JP4582983B2 - Connected device ready for use - Google Patents

Description

[0001]
The present invention relates to a device for connecting a closed recipient and a container. The invention also relates in particular to a ready-to-use assembly comprising a closed recipient and a connection device of the type described above.
[0002]
In the field of pharmaceutical packaging, it is known to store a component of a medical preparation (eg, its active ingredient) in a recipient that is closed by a stopper made of a relatively non-rigid material (eg, elastomer). In order to obtain a preparation in liquid form that can be administered to the patient at any time, in particular for the drug or vaccine, to dissolve the ingredients contained in the recipient or to put it in suspension, after the stopper piercing process Liquid can be introduced into the recipient.
[0003]
Publications WO-A-97 / 10156, WO-A-98 / 37854 and SU-A-5 925 029 have a base adapted to cover the neck of the recipient and within the flange forming the inner bore A connection device of the type described above is disclosed, wherein the piston is mounted to slide within the bore. This piston is equipped to push towards the moving position where the hollow needle is formed by this piston across the stopper of the recipient. These devices should incorporate means for maintaining the piston in each of its two positions (ie, the position where the stopper is released and the moving position). In addition, other means must be provided to guide the piston to the moving position while avoiding as much as possible rotation where rotation is detrimental to the effective drilling of the stopper. In particular, any rotation of the needle during drilling can lead to the formation of a sliver within the stopper. These guiding means complicate the parts that make up the known device, thus increasing its cost, and at the same time, different parts manufactured separately must be designed and managed one by one.
[0004]
A particular object of the invention is to overcome these drawbacks by proposing a connection device, where the piston is effectively guided between said positions in translation, while this device The assembly cost is substantially lower compared to the cost of known devices.
[0005]
To this end, the present invention relates to a device for connection between a closed recipient and a container, the recipient comprising a neck, the neck opening being sealed by a stopper, wherein The connecting device is adapted to be attached to the recipient and comprises a base with a sleeve forming an internal bore, a first position to be disengaged with respect to the stopper, and a second hollow according to the configuration of the piston A piston, adapted to slide in the inner bore between a so-called movement position where the needle crosses this stopper. The device is such that the piston and base are formed in one piece and are deformed in a direction substantially parallel to the central axis of the bore to accompany the movement of the piston between the above positions. Characterized in that they are connected by at least one elastic tongue adapted to.
[0006]
With the present invention, the base and piston are mounted in one orientation, which can optimize the scope of manufacture of the device of the present invention and reduce its cost. This elastic tong (s) determines the strength of the attempt that the user must apply to place the piston and needle between the first and second positions, such as Attempts are relatively small and facilitate their use by physicians. In particular, the piston moves much more easily than if it is connected to the base by one or more breakable tabs, which is necessary for significant effort to break. The tongue (s) of the present invention are essentially deformed in the translational direction of the piston and not in a direction that allows the piston to rotate. This is because these tongs also constitute a means for guiding the piston between these two positions in a translational motion without rotating.
[0007]
According to non-limiting advantages of the invention, the device incorporates one or more of the following features:
This device comprises a plurality of elastic tongues distributed around the central axis of the bore, which makes it possible to disperse the guide obtained by this tongue.
[0008]
This tong (s) is measured in a direction substantially parallel to the radial surface of the bore, substantially greater than its thickness measured in a direction substantially perpendicular to the radial surface of the bore. Width. Due to this shape of the tongue, they exhibit excellent stiffness against torsion so that they effectively resist any rotation of the piston about the central axis of the bore. In particular, this width is provided 5 times larger than their thickness. Thus, these tongs are sufficiently rigid to twist to guide the piston in translation within the bore without significant rotation.
[0009]
In the moving piston, the tongue forms two zones of abutment against the inner radial surface of the bore and the outer radial surface of the piston.
[0010]
The base shows a means for elastically pinching the recipient's neck, and a ring for hooping these means at the scissor position on the neck provided around these means, , Formed in one piece with a cap for protection of the base, where a continuous breakable zone connects the ring and the cap. This breakable zone is advantageously formed by a watertight and airtight membrane, so that it effectively protects this base from microbial contamination during storage of a recipient attached to a device according to the present invention. The expression “water-tight and air-tight” is understood to mean that the membrane is dense against the pressure that such devices normally resist, especially during its storage.
