Needle safety device

Abstract

The present disclosure relates to a needle safety device (1) comprising an elongated hub portion (10) having a longitudinal axis (11). The hub portion (10) comprises a cannula (12). Additionally, the device (1) comprises a tubular protective element (20) positioned to be movable along the longitudinal axis (11) relative to the hub portion (10), and the protective element (20) comprises a contact surface (21) for establishing pressure contact with an injection area. Additionally, the device (1) comprises a tubular separating element (30) comprising at least two locking portions (31, 32). Additionally, the device (1) comprises a spring element (40) that deflects the protective element (20) so that the contact surface (21) is further spaced from the hub portion (10) along the longitudinal axis (11) than the tip (13) of the cannula (12). The protective element (20) is configured to move to the injection position, and when the contact surface (21) is released from contact with the injection area, the separation element (30) is removed from the protective element (20) and separated into the locking parts (31, 32). When the protective element (20) moves to the final position, the separated locking parts (31, 32) block the protective element (20) from returning to the injection position.

Description

Technology Field

[0001] The present disclosure relates to a needle safety device for a medical injection device and a medical injection device including a needle safety device. Background Technology

[0002] For some medical injection devices, such as auto-injectors or injection pens, it is often necessary to ensure that the device is not intentionally or / or unintentionally reused. The reasons for this can vary. For instance, certain medical injection devices may be configured to be used for only a single injection procedure, such as auto-injectors used to administer emergency medications like adrenaline during allergic shock. Additionally, hygiene-related reasons are also considered. In this regard, cross-contamination must be avoided, particularly after injection, as there are cases where a person is injured or contaminated by a used needle.

[0003] In addition, for certain medical injection devices, particularly those operated by non-medical personnel such as automatic syringes or injection pens, care must be taken to prevent unintentional contact with the cannula. This is intended, for example, to prevent user injury or contamination and / or contamination of the cannula.

[0004] In particular, various solutions, especially needle safety devices, for preventing the reuse of medical injection devices and accidental contact with the cannula of said medical injection device are known in the prior art. Generally, the known needle safety devices operate on the principle that a sleeve is placed around the needle to prevent unintended contact with the needle. Additionally, the sleeve is configured to move only once upon contact with the injection site to allow injection to take place, but movement of the sleeve after injection is prevented, for example, by a locking means. However, each existing needle safety device, which is a specific solution of the prior art, has various disadvantages, some of which are presented below.

[0005] First, some existing needle safety devices for medical injection systems can cause twisting in the injection area. For example, this is because the sleeve surrounding the needle may rotate relative to the medical injection system during injection, potentially engaging the lock. This rotation is often unpleasant for the patient and, in the worst case, causes the patient to stop the injection.

[0006] Second, some needle safety devices may allow the locking means for securing the sleeve after injection to be released again in such a way that the cannula is permanently protected from contact. One reason for this may be that the action of locking the sleeve can be manually reversed, for example, by returning the sleeve to an initial unlocked state. Another reason may be that the locking means itself can be manually released again. For example, this may be by releasing the locking arm or by moving the pin out of the final position where the pin is to be held, as in the embodiment disclosed in US 9,907,916 B2.

[0007] Accordingly, the object of the present disclosure is to provide a needle safety device for a medical injection device and a medical injection device that overcome at least partially the aforementioned disadvantages. Prior art literature

[65535] Japanese Patent Publication No. 2013-523197 (June 17, 2013)

[0008] These objectives are achieved at least partially by the needle safety device for a medical injection device and the medical injection device defined in the independent claim. Further aspects of the present disclosure are defined in the dependent claim.

[0009] In particular, the above objective is achieved by a needle safety device for a medical injection device. The needle safety device can serve to prevent the reuse of the medical injection device and to prevent accidental contact with piercing means such as a cannula, and optionally, the needle safety device may provide additional functions. The medical injection device may be an automatic syringe, an injection pen, and / or a syringe. However, preferably, the medical injection device is an automatic syringe. This is particularly because the automatic syringe requires that reuse be prevented and accidental contact with piercing means be prevented. For example, this is because the automatic syringe is regularly operated by non-medical personnel, for instance, in emergency situations.

