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    • 专利摘要:
    SAFETY DEVICE FOR A PRE-LOADED SYRINGE AND INJECTION DEVICE. The present invention relates to a safety device (1) for a pre-filled syringe (2) comprising a hollow support body (1.2) for mounting the pre-filled syringe (2) therein; a hollow needle guard (1,1) that slides in relation to the support body (1.2); and the guide means for guiding the movement of the needle guard (1.1) in relation to the support body (1.2). The guide means comprising a flexible arm (1.1.4) with a guide pin (1.1.3), a guide strip (1.2.5) and a separation wall (1.2.6). The guide pin (1.1.3) extends from the flexible arm (1.14), in a radial direction, and protrudes into the guide strip (1.2.5). The separation wall (1.2.6) extends into the guide strip (1.2.5) in a direction parallel to a central axis (A) of the safety device (1). When the needle guard (1.1) slides in relation to the support body (1.2), the guide pin (1.1.3) moves along the guide band (1.2.5) to deflect the flexible arm (1.1.4 ) in a lateral direction (L) perpendicular to the central axis (A) and the movement of the guide pin (1.1.3) along the guide strip (1.2.5) is guided by the interaction between the flexible arm (1.1.4) and The (...).
    公开号:BR112013000038B1
    申请号:R112013000038-4
    申请日:2011-06-21
    公开日:2021-01-19
    发明作者:Gareth Roberts；Chris Ward；Matthew Ekman
    申请人:Sanofi-Aventis Deutschland Gmbh；
    IPC主号:
    专利说明:

    Technical Field
    [0001] The present invention relates to safety devices that provide needle safety and, more particularly, safety devices for pre-filled syringes. The safety device is adapted to prevent accidental needle sticks and needle wounds before, during and after an injection of a medicine or drug contained in the pre-filled syringe. In particular, the safety device provides needle safety for a self-administered subcutaneous injection, or for an injection administered by a healthcare professional. The present invention also relates to injection devices that comprise a pre-filled syringe. Background of the Invention
    [0002] Pre-filled syringes, which are loaded with a selected dose of a drug, are well-known injection devices for delivering the drug to a patient. Safety devices for covering a needle from a pre-filled syringe, before and after use, are also well known. Typically, these devices comprise a needle guard, which is moved either manually or moved by the action of a rest spring to surround the needle.
    [0003] A different type of safety device known in the prior art resolves the objective of providing needle safety by organizing a mobile pre-filled syringe in relation to a body, while the pre-filled syringe is retracted for the body after the injection. Summary of the Invention
    [0004] It is an objective of the present invention to provide an improved safety device for a pre-filled syringe.
    [0005] It is an additional object of the present invention to provide an improved injection device comprising a pre-filled syringe that is safe to handle and, in particular, that prevents accidental needle injuries.
    [0006] The objective is achieved by a safety device according to claim 1 and an injection device according to claim 17.
    [0007] Preferred embodiments of the invention are set out in the dependent claims.
    [0008] In the context of this specification, the terms distal and proximal are defined from the point of view of a person performing the injection. Therefore, a distal direction refers to a direction that points to the body of a patient receiving an injection and a distal end defines an end of an element that is directed towards the patient's body. Respectively, the proximal end of an element or the proximal direction is directed away from the body of the patient receiving the injection and opposite the distal end or the distal direction.
    [0009] According to the invention, a safety device for a pre-filled syringe comprises a hollow support body for mounting the pre-filled syringe in it, a hollow needle guard, which slides in relation to the support body and the guide means for guiding the movement of the needle guard in relation to the support body. The guide means comprises a flexible arm, a guide strip and a separating wall. A guide pin extends from the flexible arm in the radial direction and protrudes into the guide strip. The separation wall extends towards the guide strip in a direction parallel to a central axis of the safety device. When the needle guard slides in relation to the support body, the guide pin moves along the guide strip to deflect the flexible arm in a lateral direction perpendicular to the central axis and the movement of the guide pin along the guide strip is guided by the interaction between the flexible arm and the separation wall.
    [00010] The guide pin is moved in and along the guide band when the needle guard slides in relation to the support body to cover and / or expose, in particular, the hypodermic needle of a pre-filled syringe inserted in the body support device. The movement of the needle guard is controlled by the guide pin which moves between various positions within the guide band. The interaction of the flexible arm that deflects with the separation wall allows an orientation of the guide pin along the guide strip, which prevents the relative rotation of any external parts, such as the needle guard and the support body. Especially when the outer parts of the safety device touch a patient's skin, during the injection, the friction between these outer rotating parts and the patient's skin is uncomfortable and may even cause pain to the patient, particularly as a needle hypodermic of the pre-filled syringe still penetrates the skin. The safety device thus allows a safe and convenient injection of a medicine.
    [00011] The flexible arm is attached to either the needle guard or the support body. The guide strip is formed either on the needle guard or on the support body. Therefore, it is within the scope of the present invention that the safety device comprises the support body with the guide strip and the needle guard with the flexible arm or, alternatively, that the flexible arm is connected to the support body and the guide strip is formed inside the needle guard.
    [00012] The separation wall extends to an extended section of the guide strip that extends parallel to the central axis of the safety device. The separation wall provides, together with the flexible arm, an effective mechanism that guides the movement of the guide pin with the guide strip, whereby the guide pin is prevented from returning to the starting position and guided towards a position of far end. The guide pin in the final position permanently retains the needle guard in an advanced position, while the needle guard projects the support body to surround the hypodermic needle of the pre-filled syringe retained in the support body. The separation wall is a means that prevents re-exposure of the hypodermic needle after a single use of the safety device, so that accidental needle wounds, in particular with contaminated needles, are prevented.
    [00013] As soon as the guide pin passes the separation wall, the safety device is prevented from being reused. The separation wall has an axial dimension that extends parallel to the central axis, which substantially defines a minimum axial distance that the needle guard must be moved in relation to the support body in the proximal direction until the guide pin is left move to the flexible wall to prevent reuse of the safety device. If the needle guard is inadvertently pushed in the proximal direction for an axial length less than the axial dimension of the flexible wall, safety features, in particular, prevent reuse from being activated. Thus, an accidental activation of the safety features that prevent the reuse of the safety device is avoided.
    [00014] According to a possible embodiment of the invention, an audible feedback is generated when the needle guard is retracted from the support body by a distance that corresponds to or exceeds the minimum axial distance. This tells the user of the safety device to activate safety devices that prevent accidental needle injuries and reuse after a single injection has been performed.
    [00015] The separation wall prevents the guide pin from accessing the final position from a distal direction or from the proximal direction, while the guide pin is allowed to enter the final position from either the distal direction or the proximal direction. The separation wall provides a means that requires the needle guard to be retracted to expose the hypodermic needle, before the final position is accessed for the guide pin to enter.
