FR2900131A1 - Plug device for medication container e.g. glass vial, has manoeuvring element comprising annular edge engaged between external skirt of ring of cover and lip that forms locking unit and radially extends towards central axis of ring - Google Patents

Abstract

The device (500) has a manoeuvring element (504) mounted on a ring (503) of a cover (502) which covers a neck (12) of a container. The manoeuvring element has an annular edge (505D) adapted to be engaged between an external skirt of the ring and a lip (503G). The lip forms a locking unit and radially extends towards the central axis (X-503) of the ring, away from the skirt. The ring has an annular part at center of which an opening is defined to access an exposed face (501B) of a plug (501). An independent claim is also included for a method of mounting a plug device.

Description

The invention relates to a closure device for a container provided

  of a neck, and a method of mounting such a device and a container equipped with such a device.

  In the field of medication containers, it is known to use a glass vial to store an active ingredient in the form of lyophilisate, powder or liquid solution. Such a bottle must be sealed in order to maintain its contents in a satisfactory state of preservation, until its date of use. To seal a bottle, it is known to use a closure device which comprises an elastomeric stopper whose function is to ensure a complete seal to gases, liquids and bacteria, a metal capsule, most often aluminum, which provides a sealing function, and a tongue or flip-off which provides a tamper-proof function and which must be removed before access to the cap.

  US-A-5,678,718 discloses a capping device whose cap is multipartite. This cap is held in position on the neck of a container thanks to the elasticity of an outer ring, which is not always effective. It is these drawbacks that the invention intends to remedy more particularly by proposing a new closure device whose installation is particularly easy, which allows the protection of an elastomeric stopper at the end of the filling operation. and / or lyophilization cycle while ensuring a firm hold on the neck of a container. For this purpose, the invention relates to a closure device for a container provided with a neck, this device comprising an elastomeric stopper and a cap capable of covering both the neck and the stopper in place in the neck of the container, characterized in that the cap is made of plastic material and comprises: - a ring adapted to surround the cap and the collar in the mounted configuration, this ring being provided with a locking means on the neck and - an operating member capable of being mounted on this ring, this actuating member being provided with first means for transmitting to the ring a thrust force generally parallel to an axis of symmetry of the neck and second means for activating locking means of the ring, these first and second means extending radially inside the ring in the mounted configuration of the closure device on the neck of a container. Thanks to the invention, the plastic cap is not likely to induce, by its contacts with the surface of the container, the generation of polluting glass particles. The operating member can effectively move and lock the ring by means of the first and second means that it carries and which are protected by this ring in mounted configuration of the closure device. In addition, the maintenance of the cap on the neck of a container does not depend on the elasticity of the ring. 2.5 According to advantageous but non-obligatory aspects of the invention, such a device may include one or more of the following features taken in any technically permissible combination: - The actuator consists of an annular element which carries the first and second means and a cover immobilized on this annular element by means of attachment tabs on the edge of a central opening of the annular element, while the lid can be mounted on the annular element only with a deformation elastic of this element, this deformation resulting from a force that can be exerted only before the operating member is mounted on said ring. In this case, each lug is advantageously provided with a latching nose on the edge of the opening, the distance between the nose and the face of the lid bearing against the annular element being less than the distance, taken parallel to a central axis of the annular element and when the lid is not attached to this element, between the edge and a portion of the annular element which receives in abutment with the aforementioned face of the lid. - The force transmission means comprise at least one resilient tongue provided with a relief extending radially outwardly of the actuating member and adapted to be engaged in an annular groove formed on an inner face of the ring . It comprises means for retaining the operating member in a configuration where the second means activate the locking means of said ring, while the retaining means comprise at least a portion of an external radial flange of the member. maneuverable to be engaged in the throat. The flange is inclined opposite the activation means while moving away from a central axis of the actuating member. - The first means are arranged in windows formed in a peripheral wall of the actuating member, while retaining means of the operating member, in a configuration where the second means 30 activate the locking means of the ring , extend on the outer face of the partition, between two such windows. - The locking means of the ring on the neck comprise at least one monobloc tab with the ring, while the activation means of the operating member are able to move at least a portion of the tongue in a centrifugal direction by relative to a central axis of the neck.

