Tip cap for a medical injection device, medical injection device and process for manufacturing a tip cap.

BR112021026853B1Active Publication Date: 2026-08-04BECTON DICKINSON FRANCE SAS
View PDF 0 Cites 0 Cited by

Patent Information

Authority / Receiving Office
BR · BR
Patent Type
Patents
Current Assignee / Owner
BECTON DICKINSON FRANCE SAS
Filing Date
2020-06-29
Publication Date
2026-08-04

Smart Images

  • Figure 00000021_0000
    Figure 00000021_0000
  • Figure 00000021_0001
    Figure 00000021_0001
  • Figure 00000022_0000
    Figure 00000022_0000
Patent Text Reader

Abstract

Tip cap for a medical injection device. The present invention relates to a protective cap (1) for a medical injection device, comprising: - a tip connector (100) configured to fit a tip of the medical injection device, comprising a main body (100a) and an end portion (100b) connected to the main body by means of a frangible portion (100c); - a closing cap (101) configured to hermetically close a distal opening of the tip, the closing cap being removablely connected to the tip connector (100). Said protective cap comprises an RFID tag (2) which is an integral part of the tip connector (100) and which comprises a chip (20) and an antenna (21).the chip is overmolded into one of the main body and the end portion, and the antenna is overmolded into the other of the main body and the end portion, the chip and the antenna being electrically connected by a bridge (22) extending through the frangible portion (100c) of the end connector, the bridge being configured to break under a relative movement applied to the closing cap and the end connector in order to remove the closing cap from the end connector.
Need to check novelty before this filing date? Find Prior Art

Description

1 / 17 Tip cap for a medical injection device, medical injection device and process for manufacturing a tip cap. FIELD OF TECHNIQUE

[001] The present invention relates to a tip cap for a medical injection device and to a process for manufacturing such a tip cap. FUNDAMENTALS OF THE INVENTION

[002] Medical injection devices, such as syringes, typically include a container for containing a pharmaceutical composition, said container having an end piece in the form of a longitudinal tip that defines a fluid path through which the pharmaceutical composition is expelled. Medical injection devices may be filled with pharmaceutical compositions that may be sensitive.

[003] There is a growing need for individual traceability of medical injection devices, and typically of medical containers, from the manufacturing process to at least the end use of said medical containers, typically an injection of a pharmaceutical composition. Indeed, it is desirable to enable traceability of such medical devices in order to record all events that occur during a manufacturing process, a filling process and / or the use of the medical injection device.Medical injection devices are generally not processed individually, but may be transported or packaged with a plurality of similar medical injection devices, and traceability could ensure that the status of medical containers can be verified at any time during the life cycle of the medical injection devices, and that this status verification can be implemented without unpacking the medical injection devices. Petition 870250083092, dated 09 / 15 / 2025, p. 11 / 52 2 / 17

[004] Furthermore, it is necessary to ensure that a medical injection device contains the expected pharmaceutical composition and that it cannot be refilled with a pharmaceutical composition different from the original. In addition, there is a need to guarantee that, when a medical injection device is about to be used, said medical injection device has not been opened beforehand. Consequently, it may be desirable to provide such medical injection devices with a tamper-proof means.

[005] To date, there is no practical solution that enables the traceability and inviolability of medical injection devices. SUMMARY OF THE INVENTION

[006] One objective of the present invention is to provide a medical injection device comprising a means of traceability and tamper-evident security.

[007] This objective can be achieved by providing a tip cap for a medical injection device, comprising: - a tip connector configured to fit a tip of a medical injection device; - a closing cap configured to seal a distal opening of the tip, the closing cap being removablely connected to the tip connector; - said end cap being characterized by comprising an RFID radio frequency identification tag comprising a chip and an antenna, wherein the chip and antenna are overmolded into at least one of the end connector and the end cap, wherein the chip and antenna are electrically connected by a bridge configured so as to break under a relative movement applied to the end cap and the end connector in order to remove the end cap from the end connector.

