Adapter for attachment to a medical container, a medical container including said adapter, and a drug delivery device including said medical container - Patents.com

Abstract

An adapter for attachment to a medical container, a medical container including the adapter, and a drug delivery device including the medical container are provided. The adapter (1) comprises a tubular wall (2) having a proximal portion (4) configured to be secured to the distal tip (102) of a medical container (100) and a distal portion (6) configured to receive the connector (200). The adapter (1) further comprises an opening (8) extending through the tubular wall (2) and an internal thread (9) configured to cooperate with a connecting element (202) of the connector (200) to secure the connector (200) to the adapter (1). The internal thread (9) is configured to guide the connecting element (202) into the opening (8). The opening (8) is positioned relative to the internal thread (9) so that the connecting element (202) is visible to an end user upon completion of connection between the adapter (1) and the connector (200).

Description

[Technical field]

[0001] The present invention relates to an adaptor for attachment to a medical container, a medical container including said adaptor, and a drug delivery device including said medical container. Summary of the Invention

[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 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 container forming a reservoir for containing a medical product. The container has a distal end in the form of a longitudinal tip that defines an axial passageway through which the medicinal product is expelled from the container. However, this longitudinal tip does not by itself allow parenteral administration, but must be provided with either a staked needle or an adapter that allows a syringe to be connected to a connector such as a needle hub. This connector is typically threaded onto the adapter and engages the distal end of the container to establish a fluid pathway between the reservoir and said connector.

[0005] It is important that the connector is properly threaded into the adapter. The end user must apply sufficient torque when threading the connector into the adapter to attach the proper fitting of the connector to the distal end of the container. Under-threading or over-threading the connector into the adapter can result in the connector leaking or blowing out due to internal pressure when transferring fluid between the container and the connector.

[0006] Therefore, there is a need for a medical container that indicates to an end user that the connector is properly connected to the adapter, thus increasing the end user's confidence during the connection and injection steps.

[0007] Document US2006178627 discloses a syringe tip cap for closing a distal opening of a syringe body. Document WO2011068544 discloses a cartridge for containing and dispensing a medicament in conjunction with a pen injection device. Document US2020022870 discloses an adapter for coupling to a vial, said adapter allowing multiple sterile needle punctures by an injection device filled with the product contained in the vial.

[0008] An aspect of the present invention is an adapter for connecting a medical container to a connector, the adapter comprising: a proximal portion configured to be secured to a distal tip of a medical container; a distal portion configured to receive the connector, the adapter comprising: at least one opening extending through said tubular wall; an internal thread configured to cooperate with a connecting element of the connector to secure the connector to the adapter, the internal thread configured to guide the connecting element into the at least one opening; The at least one opening is positioned relative to the internal threads such that the connection element is visible to an end user when the connection between the adapter and the connector is complete, thus providing the adapter with a visual indication that the connection is complete.

[0009] Thus, the adapter of the present invention provides a visual indication that the connector is securely and sufficiently threaded onto the adapter, thereby preventing over- or under-threading the connector onto the adapter.

[0010] In one embodiment, the tubular wall has an inner surface configured to exert a radially inward force on the connecting elements of the connector when the connector is threaded into the adapter. This causes the connection element to hit the walls of the opening and generate a sound as it enters the opening, so that the adapter may further provide an audio indication that the connection has been completed.

[0011] Preferably, the inner surface of the tubular wall includes a tapered portion. The tapered inner surface therefore causes a gradual compression of the connecting element, thereby avoiding a sudden increase in the screwing torque. This also allows the connector to be uniformly stressed when screwed into the adapter, thereby improving the reliability of the connection.

[0012] Preferably, at least one opening extends at least partially through said inner surface, preferably through said tapered portion.

[0013] In one embodiment, the at least one opening is located at the thread root of the inner thread. This improves the reliability of the connection.

[0014] In one embodiment, the at least one opening is configured to accommodate a connecting element. The openings therefore help to maintain the connector fixed relative to the adapter, thereby preventing further screwing or unscrewing of the connector, thereby benefiting from the advantages of both threaded and snap-fit ​​connections.

[0015] The adapter advantageously includes at least two openings, so that the end user does not need to rotate the adapter to visually check that the connection is complete. Preferably, the two or more openings are regularly distributed in the circumferential direction, which makes it possible to avoid asymmetric deformation of the connector.

[0016] In one embodiment, the adapter is configured to be glued, clipped, or snap-fit ​​onto the distal tip of the medical container.

[0017] In one embodiment, the adapter is made of a light-transmitting material. This enhances the visual indication provided by the connecting element engaged in the opening.

[0018] The adapter may be injection molded.

