Safety device for a needle

Abstract

A safety device (20) for a needle (14) of a medical device, the safety device (20) comprising: • a ring (30) adapted to be fixed relative to the needle (14); • a shield (40) rotatably fixed on the ring (30), the shield (40) being configured to rotate at least in a closing direction from a retracted position, in which the shield (40) does not cover the needle (14), to a safety position, in which the shield (40) covers the needle (14), wherein the shield (40) comprises a proximal portion (44) and a distal portion (45) joined to the proximal portion so as to be able to rotate from an operating position to a tilted position, in which the distal portion (45) is tilted relative to the proximal portion (44).

Description

TECHNICAL FIELD

[0001] The present invention relates to a safety device for a needle, a safety needle hub and a medical device, such as a syringe comprising such a safety device. BACKGROUND

[0002] A large number of medical devices rely on needles to pierce the skin of a patient and to deliver a drug or to collect a body fluid. In particular, syringes are a common way to deliver a drug or a vaccine to a patient and usually comprise an injection needle to deliver such a drug into the skin or into the muscle of a patient. However, needles have a sharp tip which bears the risk of needle stick injuries, in particular for medical personnel, and it is highly desirable to prevent such needle stick injuries for safety reasons.

[0003] Therefore, safety devices have been proposed in order to cover the needle when not in use and to allow access to the needle when performing a medical action. For example, the document EP3302656 discloses such a safety device with a pivoting shield which is pivoted to a safe position covering the needle due to a simple push on the shield, allowing safe handling and disposal of the syringe after use.

[0004] However, medical personnel can be confused by the different kinds of safety devices existing on the market, some of which require different handling to reach their safe position. In particular, some of them require pressing the shield against a flat surface in order to bend the needle. However, if the shield of a safety device which requires a simple push to reach the safe position is actually pressed against a flat surface, the needle can be bent to an inappropriate angle and can then escape from the shield in the safe position, thus rendering the safety device inefficient due to such misuse.

[0005] Therefore, there is a need to propose a safety device for a needle of a medical device which allows the needle to be effectively covered by the shield in the safe position even if the proper operating instructions of the safety device are not followed. SUMMARY

[0006] This object is achieved by a safety device for a needle of a medical device, the safety device comprising:

[0007] • a ring adapted to be fixed with respect to the needle;

[0008] • a shield rotatably fixed to the ring, the shield being configured to rotate at least in a closing direction from a retracted position, in which the shield does not cover the needle, to a safe position, in which the shield covers the needle;

[0009] wherein the shield comprises a proximal portion and a distal portion, the distal portion being linked to the proximal portion so as to be able to rotate from an operating position to a tilted position in which the distal portion is tilted with respect to the proximal portion.

[0010] Thanks to the rotatable distal portion, the shield can cover the needle even if the safety device is not used properly. Thus, the safety device provides a higher level of safety for the user and the patient and helps to reduce or prevent needle stick injuries.

[0011] Advantageously, the safety positions comprise a first safety position in which the shield covers the needle and is in the operating position, and a second safety position in which the shield covers the needle and is in the tilted position. Thus, the user can choose between two different safety positions, which prevents any misuse of the safety device.

[0012] Advantageously, the proximal portion and the distal portion of the shield define a recess adapted to accommodate the needle in the safety positions. Since the recess extends in both the proximal portion and the distal portion of the shield, the needle can be effectively covered in any safety position.

[0013] Advantageously, the proximal portion and the distal portion are linked by a pivoting link adapted to face or contact the needle at least in the first safety position of the shield.

[0014] Advantageously, the distal portion is configured to rotate with respect to the proximal portion when a force equal to or greater than the driving force is applied on the distal portion. This allows the appearance and the performance of the safety device to be similar to safety devices according to the prior art, while allowing the distal portion to rotate towards the tilted position in case of misuse.

[0015] Advantageously, the distal portion is configured to rotate in the closing direction with respect to the proximal portion, which corresponds to a common misuse and can make the safety device more user-friendly.