[008] The RFID tag provides traceability of the medical container to the Petition 870250083092, dated 09 / 15 / 2025, page 12 / 52 3 / 17 opening of the closing cap, and the tamper-evident feature is deactivated after the closing cap is opened by breaking the electrical connection between the chip and the antenna. Furthermore, the overmolding process used to integrate the RFID tag into the end cap minimizes the number of assembly steps and the manufacturing cost of the end cap.

[009] In this document, the terms distal and proximal are relative terms that define a region that is still, respectively closer – along an injection axis of a pharmaceutical composition, to a user handling the medical injection device in order to inject the pharmaceutical composition into a patient's body. For example, when the medical injection device is a syringe comprising a flange configured to be contained between the user's fingers and a tip attached to a needle configured to puncture the patient's tissues and inject the pharmaceutical composition, the flange is considered proximal and the tip is considered distal.

[010] According to a preferred embodiment, the end connector comprises a main body and an end portion connected to the main body by means of a frangible portion, and the end connector and the end cap comprise mutually engaging threaded portions. The RFID tag is an integral part of the end connector. The chip is overmolded into one of the main body and the end portion, and the antenna is overmolded into the other of the main body and the end piece. The bridge extends through the frangible portion of the end connector and is therefore configured so as to break under a relative unscrewing motion applied to the end cap and the end connector in order to remove the end cap from the end connector.

[011] According to advantageous, but not limiting, embodiments of the present invention, and possibly combined: Petition 870250083092, dated 09 / 15 / 2025, page 13 / 52 4 / 17 - The closing cap comprises a sealing septum configured so as to be contiguous with the tip of the medical injection device; - The antenna has a ring shape that extends around a longitudinal axis of the tip cap; - the bridge is parallel to the longitudinal axis of the end cap; - the bridge is orthogonal to the longitudinal axis of the end cap; - The end connector and the closing cap comprise mutually interlocking protrusions and notches configured so as to rotationally secure the end portion of the end connector to the closing cap, the frangible portion being configured so as to break under a relative rotational motion applied to the closing cap and the end connector in order to remove the closing cap from the main body of the end connector. [ 012] Another object is a medical injection device comprising a cylinder and a tip comprising a distal opening and a tip cap, as described above, mounted on said tip. [ 013] Another object is a process for manufacturing a tip cap comprising a tip connector and a closing cap removablely connected to the tip connector, as described above, the process comprising the steps of: i) provide an RFID tag comprising a chip and an antenna, wherein the chip and the antenna are electrically connected by a bridge; ii) place the RFID tag in a mold adapted for injection molding of the end connector and / or the closing cap, iii) inject at least one plastic material into the mold in order to form the end connector and / or the closing cap by overmolding the chip and antenna. Petition 870250083092, dated 09 / 15 / 2025, page 14 / 52 5 / 17

[014] According to a preferred modality of said process: - in step ii), the RFID tag is placed in a mold adapted for injection molding of the end connector, - in step iii), the plastic material is injected into the mold using a first insert so as to form at least part of the end connector, and overmolding the chip and antenna, the chip and antenna presenting a level surface; - and the process also includes the following steps: iv) inject the same plastic material from step iii) using a second insert and obtaining the end connector onto which the RFID tag is overmolded; v) mold the closing cap; and vi) removablely mount the closing cap onto the end connector in order to obtain the end cap. BRIEF DESCRIPTION OF THE DRAWINGS

[015] Other features, modalities and advantages of the present invention will become apparent from the following detailed description, based on the attached drawings, in which: Figure 1 is a cross-sectional view of a cap according to a first embodiment; Figure 2 is a perspective view of a cap closure for the end cap according to the first embodiment; Figure 3 is a perspective view of a cap end connector according to the first embodiment; Figure 4 is a perspective view of an RFID tag on the end cap according to the first embodiment; Figures 5A and 5B show a view of the relative position of the closing cap and the end connector, respectively, during screwing and Petition 870250083092, dated 09 / 15 / 2025, page 15 / 52 6 / 17 after the closing cap is fully screwed onto the end cap according to the first embodiment; Figure 6 is a cross-sectional view of the end cap according to the first embodiment after unscrewing the end connector closing cap; Figure 7 is a cross-sectional view of the end cap from Figure 6 after the closing cap has been screwed back onto the end connector; Figure 8 is a perspective view of a medical injection device with a tip cap according to a second embodiment; Figure 9 is an enlarged view of the end cap of Figure 8; Figure 10 is an enlarged view of the RFID tag overmolded onto the end cap of Figure 8; Figure 11 is a partial view of the end cap according to the second embodiment, showing the end connector and the RFID tag; and Figure 12 is a partial view of the end cap according to the second embodiment, showing the closing cap and the RFID tag. DETAILED DESCRIPTION OF THE MODALITIES

