Safety device as well as medical kit and medical assembly having the same

Abstract

A safety device, a medical kit, and a medical assembly are disclosed. The safety device includes a base for being fixedly connected to the medical device, a covering movable relative to the base from an initial position, in which the covering is sleeved over an outer periphery of the base, to an activated position, in which the covering extends distally beyond the base. A limiting mechanism is provided on one or both of the base and the covering, the limiting mechanism limits distal movement of the covering from the initial position, wherein in response to overcoming limitation of the limiting mechanism, the covering is moved distally away from the initial position. In response to pushing the covering distally and / or pulling the base proximally along the longitudinal axis, the limitation of the limiting mechanism is overcome by longitudinal movement between the base and the covering.

Description

SAFETY DEVICE AS WELL AS MEDICAL KIT AND MEDICAL ASSEMBLY HAVING THE SAMECROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to Chinese Patent Application No. 202410713601 .0 entitled “Safety Device as Well as Medical Kit and Medical Assembly Having the Same” filed June 4, 2024, the disclosure of which is hereby incorporated by reference in its entirety.BACKGROUND OF THE INVENTION1. Technical Field

[0002] The present disclosure relates to a safety device, as well as a medical kit and a medical assembly having the same. In particular, the safety device may be used for being mounted to a medical device having a barrel and a needle located distal to the barrel, including a syringe such as a pre-filled syringe.2. Description of Related Art

[0003] A medical device in the form of an injection device may generally comprise a barrel and a needle located distal to the barrel. The barrel may form a container for a medical product. The needle may be used to communicate the barrel with an injection site, for example to expel the medical product to the injection site. The injection device may generally include a syringe, such as a syringe to be filled with a medical product before use or a syringe that has been pre-filled with a medical product.

[0004] The injection device may be provided with a safety device which is activated to shield a used needle, for example to reduce the risk of needle stick injury and / or secondary contamination. The safety device is different from a needle cap that maintains sterility prior to use. The needle cap is also not suitable to serve as a safety device for uses such as those described above.

[0005] Safety devices may be generally classified into automatic type or manual type. An automatic safety device may have complex triggering and driving mechanisms, which increases device complexity and manufacturing costs. A manualsafety device may require a user to perform a specific action to achieve activation of the safety device to reach a final shielded state.SUMMARY OF THE INVENTION

[0006] Although manual safety devices may reduce complexity and manufacturing costs with respect to automatic safety devices, it is desirable to simplify the configuration of manual safety devices and increase ease of use and versatility to achieve cost effectiveness.

[0007] According to the present disclosure, there is provided a safety device for being mounted to a medical device having a barrel and a needle located distal to the barrel, the safety device defining a longitudinal axis and comprising: a base component for being fixedly connected to the medical device, wherein the base component is sleeved over an outer periphery of the barrel of the medical device when the safety device is mounted to the medical device; a covering component movable relative to the base component from a proximal initial position, in which the covering component is sleeved over the outer periphery of the base component, to a distal activated position, in which the covering component extends distally beyond the base component, wherein the covering component in the distal activated position shields the needle when the safety device is mounted to the medical device; a limiting mechanism provided on one or both of the base component and the covering component, the limiting mechanism for limiting distal movement of the covering component from the proximal initial position, wherein in response to overcoming limitation of the limiting mechanism, the covering component is moved distally away from the proximal initial position; wherein in response to pushing the covering component distally and / or pulling the base component proximally in a longitudinal direction along the longitudinal axis, the limitation of the limiting mechanism is overcome by longitudinal movement between the base component and the covering component. This makes it possible to obtain a safety device with a simple structure and low cost, and even with just two components. This makes it possible to obtain a safety device which is convenient in use, and which just requires an easily applied force / movement to achieve an activation action. This makes it possible to obtain a safety device with good adaptability and without additional modification of the medical device.

[0008] According to the present disclosure, the action of pushing and / or pulling is exerted by an external force relative to the safety device. This may help to simplify the structure and the operation and reduce or eliminate the requirements resulting from unnecessary force transfer.

[0009] According to the present disclosure, the covering component is freely movable in both orientations of the longitudinal direction after being moved distally away from the proximal initial position and before being moved to the distal activated position. This may help to simplify the structure and the operation and reduce or eliminate the requirements resulting from unnecessary motion constraints.

[0010] According to the present disclosure, the safety device does not comprise an energy storage component. This may help to simplify the structure and the operation, without encountering the risk of accidental activation and creep failure of the energy storage component (e.g., spring).

[0011] According to the present disclosure, the covering component comprises a guide slot extending in the longitudinal direction and defining a width transverse to the longitudinal direction, wherein the limiting mechanism comprises a width-narrowed portion provided proximate a distal end of the guide slot, wherein the limiting mechanism comprises a positioning pin provided proximate a distal end of the base component, wherein the positioning pin protrudes at least partially into the guide slot and has an outer dimension greater than the width-narrowed portion, wherein in the proximal initial position, the positioning pin is positioned distal to the width-narrowed portion. This makes it possible to integrate an initial limit that avoids accidents and path guidance that simplifies the use, which contributes to obtaining an efficient, compact, and cost-controlled structure.

