Passive safety device, injection device including same, and method for manufacturing said injection device

Abstract

The passive safety device (1) comprises a sleeve (2) having a proximal end configured to be secured to the distal tip of the injection device (100), a hub (4) slidably mounted on the sleeve (2) between a pre-use position, an injection position in which the hub (4) is located proximal to the pre-use position, and a safety position in which the hub (4) is located distal to the injection position, a biasing element (6) configured to urge the hub (4) distally toward the safety position, and a protector (8) configured to slide between the sleeve (4) and the pre-use position and the injection position. The safety device (1) further comprises first blocking means configured to block distal movement of the protector (8) when the hub (4) is in the injection position to prevent the protector (8) from sliding back distally with the hub (4), and second blocking means configured to block proximal movement of the hub (4) when the hub (4) is in the safety position.

Description

[Technical field]

[0001] The present invention relates to a passive needle safety device, an injection device such as a pre-filled syringe comprising this passive needle safety device, and a method for manufacturing said injection device.

[0002] In this application, the distal end of a component or device should be understood to mean the end furthest from the user's hand, and the proximal end should be understood to mean the end closest to the user's hand. Similarly, in this application, the "distal direction" should be understood in relation to the passive safety device or injection device of the present invention as meaning the injection direction, and the "proximal direction" should be understood to mean the direction opposite to said injection direction, i.e., towards the user's hand.

[0003] Injection devices, such as fillable or prefilled syringes, typically comprise a hollow body or barrel forming a container for 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. The distal end is equipped with a needle designed to be inserted into the skin of a patient so that the product to be injected passes to an injection site.

[0004] To minimise the risk of needlestick injuries, it is known to provide injection devices with a safety device which protects the needle after injection, typically comprising a sleeve which slides over the distal end of the injection device and covers the needle after withdrawal from the injection site.

[0005] A safety device may be active or passive. An active safety device must be activated by the user, i.e., the user must take a specific action to trigger needle protection once the injection is complete. In contrast, a passive safety device does not require the user to take any action to ensure that the needle is protected once the injection is complete.

[0006] Patent document 1 discloses such a passive safety device. The safety device comprises a sleeve axially slidable between a needle-protecting position and an unprotecting position. The proximal portion of the sleeve is configured to deform radially outward to reach the unprotected position. This deformation allows the proximal portion of the sleeve to store energy so that, upon removal of the needle from the injection site, the proximal portion of the sleeve acts as a spring to return the entire sleeve to its initial protective position. However, to achieve an effective spring effect, the proximal portion of the sleeve needs to be deformed to the maximum extent. This involves the needle being inserted into the injection site a significant distance. This can be stressful or harmful to the user. Furthermore, as mentioned above, the proximal portion of the sleeve is configured to extend radially outward. This outward deformation makes the safety device quite cumbersome in the radial direction. Moreover, the deformation of the sleeve is visible and can be worrying to the user.

[0007] US Pat. No. 5,399,633 and US Pat. No. 5,499,623 disclose needle guards.

[0008] There is therefore a need for a more compact and easy to manufacture passive safety device, said safety device allowing reliable protection of the needle once the injection is completed. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] International Publication No. 2011 / 098831 Brochure [Patent Document 2] U.S. Pat. No. 4,894,055 [Patent Document 3] International Publication No. 2013 / 192328 Brochure Summary of the Invention

[0010] An aspect of the present invention is a passive safety device comprising: a sleeve having a proximal end configured to be secured to a distal tip of the injection device; a hub slidably mounted on the sleeve between a pre-use position, an injection position in which the hub is proximal to the pre-use position, and a safety position in which the hub is distal to the injection position; a biasing element configured to urge the hub distally toward the safe position; a protector configured to slide with the hub against the sleeve between the pre-use position and the injection position, the safety device comprising: a first blocking means configured to block distal movement of the protector when the hub is in the injection position and to prevent the protector from sliding distally with the hub; and a second blocking means configured to block proximal movement of the hub when the hub is in the safe position.

[0011] The needle safety device of the present invention is therefore compact and easy to manufacture whilst allowing reliable protection of the needle after injection.

[0012] In this application, "passive safety device" means a needle safety device that does not require the user to take any action after an injection to protect the needle after it is removed from the injection site.

