BI-INJECTED CAGE WITH A LOCKING CAP, PHARMACEUTICAL VIAL

Abstract

The invention relates to a bi-injected cage (20) for a locking cap (100) for a pharmaceutical vial, comprising: - a first material forming an upper ring (21), arms (22) whose upper ends are integral with the upper ring (21), and bridges (23) connecting the lower ends of the arms (22) in pairs, at least some of the bridges (23) having a flexible tab (24) for gripping under a collar (202) of the vial (200), and - a second material, an elastomer, forming a stopper (25) configured to seal the vial (200) when the flexible tabs (24) are gripped under the collar (202), at least one inner face of the upper ring (21) in the first material being integral with the stopper (25) in the second material. Figure to be published with the abbreviation: Figure 2c

Description

Title of the invention: Reinjected cage of a locking cap for a pharmaceutical vial. Scope 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 of two materials so as to integrate the function of the stopper.

[0002] TECHNOLOGICAL BACKGROUND OF THE INVENTION

[0003] A bottle for medical or pharmaceutical use is usually sealed by a stopper made of elastomeric material which is secured to said bottle by a locking cap as described in documents EP2464577A1 or FR3098504A1, and illustrated in figures 1a and 1b. The locking cap 100' comprises an outer body 30, a cage 20' and an upper cap 40. The foot 11 of a stopper 10' is inserted into the neck 201 of the bottle 200 and held in this position by the cage 20' which grips under the collar 202 of the bottle. The external body 30 is fixed to the cage 20' and prevents any access to it, thus securing the closure of the bottle 200. The upper cap 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 outer 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 cap 40 until its removal.

[0004] Before being attached to the bottle 200 with the stopper 10', the locking cap 100' can be supplied alone or together with the stopper 10'. The cage 20' comprises an upper ring and a plurality of arms connected to the upper ring and defining with it a general cylindrical shape. It also comprises a plurality of bridges, each connecting two adjacent arms. Some bridges have a flexible tab 24' inclined relative to the arms towards the interior of the cage 20', in the direction of the upper ring. These tabs 24' are intended to lock the stopper 10' inside the cage 20', against the upper ring, when the stopper 10' is attached to the cap 100'. The legs 24' bend to allow the head 12 of the plug 10' to pass through when it is introduced into the cage 20', and come to lock under the head 12, to prevent the plug 10' from getting out of said cage 20'.

[0005] One risk associated with this cap-cage association is that the legs 24' may damage the elastomer material of the cap 10' due to their potentially protruding edges.

[0006] Another disadvantage may arise from the fact that tolerances on the dimensions of the 10' stoppers or variations in dimensions or hardness of the 10' stoppers, depending on the suppliers, may modify the compression of the 10' stopper against the collar 202 of the bottle, by the cage 20' of the locking cap, and thus impact the sealing of the closure.

[0007] SUBJECT OF THE INVENTION

[0008] The present invention proposes a solution to remedy 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 incorporating the function of the plug.

[0009] BRIEF DESCRIPTION OF THE INVENTION

[0010] The invention relates to a bi-injected cage of a locking cap for a pharmaceutical vial, composed of:

[0011] - of a first material forming an upper ring, branches of which ex upper ends are integral with the upper ring, and with bridges connecting pairs of the lower ends of the branches, at least some bridges having a flexible tab designed to grip under a collar of the bottle, and

[0012] - of a second material, elastomer, forming a cap configured to seal the bottle when the flexible tabs are gripped under the collar,

[0013] at least one inner face of the upper ring in first material being integral with the cap in second material.

[0014] According to advantageous and non-limiting features of the invention, taken alone or in any technically feasible combination: - the stopper includes a foot sized to fit into the neck of the bottle and a head attached to an inner face of the upper ring and, advantageously, also attached to a portion of an inner face of each arm; - the base has a general cylindrical shape and includes a window in its cylindrical wall opening onto the side of its free end; - the foot has a V-shaped profile and includes a rectangular free end in which a slot is provided; - the stopper consists solely of a head attached to an inner face of the upper ring and, advantageously, also attached to a portion of an inner 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 base of the stopper has a general cylindrical shape, is hollowed out and includes a cavity which also extends into the head, so as to limit a central thickness to be crossed from the head along a main axis of the cage; - the head of the cap includes at least one recess and at least one shoulder, complementary to at least one shoulder and at least one recess defined on the inner 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 between 20 and 45 Shore A.

