A medical container, such as a prefillable or pre-filled syringe, including an RFID tag for remote identification of the medical container.

Abstract

A medical container and a method for manufacturing the medical container. The medical container (1) includes a barrel defining a reservoir for containing a medical product and a needle (4) extending into a barrel channel (24) at a distal end (20) of the barrel to establish fluid communication between the reservoir and the needle (4). The medical container (1) further includes an on-metal RFID (ROM) tag (8), the on-metal RFID (ROM) tag (8) being at least partially disposed within the barrel channel (24) and having an antenna (82) extending along the needle (4).

Description

[Technical Field]

[0001] The present invention relates to a medical container, such as a pre-fillable or pre-filled syringe, that includes an RFID tag coupled to a needle. [Background technology]

[0002] In this application, the distal end of a component or device should be understood to mean the end furthest from the user's hand, and the proximal end should be understood to mean the end closest to the user's hand. Similarly, in this application, the "distal direction" should be understood to mean the direction of injection with respect to the medical container of the present invention, and the "proximal direction" should be understood to mean the direction opposite to the direction of injection, i.e., the direction toward the user's hand holding the container with respect to the injection operation.

[0003] For example, a medical injection device, such as a prefillable or pre-filled syringe, typically comprises a hollow body or barrel that forms a container for the medical product, the body optionally comprising a distal end with a needle, and a proximal end that typically comprises 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 through to final labeling, final use or disposal.

[0005] For example, Patent Document 1 discloses a cylindrically sided container surrounded by a series of printed, machine-readable unique identifier codes. These printed unique identifier codes allow each container to be tracked and traced along the supply chain. However, these unique identifier codes are printed on the outside of the container, and as a result, they can be removed or damaged, for example, during handling or use of the container. Furthermore, the unique identifier codes cover parts of the container, and as a result, they can affect the user's visual inspection process. Finally, inkjet printers are used to print the identification codes on the outside of the container. However, this printing method using ink can lead to the risk of contamination of the container. Furthermore, if the container is placed, for example, in a sealed package, people cannot access these printed unique identifier codes. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] International Publication No. 2017 / 157784 Summary of the Invention [Problem to be solved by the invention]

[0007] In this context, the object of the present invention is to provide an apparatus that alleviates the above-mentioned drawbacks by allowing efficient individual identification of medical containers without affecting visual inspection, with little or no risk of them being removed or damaged, and with limited impact on the production process. [Means for solving the problem]

[0008] A first aspect of the present invention is a medical container comprising a barrel defining a reservoir for containing a medical product, and a needle extending into a barrel channel at a distal end of the barrel to establish fluid communication between the reservoir and the needle, the medical container further comprising an on-metal RFID (ROM) tag, the on-metal RFID (ROM) tag being at least partially disposed inside the barrel channel and having an antenna extending along the needle.

[0009] Therefore, the present invention enables individual traceability of each medical container from the manufacturing process to final use. Furthermore, the ROM tag is well protected from shedding or external damage that may occur during packaging, storage, distribution, or use of the medical container. Furthermore, the ROM tag does not come into contact with the medical product contained within the medical container. Furthermore, the ROM tag does not interfere with visual inspection by the end user. Furthermore, the ROM tag does not add any additional thickness to the medical container. Furthermore, the antenna extending along the needle allows for increased read / write distances, as the metal needle is used as an antenna transmitter.

[0010] In one embodiment, the antenna is helical and is spirally wound around the needle.

[0011] In one embodiment, the on-metal RFID (ROM) tag is an ultra-high frequency on-metal RFID (UHF-ROM) tag. Preferably, the antenna comprises two separate legs, each connected to the chip, forming two unjoined coils around the needle. This feature allows for increased read / write distance.

[0012] In one embodiment, the medical container includes an adhesive for securing the needle to the barrel channel, and the on-metal RFID (ROM) tag is embedded in the adhesive, which protects the ROM tag from the external environment and also makes it possible to prevent any contact with the end user's skin during the injection procedure.

[0013] In one embodiment, the antenna extends along a predetermined needle portion, the predetermined needle portion having a length of at least 2 mm, the predetermined needle portion corresponding at most to the entire needle portion contained within the barrel channel.

[0014] In one embodiment, the antenna is placed in close proximity to the chip of an on-metal RFID (ROM) tag.

