EP1115361B1 - Device for connecting a receptacle and a container and ready-for-use set comprising same - Google Patents

Abstract

The invention concerns a connecting device (1) comprising a base (5) mounted on the receptacle (2) and extended by a flange (9) forming an inner bore (A) and a piston (10) capable of sliding in said inner bore (A) between a released position relative to a plug (4) and a transfer position wherein a hollow needle (11) borne by the piston (10) passes through the plug (4). A scaling lip (22) is arranged on an internal surface (8d) of the bore (A) opposite the piston (10) or a surface of the piston, said lip (22) being shaped to be urged to press sealingly against the piston (10d) or against an internal surface of the bore, in the transfer position.

Description

The invention relates to a device for connecting 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 drug 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 drug preparation in liquid form ready to be administered to the patient.

From document WO-A-97/10 156, we know a device of connection of the aforementioned type which includes a suitable base for styling the neck of the container and is extended by a flange forming an internal bore while a piston is able to slide in this bore, between a released position relative to the plug and a transfer position in which a hollow needle carried by the piston crosses this plug. The displacement of the piston from its released position towards its transfer position is achieved manually by a operator. During this manipulation, it happens that the operator exercises on the piston guide flange or on the latter during movement a transverse force which may result in a perforation of the cap according to a direction inclined to a central axis of symmetry of the plug. The functional clearance between the piston and the bore internal of the base cannot be reduced too much significant to allow better axial guidance of the piston because the force resisting displacement of the piston would be so too important. The risk of a tilted perforation or "bias" of the plug is therefore not negligible, in particular when the user needs to prepare a medicine in an emergency.

A perforation of the cap at an angle means that the visible section of the orifice, created in the plug by the passage of the hollow needle, is greater than the diameter outside of this needle, to the point that leaks may occur produce through the plug, around the hollow needle. In particular, when the container and the container to which it is associated are placed in a gravity flow position of the reconstituted drug from the container to the container, i.e. when the container is placed above the containing, it is possible that the drug preparation flows from the container to the piston and flows over the hands of user, which can be dangerous for some drugs or unpleasant for less aggressive drugs.

It is to these disadvantages that we hear more particularly remedy the invention by proposing an improvement of the systems known to guarantee their tightness, including in case of perforation on the bias of the stopper which they comprise.

The device of the invention is characterized in that it includes a sealing lip, provided on an inner surface of the bore opposite the piston or on a surface of the piston, this lip being shaped to be sealed against the piston or against an internal surface of the bore in the piston transfer position.

Thanks to the invention, a confinement volume is created around the hollow needle, between the plunger and the surface internal bore, this containment volume allowing retain leaking liquid, possibly outside the container through the opening formed in the cap by the hollow needle.

According to a first advantageous variant of the invention, the base comprises a support wall against a external part of the stopper, the lip being shaped on a face of this wall facing the piston. According to a second advantageous variant, the lip is shaped on a front face of the piston oriented towards the plug. According to one another advantageous variant, the lip is shaped on an internal radial surface of the flange or on an external radial surface of the piston.

In all cases, it can be expected that the lip has, in cross section, an asymmetrical profile inducing a preferred direction of deformation. This aspect of the invention guarantees an adequate positioning of the lip when the piston is in transfer position, this adequate positioning guaranteeing the required seal.

According to another advantageous aspect of the invention, the flange carries, on its internal radial face, a circular rod able to cooperate with a corresponding shoulder of the external radial surface of the piston to lock this piston in the transfer position. The purpose of the piston lock is effect of precisely fixing the position of the piston, and thereby even, crushing or deformation of the sealing lip, which ensures tight contact between the lip and the surface with which it must cooperate. We can predict that the rod has an asymmetrical cross-section, the face of the rod oriented towards the outlet of the bore being less inclined by compared to the internal radial surface of the flange that the face of the rod facing the cap. This provision allows the rod does not interfere or slightly interferes with the sliding movement of the piston towards the plug, from its released position towards its transfer position, when it can oppose effectively to a movement of the piston in opposite direction. The rush is advantageously capable of sealingly separating a volume annular, defined in the bore around the front part of the piston in transfer position, from the ambient atmosphere. The rod then fulfills a sealing function which is added to that of the lip previously mentioned.

The invention also relates to a ready-to-use assembly, comprising a closed container containing a product, this container with a neck, the opening of which is closed by a plug of relatively soft material, and a device for connection as previously described, mounted on the container. Such an assembly allows sterile storage of a component of a drug, such as its active ingredient, and prepare in good time by mixing with a liquid without risk of dangerous or unpleasant leakage.

