Adapter for connecting a connector to a distal tip of a medical container, a tip cap assembly for engaging said adapter and a drug delivery device, and a method for manufacturing said adapter - Patents.com

Abstract

The adapter (1) includes a tubular sidewall (2) extending about a longitudinal axis (A) and defining an open proximal end (22) for receiving a distal tip (102) and an opposite open distal end (23) for receiving a connector. An inner ring (3) located at the proximal end (22) secures the adapter (1) to the distal tip (102) of the medical container (100). Two inner bulges (4) projecting inwardly from the tubular sidewall (2) define a unique inner cavity (40) for guiding translation of the connector within the adapter (1) along the longitudinal axis (A). The distal ends (23) of the inner bulges (4) define indexing openings (42) for orienting a connector relative to the adapter (1) in a first angular position that allows the connector to enter the inner cavity (40). The inner bulge (4) includes a first blocking surface (44) for blocking rotation of the connector in a first direction during insertion of the connector into the inner cavity (40). The adapter further includes two locking slots (6) located proximally of the inner cavity (40) and distally of the inner ring (3) for allowing the connector in the inserted position to rotate about the longitudinal axis (A) in a second direction opposite to said first direction such that the outer wings (204) of the connector engage with the locking slots (6). The locking slots (6) include a mechanical stop (62) for stopping rotation of the connector at a second angular position where a proximal abutment surface (60) of the locking slots (6) prevents the connector from moving back in the distal direction.

Description

[Technical Field]

[0001] The present invention relates to an adapter for enabling assembly of a connector, such as a needle hub or tip cap assembly, to a medical container, a drug delivery device including said adapter, a tip cap assembly configured to engage with the adapter to seal the distal tip of said medical container, and a method for manufacturing the 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 the direction of injection with respect to an adapter or medical container of the present invention, and a "proximal direction" is understood to mean the direction opposite to said injection direction, i.e., toward the user's hand holding the container with respect to an injection operation.

[0003] Essentially, medical containers, such as, for example, prefillable or pre-filled syringes, are preferably made of glass due to its high chemical passivity, its low gas permeability, and high transparency, which allows for long storage times and easy inspection.

[0004] A medical container typically includes a barrel defining a reservoir for containing a medical product. The container has a distal end in the form of a longitudinal tip defining an axial passageway in fluid communication with the reservoir to allow the medical product to flow out of the reservoir. However, this longitudinal tip does not by itself allow for parenteral administration; it must include either a staked needle or an adapter that allows the syringe to be connected to a connector, such as a needle hub. The adapter is typically threaded, glued, or snap-fit ​​onto the longitudinal tip of the syringe. The connector typically threads onto the adapter and engages the distal end of the container to establish a fluid pathway between the reservoir and the connector.

[0005] Patent Documents 1, 2 and 3 disclose adapters for connecting medical containers to connectors. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] European Patent No. 3868354 [Patent Document 2] European Patent No. 3868428 [Patent Document 3] European Patent No. 3868430 Summary of the Invention

[0007] It is important that the connector is properly threaded onto the adapter. The end user must apply sufficient torque to obtain a proper fit between the connector and the distal end of the container. However, it can be difficult for the end user to know exactly when proper attachment is achieved. Underthreading can cause the connector to eject or leak during fluid transfer from the container to the connector, while overthreading can alter the connection between the adapter and the longitudinal tip, thus causing the adapter to undesirably rotate or tilt relative to the longitudinal tip.

[0008] Therefore, there is a need to facilitate the connection between the connector and the adapter, and a need for the user to know when the connection between the connector and the longitudinal end of the medical container is properly achieved.

[0009] Furthermore, the adapter is usually made of plastic material by injection molding, and there is a need to simplify the molding process and reduce the manufacturing cost.

