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

Abstract

A device for connecting between a recipient and a container, including a base, mounted on the recipient and a bush forming an inner bore, and a plunger adapted to slide in this bore, between a first position disengaged with respect to the stopper of the recipient and a second, so-called transfer position, in which a hollow needle borne by the plunger traverses the stopper. The base is provided with at least one elastic catch for retaining the plunger in the transfer position, this catch projecting, from the bush, towards the interior of the bore and being adapted to cooperate with an outer radial tab of the plunger.

Description

The invention relates to a connection device between a closed container and container. The invention also relates to a ready-to-use set including, among other things, a closed container and a connection device of the aforementioned type.

In the field of drug packaging, it is known to store a component of a pharmaceutical preparation, such as for example its active ingredient, in a closed container by a plug made of relatively soft material, for example in elastomer. Liquid can be introduced into this container after perforation of the cap to dissolve or put in suspends the component contained in the container, in order to obtain a preparation, in particular a drug or a vaccine, in liquid form and ready to be administered to patients.

By documents WO-A-90/03 536 and WO-A-97/10 156, we knows connection devices each comprising a base adapted to cover the neck of a container and extending by a flange or sleeve forming a bore internal, while a piston is slidably mounted in this bore. The piston is designed to be pushed to a position transfer in which a hollow needle carried by the piston passes through the container cap. These known devices allow axial movements of the piston when it has been moved to transfer position, which could lead to leaks and does not allow effective control the dead volume of the container, i.e. the amount of liquid that cannot be drawn off.

Document WO-A-98/13 006 discloses a device suitable, in particular, for the connection between a container with perforable plug and a syringe, in which teeth are distributed around the axis of the piston and intended to be recalled centrifugally or centripetally to cooperate with a stop blank provided on a base. This device allows a piston lock aunt that the displacement effort to which it is subject is not too important. However, in certain conditions, the teeth could be deformed by plastic way, which could allow tearing of the piston in an extraction direction.

From document WO-A-98/32411, there is known a device for connection in which a piston secured to a needle is provided with a tab intended to engage in a recess formed in the thickness of a base. The rush that borders this indentation essentially deforms parallel to the direction of movement of the piston and at a narrow width in a radial direction, which does not ensure a effectively maintains the piston in the transfer position.

It is to these disadvantages that we hear more particularly remedy the invention, by proposing a connection device improved in which it is obtained a particularly locking effective piston in transfer position.

In this spirit, the invention relates to a device of the aforementioned type in which the base is provided with at least one spout elastically deformable towards the outside of the sleeve, this spout protruding from the socket inward of the bore for retaining the piston in the transfer position and being able to be driven radially outwards from the sleeve by an external radial lug of the piston, during displacement of the piston from its released position to its position of transfer, and to immobilize this tab and this piston in transfer position.

Thanks to the invention, the elastic spout guarantees locking effective piston in transfer position. This locking is all the more effective as several nozzles are advantageously provided, these spouts can be regularly distributed around the central axis of the device.

According to a first advantageous aspect of the invention, the spout is provided, on an external radial face, with a heel capable of cooperate with a locking ring in the retaining position of the piston, this ring being able to slide around the socket. This ring gives the retaining spout a sufficient rigidity to effectively withstand an effort of displacement of the piston from the transfer position. This ring is advantageously provided with a collar external radial locking in translation in a position of cooperation with the spout.

According to another advantageous aspect of the invention, the device comprises means for locking in rotation of the piston and / or locking ring. These means include advantageously longitudinal ribs formed on the internal face and / or the external face of the socket and capable of cooperate with corresponding reliefs provided on the surface external radial of the piston and / or on the internal radial surface of the ring.

According to another advantageous aspect of the invention, in clear position relative to the plug, the piston is integral of the socket by at least one breakable tab. In in addition, the base and the piston are advantageously formed in a single piece by injection of plastic material. This facilitates positioning of the piston relative to the base insofar as this positioning follows directly from the manufacturing method and where it is not necessary to provide an assembly step corresponding to the insertion of the piston into the base. In addition, the one-piece nature of the base and the piston guarantees that the piston does not risk sliding in the bore, in particular under the effect of vibrations or accelerations abrupt when transporting the device. So the point of a needle carried by the piston is maintained, inside the bore, so that it does not not likely to protrude from the base to mark or perforate a plug when installing the device on the recipient. With known devices, such a risk does not could not be completely eliminated, including during the use of piston retaining beads.

According to another advantageous aspect of the invention, a protection cap for the bore and the piston is provided on an internal face, of a member for transmitting a force of push to move the piston from the first position to the second position. Thus, the protective cap serves of the piston operating member.

