Safety device for preventing needle stick injuries from needles of medical injection devices

Abstract

A safety device comprising: a ring; and a protective shield movably coupled to the ring, the ring being configured for attachment to the distal end of a medical injection device, the protective shield being configured to assume a storage position covering a needle end, an operating position exposing the needle end, and a safety position covering the needle end. A protective cap is mounted on the ring to cover the needle end and can be separated from the ring before the device is used. A retaining system comprises a first retaining portion on the protective shield and a second retaining portion on the protective cap, the first retaining portion cooperating with the second retaining portion in the storage position to prevent the protective shield from moving to its operating position. A release system releases the retaining system and is configured to be activated by manual inward pressure applied to the protective cap.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to European Patent Application No. 20181699.8 filed on June 23, 2020, the entire disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present invention relates to a safety device for preventing needle stick injuries caused by a needle of a medical injection device and also relates to a safety assembly comprising the safety device and the medical injection device. Background Art

[0004] Medical devices provided with sharp-tipped needles are required in daily work in the medical community to perform injections or obtain samples from muscles, veins or arteries. They can be injection devices, such as syringes, pen-type injectors, catheters or blood collection devices. Sharp-tipped needles present an inherent risk of needlestick injuries for medical personnel and patients, and therefore are usually provided with a needle cap that covers the needle before use. The cap not only protects the needle from contamination, but also prevents medical personnel from unwanted contact with the needle or needlestick injuries during transportation and delivery of the needle. Such a cap needs to be removed just before the medical device is used.

[0005] Putting the needle cap back on the needle after use is strictly prohibited, as it is considered a major cause of accidents and contamination for medical personnel. In fact, the entire medical device or at least the used needle should be disposed of in a suitable needle collector after use. However, the risk of needle stick injuries still exists when medical personnel handle bare, contaminated needles before disposal.

[0006] Therefore, safety devices are designed to prevent needle stick injuries caused by the needle of such medical devices after use, i.e. between the end of injection or collection and the correct disposal of the device. Typically, such safety devices are designed to lock automatically or manually on at least the needle tip when the medical action is completed.

[0007] One type of such safety device includes:

[0008] a protective cap mounted on the medical injection device so as to cover the needle in a storage position and detached from the medical injection device before use;

[0009] and a protective shield movably coupled to the medical injection device such that the protective shield can adopt a storage position, an operating position, in which the needle is covered, and a final safety position, in which the protective shield again covers the needle tip.

[0010] For this type of safety device, it is of utmost importance to prevent the protective shield from being inadvertently moved from its storage position towards its operating position, in order to ensure the safety of medical personnel and patients.

[0011] To this end, several solutions have been provided, which include retention systems that maintain the protective shield in its storage position. However, known retention systems may not be entirely satisfactory. In particular, they may require the user to overcome considerable force to allow the protective shield to move to its operative position when appropriate. Summary of the invention

[0012] It is an object of the present invention to provide an improved safety device. In particular, the present invention aims to provide a safety device that is easier to operate without compromising safety.

[0013] To this end, according to a first aspect, the present invention relates to a safety device for preventing needle stick injuries caused by a needle extending from a distal end of a medical injection device, the safety device comprising:

[0014] a ring configured for attachment to a distal tip of a medical injection device;

[0015] a protective shield movably coupled to the ring, the protective shield being configured to successively assume a storage position, in which the protective shield covers the needle tip, an operating position, in which the protective shield exposes the needle tip, and a safety position, in which the protective shield covers the needle tip;

[0016] a protective cap which is mounted on the ring in a storage position so as to cover at least the needle tip and which can be separated from the ring before use of the medical injection device;

[0017] a retention system comprising a first retention portion disposed on the protective shield and a second retention portion disposed on the protective cap, wherein the first retention portion cooperates with the second retention portion in the storage position to prevent movement of the protective shield toward its operative position;

[0018] And further, a release system for releasing the retaining system, the release system being configured to be activated by manual inward pressure applied to the protective cap.

[0019] Thus, in the safety device of the present invention, the protective shield is prevented from inadvertently moving to its operative position by means of the retaining system. However, when appropriate, i.e. usually just before use, the user can release the retaining system to allow the protective shield to move to its operative position, which allows the use of the medical injection device.

