Needle safety device for medical devices

Abstract

This disclosure relates to a needle safety device (1) for a medical device, particularly for a medical injection device (100), the needle safety device (1) comprising: a hub (10) defining a longitudinal axis (11), wherein the hub (10) includes a sleeve (12) extending substantially along the longitudinal axis (11) from the hub (10), wherein the sleeve (12) is configured to move relative to the hub (10) along the longitudinal axis (11); a first tubular element (20) movably disposed on the hub (10) to move along the longitudinal axis (11); and a second tubular element (30) disposed on the first tubular element (20) such that the second tubular element (30) is movable together with the first tubular element (20) along the longitudinal axis (11), wherein the first tubular element (20) 20) is at least partially surrounded by a second tubular element (30), wherein the second tubular element (30) includes a contact surface (31) for establishing pressure contact with the injection area; wherein the first tubular element (20) and the second tubular element (30) are configured such that they allow rotation relative to each other; wherein the first tubular element (20) includes an elastic member (60), and wherein the second tubular element (30) includes a receiving member (70); wherein the elastic member (60) and the receiving member (70) are configured such that, when the first tubular element (20) and the second tubular element (30) rotate relative to each other, at least a portion of the elastic member (60) is caused to impact at least a portion of the receiving member (70), preferably impacting the impact portion (72) of the receiving member (70), thereby generating an acoustic signal.

Description

Technical Field

[0001] This disclosure relates to a needle safety device configured to generate an acoustic signal. This needle safety device can be used in medical devices, particularly medical injection devices. This disclosure also relates to corresponding medical devices incorporating this needle safety device. Background Technology

[0002] Medical devices, especially medical injection devices such as auto-injectors or injection pens, are known and popular among users because they offer a variety of benefits and can be used in a variety of applications.

[0003] An autoinjector is a device with a pre-filled cartridge or vial containing a medication. These injectors are typically designed to be automated, meaning users do not need to manually load the medication or set the dosage. Autoinjectors are often designed to be more user-friendly and may have features such as automatically inserting the needle and delivering the medication when a button is pressed.

[0004] An injection pen is a pen-shaped device that typically includes a cartridge or vial containing medication and a needle at the tip. The cartridge or vial usually needs to be manually assembled into the pen and the desired dosage set before injection. The user typically needs to press a button or plunger to release the medication.

[0005] For these and other medical devices, it is generally necessary to ensure that the intentional and / or unintentional reuse of medical injection devices does not occur. The reasons can be multifaceted. For example, the medical injection devices mentioned (e.g., auto-injectors for administering emergency medications such as adrenaline in the event of anaphylactic shock) may be intended for a single injection procedure only. Furthermore, it should be understood that hygiene-related reasons are also conceivable. In this regard, cross-contamination after injection, i.e., injury and contamination of a person by a used needle, must be avoided in particular.

[0006] Various solutions, particularly needle safety devices, are known in the prior art to prevent the reuse of medical injection devices and to prevent accidental contact with the cannula of the medical injection device. Typically, known needle safety devices operate by providing a sleeve around the needle device to prevent accidental contact with the same needle. Furthermore, the sleeve is configured to be displaced once by contact with the injection area, allowing injection to proceed, and subsequent displacement of the sleeve after injection is prevented, for example, by a locking device.

[0007] For such needle safety devices, feedback should typically be provided to the patient as soon as a certain operational state of the medical injection device has been reached and / or ended. For example, the user should be informed whether the needle safety device is active, such as whether it is in a state that ensures the same needle cannot be reused. Another use case for this feedback is in the administration of emergency medications with an auto-injector, such as administering epinephrine during anaphylactic shock. In this situation, the patient must be informed that the medication has been fully dispensed.

[0008] Otherwise, it cannot be guaranteed that the injection has been interrupted, for example, due to a technical malfunction. It should be understood that this could lead to significant health risks to the patient.

[0009] Various solutions for providing acoustic feedback in medical injection devices are known from the prior art. However, specific solutions in the prior art (i.e., existing needle safety devices) have several drawbacks, some of which are presented below.

[0010] For example, prior art medical injection devices configured to provide acoustic signals (e.g., those described in WO 2018 / 082886 A1) typically include components with multiple parts to generate the acoustic signal. Consequently, these multiple parts are sometimes arranged in a complex manner. Multiple parts (especially complexly arranged multiple parts) increase assembly workload and / or time. Furthermore, the presence of multiple parts increases the risk of incorrect assembly. Moreover, the increased number of parts also increases manufacturing workload, as more parts must be produced. Even further, the susceptibility to failure increases, particularly when the failure of a single component leads to the failure of the medical injection device and / or the component used to generate the acoustic signal.

[0011] Furthermore, components within medical injection devices that generate acoustic signals typically only have the function of generating acoustic signals. However, in principle, it is desirable to assign more than one function to a single component of a medical injection device.

[0012] For example, to reduce the total number of parts required for medical injection devices.

[0013] Therefore, the proposed solution has not yet yielded optimal results and needs improvement.