[0012] According to the present disclosure, the width-narrowed portion comprises substantially symmetrical protrusions extending from both sides into the guide slot with respect to the width, and / or the width-narrowed portion comprises a distal fillet. This may contribute to motion symmetry as well as guidance and modulation of overcoming action and force profile.

[0013] According to the present disclosure, the width-narrowed portion divides the guide slot into a distal positioning hole and a proximal slot segment, wherein the distal positioning hole is sized to correspond to the outer dimension of the positioning pin. This may help to establish an initial limit in a more defined manner, and facilitate assembling, moving process and overcoming movement.

[0014] According to the present disclosure, the safety device comprises a locking mechanism provided on one or both of the base component and the covering component for locking the covering component from being moved proximally away from the distal activated position when moved to the distal activated position. This may help to keep the safety device securely in a shielded state of the needle without increasing the number of components of the safety device.

[0015] According to the present disclosure, the locking mechanism comprises a locking projection provided proximate the distal end of the base component, wherein the locking mechanism comprises an elastic tab provided proximate the proximal end of the covering component, wherein when moved to the distal activated position, the elastic tab is moved distally past the locking projection, thereby being stopped on a proximal side by the locking projection. This may help to limit the covering component to a sufficiently distal position from which, once reached, return is prevented, by a mechanism that allows only unidirectional movement.

[0016] According to the present disclosure, the locking projection comprises an annular ridge around the base component. This may help to improve the robustness of the locking mechanism.

[0017] According to the present disclosure, the locking projection comprises a proximal surface and a distal surface, wherein the distal surface is inclined more steeply than the proximal surface. This may help to improve the stability of the locking mechanism.

[0018] According to the present disclosure, the covering component comprises a sidewall and an opening through the sidewall, wherein the opening defines an opening rim comprising a distal rim, wherein the elastic tab comprises a locking wing extending proximally from the distal rim of the opening at least partially within the opening. This may help to obtain an elastic tab with an extended load-bearing extent and thus enhanced stopping capability.

[0019] According to the present disclosure, the locking wing comprises a main body and a connecting portion that connects the main body to the distal rim, wherein: the locking wing is spaced apart from the opening rim along the outer periphery by a gap, except at the connecting portion, and / or transverse to the longitudinal direction, the connecting portion has a width less than that of the main body. This may help to improve the elasticity.

[0020] According to the present disclosure, the locking wing comprises a main body defining an inner surface that faces the base component, wherein the inner surface is at least partially inclined proximally inward. This may help to lower the requirement for accuracy of dimensional fit of the two components of the safety device.

[0021] According to the present disclosure, the locking wing comprises an extension located proximal to the main body, the extension defining an inner surface that faces the base component, wherein: the inner surface of the extension is inclined proximally inward at an angle of inclination greater than that of the inner surface of the main body, and / or transverse to the longitudinal direction, the extension has a thickness less than that of the main body. This may help to improve the stability of the locking mechanism.

[0022] According to the present disclosure, the medical device comprises a flange located proximal to the barrel, wherein the base component comprises a proximal snap-fit finger for fixedly receiving the flange. This may contribute to the assembling with the medical device without having to change the current manufacturing process for the medical device.

[0023] According to the present disclosure, the covering component comprises a guide slot extending in the longitudinal direction and defining a width transverse to the longitudinal direction, the limiting mechanism comprises a positioning pin provided proximate the distal end of the base component, wherein the positioning pin is positioned immediately adjacent to a proximal end of the guide slot when the elastic tab is moved distally past the locking projection. This may help to establish an activated state in a more defined manner and facilitate subsequent disposal of the medical device.

[0024] According to the present disclosure, there is provided a medical kit comprising: a medical device having a barrel and a needle located distal to the barrel; a safety device according to the present disclosure, the safety device for being mounted to the medical device. This makes it possible to achieve the same benefit as that of the safety device by the medical kit.

[0025] According to the present disclosure, there is provided a medical assembly comprising: a medical device having a barrel and a needle located distal to the barrel; a safety device according to the present disclosure, the safety device having already been mounted to the medical device. This makes it possible to achieve the same benefit as that of the safety device by the medical assembly.

[0026] According to the present disclosure, the medical device includes a prefilled syringe. This may be advantageous in that even if conventional pre-filled syringes have various specifications, the safety device with a matching size according to the present disclosure may be easily retrofitted, thereby adding safety.BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Further features of the present disclosure will become apparent from the following description of exemplary embodiments with reference to the accompanying drawings.

[0028] Fig. 1 is a schematic view of an exemplary syringe.

[0029] Fig. 2 is a schematic view of a syringe assembled with a safety device according to an embodiment of the present disclosure, with a covering component of the safety device being in a proximal initial position.

[0030] Fig. 3 is a schematic view of a syringe assembled with a safety device according to an embodiment of the present disclosure, with a covering component of the safety device being in a distal activated position.

[0031] Fig. 4 is a schematic view of a safety device according to an embodiment of the present disclosure, with the syringe removed.

[0032] Fig. 5 is a schematic view of a safety device according to an embodiment of the present disclosure, with the syringe removed.

[0033] Fig. 6 is a partial cross-sectional view at the region of a locking mechanism of the safety device according to an embodiment of the present disclosure.