[0013] In one embodiment the first blocking means is a first snap means configured to snap the protector with the sleeve when the hub reaches the injection position.

[0014] This provides a safety device that is compact and easy to manufacture.

[0015] In one embodiment, the first snap means is provided on the protector.

[0016] This feature increases the compactness of the safety device.

[0017] In one embodiment, the first snap means includes at least one first resilient leg slidably engaged in a longitudinal slot of the sleeve when the hub moves from the pre-use position towards the injection position, said at least one first resilient leg configured to deform radially relative to a distal side of the blocking member of the sleeve and to abut a proximal side of said blocking member when the hub is in the injection position.

[0018] This provides a compact and easy to manufacture solution for blocking distal movement of the protector when the hub is in the injection position.

[0019] In one embodiment the second blocking means is a second snap means configured to snap the hub when it reaches said safe position.

[0020] This provides a safety device that is compact and easy to manufacture.

[0021] In one embodiment, a second snap means is provided on the protector.

[0022] This feature increases the compactness of the safety device.

[0023] In one embodiment, the second snap means comprises at least one second resilient leg slidably engaged in a proximal slot of the hub when the hub moves from the injection position towards the safety position, said at least one resilient leg configured to deform radially relative to a distal side of the blocking member of the hub and abut a proximal side of said blocking member when the hub is in the safety position.

[0024] This provides a compact and easily manufactured solution for blocking proximal movement of the hub once it reaches the safe position.

[0025] In one embodiment, the hub includes a proximal extrusion surface defining a proximal end of a proximal slot in the hub, the proximal extrusion surface configured to abut against at least one second resilient leg to cause the protector to slide with the hub as the hub moves from the pre-use position to the injection position.

[0026] This improves the compactness of the safety device.

[0027] In one embodiment, the second snap means comprises at least one second resilient leg slidably engaged in a proximal slot of the hub when the hub moves from the injection position towards the safety position, said at least one resilient leg configured to deform radially relative to a distal side of the blocking member of the hub and abut a proximal side of said blocking member when the hub is in the safety position.

[0028] The longitudinal legs of the sleeve may include radial projections configured to abut a distal side of the retaining member in the pre-use position of the hub to retain the hub in this pre-use position and against the action of the biasing element.

[0029] In one embodiment, the hub includes at least one internal retaining element, such as a retaining hook, the biasing element includes a distal end that abuts said internal retaining element to exert a distal force on the hub, and the sleeve has a longitudinal slot with an open distal end to allow said at least one retaining element to pass through and slide into said longitudinal slot as the hub moves toward the injection position.

[0030] This improves the compactness of the safety device.

[0031] In one embodiment, the protector includes a support ring, the first blocking means includes at least one first resilient leg extending proximally from said support ring, and the second blocking means includes at least one second resilient leg extending distally from said support ring.

[0032] As a result, the first elastic leg and the second elastic leg are located on opposite sides of the support ring, which improves the compactness of the safety device.

[0033] In one embodiment, the at least one first resilient leg and the at least one second resilient leg are offset circumferentially about the support ring.

[0034] As a result, the first elastic legs and the second elastic legs alternate along the support ring, which improves the compactness of the safety device.

[0035] In one embodiment, the protector is made up of two pieces that are adapted to be assembled directly together on the hub.

[0036] This simplifies the manufacture of the safety device. Each of the two parts forming the protector may correspond to one half of the semicircle of said support ring. The two parts may be identical.

[0037] Another aspect of the invention is an injection device comprising a passive safety device as described above.