[0020] Furthermore, the way the release system is activated offers significant advantages.

[0021] Pressing the protective cap inwards is an action that can be easily performed by almost any user, does not require great strength and there is no risk of fingers slipping on the safety device.

[0022] Furthermore, inward pressure on the protective cap is less likely to occur accidentally (e.g. after an impact from surrounding elements). In case the release system and the retaining system are arranged on opposite sides of the safety device, it can usually be activated by the user pressing the safety device between his thumbs. This movement is even safer in terms of inadvertent activation.

[0023] Furthermore, this pressing movement can be performed while grasping the protective cap in order to separate it from the ring. In other words, activating the release system does not usually mean placing the fingers successively at various positions on the safety device, which would be inconvenient. However, the pressing movement requires an inward force, while removing the protective cap usually requires a differently directed force, such as a distal pulling movement. This produces two significant results. On the one hand, although the two movements can be performed simultaneously, the need for two mutually different movements improves safety by making an inadvertent activation of the release system very unlikely. On the other hand, since the two movements are mutually different, the effort required for each movement of the present invention may not be too great, compared to designs in which the movement that causes the release system to be activated and the movement that causes the protective cap to be removed are the same, which would require a greater effort.

[0024] The structure of the invention further greatly simplifies the design and manufacture of the safety device, especially in terms of dimensional chains. In fact, the same part of the device can be both part of the retention system and part on which the release system acts. Assembling the protective shield is easy because it can be done in a single step; mounting the protective shield to the rest of the safety device requires a single directional movement.

[0025] The release system may be arranged on the protective cap.

[0026] In an embodiment, in the storage position, the release system generally faces at least a portion of the retaining system in a radial direction.

[0027] In the storage position, the release system may be in contact with or in close proximity to at least a portion of the retention system. As a result, no movement over a large distance is required to initiate the release process. However, the first retention portion and the second retention portion may be configured to cooperate in said range of motion which is not too small to avoid accidental release of the retention system.

[0028] The release system can preferably be configured to release the retention system directly when activated. In other words, for such an embodiment, another intermediate member will not be needed to release the retention system.

[0029] In one embodiment, the protective cap comprises a generally tubular body having a distal radial opening, and the protective shield has a distal arm which is received in the distal radial opening of the protective cap or radially faces the distal radial opening of the protective cap in the storage position. The first retaining portion may be arranged on at least one of the two longitudinal sides of the distal arm of the protective shield, and the second retaining portion may be arranged on a portion of the circumferential wall of the generally tubular body adjacent to the distal radial opening.

[0030] The retention system and / or release system may include at least one element configured to elastically move, deflect or deform from a first state to a second state, in which the protective shield is maintained in a storage position and in which the protective shield is free to move to its operative position.

[0031] The protective shield may comprise at least one leg extending inwardly of the safety device, the leg having a protrusion extending outwardly, and the protrusion having an abutment surface forming the first retaining portion. The leg preferably extends orthogonally to the safety device axis. In an embodiment, two legs arranged opposite to each other are provided.

[0032] The protective cap may comprise at least one cavity open at least towards the interior of the safety device, one face of said cavity being a shoulder forming the second retaining portion.

[0033] The cavity may also form an abutment for axially retaining the legs, i.e., for preventing relative axial movement between the protective cap and the protective shield. In an embodiment in which pulling the protective cap distally away from the medical device automatically causes the protective shield to move toward its operative position, this arrangement prevents inadvertent movement of the protective shield to its operative position.

[0034] This cavity can extend through the protective cap peripheral wall.In other words, the cavity can be open to both the inside and the outside of the safety device.

[0035] The legs of the protective shield are configured to resiliently move, deflect or deform toward the interior of the safety device to disengage from the shoulders of the protective cap upon activation of the release system.

[0036] In one embodiment, the release system includes at least one trigger, which is accommodated in a window arranged in the peripheral wall of the protective cap, the trigger is hingedly connected to at least one edge of the window, and is constructed to be elastically moved, deflected or deformed toward the interior of the safety device by manual inward pressure applied to the trigger.

