Locking cover with cap having scored securing lugs for a container having a neck

Abstract

The invention relates to a locking cap with a cap with scored fastening lugs for a container having a neck. The locking cap (1) comprises: a holder (6) made of plastic; a body (7) made of plastic, the body (7) being fastened around the holder (6), the body comprising a central hole (9); a cap (10) configured to close the central hole (9), the cap (10) comprising a flat head (11) for covering the hole (9) and fastening lugs (12) captured between the holder (6) and the body (7). Each fastening lug (12) has a scored area (12b), and the cap (10) is made of a plastic material different from the plastic material of the holder (6) and the plastic material of the body (7), the plastic material of the cap being selected to have a resistance to rupture reduced by a dose of gamma radiation for sterilizing the locking cap (1).

Description

Technical Field

[0001] The present invention relates to a locking cap for a container comprising a neck, the locking cap being used to block a stopper in the neck of the container. More specifically, the present invention relates to a locking cap for a container having a neck for use in the medical or pharmaceutical fields, the locking cap being provided with a scored cap in order to prove the inviolability of the container. The present invention relates more specifically to the case of a container having a neck. Background Art

[0002] Inviolability or proving that a medical product has been used or a container containing a medical solution has been opened (whether intentionally or not) is an important issue, particularly with regard to limiting the risk of patient contamination.

[0003] Document FR2893922 discloses a locking cover arranged on a stopper so as to lock the assembled locking cover to a container having a neck. The locking cover comprises a central hole for accessing the contents of the container through the stopper, the hole being closed by a cap welded to the cover. In order to access the contents of the container, the connection between the cap and the cover must be disconnected. Since the cap is therefore irreversibly separated from the cover, it is impossible to reuse the cap. Therefore, the disconnection of the connection indicates that this is the first use of the container. However, the assembly method for the locking cover is relatively complicated and has a welding step in particular. It would be beneficial to have a simpler assembly method. In addition, the fact that the cap is welded may cause the cap to be held very firmly to the locking cover, thus causing the disconnection of the connection to be not particularly ergonomic.

[0004] Document WO2011 / 039004 proposes an alternative method. In this document, the cap is not welded to the cover, but is constructed so that it can be irreversibly separated from the cover without the possibility of returning to its initial state. More specifically, the cap includes a flat head and fastening lugs that protrude substantially perpendicularly relative to the head. These lugs are captured between the various elements that constitute the cover during assembly. This capture makes it possible to exceed the elastic limit of the fastening lugs, so that when the cap is separated from the locking cover, these fastening lugs remain in a folded configuration. This folded configuration of the lugs, combined with the protrusions at the ends of the lugs, makes it difficult to reassemble the cap to the locking cover.

[0005] However, it has been found that under certain very precise conditions, the cap can be reinserted onto the lid of the container, making the proof of first use and the proof of the inviolability of the container less reliable.

[0006] From documents WO2013034594 and FR1334575, locking lids comprising a cap provided with scored securing lugs are also known. Any attempt to access the contents of the container requires removal of the cap, which causes the securing lugs to break. Therefore, it is not possible to reposition the cap on the lid in order to conceal the opening of the container or attempted opening.

[0007] The design and manufacture of a cap equipped with such a scored fastening lug must be perfectly mastered. The force applied to the cap in order to remove it from the lid should not be too great for the user. At the same time, the fastening lugs should not be too fragile to avoid breaking them during the initial assembly of the cap to the rest of the lid. However, variations occurring within or between different cap production batches can affect this perfect mastery of the scored nature of the fastening lugs, which in turn can affect the manufacturing yield during the initial assembly of the cap, or can affect the ease of use of the solution due to the high variability in the effort to remove the cap from one container to another.

[0008] In general, the use of any device in the medical field requires the prior sterilization of said device, whatever the solution chosen for closing the container and accessing its inviolable contents. It is common practice to achieve this sterilization by irradiating the device with a sufficient dose of gamma rays. Therefore, the materials forming such medical devices, especially when they are made of plastic, are chosen so that they are not affected by this radiation, especially in terms of their mechanical strength. Summary of the invention

[0009] The object of the present invention is to propose a locking cap provided with a scored cap which at least partially overcomes the above-mentioned drawbacks. The object of the present invention is in particular to propose a cap for a locking cap for a container having a neck, the cap being provided with scored fastening lugs which are rigid enough to limit the risk of breakage during assembly of the cap to the cover, while being fragile enough once assembled to facilitate such breakage during removal of the cap.

