Autoinjector for automatically injecting product into injection site

Abstract

The autoinjector (1) comprises:-a housing receiving a medical container having a needle at its distal end; a needle cover (200) axially movable inside the housing between a storage position, in which the needle cover shields the needle, a retracted position, in which the needle is exposed, and a safety position, in which the needle is shielded again; -a retainer resiliently deformable between a rest position, in which the retainer retains the plunger rod in the initial position, and a deformed position, in which the retainer allows the plunger rod to move distally to urge a stop arranged inside the barrel; -a blocking member (400) rotatable inside the housing about an axis (A1) between a blocking position, in which the blocking member holds the holder in the rest position, and a release position, in which the blocking member permits deformation of the holder, the rotation of the blocking member being caused by the movement of the needle cover from the storage position to the retracted position. The blocking member comprises a locking device (450) configured to lock the needle cover (200) in the safe position.

Description

Technical Field

[0001] The present invention relates to an automatic injector.

[0002] In this application, the distal end of a component or device should be understood to refer to the end farthest from the user's hand, and the proximal end should be understood to refer to the end closest to the user's hand. Similarly, in this application, the term "distal direction" or "distally" should be understood to refer to a direction away from the user's hand, and the term "proximal direction" or "proximally" should be understood to refer to a direction toward the user's hand. Background Art

[0003] An autoinjector or autoinjector device is designed to automatically inject a medical product into an injection site. An autoinjector typically includes a housing for receiving a medical container. The medical container has a barrel defining a reservoir for containing the medical product, the barrel having a distal end provided with an injection needle and an open proximal end.

[0004] The autoinjector also includes a safety shield that can be moved between an extended position and a retracted position to respectively shield or expose the needle, and an injection mechanism for automatically injecting the medical product into the injection site. The injection mechanism typically includes a plunger rod and an initial compression spring, wherein the plunger rod is received in the proximal end of the opening of the barrel and is used to push the stopper inside the barrel of the medical container, and the initial compression spring is used to move the plunger distally. A locking device is provided to maintain the plunger rod in an initial position, in which the plunger rod is still axially blocked despite the action of the compression spring. A release member is typically arranged to release the plunger from the locking device and allow the spring to push the plunger rod distally to perform the injection. A predetermined displacement of the safety shield toward the retracted position is required to allow the release member to unlock the locking device and release the plunger rod.

[0005] Once the injection is complete, the autoinjector is removed from the injection site and the safety shield automatically moves back to the extended position where the needle is shielded.

[0006] It is of utmost importance that the needle is shielded and remains shielded after the injection in order to prevent injuries caused by the needle and contamination of the medical product.

[0007] There is therefore a need for an autoinjector provided with a mechanism for shielding the needle which is reliable while not being overly complex (which would imply additional weight and cost). Summary of the Invention

[0008] To this end, according to one aspect, the present invention relates to an autoinjector for automatically injecting a product into an injection site, said autoinjector comprising:

[0009] a housing having an axis defining a longitudinal direction, the housing being configured to receive a medical container comprising a barrel defining a reservoir for containing a medical product, the barrel having a distal end provided with a needle and an open proximal end, the open proximal end being configured to receive a plunger rod for pushing a stopper arranged inside the barrel;

[0010] an inner sleeve arranged axially inside the housing and fixed to the housing;

[0011] a needle cover coupled to the housing, the needle cover being rotationally fixed relative to the housing and axially movable within the housing between a storage position in which the needle cover projects beyond the distal end of the housing to shield the needle, a retracted position in which the needle cover is moved proximally relative to the housing from the storage position to at least partially expose the needle, and a safety position in which the needle cover is moved distally back relative to the housing from the retracted position and projects beyond the distal end of the housing to shield the needle;

[0012] - guide means fixedly arranged on the housing in order to guide the axial movement of the needle cover relative to the housing;

[0013] - first biasing means for biasing said needle cover distally;

[0014] a plunger rod movable axially inside the housing between an initial position and an end-of-injection position distal to the initial position, the plunger rod being configured to push the stopper to expel the medical product;

[0015] - second biasing means for biasing said plunger rod distally;