    [00016] According to alternative modalities, the partition wall is static or flexible and can be deflected.
    [00017] According to possible embodiments of the invention, the guide strip is formed either on a surface of the support body or on a surface of the needle guard as a recess. The guide strip does not pass completely through a wall of the corresponding part on which the guide strip is formed. According to possible modalities, this corresponding part can be the protection of the needle or the support body. This ensures that there is no direct access from the outside of the safety device to the inside and therefore increases the rigidity of the safety device. In addition, the structural stability of the part that has the guide strip is increased. As the support body and needle guard are preferably formed by an injection molding process, the recess-shaped guide strip additionally eliminates a molding defect known as a "flash" along the strip guide. The "flash" occurs when the excess material exceeds the geometry of the normal part. Thus, as the guide strip is in the form of a recess, the flash is avoided and the smoothness of the guide strip is increased.
    [00018] According to an alternative modality, the guide band forms an opening for the support or the body or the needle protection. This allows the separation wall to be flexible and capable of deflecting in the lateral direction.
    [00019] According to the same modality of the invention, the deformation of the flexible separation wall depends on the deflection of the flexible arm that supports the guide pin. The dependent interaction of the flexible arm and the flexible separation wall reduces the degree of deflection required for the flexible arm to safely guide the guide pin along the guide strip. In addition, the dependent interaction reduces the amount of time the flexible arm needs to be in its state of maximum tension. Therefore, an input force exerted on the safety device to move the needle guard relative to the support body by a user is reduced.
    [00020] According to the same modality, an elasticity of the flexible partition wall is adapted to an elasticity of the flexible arm, so that the flexible partition wall can be deflected by the flexed and deflected arm. The amount of work performed to deflect the flexible arm by the user is substantially transferred to the flexible separation wall to deflect said flexible wall. Advantageously, the flexible partition wall and the flexible arm are produced from the same resilient plastic material or from different plastic materials that have substantially the same elasticity.
    [00021] The guide pin is tilted in the lateral direction by a deflected flexible arm. According to an embodiment of the invention, the inclined guide pin exerts a force in the lateral direction on the flexible partition wall to deflect the partition wall, so that the safety features of the safety device are activated. According to another embodiment of the invention, the guide pin is angled by the flexible arm to pass the separation wall in the lateral direction.
    [00022] The flexible arm in a resting position extends essentially parallel to the central axis. The safety device is stored with the flexible arm in its resting position and tensioned during the first single use of the safety device. Since the flexible arm is a tilting medium typically produced from a resilient plastic material that is prone to material fatigue, it is advantageous to avoid storing the flexible arm in a stressed state in order to prolong the life of the arm. Safety device.
    [00023] The guide strip comprises an inclined section oriented at an angle to the central axis. When the guide pin moves along the inclined section of the guide strip, the flexible arm is deflected and thus tensioned. The design of the guide strip thus allows the flexible arm to be energized when using the safety device to prevent material fatigue. Needle safety is thus reliably provided even after periods of storage.
    [00024] The needle guard is held in an initial position by the guide pin which is being held in the initial position within the inclined section of the guide band. The needle guard, in the initial position, projects the support body in a distal direction.
    [00025] According to a possible modality, the needle protection is produced from an opaque plastic material. The hypodermic needle is hidden from the patient's view before injection by protecting the needle that is kept in the starting position. This alleviates a possible fear of the patient's needles. The safety device is therefore particularly suitable for performing self-administered injections.
    [00026] According to an alternative modality, the needle protection is produced from a transparent plastic material. A doctor using the safety device can thus visually confirm the correct positioning of the hypodermic needle that penetrates the patient's skin, even when the hypodermic needle is surrounded by the needle guard.
    [00027] Since the safety device is suitable both for self-administered injections and for injections performed by a healthcare professional, the person referred to as the user or the patient can be the same person.
    [00028] A compression spring is arranged in a non-energized state when the needle guard is in the home position. As the safety device is stored and transported with the needle guard held in the initial position, fatigue of the compression spring material is avoided. The service life of the safety device is thus extended. In addition, the requirements for the compression spring material are low, so that the safety device can be mass-produced cost-effectively.
    [00029] The needle guard is movable from the initial position to the retracted position, and also to the advanced position. The needle guard projects the support body in the home position. Needle protection in the retracted position is substantially received in the support body.
    [00030] Alternatively, the substantially cylindrical needle guard comprises a radial diameter that is dimensioned to substantially receive the support body in the retracted position. In this alternative mode, the support body slides into the needle guard when the needle guard is moved from the forward position to the retracted position.
    [00031] In the advanced position, the needle guard extends from the support body in the distal direction. The movement of the guide pin inside and along the guide strip controls the extension and retraction of the needle guard allowing for a safe injection.
    [00032] An injection device consists of a pre-filled syringe retained in the support body of the safety device. The pre-filled syringe comprises a hypodermic needle attached to a distal end of the pre-filled syringe, a cylinder with an internal cavity in fluid communication with the hypodermic needle and a plunger that hermetically seals the proximal end of the internal cavity. The piston is movable by activating a piston rod that projects a proximal end of the cylinder. The pre-filled syringe is retained inside the support body of the safety device, so that the hypodermic needle protrudes from the distal end of the support body. The hypodermic needle of the injection device is surrounded by the needle guard in the initial position and in the forward position and the hypodermic needle is exposed when the needle guard is in the retracted position. The injection device comprising the pre-filled syringe and the safety device combines the aforementioned advantages and prevents inadvertent needle sticks before, during and after an injection that releases the medicine under the patient's skin.
    [00033] The details of the present invention are described below. However, it should be understood that the detailed description and specific examples indicate the possible modalities of the invention and are presented by way of illustration only. Various changes and modifications of the modalities illustrated within the spirit and scope of the present invention are observed by those skilled in the art Brief Description of Drawings
    [00034] The present invention will be better understood from the detailed description given below. The attached drawings are given for illustrative purposes only and do not limit the scope of the present invention.
    [00035] Figure 1 shows a perspective view of an injection device according to a first embodiment of the invention before use, which comprises a safety device for a pre-filled syringe.
    [00036] Figure 2 shows a cross-sectional view of the injection device according to the first embodiment of the invention, with the safety device comprising a needle guard held in an initial position.
    [00037] Figure 3 shows a sectional view of the injection device according to the first embodiment of the invention, with the safety device with the needle guard kept in a retracted position.
    [00038] Figure 4 shows a perspective view of a support body and a needle guard from a safety device, while the needle guard is kept in a stowed position.
    [00039] Figure 5 shows a sectional view of the injection device according to the first embodiment of the invention, after an injection has been performed.
    [00040] Figures 6A to 6F show the details of a guide strip and the movement of a guide pin inside the guide strip when using the safety device according to the first embodiment of the invention.
