Adapter for a medical container, medical container comprising the adapter, and method for manufacturing the medical container

Abstract

The adapter (1) comprises: a proximal portion (2) configured to be fixed to the distal end of the medical container; a distal portion (3) configured to receive a connector; and a remotely readable electronic component (5) configured to allow remote identification of the medical container when the adapter (1) is fixed to the medical container (10), the remotely readable electronic component (5) being at least partially embedded in the adapter (1).

Description

Technical Field

[0001] The present invention relates to an adapter for mounting on a medical container, a medical container comprising the adapter, and a method for manufacturing the medical container. Background Art

[0002] In the present application, the distal end of a member or device should be understood to mean the end farthest from the user's hand, and the proximal end should be understood to mean the end closest to the user's hand. Similarly, in the present application, "distal direction" should be understood to mean the injection direction with respect to the medical container of the present invention, and "proximal direction" should be understood to mean the direction opposite to the injection direction, that is, the direction towards the user's hand holding the container for the injection operation.

[0003] Medical devices such as injection devices (such as prefillable or prefilled syringes) generally include a hollow body or barrel that forms a container for a medical product. The body includes a proximal end and a distal end, the proximal end being provided with a flange that allows the user to place his or her finger so as to apply proximal pressure on the flange, the distal end being generally provided with a needle, the distal end being in the form of a longitudinal end that defines an axial passage through which the medical product is discharged from the container. However, the longitudinal end itself does not allow parenteral administration, and must include a pile needle or adapter that allows the syringe to be connected to a connector, such as a needle holder or an intravenous (IV) line. Basically, the adapter can be fixed around the longitudinal end of the syringe by gluing, threading, snap fit or friction. Then, the connector is mounted on the adapter, for example, by threading.

[0004] There is an increasing need for individual traceability of medical containers, such as injection devices, from the manufacturing process until at least the final use of the medical container, typically the injection of a medical product.

[0005] For example, from document WO2017157784 a container is known which has a cylindrical side surface surrounded by a series of printed machine-readable unique identification codes. These printed unique identification codes allow tracking and tracing of each container along the supply chain. However, these unique identification codes are printed on the outside of the container, so they may be removed or damaged during, for example, handling or use of the container. Moreover, the unique identification codes cover a portion of the container, so they may have an impact on the customer's visual inspection process.

[0006] From document US Pat. No. 8,872,870, a method for glass marking is further known, in which an array of readable markings can be formed on the outer surface of a glass tube by means of a laser, for example for tracking purposes. However, disadvantages of any laser marking method are possible damage to the glass material and an expensive manufacturing process. In addition, the laser-written marking array requires visual access to the glass tube in order to be read, so the reading operation cannot be performed at any time. The laser-written marking array may further have an impact on the customer's visual inspection process.

[0007] Document US2014276213 further discloses an injection site information cap. Document DE102008061415 discloses a medical device hose connector for connecting a breathing hose to a breathing device, the medical device hose connector having an electronic data storage element embedded between plastic parts that are cast together. Summary of the invention

[0008] In this context, an object of the present invention is to provide an adapter that alleviates the above-mentioned drawbacks by allowing easy individual identification of medical containers from a first step of manufacturing to final use (typically an injection or disposal step), without affecting visual inspection and with little or no risk of being removed or damaged.

[0009] One aspect of the present invention is to provide an adapter for a medical container having a distal tip, the adapter comprising:

[0010] - a proximal portion configured to be fixed to a distal end of the medical container,

[0011] - a distal portion configured to receive a connector, and

[0012] - a remotely readable electronic member configured to allow remote identification of the medical container when the adapter is secured to the medical container, the remotely readable electronic member being at least partially embedded in the adapter.

[0013] By electronic components embedded in the adapter, it should be understood that the material of the adapter completely or at least partially encapsulates the electronic components, so that the electronic components are protected from the external environment and therefore cannot be damaged or removed.

[0014] By a remotely readable electronic component configured to allow remote identification of the medical container is meant that the electronic component comprises electronically stored information which can be remotely read by a reading machine such as an RFID (Radio Frequency Identification) reader, thereby enabling identification of the medical container to which the adapter of the present invention is to be fitted.

[0015] Therefore, the adapter of the present invention allows individual traceability for each medical container from the first step of the manufacturing step to the final use of the medical container or to the disposal of the medical container. In addition, because the electronic component is at least partially wrapped in the adapter, it is protected from removal or external damage that may occur due to the packaging, sterilization, storage, distribution or use of the medical container. In addition, the electronic component is located inside the adapter, so it will not affect the customer's visual inspection process. It is also envisioned that the electronic component allows remote and therefore easy identification of the medical container. The electronic component does not need to be directly observed from the reading machine, so the reading can be carried out at any time without unpacking the medical container. Moreover, the electronic component is integrated inside the adapter, so it is advantageous that the commonly used adapter or medical container cartridge does not have additional thickness, and therefore does not require any changes to the packaging or storage of the medical container.