[0038] Another aspect of the invention is a method for producing an injection device as described above, comprising the steps of: (i) securing the needle of the passive needle safety device to a distal tip of the injection device; (ii) disposing the biasing element of the passive needle safety device in the sleeve; (iii) positioning the hub of the passive needle safety device onto the sleeve against the action of the biasing element; (iv) disposing the protector of the passive needle safety device over the hub and the sleeve. [Brief description of the drawings]

[0039] The invention and the advantages arising therefrom will become apparent from the detailed description given below with reference to the accompanying drawings, in which: [Figure 1]FIG. 1 is a perspective view of a safety device according to one embodiment of the present invention. [Diagram 2] FIG. 2 is an exploded view of a safety device according to one embodiment of the present invention. [Figure 3A] FIG. 3A is a perspective view of a sleeve of a safety device according to an embodiment of the present invention. [Figure 3B] FIG. 3B is a side view of a sleeve of a safety device according to one embodiment of the present invention. [Figure 4] FIG. 4 is a perspective view of a hub of a safety device according to an embodiment of the present invention. [Diagram 5] FIG. 5 is a perspective view of a protector of a safety device according to an embodiment of the present invention. [Figure 6] FIG. 6 is a perspective view of an exploded protector of a safety device according to an embodiment of the present invention. [Figure 7A] FIG. 7A is a side view of a cap of an injection device according to an embodiment of the present invention. [Figure 7B] FIG. 7B is a cross-sectional view of an injection cap according to one embodiment of the present invention. [Figure 8] FIG. 8 is a perspective view of a safety device according to one embodiment of the present invention in a pre-use position. [Figure 9] FIG. 9 is a perspective view of a safety device according to one embodiment of the present invention in an injection position. [Figure 10] FIG. 10 is a perspective view of a safety device according to one embodiment of the present invention in a safety position. [Figure 11] FIG. 11 is a cross-sectional view of a safety device according to one embodiment of the present invention in a pre-use position. [Figure 12] FIG. 12 is a cross-sectional view of a safety device according to one embodiment of the present invention in an injection position. [Figure 13] FIG. 13 is a cross-sectional view of a safety device according to one embodiment of the present invention in a safety position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0040] 1, there is shown a passive safety device 1 according to one embodiment of the present invention. The passive safety device 1 is configured to cover the needle 102 of an injection device 100 at the end of an injection to prevent needlestick injuries.

[0041] The safety device 1 may adopt three successive positions: a pre-use position in which the safety device 1 is ready to perform an injection (FIGS. 1, 8, 11), an injection position in which the safety device 1 exposes the needle 102 to allow it to enter the injection site (FIGS. 9, 12), and a safety position in which the safety device 1 covers the needle 102 to prevent needle stick injuries (FIGS. 10, 13). The pre-use position and the safety position may be the same or different.

[0042] 1, 2, 3A and 3B, the safety device 1 includes a sleeve 2 configured to be fixedly attached to the distal tip 104 of the injection device 100, a hub 4 slidably attached to the sleeve 2, a biasing element 6 which urges the hub 4 in a distal direction, and a protector 8 slidably attached to the sleeve 2. The safety device 1 further comprises first blocking means configured to block the protector 8 when the hub 4 reaches the injection position, and second blocking means configured to block the hub 4 when the hub 4 is in the safety position, which will be described in more detail below.

[0043] The tubular sleeve 2 extends longitudinally along a longitudinal axis A. The sleeve 2 is configured to surround the distal tip 104 and a proximal portion of the needle 102. The sleeve 2 includes a proximal end and an opposite distal end. The proximal end is configured to be secured to the distal tip 104 of the injection device 100, for example, by gluing, threading, interlocking, press-fitting, etc. The sleeve 2 includes a blocking member that may be located at the proximal end of the sleeve 2 and may be in the form of a locking ring 20. As seen in FIG. 3A, the locking ring 20 defines a central through opening 204 that accommodates the distal tip 104. The locking ring 20 also has a proximal side and an opposite distal side. The distal side may define an inclined surface 200. The proximal side may define an abutment surface 202.

[0044] The sleeve 2 may further comprise one or several longitudinal legs 22 separated from each other by longitudinal slots 24. The longitudinal legs 22 and the longitudinal slots 24 may extend parallel to the longitudinal axis A. The longitudinal slots 24 may be open at their distal ends and closed at their proximal ends by the fixing ring 20. The longitudinal legs 22 may have a free distal end that may form the distal end of the sleeve 2 and an opposite proximal end that may be connected to the fixing ring 20. The longitudinal legs 22 thus extend distally from said fixing ring 20. The longitudinal legs 22 may be regularly distributed along the fixing ring 20. The longitudinal legs 22 of the sleeve 2 may be configured to deflect radially inwards. The longitudinal legs 22 may comprise radial projections 220, such as radial projections 220 extending outwards, the function of which will appear below. The radial projection 220 may be located at a free distal end of the longitudinal leg 22. The radial projection 220 has a proximal side which may define a possible tilt, deflection and / or retention surface 222 and a distal side which may define a blocking surface 224.

