Medical container comprising an RFID tag for remotely identifying the medical container

Abstract

Medical container and method for manufacturing the medical container. The medical container (1) comprises a barrel defining a reservoir for containing a medical product, and a needle (4) extending in a barrel-shaped channel (24) provided at a distal end (20) of the barrel so as to establish fluid communication between the reservoir and the needle (4). The medical container (1) further comprises a metal-on-metal RFID (ROM) tag (8) at least partially located within the barrel-shaped channel (24) and having an antenna (82) extending along the needle (4).

Description

Technical Field

[0001] This invention relates to a medical container, such as a prefillable or pre-filled syringe, which includes an RFID tag attached to a needle. 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, while the proximal end should be understood as the end closest to the user's hand. Similarly, in this application, with respect to the medical container of the present invention, "distal direction" should be understood as the injection direction, and "proximal direction" should be understood as the direction opposite to the injection direction, that is, the direction toward the user's hand holding the container during the injection operation.

[0003] Medical injection devices, such as prefillable or pre-filled syringes, typically include a hollow body or barrel that forms a container for a medical product. The body includes a distal end, which may optionally have a needle, and a proximal end, which typically has a flange.

[0004] From the manufacturing process of medical containers to their final labeling, use, or disposal, there is an increasing need for individual tracking of these medical containers (such as medical injection devices).

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

[0006] In this context, one object of the present invention is to provide an apparatus that mitigates the aforementioned disadvantages by allowing effective individual identification of medical containers without affecting visual inspection, minimizing or eliminating the risk of removal or damage, and limiting the impact on the manufacturing process.

[0007] A first aspect of the invention is a medical container comprising: a cylindrical body defining a reservoir for containing a medical product; and a needle extending in a cylindrical channel disposed at a distal end of the cylindrical body to establish fluid communication between the reservoir and the needle, wherein the medical container further comprises an RFID (ROM) tag for use on a metal, the RFID (ROM) tag for use on a metal being at least partially located within the cylindrical channel and having an antenna extending along the needle.

[0008] Therefore, this invention allows for individual tracking of each medical container from its manufacturing process to its final use. Furthermore, the ROM tag is well protected against removal or external damage that may occur during the packaging, storage, distribution, or use of the medical container. Additionally, the ROM tag does not come into contact with the medical product contained within the medical container. Moreover, the ROM tag does not obstruct visual inspection by the end user. The ROM tag also does not add any extra thickness to the medical container. Furthermore, the antenna extending along the needle increases the read / write distance because the metal needle is used as an antenna transmitter.

[0009] In one embodiment, the antenna is helical and spirally wound around the needle.

[0010] In one implementation, the RFID (ROM) tag used on metal is an ultra-high frequency RFID (UHF-ROM) tag used on metal. Preferably, the antenna includes two independent legs, each connected to the chip, forming two unconnected coils around the pin. These features increase the read / write distance.

[0011] In one embodiment, the medical container includes an adhesive for securing the needle to the cylindrical channel, with an RFID (ROM) tag for use on metal embedded in the adhesive. This protects the ROM tag from external environmental influences and further prevents any contact with the end user's skin during injection.

[0012] In one embodiment, the antenna extends along a predetermined needle portion having a length of at least 2 millimeters, and the predetermined needle portion corresponds at most to the entire needle portion contained within the cylindrical channel.

[0013] In one implementation, the antenna is located near the chip of the RFID (ROM) tag used on metal.

[0014] Another aspect of the present invention is a method for manufacturing a medical container comprising the above-described features, comprising the following steps:

[0015] i. Attach an RFID (ROM) tag, which is used on metal, to the needle;

[0016] ii. Position the needle into the tubular channel;

[0017] iii. Secure the needle inside the cylindrical channel;

[0018] iv. Store a unique device identifier (UDI) in a ROM tag for use in identifying medical containers.

[0019] It is conceivable that steps (i) and (ii) above can be performed in any suitable order. In one embodiment, step (i) may occur before step (ii). In another embodiment, step (ii) may occur before step (i).

[0020] Preferably, step (iii) occurs after steps (i) and (ii). Attached Figure Description

[0021] The invention and the advantages therefrom will become apparent from the following detailed description with reference to the accompanying drawings.

[0022] - Figure 1 It is a 3D diagram of a standard medical container.

[0023] - Figure 2 This is a semi-transparent view of a medical container according to an embodiment of the present invention.