[016] The tip cap of the present invention is configured so as to be mounted on a medical injection device. Said medical injection device may comprise a cylinder extending around a longitudinal axis, and a distal tip extending from a distal end of the cylinder. The distal tip of the medical injection device comprises a longitudinal passage orifice for the expulsion of a pharmaceutical composition that may be contained in the cylinder.

[017] The tip may be covered by a tip cap. Said tip cap comprises a tip connector configured to fit the tip, and a closing cap configured to seal a Petition 870250083092, dated 09 / 15 / 2025, page 16 / 52 7 / 17 distal tip opening. The closing cap may include a sealing septum contiguous to the tip of the medical injection device and, especially, to the distal end of the tip of said medical injection device.

[018] The closing cap can be removablely attached to the tip connector. Before using the medical injection device, the closing cap can be fitted to the tip connector to protect the distal tip from shocks and external contamination. When the medical injection device is to be used to inject a pharmaceutical composition into a patient, the closing cap is removed from the tip connector to expose the tip of the medical injection device. A needle can then be connected to the tip connector to perform the injection.

[019] According to the present invention, the end cap includes a radio frequency identification tag (RFID tag).

[020] In a self-explanatory manner, the RFID tag comprises a chip and an antenna electrically connected by a bridge. Unique identification data about the medical container and data relating to the processing of the medical container can be recorded on the chip. This data can be read by a suitable RFID tag reader. However, when any part of the RFID tag is broken, the RFID tag loses its integrity and can no longer be read by the RFID reader.

[021] In order to provide a tamper-proof function of the end cap, the chip and antenna are overmolded into at least one of the end connector and the end cap. The chip and antenna are arranged relative to the end connector and the end cap in such a way that, during a relative movement applied to the end cap and the end connector in order to remove the end cap from the end connector, the electrically connected bridge is configured to break. More specifically, a part of the label Petition 870250083092, dated 09 / 15 / 2025, page 17 / 52 8 / 17 The RFID tag (e.g., the chip) remains attached to the tip connector, while another part of the RFID tag (e.g., the antenna) remains attached to the closing cap. This movement will result in the breakage of a part of the RFID tag (e.g., the bridge), which will cause the RFID tag to be deactivated.

[022] In this way, when the end cap is opened, a clear indication of the end cap status (already open or intact) is provided when attempting to read the RFID tag. Furthermore, as long as the end cap is not open, the end cap presents a detectable unique device identifier that allows product traceability from assembly at the medical injection device manufacturer to secondary packaging of the drug container at the pharmaceutical laboratory level and, ideally, to removal of the end cap.

[023] Advantageously, said relative motion may be a rotational motion, a translational motion, or a combination of these rotational and translational motions.

[024] According to preferred embodiments, the relative movement may be an unscrewing motion. For this purpose, the end connector and the closing cap comprise threaded portions that engage with each other.

[025] The antenna may advantageously have the form of a ring extending around a longitudinal axis of the tip cap, which coincides with the longitudinal axis of the medical container.

[026] According to one modality, the bridge may be parallel to said longitudinal axis.

[027] Alternatively, the bridge can be orthogonal to the longitudinal axis of the end cap.

[028] Figures 1 to 7 refer to an early embodiment of the lid of Petition 870250083092, dated 09 / 15 / 2025, p. 18 / 52 9 / 17 tip.