[0037] The trigger may have an H-shaped configuration with a central rod on which manual inward pressure can be exerted and two branches located on two parts of the central rod, each branch being adjacent to an edge of the window and hingedly connected to said edge. Preferably, the central rod extends parallel to the safety device axis, i.e. orthogonal to the legs of the protective shield. This ensures that there is contact between the central rod and the legs so that the retention system is released and involves, for this purpose, smaller dimensional restrictions regarding the relative position of the central rod and the legs.

[0038] The trigger can be made in a single piece with the protective cap. The portion of reduced thickness can form a hinge between the trigger and the edge of the window.

[0039] The cavity may further open into the window.

[0040] The window may be arranged in an inwardly recessed portion of the peripheral wall of the protective cap to avoid inadvertent pressing movements on the trigger.

[0041] The recessed portion has an inner face and an outer face, both of which may be substantially planar.

[0042] The trigger may have a protrusion that extends outwardly from the outside of the recess in a radial direction but does not exceed the cylindrical envelope surface of the protective cap. As a result, because the trigger extends outwardly from the window, access to or proximity to the trigger becomes easier, but not too easy to prevent inadvertent triggering of the release system.

[0043] Alternatively or additionally, the trigger may have an inner face that is substantially flush with the inner face of the recessed portion. Thus, when the trigger is in the first state (i.e., the state in which the protective shield is maintained in the storage position), the trigger does not extend inwardly, and only when the user wants to activate the release system, the trigger extends inwardly.

[0044] Shoulder - i.e. one face of the cavity forming the second retaining portion - can protrude inwardly from the inner face of the recessed portion. As a result, the protrusion has an activation face that can be very close to the inner face of the recessed portion, i.e., can be very close to the inner face of the trigger.

[0045] In an embodiment, the ring has a first hinge portion and the protective shield has a second hinge portion pivotally coupled to the first hinge portion, whereby movement of the protective shield from its storage position to its operative position is a pivotal movement.

[0046] The protective cap and the protective shield may have cooperating actuation surfaces configured such that distal movement of the protective cap away from the ring automatically causes movement of the protective shield from its storage position to its operative position. Where the ring and the protective shield are pivotally connected, the actuation surface may be a cam surface.

[0047] According to a second aspect, the invention relates to a security component comprising:

[0048] A medical injection device comprising a barrel, a distal tip extending distally from the barrel, and a needle installed in the distal tip, and

[0049] A safety device as previously described wherein the ring is mounted around the distal tip of the medical injection device.

[0050] Further advantages and advantageous features of the invention are disclosed in the following description. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] A possible embodiment of the invention will now be described by way of non-limiting example with reference to the accompanying drawings:

[0052] Figure 1 is a perspective view of a safety assembly according to the present invention, the safety assembly comprising a safety device mounted on a medical injection device, the safety device being in a storage position and comprising a protective cap and a protective shield;

[0053] Figure 2 is similar to Figure 1 , showing a longitudinal cross-sectional view of the safety assembly;

[0054] Figure 3 is a perspective view of the safety assembly with the protective shield removed and the protective cap in an operative position;

[0055] Figure 4 It is a three-dimensional image of the protective cap;

[0056] Figure 5 is a perspective view of the protective cap, showing a longitudinal cross-sectional view of the protective cap;

[0057] Figure 6 is a perspective view of a protective cap, showing a radial cross-sectional view of the protective cap;

[0058] Figure 7 is a perspective view of a protective shield;

[0059] Figure 8 is a partial stereoscopic view of the protective shielding member viewed from different directions;

[0060] Fig. 9 is a partial perspective view of a protective shield, showing a longitudinal cross-sectional view of the protective shield;

[0061] Fig.10 is a perspective view of the safety assembly in a storage position showing a radial cross-section of the safety assembly around a retention system and a release system;

[0062] Fig.11It is similar to the Fig.10 A partial view of

[0063] Fig.12 The safety assembly is shown in a stored position along the axis and viewed proximally, the safety device being shown in a radial cross-section about the retention system and the release system. DETAILED DESCRIPTION

[0064] The present invention relates to a safety device 1 for preventing a user (especially a health care professional) or anyone around him (such as a patient to be treated) from being pricked by the needle of a medical injection device 100 before or after injection using the needle of the medical injection device 100.