[0010] An embodiment of the present invention is an adapter for connecting a connector including two outer wings to a distal tip of a medical container, the adapter comprising: a tubular sidewall extending about a longitudinal axis A, the tubular sidewall defining an open proximal end for receiving the distal tip and an opposite open distal end for receiving the connector; an inner ring located at the proximal end for securing the adapter to the distal tip of the medical container; two internal bulges projecting inwardly from the tubular sidewall, the two bulges defining unique internal cavities for guiding translation of the connector within the adapter along the longitudinal axis A, distal ends of the internal bulges defining indexing openings for orienting the connector relative to the adapter at a first angular position that allows the connector to enter the internal cavities, the internal bulges including a first blocking surface for blocking rotation of the connector in the first rotational direction during insertion of the connector into the internal cavities; and two locking slots located proximally to the inner cavity and distally to the inner ring to allow the connector in the inserted position to rotate about the longitudinal axis A in a second rotational direction opposite to the first rotational direction so that each of the outer wings of the connector engages with one of the locking slots, the locking slots including a mechanical stop for stopping rotation of the connector at the second angular position and an abutment surface for preventing the connector from returning in the distal direction.

[0011] The adapter of the present invention thus allows for the establishment of a secure connection between the connector (needle hub or tip cap assembly) and the distal tip of the medical container. The connection motion consists solely of axial translation followed by rotation about the longitudinal axis A. Therefore, there is little or no risk of over-threading or under-threading.

[0012] The adapter does not actually require the use of an internal thread, which also simplifies the molding process. The mold is simpler and therefore less expensive. Furthermore, the adapter is easily and quickly molded by injection molding. There is no need to use a rotating core pin, as is usually required to mold adapters with internal threads, thereby saving costs.

[0013] The adapter also provides haptic or tactile feedback that the connection is secure and complete - indeed, thanks to the mechanical stop, the end user can feel when the connection is complete, thus avoiding the risk of leakage or inadvertent disconnection.

[0014] The adapter may further include some or all of the following advantageous features:

[0015] In one embodiment, the inner ring has an inwardly protruding lug for abutting against the distal tip, improving attachment of the adapter to the distal tip and further limiting the risk of leakage or disconnection. The distal end of the lug is axially positioned proximal to the abutment surface of the locking slot so that the lug does not interfere with the connector.

[0016] In one embodiment, the inner ring includes a distal side having a tapered or frustoconical shape, which improves connection of the adapter to the distal tip of the syringe, particularly when there is a radially inward-extending groove on the outer surface of the distal tip. The tapered or frustoconical shape of the inner ring allows for easy introduction of the adapter around the distal tip and allows for deflection of the lugs when contacting the groove.

[0017] In one embodiment, the locking slot is a through-hole that extends through the side wall of the adapter, allowing the user to see whether the outer wings of the connector are engaged with the locking slot, providing a visual indication that the connection is complete, which also simplifies the molding process.

[0018] In one embodiment, the first angular position and the second angular position are separated by an angle comprised between 40° and 90°, preferably between 50° and 80°, and even more preferably an angle of 65°.

[0019] In one embodiment, the inner bulge includes a second block surface for blocking rotation of the connector in the second rotational direction as long as the connector is slid within the adapter, and the second block surface is configured to allow rotation of the connector in the second rotational direction when the connector is in the fully inserted position. For example, the second block surface terminates at or distal to the locking slot. Therefore, the connector cannot rotate within the inner cavity unless the connector is fully inserted. The first block surface may extend from the indexing opening to the inner ring, thereby blocking rotation of the connector even when the connector is in the inserted position. The second block surface may extend from the indexing opening to the locking slot (more specifically, to the distal wall of the locking slot). Therefore, the second block surface is axially shorter than the first block surface. Unlike the first block surface, the second block surface does not extend to the inner ring. Therefore, a connector in the inserted position can engage the locking slot by rotating only in the second rotational direction. The first and second block faces may extend longitudinally parallel to the longitudinal axis A.

[0020] The inner cavity may be defined by an inner wall parallel to the longitudinal axis A. The bulge has a cylindrical portion between the first stop and the second block face. The inner cavity is smooth; that is, the inner wall defining the inner cavity is free of internal threads or radial protrusions.

[0021] In one embodiment, the adapter includes a tapered portion extending between the open distal end of the adapter and the inner cavity, which allows the connector to be centered about the longitudinal axis A. The end user then simply rotates the connector toward a first angular position so that the connector can enter the indexing opening.

[0022] In one embodiment, the inner bulge has a flat distal surface, which is located at the distal end of the inner bulge and is perpendicular to the longitudinal axis A. A tapered portion extends between the distal surface of the adapter and the flat distal surface of the inner bulge.

[0023] In one embodiment, the two inner bulges and the two locking slots are diametrically opposed.