[0034] Fig. 7 is a schematic view of a base component of the safety device according to an embodiment of the present disclosure.

[0035] Fig. 8 is a schematic view of a covering component of the safety device according to an embodiment of the present disclosure.

[0036] Fig. 9 is a cross-sectional view of the covering component of the safety device according to an embodiment of the present disclosure.DETAILED DESCRIPTION OF THE EMBODIMENTS

[0037] The present disclosure is described with reference to the accompanying drawings in which some embodiments of the present disclosure are shown. However, the present disclosure may be implemented in many different forms and should not be construed as being limited to the embodiments depicted and described herein;instead, these embodiments are provided so that the present disclosure will be thorough and complete and will fully convey the scope of the present disclosure to those skilled in the art. It will also be understood that the embodiments disclosed herein may be combined in any way and / or combination to provide many other embodiments.

[0038] Unless defined otherwise, all technical and scientific terms used in the present disclosure have the same meaning as commonly understood by those of ordinary skill in the art to which the present disclosure belongs. The terms used in the description are for the purpose of describing particular embodiments only and are not intended to limit the present disclosure.

[0039] As used in this specification and the appended claims, the singular forms “a”, “an” and “the” all include plural referents, unless the content clearly indicates otherwise. It should also be noted that the term “or” is generally used in its sense including “and / or” unless the content clearly indicates otherwise.

[0040] As used in the present disclosure, the terms “proximal” and “distal” may respectively refer to directions closer to and away from a clinician that places a medical device into contact with a patient. Thus, for example, an end of the medical device closer to the patient's body will be a distal end, while the opposite end of the medical device (e.g., the end of the device manipulated by the clinician) will be a proximal end of the medical device.

[0041] For ease of illustration, the same reference signs refer to the same modules, units and / or components in the drawings.

[0042] The embodiments described below merely serve as specific examples. However, the present disclosure is not limited to the embodiments described in the specification.

[0043] Referring to Fig. 1 , an exemplary syringe 1 is shown. The syringe 1 may be a medical device having a barrel 10 and a needle 11 located distal to the barrel 10. The syringe 1 may further comprise a flange 13 located proximal to the barrel 10 and a plunger 12 located at least partially within the barrel 10. To expel the fluid within the barrel 10, a user may rest an index finger and a middle finger on a distal face of the flange 13 and push a proximal end of the plunger 12 distally with a thumb. The syringe 1 may be a pre-filled syringe (PFS), so the syringe 1 may already contain a required amount of medical product (e.g., drug, vaccine, etc.) at the time of delivery for administration.

[0044] After expelling the fluid within the barrel 10 of the medical device by pushing the plunger 12 distally or by other methods, the needle 11 needs to be removed from the administered subject. The needle 11 may be tainted with body fluid (such as blood), so it is necessary to avoid any contamination and needle stick injury. It is noted that it may be dangerous and inappropriate to put a needle cap (if present) for ensuring sterility prior to use back onto the needle 11 of the medical device. Instead, it is necessary to properly shield the needle 11 in a safe and convenient manner after use.

[0045] The present disclosure provides a safety device for being mounted to a safety device of a medical device having a barrel and a needle located distal to the barrel, which has a simple structure and may have a limited number of components (for example, only two components); the use is convenient, and protection against needle stick injury may be realized only by an axial pushing / pulling action after injection is completed; the cost is low, and various plastic components may be produced by injection molding; the assembling is simplified, and change of the manufacturing process for the medical device (e.g., current PFS manufacturing and filling processes) is not necessary, so it is suitable for retrofitting without the need of redesign; it is disposable, and easy resetting may be prevented after activation. Therefore, the present disclosure provides an economical and effective solution under the requirement of cost sensitivity.

[0046] Referring to Figs. 2-5, a safety device 2 according to an embodiment of the present disclosure is shown, which is either shown as being assembled on the syringe 1 (hereinafter collectively referred to as a medical device) (Figs. 2 and 3) or shown separately (Figs. 4 and 5). Figs. 2 and 4 show a covering component 22 of the safety device 2 in a proximal initial position. Figs. 3 and 5 show the covering component 22 of the safety device 2 in a distal activated position. In some embodiments, the safety device 2 may define a longitudinal axis. In some embodiments, a longitudinal axis of the safety device 2 may coincide substantially with a central axis of the barrel 10.

[0047] In some embodiments, the safety device 2 may comprise a base component 21 . The base component 21 may be configured to be fixedly connected to the medical device. When the safety device 2 is mounted to the medical device, i.e., when the base component 21 is fixedly connected to the medical device, the basecomponent 21 may be sleeved over an outer periphery of the barrel 10 of the medical device. In some embodiments, the base component 21 may be generally tubular.

[0048] When it is mentioned that the base component 21 is sleeved over the outer periphery of the barrel 10 of the medical device, the base component 21 may surround at least part of the length, e.g., a majority of the length, of the barrel 10 from the outside.