    [00041] Figure 7 shows a perspective view of the injection device according to a second embodiment of the invention before use, which comprises a safety device for a pre-filled syringe.
    [00042] Figure 8 shows a perspective view of a support body according to the second embodiment, which is cut open in parallel to a central axis for illustrative purposes.
    [00043] Figures 9A to 9E show the details of a guide strip and the movement of a guide pin inside the guide strip when using the safety device according to the second embodiment of the invention.
    [00044] The corresponding parts are marked with the same reference numbers in all figures. Detailed description of possible modalities
    [00045] Figure 1 shows an injection device D with a safety device 2 for a pre-filled syringe 2 according to a first embodiment of the invention, as would be presented to a user to perform an injection. The safety device 1 comprises a substantially cylindrical and hollow needle guard 1.1. Needle guard 1.1 is received within a substantially cylindrical and hollow support body 1.2, while needle guard 1.1 can slide in relation to support body 1.2. Before using the safety device 1, the needle guard 1.1 is retained in an initial position I, where the needle guard 1.1 projects the support body 1.2.
    [00046] Alternatively, the needle guard 1.1 comprises a radial diameter that is dimensioned to receive substantially the support body 1.2. In this alternative mode, the support body 1.2 slides on the needle guard 1.1 when the needle guard 1.1 is moved from the initial position I to the retracted position II.
    [00047] Figure 1 shows the safety device 1 which comprises an essentially cylindrical and hollow external body 1.3 with an open distal end and a closed proximal end. The proximal end of the support body 1.2 is received inside the open distal end of the external body 1.3, while the external body 1.3 can slide relative to the support body 1.2 in a distal direction to substantially receive the support body 1.2 in. of the external body 1.3.
    [00048] A hand flange that protrudes circumferentially and outwards 1.3.1 is integrally formed with an external surface of the external body 1.3 close to its distal end.
    [00049] Preferably, the needle guard 1.1, the support body 1.2 and the outer body 1.3 are produced from a plastic material.
    [00050] Needle protection 1.1 includes a contact surface with circumferential skin 1.1.1 at its distal end. The skin contact surface 1.1.1 is adapted to be pressed against a patient's skin and protrudes outwards radially and perpendicular to a central axis A of the safety device 1. The edges of the contact surface with 1.1.1 skin that comes into contact with the patient's skin is rounded to prevent injury. The skin contact surface 1.1.1 has a central opening centered on the central axis A of the safety device 1. The skin contact surface 1.1.1 is integral to the protection of needle 1.1 or, alternatively, a separate part linked to the needle guard 1.1 which is produced from a plastic material.
    [00051] Two first longitudinal tabs diametrically opposed 1.1.2 are formed for the outer surface on opposite sides of the needle guard 1.1. Each first longitudinal tab 1.1.2 protrudes radially and outwards and extends along an axial length parallel to a central axis A of the needle guard 1.1. As best seen in figure 2, the first longitudinal tongue 1.1.2 is received in a corresponding first longitudinal groove 1.2.1 formed on an internal surface of the support body 1.2. The relative rotation of the support body 1.2 and the needle guard 1.1 is prevented by the first longitudinal groove 1.2.1 which receives the first longitudinal tongue 1.1.2 of the needle guard 1.1.
    [00052] Correspondingly, the support body 1.2 comprises at least one second longitudinal tongue 1.2.2 which is received in a second longitudinal groove (not shown) formed on an internal surface of the external body 1.3, by means of which a rotation of external body 1.3 and support body 1.2 is prevented.
    [00053] The two longitudinal recesses 1.3.2 are formed on the opposite sides of the external body 1.3 which extend over a substantial axial length of the external body 1.3 and parallel to the central axis A. The longitudinal recess 1.3.2 comprises two sections, a first section 1.3.2.1 and a second section 1.3.2.2 separated from each other by a 1.3.3 screen.
    [00054] Each longitudinal recess 1.3.2 receives a corresponding external projection 1.2.3 that is an integral part of the support body 1.2. The external projection 1.2.3 moves inside the longitudinal recess 1.3.2 when the external body 1.3 is slid in relation to the support body 1.2 to execute the injection stroke, while the rotation of the external body 1.3 in relation to the support body 1.2 is prevented.
    [00055] Before injection, the external projection 1.2.3 is retained in the first section 1.3.2.1 of the longitudinal recess 1.3.2. The external projection 1.2.3 can be deflected in an internal radial direction, so that the external projection 1.2.3 leaves the first section 1.3.2.1 and enters the second section 1.3.2.2 when the external body 1.3 is pushed in relation to the body support 1.2 in the distal direction. The shape and elasticity of the external projection 1.2.3 and the first section 1.3.2.1 of the longitudinal recess 1.3.2 are adjusted so that a force necessary for the external projection 1.2.3 leaves the first section 1.3.2.1 exceeds a force necessary for move needle guard 1.1 from initial position I to retracted position II. This ensures a staged movement of the needle guard 1.1, the support body 1.2 and the outer body 1.3, during injection, as described in more detail here below.
    [00056] The longitudinal recess 1.3.2 shown in figure 1 is shaped like a groove. Alternatively, the longitudinal recess 1.3.2 is formed within an inner surface of the outer body 1.3 so that the outer projection 1.2.3 moves along the longitudinal recess 1.3.2 within the outer body and 1.3 is inaccessible from the side external.
    [00057] A clamping arm 1.3.4 is formed on the outer body substantially cylindrical 1.3 that deflects in the radial direction perpendicular to the central axis A. As best seen in figure 5, the clamping arm 1.3.4 comprises a 1.3.4.1 protruding inward lock that is sized to fit within a locking recess 1.2.4 formed in the support body 1.2 in proximity to a proximal end of the support body 1.2.
    [00058] A 1.1.3 guide pin is integrally formed with a flexible arm 1.1.4 of the protection 1.1. The flexible arm 1.1.4 extends in its resting position, essentially parallel to the central axis A of the safety device 1. As shown in figure 1, the guide pin 1.1.3 protrudes radially outwards in a guide strip 1.2 .5 formed into the substantially cylindrical support body 1.2 as an opening. A trapezoid cut 1.1.5 is formed inside the needle guard 1.1 adjacent to the flexible arm 1.1.4 to allow deflection and rotational movement of the flexible arm 1.1.4. Prior to the use of safety device 1, the guide pin 1.1.3 is retained within an inclined section 1.2.5.1 of the guide strip 1.2.5 in an initial position PI located at the distal end of the guide strip 1.2.5. As the flexible arm 1.1.4 is in the resting position, the guide pin 1.1.3 is laterally not tilted in the initial position PI. The inclined section 1.2.5.1 is oriented at an acute angle to the cylindrical axis A of the safety device 1.