[0024] Another aspect of the invention is a tip cap assembly configured to be connected to the adapter described above, the tip cap assembly having two outwardly protruding wings configured to engage locking slots of the adapter to removably secure the tip cap assembly to the adapter.

[0025] Possibly, the outwardly protruding wings have a guiding surface, such as a chamfer or a frustoconical shape, on their distal side to facilitate insertion of the outwardly protruding wings into the locking slots of the adapter.

[0026] Another aspect of the invention is a drug delivery device that includes a medical container having a distal tip extending longitudinally from a barrel that defines a reservoir for a medical product, an adapter as described above that is configured to be attached to the distal tip, and a connector, such as a needle hub or tip cap assembly, that is configured to be removably secured to the distal tip by the adapter.

[0027] In one embodiment, the inner cavities of the connector and adapter are complementarily shaped. Therefore, the connector cannot rotate or tilt during insertion into the adapter. This improves positioning of the connector relative to the adapter and distal tip, thereby reducing the risk of leakage.

[0028] In one embodiment, when the connector is in the second angular position, the proximal abutment surface of each of the locking slots abuts at least 50%, preferably between 50% and 90%, of the distal side of the corresponding outwardly projecting wing.

[0029] Another aspect of the present invention is a method for manufacturing the adapter described above. This method lacks the use of a rotating core pin. In fact, the adapter does not require internal threads to secure the connector. This provides an improved, cost-effective molding process. [Brief explanation of the drawings]

[0030] The invention and the advantages arising therefrom will become more apparent from the detailed description set forth below, taken in conjunction with the accompanying drawings, in which: [Figure 1A] FIG. 1A is a perspective view of an adapter according to one embodiment of the present invention. [Figure 1B] FIG. 1B is a cross-sectional view of an adapter according to one embodiment of the present invention. [Figure 1C] FIG. 1C is a partial side view of an adapter according to one embodiment of the present invention. [Figure 1D] FIG. 1D is a top view of an adapter according to one embodiment of the present invention. [Figure 2] FIG. 2 is a perspective view of a medical container engaging an adapter, according to one embodiment of the present invention. [Figure 3A] FIG. 3A is a perspective view of an adapter according to one embodiment of the present invention. [Figure 3B] FIG. 3B is a partial perspective view of an adapter according to one embodiment of the present invention. [Figure 3C] FIG. 3C is a cross-sectional view of an adapter according to one embodiment of the present invention. [Figure 4A] FIG. 4A is a perspective view of a needle hub designed to mate with an adapter according to one embodiment of the present invention. [Figure 4B] FIG. 4B is a bottom view of a needle hub designed to mate with an adapter according to one embodiment of the present invention. [Figure 5A] FIG. 5A is a side cross-sectional view of a medical container and needle hub engaging an adapter, according to one embodiment of the present invention. [Figure 5B] FIG. 5B is a detail of FIG. 5A. [Figure 6A] FIG. 6A is a perspective view of an outer cap of a tip cap assembly designed to mate with an adapter according to one embodiment of the present invention. [Figure 6B] FIG. 6B is a bottom view of the outer cap of the tip cap assembly designed to mate with an adapter according to one embodiment of the present invention. [Figure 7A] FIG. 7A is a cross-sectional view of a medical container and tip cap assembly mating with an adapter, according to one embodiment of the present invention. [Figure 7B] FIG. 7B is a perspective view of a medical container and tip cap assembly engaging an adapter, according to one embodiment of the present invention. [Figure 8A] FIG. 8A is a side view illustrating the step of engaging a needle hub with a medical container with an adapter according to one embodiment of the present invention. [Figure 8B] FIG. 8B is a side view illustrating the step of engaging a needle hub with a medical container with an adapter according to one embodiment of the present invention. [Figure 8C] FIG. 8C is a side view illustrating the step of engaging a needle hub with a medical container with an adapter according to one embodiment of the present invention. [Figure 9A] FIG. 9A is a top view of a medical container and needle hub engaged with an adapter according to one embodiment of the present invention, with the needle hub in an unlocked position. [Figure 9B]FIG. 9B is a top view of a medical container and needle hub engaged with an adapter, with the needle hub in a locked position, according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0031] 1A, an adapter 1 according to one embodiment of the present invention is shown. As shown in FIG. 2, the adapter 1 is configured to be secured to the distal tip 102 of a medical container 100. Additionally, the adapter 1 is configured to receive a connector, such as a needle hub 200 (FIG. 5A) or a tip cap assembly 202 (FIG. 7A), and secure the connector to the distal tip 102 of the medical container 100.

