Lock cover for a container having a neck, having a cap with a breakable clamping lug

Abstract

The present invention relates to a locking cover (1) for a container (2) having a cage (6) made of plastic, a body (7) made of plastic secured around the cage (6), the body having a central orifice (9), a cap (10) configured to close the central orifice (9), the cap (10) having a neck (3) with a flat head (11) covering the orifice (9) and a plurality of fastening lugs (12) sandwiched between the cage (6) and the body (7), each of the fastening lugs (12) having a breakable region (12b), the cap (10) being made of a plastic material different from the plastic material of the cage (6) and the plastic material of the body (7), the plastic material of the cap being selected to have a resistance to rupture that is reduced by a dose of gamma irradiation used to sterilize the locking cover (1).

Description

Technical Field

[0001] The present invention relates to a lock cover for a container having a neck, which is intended to block a stopper of the neck of the container. More specifically, it relates to a lock cover for a container having a neck used in the medical or pharmaceutical field, and a breakable cap is provided to prove the inviolability of the container.

Background Art

[0002] Technical Background of the Invention The inviolability, i.e., proof, that a medical product has already been used or that a container containing a medical solution has already been opened, whether intentionally or not, is an important issue, particularly from the perspective of limiting the risk of patient contamination. The present invention relates particularly to the case of a container having a neck.

[0003] French Patent Invention No. 2893922 discloses that a lock cover is arranged on a stopper and locks the container having a neck in an assembled state. This lock cover is provided with a central orifice for accessing the contents of the container through the stopper, and this orifice is closed by a cap welded to the cover. In order to access the contents of the container, it is necessary to break the connection between the cap and the cover. Thus, since the cap is irreversibly separated from the cover, the cap cannot be reused. Therefore, by breaking this connection, it can be shown that the container has been used for the first time. However, the method of assembling this lock-type cover is complicated and particularly has a welding process. It would be beneficial to have a simpler method of assembly. Also, since the cap is welded, the cap is held very strongly to the lock cover, and the breaking of the connection may not be ergonomically successful.

[0004] International Publication No. 2011 / 039004 proposes another approach. In this document, the cap is not welded to the cover but is configured to be irreversibly removed from the cover without the possibility of it being returned to its initial state. More specifically, the cap comprises a flat head and a plurality of clamping lugs projecting substantially perpendicularly to the head. These lugs are sandwiched between various elements constituting the cover during assembly. This sandwiching makes it possible to exceed the elastic limit of the clamping lugs, which remain in a folded state when the cap is separated from the locking cover. The combination of this folded shape of the lugs and the protrusions at the ends of the lugs makes it difficult to reassemble the cap onto the locking cover.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0006] However, it has been found that under very strict conditions, it is possible to reinstall the cap on the cover of the container, which reduces the reliability of the proof of first use and the proof of the inviolability of the container.

[0007] Also, as is known from the documents of International Publication No. 2013 / 034594 and French Patent Invention No. 1334575, the locking cover comprises a cap provided with breakable clamping lugs. To access the contents of the container, it is necessary to remove the cap, which leads to breaking the clamping lugs. Therefore, it is impossible to relocate the cap on the cover to hide attempts to open or attempt to open the container.

[0008] The design and manufacture of a cap fitted with such a breakable clamping lug must be fully mastered. The force applied to it to remove the cap from the cover must not be excessive for the user. At the same time, the fastener must not be too breakable so as not to break them when initially assembling the cap to the remaining part of the cover. However, variations that appear within the manufacturing process of the cap or between the manufacturing processes of different caps affect this perfect mastery of the breakable nature of the clamping lug, and as a result, affect the manufacturing yield at the first assembly of the cap, or affect the ease of use of the solution by the fact that the effort to remove the cap varies greatly from container to container.

[0009] Generally, when using equipment in the medical field, regardless of the solution selected to seal the container so that the contents cannot be accessed, it is necessary to sterilize the equipment in advance. This sterilization is generally performed by irradiating the medical device with a sufficient amount of gamma rays. Therefore, the materials forming such medical devices are selected so as not to be affected by this irradiation, especially with regard to their mechanical strength, especially when it is made of plastic.