[0045] 1, 2 and 4, the hub 4 extends longitudinally along a longitudinal axis A. The hub 4 surrounds the sleeve 2. More specifically, the hub 4 is slidably mounted to the sleeve 2 along the axis A between a pre-use position (FIGS. 1, 8, 11), in which a distal end of the hub 4 may be configured to be positioned distally beyond the tip of the needle 102 so as to cover the needle 102, an injection position (FIGS. 9, 12), in which the hub 4 is retracted proximally relative to the pre-use position to expose the needle 102, and a safety position (FIGS. 10, 13), in which the distal end of the hub 4 is configured to extend distally beyond the tip of the needle 102 so as to cover the needle 102 to avoid needle stick injury.

[0046] The tubular hub 4 has a distal end and an opposite proximal end. The distal end defines a central opening 400 configured for the needle 102 to extend through said opening 40 to perform an injection. The distal end of the hub 4 further comprises an abutment surface 402 configured to contact an injection site, typically the skin of a patient, and to press the hub 4 proximally against the injection site as the needle 102 enters the injection site. The abutment surface 402 may surround the opening 400. As shown in FIG. 4, the proximal end of the hub 4 defines an opening 44 that receives the sleeve 2.

[0047] The hub 4 includes a blocking member that may be located at a proximal end of the hub 4. The blocking member may be in the form of a blocking ring 46. The blocking ring 46 has a proximal side and an opposite distal side. As best shown in FIG. 4, the proximal side defines a blocking surface 460. The distal side may define an angled deflection surface 462.

[0048] The hub 4 includes one or more proximal slots 48 extending parallel to the longitudinal axis A. The proximal slots 48 may extend upwardly and may be aligned with the longitudinal legs 22 of the sleeve 2. The proximal slots 48 are closed at their proximal ends by a blocking ring 46. The proximal slots 48 may also be closed at their distal ends by a pushing surface 410 configured to push the protector 8 proximally as the hub 4 moves toward the injection position, causing the protector 8 to slide with the hub 4 toward the injection position.

[0049] The hub 4 may comprise one or more distal slots 49 extending parallel to the longitudinal axis A. The distal slots 49 are aligned with and located distally relative to the proximal slots 48. The distal slots 49 may be closed at their proximal end by a distal ring 40, which may form the distal end of the hub 4 and thus delimit the central opening 400 and the abutment surface 402. The distal slots 49 may be closed at their proximal end by a distal retaining surface 412. The distal retaining surface 412 may be configured to abut against the radial projections 220 of the longitudinal legs 22 so as to maintain the hub 4 in a pre-use position against the force exerted by the biasing element 6 prior to injection. The proximal slots 48 and / or the distal slots 49 may be regularly distributed along the circumferential direction of the hub 4.

[0050] The radial projections 220 of the sleeve 2 and the distal slots 49 of the hub 4 may also function as guiding means to guide the translation of the hub 4 relative to the sleeve 2 .

[0051] The hub 4 may include a retaining member that may be located at the distal end of the proximal slot 48 and / or the proximal end of the distal slot 49. The retaining member may be in the form of an intermediate ring 41 that may separate the proximal slot 48 from the adjacent distal slot 49. The intermediate ring 41 comprises a proximal side that may define an extrusion surface 410. The intermediate ring 41 comprises a distal side that may define a distal retaining surface 412. The distal retaining surface 412 may be inclined to favor an inward deformation of the longitudinal legs 22 of the sleeve 2 when the distal retaining surface 412 abuts against the radial projection 220. Thus, the radial projection 220 may disengage the distal slot 49 and engage the proximal slot 48 when the hub 4 moves towards the safe position.

[0052] The hub 4 may include one or more retaining elements, such as hooks 42, that may extend from an inner sidewall of the hub 4 to provide support to the distal end of the biasing element 6. These retaining elements are configured to enter and slide along the longitudinal slots 24 of the sleeve 2 as the hub 4 moves towards the injection position, thereby causing the biasing element 6 to store energy.

