Patent Application
20230181840
The present invention relates to a cover for a medical injection device, a medical injection device and a method for manufacturing said cover. The invention is particularly well suited for the healthcare industry.
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.
It is further known from EP2019305879, a plastic flange for a medical container, said flange comprising a remotely readable electronic component such as RFID tag including a RFID chip and a RFID antenna for remote identification of the medical container.
However, said medical container requires a complex manufacturing process which includes in particular the assembly of a plastic flange on a glass barrel.
US2019/0217018 discloses a RFID tag enabled shield assembly that provides a sterile enclosure of a medicament delivery port of a medicament container. The container can be a needleless pre-filled syringe, a vial, a cartridge, or a collapsible bag or pouch. The RFID tag is fixedly attached to one or more components of the shield assembly through co-molding or another form of permanent or removable attachment. The RFID tag is actually a RFID chip that can be optionally in electrical communication with an antenna. In one embodiment, shield assemblies comprise a two part less flexible component such as a hub and a removable top. The removable top can contain and hold the flexible component. There can be a headspace located above the terminal end face of the flexible component and the distal inside surface of the top. The flexible component can contain an RFID tag. Nevertheless, the presence of the RFID tag can inhibit the sterilization process. Usually, a sterilization gas goes through the shield assembly from the top of the shield assembly. The RFID tag in US2019/0217018 blocks the entry through which the sterilization gas flows.
In this context, an object of the present invention is to provide a device that alleviates the above-mentioned drawbacks by allowing a long range individual identification of a medical injection device with no impact on visual inspection, with few or no risks of being removed or damaged, with no risk to inhibit the sterilization process and with a limited impact on the manufacturing process.
A first aspect of the present invention is a cover for a medical injection device, said medical injection device having a hub portion defined at its distal end, the said cover comprising:
an outer casing formed of a first material, said outer casing having a distal end and a proximal end,
an inner casing formed of a second material different from the said first material and defining a cavity capable of receiving in a sealing way, at least part of the hub portion, said inner casing having a distal end and a proximal end, and being at least partly inserted within the outer casing and at least partially in contact with the outer casing and
at least one substantially ring-shaped Radio Frequency Identification (RFID) tag embedded within the cover, said ring-shaped RFID tag comprising a RFID chip connected to at least one ring-shaped RFID antenna.
Without willing to be bound by any theory, it is believed that the cover of the invention allows an optimized individual traceability of each medical injection device from the manufacturing process to the final use of the medical injection device. Besides, the ring-shaped RFID tag is well protected from removal or external damage that may occur due to the packaging, storing distribution or the use of the medical injection device. Furthermore, the ring-shaped RFID tag being embedded within the cover, there is no visual impact on the medical injection device. Additionally, the insertion of the ring-shaped RFID tag has only a limited impact on the cover manufacturing process thanks to the shape of the RFID tag. It is also contemplated that the ring-shaped RFID tag allows remote and therefore easy and longue distance identification of the medical injection device, from the manufacturing steps of the cover to the final use of the medical injection device or its disposal. Another advantage of the invention is that the RFID tag does not require a direct visual perspective from a reading machine so that the reading may occur at any time without a need to unpack the medical injection device, the medical injection device being packed in an individual packaging or packed with others medical injection devices such as in a tub and/or a sealing bag. Moreover, there is no additional thickness to an outer wall of the cover, and thus no change is required regarding the packaging or storing of the medical injection device.
According to the present invention, the ring-shaped Radio Frequency
Identification (RFID) tag is due to the at least one RFID antenna having mainly a substantially ring shape. Preferably, the RFID chip has a substantially retangular or square shape. Thus, the specific ring-shaped of the RFID tag combined with the radial dimensions of the RFID tag with respect to the cover and the specific position of the RFID tag does not inhibit, during a sterilization step, the sterilization gas such as ethylene oxide or water vapor going through the outer casing of the cover, said outer casing being impermeable to the sterilization gas. Additionally, the at least one antenna may be as long as desired within a ring conformation. This makes it possible to include a RFID tag in a cover without increasing the overall cover volume. Ultimately this allows increasing data transmission level to the RFID reader. Indeed the longer the antenna, the better the data transmission.