[0016] a retainer for retaining the plunger rod in the initial position against the action of the second biasing means, the retainer being arranged at a distal portion of the inner sleeve and being elastically deformable between a rest position in which the retainer abuts axially against the plunger rod to block the plunger rod in the initial position and a deformed position in which the retainer is radially deflected to allow the plunger rod to move distally;

[0017] - a blocking member arranged inside the housing, the blocking member being axially fixed relative to the housing and being rotatable relative to the housing about the axis between a blocking position and a release position, in which the blocking member prevents deformation of the retainer and thus retains the retainer in the rest position, and a release position in which the blocking member allows deformation of the retainer, the rotation of the blocking member from the blocking position to the release position being caused by the movement of the needle cover from the storage position to the retracted position, the blocking member comprising a locking device configured to lock the needle cover in the safety position.

[0018] The blocking member thus has the function of activating the injection mechanism by allowing the holder to deform and thus the plunger rod to be pushed distally, and has the function of locking the needle cover in the safety position.

[0019] Having a single piece (i.e., the blocking member) perform both functions allows the number of parts comprising the autoinjector to be reduced, which reduces complexity and saves material. Furthermore, thanks to the present invention, the autoinjector can have a smaller overall volume, which is particularly advantageous when using smaller medical containers (with smaller barrel capacities and / or shorter needles), for which conventional larger autoinjectors designed for larger medical containers are unnecessary. Furthermore, having fewer parts means fewer sizing and positioning adjustments between parts, which facilitates the manufacturing process and improves reliability.

[0020] In practice, the blocking member and the locking means are preferably formed as a single piece, for example by injection moulding of a plastic material.

[0021] The blocking member not only has the function of blocking the plunger rod in the storage position, but also has the function of blocking the needle cover in the safety position.

[0022] In the storage position and the safety position (which may be the same position), the needle cover is extended. In the retracted position, which is located proximally relative to the storage position, the needle cover allows injection: the retracted position is thus determined so that the needle can be inserted into the user's body at an appropriate depth for injection. Subsequently, the needle cover moves to the safety position, which is located distally relative to the retracted position.

[0023] In one embodiment, arranging the retainer at the distal portion of the inner sleeve requires that the blocking member also be arranged near the distal portion of the inner sleeve, since the blocking member is intended to cooperate with the retainer. Furthermore, in order for the axial movement of the needle cover to cause the blocking member to rotate, a part intended to cooperate with the blocking member is provided on the needle cover. Therefore, the needle cover needs to extend proximally to the blocking member. With the present invention, since the blocking member is located at a relatively distal position inside the housing (this is because the retainer is arranged at the distal portion of the inner sleeve), the needle cover length can be reduced relative to the prior art automatic injectors, in which the retainer is arranged at a more proximal position relative to the housing.

[0024] The present invention can therefore provide a shorter autoinjector, which is advantageous in terms of storage and transport, and further reduces the amount of material required to manufacture the autoinjector.

[0025] Furthermore, the autoinjector according to the invention is particularly compact and robust due to at least one of the following features:

[0026] - the retainer is arranged on the inner sleeve, the inner sleeve being a piece fixed to the housing;

[0027] - the needle cover can be moved axially inside the housing, but is rotationally fixed relative to the housing, so it is less constrained;

[0028] - the blocking member can rotate relative to the housing, but is axially fixed relative to the housing, so it is less constrained;

[0029] The inner sleeve may be made as a single piece with the housing or may be part of the housing; alternatively, the inner sleeve may initially be a separate part that is subsequently secured to the housing. Regardless of the embodiment, the inner sleeve is rotationally and slidably secured relative to the housing about and along the longitudinal direction.

[0030] The plunger rod may be arranged inside the inner sleeve and may be axially movable relative to the inner sleeve.The retainer may then be deflected outwardly from its rest position to its deformed position.

[0031] In one embodiment, the only movement of the needle cover is the above-mentioned axial movement and the only movement of the blocking member is the above-mentioned rotational movement.

