Plastic flange for medical container, medical container including the plastic flange, and method for manufacturing the medical container

Abstract

A plastic flange (1) for a medical container (2), the plastic flange (1) defining an opening (11) surrounded by a peripheral collar (10) providing support for a user's fingers, wherein the flange (1) comprises connection means for connecting the flange (1) to an outer surface (24) of a tubular barrel (20) of the medical container (2), and wherein the flange (1) further comprises a remotely readable electronic component (3) for remotely identifying the medical container (2), the remotely readable electronic component (3) being embedded in the plastic flange (1).

Description

Technical Field

[0001] The present invention relates to a plastic flange for a medical container, a medical container comprising the plastic flange, 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 relative 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, such as for injection operation.

[0003] Injection devices, such as prefillable or prefilled syringes, typically comprise a hollow body or barrel forming a container for a medical product. The body comprises a distal end, typically provided with a needle, and a proximal end, provided with a flange, which allows a user to place his or her finger in order to apply proximal pressure on the flange.

[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 said 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, for example during handling or use of the container. Moreover, the unique identification codes cover a portion of the container so that they may have an impact on the customer's visual inspection process.

[0006] From document US8872870 a method for glass marking is further known, in which a readable marking array can be formed on the outer surface of a glass tube by 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] From document WO2014114938A2, a radio frequency identification tag for positioning inside a tubular bottom portion of a self-contained cryogenic vial is further known. Document US2011199187A1 discloses a radio frequency identification tag inserted into a groove at the bottom of a vial. Document US2010102967A1 discloses a container lid with a removable radio frequency identification tag. From document US2008149584A1, a product packaging is known, the product packaging comprising a cap on a transparent bottle, wherein the cap comprises a radio frequency identification chip and an antenna. Document WO2008057150A1 further discloses a container, the container comprising a radio frequency identification insert with a disabling feature. Summary of the invention

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

[0009] One aspect of the present invention is to provide a plastic flange for a medical container, the plastic flange defining an opening, the opening being surrounded by a peripheral collar, the collar providing support for a user's finger, wherein the flange includes a connection means for connecting the flange to an outer surface of a tubular barrel of the medical container, and wherein the flange further includes a remotely readable electronic component for remotely identifying the medical container, the remotely readable electronic component being at least partially embedded in the plastic flange.

[0010] The so-called electronic components embedded in the plastic flange should be understood as the plastic flange completely or at least partially enveloping the electronic components, thereby protecting the electronic components from the external environment and thus preventing them from being damaged or removed.

[0011] By remotely readable electronic means for identifying the medical container is meant that the electronic means comprises electronically stored information which can be remotely read by a reading machine such as an RFID reader, thereby enabling identification of the medical container to which the flange of the invention is to be assembled.

[0012] Therefore, the plastic flange of the present invention allows individual traceability of each medical container from 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 plastic flange, 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 flange and has no effect on the customer's visual inspection process. It is also conceivable that the electronic component allows the medical container to be identified remotely and therefore easily. The electronic component does not require direct visual observation from a reading machine, so reading can be performed at any time without unpacking the medical container. Moreover, the electronic component is integrated inside the flange, so advantageously, the medical container barrel has no additional thickness, and therefore does not need to change the packaging or storage of the medical container. Due to the connecting device, the flange of the present invention can be advantageously mounted on a glass medical container so that the flange of the present invention allows reliable and easy identification of glass medical containers without the disadvantages of the prior art.

[0013] In a preferred embodiment, the remotely readable electronic component is selected from a radio frequency identification tag, an ultra-wideband real-time locating system (RTLS), a wireless RTLS and an infrared RTLS. Advantageously, the remotely readable electronic component is a radio frequency identification tag comprising a radio frequency identification chip and a radio frequency identification antenna. Preferably, the radio frequency identification antenna extends around the opening.

[0014] Preferably, the plastic flange is connected to the tubular barrel by gluing, screwing or fitting.

[0015] Preferably, the connection means comprises a plurality of projections radially projecting from an inner side wall of the flange and configured to abut against an outer surface of the tubular barrel.