[029] Figure 1 is a cross-sectional view of the tip cap before use of the medical injection device.

[030] The tip cap includes a tip connector 100 configured to be attached to a tip of the medical injection device (as shown in numerical reference 10 in Figures 6 and 7), and a locking cap 101 screwed onto the tip connector 100 in order to seal the distal opening of the tip. To this end, the tip connector 100 and the locking cap 101 comprise mutually engaging threaded portions 1002, 1012 (see Figures 2 and 3). When the medical injection device is to be used, the locking cap 101 is unscrewed from the tip connector 100 to provide access to the tip, while the tip connector remains attached to the tip. A needle can then be connected to the tip connector by means of the threaded portion 1002. The tip cap extends around a longitudinal axis X of the medical injection device. In this document, the term "axially" refers to the X-axis.

[031] As best observed in Figure 3, the tip connector 100 comprises a proximal ring portion 1001 configured to be mounted on the tip of the medical injection device. According to one embodiment, the tip connector is a Luer lock (LLA) type adapter. The inner surface of the ring portion 1001 may have a truncated cone shape that allows for a friction fit with the tip of the medical injection device.

[032] The end connector 100 further comprises a distal threaded female portion 1002 configured to cooperate with the proximal threaded male portion 1012 of the closing cap (see Figure 2).

[033] As illustrated in Figure 2, the closing cap 101 comprises a distal handling portion 1011. This handling portion Petition 870250083092, dated 09 / 15 / 2025, page 19 / 52 10 / 17 advantageously comprises an outer surface configured so as to be easily gripped between a user's fingers, in particular for screwing or unscrewing the closing cap onto the tip connector. Said outer surface may be grooved in order to prevent the fingers from slipping during such screwing or unscrewing motion.

[034] The closing cap 101 may be made of a rigid material, such as plastic. The closing cap 101 advantageously comprises a sealing septum 102 made of a flexible material, such as rubber or thermoplastic elastomer (TPE). The inner cap is attached to the closing cap, for example, by means of a friction fitting or clip. When the tip cap is fitted to the medical injection device, the proximal end of the flexible inner cap comes into contact with the distal end of the tip in order to create a hermetic seal that protects the contents of the medical injection device from external contamination.

[035] The tip connector comprises a proximal main body 100a and a distal end portion 100b connected to the main body by means of a frangible portion 100c. The frangible portion is configured so as to break under a relative rotational motion about the X-axis applied to the end portion 100b and the main body 100a. According to other embodiments, the frangible portion is configured so as to break under a relative translational motion or a combination of a relative rotational and translational motion about the X-axis applied to the end portion 100b and the main body 100a. The frangible portion 100c may comprise a plurality of links distributed along the circumference of the tip connector. Said links have a relatively small cross-section and extend axially between the main body 100a and the end portion 100b.

[036] The end connector 100 and the closing cap 101 comprise Petition 870250083092, dated 09 / 15 / 2025, page 20 / 52 11 / 17 mutually interlocking protrusions 1003 and notches 1013 configured so as to rotationally secure the end portion 100b of the end connector to the closing cap 101.

[037] As illustrated in Figure 5A, during screwing of the closing cap onto the end connector (direction indicated by the arrow), the protrusions 1003 do not correspond to the notches 1013.

[038] When the screwing is finished (see Figure 5B), each protrusion 1003 will fit into a corresponding notch 1013.

[039] Each notch and corresponding protrusion has a non-symmetrical profile with respect to a radius of the end cap. In the direction of threading, the front side of each protrusion 1003 will extend in a substantially radial direction, while the rear side of the protrusion 1003 will extend obliquely. In other words, the front side of the protrusion forms a steep step extending from the inner surface of the end connector, while the rear side of the protrusions is connected to said inner surface by means of a gentle slope. The shape of the notches on the end cap is complementary to that of the protrusions.

[040] This shape of the protrusions and notches allows the closing cap to be screwed onto the tip connector without the need for excessive force. However, in the unscrewing direction, the notches of the closing cap 101 apply a torque to the distal end portion 100b of the tip connector, thereby causing the weak links that form the frangible portion 100c to break.

