Plastic flange for medical container, medical container comprising the same, and production method of the medical container

Abstract

To provide a plastic flange which facilitates individual recognition of medical containers, from production, final use, infusion or discard, does not affect visual examination, and prevents or suppress risks of detachment and damage.SOLUTION: A plastic flange 1 has: a penetration opening which is configured to allow a plunger rod to pass through a reservoir defined by a tubular barrel of a syringe; connection means for connecting the flange to the outer surface of the tubular barrel. The connection means includes: multiple bumps 16 which protrude in a radial direction from the inside side wall of the flange, and contact the outer surface of the tubular barrel. The adjacent bumps of the multiple bumps define an axial channel. The connection means has at least one circular channel which is configured to establish fluid connection between the adjacent axial channel, and the axial channel and the at least one circular channel are filled with an adhesive material.SELECTED DRAWING: Figure 3

Description

Technical Field

[0001] The present invention relates to a plastic flange for a medical container, a medical container including the plastic flange, and a method for manufacturing the medical container.

Background Art

[0002] In the present application, the distal end of a component 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, 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 above injection direction, that is, the direction toward the user's hand holding the container with respect to the injection operation.

[0003] An injection device, for example, a prefillable or prefilled syringe, typically comprises a hollow body or barrel that forms a container for a medical product. This body typically comprises a distal end with a needle and a proximal end with a flange that enables the user to place a finger to apply proximal pressure to this flange.

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

[0005] For example, from Patent Document 1, a receptacle having a cylindrical side surface surrounded by a series of printed machine-readable unique identifier codes is known. These printed unique identifier codes enable the tracking and tracing of each receptacle along the supply chain. However, since these unique identifier codes are printed on the outside of the receptacle, they may be removed or damaged, for example, during the handling or use of the receptacle. Furthermore, since the unique identifier codes cover a part of the receptacle, they may affect the customer's visual inspection process.

[0006] Furthermore, Patent Document 2 discloses a method of glass marking in which an array of readable marks can be formed on the outer surface of a glass tube by a laser, for example, for tracking purposes. However, the drawbacks of any laser marking method are the possibility of damaging the glass material and the high cost of the manufacturing process. Furthermore, since the array of marks written by the laser requires visual access to the glass tube for reading, the reading operation cannot be performed at any time. The array of marks written by the laser may further affect the customer's visual inspection process.

[0007] Furthermore, Patent Document 3 discloses an RFID tag for placement inside the tubular base portion of a self-standing cryogenic vial. Patent Document 4 discloses an RFID tag inserted into a recess in the bottom of a vial. Patent Document 5 discloses a container lid with a removable RFID tag. Patent Document 6 discloses a product package with a transparent bottle cap, the cap including an RFID chip and an antenna. Patent Document 7 further discloses a container including an RFID insert having a disabling function.

[0008] In this regard, an object of the present invention is to alleviate the above-mentioned drawbacks and enable easy individual recognition of a medical container from the first step of the manufacturing process to the final use, typically injection or disposal steps, without affecting visual inspection and with little or no risk of removal or damage, by providing a plastic flange.

Prior Art Documents

Patent Documents

[0009]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

Patent Document 7

Summary of the Invention

Means for Solving the Problems

[0010] One aspect of the present invention is a plastic flange for a medical container, the plastic flange defining an opening surrounded by a peripheral color that provides support for a user's finger, the flange comprising connecting means for connecting the flange to the outer surface of the tubular barrel of the medical container, the flange further comprising remotely readable electronic components for remote identification of the medical container, the remotely readable electronic components being at least partially embedded in the plastic flange.

[0011] An electronic component incorporated in a plastic flange should be understood as one in which the plastic flange completely or at least partially encloses the electronic component, protecting the electronic component from the external environment so that it is not damaged or removed.

[0012] A remotely readable electronic component for identifying a medical container is one that contains electronically stored information that can be remotely read by a reader such as an RFID reader, and is intended to enable the identification of the medical container in which the flange of the present invention is assembled.