[0015] The invention also relates to a locking cap for a pharmaceutical vial comprising:

[0016] - a bi-injected cage such as above,

[0017] - an external body, surrounding the cage and fixed to the latter, the external body comprising an opening in its upper face, said opening being centered on and surrounding a central orifice of the upper ring of the cage,

[0018] - a capsule held on an upper surface of the external body, to close the opening and prevent access to the cap. BRIEF DESCRIPTION OF THE FIGURES

[0019] Other features and advantages of the invention will become apparent from the detailed description of the invention which follows with reference to the accompanying figures in which:

[0020] [Fig. la]

[0021] [Fig.lb] Figures 1a and 1b show a locking cap on a bottle, in an intermediate holding position (a) and in a locking position (b), according to the prior art;

[0022] [Fig.2a]

[0023] [Fig.2b]

[0024] [Fig. 2c] Figures 2a, 2b and 2c show 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 bi-material cage according to the present invention (c);

[0025] [Fig.3a]

[0026] [Fig. 3b] Figures 3a and 3b present a first variant of a bi-material cage in accordance with the present invention, side view (a) and cross-sectional view (b);

[0027] [Fig.4] Fig.4 presents a second variant of a bi-material cage conforming to the present invention, seen in perspective from below;

[0028] [Fig. 5] Figure 5 presents a third variant of a bi-material cage conforming to the present invention, seen in side perspective;

[0029] [Fig.6] Figure [Fig.6] presents a fourth variant of a portion of the bi-material cage in accordance with the present invention: the perspective view includes only the cage stopper in order to facilitate visualization of its shape.

[0030] In the descriptive part, the same references on the figures may be used for elements of the same type. DETAILED DESCRIPTION OF THE INVENTION

[0031] 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 collar 202 that is flared relative to the outer perimeter of the neck 201, as illustrated in Figures 1a and 1b of the prior art. In the field of pharmaceutical applications, there are standards in terms of the inner diameter of the neck 201 of the bottle 200: 13 mm and 20 mm are examples. The cap 100 is intended to lock a stopper 25 in the neck 201 or against the collar 202 of said bottle 200 to seal it hermetically.

[0032] When used with the bottle 200, the locking cap 100, as is known, can assume two positions on said bottle: a first position, called the intermediate holding position, in which it remains removable, similarly to the illustration in [Fig. 1a]. It can also assume a second position, called the locking position, in which it is locked onto the bottle 200, similarly to the illustration in [Fig. 1b], and hermetically seals the bottle 200.

[0033] The locking cap 100 comprises a capsule 40, an outer body 30, and a cage 20 ([Fig. 2a], [Fig. 2b], [Fig. 2c]). The originality of the locking cap 100, compared to those of the prior art, lies in its cage 20. It is formed of a first material defining an upper ring 21, arms 22 whose upper ends are integral with the upper ring 21, and bridges 23 connecting the lower ends of the arms 22 in pairs. These elements give the cage 20 a general cylindrical shape centered on a principal axis z. The upper ring 21 has a central orifice delimited by an external surface 21a, usually circular.

[0034] As can be seen in [Fig. 2c], at least some of the bridges 23 have a flexible tab 24 inclined relative to the arms 22 towards the inside of the cage 20, at an angle between 20° and 60°, advantageously around 30°, in the direction of 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 against the collar 202 of the neck 201 of the bottle 200, when the cap 100 is in the locking position.

[0035] The cage 20 is further formed of a second material, elastomer, defining a stopper 25 configured to seal the bottle 200, when the flexible tabs 24 are gripped under the collar 202, i.e., in the locking position of the cap 100 on the bottle. At least one inner face (i.e., a face facing the inside of the cage) of the upper ring 21 made of the first material is integral with the stopper 25 made of the second material. Advantageously, in addition to the inner face of the upper ring 21, a portion of an inner face of the arms 22 is also integral with the stopper 25, as illustrated in Figures 3a, 3b, and 5.

[0036] As will be described later, the bi-material cage 20 is formed by plastic bi-injection molding.

[0037] According to a first variant ([Fig.3a], [Fig.3b]), the stopper 25 of the cage 20 comprises a foot 252, generally cylindrical in shape, dimensioned to enter into and seal the neck 201 of the bottle 200. The stopper 25 also comprises a head 251 integral with the inner face of the upper ring 21 and, preferably, also integral with a portion of the inner face of each arm 22.

[0038] By way of example, for a conventional bottle 200 with an inner diameter of neck 201 of 13 mm, the diameter of the foot 252 can be 13.2 mm. When the foot 252 is fully inserted into the neck 201, in the locked position, the head 251 is held against the collar 202 of the bottle 200 with a certain degree of compression and contributes to the sealing of the closure. The foot 252 can have different lengths, along the principal axis z, for example, between 2.5 mm and 7.5 mm.

[0039] According to a second variant ([Fig.4]), the stopper 25 also includes a foot 252 and a head 251, the latter being integral with the inner face of the upper ring 21 and, advantageously, also integral with a portion of the inner face of each branch 22.