  The invention also relates to a method of mounting a device as previously described which comprises the steps consisting in: a) exerting on the edge of the central opening of the annular element a force generally parallel to the central axis of this opening, this force being applied against one side of the annular element opposite to that by which the lid is intended to be mounted, this force being exerted so as to deform this edge elastically; b) - press the cover towards the annular element in a direction opposite to that of the force, so as to bring into engagement its latching lugs against the elastically deformed edge of the aforementioned opening. The invention also relates to a container equipped with a closure device as described above. Such a container is easier to plug and use than those of the state of the art.

  The invention will be better understood and other advantages thereof will appear more clearly in the light of the following description of two embodiments of a container and a device according to its principle, given solely for example and with reference to the accompanying drawings in which: - Figures 1 to 5 show schematically in axial section and in perspective, several steps of packaging a product in a bottle according to the invention; Figures 6 and 7 show schematically, in perspective, two steps of use of the bottle; Figure 8 is an enlarged view of detail VIII of Figure 4; FIG. 9 is an axial section, in perspective and on a larger scale, of the cap of the closure device of the bottle of FIGS. 1 to 8; FIGS. 10A and 10B are perspective views, at two different angles, of a ring belonging to the cap of FIG. 9; FIGS. 11A and 11B are perspective views, at two different angles, of a part of a locking member belonging to the cap of FIG. 9; FIGS. 12A and 12B are perspective views, at two different angles, of a cover belonging to a locking member of the cap of FIG. 9, FIG. 12A including partial tearing; FIG. 13 is a view on a larger scale of the detail XIII in FIG. 4, the pressure plate being omitted; FIG. 14 is an enlarged view of detail XIV in FIG. 5; Figure 15 is an exploded perspective view of the cap of Figure 9; FIG. 16 is a view of the actuating device during assembly and FIG. 17 is an enlarged view of detail XVII in FIG. 16. In FIG. 1, a glass vial 1 is during filling with a product P, for example with a drug. A pipette 2 is introduced into the bottle 1 through its neck 11 which is defined by a neck 12 having an outer flange 13. X1 is the axis of symmetry of the bottle 1. When a predetermined amount of products P has been introduced in the bottle 1, the pipette is removed and a closure device 500 is placed on the neck 12. The device 500 comprises an elastomeric plug 501 shaped to be partially introduced into the neck 11, while resting on the 13A face of the collar 13 opposite the bottom 14 of the bottle 1. Once in place in the neck 12, the plug 501 isolates the contents of the bottle 1 from the outside. The device 500 also includes a cap 502 for covering and isolating the cap and. the collar 12 in the closed configuration of the closure device.

  As is more particularly apparent from FIG. 9, the cap 502 comprises a plastic ring 503 whose internal diameter is sufficient to allow it to surround the collar 13. The cap 502 also comprises a maneuvering member 504 constituted by a piece 505 plastic ring, which is described as key in the following, and a lid 506, also plastic material, reversibly secured to the key 505. The cover 506 has four legs 506A to be hung on the edge 505B1 of a central opening 505B of the key 505. To do this, each tab 506A is provided with a terminal nose 506A1 formed during the molding of the cover 506 and extending, with respect to a central axis X506 of the cover 506, radially outwardly of the tab 506A considered. The spouts 506A1 are engaged under the edge 505B1 when the key 505 and the cover 506 are assembled to form the member 504. More specifically, the cover 506 is provided with a substantially flat surface 506C by which it bears against a surface upper 505A1 of an annular portion 505A of the key 505 at the center of which is defined the opening 505B. In mounted configuration of the member 4, the nozzles 506A1 are engaged against the edge 505B1r on the opposite side to the surface 505A The number of tabs 506A is not limited to four, as far as it allows to distribute the effort hooking between the key 505 and the cover 506. The cover 506 is also provided with an annular lip 506B which is engaged in the opening 505B when these two elements are secured to form the member 504. The key 505 is provided a set of three elastic tongues 505C formed by the creation of three openings 505Q in a skirt 505J formed by the key 505 and centered on an axis Xsos which constitutes a central axis of the key 505. 505D is noted the annular edge of the skirt 505J which is opposed to the part 505A. Each tab 505C is provided with an external rib or spout 505E which projects radially relative to the skirt 505J. Thus, each tab 505C forms an elastic hook. We note dl the distance, taken parallel to the axis Xosos, between the ribs 505E and the edge 505D. Furthermore, the key 505 is provided with a peripheral flange 505R which protrudes radially from the skirt 505J and which extends continuously between two openings 505Q. Note d2 the distance taken parallel to the axis Xsos between the free edge 505R1 of the flange 505 and the edge 505D. The value d2 is greater than the value of dl.