[0016] Advantageously, the distal portion is linked to the proximal portion by a living hinge, i.e. a refinement or thinning of the shield formed as an integral part, which is a cost-effective and easy-to-manufacture type of hinge. Preferably, the living hinge can be configured to permanently deform due to the rotation of the distal portion, which can increase the safety level of the safety device by limiting the risk of not covering the needle tip in the safety positions, even in case of misuse.

[0017] Advantageously, the shield and the ring comprise a locking member configured to lock the shield to the ring in the safety positions. Such a locked shield can permanently cover the needle after use and provide a high level of safety.

[0018] Advantageously, the locking member comprises at least one fixed stop defined on the ring and at least one mobile stop defined on the proximal portion of the shield, and the mobile stop is configured to be on a first side of the fixed stop in the retracted position of the shield and to move to a second side of the fixed stop when the shield is rotated to the safety position. Such a locking member provides a high level of safety and is easy to manufacture, for example as a ring and a shield of appropriate shape. For example, the mobile stop is configured to be flexed or deflected by the fixed stop when it moves from the first side to the second side of the fixed stop.

[0019] Preferably, the fixed stop can be on a portion of the ring facing in a direction opposite to the closing direction of the shield, i.e. the opening direction, which allows a safe and user-friendly movement of the shield from the retracted position to the safety position. In other words, the fixed stop can be on or defined on a portion of the ring covered by the shield, for example by a lateral surface of the shield, in the retracted position of the shield.

[0020] Advantageously, the shield has a longitudinal axis, and the distal portion has a length along the longitudinal axis which is half or less than half of the length of the proximal portion along the longitudinal axis, and for example at least one sixth or one fifth of the length of the proximal portion along the longitudinal axis. Such a configuration can allow the shield to effectively cover the needle even after misuse. For example, the length of the distal portion can be one third of the length of the proximal portion.

[0021] Advantageously, the ring is centered on a central axis, and the shield is configured so that when the shield is in the safety position and the distal portion is in the tilted position, the longitudinal axis of the distal portion forms an angle of 75° to 105°, preferably 80° to 100° and again preferably 90°, with the central axis of the ring. Such a configuration can allow to provide a high level of safety for the user even during and after misuse of the safety device, such as a pressure of the distal portion on a surface.

[0022] Preferably, the longitudinal axis of the proximal portion can form an angle of 10° to 45°, preferably 15° to 40° and again preferably 25°, with the central axis of the ring when the shield is in the safety position, which allows easy handling of the safety device.

[0023] Advantageously, the shield comprises a thinned portion provided between the proximal portion and the distal portion, which can provide a cost-effective contribution to the rotatable or pivotal link of the distal portion to the proximal portion. For example, the thinned portion can be included in or can define a living hinge.

[0024] Advantageously, the shield comprises a main surface and at least a lateral surface, the thinned portion being provided at least on the lateral surface and being configured to fold when the distal portion is rotated. Such a thinned surface can thus allow to hide the pivoting link between the distal portion and the proximal portion from the user and can thus avoid that the user considers the tilted position of the distal portion as actually recommended. Preferably, two lateral surfaces are provided, each of them defining one thinned portion, and the shield can have a U-shaped cross section.

[0025] Preferably, the main surface defines at least on the distal portion of the shield a flat outer surface facing the opening direction, which can allow the user to safely rotate the shield from the retracted position to the safe position and can provide a high level of safety to the user during misuse.

[0026] A second aspect of the application is a safety shield adapted to be fixed on a tip of a medical device, for example a syringe, the safety shield comprising a needle and a safety device according to the first aspect of the application.

[0027] A third aspect of the application is a medical device comprising a needle and a safety device according to the first aspect of the application or comprising a safety shield according to the second aspect of the application.

[0028] Advantageously, the needle according to any aspect of the application has a tip and the distal portion of the shield is adapted to cover at least the tip of the needle when the shield is in the safe position.