[0019] Another aspect of the invention is a medical container including a distal tip and an adapter as described above, said adapter secured to the distal tip.

[0020] In one embodiment, the inner surface of the adapter and the outer surface of the distal tip define a cavity configured to receive the connector, said cavity having a proximally decreasing cross-section. This increases the radial pressure exerted by the inner surface of the adapter on the connecting element, thereby improving the audible indication provided to the end user.

[0021] The distal tip may have a cylindrical or frustoconical shape. In one embodiment, the distal tip has a frustoconical shape.

[0022] The adapter can be glued, clipped, or snap-fit ​​onto the distal tip.

[0023] The medical containers may be made of glass or plastic materials.

[0024] Another aspect is a drug delivery device that includes a medical container as described above and a connector configured to be secured to an adapter. The connector may be a needle hub.

[0025] In one embodiment, the at least one opening and the connecting element are complementarily shaped. Thus, the openings and connection elements provide for both threaded and snap-fit ​​connections.

[0026] In one embodiment, the connecting element is configured to strike a wall of the opening when it reaches the opening. For example, the connecting element can abut the inner edge of the opening, or distal and / or proximal abutment surfaces of said opening.

[0027] The adapter may include several openings and the connector may include several connection elements, each of which is received in a corresponding opening of the adapter, thereby making it possible to avoid asymmetric deformation of the connector. The openings may each regularly distribute the connection elements in the circumferential direction. Typically, the adapter includes two openings and the connector includes two connection elements, such as outer wings.

[0028] In one embodiment, the adapter includes a first shade and the connecting element includes a second shade different from the first shade.

[0029] The adapter may include polycarbonate (PC) and the connector may include polypropylene (PP). [Brief description of the drawings]

[0030] The invention and advantages arising therefrom will become more apparent from the detailed description given below with reference to the accompanying drawings, in which: [Figure 1] FIG. 1 is a perspective view of an adapter according to one embodiment of the present invention. [Diagram 2] FIG. 2 is a side view of an adapter according to one embodiment of the present invention. [Diagram 3] FIG. 3 is a cross-sectional view of an adapter according to one embodiment of the present invention. [Figure 4] FIG. 4 is a side view of an adapter and medical container according to one embodiment of the present invention. [Diagram 5] FIG. 5 is a side view of an adapter and a drug delivery device according to one embodiment of the present invention. [Figure 6] FIG. 6 is a cross-sectional view of an adapter and a drug delivery device according to one embodiment of the present invention. [Figure 7] FIG. 7 is a detail of FIG. 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. 4, the adapter 1 is intended to be attached to a 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 towards the distal end. The distal tip 102 extends in a longitudinal direction A. As shown in Fig. 5, the adapter 1 allows to connect a connector, more particularly a needle hub 200, to this distal tip 102. The connector comprises connecting elements such as outer wings 202 to fix the connector to the adapter 1.

[0032] 1-3, the adapter 1 comprises a cylindrical body in the form of a tubular wall 2 defining an internal cavity (lumen) 20. The adapter 1 defines a proximal portion 4, which may be in the form of a mounting ring configured to be secured to a medical container 100, and a distal portion 6, which may be in the form of a connecting ring configured to receive a connector to establish reliable fluid communication between a passageway of the distal tip 102 and said connector.

[0033] The tubular wall 2 has an inner surface 22 and an outer surface 24. The tubular wall 2 comprises one or more through-holes, e.g. two openings 8, configured to cooperate with a connection element(s) of the connector to visually indicate to the end user that the connection between the connector and the adapter 1 is completed. In the illustrated example, the tubular wall 2 comprises two openings 8, since the needle hub 200 comprises two outer wings 202. Each of these openings 8 is configured to cooperate with a corresponding one of said outer wings 202. The openings 8 may be regularly distributed in the circumferential direction. Thus, the two openings 8 shown in Figs. 1-7 are diametrically opposite.

[0034] The one or more openings 8 extend in a preferably linear radial direction from the inner surface 22 to the outer surface 24 of the tubular wall 2, thereby providing an end user with visibility of the lumen 20. As seen in FIG. 2 or FIG. 4, the one or more openings 8 may also extend in a plane perpendicular to the longitudinal axis A, thereby being angled relative to the internal threads 9.

