MXPA02004526A

MXPA02004526A - Ready to use connecting device.

Info

Publication number: MXPA02004526A
Application number: MXPA02004526A
Authority: MX
Inventors: Aneas Antoine
Original assignee: Biodome
Priority date: 1999-11-05
Filing date: 2000-11-02
Publication date: 2002-09-02
Also published as: JP4582983B2; CA2386830A1; CN1379724A; JP2010207610A; PL357270A1; HUP0203945A2; ZA200202627B; HK1048293A1; AR026357A1; AU761176B2; ES2202187T3; PT1226077E; RU2230693C2; RU2002114693A; KR100726297B1; DE60004082T2; ATE245581T1; HUP0203945A3; JP2003523227A; CN1214955C

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

CONNECTION DEVICE READY FOR EMPLOYMENT The invention relates to a connection device between a closed container and a content. The invention also concerns a ready-to-use assembly comprising, among others, a closed container and a connection device of the aforementioned type. In the field of drug conditioning, it is known to store a component of a pharmaceutical preparation, such as for example its active ingredient, in a closed container with a lid of relatively flexible material, for example elastomer. A liquid can be introduced into this container after perforation of the cap to dissolve or suspend the component contained in the container, this in order to obtain a preparation, particularly a medicament or a vaccine, in liquid form and ready to be administered to the patient. From WO-A-97/10 156, 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 which extends by a ring or bushing that forms an internal diameter, while a piston is mounted sliding on this internal diameter. The piston is provided to be pushed into a transfer position in which a hollow needle carried by this piston passes through the lid of the container. These devices must incorporate maintenance means in position of the piston in each of its two positions, that is, in its position separated from the cover and in the transfer position. In addition, other means must be provided to guide the piston in translation by avoiding, as much as possible, a rotation thereof since such rotation is detrimental to an effective perforation of the cap. In particular, a rotation of the needle at the time of perforation could lead to the formation of chips in the cap. These guiding means involve a certain complexity of the constituent parts of the known devices, which makes their cost more expensive, while different pieces manufactured individually must be conceived and treated in a unitary manner. These drawbacks are more particularly desired by the invention, by proposing a connection device in which the piston is effectively guided in its translational movement between the positions mentioned above, while the cost price of the device as a whole can be significantly reduced compared to that of the device. the known devices.

