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

Abstract

The adapter (1) includes a distal portion (2) configured to receive a connector and a proximal portion (4) configured to be mounted onto a distal tip (102) of a medical container (100). The proximal portion (4) includes an inner ring (40) protruding from a lateral tubular wall (6) of the adapter (1), the inner ring (40) having an inner edge (42) delimiting an opening configured to receive the distal tip (102). The proximal portion (4) further includes a gripping member (50) made of an elastomeric material, the gripping member (50) being connected to the inner edge (42) of the inner ring (40) to be in contact with an outer surface of the distal tip (102) when the adapter (1) is mounted onto the medical container (100).

Description

Technical Field

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

[0002] In this application, the distal end of a component or device should be understood as the end furthest from the user's hand, while the proximal end should be understood as the end closest to the user's hand. Similarly, in this application, "distal direction" should be understood as the injection direction of the adapter or medical container of the present invention, and "proximal direction" should be understood as the direction opposite to the injection direction, i.e., the direction toward the user's hand holding the medical container to perform the injection operation. Background Technology

[0003] Basically, medical containers (such as syringes) are preferably made of glass because glass has a high degree of chemical passivation, low permeability and high transparency, which allows for extended storage and easy inspection.

[0004] Medical containers typically comprise a cylinder forming a reservoir for containing medical products. The cylinder has a distal end in the form of a longitudinal tip that defines an axial channel through which the medical product is dispensed from the cylinder. However, this longitudinal tip alone does not allow for parenteral administration and must include a stalled needle or adapter that allows the syringe to be connected to a connector such as a needle hub or intravenous (IV) line.

[0005] Importantly, the connection between the medical container and the adapter is strong enough to prevent accidental disengagement that occurs during the connection of the connector to the adapter or is caused by fluid pressure within the medical container and the connector.

[0006] Document WO2015 / 007650 discloses that an adapter can be secured around the longitudinal end of a syringe by snap-fit ​​or friction (e.g., by a mechanical attachment device (such as a groove or ring) defined on the longitudinal end). However, slotting the longitudinal end can make it susceptible to defects and may potentially lead to breakage. Furthermore, adapters connected around the longitudinal end by snap-fit ​​or friction can exhibit limited torque and pull-out resistance.

[0007] Therefore, an adapter is needed that improves the connection between the longitudinal end of the medical container and the container itself. More specifically, an adapter is needed that can increase torque and enhance the adapter's pull-out force. Summary of the Invention

[0008] One aspect of the present invention is an adapter for a medical container having a distal end, the adapter comprising:

[0009] The distal portion, configured as a receiving connector; and

[0010] The proximal portion is configured to attach to the distal end of the medical container.

[0011] The proximal portion includes an inner ring projecting from the transverse tubular wall of the adapter, the inner ring having an inner edge defining an opening configured to receive the distal end.

[0012] The proximal portion further includes a gripping member made of an elastomeric material, which is connected to the inner edge of the inner ring to contact the outer surface of the distal end when the adapter is mounted onto the medical container.

[0013] Therefore, the adapter of the present invention provides a stronger grip between the adapter and the distal end of the medical container. The increased frictional force applied to the distal end by the elastomeric gripping member increases the torque and the adapter pull-out force. Because of the increased adapter pull-out force, the risk of the adapter disengaging from the distal end of the medical container is reduced. The elastomeric material of the gripping member further reduces the risk of the adapter rotating around the distal end.

[0014] In one embodiment, the inner ring includes a distal abutment surface and a proximal abutment surface abutting against the gripping member to secure the elastomeric gripping member along the longitudinal direction A of the adapter.

[0015] This limits the risk of axial disassembly between the elastomer gripping member and the inner ring.

[0016] In one embodiment, the inner ring includes a protrusion or recess (preferably including a protrusion) that combines with a complementary recess or protrusion (preferably combined with a recess) disposed on the elastomeric grip member to secure the elastomeric grip member to the inner ring.

[0017] Preferably, the protrusion or recess has a dovetail shape.

[0018] This limits the risk of axial disassembly of the gripping member and protruding ring due to the increased pull force applied to the adapter.

[0019] In one embodiment, the elastomeric gripping member includes a free distal lip.