[0029] Advantageously, the distal portion according to any aspect of the application comprises an inner pad adapted to contact the tip of the needle when the distal portion is in the tilted position. For example, the tip of the needle can be inserted in the inner pad in the tilted position and / or in the safe position, thereby providing a higher level of safety to the user or the patient, in particular in case of misuse.

[0030] Preferably, the needle is aligned on the central axis of the ring, which can provide a simple and efficient configuration of the medical device or of the safety shield.

[0031] Advantageously, the distal portion of the shield covers at most half of the distal portion, a quarter of the distal portion or a fifth of the distal portion of the needle when the shield is in the safe position, which can allow to limit the bending of the needle in case of misuse so that the shield can effectively cover the needle in the safe position. Preferably, at least the tip of the needle is covered by the distal portion in the safe position of the shield.

[0032] A fourth aspect of the application is a safety device for a needle of a medical device, the safety device comprising:

[0033] • a ring adapted to be fixed with respect to the needle;

[0034] • a shield rotatably fixed to the ring, the shield being configured to rotate at least in the closing direction from a retracted position, in which the shield does not cover the needle, to a safety position, in which the shield covers the needle;

[0035] wherein the shield comprises a proximal portion and a distal portion, the distal portion being joined to the proximal portion so as to be rotatable, preferably when a force equal to or greater than the driving force is exerted on the distal portion. BRIEF DESCRIPTION OF DRAWINGS

[0036] Other advantages and preferred embodiments of the invention will become apparent from the following specific description and drawings, in which:

[0037] Figure 1 is a side view of the safety device according to the invention in the initial position and mounted on a syringe as medical device.

[0038] Figure 2 is a detailed cross-sectional view of the safety device according to Figure 1 .

[0039] Figure 3 is a side view of the safety device according to Figure 1 in the retracted position.

[0040] Figure 4 is a side view of the safety device according to Figure 1 in the safety position.

[0041] Figure 5 is a detailed cross-sectional view of the safety device according to Figure 4 .

[0042] Figure 6 is a detailed side view of the safety device according to Figure 5 in the tilted position.

[0043] Figure 7 is a detailed cross-sectional view of the safety device according to Figure 6 . DETAILED DESCRIPTION

[0044] The safety device according to the application is intended to be used with or on any kind of injection, testing or sampling medical device using a needle adapted to pierce the body of a patient, and any kind of preventive, diagnostic, aesthetic or therapeutic medical treatment. For example, such medical device can be a medical syringe or a blood collection tube. The safety device can be mounted on the medical device or delivered as a safety hub adapted to be fixed on the neck of the medical device. Moreover, the safety device can also be proposed separately, for example to be subsequently mounted on a syringe or another medical device according to the target customer.

[0045] The safety device according to the application is described in the example of the figures as mounted on a medical syringe. Thus, in the present application, the distal direction must be understood as the injection direction of reference of the medical injection system, and the proximal direction is the opposite direction, i.e. the direction towards the hand of a user such as a medical caregiver or a patient.

[0046] Description of the principal embodiments

[0047] Reference is now made to Figure 1 and Figure 2 and from Figure 1 and Figure 2 The syringe 10 comprises, from proximal to distal or from left to right, a proximal flange 12, a syringe barrel 11 and a distal neck 13 provided with a needle 14 defining a tip 14a. The needle 14 can be stacked and / or glued to the distal neck 13.

[0048] The safety device 20 according to the application comprises a ring 30 fixed on the distal neck 13 of the syringe, for example thanks to a clamping, a gluing, a welding and / or a friction. The ring 30 can comprise a portion of a hinge 21 and a fixed stop 31, such as an ear pointing in the distal direction and for example provided with an inclined distal surface (see Figure 2 ). The ring 30 can be centered on an axis A, such as an axis of revolution of the ring 30, and this axis A can be a longitudinal and / or an axis of revolution of the needle 14 and / or of the syringe 10.

