Needle Safety Device

Abstract

To provide a needle safety device comprising an elongated hub portion with a longitudinal axis.SOLUTION: A hub portion 10 comprises a cannula 12, and a tubular protection element 20 arranged to be movable along a longitudinal axis 11 relatively to the hub portion 10. The protection element 20 comprises a contact surface 21 for establishing pressure contact with an injection area. Further, a device 1 comprises a tubular separable element 30 comprising at least two locking parts 31, 32, and a spring element 40. The spring element 40 biases the protection element 20 such that the contact surface 21 is further separated from the hub portion 10 along the longitudinal axis 11 than the tip of the cannula 12. The protection element 20 is such that the separable element 30 is removed from the protection element 20 and separates into the locking parts 31, 32 when the contact surface 21 is released from contact with the injection area, and the separated locking parts 31, 32 inhibit the protection element 20 from returning into an injection position when the protection element 20 has moved to a final position.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present disclosure relates to needle safety devices for medical injection devices and medical injection devices that include needle safety devices. [Background technology]

[0002] For some medical injection devices, such as auto-injectors or pen-type injectors, it is often necessary to ensure that intentional and / or unintentional reuse of the medical injection device cannot occur. The reasons for this can be manifold, for example, because the medical injection device in question may be intended for a single injection procedure, such as an auto-injector that injects emergency drugs such as adrenaline in the event of an allergic shock. It is further understood that hygiene-related reasons may also be considered. In this regard, cross-contamination after injection must be avoided, especially in situations where people are injured and contaminated by used needles.

[0003] Furthermore, for some medical injection devices, in particular those which are also operated by non-medical personnel, such as again auto-injectors or pen-type injectors, it must be ensured that unintentional contact with the cannula cannot occur, e.g. to prevent injury to the user, contamination and / or contamination of the cannula.

[0004] In order to prevent the reuse of a medical injection device and to prevent accidental contact with the cannula of a medical injection device, various solutions, in particular needle safety devices, are known from the prior art. Generally, the known needle safety devices are based on the principle that a sleeve is provided which is arranged around the needle, thereby preventing unintentional contact with said needle. Furthermore, the sleeve is arranged to be moved as soon as it comes into contact with the injection area so that an injection can be performed, while re-movement of the sleeve after the injection is prevented, for example by a locking means. However, certain solutions of the prior art or existing needle safety devices have several drawbacks, some of which are listed below:

[0005] First, some existing needle safety devices for medical injection devices introduce twisting into the injection area because, for example, a sleeve surrounding the needle rotates relative to the medical injection device during injection, for example to create a lock. This rotation is typically perceived as unpleasant by the patient and, in the worst case, can cause the patient to abort the injection.

[0006] Secondly, some needle safety devices allow the locking means intended to fix the sleeve in place after injection so that the cannula is permanently prevented from contact to be released again. One reason is that the movement that led to the locking of the sleeve can be manually reversed, for example by rotating the sleeve back to its unlocked initial state. Another reason is that the locking means itself can itself be manually unlocked again, for example by releasing a locking arm or by moving the pin out of the final position where it is to be held, as in the embodiment described in US Pat. No. 9,907,916. Summary of the Invention [Problem to be solved by the invention]

[0007] It is therefore an object of the present disclosure to provide a needle safety device for a medical injection device and a medical injection device that at least partially overcomes the above-mentioned drawbacks. [Means for solving the problem]

[0008] This object is achieved at least in part by a needle safety device for a medical injection device and a medical injection device as defined in the independent claims. Further aspects of the present disclosure are defined in the dependent claims.

[0009] In particular, this object of the invention is achieved by a needle safety device for a medical injection device. The needle safety device can function to prevent reuse of the medical injection device and to prevent accidental contact with a puncture means such as a cannula, and optionally the needle safety device can provide additional functions. The medical injection device can be an autoinjector, a pen injector and / or a syringe. However, preferably the medical injection device is an autoinjector, since autoinjectors in particular rely on preventing reuse and avoiding accidental contact with a puncture means. This is for example because autoinjectors are usually operated by non-medical personnel, for example in emergency situations.