[0020] This increases the pull-out force on the adapter.

[0021] In one embodiment, the gripping member is overmolded or co-molded.

[0022] In one embodiment, the elastomeric material of the gripping member is rubber or thermoplastic elastomer (TPE).

[0023] The inner ring can be made of acrylonitrile butadiene styrene (ABS). This improves the adhesion of the elastomer gripping member to the inner ring.

[0024] In one embodiment, the gripping member is in the form of a 360° extended sleeve.

[0025] This provides a 360° grip between the adapter and the distal end of the medical container, thereby increasing torque and enhancing adapter pull-out force.

[0026] In one embodiment, the adapter includes a plurality of gripping members, each of which is in the form of a partial sleeve, such that adjacent gripping members define a gap that allows the inner edge of the inner ring to contact the outer surface of the distal end when the adapter is mounted onto a medical container.

[0027] Therefore, the inner edge of the inner ring and the elastomeric gripping member alternately contact the distal end in the circumferential direction. This prevents the adapter from tilting relative to the distal end. Tilting is the rotation of the adapter relative to the distal end about an axis orthogonal to the longitudinal axes of the adapter and the distal end.

[0028] The inner edge may include a radial protrusion that extends through the gap to radially abut the distal end. Thus, the radial protrusion extends between adjacent gripping members.

[0029] Another aspect of the invention is a medical container comprising a distal end and an adapter having the above-described features.

[0030] In one embodiment, the distal end includes a bump configured to abut against the inner edge of the inner ring at a gap defined by adjacent gripping members.

[0031] Another aspect of the invention is a method for manufacturing the adapter as described above, wherein the gripping member is overmolded or co-molded.

[0032] In one embodiment, the adapter is formed by secondary injection molding. Attached Figure Description

[0033] The invention and the advantages therefrom will become apparent from the following detailed description given with reference to the accompanying drawings:

[0034] Figure 1 This is a perspective view of an adapter according to an embodiment of the present invention.

[0035] Figure 2 This is a longitudinal cross-sectional view of an adapter and a medical container according to an embodiment of the present invention.

[0036] Figure 3 This is a perspective view of an adapter according to an embodiment of the present invention.

[0037] Figure 4 This is a top view of an adapter according to an embodiment of the present invention.

[0038] Figure 5 This is a longitudinal cross-sectional view of an adapter according to an embodiment of the present invention.

[0039] Figure 6 This is a perspective view of an elastomeric gripping member of an adapter according to an embodiment of the present invention.

[0040] Figure 7 This is a cross-sectional view of an adapter and a medical container according to an embodiment of the present invention. Detailed Implementation

[0041] Reference Figure 1 This illustrates an adapter 1 according to an embodiment of the present invention. (Refer to...) Figure 2 The adapter 1 is designed to be mounted onto the distal end 102 of the medical container 100, more precisely onto the outer surface of said distal end 102. The outer surface may be cylindrical or tapered distally. The adapter 1 allows connectors such as needle hubs or syringe caps to be connected to the medical container 100.

[0042] The adapter 1 includes a distal portion 2 and a proximal portion 4. The adapter 1 includes a tubular wall 6 that defines an inner cavity surrounding a central longitudinal axis A.

[0043] The distal portion 2 is configured as a receiving connector. For example... Figure 1 As shown, the distal portion 2 defines a distal opening leading to the interior of the lumen for receiving the connector within the adapter 1. The distal portion 2 includes, for example, a connecting device with an internal thread 60, configured to engage, for example, a wing of a needle hub or a corresponding connecting device with an external thread on the connector, to secure the connector to the adapter 1 and, consequently, to the medical container 100. The connecting device may alternatively include a bayonet element, a snap-fit ​​element, or a press-fit element.

[0044] The proximal portion 4 is configured to secure the adapter 1 to the distal end 102 of the medical container 100. The proximal portion 4 defines a proximal opening into the lumen to receive the distal end 102 of the medical container 100 within the adapter 1. The proximal portion 4 further includes an inner ring 40 and at least one gripping member 50. The inner ring 40 and the gripping member 50 are configured to secure the adapter 1 to the distal end 102 of the medical container 100.