[0014] Against this backdrop, the purpose of this disclosure is to provide a needle safety device for medical devices, particularly for medical injection devices, that addresses the aforementioned needs and at least partially overcomes the shortcomings of current solutions. Summary of the Invention

[0015] The above-mentioned objectives are achieved, at least in part, by the subject matter of the independent claims. Preferred embodiments are the subject matter of the dependent claims, and other suitable aspects of the invention are described throughout the disclosure of this application.

[0016] The objective is achieved by a needle safety device for a medical device, particularly for a medical injection device, comprising: a hub defining a longitudinal axis, wherein the hub includes a sleeve extending substantially along the longitudinal axis from the hub, wherein the sleeve is configured to move relative to the hub along the longitudinal axis; a first tubular element movably disposed on the hub for movement along the longitudinal axis; a second tubular element disposed on the first tubular element such that the second tubular element can move together with the first tubular element along the longitudinal axis, wherein the first tubular element is at least partially surrounded by the second tubular element, wherein the second tubular element includes a contact surface for establishing pressure contact with an injection area; wherein the first and second tubular elements are configured such that they are allowed to rotate relative to each other; wherein the first tubular element includes an elastic member, and wherein the second tubular element includes a receiving member; wherein the elastic member and the receiving member are configured such that, when the first and second tubular elements rotate relative to each other, at least a portion of the elastic member is caused to impact at least a portion of the receiving member, preferably an impact portion of the receiving member, thereby generating an acoustic signal.

[0017] In this way, compared with known needle safety devices, this disclosure provides an improved needle safety device. In particular, the needle safety device of this disclosure facilitates the provision of acoustic feedback to the user. This acoustic feedback indicates that the safety mechanism of the needle safety device has been activated. This can mean that the medical device cannot be reused after use. Therefore, safety is improved in a user-friendly manner.

[0018] The first and second tubular elements are configured such that they are allowed to rotate relative to each other. This does not preclude them from rotating at least partially in the same direction; however, it is preferred that they rotate relative to each other in order to generate an acoustic signal.

[0019] An elastic member can refer to a component that has the ability to substantially return to its original shape or position after bending, stretching, compression, deflection, etc. An elastic member can comprise any kind of material; however, it is preferred to include flexible and / or elastic materials.

[0020] A receiving member can refer to a component designed to receive, hold, or contain another component, assembly, or material, and / or designed to be impacted by another component, assembly, or material. As detailed elsewhere herein, a receiving member may also provide locking, anti-rotation, etc. As described elsewhere herein, a receiving member may include deflection parts, impact parts, locking parts, and / or tilting parts. One or more of these parts may be integrally formed; however, they may also be distinguishable from each other as separate components. Preferably, they are integrally formed as a single piece.

[0021] At least a portion of the elastic member is caused to impact at least a portion of the impact receiving member, preferably at least a portion of the elastic member is caused to impact the impact portion of the impact receiving member. Impact can be understood as contact, etc. It should be noted that impact can cause the generation of an acoustic signal. Therefore, providing only mild contact may not be sufficient. Preferably, the acoustic signal is generated by the impact force produced by the impact.

[0022] The needle device can be fixedly disposed with the housing of the medical device. In some examples, the fixation can be substantially permanent. However, this disclosure also covers needle safety devices that can be releasably fixed to the housing of the medical device. In this way, user comfort and the applicability of the needle safety device and / or the medical device can be improved.

[0023] As used in this disclosure, "hub" can refer to an elongated hub. In some examples, the longitudinal axis of the hub can also be the longitudinal central axis of the hub. This is particularly true if the hub has a substantially cylindrical shape. It should be understood that manufacturing tolerances may need to be taken into account. Therefore, even when the hub is described as having a cylindrical shape, the shape of the hub may deviate slightly from a cylindrical shape. In some examples, the cross-section of the hub may have a substantially annular shape. The hub may be configured such that when the needle safety device is attached to the medical device, it may not be able to rotate and / or move relative to the medical device.

[0024] As used in this disclosure, "cannula" may additionally or alternatively be referred to as a needle or injection needle. The cannula may be hollow to guide fluid through it. Furthermore, the cannula may be attached directly or indirectly to the hub. The cannula may be part of a cannula assembly. For example, a cannula assembly may include multiple cannulas. The multiple cannulas may be connected to each other, for example, connected in one direction, particularly along the longitudinal axis of the hub. The multiple cannulas may partially overlap each other along the longitudinal axis, which can be used for the purpose of securing the cannula assembly.

[0025] The cannula enables puncture of a fluid reservoir within a medical device. It should be noted that the cannula may additionally or alternatively move along a different axis not parallel to the longitudinal axis. This may depend on the application of the needle safety device. However, during routine use of the needle safety device, the cannula may be moved specifically along the longitudinal axis. In a preferred example, the cannula may move parallel to the injection direction. In a preferred example, the longitudinal axis may be parallel to the injection direction.

[0026] The first tubular element and / or the second tubular element may be components or structures having a cylindrical or tubular shape. In this regard, manufacturing tolerances are required such that deviations from the cylindrical or tubular shape are well covered within this disclosure. In some examples, the first tubular element and / or the second tubular element may have a circular shape. The first tubular element and / or the second tubular element may define a hollow portion, such as a chamber within its perimeter. This hollow portion may extend from one end to the opposite end to accommodate one or more other components therein. In some examples, the first tubular element and the second tubular element may be referred to as a tubular device. This may not mean that they are integrally formed. Preferably, the first tubular element and the second tubular element are separate components.

