Re-usable safety device, injection device including this re-usable safety device and method for resetting the re-usable safety device

Abstract

This safety device (1) includes: a housing (4), extending along a longitudinal axis A and configured for accommodating a medical container (2) provided with an injection needle (21); a backstop (5) connected to the housing (4) for axially blocking the medical container (2) inside the housing (4); and a needle cover (3), movable with respect to the housing (4) between an initial position, a retracted position, proximally located with respect to the initial position, and a safety position, distally located with respect to the retracted position, in which the needle cover (3) abuts against the housing (4) so that the needle cover (3) cannot move back in the proximal direction. The backstop (5) is movable with respect to the housing (4) between a blocking position, in which the backstop (5) axially blocks the medical container (2) within the housing (4), and a release position, in which the backstop (5) no longer blocks the medical container (2) within the housing (4), thereby allowing removal of the medical container (2) from the housing (4), and wherein movement of the backstop (5) from the blocking position to the release position or removal of the medical container (2) from the housing (4) allows for movement of the needle cover (3) from the safety position to the initial position.

Description

[0001] Re-usable safety device, injection device including this re-usable safety device and method for resetting the re-usable safety device

[0002] The present invention relates to a reusable safety device and to an injection device including the reusable safety device. The invention also relates to a method for assembling the reusable safety device to the injection device.

[0003] In this application, the distal end of a component or of a device is to be understood as meaning the end furthest from the user's hand and the proximal end is to be understood as meaning the end closest to the user's hand. Likewise, in this application, the “distal direction” is to be understood as meaning the direction away from the user's hand, and the “proximal direction” is to be understood as meaning the direction toward the user's hand.

[0004] Some injection devices include a syringe provided with an injection needle, and a safety device mounted around the syringe, the safety device including a needle cover that extends in a safety position after injection to protect a user against needle stick injuries. Usually, after injection, the syringe is discarded in a sharps container together with the safety device locked in the safety position. A new syringe equipped with another safety device is required to perform another injection operation. That is, a new safety device needs to be used for every injection operation.

[0005] There is therefore a need for a safety device that provides an improved sustainability.

[0006] An aspect of the invention is a safety device configured for preventing needle sticks, the safety device including: a housing, extending along a longitudinal axis A and configured for accommodating a medical container provided with an injection needle; a backstop connected to the housing for axially blocking the medical container inside the housing, a needle cover, movable with respect to the housing between an initial position, a retracted position, proximally located with respect to the initial position, and a safety position, distally located with respect to the retracted position, in which the needle cover abuts against the housing so that the needle cover cannot move back in the proximal direction wherein the backstop is movable with respect to the housing between a blocking position, in which the backstop axially blocks the medical container within the housing, and a release position, in which the backstop no longer blocks the medical container within the housing, thereby allowing removal of the medical container from the housing, and wherein movement of the backstop from the blocking position to the release position or removal of the medical container from the housing allows for movement of the needle cover from the safety position to the initial position.

[0007] As a result of the movement of the needle cover back to the initial position, the safety device is reset and thus can be reused. The safety device of the invention accordingly improves sustainability, because only the used medical container is discarded. Once reset, the safety device of the invention can receive a new (not yet used) medical container to allow the user to safely perform another injection operation.

[0008] The locker or a guiding member of the needle cover are configured such that removal of the medical container from the housing or movement of the backstop from the blocking position to the release position allows for movement of the needle cover from the safety position back to the initial position.

[0009] The backstop may be arranged at a proximal end of the housing. The backstop may be, rotatable with respect to the housing between the blocking position and the release position.

[0010] The needle cover is axially and rotatably movable with respect to the housing. In the initial position, the needle cover is configured for protecting the injection needle before injection. A distal end of the needle cover thus extends distally with respect to a distal end of the injection needle. In the retracted position, the needle cover is configured to allow the injection needle to reach a predetermined injection depth in an injection site. The needle cover may thus proximally abut against the housing. In the safety position, the needle cover is blocked in the proximal direction to protect a user against needle sticks. A locker of the needle cover distally abuts against a blocking member of the housing so that the needle cover cannot move back in the proximal direction. Movement of the needle cover from the initial position to the retracted position being caused by a distal end of the needle cover being pressed against an injection site, and movement of the needle cover from the retracted position to the safety position being caused by biasing means pushing the needle cover in the distal direction.

[0011] In an embodiment, the needle cover includes a locker having a proximal abutment surface, the proximal abutment surface of the locker being movable between a blocking position in which the proximal abutment surface axially abuts against a blocking member of the housing so that the needle cover cannot move in the proximal direction, and a shifted position in which the distal abutment surface of the locker is shifted away from the blocking member of the housing so that the needle cover can move again in the proximal direction, movement of the proximal abutment surface of the locker from the blocking position to the shifted position being caused by movement of the backstop from the blocking position to the release position or removal of the medical container from the housing.

[0012] In an embodiment, the safety device includes re-setting means configured for allowing the proximal abutment surface of the locker to move to the shifted position upon movement of the backstop to the release position or removal of the medical container from the housing.

[0013] In an embodiment, the re-setting means include a resilient leg forming the locker, the resilient leg being radially deformable between an outward deformed position and an inward position, the resilient leg including a lateral wall configured for radially abutting against the medical container such that the resilient leg stays in the outward deformed position as long as the medical container remains in the housing.

[0014] The lateral wall may be on one side of the locker, while the proximal abutment surface is on the other side.

[0015] In an embodiment, the safety device includes a guiding track arranged on the needle cover for receiving a guiding pin of the housing in order to guide movement of the needle cover with respect to the housing between the initial position and the safety position, the guiding track including a first portion for guiding the needle cover between the initial position and the retracted position, a second portion for guiding the needle cover between the retracted position and the safety position, and a connecting portion for allowing passage of the guiding pin from the first portion to the second portion.

[0016] Possibly, the second portion has a closed proximal end.

[0017] The guiding track includes a single connecting portion. That is, the guiding track includes an orthoradial abutment surface configured to orthoradially abut against the guiding pin of the housing when the needle cover is in the safety position.

[0018] This prevents rotation of the needle cover when the needle cover is in the safety position.

[0019] In an embodiment, the re-setting means include a resetting portion of the guiding track for allowing the guiding pin of the housing to move from the safety position to the initial position upon rotation of the backstop from the blocking position towards the safety position.

[0020] The second portion has an opened proximal end which leads into the resetting portion.

[0021] In an embodiment, the safety device includes a proximal stop arranged on the needle cover for defining a predetermined injection depth.

[0022] In an embodiment, the housing includes a proximal abutment surface for axially abutting against the medical container. This helps better control the pricking depth.

[0023] In an embodiment, the safety device includes a proximal stop arranged on the needle cover for stopping proximal movement of the needle cover in a partially retracted position.

[0024] This allows the end user to grasp the needle shield in order to remove the needle shield from the medical container.

[0025] In an embodiment, the backstop is removably attached to the housing.

[0026] In an embodiment, the backstop has an opened central cavity configured for allowing axial passage of the medical container through the backstop, the central cavity being delimited by two straight edges.

[0027] This allows for blocking or allowing insertion of medical containers having a cut flange instead of a rounded flange. The backstop is not removable.

[0028] In an embodiment, the safety device includes a cap removably attached to a distal end of the needle cover, the cap including a remover configured for removing a needle shield of the medical container.

[0029] Another aspect of the invention is an injection device including the abovedescribed safety device and a medical container arranged within the housing of this safety device.