[0016] In a preferred embodiment, the remotely readable electronic component is selected from RFID tags, ultra-wideband real-time locating systems (RTLS), wireless network RTLS and infrared RTLS. Advantageously, the remotely readable electronic component is an RFID tag comprising an RFID chip and an RFID antenna, the RFID antenna preferably extending around the through hole of the adapter.

[0017] Preferably, the remotely readable electronic member is flush with an inner surface of the adapter, more preferably flush with an inner surface of a proximal portion of the adapter.

[0018] This limits the risk of the remote electronic components being damaged by the external environment before the glue material is added. This also enables the adapter to be moulded by one-shot injection moulding.

[0019] Preferably, the proximal portion has an inner surface defining at least one annular space, the annular space being configured to receive a glue material, and the remotely readable electronic member is arranged to be covered by the glue material.

[0020] As a result, the remotely readable electronic component is embedded between the adapter and the glue material. This enables a reduction in manufacturing costs while effectively protecting the remotely readable electronic component.

[0021] Thus, the adapter is configured to be fixed to the medical container by gluing.

[0022] Preferably, the remotely readable electronic component is located entirely within the proximal portion of the adapter.

[0023] Preferably, the inner surface of the proximal portion is provided with protrusions, and the RFID chip is located between two of the protrusions.

[0024] This limits the risk of the RFID chip breaking due to pressure during the injection process.

[0025] The protrusions may divide the at least one annular space into several cavities.

[0026] Preferably, the proximal portion comprises an annular ring, and the RFID antenna is located in the annular ring.

[0027] The annular ring may be disposed at a distal end of the at least one annular space.

[0028] In one embodiment, the remotely readable electronic component is fully embedded in the adapter.

[0029] This leaves the adapter dimensions unchanged relative to standard adapter dimensions so as to avoid investment costs.In this embodiment, the adapter is molded via a two-shot injection molding process.

[0030] When the remotely readable electronic component is fully embedded in the adapter, the adapter is configured to be secured to the medical container by gluing, press-fitting, threading or snap-fitting.

[0031] Another aspect of the present invention is to provide a medical container, comprising a distal tip and an adapter as described above, the adapter being mounted on the distal tip of the medical container.

[0032] Preferably, the adapter is secured to the distal tip by means of a glue material, and the remotely readable electronic component of the adapter is embedded between the adapter and the glue material.

[0033] Optionally, the adapter is secured to the distal tip by a press fit, snap fit or threaded connection, and the remotely readable electronic components of the adapter are fully embedded within the adapter.

[0034] Another aspect of the present invention is to provide a method for manufacturing the medical container as described above, the method comprising the following steps:

[0035] - providing an adapter as described above,

[0036] - providing a distal tip of said medical container,

[0037] - Connecting the adapter to the distal tip via the proximal portion of the adapter.

[0038] Preferably, the method comprises at least one step selected from the following steps:

[0039] - dispensing glue material between the proximal portion of the adapter and the distal tip;

[0040] - threading the adapter onto the distal tip; or

[0041] - snap-fitting the adaptor onto the distal tip; or

[0042] - Press fitting the adapter onto the distal tip. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] The present invention and the advantages arising therefrom will become clear from the following detailed description given with reference to the accompanying drawings, as follows:

[0044] - Figure 1 is a three-dimensional diagram of the adapter of the present invention,

[0045] - Figure 2 is a cross-sectional view of the adapter of the present invention mounted on the distal end of a medical container, and

[0046] - Figure 3 A perspective view of the remotely readable electronic components of the adapter of the present invention. DETAILED DESCRIPTION

[0047] refer to Figure 1 , showing an adapter 1 according to an embodiment of the present invention. The adapter 1 is intended to be mounted on the distal end 11 of a medical container 10, such as Figure 2 As shown in , more precisely, it is mounted on the outer surface 110 of the distal tip 11. The outer surface 110 can be cylindrical or taper distally.

[0048] The adapter 1 comprises a proximal portion 2, which may be in the form of a mounting ring, configured to be fixed to a medical container 10, and a distal portion 3, which may be in the form of a connecting ring, configured to receive a connector (not shown), such as a needle hub or an intravenous (IV) line, so as to establish a reliable fluid communication between the channel 111 of the distal end 11 and the connector. Therefore, the distal portion 3 comprises a connecting means, such as an internal thread 30, so as to fix the connector to the distal end 11. The connecting means may alternatively comprise a bayonet element, a snap element or a press-fit element.

