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

The invention concerns a connection device comprising a base (10) adapted to be mounted on a receptacle (2) and forming a sliding sleeve (15) for a piston (16) which moves or forms a hollow needle (16), an annular skirt (20) for locking the base plate (10) in snap-on configuration on the neck (4), and a cap (30) designed to isolate the plate (10) and/or the piston (16) from ambient atmosphere. The cap (30) is provided with at least one protuberance (33) designed to be engaged in the internal volume (V) of said skirt (20), said protuberance (33) extending radially relatively to a central axis (X-X′) of the cap (30) over a distance (R33) greater than the minimum distance (R25) between said central axis (X-X′) and an edge (23) of the opening (O′) providing access to the internal volume (V) of said skirt. The protuberance remains integral with the rest (31a) of the cap when the latter is removed from the device. Once the cap (30) is removed from the skirt (20), the protuberance counters its re-insertion into the internal volume (V) of the skirt.

This Application is a U.S. National filing under §371 of International Application No. PCT/FR03/00555, filed 19 Feb. 2003, claiming priority from French Appln. No. 02/02149, filed 20 Feb. 2002, now pending (which is hereby incorporated by reference).

The invention relates to a device for connection between a closed receptacle and a container. The invention also relates to a ready-to-use assembly comprising, inter alia, a closed receptacle and a connection device of the afore-mentioned type.

In the domain of packaging of medicines, it is known to store a component of a pharmaceutical preparation, such as, for example, its active ingredient, in a receptacle closed by a stopper of relatively non-rigid material, for example made of elastomer. A liquid may be introduced in this receptacle after perforation of the stopper, in order to dissolve or place the component contained in the receptacle in suspension, for the purpose of obtaining a preparation, particularly a medicine or a vaccine., in liquid form and ready to be administered to the patient.

WO-A-97/10156 discloses a connection device which comprises a base adapted to cover the neck of a receptacle and extending in a flange or sleeve forming an inner bore, while a plunger is mounted to slide in this bore. The plunger bears a needle provided to traverse the stopper of the receptacle in a so-called transfer position. This device also comprises a cap allowing the base and the plunger to be isolated with respect to the ambient atmosphere before the plunger is pushed in the direction of the stopper.

After manoeuvring the connection device, and in particular after injection of a liquid and/or withdrawal of part of the preparation that it contains, the cap of this known device may be returned into position thereon, with the result that it is not immediately apparent that the connection device has already been activated and brought into contact with the ambient atmosphere. This might lead to errors in manipulation, particularly by nursing staff who have to work under sometimes considerably stressful conditions.

It is a more particular object of the present invention to overcome these drawbacks by proposing a novel connection device which allows efficient isolation of the plunger and base with respect to the ambient atmosphere and an immediate detection of the fact that such isolation has been broken, this making it easier to differentiate a ready-to-use assembly which has already been activated from a ready-to-use assembly not yet activated.

In that spirit, the invention relates to a device for connection between a closed receptacle and a container, this closed receptacle comprising a neck of which the opening is closed by a stopper, while this connection device comprises:a base adapted to be mounted on the receptacle, comprising a sleeve forming an inner bore and adapted to be snapped on the neck;a plunger adapted to slide in this bore between a first position, disengaged with respect to the stopper and a second, so-called transfer position, in which a hollow needle displaced or formed by the plunger traverses this stopper;an annular skirt for locking the base in snap-on configuration on the neck, anda cap adapted to isolate this sleeve and/or this plunger from the ambient atmosphere, and to be withdrawn in order to allow connection of the container, while the cap is provided with at least one protuberance adapted to be engaged in the internal volume of the skirt, this protuberance extending radially with respect to a central axis of the neck and of the cap over a distance greater than the minimum distance between this axis and an edge of an opening providing access to the internal volume of the skirt, while the protuberance is connected to the principal part of the cap.

This device is characterized in that the protuberance of the cap is a radial flange extending on the periphery of the cap, with a radius greater than the internal radius of the edge of the opening of the skirt which is substantially circular and in that the skirt is elastically deformable and compatible with the extraction of the protuberance with respect to its internal volume thanks to an essentially radial deformation of its edge, with the result that it remains integral with the afore-mentioned principal part of the cap when the cap is removed from the device, before it is first used.