[0016] This allows maintaining the flange perpendicular to the tubular barrel.

[0017] Preferably, the plurality of tabs comprises a proximal stop surface configured to abut against a rim of the tubular barrel.

[0018] This allows preventing the barrel from moving in the distal direction from the flange when the medical device is used to inject a medical or pharmaceutical composition and thereby maintaining the barrel fixed to the flange.

[0019] Preferably, the connection means comprises a distal shoulder configured to receive a proximal end of the tubular barrel and arranged opposite the proximal blocking surface.

[0020] The tubular barrel is thus blocked axially relative to the flange.

[0021] Preferably, adjacent ones of the plurality of projections define an axial channel configured to be filled with glue material.

[0022] This allows adding glue material between the flange and the tubular barrel in order to prevent any rotational movement of the flange relative to the barrel.

[0023] Preferably, the connection means comprises at least one circular channel configured to establish a fluid connection between adjacent axial channels.

[0024] This allows glue material to flow into all filling chambers simultaneously so that glue dispensing is performed in a single operation.

[0025] The circular channel may extend between the distal shoulder and the plurality of tabs.

[0026] The RFID tag may advantageously be overmoulded in the plastic flange.

[0027] Preferably, the remotely readable electronic component is fully overmoulded in the plastic flange.Alternatively, the remotely readable electronic component is embedded between the plastic flange and the glue material.

[0028] This leaves the flange dimensions unchanged relative to standard flange dimensions, avoiding investment costs.

[0029] The RFID tag can be molded in a two-shot injection molding process. More specifically, the RFID tag is positioned in the mold as an insert. The first portion of the flange is formed by a first injection of plastic material and partially covers the RFID tag. Then, a second portion of the flange is formed by a second injection of plastic material, and the second portion and the first portion completely encapsulate the RFID tag. The plastic material used to form the second portion can be the same plastic material as the first portion or a different plastic material.

[0030] The RFID tag may be disposed substantially in the middle of the plastic flange.

[0031] Another aspect of the present invention is to provide a medical container, comprising:

[0032] A tubular barrel for receiving medical products,

[0033] As described above, the plastic flange protrudes from the outer surface of the tubular barrel to provide support for the user's fingers.

[0034] Preferably, the tubular barrel is made of glass material.

[0035] 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:

[0036] - providing a plastic flange as described above,

[0037] - providing said tubular barrel,

[0038] - Connecting the plastic flange to the tubular barrel by means of flange connection means.

[0039] Preferably, the method comprises at least one step selected from the following steps:

[0040] - distributing glue material between said plastic flange and said tubular barrel;

[0041] - threading the plastic flange onto the outer surface of the tubular barrel; or

[0042] - Snap-fitting the plastic flange onto the outer surface of the tubular barrel. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0044] Figure 1 is a perspective view of a medical container with a flange according to the present invention,

[0045] Figure 2 is a side cross-sectional view of a flange according to the invention, the flange receiving the barrel of a medical container,

[0046] Figure 3 is a perspective view of a flange according to the present invention,

[0047] Figure 4 is a partial perspective view of a flange according to the invention, which flange receives a barrel of a medical container,

[0048] Figure 5 is a partial side cross-sectional view of a flange according to the present invention, the flange receiving the barrel of a medical container,

[0049] Figure 6 is a partial perspective cross-sectional view of a flange according to the invention, the flange receiving the barrel of a medical container,

[0050] Figure 7 is a partial three-dimensional cross-sectional view of a medical container with a flange according to the present invention,

[0051] Figure 8 It is a partial side cross-sectional view of a medical container with a flange according to the present invention. DETAILED DESCRIPTION

[0052] refer to Figure 1 , 2 3, showing a plastic flange 1 according to the present invention. Figure 1 and 2 As shown in FIG. 1 , the plastic flange 1 is designed to be mounted on 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. Figure 1 As shown in , the tubular barrel 20 may have a distal end 20a including a preferably tapered distal tip 21 defining an axial passage 22 in fluid communication with the reservoir. The distal tip 21 may allow for the installation of an adapter or its needle. Figure 2 As shown in , the tubular barrel 20 includes a proximal end 20b, which defines a hole 25 for receiving a plunger rod (not shown). The proximal end 20b may have a rounded rim 23 protruding from the outer surface 24 of the tubular barrel 20. It should be noted that the plastic flange 1 is made of a plastic material, preferably a hard 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 plastic flange 1 may include two or more different plastic materials.

