Adapter for attachment to a medical container, medical container including the adapter, and method for manufacturing the adapter - Patents.com

Abstract

The adapter (1) comprises a distal portion (2) configured to receive a connector and a proximal portion (4) configured to be attached to the distal tip (102) of the medical container (100). The proximal portion (4) includes an inner ring (40) protruding from the tubular sidewall (6) of the adapter (1), the inner ring (40) having an inner edge (42) that defines an opening configured to receive the distal tip (102). The proximal portion (4) further includes a retention member (50) made of an elastomeric material, the retention member (50) connected to the inner edge (42) of the inner ring (40) for contacting the outer surface of the distal tip (102) when the adapter (1) is attached to the medical container (100).

Description

[Technical field]

[0001] The present invention relates to an adapter for attachment to a medical container, a medical container including said adapter, and a method for manufacturing said adapter. [Background technology]

[0002] In this application, the distal end of a component or device is understood to mean the end furthest from the user's hand, and the proximal end is understood to mean the end closest to the user's hand. Similarly, in this application, a "distal direction" is understood to mean, with respect to an adapter or medical container of the present invention, the direction of injection, and a "proximal direction" is 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 an injection operation.

[0003] Essentially, medical containers, such as syringes, are preferably made of glass due to its high chemical passivation, low gas permeability and high transparency, which allows for long-term storage and easy inspection.

[0004] A medical container typically comprises a body forming a holding chamber for containing a medical product. The body has a distal end in the form of a longitudinal tip defining an axial passageway through which the medical product is discharged from the body. However, this longitudinal tip does not itself allow for parenteral administration, but must include either a retaining needle or an adapter that allows for connection of a syringe to a connector such as a needle hub or intravenous (IV) line.

[0005] It is important that the connection between the medical container and the adapter be strong enough to prevent accidental disengagement while the connector is connected to the adapter or caused by fluid pressure within the medical container and connector.

[0006] The '1999 patent discloses that an adapter may be secured around the longitudinal tip of a syringe by a snap-fit ​​attachment or frictional forces, with mechanical attachment means defined in the longitudinal tip, such as a groove or ring. However, the incorporation of a groove in the longitudinal tip may make the longitudinal tip susceptible to scratches, which may lead to tip breakage. Furthermore, an adapter connected around the longitudinal tip by a snap-fit ​​attachment or frictional forces may have both limited torque and limited resistance to pull-out forces.

[0007] Thus, there is a need for an adapter that can improve the connection between a longitudinal end of a medical container and the container, and more specifically, there is a need for an adapter that can increase the torque and pull-out force of the adapter. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] International Publication No. 2015 / 007650 Summary of the Invention

[0009] An aspect of the present invention is an adaptor for a medical container having a distal tip, the adaptor comprising: a distal portion configured to receive a connector; a proximal portion configured to be attached to the distal tip of the medical container; the proximal portion includes an inner ring protruding from a tubular sidewall of the adapter, the inner ring having an inner edge defining an opening configured to receive the distal tip; The proximal portion further includes a retaining member made of an elastomeric material, the retaining member connected to the inner edge of the inner ring such that the retaining member contacts an outer surface of the distal tip when the adapter is attached to the medical container.

[0010] The adapter of the present invention thus provides a higher retention force between the adapter and the distal tip of a medical container. The increased frictional force that the elastomeric retention member exerts on the distal tip improves torque and increases the adapter pull-out force. Because the adapter pull-out force is increased, there is less risk of the adapter becoming dislodged from the distal tip of the medical container. The elastomeric material of the retention member further reduces the risk of the adapter rotating around the distal tip.

[0011] In one embodiment, the inner ring comprises distal and proximal abutment surfaces that abut against the elastomeric retaining member for securing said elastomeric retaining member in the longitudinal direction A of the adapter.

[0012] This limits the risk of axial disengagement between the elastomeric retaining member and the inner ring.

[0013] In one embodiment, the inner ring includes a protrusion or recess, preferably a protrusion, that engages with a complementary shaped recess or protrusion, preferably a recess, on the elastomeric retaining member to secure said elastomeric retaining member to the inner ring.