[0049] The safety device 20 further comprises a shield 40 rotatably fixed to the ring 30 thanks to a pivoting link in the form of a hinge 21 or alternatively a living hinge (not represented). This hinge 21 allows the shield 40 to adopt several positions relative to the ring 30 and the syringe 10, as described hereafter. In particular, the hinge 21 defines an opening direction of the shield 40 (see Figure 1and a closing direction of the shield 40, which is opposite to the opening direction. The ring 30 can define a portion facing the opening direction and / or facing the shield 40 when the shield 40 is in the retracted position. The fixed stop 31 can be provided on this portion of the ring 30.

[0050] With reference to Figure 1 and Figure 2 The shield comprises a main surface 41 and two side surfaces 42, for example transverse to the main surface 41. The main surface 41 is preferably flat on the outer face facing the opening direction and, together with the side surfaces 42, defines a recess 43 intended to accommodate the needle in a safe position of the shield. Thus, the shield 40 can have a U-shaped cross section. Furthermore, the shield 40 comprises a proximal portion 44 close to or facing the ring 30 and comprises a portion of the hinge 21 on the side surfaces 42. A distal portion 45 opposite the proximal portion 44 and opposite the ring 30 is also defined on the shield 40. The proximal portion 44 and the distal portion 45 are joined or connected by a pivot link 46 comprising a notch 46a in each of the side surfaces 42 of the shield 40.

[0051] The pivot link 46 is preferably a living hinge as shown in Figure 2 but can also be a hinge in another embodiment (not represented). The pivot link 46 allows the distal portion 45 to rotate relative to the proximal portion 44 into an inclined position, for example when a force (equal to or greater than the driving force) or a torque is applied to the distal portion 45. During normal operation of the shield 40, the pivot link 46 does not rotate and the distal portion is in an operating position, for example aligned with the proximal portion 44 on the longitudinal axis B of the shield 40. The pivot link 46 can rotate in the closing direction and can resist rotation in the opening direction.

[0052] The pivot link 46 can be placed on a portion of the shield 40 covering or facing the needle in an initial position and / or in a safe position such as a first safe position. For example, the pivot link 46 can be comprised in an intermediate portion of the shield 40 and / or in the recess 43 or in the portion of the shield 40 between the intermediate portion and the distal extremity. The shield (40) can have a longitudinal axis (B) and the distal portion (45) can have a length along the longitudinal axis (B) which is half or less than half of the length of the proximal portion (44) along the longitudinal axis (B).

[0053] The shield further comprises a movement stop 47 which can be located on the proximal end of the main surface 41 of the shield 40, i.e. on the proximal end of the proximal portion 44. This movement stop 47 can be elastically deformable at least in the opening direction, for example due to a reduced thickness and / or due to the material of the shield 40. Alternatively, the movement stop 47 can not be integral with the shield, but can be a separate component which is permanently fixed to the shield 40. The movement stop 47 is configured to be located on the fixed stop 31 in the initial position and to engage or abut the fixed stop 31 in the safety position of the shield 40. For example, the movement stop 47 and / or the fixed stop 31 can have an inclined surface, preferably with a similar angle as can be seen in the drawings.

[0054] Finally, the ring 30 and the shield 40 are preferably made of any rigid polymer suitable for medical use, such as high-density polyethylene (PE), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), polyoxymethylene (POM), polystyrene (PS), polybutylene terephthalate (PBT), polyamide (PA) and combinations thereof.

[0055] Operation of the principal embodiments

[0056] In operation, the syringe 10 and the safety device 20 can be arranged as can be seen in Figure 1 and Figure 2 , wherein the shield 40 is in the initial position, partially covering the needle 14. Furthermore, the distal portion 45 can be in the operating position, not rotated with respect to the proximal portion 44, and for example aligned with the proximal portion 44 along the longitudinal axis B. Thanks to this operating position, the user does not notice any change with respect to prior art safety devices comprising a shield without a pivoting link, and can therefore use the syringe 10 and the safety device 20 according to his / her usual practice.