[0030] Another aspect of the invention is a method for re-setting the above-described safety device, the method comprising the steps of: moving the backstop from the blocking position to the release position; removing a medical container from the housing.

[0031] Preferably, the removed medical container is a used medical container.

[0032] In an embodiment, the step of moving the backstop from the blocking position to the release position entails a simultaneous movement of the needle cover from the safety position to the initial position. The return of the needle cover to the initial position may be done by a rotation, without need for the needle cover to first go back to the retracted position.

[0033] In another embodiment, the step of removing the used medical container from the housing may be followed by a step of moving the needle cover back to the initial position. The return of the needle cover may here require the needle cover to first move back to the retracted position.

[0034] Optionally, the method may comprise a step of putting the needle shield back onto the medical container, preferably before moving the backstop from the blocking to the release position. The method may further include a step of inserting a new medical container within the housing. Eventually, the method may comprise moving the backstop back to the blocking position.

[0035] The invention and the advantages arising therefrom will clearly emerge from the detailed description that is given below with reference to the appended drawings as follows :

[0036] Figure 1 is an exploded view of an injection device according to an embodiment of the invention,

[0037] Figures 2 and 3 are perspective and side views of a needle cover of a safety device according to an embodiment of the invention,

[0038] Figure 4 is a perspective of an injection device according to an embodiment of the invention, the needle cover being in an initial position,

[0039] Figure 4A is a detail of Figure 4, the housing being shown transparent,

[0040] Figure 5 is a cross-section view of an injection device according to an embodiment of the invention, the needle cover being in the initial position, Figure 6 is a perspective view of the injection device according to an embodiment of the invention, in which the safety device is in the initial position after withdrawal of the needle shield,

[0041] Figure 7 is a perspective view of the injection device according to an embodiment of the invention, in which the safety device is in the retracted position,

[0042] Figure 7A is a detail of Figure 7,

[0043] Figure 8 is a perspective view of the injection device according to an embodiment of the invention, in which the safety device is in the safety position,

[0044] Figure 8A is a detail of Figure 8,

[0045] Figure 9 is a cross-sectioned view of the injection device according to an embodiment of the invention, in which the safety device is in the safety position,

[0046] Figures 10 and 11 are perspective views of a housing of a safety device according to an embodiment of the invention,

[0047] Figures 12, 13 and 14 are perspective views of a backstop of a safety device according to an embodiment of the invention,

[0048] Figures 15, 16 and 17 illustrate different steps of a method for re-setting the safety device according to an embodiment of the invention, Figure 18 is a perspective view of a needle cover of a safety device according to a second embodiment of the invention,

[0049] Figures 19 and 20 are perspective views of the needle cover of Figure 18 in the initial position, the housing being shown transparent,

[0050] Figure 21 is a perspective view of the needle cover of Figure 18 in the safety position, the housing being shown transparent,

[0051] Figures 22, 23 and 24 illustrate different steps of a method for re-setting the safety device according to the second embodiment of the invention,

[0052] Figures 25 and 26 are perspective and cross-sectioned views of a cap of a safety device according to an embodiment of the invention,

[0053] Figures27, 28 and 29 are perspective views of a backstop of a safety device according to an embodiment of the invention,

[0054] Figure 30 is a partial perspective view of a needle cover of a safety device according to an embodiment of the invention.

[0055] The different features of the embodiments can be used in combination with and used with other embodiments as long as the combined parts are not inconsistent with or interfere with the operation of the device and assembly. The phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless limited otherwise, the terms "connected," "coupled," and "mounted," and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms "connected" and "coupled" and variations thereof are not limited to physical or mechanical connections or couplings. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items. It will be understood that, although the terms first, second, etc., may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. For example, a first element could be termed a second element, and, similarly, a second element could be termed a first element without departing from the scope of the present disclosure.

[0056] With reference to Figure 1 is shown an injection device 10 according to an embodiment of the invention. The injection device 10 is configured for allowing injection of a medical product into an injection site. The injection device 10 extends along a longitudinal axis A and includes a medical container 2 configured for containing a medical product, and a reusable safety device 1 for preventing needle stick injuries.

[0057] The medical container 2 may be a prefillable or prefilled syringe. The medical container 2 includes a tubular barrel 20 defining a reservoir for containing the medical product to be injected. The barrel 20, which may be made of a glass material, has a distal end provided with an injection needle 21 , and a needle shield 22 removably attached to the distal end of the barrel 20 for protecting and sealing the injection needle 21 before use. The barrel 20 has an opened proximal end which may be provided with a radial flange 23. The proximal end of the barrel 20 defines a proximal opening configured to receive a plunger rod 24. The plunger rod 24 is configured for pushing a stopper 25 arranged inside the barrel 20 in order to expel the medical product contained within the reservoir. The plunger rod 24 has a distal end configured for pushing the stopper 25 in the distal direction and an opposite proximal end which may be provided with a pushing element 241 , which may be disc-shaped, for allowing the user to push the plunger rod 24 in the distal direction. The plunger rod 24 is movable between an initial position, in which the pushing element 241 is furthest from the medical container 2 such that the plunger rod 24 may mainly extend outside the barrel 20, and an injection end position, distal to the initial position, in which the distal end of the plunger rod 24 presses the stopper 25 against a distal end of the reservoir. In the injection end position, the plunger rod 24 may mainly extend inside the barrel 20. Distal movement of the plunger rod 24 from the initial position to the injection end position is due to the user applying his / her thumb against the pushing element 241 and accordingly pushing the plunger rod 24 in the distal direction.

[0058] As will be explained in further details below, the medical container 2 may be removably mounted within the re-usable safety device 1 .

[0059] The re-usable safety device 1 is configured for protecting users against needle stick injuries. In the present invention, the re-usable safety device 1 is further configured for allowing, after injection, removal of the used medical container 2 such that the used medical container 2 can be discarded and for allowing subsequent assembly of the re-usable safety device 1 to a new, not yet used, medical container 2 such that the re-usable safety device 1 can again protect users against needle stick injuries during and after use of this new medical container 2. The re-usable safety device 1 of the invention includes a needle cover 3 for covering the injection needle 21 , a housing 4 for accommodating the medical container 2, and a backstop 5 for keeping the medical container 2 inside the housing 4. As illustrated in Figure 1 , the re-usable safety device 1 is an add-on safety device 1 , i.e. can be removably mounted onto any medical container 2. With reference to Figures 2-3 is shown a needle cover 3 according to an embodiment of the invention. The needle cover 3 is configured for covering the injection needle 21 in order to prevent needle stick injuries. The needle cover 3 may be made of a single piece.

[0060] The needle cover 3 is axially and rotationally movable with respect to the housing

[0061] 4. The axial movement of the needle cover 3 extends between an initial position (Figures 4-4A,

[0062] 5, 6), a (fully) retracted position (Figures 7-7A) proximally located with respect to the initial position, and a safety position (Figures 8-8A, 9) distally located with respect to the retracted position. The safety position and the initial position may be similar or different; if different, the safety position may be distally located with respect to the initial position. In the initial position, the needle cover 3 protects the needle shield 22. In the retracted position, the needle cover 3 unveils the injection needle 21 so that the injection needle 21 can penetrate into the injection site. In the safety position, the needle cover 3 covers the injection needle 21 to protect the user against needle sticks. The needle cover 3 may further move to a partially retracted position (not shown), axially located between the initial position and the retracted position, to allow for withdrawal of the needle shield 22. Axial movement of the needle cover 3 in the distal direction is caused by biasing means such as a safety spring 7. Axial movement of the needle cover 3 in the proximal direction is caused by the user pressing a distal end of the needle cover 3 against an injection site.