[0032] In one embodiment, for operation of the autoinjector, no part of the autoinjector, other than the needle cover and the blocking member, moves relative to the body. This does not exclude the provision of parts that do not move but deform, such as the retainer and the locking device.

[0033] The retainers may be in the form of longitudinally extending legs.

[0034] The retainer may be provided with a retaining feature, such as a protuberance, configured to cooperate with the plunger rod.The retaining feature may be located at a distal end of the retainer.

[0035] The locking means may comprise a first stop, preferably extending substantially orthogonally to the axis, for cooperating with the needle cover in the safety position so as to prevent axial movement of the needle cover in the proximal direction.

[0036] In one embodiment, the blocking member comprises a body, and the locking device comprises a tab having a base fixed to the body and a free distal end, the tab protruding obliquely from the body in the distal direction towards the needle cover (i.e., for example, protruding outwards), the tab being elastically deflectable towards the body by movement of the needle cover from the retracted position to the safety position, the distal end of the tab forming the first stop. The body and the tab are preferably made in a single piece.

[0037] The locking means may comprise a second stop, preferably extending in a plane substantially parallel to the axis, for cooperating with the needle cover in the safety position so as to prevent the blocking member from rotating back towards the blocking position.

[0038] In one embodiment, the second stop comprises a wall extending generally axially and protruding towards the needle cover (ie, for example, protruding outwardly).The second stop may be offset relative to the first stop in a circumferential direction.

[0039] The blocking member may include a cam surface that projects toward the needle cover and is inclined relative to the axis, the cam surface being configured to cooperate with the needle cover so that movement of the needle cover from the storage position to the retracted position causes the blocking member to rotate from the blocking position to the released position.

[0040] According to one embodiment, the needle cover comprises an operating portion for cooperating with the first stop, and / or the second stop, and / or the cam surface. Thus, when the needle cover is moved from the storage position to the retracted position, the operating portion may cause the blocking member to rotate, and / or when the needle cover is moved from the retracted position to the safety position, the operating portion may cause the tab forming part of the locking device to deflect. The operating portion may comprise at least one pin protruding towards the blocking member (i.e., for example, protruding inwardly).

[0041] The retainer may include a leg provided with a protuberance, the protuberance being oriented toward the plunger rod and capable of engaging a hole or recess in the plunger rod. The leg may be resiliently deflected radially away from the plunger rod. The leg may extend axially. The leg may extend distally from a proximal wall of the housing. The leg may be part of an internal sleeve of the housing, the sleeve projecting distally from a transverse wall enclosing the proximal end of the housing.

[0042] The blocking member may have an axial groove configured to receive the retainer when the retainer is in the deformed position.The axial groove may be circumferentially offset relative to a blocking surface of the blocking member, the blocking surface retaining the retainer in the rest position.

[0043] The automatic injector may comprise an axial retaining element for blocking the blocking member in the axial direction. According to one embodiment of the axial retaining element, an abutment may be provided inside the housing, preferably in a plane substantially orthogonal to the axis, so as to prevent the blocking member from moving proximally, and the friction of the peripheral wall of the blocking member against the wall of an adjacent component may provide an additional retaining force. According to another embodiment of the axial retaining element, the blocking member may be clipped onto the housing or onto another component axially fixed to the housing, which provides both proximal and distal blocking functions. In this embodiment, a hook may be provided on the blocking member.

[0044] The barrier member may have a plane of symmetry containing the axis of the autoinjector.

[0045] The blocking member may comprise two groups symmetrical with respect to a plane containing the axis of the autoinjector, each group comprising a cam surface, a first stop (e.g. in the form of an elastically deformable tab) and a second stop. For example, the blocking member has a plane of symmetry containing the axis of the autoinjector.

[0046] The blocking member may have a generally cylindrical shape. The blocking member may include a generally cylindrical body. In one embodiment, the blocking member is disposed externally to the plunger rod and the retainer and internally to the needle cover. The blocking member may be located proximal to a support surface of the autoinjector, on which a proximal flange of the medical container barrel may be supported.

[0047] The needle cover may comprise guide means configured to cooperate with guide means fixedly arranged on the housing, thereby guiding axial movement of the needle cover relative to the housing and preferably limiting or even preventing radial or tangential movement of the needle cover relative to the housing.

