WO2001032524A1

WO2001032524A1 - Ready-to-use connecting device

Info

Publication number: WO2001032524A1
Application number: PCT/FR2000/003057
Authority: WO
Inventors: Antoine Aneas
Original assignee: Biodome
Priority date: 1999-11-05
Filing date: 2000-11-02
Publication date: 2001-05-10
Also published as: ATE245581T1; KR100726297B1; AU761176B2; HUP0203945A3; CN1214955C; ZA200202627B; PT1226077E; HUP0203945A2; CN1379724A; BR0015268A; PL357270A1; DE60004082D1; CA2386830A1; JP2003523227A; AU1286301A; DE60004082T2; EP1226077A1; MXPA02004526A; DK1226077T3; RU2230693C2

Abstract

The invention concerns a device comprising a cap (10) to be mounted on a container (2) and comprising a sleeve (18) forming an internal bore (A) and a piston (19) capable of sliding inside said bore (A), between a first released position relative to the stopper (5) and a second position, called transfer position, wherein a hollow needle (19) borne by or forming the piston passes through the stopper (5). The piston (19) and the cap (10) are formed in one single piece and connected by at least an elastic tab (26) capable of being deformed, essentially along a direction parallel to a central axis (X-X') of the bore (A) to accompany the movement of the piston between said first and second positions.

Description

READY TO USE CONNECTION DEVICE

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. 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 made of relatively soft material, for example 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 . By documents WO-A-97/10156, WO-A-98/37 854 and US-A-

5,925,029, connection devices are known, each comprising a base adapted to cover the neck of a container

• and extending by a flange or sleeve forming an internal bore, while a piston is slidably mounted in this bore. The piston is designed to be pushed towards a transfer position in which a hollow needle carried by this piston passes through the stopper of the container. These devices must incorporate means for holding the piston in position in each of its two positions, that is to say in its position away from the plug and in the transfer position. In addition, other means must be provided to guide the piston in translation, avoiding as much as possible rotation of the latter since such rotation is detrimental to effective piercing of the plug. In particular, rotation of the needle during drilling could lead to the formation of chips in the plug. These guide means imply a certain complexity of the parts

• constituting known devices, which increases all the more their cost, whereas different pieces manufactured individually must be designed and managed in a unitary way.

It is to these drawbacks that the invention more particularly intends to remedy by proposing a connection device in which the piston is effectively guided in its translational movement between the above positions while the cost price of the entire device can be significantly reduced compared to that of known devices.

In this spirit, the invention relates to a connection device between a closed container and a container, this container comprising a neck, the opening of which is closed by a sleeve while the connection device comprises a base, capable of being mounted on the container and comprising a sleeve forming an internal bore, and a piston capable of sliding in this bore, between a -draft position released relative to this plug and a second position, called transfer, in which a hollow needle carried by or constituting the piston passes through this plug. This device is characterized in that the piston and the base are formed in one piece and connected by at least one elastic tongue able to deform, essentially in a direction parallel to a central axis of the bore, to accompany the movement of the piston between the above positions.

Thanks to the invention, the base and the piston can be molded in a single operation, which makes it possible to optimize the manufacturing range of the device of the invention and to reduce the cost thereof. The elastic tab (s) determine the intensity of the effort that a user must apply to move the piston and the needle between the first and the second position, this effort being able to be relatively unimportant, which facilitates its use by the personnel. medical. In particular, the piston is much easier to move than in the case where it is connected to the base by one or more breakable tabs, the rupture of which could require significant effort. The tab (s) of the device of the invention, which essentially deform according to the direction of translation of the piston, do not deform in a dimension which would allow rotation of the piston. This is why these tongues also constitute means for guiding in translation, without rotation, the piston between these two positions.

According to advantageous but not compulsory aspects of the invention, the device incorporates one or more of the following characteristics:

It comprises several elastic tongues distributed around the central axis of the bore, which makes it possible to distribute the guidance obtained thanks to the tongues.