• la figure 1 est une coupe longitudinale, en vue éclatée, d'un dispositif de connexion conforme à l'invention et d'un récipient sur lequel il est prévu pour être monté ;
• la figure 2 est une coupe longitudinale du dispositif de la figure 1 monté sur le récipient, le tout dans une configuration de stockage ;
• la figure 3 est une coupe longitudinale analogue à la figure 2 alors que le piston du dispositif a été déplacé vers une position de transfert entre le volume intérieur du récipient et l'extérieur ;
• la figure 4 est une vue à plus grande échelle du détail IV à la figure 3 ;
• la figure 4A est une section à plus grande échelle de la lèvre d'étanchéité du dispositif au repos, c'est-à-dire dans la position de la figure 2 ;
• la figure 4B est une vue à plus grande échelle du détail B à la figure 4 ;
• la figure 5 est une vue analogue à la figure 4 pour un dispositif conforme à un second mode de réalisation de l'invention et
• la figure 6 est une vue analogue à la figure 4 pour un dispositif conforme à un troisième mode de réalisation de l'invention.

The invention will be better understood and other advantages thereof will appear more clearly in the light of the following description of three embodiments of a connection device in accordance with its principle, given solely by way of example and made with reference to the accompanying drawings in which:

• Figure 1 is a longitudinal section, in exploded view, of a connection device according to the invention and a container on which it is intended to be mounted;
• Figure 2 is a longitudinal section of the device of Figure 1 mounted on the container, all in a storage configuration;
• Figure 3 is a longitudinal section similar to Figure 2 while the piston of the device has been moved to a transfer position between the interior volume of the container and the exterior;
• Figure 4 is an enlarged view of detail IV in Figure 3;
• Figure 4A is a section on a larger scale of the sealing lip of the device at rest, that is to say in the position of Figure 2;
• Figure 4B is an enlarged view of detail B in Figure 4;
• FIG. 5 is a view similar to FIG. 4 for a device according to a second embodiment of the invention and
• Figure 6 is a view similar to Figure 4 for a device according to a third embodiment of the invention.

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. It allows other part of ensuring or establishing a tight connection between inside container 2 and inside another container 2 ', shown in phantom in Figure 3, this container may be a flexible bag containing a liquid intended for dissolve or suspend the product contained in the container 2, for example the active principle of a medicament.

The container 2 comprises a neck 3, the opening 3 a of which is closed, in a leaktight manner, by a plug 4, made of a relatively soft material, for example of elastomer and in particular rubber. The neck 3 includes an external annular bead 3 b used for mounting and fixing a base 5.

The plug 4 comprises a cylindrical central part 4 a , adapted to a flexible and tight fitting inside the opening 3 a of the neck 3, and a flattened external part 4 b supported on the bead 3 b .

The base 5 is made in one piece from a relatively hard plastic material compared to the material constituting the plug 4. It comprises several attachment teeth 6 provided to be arranged around the bead 3 b of the neck 3, in the manner shown in Figure 2 and in accordance with the technical teaching of WO-A-97/10 156.

The base 5 comprises a wall 8 bearing on the part 4 b of the plug 4, this wall being provided with a central recess 8 a whose function will be explained in the following. The wall 8 also carries two circular ribs 8 b and 8 c oriented towards the plug 4 and designed to penetrate the external part 4 b of the plug 4, so that they create a tight barrier between the wall 8 and the plug 4 The base 5 is extended by a flange 9, oriented opposite the teeth 6 relative to the wall 8 and whose internal radial surface 9 a defines a bore A of substantially circular section.

A piston 10 is provided to slide, inside of bore A, in a direction defined by the axis of symmetry X-X 'of this bore, axis which is also the axis of symmetry of the base 5 around which the teeth 6 are distributed.

The piston 10 includes a section 10 is generally perpendicular to the axis XX 'and a skirt 10 b shaped cylindrical sleeve centered on the axis XX'. A hollow needle 11 carried by the section 10a of the piston 10 is centered on the axis X-X '. The skirt 10b of the piston 10 carries a shoulder 10c while the collar 9 is provided with a peripheral internal projection 9b at the outlet of the bore A. As is more clearly shown in FIG. 2, the piston 10 can be inserted inside bore A, by elastic deformation of the flange 9, in a position such that the shoulder 10 c is in contact with the projection 9 b , the piston 10 then being locked inside of the bore A. In this position, the needle 11 is released relative to the plug 4, that is to say does not perforate this plug.

A cap 12 is provided to be arranged around the assembly formed by the base 5 and the piston 10 and comprises a lower ring 13, capable of locking the teeth 6 of the base 5 around the neck 3, and a breakable part 14 intended to protect the piston 10 in the position of FIG. 2, this part breakable being connected to the ring 13 by a breaking line 15.

When it is necessary to use the product contained in the container 2, it suffices to separate the breakable part 14 from the rest of the cap 12 to access the piston 10 which can then be pushed towards the container 2 to reach the position of transfer shown in FIG. 3 in which the needle 11 has passed through the recess 8 a of the wall 8 and perforated the plug 4.