[0013] Thus, the plastic flange of the present invention makes it possible to have individual traceability of each medical container from the manufacturing stage of the medical container to its final use or disposal of the medical container. Further, since the electronic component is at least partially enclosed by the plastic flange, it is protected from removal and external damage that may occur during the packaging, sterilization, storage, distribution, or use of the medical container. Furthermore, since the electronic component is located inside the flange, it does not affect the customer's visual inspection process. The electronic component is also intended to enable remote and easy identification of the medical container. The electronic component can be read at any time without the need to open the medical container and without the need for direct visual inspection from the reader. Further, since the electronic component is incorporated inside the flange, it is advantageous that there is no additional thickness in the barrel of the medical container, and thus no changes need to be made regarding the packaging or storage of the medical container. By means of the connecting means, the flange of the present invention can be advantageously attached to a glass medical container, and as a result, the flange of the present invention enables reliable and easy identification of the glass medical container without the drawbacks of the prior art.

[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, including an RFID chip and an RFID antenna. Preferably, the RFID antenna extends around the opening.

[0015] Preferably, the plastic flange is connected to the tubular barrel by adhesion, screwing, or attachment.

[0016] Preferably, the connecting means includes a plurality of bumps configured to project radially from the inner wall of the flange and adjacent to the outer surface of the tubular barrel.

[0017] This enables the flange to be maintained perpendicular to the tubular barrel.

[0018] Preferably, the plurality of bumps comprises a proximal blocking surface configured to abut against a bead of the tubular barrel.

[0019] This enables the medical device to be used for the injection of a medical or pharmaceutical composition and prevents the distal movement of the barrel from the flange when maintaining the barrel in the flange.

[0020] Preferably, the connecting means comprises a distal shoulder configured to receive the proximal end of the tubular barrel and disposed on the opposite side of the proximal blocking surface.

[0021] Thus, the tubular barrel is axially blocked with respect to the flange.

[0022] Preferably, the adjacent bumps of the plurality of bumps define an axial channel configured to be filled with an adhesive material.

[0023] This allows for the addition of an adhesive material between the flange and the tubular barrel in order to prevent any rotational movement of the flange relative to the barrel.

[0024] Preferably, the connecting means comprises at least one circular channel configured to establish a fluid connection between adjacent axial channels.

[0025] This enables the adhesive to be flowed into all the filling chambers at once in order to perform the distribution of the adhesive in a single operation.

[0026] The circular channel may extend between the distal shoulder and the plurality of bumps.

[0027] The RFID tag can advantageously be overmolded onto the plastic flange.

[0028] Preferably, the remotely readable electronic component is fully overmolded onto the plastic flange. Alternatively, the remotely readable electronic component is embedded between the plastic flange and the adhesive material.

[0029] This ensures that the flange dimensions are not changed relative to the standard flange dimensions in order to avoid investment costs.

[0030] The RFID tag can be molded in a two-shot injection molding process. More specifically, the RFID tag is placed as an insert into the mold. The first part of the flange is formed by the first injection of a plastic material and partially covers the RFID tag. Next, the second part of the flange, which completely encapsulates the RFID tag together with the first part, is formed by a second injection step of a plastic material which can be the same or a different plastic material as the first part.

[0031] The RFID tag may be substantially disposed at the center of the plastic flange.

[0032] Another aspect of the present invention is a medical container comprising: a tubular barrel for receiving a medical product, and a plastic flange as described above, protruding from the outer surface of the barrel to provide support for a user's finger, the plastic flange, a medical container comprising.

[0033] Preferably, the tubular barrel is made of a glass material.

[0034] Another aspect of the present invention is a method for manufacturing a medical container as described above, the method comprising: - providing a plastic flange as described above; - providing the tubular barrel; - connecting the plastic to the tubular barrel by means of the flange connecting means; and comprising.

[0035] Preferably, the method comprises at least one step selected from the following steps: - dispensing an adhesive between the flange and the tubular barrel; and - screwing the flange onto the outer surface of the tubular barrel; or - snap-fitting the flange onto the outer surface of the tubular barrel and comprising.