[0014] Preferably, said projection or recess has a dovetail shape.

[0015] This makes it possible to limit the risk of the retaining member and the protruding ring coming axially apart due to an increase in the pulling force acting on the adapter.

[0016] In one embodiment, the elastomeric retention member includes a free distal edge.

[0017] This allows the adapter to be pulled out with a large force.

[0018] In one embodiment, the retention member is overmolded or co-injection molded.

[0019] In one embodiment, the elastomeric material of the retention member is rubber or a thermoplastic elastomer (TPE).

[0020] The inner ring may be made of acrylonitrile butadiene styrene (ABS), which improves attachment of the elastomeric retaining member to the inner ring.

[0021] In one embodiment, the retaining member is in the form of a sleeve that extends 360 degrees.

[0022] This provides a 360° range of retention between the adapter and the distal tip of the medical container, thereby increasing the torque and therefore the pull-out force of the adapter.

[0023] In one embodiment, the adapter includes several retention members, each of which is in the form of a partial sleeve, whereby adjacent retention members define a gap that allows an inner edge of the inner ring to contact an outer surface of the distal tip when the adapter is attached to the medical container.

[0024] Thus, the inner edge of the inner ring and the elastomeric retention member alternately contact the distal tip in the circumferential direction, thereby preventing tilting movement of the adapter relative to the distal tip, which is rotation of the adapter relative to the distal tip about an axis perpendicular to the longitudinal axis of the adapter and the distal tip.

[0025] The inner edge may include a radial projection extending through the gap to radially abut the distal tip, such that the radial projection extends between adjacent retention members.

[0026] Another aspect of the invention is a medical container that includes a distal tip and an adapter having the features described above.

[0027] In one embodiment, the distal tip includes a ridge configured to abut the inner edge of the inner ring at a gap bounded by adjacent retention members.

[0028] Another aspect of the invention is a method for manufacturing the adapter described above, wherein the retention member is overmolded or co-injection molded.

[0029] In one embodiment, the adapter is formed from a two-shot injection mold. [Brief description of the drawings]

[0030] The invention and the advantages arising therefrom will become apparent from the detailed description given below with reference to the accompanying drawings, in which: [Figure 1] FIG. 2 is a perspective view of an adapter according to one embodiment of the present invention. [Diagram 2] FIG. 2 is a longitudinal cross-sectional view of a medical container according to one embodiment of the present invention. [Diagram 3] FIG. 3 is a perspective view of an adapter according to one embodiment of the present invention. [Figure 4] FIG. 4 is a top view of an adapter according to one embodiment of the present invention. [Diagram 5] FIG. 5 is a longitudinal cross-sectional view of an adapter according to one embodiment of the present invention. [Figure 6] FIG. 6 is a perspective view of an elastomeric retention member of an adapter according to one embodiment of the present invention. [Figure 7] FIG. 7 is a cross-sectional view of an adapter and medical container according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] With reference to Fig. 1, an adapter 1 according to an embodiment of the present invention is shown. With reference to Fig. 2, the adapter 1 is intended to be attached to the distal tip 102 of a medical container 100, more precisely to the outer surface of said distal tip 102. Said outer surface can be cylindrical or tapered distally. The adapter 1 allows to connect a connector, such as a needle hub or a syringe cap, to the medical container 100.

[0032] The adapter 1 includes a distal portion 2 and a proximal portion 4. The adapter 1 includes a tubular wall 6 that defines an interior cavity about a central longitudinal axis A.

[0033] The distal portion 2 is configured to receive a connector. As shown in FIG. 1, the distal portion 2 defines a distal opening leading to an interior of an internal cavity to receive a connector inside the adapter 1. The distal portion 2 includes a connecting means, such as internal threads 60, configured to engage with a corresponding connecting means, such as external threads on the wings of a needle hub or the connector, to secure the connector to the adapter 1 and thus to the medical container 100. The connecting means may alternatively include a bayonet element, a clasp element, or a snap-fit ​​element.