[0053] The biasing element 6 may be, for example, a spring whose distal end is connected to the hub 4 by an inwardly projecting hook 42 and whose proximal end is secured between the sleeve 2 and the distal tip 104 .

[0054] 1, 2 and 5, the protector 8 surrounds the sleeve 2 and is located proximal to the hub 4. The protector 8 is configured to slide onto the sleeve 2 together with the hub 4 as the hub 4 moves from the pre-use position to the injection position. As such, the protector 8 includes a distal abutment surface 820 that is configured to be pushed by the extrusion surface 410 of the hub 4.

[0055] The protector 8 is further configured to be fixed relative to the sleeve 2 when the hub 4 moves from the injection position to the safety position. The safety device 1 therefore comprises first blocking means configured to prevent the protector 8 from moving back in a distal direction when the hub 4 moves from the injection position to the safety position. The first blocking means may preferably be in the form of first snap means configured to snap the protector 8 with the sleeve 2 as soon as the hub 4 reaches the injection position.

[0056] The first snap means may comprise first resilient legs 81 provided on the protector 8. The first resilient legs 81 may extend parallel to the longitudinal axis A and they may be located above or aligned with the longitudinal slots 24 of the sleeve 2.

[0057] When the hub 4 is moved from the pre-use position to the injection position, the free end of the first resilient leg 81 is engaged with the longitudinal slot 24 of the sleeve 2. Thus, the first resilient leg 81 and the longitudinal slot 24 may function as a guiding means for guiding the translation of the protector 8 relative to the sleeve 2 before the hub 4 reaches the injection position.

[0058] The first resilient leg 81 is configured to deform radially outwardly when it abuts the proximal side of the fixing ring 20 of the sleeve 2 , disengaging the longitudinal slot 24 and passing behind said fixing ring 20 .

[0059] The first resilient leg 81 may be inclined to favor radial deformation of the first resilient leg 81 and may include a proximal deflection surface 810 intended to abut the distal side of the fixation ring 20.

[0060] The first resilient leg 81 may include a distal abutment surface 812 configured to abut against the distal side of the fixation ring 20 to block distal movement of the protector 8 when the hub 4 is moving from the injection position to the safety position.

[0061] The first elastic body may further include a proximal abutment surface 814 configured, for example, to abut against the distal shoulder 108 of the injection device 100 to block proximal movement of the protector 8 when the protector 8 is in the injection position.

[0062] The first resilient legs 81 advantageously include hook-shaped portions 816 which may be located at their free ends, said hook-shaped portions 816 extending radially inwards to engage with the longitudinal slots 24 of the sleeve 2 before the hub 4 reaches the injection position, and said hook portions 816 disengage from said longitudinal slots 24 to be positioned proximally relative to the fixing ring 20 when the hub 4 reaches the injection position. The distal side of the hook-shaped portions 816 may define a distal abutment surface 812. The proximal side of the hook-shaped portions 816 may define a deflection surface 810 and / or a proximal abutment surface 814.

[0063] It should be noted that the safety device 1 may be configured to maintain a distance between the proximal end of the hub 4, more specifically, the block surface 460, and the distal abutment surface 812 of the first resilient leg 81.

[0064] The safety device 1 further comprises second blocking means configured to prevent the hub 4 from moving back in the proximal direction after the hub 4 has reached the safety position. The second blocking means may be in the form of second snap means configured to snap the hub 4 with the protector 8 and / or the sleeve 2 as soon as the hub 4 has reached the safety position.

[0065] The second snap means may comprise second resilient legs 82 provided on the protector 8. The second resilient legs 82 may extend parallel to the longitudinal axis A. They may be aligned with the proximal slots 48 of the hub 4.

[0066] When the hub 4 is moved from the pre-use position to the injection position, the free end of the second resilient leg 82 is engaged with the proximal slot 48 of the hub 4. Thus, the second resilient leg 82 and the proximal slot 48 may function as a guiding means for guiding the translation of the hub 4 relative to the protector 8 before the hub 4 reaches the safe position.