[0027] The first tubular element may include a guide rail that slidably engages with a guide pin of the hub. The guide rail may be configured such that the first tubular element can rotate relative to the hub as the guide pin moves along the guide rail. This can provide relative rotation, for example, when pressure is applied to the contact surface of the second tubular element. This pressure can be established through an injection area.

[0028] When this document describes one or more components “moving along the longitudinal axis,” in some examples, this can mean that the movement is specifically along the longitudinal axis. However, in other examples, this does not preclude the possibility that…

[0029] Movement along an axis not parallel to the longitudinal axis. It should be understood that, in some cases, such movement along a different axis may be desirable. This may depend on the specific application of the needle safety device.

[0030] The movement of the first and second tubular elements can be described as follows: they can move from the “initial position” to the “injection position”, thereby encompassing multiple intermediate positions between the initial position and the injection position.

[0031] The initial position and the injection position may correspond to two end positions of the first and second tubular elements. These two end positions may be along a longitudinal axis. This may mean that further movement beyond each of these two end positions is not possible. For example, when they are in the injection position, further movement proximally along the longitudinal axis may not be possible, although this is not excluded in some examples. Furthermore, when they are in the initial position, further movement distally along the longitudinal axis may not be possible, although this is not excluded in some examples.

[0032] An "injection site" is the location where medication can be guided through a cannula to the injection area (such as the user's skin). An injection site typically indicates where an injection can be performed.

[0033] The "initial position" can be a position where, when the first and second tubular elements are in the injection position, the medication being guided through the cannula may no longer be guided through the cannula. However, the cannula may still contain residual medication components, such as components that may not have reached the injection area.

[0034] Medical devices can be medical injection devices. Any type of medical injection device is included in this disclosure. Exemplarily, a medical injection device can be an autoinjector, an injection pen, and / or a syringe. Preferably, the medical injection device is an autoinjector. This is particularly likely because autoinjectors are typically operated by non-medical personnel, such as in emergency situations. Therefore, the advancements described in this disclosure are particularly significant for these examples. However, injection pens and other medical injection devices can also significantly benefit from the advantages described herein.

[0035] It should be understood that the advantages described can also be applied to the following preferred embodiments.

[0036] In a preferred embodiment of the needle safety device disclosed herein, the relative rotation is a first relative rotation, and the resilient member and the receiving member are configured such that after at least a portion of the resilient member is caused to impact at least a portion of the receiving member, a second relative rotation opposite to the first relative rotation of the first tubular element and the second tubular element is substantially prevented. This has the advantage that rotation is allowed only in one direction, which can be helpful in providing a fail-safe arrangement for the user. Those skilled in the art can readily distinguish between the first relative rotation (i.e., the first tubular device rotates in a first direction and the second tubular device rotates in a second direction) and the second relative rotation opposite to the first relative rotation (i.e., the first tubular device rotates in the second direction and the second tubular device rotates in the first direction).

[0037] In a preferred embodiment of the needle safety device disclosed herein, the resilient member is integrally formed with the first tubular element, and / or the receiving member is integrally formed with the second tubular element. This has the advantages of simplified manufacturing, increased strength and durability, more cost-effective components, better fit, and the possibility of reducing the weight of the needle safety device. Furthermore, it ensures fewer malfunctions.

[0038] In a preferred embodiment of the needle safety device disclosed herein, the resilient member and the receiving member are configured such that, when the first tubular element and the second tubular element rotate relative to each other, the resilient member and the receiving member are at least partially in contact with each other, preferably via a deflection portion of the receiving member, causing the resilient member to deform at least partially. Optionally, the resilient member and the receiving member are configured such that, when the first tubular element and the second tubular element rotate relative to each other, the resilient member provides a restoring force in a direction substantially parallel to the longitudinal axis, preferably a restoring force from the resilient member toward the receiving member, and preferably a restoring force toward the deflection portion of the receiving member. This facilitates the easy provision of deformation of the resilient member by relative rotation. It should be noted that the force required to provide rotation can be low, while deflection can still be achieved. Furthermore, as described elsewhere herein, the resilient member can be configured to spring back once the tipping point of the receiving member has been crossed. This can provide an impact on a portion of the receiving member, thereby generating an acoustic signal.

[0039] In a preferred embodiment of the needle safety device disclosed herein, the deflection portion of the resilient member and / or receiving element has a tapered shape when viewed from the side perpendicular to the axis of relative rotation. This has the advantage that the resilient member can be easily deformed. This is likely because the sleeve is typically also elongated. The term "perpendicular to the axis of relative rotation" means that it can be perpendicular to the longitudinal axis.

[0040] In a preferred embodiment of the needle safety device disclosed herein, at least a portion of the elastic member is caused to impact at least a portion of the receiving member via axial movement along the longitudinal axis, preferably impacting the impact portion of the receiving member, and / or wherein at least a portion of the elastic member is caused to impact at least a portion of the receiving member via radial movement substantially perpendicular to the longitudinal axis, preferably impacting the impact portion of the receiving member.