[0048] The guiding means may also be arranged on the blocking member for cooperating with the needle cover guiding means.

[0049] For example, the needle cover has a distal portion including a shield portion, the shield portion being generally cylindrical, and at least one arm extending proximally from the shield portion. The needle cover preferably includes two diametrically opposed arms. The operating portion may be located near the proximal end of the or each arm.

[0050] The housing may include a channel extending axially and receiving the needle cover arm, with at least a portion of a side end of the arm abutting an inner surface of the channel. "Abutting" means in contact or in close proximity with a possible functional gap for allowing relative sliding movement parallel to the axis.

[0051] Preferably, at least a portion of the side ends of the arms abut two generally orthogonal internal faces of the channel so as to prevent movement in two orthogonal directions.

[0052] In one embodiment, a first portion of the side end of the arm contacts one interior surface of the channel, and a second portion of the side end of the arm contacts another interior surface of the channel at a different axial position than the first portion. By using different features or combinations of features, guidance can be achieved at different locations along the length of the arm. For example, at one axial position, a guide is provided to prevent tangential movement, at another axial position, a guide is provided to prevent inward radial movement, and at yet another axial position, a guide is provided to prevent outward radial movement.

[0053] The needle cover arm may have a main wall and may include at least one guide rail extending axially and projecting outwardly from the main wall. The guide rail is configured to abut the inner peripheral wall of the housing. This embodiment can prevent the needle cover from moving outwardly. Additionally or in a variation, the guide rail may be configured to abut at least one rib projecting inwardly from the housing and extending axially. This embodiment can prevent tangential movement of the needle cover. The same guide rail may abut both the inner peripheral wall of the housing and the rib, or, alternatively, different guide rails may be provided for these two functions.

[0054] The needle cover arm may include a tab having a base fixed to a main wall of the needle cover arm and a free distal end, the tab projecting obliquely from the main wall in a distal direction toward the housing, the tab being resiliently deflectable toward the axis to permit installation of the needle cover in the housing. Furthermore, in the storage position and the safety position, the distal end of the tab may be configured to abut at least one rib projecting inwardly from the housing and extending axially therefrom to prevent distal movement of the needle cover relative to the housing. The rib may be the same rib as the rib that cooperates with the needle cover guide, or may be a different rib.

[0055] When the guide rail abuts the inner peripheral wall of the housing, the main wall is recessed radially inwardly relative to the inner peripheral wall of the housing. Thus, a volume is formed between the main wall of the needle cover arm and the inner peripheral wall of the housing. The tab can be located in the volume.

[0056] In the stored position, a portion of the side end of the arm may abut a face of the blocking member, the face extending in a plane generally parallel to the axis. This helps to retain the needle cover arm in position when the needle cover is in the stored position by preventing unintentional tangential displacement. This ensures that continued movement of the autoinjector components occurs properly to enable proper operation of the autoinjector.

[0057] In one embodiment, the blocking member comprises a body comprising:

[0058] a central hole in which the inner sleeve is received, the central hole having an inner face which is, for example, substantially cylindrical;

[0059] - at least one axial groove opening into said central hole;

[0060] wherein, in the blocking position, the blocking member is positioned such that the retainer radially faces the inner face of the central hole, and in the releasing position, the blocking member is positioned such that the retainer radially faces the axial slot.

[0061] The axial groove may be configured to allow the retainer to begin to deform when the needle cover has moved axially along a predetermined length, and is preferably configured to control the speed at which the retainer deforms towards its deformed position. These effects are achieved, in particular, due to the circumferential position and / or shape of the axial groove.

[0062] As soon as the retainer begins to deform, the injection begins almost immediately. Allowing the retainer to begin deforming, when the needle cover has moved axially along a predetermined length, is equivalent to setting the starting point of the injection relative to the puncture depth. Starting the injection before the needle reaches its final puncture depth may be advantageous to ensure that when the user removes the autoinjector from the injection site, all of the medical product will be expelled from the medical container and injected into the injection site.

