Cover for a medical injection device comprising a radio frequency identification (RFID) tag

Abstract

The invention relates to a cover (10) for a medical injection device (1) having a hub (6) defined at a distal end thereof, said cover (10) comprising: - an outer shell (20) formed of a first material, said outer shell (20) having an inner wall (23) having a circumference; - an inner shell (30) formed of a second material different from said first material and defining a cavity able to receive at least a portion of the hub (6) in a sealed manner, said inner shell (30) having an outer wall (32) having a circumference, and the inner shell (30) being at least partially inserted within the outer shell (20) and at least partially in contact with the inner wall (23) of the outer shell (20); - a radio frequency identification, RFID, tag (40a, 40b, 40c, 40d) located between the outer shell (20) and the inner shell (30), said RFID tag (40a, 40b, 40c, 40d) comprising an RFID chip (41a, 41b, 41c) connected to at least one RFID antenna (42a, 42b, 42c), wherein the RFID tag (40a, 40b, 40c, 40d) has a width (W T ) extending in a range between 40% and 100% (not included) of the circumference of the inner shell (30) or of the inner wall (23) of the outer shell (20), and wherein the RFID tag (40a, 40b, 40c, 40d) has a length (L T ) extending in a range of at least 50% of the length (L) of the cover (10). The invention also relates to a medical injection device (1) comprising said cover (10) and to a method for manufacturing said cover (10).

Description

Technical Field

[0001] This invention relates to a cover for a medical injection device, a medical injection device, and a method for manufacturing the cover. This invention is particularly applicable to the healthcare industry. Background Technology

[0002] In this application, the distal end of a component or device should be understood as the end furthest from the user's hand, and the proximal end should be understood as the end closest to the user's hand. Similarly, in this application, "distal direction" should be understood as the injection direction relative to the medical container of the present invention, while "proximal direction" should be understood as the direction opposite to the injection direction, that is, the direction toward the hand of the user holding the container to perform the injection operation.

[0003] Medical injection devices, such as pre-fillable or pre-filled syringes, typically include a hollow body or barrel forming a container for a medical product. The body includes a distal end optionally provided with a needle and a proximal end typically provided with a flange.

[0004] There is an increasing need for individual traceability of medical containers (such as medical injection devices) from the manufacturing process of the medical container to its final labeling, final use or disposal.

[0005] For example, WO2017157784 discloses a container with a cylindrical side surface surrounded by a printed sequence of machine-readable unique identifiers. These printed unique identifiers allow for tracking and tracing each container along the supply chain. However, since these unique identifiers are printed on the outside of the container, they can be removed or damaged, for example, during handling or use of the container. Furthermore, the unique identifiers cover a portion of the container, potentially affecting the user's visual inspection process. Finally, inkjet printers are used to print identifiers on the outside of containers. However, this ink-based printing method may pose a risk of container contamination. Additionally, when the container is placed, for example, in sealed packaging, people may not be able to access these printed unique identifiers.

[0006] EP2019305879 also discloses a plastic flange for a medical container, the flange including remotely readable electronic components, such as an RFID tag comprising an RFID chip and an RFID antenna, for remote identification of the medical container. However, the medical container requires a complex manufacturing process, which specifically involves assembling the plastic flange onto a glass tube.

[0007] US2019 / 0217018 discloses a shielding assembly supporting RFID tags that provides a sterile seal for the drug delivery port of a pharmaceutical container. The container can be a needle-free, pre-filled syringe, vial, cartridge, or collapseable bag or pouch. An RFID tag is permanently attached to one or more parts of the shielding assembly via co-molding or another form of permanent or removable attachment. The RFID tag is essentially an RFID chip that may optionally communicate electrically with an antenna. In all the disclosed embodiments, it is clear that the size of the RFID tag is as small as possible. In fact, small RFID tags are easier to implement without affecting the covering manufacturing process. Furthermore, small RFID tags have little impact on the thickness and visual appearance of the shielding assembly. However, the level of data transmission to the RFID reader is significantly reduced. Summary of the Invention

[0008] In this context, the object of the present invention is to provide an apparatus that mitigates the aforementioned disadvantages by allowing effective individual identification of medical injection devices, having little or no impact on visual inspection, having a high level of data transmission, having little or no risk of removal or damage, and having limited impact on the manufacturing process.

[0009] A first aspect of the invention is a cover for a medical injection device having a hub defined at its distal end, the cover comprising:

[0010] - An outer shell, formed of a first material, the outer shell having an inner wall with a circumference.

[0011] - An inner housing formed of a second material different from the first material, defining a cavity capable of sealingly receiving at least a portion of the hub. The inner housing has an outer wall with a circumference, and is at least partially inserted into and at least partially in contact with the inner wall of the outer housing.

[0012] - An RFID tag located between the outer casing and the inner casing, the RFID tag including an RFID chip connected to at least one RFID antenna, wherein the width of the RFID tag extends between 40% and 100% (excluding 100%) of the circumference of the outer wall of the inner casing or the entire circumference of the inner wall of the outer casing, and wherein the length of the RFID tag extends within at least 50% of the length of the cover.