[0049] refer to Figure 1 , the adapter 1 comprises a remotely readable electronic component 5 for remotely identifying the medical container 10 by a remote reading machine. Advantageously, the remotely readable electronic component is an RFID tag 50, preferably a passive RFID tag 5. The RFID tag 50 can be read by an RFID reader without direct observation on the adapter 1.

[0050] refer to Figure 3, the RFID tag 50 includes an RFID chip 51 and an RFID antenna 52. The RFID chip 51 may include at least a storage unit storing a unique device identification (UDI) that allows the medical container 10 to be identified.

[0051] The RFID tag 5 can have some or all of the following dimensions: a total height H comprised between 0.5 mm and 10 mm, for example, approximately 2.4 mm; an antenna height h comprised between 0.1 mm and 8 mm, for example, approximately 0.5 mm; an antenna width w comprised between 0.05 mm and 1 mm, for example, approximately 0.2 mm; an antenna outer diameter comprised between 2 mm and 20 mm, for example, approximately 4.8 mm; and an RFID chip comprised between 0.5 mm×0.5 mm and 5 mm×5 mm, for example, approximately 1.8 mm×1.8 mm.

[0052] The remotely readable electronic component 5 may be overmolded in the adapter 1 .

[0053] The remotely readable electronic component 5 is at least partially embedded in the adapter 1 .

[0054] In a first embodiment, the remotely readable electronic component 5 is partially embedded in the material of the adapter 1, for example during a one-shot injection process. In this first embodiment, the remotely readable electronic component 5 will subsequently be covered by the glue material 24. As a result, the remotely readable electronic component 5 is thus partially embedded in the material of the adapter 1, but is completely embedded between the adapter 1, the glue material 24 and, if necessary, the distal end 11 of the medical container 10. According to this embodiment, the remotely readable electronic component 5 is preferably completely located in the proximal portion 2 of the adapter 1. Advantageously, when the remotely readable electronic component 5 is an RFID tag 50 comprising an RFID chip 51 and an antenna 52, the chip 51 is completely embedded between the adapter 1 and the glue material 24, while the antenna 52 may not be covered by the glue material 24, so that when the adapter 1 is mounted on said distal end 11, the antenna 52 contacts the distal end 11 of the medical container 10 and is therefore embedded between the adapter 1 and the distal end 11 of the medical container 10. The antenna 52 may or may not be in contact with the glue material 24.

[0055] The glue material can be chosen between hot melt adhesives and hot melt glues, for example acrylate-based glues.

[0056] In a second embodiment, the remotely readable electronic component 5 is completely embedded in the material of the adapter 1. For example, the remotely readable electronic component 5 can be overmolded in a two-shot process. More specifically, the remotely readable electronic component 5 is positioned as an insert in the mold. The first part of the adapter 1 is formed by a first injection of material and partially covers the remotely readable electronic component 5. The second part of the adapter 2 (which completely encapsulates the remotely readable electronic component 5 with the above-mentioned first part) is then formed by a second injection step of material, and the material used for the second part shown can be the same material as the first part or a different material. According to this embodiment, the remotely readable electronic component 5 can be located in the proximal part 2 and / or the distal part 3 of the adapter 1.

[0057] Finally, in the first and second embodiments, when the adapter 1 is mounted on the distal end 11 of the medical container 10, the remotely readable electronic component 5, in particular the chip 51 of the RFID tag 50, is preferably completely embedded between the adapter 1, the glue material 24 and / or the distal end 11 of the medical container 10, or embedded in the only adapter 1. The remotely readable electronic component 5 is thus protected from the external environment. For example, the adapter 1 or the medical container 10 can therefore undergo a sterilization process without damaging the remotely readable electronic component 5.

[0058] The adapter 1 defines a central through hole 4 extending through the proximal portion 2 and the distal portion 3 along the longitudinal axis A. The through hole 4 defines a proximal portion configured to receive the distal tip 11 and a distal portion configured to receive the distal tip 11 and a connector connected around the distal tip 11. Therefore, the distal portion has a diameter greater than the diameter of the proximal portion.

[0059] like Figure 1 and 2 As shown in , the RFID antenna 52 preferably extends around the through hole 4 of the adapter 1. Figure 1 As shown in FIG. 4 , the RFID antenna 52 extends in a ring-like manner around the through hole 4 .