[0063] The rotational movement of the needle cover 3 extends between an armed rotational position (before injection), Figures 4-4A, in which the needle cover 3 is ready to be used, and an activated rotational position (after injection), Figures 8-8A, in which the safety mechanism of the needle cover 3 is activated such that the needle cover 3 prevents from needle sticks and thus forbids re-use of the medical container 2 to perform another injection operation. Rotation of the needle cover 3 from the armed rotational position to the activated rotational position is caused by the user pressing the distal end of the needle cover 3 against the injection site. Rotation of the needle cover 3 from the activated rotational position back to the armed rotational position is caused by the user re-arming the needle cover 3 after injection and disposal of the used medical container 2 in order to re-use the safety device 1 with a new medical container 2.

[0064] With reference to Figures 2-3, the needle cover 3 may be in the form of an elongated tubular sleeve which extends along the longitudinal axis A. The needle cover 3 has a cylindrical lateral wall 30 defining an inner cavity, a distal end 31 defining a distal opening 311 for allowing passage of the injection needle 21 and of the needle shield 22, and a proximal end 32 defining a proximal opening 321 for allowing extension of the barrel 20 inside the inner cavity. The lateral wall 30 may have inspection windows 301 so that the user can visually inspect the barrel 20 and its contents. The distal end 31 of the needle cover 3 may define a circumferential ring 312 forbidding access to the inner cavity for the user’s fingers. The distal end 31 further delimits a distal pushing surface 313 configured for pressing against the injection site to cause retraction of the needle cover 3. The needle cover 3 may further include a proximal supporting surface 322, which may be arranged at the proximal end of the needle cover 3 for providing support for a safety spring 7. The needle cover 3 also includes a guiding member 33 and a locker 35 which are described in more details below.

[0065] As illustrated in Figures 2-3, the guiding member 33 may be in the form of a guiding track which may be arranged at an outer surface of the lateral wall 30 of the needle cover 3 for guiding the axial and rotational movements of the needle cover 3 with respect to the housing 4. To that end, the guiding member 33 is configured for engaging a complementary guiding member, such as a guiding pin 41 , of the housing 4. The guiding member 33 may include a delimiting rib 330a, a funnel portion 331 , a first portion 332a, a second portion 332b and a connecting portion 338a that connects the first and second portions 332a, 332b. The first portion 332a may include an initial distal stop 333 and a proximal stop 334 separated from each other by a predetermined axial distance. An injection-depth defining member 339 may be arranged at the junction of the connecting portion 338a and the second portion 332b for controlling the injection depth. The second portion 332b includes a final distal stop 337.

[0066] The delimiting rib 330a may be a continuous rib defining a groove that forms the first and second portions 332a, 332b, and the connecting portion 338a. The groove is configured to receive the guiding pin 41 of the housing 4. The delimiting rib 330a may widen in the proximal direction to delimit the funnel portion 331 and may circumferentially extend around the proximal end 32 of the needle cover 3 to define the proximal supporting surface 322. The funnel portion 331 is configured to guide insertion of the guiding pin 41 into the first portion 332a during assembly of the needle cover 3 and the housing 4. The funnel portion 331 accordingly leads to an opened proximal end 335 of the first portion 332a.

[0067] The first portion 332a may be straight from the opened proximal end 335 to its distal end, and may also be inclined with respect to the longitudinal axis A to cause a slight rotation of the needle cover 3 towards the activated rotational position. The initial distal stop 333 of the first portion 332a may be arranged between the proximal end 335 of the first portion 332a and the distal end of the first portion 332a in order to maintain the needle cover 3 in the initial position. The initial distal stop 333 is configured for axially abutting against the guiding pin 41 of the housing 4 when the needle cover 3 is in the initial position so that the needle cover 3 cannot move distally from said initial position. A ramp may be arranged on a proximal side of the initial distal stop 333 to permit assembly of the needle cover 3 and the housing 4. The proximal stop 334 of the first portion 332a may be arranged at the distal end of the first portion 332a to oppose a proximal movement of the needle cover 3 as long as the proximal force exerted on the needle cover 3 is below a predetermined threshold. This permits the user to partially retract the needle cover 3 in the partially retracted position, in which the proximal stop 334 axially abuts against the guiding pin 41 of the housing 4, such that the user may grasp and remove the needle shield 22 before an injection operation. The first portion 332a is however configured to allow passage of the guiding pin 41 over the proximal stop 334 during use of the injection device 10, i.e. when the user presses the distal end 31 of the needle cover 3 against the injection site. Therefore, the proximal stop 334 may be inclined and / or may be radially smaller than the initial distal stop 333.

[0068] The connecting portion 338a connects the distal end of the first portion 332a to the distal end of the second portion 332b, and therefore allows passage of the guiding pin 41 from the first portion 332a to the second portion 332b. The connecting portion 338a may further be configured for causing and / or completing rotation of the needle cover 3 from the armed rotational position to the activated rotational position. The connecting portion 338a is accordingly inclined with respect to the longitudinal axis A. The connecting portion 338a may have a rounded shape or may be straight. The injection-depth defining member 339 is arranged at the distal end of the second portion 332b and defines a proximal abutment surface for proximally blocking the needle cover 3. In the retracted position, the injection-depth defining member 339 thus axially abuts against the guiding pin 41 of the housing 4 so that the needle cover 3 cannot move further in the proximal direction. Since the injection depth is defined as the axial distance between a distal end of the injection needle 21 and the distal end 31 of the needle cover 3, the blocking of the needle cover 3 in the retracted position by the prickingdepth defining member 339 permits to control the injection depth.

[0069] The second portion 332b may be straight and may be parallel to the longitudinal axis A. The final distal stop 337 is arranged at a proximal end of the second portion 332b to distally block the needle cover 3. In the safety position, the final distal stop 337 thus axially abuts against the guiding pin 41 of the housing 4 so that the needle cover 3 cannot move further in the distal direction. When the guiding pin 41 of the housing 4 is in the second portion 332b of the guiding track 33, rotation of the needle cover 3 is completed: the needle cover 3 is in the activated rotational position.

[0070] The second portion 332b has a proximally and laterally closed proximal end: the guiding pin 41 is thus prevented to move in a rotational direction. Indeed, as illustrated in Figure 3, the delimiting rib 330a here defines orthoradial abutment surfaces 38 for preventing rotation of the needle cover 3 relative to the housing 4 when the guiding pin 41 is at the proximal end of the second portion 332b of the guiding track 33, i.e. when the needle cover 3 is in the safety position. Still with reference to Figures 2-3, the locker 35 is configured for proximally blocking the needle cover 3 when the needle cover 3 is in the safety position. The locker 35 is also configured for allowing disposal of the used medical container 2 and for allowing re-use of the safety device 1 . More specifically, the locker 35 is configured for allowing movement of the needle cover 3 back to the initial position after disposal of the used medical container 2. The locker 35 thus engages the housing 4 when the needle cover 3 is in the safety position and can disengage the housing 4 to re-use the safety device 1 , preferably after disposal of the used medical container 2.

[0071] In the activated rotational position, the locker 35 of the needle cover 3 and the blocking member 43 of the housing 4 are axially aligned. In the armed rotational position, the locker 35 of the needle cover 3 and the blocking member 43 of the housing 4 are not aligned; they are offset from each other. Therefore, in the armed rotational position, the locker 35 and the blocking member 43 cannot interfere with each other.