[0010] In order to achieve this object, the object of the present invention is to provide a locking cap for a container having a neck, the locking cap being used to block a stopper in the neck of the container, the locking cap comprising:

[0011] a retainer made of plastic, configured to surround the bung and the neck and to lock the bung and the neck axially in position relative to each other;

[0012] - a body made of plastic, fastened around the holder, comprising a central hole providing access from the outside of the cap through the stopper to the inside of the container;

[0013] - a cap configured to close said central hole, said cap comprising a flat head for covering said hole and a fastening lug captured between said holder and said body;

[0014] The locking cover is characterized in that:

[0015] - Each fastening lug has a scored area;

[0016] - the cap is formed of a plastic material different from the plastic material of the holder and the plastic material of the body, the plastic material of the cap being selected to have a resistance to breakage reduced by a dose of gamma radiation for sterilizing the locking cover.

[0017] According to other advantageous and non-limiting features of the invention, alone or in any technically feasible combination:

[0018] - the material of the cap comprises polypropylene;

[0019] - the scored area corresponds to a local thinning of the thickness of the fastening lug, such as a notch or a groove;

[0020] - the thickness of the scored area is between 30% and 70% of the thickness of the fastening lug;

[0021] - the scored area is located in the engagement area of ​​the fastening lug on the head of the cap;

[0022] - After receiving a dose of 50 kGy of gamma radiation, the material of the cap exhibits a loss in elongation greater than or equal to 25%.

[0023] The present invention also relates to a method for preparing a locking cap as previously disclosed, the method comprising:

[0024] - arranging the cap on the body of the cover, the fastening lug of the cap extending into the central hole of the body;

[0025] - inserting the retainer into the body to clamp the fastening lugs of the cap captured between the body and the retainer, thereby forming an assembled locking cover;

[0026] - Sterilize the assembled locking cover by gamma irradiation.

[0027] This gamma radiation can deliver doses between 10 kGy and 20 kGy. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Other features and advantages of the present invention will become apparent from the following detailed description of the invention provided with reference to the accompanying drawings, in which:

[0029] Figure 1 shows a cross-sectional view of an assembled locking cover according to the present invention;

[0030] Figure 2a and Figure 2b A bottom view and a top view of a cap according to the present invention are shown respectively;

[0031] Figure 3 A cross-sectional view showing the scored area of ​​a fastening lug according to the invention;

[0032] Figure 4 A cross-sectional view of a locking cover according to the invention is shown before full assembly. DETAILED DESCRIPTION

[0033] General Introduction of Locking Cover

[0034] Figure 1 A locking cap 1 according to the invention is shown for a container 2 having a neck 3 for blocking a stopper 4 in the neck 3 of the container 2, the cap 1 being here shown simply placed on the neck 3 without being locked.

[0035] The neck 3, here with a circular opening, has at its end a peripheral lip 5 against which the locked cap 1 is blocked when it is locked on the neck 3 of the container 2. The stopper 4 has a conventional substantially cylindrical T-shape with a head 4a and a base 4b, the head having a slightly larger diameter than the base 4b, so that when the base 4b of the stopper 4 is introduced into the neck 3, the head 4a abuts against the lip 5 of the neck 3.

[0036] The locking cap 1 comprises a retainer 6 capable of surrounding the stopper 4 and the neck 3 when the cap 1 is in the locked configuration on the neck 3 of the container 2, and a body 7 capable of being fastened around the retainer 6. The retainer 6 allows the stopper 4 to be blocked in the neck 3 by means of flexible tabs 8 arranged on the periphery of the retainer 6, the flexible tabs 8 being intended to be blocked under the lip 5. Other means of blocking the stopper 4 by the retainer 6 can of course be considered. In the assembled configuration of the cap 1, the body 7 completely covers the retainer 6 laterally, thereby preventing any access to the retainer 6 and the tabs 8 from the outside of the body 7. Both the body and the retainer are made of a plastic material that is not easily degraded after the gamma sterilization of the cap.

[0037] The loss of elongation of a material is a criterion commonly used to measure the effect of radiation on its resistance to rupture. In the context of the present application, when the loss of elongation of a material after receiving a gamma radiation dose of 50 kGy is less than 25%, the material is considered not to have degraded after receiving a dose of gamma radiation sufficient to sterilize it. Conversely, when the loss of elongation of a material after receiving a gamma radiation dose of 50 kGy is greater than or equal to 25%, the material is considered to have degraded after receiving a dose of gamma radiation sufficient to sterilize it, and its resistance to rupture is reduced.