[041] The end connector comprises an RFID tag 2 (illustrated in perspective in Figure 4). The RFID tag comprises an RFID chip 20 and an antenna 21, the RFID chip being coupled to the antenna by means of a bridge 22. The antenna 21 preferably has an annular shape extending around the X-axis, but may have any other suitable shape. Any break Petition 870250083092, dated 09 / 15 / 2025, page 21 / 52 12 / 17 of one of the RFID tag components, in particular, bridge 22, will deactivate the RFID tag.

[042] In this first embodiment according to the present invention, the RFID tag is integrated, preferably fully integrated, into the end connector 100 in such a way that the RFID chip 20 and the antenna 21 are located in different portions of the end connector with respect to the frangible portion 100b. For example, as illustrated in Figure 3, the chip 20 is integrated into the main body 100a, while the antenna is integrated into the end portion 100b, the bridge extending through the frangible portion 100c. According to an alternative embodiment (not illustrated), the chip may be integrated into the end portion, and the antenna into the main body of the end connector.

[043] When a relative rotational movement is applied to the end connector and the closing cap in order to remove the closing cap from the end connector, both the frangible portion 100c and the bridge 22 break, thereby interrupting the electrical connection between the chip and the antenna, and inactivating the RFID tag.

[044] As a result, as shown in Figure 6, when the closing cap 101 is removed from the end connector 100, the distal end portion 100b and the antenna 21 of the RFID tag remain attached to the closing cap 100 by fitting into the notches and protrusions, while the chip 20 of the RFID tag remains attached to the main body 100a of the end connector.

[045] Even when the closing cap 101 is screwed back onto the main body 100a of the tip connector, the RFID tag will remain inactive, since the broken bridge will no longer electrically connect the chip and the antenna. In this way, the RFID tag can no longer be read.

[046] When a user wants to check if the end cap has been opened, they should try to read the RFID tag with an appropriate RFID reader. If the RFID reader Petition 870250083092, dated 09 / 15 / 2025, page 22 / 52 If 13 / 17 does not detect any tag, this means the end cap has been opened. Otherwise, if the RFID reader detects the tag, this means the end cap is intact.

[047] The end cap can be manufactured as follows.

[048] On the one hand, the closing cap 101 and the sealing septum 102 can be manufactured by injection molding and assembled. Suitable materials for the closing cap 101 include polypropylene or any other rigid plastic material, and suitable materials for the sealing septum 102 include rubber and thermoplastic elastomer.

[049] On the other hand, the end connector with the RFID tag can be manufactured by an overmolding process.

[050] To this end, the RFID tag is placed in a mold adapted for injection molding of the tip connector. The mold includes a first insert configured to hold the RFID tag in a desired position relative to the main body and the distal end portion of the tip connector. In a first injection step, the plastic material is injected into the mold to partially overmold the chip and antenna. At the end of this first injection step, the chip and antenna will have a level surface. Then, the piece resulting from this first injection step is removed and placed in a second insert of the mold in order to define the shape of the remaining portion of the tip connector. In a second injection step, the same plastic material from the first injection step is then injected into the mold, thus completely overmolding the RFID tag. Suitable materials for the tip connector include polypropylene or any other rigid plastic material.

[051] The closing cap can then be mounted in a removable manner onto the end connector by screwing it on until the protrusions on the end portion of the end connector engage with the notches on the closing cap. Petition 870250083092, dated 09 / 15 / 2025, page 23 / 52 14 / 17

[052] Figures 8 to 12 illustrate a second embodiment of the pointed cap. The elements identified with the same reference numerals as in Figures 1 to 7 have the same function.

[053] As in the first embodiment, the tip cap comprises a tip connector 100 configured to fit a tip 10 of the medical injection device and a locking cap 101 screwed in a removable manner onto the tip connector and configured to seal a distal opening of the tip 10.