[0049] In some embodiments, the safety device 2 may comprise a covering component 22. The covering component 22 may be moved relative to the base component 21 from a proximal initial position (Figs. 2 and 4) to a distal activated position (Figs. 3 and 5). In the proximal initial position, the covering component 22 may be sleeved over an outer periphery of the base component 21 . In the distal activated position, the covering component 22 may extend distally beyond the base component 21. When the safety device 2 is mounted to the medical device, i.e., when the base component 21 is fixedly connected to the medical device, the covering component 22 in the distal activated position may shield the needle 11. In some embodiments, the covering component 22 may be generally tubular.

[0050] When it is mentioned that the covering component 22 is sleeved over the outer periphery of the base component 21 , the covering component 22 may surround at least part of the length, e.g., a majority of the length, of the base component 21 from the outside.

[0051] When it is mentioned that the covering component 22 extends distally beyond the base component 21 , a distal end of the covering component 22 may extend distally further than a distal end of the base component 21 .

[0052] When it is mentioned that the covering component 22 shields the needle 11 , the covering component 22 may contain the needle 11 within the covering component 22 from the outside and from the distal side, but it does not have to enclose the needle 11 (Fig. 3).

[0053] In some embodiments, the safety device 2 may comprise a limiting mechanism 25 provided on one or both of the base component 21 and the covering component 22. The limiting mechanism 25 may be configured to limit distal movement of the covering component 22 from the proximal initial position. In response to overcoming the limitation of the limiting mechanism 25, the covering component 22 may be moved distally away from the proximal initial position.

[0054] When it is mentioned that the limiting mechanism 25 is provided on one or both of the base component 21 and the covering component 22, one or more parts of the limiting mechanism 25 may be integrated with the base component 21 or the covering component 22 or may be a constituent part of the base component 21 or the covering component 22.

[0055] In some embodiments, in response to pushing the covering component 22 distally and / or pulling the base component 21 proximally in a longitudinal direction along the longitudinal axis, the limitation of the limiting mechanism 25 may be overcome by (relative) longitudinal movement between the base component 21 and the covering component 22. In other words, overcoming the limitation of the limiting mechanism 25 requires applying a longitudinal force in a proximal-distal direction which is sufficient to resist the hindering effect of the limiting mechanism 25. Thus, overcoming the limitation of the limiting mechanism 25 does not require applying a torsion to the safety device 2, instead only a simple, substantially linear motion activates the safety device 2.

[0056] In some embodiments, the action of pushing and / or pulling may be applied by an external force relative to the safety device 2. In other words, such an action is not an internal action of the safety device 2. Thus, the safety device 2 does not comprise a triggering mechanism or motive element, such as, but not limited to, an actuator that triggers activation.

[0057] In some embodiments, the covering component 22 may be freely moved in both orientations of the longitudinal direction after being moved distally away from the proximal initial position and before being moved to the distal activated position. In other words, the limitation of the limiting mechanism 25 is localized. Further, the covering component 22 is not driven by an internal force relative to the safety device 2 midway through the movement.

[0058] In some embodiments, the safety device 2 may comprise no energy storage component. In other words, the safety device 2 is a passive device. Thus, the safety device 2 is not biased, e.g., the covering component 22 is not spring-biased.

[0059] Referring to Figs. 7 to 9, the base component 21 and the covering component 22 according to an embodiment of the present disclosure, which are disassembled, are shown. One embodiment of the limiting mechanism 25 is described below.

[0060] In some embodiments, the covering component 22 may comprise a guide slot 221 extending in the longitudinal direction and defining a width transverse to the longitudinal direction. The guide slot 221 may comprise a width-narrowed portion 2210 provided proximate a distal end of the guide slot 221 . The width-narrowed portion 2210 may form a part of the limiting mechanism 25. In some embodiments, the covering component 22 may comprise a sidewall 220, and with respect to the longitudinal direction, the guide slot 221 may extend through a thickness of the sidewall 220. In some embodiments, the covering component 22 may comprise two guide slots 221 that are substantially symmetrical.

[0061] When it is mentioned that the guide slot 221 extends in the longitudinal direction, the guide slot 221 may extend substantially straight.

[0062] When it is mentioned that the guide slot 221 defines a width transverse to the longitudinal direction, the guide slot 221 with the width-narrowed portion 2210 may define at least two widths, including a maximum width for longitudinal guidance and a reduced width at the width-narrowed portion 2210.

[0063] When it is mentioned that the width-narrowed portion 2210 is provided proximate the distal end of the guide slot 221 , the width-narrowed portion 2210 may be positioned within an extent delimited by the maximum width.

[0064] In some embodiments, the base component 21 may comprise a positioning pin 211 provided proximate the distal end of base component 21. The positioning pin 211 may form a part of the limiting mechanism 25. The positioning pin 211 may be configured to at least partially protrude into the guide slot 221 and have an outer dimension greater than the width-narrowed portion 2210. In the proximal initial position, the positioning pin 211 may be configured to be positioned distal to the width-narrowed portion 2210. In some embodiments, the base component 21 may comprise a sidewall 210, and the positioning pin 211 may extend outwardly, e.g., substantially perpendicularly, from the sidewall 210. In some embodiments, the base component 21 may comprise two positioning pins 211 that are substantially symmetrical.

[0065] When it is mentioned that the positioning pin 211 at least partially protrudes into the guide slot 221 , the positioning pin 211 may extend outwardly not beyond the depth of the guide slot 221 but extend sufficiently so as not to disengage out of the guide slot 221 .