[0060] refer to Figure 2 The proximal portion 2 may advantageously include an annular ring 20 disposed at the distal end of the proximal portion 2. The annular ring 20 protrudes radially inward. The annular ring 20 may define a distal shoulder 200 separating the proximal portion 2 and the distal portion 3. Figure 1 As shown in , the annular ring 20 may further define a proximal shoulder 201 that is intended to act as a stop for glue material, as will be described in further detail below.

[0061] like Figure 1 As shown in FIG. 2 , the RFID antenna 52 is advantageously located in the annular ring 20 .

[0062] The proximal portion 2 comprises an inner surface 21 which may be provided with fixing means in order to fix the proximal portion 2 to the outer surface 110 of the distal tip 11 .

[0063] The fixing means may include an annular space 23 configured to receive glue material 24 in order to bond the adapter 1 to the distal tip 11. When the adapter 1 is mounted on the medical container 10, the annular space 23 is defined by the inner surface 21 of the proximal portion 2, the annular ring 20 (particularly its proximal shoulder 201), and the outer surface 110 of the distal tip 11. The annular space 23 may have an open proximal end to allow the glue material 24 to enter, while having a distal end that may be closed by the annular ring 20.

[0064] Preferably, the remotely readable electronic member 5, more precisely the RFID chip 51, partially delimits the annular space 23. Figure 1 As shown in the figure, the remotely readable electronic component 5 is substantially flush with the inner surface 21 of the proximal portion 2. By the remotely readable electronic component 5 being flush with the inner surface 21, it is meant that a portion of the electronic component 5 is arranged at the same level as the inner surface 21, or may slightly protrude or form a recess relative to the inner surface 21. The readable electronic component 5 is thus arranged to be covered by the glue material 24 received in the annular space 23.

[0065] The fixing means may comprise one or several protrusions, which may be in the form of longitudinal ribs 25 which may extend parallel to the longitudinal axis A. The longitudinal ribs 25 may be regularly distributed around the circumferential inner surface 21. The longitudinal ribs 25 may extend over the entire length of the inner surface 21, preferably continuously. The longitudinal ribs 25 may contact the annular ring 20 or may be spaced apart from the annular ring 20. At least one of the longitudinal ribs 25 and the annular ring 20 may contact the outer surface 110 of the distal tip 11 so as to increase the interference between the proximal part 2 of the adapter 1 and the distal tip 11. The longitudinal ribs 25 may divide the annular space 23 into several cavities. For example, as Figure 1 As shown in the figure, the proximal portion 2 of the adapter 1 comprises only three longitudinal ribs 25 in order to evenly center the adapter 1 on the distal end 11 of the medical container 10. The three longitudinal ribs 25 divide the annular space 23 into three cavities. It should be noted that at least one of these cavities, preferably each cavity, has an open proximal end to allow the glue material 24 to enter, while having a distal end that can be closed by the annular ring 20.

[0066] refer to Figure 1 , the RFID chip 51 is preferably located between two of the longitudinal ribs 25. Therefore, the RFID chip 51 is preferably not embedded behind one of the protrusions. The RFID chip 51 may partially define one of the cavities formed by the longitudinal ribs 25.

[0067] The adapter 1 can be made of a plastic material, more precisely any rigid polymer suitable for medical use, such as high-density polyethylene (PE), polypropylene (PP), polycarbonate (PC), acrylonitrile-butadiene-styrene (ABS), polyoxymethylene (POM), polystyrene (PS), polybutylene terephthalate (PBT), polyamide (PA), and combinations thereof. Preferably, the adapter 1 is made of polycarbonate (PC). In order to simplify its manufacture, the adapter 1 is preferably made of a single material. However, the adapter 1 may comprise two different materials, for example when the adapter 1 is made in a two-shot process. Preferably, the adapter 1 is made of a light-transmitting material.

[0068] refer to Figure 2 The present invention also relates to a medical container 10 which can be a syringe. The medical container 10 comprises a tubular barrel 12 which defines a reservoir for a medical product. The tubular barrel 12 is provided with a distal tip 11 which can protrude from a distal shoulder 120. The distal tip 11 can be cylindrical or taper distally. The distal tip 11 contains an internal passage 111 which is in communication with the reservoir. The tubular barrel 12 and the distal tip 11 are preferably made of glass. The medical container 10 can be provided with a piston and a plunger rod (not shown) so that the medical product is discharged from the reservoir and through the passage 111.

[0069] The medical container 10 further comprises an adapter 1 having some or all of the features described above. The adapter 1 has a proximal portion 2 mounted to a distal tip 11 .