[0065] like Figure 2 As shown, the medical injection device 100 may be a syringe or the like. The medical injection device 100 comprises a barrel 101 intended to contain a medical composition to be injected into a patient, a distal tip 102 extending distally from the barrel 101 , and a needle 103 mounted in the distal tip 102 and having a needle tip 104 .

[0066] The safety device 1 is configured for attachment to a medical injection device 100 to form a safety assembly 200 .

[0067] The medical injection device 100, the safety device 1 and the safety assembly 200 define an axis 150. The terms "axial" and "longitudinal" are used with reference to the axis 150 or an axis parallel to the axis 150. Furthermore, during the injection process, with reference to the axis 150, the distal end of the component must be understood as the end farthest from the user's hand, and the proximal end must be understood as the end closest to the user's hand. In other words, the distal direction is the injection direction, and the proximal direction is the direction opposite to the injection direction.

[0068] The term "inner" is used for components that are closer to the axis 150 than components described as "outer." The term "inwardly" refers to a direction oriented toward the axis 150, although not necessarily orthogonal to the axis 150, in contrast to the term "outwardly."

[0069] The term “radial” refers to a direction or plane that is normal to the axis 150 .

[0070] The safety device 1 may include a symmetry plane P1 (see Figure 1 and 12 ).

[0071] like Figure 1 As illustrated, axis X is defined as being parallel to axis 150 , axis Z is defined as being orthogonal to axis X and included in plane P1 , and axis Y is defined as being orthogonal to both axes X and Z.

[0072] The safety device 1 comprises a ring 10 mounted around and attached to a distal tip 102. Alternatively, the ring may be made in one piece with the distal tip 102.

[0073] like Figure 2 As shown, the ring 10 has a generally cylindrical shape and has a central through hole 15 adapted to receive a distal tip 102 of a medical injection device 100. In the installed position, the distal tip 102 extends distally beyond the ring 10;

[0074] The ring 10 may also have a first hinge part 11, the function of which will be described below. The first hinge part 11 may include outwardly extending pins on each side of the plane P1. These pins together form a pivot axis 12 orthogonal to the plane P1.

[0075] The safety device 1 further comprises a protective shield 20 configured to act as a physical barrier for preventing needle stick injuries caused by the needle 103 before and after the injection process. To this end, the safety device 1 is movably coupled to the ring 10 and configured to successively adopt the following positions:

[0076] A storage position in which the protective shield 20 covers the needle tip 104 (eg, Figure 1 and Figure 2 );

[0077] An operative position in which the protective shield 20 exposes the needle tip 104 to allow an injection to be performed ( Figure 3 );

[0078] and a safe position in which the protective shield 20 covers the needle tip 104 .

[0079] In the illustrated embodiment, the movement of the protective shield 20 from its storage position to its operative position is a pivoting movement, but this should not be considered limiting.

[0080] Reference Figures 7 to 9 The protective shield 20 includes a proximal portion 21 and a distal arm 31 extending distally from the proximal portion 21 .

[0081] The proximal portion 21 has a substantially semi-cylindrical shape, with a central portion 22 and two lateral flanges 23 protruding from the central portion 22, the two lateral flanges 23 being situated on either side of the plane P1 and facing each other. Each flange 23 has a longitudinal edge 24 and a proximal edge 25. In each flange 23 a hole 26 is provided, the hole 26 being intended to receive a pin of the ring 10. The hole 26 thus forms a second hinge portion pivotally coupled to a first hinge portion provided on the ring 10, so as to allow the protective shield 20 to pivot relative to the ring 10 about the axis 12. The flanges 23 extend generally parallel to the plane P1 - although they may be slightly curved about the longitudinal axis - while in the storage position the central portion 22 extends generally orthogonal to the axis Z - although it may be slightly curved about the longitudinal axis.

