeve 126d and exerts on the valve 127 a compressive force F x which moves the section 1211 away from the shoulder 126f, which has the effect of allowing a flow of liquid through a central notch 127j_ of the head 127f then around the sections 1273-., 127n and 127m, then around the head 127g and through a notch 127k of this head towards the chamber 123, then the channel Needle 122a.
- the "pointed" shape of the shoulder 126f_ which is a tapered circular lip, ensures a good seal between the sleeve 126d and the valve 127, including after several operations of the valve V.
- the sleeve 126d is provided with a collar 126g allowing the screwing of a nut 103b ensuring the progressiveness and the constant character of the force F 1 .
- valve 127 is symmetrical with respect to its transverse median plane P, which makes it possible to mount it without special precautions in the sleeve 126d, each section
- the invention has been shown with a container formed by a syringe 3. It is however applicable with other containers, for example a flexible bag, provided that these containers are adapted to exert on the valve 27 an effort similar to the effort F- . .
Landscapes
- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Closures For Containers (AREA)
- Nozzles (AREA)
- Quick-Acting Or Multi-Walled Pipe Joints (AREA)
Abstract
The invention concerns a device comprising a base (10), adapted to be mounted on the vessel and comprising a sleeve (11) forming an inner bore (A), and a plunger (20) adapted to slide in the bore (A), between a first released position relative to a cap (5) of the vessel (2) and a so-called transfer position, wherein a hollow needle (22), borne by or forming the plunger (20), passes through the cap (5). The plunger is equipped with a valve (V) controlling the flow of a fluid from or to the internal volume of the vessel (2), said valve (V) being integrated in part (26d) of the plunger for connecting the container (3) to the needle.
Description
DISPOSITIF DE CONNEXION ENTRE UN RECIPIENT ET UN CONTENANT ET ENSEMBLE PRET A L'EMPLOI COMPRENANT CONNECTION DEVICE BETWEEN A CONTAINER AND A CONTAINER AND READY-TO-USE ASSEMBLY INCLUDING
UN TEL DISPOSITIFSUCH 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 le récipient, ceci afin d'obtenir une préparation, notamment un médicament ou urî 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 the 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-97/10156, 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 une aiguille prévue pour traverser le bouchon du récipient dans une position dite de transfert. Ce dispositif donne satisfaction et permet en particulier le raccordement d'une seringue pourvue d'un embout luer. Cependant, certains produits utilisés, par exemple, dans le cadre de chimiothérapies pour le traitement du cancer et incorporant des molécules de type cytotoxiques sont conditionnés dans des récipients ne correspondant pas nécessairement à une dose devant être administrée en une fois à un patient. Le personnel soignant doit donc procéder à un multi- dosage du produit en question, c'est-à-dire à une administration en plusieurs fois. Du fait de leurs caractères toxiques, ces produits doivent être manipulés avec le plus grand soin
et dans des conditions évitant d'exposer le personnel soignant .WO-A-97/10156 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 a needle intended to pass through the cap of the container in a so-called transfer position. This device is satisfactory and in particular allows the connection of a syringe provided with a luer tip. However, certain products used, for example, in the context of chemotherapy for the treatment of cancer and incorporating molecules of the cytotoxic type are packaged in containers which do not necessarily correspond to a dose to be administered at once to a patient. The nursing staff must therefore carry out a multi-dosage of the product in question, that is to say an administration in several times. Due to their toxic nature, these products must be handled with the greatest care and in conditions avoiding exposing the nursing staff.
On pourrait envisager de monter sur le dispositif connu de O-A-97/10156 un clapet anti-retour permettant d'empêcher l'écoulement du liquide de l'intérieur du récipient vers l'extérieur. Cependant, un tel montage induirait des manipulations supplémentaires de la part du personnel soignant, au moment de la préparation du médicament, pour la fixation du clapet sur le dispositif, avec des risques de mauvaises manipulations. En outre, un risque de désolidarisation intempestive d'un tel clapet par rapport au dispositif demeurerait, ce qui pourrait s'avérer dangereux dans le cas où le récipient serait disposé au-dessus d'une seringue lorsqu'on tirerait sur le piston de cette seringue pour aspirer le liquide reconstitué présent dans le récipient. En effet, dans ce cas, une éventuelle fuite au niveau de l'interface entre le piston et le clapet conduirait à un écoulement de produit toxique sur les mains du personnel soignant. Enfin, l'encombrement d'un tel clapet monté sur le piston du dispositif connu empêcherait d'utiliser la coiffe de ce dispositif pour protéger le piston et l'alésage interne de l'embase entre deux prélèvements de produits, ce qui augmenterait les risques de contamination, notamment en milieu hospitalier. L'invention vise à résoudre ces problèmes en proposant un nouveau dispositif de connexion qui permet un isolement efficace du volume intérieur du récipient par rapport à l'atmosphère ambiante après que le piston a été amené dans une position de perforation du bouchon du récipient et ce, sans utilisation d'un clapet rapporté susceptible de générer des fuites et/ou de gêner les manipulations du dispositif.One could consider mounting on the device known from O-A-97/10156 a non-return valve making it possible to prevent the flow of liquid from the inside of the container to the outside. However, such an assembly would induce additional manipulations on the part of the nursing staff, during the preparation of the medicament, for fixing the valve to the device, with the risk of improper manipulations. In addition, there is a risk of inadvertent separation of such a valve from the device, which could prove dangerous if the container is placed above a syringe when the piston of this valve is pulled. syringe to aspirate the reconstituted liquid present in the container. Indeed, in this case, a possible leak at the interface between the piston and the valve would lead to a flow of toxic product on the hands of the nursing staff. Finally, the size of such a valve mounted on the piston of the known device would prevent the cap of this device from being used to protect the piston and the internal bore of the base between two product samples, which would increase the risks. contamination, especially in hospitals. The invention aims to solve these problems by proposing a new connection device which allows effective isolation of the interior volume of the container from the ambient atmosphere after the piston has been brought into a position of perforation of the container cap and this , without using an add-on valve capable of generating leaks and / or hampering the handling of the device.