[0013] Not wishing to be bound by any theory, the cover of the present invention is believed to allow individual traceability for each medical injection device from the manufacturing process to its final use. Furthermore, the RFID tag is well protected against removal or external damage that may occur due to packaging, storage, distribution, or use of the medical injection device. Moreover, the RFID tag is concealed between the outer and inner shells of the cover, having no visual impact on the medical injection device. Furthermore, the insertion of the RFID tag has only a limited impact on the cover manufacturing process. It is also anticipated that the RFID tag allows for remote identification of the medical injection device from the manufacturing steps of the cover to its final use or disposal, thus making identification easy. Another advantage of the present invention is that the RFID tag does not require direct visual penetration from a reading machine, allowing reading to occur at any time without opening the packaging of the medical injection device, whether it is packaged in a separate package or packaged with other medical injection devices (such as in a bucket and / or sealed bag). Furthermore, the RFID tag is integrated within the cover, the outer wall of the cover has no additional thickness, and therefore no changes are required in the packaging or storage of the medical injection device. Finally, the width of the RFID tag extends within a range of 40% to 100% (excluding 100%) of the circumference of the outer wall of the inner housing or the entire circumference of the inner wall of the outer housing. It is believed that if the RFID tag overlaps with the circumference of the outer wall of the inner housing or the entire circumference of the inner wall of the outer housing, there is a risk of reduced data transmission levels to the RFID reader. The length of the RFID tag extends within a range of at least 50% of the cover length. It is believed that the length of the tag, and more particularly the antenna length of the tag, may affect the data transmission level from the RFID tag to the RFID reader. Compared with the prior art, the inventors have found that implementation of the RFID tag according to the invention (which has a wide width and a wide length within the cover) is feasible. In fact, the location of the RFID tag within the cover, and more particularly between the outer and inner housings, allows for an increase in the size of the RFID tag, and thus significantly improves the data transmission level to the RFID reader without affecting the manufacturing process.

[0014] In this application, 100% of the width of the cover corresponds to the maximum width of the cover, and 100% of the length of the cover corresponds to the maximum length of the cover.

[0015] The cover of the present invention includes an inner housing having an outer wall, the outer wall of which at least partially contacts the inner wall of an outer housing. The contact is made without any adhesive. Preferably, the outer wall of the inner housing only partially contacts the inner wall of the outer housing. In this embodiment, the inner housing and the outer housing can be easily assembled together.

[0016] In one embodiment, the RFID tag includes an RFID chip connected to at least one RFID antenna, which extends substantially along the longitudinal axis of the cover.

[0017] In one embodiment, the RFID tag is located inside the inner wall of the housing.

[0018] In another embodiment, the RFID tag is located inside the outer wall of the inner housing.

[0019] In another embodiment, the RFID tag is located between the outer wall of the inner housing and the inner wall of the outer housing. For example, the RFID tag can be adhered to the outer wall of the inner housing by an adhesive bond, or the RFID tag can be adhered to the inner wall of the outer housing by an adhesive bond.

[0020] In one embodiment, the RFID tag is in the form of a wet inlay, a dry inlay, or a pressure-sensitive tag.

[0021] RFID wet and dry inserts may include a substrate, for example, made of paper or polyethylene terephthalate (PET). The RFID tag may be disposed on one side of the substrate. RFID wet and dry inserts may also include at least one protective layer on top of the RFID tag. The protective layer may be silicone paper.

[0022] RFID wet inlays are described as "wet" because they include an adhesive layer and backing paper (e.g., with a silicone liner) on the other side of the substrate. RFID dry inlays are described as "dry" because they do not have an adhesive backing. Pressure-sensitive labels are similar to high-tech stickers.

[0023] In one embodiment, the ring-shaped RFID tag is a low-frequency radio frequency identification (LF-RFID) tag. Low frequency is typically around 30 kHz to 300 kHz. In this embodiment, the RFID reader can read the HF-RFID tag, for example, at a distance of up to about ten centimeters.

[0024] In one embodiment, the RFID tag is a high-frequency radio frequency identification (HF-RFID) tag. The high frequency is typically around 1-15 MHz. In this embodiment, the RFID reader can read the HF-RFID tag, for example, at a distance of approximately one meter.

[0025] In one embodiment, the ring RFID tag is a high-frequency near-field communication (HF-NFC) tag. The frequency is typically around 13.56 MHz. In this embodiment, an NFC reader can read the HF-NFC tag, for example, at a distance of at most a few centimeters. The difference between HF-NFC and HF-RFID is that HF-NFC can be read by an NFC-enabled smartphone. In one embodiment, the ring RFID tag is a dual-frequency tag that incorporates both HF-NFC and UHF RFID. For example, it can be read with an NFC-enabled smartphone or with a UHF reader.