[0041] Axial movement can be exemplarily achieved by an inclined surface disposed at the distal or proximal end of the first and / or second tubular element, as further described below. Radial movement can be exemplarily achieved by an inclined surface disposed on the shell surface of the first and / or second tubular element, as further described below.

[0042] In a preferred embodiment of the needle safety device disclosed herein, the deflecting portion of the resilient member and / or the receiving element has an inclined surface relative to a plane perpendicular to the longitudinal axis. This further contributes to the advantages mentioned in the foregoing embodiments. Deformation of the resilient member can be simplified. As described elsewhere herein, the receiving element may include a deflecting portion. When both (i.e., the resilient member and the deflecting portion) have inclined surfaces, they may, for example, be inclined at the same or similar angles relative to a plane perpendicular to the longitudinal axis.

[0043] In a preferred embodiment of the needle safety device disclosed herein, the inclined surface is disposed near the distal end of the first tubular element, preferably at the most distal end of the first tubular element, and / or wherein the inclined surface is disposed near the shell surface of the first tubular element. This has the advantage of making it easier to access the mechanism responsible for generating the acoustic signal. In an alternative embodiment, the inclined surface may be disposed near the proximal end. When both (i.e., the elastic member and the deflector) have inclined surfaces, both may be disposed near the distal end of the first tubular element. Disposing the inclined surface near the shell surface of the first tubular element can mean that the inclined surface is disposed at any location between the distal and proximal ends of the first tubular element. It is possible to provide two or more inclined surfaces. One inclined surface may be disposed near the distal end of the first tubular element, while another inclined surface may be disposed near the shell surface of the first tubular element.

[0044] In a preferred embodiment of the needle safety device disclosed herein, the inclined surface defines an angle relative to a plane perpendicular to the longitudinal axis, the angle being at least 5°, preferably at least 8°, more preferably at least 12°, more preferably at least 14°, more preferably at least 16°, and / or at most 80°, preferably at most 70°, more preferably at most 60°, more preferably at most 50°, more preferably at most 40°, more preferably at most 30°, more preferably at most 25°, and most preferably at most 22°. This helps to improve the relative rotation of the first tubular element and the second tubular element. The angle should not be too large, as this may increase the force required for movement (e.g., rotation). The angle should not be too small, as this may reduce the generated acoustic signal. Using the angle specified in this embodiment, an optimal balance can be achieved between these different and conflicting requirements.

[0045] In a preferred embodiment of the needle safety device disclosed herein, the resilient member has an abutment surface configured to prevent a second relative rotation, wherein the abutment surface is preferably configured to contact a portion of the impact portion of the receiving member, thereby preventing the second relative rotation. This helps to effectively prevent movement, preventing the user from performing unintentional use. This improves safety. The abutment surface may be adjacent to an inclined surface. Furthermore, the contacted portion of the impact portion of the receiving member may be substantially parallel to the longitudinal axis.

[0046] In a preferred embodiment of the needle safety device disclosed herein, the abutment surface is substantially parallel to the longitudinal axis. This allows for a relatively simple structural arrangement of the elastic member. Furthermore, this abutment surface can be manufactured in a simplified manner.

[0047] In a preferred embodiment of the needle safety device disclosed herein, the receiving member (preferably a deflection portion and / or locking portion of the receiving member) is at least partially shaped to correspond to the resilient member. This can provide enhanced performance and functionality of the needle safety device. When these components are designed to correspond to each other, they can interact more effectively, resulting in a variety of possible effects, such as the resilient member being able to fit at least partially and smoothly into the receiving member. This can prevent undesirable movement or mismatch.

[0048] In a preferred embodiment of the needle safety device of this disclosure, the receiving member includes a deflector, optionally an impactor, optionally a locking portion, and optionally a tipping portion. Optionally, the elastic member is configured to pass over the tipping point before at least a portion of the elastic member is caused to impact the impactor during relative rotation of the first and second tubular elements. Optionally, the impactor includes a locking portion. The deflector, impactor, and locking portion can be the corresponding portions already mentioned in the foregoing embodiments of this disclosure. The tipping portion can be used to initiate a change in the position or orientation of the associated component. This may not mean that the tipping portion is a component independent of the receiving member, although this is not excluded. The portions mentioned herein contribute to the flexibility of movement and / or the generation of acoustic signals. It is conceivable that the impactor includes special surface treatments to improve the generation of acoustic signals. In one example, the impactor can be a locking portion. Passing over the tipping point can be understood as: during angular movement, the elastic member passes over the tipping point of the receiving member. This can cause the elastic member to return to its initial shape and / or cause the elastic member to impact the impactor.

[0049] In a preferred embodiment of the needle safety device disclosed herein, after the resilient member is caused to impact the impact portion, the first tubular element and the second tubular element are configured to further rotate in the same relative direction, causing the resilient member to engage with the locking portion. The locking portion is preferably configured to prevent a second relative rotation of the first tubular element and the second tubular element opposite to the first relative rotation, thereby substantially preventing such rotation.

[0050] Engaging the resilient member with the locking mechanism serves several purposes, including: the locking provides safety and stability in the device, ensuring that the resilient member remains in place even under physical stress, vibration, or external forces. Furthermore, the locking mechanism also functions as a safety feature by ensuring that components do not move accidentally.