[0034] The proximal portion 4 is configured to secure the adapter 1 to the distal tip 102 of the medical container 100. The proximal portion 4 defines a proximal opening to an inner cavity to receive the distal tip 102 of the medical container 100 inside the adapter 1. The proximal portion 4 further comprises an inner ring 40 and at least one retaining member 50. The inner ring 40 and the retaining member 50 are configured to secure the adapter 1 to the distal tip 102 of the medical container 100.

[0035] The inner ring 40 projects inwardly and radially from the tubular wall 6 of the adapter 1. The inner ring 40 is configured to support a retaining member 50. In this manner, the retaining member 50 is connected to the remainder of the adapter 1 by the inner ring 40, and preferably only by the inner ring 40.

[0036] The inner ring 40 has an inner edge 42 that defines a proximal opening. The inner edge 42 is configured to maintain the retaining member 50 against an outer surface of the distal tip 102 when the adapter 1 is attached to the medical container 100. As a result, the retaining member 50 may be compressed against the inner edge 42 by the distal tip 102, which has a frustoconical shape. The inner edge 42 may have a cylindrical shape and preferably extend parallel to the longitudinal axis A. The inner edge 42 extends continuously in the circumferential direction.

[0037] The inner ring 40 preferably extends in a transverse plane perpendicular to the longitudinal axis A. Thus, the inner ring 40 extends perpendicular to the tubular wall 6 of the adapter 1. As a result, the inner ring 40 is better able to withstand deformation when the adapter 1 is attached to the distal tip 102 and is able to more effectively maintain the retention member 50 against the outer surface of the distal tip 102.

[0038] The inner ring 40, and more generally the remaining part of the adapter 1, except the retaining member 50, can be made of a plastic material, more precisely any rigid polymer compatible with medical applications, such as high density polyethylene (PE), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), polyoxymethylene (POM), polystyrene (PS), polybutylene terephthalate (PBT), polyamide (PA), and combinations thereof. Said remaining part of the adapter 1 includes at least the inner ring 40, and may further include the proximal portion 4, the tubular wall 6, and / or the distal portion 2. Preferably, the adapter 1, and more specifically the inner ring 40, is made of acrylonitrile butadiene styrene (ABS). Furthermore, the adapter 1 can preferably be of an optically transmitting material.

[0039] The retaining member 50 is configured to secure the adapter 1 to the distal tip 102. The retaining member 50 is made of a material that is softer than the inner ring 40, and more generally softer than the rest of the adapter 1, to better adhere the proximal portion of the adapter 1 to the distal tip 102. More specifically, the retaining member 50 is made of an elastomeric material, such as a thermoplastic elastomer or rubber. The rubber may be either natural or synthetic rubber. In this way, the retaining member 50 forms an elastomeric inner sleeve configured to secure the adapter 1 to the medical container 100.

[0040] The retaining member 50 is supported by the inner ring 40. More specifically, the retaining member 50 covers the inner edge 42 of the inner ring 40. The retaining member 50 is thus configured to extend between said inner edge 42 and the distal tip 102 of the medical container 100. As shown in FIG. 2, the retaining member 50 is advantageously located away from the tubular wall 6 or internal threads 60 of the adapter 1. The retaining member 50 may completely cover the inner edge 42.

[0041] The retaining member 50 is fixedly attached to the inner edge 42 of the inner ring 40. For example, the retaining member 50 may be overmolded or co-injected with the inner ring 40, and more generally with the remainder of the adapter 1. In this way, the inner ring 40 and the retaining member 50 form a single adapter 1 made of two different materials. A single adapter 1 means that the inner ring 40 and the retaining member 50, made of different materials, together form a single part that cannot be disassembled or separated without damaging the adapter 1. In this way, the retaining member 50 is fixed relative to the inner ring 40.

[0042] To prevent any sliding movement of the retention member 50 relative to the inner ring 40, the inner ring 40 may include proximal and distal abutment surfaces 44a, 44b. The retention member 50 is preferably secured to these proximal and distal abutment surfaces 44a, 44b.