[0072] In the embodiment illustrated in Figures 2-17, the locker 35 is radially movable between a deactivated position, Figure 17, in which the locker 35 cannot axially abut against the housing 4 and in which the locker 35 accordingly allows the needle cover 3 to move back from the safety position to the initial position, and an activated position, Figure 8A, in which the locker 35 axially abuts against the housing 4 so that the needle cover 3 cannot move back in the proximal direction and leave the safety position. For instance, the locker 35 is in the form of a resilient hook which includes a resilient leg 351 that may outwardly radially deform between a rest position, Figure 17, in which the hook does not radially protrude over the lateral wall 30 of the needle cover 3 so that the hook cannot engage the housing 4, and a deformed position, Figure 8A, in which the hook outwardly radially protrudes over the lateral wall 30 of the needle cover 3 so that the hook can engage the housing 4. The rest position thus corresponds to the deactivated position while the deformed position may correspond to the activated position. The resilient leg 351 may form resetting means for allowing reset, and thus re-use, of the safety device 1 , as will be seen in further details below. Movement of the locker 35 from the deactivated position to the activated position is caused by the barrel 20 of the medical container 2 being introduced within the housing 4 such that the barrel 20 radially outwardly pushes against a lateral wall 357 of the locker 35, Figure 9. Movement of the locker 35 from the activated position to the deactivated position is caused by removal of the used medical container 2 from the housing 4. It is thus readily understandable that the needle cover 3 cannot be moved back from the safety position to the initial position, and the safety device 1 cannot be re-used as long as the used medical container 2 is located within the housing 4.

[0073] The locker 35 may longitudinally extend parallel to the longitudinal axis A, within a lateral opening 352 provided through the lateral wall 30 of the needle cover 3. The locker 35 has a proximal end 353 and a distal end 354; the proximal end 353 may be secured to the lateral wall 30 of the needle cover 3 while the distal end 354 may be free. The distal end 354 includes an outward radial protrusion 355 whose distal side may be inclined to ease passage of the blocking member 43 of the housing 4 over the locker 35 when the needle cover 3 moves from the retracted position to the safety position. A proximal side of this outward radial protrusion 355 defines a proximal abutment surface 356. The proximal abutment surface 356 of the locker 35 is configured for axially abutting against the housing 4 when the needle cover 3 is in the safety position. Therefore, the locker 35 prevents proximal movement of the needle cover 3 when the needle cover 3 is in the safety position. This protects the user against needle sticks.

[0074] The needle cover 3 may include one or more, for instance two diametrically opposite, guiding members 33 and one or more, for instance two diametrically opposite lockers 35, as illustrated in Figures 2-3.

[0075] With reference to Figures 10-11 , the housing 4 is configured for receiving the medical container 2 and for guiding movements of the needle cover 3. The housing 4 is further configured for accommodating biasing means in the form of the safety spring 7 for pushing the needle cover 3 in the distal direction.

[0076] The housing 4 may be in the form of a tubular sleeve extending along the longitudinal axis A and which surrounds the proximal end 32 of the needle cover 3. The housing 4 may be removably attached to the backstop 5.

[0077] The housing 4 includes a cylindrical lateral wall 40, a distal end 401 and a proximal end 403. The lateral wall 40 defines an inner cavity leading, on one hand, to a distal opening 402 delimited by the distal end 401 of the housing 4 and, on the other hand, to a proximal opening 404 delimited by the proximal end 403 of the housing 4.

[0078] The housing 4 may be made of a single piece.

[0079] The housing 4 further may further include some or all of a guiding member 41 , a proximal abutment surface 42, Figure 9, a distal abutment surface 414, a blocking member 43, a pushing member 44 and fasteners 45.

[0080] There may be one or more, for instance two diametrically opposite, guiding members 41 , one or more, for instance two diametrically opposite blocking members 43, one or more, for instance two diametrically opposite pushing members 44, and one or more fasteners 45, for instance one or two pairs of diametrically opposite fasteners 45.

[0081] The guiding member, such as a guiding pin 41 , is configured for engaging the guiding track 33 of the needle cover 3 and therefore guide axial and rotational movements of the needle cover 3 from the initial position to the safety position and vice versa.

[0082] The guiding member 41 may be in the form of an axially extending leg arranged within a window 411 provided through the lateral wall 40 of the housing 4, and includes a distal end 412 which may be free and an opposite proximal end 413 which may be fixedly connected to the lateral wall 40 of the housing 4. The guiding member 41 is arranged near the distal end 401 of the housing 4, distal to the pushing member 44 which may be axially aligned with the guiding member 41 .

[0083] The guiding member 41 is resiliently deformable in the radial direction such that the guiding member 41 can pass over the initial distal stop 333 of the guiding track 33 when the housing 4 is assembled to the needle cover 3 and over the proximal stop of the guiding track 33 when the user presses the needle cover 3 against the injection site.

[0084] The guiding member 41 includes a guiding pin shaped to engage the guiding track 33 of the needle cover 3 to guide movements of the needle cover 3 relative to the housing 4. The guiding pin radially inwardly protrudes from the guiding member 41 and may be arranged at the distal end of the guiding member 41. The guiding pin may include a distal abutment surface 414 and an inclined wall 415.

[0085] The proximal abutment surface 42 is configured for axially abutting against the radial flange 23 of the barrel 20, Figure 9. This helps control the sticking depth and to secure the medical container 2 within the housing 4.

[0086] The proximal abutment surface 42 may be delimited by a proximal side of an inner ring 421 that inwardly protrudes from an inner surface of the lateral wall 40 of the housing 4. The inner ring 421 may be located near the proximal end 403 of the housing 4. More specifically, the inner ring 421 is axially distant from the proximal end 403 of the housing 4 to define a proximal recess 422, Figure 9, shaped to receive the radial flange 23 of the medical container 2. The inner ring 421 delimits an opening 423 that allows for insertion of the barrel 20 in the housing 4.

[0087] A distal supporting surface 424, Figure 9, is configured to support a proximal end of the safety spring 7. The safety spring 7 is thus configured to extend around the barrel 20 of the medical container 2, between the distal supporting surface 424 of the housing 4 and the proximal supporting surface 322 of the needle cover 3. The distal supporting surface 424 may be delimited by a distal side of the inner ring 421. Thus, the proximal abutment surface 42 and the distal supporting surface 424 may be two opposite sides of the same inner ring 421 .

[0088] The blocking member 43 is configured for engaging the locker 35 of the needle cover 3 in order to block proximal movement of the needle cover 3 when the needle cover 3 is in the safety position.

[0089] The blocking member 43 is in the form of an axially extending leg arranged within a window 431 provided through the lateral wall 40 of the housing 4. The blocking member 43 has a proximal end 432 which is fixedly connected to the lateral wall 40 of the housing 4 and an opposite distal end 433 which may be free to ease deformation of the blocking member 43. The blocking member 43 may be arranged near the distal end 401 of the housing 4, i.e. at a distal portion of the housing 4. In the initial position of the needle cover 3, the blocking member 43 is circumferentially offset the locker 35. In the safety position, the blocking member 43 and the locker 35 are no longer offset; they are axially aligned.

[0090] The blocking member 43 is resiliently deformable in an outward radial direction, between a rest position, in which the blocking member 43 is configured for blocking the needle cover 3 in the safety position, and a deformed position, in which the blocking member 43 flexes radially outwardly such that the blocking member 43 can pass over the inclined distal side of the locker 35 of the needle cover 3 when the needle cover 3 moves in the distal direction from the retracted position to the safety position.