[0051] The object of this disclosure is also achieved by a medical device, particularly a medical injection device, which includes a needle safety device as described in this disclosure. It should be understood that, since the medical device includes a needle safety device, the features and / or advantages described with reference to the needle safety device are also applicable to the medical device, and vice versa.

[0052] In a preferred embodiment of the medical device disclosed herein, the medical device further includes a housing that engages with a second tubular element such that the second tubular element does not rotate substantially relative to a hub, wherein optionally the hub is fixed to the housing.

[0053] In a preferred embodiment of the medical device disclosed herein, the medical injection device is an auto-injector or injection pen. Attached Figure Description

[0054] The invention will be described in more detail below with reference to the following figures:

[0055] Figure 1 An embodiment of the needle safety device according to the invention is shown in perspective view, wherein the second tubular element is shown in a grid structure for illustrative purposes, at which point the device is not activated, for example, before injection.

[0056] Figure 2 Shown in different perspectives Figure 1 An embodiment of a needle safety device, wherein a portion of the needle safety device is cut off for illustrative purposes.

[0057] Figure 3 It shows Figure 1 An embodiment of a needle safety device, in which the device is activated, for example, in preparation for injection.

[0058] Figure 4 The illustration shows an embodiment of a medical device according to the present disclosure, in which the device is not activated.

[0059] Figure 5 It shows Figure 4 An example of a medical device, in which the device is activated. Detailed Implementation

[0060] The following describes only some possible embodiments of the invention in detail. However, the invention is not limited to these, and numerous other embodiments are applicable without departing from the scope of the invention. The presented embodiments can be modified in various ways and combined with each other where compatible, and certain features can be omitted as long as they appear unnecessary. In particular, the disclosed embodiments can be modified by combining certain features of one embodiment with one or more features of another embodiment.

[0061] Throughout this specification and all accompanying drawings, the same reference numerals refer to the same elements. For the sake of clarity and brevity, certain aspects of components or steps in some embodiments will not be presented in excessive detail if such details would be obvious to those skilled in the art based on the teachings herein, and / or if such details would obscure the understanding of more relevant aspects of the embodiments.

[0062] definition

[0063] As used herein, the term "proximal" refers only to one of the two ends of a component. The proximal end of a component is best understood in conjunction with the distal end of the same component. The terms proximal and distal should not be interpreted restrictively in any way. These ends may, alternatively or otherwise, be referred to as the first end and the second end, or the second end and the first end, respectively.

[0064] The distal end of a component is typically the end further from the center of the medical device than the proximal end. Furthermore, when the medical device is used for its conventional purpose, the distal end of a component is typically the end closer to the injection area than the proximal end.

[0065] This also applies to the terms "proximal direction" and "distal direction." That is, these terms may be referred to as a first direction and a second direction, or a second direction and a first direction, either separately or alternatively. The proximal direction can be a direction from distal to proximal. The distal direction can be a direction from proximal to distal.

[0066] Unless otherwise stated, the terms “substantially” or “essentially” as used in this context may be understood as largely, significantly, substantially, or essentially. In particular, this term includes manufacturing tolerances.

[0067] Description of preferred embodiments

[0068] Figures 1 to 3 The needle safety device 1 and / or a portion thereof according to the present disclosure are shown. The needle safety device 1 can be used in medical devices, particularly for medical injection devices 100 (such as...). Figure 4 and Figure 5 (As shown).

[0069] It should be noted that the second tubular element 30 is shown in a lattice structure, which is for illustrative purposes only and is not intended to limit the scope of protection. Furthermore, in Figure 2 In the middle, a portion of the first tubular element 20 and the second tubular element 30 is cut off so that their interiors can be better seen, especially the elastic member 60 and the receiving member 70. Figure 1 and Figure 2 The device 1 is shown when it is not activated. Figure 3 The device 1 is shown when it is activated.

[0070] The needle safety device 1 includes a hub 10 defining a longitudinal axis 11, wherein the hub 10 includes a sleeve 12 extending substantially along the longitudinal axis 11 from the hub 10. The sleeve 12 is configured to move relative to the hub 10 along the longitudinal axis 11. The device 1 includes a first tubular element 20 and a second tubular element 30, wherein the first tubular element 20 is movably arranged on the hub 10 to move along the longitudinal axis 11, and the second tubular element 30 is arranged on the first tubular element 20 such that the second tubular element 30 can move together with the first tubular element 20 along the longitudinal axis 11. The first tubular element 20 is at least partially surrounded by the second tubular element 30, and the second tubular element 30 includes a contact surface 31 for establishing pressure contact with an injection area (e.g., a part of the body of a user or another person). The first tubular element 20 and the second tubular element 30 are configured such that they allow rotation relative to each other.

[0071] The first tubular element 20 includes an elastic member 60, and the second tubular element 30 includes a receiving member 70. The elastic member 60 and the receiving member 70 are configured such that, when the first tubular element 20 and the second tubular element 30 rotate relative to each other, at least a portion of the elastic member 60 is caused to impact at least a portion of the receiving member 70, preferably impacting the impact portion 72 of the receiving member 70 (as compared). Figure 1 and Figure 3 (When it is most visible), thus generating an acoustic signal.