[0035] 3, the adapter 1, more specifically the distal portion 6, further comprises an internal thread 9 protruding from the inner surface 22. The internal thread 9 defines a thread crest 90 and a thread root 92. The internal thread 9 is configured to cooperate with the outer wing 202 of the needle hub 200 to secure the needle hub 200 to the adapter 1. The internal thread 9 is also configured to guide the outer wing 202 towards the opening 8 such that the outer wing 202 is visible to an end user upon completion of the connection between the needle hub 200 and the adapter 1. The one or more openings 8 are disposed on the path of the connection element(s) when the connector is screwed into the adapter 1. More specifically, the one or more openings 8 extend into the thread root 92 of the internal thread 9. The one or more openings 8 may also have one end circumferentially adjacent to or extending through the thread crest 90 of the internal thread 9, more specifically, distal to said thread crest 90, as shown in FIG.

[0036] The one or more openings 8 are in the adapter 1 such that the outer wings 202 are visible to the end user only when the connection between the needle hub 200 and the adapter 1 is secure and complete. This substantially corresponds to a predetermined position where the needle hub 200 properly fits with the distal tip 102 of the medical container 100, as shown in Figs. 5-7. Said predetermined position is advantageously defined to be the leakage limit of the needle hub 200, as defined in ISO 80369-7 (2016) (paragraphs 6.1 and 6.2). If the needle hub 200 is poorly connected and does not reach said position, leakage may still occur. On the contrary, if the needle hub 200 is over-connected, the needle hub 200 may break or be ejected from the adapter. It is noted that the one or more openings 8 are configured to accommodate the connection element, i.e. the outer wings 202, only when the needle hub 200 reaches the leakage limit position.

[0037] As shown in FIG. 3 , the one or more openings 8 may be located at least one thread pitch from the distal end of the inner thread 9 such that the outer wing 202 reaches the opening 8 after at least one 360° rotation about the longitudinal axis A.

[0038] 4, the one or more openings 8 may be located at a distance d from the distal end of the adapter 1, said distance d being, for example, at least equal to 2 mm and preferably not greater than 6 mm. The one or more openings 8 may have a width w that may be at least 0.5 mm and preferably not greater than 1 mm. The one or more openings 8 may have an arc length L that may be at least 5 mm and preferably not greater than 7 mm.

[0039] It should be noted that the inner surface 22 may be configured to exert a radially inward force on the outer wings 202 when the needle hub 200 is screwed into the adapter 1. For example, the inner surface 22 may include a proximal tapered portion 26 that defines a cross section that decreases in the proximal direction. The tapered portion 26 may have a frustoconical shape. The opening 8 may be located proximally relative to said portion 26 or may be disposed through said portion 26 of the inner surface 22, preferably at the proximal end of the portion 26. As a result, when the needle hub 200 is screwed into the adapter 1, the outer wings 202 elastically deform. The one or more openings 8 then release the outer wings 202 against the walls of the openings 8, thereby providing an audible indication to the end user that the connection is complete. The inner surface 22 may further comprise a cylindrical portion proximal and / or distal to the tapered portion 26. Although not shown in the figures, alternatively, the inner surface 22 may be completely cylindrical and may exert a reaction force against the outer wing 202, which is pressed against the inner surface 22 by the distal tip 102 having a frusto-conical shape when the needle hub 200 is screwed into the adapter 1.

[0040] Where the inner surface 22 includes a tapered portion 26, it is contemplated that only the thread roots 92 of the internal threads 9 taper. However, the thread crests 90 have a substantially cylindrical shape. That is, the thread crests 90 still define a constant diameter while the diameter of the conduit defined by the inner surface decreases proximally.

[0041] The one or more openings 8 are configured to receive a corresponding outer wing 202 to achieve a snap-fit ​​connection in addition to the threaded connection achieved by the inner thread 9 and the outer wing 202. As a result, the elastically deformed outer wing 202 pops out into the opening 8 when the connection is secure.

[0042] More specifically, the one or more openings 8 and the outer wing 202 may be complementarily shaped such that the outer wing 202 engages the opening 8 and remains trapped within said opening 8. With reference to FIGS. 6 and 7, the outer wing 202 may have a free end 204 configured to at least partially enter the opening 8. Said free end 204 may have a radially outwardly tapered shape. Thus, the free end 204 may abut the adapter 1 at the inner edge 80 of the opening 8. The one or more openings 8 may define proximal and distal abutment surfaces 82, 84 that block the outer wing 202 in the longitudinal direction A, and the one or more openings 8 may also have an orthogonal abutment surface 86 to block the outer wing 202 in the circumferential direction, thereby preventing any further or reverse threading of the needle hub 200 into the adapter 1.

[0043] The adapter 1 may preferably be glued onto the distal tip 102 of the medical container 100. Thus, the proximal portion 4 of the adapter 1 may include a receiving space configured to receive the adhesive material.

[0044] The adapter 1 may 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. Preferably, the adapter 1 is made of polycarbonate (PC). The adapter 1 is preferably made of a light-transmitting material. The adapter may be injection molded.