[0038] The body 7 and the holder 6 do not have to be made of the same material, for example the plastic material forming the body 7 may be polybutylene terephthalate (also indicated by the abbreviation "PBT") and the plastic material forming the holder 6 may be polycarbonate (also indicated by the abbreviation "PC"). Both plastics require a gamma radiation dose of much greater than 500 kGy or even greater than 1000 kGy to cause the elongation loss caused by such radiation to exceed 25%. They are therefore not susceptible to degradation during gamma sterilization of the cap within the dose range considered.

[0039] continue Figure 1 The body 7 also includes a central hole 9 which provides access from the outside of the cap 1 through the stopper 4 to the inside of the container 2. The contents of the container 2 can thus be accessed through the hole 9, for example by inserting the needle of a syringe through the stopper 4. Of course, it will be noted that, as in Figure 4 As can be seen in FIG. 2 , both the body 7 and the holder 6 also have a central opening to allow access to the stopper 4 and thus to the contents of the container 2 .

[0040] The locking cover 1 also comprises a cap 10 configured to close the central hole 9 and to prove the inviolability of the container 2. The cap 10 comprises a flat head 11 for covering the hole 9 and a plurality of fastening lugs 12. The fastening lugs 12 are captured between the retainer 6 and the body 7 in order to keep the cap 10 assembled to the locking cover 1.

[0041] Cap Detailed Description

[0042] Figure 2a and Figure 2b A cap 10 according to the invention is shown for closing the central hole 9 of the body 7. The cap 10 has fastening lugs 12, here for example eight lugs 12, which in the rest position protrude perpendicularly to the flat head 11 of the cap 10.

[0043] The cap 10 with the flat head 11 and the fastening lugs 12 is advantageously formed from a single piece of molded plastic material. For example, the flat head 11 may have a disc shape or other more complex shapes, such as a polygon, as long as its surface completely covers the central hole 9.

[0044] The flat head 11 may also be provided with gripping elements 11 a , here in the form of reinforcement points, to facilitate gripping of the cap 10 when it is removed from the lid 1 .

[0045] When the cap 10 is in an assembled configuration with the body 7, the fastening lugs 12 are distributed annularly along the periphery of the hole 9 of the body 7. The fastening lugs 12 may have a free end that is beveled and / or provided with a locking ridge 12a. The thickness of the fastening lugs 12 is between 0.3 mm and 0.6 mm; for example, it may be 0.37 mm.

[0046] The locking ridge 12a has a larger dimension than the rest of the fastening lug 12; its purpose is to better keep the cap 10 assembled to the cover 1 by creating additional resistance if an attempt is made to remove the cap 10 by sliding the fastening lug 12 out of its clamped state. In the absence of the locking ridge 12a, there is an initial resistance that requires the application of a predetermined force to release the fastening lug 12 from its clamped state. This resistance comes from the folded shape that the fastening lug 12 assumes when it is captured between the body 7 and the retainer 6. The presence of the locking ridge 12a creates the need to apply a force greater than the force initially predetermined in order to release the fastening lug 12 from its clamped state. This additional force becomes larger as the size of the ridge 12a increases. Preferably, the thickness of the ridge 12a is 35% to 170% greater than the thickness of the fastening lug 12, that is, for example, for a fastening lug 12 with a thickness of 0.37 mm, the thickness of the ridge 12a is between 0.5 mm and 1.0 mm.

[0047] Advantageously, the cap 10 is scored and is capable of breaking when it is removed from the lid 1 , more specifically at the fastening lugs 12 . This removal is therefore irreversible and is a reliable indication of first use, since the cap 10 cannot be reassembled to the lid 1 .

[0048] To achieve this, efforts are made to reduce the resistance to rupture of the cap 10 so that the force required to release the fastening lugs 12 from their gripping state is greater than the force required to break the lugs of the cap 10. Thus, the cap 10 will break before the flexible lugs 12 are released from their gripping state.

[0049] To achieve this, the cap 10 is formed of a plastic material whose resistance to rupture is reduced by gamma radiation at a dose intended to sterilize the cap 1. In other words, after being subjected to gamma radiation, the material of which the cap 10 is made becomes more brittle and its resistance to rupture is reduced. The material is characterized in that if it receives a gamma radiation dose of 50 kGy, its loss of elongation is greater than or equal to 25%.