[0072] The generation of the acoustic signal can be described as follows: the elastic member 60 can be used as a bending beam, which is deformed via the deflection portion 71 of the receiving member 70. This may introduce tension in the elastic member 60. Due to further relative rotation, the elastic member 60 can pass over the tipping point 74, which can be the tip of the serration ( Figures 1 to 3 Subsequently, the elastic member 60 can relax, for example, suddenly. Furthermore, the generation of the acoustic signal can be explained (not intended to limit the scope of protection) as follows: when two surfaces collide with each other, their impact generates vibrations that propagate as waves in the surrounding medium. These waves are perceived as sound when they reach a receiver (e.g., our ear or a microphone). The intensity, frequency, and characteristics of this signal vary depending on factors such as the type of surfaces involved, the speed and angle of the impact, and the surrounding medium.

[0073] like Figures 1 to 3 As shown, the elastic member 60 may be integrally formed with the first tubular element 20, and / or the receiving member 70 may be integrally formed with the second tubular element 30.

[0074] As can be further understood, the elastic member 60 and the receiving member 70 can be configured such that, during relative rotation, the elastic member 60 and the receiving member 70 are at least partially in contact with each other. This contact can be generated via the deflection portion 71 of the receiving member 70. This allows the elastic member 60 to deform at least partially. Furthermore, during relative rotation, the elastic member 60 provides a restoring force in a direction substantially parallel to the longitudinal axis 11, preferably a restoring force from the elastic member 60 toward the receiving member 70, and more preferably a restoring force toward the deflection portion 71 of the receiving member.

[0075] The relative rotation may be a first relative rotation, and the elastic member 60 and the receiving member 70 may be configured such that: after at least a portion of the elastic member 60 is caused to impact at least a portion of the receiving member 70, a second relative rotation of the first tubular element 20 and the second tubular element 30, which is opposite to the first relative rotation, is substantially prevented.

[0076] Viewed from the side perpendicular to the axis of relative rotation, the deflection portion 71 of the elastic member 60 and / or the receiving element 70 may have a tapered shape. Furthermore, the elastic member 60 may have an inclined surface 61. Additionally, the deflection portion 71 may have an inclined surface 71'.

[0077] The elastic member 60 may also have an abutment surface 62 configured to prevent second relative rotation. For this purpose, the abutment surface 62 may contact a portion of the impact portion 72 (e.g., Figure 3 (best visible in the middle), thus preventing a second relative rotation. The abutment surface 62 is substantially parallel to the longitudinal axis 11.

[0078] The receiving member 70 (preferably the deflector 71 and / or the locking member 73) is at least partially shaped to correspond to the resilient member 60. This has the advantage that the device operates more efficiently and / or more effectively because the components are designed to work in a coordinated manner. When the components are designed to be properly assembled together, they can absorb stress or wear more evenly, potentially extending the service life of the device. The deflector 71, in particular, can be optimized to better absorb impacts or forces. The locking member 73 can provide a secure connection, ensuring that the resilient member 60 is firmly held in place.

[0079] Pre-formed parts are easier to assemble and may require fewer additional parts, thus saving time and potentially reducing costs.

[0080] When the first tubular element 20 and the second tubular element 30 rotate relative to each other, and before at least a portion of the elastic member 60 is caused to impact the impact portion 72, the elastic member 60 is configured to pass overturning point 74 (as compared). Figure 1 and Figure 3 (Best viewed at the time).

[0081] Furthermore, when the elastic member 60 impacts the impact part 72 (such as... Figure 3 After being positioned (best visible in the center), the first tubular element 20 and the second tubular element 30 can be configured to rotate further in the same relative direction. This causes the resilient member 60 to engage with the locking part 73. This allows for better control, as the movement can be locked or unlocked as needed. The locking function protects the component by preventing unwanted movement or positional changes that could lead to wear-and-tear or damage.

[0082] like Figure 3 As can be seen from the center, the device 1 also includes a spring element 40 that is biased toward the second tubular element 30 in a distal direction relative to the hub 10.

[0083] also, Figure 3 An angle α defined by inclined surfaces 61, 71' relative to a plane perpendicular to the longitudinal axis 11 is shown (indicated by two dashed lines on surface 61, and the same applies to surface 71'), which is at least 5° and / or at most 80°, as described elsewhere herein.

[0084] like Figures 1 to 3 As shown, the elastic member 60 and / or the receiving member 70 (preferably a part of the elastic member 60 and / or a part of the receiving member 70) are arranged on the axial end of the first tubular element 20 and / or the axial end of the second tubular element 30.

[0085] Thus, at least a portion of the elastic member 60 can be caused to impact at least a portion of the impact receiving member 70, preferably the impact portion 72 of the impact receiving member 70, via axial movement along the longitudinal axis 11.

[0086] also, Figure 2 An exemplary illustration shows that the elastic member 60' and / or the receiving member 70' may be arranged along the longitudinal axis 11 on the shell surface of the first tubular element 20 and / or the shell surface of the second tubular element 30, respectively. The shell surface of the first tubular element 20 and / or the shell surface of the second tubular element 30 may be referred to as the outer peripheral surface of the first tubular element 20 and / or the outer peripheral surface of the second tubular element 30, respectively.