[054] To this end, the tip connector 100 and the closing cap 101 comprise mutually interlocking threaded portions 1002. When the medical injection device is to be used, the closing cap 101 is unscrewed from the tip connector 100 in order to provide access to the tip, while the tip connector remains attached to the tip. A needle can then be connected to the tip connector by means of the threaded portion 1002. The tip cap extends around a longitudinal axis X of the medical injection device.

[055] The tip connector 100 comprises a proximal ring portion configured to be mounted on the tip of the medical injection device. According to one embodiment, the tip connector is a Luer lock adapter (LLA). The inner surface of the ring portion may have a truncated cone shape, allowing for a friction fit with the tip of the medical injection device.

[056] As best observed in Figures 11 and 12, the tip connector 100 further comprises a distal threaded female portion 1002 configured to cooperate with the proximal threaded male portion 1012 of the closing cap.

[057] The closing cap 101 comprises a distal handling portion 1011. This handling portion advantageously comprises a surface Petition 870250083092, dated 09 / 15 / 2025, page 24 / 52 15 / 17 externally configured so as to be easily gripped between a user's fingers, particularly when screwing or unscrewing the closing cap onto the tip connector. Said external surface may be grooved in order to prevent the fingers from slipping during such screwing or unscrewing movement.

[058] As illustrated in Figure 9, the closing cap 101 includes a sealing septum 102 configured so as to be in contact with the distal end of the tip in order to create an airtight seal that protects the contents of the medical injection device from external contamination. In this embodiment, the sealing septum 102 is an integral part of the closing cap 101.

[059] The end connector 100 and the closing cap 101 are made of chemically non-bonding materials. By chemically non-bonding materials is meant a pair of materials that have no chemical bonds between them when a first material is molded over the second material. As a result, when a part made of the second material is overmolded onto a part made of the first material, the parts are not bonded to each other and can move relative to each other.

[060] According to one embodiment, the end connector may be made of polycarbonate (PC) and the closing cap may be made of a thermoplastic elastomer (TPE). However, other pairs of chemically non-bonding materials suitable for the application may be used.

[061] The end cap includes an RFID tag 2. The RFID tag comprises an RFID chip 20 and an antenna 21, the RFID chip being coupled to the antenna by means of a bridge 22. The antenna 21 preferably has an annular shape extending around the X-axis, but may have any other suitable shape. Any breakage of one of the components of the RFID tag, in particular the bridge 22, will disable the RFID tag. Petition 870250083092, dated 09 / 15 / 2025, page 25 / 52 16 / 17

[062] The RFID tag is integrated into the end cap in such a way that the RFID chip 20 and the antenna 21 are located in different portions of the cap. According to the embodiment illustrated, the chip 20 is overmolded onto the end connector 100, and the antenna 21 is overmolded onto the closing cap 101, the antenna being located at an interface between the end connector and the closing cap. According to an alternative embodiment (not illustrated), the chip may be integrated into the closing cap, and the antenna into the end connector, the antenna still being located at the interface between the end connector and the closing cap.

[063] The end cap is thus made as a single piece with the end connector and the closing cap overmolded onto the RFID tag. Because the end connector and the closing cap are made of chemically non-bonding materials, the closing cap can be removed from the end connector by unscrewing the closing cap. Since the RFID chip is embedded in the end connector, and the antenna in the closing cap, the rotational movement applied to the closing cap will have the effect of breaking the bridge 22, thus inactivating the RFID chip.

[064] As best observed in Figure 10, in a preferred embodiment, the antenna 21 comprises a plurality of protrusions 210 that extend radially inward into the material of the closing cap. These protrusions create a rotational engagement of the antenna 21 with the closing cap 101 and prevent the antenna from separating from the closing cap when the closing cap is unscrewed from the end connector.

[065] The end cap according to the second embodiment of the present invention can be manufactured as follows.

[066] A mold adapted for two-shot injection molding of the end connector and the closing cap is provided.

[067] The RFID tag is placed in the mold, the antenna being located from Petition 870250083092, dated 09 / 15 / 2025, page 26 / 52 17 / 17 mode to fit at the interface between a part of the mold that defines the end connector and a part of the mold that defines the closing cap.

