WO2007068825A1

WO2007068825A1 - Connecting device securely operating between two containers

Info

Publication number: WO2007068825A1
Application number: PCT/FR2006/002717
Authority: WO
Inventors: Antoine Aneas
Original assignee: Biocorp Recherche Et Developpement
Priority date: 2005-12-14
Filing date: 2006-12-13
Publication date: 2007-06-21
Also published as: FR2894464B1; FR2894464A1

Abstract

The invention concerns a device designed for connecting a first container (2) provided with a neck (3) closed with a perforable cap to a second container comprising a socket wherein moves a plunger equipped with a member (34) for perforating the cap. Said plunger is designed to be coupled to the second container. The plunger is capped, prior to first use, by a protective cap. Said plunger is provided with a first thread (28) designed to be coupled to the second container (40) and a second thread (32) designed to co-operate with raised parts 12) corresponding to a portion (9) of the socket by causing the plunger to move in said portion (9) of the socket towards the first container (2). Such a device is particularly suitable for connecting two containers holding constituents for medical use.

Description

CONNECTION DEVICE WITH SECURE OPERATION BETWEEN

TWO CONTAINERS

The invention relates to a device for connecting a first container provided with a neck closed by a pierceable stopper and a second container.

This type of device makes it possible to connect a first container containing a product, in pulverulent, freeze-dried or liquid form, for example for medical use, with a second container in order to suspend or dilute the contents of the first container before using the product. This separation of the product and the solvent makes it possible to facilitate their sterilization and / or to improve their preservation. When placing the two containers in communication, the sealing of the connection device and the sterility of the connection zone must be preserved.

This type of device generally comprises a base ensuring the attachment of the device to the first container and, surmounting this base, a sleeve in which moves a hollow piston. This piston is connected, in the configuration of use, to the second container. The piston is also equipped with a piercing member of the cap of the first container, in order to put in communication the contents of the containers. The device is provided, before the first use, with a protective cap.

Generally, the second container is a pre-filled syringe whose tip, said type "luer-lok" allows to connect to the first container. This tip is provided with an internal thread engaging with an open end of the piston. There is also a type of pre-filled syringe, called "Safety" which are each inserted into a protective sheath. These syringes only allow access to the tip itself by a hole of the protective sheath. The implementation of such safety syringes requires suitable connection devices. In general, the operation of such a connection device must be performed following a precise sequence. First of all, it is necessary to rotate the cap to disengage the open end of the piston, then screw the tip of the second container onto the piston and finally move the piston in translation until the perforation of the cap. This perforation of the plug is more or less easy depending on the thickness and nature of the plug. In particular, it is difficult with stoppers coated with a polytetrafluoroethylene (PTFE) film. It is therefore common for the user to perform incomplete drilling of the plug. In addition, if the attachment of the tip of the second container on the piston is not complete, there is a risk of sealing failure of the connection. WO-A-98/32411 discloses a cap whose inner face is equipped with a thread in which a piston moves in translation, provided with a tip, when the cap is rotated. This piston is equipped with a clean thread to cooperate with the tapping. When the piston has pierced the cap, further rotation of the cap allows to separate the cap of the device. It is then necessary to connect a syringe with the end of the piston. This device is not satisfactory in terms of sterility because the cap is pierced before the first container is connected to the second. In addition, it does not allow connection with a safety syringe. It is these disadvantages that the invention intends to remedy more particularly by proposing a device for connecting a container with any type of syringe, in which an easy movement allows the removal of the cap and the piercing of the cap, while guaranteeing the tightness and sterility of the device.

For this purpose, the subject of the invention is a device intended for the connection between a first container provided with a neck closed by a pierceable stopper and a second receptacle, the device comprising a sleeve in which a piston equipped with a piercing member of the cap, the piston being provided with a first thread adapted to be connected to a second container, this piston being capped, before a first use, by a protective cap, characterized in that the piston is provided with a second thread adapted to cooperate with corresponding reliefs of a portion of the sleeve by inducing a displacement of the piston in this sleeve portion towards the first container.

Thus, by the implementation of a type of movement participating in the connection of the first and second container, in this case an essentially helical movement, it avoids any risk of error in the order of handling, it ensures a perforation easy cap, it facilitates the removal of the cap and allows a dimensioning and geometry of the piston for connection to any type of syringe.

