Medical container, an adapter for mounting to the medical container, and a drug delivery device including the medical container

The medical container design addresses the issue of improper connector attachment by allowing the adapter to slide along the distal tip, ensuring proper locking and preventing leakage, thus enhancing the reliability of fluid transfer.

JP7680466B2Active Publication Date: 2025-05-20BECTON DICKINSON FRANCE SAS
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Patent Information

Application Number
JP2022558390
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2020-04-21
Filing Date
2021-04-20
Publication Date
2025-05-20
Estimated Expiration
2041-04-20

AI Technical Summary

Technical Problem

Existing medical containers face issues with improper attachment of connectors, leading to potential leakage due to premature contact between the connector and the adapter before full locking.

Method used

A medical container design featuring a distal tip with a mating portion and a mounting portion that allows the adapter to slide proximally, preventing torque increase until full connector locking, thus ensuring proper attachment and preventing leakage.

Benefits of technology

The solution ensures secure and leak-proof attachment of the connector to the medical container, preventing leakage by ensuring the connector is fully locked before fluid transfer.

✦ Generated by Eureka AI based on patent content.

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Abstract

The medical container (1) forms a reservoir for containing a medical product and has a longitudinal distal tip (11) extending along a longitudinal axis (A). The distal tip (11) defines a passageway in fluid communication with the reservoir. The distal tip (11) includes a mating portion (113) configured to mate with a connector and a mounting portion (110) disposed proximally relative to the mating portion (113) and configured to slidably connect an adapter (2) to the distal tip (11). The mounting portion (110) is configured to allow free longitudinal movement of the adapter (2) relative to the distal tip (11) when the adapter (2) is connected to the distal tip (11).
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Description

[Technical field]

[0001] The present invention relates to a medical container, an adapter for attachment to the medical container, and a drug delivery device comprising the medical container. [Background technology]

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

[0003] Basically, medical containers, such as syringes, can be made of glass or plastic materials. Preferably, medical containers are made of glass due to its high chemical passivation, its low gas permeability and high transparency, which allows long-term storage and easy inspection.

[0004] A medical container typically comprises a barrel forming a reservoir for containing the medical product. The barrel has a distal end in the form of a longitudinal tip that defines an axial passageway through which the medical product is discharged from the container. However, this longitudinal tip does not by itself allow for parenteral administration and must be provided with either a puncture needle or an adapter that allows for the connection of a syringe to a connector such as a needle hub or an intravenous (IV) line. The connector typically threads onto the adapter and engages the distal end of the medical container to establish a fluid pathway between the reservoir and the connector.

[0005] It is known for the adapter to be tightly secured to the longitudinal end of the medical container to prevent accidental disengagement during connection to the longitudinal end of the connector or caused by fluid pressure within the drug delivery device and the connector.

[0006] For example, U.S. Patent No. 5,393,633 discloses that the adapter can be secured around the longitudinal tip of the syringe by mechanical attachment means defined on the longitudinal tip, such as, for example, a groove or ring, by snap-fit, or by frictional forces.

[0007] Patent document 2 discloses alternatively providing an adapter having an attachment ring that is shaped and configured such that when the adapter is attached around the longitudinal tip of the drug delivery device, a circumferential space is created between the attachment ring and the longitudinal tip, and this circumferential space typically accommodates an adhesive layer to efficiently adhere the adapter to the longitudinal tip.

[0008] US Patent No. 5,399,663 further discloses an injection device and an adapter that allows for safe connection of the adapter to the injection device with a view to further connecting an IV (intravenous) connector to the injection device. US Patent No. 5,399,663 discloses a drug delivery device having an end piece and an adapter for engaging around the end piece to allow for safe connection of a connector on the end piece. US Patent No. 5,399,663 discloses an adapter intended for use with a drug delivery device having an end piece, the adapter having an engageable collar around the end piece to allow for safe connection of a connector onto the collar.

[0009] However, it is also important that the connector is properly threaded onto the adapter. Thus, to obtain proper seating of the connector onto the distal end of the medical container, the user must apply sufficient torque when threading the connector onto the adapter. Under-twisting or over-twisting the connector onto the adapter can inherently cause the connector to leak or erupt due to internal pressure when transferring fluid between the container and the connector.