[0050] It may be primarily a polypropylene based material, or it may be made of polypropylene.

[0051] The gamma irradiation used to sterilize the cap is preferably carried out at a dose typically between 10 kGy and 20 kGy, for example 15 kGy, and after the cap 10 has been assembled with the rest of the cap 1. Therefore only the plastic material constituting the cap 10 will be degraded by this sterilization step, the plastic material forming the retainer 6 and the body 7 having been selected not to be susceptible to excessive degradation during exposure to gamma rays.

[0052] It should be noted that a possible degradation of the material of the cap does not present a risk of contaminating the contents of the container, since the cap, due to its position in the lid and its construction, is not in contact with or exposed to the contents of the container and therefore does not present a risk of contaminating them, for example by generating particles during its degradation.

[0053] Therefore, after gamma radiation sterilization, the force that must be applied to break the lugs 12 of the cap 10 is relatively small and is less than the force required to release the flexible lugs 12 from their clamped state.

[0054] Furthermore, in order to facilitate and localize their breaking, the fastening lugs 12 each have a Figure 3 1. The notched area 12b is visible in FIG. This notched area 12b advantageously corresponds to a local thinning of the thickness of the fastening lug 12. Thus, it may be, for example, a notch or groove with a fixed or progressive thinning defined by one or more inclined bevels.

[0055] Preferably, the scored area 12b corresponds to a portion of the fastening lug 12 having a thickness comprised between 30% and 70% of the thickness of the fastening lug 12, for example between 0.11 mm and 0.26 mm for a fastening lug having a thickness of 0.37 mm. The dimensions of the scored area, and more generally of the fastening lug 12, are thus advantageously chosen so as to avoid any risk of breakage during assembly of the elements of the cover 1 prior to the irradiation step.

[0056] Advantageously too, the scored area 12 b is situated in the engagement area of ​​the fastening lug 12 on the head of the cap 10 .

[0057] The nature of the scored areas 12b and the material of the cap 10 have the effect of reducing the resistance of the cap 10 to rupture after assembly of the locking cover 1 but preventing the lugs from breaking during assembly and better locating the location where the breaking will occur. The presence of these scored areas 12b combined with the gamma ray irradiation makes it possible to further reduce the force required to break the scored areas 12b and ensure that the cap 10 breaks at said areas 12b before the fastening lugs 12 have the possibility to release themselves from their clamping state.

[0058] Preparation and use of locking covers

[0059] Now refer to Figure 1 and Figure 4 The operations for preparing the locking cover are described. Figure 4 A cross-sectional view of the cover 1 is shown, the components of which are being assembled, and Figure 1 In the embodiment shown, the components of the cap 1 have been assembled and placed on the neck 3 of the container 2 .

[0060] First, the cap 10 with the straight fastening lugs 12 is placed on the body 7 of the lid 1 so that the fastening lugs 12 extend into the central hole 9 of the body 7 and the flat head 11 completely covers the hole 9. Advantageously, the cap 10 is arranged upside down, with the fastening lugs 12 facing upwards, and then the body 7 is placed on the cap 10 so that the lugs 12 penetrate the central hole 9.

[0061] Then insert the retainer 6 into the main body 7 ( Figure 4 ) until the retainer 6 comes to bear against the body 7 so as to clamp the fastening lugs 12 of the cap 10. The fastening lugs 12 are bent between the body 7 and the retainer 6 and are held in this position by the blocking of the lugs of the retainer 6 in the body 7. Thus, the assembled locking cover 1 ( Figure 1 ). At this stage, since the cap has not yet been sterilized by gamma radiation, the material forming the cap has not degraded and therefore retains its initial resistance to breakage. Therefore, even in the presence of the scored area 12b, the risk of the lug breaking at this stage is low.

[0062] The plug 4 is introduced into the retainer 6 until it comes to rest against said retainer. When the plug 4 is inserted into the retainer 6, the flexible lugs 8' are deformed and then return to their initial shape when the plug 4 is in place by actively bearing behind the head 4a of the plug 4, so as to keep it assembled in the cap 1, as shown in FIG. Figure 1 Visible in.