Dans cet esprit, l'invention concerne un dispositif du type précité dont le piston est équipé d'une vanne de contrôle de l'écoulement d'un fluide de ou vers le volume intérieur du récipient, cette vanne étant intégrée à une partie du piston prévue pour le raccordement d'un contenant avec l'aiguille de ce piston.In this spirit, the invention relates to a device of the aforementioned type, the piston of which is equipped with a valve for controlling the flow of a fluid to or from the interior volume of the container, this valve being integrated into a part of the piston. provided for the connection of a container with the needle of this piston.
Grâce à l'invention, la vanne, qui forme un clapet anti-
retour, est en permanence en place sur le piston et ne risque pas de s'en désolidariser de façon inopportune, d'où une limitation des risques de fuite. Du fait de son intégration à la partie du piston prévue pour le raccordement du conte- nant, cette vanne ne modifie pas sensiblement les dimensions du piston, ce qui est avantageux en ce qui concerne l'encombrement global du dispositif.Thanks to the invention, the valve, which forms a check valve return, is permanently in place on the piston and does not risk detaching it inappropriately, hence limiting the risk of leakage. Due to its integration into the part of the piston provided for the connection of the container, this valve does not appreciably modify the dimensions of the piston, which is advantageous with regard to the overall dimensions of the device.
Selon des aspects avantageux de l'invention, le dispositif incorpore une ou plusieurs des caractéristiques suivan- tes :According to advantageous aspects of the invention, the device incorporates one or more of the following characteristics:
- La vanne comprend un corps de vanne monobloc avec le piston et un clapet prisonnier de ce corps. Dans ce cas, le corps forme avantageusement un épaulement interne apte à recevoir en butée une surface ou une partie d'appui du clapet. Cet épaulement interne sert à limiter un mouvement du clapet et à fermer le ou les canaux d'écoulement du liquide à l'intérieur de la vanne. Selon un mode de réalisation avantageux, l' épaulement peut pénétrer superficiellement dans une partie d'appui prévue sur le clapet. - La vanne comprend un clapet déformable élastique- ment au moins selon une direction parallèle à la direction de déplacement du piston dans l'alésage.- The valve comprises a one-piece valve body with the piston and a valve trapped in this body. In this case, the body advantageously forms an internal shoulder capable of receiving in abutment a surface or a bearing part of the valve. This internal shoulder serves to limit movement of the valve and to close the liquid flow channel (s) inside the valve. According to an advantageous embodiment, the shoulder can penetrate superficially in a bearing part provided on the valve. - The valve comprises a valve which is resiliently deformable at least in a direction parallel to the direction of movement of the piston in the bore.
- Le clapet est pourvu de rainures longitudinales formant, en coopération avec la surface interne du corps de la vanne, des canaux de circulation de fluide de ou vers le volume intérieur du récipient. Dans ce cas, le clapet comprend avantageusement une gorge périphérique séparant deux blocs dans lesquels sont ménagées des rainures longitudinales.- The valve is provided with longitudinal grooves forming, in cooperation with the internal surface of the valve body, fluid circulation channels from or to the interior volume of the container. In this case, the valve advantageously comprises a peripheral groove separating two blocks in which are formed longitudinal grooves.
- Le clapet comprend deux sections d'extrémité de diamètre plus important que le diamètre nominal d'une section intermédiaire ménagée entre les sections d'extrémité.- The valve includes two end sections of larger diameter than the nominal diameter of an intermediate section formed between the end sections.
- La gorge ou la section intermédiaire peut se déformer sous l'effet d'un effort de compression subi par le clapet . - Le clapet est symétrique par rapport à son plan médian transversal .- The groove or the intermediate section can deform under the effect of a compressive force undergone by the valve. - The valve is symmetrical with respect to its transverse median plane.
- La vanne comprend un corps de vanne pourvu de moyens de raccordement du contenant, ce corps de vanne étant
apte à accommoder une partie du contenant destinée à interagir avec un clapet de la vanne. Dans ce cas, le corps est avantageusement adapté pour recevoir un embout luer mâle appartenant au contenant, cet embout permettant de manoeuvrer le clapet en exerçant sur celui-ci un effort dirigé vers le piston.- The valve comprises a valve body provided with means for connecting the container, this valve body being able to accommodate a part of the container intended to interact with a valve flap. In this case, the body is advantageously adapted to receive a male luer tip belonging to the container, this tip allowing the valve to be operated by exerting on it a force directed towards the piston.