[0053] For example, reference Figure 1 , the plastic flange 1 comprises a remotely readable electronic component 3 for remotely identifying the medical container 2 by a remote reading machine. Advantageously, the remotely readable electronic component 3 is a radio frequency identification tag, preferably a passive radio frequency identification tag, for identifying the medical container 2. The radio frequency identification tag may be a passive radio frequency identification tag. The radio frequency identification tag may be read by an radio frequency identification reader without directly observing the plastic flange 1. The radio frequency identification tag is located within the collar 10 of the plastic flange 1. The radio frequency identification tag may be arranged roughly in the middle of the width of the plastic flange 1. The radio frequency identification tag comprises an radio frequency identification chip 31 and an radio frequency identification antenna 32. The radio frequency identification chip 31 may include at least a storage unit for storing a unique device identification (UDI), thereby allowing identification of the medical device. The radio frequency identification antenna 32 may extend completely around the opening 11 of the plastic flange 1, as shown in FIG. Figure 1 as shown in .

[0054] The RFID tag may be partially or completely 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 completely enclosed in the only collar 10 of the plastic flange 1 or completely enclosed by the collar 10 plus the adhesive material 30 that fixes the plastic flange 1 to the tubular barrel 20.

[0055] The RFID tag may advantageously be overmoulded within the plastic flange 1 .

[0056] For example, the RFID tag is molded in a two-shot injection molding process. More specifically, the RFID tag is positioned in the mold as an insert. A first portion of the plastic flange is formed by a first injection of plastic material. Then, a second portion of the flange is formed by a second injection of plastic material, the second portion encapsulating the RFID tag with the first portion, and the plastic material forming the second portion may be the same plastic material as the first portion or a different plastic material.

[0057] Preferably, the RFID tag is completely overmolded in the plastic flange 1. Alternatively, the RFID tag is partially overmolded in 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 in the plastic flange 1 by adding a glue material 30 that completely covers the RFID tag, the glue material 30 thus being in direct contact with the RFID tag.

[0058] like Figure 3 As shown in FIG. 1 , the plastic flange 1 includes a collar 10 defining a central opening 11. The collar 10 has a proximal side 10b and an opposite distal side 10a, such as Figure 2 . The distal side 10a is designed to provide support for the user's fingers when the medical container 2 is used, for example, for an injection operation. The collar 10 may have a peripheral edge formed by two parallel edges 10c, which are connected by two curved edges 10d. In another embodiment (not shown), the peripheral edge 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 further detail below. As Figure 2 As shown in , the opening 11 may be centered around the longitudinal axis A of the medical container 2 .

[0059] The plastic flange 1 may further define a through hole 12 configured to be superimposed to the hole 25 of the tubular barrel 20 so as to allow the plunger rod to enter the reservoir. The through hole 12 and the opening 11 of the plastic flange may be coaxial. The through hole 12 may be centered around the longitudinal axis A of the medical container 2. Figure 3 As shown in , the through hole 12 may have a smaller diameter than the opening 11 of the flange 1, thereby defining a distal shoulder 14 separating the opening 11 of the plastic flange 1 and the through hole 12. The through hole 12 is located proximally relative to the opening 11 of the plastic flange. The plastic flange 1 may have a proximal inclined edge 15, which may be provided on the proximal side 10b of the collar and surround the through hole 12, for example, as shown in Figure 2 as shown in .

[0060] The plastic flange 1 comprises connection means configured to connect the plastic flange 1 to the outer surface of the tubular barrel 20 of the medical container 2. The connection means are preferably located inside the opening 11 of the plastic flange 1.

