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, and a guide pin 13 extending outward from the hub portion 10. A needle safety device 1 comprises a first tubular element 20 movably arranged on the hub portion 10 to move along a longitudinal axis 11. The first tubular element 20 comprises a guide track 21 slidably engaging with the guide pin 13 and configured such that the first tubular element 20 rotates relatively to the hub portion 10 when the guide pin 13 moves along the guide track 21. The guide track 21 has a final position 22 to immovably retain the guide pin 13. The needle safety device 1 comprises a second tubular element 30 arranged to be movable along the longitudinal axis 11 together with the first tubular element 20, and to at least partially enclose the first tubular element 20.SELECTED DRAWING: Figure 1

Description

Technical Field

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

Background Art

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

[0003] Furthermore, for some medical injection devices, in particular those that are also operated by non-medical personnel, such as again auto-injectors or pen injectors, it is necessary to ensure that unintentional contact with the cannula cannot occur, for example, in order to prevent user injury, contamination and / or cannula contamination.

[0004] To prevent reuse of medical injection devices and accidental contact with the cannula of medical injection devices, various solutions, in particular needle safety devices, are known from the prior art. Generally, known needle safety devices are based on the principle that a sleeve is provided around the needle, thereby preventing unintentional contact with the needle. Furthermore, the sleeve is configured to be moved as soon as it contacts the injection area so that injection can be performed, while re-movement of the sleeve after injection is prevented, for example, by 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 cause torsion in the injection area. This is because, for example, a sleeve surrounding the needle rotates relative to the medical injection device during injection, for example to cause a lock. This rotation is usually perceived as uncomfortable by the patient and, in the worst case, may cause the patient to interrupt the injection.

[0006] Second, some needle safety devices allow the locking means, which is intended to fix the position of the sleeve after injection so that the cannula is permanently prevented from coming into contact, to be released again. One reason is that the movement that brought about the locking of the sleeve can be manually reversed, for example by rotating the sleeve back to its initial unlocked state. Another reason is that it is conceivable that the locking means itself can be manually unlocked again. For example, by releasing a locking arm or by moving a pin out of the final position in which it is to be held, as in the embodiments described in US Patent No. 9,907,916.

[0007] Third, most needle safety devices have only a single locking means for preventing the sleeve from returning to its initial unlocked position. As a result, there is usually no redundancy to prevent the sleeve from returning to its unlocked initial position if, for example, one locking means fails or is deliberately disabled. SUMMARY OF THE INVENTION PROBLEM TO BE SOLVED BY THE INVENTION

[0008] Accordingly, an object of the present disclosure is to provide a needle safety device and a medical injection device for a medical injection device that at least partially overcome the above-mentioned drawbacks. MEANS FOR SOLVING THE PROBLEM

[0009] This object is at least partly achieved by a needle safety device for a medical injection device and a medical injection device as defined in the independent claims. Another aspect of the present disclosure is defined in the dependent claims.

[0010] 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 piercing means such as a cannula. 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. This is because autoinjectors rely particularly on being prevented from being reused and from accidental contact with the piercing means. This is for example because autoinjectors are usually operated by non-medical personnel, for example in an emergency situation.

[0011] The needle safety device comprises an elongate hub portion having a longitudinal axis, the hub portion comprising a cannula extending from the hub portion substantially along the longitudinal axis and a guide pin extending outwardly from the hub portion as seen from the longitudinal axis. In particular, when the hub portion has a substantially cylindrical shape, the longitudinal axis of the hub portion may be the longitudinal central axis of the hub portion. The cannula can also be referred to as a hollow needle or a hypodermic needle. Further, the cannula may be directly or indirectly attached to the hub portion. The cannula may be part of a needle arrangement. Further, it is understood that the cannula may be designed to be movable relative to the hub portion so as to, for example, enable penetration of a liquid reservoir within a medical injection device. The guide pin may project outwardly from the hub portion substantially perpendicular to the longitudinal axis as seen from the longitudinal axis. Further, the guide pin may have a substantially cylindrical shape. However, alternatively, the guide pin may preferably have a substantially flat sliding surface extending substantially perpendicular to the longitudinal axis. The advantages of this guide pin are described below.