[0010] An object of the present invention is to propose a lock cover provided with a breakable cap that at least partially overcomes the aforementioned drawbacks. An object of the present invention is, in particular, to propose a cap for a lock cover for a container having a neck, the cap being provided with a breakable clamping lug that is rigid enough to limit the risk of breaking during assembly of the cap to the cover, while being breakable enough to facilitate this breakage during removal of the cap once assembled.

Means for Solving the Problems

[0011] Brief Description of the Invention In order to achieve this object, the object of the present invention is to propose a locking cover for a container having a neck intended to block a stopper of the neck of the container, - A cage made of a plastic material, configured to surround the stopper and the neck and lock them in an axial position relative to each other, - A body made of a plastic material, clamped around the cage, the body having a central orifice that provides access from the outside of the cover to the inside of the container through the stopper, - A cap configured to close the central orifice, the cap comprising a flat head for covering the orifice and a plurality of clamping lugs sandwiched between the cage and the body, The locking cover comprises, - Each of the clamping lugs has a frangible region, - The cap is formed of a plastic material different from the plastic material of the cage and the plastic material of the body, and the plastic material of the cap is selected to have a resistance to rupture that decreases with the dose of gamma ray irradiation for sterilizing the locking cover.

[0012] According to other advantageous and non-limiting features of the present invention, alone or in any technically feasible combination, - The material of the cap contains polypropylene, - The frangible region corresponds to a local thickness reduction of the thickness of the clamping lug, such as a notch or a groove, - The frangible region has a thickness of 30% to 70% of the thickness of the clamping lug, - The frangible region is located at the joint region of the clamping lug on the head of the cap, - After being irradiated with 50 kGy of gamma rays, the material of the cap shows a loss of elongation of 25% or more.

[0013] The present invention also relates to a method for preparing a locking cover as disclosed above, - Place the cap on the cover body, with the tightening lug of the cap extending into the central orifice of the body. - Insert the cage into the body and grip the tightening lug of the cap sandwiched between the body and the cage to form the assembled lock cover. - Include sterilizing the assembled lock cover by gamma rays.

[0014] This gamma-ray irradiation can be at a dose of 10 kGy to 20 kGy.

[0015] Other features and advantages of the present invention will become apparent from the following detailed description of the present invention provided with reference to the accompanying drawings.

Brief Description of the Drawings

[0016]

Figure 1

Figure 2a

Figure 2b

Figure 3

Figure 4

Modes for Carrying Out the Invention

[0017] Detailed Description of the Invention Overall image of the lock cover Figure 1 shows a lock cover 1 for a container 2 having a neck 3 according to the present invention, which is intended to block a stopper 4 within the neck 3 of the container 2, and the cover 1 is shown here simply placed on the neck 3 without being locked.

[0018] Here, the neck 3 having a circular opening has an outer peripheral lip 5 at its end, and when the cover 1 is locked to the neck 3 of the container 2 on this lip, the locking cover 1 is blocked. The stopper 4 has a conventional generally cylindrical T-shape with a head 4a and a base 4b, the head having a diameter slightly larger than that of the base 4b, and when the base 4b of the stopper 4 is introduced into the neck 3, the head 4a comes into contact with the lip 5 of the neck 3.

[0019] The locking cover 1 comprises a cage 6 that can surround the stopper 4 and the neck 3 when the cover 1 is in the locked configuration on the neck 3 of the container 2, and a body 7 that can be fixed around the cage 6. The cage 6 is enabled by flexible tabs 8 arranged on the outer periphery of the cage 6 to block the stopper 4 within the neck 3, which is intended to be blocked under the lip 5. Other means of blocking the stopper 4 by the cage 6 are, of course, conceivable. In the assembled configuration of the cover 1, the body 7 completely covers the cage 6 laterally and prevents access to the cage 6 and the tabs 8 from the outside of the body 7. Both the body and the cage are formed from a plastic material that is less likely to deteriorate during gamma sterilization of the cover.

[0020] The loss of elongation of the material is a generally used criterion for measuring the effect of irradiation on its resistance to rupture. In the context of the present application, if the loss of elongation of the material after receiving a gamma-ray irradiation dose of 50 kGy is less than 25%, it is considered that the material has not deteriorated after receiving a sufficient amount of gamma rays for sterilization. Conversely, if the loss of elongation after receiving a gamma-ray irradiation dose of 50 kGy is 25% or more, it is considered that the material has deteriorated after receiving a sufficient amount of gamma-ray dose for sterilization and its resistance to rupture has decreased.