[0066] When it is mentioned that the positioning pin 211 has an outer dimension greater than the width-narrowed portion 2210, the outer dimension of the positioning pin 211 may at least involve a mating dimension of the positioning pin 211 with respect to the width direction of the guide slot 221 , e.g., an outer diameter of a segment protruding into the guide slot 221 in the case of a cylindrical pin.

[0067] When it is mentioned that the positioning pin 211 in the proximal initial position is positioned distal to the width-narrowed portion 2210, overcoming the limitation of the limiting mechanism 25 may include that the positioning pin 211 is moved past the width-narrowed portion 2210 to a proximal side thereof and / or the width-narrowed portion 2210 is moved past the positioning pin 211 to a distal side thereof as one or both of the positioning pin 211 and the width-narrowed portion 2210 are caused to deform.

[0068] In some embodiments, the width-narrowed portion 2210 may comprise substantially symmetrical protrusions extending into the guide slot 221 from both sides with respect to the width (Fig. 9).

[0069] When it is mentioned that the protrusions are substantially symmetrical, the deformation of the width-narrowed portion 2210 may be substantially symmetrical, if any.

[0070] In some embodiments, the width-narrowed portion 2210 (e.g., protrusions) may comprise a distal fillet (Fig. 9).

[0071] In some embodiments, the width-narrowed portion 2210 may divide the guide slot 221 into a distal positioning hole 2211 and a proximal slot segment 2212. The distal positioning hole 2211 may be sized to correspond to the outer dimension of the positioning pin 211 .

[0072] When referring to dividing the guide slot 221 , the guide slot 221 may have sequentially from distal to proximal, the distal positioning hole 2211 , the width- narrowed portion 2210 and the proximal slot segment 2212.

[0073] When it is mentioned that the size of distal positioning hole 2211 corresponds to the outer dimension of the positioning pin 211 , the distal positioning hole 2211 may form a transition fit with the positioning pin 211 .

[0074] Referring to Figs. 2-5, in some embodiments, the safety device 2 may comprise a locking mechanism 26 provided on one or both of the base component 21 and the covering component 22. The locking mechanism 26 may be configured to lockthe covering component 22 from being moved proximally away from the distal activated position when moved to the distal activated position.

[0075] When it is mentioned that the locking mechanism 26 is provided on one or both of the base component 21 and the covering component 22, one or more portions of the locking mechanism 26 may be integrated with the base component 21 or the covering component 22 or may be a constituent part of the base component 21 or the covering component 22.

[0076] With reference to Figs. 7 and 8, and with further reference to Figs. 6 and 9, a partial portion of the safety device 2 according to an embodiment of the present disclosure is shown in cross-sectional views. One embodiment of the locking mechanism 26 is described below.

[0077] In some embodiments, the base component 21 may comprise a locking projection 212 provided proximate the distal end of the base component 21. The locking projection 212 may form a part of the locking mechanism 26. In some embodiments, the locking projection 212 may extend outwardly from the sidewall 210 of the base component 21 .

[0078] In some embodiments, the locking projection 212 may comprise an annular ridge around the base component 21 . In other words, the annular ridge may extend outside the sidewall 210 of the base component 21 . Alternatively, with respect to the longitudinal direction, the locking projection 212 may be circumferentially offset (e.g., by approximately 90 °) relative to the positioning pin 211 (or more generally a part of the limiting mechanism 25 provided on the base component 21 ).

[0079] In some embodiments, the locking projection 212 may comprise a proximal surface 2121 and a distal surface 2122. The distal surface 2122 may be configured to be inclined more steeply than the proximal surface 2121 . In other words, in the distal direction, when the proximal surface 2121 forms an acute angle a with the longitudinal axis, an angle [3 formed by the distal surface 2122 with the longitudinal axis may be between a and 180° - a. In some embodiments, the angle a may be approximately 30° -60°, such as 45°, and / or the angle [3 may be approximately 90°.

[0080] In some embodiments, the covering component 22 may comprise an elastic tab 222 provided proximate the proximal end of the covering component 22. The elastic tab 222 may form a part of the locking mechanism 26. When moved to the distal activated position, the elastic tab 222 may be moved distally past the locking projection 212, thereby being stopped on a proximal side by the locking projection 212.In some embodiments, the covering component 22 may comprise two elastic tabs 222 that are substantially symmetrical. In some embodiments, with respect to the longitudinal direction, the guide slot 212 may be circumferentially offset (e.g., by approximately 90°) relative to the elastic tab 222 (or more generally a part of the locking mechanism 26 provided on the covering component 22).

[0081] When referring to the elastic tab 222, the elastic tab 222 may be capable of flexing from an initial configuration to a deformed configuration and returning to the initial configuration.

[0082] When it is mentioned that the elastic tab 222 is moved distally past the locking projection 212, the elastic tab 222 may flex due to the presence of the locking projection 212 and then rebound on a distal side of the locking projection 212.

[0083] When it is mentioned that the elastic tab 222 is stopped on a proximal side by the locking projection 212, the elastic tab 222 may be incapable of being moved proximally past the locking projection 212 due to at least partial abutment against the distal surface 2122 of the locking projection 212.