- Une coiffe de protection et d'isolement du piston par rapport à l'atmosphère ambiante est apte à être montée sur l'embase en protégeant et en isolant la vanne, indépendamment de la position du piston. Grâce à cet aspect de l'invention, la coiffe peut être mise en place avant et après une première utilisation du dispositif, notamment afin de le protéger en vue d'une utilisation ultérieure dans le cas d'un multi- dosage . 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, un multi-dosage étant possible sans risque de fuite. 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 :- A protective cap and isolation of the piston from the ambient atmosphere is able to be mounted on the base by protecting and isolating the valve, regardless of the position of the piston. Thanks to this aspect of the invention, the cap can be put in place before and after a first use of the device, in particular in order to protect it for later use in the case of a multi-dosage. 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 makes it possible to sterile store a component of a medicament or a vaccine, in particular its active principle, and to prepare it in good time by mixing with a liquid, a multi-dosage being possible without risk of leakage. 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:
- la figure 1 est une vue éclatée de côté d'un ensemble prêt à l'emploi conforme à l'invention et d'une seringue prévue pour coopérer avec cet ensemble ;- Figure 1 is an exploded side view of a ready-to-use assembly according to the invention and a syringe provided to cooperate with this assembly;
- la figure 2 est une coupe axiale du dispositif monté sur l'ensemble de la figure 1, en configuration de stockage ;- Figure 2 is an axial section of the device mounted on the assembly of Figure 1, in storage configuration;
- la figure 3 est une vue analogue à la figure 2 lors de l'introduction d'un liquide dans le récipient au moyen
d'une seringue ;- Figure 3 is a view similar to Figure 2 during the introduction of a liquid into the container by means a syringe;
- la figure 4 est une vue analogue à la figure 3 alors que le récipient a été retourné et que la seringue a été retirée ; - la figure 5 est une vue en perspective avec arrachement partiel du piston du dispositif des figures 1 à 4 ;- Figure 4 is a view similar to Figure 3 while the container has been inverted and the syringe has been withdrawn; - Figure 5 is a perspective view with partial cutaway of the piston of the device of Figures 1 to 4;
- la figure 6 est une coupe longitudinale du piston d'un dispositif conforme à un second mode de réalisation de l'invention, en configuration bloquée de la vanne qu'il intègre ;- Figure 6 is a longitudinal section of the piston of a device according to a second embodiment of the invention, in the blocked configuration of the valve it incorporates;
- la figure 7 est une vue analogue à la figure 6 alors que la vanne est passante et- Figure 7 is a view similar to Figure 6 while the valve is on and
- la figure 8 est une vue analogue à la figure 5 pour le piston des figures 6 et 7.- Figure 8 is a view similar to Figure 5 for the piston of Figures 6 and 7.
Le dispositif 1 conforme à l'invention 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. Ce produit qui peut être une poudre contenant le principe actif d'un médicament, tel que des molécules cytotoxiques utilisées pour le traitement du cancer dans le cadre de chimiothérapie. Il peut s'agir de tout autre type de préparation pharmaceutique. 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'une seringue 3 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 pourrait être formé par une poche souple ou un autre flacon en verre.The device 1 according to the invention has a double function. On the one hand, it ensures the inviolability of a container 2, for example a glass bottle, containing a product which is not shown and which has previously been closed or capped. This product which can be a powder containing the active principle of a drug, such as cytotoxic molecules used for the treatment of cancer within the framework of chemotherapy. It can be any other type of pharmaceutical preparation. 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 syringe 3 containing a liquid intended to dissolve or suspension of the product contained in container 2. Instead of a syringe, the container could be formed by a flexible bag or another glass vial.
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 4b 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 comprises a central part 5a which is substantially cylindrical, suitable for a flexible and watertight fitting. inside the opening 4a and a flattened part 5b, supported on the part 4b and possibly covered by the capsule.
Le dispositif 1 comprend une embase 10 réalisée par injection de matière plastique, par exemple de polyéthylêne et/ou de polypropylène, destinée à être montée autour des éléments 4 et 5. L'embase 10 comprend un manchon 11 globalement cylindrique et centré sur l'axe X-X' de symétrie des éléments 2, 4 et 5. Le manchon 11 est relié à une partie annulaire 12 pourvue d'un jonc 13 à profil en pointe destiné à pénétrer superficiellement dans la surface supérieure ou exposée 5ç_ du bouchon 5. La partie 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, intended to be mounted around the elements 4 and 5. The base 10 comprises a sleeve 11 generally cylindrical and centered on the axis XX 'of symmetry of the elements 2, 4 and 5. The sleeve 11 is connected to an annular part 12 provided with a rod 13 with a pointed profile intended to penetrate superficially in the upper or exposed surface 5ç_ of the plug 5. The part 12 is extended, opposite the sleeve 11 by several elastic tabs 14 each provided with a spout 15 adapted to cooperate with the external surface of the neck 4, for an elastic snap-fitting of the base 10 on the neck.
Le volume intérieur du manchon constitue un alésage A à l'intérieur duquel peut coulisser un piston 20 qui est constitué essentiellement de deux pièces en matière plastique moulée. La première pièce 21 forme une aiguille creuse 22 pourvue de deux canaux 22a et 22b et apte à perforer le bouchon 5, en passant à travers une ouverture centrale 12a de la partie annulaire 12, lorsque le piston 20 est déplacé jusqu'au contact du bouchon 5. Le canal 22a est relié à une chambre centrale 23 de forme cylindrique alors que le canal 22b est relié à une chambre annulaire 24 dans laquelle est placé un filtre hydrophobe 25. La chambre 24 est définie entre la pièce 21 et une seconde pièce 26 faisant également partie du piston 20 et immobilisée sur la pièce 21 par tout moyen approprié, notamment par soudage ou collage.The internal volume of the sleeve constitutes a bore A inside which a piston 20 can slide, which essentially consists of two pieces of molded plastic. The first part 21 forms a hollow needle 22 provided with two channels 22a and 22b and capable of perforating the plug 5, passing through a central opening 12a of the annular part 12, when the piston 20 is moved until contact with the plug 5. The channel 22a is connected to a central chamber 23 of cylindrical shape while the channel 22b is connected to an annular chamber 24 in which is placed a hydrophobic filter 25. The chamber 24 is defined between the part 21 and a second part 26 also forming part of the piston 20 and immobilized on the part 21 by any suitable means, in particular by welding or gluing.
La pièce 26 comprend une jupe annulaire 26a qui entoure la pièce 21, cette jupe 26a étant apte à coulisser contre la surface interne lia du manchon 11. La surface interne du manchon 11 et la surface externe de la jupe 26a peuvent être conformées de telle sorte qu'elles forment des rainures de guidage en translation du piston 20 à l'intérieur de l'alésage A.The part 26 comprises an annular skirt 26a which surrounds the part 21, this skirt 26a being able to slide against the internal surface 11a of the sleeve 11. The internal surface of the sleeve 11 and the external surface of the skirt 26a can be shaped so that they form guide grooves in translation of the piston 20 inside the bore A.
