Adaptor for medical container, medical container comprising such adaptor, and method for manufacturing such medical container

Abstract

To provide a medical container with an adapter which facilitates individual identification of the medical container from a first step of a manufacturing process to a final use, typically an injection or disposal step, does not affect visual inspection, has little or no risk of removal or damage, and reduces conventional defects, and to provide a method for manufacturing the medical container.SOLUTION: The adapter includes: a proximal portion to be secured to a distal tip of a medical container; a distal portion to receive the connector; and a remotely readable electronic component to enable remote identification of the medical container when the adapter is secured to the medical container, the remotely readable electronic component being at least partially embedded in the adapter. The adapter is secured to the distal tip by a glue material, and the remotely readable electronic component is flush with an inner surface of the adapter and is embedded between the adapter and the glue material.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] The present invention relates to an adapter for attachment to a medical container, a medical container equipped with the adapter, and a method for manufacturing the medical container.

[0002] In the present application, the distal end of a part 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 the present application, the "distal direction" is understood to mean the direction of injection with respect to the medical container of the present invention, and the "proximal direction" is understood to mean the direction opposite to said injection direction, i.e., in the case of an injection operation, towards the user's hand holding the container. [Background technology]

[0003] A medical device, for example an injection device such as a prefillable or prefilled syringe, typically comprises a hollow body or barrel forming a container for a pharmaceutical product. This body comprises a proximal end with a flange on which the user can place his finger to apply proximal pressure to the flange, and a distal end, usually with a needle, in the form of a longitudinal tip that defines an axial passage through which the pharmaceutical product is expelled from the container. However, this longitudinal tip does not allow parenteral administration by itself, but must comprise either a staked needle or an adapter that allows the connection of the syringe to a connector such as a needle hub or an intravenous (IV) line. Essentially, the adapter can be fixed around the longitudinal tip of the syringe by gluing, screwing, snap-fitting or frictional forces. The connector is thus attached to the adapter, for example by screwing.

[0004] The need for individual traceability of medical containers, such as injection devices, increases from the manufacturing process at least through to the end use of the medical container, typically the injection of a pharmaceutical product.

[0005] For example, from WO2017157784, containers are known that have a cylindrical side that is surrounded by a sequence 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 and can be removed or damaged, for example, during handling or use of the container. Furthermore, the unique identification codes cover parts of the container and can therefore affect the customer's visual inspection process.

[0006] Furthermore, from US8872870, a method for glass marking is known, in which an array of readable marks can be formed by a laser on the outer surface of a glass tube, for example for tracking purposes. However, the disadvantages of the laser marking method are the possible damage to the glass material and the expensive manufacturing process. Also, the array of laser-written marks requires visual access to the glass tube to be read, so that the reading operation cannot be performed at any time. The array of laser-written marks can further affect the customer's visual inspection process.

[0007] Patent document 3 (US2014276213) further discloses an injection site information cap. Patent document 4 (DE102008061415) discloses a hose connector for a medical device for connecting a breathing hose to a breathing device, the connector having an electronic data storage element embedded between co-molded plastic parts. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] WO2017157784 [Patent Document 2] US8872870 [Patent Document 3] US2014276213 [Patent Document 4] DE102008061415 Summary of the Invention [Problem to be solved by the invention]

[0009] In this context, the object of the present invention is to provide an adapter that facilitates individual identification of medical containers from the first steps of the manufacturing process until final use, typically the injection or disposal step, without affecting visual inspection and with little or no risk of removal or damage, thus mitigating the above-mentioned drawbacks. [Means for solving the problem]

[0010] One aspect of the present invention is an adaptor for a medical container having a distal tip, the adaptor comprising: a proximal portion configured to be secured to a distal tip of a medical container; a distal portion configured to receive a connector; a remotely readable electronic component configured to enable remote identification of the medical container when the adapter is secured to the medical container, the remotely readable electronic component being at least partially embedded within the adapter; Equipped with.

[0011] By electronic components embedded within the adapter it should be understood that the material of the adapter completely or at least partially encases the electronic components, so that the electronic components are protected from the external environment and therefore cannot be damaged or removed.

[0012] A remotely readable electronic component configured to allow remote identification of a medical container means that the electronic component includes electronically stored information that is remotely readable by a reader, such as an RFID reader, to allow identification of the medical container for which the adapter of the present invention is intended to be assembled.