[0024] - Figure 3 yes Figure 2 Details

[0025] - Figure 4 This is a perspective view of a ROM tag positioned on a needle in a medical container according to the present invention. Detailed Implementation

[0026] Reference Figure 1 The image shows a medical container 1, such as a prefillable or pre-filled syringe. The medical container 1 includes a cylindrical body 2 defining a reservoir 26 for storing a medical product, such as a medical composition. The body 2 extends along a longitudinal axis A and has a distal end, which may be in the form of a longitudinally distal end 20. This end may extend distally from a distal shoulder 22 of the body 2. The distal end 20 defines a cylindrical channel 24 configured to receive a needle 4 to establish fluid communication between the reservoir 26 and the needle. The medical container 1 also includes a plunger rod 6 having a plunger 60 at its distal end for discharging the medical product contained in the reservoir 26 through the needle. The body 2 may be made of glass or plastic. In an alternative embodiment (not shown), the needle 4 may be fixed to a needle hub connected to the distal end 20 of the body 2; the needle hub may be threadedly connected to an adapter mounted on the distal end 20 of the body 2.

[0027] Reference Figures 2 to 3 The medical container 1 of the present invention includes a ROM (RFID on metal) tag 8 attached to a needle 4 and located wholly or at least partially within a cylindrical channel 24, such that the ROM tag 8 is substantially invisible to the end user and protected relative to the external environment. The RFID on metal tag 8 is a radio frequency identification (RFID) tag 8 configured to perform a predetermined function when attached near a metal object. More specifically, the ROM tag 8 is disposed in a gap 240 defined between the outer surface of the needle 4 and the inner surface of the cylindrical channel 24.

[0028] The ROM label 8 is attached to the needle 4 by adhesive 10. In a preferred embodiment, the needle 4 is first inserted into the cylindrical channel 24. Then, the ROM label 8 is inserted into the cylindrical channel 24, positioned close to the needle 4, and the ROM label 8 is secured to the needle 4 by an adhesive material that also secures the needle 4 to the cylinder 2, the adhesive material filling the gap 240 formed between the needle 4 and the inner wall of the cylindrical channel 24.

[0029] In another embodiment, the ROM tag 8 is secured to the needle 4 before the needle 4 is inserted into the cylindrical channel 24. The ROM tag 8 may be located on a substrate with an adhesive layer, such as a ceramic or plastic substrate, which is secured to the outer surface of the needle 4 by the adhesive layer. The needle 4 is then secured to the cylinder 2 and into the cylindrical channel 24 by filling the gap 240 with adhesive material.

[0030] It is advisable that the ROM label 8 should not come into contact with the needle 4, i.e., it should be separated from the needle 4 by the substrate and / or adhesive 10.

[0031] In another embodiment, the ROM tag 8 is first secured to the pin 4 by welding a portion of the antenna 82 to the pin 4. Then, the pin 4 is inserted into the cylindrical channel 24 and secured to the cylinder 2 by adhesive material filling the gap 240.

[0032] It is advisable that the adhesive material used to fix the needle 4 to the cylinder 2 preferably completely embeds the ROM label 8, thereby preventing the ROM label 8 from coming into any contact with the external environment.

[0033] like Figures 2 to 4 As shown, the ROM tag 8 includes a chip 80 and an antenna 82. The chip 80 is configured to store a unique device identifier (UDI). The UDI allows for remote identification of the medical container 1 from the manufacturing process until the final labeling, final use, or disposal.

[0034] Antenna 82 extends longitudinally along pin 4, thus pin 4 becomes an extension of antenna 82, thereby improving the read range of ROM tag 8. Alternatively, antenna 82 extends from chip 80 in a proximal direction. For example, see reference... Figure 3 The antenna 82 may have a spiral shape and may be wound around the needle 4 to increase the read range. Preferably, the antenna 82 extends over a predetermined needle portion 40, the predetermined needle portion 40 having a length of at least 2 mm. At most, the antenna 82 extends along the entire needle portion 42 located within the cylindrical channel 24.

[0035] The ROM tag 8 can be a low-frequency (approximately 30-300kHz) ROM (LF-ROM) tag 8, a high-frequency (approximately 3-30MHz) ROM (HF-ROM) tag 8, or, preferably, an ultra-high frequency (approximately 400-1000MHz) ROM (UHF-ROM) tag 8. For example, an RFID reader can read the LF-ROM tag 8 at a distance of up to approximately 10 centimeters, the HF-ROM tag 8 at a distance of approximately 1 meter, and the UHF-ROM tag 8 at a distance of approximately 15 meters.