[0057] Furthermore, a needle cap can surround and protect the needle 14 (not represented in the drawings). This needle cap can be removed from the needle 14 before using the syringe 10, as known by the person skilled in the art. In the initial position, the shield 40 can be substantially parallel to the syringe 10. For example, the longitudinal axis B of the shield 40 can be parallel to the central axis A of the ring 30 and / or of the syringe 10 (see Figure 2 ).

[0058] In the initial position of Figure 1 and Figure 2 , the movement stop 47 is located on the first side of the fixed stop 31, for example between the central axis A and the longitudinal axis B, and is not engaged or locked by the fixed stop 31. Therefore, the shield 40 can be rotated in the opening direction with respect to the ring 30 in order to pass from the initial position of Figure 1 and Figure 2 (seeFigure 1 moves to the retracted position of the shield 40. In the retracted position, the shield 40 can form an angle of preferably at least 45°, preferably 75° and again preferably at least 90° with the syringe, for example between the longitudinal axis B of the shield 40 and the central axis A. In this retracted position, the needle 14 is fully accessible and the syringe 10 can be used for delivering a drug to a patient, for example according to customary medical practice. Figure 3

[0059] At the end of the injection operation, the shield 40 can be rotated in the closing direction (see black arrow in Figure 3 ) for example due to a force exerted by the user's thumb on the main surface 41 of the shield 40 (see white arrow in Figure 3 ). The fixed stop 31 is placed in the path of the mobile stop 47 in the closing direction and according to the operating instructions, an additional force has to be exerted on the shield 40 in order to deflect the mobile stop 47. This force can preferably be limited to for example 1 N to 5 N, for example 3 N.

[0060] Thus, the mobile stop 47 can reach the second side of the fixed stop 31 at the end of the closing movement of the shield 40. Thus, the shield 40 has reached a safe position, such as a first safe position, and forms an angle of about 25° between its longitudinal axis B and the central axis A of the syringe (see Figure 4 and Figure 5 ). Figure 5

[0061] With reference to Figure 5 , the mobile stop 47 abuts against the fixed stop 31 on the other side of the fixed stop 31 of the ring 30, which prevents any movement of the shield and locks the shield 40 to the ring 30. Thus, the fixed stop 31 and the mobile stop 47 act as locking members to lock the shield 40 in the safe position. Furthermore, the bent or inclined surfaces of the fixed stop 31 and the mobile stop 47 can be similar or complementary in order to facilitate the locking engagement.

[0062] Furthermore, due to the angle formed between the shield 40 and the syringe 10, the needle 14 is bent, for example on the deflection point 14B, due to the rotational movement of the shield 40, so as to make the syringe 10 significantly unsuitable for use. Preferably, a portion of the needle 14 can be housed in the internal slot of the recess 43 of the shield 40.

[0063] With reference now to Figure 6 and Figure 7 , in the case of misuse of the safety device 20, the main surface 41 of the distal portion 45 can be pressed on a flat surface, for example a table, despite the operating instructions to keep the safety device in Figure 4 and Figure 5 ​​In this case, the distal portion 45 can be rotated in the tilted position relative to the proximal portion 44, for example so as to form an angle of 90° or at least 80° between the longitudinal axis C of the distal portion 45 and the central axis A, and the shield 40 can be in the second safety position. The force to rotate the distal portion is preferably higher than the force to move the shield into the safety position, for example 5 to 20 N, preferably 12 N.

[0064] Thanks to the pivoting link 46 located on the needle or facing the needle in the safety position, an appropriate angle can be maintained between the syringe (axis A) and the proximal portion 44 of the shield 40 (axis B). Thus, the additional bending of the needle 14 resulting from misuse (i.e. the distal portion 45 pressed against a surface) can be limited, and the deflection point 14B of the needle is maintained at a distance from the proximal portion 44 of the shield 40. Figure 4 and Figure 5 The safety position of the shield 40 can not be changed.