[0032] As shown in FIGS. 1A, 1B, and 1C, adapter 1 may include a tubular sidewall 2 extending about longitudinal axis A. Sidewall 2 of adapter 1 may have a cylindrical shape. Axial ribs 20 may be disposed on its outer surface to allow an end user to grip adapter 1. Sidewall 2 has an inner surface with two diametrically opposed cylindrical portions 21. Tubular sidewall 2 leads to an open proximal end 22 configured to receive distal tip 102 of medical container 100 and an opposite open distal end 23 configured to receive a connector.

[0033] The proximal end 22 of the adapter 1 has an inner ring 3 for securing the adapter 1 to the distal tip 102 of the medical container 100. As seen in Figures 5A and 5B, the distal tip 102 may include a groove 103, and the inner ring 3 may be configured to engage with the groove 103 of the distal tip 102 to secure the adapter 1 to the distal tip 102.

[0034] As shown in FIGS. 1A and 1D, the inner ring 3 may include lugs 30 that protrude radially inward, which may be regularly distributed circumferentially. The lugs 30 include free ends 31 that may have a cylindrical shape for abutting the outer surface of the distal tip 102 or the outer surface of a groove 103 present on the distal tip 102. The lugs 30 may be separated by open radial windows 32 to allow the lugs 30 to deform slightly when the adapter 1 is attached to the distal tip 102. As shown in FIGS. 1B, 5A, or 7A, the distal side 33 of the inner ring 3 may have a distally tapered or frustoconical shape, and the proximal side 34 of the inner ring 3 may be perpendicular to the longitudinal axis A.

[0035] Referring to FIG. 1A, two diametrically opposed inner bulges 4 protrude from the inner surface of sidewall 2. The inner bulges 4 define an inner cavity 40 therebetween for guiding insertion of a connector proximally within adapter 1. The inner bulges 4 have a distal end 41, which may have a flat surface (orthogonal to longitudinal axis A) to enable positioning of the connector relative to adapter 1 prior to insertion. For example, a tapered portion 24 having a frustoconical shape may extend between distal end 23 of adapter 1 and distal end 41 of inner cavity 40 for centering the connector. In an alternative embodiment shown in FIGS. 3A-3C, the distal end 41 of inner bulge 4 is tapered, thus forming tapered portion 24.

[0036] The distal end 41 of the inner bulge 4 further defines an indexing opening 42. The indexing opening 42 is the entrance to the inner cavity 40, which provides only one possibility for inserting a connector into the adapter 1. The indexing opening 42 allows a connector to be inserted into the inner cavity 40 only when the connector is rotationally positioned at a first predetermined angular position (FIG. 9A). That is, the indexing opening 42 allows the connector to enter the inner cavity 40 when the connector is in a first angular position and prevents the connector from entering the inner cavity 40 as long as the connector is in an angular position different from the first angular position. To that end, the indexing opening 42 and the connector, such as the needle hub 200 or the tip cap assembly 202, have the same cross-sectional shape S, as seen in FIGS. 1D, 4B, and 6B. More specifically, the inner bulge 4 may have a cylindrical surface 43, a first flat surface 44 on one side of the cylindrical surface 43, and a second flat surface 45 on the other side of the cylindrical surface 43. The cylindrical surface 43 of the inner bulge 4, the first flat surface, the second flat surface and the cylindrical portion 21 of the side wall 2 define an inner cavity 40 and thus form a predetermined cross-sectional shape S.

[0037] Inner bulge 4 may be configured to prevent rotation of the connector unless the connector is fully inserted into adapter 1, but may also be configured to allow rotation of the connector once the connector is fully inserted into adapter 1, meaning the connector does not have to be inserted further distally. To that end, inner bulge 4 has a first, planar, first blocking surface 44 for blocking rotation of the connector in a first rotational direction, preferably a counterclockwise direction, and a second, planar, second blocking surface 45 for blocking rotation of the connector in an opposite, second rotational direction, preferably a clockwise direction.