[0043] As can be seen in FIG. 2, the proximal and distal abutment surfaces 44a, 44b may be provided on two sides of a radial protrusion 44, such as a circular rib, provided on the inner ring 40. The retaining member 50 defines a complementary shaped recess 54, as shown in FIG. 6, configured to receive the radial protrusion 44. The proximal and / or distal abutment surfaces 44a, 44b may be inclined with respect to a horizontal plane. Thus, as can be seen in FIGS. 2 and 5, the radial protrusion 44 and the complementary shaped recess 54 preferably form a dovetail joint to reduce the risk of the retaining member 50 becoming detached. 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 said radial protrusion 44 may be provided on the retaining member 50. In this case, the proximal and distal abutment surfaces 44a, 44b may be provided on two sides of the circular groove of the inner ring 40.

[0044] The inner ring 40 may further include a bottom radial shoulder 46a and / or a top radial shoulder 46b, which are disposed proximally and distally, respectively, relative to the inner edge 42. A retention member 50 is also advantageously secured to the bottom radial shoulder 46a and / or top radial shoulder 46b.

[0045] Also, note that the retaining member 50 has a bottom proximal surface 57a that does not extend beyond the bottom proximal surface 47a of the inner ring 40. The retaining member 50 can also have a top distal surface 57b that does not extend beyond the top distal surface 47b of the inner ring 40. Preferably, the bottom proximal surface 57a of the retaining member 50 is flush with the bottom proximal surface 47a of the inner ring 40 and / or the top distal surface 57b of the retaining member 50 is flush with the top distal surface 47b of the inner ring 40.

[0046] As shown in FIG. 2, the retaining member 50 advantageously comprises a free distal edge 52 extending parallel to the longitudinal axis A. The free distal edge 52 is configured to prevent tilting movement of the adapter 1 relative to the distal tip 102, i.e., rotation of the adapter 1 about a transverse axis thereof, when the adapter 1 is attached to the distal tip 102. The transverse axis is an axis perpendicular to the longitudinal axis A. The free distal edge 52 extends distally from a base portion 58 of the retaining member 50, which is fixed to the inner ring 40. The free distal edge 52 can extend distally beyond a proximal end 60a of the internal thread 60. As can be seen in FIG. 2, the free distal edge 52 is advantageously distally tapered.

[0047] 1 and 2, the adapter 1 comprises a single retaining member 50. The retaining member 50 may be in the form of a sleeve with a 360° extent. In this embodiment, only the retaining member 50 of the adapter 1 contacts the distal tip 102.

[0048] Alternatively, as shown in Figures 3 to 6, the retaining member 50 may be in the form of a sleeve interrupted in the circumferential direction. The adapter 1 in fact includes a plurality of retaining members 50, each in the form of a partial sleeve or cylinder. As shown in Figures 3 to 6, the adapter 1 may include at least three retaining members 50 spaced apart from one another. These retaining members 50 may be regularly distributed in the circumferential direction. As seen in Figures 3 and 4, the retaining members 50 are separated from one another by circumferential gaps 48 that allow the inner edge 42 of the inner ring 40 to contact the distal tip 102 of the medical container 100 when the adapter 1 is attached to the distal tip 102 of said medical container 100. As a result, the inner edge 42 contacts the distal tip 102 and the retaining members 50 alternately along the circumferential direction. This helps to prevent tilting movement of the adapter 1 relative to the distal tip 102. Preferably, the retaining members 50 are longer than the gaps 48 in the circumferential direction. 3-6, the inner edge 42 may include radial protrusions that extend into the gaps 48, i.e., between adjacent retention members 50, for contacting the outer surface of the distal tip 102. Alternatively or complementary, the distal tip 102 may include radial ridges that are received in the gaps bounded by the retention members 50, and these radial ridges contact the inner edge 42. This allows for a rigid connection between the adapter 1 and the distal tip 102.