Thanks to the invention, the cap remains captive of the skirt inside which it is locked by its protuberance which comes into abutment and is blocked against the edge of the opening. In this first position, the connection device has not yet been used. In order to use the connection device, the cap must be separated from the cover, which involves extracting the protuberance from the internal volume of the skirt. This operation is irreversible, with the result that the user will immediately notice when such an extraction has taken place.

According to advantageous but non-compulsory aspects of the invention, the device incorporates one or more of the following characteristics:The geometry of the protuberance of the cap and the geometry of the edge of the opening of the skirt allow the extraction of the protuberance with respect to the internal volume of the skirt, through the afore-mentioned opening and in a direction parallel to the axis of slide of the plunger, while these geometries oppose an introduction of the cap in the afore-mentioned volume through the afore-mentioned opening. In other words, the geometry of the protuberance and of the edge makes it possible to extract the cap from the internal volume of the skirt but opposes a later introduction of the cap in the skirt, this avoiding a fresh positioning of the cap on the base and around the plunger after activation of the device, i.e. after displacement of the plunger from its disengaged position towards its transfer position.The flange presents an outer radial surface which is truncated and convergent in the direction of the bottom of the cap, while the edge of the opening of the skirt is truncated and convergent opposite means for snapping the device on the neck. Thanks to this aspect of the invention, the flange and the edge form two truncated surfaces capable of coming into surface abutment against each other, which allows an efficient transmission of effort when the protuberance abuts against the edge of the opening, this effort making it possible to retain the cap in position partially engaged in the skirt. The afore-mentioned transmission of effort also makes it possible to envisage a radial expansion of the edge of the opening under the effect of an effort transmitted by the flange while the cap is being withdrawn.An O-ring made of elastomer is provided, interposed between the cap and the base when the afore-mentioned protuberance is engaged in the internal volume of the skirt. This elastomeric O-ring guarantees seal of the cap with respect to the base, including when the connection device is subjected to a terminal sterilization in an autoclave for a duration of about 20 minutes and at a temperature of about 120° C. In that case, the O-ring is advantageously made of injectable elastomer, for example Santoprene (Registered Trademark), such a material conserving the essential of its properties of elasticity after a terminal sterilization treatment. Such is not the case of the plastics material conventionally used for making a base or a cap, such as polypropylene or polyethylene, while compounds based on styrene are likely to melt at the sterilization temperatures employed.The cap is provided with a tapping adapted to cooperate with at least one protuberance formed on the outer surface of the sleeve for positioning the cap along the axis of slide of the plunger. Such tapping and protuberance make it possible to considerably increase the effort exerted by a user on the cap and transmitted to the edge of the opening, which makes it possible to exert a sufficient effort of radial expansion of this edge. This protuberance and tapping also make it possible to exert an effort of compression of the injectable elastomer O-ring when such a seal is provided.The cap and the skirt are in one-piece, and made in the form of a single piece of plastics material, breakable bridges being provided in order to join this cap and this skirt. The fact of making the cap and the skirt in one piece guarantees their relative positioning at the beginning of assembly and facilitates assembling of the device.

The invention also relates to a ready-to-use assembly which comprises a closed receptacle containing a product, particularly a pharmaceutical preparation, this receptacle being provided with a neck whose opening is closed by a stopper, and a connection device as described hereinbefore mounted on this receptacle. Such a receptacle makes it possible to keep sterile a component of a medicine or a vaccine, particularly its active ingredient, while a user can immediately notice whether such an assembly has already been activated or not.

The device1according to the invention has a dual function. On the one hand, it renders tamperproof a receptacle2, for example a previously closed or stoppered glass flask, containing a product (not shown). This product may be a powder containing an active ingredient of a medicine or a vaccine. On the other hand, the device1ensures or establishes a tight connection between the interior of the receptacle2and the interior of another container, such as a syringe3containing a liquid intended to place the product contained in the receptacle2in solution or in suspension. In place of a syringe, the container might be formed by a supple bag or another glass flask.