[0045] With reference to Fig. 4, the present invention also relates to a medical container 100 comprising a distal tip 102 and the above-mentioned adapter 1, said adapter 1 being attached to the distal tip 102, for example by gluing. The medical container may be made of glass. Preferably, the medical container is a syringe, for example a pre-filled or fillable syringe. The medical container 100 comprises a tubular barrel 104 defining a reservoir for the medical product. The distal tip 102 may be cylindrical or distally tapered.

[0046] Due to the conical portion 26 of the inner surface 22 and / or the conical shape of the distal tip 102, the inner cavity 20 has a proximally decreasing cross section. The inner surface 22 therefore exerts a radial force on the outer wing 202, which is elastically deformed. The outer wing 202 returns to its original shape from the moment it reaches the opening 8, thereby generating a sound indicating a completed connection.

[0047] 5 and 6, the present invention also relates to a drug delivery device 300 including a connector such as a needle hub 200 secured to the medical container 100 and adapter 1 described above. The needle hub 200 has a distal tip 102, a needle cannula, and an open proximal end for receiving a resilient arm 206, said resilient arm 206 having an end provided on an outer wing 202.

[0048] The adapter 1 of the drug delivery device 300 may comprise as many openings as the outer wings 202 of the needle hub 200. Each of the outer wings 202 cooperates with one of the openings 8. The openings 8 and the respective outer wings 202 may be regularly distributed in the circumferential direction.

[0049] The adapter 1 may advantageously comprise a first shade while the needle hub 200 includes a second shade different from said first shade. The first shade may be a light-transmitting material and the second shade may be a more opaque material than the first shade. Alternatively, the first shade may be a first color or shade and the second shade may be a different color or shade.

[0050] The adapter 1 may be polycarbonate (PC) and the needle hub 200 may be polypropylene (PP).

Claims

1. An adapter (1) for connecting a medical container (100) to a connector (200) such as a needle hub, the adapter (1) comprising: a proximal portion (4) configured to be secured to a distal tip (102) of a medical container (100); a distal portion (6) configured to receive the connector (200), and the adapter (1) further comprises: At least one opening (8) extending through said tubular wall (2); an internal thread (9) configured to cooperate with a connection element (202), such as an outer wing, of the connector (200) to fasten the connector (200) to the adapter (1), the internal thread (9) being configured to guide the connection element (202) into the at least one opening (8); the at least one opening (8) is positioned relative to the internal thread (9) such that the connection element (202) is visible to an end user when the connector (200) reaches a leak limit position where the connection between the adapter (1) and the connector (200) is completed; The adapter (1), wherein the tubular wall (2) has an inner surface (22) configured to exert a radially inward force on the connecting element (202) of the connector (200) when the connector (200) is screwed into the adapter (1), the inner surface (22) of the tubular wall (2) comprising a tapered portion (26) disposed relative to the opening (8) to release the connecting element (202) within the opening (8), thereby providing an audible indication to the end user that the connection is complete.

2. The adapter (1) of claim 1, wherein the opening (8) extends at least partially through the inner surface (22).

3. 3. The adapter (1) according to claim 1 or 2, wherein the opening (8) is located in a thread (92) of the internal thread (9).

4. The adapter (1) according to any one of claims 1 to 3, wherein the opening (8) is configured to accommodate the connecting element (202).

5. The adapter (1) of any one of claims 1 to 4, wherein the adapter (1) is configured to be glued, clipped or snap-fitted to the distal tip (102) of the medical container (100).

6. The adapter (1) according to any one of claims 1 to 5, wherein the adapter (1) is made of a light-transmitting material.

7. A medical container (100) comprising a distal tip (102) and an adapter (1) according to any one of claims 1 to 6, said adapter (1) being fixed to said distal tip (102).

8. 8. The medical container (100) of claim 7, wherein an inner surface (22) of the adapter (1) and an outer surface (103) of the distal tip (102) define a cavity (20) configured to receive the connector (200), the cavity (20) having a proximally decreasing cross-section.

9. The medical container (100) of claim 7 or claim 8, wherein the distal tip (102) has a frustoconical shape.

10. A drug delivery device (300) comprising a medical container (100) according to any one of claims 7 to 9 and a connector (200) configured to be fixed to the adapter (1).

11. The drug delivery device (300) of claim 10, wherein the opening (8) and the connecting element (202) have complementary shapes.

12. The drug delivery device (300) of claim 10 or 11, wherein the connecting element (202) is configured to strike a wall of the opening (8) upon reaching the opening (8).

13. The drug delivery device (300) of any one of claims 10 to 12, wherein the adapter (1) has a first shade and the connecting element (202) has a second shade different from the first shade.

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