[0021] The body 7 and the cage 6 do not necessarily have to be made of the same material. For example, the plastic material forming the body 7 can be polybutylene terephthalate (also known by the abbreviation "PBT"), and that of the cage 6 can be polycarbonate (also known by the abbreviation "PC"). These two plastics require a gamma ray dose much larger than 500 kGy, or even larger than 1000 kGy, and the elongation loss caused by this irradiation will exceed 25%. Therefore, within the considered dose range, these do not deteriorate during the gamma sterilization of the cover.

[0022] Continuing with the general disclosure of the cover 1 in FIG. 1, the body 7 also includes a central orifice 9 that provides access from the outside of the cover 1, through the stopper 4, to the inside of the container 2. Thus, it is possible to access the contents of the container 2 through this orifice 9, for example, by inserting the needle of a syringe through the stopper 4. Of course, as can be seen in FIG. 4, it should be noted that the body 7 and the cage 6 also each have a central opening that allows access to the stopper 4 and thus to the contents of the container 2.

[0023] The lock cover 1 also includes a cap 10 configured to close the central orifice 9 and demonstrate the inviolability of the container 2. This cap 10 includes a flat head 11 for covering the orifice 9 and a plurality of clamping lugs 12. The plurality of clamping lugs 12 are sandwiched between the cage 6 and the body 7 to assemble the cap 10 to the lock cover 1.

[0024] Detailed description of the cap FIGS. 2a and 2b show the cap 10 according to the invention for closing the central orifice 9 of the body 7. This cap 10 has a plurality of clamping lugs 12, here, for example, eight lugs 12, which project perpendicularly to the flat head 11 of the cap 10 in the rest position.

[0025] The cap 10 having a flat head 11 and a plurality of clamping lugs 12 is preferably formed from a single piece of molded plastic material. The flat head 11 may have a shape such as a disc shape or other more complex shapes such as a polygon as long as the flat head surface 11 completely covers the central orifice 9.

[0026] The flat head 11 is provided here with gripping elements 11a in the form of reinforcement points, which can facilitate the gripping when removing the cap 10 from the cover 1.

[0027] The clamping lugs 12 are distributed circularly along the periphery of the orifice 9 of the body 7 when the cap 10 is in the assembled configuration on the body 7. The clamping lugs 12 may have chamfered and / or free ends with locking ridges 12a. The thickness of the clamping lugs 12 is 0.3 - 0.6 mm and may be, for example, 0.37 mm.

[0028] The locking ridges 12a have dimensions larger than the rest of the clamping lugs 12, and their purpose is to generate additional resistance to better secure the cap 10 to the cover 1 when attempting to remove the cap 10 by sliding the plurality of clamping lugs 12 out of their vise part. In the absence of the locking ridges 12a, there is an initial resistance that requires the application of a certain force to release the plurality of clamping lugs 12 from their vise part. This resistance is due to the folded shape made by them when the plurality of clamping lugs 12 are sandwiched between the body 7 and the cage 6. The presence of the locking ridges 12a causes the need to apply a force greater than a pre - determined force initially, to release the plurality of clamping lugs 12 from their vise part. This additional force increases as the dimensions of the ridges 12a increase. Preferably, the ridges 12a have a thickness 35% - 170% greater than the thickness of the clamping lugs 12, that is, for example, a thickness of 0.5 - 1.0 mm for clamping lugs 12 having a thickness of 0.37 mm.

[0029] It is beneficial that the cap 10 is destructible, and more particularly, it can be broken by a plurality of tightening lugs 12 when removed from the cover 1. In this way, since the cap 10 cannot be reattached to the cover 1, the drawer is irreversible and serves as a reliable indicator of first use.

[0030] To achieve this purpose, efforts have been made to reduce the resistance of the cap 10 to rupture, such that the force required to release the plurality of tightening lugs 12 from its vice part is greater than the force required to break the lugs of the cap 10. Thus, the cap 10 will break before the plurality of flexible lugs 12 are released from its vice part.

[0031] To achieve this, the cap 10 is formed from a plastic material, and its resistance to rupture is reduced by gamma-ray irradiation at a dose intended for sterilization of the cover 1. That is, the material from which the cap 10 is manufactured becomes more brittle after being subjected to gamma-ray irradiation, and its resistance to rupture decreases. This material is characterized by showing a loss of elongation of 25% or more when subjected to a gamma-ray irradiation dose of 50 kGy.