According to advantageous but non-mandatory aspects of the invention, such a device may incorporate one or more of the following features: - The first thread is formed by a helical relief extending outwardly from the outer face of one end of the piston.

- The second thread is formed by a helical relief extending outwardly from the outer face of the piston body. - The first relief is adapted to cooperate with a tapped hole in a mouthpiece of the second container.

- The second relief is adapted to cooperate with two reliefs of complementary shape, formed on the inner wall of said sleeve portion.

- The outer face of a portion of the sleeve is equipped with a relief adapted to fit into a housing formed in the inner wall of the cap.

- The perforating member of the piston is a double-cone tip equipped with at least one window and adapted to perform a helical movement perforation of the plug.

- The device comprises a tamper-proof ring connected to the cap by breakable pins during a first use.

The invention also relates to a container equipped with a connection device according to one of the preceding features.

The invention will be better understood and other advantages thereof will appear more clearly on reading the following description of an embodiment of a device according to the invention, given solely by way of example. and with reference to the accompanying drawings in which:

- Figure 1 is a perspective view of certain parts of a device according to the invention, before mounting and placing on the neck of a first container, the cap not being shown, - Figure 2 is a side view, on a reduced scale, of the device of Figure 1 once assembled, the cap being in position, before installation of the device on the neck of the first container,

FIG. 3 is a section along the line III-III in FIG. 2; FIG. 4 is a side view of a first container equipped with the device of FIG. 2, before a first use,

FIG. 5 is a section along the line V-V, the cap not being shown,

FIG. 6 is a view of a first container equipped with the device of FIG. 4, the piston being connected to the tip of a second container, partially shown, the plug of the first container being perforated and

- Figure 7 is a section along the line VII-VII in Figure 6.

The parts represented in FIG. 1 comprise a base 1 adapted to ensure a durable and leakproof fixation of the device on a first container, generally a bottle 2 as illustrated in FIGS. 4 to 7. This base 1 comes into engagement with a on the underside of a flange 3A of the neck 3 of the bottle 2 and, on the other hand, on the upper face of a plug 4 closing this neck 3. This fastening of the base is effected by a skirt 5 discontinuous. This skirt 5 is surmounted by a tubular portion 6 with a circular section, part of which is adapted to come in the vicinity of the upper face of the plug when the base 1 is in place on the neck 3.

When the device is in place on the container 2, as shown in Figures 4 to 7, the base 1 is capped by the main body 70 of a sleeve 7. This sleeve 7 is generally cylindrical. When the device is in the pre-assembly position as illustrated in FIGS. 2 and 3, one end of the main body 70 is received in an annular groove 8 of the base 1 formed by the junction zone between the tubular part 6 and the skirt 5. The sleeve 7 comprises an intermediate portion formed by a member 9, of tubular shape and circular section, visible in particular in Figures 3, 5 and 7. This member 9 has a smaller external diameter than the internal diameter of the body 70 of the sleeve 7. It is disposed coaxially in the body 70 and centered on the central axis X ₇ o of the body 70. It is in the central bore of this member that a piston 10 moves. The member 9 is equipped with lower part when the device is in place on the bottle 2, means 11 for hooking on the base 1.

The upper end 90 of the member 9 is open and equipped with two reliefs 12. These reliefs 12 are arranged symmetrically on the inner wall, in a curvilinear direction corresponding to an angular sector of the internal circumference of at least 50 °. One of these reliefs 12 is in particular visible in FIG.

An outer ring or ring 13 is disposed coaxially at this end 90 of the member 9. This ring 13 is held in position by pressing on a radial shoulder 14 extending from the wall of the member 9 towards the external wall of the sleeve 7. Thus, thanks to the difference in diameters between the ring 13 and the member 9, an annular space forming a reception housing for a part of the cap 15 is housed. This housing receives an open end 16 of the shape cap complementary and capping the device before a first use. In this case, the open end 16 of the cap also comprises a coaxial ring 17 defining, with a wall 18 of the cap, an annular housing. In other words, the open end 16 of the cap 15 is formed of two circular walls 17, 18 concentric similar to the end of the assembly formed of the sleeve 7 and the member 9.