    [00059] Needle guard 1.1 is retained in an initial position I by the guide pin 1.1.3 which is retained in a starting position PI in the inclined section 1.2.5.1 of the guide band 1.2.5. The needle shield 1.1 is produced from an opaque plastic material, so that the hypodermic needle 2.1 is hidden from the patient's view prior to administration.
    [00060] Alternatively, needle protection 1.1 is produced from a transparent plastic material, so that a healthcare professional who performs the injection can visually confirm the correct positioning of the hypodermic needle 2.1 before penetrating the skin of the patient.
    [00061] The guide pin 1.1.3 is prevented from leaving the initial position PI through an interaction of several components of the safety device 1: the flexible arm 1.1.4 tilts the guide pin 1.1.3 in the lateral direction L, the guide pin 1.1. 3 is in contiguity with the distal end of the inclined section 1.2.5.1 in the lateral direction L and in the distal direction and a compression spring 1.4, as best seen in figure 2 is arranged between the support body 1.2 and the needle guard 1.1 , so that the needle guard 1.1 and the guide pin 1.1.3 connected to it are tilted in the distal direction.
    [00062] The guide strip 1.2.5 comprises an enlarged section 1.2.5.2 that extends parallel to the central axis A of the safety device 1. The separation wall 1.2.6 extends parallel to the central axis A and to the expanded section 1.2.5.2 from a distal direction. The separation wall 1.2.6 is an integral part of the support body 1.2 and acts as a non-return feature that prevents the guide pin 1.1.3 from returning to its initial position PI after an injection stroke has been carried out. In addition, the separation wall 1.2.6 guides the movement of the guide pin 1.1.3 in the guide strip 1.2.5, so that the guide pin 1.1.3 is prevented from entering a final position PIII from the distal direction, but allowed to enter from the proximal direction. The final position PIII is defined by a U-shaped indentation between a proximal and distal end of the guide strip 1.2.5.
    [00063] According to the first embodiment of the invention shown in figures 1 to 6F, the separation wall 1.2.6 is flexible and can deflect in the lateral direction L.
    [00064] The injection device D comprises the safety device 1 with the pre-filled syringe 2 retained inside the support body 1.2. Figure 2 shows the pre-filled syringe 2 received inside the support body 1.2, which comprises a hypodermic needle 2.1 covered by a needle cap 2.2 fixed in a friction way to a distal end of a cylinder 2.3. Cylinder 2.3 has an internal cavity 2.3.1 that contains medication. The internal cavity 2.3.1 is in fluid communication with the hypodermic needle 2.1. The proximal end of the internal cavity 2.3.1 is hermetically sealed by a plunger 2.4, which is connected to a plunger rod 2.5. The piston 2.4 is movable at least in the distal direction by the actuation of the piston rod 2.5 projects the cylinder 2.3 in the proximal direction. The cylinder 2.3 of the pre-filled syringe 2 comprises a cylinder collar 2.3.2 which is contiguous with an internal surface that protrudes into the support body 1.2 at its proximal end which secures the pre-filled syringe 2 to the body of support 1.2.
    [00065] With cross reference to figure 4, it can be seen that the support body 1.2 comprises clips 1.2.7 that engage the cylinder ring 2.3.2 to retain the pre-filled syringe 2 inside the support body 1.2.
    [00066] The pre-filled syringe 2 is kept inside the support body 1.2, by means of which the hypodermic needle 2.1 projects the support body 1.2 in the distal direction.
    [00067] In the packaged state, as shown in figures 1 and 2, the hypodermic needle 2.1 is covered by a needle cap 2.2 which is surrounded by the needle guard 1.1 before use of the injection device D. The needle cap 2.2 is preferably at least partially produced from a plastic material, such as rubber. The width of the central opening of the skin contact surface 1.1.1 corresponds to an outer diameter of the needle cap 2.2. A needle cover remover 3 is inserted into the central opening of the skin contact surface 1.1.1 and projects the skin contact surface 1.1.1 in a distal direction, so that the user can easily remove the cover from the skin. needle 2.2 of the pre-filled syringe 2 by pulling the needle cap remover 3 in the distal direction. The needle cap remover 3 comprises the fixing means 3.1 which are attached to a distal end of the needle cap 2.2.
    [00068] Alternatively, the injection device D comprising the safety device 1 with the pre-filled syringe 2 retained in it is sent and delivered to an end user, with a needle remover cap 3 attached to the distal end of the needle cap 2.2 retained inside the safety device 1, so that the needle cap remover 3 projects the needle guard 1.1 in the distal direction.
    [00069] The proximal end of the plunger rod 2.5 is in contiguity with the closed distal end of the external body 1.3, so that the plunger 2.4 is movable in a distal direction by distal displacement of the external body 1.3 in relation to the support body 1.2.
    [00070] Alternatively, the piston rod 2.5 is connected to the external body 1.3 or to an integral part of the external body 1.3. This alternative mode has the additional advantage of a low overall part count, so that production costs are reduced.
    [00071] The needle guard 1.1 is in the initial position, I turn the hypodermic needle 2.1 of the pre-filled syringe 2. The compression spring 1.4 is disposed inside the safety device 1 in a state partially tilted distally against a inner surface of the needle guard 1.1 and proximally against an inner surface of the support body 1.2, thus tilting these two parts 1.1, 1.2 away from each other. The needle guard 1.1 is retained in the initial position I by the guide pin 1.1.3 which is against the support body 1.2 in the initial position PI.
    [00072] Figure 3 shows a sectional view of needle guard 1.1 in the retracted position II, where needle guard 1.1 is substantially received within the support body 1.2. The hypodermic needle 2.1 projects distally the skin contact surface 1.1.1 of the needle shield 1.1. The compression spring 1.4, which is arranged inside the safety device 1, is completely compressed and thus fully energized.
    [00073] Figure 4 shows a perspective view of the needle guard 1.1 in a retracted position II, where the needle guard 1.1 is substantially received within the support body 1.2. The guide pin 1.1.3, which is an integral part of the needle protection 1.1, is in an intermediate position PII within the guide band 1.2.5 and in the proximity of a proximal end of the same. The PII position corresponding to the retracted position II of the needle guard 1.1.
    [00074] The support body 1.2 also comprises two clips 1.2.7 disposed diametrically opposed to each other. Clips 1.2.7 are located near the proximal end of the support body 1.2 and attached to the collar 2.3.2 of the pre-filled syringe 2 to secure the pre-filled syringe 2 to the support body 1.2, so that the second pre-loaded 2 is firmly retained inside the support body 1.2.