In order for a user to be able to effectively move the piston 10 in the direction of the plug 4, it is necessary that the radial clearance J between the surface 9 a and the skirt 10 b is not too tight, otherwise the device would risk to hang. It is therefore not excluded that the orifice 20, formed by the needle 11 in the plug 4 and which is of cylindrical shape, has an axis slightly inclined with respect to the axis XX ', which has been shown, exaggeratedly, with the axis YY 'in Figure 4.

According to the invention, the face 8 d of the wall 8 oriented towards the piston 10 carries a lip 22 directed towards the front face 10 d of the section 10 a of the piston 10. The lip 22 is in one piece with the wall 8, it even in one piece with the rest of the base 5 which is made of plastic material harder than the plug 4, but having a flexibility allowing the deformation of the lip 22.

The lip 22 is circular, that is to say extends over a circumference centered on the axis XX ′, so that, when it is in contact with the front face 10 d of the piston 10, it closes a volume V for confinement of a possible leak of liquid through the orifice 20, this volume being shown in gray in FIG. 4.

At rest and as shown in FIG. 4A, the lip 22 has an asymmetrical cross section in the shape of an inclined tooth. The angle of inclination α of its external face 22 a relative to a normal N to the face 8 d is greater than the angle β of its internal face 22 b relative to a normal N 'to the face 8 d . The edge 22 c of the lip 22 projects inwardly relative to the foot 22 d of the internal face 22 b . Thus, the direction of crushing of the lip 22 when the front face 10 d is pressed is turned towards the axis XX 'so that the seal is produced with the external face 22 a of the lip 22 having a tangent generally parallel to the front face 10 d of the piston 10, which guarantees optimum sealing, even when the pressure of the piston 10 on the lip 22 is not very high.

The lip 22 exerts on the piston 10 a reaction force which increases when liquid is present in the volume V, this liquid exerting a pressure on the internal face 22 b of the lip 22, a pressure which tends to bring the lip 22 back into its configuration of FIG. 4A.

A ring 24 is provided on the internal radial surface 9 a of the flange 9, at a height such as relative to the wall 8 that it cooperates with the shoulder 10 c of the skirt 10 b to lock the piston 10 in the position transfer of figures 3 and 4. the rod 24 extends advantageously over the entire circumference of the surface 9 and has, in cross section and as shown in Figure 4B, a face 24 a facing the opening of the bore A and a face 24 b directed towards the bottom of this bore, that is to say towards the plug 4 and the wall 8.

The angle of inclination δ of the surface 24 a relative to the surface 9 a is of the order of 30 °, while the angle of inclination γ of the surface 24 b relative to this same surface is around 60 °. This asymmetrical shape of the ring 24 allows it not to oppose too strongly the driving movement of the piston 10 inside the bore A, because the face 24 a is slightly inclined relative to the axis X- X ', while it effectively locks the shoulder 10 c thanks to the significant inclination of its face 24 b .

The rod locking function 24 guarantees that adequate pressure is exerted by the piston 10 on the lip 22 in order to obtain a satisfactory seal.

As the rod 24 extends over the entire periphery of the surface 9 a, it also contributes to the sealing of the entire device 1 to the extent that the liquid, which successfully outside the volume V because of 'a leak at the level of the lip 22, would remain confined in the volume V' defined between the front face 10 d and the wall 8 outside the lip 22 and by the annular clearance J between the skirt 10 b and the surface 9 a , at the front of the piston 10. The ring 24 therefore has a double locking and sealing function.

In the second embodiment of the invention shown in Figure 5, elements similar to those of the embodiment of Figures 1 to 4 bear identical references increased by 50. The device of this embodiment differs from the previous essentially in that the sealing lip 72 is carried by the front face 60 d of the piston 60 and intended to come into contact with the upper face 58 d of the partition 58 of the base 55. The lip 72 therefore makes it possible to define a volume of containment V of a possible leak of liquid. A ring 74 is also provided on the inner radial surface 59a of the flange 59 to lock the piston 60 in position relative to the base 55 and to form a second sealing barrier of a second closed volume V ' . The piston 60 carries a shoulder 60 c capable of cooperating with the rod 74. The front face 60 d of the piston 60 carries a groove 76 inside which the lip 72 is immobilized, which can be made of a material separate from that of the piston 72 and, in particular, in a more flexible material allowing increased deformation when the piston 60 is pressed against the wall 58 in order to improve the seal.

The lip 72 is immobilized in the groove 76 by all appropriate means and, in particular, by cooperation of forms and / or bonding.