The flask2comprises a neck4of which the opening4ais hermetically closed by a stopper5made of a relatively non-rigid material, for example of elastomer, preferably rubber. According to a variant of the invention (not shown), a capsule may be disposed around the stopper5and an outer annular part4bof the neck4.

The device1comprises a base10made by injection of polyethylene and/or of polypropylene, which comprises a cylindrical part11provided to be centred on the axis of symmetry X-X′ of the elements2,4and5. The part11extends in a plurality of elastic tabs12each equipped with a spout13and adapted to cooperate with the outer surface of the neck4with a view to the base10being elastically snapped on the neck.

Opposite a lower edge11aintended to penetrate superficially in the upper surface of the stopper5, the part11extends in an annular band14for join with a sleeve15which forms an inner bore A for storage and displacement of a plunger16principally constituted by a hollow needle. The inner radial surface17of the sleeve15is cylindrical with circular base and centred on axis X-X′ which is thus the central axis of the bore A.

The sleeve15also bears four “ears”181,182,183and184allowing it to cooperate with a nut6associated with the syringe3. A connecting piece3aof the “LUER LOCK” type is provided on the syringe and is intended to be introduced in the sleeve15, as shown inFIG. 5.

The lower edge15aof the sleeve15is intended to penetrate superficially in the stopper5.

The hollow needle16forms a central channel19and is joined to the sleeve15by three elastic tongues of which two are shown in the Figures under reference16a, with the result that elements11to19form a single piece, in accordance with the technical teaching of WO-A-01/32524.

Other forms of plunger may be envisaged with the present invention, in particular such as disclosed by WO-A-97/10156, WO-A-98/13006, WO-A-00/16730 or WO-A-00/47159.

A skirt or ring20is mounted around the base10and comprises two inner beads21and22intended to be selectively engaged in an outer radial groove10aof the base10. The passage of the ring20from the position ofFIG. 2to that ofFIGS. 3 to 6makes it possible to immobilize the tabs12in position around the neck4, in accordance with the technical teaching of WO-A-97/10156.

The skirt20is provided, opposite the bead21, with an inner radial flange23which forms the edge of an opening O providing access to the internal volume V of the skirt20, when the latter is in place around the base10. The inner radial face23aof the flange23is truncated, centred on axis X-X′ and convergent opposite the bead21.

A cap30is provided around the sleeve15and is, in essence, in position in the volume V in the configuration ofFIG. 2while it is, in essence, disposed outside this volume when the ring20is in the position ofFIGS. 3 to 5.

This cap30comprises a principal part31ain the form of a cover substantially symmetrical about the axis X-X′ and provided with outer ribs31bfacilitating grip in the hand. The cap also comprises a bottom31c. The cap30defines an opening O′ through which the sleeve15can be introduced in this cap. An inner thread32forms a tapping inside the cap30.

An outer flange33in one piece with the cap30is adjacent the opening O′. The flange33comprises a radial surface33acentered on the axis of symmetry of the cap30, which merges with the axis X-X′, and convergent in the direction of the bottom31c.

The maximum radius R33of the surface33ais greater than the minimum radius R23of the surface23a.

In this way, when the skirt20is in the position ofFIG. 3, the flange23opposes extraction of the flange33with respect to the internal volume V of the skirt20.

More precisely, the respective apex angles α23and α33of the surfaces23aand33aare substantially equal, with the result that a surface abutment of the surfaces23aand33amay be obtained in the configuration ofFIG. 3.

Taking the foregoing into account, the flange23contributes to holding the cap30in position in the configuration ofFIG. 3.

The cap30also presents teeth34provided to penetrate superficially in the band14, this making it possible to create a tight connection between the cap30and the base10and to isolate the sleeve15and the plunger16with respect to the ambient atmosphere. It will be noted that the thread32may cooperate with the ears18and18′ so that, thanks to an effort of screwing represented by the arrow of rotation R inFIG. 3, the teeth34are firmly engaged in the band14.