La pièce 26 comprend également une partie centrale 26b
qui définit, en coopération avec la pièce 21, la chambre 24 et dans laquelle sont percés des évents 26ç_ de mise à l'air de la chambre 24.The part 26 also includes a central part 26b which defines, in cooperation with the part 21, the chamber 24 and in which are pierced vents 26ç_ for venting the chamber 24.
La pièce 26 comporte également, à l'opposé de la jupe 26a par rapport à la partie 26b, un manchon 26d monobloc avec le reste de la pièce 26 et centré sur l'axe X-X' .The part 26 also comprises, opposite the skirt 26a with respect to the part 26b, a sleeve 26d integral with the rest of the part 26 and centered on the axis XX '.
Un clapet 27 globalement cylindrique est disposé dans le volume intérieur du manchon 26b. Ce clapet 27 est réalisé dans un matériau relativement souple tel qu'un élastomère, par exemple en caoutchouc. Le manchon 27 comprend deux blocs 27a et 27b séparés par une partie 27ç_ de diamètre plus faible que celui des blocs 27a et 27b. En d'autres termes, une gorge périphérique 27d est prévue entre les blocs 27a et 27 b au niveau de la partie 27ç_. La gorge 27d peut être déformée en cas de compression axiale du clapet 27.A generally cylindrical valve 27 is disposed in the interior volume of the sleeve 26b. This valve 27 is made of a relatively flexible material such as an elastomer, for example rubber. The sleeve 27 comprises two blocks 27a and 27b separated by a part 27ç_ of smaller diameter than that of the blocks 27a and 27b. In other words, a peripheral groove 27d is provided between the blocks 27a and 27b at the part 27ç_. The groove 27d can be deformed in the event of axial compression of the valve 27.
Le clapet 27 est symétrique par rapport à son plan médian transversal P qui est perpendiculaire à l'axe X-X' et passe par le milieu de la gorge 27d, de sorte que le clapet peut être monté dans les deux sens dans le manchon 26d. Ceci facilite le montage du clapet 27 dans le piston 20 puisqu' aucun repérage particulier ne doit être effectué avant la mise en place du clapet dans le manchon.The valve 27 is symmetrical with respect to its transverse median plane P which is perpendicular to the axis XX ′ and passes through the middle of the groove 27d, so that the valve can be mounted in both directions in the sleeve 26d. This facilitates the mounting of the valve 27 in the piston 20 since no particular identification must be carried out before the installation of the valve in the sleeve.
Les surfaces radiales externes des blocs 27a et 27b sont pourvues de rainures longitudinales 27e qui sont globalement parallèles à l'axe X-X'. Le clapet 27 est également pourvu, à ses extrémités, de deux têtes 27f et 27g, dont la tête 27g repose contre la pièce 21 au niveau de la chambre 23. Les têtes 27f et 27g ont des diamètres inférieurs à ceux des blocs 27a et 27b, de sorte qu'il est créé des épaulements 27h et 27i entre ces blocs et ces têtes.The external radial surfaces of the blocks 27a and 27b are provided with longitudinal grooves 27e which are generally parallel to the axis XX '. The valve 27 is also provided, at its ends, with two heads 27f and 27g, the head 27g of which rests against the part 21 at the level of the chamber 23. The heads 27f and 27g have diameters smaller than those of the blocks 27a and 27b , so that shoulders 27h and 27i are created between these blocks and these heads.
La surface intérieure du manchon 26e présente également un épaulement 26f_ contre lequel peut venir en appui l' épaulement 27h du clapet 27.The inner surface of the sleeve 26e also has a shoulder 26f_ against which the shoulder 27h of the valve 27 can bear.
Les dimensions du manchon 26d et du clapet 27 sont choisies de telle sorte qu'en l'absence de sollicitations extérieures, l' épaulement 27h du clapet 27 est en appui contre 1' épaulement 26f du manchon 26d, comme représenté aux figures 2, 4 et 5. Dans ces conditions, les rainures 27e du bloc 27
sont obturées par l' épaulement 26f et la vanne V formée par des éléments 26f et 27 n'est pas passante.The dimensions of the sleeve 26d and of the valve 27 are chosen such that, in the absence of external stresses, the shoulder 27h of the valve 27 is in abutment against the shoulder 26f of the sleeve 26d, as shown in FIGS. 2, 4 and 5. Under these conditions, the grooves 27e of the block 27 are closed by the shoulder 26f and the valve V formed by elements 26f and 27 is not passable.
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-97/10156.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-97/10156 technique.
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'atmos- phère ambiante tant que la section sécable n'a pas été rompue. On note que la hauteur h de la coiffe 33 est suffisante pour qu'elle recouvre également la vanne V sans interférer avec celle-ci .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 until the breakable section has been broken. It is noted that the height h of the cap 33 is sufficient for it also to cover the valve V without interfering with it.
