Bi-injected vial cap cage for pharmaceutical use

Description

FIELD OF THE INVENTION

[0001] The present invention relates to a locking cap for a necked bottle, said cap being intended to lock a stopper in the neck or on a collar of the bottle. The invention relates in particular to a bi-injected cage forming part of said cap and formed from two materials so as to integrate the function of the stopper. TECHNOLOGICAL BACKGROUND OF THE INVENTION

[0002] A bottle for medical or pharmaceutical use is usually sealed by a stopper made of elastomeric material which is secured on said bottle by a locking cap as described in documents EP2464577A1 or FR3098504A1, and illustrated in the figures 1a et 1b . The locking cap 100' comprises an outer body 30, a cage 20' and an upper capsule 40. The foot 11 of a stopper 10' is pushed into the neck 201 of the bottle 200 and held pressed, in this position, by the cage 20' which grips under the collar 202 of the bottle. The outer body 30 is fixed to the cage 20' and prevents any access to it, thus securing the closure of the bottle 200. The upper capsule 40 is removable to allow access to the stopper 10' and the withdrawal of the pharmaceutical solution contained in the bottle 200, for example using a syringe. To allow access to the cap 10', the external body 30 and the cage 20' of the locking cap 100' each have an opening at their respective upper faces, an opening which is closed by the capsule 40 until it is removed.

[0003] Before being fixed on the bottle 200 with the cap 10', the locking cap 100' can be provided alone or associated with the cap 10'. The cage 20' comprises an upper ring and a plurality of branches connected to the upper ring and defining with it a generally cylindrical shape, it also comprises a plurality of bridges, each connecting two neighboring branches together. Some bridges carry a tab 24', flexible and inclined relative to the branches towards the inside of the cage 20', in the direction of the upper ring. These tabs 24' are intended to block the cap 10' inside the cage 20', against the upper ring, when the cap 10' is associated with the cap 100'. The legs 24' flex to allow the head 12 of the plug 10' to pass when the latter is introduced into the cage 20', and come to lock under the head 12, to prevent the plug 10' from being extracted from said cage 20'.

[0004] A risk associated with this cap-cage combination is that the 24' legs damage the elastomeric material of the 10' cap due to their potentially protruding edges.

[0005] Another disadvantage may come from the fact that the tolerances on the dimensions of the 10' caps or the variations in dimensions or hardness of the 10' caps, depending on the suppliers, may modify the compression of the 10' cap against the collar 202 of the bottle, by the cage 20' of the locking cap, and thus impact the sealing of the closure. SUBJECT OF THE INVENTION

[0006] The present invention provides a solution to address all or part of the problems stated. The invention relates to a bi-injected cage for a locking cap, composed of two different materials and integrating the function of the cap. BRIEF DESCRIPTION OF THE INVENTION

[0007] The invention relates to a bi-injected cage of a locking cap for a vial for pharmaceutical use, in accordance with claim 1, composed of: of a first material forming an upper ring, branches whose upper ends are integral with the upper ring, and bridges connecting two by two of the lower ends of the branches, at least some bridges comprising a flexible tab intended to grip under a collar of the bottle, and of a second material, elastomer, forming a stopper configured to seal the bottle when the flexible tabs are gripped under the collar, at least one internal face of the upper ring made of the first material being integral with the stopper made of the second material.

[0008] According to advantageous and non-limiting characteristics of the invention, taken alone or in any technically feasible combination: the stopper comprises a foot sized to fit into the neck of the bottle and a head secured to an internal face of the upper ring and, advantageously, also secured to a portion of an internal face of each branch; the foot has a generally cylindrical shape and includes a window in its cylindrical wall opening out on the side of its free end; the foot has a V-shaped profile and includes a rectangular free end in which a slot is arranged; the stopper consists solely of a head secured to an internal face of the upper ring and, advantageously, also secured to a portion of an internal face of each branch; the head of the stopper extends into a central orifice of the upper ring, until it is flush with an external surface of said ring delimiting the central orifice;the foot of the plug has a generally cylindrical shape, is hollowed out and comprises a cavity which also extends into the head, so as to limit a central thickness to be crossed by the head along a main axis of the cage; the head of the plug comprises at least one recess and at least one shoulder, complementary to at least one shoulder and at least one recess defined on the internal face of the upper ring and / or the branches; the first material is polycarbonate; the second material is chosen from silicone and a thermoplastic elastomer material; the second material has a hardness of between 20 and 45 Shore A.;