[0063] For example, in one embodiment, the retainer may be permitted to deform after the blocking member has been rotated through an angle of 22°, which corresponds to an axial movement of the needle cover of approximately 5 mm.

[0064] Controlling the speed of deformation of the retainer towards its deformed position allows controlling the operation of the plunger rod during the period between the moment the retainer starts to release and the moment the plunger rod is free to move distally to actually perform an injection.

[0065] It may be preferred that this time period is relatively short, but not too short, as this may result in a shock to the user. Additionally, some constraints (such as assembly considerations of the automatic injector) may limit the speed that can be achieved.

[0066] For example, the longitudinal edge between the inner face and the axial groove is the last contact portion between the retainer and the inner face before the retainer is deformed after the blocking member is allowed to rotate, and is called an activation edge.

[0067] In one embodiment, the axial groove includes a control surface extending from the activation edge toward the interior space of the axial groove (i.e., away from the interior surface) and away from the housing axis, the control surface being inclined at an angle between 25° and 50°, preferably between 35° and 45°, relative to a radial line segment of the housing passing through the activation edge. The angle is observed in a plane orthogonal to the housing axis.

[0068] Such an angle needs to be high enough to provide a control surface with a sufficiently steep slope to cause rapid deformation of the retainer and thus rapid release of the plunger rod, which means rapid actual initiation of the injection. However, an angle that is too high may result in excessively abrupt movement, which may cause shock and impair the proper functioning of the autoinjector. Furthermore, an angle that is too high may make it difficult or even impossible to assemble the various parts of the autoinjector correctly.

[0069] According to a second aspect, the present invention relates to a medical device comprising an automatic injector as described above and a medical container, the medical container comprising a barrel defining a reservoir for containing a medical product, the barrel having a distal end provided with a needle and an open proximal end, the open proximal end being configured to receive a plunger rod for pushing a stopper arranged inside the barrel, the medical container being received in the housing of the automatic injector.

[0070] According to a third aspect, the present invention relates to an autoinjector for automatically injecting a product into an injection site, the autoinjector comprising:

[0071] a housing having an axis defining a longitudinal direction, the housing being configured to receive a medical container comprising a barrel defining a reservoir for containing a medical product, the barrel having a distal end provided with a needle and an open proximal end, the open proximal end being configured to receive a plunger rod for pushing a stopper arranged inside the barrel;

[0072] a needle cover coupled to the housing and movable axially within the housing between a storage position in which the needle cover projects beyond the distal end of the housing to shield the needle, a retracted position in which the needle cover is moved proximally relative to the housing from the storage position to at least partially expose the needle, and a safety position in which the needle cover is moved distally back relative to the housing from the retracted position and projects beyond the distal end of the housing to shield the needle;

[0073] - first biasing means for biasing said needle cover distally;

[0074] a plunger rod movable axially inside the housing between an initial position and an end-of-injection position distal to the initial position, the plunger rod being configured to push the stopper to expel the medical product;

[0075] - second biasing means for biasing said plunger rod distally;

[0076] a retainer for retaining the plunger rod in the initial position against the action of the second biasing means, the retainer being configured to be in an engaged state, in which the retainer retains the plunger rod in the initial position, and a non-engaged state, in which the retainer allows the plunger rod to move distally;

[0077] a blocking member arranged inside the housing and movable inside the housing between a blocking position, in which the blocking member holds the retainer in the engaged position, and a release position, in which the retainer is free to move towards its non-engaged state, the movement of the blocking member from the blocking position to the release position being caused by the movement of the needle cover from the storage position to the retracted position;

[0078] wherein the needle cover comprises a shielding portion and an inner portion at a distal end thereof, the shielding portion being configured to shield the needle in the storage position and the safety position, the inner portion extending proximally from the shielding portion within the housing, the inner portion having a main wall and a stopper protruding outwardly from the main wall, wherein, in the storage position and the safety position, the stopper is configured to abut at least one rib protruding inwardly from the housing and extending axially so as to prevent the needle cover from moving distally relative to the housing from the storage position or the safety position.

[0079] Such an arrangement allows the needle cover to be effectively retained relative to the case during drop testing of the autoinjector and thus ensures the robustness and proper functioning of the autoinjector.