[0010] The needle safety device comprises an elongated hub portion having a longitudinal axis, the hub portion comprising a cannula extending from the hub portion substantially along the longitudinal axis. If the hub portion has a substantially cylindrical shape, the longitudinal axis of the hub portion may be the central longitudinal axis of the hub portion. The cannula may also be referred to as a hollow needle or injection needle. Furthermore, the cannula may be directly or indirectly attached to the hub portion. The cannula may be part of a needle arrangement. It is further understood that the cannula may be designed to be movable relative to the hub portion, for example to achieve the penetration of a liquid reservoir in a medical injection device.

[0011] Furthermore, the needle safety device comprises a tubular protective element arranged to be movable along the longitudinal axis relative to the hub part, the protective element comprising a contact surface for establishing a pressure contact with the injection area, which contact surface is further away from the hub part along the longitudinal axis than the tip of the cannula in the initial position of the needle safety device. The tubular protective element makes it possible to protect the tip of the cannula from unintentional contact. In particular, in the initial position, i.e. before starting the injection process, the protective element can prevent contact with the tip of the cannula. For example, when a human finger approaches the tip of the cannula, the finger does not immediately contact the tip of the cannula, but first contacts the contact surface. It is understood that the protective element may surround the cannula.

[0012] Furthermore, the needle safety device comprises a tubular separable element, which is removably arranged in the protective element in the initial position so as to be movable along the longitudinal axis together with the protective element, and the separable element comprises at least two locking members. For example, the tubular separable element may be removably attached to the protective element in the initial position. In this case, the tubular separable element may be attached directly or indirectly. Exemplarily, an inner surface of the tubular protective element may be removably engaged with an outer surface of the tubular separable element, for example by form-fitting.

[0013] The needle safety device further comprises a spring element which biases the protective element in a distal direction relative to the hub portion, such that the contact surface is spaced further from the hub portion along the longitudinal axis than the tip of the cannula when the contact surface is not pressing against the injection area. The bias of the protective element prevents accidental contact with the tip of the cannula, particularly when the contact surface is not pressing against the injection area, i.e. when no injection is being performed. The spring element may be a coil spring. However, it is understood that different spring elements are also contemplated.

[0014] The protective element is configured to move to an injection position when the contact surface is pressed against the injection area, where the tip of the cannula is further away from the hub portion along the longitudinal axis than the contact surface, and where the separable element is removed from the protective element when the contact surface is released from the injection area, thereby separating into at least two locking members. The separated locking members prevent the protective element from returning to the injection position when the protective element moves to a final position. In the final position, the contact surface is further away from the hub portion along the longitudinal axis than the tip of the cannula. Due to the tip of the cannula being further away from the hub portion along the longitudinal axis than the contact surface in the injection position, the tip of the cannula can be inserted into the injection area. Furthermore, the separable element can be removed from the protective element, for example by being held by the hub portion, while the spring element biases the protective element in a distal direction relative to the hub portion. Furthermore, the separable element can be separated, for example, into at least two locking members, by a preload on the separable element that is released after the separable element is removed from the protective element. Furthermore, the separable element can be separated, for example, into at least two locking members, by respective means on the separable element and / or the hub portion. For example, the separated locking members can prevent the protective element from returning to the injection position, in that separation positions the locking members such that the mobility of the protective element in the longitudinal axis direction is limited. The separated locking members preventing the protective element from returning to the injection position enable the needle safety device to serve to prevent reuse of the medical injection device.

[0015] The described needle safety device has several advantages over the prior art, two of which are detailed below.

[0016] First, because the needle safety does not rely on a guide pin sliding through a guide track in a rotating sleeve, the needle safety allows for a torsion-free configuration in the injection area, which can make the injection process more comfortable for the patient.

[0017] Secondly, the tubular separable element makes it more difficult for the needle safety device to return intentionally and unintentionally to its initial position, especially compared to devices in which a guide pin engages in a guide track, since the separated locking member needs to be reassembled and placed again in the protective element, which has proven to be extremely difficult, resulting in a high level of safety of the needle safety device against reuse.

[0018] It is understood that the advantages described may also be applied to those described below in different terms.

[0019] Optionally, in the initial position, the at least two locking members are not physically connected to each other. Exemplarily, the locking members may be in abutment with each other. Also exemplarily, in the initial position, the locking members may be preloaded against each other within the protective element. Thus, the separable element can be separated into the at least two locking members by releasing said preload after removing the separable element from the protective element. By not being physically connected to each other, separation of the locking members can be more reliably performed.