The inner casing of the cover of the present invention comprises an outer wall being at least partly in contact with the inner wall of the outer casing. The contact is made without any adhesive. Preferably, the outer wall of the inner casing is only partly in contact with the inner wall of the outer casing. In this embodiment, the inner and outer casings can be easily assembled together.
Preferably, the first material forming the outer casing of the cover of the invention is more rigid than the second material forming the inner casing of the cover of the invention.
Preferably, said first material is a thermoplastic, and may be polypropylene (PP), polyethylene (PE), polyethylene terephthalate (PET), polystyrene (PS) or polycarbonate (PC).
Preferably, the second material is a deformable material, made of a material having elastomeric properties, such as Thermo Plastic Elastomer (“TPE”), rubber or elastomer. Materials with elastomeric properties that are sterilizable are preferred.
Advantageously, the cover of the present invention comprises one substantially ring-shaped RFID tag. The ring-shaped RFID tag is embedded within the cover. In other words, the ring-shaped RFID tag is inextricably linked to the cover, and the ring-shaped RFID tag may not be removed from the cover. In the present invention, “embedded” means that the ring-shaped RFID tag is overmolded within the cover or that the ring-shaped RFID that is implemented within the cover by adhesive bonding or by assembly.
In one embodiment, the ring-shaped RFID tag is located at the distal ends of the outer and inner casings.
In another embodiment, the ring-shaped RFID tag is located at a middle portion of the outer casing.
In another embodiment, the ring-shaped RFID tag is located at a proximal of the outer and inner casings.
In one embodiment, the ring-shaped RFID tag is located on a top inner wall of the outer casing or on a top outer wall of the inner casing. Preferably, the ring-shaped RFID tag is located on a top inner wall of the outer casing.
In one embodiment, the ring-shaped RFID tag is embedded within the outer casing, especially between a lateral inner wall of the outer casing and a lateral outer wall of the outer casing.
In one embodiment, the ring-shaped RFID tag is embedded within the outer casing and is flush with a lateral inner wall of the outer casing. Preferably, the ring-shaped RFID tag is not embedded within the external surface of the cover, in particular the ring-shaped RFID tag is not embedded within the outer casing.
In one embodiment, the ring-shaped RFID tag embedded in the cover of the invention is in a form of wet inlay, dry inlay, or pressure sensitive label.
RFID tags, and particularly RFID Wet Inlays and RFID Dry Inlays, can comprise a substrate, for example made of paper or Polyethylene terephthalate (PET). The RFID tag can be disposed on one side of the substrate. RFID Wet Inlays and RFID Dry Inlays can further comprise at least one protective layer on top of the RFID tag. The protective layer can be a siliconized paper.
RFID Wet Inlays are described as “wet” as they include an adhesive layer on the other side of the substrate and a backing paper, for example with a silicon liner. RFID Dry Inlays are described as “Dry” due to their lack of adhesive backing. Pressure-sensitive labels are analogous to a high-tech sticker.
In one embodiment, the ring-shaped RFID tag is a Low Frequency Radio Frequency Identification (LF-RFID) tag. Low frequencies are usually about 30 KHz to 300 KHz. In this embodiment, a RFID reader can for example read the LF-RFID tag at a distance up to about 10 cm.
In one embodiment, the ring-shaped RFID tag is a High Frequency Radio Frequency Identification (HF-RFID) tag. High frequencies are usually about 3-30 MHz. In this embodiment, a RFID reader can for example read the HF-RFID tag at a distance about one meter.
In one embodiment, the ring-shaped RFID tag is a High-Frequency Near Field Communication (HF-NFC) tag. The frequency is usually about 13.56 MHz. In this embodiment, a NFC reader can for example read the HF-NFC tag at a distance up to a few centimeters. HF-NFC differs from HF-RFID in that it can be read by a NFC smartphone.