[0082] The distal arm 31 has a generally U-shaped cross section comprising a central portion 32 and two side panels 33 protruding from the central portion 32, the side panels 33 being located on either side of the plane P1 and facing each other. Each side panel 33 has a longitudinal edge 34. The distal arm 31 also comprises a distal radial wall 35. The side panels 33 extend generally parallel to the plane P1 and are preferably generally flat, while the central portion 32 extends generally orthogonal to the axis Z, although it may be slightly curved around the longitudinal axis.

[0083] Along the axis Y, the distance between the two side panels 33 is smaller than the distance between the two side flanges 23. Along the axis Z, in the storage position, the distance between the central portion 32 and the longitudinal edge 34 - in other words, the height of the side panels 33 - is smaller than the distance between the central portion 22 and the longitudinal edge 24 - in other words, smaller than the height of the flanges 23. Furthermore, along the axis Z, in the storage position, the height of the distal radial wall 35 is greater than the height of the side panels 33.

[0084] Each of the side panels 33 includes a leg 40 extending away from the central portion 32. The leg 40 may be formed between two parallel slots 41 formed in the side panel 33. In the storage position, the slots 41 and therefore the leg 40 may extend along the axis Z. The leg 40 extends from its base 42, by which it is connected to the side panel 33, to its free end 43, which is preferably further away from the central portion 32 than the longitudinal edge 34 of the side panel 33. The leg 40 has an outwardly extending protrusion 45. As shown in FIG. Figure 8 As best seen in FIG. 4 , protrusion 45 has:

[0085] an end surface 46, which may be located close to the leg free end 43 or flush with the leg free end 43 and preferably forms a bevel;

[0086] an abutment face 47 opposite the end face 46 and, in the storage position, preferably oriented substantially orthogonal to the axis Z; and

[0087] An actuation face 48 forms the outer face of the protrusion 45. Along the axis Y, the actuation face 48 is preferably further from the axis 150 than the side panel 33 and closer to said axis 150 than the flange 23. The actuation face 48 may be substantially flat and parallel to the plane P1.

[0088] In the figures, the legs 40 are shown in a first state in which they are substantially parallel to the plane P1. From this first state, the legs 40 can elastically move, deflect or deform towards the interior of the security device 1 towards a second state due to the slots 41, as will be described.

[0089] The safety device 1 further comprises a protective cap 50 which is mounted on the ring 10 in the storage position so as to cover at least the needle tip 104 and which can be detached from the ring 10 before use of the medical injection device 100 .

[0090] Reference Figure 2 and Figures 4 to 6 The protective cap 50 comprises a generally tubular body in which the needle 103 is housed in the storage position. The generally tubular body has a peripheral wall 51 which is included in a generally cylindrical envelope surface.

[0091] In the proximal portion 52 of the protective cap 50, the peripheral wall 51 is recessed inwardly relative to the cylindrical envelope surface, thereby forming a semi-cylindrical housing for receiving the proximal portion 21 of the protective shield 20, so that in the storage position, the proximal portion 21 is located inside the cylindrical envelope surface.

[0092] The protective cap 50 may include two side plugs 53 extending proximally from the proximal end of the protective cap 50. The distal side 54 of the plugs 53 may be concavely curved.

[0093] Furthermore, the protective cap 50 may have a distal radial wall 55 provided with a hole 56 .

[0094] In the distal portion 57 of the protective cap 50, the protective cap 50 may have a distal radial opening 58, which may be configured to receive the distal arm 31 of the protective shield 20. To this end, preferably, the distal radial opening 58 is elongated along the axis 150, and its dimension along the axis Y is substantially the same as or slightly larger than the distance between the respective outer faces of the side panels 33 along the axis Y, so as to provide an appropriate fit gap, such as in Fig.12 Best seen in.

[0095] In the distal portion 57 of the protective cap 50, on both sides of the plane P1, the peripheral wall 51 has an inwardly recessed portion 60, which has an inner surface 61 and an outer surface 62, and the inner surface 61 and the outer surface 62 can be substantially parallel to P1, for example, as shown in FIG. Fig.12 shown.