[0026] Preferably, the RFID tag is an ultra-high frequency radio frequency identification (UHF-RFID) tag. Ultra-high frequency is typically around 400-1000MHz. In this embodiment, the RFID reader can read the UHF-RFID tag, for example, at a distance of approximately 15 meters.

[0027] Preferably, the RFID antenna has at least one branch. For example, the RFID antenna may have two or four branches. More preferably, the RFID antenna has two branches, each with an end. For example, the RFID antenna may have two branches, and these two branches may have multiple stable steps. According to the invention, stable steps mean that the two branches of the RFID antenna may have multiple uniform steps. For example, the stable steps are formed in the shape of a square, rectangle, triangle, or wave. Preferably, the multiple stable steps have the same amplitude.

[0028] For example, an RFID antenna may have two sinusoidal branches, a straight branch, or a coil-shaped branch. Preferably, when the RFID antenna has two sinusoidal branches, both branches are composed of multiple sinusoids. For example, when the RFID tag is a UHF-RFID tag, the two branches have a sinusoidal shape. For example, when the RFID tag is an HF-RFID tag, the two branches have a coil shape. In fact, it is believed that in these embodiments, the shape of the branches further improves the communication between the RFID tag chip, the antenna, and the RFID reader.

[0029] Preferably, the RFID antenna forms a loop between the branches, and the RFID chip is located between the loop and the branches of the RFID antenna.

[0030] In one embodiment, the RFID tag is asymmetric, meaning the RFID chip is not located at an equal distance from the ends of the two RFID antennas.

[0031] Preferably, the RFID chip is located at an equal distance from the ends of the two RFID antennas.

[0032] Preferably, the width of the RFID tag extends within a range of 50% to 100% of the circumference of the outer wall of the inner housing or the inner wall of the outer housing; more preferably, it extends within a range of 50% to 90% of the circumference of the outer wall of the inner housing or the inner wall of the outer housing; or advantageously, it extends within a range of 40% to 90% of the circumference of the outer wall of the inner housing or the inner wall of the outer housing. In this embodiment, the data transmission level to the RFID reader is believed to be improved without any risk of interference.

[0033] Advantageously, the extension length of the RFID tag is strictly less than 100% of the cover length. Preferably, the RFID tag has a length that extends over at least 70% of the cover length. In this embodiment, the length of the tag is believed to have a significant impact on the data transmission level from the RFID tag to the RFID reader.

[0034] Preferably, the radius of curvature of the RFID tag is between the radius of curvature of the outer shell and the radius of curvature of the inner shell.

[0035] Preferably, the longitudinal axis of the RFID tag is parallel to the longitudinal axis of the cover.

[0036] Preferably, the first material has greater rigidity than the second material.

[0037] Preferably, the first material is a thermoplastic. The first material may be polypropylene (PP), polyethylene (PE), polyethylene terephthalate (PET), polystyrene (PS), or polycarbonate (PC).

[0038] Preferably, the second material is a deformable material made of a material with elastomeric properties, such as a thermoplastic elastomer (“TPE”), rubber, or elastomer. Sterilizable elastomeric materials are preferred.

[0039] A second aspect of the invention is a medical injection device comprising a hub and a cover according to the invention. Advantageously, the hub of the medical injection device of the invention comprises a needle.

[0040] A third aspect of the invention is a method for manufacturing a covering according to the invention, the method comprising:

[0041] A. Provides an inner housing having an outer wall and an outer housing having an inner wall, the inner housing defining a cavity for sealingly receiving at least a portion of a hub defined at a distal end of a medical injection device, and

[0042] B. Position the RFID tag between the outer wall of the inner housing and the inner wall of the outer housing.

[0043] In step A), the inner housing and the outer housing can be manufactured separately or together. For example, the inner housing and the outer housing can be manufactured together by co-molding or overmolding. For example, the inner housing and the outer housing can be manufactured separately by molding, particularly by injection molding.

[0044] Preferably, in step B), the RFID tag is fixed to the inner wall of the outer shell, the outer wall of the inner shell, or between the outer wall of the inner shell and the inner wall of the outer shell by molding, in-mold labeling, adhesive bonding, assembly, co-molding, or overmolding.

[0045] Preferably, the RFID tag is fixed to the inner wall of the outer casing by in-mold labeling. Preferably, the RFID tag is fixed to the outer wall of the inner casing by in-mold labeling or adhesive bonding. For example, when the second material of the inner casing is TPE, the RFID tag is fixed to the outer wall of the inner casing by in-mold labeling. For example, when the second material of the inner casing is rubber, the RFID tag is fixed to the outer wall of the inner casing by adhesive bonding. Preferably, the RFID tag is fixed between the outer wall of the inner casing and the inner wall of the outer casing by adhesive bonding or by assembly. Assembly means that the RFID tag is held between the outer wall of the inner casing and the inner wall of the outer casing because the inner casing has an outer wall that at least partially contacts the inner wall of the outer casing. Preferably, the RFID insert is fixed to the inner wall of the outer casing, the outer wall of the inner casing, or between the outer walls of the inner casing and the inner walls of the outer casing by in-mold labeling or overmolding.