[0010] However, some connectors may abut against the distal face of the adapter when threaded onto the adapter, and when such abutment occurs, further rotation of the needle hub relative to the adapter creates contact between the connector and the adapter prior to proper connection of the connector to the adapter.

[0011] This premature contact can give the user the false impression that sufficient threading torque is achieved, but the connector is not yet properly attached to the distal end of the medical container. That is, when the user stops threading, thinking the connection is complete, the connector does not fully engage the distal end, leaving a gap between the connector and the outer surface of the distal end. Such a gap can result in leakage when transferring fluid from the reservoir of the medical container to the connector. [Prior art documents] [Patent documents]

[0012] [Patent Document 1] International Publication No. 2015 / 007650 [Patent Document 2] International Publication No. 2016 / 198580 [Patent Document 3] International Publication No. 2010 / 052517 [Patent Document 4] European Patent No. 2545956 [Patent Document 5] International Publication No. 2012 / 049532 Summary of the Invention [Problem to be solved by the invention]

[0013] Therefore, a need exists for a medical container that prevents improper attachment and the risk of leakage between the connector and the distal tip even when the connector abuts the distal face of the adapter when the connector is threaded onto the adapter. [Means for solving the problem]

[0014] One aspect of the invention is a medical container forming a reservoir for containing a medical product and having a longitudinal distal tip extending along a longitudinal axis A, the distal tip defining a passageway in fluid communication with the reservoir, the distal tip comprising: a mating portion configured to mate with the connector; a mounting portion disposed proximally relative to the mating portion and configured to slidably connect the adapter to the distal tip; The mounting portion is characterized in that it is configured to allow free longitudinal movement of the adapter relative to the distal tip when the adapter is connected to the distal tip.

[0015] In this way, the medical container of the present invention allows the adapter to slide proximally along the distal tip when the connector abuts against the distal face of the adapter. This prevents the screwing torque from increasing before the connector is fully locked onto the distal tip. Therefore, the user will continue to screw the connector until it is properly mated with the distal tip of the medical container. As a result, the risk of leakage is avoided.

[0016] In one embodiment, the attachment portion comprises a guiding means configured to guide translational movement of the adaptor relative to the distal tip and to prevent rotation of the adaptor relative to the distal tip.

[0017] Translational motion is longitudinal motion along the longitudinal axis A.

[0018] In one embodiment the guiding means comprises at least one longitudinal protrusion, preferably three longitudinal protrusions.

[0019] This allows translational movement of the adapter along the tip and prevents any rotation of the adapter around the tip. The attachment of the distal tip may be made of glass or plastic material and is indeed highly stressed when the connector is fixed to the adapter. A single longitudinal protrusion is easier to manufacture. However, three longitudinal protrusions provide efficient guidance along the longitudinal direction A and efficient prevention of any rotation about the longitudinal axis A.

[0020] In one embodiment, the mounting portion has a cylindrical shape.

[0021] Thus, the fitting guides the adapter all the way along the fitting with reduced friction.The fitting has a constant outer diameter.

[0022] By cylindrical, it is meant that the mounting part has the shape of any straight cylinder, the bottom of which may be a circle, or a polygon, a square, an ellipse, or any other non-circular geometric shape. A mounting part with a non-circular cross-section allows guiding the adapter in the longitudinal direction while preventing rotation of the adapter about the distal tip. A mounting part with such a non-circular shape may form a guiding means instead of at least one longitudinal protrusion. However, a mounting part with a circular cross-section is easier to manufacture.

[0023] In one embodiment, the medical container includes a blocking means configured to limit free longitudinal movement of the adapter relative to the distal tip.

[0024] In one embodiment, the blocking means comprises a distal abutment surface and a proximal abutment surface.

[0025] The distal abutment surface prevents removal of the adapter from the distal tip of the medical container and helps to maintain the closure cap of the medical container by blocking the adapter in its most distal position, while the proximal abutment surface prevents the adapter from being engaged too far at the distal tip by blocking the adapter in its most proximal position, in which case it would no longer be possible to engage the external thread of the connector with the internal thread of the adapter.

[0026] In one embodiment, the distal and proximal abutment surfaces are each provided on a projection.