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 et le piston 20 est déplacé vers sa position de transfert de la figure 3 où l'aiguille 22 traverse le bouchon 5. Ensuite, l'embout luer 3a de la seringue 3 est introduit dans le manchon 26d de la vanne V, alors qu'un écrou 3b est vissé sur une collerette externe 26g du manchon 26d. Le manchon 26d constitue un embout luer femelle pour l'embout 3a. Le serrage de l' écrou 3d a pour effet de faire avancer l'embout 3a en direction de la pièce 21 du piston 20, ce qui se traduit par un effort Fλ de compression sur le clapet 27, de telle sorte que son épaulement 27h est éloigné de l' épaulement 26f . Une circulation de liquide peut ainsi avoir lieu à travers une échancrure centrale 27_ la tête 27f puis à travers les rainures 27e du bloc 27a en direction de la gorge 27d où l'écoulement est réparti entre les rainures 27e du bloc 27b avant que l'écoulement ne se répartisse à nouveau autour de la tête 27g et ne pénètre, à travers l' échancrure centrale 27k de cette tête dans la chambre 23. La vanne V est alors passante. A partir de la chambre 25, le liquide peut être injecté à l'intérieur du récipient 2.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 and the piston 20 is moved to its transfer position of FIG. 3 where the needle 22 passes through the stopper 5. Next, the luer nozzle 3a of the syringe 3 is introduced into the sleeve 26d of the valve V, while a nut 3b is screwed onto an external flange 26g of the sleeve 26d. The sleeve 26d constitutes a female luer tip for the tip 3a. Tightening the nut 3d has the effect of advancing the tip 3a in the direction of the part 21 of the piston 20, which results in a compression force F λ on the valve 27, so that its shoulder 27h is far from the shoulder 26f. A circulation of liquid can thus take place through a central notch 27_ the head 27f then through the grooves 27e of the block 27a in the direction of the groove 27d where the flow is distributed between the grooves 27e of the block 27b before the flow is not distributed again around the head 27g and does not penetrate, through the central notch 27k of this head into the chamber 23. The valve V is then on. From the chamber 25, the liquid can be injected inside the container 2.
Dans la position de la figure 3, des pattes 21a de la pièce 21 qui sont pourvues de becs 21b coopèrent avec le bord 12b de l'ouverture 12a pour immobiliser le piston en position
de transfert, conformément à l'enseignement technique de WO-A- 98/13 006.In the position of FIG. 3, lugs 21a of the part 21 which are provided with spouts 21b cooperate with the edge 12b of the opening 12a to immobilize the piston in position transfer, in accordance with the technical teaching of WO-A- 98/13 006.
Lorsqu'une quantité suffisante du liquide a été introduite 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 d'extraire le mélange du récipient 2 en l'aspirant grâce à la seringue 3.When a sufficient quantity of the liquid has been introduced into the container 2, it is possible to stir the latter to mix the liquid with the product originally present in the container 2 in order to obtain the desired solution or suspension. It is then possible to extract the mixture from the container 2 by aspirating it using the syringe 3.
Lorsqu'une quantité suffisante de produit a été extraite, même si le récipient 2 n'a pas été complètement vidé, il est possible de desserrer 1 ' écrou 3b et de retirer l'embout 3a du manchon 3 pour utiliser le produit contenu dans la seringue. Le retrait de l'embout 3a du manchon 26d a pour effet de relâcher l'effort Fx exercé sur le clapet 27 dans la configu- ration de la figure 3. Du fait du relâchement de cet effort et sous l'effet de son élasticité naturelle, le clapet 27 reprend sa configuration de la figure 2 où son épaulement 27h vient en appui contre l' épaulement 26f du manchon 26d, ce qui conduit a une fermeture de la vanne V. Le volume intérieur du récipient 2 est alors isolé par rapport à l'atmosphère ambiante et le récipient 2 peut être retourné, comme représenté à la figure 4, sans risque de fuite du mélange potentiellement toxique.When a sufficient quantity of product has been extracted, even if the container 2 has not been completely emptied, it is possible to loosen the nut 3b and remove the end piece 3a from the sleeve 3 to use the product contained in the syringe. The withdrawal of the nozzle 3a from the sleeve 26d has the effect of relaxing the force F x exerted on the valve 27 in the configuration of FIG. 3. Due to the relaxation of this force and under the effect of its elasticity natural, the valve 27 resumes its configuration of FIG. 2 where its shoulder 27h comes to bear against the shoulder 26f of the sleeve 26d, which leads to a closing of the valve V. The interior volume of the container 2 is then isolated from to the ambient atmosphere and the container 2 can be returned, as shown in Figure 4, without risk of leakage of the potentially toxic mixture.
Dans cette position, le liquide ne risque pas de s'écouler par le canal 22b de l'aiguille 22 dans la mesure où le filtre hydrophobe 25 ne laisse passer que l'air.In this position, the liquid does not run the risk of flowing through the channel 22b of the needle 22 insofar as the hydrophobic filter 25 allows only air to pass.
Le canal 22b, la chambre 24 et les évents 26ç_ permettent d'évacuer l'air, sans risque de création d'une surpression à l'intérieur du récipient 2 lors de l'introduction du liquide dans le récipient 2. On limite ainsi les risques d' éclaboussu- re, notamment lors du retrait de l'embout 3a par rapport au manchon 26d.The channel 22b, the chamber 24 and the vents 26c allow the air to be evacuated, without the risk of creating an overpressure inside the container 2 during the introduction of the liquid into the container 2. This limits the risk of splashing, in particular during the withdrawal of the end piece 3a relative to the sleeve 26d.
Dans le second mode de l'invention représenté aux figures 6 à 8, les éléments analogues à ceux du premier mode de réalisation portent des références identiques augmentées de 100.In the second embodiment of the invention shown in FIGS. 6 to 8, elements similar to those of the first embodiment bear identical references increased by 100.