[0038] As shown in FIG. 1B, the first block face 44 may extend axially from the distal end 23 of the inner bulge 4 to the inner ring 3. As a result, the connector in the proximal-most position shown in FIG. 5A cannot rotate in a first rotational direction. The proximal-most position corresponds to a fully inserted position of the connector within the adapter 1, and the connector cannot slide further in the proximal direction.

[0039] Unlike the first block face 44, the second block face 45 does not extend axially to the inner ring 3. As shown in FIG. 1B , the second block face 45 may extend axially from the distal end 23 of the inner bulge 4 to the locking slot 6 extending between the proximal end of the second block face 45 and the inner ring 3. Thus, the proximal end of the second block face 45 is axially disposed distal to the inner ring 3. Thus, the second block face 45 is axially shorter than the first block face 44. The second block face 45 allows the connector to engage with the locking slot 6 by rotating in a second rotational direction.

[0040] The inner cavity 40 of the adapter 1 is intended to be free of any internal threads. The cylindrical portion 21 of the side wall 2, the cylindrical surface 43 of the inner bulge 4, and the first and second block faces 44, 45 all extend parallel to the longitudinal axis A. They are smooth and have no radial protrusions. As a result, insertion of the connector into the adapter 1 is a translational movement along the longitudinal axis A without rotation.

[0041] Insertion of the connector into the adapter 1 is limited by conical contact between the inner surface of the connector and the outer surface of the distal tip 102. The most proximal position (insertion position) may be the leak limit position of the needle hub 200 as defined in ISO 80369-7(2016) (sections 6.1 and 6.2).

[0042] The adapter 1 further includes two diametrically opposed locking slots 6, preferably located at the proximal end 22 of the inner bulge 4. The locking slots 6 are configured to receive the outer wings 204 of the connector when the connector is rotated in the second rotational direction (clockwise). The locking slots 6 extend circumferentially longitudinally. Preferably, the locking slots 6 are through-openings that extend radially from side to side in the side wall 2 of the adapter 1. As a result, a user can see whether the connector is properly engaged with the locking slots 6.

[0043] The locking slot 6 may have four walls: an upper (distal) wall 60 and a lower (proximal) wall 61, which may be perpendicular to the longitudinal axis A, and two lateral side walls 62, 63. The distal wall 60, the proximal wall 61, and the first and second side walls 62, 63 are preferably flat surfaces.

[0044] The distal wall 60 of the locking slot 6 forms a proximal abutment surface configured to abut the distal side of the connector's outer wing 204 to prevent the connector from returning distally. The proximal abutment surface 60 is dimensioned to cover at least 50%, and preferably between 50% and 90%, of the distal side of the corresponding outer wing 204. This distal wall 60 is in constant contact with the distal side of the corresponding outer wing 204 as the connector rotates toward the second angular position.

[0045] A first of the two side walls 62, 63 may be configured such that the outer wings 204 of the connector abut against the first side wall 62 of the locking slot 6 when the connector rotates in the second rotational direction, but do not abut against the second side wall 63 when the connector rotates back to the first rotational direction. The first side wall 62 of the locking slot 6 is adjacent to the first block face 44 of the inner bulge 4, and the second side wall 63 is adjacent to the second block face 45.

[0046] Thus, the first side wall 62 of the locking slot 6 forms a mechanical stop for terminating the rotation of the connector at a second predetermined angular position when the connector is rotated in a second rotational direction. At the second angular position, the connection between the connector and the adapter 1 is completed. Referring to Figures 9A and 9B, the angle α defined between the first and second angular positions is between 40° and 90°, preferably between 50° and 80°, and even more preferably about 65°.

[0047] 6A-7B, the present invention also relates to a tip cap assembly 202. The tip cap assembly 202 is configured to be secured to the adapter 1 to seal the axial passage 104 of the distal tip 102. The tip cap assembly 202 includes an outer cap 206 and an inner cap 208 disposed inside the outer cap 206. The outer cap 206 may be made of a rigid material, and the inner cap 208 may be made of an elastically deformable material. The outer cap 206 includes a skirt 210 protruding proximally from a shoulder 212. The shoulder 212 is configured to abut the distal end 23 of the adapter 1, and the skirt 210 is configured to engage with the inner cavity 40.

[0048] The tip cap assembly 202 has two diametrically opposed outer wings 204 configured to engage the two locking slots 6 of the adapter 1. The outer wings 204 are disposed at the proximal end 22 of the skirt 210. They extend perpendicular to the longitudinal axis A. The outer wings 204, the indexing opening 42, and the inner cavity 40 have the same cross-sectional shape S.