[0027] The adapter is free to move relative to the distal tip along a predefined amplitude a along the longitudinal axis A. Free longitudinal movement means that the adapter slides along the tip while it is simply pushed axially proximally or distally. This predefined amplitude a may be configured to be 0.9 mm-1.3 mm, preferably about 1.1 mm, along the longitudinal axis A. That is, the blocking means may be configured such that the amplitude a of the free longitudinal movement of the adapter is configured to be 0.9 mm-1.3 mm, preferably about 1.1 mm. The larger the tip outer diameter, the smaller the amplitude a needs to be. Conversely, the smaller the tip outer diameter, the larger the amplitude a needs to be.

[0028] Another aspect of the invention is an adapter for connecting the aforementioned medical container, the adapter comprising a connection means configured to cooperate with a complementary connection means on the connector, and an attachment ring for attaching the adapter to a distal tip of the medical container, the attachment ring configured to slidably engage an attachment portion of the distal tip.

[0029] In one embodiment, the attachment ring defines a through opening whose diameter is at least equal to, and preferably greater than, the outer diameter of the attachment portion of the distal tip.

[0030] Thus, there is no radial compression exerted by the attachment ring on the attachment portion of the distal tip.

[0031] Preferably, the difference between the diameter of the through opening and the outer diameter of the mounting part is comprised between 0.1 mm and 0.3 mm, typically 0.2 mm.

[0032] In one embodiment, the mounting ring is in the form of a frusto-conical disk.

[0033] The disk is angled distally relative to the tubular wall of the adapter, which reduces the insertion force while increasing the withdrawal force of the adapter.

[0034] Another aspect of the invention is a drug delivery device comprising a medical container as described above and an adapter as described above, the adapter being slidably attached to a mounting portion at the distal tip.

[0035] The adapter is free to move relative to the distal tip along a predetermined amplitude, which is preferably comprised between 0.9 mm and 1.3 mm along the longitudinal axis A.

[0036] In one embodiment, the drug delivery device further includes a needle hub having an inner conduit configured to fit over the distal tip and outer wings configured to engage internal threads of the adapter, the needle hub including a ramp for guiding a user's finger toward the pivot arm to move the pivot arm back toward a safe position where the pivot arm covers the needle.

[0037] The invention and the advantages arising therefrom will become clearly apparent from the detailed description given below, taken in conjunction with the accompanying drawings, in which: [Brief description of the drawings]

[0038] [Figure 1] 1 is a perspective view of a medical container according to one embodiment of the present invention. [Diagram 2] FIG. 2 is a perspective view of an adapter, according to one embodiment of the present invention. [Diagram 3] 1 is a cross-sectional view of a drug delivery device according to one embodiment of the present invention. [Figure 4A] 1 is a cross-sectional view of a drug delivery device according to one embodiment of the present invention when the needle hub is screwed onto the adapter. [Figure 4B] 1 is a cross-sectional view of a drug delivery device according to one embodiment of the present invention when the needle hub is screwed onto the adapter. [Diagram 5] FIG. 1 is a perspective view of a needle hub for cooperation with a drug delivery device, according to one embodiment of the present invention. [Figure 6] 1 is a cross-sectional view of a needle hub for cooperation with a drug delivery device according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0039] 1-4B, there is shown a medical container 1, an adapter 2, and a drug delivery device 3 according to one embodiment of the present invention. The drug delivery device 3 is intended to cooperate with a connector, such as the needle hub 40 shown in Figures 5 and 6.

[0040] As shown in Figure 1, the medical container 1 comprises a barrel 10 defining a reservoir for containing a medical product. A distal tip 11 defining a passage in fluid communication with the reservoir extends longitudinally along a longitudinal axis A of the medical container 1. The medical container 1 may be made of a glass or plastic material. The distal tip 11 may in turn be made by either glass molding or injection molding.

[0041] The distal tip 11 of the medical container 1 has a mounting portion 110. The mounting portion 110 is configured to receive a mounting ring 22 of the adapter 2 for connecting the adapter 2 onto the tip 11, as shown in FIG. 3. The mounting portion 110 preferably extends to a proximal region of the distal tip 11. More specifically, the mounting portion 110 may be closer to the distal shoulder 12 of the barrel 10 than the distal face 112 of the longitudinal tip 11. Typically, if the distal tip 11 is divided into thirds, the mounting portion 110 is located in the proximal-most third of the distal tip 11.