[0045] The inner ring 40 protrudes radially inward from the tubular wall 6 of the adapter 1. The inner ring 40 is configured to support the gripping member 50. The gripping member 50 is thus connected to the rest of the adapter 1 through the inner ring 40, and preferably only through the inner ring 40.

[0046] The inner ring 40 has an inner edge 42 defining a proximal opening. The inner edge 42 is configured to hold the gripping member 50 against the outer surface of the distal end 102 when the adapter 1 is mounted onto the medical container 100. Therefore, the gripping member 50 can be pressed against the inner edge 42 by the outer surface of the distal end 102, which has a truncated conical shape. The inner edge 42 may be cylindrical and may preferably extend parallel to the longitudinal axis A. The inner edge 42 extends continuously in the circumferential direction.

[0047] The inner ring 40 preferably extends in a transverse plane orthogonal to the longitudinal axis A. Accordingly, the inner ring 40 extends orthogonally to the tubular wall 6 of the adapter 1. The inner ring 40 thus better withstands deformation and better retains the gripping member 50 against the outer surface of the distal end 102 when the adapter 1 is mounted onto the distal end 102.

[0048] The inner ring 40 of adapter 1, and more generally, the rest of adapter 1 except for the gripping member 50, can be made of plastic material, more precisely, of any rigid polymer suitable for medical use, such as high-density polyethylene (PE), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), polyoxymethylene (POM), polystyrene (PS), polybutylene terephthalate (PBT), polyamide (PA), and combinations thereof. The rest of adapter 1 includes at least the inner ring 40 and may further include a proximal portion 4, a tubular wall 6, and / or a distal portion 2. Preferably, adapter 1 (more specifically, the inner ring 40) is made of acrylonitrile butadiene styrene (ABS). Furthermore, adapter 1 may preferably be made of a light-transmitting material.

[0049] The gripping member 50 is configured to secure the adapter 1 to the distal end 102. The gripping member 50 is made of a material softer than the inner ring 40 and more generally than the rest of the adapter 1 to enhance adhesion of the proximal portion of the adapter 1 to the distal end 102. More specifically, the gripping member 50 is made of an elastomeric material such as thermoplastic elastomer or rubber. The rubber can be natural or synthetic rubber. The gripping member 50 thus forms an inner sleeve of elasticity configured to secure the adapter 1 to the medical container 100.

[0050] The gripping member 50 is supported by the inner ring 40. More specifically, the gripping member 50 covers the inner edge 42 of the inner ring 40. Therefore, the gripping member 50 is configured to extend between the inner edge 42 and the distal end 102 of the medical container 100. Figure 2 As shown, the gripping member 50 is advantageously positioned away from the tubular wall 6 or internal thread 60 of the adapter 1. The gripping member 50 can completely cover the inner edge 42.

[0051] The gripping member 50 is fixedly attached to the inner edge 42 of the inner ring 40. For example, the gripping member 50 may be overmolded or co-molded with the inner ring 40 of the adapter 1 and more generally with the rest of the adapter 1. The inner ring 40 and the gripping member 50 thus form a one-piece adapter 1 made of two different materials. A one-piece adapter 1 means that the inner ring 40 and the gripping member 50, made of different materials, are formed together as a single component that cannot be disassembled or separated without damaging the adapter 1. The gripping member 50 is thus fixed relative to the inner ring 40.

[0052] To prevent any sliding movement of the gripping member 50 relative to the inner ring 40, the inner ring 40 may include a proximal abutment surface 44a and a distal abutment surface 44b. The gripping member 50 is preferably fixed to these proximal abutment surfaces 44a and distal abutment surfaces 44b.

[0053] like Figure 2 As can be seen, the proximal abutment surface 44a and the distal abutment surface 44b can be provided on two lateral sides of the radial protrusion 44 (e.g., a circular rib), which is provided on the inner ring 40. The gripping member 50 can define a recess 54 with complementary shapes (e.g., Figure 6 As shown), the complementary recesses are configured to receive the radial protrusion 44. The proximal abutment surface 44a and / or the distal abutment surface 44b may be inclined relative to the transverse plane. Therefore, as Figure 2 and Figure 5 As shown, the radial protrusion 44 and the complementary-shaped recess 54 preferably form a dovetail joint to reduce the risk of the gripping member 50 being removed. In an alternative embodiment not shown, the recess 54 may be provided on the inner ring 40, for example in the form of a circular groove, while the radial protrusion 44 may be provided on the gripping member 50. In this case, the proximal abutment surface 44a and the distal abutment surface 44b may be provided on the two lateral sides of the circular groove of the inner ring 40.