[0049] More specifically, the outer wings 204 define sides for guiding insertion of the connector within the inner cavity 40 of the adapter 1, and the sides may include two pairs of diametrically opposed cylindrical surfaces 214, 216 for cooperating with the cylindrical portion 21 of the adapter 1 and the cylindrical surface 43 of the inner bulge 4, respectively, and four abutment surfaces 218, 220, which may be flat and parallel to the longitudinal axis A. Two of the abutment surfaces 218 are configured to abut against the first block surface 44 of the inner bulge 4, and the other two abutment surfaces 220 are configured to abut against the second block surface 45 (during translation of the connector within the adapter 1) and then against the first side wall 62 of the locking slot 6 (when the connector is rotated from the first angular position to the second angular position).

[0050] The outer wing 204 has a width w that decreases significantly in the radial direction. As a result, the free end 222 of the outer wing 204 may be thinner than the base portion 224 of the outer wing 204. That is, the distal side of the outer wing 204 may include a guide surface 226 having a chamfer or frustoconical shape to facilitate insertion of the outer wing 204 into the locking slot 6 of the adapter 1. Upon engagement with the locking slot 6, the guide surface 226 of the outer wing 204 abuts the proximal abutment surface 60 of the adapter 1 to block axial movement of the connector in the distal direction. Opposite the distal side and the guide surface 226, the outer wing 204 has a proximal side 228.

[0051] It should be noted that tip cap assembly 202 does not have any external threads, which simplifies the manufacturing process of tip cap assembly 202.

[0052] 7A-7B or 8A-8C, the present invention also relates to a drug delivery device 300 including a medical container 100 and the above-described adapter 1. The medical container 100 has a tubular barrel 106 defining a reservoir for a medical product and a longitudinally protruding distal tip 102 defining an axial passage 104 in fluid communication with the reservoir. The outer surface of the distal tip 102 is preferably conical. The distal tip 102 may include a groove 103 for receiving the inner ring 3 of the adapter 1 and securing the adapter 1 to the distal tip 102. As shown in FIGS. 5A and 7A, the drug delivery device 300 may further include a needle hub 200 (FIG. 5A) for fluidly connecting the axial passage 104 of the distal tip 102 to a needle or IV catheter (not shown), or the above-described tip cap assembly 202 (FIG. 7A) for sealing the axial passage 104.

[0053] The operation of the drug delivery device 300 according to the present invention will now be described below with reference to Figures 8A-8C and 9A-9B.

[0054] 8A and 8B, the needle hub 200 (or tip cap assembly 202) must first be placed in a first angular position that allows entry of the connector into the inner cavity 40 of the adapter 1 through the indexing opening 42.

[0055] The needle hub 200 is translated proximally along the longitudinal axis A within the inner cavity 40 of the adapter 1 until the needle hub 200 is in its proximal-most position, i.e., the fully inserted position (FIG. 8C). The needle hub 200 is guided by the inner bulge 4 of the adapter 1 without rotation, so that the needle hub 200 is still in the first angular position (FIG. 9A). At this stage, the conical needle hub 200 fits properly into the complementary-shaped distal tip 102 (FIG. 8C), but the connection is not yet complete, as the needle hub 200 can move back distally.

[0056] The user simply rotates the needle hub 200 in the second rotational direction (clockwise). This is possible because the second blocking surface 45 of the inner bulge 4 no longer blocks rotation in the second rotational direction. Furthermore, the outer wings 204 are positioned in the locking slot 6. Thus, rotation of the needle hub 200 in the second rotational direction engages the outer wings 204 with the locking slot 6. The outer wings 204 abut against the first side wall 62 of the locking slot 6 ( FIG. 9B ), thereby providing the user with tactile feedback that the connection is complete. The distal side 226 of the outer wings 204 abuts against the upper (distal) wall 60 of the locking slot 6. Thus, the connector is axially blocked and removably secured to the distal tip 102 of the medical container 100.

[0057] To remove the connector, the user must first rotate the connector back in the first rotational direction until the outer wings 204 of the connector abut the first block face 44 of the inner bulge 4, and then slide the connector distally so that it emerges from the inner cavity 40.