[0042] The distal tip 11 further comprises a mating portion 113. The mating portion 113 extends distally from the attachment portion 110. The mating portion 113 is configured to mate with an internal conduit of the needle hub 40 to establish a fluid pathway from a reservoir of the medical container 1 to a needle (not shown) of the needle hub 40. The mating portion 113 preferably has a frusto-conical shape.

[0043] According to the invention, the mounting portion 110 of the distal tip 11 is provided with guiding means for guiding longitudinal sliding movement of the adapter 2 along the longitudinal axis A and for preventing rotational movement of the adapter 2 relative to the distal tip 11 about the longitudinal axis A.

[0044] As a result, the adapter 2 is free to move relative to the distal tip 11 along a predetermined amplitude a. The predetermined amplitude a is defined by the difference between the length L of the mounting portion 110 and the thickness of the mounting ring 22, as shown in FIG. 3. This predetermined amplitude a may be configured between 0.9 mm and 1.3 mm, preferably about 1.1 mm, along the longitudinal axis A. The adapter 2 is free to slide along the longitudinal axis A within the predetermined amplitude a, i.e. between the most distal and most proximal positions of the adapter 2 when the adapter 2 is attached to the distal tip 11.

[0045] This longitudinal movement of the adapter 2 relative to the tip 11 allows the distance d between the distal face 112 of the tip 11 and the distal face 24 of the adapter 2 to be changed, as seen in Figures 4A and 4B. As a result, the adapter 2 may be pushed proximally by the needle hub 40 abutting against the distal face 24 of the adapter 2, thereby increasing the distance d. This allows the distal tip 11 to properly fit into the internal conduit of the needle hub 40. The risk of leakage due to insufficient threading of the needle hub 40 into the adapter 2 due to contact between the needle hub 40 and the distal face 24 of the adapter 2 is thus avoided.

[0046] 1, the guiding means may comprise at least one longitudinal protrusion 114. The at least one longitudinal protrusion 114 extends in a linear direction parallel to the longitudinal axis A. Instead of a longitudinal groove, which would form a recess with respect to the outer wall of the mounting portion 110, having a protrusion protruding from the outer wall of the mounting portion 110 has the advantage of strengthening rather than weakening the mounting portion 110 and the tip portion 11.

[0047] It should be noted that the outer diameter of the attachment portion 110, excluding the protrusions 114, 117, 119, is equal to or smaller than, and preferably equal to, the maximum outer diameter of the mating portion 113 of the distal tip 11. In other words, the attachment portion 110 of the distal tip 11 is preferably not thinner than the other parts of the tip 11. As a result, the attachment portion 110 does not have any grooves or recesses. This limits the risk of breakage, especially when the medical container 1 is made of glass.

[0048] As shown in FIG. 1, the at least one longitudinal projection 114 may be in the form of a longitudinal rib that extends all the way along the mounting portion 110 .

[0049] At least one longitudinal protrusion 114 may have a rounded shape, as shown in Figure 1. At least one protrusion 114 may define a concave lateral edge 115.

[0050] Preferably, the guiding means may comprise three longitudinal protrusions 114. Having three longitudinal protrusions 114 provides a satisfactory redistribution of the screwing torque around the tip 11 to avoid breakage, especially if the tip 11 is made of glass, without complicating the manufacturing process. The three longitudinal protrusions 114 may be regularly distributed around the mounting part 110. However, the guiding means may have fewer or more longitudinal protrusions 114 than three.

[0051] The mounting portion 110 preferably has a cylindrical shape. Alternatively or complementary to the at least one longitudinal projection 114, the guiding means may comprise a mounting portion 110 having a square, elliptical, polygonal or any other non-circular cross-sectional shape. Such a shape allows the adapter 2 to slide along the mounting portion 110 without rotating around it.

[0052] 1 or 3-4B, the mounting portion 110 may further comprise a blocking means for blocking translational movement of the adapter 2 relative to the tip portion 11.