[0011]
The base comprises means for abutments on the outer surface of the stopper around the hollow needle, the diameter of these means being slightly larger than the diameter of this needle. Thus, these means make it possible to avoid stopper bulges while drilling and guide the needle during drilling, if necessary. In particular, these means are provided to be constituted by a sleeve that forms part of the bore closest to the stopper, the edge of the sleeve allowing surface perforation of this edge on the outer surface of the stopper It is intended to be an abutment against a stopper having a profile. Therefore, a limited volume with a relatively small diameter is formed around the piston and inside the bore, especially if the needle is not driven in the stopper in a direction that is strictly parallel to the central axis of the bore This capacity limits the amount of product that can be lost due to leakage between the needle and the stopper.
[0012]
The present invention also relates to an assembly for immediate use, which comprises a closed recipient containing a product (particularly a pharmaceutical preparation) and a connection device as described above attached to the recipient, The recipient includes a neck, and the neck opening is sealed by a stopper. Such an assembly makes it possible to store the components of the pharmaceutical or vaccine (especially the active component, sterile component) and to prepare it when required to be mixed with a liquid, where This piston is effectively maintained in the piston and is guided during the exchange.
[0013]
The present invention is readily understood and other advantages will become more apparent upon reading the following description of an embodiment of an embodiment of a connecting device according to its principles, given by way of example only and using the accompanying drawings .
[0014]
Referring now to the drawings, the device 1 according to the present invention has two functions: on the one hand, this ensures the taper proof properties of the recipient 2 (eg a glass flask containing the product (not shown)), And it is tightened beforehand. The product can be a powder intended to form an orally ingested vaccine, or it can be any other type of pharmaceutical preparation, in particular any type of pharmaceutical liquid.
[0015]
On the other hand, the device 1 is in a separate container from the interior of the recipient 2 (eg, a syringe 3 containing a liquid intended to dissolve the product contained in the recipient 2 or place it in suspension). Ensure or establish a close connection with the inside. Instead of a syringe, the container 3 can be formed by a flexible bag, another glass flask or any other container.
[0016]
The flask 2 includes a neck 4, and the neck opening 4 a is tightly sealed by a stopper 5 made of a relatively non-rigid material (eg, elastomer, in particular rubber). According to a modified embodiment of the invention (not shown), a capsule can be arranged around the stopper 5 and the outer annular part 4b of the neck 4, this capsule being provided with a central opening through which the stopper 5 can be pierced. . This stopper 5 carries a substantially cylindrical central part 5a adapted for flexible and tight attachment inside this opening 4a, and a part 4b, and a flat part 5b possibly covered by a capsule. Prepare.
[0017]
The device 1 is a two-part made by injection molding of a plastic material (eg polyethylene and / or polypropylene) (ie a base element intended to be mounted around the elements 4 and 5 ie base 10 and an envelope). Is essentially formed by.
[0018]
The base 10 comprises a cylindrical part 11 provided in the center of the axis of symmetry XX ′ of the elements 2, 4 and 5. This part 11 comprises a sharp profile intended to surface drill into the lower edge 11a (shown in cross section), the top surface of the stopper 5 or the exposed surface. The portion 11 extends within a plurality of elastic tabs 12 each provided with a beak-shaped projection 13 that is adapted to cooperate with the outer surface of the neck 4 so that the base 10 is elastically sandwiched on the neck.
[0019]
In the connection between the tab 12 and the part 11, the base 10 is provided with teeth 14 forming a device for preventing the rotation of the base 10 with respect to the stopper 5 with which the teeth 14 are engaged.
[0020]
In contrast to the teeth 14 for the zone 15 of the connection between the tab 12 and the part 11, the base 10 supports a second series of teeth 16.
[0021]
On the opposite side of the edge 11a, the part 11 extends in an annular band 17 for connection with a sleeve 18 forming an inner bore A for storage and replacement of a piston 19 constituted by a hollow needle. The inner radial surface 10 of the sleeve is substantially cylindrical and is on the center of the XX ′ axis, and thus on the central axis of bore A, while its outer surface 21 is slightly shortened, and This supports one doubly beveled lugs 22 and 22 ′, by which these lugs use a nut 6 for attaching the syringe 3 to the base 10, which makes it “LUER-LOCK”. Can cooperate with a system for fixing the syringe 3 of the mold. The syringe 3 and the nut 6 can be connected by clipping due to the fact that the nut 6 forms an integral part of the syringe 3.