    [00075] Figure 5 shows a sectional view of the injection device D according to the first embodiment of the invention after injection of the drug. The sectional view shown in figure 5 is rotated in relation to the sectional views shown in figures 2 and 3 by about a 90 degree angle around the central axis A. Needle guard 1.1 is in an advanced position III that it projects distally from the support body 1.2, while the hypodermic needle 2.1 is surrounded by the needle guard 1.1 to prevent accidental needle injuries. The needle guard 1.1 is fixed to the advanced position III by the guide pin 1.1.3 which is retained in the final position PIII.
    [00076] The plunger 2.4 is completely attached inside the cylinder 2.3 of the pre-filled syringe 2. The support body 1.2 is received inside the external body 1.3 and locked to it, so that the reuse of the safety device 1 is prevented. The inwardly protruding locking insert 1.3.4.1 formed in the locking arm 1.3.4 attaches to the corresponding locking recess 1.2.4 formed in the support body 1.2 to irreversibly lock the support body 1.2 in relation to the body external 1.3.
    [00077] Figures 6A to 6F show the details of the guide strip 1.2.5 formed inside the support body 1.2 and the movement of the guide pin 1.1.3 in the guide strip 1.2.5 when using the safety device 1 according to the first modality. Figures 6A to 6F illustrate the dependent interaction of the flexible arm 1.1.4 with the flexible and deflectable partition wall 1.2.6.
    [00078] As shown in figure 6A, the guide pin 1.1.3 is retained prior to injection in the starting position PI at the distal end of the inclined section 1.2.5.1 of the guide band 1.2.5, securing the needle guard 1.1 in the starting position I. In initial position I, the hypodermic needle 2.1 is surrounded by the protection of needle 1.1.
    [00079] The injection is performed by orienting the central axis A essentially perpendicular to the patient's skin, while the skin contact surface 1.1.1 of the needle guard 1.1 rests on the patient's skin surface and the proximal section of the external body 1.3 proximal to the hand flange 1.3.1 is gripped by the user performing the injection. The hand flange 1.3.1 supports the user's hand to perform an injection course, in which the external body 1.3 is moved distally towards the surface of the patient's skin to initiate the injection.
    [00080] The injection is performed in stages. In a first step, the needle guard 1.1 is pushed into the support body 1.2 in the proximal direction against the pressure force of the compression spring 1.4. As shown in figure 6B, the guide pin 1.1.3 leaves its PI starting position and moves along the inclined section 1.2.5.1 of the guide strip 1.2.5. As the distal end section 1.2.5.1 is oriented at an acute angle to the central axis A, the movement of the guide pin 1.1.3 causes the flexible arm 1.1.4 to be deflected sideways and tensioned so that the guide pin 1.1.3 is tilted in a lateral direction.
    [00081] The guide pin 1.1.3 still moves along the guide strip 1.2.5 in the proximal direction. As shown in figure 6C, the guide pin 1.1.3 enters the extended section 1.2.5.2 of the guide strip 1.2.5 and is in contiguity with the flexible separation wall 1.2.6 in the lateral direction. The flexible partition wall 1.2.6 is deflected sideways by a force exerted on the flexible partition wall 1.2.6 by the tensioned flexible arm 1.1.4. The elasticity of the flexible partition wall 1.2.6 is adapted to match the elasticity of the flexible arm 1.1.4, so that the flexible partition wall 1.2.6 can be deflected by the flexed and deflected flexible arm 1.1.4.
    [00082] The separation wall 1.2.6 prevents the guide pin 1.1.3 from entering the final position PIII as the guide pin 1.1.3 enters the extended section 1.2.5.2 from the distal direction.
    [00083] The guide pin 1.1.3 moves further proximally to an intermediate position PII and reaches a proximal end of the flexible separation wall 1.2.6, as shown in figure 6D. At this point, the safety features of the safety device 1 are activated, as the flexible partition wall 1.2.6 relaxes and fits in its resting position substantially parallel to the central axis A. From now on, the final position PIII is accessible for the guide pin 1.1.3 to enter, while the guide pin 1.1.3 is prevented from re-entering the PI initial position. Removing the safety device 1 causes the needle guard 1.1 and the guide pin 1.1.3 to move distally so that the needle guard 1.1 surrounds the hypodermic needle 2.1 of the pre-filled syringe 2 in one position advanced III.
    [00084] The separation wall 1.2.6 has an axial dimension that extends parallel to the central axis A and to the extended section 1.2.5.2 of the guide strip 1.2.5. The axial dimension defines a minimum axial distance that the needle guard 1.1 must be moved in relation to the support body 1.2 before the advanced position III is accessed for the needle guard 1.1 to enter and the safety features that prevent reuse of the device security 1 are activated. This avoids involuntary activation of the safety features of the safety device 1, when the needle guard 1.1 is accidentally pushed distally by an axial length that is less than the minimum axial distance.
    [00085] Safety device 1 generates an audible feedback that indicates the activation of safety features. The audible feedback can be generated by the flexible separation wall 1.2.6 which returns to its resting position substantially parallel to the central axis A, when the needle guard 1.1 is moved distally in relation to the support body 1.2 by an axial length that exceeds the minimum axial distance.
    [00086] Before the medication is expelled through the hypodermic needle 2.1, the needle guard 1.1 is moved further in the proximal direction until it reaches the retracted position III shown in figure 3, in which the guide pin 1.1.3 is retained inside the guide strip 1.2.5 in the intermediate position PII. Compression spring 1.4 is fully compressed and fully loaded. The hypodermic needle 2.1 penetrates the patient's skin, so that the medicine contained within cavity 2.3.1 can be injected in the second step following the injection.
    [00087] Throughout the first injection stage, the external projection 1.2.3 is retained in the first section 1.3.2.1 of the longitudinal recess 1.3.2, in which a distal movement of the external body 1.3 with respect to the support body 1.2 is prevented . When the guide pin 1.1.3 reaches the intermediate position PII and the needle guard 1.1 enters the corresponding retracted position II, the external projection 1.2.3 deflects in the internal radial direction, leaves the first section 1.3.2.1 and enters the second section 1.3 .2.2 of the longitudinal recess 1.3.2, so that the external body 1.3 can move in relation to the support body 1.2 in the second injection stage.
    [00088] In the second stage, the external body 1.3 moves in relation to the support body 1.1 in the distal direction. At the same time, the plunger rod 2.5 that interacts with the external body 1.3 is actuated to move the plunger 2.4 in the distal direction, whereby the medicine contained in the internal cavity 2.3.1 is released through the hypodermic needle 2.1 and under the patient's skin.
    [00089] At the end of the injection stroke, the locking insert that protrudes inwards 1.3.4.1 formed for the locking arm 1.3.4 is attached to the corresponding locking recess 1.2.4 formed in the support body 1.2 to lock in irreversibly the support body 1.2 in relation to the external body 1.3.