[0046] Preferably, the RFID wet insert is fixed to the inner wall of the outer shell, the outer wall of the inner shell, or between the outer wall of the inner shell and the inner wall of the outer shell by in-mold labeling, adhesive bonding, assembly, co-molding, or overmolding.

[0047] After step B), when the inner shell and outer shell are manufactured separately, the inner shell and outer shell can be assembled to form the cover of the present invention. Attached Figure Description

[0048] The invention and the advantages therefrom will become apparent from the detailed description given below with reference to the accompanying drawings:

[0049] Figure 1 This is a side view of a medical injection device equipped with a needle designed to receive a covering according to the invention;

[0050] Figure 2 This is a cross-sectional view of an embodiment of the covering according to the present invention;

[0051] Figure 3 yes Figure 2 The illustrated perspective view of the embodiment;

[0052] Figure 4 This is a perspective view of another embodiment of the covering according to the present invention;

[0053] Figure 5 and Figure 6 This is a perspective view of another embodiment of the covering according to the present invention;

[0054] Figure 7 yes Figure 5 and Figure 6 A perspective view of the embodiment shown;

[0055] Figure 8 yes Figures 5 to 7 A top cross-sectional view of the embodiment described herein;

[0056] Figure 9 This is a side view of a medical injection device equipped with a needle designed to receive a covering according to the invention;

[0057] Figure 10 yes Figure 9 The diagram shows a cross-sectional view of the outer shell of the covering.

[0058] Figure 11 yes Figure 9 The diagram shows a cross-sectional view of the covering. Detailed Implementation

[0059] Figure 1 A medical injection device 1, such as a syringe, is shown, which includes a longitudinal axis A. l An extended body 3. The body 3 includes sidewalls 11 and thus forms a reservoir suitable for receiving the drug composition 4 to be injected.

[0060] The medical injection device 1 also includes a portion disposed at its distal end 13 and extending from the distal end of the main body 3 along axis A. l Extended hub 6. Hub 6 is partially hollow to form a channel 5 in fluid communication with the body 3.

[0061] The needle 2 can be attached to the hub 6 of the medical injection device. For example, the needle 2 can be glued to the hub 6. The cover of the present invention is intended to cover the hub 6 of the medical injection device in order to protect the needle 2. The medical injection device 1 may also include a distal shoulder 7 at its distal end, the distal shoulder 7 being narrower relative to the body 3. At its proximal end, the body may suitably include a body flange 12.

[0062] Figure 1The illustrated medical injection device or syringe 1 also includes a plunger rod 9 having a stopper 8 disposed at its end. The stopper 8 is slidable along the inner surface of the sidewall 11 within the body 3 to allow the medical composition 4 to be dispensed from the body 3 through the needle 2. The medical composition contained in the medical injection device 1 can be, for example, a liquid agent, a drug, or a pharmaceutical composition such as a vaccine.

[0063] Figure 2 and Figure 3 A cover 10 according to an embodiment of the invention is shown. The cover 10 of the invention is intended to protect a needle 2 mounted on a hub 6 of a medical injection device 1. The cover 10 is intended to be mounted on the hub 6 of the medical injection device 1. The cover 10 includes an outer shell 20 and an inner shell 30. The outer shell 20 is generally made of a rigid material, while the inner shell 30 is made of a flexible material, and the needle 2 is directly engaged in the inner shell 30 when the cover 10 is mounted on the hub 6 of the medical injection device 1. Preferably, the outer shell 20 is made of polypropylene (PP), polyethylene (PE), polyethylene terephthalate (PET), polystyrene (PS), or polycarbonate (PC), more preferably polypropylene. Advantageously, the inner shell 30 is made of a deformable material such as TPE (thermoplastic elastomer). According to one embodiment, the outer shell 20 includes a closed distal end and an open proximal end. According to another embodiment, the inner shell 30 includes a closed distal end and an open proximal end. The outer casing 20 may be manufactured such that, at its proximal end, the outer casing 20 includes at least one locking window 21. The locking window defines a through-hole and is configured to receive at least one radial lug 31 of the inner casing 30. The radial lug 31 of the inner casing 30 engages with at least one window 21 of the outer casing 20. Typically, the outer casing includes two diametrically opposed locking windows 21. The outer casing 20 may include an abutment 22 located immediately adjacent to the locking window 21, allowing the inner casing 20 to be locked when the radial lug 31 engages in the locking window 21. The outer casing 20 may be manufactured by overmolding or injection molding.

[0064] The outer casing 20 includes an inner wall 23 that can receive the outer surface 32 of the inner casing 30. Both the inner wall 23 of the outer casing 20 and the outer wall of the inner casing 30 can have a circular cross-section.