[0013] Thus, the adapter of the present invention makes it possible to have individual traceability of each medical container from the first stage of the manufacturing process to the final use of the medical container or the disposal of the medical container. Also, since the electronic components are at least partially enclosed in the adapter, they are protected from removal or external damage that may occur due to packaging, sterilization, storage, distribution or use of the medical container. Also, since the electronic components are placed in the adapter, they do not affect the customer's visual inspection process. Furthermore, it is believed that the electronic components allow for easy remote identification of the medical container. Since the electronic components do not require a direct visual perspective from the reader, reading can be performed at any time without the need to open the medical container. Moreover, it is also advantageous that the electronic components, since they are integrated inside the adapter, do not add any thickness to the adapter or medical container barrel that is normally used, and therefore do not require any changes regarding the packaging or storage of the medical container.

[0014] In a preferred embodiment, the remotely readable electronic component is selected from the group consisting of an RFID tag, an ultra-wideband real-time location system (RTLS), a wifi RTLS and an infrared RTLS. Advantageously, the remotely readable electronic component is an RFID tag comprising an RFID chip and an RFID antenna, which preferably extends around the through opening of the adapter.

[0015] Preferably, the remotely readable electronic component is flush with the inner surface of the adapter, and more preferably, is flush with the inner surface of the proximal portion of the adapter.

[0016] This limits the risk of the remote electronics being damaged by the outside environment before the glue material is added. It also allows the adapter to be molded in a one-shot molding.

[0017] Preferably, the proximal portion has an inner surface defining at least one annular space configured to receive a glue material, and the remotely readable electronic component is positioned to be covered by the glue material.

[0018] As a result, the remotely readable electronic components are embedded between the adapter and the glue material, which can effectively protect the remotely readable electronic components while reducing manufacturing costs.

[0019] The adapter is thus configured to be secured to the medical container by adhesive.

[0020] Preferably, the remotely readable electronics are located entirely within the proximal portion of the adapter.

[0021] Preferably, the inner surface of the proximal portion is provided with protrusions, the RFID chip being located between two of the protrusions.

[0022] This limits the risk of the RFID chip being destroyed by pressure during the injection process.

[0023] The protrusions may divide the at least one annular space into a plurality of cavities.

[0024] Preferably, the proximal portion includes an annular ring and the RFID antenna is disposed within the annular ring.

[0025] An annular ring may be provided at a distal end of the at least one annular space.

[0026] According to one embodiment, the remotely readable electronics fits completely into the adapter.

[0027] As a result, the adapter dimensions are not changed with respect to standard adapter dimensions to avoid investment costs. In this embodiment, the adapter is molded by a two-shot injection molding process.

[0028] Once the remotely readable electronics are fully seated within the adapter, the adapter is configured to be secured to the medical container by adhesive, press-fit threading or snap-fit.

[0029] Another aspect of the invention is a medical container comprising a distal tip and an adapter as described above, the adapter being attached to the distal tip of the medical container.

[0030] Preferably, the adapter is secured to said distal tip by a glue material, and the remotely readable electronics of the adapter are embedded between the adapter and said glue material.

[0031] Alternatively, the adapter is secured to the distal tip by press-fit, snap-on or threaded means, with the adapter's remotely readable electronics fully fitted within the adapter.

[0032] Another aspect of the present invention is a method for producing a medical container as described above, the method comprising the steps of: providing an adapter as above; Providing a distal tip of a medical container; connecting an adapter to the distal tip by a proximal portion of the adapter; Includes.

[0033] Preferably, the method comprises at least one step selected from the following steps:

[0034] dispensing a glue material between the proximal and distal tips of the adapter; threading the adapter onto the distal tip; or snapping the adapter onto the distal tip; or Pressing the adapter onto the distal tip. [Brief description of the drawings]

[0035] The invention and the advantages arising therefrom will become more clearly apparent from the detailed description given below with reference to the accompanying drawings, in which: [Figure 1] FIG. 2 is a perspective view of the adapter of the present invention. [Diagram 2]FIG. 2 is a cross-sectional view of an adapter of the present invention attached to a distal tip of a medical container. [Diagram 3] FIG. 2 is a perspective view of the remotely readable electronics of the adapter of the present invention; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0036] With reference to Figure 1, an adapter 1 according to one embodiment of the present invention is shown. The adapter 1 is intended to be attached to the distal tip 11 of a medical container 10, more precisely to the outer surface 110 of said distal tip 11, as shown in Figure 2. The outer surface 110 may be cylindrical or distally tapered.