In one embodiment, the ring-shaped RFID tag is a double frequency tag including simultaneously a HF-NFC and an UHF RFID. For example, it can be read with both a NFC smartphone or an UHF reader.
Preferably, the ring-shaped RFID tag is an Ultra High Frequency Radio Frequency Identification (UHF-RFID) tag. Ultra high frequencies are usually about 400-1000 MHz. In this embodiment, a RFID reader can for example read the UHF-RFID tag at a distance about fifteen meters. A ring-shaped RFID tag means that the at least one antenna has substantially ring shape.
In one embodiment, the ring-shaped RFID tag comprises at least one antenna having two extremities, each extremity being linked to a portion of the RFID chip. In this embodiment, the RFID tag comprises a RFID chip and at least one antenna having a substantially ring shape.
In another embodiment, the ring-shaped RFID tag comprises at least one antenna having two legs including respectively a first extremity and a second extremity, each first extremity of the legs being linked to a portion of the RFID chip. Preferably, the second extremities of the legs of the RFID antenna are not in contact with each other. It is believed that in these embodiments, the shape of the legs further improves the communication between the chip, the antenna of the RFID tag and the RFID reader.
In another embodiment, the ring-shaped RFID tag comprises at least one antenna having two legs including respectively a first extremity and a second extremity, each first extremity of the legs being linked to a portion of the RFID chip and each second extremity including a plurality of sub-legs. In this embodiment, the two legs are respectively in a form of a rake.
In one embodiment, the at least one RFID antenna has a linear form.
In other embodiment, the at least one RFID antenna is made of a plurality of steady steps. For example, the RFID antenna has two legs which may have a plurality of steady steps. For example, the steady step forms a square, triangle, rectangle or wave shape. Preferably, the plurality of steady steps have the same amplitude.
For example, the RFID antenna has two sinusoidal shaped legs, straight-shaped legs or coil-shaped legs. Preferably, when the RFID antenna has two sinusoidal shaped legs, both legs of the RFID antenna being made of a plurality of sinusoids. For example, when the RFID tag is an UHF-RFID tag, the two legs have sinusoidal shape. For example, when the RFID tag is a HF-RFID tag, the two legs have a coil shape. Indeed, it is believed that in these embodiments, the shape of the legs further improves the communication between the chip, the antenna of the RFID tag and the RFID reader.
Preferably, the RFID antenna forms a loop between the legs, the RFID chip being located between the loop and the legs of the RFID antenna.
In one embodiment, the RFID tag is dissymmetrical, i.e. the RFID chip is not located at equidistance of both RFID antenna extremities.
Preferably, the RFID chip is located at equidistance of both RFID antenna extremities.
In one embodiment, the ring-shaped RFID tag comprises at least one dipole antenna. A dipole antenna commonly consists of two identical conductive antennas such as metal wires or rods connected to the RFID chip.
A second aspect of the present invention is a medical injection device comprising a hub portion, and a cover according to the present invention.
A third aspect of the present invention is a method for manufacturing a cover comprising an inner casing and an outer casing according to the present invention, comprising:
In step A), the inner casing and the outer casing may be manufactured separately. For example, the inner casing and the outer casing can be manufactured separately by molding.
Preferably, in step B), the inner casing and/or outer casing is provided with a ring-shaped RFID tag by overmolding, by adhesive bonding or by assembly.
For example, the ring-shaped RFID tag may be embedded within a top inner wall of the outer casing or on a top outer wall of the inner casing by over-molding or by assembly. Preferably, the ring-shaped RFID tag may be embedded within a top inner wall of the outer casing or on a top outer wall of the inner casing by over-molding.
For example, when the ring-shaped RFID tag is embedded between the inner casing and the outer casing, the ring-shaped RFID tag is implemented between a top inner wall of the outer casing and a top outer wall of the inner casing. For example the ring-shaped RFID tag may adhere to the outer wall of the inner casing or to the inner wall of the outer casing by adhesive bonding or by assembly.