[0091] The blocking member 43 includes a distal abutment surface 434 configured for axially abutting against the proximal abutment surface 356 of the needle cover 3 when the needle cover 3 is in the safety position. This abutment axially blocks the needle cover 3 in the safety position. The distal abutment surface 434 is defined by a distal side of an inward protrusion 435 which protrudes radially inwardly from the blocking member 43, at the distal end 433 thereof.

[0092] The blocking member 43 also includes a proximal ramp 436 configured for easing deformation and passage of the blocking member 43 over the locker 35 of the housing 4 when the needle cover 3 moves in the distal direction towards the safety position. The proximal ramp 434 is delimited by a proximal side of the inward protrusion 435.

[0093] The pushing member 44 is configured for providing support to the user’s fingers, so that the user can easily push the injection device 10 towards the injection site and have the injection needle 21 penetrate the injection site at the right pricking depth.

[0094] The pushing member 44 may be a radially extending plate-shaped wing that outwardly protrudes from the lateral wall of the housing 4. The pushing member 44 is preferably aligned in the axial direction with the guiding member 41 of the housing 4 to better control the pricking depth.

[0095] The pushing member 44 includes a proximal supporting surface 441 arranged on a proximal side of the plate-shaped wing for receiving the pressure of the user’s fingers so that the user can exert a distal force on the housing 4. The proximal supporting surface 441 may have a concave shape that forms a recess 442 for receiving the user’s fingers. The pushing member 44 further includes a buttress 443 arranged on a distal side thereof for rigidifying the pushing member 44.

[0096] The fasteners 45 are configured for allowing removable attachment of the backstop 5 to the housing 4. To that end, the fasteners 45 of the housing 4 are configured for engaging complementarily shaped fasteners 54 of the backstop 5. The fasteners 45 may be in the form of radially extending tabs that may outwardly protrude from the lateral wall of the housing 4. The fasteners 45 may be located at the proximal end 403 of the housing 4, as shown in Figures 10-11. The fasteners 45 may be regularly distributed in the circumferential direction.

[0097] The fasteners 45 of the housing 4 include a distal abutment surface 451 and an opposite proximal abutment surface for axially securing the housing 4 and the backstop 5 such that, after assembly of the backstop 5 to the housing 4, the backstop 5 and the housing 4 cannot move axially relative to each other. As will be seen below, the fasteners 45 are however configured for allowing rotation of the backstop 5 with respect to the housing 4 such that the backstop 5 can be mounted to or removed from the housing 4 by rotation. The fasteners 45 may have a chamfered edge 452, Figure 10, to ease their insertion into the recesses of the backstop 5.

[0098] The backstop 5 is configured for providing support to a user’s fingers and also to axially secure the medical container 2 within the housing 4.

[0099] With reference to Figures 12-14, the backstop 5 is in the form of a radially extending flange which is mounted onto the proximal end 403 of the housing 4. The backstop 5 is removably attached to the housing 4, such that after injection the backstop 5 can be disassembled to allow disposal of the used medical container 2 and reset of the re-usable safety device 1 .

[0100] The backstop 5 includes two outer wings 51 , a proximal side 511 , an opposite distal side 512 configured for providing support to the user’s fingers when the user pushes the plunger rod 24 in the distal direction, and a central ring 52 that defines a central cavity 53 which axially extends along the longitudinal axis A between an opened proximal end 531 and an opened distal end 532 to allow the housing 4 and the medical container 2 to extend therethrough. The opened distal end 532 may be greater than the opened proximal end 531 ; thus, the opened distal end 532 can receive the housing 4 while the opened proximal end 531 can allow passage and movement of the plunger rod 24 through the backstop 5. The central cavity 53 is laterally opened. That is, the backstop 5 has a cutout 533 that allows radial insertion or removal of the plunger rod 24 in or out the central cavity 53. The backstop 5 has a transversal wall 534 configured for axially abutting against the proximal end 403 of the housing 4. The transversal wall 534 also defines a distal stop that axially abuts against the radial flange 23 of the medical container 2 such that the radial flange 23 of the medical container 2 is caught and axially blocked between the backstop 5 and the housing 4, as shown for instance in Figure 9.

[0101] The backstop 5 further includes fasteners 54 configured for cooperating with the fasteners 45 of the housing 4 to axially secure the backstop 5 to the housing 4. The fasteners 54 may be orthoradial recesses configured for accommodating the fasteners 45 of the housing 4. The orthoradial recesses are delimited by a first wall 541 whose distal side defines a proximal stop for axially abutting against the distal abutment surface 451 of the fasteners 45 of the housing 4, and a second wall 542 that defines an orthoradial stop for stopping rotation of the backstop 5 when the backstop 5 is assembled to the housing 4. Opposite the second wall 542, the recesses have an orthoradial opening 543 that allows insertion of the fasteners 45 of the housing 4 inside the recesses when the backstop 5 is assembled to the housing 4 or that allows for removal of these fasteners 45 when the backstop 5 is removed from the housing 4. Opposite the first wall 541 , axial openings 544, Figure 12, may be provided through the proximal side of the backstop 5 to give a visual indication to the user that the backstop 5 is firmly engaged with the housing 4. The backstop 5 may include one or more fasteners 54, for instance two pairs of diametrically opposite fasteners 54. The fasteners 54 and the transversal wall 534 of the backstop 5 allow that, once assembled, the backstop 5 is axially fixed with respect to the housing 4.

[0102] The backstop 5 is rotatably movable with respect to the housing 4 and around the longitudinal axis A between a blocking position, in which the backstop 5 axially blocks the medical container 2 inside the housing 4, and a release position, in which the backstop 5 allows for withdrawal of the medical container 2 outside the housing 4 so that the medical container 2 can be discarded and a new medical container 2 can be inserted within the housing 4.

[0103] Rotation of the backstop 5 from the blocking position to the release position, or vice versa, is caused by the user. This permits assembly or disassembly of the backstop 5, and so insertion of a new medical container 2 or removal of a used medical container 2.

[0104] The operation of the injection device 10 is described below with reference to Figures 4-8.

[0105] In Figure 4-4A, the needle cover 3 is in the initial position. The backstop 5 is in the blocking position so that the medical container 2 is axially secured within the housing 4. The locker 35 is in the activated (deformed) position due to the medical container 2 which is present inside the housing 4 and which, due to this presence, continuously presses against the locker 35 in an outward radial direction. The blocking member 43 of the housing 4 and the locker 35 are still offset at this stage (they do not axially face each other).

[0106] The needle shield 22 may, or may not, slightly extend distal to the distal end 31 of the needle cover 3. In order to remove the needle shield 22, the user may thus either grab the needle shield 22 or first slightly push the needle cover 3 in the proximal direction to unveil the needle shield 22 and then grab it. As a result, the guiding pin 41 , which was abutting against the initial distal stop 333, moves towards the proximal stop 334 of the first portion 332a of the guiding track 33. The proximal stop 334 prevents the needle cover 3 from going too far towards the retracted position and possibly inadvertently reaching the safety position whereas the injection has not yet been performed. After removal of the needle shield 22, the needle cover 3 may move back to the initial position to protect the needle 21 before injection, see Figure 6. The injection needle 21 does not extend distally beyond the distal end 31 of the needle cover 3.