Le dispositif 101 de ce mode de réalisation comprend un piston 120 formé de deux pièces 121 et 126 assemblées de façon
rigide et étanche et définissant entre elles . une chambre annulaire 124 dans laquelle est disposé un filtre hydrophobe 125. La pièce 121 forme également une aiguille creuse 122 dont un premier canal 122a est relié à une chambre centrale 123 alors que son second canal 122b est relié à la chambre 124. Comme dans le premier mode de réalisation, des évents 126ç_ sont prévus dans la pièce 126 pour la chambre 124, de même qu'un manchon 126d monobloc avec le reste de la pièce 126. Le manchon 126d est centré sur un axe X-X' qui est également l'axe central des pièces 121 et 122 et l'axe de coulissement du piston 120 dans un alésage d'une embase non représentée, du type de l'embase 10 du premier mode de réalisation. A l'intérieur du manchon 126, est disposé un clapet 127 réalisé en élastomère et pourvu de deux têtes 127f et 127g du type des têtes 27f et 27g du premier mode de réalisation. Entre les têtes 127f et 127g, le clapet 127 présente deux sections 1271 et 127m de diamètre dx plus important que le diamètre d2 qu'une section intermédiaire 127m ménagée entre les sections 1271. et 127m.The device 101 of this embodiment comprises a piston 120 formed of two parts 121 and 126 assembled so rigid and waterproof and defining between them. an annular chamber 124 in which a hydrophobic filter 125 is disposed. The part 121 also forms a hollow needle 122 of which a first channel 122a is connected to a central chamber 123 while its second channel 122b is connected to the chamber 124. As in the first embodiment, vents 126c are provided in the part 126 for the chamber 124, as is a sleeve 126d integral with the rest of the part 126. The sleeve 126d is centered on an axis XX 'which is also the central axis of the parts 121 and 122 and the sliding axis of the piston 120 in a bore of a base not shown, of the type of the base 10 of the first embodiment. Inside the sleeve 126, is disposed a valve 127 made of elastomer and provided with two heads 127f and 127g of the type of heads 27f and 27g of the first embodiment. Between the heads 127f and 127g, the valve 127 has two sections 1271 and 127m of diameter d x larger than the diameter d 2 than an intermediate section 127m formed between sections 1271. and 127m.
Le manchon 126d est pourvu d'un épaulement interne 126f à section en forme de pointe, le diamètre intérieur d3 du manchon 126d au niveau de l' épaulement 126f. étant inférieur au diamètre d1# de telle sorte que l' épaulement 126f peut venir en appui et pénétrer superficiellement dans la section 1211 du clapet 127, ce qui assure un appui étanche du clapet 127 contre l' épaulement 126f_. En effet, les dimensions intérieures du manchon 126d et les dimensions du clapet 127 sont choisies de telle sorte que, en l'absence de contrainte, le clapet a la configuration représentée sur la figure 6.The sleeve 126d is provided with an internal shoulder 126f with a point-shaped section, the internal diameter d 3 of the sleeve 126d at the level of the shoulder 126f . being smaller than the diameter d 1 # so that the shoulder 126f can come to bear and penetrate superficially into the section 1211 of the valve 127, which ensures a sealed support of the valve 127 against the shoulder 126f_. In fact, the internal dimensions of the sleeve 126d and the dimensions of the valve 127 are chosen so that, in the absence of stress, the valve has the configuration shown in FIG. 6.
Lorsqu'il convient de faire pénétrer un liquide dans un récipient du type du récipient 2 du premier mode de réalisation sur lequel est monté le dispositif 101 incorporant le piston 120, l'embout luer mâle 103a d'un contenant 103 est introduit dans le manchon 126d et exerce sur le clapet 127 un effort Fx de compression qui éloigne la section 1211 de l' épaulement 126f, ce qui a pour effet de permettre un
écoulement de liquide à travers une échancrure centrale 127j_ de la tête 127f puis autour des sections 1273-., 127n et 127m, puis autour de la tête 127g et à travers une échancrure 127k de cette tête en direction de la chambre 123, puis du canal 122a de l'aiguille 122.When it is appropriate to make a liquid penetrate into a container of the type of container 2 of the first embodiment on which the device 101 incorporating the piston 120 is mounted, the male luer nozzle 103a of a container 103 is introduced into the sleeve 126d and exerts on the valve 127 a compressive force F x which moves the section 1211 away from the shoulder 126f, which has the effect of allowing a flow of liquid through a central notch 127j_ of the head 127f then around the sections 1273-., 127n and 127m, then around the head 127g and through a notch 127k of this head towards the chamber 123, then the channel Needle 122a.
On est alors dans la configuration de la figure 7 où la compression du clapet 127 est obtenue grâce à un fluage de la matière au niveau de la section 127n sous l'effet de l'effort Fl r cette déformation localisée du clapet ne gênant pas l'écoulement du liquide du fait que le diamètre d2 de la section 127n au repos est sensiblement plus petit que le diamètre intérieur d4 du manchon 126d au niveau du clapet 127.We are then in the configuration of FIG. 7 where the compression of the valve 127 is obtained thanks to a creep of the material at the level of the section 127n under the effect of the force F lr this localized deformation of the valve does not interfere with the flow of the liquid because the diameter d 2 of the section 127n at rest is substantially smaller than the inside diameter d 4 of the sleeve 126d at the valve 127.
Dès que l'embout luer mâle 103a est retiré du manchon 126d, le clapet reprend sa conformation des figures 6 et 8 et la vanne V formée des éléments 126d et 127 est à nouveau fermée .As soon as the male luer tip 103a is removed from the sleeve 126d, the valve resumes its conformation of FIGS. 6 and 8 and the valve V formed of the elements 126d and 127 is again closed.
La forme "en pointe" de l' épaulement 126f_, qui est une lèvre circulaire effilée, assure une bonne étanchéité entre le manchon 126d et le clapet 127, y compris après plusieurs manoeuvres de la vanne V.The "pointed" shape of the shoulder 126f_, which is a tapered circular lip, ensures a good seal between the sleeve 126d and the valve 127, including after several operations of the valve V.
Comme précédemment, le manchon 126d est pourvu d'une collerette 126g permettant le vissage d'un écrou 103b assurant la progressivité et le caractère constant de l'effort F1.As before, the sleeve 126d is provided with a collar 126g allowing the screwing of a nut 103b ensuring the progressiveness and the constant character of the force F 1 .