[0067] The second resilient leg 82 is configured to deform radially outward when it abuts the proximal side of the block ring 46 of the hub 4 , disengaging the proximal slot 48 and passing behind said block ring 46 .

[0068] The second resilient leg 82 may be angled to favor radial deformation of the second resilient leg 82 and may include a proximal deflection surface 822 intended to abut against the block ring 46.

[0069] The second resilient leg 82 may include a distal abutment surface 820 configured to abut against a distal side of the block ring 46 to block proximal movement of the hub 4 when the hub 4 is in the safe position. It is noted that the distal abutment surface of the second resilient leg 82 advantageously corresponds to the distal abutment surface 820 extruded by the extrusion surface 410 of the hub 4.

[0070] The second resilient legs 82 advantageously include hook-shaped portions 824 which may be located at their free ends, said hook-shaped portions 824 extending radially inwardly into the proximal slots 48 of the hub 4 before the hub 4 reaches the safe position and disengaging said proximal slots 48 to be positioned proximally relative to the block ring 46 when the hub 4 reaches the safe position. The distal side of the hook-shaped portions 816 may define a distal abutment surface 812. The proximal side of the hook portions may define a proximal deflection surface 822.

[0071] It is contemplated that the second snap means may alternatively or complementary include a longitudinal leg 22 of the sleeve 2 which may pass behind the intermediate ring 41 of the hub 4 when the hub 4 reaches the safe position, and the block surface 224 of the radial projection 220 may abut against the proximal side of the intermediate ring 41, thereby preventing the hub 4 from being returned in the proximal direction when the hub 4 is in the safe position.

[0072] The protector 8 advantageously comprises a support ring 80 surrounding the hub 4 and supporting both a first and a second resilient leg 81, 82. More specifically, the first resilient leg 81 extends proximally from said support ring 80, while the second resilient leg 82 extends distally from said support ring 80. The first and second resilient legs 81, 82 may be offset in the circumferential direction of the support ring 80, thereby alternating along the circumference of the support ring 80. The first and second resilient legs 81, 82 may be regularly distributed along the support ring 80.

[0073] 2 and 6, the protector 8 may be made of two parts 8a, 8b assembled together, each of said parts 8a, 8b corresponding to a semicircular half of said support ring 80. The two halves of the protector 8 may then be assembled directly around the hub 4. The two parts 8a, 8b may be identical. More specifically, the two parts 8a, 8b may comprise snap means to be fixed together. The snap means may comprise an axial slot 84 arranged to receive an axial rib 86 provided on the other part, and an axial rib 86 arranged to engage with the axial slot 84 of said other part. The two parts 8a, 8b of the protector 8 may further comprise guiding means, such as a rod 88 arranged to enter a hole 89 of the other part, and a hole 89 arranged to receive the rod 88 of said other part. The guiding means may be perpendicular to the longitudinal axis A and perpendicular to the joining line of said two parts 8a, 8b.

[0074] 1 and 2, the present invention also relates to an injection device 100, such as a pre-filled or pre-fillable syringe, comprising a barrel 106 defining a reservoir for a medical product, a distal tip 104 defining a passageway communicating with the reservoir, and a needle 102 fixed to the distal tip 104 to enable said medical product to be injected at an injection site. The injection device 100 further comprises a passive safety device 1 as described above, said safety device 1 fixed on the distal tip 104.

[0075] The barrel 106 defines a distal shoulder 108 separating the sleeve 2 from a groove intended to receive a first blocking means when the hub 4 reaches the injection position. The distal shoulder 108 may block proximal movement of the protector 8 relative to the sleeve 2, thereby preventing proximal movement of the hub 4 relative to the sleeve 2 when the hub 4 is blocked in a safe position by a distal abutment surface 820 of the protector 8.

[0076] 7A and 7B, the injection device 100 may further comprise a cap 110 configured to be attached to the safety device 1. The cap 110 may be made of two different materials, for example a first inner material 111 such as rubber or TPE and a second outer material 112 such as polycarbonate. The first material 111 may be soft and the second material 112 may be rigid. The inner material 111 may extend through one or more grooves in the second material 112 to provide one or more gripping surfaces 114 on the outer sidewall of the cap 110. The inner material 111 may have a portion 116 that is pierced by a needle when the cap is attached onto the safety device 1. This portion 116 may be surrounded by an inner protective sleeve 118 that may be made of the second material 112. The cap 110 defines a cavity 120 configured to accommodate the safety device 1. The cap 110 is configured to be removed by simply pulling the cap 110 in a distal direction.