[0058] The present invention also relates to a method for manufacturing the above-mentioned adapter 1. The method includes forming the adapter 1 by injection molding. However, this method does not use a rotating core pin, as the adapter 1 does not require an internal thread for securing the connector.

[0059] The present invention thus allows for removably securing a connector to the distal tip 102 of a medical container 100 without the risk of over- or under-threading. The method for manufacturing the adapter 1 does not require the use of a rotating core pin, making the adapter 1 easy to manufacture. The present invention therefore provides a cost-effective solution for easily connecting (axial translation followed by limited rotation) a needle hub 200 or tip cap assembly 202 to the distal tip 102 of a medical container 100 while reliably preventing leakage between the distal tip 102 and said needle hub 200 or tip cap assembly 202.

[0060] The present invention includes the following embodiments: [ Configuration 1] An adapter (1) for connecting a connector having two outer wings (204) to a distal tip (102) of a medical container (100), said adapter (1) comprising: a tubular sidewall (2) extending about a longitudinal axis (A), said tubular sidewall (2) defining an open proximal end (22) for receiving said distal tip (102) and an opposite open distal end (23) for receiving said connector; an inner ring (3) located at the proximal end (22) for securing the adapter (1) to the distal tip (102) of the medical container (100); two inner bulges (4) protruding inward from the tubular side wall (2), the two bulges (4) defining a unique inner cavity (40) for guiding translation of the connector along the longitudinal axis (A) within the adapter (1), a distal end (23) of the inner bulges (4) defining an indexing opening (42) for orienting the connector relative to the adapter (1) at a first angular position allowing entry into the inner cavities (40), the inner bulges (4) including a first blocking surface (44) for blocking rotation of the connector in a first rotational direction during insertion of the connector into the inner cavities (40); an adapter (1) comprising two locking slots (6) disposed proximally of the inner cavity (40) and distally of the inner ring (3) to allow the connector in an inserted position to rotate about the longitudinal axis (A) in a second rotational direction opposite to the first rotational direction so that each of the outer wings (204) of the connector engages with one of the locking slots (6), the locking slots (6) including a mechanical stop (62) for stopping rotation of the connector at a second angular position and an abutment surface (60) for preventing the connector from returning in the distal direction. [Configuration 2] 2. The adapter (1) of claim 1, wherein the inner ring (3) has inwardly projecting lugs (30) for abutting the distal tip (102). [Configuration 3] 3. The adapter (1) of configuration 2, wherein the inner ring (3) includes a distal side (33) having a tapered or frustoconical shape. [Configuration 4] 4. The adapter (1) of any one of configurations 1 to 3, wherein the locking slot (6) is a through opening extending through the side wall (2) of the adapter (1). [Configuration 5] 5. The adapter (1) of any one of configurations 1 to 4, wherein the first angular position and the second angular position are separated by an angle (α) comprised between 40° and 90°, preferably between 50° and 80°, and even more preferably an angle of 65°. [Configuration 6] 6. The adapter (1) of any one of configurations 1 to 5, wherein the inner bulge (4) includes a second blocking surface (45) for blocking rotation of the connector in the second rotational direction as long as the connector is slid inside the adapter, and the second blocking surface (45) is configured to allow rotation of the connector in the second rotational direction when the connector is in an insertion position. [Configuration 7] The adapter (1) of any one of configurations 1 to 6, wherein the adapter (1) includes a tapered portion (24) extending between the open distal end (23) of the adapter (1) and the inner cavity (40). [Configuration 8] 8. The adapter (1) of any one of configurations 1 to 7, wherein the inner bulge (4) has a flat distal surface (41). [Configuration 9] 9. The adapter (1) of any one of configurations 1 to 8, wherein the two inner bulges (4) and respectively the two locking slots (6) are diametrically opposed. [Configuration 10] A tip cap assembly (202) configured to be connected to an adapter (1) described in any one of configurations 1 to 9, wherein the tip cap assembly (202) has two outwardly protruding wings (204) configured to engage with the lock slot (6) of the adapter (1) to removably secure the tip cap assembly (202) to the adapter (1). [Configuration 11] A drug delivery device (300) comprising a medical container (100) having a distal tip (102) extending longitudinally from a barrel (106) defining a reservoir for a medical product, an adapter (1) described in any one of claims 1 to 9 configured to be attached to the distal tip (102), and a connector such as a needle hub (200) or a tip cap assembly (202) configured to be removably secured to the distal tip (102) by the adapter (1). [Configuration 12] 12. The drug delivery device (300) of claim 11, wherein the connector and the inner cavity (40) of the adapter (1) are complementarily shaped. [Configuration 13] A drug delivery device (300) according to configuration 11 or 12, wherein when the connector is in the second angular position, the proximal abutment surface (60) of each of the locking slots (6) abuts at least 50%, preferably between 50% and 90%, of the distal side of the corresponding outwardly protruding wing (204).