[0015] Another aspect of the present invention is a method for producing a medical container comprising the above features, comprising: (i) attaching an on-metal RFID (ROM) tag to the needle; (ii) placing the needle within the barrel channel; (iii) securing the needle within the barrel channel; (iv) storing a unique device identifier (UDI) in the ROM tag for identification of the medical container;

[0016] It is contemplated that steps (i) and (ii) above may occur in any suitable order. In one embodiment, step (i) may occur before step (ii). In another embodiment, step (ii) may occur before step (i).

[0017] Preferably, step (iii) occurs after steps (i) and (ii).

[0018] The present invention and the advantages arising therefrom will become more clearly apparent from the detailed description given below, taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0019] [Figure 1] FIG. 1 is a perspective view of a standard medical container. [Figure 2] 1 is a semi-transparent view of a medical container according to one embodiment of the present invention. [Figure 3] FIG. 3 is a detailed view of FIG. 2. [Figure 4] FIG. 1 is a perspective view of a ROM tag disposed on a needle of a medical container according to the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0020] Referring to FIG. 1 , a medical container 1, such as a prefillable or pre-filled syringe, is shown. The medical container 1 includes a cylindrical barrel 2 defining a reservoir 26 for containing a medical product, such as a medical composition. The barrel 2 extends along a longitudinal axis A and has a distal end that may be in the form of a longitudinal distal tip 20. The tip may extend distally from a distal shoulder 22 of the barrel 2. The distal tip 20 defines a barrel 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 expelling the medical product contained in the reservoir 26 through the needle. The barrel 2 may be fabricated from a glass or plastic material. In another embodiment (not shown), the needle 4 may be secured to a needle hub connected to the distal end 20 of the barrel 2, and the needle hub may be threaded onto an adapter attached to the distal end 20 of the barrel 2.

[0021] 2-3, the medical container 1 of the present invention includes an on-metal RFID (ROM) tag 8 attached to the needle 4 and disposed completely or at least partially within the barrel channel 24, such that the ROM tag 8 is largely invisible to the end user and protected from the external environment. The on-metal RFID (ROM) 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 barrel channel 24. ROM tag 8 is attached to needle 4 by adhesive 10. In a preferred embodiment, needle 4 is first inserted into barrel channel 24. ROM tag 8 is then inserted into barrel channel 24 and positioned near needle 4, and ROM tag 8 is secured to needle 4 by an adhesive material that also secures needle 4 to barrel 2, filling gap 240 formed between needle 4 and the inner wall of barrel channel 24.

[0022] In another embodiment, the ROM tag 8 is secured to the needle 4 prior to inserting the needle 4 into the barrel channel 24. The ROM tag 8 may be disposed on a substrate, such as a ceramic or plastic substrate, having an adhesive layer secured to the outer surface of the needle 4 by the adhesive layer. The needle 4 is then secured to the barrel 2 within the barrel channel 24 by the adhesive material filling the gap 240.

[0023] It is contemplated that ROM tag 8 preferably does not contact needle 4 , ie, ROM tag 8 is separated from needle 4 by a substrate and / or adhesive 10 .

[0024] In yet another embodiment, the ROM tag 8 is first secured to the needle 4 by welding a portion of the antenna 82 to the needle 4. The needle 4 is then inserted inside the barrel channel 24 and secured to the barrel 2 by an adhesive material that fills the gap 240.

[0025] The adhesive material securing needle 4 to barrel 2 would preferably completely embed ROM tag 8, thereby preventing any contact between ROM tag 8 and the external environment.

[0026] 2-4, the ROM tag 8 includes a chip 80 and an antenna 82. The chip 80 is configured to store a unique device identifier (UDI), which allows for remote identification of the medical container 1 from its manufacturing process through final labeling, final use, or disposal.

[0027] The antenna 82 extends longitudinally along the needle 4 such that the needle 4 is an extension of the antenna 82, thereby improving the read range of the ROM tag 8. Alternatively, the antenna 82 extends proximally from the chip 80. For example, with reference to FIG. 3 , the antenna 82 may have a helical shape and may be wrapped around the needle 4 to increase the read range. Preferably, the antenna 82 extends across a given needle segment 40, the given needle segment 40 having a length of at least 2 mm. At most, the antenna 82 extends along the entire needle segment 42 that is disposed inside the barrel channel 24.