[0009] The invention also relates to a locking cap for a vial for pharmaceutical use comprising: a bi-injected cage as above, an external body, surrounding the cage and fixed to the latter, the external body having an opening in its upper face, said opening being centered on and surrounding a central orifice of the upper ring of the cage, a capsule held on an upper face of the external body, to close the opening and prevent access to the plug. BRIEF DESCRIPTION OF THE FIGURES

[0010] Other characteristics and advantages of the invention will emerge from the detailed description of the invention which follows with reference to the appended figures in which: [ Fig. 1a ] [ Fig. 1b ] THE figures 1a et 1b have a locking cap on a bottle, in an intermediate holding position (a) and in a locking position (b), according to the state of the art; [ Fig. 2a ] [ Fig. 2b ] [ Fig. 2c ] THE figures 2a, 2b et 2c present all or part of a locking cap according to the invention, perspective view (a), truncated view with only the external body and the capsule (b), perspective views with only a two-material cage according to the present invention (c); [ Fig. 3a ] [ Fig. 3b ] THE figures 3a et 3b present a first variant of a two-material cage in accordance with the present invention, side view (a) and sectional view (b); [ Fig. 4 ] There figure 4 presents a second variant of a two-material cage in accordance with the present invention, seen in perspective from below; [ Fig. 5 ] There figure 5 presents a third variant of a two-material cage in accordance with the present invention, seen in side perspective; [ Fig. 6 ] There figure 6 presents a fourth variant of a part of the two-material cage in accordance with the present invention: the perspective view only includes the cap of the cage in order to facilitate the visualization of its shape.

[0011] In the descriptive part, the same references in the figures may be used for elements of the same type. DETAILED DESCRIPTION OF THE INVENTION

[0012] The present invention relates to a locking cap 100 for a bottle 200 with a neck. The bottle 200 has a neck 201 with a circular opening, terminating in a flange 202 which flares relative to the outer perimeter of the neck 201, as illustrated in the figures 1a et 1b of the state of the art. In the field of pharmaceutical applications, there are standards in terms of the internal diameter of the neck 201 of the bottle 200: 13 mm and 20 mm are examples. The cap 100 is intended to block a stopper 25 in the neck 201 or against the collar 202 of said bottle 200 to seal it hermetically.

[0013] When associated with the bottle 200, the locking cap 100, as is known per se, can adopt two positions on said bottle: a first position, called intermediate holding in which it remains removable, in a manner similar to the illustration in figure 1a . It can also adopt a second position, called locking, in which it is locked onto the bottle 200, in a manner similar to the illustration in figure 1b , and hermetically closes the bottle 200.

[0014] The locking cap 100 comprises a capsule 40, an outer body 30 and a cage 20 ( figure 2a, figure 2b, figure 2c ). The originality of the locking cap 100, compared to those of the state of the art, comes from its cage 20. It is formed from a first material defining an upper ring 21, branches 22 whose upper ends are integral with the upper ring 21, and bridges 23 connecting two by two lower ends of the branches 22. These elements give the cage 20 a generally cylindrical shape centered on a main axis z. The upper ring 21 has a central orifice delimited by an external surface 21a, usually circular.

[0015] As can be seen on the figure 2c , at least some bridges 23 comprise a flexible tab 24 inclined relative to the branches 22 towards the inside of the cage 20, at an angle of between 20° and 60°, advantageously around 30°, towards the upper ring 21. These tabs 24 remain above the collar 202, slightly raised or in contact with it, when the cap 100 is in the intermediate holding position. They are intended to bear under the collar 202 of the neck 201 of the bottle 200, when the cap 100 is in the locking position.

[0016] The cage 20 is further formed of a second material, elastomer, defining a cap 25 configured to seal the bottle 200, when the flexible tabs 24 are gripped under the collar 202, that is to say in the locking position of the cap 100 on the bottle. At least one internal face (that is to say a face oriented towards the inside of the cage) of the upper ring 21 made of the first material is integral with the cap 25 made of the second material. Advantageously, in addition to the internal face of the upper ring 21, a portion of an internal face of the branches 22 is also integral with the cap 25, as illustrated in the figures 3a, 3b , 5 .