[0096] A window 63 is arranged in the recessed portion 60, which window 63 may be substantially rectangular and elongated along the axis 150. In addition, the protective cap 50 comprises a cavity 64 open to the interior of the safety device 1. The cavity 64 may be arranged in the recessed portion 60. It may extend through the peripheral wall 51, i.e. also open to the exterior of the safety device 1. The cavity 64 may further open to the window 63. In the illustrated embodiment, in the storage position, the cavity 64 is located closer to the distal arm 31 of the protective shield 20 than the window 63. The cavity 64 may have an opposing face 65 orthogonal to the axis 150, and a face 66 orthogonal to the axis Z forming a shoulder.

[0097] The protective cap 50 includes a trigger 70 housed in the window 63. The trigger 70 may have an H-shape including a central rod 71, preferably extending parallel to the axis 150, and two branches 72 on two portions of the central rod 71. Each branch 72 may be adjacent to an edge 67 of the window 63 and hingedly connected to said edge 67. In an embodiment, the trigger 70 is made in a single piece with the protective cap 50, and the portion 73 of reduced thickness forms a hinge between the trigger 70 and the edge 67 of the window.

[0098] The trigger 70 may have a protrusion 74 that extends outwardly from the recessed portion outer surface 62 in a radial direction but does not exceed the cylindrical envelope surface of the protective cap 50. In addition, the trigger 70 may have an inner surface 75 that is substantially flush with the recessed portion inner surface 61.

[0099] The trigger 70 is configured to be elastically moved, deflected or deformed towards the interior of the safety device 1 by manual inward pressure exerted on the trigger 70. This can be produced by a hinge 73 formed by a portion of reduced thickness and connecting the trigger 70 to the tubular body of the protective cap 50.

[0100] Each of the ring 10, the protective shield 20 and the protective cap 50 is preferably made of any rigid polymer suitable for medical use, such as high-density polyethylene (PE), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), polyoxymethylene (POM), polystyrene (PS), polybutylene terephthalate (PBT), polyamide (PA) and combinations thereof.

[0101] In storage location, such as Figure 1 , Figure 2 and Figures 10 to 12 As shown, the protective cap 50 is mounted on the ring 10 so as to cover the needle 103 up to the needle tip 104 and preferably beyond the needle tip 104 in the distal direction.

[0102] The protective shield 20 is mounted on the ring 10, and the first hinge part 11 (for example a pin) engages in the corresponding hole 26, so that the protective shield 20 can be moved about the pivot axis 12 towards Figure 3 Its operative position is shown rotated. In the storage position, the distal arm 31 can extend generally parallel to the axis 150, while in the operative position, the distal arm 31 can extend generally parallel to the axis z.

[0103] The protective shield 20 also cooperates with the protective cap 50. More specifically, as previously explained, the distal arms 31 are at least partially housed in the distal radial openings 58 of the protective cap 50. Alternatively, the distal arms 31 may only radially face the distal radial openings 58 without being received in the distal radial openings 58. The distal radial walls 35 of the distal arms 31 may then be positioned adjacent to the distal radial walls 55 of the protective cap 50 inside the safety device 1 so as to close the holes 56. The proximal portion 21 of the protective shield 20 may also be arranged such that the proximal edge 25 of each side flange 23 is adjacent to the distal side 54 of the peg 53 of the protective cap 50.

[0104] As from Fig.10 , Fig.11 and Fig.12 As can be best seen, in the storage position, on each side of the plane P1, the legs 40 of the protective shield 20 extend towards the interior of the security device 1. The legs 40 are engaged in the cavity 64, and the abutment surface 47 of the protrusion 45 is in contact with or very close to the surface 66 of the cavity 64. Therefore, the abutment surface 47 forms a first retaining part of the retaining system, and the surface or shoulder 66 forms a second retaining part of the retaining system. Due to the cooperation between the first retaining part 47 and the second retaining part 66 in the storage position, the retaining system is able to prevent the protective shield 20 from moving to its operating position.

[0105] The legs 40 are further located between opposite faces 65 of the cavity 64. Providing no gap or only a small gap between the legs 40 and said faces 65 also prevents any relative axial movement between the protective cap 50 and the protective shield 20.