[0036] Reference Figure 4 When the ROM tag 8 is an UHF ROM tag 8, the antenna 82 may include two separate legs 820, each leg being connected to the chip 80 and forming two unconnected coils around the pin. The two legs 820 preferably extend from the chip 80 in a proximal direction.

[0037] The dimensions of the ROM tag 8 can be configured to make the ROM tag 8 very compact and not increase the thickness of the medical container 1. For example, the diameter of the antenna 82 can be no more than 0.4 mm, for example, about 0.2 mm. The dimensions of the chip 80 can be approximately 1 mm × 0.5 mm × 0.1 mm (length × width × thickness).

[0038] The present invention also relates to a method for manufacturing the above-described medical container 1.

[0039] The method includes step (i) of positioning the ROM tag 8 onto the pin.

[0040] This step (i) can occur after the needle 4 is inserted into the cylindrical channel 24; then, the adhesive material fills the gap 240 to secure the ROM label 8 to the needle 4 and the needle 4 to the cylinder 2.

[0041] Alternatively, step (i) can occur before the needle 4 is inserted into the cylindrical channel 24. For example, the ROM tag 8 is placed on a tubular plastic or ceramic substrate. The substrate is positioned around the needle. In one embodiment, the substrate has an adhesive layer for direct attachment to the needle. In another embodiment, the substrate has no adhesive layer and can subsequently be attached to the needle 4 by filling the cylindrical channel 24 with an adhesive material to secure the needle 4 to the cylinder 2. In another example, a portion of the antenna 82 is soldered to the needle 4 before the needle 4 is inserted into the cylindrical channel 24.

[0042] The method also includes step (ii) of positioning the needle 4 into the cylindrical channel 24. As described above, step (ii) may occur before or after step (i) of positioning the ROM tag 8 into the needle 4.

[0043] The method further includes step (iii) of securing the needle 4 within the cylindrical channel 24 to firmly fix the needle 4 to the cylinder 2. For this purpose, the gap 240 between the inner wall of the cylindrical channel 24 and the outer wall of the needle 4 is filled with adhesive material. Any adhesive material commonly used to secure needles in cylindrical channels can be used. This step may include embedding the ROM label 8 into the adhesive material.

[0044] The method also includes the step of writing a unique device identifier (UDI) into a ROM tag 8 for use in identifying the medical container 1.

Claims

1. A medical container (1), said medical container comprising: A cylindrical body (2) is defined for containing a reservoir (26) of a medical product; and a metal needle (4) extending in a cylindrical channel (24) disposed at the distal end (20) of the cylindrical body (2) to establish fluid communication between the reservoir (26) and the metal needle (4), wherein the medical container (1) further includes an RFID tag (8) on the metal, the RFID tag (8) on the metal being at least partially located within the cylindrical channel (24) so ​​as not to affect visual inspection of the medical container (1) and without the risk of the tag being removed or damaged, and having an antenna (82) extending along a needle portion (42) located within the cylindrical channel (24), such that the antenna (82) extends within the cylindrical channel (24); and The metal needle (4) is used as an antenna transmitter.

2. The medical container (1) according to claim 1, wherein, The antenna (82) is spiral-shaped and spirally wound around the metal needle (4).

3. The medical container (1) according to claim 1, wherein, The RFID tag (8) used on metal is an ultra-high frequency RFID tag (8) used on metal.

4. The medical container (1) according to claim 3, wherein, The antenna (82) includes two separate legs (820), each leg being connected to the chip (80) and forming two unconnected coils around the metal pin (4).

5. The medical container (1) according to claim 1, wherein, The medical container (1) includes an adhesive (10) for securing the metal needle (4) to the cylindrical channel (24), and the RFID tag (8) used on the metal is embedded in the adhesive (10).

6. The medical container (1) according to claim 1, wherein, The antenna (82) is located near the chip (80) of the RFID tag (8) used on the metal.

7. A method for manufacturing the medical container (1) according to claim 1, comprising the following steps: i. Position the RFID tag (8) used on the metal onto the metal needle (4); ii. Position the metal needle (4) into the cylindrical channel (24); iii. Fix the metal needle (4) inside the cylindrical channel (24); iv. Store a unique device identifier (UDI) in an RFID tag (8) used on metal for identification of medical containers (1).

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