    [00090] The injection device D comprising the safety device 1 with the pre-filled syringe 2 received there is removed from the skin surface. Needle guard 1.1 immediately moves distally to the advanced position PIII by the action of the relaxing compression spring 1.4. As shown in figure 6E, the guide pin 1.1.3 moves together with the needle guard 1.1 distally, so the guide pin 1.1.3 is guided by the separation wall 1.2.6 to the final position PIII.
    [00091] As indicated in figure 6F, the guide pin 1.1.3 enters the U-shaped recess that defines the final position PIII of the guide strip 1.2.5, through which the flexible arm 1.1.4 relaxes to move the pin guide 1.1.3 towards the side to the final position PIII.
    [00092] The guide pin 1.1.3 is firmly retained in the final position PIII, as the guide pin 1.1.3 is in contiguity with the U-shaped recess in the distal and lateral direction. The flexible arm 1.1.4 is in the resting position, so that the guide pin 1.1.3 is laterally not tilted in the final position PIII. A lateral movement of the guide pin 1.1.3 is prevented by the shape of the U-shaped recess of the guide strip 1.2.5 in the end position PIII and by the flexible arm 1.1.4. Thus, the guide pin 1.1.3 in the end position PIII irreversibly locks the needle guard 1.1 in the advanced position III, after a single use of the safety device 1.
    [00093] In an embodiment of the invention, the hypodermic needle 2.1 is hidden from view of the patient during the injection.
    [00094] Figure 7 shows a perspective view of the injection device D according to a second embodiment. The safety device 1 of the injection device D comprises a hollow support body 1.2 with two substantially flat sides 1.2.8 which are disposed opposite one another. A guide strip 1.2.5 is formed within an outer surface of each of the two substantially flat sides 1.2.8. The guide strip 1.2.5 according to the second modality is in the form of a recess and does not pass completely through the flat side 1.2.8.
    [00095] The needle guard 1.1 has an opening at a proximal end that includes a contour that corresponds to a cross section of the support body 1.2 with the two substantially flat sides 1.2.8. The needle guard 1.1 is dimensioned to receive substantially the support body 1.2. The support body 1.2 slides into the needle guard 1.1 when the needle guard 1.1 is moved from the initial position I to the retracted position II.
    [00096] The flexible arm 1.1.4 is arranged inside the hollow needle guard 1.1 in a way that the flexible arm 1.1.4 is inaccessible from the outside. The distal end of the flexible arm 1.1.4 is connected to a distal end of the needle guard 1.1. The flexible arm 1.1.4 extends in its non-tilted position, essentially parallel to the central axis A. The guide pin 1.1.3 protrudes from the proximal end of the flexible arm 1.1.4 in a radial inward and outward direction. the guide strip 1.2.5. The flexible arm 1.1.4 is connected to the needle guard 1.1 in a way that allows a substantially flat movement of the guide pin 1.1.3 when the flexible arm 1.1.4 is deflected during the use of the injection device D. During the injection, the guide pin 1.1.3 moves in and along the guide strip 1.2.5 formed to the substantially flat side 1.2.8 of the support body 1.2.
    [00097] The proximal end of the support body 1.2 is received inside the open distal end of the external body 1.3, while the external body 1.3 slides relative to the support body 1.2 in a distal direction to receive substantially the body of su - size 1.2 inside the external body 1.3. The outer body 1.3 has a shape that corresponds to the shape of the support body 1.2 and comprises two substantially flat outer sides 1.3.5 opposite the two substantially flat sides 1.2.8 of the support body 1.2.
    [00098] The circumferential hand flange projecting outward 1.3.1 is integrally formed with an external surface of the external body 1.3 near its distal end.
    [00099] The skin contact surface 1.1.1 of the needle guard 1.1 is adapted to be pressed against a patient's skin. The skin contact surface 1.1.1 provides, in addition to the central opening of a size that corresponds to an outer diameter of the needle cap 2.2 of the pre-filled syringe 2 retained within the safety device 1, a closure of the distal end of the substantially flat needle protection 1.1.
    [000100] Two longitudinal tongues opposite diametrically 1.2.2 are formed on the outer surface of each flat side 1.2.8. The longitudinal tabs 1.2.2 are located adjacent to each guide strip 1.2.5 and extend along an axial length of the support body 1.2 and parallel to the central axis A. Each second longitudinal tab 1.2.2 is received in a groove of corresponding shape (not shown) formed on the inner surface of the needle guard 1.1 when the needle guard 1.1 is moved in relation to the support body 1.2 from the initial position to the retracted position II. This prevents blocking of the support body 1.2 and the needle guard 1.1 when these parts 1.2, 1.1 are moved relative to each other.
    [000101] In addition, the longitudinal tongues 1.2.2 also act at a secondary depth stop to prevent the outer body 1.3 from moving away in the distal direction.
    [000102] The separation wall 1.2.6 is formed for the outer surface of the flat side 1.2.8 of the support body 1.2. The separation wall 1.2.6 extends to the extended section 1.2.5.2 of the guide strip 1.2.5 and parallel to the central axis A.
    [000103] The separation wall 1.2.6 according to the second embodiment shown in figure 7, is not susceptible to deflection and remains static during the use of the injection device D.
    [000104] Figure 8 shows a perspective view of the support body 1.2 according to the second embodiment, which is cut openly in parallel from the central axis A for illustrative purposes. The guide strip 1.2.5 is in the form of a recess, so that an interior of the support body 1.2 is inaccessible from the outside. The projection outwards 1.2.3 is received in the longitudinal lock recess 1.3.2 formed on an internal surface of the external body 1.3.
    [000105] Figures 9A to 9E show the details of the guide strip 1.2.5 formed into the support body 1.2 and the movement of the guide pin 1.1.3 in the guide strip 1.2.5 according to the second mode, during the injection . Figures 9A to 9E illustrate the movement of the guide pin 1.1.3 in the guide strip 1.2.5 according to the second modality, in which the separation wall 1.2.6 remains static during the injection.
    [000106] As shown in figure 9A, the guide pin 1.1.3 is retained prior to injection in the starting position PI at the distal end of the inclined section 1.2.5.1 of the guide strip 1.2.5, securing the needle guard 1.1 to the position initial I. In initial position I, the hypodermic needle 2.1 is surrounded by the needle guard 1.1.
    [000107] The injection is performed by orienting the central axis A essentially perpendicular to the patient's skin, while the skin contact surface 1.1.1 of the needle guard 1.1 rests on the patient's skin surface, and the section proximal to the external body 1.3 proximal to the hand flange 1.3.1 is gripped by the user performing the injection. The hand flange 1.3.1 supports the user's hand to perform an injection course, in which the external body 1.3 is moved distally towards the surface of the patient's skin to initiate the injection.