When the cap 15 is in place, the ends of the cap 15, the member 9 and the ring 13 interpenetrate, the annular space of one forming a receiving housing of an end wall of the 'other. The dimensions of the various elements allow mutual engagement of the U-shaped parts so as to ensure the tightness of the connection.

A tamper-evident ring 19 equips the open end 16 of the cap 15 before a first use. As shown in Figure 3, the inner face of this ring 19 is provided with a radial shoulder 20 extending inwardly. This shoulder bears, before a first use of the device, on the underside of the shoulder 14 supporting the outer ring 13. This tamper-evident ring 19 is held in position by pins 190 breakable during the first use.

The outer wall of the ring 13 of the sleeve 7 is equipped with two curvilinear projections 21 each extending over an angular sector of the circumference of the ring by at least 50 °, as shown in FIG.

These reliefs 21 are adapted to be housed in a helical groove 22 formed in the inner face of the ring 17 of the end 16 of the cap, that is to say in the wall of greater diameter of the end 16. The body 23 of the cap 15 has recessed areas 24 facilitating the grip by the user. The closed upper end 25 of the cap 15 is equipped on its inner face with a central boss 26 which closes the open end 27 of the piston 10 when the latter is in the non-use position, typically before a first use.

In the upper part of the piston, in the vicinity of its open end 27, the outer face of the piston 10 is equipped with a first helical relief 28 extending outwards. This relief forms a first thread 28 adapted to cooperate with a tapping 29 formed in a so-called luer-lok tip 30 belonging to a syringe 40 containing a solvent of a product contained in the bottle.

The leader of the first thread 28 is located on the end 27 of the piston 10 and the first thread extends for a length sufficient to allow the connection of any type of tip provided with a tapping of the tapping type 29.

The piston 10 is hollow and comprises a tubular body 31 with a substantially conical bore.

This tubular body 31 is also provided on its outer face 310 with a helical relief 32 extending outwards. This relief forms a second thread 32 over most of the length of the piston 10, with the exception of its open end 27 where the thread 28 is present.

The beginning of this second thread 32 is located near the lower end 33 of the piston 10 when the device is in place on a container 2 before a first use. In other words, the primer is at the level of the fixing region of the perforating member 34 on the piston 10. This primer is, before a first use, bearing against the reliefs 12 formed on the inner wall of the member 9. These reliefs 12 block the piston 10, preventing it from coming out completely through the upper part 90 of the member 9. Only a displacement of the piston 10 in a helical path towards the plug 4 is authorized. In this case, the piston 10 is held in position so that, before a first use, only the end 33 of the piston 10 comprising the perforating member 34 is inserted into the member 9.

The pitch of the second thread 32 is different from the pitch of the first thread 28. According to a variant not shown, the pitch of the threads are identical.

The piercing member is a hollow point 34 terminated by a double cone. In the vicinity of its end, this point 34 is equipped with at least one window 35, preferably three windows. These windows 35 provide communication between the inner channel of the tip 34, so between the inside of the piston 10, and the outside.

When the device is in position on a container as illustrated in Figures 4 and 5, the cap 15 is in place on the piston 10, the tamper ring 19 is retained by its pins 190 to the cap 15. In this configuration, the The body 31 of the piston 10 is globally housed entirely in the cap 15. Its sterility, in particular that of its bore, is preserved because its open end 27 is closed by the boss 26 of the cap 15. The latter is positioned in a sealed manner on the sleeve 7. The perforating member 34 is in contact with the upper face of the plug 4. In a first use, the cap 15 is rotated to remove it from the device 1 in an intuitive unscrewing motion. This movement, essentially helical and upward, of the cap 15 is facilitated and guided by the helical reliefs 21 formed on the outer face of the ring 13. During this movement, there is a break of the pins 190 and fall, by gravity of the tamper evident ring 19. This ring 19 rests on a shoulder 36 connecting the member 9 to the sleeve 7. Sufficient space is provided between the shoulders 14 and 36 involved in maintaining the ring 19 between its positions attached and free. This important clearance makes it possible to easily visualize the first opening of the cap 15. This visualization is facilitated, for example, by the appearance of a color marking at the wall of the member 9 disengaged by the fall of the ring. . This marking is masked when the tamper ring 19 is in position.