[0020] In the initial position, the separable element may be at least partially surrounded by the protective element such that at least two locking members are held together and abut each other. This configuration allows for avoiding undesired removal of the separable element from the protective element, in particular by the separable element being at least partially surrounded by the protective element. Furthermore, this configuration allows for easy separation of the separable element into the locking members after removal of the separable element from the protective element.

[0021] In the initial position, the at least two locking members may be integrally formed with one another. Here, "integrally formed" may relate to a manner in which it is not possible to identify a material boundary between the at least two locking members in at least one position. It has been found that by forming the at least two locking members integrally with one another, the assembly of the needle safety device can be simplified. Furthermore, undesired separation can be more easily avoided.

[0022] Furthermore, the contact surface may have an opening through which the tip of the cannula passes when the protective element is being moved into the injection position, whereby the opening may have a diameter that avoids the insertion of a human finger into the protective element.

[0023] Furthermore, the protective element may be configured to be substantially non-rotatable relative to the hub portion. Thus, the injection area can be particularly prevented from twisting. This makes the injection process more comfortable for the patient. Exemplarily, the protective element can be directly engaged with the hub portion. Alternatively, an intermediate element, such as a housing, fixedly attached to the hub portion can ensure that the protective element cannot rotate relative to the hub portion.

[0024] The protective element and the separable element may be configured to allow rotation relative to one another, and optionally the separable element is in rotatable, sliding engagement with the protective element, which rotation can be used, for example, to securely remove the separable element from the protective element.

[0025] The hub portion and the separable element may each comprise a retaining means configured to engage with each other such that the separable element is held in place relative to the hub portion when the protective element is moved to the final position. It will be appreciated that the protective element moves from the injection position to the final position. Being held in place relative to the hub portion when the protective element moves from the injection position to the final position ensures that the separable element can be removed from the protective element. For example, the retaining means may each comprise an abutment surface configured to engage with each other.

[0026] Optionally, the hub part and / or the separable element comprise a rotating means, which rotates the separable element relative to the hub part when the protective element, in which the separable element is arranged, moves from the initial position to the injection position. By rotating the separable element relative to the hub part, the retaining means engage with each other. Preferably, the rotating means is configured to rotate the separable element relative to the hub part about the longitudinal axis. Due to the feature that the retaining means engage with each other by rotating the separable element relative to the hub part, on the one hand, unintentional detachment of the separable element from the protective element can be avoided, and on the other hand, it is particularly difficult to move the needle safety device from the final position to the initial position. Thus, the overall safety of the needle safety device can be improved.

[0027] Furthermore, in the initial position, the separable element may be removably arranged in the protective element by a form-fitting connection, optionally with the protective element comprising a protrusion and the separable element comprising a groove, the protrusion and the groove being engaged in the initial position. For example, the protrusion may be provided on the inside of the protective element and the groove on the outside of the separable element. It has been found that a form-fitting connection allows a secure connection on the one hand and ensures easy release on the other hand. Furthermore, such a connection makes it possible in particular to provide the above-mentioned rotatability between the separable element and the protective element.

[0028] The at least two locking members are movable radially outwardly as viewed from the longitudinal axis, such that they separate from one another when the separable element is removed from the protective element. Optionally, the hub portion and / or the separable element have a separation means for moving the at least two locking members radially outwardly. The separation may be such that the locking members are positioned to prevent the protective element from returning to the injection position when the protective element is moved to the final position. Exemplarily, the separation means may be a ramp-like element that presses the at least two locking members radially outwardly, for example by gravity.

[0029] Optionally, the hub portion comprises a first abutment surface and the protective element comprises a second abutment surface, and when pressure is applied to the contact surfaces such that in the final position at least one of the separated locking members abuts against the first and second abutment surfaces, said separated locking member prevents the protective element from returning to the injection position, thus preventing reuse of the needle safety device.

[0030] The spring element may abut against the hub portion and the protective element, this arrangement having been found to be advantageous in preventing the spring element from influencing the rotation of the separable element.

[0031] Furthermore, the above-mentioned object is achieved by a medical injection device comprising a needle safety device as described above, whereby it is understood that the features and / or advantages described with respect to the needle safety device are also applicable to the medical injection device, since the medical injection device comprises a needle safety device as described above.

[0032] The medical injection device may include a housing that engages the protective element such that the protective element is substantially non-rotatable relative to the hub portion.