[0107] When the user is ready to perform the injection operation, he / she may press the distal end 31 of the needle cover 3 against the injection site, until the injection needle 21 reaches the right pricking and injection depth, Figure 7. During the proximal movement (retraction) of the needle cover 3 within the housing 4, the guiding pin 41 slides against the connecting portion 338a which causes a slight rotation of the needle cover 3. The penetration of the injection needle 21 ends when the needle cover 3 cannot move further in the proximal direction, i.e. when the needle cover 3 reaches the retracted position. The guiding pin 41 now abuts against the injection-depth defining member 339, Figure 7A; the injection needle 21 is at the right injection depth. That is, the user does not have to select the injection depth, which is already set by the injection device 10. Besides, there is very small dispersion of the pricking and injection depth because this pricking and injection depth depends on three axial dimensions only, Figure 7: the distance d1 between the distal end of the injection needle 21 and the radial flange 23 of the barrel 20, the distance d2 between the distal end 31 of the needle cover 3 and the injection depth defining member 339 which abuts against the distal abutment surface 414 of the guiding pin 41 , and the distance d3 between the distal abutment surface 414 of the guiding pin 41 and the proximal abutment surface 42 of the housing 4 which abuts against the radial flange 23 of the barrel 20. The difference between d1 and the sum of d2 plus d3 is the pricking depth. To help the user insert the injection needle 21 into the injection site despite the distal force exerted by the safety spring 7 on the needle cover 3, the user may place his / her fingers, typically the forefinger and the middle finger, onto the proximal side of the pushing members 44 so as to exert a distal force on the housing 4.

[0108] The user can then perform the injection operation by exerting a distal push on the plunger rod 24, so that the medical product contained in the medical container 2 is expelled from the barrel 20 into the injection site via the injection needle 21 .

[0109] When the injection operation is completed, the user removes the injection device 10 from the injection site. As a result, the safety spring 7 pushes the needle cover 3 back in the distal direction towards the safety position. Thus, the guiding pin 41 moves along the second portion 332b of the guiding track 33 towards the proximal end of this second portion 332b. It is contemplated that, due to rotation of the needle cover 3, the locker 35 of the needle cover 3 and the blocking member 43 are now aligned; more specifically, the blocking member 43 of the housing 4 is now in the axial path of the locker 35 of the needle cover 3. Therefore, they come into contact against each other. Due to the pressure of the safety spring 7, the locker 35 causes outward deformation of the blocking member 43 which accordingly passes over the locker 35. The needle cover 3 then reaches the safety position: the proximal abutment surface 356 of the needle cover 3 now abuts against the distal abutment surface 434 of the housing 4, thereby preventing proximal movement of the needle cover 3, and the final distal stop 337 of the guiding track 33 abuts against the guiding pin 41 of the housing 4, thereby preventing distal movement of the needle cover 3; As a result, the needle cover 3 is locked in the safety position. Since the distal end 31 of the needle cover 3 extends distally beyond the distal end of the injection needle 21 , needle stick injuries are prevented.

[0110] Having said that, it is important to notice that the safety device 1 is a re-usable safety device 1 , which can thus be re-used with another (not yet used) medical container 2 to perform another injection operation. But since the needle cover 3 is axially locked in the safety position, as we have seen before, the safety device 1 needs to be reset.

[0111] With reference to Figures 15-17 is illustrated a method for resetting the safety device 1 according to the invention in order to re-use the re-usable safety device 1.

[0112] With reference to Figure 15, the user may first put the needle shield 22 back onto the used medical container 2. This is accomplished by inserting the needle shield 22 through the distal opening formed at the distal end of the needle cover 3 and pushing the needle shield 22 in the proximal direction until the needle shield 22 is attached to the medical container. This step has the advantage to prevent any accidental needle stick injury between the removal of the used medical container 2 from the device 1 and the disposal of the used medical container 2 in a sharps container.

[0113] With reference to Figure 16, the user can rotate the backstop 5 from the blocking position to the release position. Rotation of the backstop 5 makes the fasteners 45, 54 disengage from each other so that the backstop 5 can be moved along the longitudinal axis A in the proximal direction to disengage with the housing 4. Then, the user can put the backstop 5 apart. This is accomplished by moving the backstop 5 in the radial direction such that the plunger rod 24 moves outside the central cavity 53 of the backstop 5, via the cutout 533. The used medical container 2 is now free to be moved outside the housing 4, by proximal movement relative to the housing 4. The user can then discard the used medical container 2.

[0114] At this stage, the safety device 1 is freed of the used medical container 2. As a result, the barrel 20 of the medical container 2 no longer radially outwardly presses the locker 35. The locker 35 of the needle cover 3 accordingly moves back to the deactivated position (rest position). However, the safety device 1 cannot be re-use as it is. The needle cover 3 has to be moved back to the initial position. This re-arming step is illustrated in Figure 17. With reference to Figure 17, the user moves the needle cover 3 from the safety position back to the initial position. In the present embodiment, this is accomplished by moving the guiding pin 41 back in the guiding track 33. First, the user can move the needle cover 3 in the proximal direction from the safety position to the retracted position, see arrow A1 . This proximal movement of the needle cover 3 has been made possible by the disengagement of the locker 35 from the blocking member 43, which itself results from the removal of the used medical container 2 as above mentioned. Therefore, the re-setting of the needle cover 3 becomes possible only after removal of the used medical container 2. The used medical container 2 must be thrown away to allow for the needle cover 3 to leave the safety position. The user then moves the needle cover 3 back in the distal direction, from the fully retracted to the initial position, along the connecting portion 338a and the first portion 332a, see arrows A2 and A3. During this movement, the needle cover 3 also rotates from the activated rotational position to the armed rotational position. The locker 35 and the blocking member 43 thus become rotationally distant; they no longer axially face each other.

[0115] Once the needle cover 3 is back to the initial position, the safety device 1 is ready to accommodate a new (not yet used) medical container 2, i.e. is ready to be re-used. When the user introduces a new medical container 2 within the housing 4, this moves the locker 35 radially outwardly back to the activated position. The user can put the backstop 5 back onto the housing 4. This is accomplished by radially moving the backstop 5 with respect to the medical container 2 so that the plunger rod 24 moves to the central cavity 53 via the cutout 533, and by axially moving the backstop 5 in the distal direction until the transversal wall 534 of the backstop 5 abuts against the proximal end of the housing 4. The backstop 5 is then rotated with respect to the housing 4 around the longitudinal axis A such that the fasteners 45, 54 engage with each other. As a result, the backstop 5 is axially secured to the housing 4; the radial flange 23 of the new medical container 2 is caught between the backstop 5 and the housing 4. The new medical container 2 is accordingly secured within the housing 4. The injection device 10 is ready for use. An injection operation can be performed with the new medical container 2 equipped with the re-usable safety device 1 , as above described with reference to Figures 4-8.

[0116] The safety device 1 of the invention thus permits to be re-used instead of being discarded together with the used medical container 2, which improves sustainability. This reusable feature of the safety device 1 of the invention is not accompanied by a complexification of the safety device 1 , instead the safety device 1 of the invention remains simple to use, assemble and manufacture.

[0117] With references to Figures 18-24 is shown a second embodiment of the invention. In this second embodiment, all the elements, including the medical container 2, the backstop 5, and the housing 4, may be similar to those described above in connection with the first embodiment, except for the needle cover 3. The same features between the first and the second embodiments are designated with the same numeral references.

[0118] With reference to Figure 18 is shown the needle cover 3 according to the second embodiment. The features of the needle cover 3 shown in this Figure 18 may be the same as the needle cover 3 of the safety device 1 according to the first embodiment, except for the guiding member 33 and the locker 35.