    [000108] The injection is performed in stages. In a first step, the support body 1.2 is pushed into the needle guard 1.1 in the distal direction against the pressure force of the compression spring 1.4. As shown in figure 9B, the guide pin 1.1.3 leaves its PI starting position and moves along the inclined section 1.2.5.1 of the guide strip 1.2.5. As the inclined section of the distal end 1.2.5.1 is oriented at an acute angle to the central axis A, the movement of the guide pin 1.1.3 causes the flexible arm 1.1.4 to be deflected and tensioned sideways, so that the guide pin 1.1.3 is tilted in a lateral direction.
    [000109] The guide pin 1.1.3 is in contiguity with the separation wall 1.2.6 in the lateral direction. The separation wall 1.2.6 remains static and guides the guide pin 1.1.3 further in the proximal direction.
    [000110] The separation wall 1.2.6 prevents the guide pin 1.1.3 from entering the final position PIII as the guide pin enters the extended section 1.1.3 1.2.5.2 from the initial position PI.
    [000111] The guide pin 1.1.3 moves even more proximally to an intermediate position PII and reaches the proximal end of the separation wall 1.2.6, as shown in figure 9C. The inclined guide pin 1.1.3 passes the separation wall 1.2.6 in the lateral direction L, as shown in figure 9D, through which the flexible arm is deflected and energized 1.1.4 at least partially relaxes.
    [000112] At that time, the safety features of the safety device 1 which, in particular, prevent the reuse of the injection device D are activated, as the final position PIII is accessible for the guide pin 1.1.3 to enter, while the guide pin 1.1. 3 is prevented from entering the PI starting position again.
    [000113] Before the medication is expelled through the hypodermic needle 2.1.1.1, the needle guard is moved further in the proximal direction until it reaches the retracted position III shown in figure 3, where the guide pin 1.1.3 is retained inside of the guide strip 1.2.5 in the intermediate position PII. Compression spring 1.4 is fully compressed and fully loaded. The hypodermic needle 2.1 penetrates the patient's skin, so that the medicine contained in the internal cavity 2.3.1 can be injected in the second following injection stage.
    [000114] In the second stage, the external body 1.3 moves in relation to the support body 1.2 in the distal direction. At the same time, the plunger rod 2.5 that interacts with the external body 1.3 is actuated to move the plunger 2.4 in the distal direction, in which the medicine contained in the internal cavity 2.3.1 is released through the hypodermic needle 2.1 and under the patient's skin.
    [000115] Subsequent removal of the safety device 1 causes the needle guard 1.1 and the guide pin 1.1.3 to advance distally, so that the needle guard 1.1 surrounds the hypodermic needle 2.1 of the pre-filled syringe in an advanced position III. Figure 9E shows the needle protection 1.1 firmly retained in the forward position III by the guide pin 1.1.3 being retained in the U-shaped recess of the guide strip 1.2.5 that defines the end position PIII, in which the reuse of the injection and / or safety device 1 is prevented.
    [000116] The safety device 1 presented here provides a simple mechanism to prevent injury from needles. The injection is carried out by a simple linear movement of the external body 1.3 towards the patient's skin, through which the safety features, which provide the protection of the needle and prevent the reuse of the safety device 1, are automatically activated . Reference List 1 safety device 1.1 needle protection 1.1.1 skin contact surface 1.1.2 first longitudinal tongue 1.1.3 guide pin 1.1.4 flexible arm 1.1.5 trapezoid cut 1.2 support body 1.2.1 first groove longitudinal 1.2.2 second longitudinal tongue 1.2.3 external projection 1.2.4 locking recess 1.2.5 guide strip 1.2.5.1 inclined section 1.2.5.2 enlarged section 1.2.6 separation wall 1.2.7 clips 1.2.8 planar side 1.3 body external 1.3.1 hand flange 1.3.2 longitudinal recess 1.3.2.1 first section 1.3.2.2 second section 1.3.3 net 1.3.4 clamping arm 1.3.4.1 locking insert 1.3.5 flat outer sides 1.4 compression spring 2 syringe preloaded 2.1 hypodermic needle 2.2 needle cover 2.3 cylinder 2.3.1 inner cavity 2.3.2 cylinder collar 2.4 plunger 2.5 plunger rod 3 cap remover 3.1 fitting means A central axis D injection device L side direction I starting position II retracted position III forward position PI starting position PII intermediate position PIII final position
    权利要求:
    Claims (18)
    [0001]
    1. Safety device (1) for a pre-filled syringe (2), comprising: - a hollow support body (1.2) for mounting the pre-filled syringe (2) inside; - a hollow needle guard (1.1), which can slide in relation to the support body (1.2); and - the guide means for guiding the movement of the needle guard (1.1) in relation to the support body (1.2), wherein the guide means comprise: - a flexible arm (1.1.4) with a guide pin (1.1 .3) extending from the flexible arm (1.1.4), in a radial direction; - a guide strip (1.2.5), in which the guide pin (1.1.3) protrudes into the guide strip (1.2.5); and - a separation wall (1.2.6) that extends into the guide strip (1.2.5) in a direction parallel to a central axis (A) of the safety device (1) and in which, when the protection of the needle (1.1) slides in relation to the support body (1.2), the guide pin (1.1.3) moves along the guide strip (1.2.5) and the movement of the guide pin (1.1.3) along the strip guide (1.2.5) is guided by the interaction between the flexible arm (1.1.4) and the separation wall (1.2.6), characterized by the fact that when the needle guard (1.1) slides in relation to the support body ( 1.2), the guide pin (1.1.3) moves along the guide strip (1.2.5) to deflect the flexible arm (1.1.4) in a lateral direction (L) perpendicular to the central axis (A) and that the safety device (1) comprises the means (1.2.1, 1.2.2) to prevent the relative rotation between the support body (1.2) and the needle guard (1.1).
    [0002]
    2. Safety device (1) according to claim 1, characterized by the fact that the flexible arm (1.1.4) is connected to either the needle guard (1.1) or the support body (1.2), and the guide strip (1.2.5) is formed on the other, either the needle guard (1.1) or the support body (1.2).
    [0003]
    3. Safety device (1) according to claim 1 or 2, characterized by the fact that the separation wall (1.2.6) extends to an enlarged section (1.2.5.2) of the guide strip (1.2.5 ) which extends parallel to the central axis (A) of the safety device (1).
    [0004]
    4. Safety device (1) according to any one of the preceding claims, characterized by the fact that the separation wall (1.2.6) has an axial dimension that extends parallel to the central axis (A) which substantially defines a minimum axial distance that the needle guard (1.1) must be moved in relation to the support body (1.2) until the safety device (1) is prevented from being reused.
    [0005]
    5. Safety device (1) according to any one of the preceding claims, characterized by the fact that an audible return is generated when the needle guard (1.1) is retracted from the support body (1.2) by a distance that matches or exceeds the minimum axial distance.