[0061] like Figure 3 As shown in FIG. 1 , the connection device may include a plurality of protrusions 16 radially protruding from an inner surface 17 of the plastic flange 1. The inner surface 17 may define the opening 11. The protrusions 16 are configured to abut against an outer surface 24 of the tubular barrel 20, for example, as Figure 4 The projections 16 can be regularly distributed angularly around the longitudinal axis A and are preferably located inside the opening 11. The connection device comprises at least one, preferably two projections 16. In the illustrated embodiment, the connection device comprises six projections 16. In addition, they can include three, four, five or more projections 16.

[0062] like Figure 5 As shown in , the projection 16 can include a radial abutment surface 160, which is configured to abut against the outer surface 24 of the tubular barrel 20. The diameter defining the radial abutment surface 160 can be smaller than the outer diameter of the tubular barrel 20, so that the projection 16 is configured to apply radial pressure to the outer surface 24 of the tubular barrel 20. For this reason, the flange or projection 16 can be made of an elastic material. The radial abutment surface 160 can be flat or can preferably have a shape complementary to the shape of the outer surface 24 of the tubular barrel 20, such as a cylindrical shape.

[0063] Still reference Figure 5 The protrusion 16 may include a proximal blocking surface 162 configured to block distal movement of the tubular barrel 20 relative to the plastic flange. For example, the proximal blocking surface 162 abuts against a rim 23 disposed at the proximal end of the tubular barrel. Figure 5 As shown in FIG, the proximal blocking surface 162 may be inclined relative to the longitudinal axis A of the medical container 2. The proximal blocking surface 162 is arranged proximally relative to the first radial abutment surface 160.

[0064] The projection 16 may define a radial groove 164 configured to receive a corresponding protruding portion of the tubular barrel 20, such as the rim 23 of the tubular barrel 20. The groove 164 has a bottom abutment surface that may be configured to abut against the tubular barrel 20 so as to limit the pivotal movement of the tubular barrel 20 relative to the plastic flange 1 about an axis perpendicular to the longitudinal axis A. The bottom abutment surface may define a diameter greater than the diameter defined by the radial abutment surface 160 described above. The groove 164 may have a shape that is complementary to the shape of the outer surface 24 of the tubular barrel 20. The grooves 164 and their bottom abutment surfaces are located proximally relative to the proximal blocking surface 162.

[0065] like Figure 5 As shown in FIG, the proximal end 20 b of the tubular barrel 20 abuts the distal shoulder 14 so that the distal shoulder 14 blocks the proximal movement of the tubular barrel 20 relative to the plastic flange 1. The distal shoulder 14 may be flat and preferably perpendicular to the longitudinal axis A. The distal shoulder 14 faces the proximal blocking surface 162 of the projection 16.

[0066] like Figure 4 As shown in Figure 6, adjacent protrusions 16 can define an axial channel 18 between them, which is configured to be filled with glue material 30. At least one of the axial channels 18 can have a distal open end 180 that allows the glue material 30 to enter. The axial channel 18 can extend longitudinally along the longitudinal axis A and extend laterally around the longitudinal axis A. The axial channel 18 can have a cylindrical shape. The axial channel 18 is actually defined by the side wall 168 of the protrusion 16, the inner side surface 17 of the plastic flange 1, and the outer surface 24 of the tubular barrel 20.

[0067] The glue material 30 may be selected between a hot melt adhesive and a glue, such as an acrylate based glue.

[0068] like Figure 3 , 5 As shown in FIGS. 1 and 8 , the connection device may further include at least one circular channel 166 that establishes fluid communication between at least two adjacent axial channels 18. The circular channel 166 may interconnect all of the axial channels 18 together so as to allow the adhesive material 30 to flow into all spaces between the outer surface 24 of the tubular barrel 20 and the plastic flange 1. The circular channel 166 may be formed by a groove arranged between the distal shoulder 14 and the bump 16, and may be located proximally relative to the groove 164 of the bump 16. For example, the circular channel 166 is a groove defined in the inner surface 17 of the bump 16 or the distal shoulder 14 or the plastic flange 1.