[0022]
The hollow needle 19 forms a central channel 23 and three openings (two of which are shown in FIGS. 2 and 4) near the sharp advantage 25.
[0023]
As shown in more detail in FIG. 3, the sleeve 18 and the needle 19 are connected by three elastic tongues 26, so that the elements 11-26 form a single piece that constitutes the base 10.
[0024]
The tongue 26 has a width l measured parallel to the surface 20 of the needle 19 or the outer radial surface 27 that is greater than the thickness e measured perpendicular to the surfaces 20 and 27. Thus, the tongue 26 can be deformed in a direction parallel to the axis XX ′, but exhibits a relatively strong stiffness against rotation about the axis XX ′. In practice, the width l is at least 5 times greater than the thickness e.
[0025]
The edge 18a of the sleeve 18 opposite the flange 2 exhibits a sharp profile that allows surface drilling in the surface 5c of the stopper 5, similar to the edge 11a, and the hollow volume 28 is the sleeve closest to the stopper 5 It is defined between 18 parts and the cylindrical part 11.
[0026]
When the beak-shaped protrusion 13 is on the underside of the portion 4 b of the neck 4, the envelope 40 is also a single piece and comprises a ring 41 that serves as a hoop for the tab 12. The ring 41 contacts an inner flange 41 for locking under the beak-shaped protrusion 13. This ring 41 extends within a slightly smaller diameter second ring 42 that surrounds a more specific portion 11 of the base 10. At the level of the connection zone 43 on its inner surface between the rings 41 and 42, the envelope 40 cooperates with the teeth 16 of the base 10 to enable the anchoring of the envelope 40 to the base 10 during rotation. The tooth part 44 provided so that it may be provided.
[0027]
At this inner radial surface, the ring 42 can be positioned between the base 10 and the envelope 40 without the intervention of a seal and perpendicular to and relative to the center of the XX ′ axis to form a dense assembly. The intended three ribs 45 are produced. The assembly between the base 10 and the envelope 40 is dense as long as the ring 42 supports at least one rib of the type such as the rib 45. The actual number of ribs, which can be three or less, depends on the design choice.
[0028]
The cap 46 forms an integral part of the envelope 40 and is connected to the upper edge of the ring 42 by a small thickness continuous breakable zone 47. The thickness of zone 47 is 0. It is placed in between the 0 5mm and 0.1mm.
[0029]
2 and 3, the device 1 is attached to the recipient 2 for a relatively long time during storage of the product contained in the recipient 2. When the syringe 3 is connected to the recipient 2, the cap 45 is removed by exerting a rotational movement R which has the effect of tearing the zone 47 thereon. This is because the elements 10-45 are fixed against rotation around the neck 4.
[0030]
It is then possible to introduce the end 3 a of the syringe 3 inside the sleeve 18 by using a nut 6 for advancing the end 3 a in the sleeve 18. In particular, if the syringe is not equipped with a type of nut such as nut 6, it is also possible to push the syringe 3 in the direction of the recipient in order to transmit the translational movement to the needle 19. Thus, a pressing attempt, represented by arrow F in FIG. 4, is produced on the needle 19 so that it pierces the stopper 5 and thereby through the channel 23 and the opening 24 to the recipient 2 And the internal capacity of the channel 3b of the end 3a can be arranged in communication.
[0031]
In this configuration, the tongs 26 are modified relative to those configurations of FIGS.
[0032]
In the configuration of FIGS. 2 and 3, each tongue 26 has an end 29 secured to the piston 19 that is spaced a distance d from the surface 5c, while an end 30 secured to the surface 20. Are fixed to a surface 20 spaced a distance d ′ from the same surface 5c. The distance d is greater than the distance d ′ of the configuration of FIGS. Conversely, in the configuration of FIG. 4, the distance d is less than the distance d ′ that remains constant. In other words, the end 29 of each tongue 26 advances toward the stopper 5 during translation of the needle or piston 19 corresponding to the perforation of the stopper 5.