  The flange is generally frustoconical about the Xsos axis and diverging away from the edge 505D. The ring 503 comprises, in turn, a peripheral annular skirt 503A 503B of which a first edge is noted. Inside the skirt 503A and opposite the edge 503B is formed an annular portion 503C generally perpendicular to a central axis X503 of the ring 503 and the skirt 503A. The portion 503C is extended, at five angular sectors distributed around the axis X503, by five bridges 503D which are connected to the inner surface of the skirt 503A in the vicinity of the edge 503B. The bridges 503D extend away from the inner surface of the skirt 503A, so that they define five individual elongated housings 503E into which the skirt 505J of the wrench 505 can be inserted through the side of the ring 503 which carries the portion 503C and which is visible in Figure 10A. In the angular sectors where the portion 503C is not extended by bridges 503D, are provided five openings 503E in each of which can also be introduced the skirt 505J when this skirt is introduced into the housing 503E. Opposite each opening 503F is formed a tab or locking tab 503G which extends, from the inner face of the skirt 503A, radially towards the axis X503. There is 503J the free edge of each leg 503G. The ends of the bridges 503D and the tabs 503G are arranged alternately, inside the skirt 503A and in the vicinity of the edge 503B.

  On each bridge 503D is provided a 503K pin jamming plug 501 in the configuration of Figure 2. The pads 503K are provided to penetrate superficially in the plug 501 to immobilize it with respect to the skirt 503.

  A rib 503N is provided on each bridge 503D, on the inner face of its portion bent at about 90, to bind the ring 503 and the plug 501 in rotation penetrating radially into the outer surface of the plug.

  When the cover 506 is to be mounted on the key 505, the nozzles 506A1 must be engaged against the edge 505B1r through the opening 505B. To do this, as shown in FIG. 16, the key 505 is placed on a tool 600 which defines an annular surface 601 for receiving the portion 505A of the key 505 in abutment. The plug 506 is then presented above the key 505, substantially aligning the axes X5o5 and X506, the X506 axis being already aligned on a central axis X600 of the tool 600. The lid 506 is then pushed towards the tool 600 by means of a parallel force Fo X505, X506 and X600 axes, which has the effect of engaging the lip 506B in the opening 505B and then have the spouts 506A1 bear against the edge 505B1 of the opening 505B. When maintaining the force Fo on the cover 506, the surface 506C abuts against the upper surface 505A1 of the portion 505A and transmits to the key 505 a force F'0 which induces a sliding of the skirt 505J in the direction of the arrow F505 in Figure 16, that is to say in the direction of the base of the tool 600. Insofar as the portion 505A of the key 505 is already resting on the surface 601, an effort of Reaction F600 is exerted by the surface 601 on the lower surface 505A2 of the portion 505A, which is defined on the side of the portion 505A opposite the cover 506. The effort F600 is opposite to the effort Fo.