[0106] Furthermore, in the storage position, a portion of the leg 40 radially faces a portion of the trigger 70. More specifically, the actuation surface 48, ie, the outer surface of the protrusion 45 disposed on the leg 40, contacts or is in close proximity with the inner surface 75 of the central rod 71 of the trigger 70.

[0107] When the user wants to use the medical injection device 100, he first has to remove the protective cap 50. To do this, the user has to exert inward pressure on the trigger 70, for example on the protrusion 74 of the central rod 71, which is usually done by pressing the protective cap 50 between his thumbs. As a result, the trigger 70 is elastically moved, deflected or deformed inwardly. Due to the cooperation between the actuation surface 48 of the leg 40 and the inner face 75 of the trigger 70, the trigger 70 in turn causes the leg 40 to be elastically moved, deflected or deformed inwardly until the abutment surface 47 of the protrusion 45 of the leg 40 disengages from the shoulder 66 of the cavity 64.

[0108] In other words, the trigger 70 forms part of a release system which can be activated by means of manual inward pressure and which allows the retaining system to be released.

[0109] Thus, the release system (particularly the trigger 70) and the retaining system (particularly the shoulder 66 and the abutment surface 47) change from a first state in which the protective shield 20 is maintained in the storage position to a second state in which the protective shield 20 is free to move toward its operating position.

[0110] The user can then pull the protective cap 50 distally away from the ring 10. During this pulling motion, the distal side 54 of the peg 53 of the protective cap 50 can cooperate with the proximal edge 25 of the side flange 23 of the protective shield 20 as a camming surface to automatically rotate the protective shield 20 from its storage position to its operative position.

[0111] exist Figure 3 In the illustrated operating position, the needle 103 is no longer covered by the protective cap 50 or the protective shield 20 and an injection can be performed.

[0112] Once the injection is complete, the user can move the protective shield 20 to a safe position where it covers the needle tip 104. The safe position may be the same as the storage position. Alternatively, in the safe position, the protective shield 20 may be closer to the needle 103 than in the storage position. In any case, the safe position ensures that a needle stick injury will not occur.

[0113] Other advantages of the present invention are listed as follows:

[0114] The safety device of the present invention does not require a triggering step to expose the needle tip before use, thus allowing the speed of medical actions to be enhanced and the safety level of the medical device to be increased;

[0115] The diameter of the safety device of the present invention is no larger than the syringe barrel, and the length of the safety device of the present invention is limited. Therefore, it can be contained in standard packaging for prefilled syringes;

[0116] The safety device of the present invention allows the needle tip to be fully exposed without interfering with the medical procedure because it provides direct visualization and access to the needle tip.

[0117] It should be understood that the present invention is not limited to the embodiments described above and shown in the drawings; on the contrary, those skilled in the art will recognize that many changes and modifications are possible within the scope of the appended claims.

Claims

1. A safety device (1) for preventing needle stick injuries caused by a needle (103) extending from a distal end (102) of a medical injection device (100), the safety device comprising: a ring (10) configured for attachment to the distal tip (102) of the medical injection device (100); a protective shield (20) movably coupled to the ring (10), the protective shield (20) being configured to successively adopt a storage position, an operating position, and a safety position, wherein the protective shield (20) covers the needle tip (104), the operating position, wherein the protective shield (20) exposes the needle tip (104), and the safety position, wherein the protective shield (20) covers the needle tip (104); a protective cap (50) which is mounted on the ring (10) in a storage position so as to cover at least the needle tip (104) and which can be detached from the ring (10) before using the medical injection device (100); a retention system comprising a first retention portion (47) disposed on the protective shield (20) and a second retention portion (66) disposed on the protective cap (50), wherein the first retention portion (47) and the second retention portion (66) cooperate in the storage position to prevent the protective shield (20) from moving toward its operative position; Characterized in that the safety device further comprises a release system for releasing the retaining system, wherein the release system is configured to be activated by manual inward pressure exerted on the protective cap (50).

2. The safety device according to claim 1, wherein: The release system is arranged on the protective cap (50).

3. The safety device according to claim 1, wherein: In the storage position, the release system generally faces at least a portion of the retaining system in a radial direction.