    [0006]
    6. Safety device (1) according to any one of the preceding claims, characterized by the fact that the separation wall (1.2.6) prevents the guide pin (1.1.3) from reaching a final position (PIII) within the guide strip (1.2.5) from either the distal direction or the proximal direction, while the guide pin (1.1.3) is allowed to enter the final position (PIII) from another in the distal direction or direction proximal.
    [0007]
    7. Safety device (1) according to any one of the preceding claims, characterized by the fact that the guide strip (1.2.5) is formed within a surface of the support body (1.2) or on a surface of the protection of the needle (1.1) as a recess.
    [0008]
    Safety device (1) according to any one of claims 1 to 6, characterized by the fact that the guide strip (1.2.5) forms an opening either in the needle guard (1.1) or in the support body ( 1.2).
    [0009]
    9. Safety device (1) according to claim 8, characterized by the fact that the separation wall (1.2.6) is flexible and the guide pin (1.1.3) moves along the guide strip (1.2 .5) to deflect the partition wall (1.2.6), whereby the deflection of the flexible partition wall (1.2.6) depends on the deflection of the flexible arm (1.1.4).
    [0010]
    10. Safety device (1) according to claim 8 or 9, characterized in that an elasticity of the separation wall (1.2.6) is adapted to an elasticity of the flexible arm (1.1.4), so that the partition wall (1.2.6) can be deflected by the deflected flexible arm (1.1.4).
    [0011]
    11. Safety device (1) according to any one of the preceding claims, characterized by the fact that the guide pin (1.1.3) is tilted in the lateral direction (L) by the deflected flexible arm (1.1.4).
    [0012]
    12. Safety device (1) according to any one of the preceding claims, characterized by the fact that the flexible arm (1.1.4) in a resting position extends essentially parallel to the central axis (A).
    [0013]
    13. Safety device (1) according to any one of the preceding claims, characterized by the fact that the guide strip (1.2.5) comprises an inclined section (1.2.5.1) oriented at an angle to the central axis ( THE).
    [0014]
    14. Safety device (1) according to any one of the preceding claims, characterized by the fact that the needle guard (1.1) is maintained in the initial position (I) by the guide pin (1.1.3) which is retained in a starting position (PI) within the inclined section (1.2.5.1) of the guide strip (1.2.5), while the needle guard (1.1) in the initial position (I) projects the support body (1.2) into a distal direction.
    [0015]
    15. Safety device (1) according to claim 10, characterized by the fact that the safety device (1) comprises a compression spring (1.4) arranged in a non-energized state when the needle guard (1.1) is in the starting position (I).
    [0016]
    16. Safety device (1) according to any one of the preceding claims, characterized by the fact that the needle guard (1.1) is movable from the initial position (I) to a retracted position (II) and also to an advanced position (III), while the needle guard (1.1) projects the support body (1.2) in the initial position (I) and in the advanced position (III).
    [0017]
    17. Safety device (1) according to any one of the preceding claims, characterized in that the means for preventing the relative rotation between the support body (1.2) and the needle guard (1.1) comprise a first longitudinal (1.2.1) and a first longitudinal tongue (1.1.2).
    [0018]
    18. Injection device (D) comprising a safety device (1), as defined in any of the preceding claims, and a pre-filled syringe (2), with a hypodermic needle (2.1) attached to a distal end of the pre-filled syringe (2), in which the safety device (1) comprises: - a hollow support body (1.2) for mounting the pre-filled syringe (2) inside; - a hollow needle guard (1.1) that can slide in relation to the support body (1.2); and - the guide means for guiding the movement of the needle guard (1.1) in relation to the support body (1.2), wherein the guide means comprise: - a flexible arm (1.1.4) with a guide pin (1.1 .3) extending from the flexible arm (1.14), in a radial direction; - a guide strip (1.2.5), in which the guide pin (1.1.3) protrudes into the guide strip (1.2.5); and - a separation wall (1.2.6) extending into the guide strip (1.2.5) in a direction parallel to a central axis (A) of the safety device (1), characterized by the fact that, when the needle guard (1.1) slides in relation to the support body (1.2), the guide pin (1.1.3) moves along the guide band (1.2.5) to deflect the flexible arm (1.1.4) by one lateral direction (L) perpendicular to the central axis (A) and the movement of the guide pin (1.1.3) along the guide strip (1.2.5) is guided by the interaction between the flexible arm (1.1.4) and the wall of separation (1.2.6), and where the pre-filled syringe (2) is retained inside the support body (1.2) of the safety device (1) so that the hypodermic needle (2.1) protrudes at the distal end of the support body (1.2), while the hypodermic needle (2.1) is surrounded by the needle guard (1.1) in the initial position (I) and in the forward position (III) and exposed in the retracted position (II).
    类似技术:
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    BR112013000038B1|2021-01-19|safety device for a pre-filled syringe and injection device
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    US9586011B2|2017-03-07|Safety device for a pre-filled syringe and injection device
    JP5832532B2|2015-12-16|Injection device with needle shield
    JP5938403B2|2016-06-22|Safety devices for drug-filled syringes and injection devices
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    MX2012015039A|2013-02-15|Safety device for a pre-filled syringe and injection device.
    同族专利:
    公开号 | 公开日
    JP5938402B2|2016-06-22|
    RU2013104397A|2014-08-10|
    PL2588168T3|2015-08-31|
    MX2013000061A|2013-02-15|
    SG186317A1|2013-01-30|
    CA2803628A1|2012-01-05|
    ES2538371T3|2015-06-19|
    EP2588168A1|2013-05-08|
    TWI598123B|2017-09-11|
    ZA201208884B|2013-09-25|
    RU2569702C2|2015-11-27|
    AR082053A1|2012-11-07|
    US20130324923A1|2013-12-05|
    TW201210649A|2012-03-16|
    US9352099B2|2016-05-31|
    NZ604077A|2014-07-25|
    KR101840625B1|2018-03-21|
    AU2011273724B2|2015-01-15|
    BR112013000038A2|2020-08-25|
    WO2012000835A1|2012-01-05|
    DK2588168T3|2015-06-08|
    EP2588168B1|2015-03-04|
    KR20130041153A|2013-04-24|
    CN103079612B|2015-09-16|
    HUE025529T2|2016-04-28|
    JP2013529988A|2013-07-25|
    CN103079612A|2013-05-01|
    AU2011273724A1|2013-01-10|
    HK1184731A1|2014-01-30|
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    法律状态:
    2020-09-08| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2020-09-15| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-12-08| B09A| Decision: intention to grant|
    2021-01-19| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 21/06/2011, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    EP10168317.5|2010-07-02|
    EP10168317|2010-07-02|
    PCT/EP2011/060319|WO2012000835A1|2010-07-02|2011-06-21|Safety device for a pre-filled syringe and injection device|
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