[0049] The present invention also relates to a medical container 100, for example as shown in FIG. 2 or FIG. 7. The medical container 100 can be a syringe, such as a fillable or prefilled syringe. The medical container 100 includes a tubular body 104 that defines a reservoir for medical supplies. The distal tip 102 can be cylindrical or distally tapered. The tubular body 104 and the distal tip 102 are preferably made of glass. The medical container 100 further includes an adapter 1 as described above that is secured to the distal tip 102 by a retaining member 50 that adheres to the outer surface of the distal tip 102. To improve the interference fit between the adapter 1 and the retaining member 50, the retaining member 50 can have an inner diameter equal to or smaller than the outer diameter of the distal tip 102.

[0050] As seen in FIG. 7 , the medical container 100 can include a cap 106 having external threads 108 configured to engage with the internal threads 60 of the adapter 1 to secure the cap 106 to the adapter 1. The cap 106 is configured to be secured to the adapter 1 without its external threads abutting the retaining member 50, more specifically the free distal edge 52 of the retaining member 50. Thus, the cap 106 can include a connecting portion having a length less than the distance between the distal end of the adapter 1 and the retaining member 50. The connecting portion extends from a proximal abutment surface 110 configured to abut the distal end of the adapter 1 to the distal end of the cap's external threads 108. The cap 106 can include an inner cap 112 made of a softer material than the cap 106 to seal the distal tip 102.

[0051] The present invention also relates to a method of manufacturing the above-described adapter 1. The method may include overmolding or co-injection molding of the retaining member 50 with the remainder of the adapter 1. Preferably, the adapter 1 is formed in a two-shot injection molding process.

Claims

1. An adapter (1) for a medical container (100) having a distal tip (102), said adapter (1) comprising: a distal portion (2) configured to receive a connector; a proximal portion (4) configured to be attached to the distal tip (102) of the medical container (100); the proximal portion (4) includes an inner ring (40) protruding from a tubular side wall (6) of the adapter (1), the inner ring (40) having an inner edge (42) defining an opening configured to receive the distal tip (102); the proximal portion (4) further comprises a retaining member (50) made of an elastomeric material, the retaining member (50) being connected to the inner edge (42) of the inner ring (40) so as to contact an outer surface of the distal tip (102) when the adapter (1) is attached to the medical container (100); the inner ring (40) includes a protrusion (44) or recess, preferably a protrusion (44), that engages a complementary shaped recess (54) or protrusion, preferably a recess (54), on the elastomeric retaining member (50) to secure the elastomeric retaining member (50) to the inner ring (40); The adapter (1) comprises several retaining members (50), each of which is in the form of a partial sleeve, whereby adjacent retaining members (50) define a gap that allows the inner edge (42) of the inner ring (40) to contact the outer surface of the distal tip (102) when the adapter (1) is attached to the medical container (100).

2. 2. The adapter (1) of claim 1, wherein the inner ring (40) has distal and proximal abutment surfaces (46a, 46b) that abut against the elastomeric retaining member (50) for fixing the elastomeric retaining member (50) in the longitudinal direction (A) of the adapter (1).

3. The adapter (1) according to claim 1 or 2, wherein the projection (44) or recess (44) has a dovetail shape.

4. An adapter (1) as claimed in any one of claims 1 to 3, wherein the elastomeric retention member (50) includes a free distal edge (52).

5. 5. The adapter (1) according to any one of claims 1 to 4, wherein the elastomeric material of the retaining member (50) is rubber or a thermoplastic elastomer (TPE).

6. A medical container (100) comprising a distal tip (102) and an adapter (1) according to any one of claims 1 to 5.

7. 7. The medical container (100) of claim 6, wherein the distal tip (102) includes a ridge configured to abut the inner edge (42) of the inner ring (40) at the gap defined by the adjacent retaining members (50).

8. A method for manufacturing an adapter (1) according to any one of the preceding claims, wherein the retaining member (50) is overmolded or co-injection molded.

9. The method according to claim 8, wherein the adapter (1) is formed by two-shot injection molding.

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