- The tab (s) have a width, measured in a direction generally parallel to a radial surface of the bore, substantially greater than their thickness, measured in a direction generally perpendicular to this surface. This geometry of the tongues makes it possible to give them good torsional rigidity, so that they effectively oppose a rotation of the piston around the central axis of the bore. We can in particular provide that their width is greater than five times their thickness. The tab (s) thus have rigidity. in sufficient torsion to guide the piston in translation, without significant rotation, in the bore.

- In the transfer position, the tab or tabs form two bearing zones against an internal radial surface of the bore and against an external radial surface of the piston.

- The base carries elastic snap-fastening means on the neck of the container, a hooping ring of these means in the snapped-in position on this neck being provided around these means, this ring being formed in one piece with a cap of protection of the base, while a continuous breakable zone connects this ring and this cap. This breakable zone is advantageously formed by a liquid and gas tight membrane, so that it effectively protects the base against microbial pollution during the storage of a container equipped with a device in accordance with

-l'invention. By the expression "liquid and gas tight" is meant that the membrane is tight at the pressures that usually supports such a device, especially during storage.

The base includes support means on the external surface of the plug around the hollow needle, the diameter of these means being slightly greater than the diameter of this needle. These means thus make it possible to avoid bulging of the plug during its drilling and to guide, if necessary, the needle during drilling. One can, in particular, provide that these means consist of a sleeve forming the part of the bore closest to the plug, the edge of this sleeve intended to be pressed against the plug having a profile allowing a surface penetration of this edge in the outer surface of the cap. A confined volume, of relatively small diameter, is thus created around the piston and inside the bore, this volume limiting the quantity of product liable to be lost due to a leak between the needle or the needle. and the plug in particular ^" in the case where the needle is not pressed into the plug in a direction strictly parallel to the central axis of the bore.

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 the container. Such an assembly makes it possible to sterilize a component of a drug or a vaccine, in particular its active principle, and to prepare it in good time by mixing with a liquid, while its piston is effectively held in position and guided during a trip.

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 and a syringe provided to cooperate with this assembly;

- Figure 2 is an axial section of the device mounted on the assembly of Figure 1, in storage configuration, - Figure 3 is a perspective view with partial cutaway of the part forming a base of the device of Figure and

- Figure 4 is a section similar to Figure 2 while the device is in the transfer configuration.

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 can be a powder intended to form an oral vaccine. It can be any other type of pharmaceutical preparation, in particular any type of drug.

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 in suspension the product contained in the container 2. In place of a syringe, the container 3 could be formed by a flexible pouch, another glass vial or any other container.

The bottle 2 has a neck 4, the opening 4a of which is sealed off by a plug 5 made of a relatively soft material, for example an elastomer, in particular 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, this capsule being provided with a central opening through which it is possible to perforate the plug. 5. The plug 5 has a substantially cylindrical central part 5a, suitable for a flexible and tight fitting inside the opening 4a, and a flattened part 5b, supported on the part 4b and possibly covered by the capsule.

The device 1 is essentially formed of two parts produced by injecting plastic material, for example polyethylene and / or polypropylene, namely a base element or base 10, intended to be mounted around elements 4 and 5, and an external envelope 40. The base 10 comprises a cylindrical part 11 intended to be centered on the axis XX 'of symmetry of the elements 2, 4 and 5. This part 11 comprises a lower north 11a having in cross section a pointed profile intended to penetrate superficially in the upper or exposed surface 5c of the plug 5. The part 11 is extended by several elastic tabs 12 each equipped with a spout 13 capable of cooperating with the external surface of the neck 4 for the purpose of an elastic snap-fastening of the base 10 on the neck.

At the junction between the tabs 12 and the portion 11, the base 10 is provided with teeth 14 forming a rotational locking device of the base 10 relative to the plug 5 with lecuel teeth 14 are ⁿ πsβ.

Opposite the teeth 14 relative to the zone 15 of junction between the lugs 12 and the part 11, the base 10 carries a second series of teeth 16.