[0010] A needle safety device comprises an elongated hub portion having a longitudinal axis, and the hub portion comprises a cannula extending substantially along the longitudinal axis from the hub portion. The longitudinal axis of the hub portion may also be the longitudinal central axis of the hub portion. In particular, the cannula may also be referred to as a hollow needle or an injection needle. Additionally, the cannula may be attached directly or indirectly to the hub portion. The cannula may be part of a needle array. Furthermore, it is thought that the cannula may be designed to be movable relative to the hub portion, for example, to enable penetration of a liquid reservoir inside a medical injection device.

[0011] Additionally, the needle safety device includes a tubular protection element positioned to move along the longitudinal axis relative to the hub portion, and the protection element includes a contact surface for establishing pressure contact with the injection area. In the initial position of the needle safety device, the contact surface is spaced further from the hub portion along the longitudinal axis than the tip of the cannula. The tubular protection element allows the tip of the cannula to be protected from unintended contact. In particular, in the initial position, that is, before the injection process begins, the protection element can prevent contact with the tip portion of the cannula. For example, when a person's 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 thought that the protection element can surround the cannula.

[0012] Additionally, the needle safety device includes a tubular separable element, which is removablely positioned within the protective element in an initial position so as to be movable along the longitudinal axis together with the protective element, and the separable element includes at least two locking parts. For example, the tubular separable element may be removablely attached to the protective element in an initial position. Thus, the tubular separable element may be attached directly or indirectly. For example, the inner surface of the tubular protective element may be disengaged from the outer surface of the tubular separable element by, for example, a form-fit connection.

[0013] Additionally, the needle safety device includes a spring element that deflects the protective element distally relative to the hub portion such that the contact surface is further separated from the hub portion along the longitudinal axis than the tip of the cannula when the contact surface is not in pressure contact with the injection area. By the aforementioned deflection of the protective element, accidental contact with the tip of the cannula can be prevented. In particular, this is the case when the contact surface is not in pressure contact with the injection area, i.e., when no injection is being performed. The spring element may be a coil spring. However, it is thought that other spring elements may be considered.

[0014] A protective element is configured to move to an injection position when the contact surface comes into pressure contact with the injection area, and at the injection position, the tip of the cannula is further spaced from the hub portion along the longitudinal axis than the contact surface, and when the contact surface is released from pressure contact with the injection area, a separating element is removed from the protective element and separated into at least two locking parts, and when the protective element moves to a final position, the separated locking part blocks the protective element from returning to the injection area, and at the final position, the contact surface is further spaced from the hub portion along the longitudinal axis than the tip of the cannula. By the tip of the cannula in the injection position, which is further spaced from the hub portion along the longitudinal axis than the contact surface, the tip of the cannula can be inserted into the injection area. Additionally, while a spring element deflects the protective element distally relative to the hub portion, the separating element can be separated from the protective element by being held, for example, by the hub portion. Additionally, due to the initial tension of the separating element which is released after the separating element is removed from the protective element, the separating element can be separated into at least two locking parts, for example. Additionally, due to the respective provision of the separation element and / or the hub portion, the separation element may be separated into, for example, at least two locking parts. For example, the separated locking parts may be positioned in such a way that the movement of the protective element in the longitudinal direction is restricted by the separation, so that the separated locking parts may block the protective element from returning to the injection position. Due to the separated locking parts that block the protective element from returning to the injection position, the needle safety device serves to prevent the reuse of the medical injection device.

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

[0016] First, since this needle safety device does not rely on a guide pin sliding through the guide track of a rotating sleeve, it enables a configuration that prevents twisting in the injection area. This can make the injection process more comfortable for the patient.

[0017] Second, tubular separation elements, particularly when compared to devices where the guide pin engages with the guide track, make it more difficult to transition the needle safety device to its initial position, whether intentionally or unintentionally. This is because the separated lock must be reassembled and repositioned within the protective element. This has proven to be extremely difficult and leads to a high level of security for the needle safety device regarding reuse.

[0018] It is thought that the aforementioned advantages can also be applied to the following in different expressions.

[0019] Optionally, at least two locking parts are not materially bonded to each other in the initial position. For example, the locking parts may come into contact with each other. Also, for example, at the initial position, the locking parts may be pre-tensioned against each other within the protective element. Thus, due to the initial tension released after removing the separating element from the protective element, the separating element may be separated into at least two locking parts. By not being materially bonded to each other, the separation of the locking parts can be performed more reliably.