[0012] Furthermore, the needle safety device comprises a first tubular element movably arranged on the hub portion so as to move along the longitudinal axis, the first tubular element comprising a guide track slidably engaged with a guide pin, the guide track being configured such that when the guide pin moves along the guide track, the first tubular element rotates relative to the hub portion, and the guide track having a final position configured to hold the guide pin. For example, the first tubular element may be movably arranged on the hub portion by an inner surface of the first tubular element slidably guided by an outer surface of the hub portion. The hub portion may be configured to not allow rotation relative to the medical injection device when the needle safety device is assembled to the medical injection device. Furthermore, the aspect that the final position is configured to hold the guide pin may mean that the guide pin is prevented from returning to another part of the guide track. Thus, thereby the needle safety device can function to prevent reuse of the medical injection device. Furthermore, by means of the substantially flat sliding surface that the guide pin may comprise, a lower friction can be achieved in a predetermined section of the guide track, for example, compared to a substantially cylindrical guide element. This can be achieved, for example, by forming a surface contact between the guide pin and the guide track.

[0013] Furthermore, the needle safety device comprises a second tubular element arranged on the first tubular element so as to be movable along the longitudinal axis together with the first tubular element. The first tubular element is at least partially surrounded by the second tubular element, and the second tubular element has a contact surface for establishing pressure contact with the injection area. For example, the second tubular element may be arranged on the first tubular element such that the inner surface of the second tubular element is guided by the outer surface of the first tubular element. Furthermore, the first tubular element may be surrounded by the second tubular element such that a human finger, for example, is not accessible to the guide pin and / or the guide track.

[0014] Furthermore, the needle safety device comprises a spring element which biases the first tubular element and / or the second tubular element in a distal direction relative to the hub portion, such that when the contact surface is not in pressure contact with the injection area, the contact surface is further spaced from the hub portion along the longitudinal axis than the tip of the cannula. By the above-described biasing of the first tubular element and / or the second tubular element, accidental contact with the tip of the cannula can be prevented. The spring element may be a coil spring. However, it is understood that different spring elements are also conceivable.

[0015] The described needle safety device has several advantages over the prior art, and two of these advantages are shown in detail below.

[0016] First, by arranging the second tubular element on the first tubular element, rotation of the injection area can be prevented. This is because rotation of the first tubular element relative to the hub portion can be separated from the injection area by the second tubular element having a contact surface. This can make the injection process more comfortable for the patient.

[0017] Second, by the first tubular element being at least partially surrounded by the second tubular element, the needle safety device prevents the guide pin from being released again when it has reached its final position. In particular, the guide pin cannot be manually unlocked again, i.e., the guide pin cannot be moved out of the final position in which it is to be held. This is because intentional and / or unintentional contact with the guide pin and / or the guide track can be avoided.

[0018] It is understood that the described advantages may also apply to those described in different forms below.

[0019] The guide track may comprise a first guide segment extending from an initial position to an injection position, wherein at the injection position the tip of the cannula extends further along the longitudinal axis from the hub portion than the contact surface, and the guide track is configured such that the guide pin moves to the injection position when the contact surface is in pressure contact with the injection area. The guide track may further comprise a second guide segment extending from the injection position to a final position, and the guide pin moves to the final position when the contact surface is released from pressure contact with the injection area. Thus, after injection, the cannula may be safely stored within the needle safety device. The first guide segment and the second guide segment may partially overlap.

[0020] Optionally, at the initial and final positions, the contact surface extends further along the longitudinal axis from the hub portion than the tip of the cannula. Thus, when the needle safety device is in the initial or final position, the second tubular element can prevent contact between the tip of the cannula and the finger. For example, when a human finger approaches the tip of the cannula, the finger first contacts the contact surface rather than immediately contacting the tip of the cannula.