[0065] The inner housing 30 also includes an inner wall (not shown) that is designed to mate with the hub 6 of the medical injection device 1 when the cover 10 is mounted on the hub 6 of the medical injection device 1. The inner wall of the inner housing 30 is designed to sealably engage with the outer surface of the hub 6 of the medical injection device 1.

[0066] like Figure 3 and Figure 4 As shown, RFID tags 40a and 40b can be located between the outer wall 32 of the inner housing 30 and the inner wall 23 of the outer housing 20. Advantageously, the RFID tags 40a and 40b include RFID chips 41a and 41b connected to at least one RFID antenna 42a and 42b, which extend substantially along the longitudinal axis A of the cover 10. When the cover 10 is mounted on the hub 6 of the medical injection device 1, the longitudinal axis A of the cover 10 is substantially parallel to the longitudinal axis A of the medical injection device. l .

[0067] like Figure 3 As shown, the RFID tag 40a can be a UHF-RFID tag 40a, which includes an RFID antenna 42a with two branches L1 and L2. Branch L1 has an end E1, and branch L2 has an end E2. The RFID tag 40a is disposed between these two ends E1 and E2 of branches L1 and L2. The RFID chip 41a can be disposed at any position between the two ends E1 and E2, but at the ends; or advantageously, the RFID chip 41a can be equidistant from the two ends E1 and E2.

[0068] The RFID tag 40a can be formed into a square, rectangle, or circle, and is typically formed into a square or rectangle. When the RFID tag 40a is located within the outer wall 32 of the inner housing 30, the RFID tag 40a extends over a range of less than 100% (excluding 100%) of the entire circumference of the outer wall 32 of the inner housing 30. When the RFID tag 40a is located within the inner wall 23 of the outer housing 20, the RFID tag 40a extends over a range of less than 100% (excluding 100%) of the entire circumference of the inner wall 23 of the outer housing 20. When the RFID tag 40a is located between the outer wall 32 of the inner housing 30 and the inner wall 23 of the outer housing 20, the RFID tag 40a extends over a range of less than 100% (excluding 100%) of the entire circumference of the inner wall 23 of the outer housing 20. Preferably, the two opposite sides of the RFID tag 40a do not contact each other. Preferably, the RFID tag 40a has a width W. T It extends over at least 40% of the circumference of the outer wall 32 of the inner housing 30. More preferably, the RFID tag 40a has a width W T The RFID tag extends between 40% and 100% (excluding 100%) of the circumference of the outer wall 32 of the inner housing 30, preferably between 50% and 100%, and more preferably between 50% and 90%, or advantageously between 40% and 90%. The RFID tag extends along the length L of the cover 10. The RFID tag 40a has a length L. TIt can extend over at least 50%, typically at least 70%, of the length L of the cover 10. Advantageously, the RFID tag 40a extends over the entire length L of the cover 10. This maximizes the antenna's exposure to electromagnetic waves.

[0069] The radius of curvature of the RFID tag 40a is between the radius of curvature of the inner shell and the radius of curvature of the outer shell.

[0070] The inventor has implemented such Figure 3 The illustration shows a first RFID tag located between the outer walls of the inner housing. The RFID tag has a width W extending over 63% of the circumference of the outer wall of the inner housing. T The RFID tag has a length L that extends over a range of 49% of the coverage length L. T In this example, the RFID tag has a maximum data read range of 270 mm when read from the side and below.

[0071] The inventor implemented such Figure 3 The illustration shows a second RFID tag located between the inner and outer walls of the housing. The RFID tag has a width W extending over 97% of the circumference of the outer wall of the inner housing. T The RFID tag has a length L that extends over 74% of the coverage length L. T In this example, the RFID tag has a maximum data reading range of 430 mm when read from the side and a maximum data reading range of 700 mm when read from below.

[0072] Therefore, the cover including the second RFID tag provides a significantly higher level of data transmission than the cover including the first RFID tag. Furthermore, the position of the RFID tag between the outer wall of the inner housing and the inner wall of the outer housing does not affect the cover manufacturing process and has minimal impact on visual inspection.

[0073] exist Figure 4 In the illustrated embodiment, the RFID tag 40b is a UHF-RFID tag 40b including an RFID antenna 42b, which has two branches L1 and L2. Branch L1 has an end E1, and branch L2 has an end E2. Figure 4 As shown, the RFID antenna 42b forms a loop, and the UHF-RFID chip 41b is located at the junction of the two branches L1 and L2 of the RFID antenna 42b with the loop. This loop can be used to capture near-frequency fields, while each branch can be used to capture far-frequency fields.