[0037] The adapter 1 comprises a proximal portion 2, which may be in the form of an attachment ring and configured to be secured to the medical container 10, and a distal portion 3, which may be in the form of a connecting ring and configured to receive a connector (not shown), such as a needle hub or an intravenous (IV) line, to establish reliable fluid communication between the passage 111 of the distal tip 11 and the connector. The distal portion 3 thus comprises connecting means, such as an internal thread 30, for securing the connector to the distal tip 11. The connecting means may alternatively comprise a bayonet element, a snap element, or a press-fit element.

[0038] 1, the adapter 1 comprises a remotely readable electronic component 5 for remote identification of the medical container 10 by a remote reader. 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 needing a direct perspective view of the adapter 1.

[0039] 3, the RFID tag 50 comprises an RFID chip 51 and an RFID antenna 52. The RFID chip 51 may include at least a storage unit for storing a unique device identification (UDI) that allows identification of the medical container 10.

[0040] The RFID tag 5 may have some or all of the following dimensions: overall height H of 0.5 mm to 10 mm, e.g., about 2.4 mm; antenna height h of 0.1 mm to 8 mm, e.g., about 0.5 mm; antenna width w of 0.05 mm to 1 mm, e.g., about 0.2 mm; antenna outer diameter of 2 mm to 20 mm, e.g., about 4.8 mm; RFID chip of 0.5 x 0.5 mm to 5 x 5 mm, e.g., about 1.8 x 1.8 mm.

[0041] Additionally, the adapter 1 may be overmolded with remotely readable electronic components 5 .

[0042] A remotely readable electronic component 5 is at least partially fitted in the adapter 1 .

[0043] 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 is then intended to be covered by the glue material 24. As a result, the remotely readable electronic component 5 is partially embedded in the material of the adapter 1, but fully embedded between the adapter 1 and the glue material 24 and, if necessary, the distal tip 11 of the medical container 10. According to this embodiment, the remotely readable electronic component 5 is preferably completely located in the proximal part 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 fully embedded between the adapter 1 and the glue material 24, while the antenna 52 may remain uncovered by the glue material 24, so that the antenna 52 contacts the distal tip 11 of the medical container 10 and is thus embedded between the adapter 1 and the distal tip 11 of the medical container 10 when the adapter 1 is attached to the distal tip 11. The antenna 52 may or may not be in contact with the glue material 24.

[0044] The glue material may be selected between a hot melt adhesive and a glue, for example a glue having an acrylate base.

[0045] In a second embodiment, the remotely readable electronic component 5 is fully embedded in the material of the adapter 1. For example, the remotely readable electronic component 5 may be overmolded in a two-shot injection process. More specifically, the remotely readable electronic component 5 is positioned as an insert in a mold. A first part of the adapter 1 is formed by a first injection of material and partially covers the remotely readable electronic component 5. A second part of the adapter 2 is formed by a second injection step of material that fully encases the remotely readable electronic component 5 together with the first part and thus may be of the same material as the first part or a different material. According to this embodiment, the remotely readable electronic component 5 may be located in the proximal part 2 and / or the distal part 3 of the adapter 1.

[0046] Finally, in both the first and second embodiments described above, when the adapter 1 is attached to the distal tip 11 of the medical container 10, the remotely readable electronic component 5, in particular the chip 51 of the RFID tag 50, is preferably fully fitted either between the adapter 1, the glue material 24 and / or the distal tip 11 of the medical container 10, or only within the adapter 1. This protects the remotely readable electronic component 5 from the external environment. For example, the adapter 1 or the medical container 10 can thus be subjected to a sterilization process without damaging the remotely readable electronic component 5.

[0047] The adapter 1 defines a central through opening 4 extending through a proximal portion 2 and a distal portion 3 along a longitudinal axis A. The through opening 4 defines a proximal portion and a distal portion, the proximal portion configured to receive a distal tip 11 and the distal portion configured to receive both the distal tip 11 and a connector that is connected about the distal tip 11. Thus, the distal portion has a larger diameter than the proximal portion.