[0119] The guiding member here is in the form of a guiding track 33 which may include, like the guiding track 33 of the first embodiment, a delimiting rib 330a, a funnel portion 331 , a first portion 332a, a second portion 332b and a (first) connecting portion 338a that connects the first and second portions 332a, 332b. The difference with the first embodiment is that the guiding track 33 further includes a resetting portion 338b which is a second connecting portion 338b that connects the first and second portions 332a, 332b. The resetting portion 338b may form resetting means for allowing reset, and thus re-use, of the safety device 1. It is contemplated that the first connecting portion 338a connects the distal ends of the first and second portions 332a, 332b, whereas the resetting portion 338b connects the proximal ends of the first and second portions 332a, 332b. As a result, the guiding track 33 forms some sort of closed loop configured to be traveled by the guiding pin 41 of the housing 4 each time the safety device 1 is being used. A second, and closed, delimiting rib 330b is arranged inside the first delimiting rib 330a to help guide the guiding pin 41 along the guiding track 33. That is, the guiding track 33 is here delimited by two delimiting ribs 330a, 330b, whereas in the embodiment illustrated in Figures 1-17, the guiding track 33 may be delimited by a single delimiting rib 330a.

[0120] The second connecting portion 338b allows for moving the guiding pin 41 of the housing 4 from the second portion 332b to the first portion 332a of the guiding track 33 by a mere rotation of the needle cover 3 around the longitudinal axis A. Therefore, the re-setting of the needle cover 3 may be faster than in the first embodiment. The second connecting portion 338b may be straight, and may extend orthogonal to the longitudinal axis A. As illustrated in Figure 18, on one side, the second connecting portion 338b may be at the same axial position as the final distal stop 337 so that the guiding pin 41 can leave the safety position by a simple rotation, without requiring any axial movement of the guiding pin 41 with respect to the needle cover 3. On the other side, the second connecting portion 338b opens into the first portion 332a at a location axially comprised between the initial distal stop 333 and the proximal stop of the first portion 332a, preferably closer to the initial distal stop 333 than to the proximal stop. An anti-return shoulder 336b, defining an orthoradial abutment surface, may separate the initial distal stop 333 from the second connecting portion 338b to prevent the guiding pin 41 from directly moving from the initial position to the safety position by a simple rotation of the needle cover 3 around the longitudinal axis A. That is, in the initial position, the anti-return shoulder 336b prevents any rotation of the needle cover 3 so that the only possible movement of the guiding pin 41 is an axial movement along the first portion 332a in the distal direction with respect to the needle cover 3.

[0121] Still with reference to Figure 18, the locker 35 is no longer in the form of a resilient hook, but of a protrusion that outwardly radially protrudes from the lateral wall 30 of the needle cover 3. Thus, the locker 35 is here fixed with respect to the rest of the needle cover 3. The locker 35 however still rotate together with the needle cover 3 with respect to the housing 4. In the activated rotational position, the locker 35 of the needle cover 3 and the blocking member 43 of the housing 4 are axially aligned. In the armed rotational position, the locker 35 of the needle cover 3 and the blocking member 43 of the housing 4 are not aligned; they are offset from each other, as illustrated in Figure 20. This allows for assembly of the housing 4 and the needle cover 3. The locker 35 may here longitudinally extend orthogonal to the longitudinal axis A. The distal side of the locker 35 forms a ramp configured to ease passage of the blocking member 43 of the housing 4 over the locker 35 when the needle cover 3 moves from the retracted position to the safety position. A proximal side of the locker 35 defines the proximal abutment surface 356 configured for axially abutting against the housing 4 when the needle cover 3 is in the safety position. Therefore, the locker 35 prevents proximal movement of the needle cover 3 when the needle cover 3 is in the safety position. This protects the user against needle sticks.

[0122] The operation of the injection device 10 according to the second embodiment is similar to the operation described with reference to Figures 4-8. However, the method for resetting the safety device 1 differs. This method is described hereafter with reference to Figures 22-24.

[0123] With reference to Figure 22, the user may first put the needle shield 22 back onto the used medical container 2. This is accomplished by inserting the needle shield 22 through the distal opening formed at the distal end of the needle cover 3 and pushing the needle shield 22 in the proximal direction.

[0124] With reference to Figure 23, the user can rotate the backstop 5 from the blocking position to the release position. Rotation of the backstop 5 first causes the housing 4 to rotate together with the backstop 5 relative to the needle cover 3. As a result, the guiding pin 41 of the housing 4 moves along the second connecting portion 338b of the guiding track 33, from the safety position towards the initial position. When the guiding pin 41 orthoradially abuts against a lateral side 336a of the guiding track 33, rotation of the housing 4 relative to the needle cover 3 stops. The user carries on rotating the backstop 5; the backstop 5 can now rotate relative to the housing 4. This further rotation of the backstop 5 makes the fasteners 45, 54 of the backstop 5 and of the housing 4 disengage from each other. The backstop 5 is freed from the housing 4; the user can move the backstop 5 along the longitudinal axis A in the proximal direction to separate the backstop 5 from the housing 4. Then, the user can put the backstop 5 apart. This is accomplished by moving the backstop 5 in the radial direction such that the plunger rod 24 moves outside the central cavity 53 of the backstop 5 via the cutout 533. The used medical container 2 is now free to be moved outside the housing 4, by proximal movement relative to the housing 4. The user can then discard the used medical container 2.

[0125] At this stage, the medical container 2 can be removed from the housing 4, because the backstop 5 no longer retains the medical container 2 inside the housing 4. As soon as the used medical container 2 is thrown away, the safety device 1 is ready to accommodate a new (not yet used) medical container 2 because the needle cover 3 is already in the initial position.

[0126] The safety device 1 of the invention can thus be re-used instead of being discarded together with the used medical container 2. This improves sustainability. This reusable feature of the safety device 1 of the invention is realized without any complexification of the safety device 1. The safety device 1 of the invention keeps the advantage of being simple to use, assemble and manufacture.

[0127] With reference to Figures 25-26, the injection device 10 can include a cap 6 configured for removing the needle shield 22.

[0128] The cap 6 has a tubular wall 61 defining an inner cavity leading to an opened distal end and 62 an opposite opened proximal end 63. The opened distal end 62 allows for ejection of the needle shield 22 from the cap 6. The opened proximal end 63 is configured for allowing insertion of the needle shield 22 and the distal end 31 of the needle cover 3 within the cap 6. The cap 6 has a retainer 64 configured for removable attachment of the cap 6 to the needle cover 3 and a remover 65 for pulling the needle shield 22 off the medical container 2.

[0129] The retainer 64 is in the form of a hook having an inclined proximal side and a distal side defining a distal abutment surface 641 configured for axially abutting against a proximal stop 34 of the needle cover 3. The proximal stop 34 may be arranged at a proximal side of the circumferential ring 312 of the needle cover 3.

[0130] The remover 65 may be a flexible leg provided with a distal abutment surface for axially abutting a proximal stop 221 of the needle shield 22. The proximal stop may be located at a distal end 223 of the needle shield 22.

[0131] Before performing an injection operation, the user has to remove the cap 6 from the needle cover 3, by pulling the cap 6 in the distal direction. Due to the remover 65, withdrawal of the cap 6 entails simultaneous withdrawal of the needle shield 22 from the medical container 2. The user has then to carry out the steps described in connection with Figures 4-8 to perform injection.