According to another advantageous aspect of the invention, the socket comprises, near its free edge, means for blocking of the container by cooperation of forms, in particular of bayonet locking lights adapted to cooperate with the minus one leg of the container.

According to another advantageous aspect, the base comprises a cylindrical surface defining a skirt which extends around the container neck and has hooking teeth, this skirt comprising at least one access opening to the spout and / or to some hooking teeth from the outside. These openings are particularly useful for efficient molding of the beaks and corresponding teeth.

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 device connection as previously described mounted on the container. Such an assembly allows sterile storage of a component of a drug or vaccine, including its active ingredient, and to prepare it in good time by mixing with a liquid, while its piston is effectively held in position.

• la figure 1 est une vue éclatée de côté d'un ensemble prêt à l'emploi conforme à l'invention ;
• la figure 2 est une coupe transversale selon la ligne II-II à la figure 1 ;
• la figure 3 est une coupe brisée selon la ligne III-III à la figure 2, on y a également indiqué en II-II le plan de coupe de la figure 2 ;
• la figure 4 est une coupe analogue à la figure 3 lors d'une première étape de mise en oeuvre du dispositif et
• la figure 5 est une coupe analogue à la figure 3 lors d'une seconde étape de mise en oeuvre du dispositif.

The invention will be better understood and other advantages thereof will appear more clearly in the light of the following description of an embodiment of a connection device 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;
• Figure 2 is a cross section along line II-II in Figure 1;
• Figure 3 is a broken section along line III-III in Figure 2, there is also indicated in II-II the section plane of Figure 2;
• FIG. 4 is a section similar to FIG. 3 during a first step of implementing the device and
• Figure 5 is a section similar to Figure 3 during a second step of implementing the device.

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 non- shown and previously closed or blocked. This product can be a powder intended to form an oral vaccine. he can be any other type of pharmaceutical preparation, in particular particular of any type of medication. Device 1 allows secondly to ensure or establish a tight connection between the interior of container 2 and the interior of another container 3, such as a syringe containing a liquid intended to deliver solution or suspension the product contained in the container 2. Instead of a syringe, container 3 could be formed by a flexible pouch or other glass vial.

The container 2 has a neck 4, the opening 4 a of which is sealed off by a plug 5 made of a relatively soft material, for example an elastomer and in particular rubber. The neck 4 comprises an external annular bead 4 b on which is crimped a capsule 6 which also covers a peripheral part of the plug 5 and which is provided with a central opening 6 a through which it is possible to perforate the plug 5. The plug 5 has a substantially cylindrical central part 5 a , suitable for a flexible and tight fitting inside the opening 4 a , and an external part 5 b , flattened, supported on the bead 4 a , and covered by the capsule 6.

The device 1 is essentially formed of two parts made by injecting plastic, for example polyethylene, polypropylene, polyamide or ABS (polyacrylonitryl / butadiene / styrene), namely a basic element or base 10 intended to be mounted around elements 3 to 6, and a cap 30.

The basic element 10 comprises several attachment teeth 11 intended to be arranged around the bead 4 b , in the manner shown in FIG. 3. These teeth are defined in the lower part of a cylindrical skirt 12 surrounding the neck 4. the element 10 comprises a wall 13 bearing on the upper part of the cap 6, this wall being provided with a central recess 13 is bordered by a cylindrical sleeve 14, concentric with the skirt 12 and extending the opposite of the wall 13 relative to this skirt.

We denote XX 'the central axis of the device 1 which is, in particular, the axis of the skirt 12 and of the sleeve 14. The socket 14 extends to contact with the capsule 6 and defines a bore A centered on the axis XX '.

In its part 14 a closest to the plug 5, the sleeve 14 is equipped with two nozzles 15 and 15 'projecting radially towards the inside of the bore A. Taking into account the plastic material used for molding the element 10, these nozzles have a flexibility such that they can be elastically deformed, as shown by the arrow F in FIG. 3.

As appears more clearly in Figure 2, the spouts 15 and 15 'are diametrically opposite. However, others allocations can be considered, as well as a number of different from retaining spouts.

Inside the bore A is arranged a piston 20 forming a hollow needle 21 capable of perforating the plug 5 in its central part. The piston 20 is connected to the sleeve 14 by tabs 22 which are three in number and regularly distributed around the periphery of the piston 20. Thus, the piston 20 is in one piece with the base 10 until the tabs 22.