[0033]
In the configuration of FIG. 4, the tongue 26 forms two zones of the abutments 31 and 32 of the surfaces 27 and 20, respectively, so that the advancement of the needle 19 in the direction of the internal volume of the recipient 2 is this configuration. Is blocked. In this way, the tongue 26 can stop the displacement of the needle 19 during the perforation of the stopper 5.
[0034]
During the piercing of the stopper 5, the edge 18a of the sleeve 18 is an abutment that is permanently fixed to the stopper 5, whereby the stopper is caused by creeping of the material that constitutes the abutment. Any effects of ridges can be avoided. Furthermore, the perforation of the edge 18a in the surface 5c provides a seal between the volume 50 defined inside the sleeve 18 around the needle 19 and between the stopper 5, the syringe end 3a and the volume 28. Guarantee. The dead volume 50 constitutes a volume through which a part of the liquid from the recipient 2 can flow due to leakage between the needle 19 and the stopper 5. Thus, the maximum loss of active liquid is limited to this volume 50, which can be relatively small due to the very slight difference in diameter between surfaces 20 and 27.
[0035]
The elasticity of the tongue 26 can be selected such that this configuration shown in FIG. 4 is a stable configuration, where the needle 19 is a sleeve fitted with a flange 22, including after removal of the end 3a. There is no tendency to rise in the direction of the opening.
[Brief description of the drawings]
FIG. 1 is an enlarged side view of a ready-to-use assembly according to the present invention and a syringe provided to cooperate with the assembly.
FIG. 2 is an axial portion of a device attached to the assembly of FIG. 1 in a storage structure.
FIG. 3 is a perspective view of a part forming the base of the device of FIG. 2, with the part removed.
FIG. 4 is the same part as FIG. 2 with the device in a moving structure.

Claims (9)

A device (1) for connecting between a closed recipient (2) and a container (3), the closed recipient comprising a neck (4), the neck opening (4a) being Sealed by a stopper (5), the coupling device is:
A base (10) comprising a sleeve (18) adapted to be attached to the recipient and forming an internal bore (A); and a piston (19) comprising the stopper between a first position not engaged, to engage the stopper by either supported by the piston, or the hollow needle which constitutes the said piston passes through the stopper, and a second position A piston adapted to slide parallel to the central axis (XX ′) within the bore;
The piston (19) and said base (10) is formed in one piece, and, characterized in that it is connected by the at no less one resilient tongue (26), further,
The at least one elastic tongue (26) is greater than the thickness (e) of the at least one elastic tongue measured in a direction substantially perpendicular to the radial surface (20, 27) of the bore (A). Characterized by having a width (I) measured in a direction substantially parallel to the radial surface (20, 27) of the bore (A) that is substantially large;
device.   The device according to claim 1, characterized in that it comprises a plurality of elastic tongues (26) distributed around the central axis (X-X '). Device according to claim 1 or 2 , characterized in that the width ( I ) is 5 times larger than the thickness (e). The device according to any one of claims 1 to 3 , wherein in the second position, the tongue (26) comprises an internal radial surface (20) of the bore (A) and the piston (19). outer radial surface (27) and that Sessu, devices. A device according to any one of claims 1 to 4, wherein the base portion (10), means for sandwiching elastically on the neck (4) (12, 13), around the said means A ring (42) for enclosing the means in a scissor position on the neck provided, formed in one piece with a cap (46) for protecting the base, and the ring and the ring and Device having a continuous breakable zone (47) having a thickness between 0.05 mm and 0.1 mm connecting the caps. Said breakable zone (47), wherein the film Der Rukoto watertight and airtight device according to claim 5. A device according to any one of claims 1 to 6, wherein the base portion (10) comprises a stopper (5) elongated to contact with the outer surface (5c) of around the hollow needle (19) preparedness end portion (18a), the diameter of the end portion may slightly larger than the diameter of the needle, the device. 8. The device according to claim 7 , wherein the end is constituted by a part of the sleeve (18) closest to the stopper (5), the end being taken radially from the central axis. A device characterized by being tapered toward the tip when viewed in cross section . A ready-to-use assembly comprising a closed recipient (2) comprising a product, in particular a pharmaceutical preparation, the recipient being provided with a neck (4), the neck opening (4a) being 9. An assembly sealed by a coupling device (1) according to any one of claims 1 to 8 , attached to the recipient, a stopper (5), and the recipient.

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