[0084] Referring to Figs. 6, 8 and 9, one embodiment of the elastic tab 222 is described below.

[0085] In some embodiments, the covering component 22 may comprise an opening 223 through the sidewall 220. The opening 223 may define an opening rim that includes a distal rim 2231 . The elastic tab 222 may comprise a locking wing 2220 extending proximally from the distal rim 2231 of the opening 223 at least partially within the opening 223. In some embodiments, the opening 223 and / or the locking wing 2220 may be generally rectangular.

[0086] When referring to the opening 223 through the sidewall 220, the opening 223 may extend through a thickness of the sidewall 220 with respect to the longitudinal direction.

[0087] When it is mentioned that the locking wing 2220 is at least partially within the opening 223, the locking wing 2220 may extend inwardly beyond the depth of the opening 223 or the thickness of the sidewall 220 (Figs. 6 and 9).

[0088] In some embodiments, the locking wing 2220 may comprise a main body 2221 and a connecting portion 2222 that connects the main body 2221 to the distal rim 2231 .

[0089] In some embodiments, the locking wing 2220 may be spaced apart from the opening rim along the outer periphery by a gap, except at the connecting portion 2222.

[0090] In some embodiments, transverse to the longitudinal direction, the connecting portion 2222 may have a width less than that of the main body 2221 .

[0091] When it is mentioned that the connecting portion 2222 connects the main body 2221 to the distal rim 2231 , the main body 2221 , the connecting portion 2222, and the sidewall 220 delimiting the distal rim 2231 may be a continuous material.

[0092] In some embodiments, the main body 2221 may define an inner surface that faces the base component 21 . The inner surface may be configured to be at least partially inclined proximally inward (Figs. 6 and 9).

[0093] When it is mentioned that the inner surface is at least partially inclined proximally inward, a proximal portion of the inner surface may be configured to be closer to the base component 21 than a distal portion of the inner surface (Fig. 6).

[0094] In some embodiments, the locking wing 2220 may comprise an extension 2223 located proximal to the main body 2221 . The extension 2223 may define an inner surface that faces the base component 21 .

[0095] In some embodiments, the inner surface of the extension 2223 may be inclined proximally inward at an angle of inclination greater than that of the inner surface of the main body 2221 . In other words, the inner surface of the extension 2223 is inclined more steeply than the inner surface of the main body 2221 (Fig. 9).

[0096] In some embodiments, with respect to the longitudinal direction, the extension 2223 may have a thickness less than that of the main body 2221 .

[0097] When it is mentioned that the extension 2223 is located proximal to the main body 2221 , the extension 2223 and the main body 2221 may be a continuous material, and / or the extension 2223 may form a proximal free end of the locking wing 2220.

[0098] When it is mentioned that the inner surface of the extension 2223 is inclined proximally inward at a greater angle, the extension 2223 may be stopped on a proximal side by a near-root position of the distal surface 2122 of the locking projection 212 as it is moved distally past the locking projection 212 (Fig. 6).

[0099] Referring to Figs. 2 and 3, the safety device 2 may be mounted to the medical device via suitable means. In some embodiments, the base component 21 may comprise a proximal snap-fit finger 213. The proximal snap-fit finger 213 may beconfigured to fixedly receive the flange 13 which the medical device comprises and which is located proximal to the barrel 10. In some embodiments, the proximal snap- fit finger 213 may be provided in pairs (for example, two pairs are provided). In some embodiments, two proximal snap-fit fingers 213 in each pair may be provided with inclined distal segments 2132 opposite to each other supported by support segments 2131. In some embodiments, a receiving space for the flange 13 may be formed between corresponding support segments 2131 on a distal side of the inclined distal segments 2132. Thus, during assembling, when the medical device is inserted from a proximal side to a distal side into the safety device 2 and / or the safety device 2 is sleeved from a distal side to a proximal side onto the medical device, the proximal snap-fit fingers 213 may flex at least partially outwardly as the flange 13 passes the inclined distal segments 2132, thereby allowing the flange 13 to snap fit into the receiving space past the inclined distal segments 2132. Since the flange 13 is fixed in a snap-fit manner, the base component 21 may comprise a proximal flange 214 that substitutes the function of the flange 13. To expel the fluid within the barrel 10, a user may rest an index finger and a middle finger on a distal face of the proximal flange 214 and push a proximal end of the plunger 12 distally with a thumb. In some embodiments, the support segment 2131 may extend proximally from a proximal surface of the proximal flange 214.

[0100] Referring to Figs. 5 and 6 in combination, the movement extent of the covering component 22 may be effectively limited when moved to the distal activated position. In some embodiments, the positioning pin 211 may be positioned immediately adjacent to a proximal end of the guide slot 221 when the elastic tab 222 moves distally past the locking projection 212. In other words, in the distal activated position, the positioning pin 211 may be stopped on a proximal side by the proximal end of the guide slot 221 , thereby locking the covering component 22 from being moved further distally from the distal activated position. In other words, when the proximal end of the guide slot 221 is distal to the proximal end of the elastic tab 222 (e.g., the proximal free end of the locking wing 2220), the positioning pin 211 may also be distal to the locking projection 212, and vice versa. Further, along the longitudinal direction, a distance between the proximal end of the guide slot 221 and the proximal end of the elastic tab 222 (e.g., the proximal free end of the locking wing 2220) may be only slightly greater than a distance between the positioning pin 211 and the locking projection 212.