[0080] Furthermore, having the needle cover abut directly against the housing without intermediate parts makes the design of the autoinjector simpler and saves material. The direct contact between the needle cover and the housing also means fewer dimensional and positioning adjustments between parts, which facilitates the manufacturing process and improves reliability.

[0081] In one embodiment, the inner portion of the needle cover comprises a tab having a base fixed to the main wall and a free distal end, the tab protruding obliquely from the main wall in the distal direction towards the housing, the tab being elastically deflectable towards the axis to allow the needle cover to be mounted in the housing, the distal end of the tab forming the stop.

[0082] The inner portion of the needle cover may further comprise at least one guide rail extending axially and projecting outwardly from the main wall, the guide rail being configured to abut an inner peripheral wall of the housing.

[0083] Due to the presence of the guide track, the tab can be housed in a region formed between the main wall of the inner portion of the needle cover and the inner peripheral wall of the housing.

[0084] The shielding portion may be generally cylindrical.The inner portion may comprise at least one arm, preferably two diametrically opposed arms.

[0085] The inner portion of the needle cover may allow the needle cover to be guided for axial movement to limit or prevent radial or tangential movement of the needle cover relative to the housing.

[0086] The inner part may further comprise an operating portion for cooperating with the blocking member to cause movement of the blocking member and / or to lock the needle cover in the safety position.

[0087] The automatic injector may also have one of the aforementioned features, which may be used alone or in combination. In particular, the retainer may be elastically deformable between an engaged state (also referred to as a rest position) and a non-engaged state (also referred to as a deformed position), wherein in the engaged state, the retainer axially abuts the plunger rod for blocking the plunger rod in the initial position, and in the non-engaged state, the retainer radially deflects to allow the plunger rod to move distally. The blocking member may be rotatable about the axis between a blocking position and a release position; if the retainer is deformable as described above, when in the blocking position, the blocking member may prevent the retainer from deforming and thereby retain the retainer in the rest position. In addition, the blocking member may include a locking device configured to lock the needle cover in the safety position.

[0088] According to a fourth aspect, the present invention relates to an autoinjector for automatically injecting a product into an injection site, the autoinjector comprising:

[0089] a housing having an axis defining a longitudinal direction, the housing being configured to receive a medical container comprising a barrel defining a reservoir for containing a medical product, the barrel having a distal end provided with a needle and an open proximal end, the open proximal end being configured to receive a plunger rod for pushing a stopper arranged inside the barrel;

[0090] a needle cover coupled to the housing and movable axially within the housing between a storage position in which the needle cover projects beyond the distal end of the housing to shield the needle, a retracted position in which the needle cover is moved proximally relative to the housing from the storage position to at least partially expose the needle, and a safety position in which the needle cover is moved distally back relative to the housing from the retracted position and projects beyond the distal end of the housing to shield the needle;

[0091] - first biasing means for biasing said needle cover distally;

[0092] a plunger rod movable axially inside the housing between an initial position and an end-of-injection position distal to the initial position, the plunger rod being configured to push the stopper to expel the medical product;

[0093] - second biasing means for biasing said plunger rod distally;

[0094] a retainer for retaining the plunger rod in the initial position against the action of the second biasing means, the retainer being configured to be elastically deformable between a rest position in which the retainer abuts axially against the plunger rod to block the plunger rod in the initial position and a deformed position in which the retainer is radially deflected to allow distal movement of the plunger rod;

[0095] a blocking member arranged inside the housing, the blocking member being rotatable about the axis between a blocking position, in which the blocking member prevents deformation of the holder and thus holds the holder in the rest position, and a release position, in which the blocking member allows deformation of the holder, the rotation of the blocking member from the blocking position to the release position being caused by the movement of the needle cover from the storage position to the retracted position, the blocking member comprising a locking device configured to lock the needle cover in the safety position,

[0096] wherein the blocking member comprises a body including a central bore having an inner face and at least one axial slot opening into the central bore, and wherein, in the blocking position, the blocking member is positioned such that the retainer radially faces the inner face of the central bore, and wherein, in the releasing position, the blocking member is positioned such that the retainer radially faces the axial slot.