[0053] The blocking means may comprise a first abutment surface 116 for blocking the adapter 2 in the distal direction respectively. The first abutment surface 116 further prevents withdrawal of the adapter 2. In the most distal position (FIG. 3), the attachment ring 22 abuts against the first abutment surface 116.

[0054] The first abutment surface 116 defines the distal end of the mounting portion 110. The first abutment surface 116 may be disposed proximal of a first perpendicular radial projection 117 that projects from an outer wall of the distal tip 11. If the first abutment surface 116 is present, it is defined by the projection 117 instead of being defined by a shoulder. The first perpendicular radial projection 117 may be in the form of a circumferential rib that extends around the entire circumference of the tip 11.

[0055] 3, the first perpendicular radial projection 117 may have a ramp 120 provided on the distal side of the projection 117 to facilitate passage of the mounting ring 22 of the adapter 2 over the first perpendicular radial projection 117 in the proximal direction. This assists the user in mounting the adapter 2 to the mounting portion 110 of the tip portion 11.

[0056] The blocking means may comprise a second abutment surface 118 for respectively blocking the adapter 2 in the proximal direction. In the most proximal position (FIG. 4B), the mounting ring 22 abuts against the second abutment surface 118.

[0057] The second abutment surface 118 defines the proximal end of the mounting portion 110. The second abutment surface 118 may be disposed distal to a second perpendicular radial projection 119 that projects from an outer wall of the distal tip 11. If the second abutment surface 118 is present, it is defined by the projection 119 instead of being defined by a shoulder. The second perpendicular radial projection 119 may be in the form of a circumferential rib that extends around the entire circumference of the tip 11.

[0058] The second abutment surface 118 may be positioned such that when the adapter 2 is connected to the tip 11, the distance d between the distal surface of the tip 11 and the distal surface 24 of the adapter 2 is 2.7 mm or less. This allows the needle hub 40 to engage the adapter 2 even though the adapter 2 is in its most proximal position. In fact, if the distance d were too large, the needle hub 40 would not be able to engage the adapter 2 at all. More specifically, a maximum distance d of 2.7 mm allows the threads of the needle hub 40 to engage the threads 21 of the adapter 2 when the distal tip 11 has a large outer diameter.

[0059] The blocking means may define a length L of the attachment portion 110. With reference to Figure 3, this length L may be defined by the distance between the first and second abutment surfaces 116, 118.

[0060] FIG. 4A shows the needle hub 40 mounted on the distal tip 11 having a first diameter, while FIG. 4B shows the needle hub 40 mounted on the distal tip 11 having a second diameter smaller than the first diameter. As can be seen in these figures, the sliding movement of the adapter 2 along the distal tip 11 allows the needle hub 40 to reach a predetermined position relative to the distal tip 11, where the needle hub 40 fits properly on the tip 11. This predetermined position is advantageously defined to be the leakage limit of the needle hub 40, as defined in ISO 80369-7 (2016) (paragraphs 6.1 and 6.2). If the needle hub 40 is underconnected and does not reach said position, leakage may occur. The sliding movement allows the needle hub 40 to reach the leak limit position despite contact that may be generated between the needle hub and the distal face of the adapter 2.

[0061] 2 and 3, the present invention also relates to an adapter 2 configured to be connected to the attachment portion 110 of the tip portion 11.

[0062] The adapter 2 has a tubular wall 20 defining an internal cavity for receiving a needle hub 40. The internal cavity is provided with connection means, such as internal threads 21, for securing the needle hub 40 to the adapter 2.

[0063] The adapter 2 further has a mounting ring 22 that projects inwardly from the proximal end of the adapter 2. The mounting ring 22 allows for connection of the adapter 2 onto the distal tip 11.

[0064] The mounting ring 22 defines a through opening 23 for receiving the mounting portion 110 of the tip 11. The through opening 23 may be shaped to complementarily engage the mounting portion 110 of the tip 11. The thickness of the mounting ring 22 should be thick enough to prevent pull-out of the adapter 2, yet thin enough to avoid increasing the length of the mounting portion 110, and thus the length of the distal tip 11. For example, the thickness may be configured to be between approximately 0.6 mm and 1.4 mm.

