Plastic flange for medical container, medical container including said plastic flange, and method for manufacturing said 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 technology]

[0002] In this application, the distal end of a component or device shall be understood to mean the end furthest from the user's hand, and the proximal end shall be understood to mean the end closest to the user's hand. Similarly, in this application, a "distal direction" shall be understood to mean the direction of injection with respect to the medical container of the present invention, and a "proximal direction" shall be understood to mean the direction opposite to said injection direction, i.e., the direction toward the user's hand holding the container with respect to the injection operation.

[0003] Injection devices, such as prefillable or prefilled syringes, typically include a hollow body or barrel that forms a container for the medical product. The body typically includes a distal end with a needle and a proximal end with a flange that allows a user to place a finger on the flange to apply proximal pressure.

[0004] There is an increasing need for individual traceability of medical containers, such as infusion devices, from the manufacturing process at least to the end use of said medical containers, typically the infusion of a medical product.

[0005] For example, U.S. Patent No. 5,949,949 discloses a receptacle having a cylindrical side surrounded by a series of printed, machine-readable, unique identifier codes. These printed unique identifier codes enable tracking of each receptacle along the supply chain. However, because these unique identifier codes are printed on the outside of the receptacle, they can be removed or damaged, for example, during handling or use of the receptacle. Furthermore, because the unique identifier codes cover part of the receptacle, they can 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 disadvantages of any laser marking method are that it can damage the glass material and the manufacturing process is expensive. Furthermore, the array of marks written by a laser requires visual access to the glass tube to read, so the reading operation cannot be performed at any time. The array of marks written by a 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 of a freestanding cryogenic vial. Patent Document 4 discloses an RFID tag inserted into a recess in the bottom of the 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 with a deactivation function.

[0008] In this context, the object of the present invention is to alleviate the above-mentioned drawbacks and to provide a plastic flange that allows easy individual recognition of medical containers from the first manufacturing steps to their final use, typically filling or disposal steps, without affecting visual inspection and with little or no risk of removal or damage. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] International Publication No. 2017157784 [Patent Document 2] U.S. Patent No. 8,872,870 [Patent Document 3] International Publication No. 2014114938 [Patent Document 4] U.S. Patent No. 2011199187 [Patent Document 5] U.S. Patent No. 2010102967 [Patent Document 6] U.S. Patent No. 2008149584 [Patent Document 7] International Publication No. 2008057150 Summary of the Invention [Means for solving the problem]

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

[0011] An electronic component integrated into a plastic flange is to be understood as one in which the plastic flange completely or at least partially encases the electronic component, thereby protecting it from the external environment and preventing it from being damaged or removed.

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

[0013] Thus, the plastic flange of the present invention allows for the individual traceability of each medical container from the manufacturing stage of the medical container to its final use or disposal. Furthermore, because the electronic components are at least partially enclosed in the plastic flange, they are protected from removal or external damage that may occur during the packaging, sterilization, storage, distribution, or use of the medical container. Furthermore, because the electronic components are located inside the flange, they do not affect the customer's visual inspection process. The electronic components are also intended to enable remote and easy identification of the medical container. The electronic components do not require direct visual inspection from a reader, so that readings can be performed at any time without the need to open the medical container. Furthermore, because the electronic components are integrated inside the flange, they advantageously do not add any additional thickness to the barrel of the medical container, and therefore, no changes need to be made to the packaging or storage of the medical container. The flange of the present invention can be advantageously attached to a glass medical container via a connecting means, thereby enabling reliable and easy identification of glass medical containers without the drawbacks of the state-of-the-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 Wi-Fi 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 gluing, threading or attachment.

[0016] Preferably, the connection means comprises a plurality of bumps that project radially from the inner wall of the flange and are configured to abut the outer surface of the tubular barrel.

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

[0018] Preferably, the plurality of bumps include proximal blocking surfaces configured to abut beads on the tubular barrel.

[0019] This allows for preventing movement of the barrel distally from the flange when the medical device is used to inject a medical or pharmaceutical composition and maintaining the barrel on the flange.

[0020] Preferably, the connecting means is configured to receive the proximal end of the tubular barrel and includes a distal shoulder located opposite the proximal block face.