[0020] In the initial position, the separating element may be at least partially surrounded by a protective element so that at least two locking parts are held together and in contact with each other. This configuration can prevent the separating element from being undesirably removed from the protective element, particularly due to the separating element being at least partially surrounded by the protective element. Additionally, this configuration facilitates the separation of the separating element into the locking parts after the separating element has been removed from the protective element.

[0021] At the initial position, at least two locking parts can be formed integrally with each other. Here, "formed integrally" may mean that it is impossible to identify the material boundary between at least two locking parts at at least one position. It has been found that by forming at least two locking parts integrally with each other, a simplified assembly of the needle safety device is possible. Additionally, unwanted separation can be avoided more easily.

[0022] Additionally, the contact surface may have an opening through which the tip of the cannula passes when the protective element transitions to the injection site. Thus, the opening may have a diameter that prevents a person's finger from being inserted into the protective element.

[0023] Additionally, the protective element can be configured so as not to rotate substantially relative to the hub portion. Therefore, twisting of the injection site can be prevented. This makes the injection process more comfortable for the patient. For example, the protective element can engage directly with the hub portion. Alternatively, an intermediate element, such as a housing fixedly attached to the hub portion, can prevent the protective element from rotating relative to the hub portion.

[0024] The protective element and the separating element can be configured to allow rotation relative to each other, and optionally, the separating element is in a rotatable sliding engagement with the protective element. For example, this rotation can be used to reliably remove the separating element from the protective element.

[0025] The hub portion and the separating element may each include retention means configured to interlock with each other so that the separating element is maintained in a relative position to the hub portion when the protective element moves to the final position. The protective element is thought to move from the injection position to the final position. By being maintained in a relative position to the hub portion when the protective element moves from the injection position to the final position, the separating element can be reliably removed from the protective element. For example, the retention means may each include abutment surfaces configured to interlock with each other.

[0026] Optionally, the hub portion and / or the separating element includes a rotating means for rotating the separating element relative to the hub portion when the protective element, in which the separating element is placed, moves from an initial position to an injection position, and rotating the separating element relative to the hub portion causes the retaining means to engage with each other. Preferably, the rotating means is configured to rotate the separating element relative to the hub portion about a longitudinal axis. Due to the feature that rotating the separating element relative to the hub portion causes the retaining means to engage with each other, on the one hand, unintended removal of the separating element from the protective element can be prevented, and on the other hand, removing the needle safety device from the final position to the initial position becomes particularly difficult. Thus, the overall safety of the needle safety device can be improved.

[0027] Additionally, in the initial position, the separating element can be removably positioned within the protective element by a form-fit connection, optionally the protective element includes a protrusion and the separating element includes a groove, and in the initial position, the protrusion and the groove are engaged. For example, the protrusion may be provided inside the protective element and the groove may be provided outside the separating element. The form-fit connection has been proven to allow for a stable connection on the one hand and ensure easy release from each other on the other. Furthermore, this connection enables the aforementioned rotational capability, particularly between the separating element and the protective element.

[0028] When the separating element is removed from the protective element, at least two locking members may move radially outward when viewed from the longitudinal axis and separate from each other, and optionally the hub portion and / or the separating element has a separation means for moving at least two locking members radially outward. The separation may cause the locking members to be positioned so as to prevent the protective element from returning to the scanning position when the protective element has moved to the final position. For example, the separation means may be a ramp-shaped element that pushes at least two locking members radially outward, for example, due to gravity.

[0029] Optionally, the hub portion includes a first bonding surface and the protective element includes a second bonding surface, and when pressure is applied to the contact surface at the final position such that at least one of the separated locking portions contacts the first bonding surface and the second bonding surface, the protective element is blocked from returning to the injection position by said separated locking portion. Thus, reuse of the needle safety device is prevented.

[0030] The spring element can come into contact with the hub portion and the protective element. This configuration has proven advantageous in that it prevents the spring element from affecting the rotation of the separating element.

[0031] Furthermore, the above objective is achieved by a medical injection device comprising the needle safety device described above. Since the medical injection device comprises a needle safety device as described above, it is believed that the features and / or advantages described in relation to the needle safety device may also be applied to the medical injection device.