[0048] 1 and 2, the RFID antenna 52 preferably extends around the periphery of the through opening 4 of the adapter 1. As can be seen in FIG.

[0049] With reference to Fig. 2, the proximal portion 2 may advantageously comprise an annular ring 20 provided at its distal end. The annular ring 20 projects radially inwards. The annular ring 20 may define a distal shoulder 200 separating the proximal portion 2 and the distal portion 3. As shown in Fig. 1, the annular ring 20 may further define a proximal shoulder 201 intended to act as a stop for a glue material, as will be explained in more detail below.

[0050] As shown in FIG. 1 or FIG. 2, an RFID antenna 52 is advantageously disposed within this annular ring 20 .

[0051] The proximal portion 2 comprises an inner surface 21 which may be provided with fastening means for fastening said proximal portion 2 on the outer surface 110 of the distal tip 11 .

[0052] The fastening means may include an annular space 23 configured to receive glue material 24 to couple the adapter 1 to the distal tip 11. The annular space 23 is bounded by the inner surface 21 of the proximal portion 2, the annular ring 20, in particular the proximal shoulder 201, and the outer surface 110 of the distal tip 11 when the adapter 1 is attached to the medical container 10. The annular space 23 may have a proximal end that is open to receive the glue material 24, while it may have a distal end that may be closed by the annular ring 20.

[0053] Preferably, the remotely readable electronic component 5, more precisely the RFID chip 51, partially defines the annular space 23. The remotely readable electronic component 5 is substantially flush with the inner surface 21 of the proximal part 2, as shown in Fig. 1. The remotely readable electronic component 5 being flush with the inner surface 21 means that a part of said electronic component 5 may be located at the same height as the inner surface 21 or may slightly protrude or form a recess with respect to said inner surface 21. Thereby, the readable electronic component 5 is arranged so as to be covered by said glue material 24 contained in the annular space 23.

[0054] The fastening means may comprise one or several projections 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 arranged around the circumference on the circumferential inner surface 21. The longitudinal ribs 25 may extend, preferably continuously, over the entire length of the inner surface 21. The longitudinal ribs 25 may contact the annular ring 20 or may be spaced apart from the annular ring 25. At least one of the longitudinal ribs 25 and the annular ring 20 may be in contact with the outer surface 110 of the distal tip 11 in order to increase the interference between the proximal part 2 of the adapter 1 and said distal tip 11. The longitudinal ribs 25 may divide the annular space 23 into several cavities. For example, as shown in Fig. 1, the proximal portion 2 of the adapter 1 comprises only three longitudinal ribs 25 in order to have an isostatic centering of the adapter 1 on the distal tip 11 of the medical container 10. The three longitudinal ribs 25 divide the annular space 23 into three cavities. It is noted that at least one of these cavities, and preferably each cavity, may have a proximal end that is open to receive the glue material 24, while having a distal end that may be closed by the annular ring 20.

[0055] 1, RFID chip 51 is preferably disposed between two of the longitudinal ribs 25. Thus, RFID chip 51 is preferably not recessed behind one of the protrusions. RFID chip 51 may partially define one of the cavities formed by longitudinal ribs 25.

[0056] The adapter 1 may be made of a plastic material, more precisely any rigid polymer compatible with medical applications, 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). The adapter 1 is preferably manufactured from a single material to simplify its manufacture. However, the adapter 1 may comprise two different materials, for example when manufactured in a two-shot injection process. Preferably, the adapter 1 is made of an optically transparent material.

[0057] Referring to FIG. 2, the present invention also relates to a medical container 10, which may be a syringe. The medical container 10 includes a tubular barrel 12 that defines a reservoir for a pharmaceutical product. The tubular barrel 12 includes a distal tip 11 that may protrude from a distal shoulder 120. The distal tip 11 may be cylindrical or may be distally tapered. The distal tip 11 includes an internal passageway 111 that communicates with the reservoir. The tubular barrel 12 and the distal tip 111 are preferably made of glass. The medical container 10 may include a piston and plunger rod (not shown) to expel the pharmaceutical product from the reservoir through the passageway 111.

[0058] The medical container 10 also includes an adapter 1 having some or all of the features described above. The adapter 1 has a proximal portion 2 attached to a distal tip 11.