[0101] The present disclosure also provides a medical kit and a medical assembly 3 having a safety device 2 according to the present disclosure. The medical kit and medical assembly 3 also have a medical device, such as a medical device having a barrel and a needle located distal to the barrel. The medical device may include a syringe 1 , such as a pre-filled syringe. In the medical kit, the medical device and the safety device 2 may be provided separately so that the safety device 2 is subsequently assembled on the medical device. In the medical assembly 3, the safety device 2 may have already been mounted to the medical device (Figs. 2 and 3).

[0102] According to some embodiments, assembling of the safety device 2 and a medical device as a pre-filled syringe (hereinafter simply referred to as syringe 1 ) is described below. The safety device 2 may be provided in a way such that the covering component 22 is in a proximal initial position relative to the base component 21 . For example, before use, the covering component 22 may be fixed to the base component 21 by the positioning pin 211 inserted into the positioning hole 2211 . In the assembling, the flange 13 of the syringe 1 may be pushed to insert the syringe 1 into the safety device 2 until the flange 13 of the syringe 1 is gripped by the proximal snap-fit fingers 213 of the base component 21 of the safety device 2. As a result, the syringe 1 such as a PFS may be clipped into the safety device 2 and held in place by its flange 13.

[0103] According to some embodiments, injection operation of the syringe 1 with the safety device 2 mounted thereto is described below. After assembling, administration may be performed with the proximal flange 214 of the base component 21 of the safety device 2 substituting the function of the flange 13 of the syringe 1 . If the syringe 1 has a needle cap, the needle cap may be removed before insertion of the needle 11 into the body of the subject to be administered.

[0104] According to some embodiments, safe operation of the syringe 1 with the safety device 2 mounted thereto is described below. After the needle 11 is removed from the administered subject after injection is completed, the covering component 22 may be gripped and pushed distally, for example, to cause the positioning pin 211 within the positioning hole 2211 to overcome the limiting force of the width-narrowed portion 2210. Then, the covering component 22 may continue to be pushed distally until the elastic tab 220 (for example, locking wing 2220) snaps past, for example, the annular locking projection 212, which will prevent the covering component 22 from being pushed proximally back. The positioning pin 211 may prevent the coveringcomponent 22 from being pushed further distally and thus being separated from the base component 12.

[0105] Different operation steps and / or sequences may be contemplated in conjunction with the above description, without departing from the spirit, concept, and scope of the present disclosure.

[0106] It is to be noted that while the present disclosure has described advantageous forms of a safety device, and a medical kit and a medical assembly with the same, the present disclosure is not limited to the exact forms that are shown and described. Instead, the detailed description should be construed as being exemplary only. Thus, analogical features of one example may be applied to or replace another example without materially departing from the novel teachings and advantages of the present disclosure.

[0107] The above is a description of the present disclosure and should not be construed as limiting the present disclosure. Although exemplary embodiments of the present disclosure have been described, those skilled in the art will readily understand that without materially departing from the novel teachings and advantages of the present disclosure, many modifications may be made in the exemplary embodiments, e.g., features relating to the device and features relating to the method may be combined in any manner to form other embodiments. Accordingly, all these modifications are intended to be included within the scope of the present disclosure as defined in the claims. The present disclosure is defined by the following claims, with equivalents of the claims included therein.

Claims

WHAT IS CLAIMED IS:1 . A safety device for being mounted to a medical device having a barrel and a needle located distal to the barrel, the safety device defining a longitudinal axis and comprising: a base component for being fixedly connected to the medical device, wherein the base component is sleeved over an outer periphery of the barrel of the medical device when the safety device is mounted to the medical device, a covering component movable relative to the base component from a proximal initial position, in which the covering component is sleeved over the outer periphery of the base component, to a distal activated position, in which the covering component extends distally beyond the base component, wherein the covering component in the distal activated position shields the needle when the safety device is mounted to the medical device, a limiting mechanism provided on one or both of the base component and the covering component, the limiting mechanism for limiting distal movement of the covering component from the proximal initial position, wherein in response to overcoming limitation of the limiting mechanism, the covering component is moved distally away from the proximal initial position, wherein in response to pushing the covering component distally and / or pulling the base component proximally in a longitudinal direction along the longitudinal axis, the limitation of the limiting mechanism is overcome by longitudinal movement between the base component and the covering component.

2. The safety device according to claim 1 , wherein the action of pushing and / or pulling is exerted by an external force relative to the safety device.

3. The safety device according to claim 1 , wherein the covering component is freely movable in both orientations of the longitudinal direction after being moved distally away from the proximal initial position and before being moved to the distal activated position.

4. The safety device according to claim 1 , wherein the safety device does not comprise an energy storage component.

5. The safety device according to claim 1 , wherein the covering component comprises a guide slot extending in the longitudinal direction and defining a width transverse to the longitudinal direction, wherein the limiting mechanism comprises a width-narrowed portion provided proximate a distal end of the guide slot, wherein the limiting mechanism comprises a positioning pin provided proximate a distal end of the base component, wherein the positioning pin protrudes at least partially into the guide slot and has an outer dimension greater than the width-narrowed portion, wherein in the proximal initial position, the positioning pin is positioned distal to the width- narrowed portion.