With this intention, the invention relates to a connection device between a closed container and a content, that this container comprises a neck whose opening is blocked by a cover while the connection device comprises a base, apt to be mounted on the container and consisting of a sleeve forming an internal diameter, and a piston able to slide in this diameter, between a first position detached relative to this cover and a second position, called transfer, in which a hollow needle carried by or that constitutes the piston goes through this cover. This device is characterized in that the piston and the base are formed in a single piece and joined by at least one elastic tongue able to deform, essentially in a direction parallel to a central axis of the internal diameter, to accompany the movement of the piston between the positions cited above. 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. The elastic tongue or tongues determine the intensity of the force that a user must apply to move the piston and needle between the first and the second position, that this force may be relatively unimportant, which facilitates its use by medical personnel. . In particular, the piston is much easier to move than in the case in which it is attached to the base by one or more divisible legs whose rupture could demand a significant force. The tongue or tabs of the device of the invention, which deform essentially according to the direction of translation of the piston, do not deform in a dimension that would allow a rotation of the piston. This is because these tabs also constitute guide means in translation, without rotation, of the piston between these two positions. According to advantageous but not mandatory aspects of the invention, the device incorporates one or more of the following characteristics: It comprises several elastic tabs distributed around the central axis of the internal diameter, which allows distributing the guide obtained thanks to the tabs. The tongue or tongues have a width, measured according to a direction generally parallel to a radial surface of the internal diameter, substantially greater than its thickness, measured according to a direction generally perpendicular to this surface. This geometry of the tongues allows them to be given a good rigidity in torsion, in such a way that they effectively oppose a rotation of the piston around the central axis of the internal diameter. In particular, it can be provided that its width is greater than five times its thickness. The tongue or tongues thus have sufficient torsional rigidity to guide the piston in translation, without noticeable rotation, in the internal diameter. In the transfer position, the tongue or tongues form two bearing zones against an internal radial surface of the internal diameter and against an external radial surface of the piston. - The base carries resilient locking means on the neck of the container, that a ring for strapping these means in position locked on this neck is provided around these means, that this ring is formed in one piece with a protective cap of the base, while a divisible continuous zone joins this ring and this cap. This divisible zone is advantageously formed by a membrane sealed to liquids and gases, in such a way that it effectively protects the base against a microbial pollution during the storage of a container equipped with a device according to the invention. By the expression "liquid and gas-tight" *, it is understood that the membrane is sealed against the pressures normally supported by such a device, particularly during its storage - The base comprises support means on the external surface of the cover around of the hollow needle, that the diameter of these means is slightly "greater than the diameter of this needle." This means, in this way, avoids a curvature of the lid at the moment of its perforation and guides, in case of necessity, the needle at the moment of perforation. that these means are constituted by a sleeve forming the part of the inner diameter closest to the cover, that the edge of this sleeve intended to be in support against the cover has a profile that allows a superficial penetration of this edge on the external surface This way, a closed volume of relatively unimportant diameter is created around the piston and inside the internal diameter, this volume limits the amount of product that can be lost due to a leak between the needle and the lid, in particular in the case where the needle is not sunk in the lid in a direction strictly parallel to the central axis of the internal diameter. to a ready-to-use assembly comprising a closed container containing a product, particularly a pharmaceutical preparation, that this container is provided with a neck whose opening is blocked by a cover, and a connection device as described above assembled over the container. Such a set makes it possible to sterilely conserve a component of a medicine or a vaccine, particularly its active principle, and prepare it in useful time by mixing with a liquid, while its piston is effectively maintained in position and guided at the time of displacement. The invention will be better understood and other advantages thereof will appear more clearly in the light of the description that will continue of an embodiment of a connection device according to its principle, given only by way of example and made with reference to the accompanying drawings in which: - Figure 1 is a fragmentary side view of an assembly ready for use according to the invention and of a syringe intended 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 section of the base forming part of the device of the Figure and - Figure 4 is a section analogous to Figure 2 while the device is in transfer configuration. The device 1 according to the invention has a double function. It ensures on the one hand the inviolability of a container 2, for example a glass bottle, containing a product not represented and previously closed or covered. This product can be a powder intended to form a drinkable vaccine. It can be any other type of pharmaceutical preparation, in particular of all types of medicine. The device 1 furthermore allows securing or establishing a tight connection between the interior of the container 2 and the interior of another content, such as a syringe 3 containing a liquid intended to put in solution or in suspension the product contained in the container 2. Instead of a syringe, the content 3 could be formed by a soft bag, another glass jar or any other content. The bottle 2 consists of a neck 4, whose opening 4a is sealed in a sealed manner by a cover 5 made of a relatively flexible material, for example an elastomer, particularly rubber. According to a variant not shown of the invention, a capsule can be arranged around the lid 5 and an external annular part 4b of the neck 4, that this capsule is provided with a central opening through which it is possible to perforate the lid 5. The cover 5 consists of a central part 5a almost cylindrical, adapted to a flexible assembly and sealed within the opening 4a, and a flattened part 5b, resting on the part 4b and eventually covered by the capsule. The device 1 is essentially formed by two parts made by injection in plastic material, for example polyethylene and / or polypropylene, namely a base or base element 10, intended to be mounted around the elements 4 and 5, and an outer cover 40. The base 10 comprises a cylindrical part 11 provided for to be centered on the axis XX 'of symmetry of the elements 2, 4 and 5. This part 11 comprises a lower edge Ia having in cross section a pointed profile intended to penetrate superficially on the upper or exposed surface 5c of the cover 5 The part 11 is extended by several elastic legs 12 each equipped with a pick 13 able to cooperate with the external surface of the neck 4 for the purpose of an elastic interlocking of the base 10 on the neck. At the junction between the legs 12 and the part 11, the base 10 is provided with teeth 14 that form a locking device in rotation of the base 10 with reference to the cover 5 in which the teeth 14 are in grip. In the part opposite the teeth 14 in relation to the joining area 15 between the legs 12 and the part 11, the base 10 carries a second series of teeth 16. In the part opposite the edge 1 l, the part 11 extends by an annular band 17 joining with a sleeve 18 forming an internal diameter A for storage and displacement of a piston 19 constituted by a hollow needle. The internal radial surface 20 of the sleeve 18 is globally cylindrical and centered on the axis XX 'which is thus the central axis of the internal diameter A, while its external surface 21 is slightly tronconical and bears two doubly beveled ears 22 and 22 'which allow it to cooperate with a fixing system of 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 pinching or by the fact that the nut 6 forms an integral part of the syringe 3. The hollow needle 19 forms a central channel 23 and three openings 24, of which two appear in Figures 2 and 4, in the vicinity of its tip sharp 25 As is more particularly apparent in Figure 3, the sleeve 18 and the needle 19 are joined by three resilient tabs 26, such that the elements 11 to 26 form a single monobloc piece constituting the base 10. The tabs 26 have a width 1, measured parallel to the surface 20 or the external radial surface 27 of the needle 19, widely greater than its thickness e which is measured perpendicularly to the surfaces 20 and 27. In this way, the tabs 26 can be deformed in a direction parallel to the axis XX 'but have a relatively important stiffness in rotation about the X-X' axis. In practice, width 1 is at least five times greater than thickness e. The edge 18a of the sleeve 18 which is opposite the ring 2 has, like the edge Ia, a pointed profile that allows it to penetrate superficially on the surface 5c of the cover 5, that a hollow volume 28 is defined between the part of the sleeve 18 Closer to the lid 5 and the cylindrical part 11. The cover 40 is also monobloc and comprises a ring 41 which serves as a clamp to the legs 12 when the peaks 13 are in place under the part 4b of the neck 4. The ring 41 is flanged by an internal locking flange 41a under the peaks 13. This ring 41 is extended by a second ring 42 of slightly smaller diameter and more specifically surrounds the part 11 of the base 10. At the level of the joining area 43 between rings 41 and 42 and on its inner surface, the cover 40 is provided with teeth 44 provided to cooperate with the teeth 16 of the base 10 in order to allow a rotational immobilization of the cover 40 relative to the base 10. In its internal radial surface, the ring 42 carries three ribs 45, centered on the axis XX 'and perpendicular to it, intended to create a tight assembly, without interposition of connection, between the base 10 and the cover 40. In assembled between the base 10 and the cover 40 is sealed as the ring 42 carries at least one rib of the type of the ribs 45. The exact number of the rib, which may be less than or greater than three, depends on the choice of design. A cap 46 is an integral part of the cover 40 and is attached to an upper edge of the ring 42 by a continuous divisible zone 47 of low thickness. The zone 47 can have a thickness comprised between 0.5 and 1 tenth of a millimeter. A device 1 is mounted on a container 2 in the configuration of Figures 2 and 3 for a relatively long period, at the time of storage of the product contained in the container 2. When it is convenient to connect the syringe 3 to the container 2, the cap 46 it is removed by exerting on it a rotary movement R which has the effect of tearing the area 47 since the elements 10 to 45 are immobilized in rotation around the neck 4.