[0032] It can mainly be a polypropylene-based material, or it can be manufactured from polypropylene.

[0033] Gamma-ray irradiation for the purpose of sterilizing the cover is preferably carried out, typically at a dose of 10 kGy to 20 kGy, for example 15 kGy, after the cap 10 is assembled to the rest of the cover 1. Thus, only the plastic material constituting the cap 10 is deteriorated by this sterilization step, and the plastic materials forming the cage 6 and the body 7 are selected such that they are not likely to be excessively deteriorated during exposure to gamma rays.

[0034] It should be noted that even if the material of the cap deteriorates, there is no risk of contamination of the contents of the container. This is because the cap, due to its position and the configuration within the cover, does not come into contact with or expose the contents of the container, and for example, there is no risk of generating particles during deterioration and contaminating the container.

[0035] Therefore, the force that must be applied to break the plurality of lugs 12 of the cap 10 is lower after sterilizing gamma ray irradiation, and it becomes smaller than the force required to release the plurality of flexible lugs 12 from its vice part.

[0036] In addition, in order to promote and localize the breakage, each of the plurality of clamping lugs 12 has a breakable region 12b visible in FIG. 3. This breakable region 12b preferably corresponds to a local thinning of the thickness of the clamping lug 12. Thus, for example, it may be a notch or groove having a fixed or progressive thickness reduction delimited by one or more inclined slopes.

[0037] Preferably, the breakable region 12b corresponds to a part of the clamping lug 12 having a thickness of 0.11 - 0.26 mm for a clamping lug having a thickness of 30% - 70% of the thickness of the clamping lug 12, for example a thickness of 0.37 mm. Therefore, the dimensions of the breakable region, and more generally of the plurality of clamping lugs 12, are preferably selected so as to avoid the risk of breakage during the assembly of the elements of the cover 1 before the irradiation step.

[0038] Also preferably, the breakable region 12b is arranged at the joining region of the clamping lugs 12 on the head of the cap 10.

[0039] The characteristics of the destructible area 12b and the material of the cap 10 reduce the resistance of the cap 10 to rupture after the assembly of the lock cover 1, but prevent a plurality of lugs from breaking during assembly and have the effect of better identifying the location where the breakage occurs. By combining the presence of these destructible areas 12b with gamma-ray irradiation, the force required to break the destructible area 12b is further reduced, ensuring that the cap 10 breaks at the area 12b before the plurality of clamping lugs 12 have the possibility of becoming free from their vice parts.

[0040] Preparation and use of the lock cover Next, an operation for preparing the lock cover will be described with reference to FIGS. 1 and 4. FIG. 4 is a cross-sectional view of the cover 1, the components of which are assembled, while in FIG. 1, the components of the cover 1 are already assembled and arranged on the neck 3 of the container 2.

[0041] First, a cap 10 having a plurality of straight clamping lugs 12 is arranged on the body 7 of the cover 1, and the plurality of clamping lugs 12 extend into the central orifice 9 of the body 7 so that the flat head 11 completely covers the orifice 9. Advantageously, the cap 10 is arranged upside down, the plurality of clamping lugs 12 are upward, and then the body 7 is arranged on the cap 10 so that the plurality of tabs 12 penetrate the central orifice 9.

[0042] Next, the cage 6 is inserted into the body 7 (FIG. 4) until the cage 6 abuts against the body 7 in order to grip the plurality of clamping lugs 12 of the cap 10. The latter is bent between the body 7 and the cage 6 and is blocked by the plurality of lugs of the cage 6 in the body 7, so it is kept in this position. In this way, the assembled lock cover 1 is formed (FIG. 1). At this stage, since the cover has not yet been sterilized by gamma-ray irradiation, the material forming the cap has not deteriorated and thus retains its initial resistance to rupture. Therefore, the risk of the lugs breaking at this stage is low even if the destructible area 12b exists.

[0043] The stopper 4 is introduced into the cage 6 until it abuts against the cage. When inserting the stopper 4 into the cage 6, the plurality of flexible lugs 8' are deformed and then, as seen in FIG. 1, return to their initial shape when the stopper 4 is in a predetermined position by a positive bearing behind the head 4a of the stopper 4, so as to keep it in the assembled state with the cover 1.