[068] A first material (e.g., polycarbonate) is injected into the mold to form the end connector 100, wherein the chip and a first part of the bridge (i.e., the part of the bridge adjacent to the chip) of the RFID tag are overmolded in said first material. Then, a second material (e.g., a thermoplastic elastomer) chemically unbonded to the first material is injected into the mold to form the closing cap 101, wherein the antenna 21 and a second part of the bridge (i.e., the part of the bridge adjacent to the antenna) are overmolded in said second material.

[069] One advantage of this process is that the tip cap is obtained directly with the tip connector and the closing cap in a removable assembled state.

[070] Obviously, the appended drawings are provided for illustrative purposes only and are not intended to limit the scope of application of the present invention. Petition 870250083092, dated 09 / 15 / 2025, p. 27 / 52

Claims

1 / 3 CLAIMS 1. Tip cap (1) for a medical injection device, comprising: - a tip connector (100) configured to fit a tip of the medical injection device, comprising a main body (100a) and an end portion (100b) connected to the main body by means of a frangible portion (100c); - a closing cap (101) configured to seal a distal opening of the tip, the closing cap being removablely connected to the tip connector (100) by mutually interlocking threaded portions (1002, 1012);- the end cap (1) further comprising an RFID tag (2) integral with the end connector (100) and comprising a chip (20) and an antenna (21), the end cap (1) CHARACTERIZED in that the chip (20) is overmolded into one of the main body (100a) and the end portion (100b), and the antenna (21) is overmolded into the other of the main body (100a) and the end portion (100b), the chip (20) and the antenna (21) being electrically connected by a bridge (22) extending through the frangible portion (100c) of the end connector (100), the bridge (22) being configured to break under a relative movement applied to the closing cap (101) and the end connector (100) in order to remove the closing cap from the end connector.; 2. Tip cap, according to claim 1, CHARACTERIZED in that the closing cap (101) comprises a sealing septum (102) configured to be contiguous to the tip (10) of the medical injection device.

3. End cap, according to claim 1 or 2, CHARACTERIZED in that the antenna (21) has a ring shape that Petition 870260044859, dated 12 / 05 / 2026, page 8 / 13 2 / 3 extends around a longitudinal axis (X) of the end cap (1).

4. End cap, according to claim 3, CHARACTERIZED in that the bridge (22) is parallel to the longitudinal axis (X) of the end cap.

5. End cap, according to claim 3, CHARACTERIZED in that the bridge (22) is orthogonal to the longitudinal axis (X) of the end cap.

6. Tip cap, according to any one of claims 1 to 5, CHARACTERIZED in that the tip connector (100) and the closing cap (101) comprise mutually interlocking protrusions (1003) and notches (1013) configured to rotationally secure the end portion (100b) of the tip connector (100) to the closing cap (101), the frangible portion (100c) being configured to break under a relative rotational motion applied to the closing cap (101) and the tip connector (100) in order to remove the closing cap (101) from the main body (100a) of the tip connector.

7. Medical injection device CHARACTERIZED by comprising a cylinder and a tip (10) comprising a distal opening, and a tip cap (1), as defined in any one of claims 1 to 6, mounted on said tip.

8. Process for manufacturing a tip cap, as defined in any of claims 1 to 6, the process being CHARACTERIZED in that it comprises the steps of: i) providing an RFID tag (2) comprising a chip (20) and an antenna (21), the chip (20) and the antenna (21) being electrically connected by a bridge (22); ii) placing the RFID tag in a mold adapted for injection molding of the tip connector (100); iii) injecting at least one plastic material into the mold using a first Petition 870260044859, dated 12 / 05 / 2026, page.9 / 13 3 / 3 insert so as to form at least part of the end connector (100), and overmolding the chip and antenna, the chip and antenna having a level surface; iv) inject the same plastic material as in step iii) using a second insert and obtaining the end connector (100) in which the RFID tag (2) is overmolded; v) mold the closing cap (101); and vi) removablely mount the closing cap on the end connector in order to obtain the end cap. Petition 870260044859, dated 12 / 05 / 2026, page 10 / 13.