It is then possible to insert the end 3a of the syringe 3 inside the sleeve 18 using the nut 6 to force the progression of the end 3a in the sleeve 18. It is also possible to push the syringe 3 towards the container 2, particularly when the The syringe is not equipped with a nut of the type of the nut 6, in order to transmit a translation movement to the needle 19. In this way a pushing force is created on the needle 19, represented by the arrow F in the Figure 4, in such a way that the needle perforates the cover 5, which allows to put in communication the internal volume of the container 2 and a channel 3b of the end 3a, through the channel 23 and the openings 24. In this configuration, the tabs 26 have been deformed in relation to their configuration of Figures 2 and 3. In the configuration of Figures 2 and 3, each tab 26 has a solid end 29 of the piston 19 remote at a distance d relative to the surface 5c while its end 30 integral with the surface 20 is remote at a distance d ^ in relation to the same surface 5c. The distance d is greater than the distance (P in the configuration of Figures 2 and 3. On the contrary, in the configuration of Figure 4, the distance d is less than the distance (P that remains constant) In other words, the end 29 of each tongue 26 approaches the cover 5 at the moment of translation of the needle or piston 19 corresponding to the perforation of the lid 5. In the configuration of Figure 4, the tongues 26 form two support zones 31 and 32, respectively against the surfaces 27 and 20, in such a way that the progression of the needle 19 in the direction of the inner volume of the container 2 is locked in this configuration, in this way, the tongues 26 can constitute a stop for the displacement of the needle 19 at the moment of the perforation of the cover 5. During the perforation of the cover 5, the edge 18a of the sleeve 18 is permanently in firm support against the cover 5, which makes it possible to avoid any effect of curvature of the cover as a result of a deformation of its constituent material. 8a on the surface 5c guarantees a tightness between the volume 50, defined inside the sleeve 18 around the needle 19 and between the cover 5 and the end 3a of the syringe 3, and the volume 28. The dead volume 50 constitutes the volume in which a part of the liquid coming from the container 2 could flow as a result of a leakage between the needle 19 and the cover 5. In this way, the maximum loss of the active liquid is confined to this volume 50 which may be relatively low as a consequence of the unimportant diameter difference between the surfaces 20 and 27. The elasticity of the tabs 26 can be chosen, such that their configuration shown in Figure 4 is a stable configuration in this sense that the needle 19 has no tendency to rise again in the direction of the mouth of the sleeve 18 equipped with the flange 22, included there after the withdrawal of the end 3a.