Opposite the edge 11a, the part 11 is extended by an annular strip 17 of junction with a sleeve 18 which forms an internal bore A for storage and displacement of a piston 19 constituted by a hollow needle. The internal radial surface 20 of the sleeve 18 is generally cylindrical and centered on the axis XX 'which is thus the central axis of the bore A, while its external surface 21 is slightly frustoconical and that it carries two doubly chamfered ears - born 22 and 22 'allowing it to cooperate with a system for fixing the syringe 3 of the "LUER-LOCK" type by means of a nut 6 for mounting the syringe 3 on the base 10. The connection between the syringe 3 and the nut 6 can be obtained by clipping or by the fact that the nut 6 is an integral part of the syringe 3. The hollow needle 19 forms a central channel 23 and three openings 24, two of which appear in FIGS. 2 and 4, near its tapered tip 25.

As can be seen more particularly from FIG. 3, the sleeve 18 and the needle 19 are connected by three elastic tongues 26, so that the elements 11 to 26 form a single piece constituting the base 10.

The tongues 26 have a width 1, measured parallel to the surface 20 or to the external radial surface 27 of the needle 19, much greater than their thickness e which is measured perpendicular to the surfaces 20 and 27. Thus, the tongues 26 can deform in a direction parallel to the axis XX 'but have relatively high rigidity in rotation about the axis XX'. In practice, the width 1 _. is at least five times the thickness e.

The edge 18a of the sleeve 18 which is opposite the flange 2 has, like the edge 11a, a pointed profile allowing it to penetrate superficially in the surface 5c of the plug 5, a hollow volume 28 being defined between the part of the sleeve 18 la ^*, read close to the plug 5 and the cylindrical ^{n **} ιrti6 11.

The envelope 40 is also monobloc and comprises a ring 41 serving as a hoop for the legs 12 when the spouts 13 are in place under the part 4b of the neck 4. The ring 41 is bordered by an internal collar 41a for locking under the spouts 13 This ring 41 is extended by a second ring 42 of slightly smaller diameter and which more specifically surrounds the part 11 of the base 10. At the area 43 of junction between the rings 41 and 42 and on its internal surface. , the envelope 40 is provided with teeth 44 intended to cooperate with the teeth 16 of the base 10 in order to allow immobilization in rotation of the envelope 40 relative to the base 10.

On its internal radial surface, the ring 42 carries three ribs 45, centered on the axis XX 'and perpendicular thereto, intended to create a sealed assembly, without interposition of seal, between the base 10 and the casing 40 The assembly between the base 10 and the casing 40 is tight as long as the ring 42 carries at least one rib of the type of ribs 45. The exact number of ribs, which may be less than or greater than three, depends on design choice. A cap 46 is an integral part of the envelope 40 and is connected to an upper edge of the ring 42 by a continuous breakable zone 47 of small thickness. The area 47 can have a thickness of between 0.5 and 1 tenth of a millimeter. A device 1 is mounted on a container 2 in the configuration of FIGS. 2 and 3 for a relatively long period, during the storage of the product contained in the container 2. When it is appropriate to connect the syringe 3 to the container 2, the cap 46 is removed by exerting on it a rotational movement R which has the effect of tearing the zone 47 since the elements 10 to 45 are immobilized in rotation around the neck 4.

It is then possible to introduce the end 3a of the syringe 3 inside the clamp 18 using the nut 6 to force the progression of the end 3a in the sleeve 18. It is also possible to push the serm ue 3 towards the container 2 in particular when the syringe is not fitted with a nut of the type of the nut 6, in order to transmit a translational movement to the needle 19. It is thus created an effort of thrust on the needle 19, represented by the arrow F in FIG. 4, so that the needle pierces the stopper 5, which allows the interior volume of the container 2 to be placed in communication with a channel 3b at the end 3a, through the channel 23 and the openings 24.

In this configuration, the tongues 26 have been deformed relative to their configuration in FIGS. 2 and 3.