Le clapet 127 est symétrique par rapport à son plan médian transversal P, ce qui permet de le monter sans précaution particulière dans le manchon 126d, chaque sectionThe valve 127 is symmetrical with respect to its transverse median plane P, which makes it possible to mount it without special precautions in the sleeve 126d, each section
1271 ou 127m pouvant coopérer avec l' épaulement ou lèvre 126f.1271 or 127m capable of cooperating with the shoulder or lip 126f.
L'invention a été représentée avec un contenant formé par une seringue 3. Elle est cependant applicable avec d'autres contenants, par exemple une poche souple, pour autant que ces contenants sont adaptés à exercer sur le clapet 27 un effort analogue à l'effort F-..
The invention has been shown with a container formed by a syringe 3. It is however applicable with other containers, for example a flexible bag, provided that these containers are adapted to exert on the valve 27 an effort similar to the effort F- . .
Claims
1. Dispositif de connexion entre un récipient fermé et un contenant, ledit récipient fermé comprenant un col dont l'ouverture est obturée par un bouchon, ledit dispositif de connexion comprenant :1. Connection device between a closed container and a container, said closed container comprising a neck, the opening of which is closed by a plug, said connection device comprising:
- une embase apte à être montée sur ledit récipient et comportant un manchon formant un alésage interne et - un piston apte à coulisser dans ledit alésage, entre une première position dégagée par rapport audit bouchon et une position, dite de transfert, dans laquelle une aiguille creuse, portée par ou constituant ledit piston, traverse ledit bouchon, caractérisé en ce que ledit piston (20 ; 120) est équipé d'une vanne (V) de contrôle de l'écoulement d'un fluide de ou vers le volume intérieur dudit récipient (2), ladite vanne étant intégrée à une partie (26 ; 126) dudit piston prévue pour le raccordement dudit contenant (3) à ladite aiguille (22 ; 122) . - A base adapted to be mounted on said container and comprising a sleeve forming an internal bore and - a piston capable of sliding in said bore, between a first position released relative to said stopper and a position, called transfer, in which a needle hollow, carried by or constituting said piston, passes through said plug, characterized in that said piston (20; 120) is equipped with a valve (V) for controlling the flow of a fluid to or from the interior volume of said container (2), said valve being integrated into a part (26; 126) of said piston provided for the connection of said container (3) to said needle (22; 122).
2. Dispositif selon la revendication 1, caractérisé en ce que ladite vanne (V) comprend un corps de vanne (26d ; 126d) monobloc avec ledit piston (20, 21, 26 ; 120, 121, 126) et un clapet (27 ; 127) prisonnier dudit corps.2. Device according to claim 1, characterized in that said valve (V) comprises a valve body (26d; 126d) integral with said piston (20, 21, 26; 120, 121, 126) and a valve (27; 127) prisoner of the said body.
3. Dispositif selon la revendication 2, caractérisé en ce que ledit corps (26d ; 126d) forme un épaulement interne3. Device according to claim 2, characterized in that said body (26d; 126d) forms an internal shoulder
(26f. ; 126JI) apte à recevoir en butée une surface (27h) ou partie (1271) d'appui dudit clapet (27). (26f;. 126JI) adapted to receive in abutment a surface (27b) or portion (1271) for supporting said valve (27).
4. Dispositif selon la revendication 3, caractérisé en ce que ledit épaulement (126d) est apte à pénétrer superfi- ciellement dans ladite partie d'appui (1271).4. Device according to claim 3, characterized in that said shoulder (126d) is able to penetrate superficially in said bearing part (1271).
5. Dispositif selon l'une des revendications précédentes, caractérisé en ce que ladite vanne (V) comprend un clapet (27 ; 127) déformable élastiquement au moins selon une direction (X-X' ) parallèle à la direction de déplacement dudit piston (20 ; 120) dans ledit alésage (A) .5. Device according to one of the preceding claims, characterized in that said valve (V) comprises a valve (27; 127) elastically deformable at least in a direction (XX ') parallel to the direction of movement of said piston (20; 120) in said bore (A).
6. Dispositif selon l'une des revendications précédentes, caractérisé en ce que ladite vanne (V) comprend un clapet (27) pourvu de rainures longitudinales (27e) formant, en coopéra- tion avec la surface interne d'un corps (26d) de ladite vanne, des canaux de circulation de fluide de ou vers le volume intérieur dudit récipient (2) .6. Device according to one of the preceding claims, characterized in that said valve (V) comprises a valve (27) provided with longitudinal grooves (27e) forming, in cooperation tion with the internal surface of a body (26d) of said valve, of the fluid circulation channels to or from the internal volume of said container (2).
7. Dispositif selon la revendication 6, caractérisé en ce que ledit clapet (27) comprend une gorge périphérique (27d) séparant deux blocs (27a, 27b) dans lesquels sont ménagées lesdites rainures longitudinales (27ç_) .7. Device according to claim 6, characterized in that said valve (27) comprises a peripheral groove (27d) separating two blocks (27a, 27b) in which are formed said longitudinal grooves (27ç_).
8. Dispositif selon l'une des revendications 1 à 5, caractérisé en ce que ladite vanne comprend un clapet comprenant deux sections d'extrémité (1273-., 127m) de diamètre (d- plus important que le diamètre nominal (d2) d'une section intermédiaire (127n) ménagée entre lesdites sections d'extrémité .8. Device according to one of claims 1 to 5, characterized in that said valve comprises a valve comprising two end sections (1273- . , 127m) of diameter (d- larger than the nominal diameter (d 2 ) an intermediate section (127n) formed between said end sections.
9. Dispositif selon l'une des revendications 7 ou 8 , caractérisé en ce que ladite gorge (27d) ou ladite section intermédiaire (127n) est apte à se déformer sous l'effet d'un effort de compression (Fx) subi par ledit clapet (27 ; 127) .9. Device according to one of claims 7 or 8, characterized in that said groove (27d) or said intermediate section (127n) is able to deform under the effect of a compressive force (F x ) undergone by said valve (27; 127).