[0021] Furthermore, the guide track may be configured such that when the guide pin moves from the initial position to the injection position, the first tubular element rotates about the longitudinal axis by a first angle, and when the guide pin moves from the injection position to the final position, the first tubular element rotates about the longitudinal axis by a second angle.

[0022] The guide track may be configured such that the first tubular element rotates relative to the hub portion in one direction about the longitudinal axis while the guide pin moves from the initial position through the injection position to the final position. Thus, the first tubular element can rotate by a first angle about the longitudinal axis when the guide pin moves from the initial position to the injection position, and the first tubular element can rotate by a second angle about the longitudinal axis in the same direction of rotation when the guide pin moves from the injection position to the final position. For example, it is not necessary to eliminate a short reversal of the direction of rotation. This configuration has been found to prevent, in particular, the first tubular element from being inadvertently rotated back to its initial position after reaching the injection position.

[0023] Furthermore, the contact surface may have an opening through which the tip of the cannula passes when the guide pin moves from the initial position to the injection position. Thus, the opening may have a diameter that avoids insertion of a human finger into the second tubular element.

[0024] The first tubular element and the second tubular element may be configured to allow rotation relative to each other, and optionally, the first tubular element is in rotational sliding engagement with the second tubular element. Thus, it is possible to specifically prevent the injection area from being twisted. This is because the second tubular element having the contact surface can disconnect the rotation of the first tubular element relative to the hub portion from the injection area. Thereby, the injection process becomes more comfortable for the patient.

[0025] The second tubular element may be configured to be substantially non-rotatable relative to the hub portion. This can ensure that the rotation of the first tubular element cannot be affected from the outside of the needle safety device. For example, the second tubular element may be directly engaged with the hub portion. Alternatively, an intermediate element fixedly attached to the hub portion can ensure that the second tubular element cannot rotate relative to the hub portion.

[0026] Furthermore, the first tubular element and the second tubular element may comprise latching means configured to allow the first tubular element to rotate relative to the second tubular element about the longitudinal axis in one direction and to prevent rotation in the other direction. Accordingly, in addition to the final position of the guide track holding the guide pin, additional locking means are provided to prevent the first tubular element from returning to its initial unlocked position. As a result, for example, redundancy is provided to prevent the first tubular element from returning to its unlocked initial position in the event that the engagement of the guide pin with the guide track in the final position fails to hold the guide pin. For example, the latching means may comprise inclined surfaces supported relative to each other, the inclined surfaces having undercuts such that after relative movement of the inclined surfaces relative to each other, the inclined surfaces are locked and reverse rotation cannot be effected.

[0027] Optionally, the latching means prevents the guide pin from returning to its initial position when the guide pin is moving towards the injection position and / or the latching means prevents the guide pin from moving out of the final position. This allows for the provision of additional locking means for particularly critical positions, thereby enhancing the safety and / or reliability of the needle safety device.

[0028] The spring element may abut against the hub portion and the second tubular element. This configuration has proven to be advantageous in that it prevents the spring element from influencing the rotation of the first tubular element.

[0029] Optionally, the first tubular element cannot be moved relative to the second tubular element substantially along the longitudinal axis. This ensures that the guide track and the guide pin are not externally accessible.

[0030] Furthermore, the hub portion may be substantially cylindrical. This allows for a particularly stable guide of the first tubular element in the hub portion.

[0031] Furthermore, the above object is achieved by a medical injection device provided with a needle safety device as described above. Since the medical injection device is provided with a needle safety device as described above, it is understood that the features and / or advantages described with respect to the needle safety device may also apply to the medical injection device.

[0032] The medical injection device may comprise a housing, which engages with a second tubular element such that the second tubular element is substantially non-rotatable relative to the hub portion, and optionally the hub portion is fixed to the housing.

[0033] The accompanying drawings are briefly described below.

Brief Description of the Drawings

[0034]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Modes for Carrying Out the Invention

[0035] Figures 1 to 9 all show the whole or part of the needle safety device 1 according to the present disclosure.