[0054] The inner ring 40 may further include a radial bottom shoulder 46a and / or a radial top shoulder 46b. The bottom shoulder 46a and the top shoulder 46b are arranged proximal and distal, respectively, relative to the inner edge 42. The gripping member 50 is advantageously also secured to the radial bottom shoulder 46a and / or the radial top shoulder 46b.

[0055] It should also be noted that the gripping member 50 may have a bottom proximal side 57a that does not extend beyond the bottom proximal side 47a of the inner ring 40. The gripping member 50 may also have a top distal side 57b that does not extend beyond the top distal side 47b of the inner ring 40. Preferably, the bottom proximal side 57a of the gripping member 50 is flush with the bottom proximal side 47a of the inner ring 40, and / or the top distal side 57b of the gripping member 50 is flush with the top distal side 47b of the inner ring 40.

[0056] like Figure 2 As shown, the gripping member 50 advantageously includes a free distal lip 52 that can extend parallel to the longitudinal axis A. The free distal lip 52 is configured to prevent any tilting movement of the adapter 1 relative to the distal end 102 when the adapter 1 is mounted onto the distal end 102, i.e., any rotation of the adapter 1 about a transverse axis. The transverse axis is an axis orthogonal to the longitudinal axis A. The free distal lip 52 extends distally from a base portion 58 of the gripping member 50, which is secured to the inner ring 40. The free distal lip 52 can extend distally beyond the proximal end 60a of the internal thread 60. Figure 2 As shown, the free distal lip 52 advantageously tapers distally into a cone shape.

[0057] according to Figure 1 and Figure 2 The adapter 1 includes a single gripping member 50. The gripping member 50 may be in the form of a 360° sleeve. In this embodiment, only the gripping member 50 of the adapter 1 contacts the distal end 102.

[0058] Alternatively, such as Figures 3 to 6 As shown, the gripping member 50 can be in the form of a discontinuous circumferential sleeve. The adapter 1 actually includes multiple gripping members 50, each of which is in the form of a partial sleeve or a cylindrical body. For example... Figures 3 to 6 As shown, adapter 1 may include at least three gripping members 50 spaced apart from each other. These gripping members 50 may be regularly distributed along a circumferential direction. Figure 3 and Figure 4 As can be seen, the gripping members 50 are separated from each other by a circumferential gap 48, thereby allowing the inner edge 42 of the inner ring 40 to contact the distal end 102 of the medical container 100 when the adapter 1 is mounted onto the distal end 102 of the medical container 100. As a result, the inner edge 42 alternately contacts the distal end 102 with the gripping member 50 in the circumferential direction. This helps prevent tilting movement of the adapter 1 relative to the distal end 102. Preferably, the gripping member 50 is longer than the gap 48 in the circumferential direction. Although in Figure 3-6Not shown, but the inner edge 42 may include radially projecting portions extending in the gap 48 (i.e., between adjacent gripping members 50) to contact the outer surface of the distal end 102. Alternatively or complementaryly, the distal end 102 includes radial bumps received in the gap defined by the gripping members 50, these radial bumps contacting the inner edge 42. This allows for a rigid connection between the adapter 1 and the distal end 102.

[0059] The present invention also relates to, for example Figure 2 or Figure 7 The medical container 100 is shown. The medical container 100 may be a syringe, such as a pre-fillable syringe or a pre-filled syringe. The medical container 100 includes a tubular tube 104 defining a reservoir for a medical product. The distal end 102 may be cylindrical or tapered distally. The tubular tube 104 and the distal end 102 are preferably made of glass. The medical container 100 further includes the aforementioned adapter 1, which is secured to the distal end 102 by a gripping member 50 attached to the outer surface of the distal end 102. To improve the interference fit between the adapter 1 and the gripping member 50, the inner diameter of the gripping member 50 may be equal to or smaller than the outer diameter of the distal end 102.