[0021] The tubular barrel is therefore axially blocked against the flange.

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

[0023] This allows for the addition of adhesive material between the flange and the tubular barrel 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 allows adhesive to be flowed into all the fill chambers at once in order to perform adhesive dispensing in a single operation.

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

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

[0028] Preferably, the remotely readable electronic component is completely overmolded onto the plastic flange, or 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 using a two-shot injection molding process. More specifically, the RFID tag is placed as an insert into a mold. A first portion of the flange is formed by a first injection of plastic material, partially covering the RFID tag. A second portion of the flange, which together with the first portion completely encapsulates the RFID tag, is then formed by a second injection of plastic material, which can be the same or a different plastic material as the first portion.

[0031] The RFID tag may be located substantially in the center of the plastic flange.

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

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

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

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

[0036] The invention and the advantages arising therefrom will become apparent from the detailed description set forth below with reference to the accompanying drawings in which: [Brief explanation of the drawings]

[0037] [Figure 1] FIG. 1 is a perspective view of a medical container having a flange according to the present invention. [Figure 2] FIG. 2 is a side cross-sectional view of a flange according to the present invention that receives the barrel of a medical container. [Figure 3] FIG. 3 is a perspective view of a flange according to the present invention. [Figure 4] FIG. 4 is a partial perspective view of a flange according to the present invention that receives the barrel of a medical container. [Figure 5] FIG. 5 is a partial side cross-sectional view of a flange according to the present invention that receives the barrel of a medical container. [Figure 6] FIG. 6 is a partial cross-sectional perspective view of a flange according to the present invention for receiving the barrel of a medical container. [Figure 7] FIG. 7 is a partial perspective cross-sectional view of a medical container having a flange according to the present invention. [Figure 8] FIG. 8 is a partial cross-sectional side view of a medical container having a flange in accordance with the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0038] 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 attach to a medical container 2, such as a syringe. The medical container 2 may include 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 for 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 an outer side surface 24 of the tubular barrel 20. The flange 1 is made of a plastic material, preferably a rigid plastic material such as polycarbonate, polypropylene, or cyclic olefin copolymer (COC), while 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] For example, referring to FIG. 1 , plastic flange 1 includes a remotely readable electronic component 3 for remotely identifying medical container 2 by a remote reader. Advantageously, remotely readable electronic component 3 is an RFID tag for identifying 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 requiring direct view of plastic flange 1. The RFID tag is disposed within collar 10 of plastic flange 1. The RFID tag may be disposed substantially in the center of the width of plastic flange 1. The RFID tag includes an RFID chip 31 and an RFID antenna 32. RFID chip 31 may include at least a memory unit that stores a unique device identifier (UDI), which allows identification of the medical device. RFID antenna 32 may extend completely around opening 11 of plastic flange 10, as seen in FIG. 1 .

[0040] The RFID tag may be partially or completely embedded in the plastic flange 1 so that it is protected from the external environment. When assembled into the medical container 2, the plastic flange 1 preferably completely encases the RFID tag. For example, the RFID tag may either be completely encased in the sole collar 10 of the plastic flange 1, or in addition to the collar 10, be completely encased by the adhesive material 30 that secures the plastic flange 1 to the tubular barrel 20.

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

[0042] For example, RFID tags are molded using a two-shot injection molding process. More specifically, the RFID tag is placed as an insert into a mold. A first portion of the flange is formed by a first injection of a plastic material. Then, a second portion of the flange, which together with the first portion completely encases the RFID tag, is formed by a second injection of a plastic material, which can be the same or a different plastic material as the first portion.

[0043] Preferably, the RFID tag is completely overmolded onto the plastic flange 1. Alternatively, the RFID tag may be partially overmolded onto the plastic flange 1 (e.g., a portion of the RFID tag may be flush with the surface of the plastic material of the flange 1) and then completely embedded within the plastic flange 1 by the addition of 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 defining 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 for a user's fingers when the medical container 2 is being used, for example, for 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 insertion of the tubular barrel 20 of the medical container 2, as 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 align with the opening 25 of the tubular barrel 20 to allow passage of the plunger rod into the reservoir. The through opening 12 and the flange opening 11 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 smaller diameter than the flange opening 11, thereby defining a distal shoulder 14 separating the opening 11 and the flange opening 12. The through opening 12 is disposed proximally relative to the flange opening 11. The plastic flange 1 may exhibit a proximal chamfered edge 15, which may be provided on the proximal surface 10b of the collar and surround the through opening 12, as seen in FIG. 2 , for example.