4. The safety device according to claim 1, wherein: In the storage position, the release system is in contact with or in close proximity to at least a portion of the retention system, the release system being configured to directly release the retention system when activated.

5. The safety device according to claim 1, wherein: The protective cap (50) includes a generally tubular body having a distal radial opening (58), and the protective shield (20) has a distal arm (31), which is accommodated in the distal radial opening (58) of the protective cap (50) or radially faces the distal radial opening (58) in the storage position, wherein the first retaining portion (47) is arranged on at least one of the two longitudinal sides of the distal arm (31) of the protective shield (20), and the second retaining portion (66) is arranged on a portion of the peripheral wall (51) of the generally tubular body adjacent to the distal radial opening (58).

6. The safety device according to claim 1, wherein: The retaining system and / or the release system comprises at least one element configured to elastically move or deform from a first state, in which the protective shield (20) is maintained in the storage position, toward a second state, in which the protective shield (20) is free to move toward its operating position.

7. The safety device according to claim 1, wherein: The protective shield (20) comprises at least one leg (40) extending towards the interior of the safety device (1), the leg (40) having a protrusion (45) extending outwardly, and the protrusion having an abutment surface forming the first retaining portion (47).

8. The safety device according to claim 1, wherein: The protective cap (50) comprises at least one cavity (64) which is open at least towards the interior of the safety device (1), and one face of the cavity (64) is a shoulder forming the second retaining portion (66).

9. The safety device according to claim 7, wherein: The protective cap (50) comprises at least one cavity (64) which is open at least toward the interior of the safety device (1), one surface of the cavity (64) forming a shoulder of the second retaining portion (66), and wherein the leg (40) of the protective shield (20) is configured to elastically move or deform toward the interior of the safety device (1) when the release system is activated so as to disengage from the shoulder of the protective cap (50).

10. The safety device according to claim 8, wherein: The release system comprises at least one trigger (70), which is accommodated in a window (63) arranged in the peripheral wall (51) of the protective cap (50), the trigger (70) being hingedly connected to at least one edge (67) of the window (63) and being configured to elastically move or deform toward the interior of the safety device (1) by manual inward pressure applied to the trigger (70).

11. The safety device according to claim 10, wherein: The trigger (70) has an H-shape, with a central rod (71) and two branches (72) located on two parts of the central rod (71), on which manual inward pressure can be applied, each branch (72) being adjacent to the edge (67) of the window and hingedly connected to the edge (67).

12. The safety device according to claim 10, wherein: The trigger (70) is made in a single piece with the protective cap (50), and a portion (73) of reduced thickness forms a hinge between the trigger (70) and the edge (67) of the window.

13. A safety device according to any one of claims 10 to 12, wherein: The cavity (64) is also open to the window (63).

14. A safety device according to any one of claims 10 to 12, wherein: The window (63) is arranged in an inwardly recessed portion (60) of the peripheral wall (51) of the protective cap (50).

15. The safety device according to claim 14, wherein: The recessed portion (60) has an inner surface (61) and an outer surface (62), and the trigger (70) has: a protrusion (74) extending outwardly from the outer surface (62) of the recessed portion in a radial direction but not exceeding the cylindrical envelope surface of the protective cap (50); and / or An inner surface (75) is substantially flush with the inner surface (61) of the recessed portion.

16. A safety device according to any one of claims 1 to 12, wherein: The ring (10) has a first hinge portion (11), and the protective shield (20) has a second hinge portion (26) pivotally connected to the first hinge portion (11), so that the movement of the protective shield (20) from its storage position to its operating position is a pivotal movement.

17. A safety device according to any one of claims 1 to 12, wherein: The protective cap (50) and the protective shield (20) have cooperating actuation surfaces (54, 25) configured such that distal movement of the protective cap (50) away from the ring (10) automatically causes movement of the protective shield (20) from its storage position to its operative position.

18. A security component (200), comprising: A medical injection device (100) comprising a barrel (101), a distal tip (102) extending distally from the barrel (101), and a needle (103) installed in the distal tip (102), and A safety device (1) according to any one of claims 1 to 17, wherein the ring (10) is mounted around the distal tip (102) of the medical injection device (100).

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