  This has the effect of bringing the edge 505B1 closer to the surface 506C, which allows the noses 506A1 of the tabs 506A to protrude beyond this edge and engage below it in the representation of FIG. 506A1 under the edge 505B1 is only possible thanks to the elastic deformation of the edge 505B1r deformation obtained thanks to the reaction force F600. D3 is the distance, taken parallel to the axis X505, between the edge 505B1 and the portion of the portion 505A which supports the cover 506 in the configuration of Figure 16. Note also d4 height, taken in parallel to the axis X506r of the tabs 506A between the surface 506C and their respective beaks 506A1. At rest, that is to say in the absence of effort exerted on the parts 505 and 506, the distance d3 has a value greater than that of the distance d4. Only because the tool 600 exerts on the part 505A the reaction force F600 in the opposite direction to the force F0 that the distance d3 is reduced temporarily to a value less than the distance d4, which allows the hooking of the nozzles 506A1 below the edge 505B1 in FIG. 17. It will be noted that, when the member 504 is mounted on the ring 503, it is no longer possible to reach the lower surface 505A2 of the portion 505A of the key 505 to exert the effort F600. The assembly of the device 500 takes place by mounting the cover 106 on the key 105 as explained above, then aligning the axes X505 and X506, already merged, with the axis X503 and engaging the skirt 505J in an annular volume. 503V defined between the skirt 503A, the bridges 503D and the locking tabs 503G. Given the annular nature of the edge 505D and the volume 503V, the member 504 can be mounted on the ring 503 without particular care as to its angular orientation around the axis X503. In other words, the member 504 can have any orientation with respect to the X505 and X506r axes, which coincide, when inserting the edge 505D, through the entries of the housings 503E and the openings 503F, in the direction of the volume 503V. This facilitates the mounting of the cap 502 because this orientation does not have to be controlled. The inner face of the skirt 503A is provided with a peripheral groove 503L formed near the edge 503M of the skirt 503A opposite the edge 503B and adjacent to the portion 503C. The groove 503L is configured to receive the ribs 505E of the tabs 505C when the member 504 is mounted on the ring 503. More specifically, when mounting the member 504 on the ring 503, the skirt 505J enters the volume 503V to through the openings 503F and the entrance openings of the housing 503E. The skirt 505 then progresses towards the edge 503B until the ribs 505E of the tongues 505C engage in the groove 503L, thereby keeping the member 504 away from the portion 503C, in the position shown in FIG. Figure 9. It is then possible to introduce the cap 501 in the cap 502 and to trap it by means of the pads 503K. The device 500 thus formed can then be placed on the neck 12 of the bottle 1, as shown in Figure 2. In this configuration, the cap 501 does not completely close the neck 11 since this cap is provided with a side cut 501A providing a gap 200 at a portion of the face 13A. The bottle 1 equipped with the device 500 can then be introduced into a lyophilizer 300 where the water molecules present in the bottle 1 are discharged to the outside, as represented by the arrows F1 in FIGS. 3 and 8, through the interstices which then remain between the cap 502 and the flange 13.

  The plug 501 is provided on its outer radial surface with stop protrusions in the configuration of FIGS. 3 and 8. Inside the lyophilizer 300, it is then possible, as shown in FIG. 4, to exert on the device 500 a force F2 parallel to the longitudinal axis X1 of the bottle 1 and the neck 11, axis with which are then confused the axes X503, X50 and X506. This axial force F2 is exerted by a plate 301 movable inside the lyophilizer and capable of exerting at the same time substantially the same effort F2 on all of the bottles 1 arranged at the same level in this lyophilizer. When the force F2 is exerted on the plug 506 of the member 504, the ribs 505E of the tabs 505C1 transmit this force to the ring 503 via the interaction between these ribs 505E and the groove 503L. The tabs 505C thus play the role of pushers in that they allow to move or push the ring 503 towards the bottom 14 of the bottle 1, under the effect of the effort F2, which allows to reach the configuration of Figure 5. Due to this movement, the locking tabs 503G are folded towards the inner surface of the skirt 503A without the need to radially deform this skirt 503A. Thus, the force F2 to be applied to arrive in the configuration of FIGS. 4 and 13 is relatively small. When the locking tabs 503G have passed the flange 13 and reaches the position of FIGS. 4 and 13, the ring 503 can no longer be moved towards the bottom 14 because the portion 503C bears against the cap 101 which is engaged in the neck 12. Maintaining the force F2 then has the effect of driving the ribs 505E out of the groove 503L and moving the member 504 relative to the ring 503 to the point of bringing the edge 505D into the bottom of the volume 503V between the locking tabs 503G and the inner surface of the ring 503A. This engagement of the edge 505B between the locking tabs 503G and the skirt 503A has the effect of radially deforming these tabs centripetally, their respective free edges 503J being moved in the direction of the axis X. These edges then bear against the annular face 13B of the collar 13 directed towards the bottom 14, so that the capsule 500 is firmly locked on the neck 12, as shown in Figures 5 and 14.