In the third embodiment of the invention shown in Figure 6, elements similar to those of the embodiment of Figures 1 to 4 bear identical references increased by 100. A sealing lip 122 is provided on the radial surface internal 109 a of the flange 109 facing the external radial surface 110 e of the skirt 110 b of the piston 110 to delimit a confinement volume V. As previously, a ring 124 is provided on the surface 109 a for immobilizing d a shoulder 110 c of the piston 110 relative to the base 105 in the transfer position. It also acts as a sealing barrier for a second closed volume V '.

According to a variant not shown of the invention and taking a mirror solution relative to that of the embodiment of Figure 6, the sealing lip could be carried by the outer surface 110 e of the skirt 110. Similarly way, the skirts 22 and 122 could be constituted by elements attached to the base, according to a technique analogous to that evoked with reference to the embodiment of FIG. 5. Of course, the lip carried by the piston in the mode of embodiment of Figure 5 could also be in one piece with this piston.

We note that the lips 72 and 122 have an asymmetrical profile, just like lip 22, which gives them direction of privileged deformation.

It is possible to provide that the rod 24, 74 or 124 is formed of discrete angular sectors, i.e. not joined, in which case it effectively performs its function of locking but does not participate in sealing the volume V '.

Whatever the embodiment considered, the immobilization piston 10, 60 or 110 thanks to rod 24, 74 or 124 guarantees constant positioning of needle 11 or equivalent, relative to container 2, so that the dead volume of container 2, i.e. the quantity of product contained in the container which cannot be recovered from made of the distance between the end of the needle 11 and the container neck, is constant from one device to another. The quantity of product introduced into container 2 or equivalent before being closed by the corresponding cap can therefore be determined with precision, taking into account what constant dead volume.

It should be noted that the invention is applicable independently of the method of fixing the base 5 to the container 2 and, so general, that it can be used in any device connection comprising a piston, movable inside a bore of a base mounted on a container.

Claims (10)

1. Device for connection between a closed recipient (2) and a container (2'), said recipient comprising a neck (3) whose opening (3a) is obturated by a stopper (4), said connection device comprising a base (5), mounted on said recipient (2) and extending in a flange (9) forming an inner bore (A), a plunger (10) adapted to slide in said inner bore, between a position disengaged with respect to said stopper and a transfer position in which a hollow needle (11) borne by said plunger traverses said stopper (4), characterized in that it comprises a sealing lip (22; 72; 122) provided on an internal surface (8d; 109a) of said bore (A) opposite said plunger (10; 110) or on a surface (60d) of said plunger (60), said lip being shaped to be in tight abutment against said plunger (10; 110) or against an internal surface (58d) of said bore, in said transfer position of said plunger.
2. Device according to Claim 1, characterized in that said base (5) comprises a wall (8) for abutment against an outer part (4b) of said stopper (4), said lip (22) being shaped on a face (8d) of said wall (8) oriented towards said plunger (10).
3. Device according to Claim 1, characterized in that said lip (72) is shaped on a face (60d), called front face, of said plunger (60) oriented towards said stopper (4).
4. Device according to Claim 1, characterized in that said lip (122) is shaped on an inner radial surface (109a) of said flange (109) or on an outer radial surface (110e) of said plunger (110).
5. Device according to one of the preceding Claims, characterized in that said lip (22; 72; 122) presents, in cross-section, an asymmetrical profile (α, β) inducing a privileged direction of deformation.
6. Device according to one of the preceding Claims, characterized in that said flange (9; 59; 109) bears, on an inner radial face (9a; 59a; 109a), a circular ring (24; 74; 124) adapted to cooperate with a corresponding shoulder (10c: 60c; 110c) of the outer radial surface of said plunger (10; 60; 110) in order to lock said plunger in said transfer position.
7. Device according to Claim 6, characterized in that said ring (24; 74; 124) is disposed so that it locks said plunger (10; 60; 110) in a position of tight bearing of said lip (22; 72; 122) against said plunger (10; 110) or against an inner surface (58d) of said bore (A).
8. Device according to one of Claims 6 or 7, characterized in that said ring (24; 74, 124) presents an asymmetrical cross-section, the face (24a) of said ring oriented towards the opening (9b) of said bore (A) being less inclined (δ, γ) with respect to the inner radial surface (9a) of said flange (9) than the face (24b) of said ring oriented towards said stopper.
9. Device according to one of Claims 6 to 8, characterized in that said ring (24; 74; 124) is adapted to separate an annular volume (V'), defined in said bore (A) around the front part of said plunger (10; 60, 110) in transfer position, hermetically with respect to the ambient atmosphere.
10. Ready-for-use assembly, comprising a closed recipient (2) containing a product, said recipient comprising a neck (3) whose opening (3a) is obturated by a stopper (4) and a connection device (5-24; 60-76; 109-124) according to any one of Claims 1 to 9, mounted on said recipient.

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