[0132] With reference to Figures 27-29 is shown a variant of the backstop 5 designed to cooperate with cut flange syringes. Cut flange syringes are syringes whose radial flange 23 has two parallel opposite edges 230, as illustrated in Figure 27, as opposed to rounded flange 23 syringes whose radial flange 23 has a circular edge 231 , see for instance Figure 1 .

[0133] As illustrated in Figures 27-29, the backstop 5 here has a circumferentially closed central cavity 53. That is, the backstop 5 does not include a cutout 533, unlike the backstop 5 illustrated for instance in Figure 13. The central cavity 53 and the cut flange 23 have the same shape. Thus, the backstop 5 has a proximal opening including two parallel and diametrically opposite straight edges 55 connected by two diametrically opposite rounded edges 56. The proximal opening of the central cavity 53 is however slightly greater than the cut flange 23 so that the cut flange 23 can be inserted into or removed from the central cavity 53 by axial movement of the medical container 2 with respect to the backstop 5.

[0134] In the blocking position, Figure 27, the parallel edges 55 of the backstop 5 and the parallel edges 230 of the cut flange 23 are not aligned. As a result, the transversal wall 534 of the backstop 5 axially faces the rounded edges 56 of the cut flange 23. The medical container 2 cannot be removed from the housing 4. In the release position, Figure 28, the parallel edges 55 of the backstop 5 and the parallel edges 230 of the cut flange 23 are aligned. The transversal wall 534 of the backstop 5 no longer axially faces the cut flange 23, which can be moved in the proximal direction to remove the medical container 2 from the housing 4, via the central cavity 53 of the backstop 5. The blocking position and the release position may be angularly separated by a predetermined angle, for instance 90°.

[0135] During the method for resetting the safety device 1 , the user simply has to turn the backstop 5 from the blocking position to the release position to then discard the used medical container 2. This variant has the advantage that there is no need to put the backstop 5 apart. Indeed, the backstop 5 does not need to be removably detached from the housing 4. Instead the backstop 5 is axially secured to the housing 4 and can only rotate around the longitudinal axis A with respect to the housing 4.

[0136] It is contemplated that this backstop 5 is suitable for equipping the safety device 1 according to either the first or the second above-described embodiments.

[0137] With reference to Figure 30 is shown a variant of the safety device 1 according to the first embodiment, in which the guiding track 33 of the needle cover 3 has a connecting portion 338a extending in a straight direction between the distal end of the first portion 332a and the distal end of the second portion 332b instead of having a rounded shape. The shape of the connecting portion 338a is not limited a curved or straight direction, and may include any variant that allows for the guiding pin 41 to pass from the first portion 332a to the second portion 332b while possibly further causing rotation of the needle cover 3 from the armed rotational position to the activated rotational position. It is readily understandable from the above description that the safety device 1 of the invention is re-usable and therefore provides an improved sustainability. The injection device 10 that includes this re-usable safety device 1 allows for performing a manual injection operation, while benefitting from an automatic activation of the safety device 1. It is to be understood that the present invention is not limited to the embodiments described above and illustrated in the drawings; rather, the skilled person will recognize that many changes and modifications may be made within the scope of the appended claims.

Claims

CLAIMS1. Safety device (1) configured for preventing needle sticks, the safety device (1) including: a housing (4), extending along a longitudinal axis A and configured for accommodating a medical container (2) provided with an injection needle (21); a backstop (5) connected to the housing (4) for axially blocking the medical container (2) inside the housing (4), a needle cover (3), movable with respect to the housing (4) between an initial position, a retracted position, proximally located with respect to the initial position, and a safety position, distally located with respect to the retracted position, in which the needle cover (3) abuts against the housing (4) so that the needle cover (3) cannot move back in the proximal direction, wherein the backstop (5) is movable with respect to the housing (4) between a blocking position, in which the backstop (5) axially blocks the medical container (2) within the housing (4), and a release position, in which the backstop (5) no longer blocks the medical container (2) within the housing (4), thereby allowing removal of the medical container (2) from the housing (4), and wherein movement of the backstop (5) from the blocking position to the release position or removal of the medical container (2) from the housing (4) allows for movement of the needle cover (3) from the safety position to the initial position, wherein the needle cover (3) includes a locker (35) having a proximal abutment surface (356), the proximal abutment surface (356) of the locker (35) being movable between a blocking position in which the proximal abutment surface (356) axially abuts against a blocking member (43) of the housing (4) so that the needle cover (3) cannot move in the proximal direction, and a shifted position in which the distal abutment surface (356) of the locker (35) is shifted away from the blocking member (43) of the housing (4) so that the needle cover (3) can move again in the proximal direction, movement of the proximal abutment surface (356) of the locker (35) from the blocking position to the shifted position being caused by movement of the backstop (5) from the blocking position to the release position or removal of the medical container (2) from the housing (4), and wherein the safety device (1) includes re-setting means configured for allowing the proximal abutment surface (356) of the locker (35) to move to the shifted position upon movement of the backstop (5) to the release position or removal of the medical container (2) from the housing (4).

2. Safety device (1) according to the preceding claim, wherein the re-setting means include a resilient leg (351) forming the locker (35), the resilient leg (351) being radially deformable between an outward deformed position and an inward position, the resilient leg (351) including a lateral wall (357) configured for radially abutting against the medical container (2) such that the resilient leg (351) stays in the outward deformed position as long as the medical container (2) remains in the housing (4).

3. Safety device (1) according to any of the preceding claims, wherein the safety device (1) includes a guiding track (33) arranged on the needle cover (3) for receiving a guiding pin (41) of the housing (4) in order to guide movement of the needle cover (3) with respect to the housing (4) between the initial position and the safety position, the guiding track (33) including a first portion (332a) for guiding the needle cover (3) between the initial position and the retracted position, a second portion (332b) for guiding the needle cover (3) between the retracted position and the safety position, and a connecting portion (338a) for allowing passage of the guiding pin (41) from the first portion (332a) to the second portion (332b).

4. Safety device (1) according to the preceding claim, wherein the re-setting means include a resetting portion (338b) of the guiding track (33) for allowing the guiding pin (41) of the housing (4) to move from the safety position to the initial position upon rotation of the backstop (5) from the blocking position towards the safety position.

5. Safety device (1) according to any of the preceding claims, wherein the safety device (1) includes a proximal stop (339) arranged on the needle cover (3) for defining a predetermined injection depth.

6. Safety device (1) according to any of the preceding claims, wherein the housing (4) includes a proximal abutment surface (42) for axially abutting against the medical container (2).

7. Safety device (1) according to any of the preceding claims, wherein the safety device (1) includes a proximal stop (334) arranged on the needle cover (3) for stopping proximal movement of the needle cover (3) in a partially retracted position.

8. Safety device (1) according to any of the preceding claims, wherein the backstop (5) is removably attached to the housing (4).

9. Safety device (1) according to any of the preceding claims, wherein the backstop (5) has an opened central cavity (53) configured for allowing axial passage of the medical container (2) through the backstop (5), the central cavity (53) being delimited by two straight edges (55).

10. Safety device (1) according to any of the preceding claims 1-9, wherein the safety device (1) includes a cap (6) removably attached to a distal end (31) of the needle cover (3), the cap (6) including a remover (65) configured for removing a needle shield (22) of the medical container (2).

11. Injection device (10) including the safety device (1) according to any of the preceding claims, and a medical container (2) arranged within the housing (4) of this safety device (1).

12. Method for re-setting the safety device (1) according to any of the preceding claims, the method comprising the steps of: moving the backstop (5) from the blocking position to the release position; removing a medical container (2) from the housing (4).

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