[0036] The present invention and the advantages resulting therefrom will become apparent from the following detailed description with reference to the following attached drawings:

Brief Description of the Drawings

[0037]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

[0038] Referring to FIGS. 1, 2 and 3, a plastic flange 1 according to the present invention is shown. As shown in FIGS. 1 and 2, the plastic flange 1 is designed to be attached to a medical container 2 such as a syringe. The medical container 2 may comprise a tubular barrel 20 defining a reservoir for containing a medical product. As shown in FIG. 1, the tubular barrel 20 may have a distal end 20a, preferably including a tapered distal tip 21, defining an axial passage 22 in fluid communication with the reservoir. The distal tip 21 may allow attachment of an adapter or its needle. As shown in FIG. 2, the tubular barrel 20 includes a proximal end 20b defining an opening 25 for receiving a plunger rod (not shown). The proximal end 20b may exhibit a circular bead 23 protruding from the outer side surface 24 of the tubular barrel 20. While the flange 1 is made of a plastic material, preferably a rigid plastic material such as polycarbonate, polypropylene or cyclic olefin copolymer (COC), the medical container 2 may be made of a glass material. In an embodiment not shown, the flange 1 may comprise two or more different plastic materials.

[0039] Referring to FIG. 1 for example, the plastic flange 1 comprises a remotely readable electronic component 3 for remotely identifying the medical container 2 by a remote reader. Advantageously, the remotely readable electronic component 3 is an RFID tag for identifying the medical container 2, preferably a passive RFID tag. The RFID tag may be a passive RFID tag. The RFID tag may be read by an RFID reader without the need for direct penetration of the plastic flange 1. The RFID tag is disposed within the color 10 of the plastic flange 1. The RFID tag may be disposed substantially at the center of the width of the plastic flange 1. The RFID tag includes an RFID chip 31 and an RFID antenna 32. The RFID chip 31 may include at least a storage unit storing a device unique identifier (UDI) that enables identification of the medical device. The RFID antenna 32 may extend entirely around the opening 11 of the plastic flange 10 as seen in FIG. 1.

[0040] The RFID tag may be partially or fully embedded in the plastic flange 1 so as to be protected from the external environment. When assembled to the medical container 2, the plastic flange 1 preferably completely encloses the RFID tag. For example, the RFID tag may be either completely enclosed in the sole color 10 of the plastic flange 1 or, in addition to the color 10, completely enclosed by an adhesive material 30 that secures the plastic flange 1 to the tubular barrel 20.

[0041] The RFID tag may advantageously be overmolded into the plastic flange.

[0042] For example, the RFID tag is molded in a two-shot injection molding process. More specifically, the RFID tag is placed as an insert into the mold. The first part of the flange is formed by the first injection of the plastic material. Next, the second part of the flange, which completely encapsulates the RFID tag together with the first part, is formed by a second injection step of the plastic material, which can be the same or a different plastic material as the first part.

[0043] Preferably, the RFID tag is completely overmolded onto the plastic flange 1. Alternatively, the RFID tag is partially overmolded with the plastic flange 1 (for example, a part of the RFID tag can be at the same height as the surface of the plastic material of the flange 1), and then is completely embedded within the plastic flange 1 by the addition of an adhesive material 30 that completely covers the RFID tag, such that the adhesive material 30 is in direct contact with the RFID tag.

[0044] As shown in FIG. 3, the plastic flange 1 includes a collar 10 that defines a central opening 11. As seen in FIG. 2, the collar 10 has a proximal surface 10b and an opposite distal surface 10a. The distal surface 10a is designed to provide support to the user's finger when the medical container 2 is being used, for example, during an injection operation. The collar 10 may have a peripheral rim formed by two parallel edges 10c connected by two curved edges 10d. In another embodiment (not shown), the peripheral rim may be completely circular. The opening 11 is configured to allow the insertion of the tubular barrel 20 of the medical container 2, as will be described in more detail below. As shown in FIG. 2, the opening 11 may be centered about the longitudinal axis A of the medical container 2.

[0045] The plastic flange 1 may further define a through opening 12 configured to be superimposed on the opening 25 of the tubular barrel 20 so that the plunger rod can pass through the reservoir. The through opening 12 and the opening 11 of the flange may be coaxial. The through opening 12 may be centered on the longitudinal axis A of the medical container 2. As shown in FIG. 3, the through opening 12 may have a diameter smaller than that of the opening 11 of the flange, thereby defining a distal shoulder 14 that separates the opening 11 and the through opening 12 of the flange 1. The through opening 12 is disposed proximally with respect to the opening 11 of the flange. The plastic flange 1 may be provided on the proximal surface 10b of the collar and may exhibit a proximal chamfered edge 15 surrounding the through opening 12, as seen, for example, in FIG. 2.