[0017] As will be described later, the bi-material cage 20 is formed by plastic bi-injection molding.

[0018] According to a first variant ( figure 3a, figure 3b ), the stopper 25 of the cage 20 comprises a foot 252, of generally cylindrical shape, sized to enter and close the neck 201 of the bottle 200. The stopper 25 also comprises a head 251 secured to the internal face of the upper ring 21 and, preferably, also secured to a portion of the internal face of each branch 22.

[0019] For example, for a conventional bottle 200 whose inner diameter of the neck 201 is 13 mm, the diameter of the foot 252 may be 13.2 mm. When the foot 252 is fully inserted into the neck 201, in the locking position, the head 251 is held in contact with the collar 202 of the bottle 200 with a certain level of compression and contributes to the sealing of the closure. The foot 252 may have different lengths, depending on the main axis z, for example between 2.5 mm and 7.5 mm.

[0020] According to a second variant ( figure 4 ), the plug 25 also comprises a foot 252 and a head 251, the latter being integral with the internal face of the upper ring 21 and, advantageously, also integral with a portion of the internal face of each branch 22.

[0021] This variant is particularly suitable when the contents of the bottle 200 are intended to be lyophilized, before sealing. Indeed, the foot 252 of the stopper 25 has a window 252f in its cylindrical wall opening out on the side of its free end, to allow the passage of evaporative flows from the inside of the bottle 200 to the outside, as long as said foot 252 is not completely pushed into the neck 201, that is to say in the intermediate holding position of the locking cap 100. Optionally, at least the bridge 23 opposite this window 252f may include an open space, so as to further facilitate the evaporative flows. For example, the open space may be similar to that proposed in document FR3098504A1.Note that the option of providing an open space in at least one bridge 23 of the cage 20 can also be implemented within the framework of the first variant or even the third variant described below, when freeze-drying of the contents of the bottle 200 is planned, with the locking cap 100 in the intermediate holding position.

[0022] According to a third variant, the plug 25 comprises only a head 251, without a foot 252. The head 251 is integral with the internal face of the upper ring 21 and, advantageously, also integral with a portion of the internal face of each branch 22, as illustrated in the figure 5 .

[0023] In this configuration, it is only the compression of the head 251 against the collar 202 of the bottle 200, in the locking position of the cap 100, which ensures the seal.

[0024] According to a fourth variant ( Figure 6 ), the stopper 25 comprises a head 251 and a foot 252 with a V-shaped profile. Even if the other elements of the cage 20 (ring 21, branches 22, bridges 23, tabs 24) are not shown on the figure 6 to facilitate the visualization of the stopper 25, they are indeed part of the cage 20 according to this variant and the head 251 is here again integral with the internal face of the upper ring 21 and, advantageously, also integral with a portion of the internal face of each branch 22. The free end 252b of the foot 252 is rectangular and has a slot, through which a pipette can for example be inserted to take the solution contained in the bottle 200, after removal of all or part of the locking cap 100. The particular configuration of the foot 252 makes it possible to maintain a seal when the pipette is removed.

[0025] In the various variants stated, the sealing of the bottle 200 is ensured by the insertion of the foot 252 into the neck 201 (when the foot is present) and by the compression of the head 251 of the stopper 25 against the collar 202 when the tabs 24 of the cage 20 are gripped under said collar 202. The thickness of the head 251 (along the main axis z) in line with the upper ring 21 of the cage 20, which thickness will also be in line with the collar 202 in the locking position of the cap 100, must therefore be precisely adjusted with the positioning of the tabs 24. The hardness of the second material forming the head 251 of the stopper 25 is also an important parameter.The thickness and hardness of the head 251 must be able to absorb the thickness tolerances of the collar 202 of the bottle 200; they must also ensure that the upper ring 21 of the cage 20 puts the head 251 in compression against the collar 202, to guarantee sealing, when the tabs 24 are gripped under said collar.

[0026] Advantageously, the hardness of the second material is between 20 and 45 Shore A.

[0027] The characteristics of the bi-material cage 20 therefore give it the dual function of stopper 25 for sealing the bottle 200 and of a member for locking said stopper on the bottle 200.