[0046] The flange 1 is provided with a connecting means, said connecting means being 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 located inside the opening 11 of the flange 1.

[0047] As shown in FIG. 3, the connecting means may comprise a plurality of bumps 16 projecting radially from an inner sidewall 17 of the flange 1. The inner sidewall 17 may delimit an opening 11. The bumps 16 may be configured adjacent to an outer sidewall 24 of the tubular barrel 20, as shown, for example, in FIG. 4. The bumps 16 may be arranged at regular angles about the longitudinal axis A, preferably inside the opening 11. The connecting means comprises at least one, and preferably two, bumps 16. In the illustrated embodiment, the connecting means comprises six bumps 16. Alternatively, the connecting means may comprise three, four, five, or more bumps 16.

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

[0049] 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 a bead 23 provided at the proximal end of the end portion. As seen in FIG. 5, the proximal blocking surface 162 may be angled relative to the longitudinal axis A of the medical container 2. The proximal blocking surface 162 is disposed proximally relative to the first radial abutment surface 160.

[0050] The bump 16 may define a radial recess 164 configured to receive a corresponding protruding portion of the tubular barrel 20, such as the bead 23 of said tubular barrel 20. The recess 164 has a bottom abutment surface that may be configured to abut the tubular barrel 20 to limit pivotal movement of the tubular barrel 20 relative to the flange 1 about an axis perpendicular to the longitudinal axis A. The bottom abutment surface may define a diameter that is larger than the diameter defined by the radial abutment surface 160. The recess 164 may have a shape complementary to the shape of the outer side surface 24 of the tubular barrel 20. The recesses 164 and their bottom abutment surfaces are disposed proximally relative to the proximal blocking surface 162.

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

[0052] As shown in FIG. 4 or 6 , the abutting bumps 16 may define axial channels 18 therebetween that are configured to be filled with adhesive material 30. At least one of the axial channels 18 may have a distal open end 180 that allows entry of said adhesive material 30. The axial channels 18 may extend longitudinally along the longitudinal axis A and transversely about said longitudinal axis A. The axial channels 18 may have a cylindrical shape. The axial channels 18 are actually bounded by the sidewalls 168 of the bumps 16, the inner side surface 17 of the flange 1, and the outer surface 24 of the tubular barrel 20.

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

[0054] 3, 5, and 8, the connecting means may further comprise at least one circular channel 166 establishing fluid communication between at least two abutting axial channels 18. The circular channel 166 may interconnect all of the axial channels 18 together to allow the adhesive material 30 to flow to all spaces located between the outer 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 said 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] It should be noted that the connection means may alternatively comprise a snap fit, press fit, or threaded elements for positioning or securing the flange to the tubular barrel 20. Thus, the plastic flange 1 may be connected to the tubular barrel 20 by gluing, screwing, or attaching.

[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 a connecting means.

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

[0058] The step of providing the plastic flange 1 may include overmolding the 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 dispensing an adhesive material 30 between the flange 1 and the tubular barrel 20, or threading the flange 1 onto the outer side surface 24 of the tubular barrel 20, or 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) surrounded by a surrounding collar (10), said collar (10) providing support for a user's fingers, 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); the connecting means includes a plurality of bumps (16) that protrude radially from an inner sidewall (17) of the flange (1) and are configured to abut the outer surface (24) of the tubular barrel (20), adjacent bumps (16) of the plurality of bumps (16) define axial channels (18), the connecting means includes at least one circular channel (166) configured to establish a fluid connection between adjacent axial channels (18), and the axial channel (18) and the at least one circular channel (166) are 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. 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 connecting means comprises a distal shoulder (14) configured to receive the proximal end (20b) of the tubular barrel (20) and positioned opposite the proximal blocking surface (162).

6. The plastic flange (1) according to any one of claims 1 to 5, 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 claims 1 to 5, 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 the outer surface (24) of the barrel (20) to provide support for the user's fingers.

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

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

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