[0040] This variant is particularly suitable when the contents of the vial 200 are intended to be lyophilized before sealing. Indeed, the foot 252 of the cap 25 has a window 252f in its cylindrical wall opening at its free end, to allow the passage of evaporative fluxes from the inside of the vial 200 to the outside, as long as said foot 252 is not fully inserted into the neck 201, i.e., in the intermediate holding position of the locking cap 100. Optionally, at least the bridge 23 opposite this window 252f may have an open space, so as to further facilitate the evaporative fluxes. 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 in the first variant or the third variant described below, when lyophilization of the contents of the vial 200 is planned, with the locking cap 100 in the intermediate holding position.

[0041] According to a third variant, the cap 25 comprises only a head 251, without foot 252. The head 251 is integral with the inner face of the upper ring 21 and, advantageously, also integral with a portion of the inner face of each branch 22, as illustrated in [Fig.5].

[0042] 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, that ensures the seal.

[0043] According to a fourth embodiment ([Fig. 6]), the stopper 25 comprises a head 251 and a foot 252 with a V-shaped profile. Although the other elements of the cage 20 (ring 21, arms 22, bridges 23, tabs 24) are not shown in [Fig. 6] to facilitate visualization of the stopper 25, they are indeed part of the cage 20 according to this embodiment, and the head 251 is again integral with the inner face of the upper ring 21 and, advantageously, also integral with a portion of the inner face of each arm 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 withdraw 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 ensures a seal when the pipette is withdrawn.

[0044] In the various variants described, 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 compressing the head 251 of the cap 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 principal axis z) directly above the upper ring 21 of the cage 20, which thickness will also be directly above 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 cap 25 is also an important parameter.The thickness and hardness of the head 251 must be able to accommodate the thickness tolerances of the collar 202 of the bottle 200; they must also ensure that the upper ring 21 of the cage 20 compresses the head 251 against the collar 202, to guarantee sealing, when the tabs 24 are gripped under said collar.

[0045] Advantageously, the hardness of the second material is between 20 and 45 Shore A.

[0046] The characteristics of the bi-material cage 20 therefore give it the dual function of a stopper 25 to seal the bottle 200 and of a locking element for said stopper on the bottle 200.

[0047] As mentioned previously, the first and second materials of cage 20 are bi-injected, that is, manufactured using a known bi-injection or two-material plastic injection process. Such a process makes it possible to produce on a single press, with a single tooling, one part (the cage 20) composed of two materials with different characteristics.

[0048] The fact that the two materials are bi-injected guarantees a perfect fit of the dimensions and excellent bonding between the different elements constituting the cage 20, namely the plug 25 on the one hand, and the upper ring 21, the arms 22, the bridges 23 and the tabs 24 on the other hand.

[0049] The second material can be chosen from silicone or a thermoplastic elastomer (TPE), materials with a low extractability profile (i.e., few or no constituent species are likely to migrate into the pharmaceutical solution contained in the vial 200). The first material is advantageously polycarbonate, due to its mechanical strength. The bond between the first and second materials can be chemical and / or mechanical. It will be chemical if the two materials used are capable of adhering to each other during the bi-injection molding process. Generally, a mechanical bond is achieved (with or without chemical contribution to the bond) by defining retention means and complementary recesses at the surfaces of the two materials in contact.Typically, the head 251 of the plug 25 comprises at least one first recess Evl and at least one first shoulder Epi,Epi', complemented by at least one second shoulder Ep2 and at least one second recess Ev2,Ev2' defined on the inner face of the upper ring 21 or on the inner face of the arms 22 ([Fig.3a], [Fig.3b]). The recesses and shoulders may be circular or extend only locally on the contacting faces, as can be seen in [Fig.6].

[0050] Advantageously, the head 251 of the cap 25 extends into the central orifice of the upper ring 21, until it is flush with the outer surface 21a of said ring 21 ([Fig. 2c], [Fig. 3b]). Since the upper surface 251a of the head 251 is at the same level, along the principal axis z, as the outer surface 21a, there is no retention zone for liquid(s) or particle(s) in the central orifice, a retention zone ZR that exists in prior art locking caps (Figures 1a and 1b). Such a zone can pose contamination problems when the contents of the bottle 200 are withdrawn by inserting a sampling needle through the cap 25, at the level of the central orifice of the upper ring 21.

[0051] Also advantageously, the foot 252 of the cap 25 (when present and generally cylindrical in shape) is hollowed out and includes a cavity that can also extend into the head 251, particularly when the upper surface 251a of said head 251 is flush with the outer surface 21a of the upper ring 21, so as to limit the central thickness to be traversed along the principal axis z by a sampling syringe ([Fig. 3b]). This central thickness to be traversed is intended to be identical to the usual thickness to pass through state-of-the-art stoppers (typically between 1mm and 5mm), so that the user does not perceive any difference when sampling, regardless of the type of stopper and / or locking cap.