The piston 20 also forms a receiving jacket 23 of the nose 3a of the syringe 3. The inside diameter of the jacket 23 is chosen low enough that only syringes can be inserted inside this shirt correspond to a special production dedicated to this use.

The piston 20 has two legs 24 extending radially outward at the transition zone 25 between the needle 21 and the shirt 23.

On its internal radial surface, the sleeve 14 carries three longitudinal ribs 16 which cooperate with the sides of the tabs 24 to prevent rotation of the piston 20 around the axis XX '.

The cap 30 is formed of a removable part 31, surrounding the free edge 14b of the sleeve 14, and of a ring 32 disposed around the sleeve 14, the parts 31 and 32 being connected by a breakable zone 33.

Near its free edge 14b , the sleeve 14 is provided with an external rod 14 c intended to penetrate an internal peripheral groove 32 c of the ring 32. This rod and this groove allow the cap 30 to be held in position by relative to the element 10 in the storage position of Figures 1 to 3. The device 1 can be kept in this position for several months on the bottle 2 before use.

On its internal face 31 a , the part 31 is equipped with an extension 34 whose shape is adapted so that it can partially engage in the path 23. This extension has, in cross section, a cross shape, because it is formed by two substantially orthogonal ribs 34 a and 34 b intersecting at the level of the axis XX '. In the position of FIG. 3, the positioning of the extension 34, and in particular its depth of insertion into the jacket 23, is determined by the cooperation of the rod 14 c and the groove 32 c .

When it is necessary to mix the contents of the syringe 23 and the container 2, a force is exerted on the part 31 of the cap 30, represented by the arrow E in FIG. 3, which has the effect of making wear shoulders 34 c ribs 34 a and 34 b against the free edge of the shirt 23, while chasing the groove 32 c relative to the rod 14 c . The ring 32 then moves along the sleeve 14 in the direction of the wall 13. The force transmitted by the extension 34 to the jacket 23 has the effect of cutting the tabs 22 and pushing the piston 20 towards the opening central 6 a of the capsule 6, so that the tapered tip 21 a of the needle 21 enters the bottle 2 through the stopper 5. The effort E is maintained until the ring 32 is received in an annular space 17 defined between the upper part of the skirt 12 and the lower part 14 a of the sleeve 14. This movement of the ring 32 corresponds to a movement of the piston 20 such that the transition zone 25 between the needle 21 and the jacket 23 is arranged in the immediate vicinity of the upper surface of the capsule 6.

This displacement of the piston 20 has the effect of engaging the legs 24 and 24 'respectively behind the spouts 15 and 15', these spouts being driven radially outwardly of the sleeve 14, by legs 24 and 24 'during of the advance movement of the piston 20. This is possible because the front face 15 a of the spout 15 visible in Figures 3 to 5 is inclined relative to the axis XX '. We are then in the position of FIG. 4 where the ring 32 exerts on a heel 15 b situated on an external rear or radial surface 15 c of the beak 15 a centripetal force which maintains the beak 15 in an effective locking position of the tab 24. The spout 15 'which is identical operates in the same way.

In order to guarantee a constant positioning of the ring 32 inside the volume 17, this ring is provided with an external flange 32 d able to engage under an upper returning flange 12 a of the skirt 12 provided on an angular sector at the level of the spout 15. A similar returning flange 12 ' a is provided at the level of the spout 15'.

Thus, the ring 32 is firmly held in a position such that it prevents elastic deformation of the spout 15 which could allow movement of the legs 24 in a direction of distance from the plug 5. Operation is similar at the level of the spout 15 '.

At its part 14 a , the sleeve 14 is provided with external ribs 14 e intended to engage in corresponding notches 32 e formed on the internal radial surface of the ring 32. Thus, in the position of FIG. 4, the ring 32 is immobilized in rotation about the axis XX '. It is then possible to exert on the part 31 of the cap 30 a torque C making it possible to break the breakable part 33 so as to remove this part 31, while the ring 32 remains in the locking position of the spouts 15 and 15 '.

The nose 3 a of the syringe 3 is then introduced into the jacket 23, as shown in FIG. 5, using one or more tabs 3 b provided at the level of a base socket 3 c of the syringe 3 to each penetrate into a bayonet locking light 14 f provided near the free edge 14 b of the sleeve 14. This particular construction allows effective locking of the syringe 3 relative to the device 1 during the operations of transit of the liquid from the syringe to the vial and recovering the preparation in the syringe.