[0032] A medical injection device may include a housing that engages with a protective element so that the protective element does not substantially rotate relative to the hub portion. Brief explanation of the drawing

[0033] The following is a brief description of the attached drawings: FIG. 1 illustrates a needle safety device according to the present invention prior to injection in a perspective view; FIG. 2 shows a cross-sectional view of a needle safety device prior to injection; FIG. 3 illustrates a needle safety device during injection in a cross-sectional view; FIG. 4 illustrates a cross-sectional view of a needle safety device after injection; FIG. 5 illustrates a cross-sectional view of a needle safety device after injection; FIG. 6 illustrates a cross-sectional view of a needle safety device when there is an attempt to reactivate the device after injection; FIG. 7 shows a perspective view of a tubular separation element of a needle safety device; FIG. 8 illustrates a perspective view of a needle safety device according to the present invention after injection; and FIG. 9 illustrates a medical injection device according to the present disclosure after injection. Specific details for implementing the invention

[0034] FIGS. 1 to 9 illustrate a needle safety device (1) or a part thereof according to the present disclosure. The needle safety device (1) includes an elongated hub portion (10) having a longitudinal central axis (11).

[0035] For example, as illustrated in detail in FIG. 2, the hub portion (10) includes a cannula (12) extending substantially along the longitudinal axis (11) from the hub portion (10). In particular, the cannula (12) is indirectly attached to the hub portion through a carrier element that is fixedly attached to the cannula (12). Additionally, the cannula is designed to be movable relative to the hub portion to realize penetration of a liquid reservoir inside the medical injection device (100).

[0036] Additionally, the hub portion (10) includes a tubular protective element (20) positioned to be movable along the longitudinal axis (11) relative to the hub portion (10). The protective element (20) includes a contact surface (21) for establishing pressure contact with an injection area, and, for example, in the initial position of the needle safety device (1) shown in FIGS. 1 and 2, the contact surface (21) is spaced further from the hub portion (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) transitions to an injection position (see FIG. 3).

[0037] Additionally, the hub portion (10) includes a tubular separation element (30), which is removablely positioned within the protection element (20) at an initial position so as to be movable along the longitudinal axis (11) together with the protection element (20), and the tubular separation element (30) includes at least two locking portions (31, 32).

[0038] Additionally, the hub portion (10) includes a spring element (40) that deflects the protective element (20) distally with respect to the hub portion (10) so that when the contact surface (21) does not make pressure contact with the injection area (e.g., see FIG. 1 and 2), the contact surface (21) is further separated from the hub portion (10) along the longitudinal axis than the tip (13p) of the cannula (12). The spring element (40) contacts the hub portion (10) and the protective element (20).

[0039] The protective element (20) is configured to move to the injection position, for example, illustrated in FIG. 3, when the contact surface (21) comes into pressure contact with the injection area, and as illustrated, the tip (13) of the cannula (12) at the injection position is further apart from the hub portion (10) along the longitudinal axis than the contact surface (21).

[0040] Additionally, as illustrated in FIGS. 3 and 4, when the contact surface (21) is released from pressure contact with the injection area, the separation element (30) is removed from the protection element (20) and separated into at least two locking parts (31, 32). In particular, when the separation element (30) is removed from the protection element (20), the at least two locking parts (31, 32) move radially outward when viewed from the longitudinal axis (11) and separate from each other.

[0041] Accordingly, as shown in FIG. 6, when the protective element (20) moves to the final position, the separated locking parts (31, 32) block the protective element (20) from returning to the injection position.

[0042] At the final position (see FIG. 5 and FIG. 8), the contact surface (21) is further away from the hub portion (10) along the longitudinal axis (11) than the tip (13) of the cannula (12).

[0043] As illustrated in FIG. 7, at the initial position, at least two locking parts (31, 32) are not materially joined to each other. Rather, as understood by a person skilled in the art from FIG. 1 and FIG. 2, at the initial position, the separating element (30) is surrounded by a protective element (20) so that at least two locking parts (31, 32) are held together and come into contact with each other.

[0044] The protective element (20) is configured so as not to substantially rotate with respect to the hub portion (10). For example, in FIG. 8, the protrusion of the protective element (20) is engaged with the guide means of the housing (110) of the medical injection device so as not to substantially rotate with respect to the hub portion (10) attached to the housing (110).