[0036] As shown in FIG. 1, the needle safety device 1 includes an elongated hub portion 10 having a longitudinal axis 11. Since the hub portion 10 has a substantially cylindrical shape, it is understood that the longitudinal axis 11 of the hub portion 10 can also be referred to as the longitudinal central axis 11 of the hub portion 10.

[0037] In particular, as shown in FIGS. 5 and 6, the hub portion 10 includes a cannula 12 extending along the longitudinal axis 11 from the hub portion 10. The cannula 12 is indirectly attached to the hub portion 10 via a carrier portion surrounding the cannula 12. Further, the cannula 12 is movable relative to the hub portion 10 to effect penetration of a liquid reservoir in a medical injection device.

[0038] Furthermore, as shown in detail in FIG. 8, the hub portion 10 further includes a guide pin 13 extending outwardly from the hub portion 10 as viewed from the longitudinal axis 11. In particular, the guide pin 13 projects substantially perpendicular to the longitudinal axis 11 outwardly from the hub portion 10 as viewed from the longitudinal axis 11. Further, as shown in FIG. 4, the guide pin 13 includes a substantially flat sliding surface extending substantially perpendicular to the longitudinal axis 11.

[0039] The needle safety device 1 further includes a first tubular element 20. The first tubular element 20 is movably disposed on the hub portion 10 so as to move along the longitudinal axis 11. This first tubular element 20 is specifically shown in detail in, for example, FIG. 8. The first tubular element 20 includes a guide track 21 that slidably engages with the guide pin 13. The guide track 21 is configured such that when the guide pin 13 moves along the guide track 21, the first tubular element 20 rotates relative to the hub portion 10. The guide track 21 has a final position 22 configured to hold the guide pin 13. Exemplarily in FIGS. 3 and 4, the guide pin 13 has reached the final position 22. FIG. 4 illustrates how an attempt to repeatedly expose the cannula 12 is blocked. Specifically, the guide pin 13 abuts against a corresponding region of the guide track, thereby holding the guide pin 13 in the final position 22, thereby preventing the guide pin 13 from returning to another portion of the guide track 21.

[0040] By virtue of the substantially flat sliding surface provided on the guide pin 13, in a predetermined section of the guide track 21, for example, better sliding can be achieved compared to a substantially cylindrical guide element. This can be achieved, for example, by forming a surface contact between the guide pin and the guide track. This aspect will be understood by those skilled in the art when referring to, for example, FIG. 4.

[0041] Furthermore, the needle safety device 1 includes a second tubular element 30, and this second tubular element 30 is disposed on the first tubular element 20 so as to be movable along the longitudinal axis 11 together with the first tubular element 20. The first tubular element 20 is surrounded by the second tubular element 30. Furthermore, the second tubular element 30 includes a contact surface 31 for establishing pressure contact with the injection region. The contact surface 31 has an opening 32, and when the guide pin 13 moves from the initial position 24 to the injection position 25, the tip 14 of the cannula 12 passes through this opening 32.

[0042] Furthermore, the needle safety device 1 comprises a spring element 40 which biases the second tubular element 30 in a distal direction with respect to the hub portion 10, such that when the contact surface 31 is not in pressing contact with the injection area, the contact surface 31 is further spaced from the hub portion 10 along the longitudinal axis 11 than the tip 14 of the cannula 12. In particular, the spring element 40, which is a coil spring, abuts against the hub portion 10 and the second tubular element 30.

[0043] As shown in FIGS. 1 to 4, the guide track 21 comprises a first guide segment 23 extending from the initial position 24 to the injection position 25. At the injection position 25, the tip 14 of the cannula 12 is further spaced from the hub portion 10 along the longitudinal axis 11 than the contact surface 31. The guide track 21 is configured such that the guide pin 13 moves to the injection position 25 when the contact surface 31 is in pressing contact with the injection area. Furthermore, the guide track 21 comprises a second guide segment 26 extending from the injection position 25 to the final position 22, and the guide pin 13 moves to the final position 22 when the contact surface 31 is released from pressing contact with the injection area.