Claims

CLAIMS 1. Connection device (1) between a closed container (2) and a content (3), said closed container comprising a neck (4) whose opening (4a) is closed by a cover (5), which said connection device comprises: a base (10) able to be mounted on said container and consisting of a sleeve (18) forming an internal diameter (A) and - a piston (19) able to slide in the said internal diameter, between a first position detached in relation to said cover and a second position, called transfer, in which a hollow needle carried by or constituting said piston passes through said cover, characterized in that said piston (19). ) and said base (10) are formed by a single piece and joined by at least one elastic tongue (26) capable of being deformed, essentially in a direction parallel to a central axis (X-X ') of said internal diameter (A ), to accompany the movement of the aforementioned piston between the first and second positions. Device according to claim 1, characterized in that it comprises several elastic tongues (26) distributed around said central axis (X-X '). Device according to one of the preceding claims, characterized in that said or said tabs (26) have a width (1), measured in a direction generally parallel to a radial surface (20, 27) of said internal diameter (A) ), substantially greater than its thickness (e), measured according to 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). Device according to one of the preceding claims, characterized in that, in the transfer position, said or said tongues (26) form two support zones (31, 32) against an internal radial surface (20) of said inner diameter (A) and against an external radial surface (27) of said piston (19). Device according to one of the preceding claims, characterized in that said base (10) carries elastic locking means (12, 13) on said neck (4), which a ring (42) for strapping said means in Position nailed on said neck is provided around said means, said ring being formed in one piece with a protective cap (46) of said base, that a divisible zone (47) joins said ring and cited cap. 7. Device according to claim 6, characterized in that said divisible zone (47) is formed by a membrane sealed to liquids and gases. Device according to one of the preceding claims, characterized in that said base (10) comprises support means (18a) on the external surface (5c) of said cover (5) around said hollow needle (19), that the diameter of said means is 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 lid (5), that the edge (18a) of said sleeve intended to be in Support against said lid has a profile that allows a superficial penetration of said edge into said surface (5c) of said lid. 10. Ready-to-use assembly comprising a closed container (2) containing a product, particularly a pharmaceutical preparation, that said container is provided with a neck (4) whose opening (4a) is sealed by a cover (5). ) and a connection device (1), according to one of the preceding claims, mounted on said container.