[0077] The operation of the safety device 1 and injection device 100 of the present invention will now be described with reference to Figures 8-10 and 11-13.

[0078] A user may remove the cap 110 by first pulling the cap 110 distally along the longitudinal axis A. The safety device 1 is in a pre-use position as shown in FIGS.

[0079] The user may then apply the distal end of the hub 4 to the injection site and press the injection device 100 against the injection site (FIG. 11). This causes the hub 4 to slide proximally from the pre-use position to the injection position, with the needle 102 entering the injection site. The extrusion surface 410 of the hub 4 abutting the distal abutment surface 820 of the protector 8 causes the protector 8 to slide together with the hub 4 in the proximal direction relative to the sleeve 2. The distal end of the sleeve 2 slides distally within the distal slot 49 of the hub 4. The first resilient leg 81 slides proximally within the longitudinal slot 24 of the sleeve 2. The biasing element 6 stores energy as it is compressed by the proximal movement of the retaining element.

[0080] When the hub 4 reaches the injection device 100, the free end of the first resilient leg 81 abuts against the distal side of the fixing ring 20 and is radially deformed to move behind said fixing ring 20. Thus, the hook-shaped portion 814 of the first resilient leg 81 is blocked between the proximal side of the fixing ring 20 and the distal shoulder 108 of the barrel 106, thereby preventing the protector 8 from moving in the distal and proximal directions (Figures 9 and 12).

[0081] Once the injection is completed, the user withdraws the needle 102 from the injection by moving the injection device 100 away from the injection site. The biasing element 6 thus releases its stored energy, thereby causing the hub 4 to slide backwards relative to the sleeve 2 from the injection position towards the safety position in the distal direction. The protector 8, however, remains in the injection position due to the abutment of the distal abutment surface 812 of the hook-shaped portion 814 against the abutment surface 202 of the fixing ring 20. The second resilient leg 82 thus slides proximally into the proximal slot 48.

[0082] When the hub 4 reaches the safety position, the free end of the second elastic leg 82 abuts against the distal side of the block ring 46 of the hub 4 and thus deforms radially to move behind said block ring 46. The free ends of the longitudinal legs 22 of the sleeve 2 may before or at the same time abut against the distal side of the intermediate ring 41 and deform radially inwards to move behind said intermediate ring 41. The abutment of the proximal side of the block ring 46 against the distal abutment surface 820 of the free end of the second elastic leg 82 and / or the abutment of the proximal side of the intermediate ring 41 against the block surface 224 of the free end of the longitudinal leg 22 prevents the hub 4 from moving back in the proximal direction. The hub 4 in the safety position thus protects the needle 102 and avoids needlestick injuries.

[0083] The present invention also relates to a method for manufacturing the above-mentioned injection device 100, comprising: (i) securing the needle onto the distal tip 104 of the injection device 100; (ii) placing said biasing element 6 on said sleeve 2; (iii) placing the hub 4 on the sleeve 2 against the action of the biasing element 6; (iv) placing a protector 8 onto the hub 4 and the sleeve 2; Includes.

[0084] Steps (ii) and (iii) may be carried out simultaneously.

[0085] Step (iii) may involve preloading the biasing element 6 until the distal ends of the legs of the sleeve 2 abut the distal side of the intermediate ring 41 of the hub 4 .

[0086] Step (iv) may include assembling the two part protector 8 directly around the hub 4 and sleeve 2. It will be appreciated that by assembling the two part protector 8 directly around the hub 4 and sleeve 2, this assembly results in the protector 8 being assembled and positioned on the hub 4 and sleeve 2 in a ready-to-use state. This step may be performed by the above-mentioned snap and / or guide means of the two halves of the protector 8.