[0046] The flange 1 is provided with connecting means, and the connecting means is configured to connect the flange 1 to the outer surface of the tubular barrel 20 of the medical container 2. The connecting means is preferably disposed inside the opening 11 of the flange 1.

[0047] As shown in FIG. 3, the connecting means may include a plurality of bumps 16 that project radially from the inner side wall 17 of the flange 1. The inner side surface 17 may delimit the opening 11. The bumps 16 are configured to be adjacent to the outer side surface 24 of the tubular barrel 20, as shown, for example, in FIG. 4. The bumps 16 may be preferably disposed inside the opening 11 at regular angles around the longitudinal axis A. The connecting means includes at least one, preferably two bumps 16. In the illustrated embodiment, the connecting means includes six bumps 16. In other cases, it may include three, four, five, or more bumps 16.

[0048] As shown in FIG. 5, the bump 16 may include a radially abutting surface 160 configured to abut against the outer surface 24 of the tubular barrel 20. The diameter defining the radially abutting surface 160 may be smaller than the outer diameter of the tubular barrel 20, such that the bump 16 is configured to apply a radial pressure against the outer surface 24 of the tubular barrel 20. For this purpose, the flange or bump 16 may be made of an elastic material. The radially abutting surface 160 may be flat or, preferably, may have a shape complementary to the shape of the outer side surface 24 of the tubular barrel 20, such as cylindrical.

[0049] Referring further to FIG. 5, the bump 16 may include a proximal blocking surface 162 configured to block distal movement of the tubular barrel 20 relative to the flange. For example, the blocking surface 162 abuts against a bead 23 provided at the proximal end of the end portion. As seen in FIG. 5, the proximal blocking surface 162 may be inclined with respect to the longitudinal axis A of the medical container 2. The proximal blocking surface 162 is disposed proximal to the first radially abutting surface 160.

[0050] The bump 16 may define a radially concave portion 164 configured to receive a corresponding protruding portion of the tubular barrel 20, such as the bead 23 of the tubular barrel 20. The concave portion 164 may have a bottom abutting surface configured to abut against the tubular barrel 20 so as to limit pivotal movement of the tubular barrel 20 relative to the flange 1 about an axis orthogonal to the longitudinal axis A. The bottom abutting surface may define a diameter larger than the diameter defined by the radially abutting surface 160 described above. The concave portion 164 may have a shape complementary to the shape of the outer side surface 24 of the tubular barrel 20. The concave portions 164 and their bottom abutting surfaces are disposed proximal to the proximal blocking surface 162.

[0051] As shown in FIG. 5, the proximal end 20b of the tubular barrel 20 is adjacent to the distal shoulder 14, such that the distal shoulder 14 blocks the proximal movement of the tubular barrel 20 relative to the flange 1. The distal shoulder 14 may be flat and preferably is orthogonal to the longitudinal axis A. The distal shoulder 14 faces the proximal blocking surface 162 of the bump 16.

[0052] As shown in FIGS. 4 or 6, the abutting bumps 16 may define an axial channel 18 therebetween that is configured to be filled with an adhesive material 30. At least one of the axial channels 18 may have a distal open end 180 that allows entry of the adhesive material 30. The axial channel 18 extends longitudinally along the longitudinal axis A and may extend laterally about the longitudinal axis A. The axial channel 18 may have a cylindrical shape. The axial channel 18 is in fact delimited by the side wall 168 of the bump 16, the inner side surface 17 of the flange 1, and the outer side surface 24 of the tubular barrel 20.

[0053] The adhesive material 30 may be selected between a hot melt adhesive and an adhesive having, for example, an acrylate base.

[0054] As shown in FIGS. 3, 5, and 8, the connection means may further comprise at least one circular channel 166 that establishes fluid communication between at least two abutting axial channels 18. The circular channel 166 may interconnect all of the axial channels 18 such that the adhesive material 30 can flow into all of the spaces located between the outer side surface 24 of the tubular barrel 20 and the flange 1. The circular channel 166 may be formed by a groove disposed between the distal shoulder 14 and the bump 16 and may be disposed proximal to the recess 164 of the bump 16. For example, the circular channel 166 is a groove defined in the bump 16, the distal shoulder 14, or the inner side surface 17 of the flange 1.