In step C), the inner casing and the outer casing can be assembled to form the cover of the invention so that the RFID tag is embedded within the cover.
The invention and advantages arising therefrom will clearly emerge from the detailed description that is given below with reference to the appended drawings as follows:
A needle 8 may be attached to the hub portion 5 of the medical injection device 1. For example, the needle 8 may be glued using a glue 9 to the hub portion 5. The cover of the invention is intended to cover the hub portion 5 of the medical injection device 1, so as to protect the needle 8.
The medical injection device or syringe 1 shown in
The outer casing 20 can comprise a top inner wall 23, which may receive a top outer wall 32 of the inner casing 30.
The inner casing 30 may also comprise an inner lateral wall 33 which is intended to at least partially cooperate with the hub portion 5 of the medical injection device 1 when the cover 10 is mounted on said hub portion 5. Said inner lateral wall 33 of the inner casing 30 is intended to sealingly engage an outer surface of the hub portion 5 of the medical injection device 1.
As illustrated in
The ring-shaped tag 40, 50 may be in a form of a dry inlay or wet inlay. When the ring-shaped RFID tags 40, 50 are in a form a wet inlay, the ring-shaped RFID tag are, independently from each other, embedded between a top inner wall 23 of the outer casing 20 and a top outer wall 32 of the inner casing 30.
The ring-shaped tags 40, 50 may be independently from each other LF-RFID tag, HF-RFID tag or HF-RFID tag. Preferably, the ring-shaped tags 40, 50 may be independently from each other a HF-RFID tag.
Nowadays, a RFID tag allows an individual traceability of the medical containers, such as medical injection devices, especially from the manufacturing process until the use in hospital, and preferably until the final user when he is at home. HF-NFC tag are usually used by the final user. In one embodiment, the cover comprises one substantially ring-shaped HF-RFID tag and one HF-NFC tag.
An adaptor 110 is intended to be mounted on the distal end 105 of the medical injection device 100, more precisely onto an outer surface of the hub portion 104 of the medical injection device 100.
The adaptor 110 is configured to be secured to the medical container 100 at its proximal end, and may be in the form of a connecting ring at its distal end, configured to receive a cover 120 according to the present invention. In practice, to use the medical injection device 100, the cover 120 is removed from the adaptor 110 and a connector (not shown), such as a needle hub or an intravenous line, is mounted on the adaptor 110 in order to establish a fluidic communication between a passageway 106 of the medical container 100 and said connector.
As illustrated in
Alternatively, the ring-shaped RFID tag 150 may be embedded at the proximal ends of the outer 130 and inner casings 140.
For example, the ring-shaped RFID tag 160 may comprise at least one antenna having two legs including respectively a first extremity and a second extremity, each first extremity of the legs being linked to a portion of the RFID chip and each second extremity including a plurality of sub-legs (not shown). In this Example, the two legs are respectively in a form of a rake (not shown). For example, the RFID chip is located at equidistance of both RFID antenna extremities.
The ring-shaped tags 150, 160 may be in a form of a dry inlay or wet inlay. When the ring-shaped RFID tags 150, 160 are in a form a wet or dry inlay, the ring-shaped RFID tags 150, 160 are respectively embedded between a lateral inner wall 131 of the outer casing 130 and a lateral outer wall 132 of the outer casing 130 by overmolding.
The ring-shaped tags 150, 160 may be independently from each other LF-RFID tag, HF-RFID tag or HF-RFID tag. Preferably, the ring-shaped tags 150, 160 may be independently from each other a HF-RFID tag.
The cover according to the present invention allows a long distance highly effective individual identification of a medical injection device 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.
| Number | Date | Country | Kind |
|---|---|---|---|
| 20175265.6 | May 2020 | EP | regional |
This application is the United States national phase of International Application No. PCT/EP2021/061883 filed May 5, 2021, and claims priority to European Patent Application No. 20175265.6 filed May 18, 2020, the disclosures of which are hereby incorporated by reference in their entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2021/061883 | 5/5/2021 | WO |