[0065] The width or diameter of the through opening 23 may be at least equal to, and preferably greater than, the outer width or diameter of the mounting part 110, so that a clearance is provided between the mounting ring 22 and the mounting part 110, which favors a sliding movement of the adapter 2 relative to the tip 11.

[0066] 2, the mounting ring 22 includes at least one guide window 25. The at least one window 25 is configured to engage with the at least one longitudinal protrusion 114 to guide the sliding movement of the adapter 2 relative to the tip 11 and to prevent any rotation of the adapter 2 relative to the tip 11. To that end, the at least one guide window 25 and the longitudinal protrusion 114 may be complementary shaped, while allowing free sliding movement of the adapter 2 relative to the distal tip 11. Preferably, the at least one guide window 25 and the at least one longitudinal protrusion 114 are configured such that the adapter 2 and the distal tip 11 are snap-fit. For example, the at least one guide window 25 may be slightly larger than the at least one longitudinal protrusion 114. The adapter 2 may include as many guide windows 25 as there are longitudinal protrusions 114, for example, three guide windows as shown in FIG. 2.

[0067] 2, the at least one guide window 25 may open into the through opening 23 defined by the mounting ring 22. Thus, the adapter 2 may be clipped onto the mounting ring 22 and onto the at least one longitudinal protrusion 114. The at least one window 25 may have a lateral edge 26 configured to engage with a corresponding lateral edge 115 of the at least one longitudinal protrusion 114. This improves the clipping of the mounting ring 22 onto the at least one longitudinal protrusion 114. The lateral edge 26 may be part of a snap-fastening means for connecting the adapter 2 to the mounting part 110.

[0068] 3, the mounting ring 22 of the adapter 2 may be in the form of a resilient frusto-conical disk. The frusto-conical shape is inclined with respect to the longitudinal axis A and points in the distal direction. This increases the pull-out force of the adapter 2. This further aids in the passage of the adapter 2 over the first perpendicular radial projection 117. The inclined proximal side of the mounting ring 22 cooperates with the inclined portion 120 of the first perpendicular radial projection 117 to allow for resilient deformation of the mounting ring 22. Furthermore, the proximal side of the mounting ring 22 may be provided with a chamfered edge 27.

[0069] The adapter 2 may be made of any rigid polymer adapted for 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. To simplify its manufacture, the adapter 2 is preferably made of a single material, preferably an optically transparent material. The adapter 2 may be made by injection molding.

[0070] 5 and 6, the present invention further relates to a drug delivery device 3, comprising a medical container 1 and an adapter 2 connected to a distal tip 11 of the medical container 1. The drug delivery device 3 can be a syringe, such as a prefilled or prefillable syringe.

[0071] The drug delivery device 3 may include a connector such as a needle hub 40, as shown in Figures 5 and 6. The needle hub 40 includes a proximal end defining an internal conduit 45 for receiving the distal tip 11 of the medical container 1. The proximal end includes a connection means, such as two diametrically opposed outer wings 41, configured to engage with the connection means, e.g., the internal threads 21, of the adapter 2 to secure the needle hub 40 to the adapter 2. The needle hub 40 further includes a distal end that may include an attachment port 42 for attaching an injection needle, thereby establishing a fluid path from the reservoir to the injection needle. A pivot arm (not shown) may be connected to a pivot connection 43 in the form of a hook, the pivot arm configured to cover or uncover the injection needle. To help the user move the pivot arm back towards the injection needle, the needle hub 40 may include a ramp 44 configured to guide the user's fingers relative to the pivot arm. For example, the needle hub 40 may be a BD Eclipse®.

[0072] Thus, the present invention allows longitudinal movement of the adapter 2 relative to the tip 11 of the medical container 1. This axial freedom allows for a proper fit between the needle hub 40 and the distal tip 11 of the medical container 1 in all circumstances. More specifically, longitudinal movement of the adapter 2 relative to the tip 11 allows the needle hub 40 to reach a leak limit position even when the needle hub 40 abuts against the distal face of the adapter 2. Longitudinal movement of the adapter 2 relative to the tip 11 allows the needle hub 40 to reach a leak limit position regardless of the diameter of the distal tip 11. As a result, the risk of leakage due to an improper fit between the tip 11 and the needle hub 40 is avoided.