  In the configuration of Figures 5 and 14, the collar 505R engages in the groove 503L, which allows to immobilize the member 504 relative to the ring 503. In other words, the difference between the distances dl and d2 corresponds to the stroke of the member 504 between the positions of FIGS. 4 and 5, which makes it possible to automatically engage the flange 505R with the groove 503L when the locking lugs 503G are locked in the retaining position of the cap 502 on the neck 12. Due to this movement, the ribs 503N penetrate superficially into the plug 501, which firmly secures the plug 501 and the ring 503 in rotation. Thus, the final positioning of the cap 502 takes place in two step. In the first step, the plug 501 is put in place and the tabs 503G are folded towards the skirt 503A to pass the flange 13. In the second step, the tabs 503G are locked in position by the edge 505D. These two steps are obtained thanks to a thrust force F2 whose intensity can be adapted to each step, while retaining a value substantially lower than that which would be necessary for a one-step implementation, insofar as the the friction forces to be overcome and the strain forces to be obtained are, thanks to the invention, offset in time, being distributed between the two steps. In addition, since the skirt 503A does not have to be expanded radially during the passage of the legs 503G at the collar 13, the force F2 can be relatively low, which facilitates the introduction of the cap 500. In the first step, we go from the configuration of Figure 3 to that of Figure 4. In the second step, we go from the configuration 4 to that of Figure 5.

  In this configuration, the bottle 1 is hermetically closed by the stopper 501 and is protected by the cap 502, the latter can not be removed due to the lock obtained thanks to the tabs 503G.

  In this configuration, as shown in FIG. 14, the lip 506B of the cover 106 abuts, through the opening 505B and through the central opening 503Q of the portion 503C, against the external surface 501B of the plug 501 which is intended to be exposed when it is desired to access the contents of the bottle 1. Under the action of the lip 506B, the surface 501B deforms locally, as can be seen in FIG. 14, because the material of the plug 501 is more flexible than that of the 506. More specifically, the lip 506B completely insulates a disk-shaped central portion 501C from the surface 501B, which portion may be considered clean and sterile since it has been insulated from the outside within the hyophilizer 300. It is advisable to use the contents of the bottle 1, the lid 506 is removed thanks to a centripetal elastic deformation of the tabs 506A, as represented by the arrow F3 in FIG. 6, which allows access to to the portion 501C above, whose decontamination may be omitted. It is then possible to inject into the bottle 1 a liquid for reconstitution of its contents, this by means of a syringe 400, as shown in FIG. 7, and then to pump the reconstituted product by means of the same syringe whose needle crosses the cap 501 according to an approach known to hospital staff.

  Since all capping operations take place in an environment isolated from the outside, the stopper 501 is kept sterile, in particular at its portion 501C. When the cover 506 has been removed, it is no longer possible to replace it because the key 504 has resumed a configuration in which the distance d3 is greater than the distance d4. The lid 506 thus acts as a first opening indicator of the device 500 since it can not be put back in place after a first withdrawal because it is not possible to exert on the part 505A a similar effort to the force F600 since this part then rests on the part 503C of the ring 503 and the plug 501. The materials used to form the parts 503, 505 and 506 which are monobloc are adapted to maintain their mechanical property over a range of temperatures between -80 and +120 C. It may be, for example, polyoxymethylene. The invention has been described in the case of use for a vial whose contents are lyophilized. It is also applicable in case the contents of the bottle are not lyophilized. In this case, the stopper 501 can be put in place on the vial 1 during a step immediately following its filling, then the cap 502 can be put in place immediately afterwards, in a sterile enclosure that is not shown, and by a force axial, which also achieves a sealed configuration similar to that of Figures 5 and 14.25