In the configuration of FIGS. 2 and 3, each tongue 26 has one end 29 secured to the piston 19 distant from a distance d relative to the surface 5ç_ while its end 30 secured to the surface 20 is distant from a distance d ' relative to the same surface 5ç. The distance d is greater than the distance d 'in the configuration of FIGS. 2 and 3. On the contrary, in the configuration of FIG. 4, the distance d is less than the distance d' which remains constant. In other words, the end 29 of each tongue 26 is approached to the plug 5 during the translation of the needle or piston 19 corresponding to the perforation of the plug 5.

In the configuration of FIG. 4, the tongues 26 form two bearing zones 31 and 32, respectively against the surfaces 27 and 20, so that the progression of the needle 19 towards the interior volume of the container 2 is blocked in this configuration. Thus, the tongues 26 can constitute a stop for the displacement of the needle 19 during the perforation of the plug 5. During the perforation of the plug 5, the edge 18a of the sleeve 18 is permanently in firm support against the plug 5, which avoids any bulging effect of the plug due to a creep of its constituent material. In addition, the surface penetration of the edge 18a into the surface 5c_ guarantees a seal between the volume 50, defined inside the sleeve 18 around the needle 19 and between the plug 5 and the hole 3a of the syringe 3, and the volume 28. The dead volume 50 constitutes the volume in which part of the liquid from the container 2 could flow due to a leak between the needle 19 and the stopper 5. Thus, the maximum loss of active liquid is confined to this volume 50 which can be relatively small due to the small difference in diameter between the surfaces 20 and 27 The elasticity of the tabs 26 can be chosen, so that their configuration shown at FIG. 4 is a stable configuration in the sense that the needle 19 does not tend to rise towards the outlet of the sleeve 18 fitted with the flange 22, including after removal of the end 3a.

Claims

1. Connection device (1) between a closed container (2) and a container (3), said closed container comprising a neck (4) whose opening (4a) is closed by a plug (5), said device connection including:

a base (10) capable of being mounted on said container and comprising a sleeve (18) forming an internal bore (A) and a piston (19) capable of sliding in said bore, between a first position released with respect to said plug and a second position, said transfer, in which a hollow needle borne by or constituting the piston passes through said stopper, characterized in that said piston (19) and said base (10) are formed in one ^{r *} 'and connected IECE by at least one elastic tongue (26) able to deform, essentially in a direction parallel to a central axis (XX ') of said bore (A), to accompany the movement of said piston between said first and second positions.

2. Device according to claim 1, characterized in that it comprises several elastic tongues (26) distributed around said central axis (X-X ').

3. Device according to one of the preceding claims, characterized in that said one or more tongues (26) have a width (1), measured in a direction generally parallel to a radial surface (20, 27) of said bore (A), substantially greater than their thickness (e), measured in a direction generally perpendicular to said surface.

4. Device according to claim 3, characterized in that said width (1) is greater than five times said thickness (e).

5. Device according to one of the preceding claims, characterized in that, in the transfer position, said one or more tongues (26) form two zones (31, 32) bearing against an internal radial surface (20) of said bore ( A) and against an external radial surface (27) of said piston (19).

6. Device according to one of the preceding claims, characterized in that said base (10) carries means (12, 13) of elastic snap-fastening on said neck (4), a ring (42) for hooping said means in position snapped onto said neck being provided around said means, said ring being formed in one piece with a cap (46) for protecting said base, a continuous breakable zone (47) connecting said ring and said cap.

7. Device according to claim 6, characterized in that said breakable zone (47) is formed by a membrane impermeable to liquids and gases.

8. Device according to one of the preceding claims, characterized in that said base (10) comprises means (18a) for bearing on the external surface (5c) of said plug (5) around said hollow needle (19), the diameter of said means being slightly greater than the diameter of said needle.

9. Device according to claim 8, characterized in that said support means are constituted by the part of said sleeve (18) closest to said plug (5), the edge (18a) of said sleeve intended to be pressed against said plug having a profile allowing superficial penetration of said edge into said surface (5ç_) of said plug.

10. 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 (4a) of which is closed by a plug (5) and a connection device (1), according to one of the preceding claims, mounted on said container.