[0087] Thus, at least a portion of the elastic member 60' can be caused to impact at least a portion of the receiving member 70', preferably the impact portion 72 of the impact receiving member 70', via radial movement. This movement can be substantially perpendicular to the longitudinal axis 11.

[0088] It should be noted that the same features and benefits described with reference to the resilient member 60 and / or the receiving member 70 are applicable to the resilient member 60' and / or the receiving member 70' (arranged on the shell surface). Furthermore, reference numeral 60' is used only to indicate the location of the arrangement and does not impose further limitations on the resilient member having reference numeral 60. Similarly, it should be noted that reference numeral 70' is used only to indicate the location of the arrangement and does not impose further limitations on the receiving member having reference numeral 70.

[0089] The angle segment spanned by the receiving member 70 (preferably the deflection part 71, the impact part 72, and the locking part 73) around the rotation axis of the first tubular element 20 and the second tubular element 30 is at least 5° (preferably at least 10°, more preferably at least 20°, more preferably at least 30°) and / or at most 180° (preferably at most 90°, more preferably at most 80°, more preferably at most 70°, more preferably at most 60°, and most preferably at most 50°).

[0090] The angle should not be too large, as this would require more material for the component to generate the acoustic signal. Furthermore, the angle should not be too small, as this would necessitate a rather steep angle for components such as deflectors, resulting in greater resistance to relative movement. Using the angle specified in this embodiment achieves an optimal balance between these differing and conflicting requirements.

[0091] The elastic member 60 may comprise one or more of the following materials: polymers, metals. The elastic member 60 is preferably an injection-molded member. The receiving member 70 comprises one or more of the following materials: polymers, metals. The receiving member 70 is preferably an injection-molded member. Compared to the elastic member 60, the receiving member 70 preferably has greater stiffness. This allows the elastic member 60 to deform more easily.

[0092] like Figures 1 to 3 As can be seen, when viewed from the side perpendicular to the axis of relative rotation, the deflection part 71 and the locking part 73 each have a conical shape, preferably a shape with one or more serrations. Furthermore, when viewed from the side perpendicular to the axis of relative rotation, the impact part 72 has a substantially flat shape.

[0093] The first tubular element 20 may include a guide rail that slidably engages with a guide pin of the hub 10. The guide rail may be configured such that the first tubular element 20 rotates relative to the hub 10 as the guide pin moves along the guide rail. The guide rail may include features configured to hold the guide pin in its final position.

[0094] The needle safety device 1 described herein has the advantage of helping to prevent the reuse of medical devices, particularly medical injection devices 100. This is achieved through a guide pin in the aforementioned hub 10. When the first tubular element 20 rotates relative to the hub 10, i.e., when the needle safety device 1 moves from an inactive state to an active state, the guide pin can move substantially along a guide rail, which includes a guide rail configured to hold the guide pin in its final position. This may mean that the guide pin is prevented from returning to other parts of the guide rail.

[0095] Figure 4 and Figure 5 A medical device is shown, particularly a medical injection device 100 according to the present disclosure, which includes the needle safety device 1 as described above. Figure 4 The inactive state is shown. Figure 5 The activated state is shown. The medical injection device 100 includes a housing 110 that engages with a second tubular element 30 such that the second tubular element 30 is substantially non-rotating relative to the hub 10. Optionally, the hub 10 (such as...) Figure 2 The hub 10 (shown) is secured to the housing 110. The fixation between the hub 10 and the housing 110 can be substantially permanent. However, the hub 10 can alternatively be releasably secured to the housing 110. This improves user comfort and the applicability of the needle safety device 1 and / or the medical device. The medical injection device 100 can be an auto-injector or an injection pen, etc.

[0096] It should be noted that any one or more of the embodiments and / or examples described herein can be combined with other aspects described herein, and details of the embodiments and / or examples may be omitted, as will be understood by those skilled in the art. The scope of protection is determined by the claims and is not limited to the embodiments and / or examples disclosed in the foregoing drawings.

[0097] List of reference numerals

[0098] 1 needle safety device

[0099] 10 Hub

[0100] 11. Longitudinal axis

[0101] 12 casings

[0102] 20 First tubular element

[0103] 30 Second tubular element

[0104] 31 Contact surface of the second tubular element

[0105] 40 Spring elements

[0106] 60 Elastic Components

[0107] 60' elastic member

[0108] 61 Inclined surface of an elastic member

[0109] 62. The contact surface of the elastic member

[0110] 70 Receiving Components

[0111] 70' Receiving component

[0112] 71 Deflection section of receiving component

[0113] 71' Inclined surface of the deflection portion of the elastic member

[0114] 72 Impact portion of the receiving component

[0115] 73 Locking part of receiving component

[0116] 74. Tilting section of receiving component

[0117] 100 Medical Injection Devices

[0118] 110 Casing

[0119] α Angle.