[0033] The accompanying drawings are briefly described below. [Brief description of the drawings]

[0034] [Figure 1] FIG. 2 is a perspective view of a needle safety device according to the present invention prior to injection. [Diagram 2] FIG. 1 is a cross-sectional view showing the needle safety device prior to injection. [Diagram 3] FIG. 13 is a cross-sectional view showing the needle safety device during injection. [Figure 4] FIG. 13 is a cross-sectional view showing the needle safety device after injection. [Diagram 5] FIG. 13 is a cross-sectional view showing the needle safety device after injection. [Figure 6] FIG. 13 is a cross-sectional view of the needle safety device after an injection when an attempt is made to reactivate the device. [Figure 7] FIG. 2 is a perspective view showing a tubular separable element of the needle safety device. [Figure 8] FIG. 2 is a perspective view of a needle safety device according to the present invention after an injection. [Figure 9] FIG. 1 illustrates a medical injection device according to the present disclosure after injection. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] 1-9 show all or part of a needle safety device 1 according to the present disclosure. Needle safety device 1 includes an elongated hub portion 10 having a central longitudinal axis 11.

[0036] 2, the hub portion 10 comprises a cannula 12 extending substantially along a longitudinal axis 11 from the hub portion 10. In particular, the cannula 12 is indirectly attached to the hub portion via a carrier element fixedly attached to the cannula 12. Furthermore, the cannula is designed to be movable relative to the hub portion in order to realize the penetration of a liquid reservoir in the medical injection device 100.

[0037] Furthermore, the hub part 10 comprises a tubular protective element 20 arranged to be movable along the longitudinal axis 11 relative to the hub part 10. The protective element 20 comprises a contact surface 21 for establishing a pressure contact with the injection area, which in the initial position of the needle safety device 1, for example as shown in Figures 1 and 2, is further away from the hub part 10 along the longitudinal axis 11 than the tip 13 of the cannula 12. The contact surface 21 has an opening 22 through which the tip 13 of the cannula 12 passes when the protective element 20 is moved to the injection position (see Figure 3).

[0038] Furthermore, the hub portion 10 comprises a tubular separable element 30, which is removably arranged on the protective element 20 in an initial position, such that the separable element 30 is movable together with the protective element 20 along the longitudinal axis 11. The separable element 30 comprises at least two locking members 31, 32.

[0039] Additionally, hub portion 10 includes a spring element 40 that biases protective element 20 in a distal direction relative to hub portion 10 such that contact surface 21 is spaced further from hub portion 10 along longitudinal axis 11 than tip 13 of cannula 12 when contact surface 21 is not pressing against an injection area (see, e.g., FIGS. 1 and 2). Spring element 40 abuts hub portion 10 and protective element 20.

[0040] The protective element 20 is configured to move to an injection position, for example as shown in Figure 3, in which the tip 13 of the cannula 12 is further away from the hub portion 10 along the longitudinal axis 11 than the contact surface 21 when the contact surface 21 is pressed against the injection area, as shown.

[0041] 3 and 4, when the contact surface 21 is released from pressure contact with the injection area, the separable element 30 is removed from the protective element 20, thereby separating into the at least two locking members 31, 32. In particular, when the separable element 30 is removed from the protective element 20, the at least two locking members 31, 32 move radially outwardly as viewed from the longitudinal axis 11, thereby separating from one another.

[0042] Thereby, as shown in FIG. 6, the separated locking members 31, 32 prevent the protective element 20 from returning to the injection position when the protective element 20 has been moved to its final position.

[0043] In the final position (see FIGS. 5 and 8), contact surface 21 is spaced further along longitudinal axis 11 from hub portion 10 than tip 13 of cannula 12 .

[0044] As shown in Figure 7, in the initial position, the at least two locking members 31, 32 are not substantially coupled to one another. Rather, as one skilled in the art will appreciate from Figures 1 and 2, in the initial position, the separable element 30 is surrounded by the protective element 20 such that the at least two locking members 31, 32 are held together and abut one another.

[0045] The protective element 20 is configured to be substantially non-rotatable relative to the hub portion 10. Exemplarily, in FIG. 8 , a protrusion of the protective element 20 engages with a guide means of the housing 110 of the medical injection device, so that the protective element 20 is substantially non-rotatable relative to the hub portion 10 attached to the housing 110.