[0028] The ROM tag 8 can be a low frequency (about 30-300 kHz) ROM (LF-ROM) tag 8, a high frequency (about 3-30 MHz) ROM (HF-ROM) tag 8, or preferably an ultra high frequency (about 400-1000 MHz) ROM (UHF-ROM) tag 8. An RFID reader can, for example, read an LF-ROM tag 8 at a distance of up to about 10 cm, an HF-ROM tag 8 at a distance of about 1 meter, and an UHF-ROM tag 8 at a distance of about 15 meters.

[0029] 4, if the ROM tag 8 is a very high frequency ROM tag 8, the antenna 82 may include two separate legs 820, each connected to the tip 80 and forming two unjoined coils around the needle. Both legs 820 preferably extend proximally from the tip 80.

[0030] The dimensions of the ROM tag 8 can be such that the ROM tag 8 is very compact and does not add thickness to the medical container 1. For example, the diameter of the antenna 82 can be 0.4 mm or less, e.g., about 0.2 mm. The dimensions of the chip 80 can be about 1 mm x 0.5 mm x 0.1 mm (length x width x thickness).

[0031] The present invention also relates to a method for producing the medical container 1 described above.

[0032] The method includes step (i) of placing a ROM tag 8 on the needle.

[0033] This step (i) may occur after the needle 4 is inserted into the barrel channel 24 , and then adhesive material fills the gap 240 to secure the ROM tag 8 to the needle 4 and secure the needle 4 to the barrel 2 .

[0034] Alternatively, step (i) can occur before the insertion of the needle 4 into the barrel channel 24. For example, the ROM tag 8 is disposed on a tubular plastic or ceramic substrate. This substrate is disposed around the needle. In one embodiment, the substrate has an adhesive layer such that it is secured directly to the needle. In another embodiment, the substrate does not have any adhesive layer and may be later secured to the needle 4 by an adhesive material that fills the barrel channel 24 to secure the needle 4 to the barrel 2. In yet another example, a portion of the antenna 82 is welded to the needle 4 before the needle 4 is inserted into the barrel channel 24.

[0035] The method further includes step (ii) of placing the needle 4 within the barrel channel 24. As explained above, this step (ii) can occur before or after step (i) of placing the ROM tag 8 on the needle 4.

[0036] The method further includes step (iii) of securing the needle 4 inside the barrel channel 24 such that the needle 4 is securely fixed to the barrel 2. To that end, the gap 240 between the inner wall of the barrel channel 24 and the outer wall of the needle 4 is filled with an adhesive material. Any adhesive material typically used to secure needles within a barrel channel may be used. This step may include embedding the ROM tag 8 within the adhesive material.

[0037] The method further includes writing a unique device identifier (UDI) into the ROM tag 8 for identification of the medical container 1 .

Claims

1. 1. A medical container (1) comprising: a barrel (2) defining a reservoir (26) for containing a medical product; and a needle (4) extending into a barrel channel (24) provided at a distal end (20) of the barrel (2) to establish fluid communication between the reservoir (26) and the needle (4), wherein the medical container (1) further comprises an on-metal RFID (ROM) tag (8), the on-metal RFID (ROM) tag (8) having an antenna (82) disposed at least partially within the barrel channel (24) and extending along a needle portion (42) disposed within the barrel channel (24).

2. 2. A medical container (1) according to claim 1, characterized in that the antenna (82) is helical in shape and is wound helically around the needle (4).

3. 3. The medical container (1) according to claim 1 or 2, characterized in that the on-metal RFID (ROM) tag (8) is an ultra-high frequency on-metal RFID (UHF-ROM) tag (8).

4. 4. A medical container (1) according to claim 3, characterized in that the antenna (82) comprises two separate legs (820), each connected to a tip (80) and forming two unjoined coils around the needle (4).

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

6. A medical container (1) according to any one of claims 1 to 5, characterized in that the antenna (82) is positioned in close proximity to the chip (80) of the on-metal RFID (ROM) tag (8).

7. 7. A method for manufacturing a medical container (1) according to any one of claims 1 to 6, comprising the steps of: (i) placing the on-metal RFID (ROM) tag (8) on the needle (4); (ii) placing the needle (4) in the barrel channel (24); (iii) fixing the needle (4) in the barrel channel (24); and (iv) storing a unique device identifier (UDI) in the ROM tag (8) for identifying the medical container (1).

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