10. Dispositif selon l'une des revendications 5 à 9, caractérisé en ce que ledit clapet (27 ; 127) est symétrique par rapport à son plan médian transversal (P) .10. Device according to one of claims 5 to 9, characterized in that said valve (27; 127) is symmetrical relative to its transverse median plane (P).
11. Dispositif selon l'une des revendications précédentes, caractérisé en ce que ladite vanne (V) comprend un corps de vanne (26d ; 126d) pourvu de moyens (26g ; 126g) de raccordement dudit contenant (3 ; 103) , ledit corps de vanne étant apte à accommoder une partie (3a ; 103a) dudit contenant destinée à interagir (Fx) avec un clapet (27 ; 127) de ladite vanne .11. Device according to one of the preceding claims, characterized in that said valve (V) comprises a valve body (26d; 126d) provided with means (26g; 126g) for connecting said container (3; 103), said body valve being able to accommodate a part (3a; 103a) of said container intended to interact (F x ) with a valve (27; 127) of said valve.
12. Dispositif selon la revendication 11, caractérisé en ce que ledit corps (26d ; 126d) est adapté pour recevoir un embout luer mâle (3a ; 103a) appartenant audit contenant (3 ;12. Device according to claim 11, characterized in that said body (26d; 126d) is adapted to receive a male luer tip (3a; 103a) belonging to said container (3;
103) , ledit embout permettant de manoeuvrer ledit clapet (27 ; 127) en exerçant sur celui-ci un effort (F dirigé vers ledit piston (20 ; 120) .103), said end piece making it possible to operate said valve (27; 127) by exerting on it a force (F directed towards said piston (20; 120).
13. Dispositif selon l'une des revendications précéden- tes, caractérisé en ce qu'il comprend une coiffe (30) de protection et d'isolement dudit piston (20 ; 120) par rapport à l'atmosphère ambiante, ladite coiffe étant apte (h) à être montée sur ladite embase (10) en protégeant et en isolant ladite vanne (V) , indépendamment de la position dudit piston. 13. Device according to one of the preceding claims, characterized in that it comprises a cap (30) for protecting and isolating said piston (20; 120) from the ambient atmosphere, said cap being suitable (h) to be mounted on said base (10) while protecting and insulating said valve (V), regardless of the position of said piston.
14. Ensemble prêt à l'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 (1 ; 101) de connexion selon l'une des revendications précédentes, monté sur ledit récipient (2) . 14. 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; 101) according to one of the preceding claims, mounted on said container (2).
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR0013297A FR2815328B1 (en) | 2000-10-17 | 2000-10-17 | CONNECTION DEVICE BETWEEN A CONTAINER AND A CONTAINER AND READY-TO-USE ASSEMBLY COMPRISING SUCH A DEVICE |
FR0013297 | 2000-10-17 | ||
PCT/FR2001/003198 WO2002032372A1 (en) | 2000-10-17 | 2001-10-16 | Device for connection between a vessel and a container and ready-to-use assembly comprising same |
Publications (1)
Publication Number | Publication Date |
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EP1239808A1 true EP1239808A1 (en) | 2002-09-18 |
Family
ID=8855445
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Application Number | Title | Priority Date | Filing Date |
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EP01978541A Withdrawn EP1239808A1 (en) | 2000-10-17 | 2001-10-16 | Device for connection between a vessel and a container and ready-to-use assembly comprising same |
Country Status (17)
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US (1) | US20020193777A1 (en) |
EP (1) | EP1239808A1 (en) |
JP (1) | JP2004511306A (en) |
KR (1) | KR20020065571A (en) |
CN (1) | CN1392793A (en) |
AR (1) | AR030896A1 (en) |
AU (1) | AU1064702A (en) |
BR (1) | BR0107328A (en) |
CA (1) | CA2393378A1 (en) |
FR (1) | FR2815328B1 (en) |
HU (1) | HUP0204000A3 (en) |
MX (1) | MXPA02006005A (en) |
PL (1) | PL354705A1 (en) |
RU (1) | RU2002117648A (en) |
TW (1) | TW575442B (en) |
WO (1) | WO2002032372A1 (en) |
ZA (1) | ZA200204187B (en) |
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- 2001-10-16 RU RU2002117648/14A patent/RU2002117648A/en not_active Application Discontinuation
- 2001-10-16 EP EP01978541A patent/EP1239808A1/en not_active Withdrawn
- 2001-10-16 KR KR1020027007676A patent/KR20020065571A/en not_active Application Discontinuation
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- 2001-10-16 CN CN01803136A patent/CN1392793A/en active Pending
- 2001-10-16 WO PCT/FR2001/003198 patent/WO2002032372A1/en not_active Application Discontinuation
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- 2001-10-16 AU AU10647/02A patent/AU1064702A/en not_active Abandoned
- 2001-10-16 JP JP2002535611A patent/JP2004511306A/en not_active Withdrawn
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Also Published As
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ZA200204187B (en) | 2003-01-23 |
PL354705A1 (en) | 2004-02-09 |
JP2004511306A (en) | 2004-04-15 |
AR030896A1 (en) | 2003-09-03 |
BR0107328A (en) | 2002-08-27 |
HUP0204000A2 (en) | 2003-03-28 |
CN1392793A (en) | 2003-01-22 |
AU1064702A (en) | 2002-04-29 |
FR2815328B1 (en) | 2002-12-20 |
FR2815328A1 (en) | 2002-04-19 |
KR20020065571A (en) | 2002-08-13 |
RU2002117648A (en) | 2004-02-10 |
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US20020193777A1 (en) | 2002-12-19 |
WO2002032372A1 (en) | 2002-04-25 |
CA2393378A1 (en) | 2002-04-25 |
TW575442B (en) | 2004-02-11 |
MXPA02006005A (en) | 2002-12-05 |
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