[0046] Furthermore, the protective element 20 and the separable element 30 are configured to allow rotation relative to one another, with the separable element 30 in rotatable, sliding engagement with the protective element 20. In particular, in an initial position, the separable element 30 is removably arranged in the protective element 20 by form-fitting, with the protective element 20 comprising a protrusion 25 and the separable element 30 comprising a groove 35, with the protrusion 25 and the groove 35 engaging in the initial position. This engagement allows the protective element 20 and the separable element 30 to rotate relative to one another.

[0047] Furthermore, the hub portion 10 and the separable element 30 each comprise a retaining means 16, 36 configured to engage with one another such that the separable element 30 is held in position relative to the hub portion 10 when the protection element 20 moves to its final position (see Figures 3 and 4).

[0048] It will be understood by those skilled in the art that FIG. 4 shows the separable element 30 immediately after it has been separated from the protective element 20, whereas FIG. 5 shows the protective element 20 fully returned by the spring element 40 and the locking members 31, 32 dropped by gravity into the housing 110.

[0049] Furthermore, the hub part 10 and the separable element 30 are provided with rotation means 17, 37 for rotating the separable element 30 relative to the hub part 10 when the protective element 20, in which the separable element 30 is arranged, moves from the initial position to the injection position. Rotating the separable element 30 relative to the hub part 10 causes the retaining means 16, 36 to engage with each other (see Figures 2 and 3).

[0050] In particular, a person skilled in the art will understand from Figures 1 to 4 that the retaining means 16 of the hub part 10 is a circumferential abutment surface formed by the hub part 10 and configured to abut the retaining means 36 of the separable element 30. Furthermore, as shown in Figure 1, the rotating means 17 of the hub part 10 is a partially curved guide track configured to abut against the rotating means 37 of the separable element 30 so that rotation of the separable element 30 relative to the hub part 10 can be achieved.

[0051] Furthermore, as shown in Figures 4, 6 and 7, the retaining means 36 of the separable element 30 is an abutment surface formed at a first end of a rib formed on the inside of the tubular separable element 30. The rib extends substantially parallel to the longitudinal axis 11. The rotating means 37 of the separable element 30 is an abutment surface formed at a second end of said rib. Thus, the retaining means 36 of the separable element 30 and the rotating means 37 of the separable element 30 are integrally formed.

[0052] Furthermore, the hub part 10 has a longitudinal cutout running parallel to the longitudinal axis 11 and through the circumferential abutment surface of the retaining means 16 of the hub part 10 (see FIG. 1). Thus, in an initial position, the separable element 30 is arranged in the protective element 20, whereby the integrally formed retaining means 36 and rotating means 37 can slide through the longitudinal cutout.

[0053] Furthermore, as shown for example in Figures 2 and 3, the hub part 10 comprises a first abutment surface 14 and the protective element 20 comprises a second abutment surface 24. When pressure is applied to the contact surface 21 in the final position such that at least one of the separated locking members 31, 32 abuts against the first abutment surface 14 and the second abutment surface 24, the protective element 20 is then prevented from returning to the injection position by the separated locking members. This situation is shown in Figure 6.

[0054] 9 shows a medical injection device 100 according to the present disclosure, comprising a needle safety device 1 as described above. As described above, the medical injection device 100 comprises a housing 110 that engages the protective element 20 such that the protective element 20 is substantially non-rotatable relative to the hub portion 10. [Explanation of symbols]

[0055] 1 Needle Safety Device 10 Long and narrow hub section 11 Longitudinal axis 12 Cannula 13 Tip of cannula 14 First contact surface 16 Retention means 17 Rotation means 20 Tubular protective elements 21 Contact surface 22 Contact surface opening 24 Second abutment surface 25 Protrusion 30 Tubular separable elements 31 First lock member 32 Second locking member 35 Groove 36 Retention means 37 Rotation means 40 Spring elements 100 Medical injection device 110 Housing