[0074] The RFID tag 40b can be formed as a square, rectangle, or circle, and is typically formed as a square or rectangle. When the RFID tag 40b is located within the outer wall 32 of the inner housing 30, it extends over less than 100% (excluding 100%) of the entire circumference of the outer wall 32. When the RFID tag 40b is located within the inner wall 23 of the outer housing 20, it extends over less than 100% (excluding 100%) of the entire circumference of the inner wall 23. When the RFID tag 40b is located between the outer wall 32 of the inner housing 30 and the inner wall 23 of the outer housing 20, it extends over less than 100% (excluding 100%) of the entire circumference of the inner wall 23. Preferably, the two opposite sides of the RFID tag 40b do not contact each other. Preferably, the RFID tag 40b has a width W extending over at least 40% of the circumference of the outer wall 32 of the inner housing 30. T More preferably, the RFID tag 40b has a width W extending between 40% and 100% (excluding 100%), preferably between 50% and 100%, and more preferably between 50% and 90%, or advantageously between 40% and 90% of the outer wall 32 of the inner housing 30. T The RFID tag 40b extends along the length L of the cover 10. The RFID tag 40b may have a length L extending over at least 50%, and typically at least 70%, of the length L of the cover 10. T Advantageously, the RFID tag 40b extends over the entire length L of the cover 10. This maximizes the antenna's exposure to electromagnetic waves.

[0075] exist Figure 3 and Figure 4 In this assembly, RFID tags 40a and 40b are disposed between the outer wall 32 of the inner housing 30 and the inner wall 23 of the outer housing 20. The RFID tags 40a and 40b can be in the form of dry inserts or wet inserts. When the RFID tags 40a and 40b are in the form of wet inserts, they are bonded to the inner housing by adhesive. Otherwise, the RFID tags 40a and 40b can be fixed to the inner housing by in-mold labeling, adhesive bonding, assembly, co-molding, or overmolding.

[0076] like Figure 5 and Figure 6 As shown, the RFID tag 40c can be located inside the inner wall 23 of the housing 20. The UHF-RFID tag 40c includes a UHF-RFID chip 41c connected to at least one UHF-RFID antenna 42c, which extends substantially along the longitudinal axis A of the cover 10.

[0077] The RFID tag 40c is a UHF-RFID tag 40c, which includes an RFID antenna 42c with two branches L1 and L2. Branch L1 has an end E1, while branch L2 has an end E2.

[0078] The RFID tag 40c can be formed into a square, rectangle, or circle, and is typically formed into a square or rectangle. When the RFID tag 40c is located within the outer wall 32 of the inner housing 30, it extends over less than 100% (excluding 100%) of the entire circumference of the outer wall 32. When the RFID tag 40c is located within the inner wall 23 of the outer housing 20, it extends over less than 100% (excluding 100%) of the entire circumference of the inner wall 23. When the RFID tag 40c is located between the outer wall 32 of the inner housing 30 and the inner wall 23 of the outer housing 20, it extends over less than 100% (excluding 100%) of the entire circumference of the inner wall 23. Preferably, the two opposite sides of the RFID tag 40c do not contact each other. Preferably, the RFID tag 40c has a width W. T It extends over at least 40% of the circumference of the outer wall 32 of the inner housing 30. More preferably, the RFID tag 40c has a width W T The RFID tag extends within 40% to 100% (excluding 100%) of the circumference of the outer wall 32 of the inner housing 30, advantageously within 50% to 100% of the circumference of the outer wall 32 of the inner housing 30, more preferably within 50% to 90% of the circumference of the outer wall 32 of the inner housing 30, or advantageously within 40% to 90% of the circumference of the outer wall 32 of the inner housing 30. The RFID tag extends along the length L of the cover 10. The RFID tag 40c has a length L. T The RFID tag 40c can extend over at least 50% of the length L of the cover 10, and typically over at least 70% of the length L of the cover 10. Advantageously, the RFID tag 40c extends over the entire length L of the cover 10. This maximizes the antenna's exposure to electromagnetic waves.

[0079] Figure 6 It shows Figure 5 Another view of the embodiment.

[0080] exist Figure 5 and Figure 6 In this case, the RFID tag 40c in the form of a wet inlay is disposed within the inner wall 23 of the housing 20 by means of, for example, an adhesive.

[0081] In all examples, the two branches L1 and L2 of RFID antennas 42a, 42b, and 42c are composed of multiple square sine curves with the same amplitude. The longitudinal axis A of RFID tags 40a, 40b, and 40c can be parallel to the longitudinal axis A of the covering device. T .

[0082] Figure 7 The diagram illustrates the following: Figure 5 and Figure 6 The RFID tag 40c shown in the embodiment.

[0083] Figure 8 The illustration shows a cross-sectional view of a cover 10 including an RFID tag 40c, which includes an antenna 42c and a chip 41c.

[0084] Figure 9 A medical injection device 1 is shown, which includes components along a longitudinal axis A. l An extended body 3. The body 3 includes sidewalls 11 and thus forms a reservoir suitable for receiving the medical composition 4 to be injected.

[0085] The medical injection device 1 also includes a portion disposed at its distal end 13 and extending from the distal end of the main body 3 along axis A. l Extended hub 6. Hub 6 is partially hollow to form a channel (not shown) in fluid communication with the main body 3.