6. The safety device according to claim 5, wherein the width-narrowed portion comprises substantially symmetrical protrusions extending from both sides into the guide slot with respect to the width, and / or the width-narrowed portion comprises a distal fillet.

7. The safety device according to claim 5, wherein the width-narrowed portion divides the guide slot into a distal positioning hole and a proximal slot segment, wherein the distal positioning hole is sized to correspond to the outer dimension of the positioning pin.

8. The safety device according to claim 1 , comprising a locking mechanism provided on one or both of the base component and the covering component for locking the covering component from being moved proximally away from the distal activated position when moved to the distal activated position.

9. The safety device according to claim 8, wherein the locking mechanism comprises a locking projection provided proximate the distal end of the base component, wherein the locking mechanism comprises an elastic tab provided proximate the proximal end of the covering component, wherein when moved to the distal activated position, the elastic tab is moved distally past the locking projection, thereby being stopped on a proximal side by the locking projection.

10. The safety device according to claim 9, wherein the locking projection comprises an annular ridge around the base component.

11. The safety device according to claim 9, wherein the locking projection comprises a proximal surface and a distal surface, wherein the distal surface is inclined more steeply than the proximal surface.

12. The safety device according to claim 9, wherein the covering component comprises a sidewall and an opening through the sidewall, wherein the opening defines an opening rim comprising a distal rim, wherein the elastic tab comprises a locking wing extending proximally from the distal rim of the opening at least partially within the opening.

13. The safety device according to claim 12, wherein the locking wing comprises a main body and a connecting portion that connects the main body to the distal rim, wherein: the locking wing is spaced apart from the opening rim along the outer periphery by a gap, except at the connecting portion, and / or transverse to the longitudinal direction, the connecting portion has a width less than that of the main body.

14. The safety device according to claim 12, wherein the locking wing comprises a main body defining an inner surface that faces the base component, wherein the inner surface is at least partially inclined proximally inward.

15. The safety device according to claim 14, wherein the locking wing comprises an extension located proximal to the main body, the extension defining an inner surface that faces the base component, wherein: the inner surface of the extension is inclined proximally inward at an angle of inclination greater than that of the inner surface of the main body, and / or transverse to the longitudinal direction, the extension has a thickness less than that of the main body.

16. The safety device according to claim 1 , wherein the medical device comprises a flange located proximal to the barrel, wherein the base component comprises a proximal snap-fit finger for fixedly receiving the flange.

17. The safety device according to claim 9, wherein the covering component comprises a guide slot extending in the longitudinal direction and defining a width transverse to the longitudinal direction, the limiting mechanism comprises a positioning pin provided proximate the distal end of the base component, wherein the positioning pin is positioned immediately adjacent to a proximal end of the guide slot when the elastic tab is moved distally past the locking projection.

18. A medical kit, comprising: a medical device having a barrel and a needle located distal to the barrel; and a safety device for being mounted to the medical device, the safety device defining a longitudinal axis and comprising: a base component for being fixedly connected to the medical device, wherein the base component is sleeved over an outer periphery of the barrel of the medical device when the safety device is mounted to the medical device, a covering component movable relative to the base component from a proximal initial position, in which the covering component is sleeved over the outer periphery of the base component, to a distal activated position, in which the covering component extends distally beyond the base component, wherein the covering component in the distal activated position shields the needle when the safety device is mounted to the medical device, a limiting mechanism provided on one or both of the base component and the covering component, the limiting mechanism for limiting distal movement of the covering component from the proximal initial position, wherein in response to overcoming limitation of the limiting mechanism, the covering component is moved distally away from the proximal initial position, wherein in response to pushing the covering component distally and / or pulling the base component proximally in a longitudinal direction along the longitudinal axis, the limitation of the limiting mechanism is overcome by longitudinal movement between the base component and the covering component.

19. The medical kit according to claim 18, wherein the medical device comprises a pre-filled syringe.

20. A medical assembly, comprising: a medical device having a barrel and a needle located distal to the barrel; and a safety device which has already been mounted to the medical device, the safety device defining a longitudinal axis and comprising: a base component for being fixedly connected to the medical device, wherein the base component is sleeved over an outer periphery of the barrel of the medical device when the safety device is mounted to the medical device, a covering component movable relative to the base component from a proximal initial position, in which the covering component is sleeved over the outer periphery of the base component, to a distal activated position, in which the covering component extends distally beyond the base component, wherein the covering component in the distal activated position shields the needle when the safety device is mounted to the medical device, a limiting mechanism provided on one or both of the base component and the covering component, the limiting mechanism for limiting distal movement of the covering component from the proximal initial position, wherein in response to overcoming limitation of the limiting mechanism, the covering component is moved distally away from the proximal initial position, wherein in response to pushing the covering component distally and / or pulling the base component proximally in a longitudinal direction along the longitudinal axis, the limitation of the limiting mechanism is overcome by longitudinal movement between the base component and the covering component.

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