[0097] In one embodiment, the axial slot is configured to allow the retainer to begin deforming once the needle cover has moved axially along a predetermined length, and preferably is configured to control the speed of deformation of the retainer towards its deformed position.

[0098] In one embodiment, the axial groove includes a control surface, which extends from the activation edge toward the interior space of the axial groove (i.e., away from the interior surface) and away from the axis of the shell, and the control surface is inclined at a certain angle relative to a radial line segment of the shell passing through the activation edge, and the angle is between 25° and 50°, preferably between 35° and 45°.

[0099] The automatic injector may further include an inner sleeve axially arranged inside the housing and fixed to the housing, the inner sleeve being received in the central hole of the blocking member.The retainer may be arranged at a distal portion of the inner sleeve.

[0100] The autoinjector may also have one of the aforementioned features, which may be used alone or in combination. BRIEF DESCRIPTION OF THE DRAWINGS

[0101] Possible embodiments of the invention will now be described by way of non-limiting example with reference to the accompanying drawings:

[0102] Figure 1 shows a medical device comprising an autoinjector in a storage position according to an embodiment of the present invention,

[0103] Figure 2 A medical container is shown ready to be received into an auto-injector,

[0104] Figure 3 This is an exploded view of the automatic injector.

[0105] Figure 4 is a perspective view from the side of the top housing of the housing belonging to the automatic injector,

[0106] Figure 5 for Figure 4 A perspective view of the top housing viewed from the distal end,

[0107] Figure 6 is a perspective view from the side of the bottom housing of the housing of the automatic injector,

[0108] Figure 7 for Figure 6 A perspective view of the bottom housing viewed from the distal end,

[0109] Figure 8 for Figure 6A partial perspective view of the bottom shell viewed from the proximal end,

[0110] Figure 9 A perspective view of the top plunger rod of an automatic syringe.

[0111] Figure 10 A perspective view of a needle cover of an automatic syringe as viewed from the side,

[0112] Figure 11 for Figure 10 A perspective view of the needle cover as viewed from the distal end,

[0113] Figure 12 is a perspective view of a blocking member of an automatic injector as viewed from the side,

[0114] Figure 13 for Figure 12 a perspective view of the blocking member as viewed from the proximal end,

[0115] Figure 14 for Figure 12 A detailed cross-sectional view of the barrier member,

[0116] Figure 15 and 16 A perspective view of the cap of an automatic syringe,

[0117] Figure 17 and 18 is a longitudinal section through two mutually orthogonal planes of the autoinjector in the storage position,

[0118] Figure 19 is a bottom view of the autoinjector in the storage position,

[0119] Figure 20 is a partial perspective view of an automatic injector in a storage position,

[0120] Figure 21 、 22 , 23 and 24 are respectively the automatic injector in the storage position, Figure 1 Transverse cross-sectional view of lines AA, BB, CC and DD,

[0121] Figure 25 is a partial perspective view from the distal end of the autoinjector in the storage position,

[0122] Figure 26 is a transverse cross-sectional view of the autoinjector in the storage position, wherein the blocking member is in the blocking position,

[0123] Figure 27 and 28is a partial longitudinal sectional view of an automatic injector showing the steps of its use starting from the storage position,

[0124] Figure 29 is a partial side view of the automatic injector showing movement of the blocking member from the blocking position to the release position,

[0125] Figure 30 is when the blocking member is in its released position Figure 26 A similar diagram,

[0126] Figure 31 Before injection Figure 17 Similar view with the needle cover in the retracted position,

[0127] Figure 32 After the injection is completed Figure 31 Similar views,

[0128] Figure 33 is a partial side view of the autoinjector showing the blocking member in the released position and the movement of the needle cover from the retracted position to the safety position,

[0129] Figure 34 For Figure 18 Similar view with the needle cover in the safety position,

[0130] Figure 35 is a partial perspective view of an automatic injector in a storage position according to another embodiment of the present invention,

[0131] Figure 36 for Figure 35 A longitudinal cross-sectional view of an automatic injector;