[0059] In a preferred embodiment, the proximal portion 2 of the adapter 1 is secured to the distal tip 11 by a glue material 24, such that the remotely readable electronic component 5 is fitted between the adapter 1 and the glue material 24. This adhesive layer of glue material 24 allows the adapter 1 to be glued around the distal tip 11 without the need for grooves or rings on the outer surface 110 of the distal tip 11. Thus, the distal tip 11 is devoid of such grooves or rings.

[0060] In another preferred embodiment, the proximal portion 2 of the adapter 1 may be secured to the distal tip 11 by press-fit, snap-on or threaded means. Thus, the remotely readable electronics 5 may be fully fitted within the adapter 1.

[0061] The present invention also relates to a method for manufacturing the medical container 10, the method comprising the steps of: providing an adapter 1 having some or all of the above mentioned features, in which a remotely readable electronic component 5 is partially or completely overmolded within the adapter 1, for example in a one-shot or two-shot injection process; providing a distal tip 11 of a medical container 10; connecting the adapter 1 to the distal tip 11 by the proximal portion 2 of the adapter 1; Includes.

[0062] As shown in FIG. 2, the adapter 1 may be connected to an outer surface 110 of the distal tip 11 .

[0063] The step of connecting the adapter 1 to the distal tip portion 11 includes the following steps: dispensing glue material 24 between the proximal portion 22 and the distal tip 11 of the adapter 2, optionally dispensing glue material 24 within the annular space 23; or threading the adapter 1 onto the distal tip 11; or snapping the adapter 1 onto the distal tip 11; or Pressing the adapter 1 into the distal tip 11 The method may include at least one step selected from the following:

[0064] It should be noted that if the method includes dispensing glue material 24 between the proximal portion 2 and the distal tip 11 of the adapter 1, the glue material 24 may be dispensed before or after the adapter 1 is placed around the distal tip 11. Additionally, dispensing glue material 24 between the proximal portion 2 and the distal tip 11 of the adapter 2 includes covering the remotely readable electronic component 5 when the remotely readable electronic component 5 is partially fitted within the adapter 1, such that the remotely readable electronic component 5 is eventually fully encased within the adapter 1 to which the glue material 24 has been added.

Claims

1. A medical container (10) comprising a distal tip (11) and an adapter (1), said adapter (1) comprising: a proximal portion (2) configured to be fixed to the distal tip (11) of the medical container (10); a distal portion (3) configured to receive a connector; a remotely readable electronic component (5) configured to enable remote identification of the medical container (10) when the adapter (1) is fixed to the medical container (10), the remotely readable electronic component (5) being at least partially fitted within the adapter (1); Equipped with The adapter (1) is secured to the distal tip (11) by a glue material (24); The medical container (10), wherein the remotely readable electronic component (5) is flush with an inner surface (21) of the adapter (1) and is fitted between the adapter (1) and the glue material (24).

2. 2. The medical container (10) according to claim 1, wherein the remotely readable electronic component (5) is an RFID tag (50) comprising an RFID chip (51) and an RFID antenna (52), the RFID antenna (52) extending around the through opening (4) of the adapter (1).

3. 3. The medical container (10) of claim 1 or claim 2, wherein the proximal portion (2) has an inner surface (21) defining at least one annular space (23) configured to accommodate the glue material (24), and the remotely readable electronic component (5) is arranged to be covered by the glue material (24).

4. The medical container (10) of claim 3, wherein the adapter (1) is configured to be secured to the medical container (10) by gluing.

5. 5. The medical container (10) according to any of the preceding claims, wherein the remotely readable electronic component (5) is located entirely within the proximal part (2) of the adapter (1).

6. A medical container (10) as described in claim 2, or a medical container (10) as described in any one of claims 3 to 5 when dependent on claim 2, wherein the inner surface (21) of the proximal portion (2) is provided with protrusions, and the RFID chip (51) is positioned between two of the protrusions.

7. The medical container (10) of claim 2, or any of claims 3 to 6 when dependent on claim 2, wherein the proximal portion (2) comprises an annular ring (20) and the RFID antenna (52) is disposed within the annular ring (20).

8. A method for manufacturing a medical container (10) according to any one of claims 1 to 7, comprising the steps of: Providing an adapter (1); providing a distal tip (11) of said medical container (10); connecting the adapter (1) to the distal tip (11) by the proximal part (2) of the adapter (1); A method comprising:

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