Claims (10)

  A closure device for a container (11) provided with a neck (12), said device comprising a plug (501) of elastomer and a cap (502) adapted to cover both said neck and said plug in place in said collar, characterized in that said cap is made of plastic and comprises: - a ring (503) adapted to surround said plug and said neck in mounted configuration, said ring being provided with means (503G) for locking on said neck and - a maneuvering member (504) adapted to be mounted on said ring, said operating member being provided with first means (505C) for transmitting to said ring a thrust force (F2) generally parallel to an axis of symmetry of said collar; and second means (505D) for activating said ring locking means, said first and second means (505C, 505D) extending radially inside said ring in the mounted configuration of the closure device on a collar. récipien t.   2. Device according to claim 1, characterized in that said operating member (504) consists of an annular element (505) which carries the first and second means (505C, 505D) and a cover (506). immobilized on said annular element by means of tabs (506A) for hooking onto the edge (505B1) of a central opening (505B) of the annular element and in that said lid can not be mounted (Fo) on said element annular only by means of an elastic deformation of said annular element, said deformation resulting from a force (F600) which can be exerted only before said operating member is mounted on said ring (503).   3. Device according to one of the preceding claims, characterized in that each lug (506A) is provided with a nose (506A1) hooking on said edge (505B1) of said opening (505B), the distance (d4) between said nose and the face (506C) of said lid (506) bearing against said annular element being less than the distance (d4), taken parallel to a central axis (X505) of said annular element (505) and when the lid (506) ) is not attached to said annular element, between said edge (505B1) and a portion (505A) of the annular element which supports said face of said cover.   4. Device according to one of the preceding claims, characterized in that said force transmission means comprise at least one resilient tongue (5056) provided with a relief (505E) extending radially outwardly of said body member. maneuver (504) and adapted to be engaged in an annular groove (503L) formed on an inner face of said ring (503).   5. Device according to claim 4, characterized in that it comprises means for retaining the operating member (504) in a configuration where said second means (505D) activate the locking means (503G) of said ring ( 503) and in that the retaining means comprise at least a portion of an outer radial flange (505R) of said operating member (505) adapted to be engaged in said groove (503L).   6. Device according to claim 5, characterized in that said flange (505R) is inclined opposite the activation means (505D) away from a central axis (X505) of said actuating member (504) .   7. Device according to one of the preceding claims, characterized in that the first means (505C) are arranged in windows (505Q) formed in a peripheral wall (505J) of said actuating member (504) and in that means (505R) for retaining the operating member (504), in a configuration where said second means (505D) activate the locking means (503G) of said ring (505), extend on the outer face of said partition , between two such windows.   8. Device according to one of the preceding claims, characterized in that the locking means of said ring (503) on said neck (12) comprise at least one tab (503G) integral with said ring and in that the means of activation (505D) of said operating member (503) is adapted to move at least a portion of the tongue in a direction centrifugal relative to a central axis (X1) of said neck (12).   9. A method of mounting a device according to one of claims 2 or 3, characterized in that it comprises steps of: a) - exert on the edge (505B1) of the central opening (505B) of the annular element (505) a force (F6000) generally parallel to a central axis (X505) of said opening, said. force being applied against one side (505A2) of the annular element opposite to that (505A1) by which said cover (506) is intended to be mounted, said force being exerted so as to elastically deform said edge; b) - pressing (Fa) said cover towards said annular element in a direction opposite to that of said force, so as to bring into engagement its latching lugs (506A) against said elastically deformed edge (505B1).   Container (1) equipped with a closure device (500) according to one of the preceding claims.