[0028] As mentioned above, the first material and the second material of the cage 20 are bi-injected, that is to say manufactured using a known bi-injection or bi-material plastic injection process. Such a process makes it possible to produce on a single press, with a single tool, a part (the cage 20) composed of two materials with different characteristics.

[0029] The fact that the two materials are bi-injected guarantees a perfect adjustment of the dimensions and excellent solidarity between the different elements constituting the cage 20, namely the cap 25 on the one hand, and the upper ring 21, the branches 22, the bridges 23 and the tabs 24 on the other hand.

[0030] The second material may be chosen from silicone or a thermoplastic elastomer (TPE) material, materials having a low extractable profile (i.e., few or no species composing them are likely to migrate into the pharmaceutical solution contained in the bottle 200). The first material is advantageously polycarbonate, due to its mechanical strength. The attachment between the first and second materials may be chemical and / or mechanical in nature. It will be chemical in nature if the two materials used are capable of adhering to each other, during bi-injection molding. In general, a mechanical attachment is implemented (with or without chemical contribution to the attachment) by defining additional retaining means and recesses at the surfaces of the two materials that are in contact.Typically, the head 251 of the plug 25 comprises at least one first recess Ev1 and at least one first shoulder Ep1, Ep1', complementary to at least one second shoulder Ep2 and at least one second recess Ev2, Ev2' defined on the internal face of the upper ring 21 or on the internal face of the branches 22 (. figure 3a, figure 3b ). The recesses and shoulders may be circular or extend only locally on the contacting faces, as seen in the figure 6 .

[0031] Advantageously, the head 251 of the plug 25 extends into the central orifice of the upper ring 21, until it is flush with the external surface 21a of said ring 21 ( figure 2c , figure 3b ). The upper surface 251a of the head 251 being at the same level, along the main axis z, as the external surface 21a, there is no retention zone for liquid(s) or particle(s) in the central orifice, retention zone ZR which exists in the locking caps of the state of the art ( figures 1a et 1b ). Such an area may pose contamination problems when the contents of the bottle 200 are withdrawn by inserting a sampling needle through the stopper 25, at the central orifice of the upper ring 21.

[0032] Also advantageously, the foot 252 of the plug 25 (when it is present and has a generally cylindrical shape) is hollowed out and comprises a cavity which can also extend into the head 251, in particular when the upper surface 251a of said head 251 is flush with the external surface 21a of the upper ring 21, so as to limit the central thickness to be crossed along the main axis z by a sampling syringe ( figure 3b ). This central thickness to be passed through is intended to be identical to the usual thickness to be passed through for state-of-the-art caps (typically between 1mm and 5mm), so that the user does not perceive any difference when taking the sample, whatever the type of cap and / or locking cap.

[0033] The locking cap 100 therefore comprises the previously described bi-injected cage 20, as well as an external body 30 and a capsule 40. The external body 30 is configured to completely surround the cage 20, so as to prevent any access to said cage 20 from the outside, when the cap 100 locks the container 200. The external body 30 has a generally cylindrical shape; it is defined by an upper face 31 and a cylindrical wall 32 centered on the main axis z ( figures 2b ). The free end of the cylindrical wall 32 defines an opening, adapted to accommodate the cage 20, before the positioning of the cap 100 on the neck 201 of the bottle 200. Another opening, called the upper opening, is provided in the upper face 31.

[0034] The external body 30 is fixed to the cage 20, for example, by cooperation of lugs 221 with a complementary groove 321 arranged on the internal face of the cylindrical wall 32 of the body 30 ( figure 2b, figure 2c ). The upper opening is centered on and surrounds a central orifice of the upper ring 21 of the cage 20.

[0035] The capsule 40 is held on the upper face 31 of the outer body 30, to close the upper opening and prevent access to the head 251 of the cap 25. As illustrated in the figure 2b, the capsule 40 may comprise a plurality of tabs 41, arranged in the upper opening of the body 30. These tabs 41 are then deformed to be pressed against the internal surface of the upper face 31, that is to say to extend substantially in the plane (x,y). The fixing of the capsule 40 on the body 30 can be carried out by shaping. After this step, the cage 20 can be introduced into the body 30 to be fixed axially by cooperation of the lugs 221 with the complementary groove 321. The locking cap 100 thus assembled can then be arranged in the intermediate holding position then in the locking position on the bottle 200 to be sealed.