[0070] In a preferred embodiment, the proximal portion 2 of the adapter 1 is fixed to said distal tip 11 by means of a glue material 24. The remotely readable electronic component 5 is thus embedded between the adapter 1 and said glue material 24. Due to the presence of this adhesive layer of glue material 24, the adapter 1 can be bonded around the distal tip 11 without requiring any groove or ring on the outer surface 110 of the distal tip 11. The distal tip 11 therefore has no such groove or ring.

[0071] In another preferred embodiment, the proximal portion 2 of the adapter 1 can be fixed to the distal tip 11 by means of a press fit, a snap fit or a screw connection. The remotely readable electronic component 5 can accordingly be completely embedded in the adapter 1 .

[0072] The present invention also relates to a method for manufacturing the medical container 10. The method comprises the following steps:

[0073] - providing an adapter 1 having some or all of the above features, for example in a one-shot or two-shot process, wherein the remotely readable electronic component 5 is partially or completely overmoulded in the adapter 1 ,

[0074] - providing a distal tip 11 of the medical container 10,

[0075] - Connecting the adapter 1 via its proximal part 2 to the distal tip 11 .

[0076] like Figure 2 As shown in , the adapter 1 can be connected to the outer surface 110 of the distal tip 11.

[0077] Furthermore, the step of connecting the adapter 1 to the distal tip 11 may include at least one step selected from the following steps:

[0078] - dispensing glue material 24 between the proximal portion 2 and the distal tip 11 of the adapter 2, wherein the glue material 24 may be dispensed in the annular space 23; or

[0079] - threading the adapter 1 onto the distal tip 11; or

[0080] - snap-fitting the adapter 1 onto the distal tip 11; or

[0081] - Press-fit the adapter 1 onto the distal tip 11 .

[0082] When the method includes the step of dispensing glue material 24 between the proximal portion 2 and the distal end 11 of the adapter 1, it should be noted that the glue material 24 can be dispensed before or after the adapter 1 is positioned around the distal end 11. Moreover, the step of dispensing glue material 24 between the proximal portion 2 and the distal end 11 of the adapter 1 can include covering the remotely readable electronic component 5 when the remotely readable electronic component 5 is partially embedded in the adapter 1, so that the remotely readable electronic component 5 is ultimately completely encased in the adapter 1 plus the glue material 24.

Claims

1. An adapter (1) for a medical container (10) having a distal tip (11), the adapter (1) comprising: a proximal portion (2) configured to be fixed to a distal end (11) of the medical container (10), - a distal portion (3) configured to receive a connector, and a remotely readable electronic component (5) configured to allow remote identification of the medical container (10) when the adapter (1) is secured to the medical container (10), the remotely readable electronic component (5) being at least partially embedded in the adapter (1), wherein the remotely readable electronic component (5) is flush with an inner surface (21) of the proximal portion (2) of the adapter (1), wherein the inner surface (21) defines at least one annular space (23), the annular space being configured to accommodate a glue material (24), and the remotely readable electronic component (5) being arranged to be covered by the glue material (24); Wherein, the remotely readable electronic component (5) is an RFID tag (50) comprising an RFID chip (51) and an RFID antenna (52); Wherein, the proximal portion (2) comprises an annular ring (20) arranged at a distal end of the proximal portion, and the RFID antenna (52) is located in the annular ring (20); The inner surface (21) of the proximal portion (2) is provided with a plurality of protrusions, and the RFID chip (51) is located between two protrusions among the plurality of protrusions.

2. The adapter (1) according to claim 1, characterized in that The RFID antenna (52) extends around the through hole (4) of the adapter (1).

3. The adapter (1) according to claim 1, characterized in that The adapter (1) is configured to be fixed to the medical container (10) by gluing.

4. The adapter (1) according to any one of claims 1 to 3, characterized in that: The remotely readable electronic component (5) is located entirely within the proximal portion (2) of the adapter (1).

5. A medical container (10), comprising a distal tip (11) and an adapter (1) according to any one of claims 1 to 4, wherein the adapter (1) is mounted on the distal tip (11) of the medical container (10).

6. The medical container (10) according to claim 5, characterized in that The adapter (1) is fixed to the distal tip (11) by means of an adhesive material (24), and the remotely readable electronic component (5) of the adapter (1) is embedded between the adapter (1) and the adhesive material (24).

7. A method for manufacturing a medical container (10) according to any one of claims 5-6, the method comprising the following steps: - providing an adapter (1) according to any one of claims 1 to 4, - providing a distal tip (11) of the medical container (10), - connecting the adapter (1) to the distal tip (11) via the proximal portion (2) of the adapter (1).

Images