When the cap30is to be removed, it suffices to exert thereon an effort of rotation represented by arrow R′ inFIGS. 3 and 4, this effort having the effect of displacing the cap30opposite the part11of the base10, as represented by arrow F1inFIG. 4. As the flange33remains fast with the principal part31ait must be extracted from the volume V, this being possible thanks to a radial expansion of the flange23and, more generally of the skirt20, allowing the passage of the flange33of the cap30at the level of opening O. Such expansion is represented by arrows F2inFIG. 4.

The cooperation of the thread32and of the ears18and18′ allows the effort of rotation R′ to be considerably increased in order to expand the flange23radially.

When the cap30has been removed, the nut6of the syringe3can be screwed on the sleeve15, which induces a displacement of the plunger-needle16towards the internal volume of the flask2. Such displacement allows the needle to pass through the stopper5in order to pour into the receptacle2aliquid of which the flow is represented by arrow E inFIG. 5.

As shown inFIG. 6, if it is attempted to replace the cap30on the elements10and20, the flange33opposes an introduction of the cap30through the opening O, the cap30in that case resting on the upper surface23bof the flange23, the total height of the device1in that case being different from that of this same device in the configuration ofFIG. 3.

In other words, the respective values of the radii R23and R33are incompatible with an introduction of the cap30in the volume V through opening O.

In the second form of embodiment of the invention shown inFIGS. 7 to 9, elements similar to those of the first embodiment bear identical references increased by100. The device101of this embodiment comprises a base110provided with tabs112presenting spouts113for fastening on the neck104of a flask102. The base110forms a sleeve115which defines a bore A for slide of a plunger-needle116. In practice, the base110is identical to the base10of the first embodiment.

A skirt120is provided to lock the tabs112around the neck104, while a cap130is provided to isolate the base110from the ambient atmosphere.131a,131band131crespectively denote the principal part, the ribs for gripping and the bottom of the cap130.

Elements120and130are made in one piece and joined, at the level of outer ribs135of the cap130, by breakable bridges136, the skirt120being able to pass from the configuration ofFIG. 7to that ofFIG. 8by rupture of these bridges136.

As before, the skirt120is provided with a flange123defining an opening O providing access to the internal volume V of the skirt120and of which R123denotes the radius and123athe inner radial face.

A flange133is provided in the vicinity of the opening O′ of the cap130and133adenotes its outer radial surface and R133its maximum radius.

As before, the radius R133is greater than radius R123, this preventing a re-introduction of the cap130in the volume V through the opening O, from the configuration ofFIG. 9.

An O-ring140made of Santoprene (Registered Trademark) is interposed between the cap130and the base110. In practice, this O-ring is driven in a groove137of the cap130and is adjacent the opening O′ of this cap.

This Santoprene O-ring makes it possible efficiently to isolate the internal volume of the cap130with respect to the ambient atmosphere independently of the use of teeth such as teeth34of the first embodiment. This O-ring is particularly adapted to the case of the product contained in the flask2being a vaccine or containing a molecule in liquid form which must be subjected to a terminal sterilization in an autoclave, at a temperature of about 120° C. and for a duration of about twenty minutes. Pieces made of polyethylene or polypropylene, such as the cap or the base, prove to be slightly deformed by a step of terminal sterilization. In effect, the temperature rise necessary during such sterilization induces a relaxing of the internal tensions of the matter and a decrease in the effort of pressure generated at the level of protuberances, such as the teeth34of the first embodiment. The efficiency of these teeth can therefore not be guaranteed.

Furthermore, it is not possible to use compounds based on styrene for making the pieces110and130, as such compounds are degraded during a sterilization step as mentioned above.

An elastomeric O-ring therefore performs the function of seal, while being compatible with a sterilization step under the conditions mentioned above. The use of an injectable elastomer such as Santoprene is particularly advantageous as this material is stable at the temperatures in question and its cost price is satisfactory.

According to an advantageous aspect of the invention (not shown), the plunger of the device according to the invention may be equipped with a valve for controlling the flow of a fluid from or towards the internal volume of the receptacle.

According to another aspect of the invention (not shown), the flange33or133of the cap may be replaced by one or more protuberances extending over only a part of the circumference of the opening O′. Similarly, the flange23or123may be interrupted on one or more parts of the circumference of the opening O.

The characteristics of the two forms of embodiment shown may, of course, be combined together.