[0044] As shown in FIGS. 1 and 3, at the initial position 24 and the final position 22, the contact surface 31 is further spaced from the hub portion 10 along the longitudinal axis 11 than the tip 14 of the cannula 12. Thus, unintentional contact with the tip 14 of the cannula 12 is prevented.

[0045] Furthermore, as shown in FIGS. 1 to 3, further, when the guide pin 13 moves from the initial position 24 to the injection position 25, the first tubular element 20 rotates by a first angle about the longitudinal axis 11, and when the guide pin 13 moves from the injection position 25 to the final position 22, the first tubular element 20 is configured to rotate by a second angle about the longitudinal axis 11. In particular, the guide track 21 is configured such that while the guide pin 13 moves from the initial position 24 through the injection position 25 to the final position 22, the first tubular element 20 rotates with respect to the hub portion 10 in one direction about the longitudinal axis 11.

[0046] The first tubular element 20 and the second tubular element 30 are configured to allow rotation relative to each other, and the first tubular element 20 is slidably engaged with the second tubular element 30 in a rotatable manner. In particular, as shown in FIGS. 1 to 3, the protrusion of the first tubular element 20 is slidably engaged with the notch of the second tubular element 30.

[0047] Furthermore, although not explicitly shown, it is understood from FIGS. 1 to 3 that the second tubular element 30 is configured not to be able to rotate with respect to the hub portion 10. For example, this can be inferred from the fact that the protrusion of the first tubular element 20 is in a different position within the notch of the second tubular element 30 while the second tubular element 30 is not rotated. Specifically, as shown in FIGS. 5 and 6, the housing 110 engages with the second tubular element 30, whereby the second tubular element 30 is substantially prevented from rotating with respect to the hub portion 10.

[0048] Furthermore, as shown in FIGS. 2 and 8, the first tubular element 20 and the second tubular element 30 are provided with latching means 29, 39. The latching means 29, 39 are configured to allow the first tubular element 20 to rotate relative to the second tubular element 30 in one direction about the longitudinal axis 11 and to prevent rotation in the other direction. In particular, the latching means 29, 39 prevent the guide pin 13 from returning to the initial position 24 when the guide pin 13 is moving to the injection position 25 and prevent the guide pin 13 from moving out of the final position 22.

[0049] As will be apparent to those skilled in the art from FIGS. 1 to 3, the first tubular element 20 cannot be substantially moved relative to the second tubular element 30 along the longitudinal axis 11.

[0050] FIG. 9 shows a medical injection device 100 provided with a needle safety device 1 as described above. As shown, the hub portion 10 is fixed to the housing 110. However, unlike FIGS. 5 and 6, the portion of the housing 110 that engages the second tubular element 30 so that the second tubular element 30 does not substantially rotate relative to the hub portion 10 is not shown.

Explanation of Reference Numerals

[0051] 1 Needle safety device 10 Elongated hub portion 11 Longitudinal axis 12 Cannula 13 Guide pin 14 Tip of the cannula 20 First tubular element 21 Guide track 22 Final position 23 First guide segment 24 Initial position 25 Injection position 26 Second guide segment 29 Latching means 30 Second tubular element 31 Contact surface 32 Opening of the contact surface 39 Latch means 40 Spring element 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), a cannula (12) extending from the hub portion (10) along the longitudinal axis (11), and a guide pin (13) extending outwardly from the hub portion (10) as viewed from the longitudinal axis (11). A hub portion (10); A first tubular element (20) movably disposed on the hub portion (10) so as to move along the longitudinal axis (11), the first tubular element (20) having a guide track (21) slidably engaged with the guide pin (13). The guide track (21) is configured such that when the guide pin (13) moves along the guide track (21), the first tubular element (20) rotates relative to the hub portion (10). The guide track (21) has a final position (22) configured to hold the guide pin (13). A first tubular element (20); A second tubular element (30) disposed on the first tubular element (20) so as to be movable along the longitudinal axis (11) together with the first tubular element (20), the first tubular element (20) being at least partially surrounded by the second tubular element (30). The second tubular element (30) having a contact surface (31) for establishing pressure contact with the injection area. A second tubular element (30); A spring element (40) biasing the first tubular element (20) and / or the second tubular element (30) in a distal direction relative to the hub portion (10), such that when the contact surface (31) is not in pressure contact with the injection area, the contact surface (31) is further spaced from the hub portion (10) along the longitudinal axis (11) than the tip (14) of the cannula (12). A spring element (40); A needle safety device (1) comprising.