[0086] In the illustrated example, an adapter 50, including an internal thread 51, can be mounted around the hub 6 of the medical injection device, such that an annular space is formed between the adapter 50 and the hub 6. The adapter can be connected to the medical injection device by any suitable connection means. The cover 10 of the present invention is intended to cover the hub 6 of the medical injection device. The medical injection device 1 may also include a distal shoulder at its distal end that narrows relative to the body 3.

[0087] Figure 9 The illustrated medical injection device or syringe 1 also includes a plunger rod 9 having a stopper 8 and a body flange 12 disposed at its end. The stopper 8 is slidable along the inner surface of the sidewall 11 within the body 3 to allow the medical composition 4 to be discharged from the body 3 through the hub 6. The medical composition contained in the medical injection device 1 can be, for example, a liquid agent, a drug, or a pharmaceutical composition such as a vaccine.

[0088] like Figures 9 to 11As shown, the cover 10 includes an outer shell 20 and an inner shell 30. The cover 10 can be manufactured, for example, by injection molding. According to one embodiment, the outer shell 20 includes an open distal end and an open proximal end, and the inner shell 30 includes a closed distal end and an open proximal end. At its distal end, the outer shell 20 includes a reinforcing member 10d to increase the rigidity of the cover 10, and at its proximal end, the outer shell 20 includes an external thread 10a configured to be screwed into an internal thread 51 of an adapter 50. The outer shell 20 includes a proximal opening 10b at its proximal end configured to receive the inner shell 30, which defines a cavity at its proximal end capable of sealingly receiving the hub 6. The inner shell 30 may include papillary protrusions 33 configured to ensure a tight and sterile seal of the distal hub 6 on the medical injection device 1.

[0089] Both the inner wall 23 of the outer casing 20 and the outer wall 32 of the inner casing 30 can have a circular cross-section. When the cover 10 is mounted on the hub 6 of the medical injection device 1, the inner casing 30 is designed to mate with the hub 6 of the medical injection device 1. The inner casing 30 is designed to sealably engage the outer surface of the hub 6 of the medical injection device 1.

[0090] like Figure 10 and Figure 11 As shown, the RFID tag 40d can be located within the inner wall 23 of the housing 20. The RFID tag 40d includes an RFID chip connected to at least one RFID antenna, which is substantially along the longitudinal axis A of the cover 10. l Further, the RFID tag 40d can be an LF-RFID tag, an HF-RFID tag, a UHF-RFIF tag, or an HF-NFC RFID tag. In other embodiments, the RFID tag 40d is located inside the outer wall 32 of the inner housing 30, or between the outer wall 32 of the inner housing 30 and the inner wall 23 of the outer housing 20.

[0091] The RFID tag 40d can be formed into a square, rectangle, or circle, and is typically formed into a square or rectangle. When the RFID tag 40d is located within the inner wall 23 of the housing 20, the RFID tag 40d extends over a range of less than 100% (excluding 100%) of the entire circumference of the inner wall 23 of the housing 20. Preferably, the two opposite sides of the RFID tag 40d do not contact each other. Preferably, the RFID tag 40d has a width W. T It extends over at least 40% (excluding 100%) of the circumference of the inner wall 23 of the housing 20. More preferably, the RFID tag 40d has a width W TThe RFID tag extends within 40% to 100% of the inner wall 23 of the outer casing 20, preferably within 50% to 100%, and more preferably within 50% to 90%, or advantageously within 40% to 90%. The RFID tag extends along the length L of the cover 10. The RFID tag 40d has a length L. T It can extend over at least 50% of the length L of the cover 10. More preferably, the RFID tag 40d has a length L T The RFID tag 40d extends over at least 70% of the length L of the cover 10. Advantageously, the RFID tag 40d extends over the entire length L of the cover 10. This maximizes the exposure of the antenna to the reader's electromagnetic waves.

[0092] The radius of curvature of the RFID tag 40d lies between the radius of curvature of the inner shell and the radius of curvature of the outer shell.

[0093] RFID tags 40d can be presented as dry inlays or wet inlays.

[0094] The covering according to the invention allows for efficient individual identification of medical injection devices without affecting visual inspection, with little or no risk of removal or damage, and has limited impact on the manufacturing process.

Claims

1. A cover (10) for a medical injection device (1), the medical injection device (1) having a hub (6) defined at a distal end thereof, the cover (10) comprising: - an outer shell (20) formed of a first material, the outer shell (20) having an inner wall (23) with a circumference, - an inner shell (30) formed of a second material different from the first material, the inner shell defining a cavity able to receive at least a portion of the hub (6) in a sealed manner, the inner shell (30) having an outer wall (32) with a circumference, the inner shell (30) being at least partially inserted within the outer shell (20) and at least partially in contact with the inner wall (23) of the outer shell (20), - a radio frequency identification, RFID, tag (40a, 40b, 40c, 40d) located between the outer casing (20) and the inner casing (30), the RFID tag (40a, 40b, 40c, 40d) comprising an RFID chip (41a, 41b, 41c) connected to at least one RFID antenna (42a, 42b, 42c), wherein the RFID tag (40a, 40b, 40c, 40d) has a width (W T ) extending in a range between 40% and 100%, inclusive of 40%, of the circumference of an outer wall (32) of the inner casing (30) or of the entire circumference of an inner wall (23) of the outer casing (20), and wherein the RFID tag (40a, 40b, 40c, 40d) has a length (L T ) extending in a range of at least 50% of the length (L) of the cover (10).