[0065] Preferably, the pivoting link 46 is located at the middle portion of the shield 40 or distally of this middle portion, for example at a third of the length of the shield 40 distal section, which allows limiting the angle formed by the bent needle 14 and prevents the bent needle 14 from escaping from the recess 43. In other words, the length of the distal portion 45 of the shield 40 is half or less than half the length of the proximal portion (44) along the longitudinal axis (B) allows effectively covering the needle 14 in the second safety position defined by the tilted shield.

[0066] Preferably, the pivoting 46 can allow permanent deformation of the shield 40, and the distal portion 45 can be permanently in the tilted position. Figure 6 and Figure 7 This permanent deformation can be a plastic deformation obtained for example by choosing a material having a low elastic limit, such as lower than the force required to move the distal portion, i.e. lower than 20 N or preferably lower than 5 N. This embodiment provides a high level of safety, as the user cannot access the needle 14 after use: needle stick injuries are limited or prevented as well as any unwanted reuse of the syringe 10.

[0067] Other embodiments

[0068] In another embodiment, the pivoting link 46 of the shield 40 can have elastic properties, and the distal portion 45 can at least partially return to its operating position (i.e. aligned or close to the alignment with the proximal portion). However, the deflection of the needle 14 has been limited by the rotation of the distal portion 45, and the tip 14a of the needle 14 can be kept within the recess 43 or at least covered by the shield 40 even if the distal portion 45 returns into the operating position. Thus, such a safety device can maintain an appropriate level of user protection even in misuse.

[0069] Furthermore, an inner pad (not represented) can be provided inside the recess 43 in order to contact or be pierced by the tip of the needle in the tilted position of the distal portion 45 and / or in the safety position of the shield 40 in order to further improve the safety level of the safety device according to the application.

[0070] In another embodiment, the recess 46a can be filled with a thin material and for example contained in a thinned portion of the shield or masked using a label or a polymer film. For example, the thinned portion has a thickness of 0.10 mm to 0.20 mm, preferably 0.15 mm, and can contain polyoxymethylene (POM). Alternatively or in combination, the lateral surface of the distal portion can be displaced relative to the lateral surface of the proximal portion and then the recess 46a can be a slot. These embodiments are valuable to avoid the idea of the user that the tilted position of the distal portion is appropriate according to the operating instructions.

[0071] The locking member can also have different designs, for example with a stepped surface and / or located in another portion of the ring and of the shield, for example on the lateral faces of the ring and of the shield, i.e. around the hinge 21.

[0072] All these embodiments can be combined together and / or with the main embodiments.

[0073] While the application has been described and illustrated in detail, it is clearly understood that the same is by way of illustration and example only and is not to be taken by way of limitation, the scope of the application being limited only by the terms of the appended claims.

Claims

1. A safety device (20) for a needle (14) of a medical device, the safety device (20) comprising: - a ring (30) adapted to be fixed relative to the needle (14); - a shield (40) rotatably fixed to the ring (30), the shield (40) being configured to rotate at least in a closing direction from a retracted position, in which the shield (40) does not cover the needle (14), to a safety position, in which the shield (40) covers the needle (14), - wherein the shield (40) comprises a proximal portion (44) and a distal portion (45) joined to the proximal portion (44) so as to be able to rotate from an operating position to an inclined position, in which the distal portion (45) is inclined relative to the proximal portion (44), - wherein a distal direction is the direction of injection and a proximal direction is the opposite direction, - wherein the safety position comprises a first safety position in which the shield (40) is in the operating position after use of the needle (14) and a second safety position in which the shield (40) is in the inclined position in case of misuse of the safety device, and - wherein the shield is configured to bend the needle by rotating the shield to the safety position in which the shield covers the needle, so that a point of deflection of the needle remains in the proximal portion or in the distal portion in the first safety position and in the second safety position.

2. The safety device (20) according to claim 1, wherein the proximal portion (44) and the distal portion (45) of the shield (40) define a recess (43) adapted to accommodate the needle in the first safety position and in the second safety position.