Claims

1. A needle safety device (1) for a medical injection device (100), the needle safety device (1) comprising: an elongated hub portion (10) having a longitudinal axis (11) and including a cannula (12) extending from said hub portion (10) substantially along said longitudinal axis (11); a tubular protective element (20) arranged to be movable along the longitudinal axis (11) relative to the hub portion (10), the protective element (20) having a contact surface (21) for establishing a pressure contact with an injection area, the contact surface (21) being further away from the hub portion (10) along the longitudinal axis (11) than the tip end (13) of the cannula (12) in an initial position of the needle safety device (1); a tubular separable element (30) removably arranged in the protective element (20) in the initial position, whereby the separable element (30) is movable along the longitudinal axis (11) together with the protective element (20), the separable element (30) comprising at least two locking members (31, 32); a spring element (40) biasing the protection element (20) in a distal direction relative to the hub portion (10), such that the contact surface (21) is further away from the hub portion (10) along the longitudinal axis (11) than the tip end (13) of the cannula (12) when the contact surface (21) is not pressing against the injection area; Equipped with The protective element (20) is configured to move to an injection position when the contact surface (21) is pressed against the injection area, in which the tip (13) of the cannula (12) is further away from the hub portion (10) along the longitudinal axis (11) than the contact surface (21), and the separable element (30) is removed from the protective element (20) when the contact surface (21) is released from pressure contact with the injection area. a contact surface (21) extending from the distal end (13) of the cannula (12) along the longitudinal axis (11) and extending from the distal end (13) of the cannula (12) along the longitudinal axis (11) to the distal end (13), thereby separating the contact surface (21) into at least two locking members (31, 32) which prevent the protective element (20) from returning to the injection position when the protective element (20) is moved to a final position in which the contact surface (21) is further away from the hub portion (10) along the longitudinal axis (11) than the tip end (13) of the cannula (12).

2. 2. The needle safety device (1) according to claim 1, wherein in the initial position, the at least two locking members (31, 32) are not materially connected to one another.

3. 3. The needle safety device (1) according to claim 1 or 2, wherein in the initial position, the separable element (30) is at least partially surrounded by the protective element (20) such that the at least two locking members (31, 32) are held together and abut against each other.

4. 2. The needle safety device (1) according to claim 1, wherein in the initial position, the at least two locking members (31, 32) are formed integrally with one another.

5. 2. The needle safety device (1) of claim 1, wherein the contact surface (21) has an opening (22) through which the tip (13) of the cannula (12) passes when the protective element (20) is moved to the injection position.

6. The needle safety device (1) of claim 1, wherein the protection element (20) is configured to be substantially non-rotatable relative to the hub portion (10).

7. 2. The needle safety device (1) of claim 1, wherein the protective element (20) and the separable element (30) are configured to allow rotation relative to one another, and optionally, the separable element (30) is in rotatable sliding engagement with the protective element (20).

8. 2. The needle safety device (1) of claim 1, wherein the hub portion (10) and the separable element (30) each have a retaining means (16, 36) configured to engage with each other such that the separable element (30) is held in a predetermined position relative to the hub portion (10) when the protective element (20) moves to the final position.

9. 9. The needle safety device (1) according to claim 8, wherein the hub part (10) and / or the separable element (30) are provided with rotation means (17, 37) which rotate the separable element (30) relative to the hub part (10) when the protective element (20) in which the separable element (30) is arranged moves from the initial position to the injection position, thereby rotating the separable element (30) relative to the hub part (10), thereby engaging the retaining means (16, 36) with each other.

10. 2. The needle safety device (1) of claim 1, wherein in the initial position, the detachable element (30) is removably arranged in the protective element (20) by a form-fitting connection, and optionally, the protective element (20) comprises a protrusion (25) and the detachable element (30) comprises a groove (35), and in the initial position, the protrusion (25) and the groove (35) are engaged.

11. 2. The needle safety device (1) according to claim 1, wherein the at least two locking members (31, 32) move radially outwardly as viewed from the longitudinal axis (11), whereby the locking members separate from one another when the separable element (30) is removed from the protective element (20), and optionally the hub portion (10) and / or the separable element (30) comprise separation means for moving the at least two locking members (31, 32) radially outwardly.

12. 2. The needle safety device (1) according to claim 1, wherein the hub portion (10) comprises a first abutment surface (14) and the protective element (20) comprises a second abutment surface (24), and when pressure is applied to the contact surface (21) such that in the final position, at least one of the separated locking members (31, 32) abuts against the first abutment surface (14) and the second abutment surface (24), the separated locking member prevents the protective element (20) from returning to the injection position.

13. 2. The needle safety device (1) according to claim 1, wherein the spring element (40) abuts against the hub portion (10) and the protective element (20).

14. A medical injection device (100) comprising a needle safety device (1) according to claim 1.

15. The medical injection device (100) of claim 14, wherein the medical injection device (100) comprises a housing (110) that engages the protective element (20) such that the protective element (20) is substantially prevented from rotating relative to the hub portion (10).

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