[0036] The outer body 30 and the cap 40 may be formed from materials such as polycarbonate (PC), polypropylene (PP) or polybutylene terephthalate (PBT). Advantageously, the cap 40 is formed from flexible plastic materials such as, for example, polypropylene (PP), to facilitate its gripping. It is recalled, in fact, that when the user wishes to remove the contents of the bottle 200 sealed by the locking cap 100, he applies a force to the cap 40 to remove it and thus have access to the cap 25, via the upper opening of the body 30.

[0037] Thanks to the characteristics of the locking cap 100 according to the invention, and in particular thanks to the characteristics of the dual-function bi-injected cage 20, the number of elements to be assembled to form the cap 100 is limited, the problems linked to uncertainties or variability of dimensions between the elements are removed, in particular between an independent cap and a conventional cage, and finally the disadvantages and risks of damage to the cap by its mechanical association in a conventional cage are eliminated.

[0038] Of course, the invention is not limited to the embodiments and examples described, and variant embodiments may be made without departing from the scope of the invention as defined by the claims.

Claims

1. Bi-injection molded housing (20) of a locking cap (100) for a pharmaceutical vial, composed of: - a first material forming an upper ring (21), legs (22) of which the upper ends are rigidly connected to the upper ring (21), and bridges (23) connecting the lower ends of the legs (22) in pairs, at least some bridges (23) comprising a flexible tab (24) intended to engage under a flange (202) of the vial (200), and - a second material, elastomer, forming a stopper (25) which is configured to seal the vial (200) when the flexible tabs (24) engage under the flange (202), at least one inner face of the upper ring (21), made of the first material, being rigidly connected to the stopper (25), made of the second material.

2. Bi-injection molded housing (20) according to the preceding claim, wherein the stopper (25) comprises a base (252) which is dimensioned for being inserted into the neck (201) of the vial (200), and a head (251) which is rigidly connected to an inner face of the upper ring (21) and, advantageously, also rigidly connected to a portion of an inner face of each leg (22).

3. Bi-injection molded housing (20) according to the preceding claim, wherein the base (252) has a generally cylindrical shape and comprises a window (252f) in its cylindrical wall that opens on the side of its free end.

4. Bi-injection molded housing (20) according to claim 2, wherein the base (252) has a V-shaped profile and comprises a rectangular free end (252b) in which a slot is arranged.

5. Bi-injection molded housing (20) according to claim 1, wherein the stopper (25) consists only of a head (251) that is rigidly connected to an inner face of the upper ring (21) and, advantageously, also rigidly connected to a portion of an inner face of each leg (22).

6. Bi-injection molded housing (20) according to one of claims 2 to 5, wherein the head (251) of the stopper (25) extends into a central hole of the upper ring (21) until flush with an outer surface (21a) of said ring (21) delimiting the central hole.

7. Bi-injection molded housing (20) according to one of claims 2, 3 and 6, wherein the base (252) of the stopper (25) has a generally cylindrical shape, is recessed and comprises a cavity which also extends into the head (251) so as to limit a central thickness of the head (251) to be passed through along a main axis (z) of the housing (20).

8. Bi-injection molded housing (20) according to one of claims 2 to 7, wherein the head (251) of the stopper (25) comprises at least one recess (Ev1) and at least one shoulder (Ep1, Ep1') which are complementary to at least one shoulder (Ev2) and at least one recess (Ev2, Ev2') defined on the inner face of the upper ring (21) and / or of the legs (22).

9. Bi-injection molded housing (20) according to one of the preceding claims, wherein the first material is made of polycarbonate.

10. Bi-injection molded housing (20) according to one of the preceding claims, wherein the second material is selected from among silicone and a thermoplastic elastomer material.

11. Bi-injection molded housing (20) according to one of the preceding claims, wherein the second material has a hardness of between 20 and 45 Shore A.

12. Locking cap (100) for a pharmaceutical vial, comprising: - a bi-injection molded housing (20) according to one of the preceding claims, - an external body (30) that surrounds the housing (20) and is fixed thereto, the external body (30) comprising an opening in its upper face (31), said opening being centered on and surrounding a central hole of the upper ring (21) of the housing (20), - a capsule (40) held on an upper face (31) of the outer body (30) for closing the opening and preventing access to the stopper (25).