[0045] Additionally, the protective element (20) and the separating element (30) are configured to allow rotation relative to each other, and the separating element (30) is in a rotatable sliding engagement state with the protective element (20). In particular, in the initial position, the separating element (30) is removably positioned within the protective element (20) by a shape-fit connection, the protective element (20) includes a protrusion (25) and the separating element (30) includes a groove (35), and in the initial position, the protrusion (25) and the groove (35) are in an engagement state. This engagement allows the protective element (20) and the separating element (30) to rotate relative to each other.

[0046] Additionally, the hub portion (10) and the separating element (30) each include a retaining means (16, 36) configured to interlock with each other so that the separating element (30) is maintained in a predetermined position relative to the hub portion (10) when the protective element (20) moves to a final position (see FIG. 3 and FIG. 4).

[0047] A skilled person will understand that in FIG. 4, the state immediately after the separation element (30) is separated from the protection element (20) is shown, whereas in FIG. 5, the state in which the locking part (31, 32) has fallen down inside the housing (110) due to gravity is shown when the protection element (20) is fully returned by the spring element (40).

[0048] Additionally, the hub portion (10) and the separating element (30) include a rotation means (17, 37) for rotating the separating element (30) relative to the hub portion (10) when the protective element (20), in which the separating element (30) is disposed inside, moves from an initial position to an injection position, and rotating the separating element (30) relative to the hub portion (10) causes the holding means (16, 36) to interlock with each other (see FIG. 2 and FIG. 3).

[0049] In particular, a person skilled in the art will understand from FIGS. 1 to 5 that the retaining means (16) of the hub portion (10) is a circumferential joint surface formed by the hub portion (10) and configured to be in contact with the retaining means (36) of the separating element (30). Also, as shown in FIG. 1, the rotation means (17) of the hub portion (10) is a partially curved guide track configured to be in contact with the rotation means (37) of the separating element (30) so that rotation of the separating element (30) relative to the hub portion (10) can be achieved.

[0050] Additionally, as illustrated in FIGS. 4, 6 and 7, the retaining means (36) of the separating element (30) is a bonding surface formed at the first end of a rib formed inside the tubular separating element (30). The rib extends nearly parallel to the longitudinal axis (11). The rotational means (37) of the separating element (30) is a bonding surface formed at the second end of the rib. Thus, the retaining means (36) of the separating element (30) and the rotational means (37) of the separating element (30) are formed integrally.

[0051] Additionally, the hub portion (10) has a longitudinal recess that extends parallel to the longitudinal axis (11) and extends through a circumferential joint surface that is a retaining means (16) of the hub portion (10) (see FIG. 1). Thus, at the initial position, the separation element (30) is placed within the protection element (20) so that the integrally formed retaining means (36) and rotation means (37) can slide through the longitudinal recess.

[0052] Additionally, for example, as illustrated in FIGS. 2 and 3, the hub portion (10) includes a first bonding surface (14), and the protective element (20) includes a second bonding surface (24). When pressure is applied to the contact surface (21) at the final position such that at least one of the separated locking portions (31, 32) is adjacent to the first bonding surface (14) and the second bonding surface (24), the protective element (20) is blocked from returning to the injection position by the separated locking portion. This situation is illustrated in FIG. 6.

[0053] FIG. 9 illustrates a medical injection device (100) according to the present disclosure including the needle safety device (1) described above. As described above, the medical injection device (100) includes a housing (110) that engages with the protective element (20) so that the protective element (20) does not substantially rotate with respect to the hub portion (10). Explanation of the symbols

[0054] 1: Needle safety device 10: Slender hub section 11: Breeding axis 12: Cannula 13: Cannula Tips 14: First joint surface 16: Means of maintenance 17: Rotation means 20: Tubular protective element 21: Contact surface 22: Opening of the contact surface 24: Second joint surface 25: Protrusion 30: Tubular separator 31: First locking part 32: Second locking part 35: Groove 36: Means of maintenance 37: Rotation means 40: Spring element 100: Medical injection device 110: Housing