2. The guide track (21) is A first guide segment (23) extending from the initial position (24) to the injection position (25), wherein at the injection position (25), the tip (14) of the cannula (12) is further spaced from the hub portion (10) along the longitudinal axis (11) than the contact surface (31), and the guide track (21) is configured such that the guide pin (13) moves to the injection position (25) when the contact surface (31) is in pressure contact with the injection area, the first guide segment (23); A second guide segment (26) extending from the injection position (25) to the final position (22), wherein the guide pin (13) moves to the final position (22) when the contact surface (31) is released from pressure contact with the injection area, the second guide segment (26); The needle safety device (1) according to claim 1, comprising the above.

3. The needle safety device (1) according to claim 2, wherein at the initial position (24) and the final position (22), the contact surface (31) is further spaced from the hub portion (10) along the longitudinal axis (11) than the tip (14) of the cannula (12).

4. The guide track (21) is configured such that when the guide pin (13) moves from the initial position (24) to the injection position (25), the first tubular element (20) rotates by a first angle about the longitudinal axis (11), and when the guide pin (13) moves from the injection position (25) to the final position (22), the first tubular element (20) rotates by a second angle about the longitudinal axis (11), the needle safety device (1) according to claim 2 or 3.

5. The guide track (21) is configured such that the first tubular element (20) rotates about the longitudinal axis (11) in one direction with respect to the hub portion (10) while the guide pin (13) moves from the initial position (24) through the injection position (25) to the final position (22), the needle safety device (1) according to claim 2.

6. The contact surface (31) has an opening (32), and when the guide pin (13) moves from the initial position (24) to the injection position (25), the tip (14) of the cannula (12) passes through the opening (32). The needle safety device (1) according to claim 2.

7. The needle safety device (1) according to claim 1, wherein the first tubular element (20) and the second tubular element (30) are configured to allow rotation relative to each other.

8. The needle safety device (1) according to claim 7, wherein the first tubular element (20) is slidably engaged with the second tubular element (30) in a rotatable manner.

9. The needle safety device (1) according to claim 7 or 8, wherein the second tubular element (30) is configured not to be rotatable relative to the hub portion (10).

10. The first tubular element (20) and the second tubular element (30) are provided with latching means (29, 39), and the latching means (29, 39) allows the first tubular element (20) to rotate relative to the second tubular element (30) in one direction about the longitudinal axis (11) and blocks rotation in another direction. The needle safety device (1) according to claim 9.

11. The latching means (29, 39) prevents the guide pin (13) from returning to the initial position (24) when the guide pin (13) is moving to the injection position (25), and / or the latching means (29, 39) prevents the guide pin (13) from moving out of the final position (22). The needle safety device (1) according to claim 10.

12. The needle safety device (1) according to claim 1, wherein the spring element (40) abuts against the hub portion (10) and the second tubular element (30).

13. The needle safety device (1) according to claim 1, wherein the first tubular element (20) cannot be moved relative to the second tubular element (30) along the longitudinal axis (11).

14. The needle safety device (1) according to claim 1, wherein the hub portion (10) is cylindrical.

15. A medical injection device (100) comprising the needle safety device (1) according to claim 1.

16. The medical injection device (100) according to claim 15, wherein the housing (110) engages with the second tubular element (30) so that the second tubular element (30) does not rotate relative to the hub portion (10).

17. The medical injection device (100) according to claim 16, wherein the hub portion (10) is fixed to the housing (110).

Images