Claims

1. A medical container (1) forming a reservoir for containing a medical product and having a longitudinal distal tip (11) extending along a longitudinal axis (A), said distal tip (11) defining a passage in fluid communication with said reservoir, said distal tip (11) comprising: - a mating part (113) adapted to mate with a connector; - a mounting portion (110) arranged proximally with respect to said mating portion (113) and configured for slidably connecting an adapter (2) to said distal tip (11); the attachment portion (110) is configured to allow free longitudinal movement of the adapter (2) relative to the distal tip (11) when the adapter (2) is connected to the distal tip (11); the mounting portion (110) comprises a guiding means configured to guide translational movement of the adapter (2) relative to the distal tip (11) and to prevent rotation of the adapter (2) relative to the distal tip (11); said guiding means comprising at least one longitudinal projection (114) adapted to engage with at least one guiding window (25) of a mounting ring (22) of said adapter (2); and The at least one longitudinal protrusion (114) has a radially rounded outer portion and defines a lateral edge-like recess (115) formed between the at least one longitudinal protrusion (114) and an outer wall of the mounting part (110), the lateral edge-like recess (115) being configured to receive a lateral edge (26) formed on a radially inner portion of the mounting ring (22) around the at least one guide window (25), thereby enabling a snap-fit ​​connection between the adapter (2) and the mounting part (110) of the distal tip (11).

2. 2. The medical container (1) according to claim 1, characterized in that the attachment portion (110) has a cylindrical shape.

3. A medical container (1) as claimed in claim 1 or 2, characterized in that it comprises a blocking means configured to limit free longitudinal movement of the adapter (2) relative to the distal tip (11).

4. 4. The medical container (1) according to claim 3, characterized in that the blocking means comprises a distal abutment surface (116) and a proximal abutment surface (118).

5. 5. The medical container (1) according to claim 4, characterized in that the distal abutment surface (116) and the proximal abutment surface (118) are provided on protrusions (117, 119), respectively.

6. A medical container (1) according to any one of claims 3 to 5, characterized in that the blocking means is configured such that the amplitude (a) of the free longitudinal movement of the adapter (2) is between 0.9 mm and 1.3 mm.

7. An adapter (2) to be connected to a medical container (1) according to any one of claims 1 to 6, said adapter (2) having connection means for connecting a connector adapted to cooperate with complementary connection means provided on the connector, and a mounting ring (22) for mounting said adapter (2) to a distal tip (11) of said medical container (1), said mounting ring (22) adapted to slidably engage with said mounting portion (110) of said distal tip (11), said mounting ring (22) being adapted to engage with at least one longitudinal protrusion (110) of said mounting portion (110) for guiding a sliding movement of said adapter (2) relative to said tip (11) and for preventing any rotation of said adapter (2) relative to said tip (11).

1. An adapter (2) comprising at least one guide window (25) adapted to engage with a corresponding lateral edge-like recess (115) formed in a radially inner portion of the mounting ring (22) around the at least one guide window (25), the lateral edge (26) being adapted to engage with a corresponding lateral edge-like recess (115) formed between the at least one longitudinal projection (114) and an outer wall of the mounting part (110), the at least one longitudinal projection (114) having a radially rounded outer portion, the lateral edge (26) forming a snap-fit ​​means for connecting the adapter (2) to the mounting part (110).

8. 8. The adapter (2) of claim 7, wherein the mounting ring (22) defines a through opening (23) whose diameter is at least equal to or greater than the outer diameter of the mounting portion (110) of the distal tip (11).

9. 9. An adapter (2) according to claim 7 or 8, characterized in that the mounting ring (22) is in the form of a frusto-conical disk.

10. A drug delivery device (3) comprising a medical container (1) described in any one of claims 1-6 and an adapter (2) described in any one of claims 7-9, characterized in that the adapter (2) is slidably attached to the mounting portion (110) of the distal tip portion (11).

11. 11. The drug delivery device (3) of claim 10, further comprising a needle hub (40) having an inner conduit configured to fit onto the distal tip (11) and outer wings (41) configured to engage with the inner threads (21) of the adapter (2), wherein the needle hub (40) includes a ramp (44) for guiding a user's finger towards the pivot arm to move the pivot arm back to a safe position where the pivot arm covers the needle.

Citation Information

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