The sleeve 12 is provided, at the level of the spout 15, with an opening 18 which allows a movable drawer to conform the rear part of the spout 15 and the re-entrant flange 12 a of the skirt 12 during molding. The teeth 11 can be obtained during the molding of the element 10 by drawers penetrating to the bottom of the skirt 12 through openings 13 b provided in the wall 13. Taking into account the geometry and the location of the spouts 15, this is not possible for the teeth 11 located in the same angular sector as the nozzles 15 and 15 '. An opening 19 is provided in the skirt 12, below the opening 18, to allow the passage of a movable drawer of conformation of the corresponding tooth 11 during the molding of the device 1. Of course corresponding openings are provided in the angular sector corresponding to the spout 15 '.

The particular structure of the spouts 15 and 15 'and their cooperation with ring 32 guarantee locking effective piston 20 in the transfer position of the figures 4 and 5. It is easy to understand that the number and the distribution nozzles 15, 15 'or equivalent depend on a choice of design within the reach of the skilled person, depending on the strength sought locking and stiffness of materials used.

The invention has the particular advantage that it is adaptable to bottles packaged in a conventional manner with a cap and a crimped capsule 6, which allows its setting work after conditioning part of the drugs on a classic chain.

The invention is applicable regardless of the mode of fixing the element or base 10 on the container 2 and, in general, it can be used in any device for connection comprising a movable piston inside a bore of a base mounted on a container.

Claims (11)

1. Device for connecting a closed receptacle (2) and a container (3), the said closed receptacle comprising a neck (4) the opening (4a) of which is sealed by a stopper (5), the said connecting device comprising:

   a base unit (10), which can be mounted on the said receptacle and which comprises a sleeve (14) forming an internal bore (A),

   a piston (20) able to slide in the said bore, between a first position clear of the said stopper (5) and a second position, known as the transfer position, in which a hollow needle (21) carried by the said piston passes through the said stopper,

   characterized in that the said base unit (10) is provided with at least one spur (15, 15') that is elastically deformable (F) towards the outside of the said sleeve (14), the said spur protruding, from the said sleeve (14), towards the inside of the said bore (A) to retain the said piston in the transfer position and being capable of being driven radially towards the outside of the said sleeve by an external radial tab (24) of the said piston (20), as the said piston moves between the said first and second positions, and of immobilizing the said tab and the said piston in the transfer position.
2. Device according to Claim 1, characterized in that the said spur (15, 15') is provided, on an external radial face (15c), with a heel (15b) able to collaborate with a ring (32) for locking the said piston (20) in the retained position, the said ring being able to slide around the said sleeve (14).
3. Device according to Claim 2, characterized in that the said ring (32) is provided with an external radial flange (32d) for locking in terms of translation in a position of collaboration with the said spur.
4. Device according to one of the preceding claims, characterized in that it comprises means (16, 24, 14e, 32e) of locking the said piston (20) and/or the said ring (32) in terms of rotation about a central axis (XX') of the said bore (A).
5. Device according to Claim 4, characterized in that the said means of locking in terms of rotation comprise longitudinal ribs (16, 14e) formed on the internal face and/or the external face of the said sleeve (14) and able to collaborate with corresponding reliefs (24, 32c) provided on the external radial surface of the said piston (24) and/or on the internal radial surface of the said ring (32).
6. Device according to one of the preceding claims, characterized in that, in the said position clear of the said stopper (5), the said piston (20) is secured to the said sleeve (14) by at least one frangible tag (22).
7. Device according to one of the preceding claims, characterized in that the said base unit (11-19) and the said piston (20) are formed as a one-piece part (10) by the injection moulding of plastic.
8. Device according to one of the preceding claims, characterized in that it comprises a cap (30) protecting the said bore (A) and the said piston (20), the said cap being provided, on an internal face, with a member (34) for transmitting a thrusting force (E) for moving the said piston (20) from the said first position towards the said second position.
9. Device according to one of the preceding claims, characterized in that the said sleeve (14) comprises, near its free edge (14b), means of immobilizing the said container (3) through the collaboration of shapes, particularly bayonet-type locking slots (14f) able to collaborate with at least one lug (3b) of the said container.
10. Device according to one of the preceding claims, characterized in that the said base unit (10) comprises a skirt (12) which extends around the said neck (4) of the said receptacle (2) and carries catching teeth (11), the said skirt comprising at least one opening (18, 19) for access to the said spur (15) and/or to certain catching teeth (11) from the outside.
11. Ready-to-use assembly comprising a closed receptacle (2) containing a product, particularly a pharmaceutical preparation, the said receptacle being provided with a neck the opening of which is sealed by a stopper (5), and a connecting device (10-34) according to any one of the preceding claims, mounted on the said receptacle.

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