Claims

1. A passive safety device (1), comprising: a sleeve (2) having a proximal end configured to be secured to a distal tip (104) of the injection device (100); a hub (4) slidably mounted on the sleeve (2) between a pre-use position, an injection position in which the hub (4) is located proximal to the pre-use position, and a safety position in which the hub (4) is located distal to the injection position; and A biasing element (6) configured to bias the hub (4) distally toward a safe position; and a protector (8) configured to slide together with the hub (4) relative to the sleeve (2) between a pre-use position and an injection position; The safety device (1) further comprises: a first blocking means configured to block distal movement of the protector (8) to prevent the protector (8) from sliding back distally with the hub (4) when the hub (4) is in the injection position; and and second blocking means configured to block proximal movement of the hub (4) when the hub (4) is in a safe position, the protector (8) comprises a support ring (80), the first blocking means comprises at least one first resilient leg (81) extending proximally from the support ring (80), and the second blocking means comprises at least one second resilient leg (82) extending distally from the support ring (80); the at least one first resilient leg (81) is configured to slidably engage with a longitudinal slot (24) of the sleeve (2) when the hub (4) moves from the pre-use position towards the injection position, and the at least one first resilient leg (81) is configured to deform radially relative to a distal side of a blocking member of the sleeve (2) and abut against a proximal side of the blocking member of the sleeve (2) when the hub (4) is in the injection position; A passive safety device (1), wherein the at least one second resilient leg (82) is configured to slidably engage with a proximal slot (48) of the hub (4) when the hub (4) moves from the injection position toward the safety position, and the at least one second resilient leg (82) is configured to deform radially relative to a distal side of a blocking member of the hub (4) and abut against a proximal side of the blocking member of the hub (4) when the hub (4) is in the safety position.

2. 2. A passive safety device (1) as claimed in claim 1, wherein the first blocking means is a first snap means configured to snap the protector (8) together with the sleeve (2) when the hub (4) reaches the injection position.

3. A passive safety device (1) according to claim 2, wherein the first snap means is provided on the protector (8).

4. A passive safety device (1) according to any one of claims 1 to 3, wherein the second blocking means is a second snap means configured to snap the hub (4) when the hub (4) reaches the safety position.

5. A passive safety device (1) according to claim 4, wherein the second snap means is provided on the protector (8).

6. 2. The passive safety device (1) of claim 1, wherein the hub (4) comprises a proximal extrusion surface (410) defining a distal end of a proximal slot in the hub (4), the proximal extrusion surface (410) being configured to bias against the at least one second elastic leg (82) to cause the protector (8) to slide together with the hub (4) when the hub (4) moves from the pre-use position to the injection position.

7. A passive safety device (1) as claimed in claim 4 or 5, wherein the second snap means comprises at least one longitudinal leg (22) of the sleeve (2) which slidably engages within a distal slot (49) of the hub (4) when the hub (4) moves from the injection position towards the safety position, the at least one longitudinal leg (22) being configured to deform radially relative to a distal side of a retaining member of the hub (4) and abut against a proximal side of the retaining member when the hub (4) is in the safety position.

8. A passive safety device (1) according to any one of claims 1 to 7, wherein the hub (4) comprises at least one internal retaining element such as a retaining hook (42), a biasing element (6) comprises a distal end abutting the at least one internal retaining element for exerting a distal force on the hub (4), and the sleeve (2) has a longitudinal slot (24) with an open distal end such that the at least one internal retaining element can penetrate and slide into the longitudinal slot (24) when the hub (4) moves towards the injection position.

9. A passive safety device (1) according to any one of claims 1 to 8, wherein the at least one first resilient leg (81) and the at least one second resilient leg (82) are offset in the circumferential direction of the support ring (80).

10. A passive safety device (1) according to any one of the preceding claims, wherein the protector (8) is made of two parts adapted to be assembled together directly onto the hub (4).

11. An injection device (100) comprising a passive safety device (1) according to any one of the preceding claims.

12. A method for manufacturing an injection device (100) according to claim 11, comprising the steps of: (i) fixing a needle of the passive safety device (1) onto the distal tip (104) of the injection device (100); (ii) positioning the biasing element (6) of the passive safety device (1) within the sleeve (2); (iii) positioning the hub (4) of the passive safety device (1) on the sleeve (2) against the action of the biasing element (6); (iv) positioning the protector (8) of the passive safety device (1) over the hub (4) and the sleeve (2); A method comprising:

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