2. The covering (10) of claim 1, wherein, the RFID tag (40a, 40b, 40c, 40d) being located within the inner wall (23) of the outer shell (20).

3. The covering (10) of claim 1, wherein, the RFID tag (40a, 40b, 40c, 40d) being located within the outer wall (32) of the inner shell (30).

4. The covering (10) of claim 1, wherein, the RFID tag (40a, 40b, 40c, 40d) being located between the outer wall (32) of the inner shell (30) and the inner wall (23) of the outer shell (20).

5. The covering (10) of any of claims 1 to 4, wherein, the RFID tag (40a, 40b, 40c, 40d) is a low frequency radio frequency identification, LF-RFID, tag, an ultra-high frequency radio frequency identification, UHF-RFID, tag, a high frequency near field communication, HF-NFC, tag or a high frequency radio frequency identification, HF-RFID, tag.

6. The covering (10) of any of claims 1 to 4, wherein, the RFID antenna (42a, 42b, 42c) has two branches (LI, L2), branch (LI) having a terminal end (El) and branch (L2) having a terminal end (E2).

7. The covering (10) of claim 6, wherein, the two branches (LI, L2) of the RFID antenna (42a, 42b, 42c) are constituted by a plurality of stable steps.

8. The covering (10) of claim 7, wherein, the plurality of stable steps have the same amplitude.

9. The covering (10) of any of claims 1 to 4, wherein, The RFID tag (40a, 40b, 40c) has a width (W T ) extending in a range between 50% and 100% of the circumference of the outer wall (32) of the inner housing (30) or the entire circumference of the inner wall (23) of the outer housing (20).

10. The covering (10) as claimed in any of claims 1 to 4, wherein, The RFID tag (40a, 40b, 40c) has a width (W T ) extending in a range between 50% and 90% of the circumference of the outer wall (32) of the inner housing (30) or the entire circumference of the inner wall (23) of the outer housing (20).

11. The covering (10) of any of claims 1 to 4, wherein, Said RFID tag (40a, 40b, 40c) has a width (W T ) extending in a range between 40% and 90% of the entire circumference of the outer wall (32) of the inner housing (30) or of the inner wall (23) of the outer housing (20).

12. The covering (10) of any of claims 1 to 4, wherein, Said RFID tag (40a, 40b, 40c) has a length (L T ) extending in a range of at least 70% of the length (L) of the covering (10).

13. The covering (10) of any of claims 1 to 4, wherein, the radius of curvature of the RFID tag (40a, 40b, 40c, 40d) is comprised between the radius of curvature of the outer shell and the radius of curvature of the inner shell.

14. The covering (10) of any of claims 1 to 4, wherein, Said RFID tags (40a, 40b, 40c, 40d) have a longitudinal axis (A T ) parallel to the longitudinal axis (A) of the covering (10).

15. A medical injection device (1) comprising a hub (6) and a cover (10) as claimed in any one of claims 1 to 14.

16. A method of manufacturing a cover as claimed in any one of claims 1 to 14, comprising: A. providing an inner shell (30) having an outer wall (32) and an outer shell (20) having an inner wall (23), the inner shell (30) defining a cavity for receiving at least a portion of a hub (6) defined at a distal end of a medical injection device (1) in a sealed manner, and B. positioning the RFID tag (40a, 40b, 40c, 40d) between the outer wall (32) of the inner shell (30) and the inner wall (23) of the outer shell (20).

17. The method of claim 16, wherein, In step B, the RFID marker (40a, 40b, 40c, 40d) is secured within the inner wall (23) of the outer housing (20), the outer wall (32) of the inner housing (30), or between the outer wall (32) of the inner housing (30) and the inner wall (23) of the outer housing (20) by molding, in-mold labeling, adhesive bonding, or assembly.

18. The method of claim 16, wherein, In step B, the RFID marker (40a, 40b, 40c, 40d) is secured within the inner wall (23) of the outer housing (20), the outer wall (32) of the inner housing (30), or between the outer wall (32) of the inner housing (30) and the inner wall (23) of the outer housing (20) by co-molding or over-molding. In step B, the RFID marker (40a, 40b, 40c, 40d) is secured within the inner wall (23) of the outer housing (20), the outer wall (32) of the inner housing (30), or between the outer wall (32) of the inner housing (30) and the inner wall (23) of the outer housing (20) by co-molding or over-molding.

Images