Claims

1. A needle safety device (1) for a medical device, particularly for a medical injection device (100), said needle safety device (1) comprising: Hub (10) defining a longitudinal axis (11), wherein the hub (10) includes a sleeve (12) extending substantially along the longitudinal axis (11) from the hub (10), wherein the sleeve (12) is configured to move relative to the hub (10) along the longitudinal axis (11); A first tubular element (20) is movably arranged on the hub (10) to move along the longitudinal axis (11); A second tubular element (30) is arranged on the first tubular element (20) such that the second tubular element (30) can move together with the first tubular element (20) along the longitudinal axis (11), wherein the first tubular element (20) is at least partially surrounded by the second tubular element (30), wherein the second tubular element (30) includes a contact surface (31) for establishing pressure contact with the injection area. The first tubular element (20) and the second tubular element (30) are configured such that they are allowed to rotate relative to each other; The first tubular element (20) includes an elastic member (60), and the second tubular element (30) includes a receiving member (70). The elastic member (60) and the receiving member (70) are configured such that when the first tubular element (20) and the second tubular element (30) rotate relative to each other, at least a portion of the elastic member (60) is caused to strike at least a portion of the receiving member (70), preferably striking the impact portion (72) of the receiving member (70), thereby generating an acoustic signal.

2. The needle safety device (1) according to the preceding claim, wherein, The relative rotation is a first relative rotation, and wherein the elastic member (60) and the receiving member (70) are configured such that after at least a portion of the elastic member (60) is caused to impact at least a portion of the receiving member (70), a second relative rotation of the first tubular element (20) and the second tubular element (30) opposite to the first relative rotation is substantially prevented.

3. The needle safety device (1) according to any one of the preceding claims, wherein the elastic member (60) is integrally formed with the first tubular element (20), and / or wherein the receiving member (70) is integrally formed with the second tubular element (30).

4. The needle safety device (1) according to any one of the preceding claims, wherein, The elastic member (60) and the receiving member (70) are configured such that when the first tubular element (20) and the second tubular element (30) rotate relative to each other, the elastic member (60) and the receiving member (70) are at least partially in contact with each other, preferably via a deflection portion (71) of the receiving member (70), causing the elastic member (60) to deform at least partially. Optionally, the elastic member (60) and the receiving member (70) are configured such that when the first tubular element (20) and the second tubular element (30) rotate relative to each other, the elastic member (60) provides a restoring force, the direction of which is substantially parallel to the longitudinal axis (11). Preferably, the restoring force is directed from the elastic member (60) toward the receiving member (70), and preferably, the restoring force is directed from the elastic member (60) toward the deflection portion (71) of the receiving member (70).

5. The needle safety device (1) according to any one of the preceding claims, wherein, Viewed from the side perpendicular to the axis of relative rotation, the deflection portion (71) of the elastic member (60) and / or the receiving element (70) has a tapered shape.

6. The needle safety device (1) according to any one of the preceding claims, wherein, At least a portion of the elastic member (60) is caused to impact at least a portion of the receiving member (70) via axial movement along the longitudinal axis (11), preferably impacting the impact portion (72) of the receiving member (70). And / or wherein at least a portion of the elastic member (60') is caused to impact at least a portion of the receiving member (70') via a radial movement substantially perpendicular to the longitudinal axis (11), preferably impacting the impact portion (72) of the receiving member (70').

7. The needle safety device (1) according to any one of the preceding claims, wherein, The deflection portion (71) of the elastic member (60) and / or the receiving element (70) has an inclined surface (61, 71') relative to a plane perpendicular to the longitudinal axis (11).

8. The needle safety device (1) according to claim 7, wherein, The inclined surfaces (61, 71') are arranged near the distal end of the first tubular element (20), preferably at the distal end of the first tubular element (20), and / or The inclined surfaces (61, 71') are arranged near the shell surface of the first tubular element (20).

9. The needle safety device (1) according to any one of the preceding claims of claim 2, wherein, The elastic member (60) has an abutment surface (62) configured to prevent the second relative rotation, wherein the abutment surface (62) is preferably configured to contact a portion of the impact portion (72) of the receiving member (70) to prevent the second relative rotation.

10. The needle safety device (1) according to claim 9, wherein, The contact surface (62) is substantially parallel to the longitudinal axis (11).

11. The needle safety device (1) according to any one of the preceding claims, wherein, The receiving member (70), preferably the deflection portion (71) and / or locking portion (73) of the receiving member (70), is at least partially shaped to correspond to the elastic member (60).

12. The needle safety device (1) according to any one of the preceding claims, wherein, The receiving member (70) includes a deflection part (71), optionally includes the impact part (72), optionally includes a locking part (73), and optionally includes a tilting part (74). Optionally, the elastic member (60) is configured to pass over the tipping point (74) while the first tubular element (20) and the second tubular element (30) are rotating relative to each other, and before at least a portion of the elastic member (60) is caused to impact the impact portion (72). Optionally, the impact part (72) includes the locking part (73).

13. The needle safety device (1) according to claim 12, wherein, After the elastic member (60) is caused to impact the impact portion (72), the first tubular element (20) and the second tubular element (30) are configured to rotate further in the same relative direction, causing the elastic member (60) to engage with the locking portion (73).

14. A medical device, particularly a medical injection device (100), comprising a needle safety device (1) according to any one of the preceding claims.

15. The medical device according to the preceding claim, wherein, The medical injection device (100) is an auto-injector or injection pen.

Images