[0044] Next, the assembled lock cover 1 is sterilized by gamma irradiation at a dose on the order of 10 kGy to 20 kGy, preferably 15 kGy. During this step, only the mechanical properties of the material of the cap 10 are effectively changed and the resistance to breakage is reduced, and the other elements of the cover are formed from another material that is less likely to deteriorate during this step.

[0045] At the end of this step, the lock cover 1 is ready to be used to block the stopper 4 at the neck 3 of the container 2 at the neck 3. The assembly formed by the lock cover 1 and the stopper 4 can then be mounted on the container 2 by introducing the base 4b of the stopper 4 into the neck 3 of the container 2 by a simple axial pressure on the cap 10. An impermeable closure of the container 2 without leakage is obtained by the stopper 4 with the plurality of flexible tabs 8 of the lock cover 1 blocked under the lip 5 of the neck 3.

[0046] The presence of the cap 10 attests to the inviolability of the container 2. In fact, in order to access the contents of the container 2, it is necessary to remove the cap 10. When the cap 10 is removed, since the force required to break the breakable area 12b is smaller than the force required to release the clamping lug 12 from its vice part, most of the plurality of clamping lugs 12, that is, 50% or more, preferably 80% or more (or all) of the breakable areas 12b are broken, and a part of the lug remains caught in the cover 1. Thereafter, it is no longer possible to close the orifice 9, and the breaking of the breakable area 12b thus attests to the first use of the container 2.

[0047] Also, the inviolability of the cover 1 also stems from the fact that, for example, when trying to remove the cover 1 once assembled to the container 2, the elements that serve to assemble the cage 6 to the body 7 are broken and are configured so as not to be broken and reused.

[0048] As can be easily understood, the present invention is not limited to the described embodiments, and it is possible to modify it without departing from the scope of the present invention defined by the claims.

[0049] In particular, forms of the body and the cage other than those shown in the figures may also be envisaged. Also, it would be possible to include additional elements in the locking cover without departing from the scope of the present invention defined by the claims.

Claims

1. A locking cover (1) for a container (2) having a neck (3) intended to block a stopper (4) located at the neck (3) of the container (2), - a cage (6) made of a plastic material, configured to surround the stopper (4) and the neck (3) and lock them in an axial position relative to each other, - a body (7) made of a plastic material, clamped around the cage (6), the body having a central orifice (9) for providing access from the outside of the cover (1) to the inside of the container (2) through the stopper (4), - a cap (10) configured to close the central orifice (9), the cap (10) comprising a flat head (11) for covering the orifice (9) and a plurality of clamping lugs (12) sandwiched between the cage (6) and the body (7), wherein the locking cover (1) - each of the clamping lugs (12) has a breakable region (12b), - the cap (10) is formed of a plastic material different from the plastic material of the cage (6) and the plastic material of the body (7), and the cap is configured to be more breakable and break at the breakable region (12b) of the clamping lugs (12) by a dose of gamma irradiation for sterilizing the locking cover (1).

2. The locking cover (1) according to claim 1, wherein the material of the cap (10) contains polypropylene.

3. The locking cover (1) according to claim 1 or 2, wherein the breakable region (12b) corresponds to a local thickness reduction of the thickness of the clamping lug (12) such as a notch or a groove.

4. The locking cover (1) according to any one of claims 1 to 3, wherein each of the clamping lugs (12) has the breakable region (12b), a locking ridge (12a), and a straight remaining portion, and the breakable region (12b) has a thickness of 30 to 70% of the thickness of the straight remaining portion of the clamping lug (12).

5. The locking cover (1) according to any one of claims 1 to 4, wherein the breakable region (12b) is located at a joint region of the clamping lug (12) on the head (11) of the cap (10).

6. A method for preparing a lock cover (1), wherein the lock cover is according to any one of claims 1 to 5, - arranging the cap (10) on the body (7) of the lock cover (1), wherein the tightening lug (12) of the cap (10) extends into the central orifice (9) of the body (7), - inserting the cage (6) into the body (7) and gripping the tightening lug (12) of the cap (10) sandwiched between the body (7) and the cage (6) to form the assembled lock cover (1), - sterilizing the assembled lock cover (1) by gamma ray irradiation, The method comprising.

7. The preparation method according to claim 6, wherein the dose of the gamma ray irradiation is 10 kGy to 20 kGy.

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