[0063] The assembled locking cap 1 is then sterilized by gamma ray irradiation at a dose between 10 kGy and 20 kGy, preferably of the order of 15 kGy. During this step, only the mechanical properties of the material of the cap 10 are effectively altered, making it less resistant to rupture, the other elements of the cap being formed of different materials that are less susceptible to degradation during this step.

[0064] At the end of this step, the locking cap 1 is ready for blocking the stopper 4 in the neck 3 of a container 2 having a neck 3. The assembly formed by the locking cap 1 and the stopper 4 is then mounted on the container 2 by introducing the base 4 b of the stopper 4 into the neck 3 of the container 2, by simple axial pressure on the cap 10. A leaktight and inviolable closure of the container 2 is obtained by the stopper 4, thanks to the locking cap 1, whose flexible tabs 8 are blocked under the lip 5 of the neck 3.

[0065] The presence of the cap 10 proves the inviolability of the container 2. In fact, in order to access the contents of the container 2, the cap 10 must be removed. When removing the cap 10, since the force required to break the scored area 12b is less than the force required to release the fastening lug 12 from its clamped state, a large part of the scored area 12b of the fastening lug 12, i.e. more than 50% and preferably more than 80% (or even all) is broken, and a piece of the lug remains captured in the lid 1. It is thus impossible to close the hole 9 again, and the breaking of the scored area 12b therefore proves the first use of the container 2.

[0066] Furthermore, the inviolable nature of the lid 1 also derives from the fact that the lid 1 is constructed so as to break and be non-reusable, for example by breaking the element responsible for assembling the retainer 6 with the body 7, if an attempt is made to remove the lid once it has been assembled to the container 2.

[0067] As will be readily appreciated, the invention is not limited to the embodiments described and variations may be added thereto without departing from the scope of the invention as defined by the claims.

[0068] In particular, forms of body and holder other than those shown in the figures may be envisaged.The locking cover may also comprise additional elements without departing from the scope of the invention as defined by the claims.

Claims

1. A locking cap (1) for a container (2) having a neck (3), the locking cap (1) being used to block a stopper (4) in the neck (3) of the container (2), the locking cap (1) comprising: a retainer (6) made of plastic, the retainer (6) being configured to surround the plug (4) and the neck (3) and to lock the plug (4) and the neck (3) axially in position relative to each other; a body (7) made of plastic, which is fastened around the holder (6) and comprises a central hole (9) providing access from the outside of the locking cap (1) through the stopper (4) to the inside of the container (2); a cap (10) configured to close the central hole (9), the cap (10) comprising a flat head (11) for covering the central hole (9) and a fastening lug (12) captured between the retainer (6) and the body (7); The locking cover (1) is characterized in that: Each fastening lug (12) has a scored area (12b); The cap (10) is formed of a plastic material different from the plastic material of the holder (6) and the plastic material of the body (7), the plastic material of the cap being selected to have a resistance to breakage reduced by a dose of gamma radiation for sterilizing the locking cover (1).

2. The locking cover (1) according to claim 1, wherein: The material of the cap (10) exhibits an elongation loss greater than or equal to 25% after receiving a dose of 50 kGy of gamma radiation.

3. The locking cover (1) according to claim 1 or 2, wherein: The material of the cap (10) includes polypropylene.

4. The locking cover (1) according to claim 1 or 2, wherein: The scored area (12b) corresponds to a local thinning of the thickness of the fastening lug (12).

5. The locking cover (1) according to claim 4, wherein: The thickness of the scored area (12b) is between 30% and 70% of the thickness of the fastening lug (12).

6. The locking cover (1) according to claim 1 or 2, wherein: The scored area (12b) is located in the engagement area of ​​the fastening lug (12) on the flat head (11) of the cap (10).

7. The locking cover (1) according to claim 4, wherein: The scored area (12b) is a notch or groove.

8. A method for preparing a locking cover (1), wherein the locking cover (1) is a locking cover according to any one of claims 1 to 7, the method comprising: Arranging the cap (10) on the body (7) of the locking cover (1), the fastening lug (12) of the cap (10) extending into the central hole (9) of the body (7); inserting the retainer (6) into the body (7) to clamp the fastening lugs (12) of the cap (10) captured between the body (7) and the retainer (6) to form an assembled locking cover (1); as well as The assembled locking cover (1) is sterilized by gamma irradiation.

9. The preparation method according to claim 8, wherein: The dose of the gamma radiation is between 10 kGy and 20 kGy.

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