[0052] The locking cap 100 therefore comprises the previously described bi-injected cage 20, as well as an outer body 30 and a cap 40. The outer body 30 is configured to completely surround the cage 20, so as to prevent any external access to said cage 20 when the cap 100 locks the container 200. The outer body 30 is generally cylindrical in shape; it is defined by an upper face 31 and a cylindrical wall 32 centered on the principal axis z (Figures 2b). The free end of the cylindrical wall 32 defines an opening, adapted to receive the cage 20, before the cap 100 is positioned on the neck 201 of the bottle 200. Another opening, called the upper opening, is provided in the upper face 31.

[0053] The external body 30 is fixed to the cage 20, for example, by cooperation of lugs 221 with a complementary groove 321 formed on the inner face of the cylindrical wall 32 of the body 30 ([Fig. 2b], [Fig. 2c]). The upper opening is centered on and surrounds a central orifice of the upper ring 21 of the cage 20.

[0054] The cap 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 [Fig. 2b], the cap 40 may have 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 inner surface of the upper face 31, i.e., to extend substantially in the (x,y) plane. The cap 40 can be attached to the body 30 by shaping. After this step, the cage 20 can be inserted into the body 30 and axially secured by the cooperation of the tabs 221 with the complementary groove 321. The locking cap 100 thus assembled can then be positioned in an intermediate holding position and then in a locking position on the bottle 200 to be sealed.

[0055] 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 should be noted that when the user wishes to withdraw the contents of the bottle 200 sealed by the locking cap 100, they apply force to the cap 40 to remove it and thus gain access to the stopper 25, via the upper opening of the body 30.

[0056] 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, and the problems are overcome. matics related to uncertainties or variabilities of dimensions between elements, in particular between an independent plug and a classic cage, finally we eliminate the disadvantages and risks of damage to the plug by its mechanical association in a classic cage.

[0057] Of course, the invention is not limited to the modes of implementation and examples described, and alternative embodiments can be made without departing from the scope of the invention as defined by the claims.

Claims

Claims

1. Bi-injected cage (20) of a locking cap (100) for a bottle for pharmaceutical use, composed of: - a first material forming 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), at least some bridges (23) comprising a flexible tab (24) intended to grip under a collar (202) of the bottle (200), and - a second material, elastomer, forming a stopper (25) configured to seal the bottle (200) when the flexible tabs (24) are gripped under the collar (202), at least one internal face of the upper ring (21) in first material being integral with the stopper (25) in second material.

2. Bi-injected cage (20) according to the preceding claim, in which the stopper (25) comprises a foot (252) sized to fit into the neck (201) of the bottle (200) and a head (251) secured to an internal face of the upper ring (21) and, advantageously, also secured to a portion of an internal face of each branch (22).

3. Bi-injected cage (20) according to the preceding claim, in which the foot (252) has a generally cylindrical shape and comprises a window (252f) in its cylindrical wall opening out on the side of its free end.

4. Bi-injected cage (20) according to claim 2, in which the foot (252) has a V-shaped profile and comprises a rectangular free end (252b) in which a slot is arranged.

5. Bi-injected cage (20) according to claim 1, in which the plug (25) is solely made up of a head (251) secured to an internal face of the upper ring (21) and, advantageously, also secured to a portion of an internal face of each branch (22).

6. Bi-injected cage (20) according to one of claims 2 to 5, in which the head (251) of the plug (25) extends into a central orifice of the upper ring (21), until it is flush with an external surface (21a) of said ring (21) delimiting the central orifice.

7. Bi-injected cage (20) according to one of claims 2, 3 and 6, in which the foot (252) of the plug (25) has a generally cylindrical shape, is hollowed out and comprises a cavity which also extends into the head (251), so as to limit a central thickness to be crossed by the head (251) along a main axis (z) of the cage (20).

8. Bi-injected cage (20) according to one of claims 2 to 7, in which the head (251) of the plug (25) comprises at least one recess (Evl) and at least one shoulder (Epi, Epi'), complementary to at least one shoulder (Ev2) and at least one recess (Ev2, Ev2') defined on the internal face of the upper ring (21) and / or the branches (22).

9. Bi-injected cage (20) according to one of the preceding claims, in which the first material is polycarbonate.

10. Bi-injected cage (20) according to one of the preceding claims, in which the second material is chosen from silicone and a thermoplastic elastomer material.

11. Bi-injected cage (20) according to one of the preceding claims, in which the second material has a hardness of between 20 and 45 Shore A.

12. Locking cap (100) for a vial for pharmaceutical use comprising: - a bi-injected cage (20) according to one of the preceding claims, - an external body (30), surrounding the cage (20) and fixed to the latter, the external body (30) having an opening in its upper face (31), said opening being centered on and surrounding a central orifice of the upper ring (21) of the cage (20), - a capsule (40) held on an upper face (31) of the external body (30), to close the opening and prevent access to the stopper (25).

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