3. The safety device (20) according to claim 1, wherein the proximal portion (44) and the distal portion (45) are joined by a pivoting link (46) adapted to face the needle (14) at least in the first safety position of the shield (40).

4. The safety device (20) according to claim 1, wherein the proximal portion (44) and the distal portion (45) are joined by a pivoting link (46) adapted to contact the needle (14) at least in the first safety position of the shield (40).

5. The safety device (20) according to any one of claims 1 to 4, wherein the distal portion (45) is configured to rotate relative to the proximal portion (44) when a force equal to or greater than a driving force is applied on the distal portion (45).

6. The safety device (20) according to any one of claims 1 to 4, wherein the distal portion (45) is configured to rotate relative to the proximal portion (44) in the closing direction.

7. The safety device (20) according to claim 3 or 4, wherein the pivoting link (46) is a living hinge configured to permanently deform due to the rotation of the distal portion (45).

8. Safety device (20) according to any one of claims 1 to 4, wherein the shield and the ring comprise a locking member configured to lock the shield (40) to the ring (30) in the first safety position.

9. Safety device (20) according to claim 8, wherein the locking member comprises at least one fixed stop (31) defined on the ring (30) and at least one mobile stop (47) defined on the proximal portion (44) of the shield (40), and wherein the mobile stop (47) is configured to be on a first side of the fixed stop (31) in the retracted position of the shield and to move to a second side of the fixed stop (31) when the shield (40) is rotated to the first safety position.

10. Safety device (20) according to any one of claims 1 to 4, wherein the shield (40) has a longitudinal axis (B) and the distal portion (45) has a length along the longitudinal axis (B) which is half or less than half of a length of the proximal portion (44) along the longitudinal axis (B).

11. Safety device (20) according to claim 10, wherein the ring (30) is centered on a central axis (A) and the shield (40) is configured so that a longitudinal axis (C) of the distal portion (45) forms an angle of 75° to 105° with the central axis (A) of the ring (30) when the shield (40) is in the second safety position and the distal portion (45) is in the tilted position.

12. Safety device (20) according to claim 3 or 4, wherein the shield (40) comprises a thinned portion comprising the pivoting link (46) and disposed between the proximal portion (44) and the distal portion (45).

13. Safety device (20) according to claim 12, wherein the shield (40) comprises a main surface (41) and at least a lateral surface (42), the thinned portion being disposed at least on the lateral surface (42) and being configured to fold when the distal portion (45) is rotated.

14. Safety hub adapted to be fixed on a tip of a medical device, the safety hub comprising a needle and a safety device (20) according to any one of claims 1 to 13.

15. Safety hub according to claim 14, wherein the needle (14) has a tip (14a) and the distal portion (45) of the shield (40) is adapted to cover at least the tip (14a) of the needle (14) when the shield (40) is in the first safety position or in the second safety position.

16. Safety hub according to claim 15, wherein the distal portion (45) comprises an internal pad adapted to contact the tip (14a) of the needle (14) when the distal portion (45) is in the tilted position.

17. The safety needle hub of any of claims 14 to 16, wherein the distal portion (45) of the shield (40) covers at most one half of the distal portion of the needle (14) when the shield (40) is in the first safety position.

18. A medical device (10) comprising a needle (14) and a safety device (20) according to any of claims 1 to 13.

19. The medical device (10) of claim 18, wherein the needle (14) has a tip (14a) and the distal portion (45) of the shield (40) is adapted to cover at least the tip (14a) of the needle (14) when the shield (40) is in the first safety position or the second safety position.

20. The medical device (10) of claim 19, wherein the distal portion (45) comprises an inner pad adapted to contact the tip (14a) of the needle (14) when the distal portion (45) is in the tilted position.

21. The medical device (10) of any of claims 18 to 20, wherein the distal portion (45) of the shield (40) covers at most one half of the distal portion of the needle (14) when the shield (40) is in the first safety position.

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