Once the cap 15 has been removed, the body 31 of the piston 10 protrudes sufficiently from the ring 13, taking into account the total length of the piston 10, so that its open end 27 fits without difficulty into the nozzle 30.

In variant not shown, this end 27 can be screwed into the orifice of the safety cone of a syringe, the environment of the body 31 of the piston being cleared of any element hindering the establishment. A screwing movement of the tip 30 on the first thread 28 makes it possible to connect, in a safe and sealed manner, the syringe 40, which forms a second container, to the piston 10. The rotational movement is continued, in this case in the same direction, until the first thread 32 is fully engaged in the tapping 29 of the nozzle 30 and locked in position. The continued screwing of the tip 30, always in the same direction, generates a helical movement of descent of the piston 10 in the bore of the member 9 towards the first container. This movement is induced by the second thread 32 which is guided by the reliefs 12. This descent of the piston 10 is accompanied by the perforation of the plug 4. This perforation is facilitated by a translational movement and rotation of the tip 34, the like to the movement of the piston 10. This produces a helical effect or screwing of the tip 34 in the plug. When the latter is coated with a polytetrafluoroethylene (PTFE) film, the helical movement of the tip 34 makes it easy to pierce and tear the film, which avoids pushing back the film by forming a pocket in the outer face of the plug.

When the piston 10 is fully lowered in the member 9, that is to say when the perforating member 34 has pierced the plug 4 and the end 33 of the body 31 of the piston equipped with the tip 34 is in support on the plug 4, the movement of the piston 10 is blocked. The support of the end 33 of the piston 10 on the plug seals around the perforated zone by the tip 34.

In this way, it facilitates and is carried out without risk of error the connection between the two containers 2 and 40. A single movement, in this case screwing successively ensures the connection of the second container and the perforation of the cap. The latter intervenes last, after the connection of the second container, the sterility of the contents of the first container is preserved. In addition, there is more risk of error in the movement since a movement in the wrong direction would not screw the tip on the piston. The user would then quickly perceive his mistake and the good movement. This error would, in any case, resulted in no detrimental displacement of the piston, the plug not being perforated.

In addition, the second thread 32 prohibits any displacement in translation by direct support on the piston 10 and necessarily induces a screwing movement which facilitates the perforation of the plug. The main part of the body 31 of the piston protruding from the sleeve 7, before a first use of the device, makes it easy to connect any type of tip, whatever its shape and / or its dimensions.

Claims

1. Device for the connection between a first container (2) provided with a neck (3) closed by a pierceable stopper (4) and a second container (40), said device comprising a sleeve (7) in which moves a piston (10) equipped with a perforating member (34) of said plug (4), said piston (10) being provided with a first thread (28) adapted to be connected to said second container, said piston (10) being capped , before a first use, by a cap (15) of protection, characterized in that said piston (10) is provided with a second thread (32) adapted to cooperate with corresponding reliefs (12) of a part (9) ) of said bushing (7) by inducing movement of said piston (10) in said bushing portion (9) towards the first container (2).

2. Device according to claim 1, characterized in that said first thread is formed by a helical relief (28) extending outwardly from the outer face of an end (27) of said piston (10).

3. Device according to claim 1, characterized in that said second thread (32) is formed by a helical relief (32) extending outwardly from the outer face (310) of the body (31) of the piston (10).

4. Device according to claim 2, characterized in that said first relief (28) is adapted to cooperate with a thread (29) formed in a tip (30) of said second container (40).

5. Device according to claim 3, characterized in that said second relief (32) is adapted to cooperate with two reliefs (12) of complementary shape, formed on the inner wall of said portion (9) of sleeve (7).

6. Device according to one of the preceding claims, characterized in that the outer face of a portion (13) of the sleeve (7) is equipped with a relief (21) adapted to be inserted into a housing (22). ) formed in the inner wall of the cap (15).

7. Device according to one of the preceding claims, characterized in that said perforator member (34) of the piston (10) is a tip (34) with double cone equipped with at least one window (35) and adapted to achieve a helical movement of perforation of the plug (4).

8. Device according to one of the preceding claims, characterized in that it comprises a tamper-evident ring (19), connected to said cap (10) by pins (190) breakable during a first use.

Container (2) equipped with a connecting device (1) according to one of the preceding claims.