Claims

1. An adapter (1) for connecting a connector having two outer wings (204) to a distal tip (102) of a medical container (100), said adapter (1) comprising: a tubular sidewall (2) extending about a longitudinal axis (A), said tubular sidewall (2) defining an open proximal end (22) for receiving said distal tip (102) and an opposite open distal end (23) for receiving said connector; an inner ring (3) located at the proximal end (22) for securing the adapter (1) to the distal tip (102) of the medical container (100); two inner bulges (4) protruding inward from the tubular side wall (2), the two bulges (4) defining a unique inner cavity (40) for guiding translation of the connector along the longitudinal axis (A) within the adapter (1), a distal end (23) of the inner bulges (4) defining an indexing opening (42) for orienting the connector relative to the adapter (1) at a first angular position allowing it to enter the inner cavities (40), the inner bulges (4) including a first blocking surface (44) for blocking rotation of the connector in a first rotational direction during insertion of the connector into the inner cavities (40); an adapter (1) comprising: two locking slots (6) disposed proximally of the inner cavity (40) and distally of the inner ring (3) to allow the connector in an inserted position to rotate about the longitudinal axis (A) in a second rotational direction opposite to the first rotational direction so that each of the outer wings (204) of the connector engages with one of the locking slots (6), the locking slots (6) including a mechanical stop (62) for stopping rotation of the connector at a second angular position and an abutment surface (60) for preventing the connector from returning in the distal direction.

2. 2. The adapter (1) of claim 1, wherein the inner ring (3) has inwardly projecting lugs (30) for abutting the distal tip (102).

3. 3. The adapter (1) according to claim 2, wherein the inner ring (3) includes a distal side (33) having a tapered or frustoconical shape.

4. The adapter (1) of claim 1, wherein the locking slot (6) is a through opening extending through the side wall (2) of the adapter (1).

5. 2. The adapter (1) according to claim 1, wherein the first angular position and the second angular position are separated by an angle (α) comprised between 40° and 90°, preferably between 50° and 80°, and even more preferably an angle of 65°.

6. 2. The adapter (1) of claim 1, wherein the inner bulge (4) includes a second blocking surface (45) for blocking rotation of the connector in the second rotational direction as long as the connector is slid inside the adapter, the second blocking surface (45) being configured to allow rotation of the connector in the second rotational direction when the connector is in an inserted position.

7. 2. The adapter (1) of claim 1, wherein the adapter (1) includes a tapered portion (24) extending between the open distal end (23) of the adapter (1) and the inner cavity (40).

8. 2. The adapter (1) according to claim 1, wherein the inner bulge (4) has a flat distal surface (41).

9. 2. An adapter (1) according to claim 1, wherein said two inner bulges (4) and respectively said two locking slots (6) are diametrically opposite.

10. 2. A tip cap assembly (202) configured to be connected to an adapter (1) as described in claim 1, wherein the tip cap assembly (202) has two outwardly protruding wings (204) configured to engage with the locking slot (6) of the adapter (1) to removably secure the tip cap assembly (202) to the adapter (1).

11. A drug delivery device (300) comprising a medical container (100) having a distal tip (102) extending longitudinally from a barrel (106) defining a reservoir for a medical product, an adapter (1) as described in claim 1 configured to be attached to the distal tip (102), and a connector such as a needle hub (200) or a tip cap assembly (202) configured to be removably secured to the distal tip (102) by the adapter (1).

12. 12. The drug delivery device (300) of claim 11, wherein the connector and the inner cavity (40) of the adapter (1) are complementarily shaped.

13. A drug delivery device (300) as described in claim 11, wherein when the connector is in the second angular position, the proximal abutment surface (60) of each of the locking slots (6) abuts at least 50%, preferably between 50% and 90%, of the distal side of the corresponding outwardly protruding wing (204).

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