Claims

Claim 1 A needle safety device (1) for a medical injection device (100), wherein the needle safety device (1) comprises: an elongated hub portion (10) having a longitudinal axis (11), wherein the hub portion (10) includes a cannula (12) extending substantially along the longitudinal axis (11) from the hub portion (10); a tubular protective element (20) positioned to be movable along the longitudinal axis (11) relative to the hub portion (10), wherein the protective element (20) includes a contact surface (21) for establishing pressure contact with an injection area, and wherein, in the initial position of the needle safety device (1), the contact surface (21) is spaced further from the hub portion (10) along the longitudinal axis (11) than the tip (13) of the cannula (12); and a separating element (30) together with the protective element (20) along the longitudinal axis (11) A tubular separation element (30) that is removablely disposed within a protective element (20) at an initial position so as to be moved along, wherein the separation element (30) comprises at least two locking parts (31, 32);The device includes a spring element (40) that deflects the protective element (20) distally with respect to the hub portion (10) such that when the contact surface (21) does not make pressure contact with the injection area, the contact surface (21) is further separated from the hub portion (10) along the longitudinal axis (11) than the tip (13) of the cannula (12); the protective element (20) is configured to move to an injection position when the contact surface (21) makes pressure contact with the injection area, and at the injection position, the tip (13) of the cannula (12) is further separated from the hub portion (10) along the longitudinal axis (11) than the contact surface (21); when the contact surface (21) is released from pressure contact with the injection area, the separation element (30) is removed from the protective element (20) and separated into at least two locking parts (31, 32); and when the protective element (20) moves to a final position, the separated locking parts (31, 32) are such that the protective element (20) A needle safety device (1) that blocks return to the injection position, and at the final position, the contact surface (21) is further spaced from the hub portion (10) along the longitudinal axis (11) than the tip (13) of the cannula (12). Claim 2 In claim 1, at least two locking parts (31, 32) in the initial position are not materially joined to each other, a needle safety device (1). Claim 3 In claim 1 or 2, the needle safety device (1) in which, at the initial position, the separation element (30) is at least partially surrounded by a protective element (20) so that at least two locking parts (31, 32) are held together and come into contact with each other. Claim 4 In claim 1, at least two locking parts (31, 32) at the initial position are integrally formed with each other, a needle safety device (1). Claim 5 In claim 1, the contact surface (21) has an opening (22) through which the tip (13) of the cannula (12) passes when the protective element (20) is transitioned to an injection position, a needle safety device (1). Claim 6 In claim 1, the needle safety device (1) is configured such that the protective element (20) does not substantially rotate relative to the hub portion (10). Claim 7 In claim 1, the protective element (20) and the separating element (30) are configured to allow rotation relative to each other, and optionally the separating element (30) is in a rotatable sliding engagement state with the protective element (20), a needle safety device (1). Claim 8 A needle safety device (1) according to claim 1, wherein the hub portion (10) and the separating element (30) each include a retaining means (16, 36) configured to interlock with each other so that the separating element (30) is maintained in a relative position with respect to the hub portion (10) when the protective element (20) moves to a final position. Claim 9 In claim 8, the hub portion (10) and / or the separation element (30) comprises a rotation means (17, 37) for rotating the separation element (30) relative to the hub portion (10) when the protective element (20) having the separation element (30) disposed therein moves from an initial position to an injection position, and the rotation of the separation element (30) relative to the hub portion (10) causes the retaining means (16, 36) to engage with each other, the needle safety device (1). Claim 10 In claim 1, the separation element (30) is removablely disposed within the protection element (20) by a form-fit connection in the initial position, optionally the protection element (20) includes a protrusion (25) and the separation element (30) includes a groove (35), and in the initial position the protrusion (25) and the groove (35) are engaged, a needle safety device (1). Claim 11 A needle safety device (1) according to claim 1, wherein when the separation element (30) is removed from the protection element (20), at least two locking parts (31, 32) move radially outward when viewed from the longitudinal axis (11) and optionally the hub part (10) and / or the separation element (30) have separation means for moving at least two locking parts (31, 32) radially outward. Claim 12 A needle safety device (1) according to claim 1, wherein the hub portion (10) includes a first bonding surface (14) and the protective element (20) includes a second bonding surface (24), and when pressure is applied to the contact surface (21) at the final position so that at least one of the separated locking portions (31, 32) contacts the first bonding surface (14) and the second bonding surface (24), the protective element (20) is blocked from returning to the injection position by the separated locking portion. Claim 13 In claim 1, the spring element (40) is a needle safety device (1) that contacts the hub portion (10) and the protection element (20). Claim 14 A medical injection device (100) comprising a needle safety device (1) according to claim 1. Claim 15 In claim 14, the medical injection device (100) comprises a housing (110) that engages with the protective element (20) so that the protective element (20) does not substantially rotate with respect to the hub portion (10).

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