[0055] Note that in order to position or fix the flange on the tubular barrel 20, it should be noted that the connecting means may alternatively comprise snap-fit, press-fit, or screw elements. Thus, the plastic flange 1 may be connected to the tubular barrel 20 by adhesion, screwing, or attachment.

[0056] The present invention also relates to a medical container 2 comprising a tubular barrel 20 for receiving a medical product and the above-mentioned plastic flange 1 protruding from the outer surface of the tubular barrel 20, wherein the tubular barrel 20 is made of a glass material, and the tubular barrel 20 and the plastic flange 1 are fixed together by connecting means.

[0057] The present invention also relates to a method for manufacturing the medical container 2, the method comprising the steps of providing the above-mentioned plastic flange 1 constituting a remotely readable electronic component 3, providing a tubular barrel 20, and connecting the plastic flange 1 to the tubular barrel 20 by flange connecting means.

[0058] The step of providing the plastic flange 1 may include overmolding a remotely readable electronic component 3, for example, during a two-shot injection molding process.

[0059] The step of connecting the plastic flange 1 to the tubular barrel 20 may include the step of dispensing an adhesive material 30 between the flange 1 and the tubular barrel 20, or the step of screwing the flange 1 onto the outer side surface 24 of the tubular barrel 20, or the step of snap-fitting the flange 1 onto the outer side surface 24 of the tubular barrel 20.

Claims

1. A plastic flange (1) for a syringe (2), said plastic flange (1) defining an opening (11), said opening (11) being surrounded by a surrounding collar (10), said collar (10) providing support for a user's finger, said flange (1) comprising a through opening (12) configured to allow passage of a plunger rod into a reservoir defined by a tubular barrel (20) of said syringe (2), and connection means for connecting said flange (1) to an outer surface (24) of the tubular barrel (20) of said syringe (2), said flange (1) further comprising a remotely readable electronic component (3) for remote identification of said syringe (2), said remotely readable electronic component (3) being at least partially embedded in said plastic flange (1), 1. The plastic flange (1), characterized in that the connection means includes a plurality of bumps (16) protruding radially from an inner sidewall (17) of the flange (1) and configured to abut the outer surface (24) of the tubular barrel (20), adjacent bumps (16) of the plurality of bumps (16) defining axial channels (18), the connection means comprising at least one circular channel (166) configured to establish a fluid connection between adjacent axial channels (18), the axial channel (18) and the at least one circular channel (166) being filled with an adhesive material (30).

2. 2. The plastic flange (1) according to claim 1, characterized in that the remotely readable electronic component (3) is an RFID tag comprising an RFID chip (31) and an RFID antenna (32), the RFID antenna (32) extending around the opening (11).

3. The plastic flange (1) according to claim 1 or 2, characterized in that the plastic flange (1) is connected to the tubular barrel (20) by gluing.

4. The plastic flange (1) according to any one of claims 1 to 3, characterized in that the plurality of bumps (16) have proximal blocking surfaces (162) configured to abut against beads (23) of the tubular barrel (20).

5. 5. The plastic flange (1) according to claim 4, characterized in that the connection means comprises a distal shoulder (14) configured to receive the proximal end (20b) of the tubular barrel (20) and disposed opposite the proximal blocking surface (162).

6. A plastic flange (1) according to any one of the preceding claims, characterized in that the remotely readable electronic component (3) is embedded between the plastic flange (1) and an adhesive material (30).

7. The plastic flange (1) according to any one of the preceding claims, characterized in that the remotely readable electronic component (3) is completely overmolded onto the plastic flange (1).

8. a tubular barrel (20) for receiving a medical product; A syringe (2) comprising a plastic flange (1) according to any one of claims 1 to 7, the plastic flange (1) protruding from an outer surface (24) of the barrel (20) to provide support for a user's fingers.

9. 9. The syringe (2) according to claim 8, characterized in that the tubular barrel (20) is made of a glass material.

10. A method for manufacturing a syringe (2) according to claim 8 or 9, said method comprising the steps of: Providing a plastic flange (1) according to any one of claims 1 to 7; Providing said tubular barrel (20); and connecting said plastic flange (1) to said tubular barrel (20) using said flange connection means.

11. The method comprises: A method according to claim 10, characterized in that it comprises the step of dispensing an adhesive material (30) between said flange (1) and said tubular barrel (20).

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