US-12616794-B2 - Medical container, such as a pre-fillable or prefilled syringe, comprising a RFID tag for remote identification of said medical container

Abstract

This medical container includes a barrel defining a reservoir for containing a medical product, and a needle extending in a barrel channel provided at a distal end of the barrel so as to establish a fluid communication between the reservoir and the needle. The medical container further includes a RFID on-metal (ROM) tag, said RFID on-metal tag being located at least partly inside the barrel channel and having an antenna extending along the needle.

Inventors

• Cédric Rivier
• Nicolas Euvrard

Assignees

• BECTON DICKINSON FRANCE
• BECTON, DICKINSON AND COMPANY

Dates

Publication Date

20260505

Application Date

20210726

Priority Date

20200727

Claims (8)

1. 1 . A medical container comprising a barrel defining a reservoir for containing a medical product, and a needle extending in a barrel channel provided within the barrel at a distal end of the barrel so as to establish a fluid communication between the reservoir and the needle, wherein the medical container further comprises a RFID on-metal (ROM) tag, said RFID on-metal (ROM) tag being located at least partly inside the barrel channel and having an antenna extending along and contacting a needle portion located inside the barrel channel.
2. 2 . The medical container according to claim 1 , wherein the antenna is spiral-shaped and helically wound up around the needle.
3. 3 . The medical container according to claim 1 , wherein the RFID on-metal (ROM) tag is an Ultra High Frequency RFID on-metal (UHF-ROM) tag.
4. 4 . The medical container according to claim 1 , wherein the antenna comprises two separate legs each connected to a chip and forming two non-jointed coils around the needle.
5. 5 . The medical container according to claim 1 , wherein the medical container comprises an adhesive for securing the needle to the barrel channel, and the RFID on-metal (ROM) tag is embedded into said adhesive.
6. 6 . The medical container according to claim 1 , wherein the needle portion along which the antenna extends is a predetermined needle portion, said predetermined needle portion having a length of at least 2 mm and said predetermined needle portion corresponding at most to the whole needle portion that is contained inside the barrel channel.
7. 7 . The medical container according to claim 1 , wherein the antenna is located proximal to a chip of the RFID on-metal (ROM) tag.
8. 8 . The method for manufacturing a medical container according to claim 1 , comprising the steps of: i. positioning the RFID on-metal (ROM) tag onto the needle; ii. positioning the needle into the barrel channel; iii. securing the needle inside the barrel channel; storing a Unique Device Identifier (UDI) into the ROM tag for identification of the medical container.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is the United States national phase of International Application No. PCT/EP2021/070879 filed Jul. 26, 2021, and claims priority to European Patent Application No. 20305859.9 filed Jul. 27, 2020, the disclosures of which are hereby incorporated by reference in their entirety. BACKGROUND OF THE INVENTION Field of the Invention The present invention relates to a medical container, such as a pre-fillable or prefilled syringe, comprising a RFID tag linked to a needle. Description of Related Art In this application, the distal end of a component or of a device is to be understood as meaning the end furthest from the user's hand and the proximal end is to be understood as meaning the end closest to the user's hand. Likewise, in this application, the “distal direction” is to be understood as meaning the direction of injection, with respect to a medical container of the invention, and the “proximal direction” is to be understood as meaning the opposite direction to said direction of injection, that is to say the direction towards the user's hand holding a container as for an injection operation. Medical injection devices, for example pre-fillable or prefilled syringes, usually comprise a hollow body or barrel forming a container for a medical product. This body comprises a distal end, optionally provided with a needle, and a proximal end, usually provided with a flange. There is an increasing need for individual traceability of the medical containers, such as medical injection devices, from the manufacturing process until the final labeling, the final use or the disposal of said medical containers. It is known, for example, from WO2017157784, a receptacle having a cylindrical lateral surface surrounded by a sequence of printed machine-readable unique identifier codes. These printed unique identifier codes allow tracking and tracing of each receptacle along a supply chain. However, these unique identifier codes are printed on an external side of the receptacle so that they may be removed or damaged, for example, during handling or use of the receptacle. Moreover, the unique identifier codes cover a portion of the receptacle so that they may have an impact on a user visual inspection process. Finally, an inkjet printer is used to print the identifier codes on the external side of the receptacle. However, this printing method, using ink, may lead to a risk of contamination of the receptacle. Moreover, one may not have access to these printed unique identifier codes when the receptacle is put, for example, in a sealed packaging. SUMMARY OF THE INVENTION In this context, an object of the present invention is to provide a device that alleviates the above-mentioned drawbacks by allowing an efficient individual identification of a medical container with no impact on visual inspection, with few or no risks of being removed or damaged, and with a limited impact on the manufacturing process. A first aspect of the invention is a medical container comprising a barrel defining a reservoir for containing a medical product, and a needle extending in a barrel channel provided at a distal end of the barrel so as to establish a fluid communication between the reservoir and the needle, wherein the medical container further comprises a RFID on-metal (ROM) tag, said RFID on-metal (ROM) tag being located at least partly inside the barrel channel and having an antenna extending along the needle. The invention therefore allows individual traceability of each medical container from the manufacturing process to the final use of the medical container. Besides, the ROM tag is well protected from removal or external damage that may occur due to the packaging, storing distribution or the use of the medical container. Additionally, the ROM tag is not into contact with the medical product contained inside the medical container. Furthermore, the ROM tag does not hinder the end user visual inspection. The ROM tag also does not provide any additional thickness to the medical container. Additionally, the antenna extending along the needle permits to increase the reading/writing distance since the metal needle is being used as an antenna transmitter. In an embodiment, the antenna is spiral-shaped and helically wound up around the needle. In an embodiment, the RFID on-metal (ROM) tag is a Ultra High Frequency RFID on-metal (UHF-ROM) tag. Preferably, the antenna comprises two separate legs each connected to the chip and forming two non-jointed coils around the needle. The above features enable to increase the reading/writing distance. In an embodiment, the medical container comprises an adhesive for securing the needle to the barrel channel, and the RFID on-metal (ROM) tag is embedded into said adhesive. This permits to protect the ROM tag from the outside environment and to further prevent any contact with the skin of the end user during an injection operation. In an embodiment, the antenna extends