[0060] like Figure 7 As can be seen, the medical container 100 may include a cap 106 having external threads 108 configured to engage the internal threads 60 of the adapter 1 to secure the cap to the adapter 1. The cap 106 is configured to be secured to the adapter 1 without its external threads abutting against the gripping member 50, and more specifically, without abutting against the free distal lip 52 of the gripping member 50. Therefore, the cap 106 may include a connecting portion whose length is less than the distance between the distal end of the adapter 1 and the gripping member 50. The connecting portion extends from a proximal abutment surface 110 configured to abut against the distal end of the adapter 1 to the distal end of the cap's external threads 108. The cap 106 may include an inner cap 112 to sealably close the distal end 102, the inner cap being made of a material softer than the cap 106.

[0061] The present invention also relates to a method for manufacturing the adapter 1 described above. The method may include overmolding or co-injection molding of the gripping member 50 and the remainder of the adapter 1. Preferably, the adapter 1 is formed using a two-stage injection molding process.

Claims

1. An adapter (1) for a medical container (100), the medical container having a distal end (102), the adapter (1) comprising: The distal portion (2) is configured as a receiving connector and includes an internal thread (60). and The proximal portion (4) is configured to be mounted on the distal end (102) of the medical container (100). The proximal portion (4) includes an inner ring (40) protruding from the transverse tubular wall (6) of the adapter (1), the inner ring (40) having an inner edge (42) defining an opening configured to receive the distal end (102), and The proximal portion (4) further includes an elastomeric gripping member (50) made of an elastomeric material, the elastomeric gripping member (50) being connected to the inner edge (42) of the inner ring (40) to contact the outer surface of the distal end (102) when the adapter (1) is mounted on the medical container (100). The inner ring (40) includes a protrusion (44) or a recess, which combines with a complementary recess (54) or protrusion disposed on the elastomeric gripping member (50) to secure the elastomeric gripping member (50) to the inner ring (40). The elastomeric gripping member (50) includes a free distal lip (52) that extends distally beyond the proximal end (60a) of the internal thread (60).

2. The adapter (1) according to claim 1, wherein, The inner ring (40) includes the protrusion (44), which is combined with the complementary recess (54) disposed on the elastomeric grip member (50).

3. The adapter (1) according to claim 1 or 2, wherein, The inner ring (40) includes a distal abutment surface and a proximal abutment surface (46a, 46b) abutting against the elastomeric grip member (50) to secure the elastomeric grip member (50) along the longitudinal direction (A) of the adapter (1).

4. The adapter (1) according to claim 1, wherein, The protrusion (44) or recess has a swallowtail shape.

5. The adapter (1) according to claim 1 or 2, wherein, The elastomeric gripping member (50) is overmolded or co-molded.

6. The adapter (1) according to claim 1 or 2, wherein, The elastomeric material of the elastomeric gripping member (50) is rubber or thermoplastic elastomer.

7. The adapter (1) according to claim 1 or 2, wherein, The elastomeric gripping member (50) is in the form of a 360° extended sleeve.

8. The adapter (1) according to claim 1 or 2, wherein, The adapter (1) includes a plurality of elastomeric grip members (50), each of which is in the form of a partial sleeve, wherein adjacent elastomeric grip members (50) define a gap that allows the inner edge (42) of the inner ring (40) to contact the outer surface of the distal end (102) when the adapter (1) is mounted on the medical container (100).

9. A medical container (100) comprising a distal end (102) and an adapter (1) according to any one of claims 1 to 7.

10. A medical container (100) comprising a distal end (102) and an adapter (1) according to claim 8, wherein, The distal end (102) includes a bump configured to abut against the inner edge (42) of the inner ring (40) at a gap defined by adjacent elastomeric gripping members (50).

11. A method for manufacturing an adapter (1) according to any one of claims 1 to 8, wherein, The elastomeric gripping member (50) is overmolded or co-molded.

12. The method according to claim 11, wherein, The adapter (1) is formed by secondary injection molding.

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