[0069] It should be noted that the connection means may alternatively comprise snap-fit, press-fit or threaded elements in order to position or secure the plastic flange to the tubular barrel 20. The plastic flange 1 may thus be connected to the tubular barrel 20 by gluing, threading or fitting.

[0070] The present invention also relates to a medical container 2, which comprises a tubular barrel 20 for receiving medical products 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 glass material, and the tubular barrel 20 and the plastic flange 1 are fixed together by a connecting device.

[0071] The invention also relates to a method for manufacturing said medical container 2, wherein said method comprises the steps of providing a plastic flange 1 as described above, said plastic flange comprising 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.

[0072] The step of providing the plastic flange 1 may comprise overmoulding the remotely readable electronic component 3 , for example in a two-shot injection moulding process.

[0073] The step of connecting the plastic flange 1 to the tubular barrel 20 may include dispensing glue material 30 between the plastic flange 1 and the tubular barrel 20, or threading the plastic flange 1 onto the outer surface 24 of the tubular barrel 20, or snap-fitting the plastic flange 1 onto the outer surface 24 of the tubular barrel 20.

Claims

1. A plastic flange (1) for a syringe (2), the plastic flange (1) defining an opening (11), the opening (11) being surrounded by a peripheral collar (10), the collar (10) providing support for a user's finger, wherein the plastic flange (1) comprises: a through hole (12) configured to allow a plunger rod to enter a reservoir defined by a tubular barrel (20) of the syringe (2); and connection means for connecting the plastic flange (1) to the outer surface (24) of the tubular barrel (20) of the syringe (2), and wherein the plastic flange (1) further comprises a remotely readable electronic component (3) for remotely identifying the syringe (2), the remotely readable electronic component (3) being at least partially embedded in the plastic flange (1); wherein the connection device comprises a plurality of protrusions (16) radially protruding from an inner side wall (17) of the flange (1) and configured to abut against an outer surface (24) of the tubular barrel (20), wherein adjacent protrusions (16) of the plurality of protrusions (16) define an axial channel (18) configured to be filled with a glue material (30), wherein the remotely readable electronic component (3) is embedded between the plastic flange (1) and the glue material (30); The connection device comprises at least one circular channel (166), and the at least one circular channel is configured to establish a fluid connection between adjacent axial channels (18).

2. The plastic flange (1) according to claim 1, characterized in that The remotely readable electronic component (3) is a radio frequency identification tag comprising a radio frequency identification chip (31) and a radio frequency identification antenna (32), wherein the radio frequency identification antenna (32) extends around the opening (11).

3. The plastic flange (1) according to claim 1, characterized in that: The plurality of projections (16) include a proximal stop surface (162) configured to abut against a rim (23) of the tubular barrel (20).

4. The plastic flange (1) according to claim 3, characterized in that The connection device comprises a distal shoulder (14) configured to receive a proximal end (20b) of the tubular barrel (20) and arranged opposite the proximal blocking surface (162).

5. A syringe (2), comprising: A tubular cartridge (20) for receiving a medical product, The plastic flange (1) according to any one of claims 1 to 4, the plastic flange (1) protruding from the outer surface (24) of the tubular barrel (20) to provide support for the user's fingers.

6. The syringe (2) according to claim 5, characterized in that The tubular barrel (20) is made of glass material.

7. A method for manufacturing a syringe (2) according to any one of claims 5 to 6, the method comprising the following steps: A plastic flange (1) according to any one of claims 1 to 4 is provided, Providing the tubular barrel (20), The plastic flange (1) is connected to the tubular barrel (20) by means of the connecting means of the plastic flange.

8. The method according to claim 7, characterized in that The method comprises at least one step selected from the following steps: - distributing glue material (30) between the plastic flange (1) and the tubular barrel (20); - screwing the plastic flange (1) onto the outer surface (24) of the tubular barrel (20); or - Snap-fitting the plastic flange (1) onto the outer surface (24) of the tubular barrel (20).

Images