[0132] Figure 37 for Figure 4 A partially cutaway perspective view of a top shell;

[0133] Figure 38 For Figure 35 A perspective view of the top housing of the automatic injector,

[0134] Figure 39 is a transverse cross-sectional view of the automatic injector in which the blocking member has been rotated from its blocking position while still holding the holder in the rest position,

[0135] Figure 40 is a transverse cross-sectional view of the autoinjector wherein the blocking member has been rotated from its blocking position and is about to allow the holder to deform. DETAILED DESCRIPTION

[0136] Figure 1 An autoinjector 1 according to an embodiment of the present invention is shown.

[0137] The autoinjector 1 is designed for automatically injecting a product into an injection site.The autoinjector 1 extends along an axis A1 which defines a longitudinal direction and is also the axis of the components of the autoinjector 1 in the installed position.

[0138] like Figure 3 As shown in , the autoinjector 1 comprises various components including a housing 100 , a needle cover 200 , a plunger rod 300 , and a blocking member 400 .

[0139] The housing 100 having a longitudinally extending axis A100 is configured to receive Figure 3 The medical container 2 is illustrated in FIG. The medical container 2 has an axis A2 and comprises a barrel 3 defining a reservoir for containing a medical product. The barrel 3 has a distal end 4 provided with a needle 5 (also referred to as an injection needle) and a proximal end 6, the distal end being open and configured to receive a plunger rod 300. A stopper 7 is arranged inside the barrel 3 proximal to the medical product (e.g., see FIG. Figure 17 ), and is intended to be pushed by a plunger rod 300 to expel the medical product through the needle 5. The medical container 2 also includes a flange 8 extending outwardly from the proximal end 6. A rigid needle shield 9 is removably attached to the barrel 3 for shielding the needle 5 before use.

[0140] exist Figures 4 to 8 The housing 100 is illustrated in FIG.

[0141] The housing 100 has two symmetry planes P1 and P2 , both of which include the axis A100 and are orthogonal to each other.

[0142] The housing 100 may include a bottom housing 101 having an axis A101 and a top housing 150 having an axis A150, the bottom housing and the top housing being assembled to each other by any suitable fixing means (e.g., snap-fit ​​means). The bottom housing 101 and the top housing 150 may have corresponding cylindrical shapes so that when they are assembled, they generally form a cylinder, wherein the axes A101, A150, and A100 are generally the same axis. Similarly, preferably, both the bottom housing 101 and the top housing 150 have two planes of symmetry that coincide with planes P1 and P2 in the installed position. Therefore, the reference numerals P1 and P2 are used to identify the planes of symmetry of the bottom housing 101 and the top housing 150.

[0143] refer to Figures 6 to 8 The bottom housing 101 is described.

[0144] The bottom housing 101 may be realized as a single piece, for example by injection molding of a plastic material.

[0145] The bottom housing 101 includes a peripheral wall 102 that is preferably generally cylindrical and has an interior face 103, an exterior face 104, an open distal end 105, and an open proximal end 106. The bottom housing 101 may also include an interior sheath 107 that is generally cylindrical and coaxial with the peripheral wall 102. An open distal end 108 of the sheath 107 may be located proximal to the open distal end 105 of the peripheral wall 102, and an open proximal end 109 of the sheath 107 may be located distal to the open proximal end 106 of the peripheral wall 102.

[0146] In one embodiment, a dividing wall 110 extends generally parallel to the plane P2 on either side of the axis A101, generally from the sheath distal end 108 to the sheath proximal end 109. The dividing wall 110 may be nearly tangential to the sheath 107, while being slightly offset relative to the sheath 107 toward the axis A101. The longitudinal edges 111 of the dividing wall 110 may be directly coupled to the inner face 103 of the bottom housing peripheral wall 102 (see FIG. Figure 7 and 23 ), except at a location near the proximal end 109 of the sheath, where each of said longitudinal edges 111 may be spaced apart from said interior face 103 and extended by a side wall 112 having at least a portion orthogonal to the dividing wall 110 and joined to the interior face 103 of the bottom housing peripheral wall 102 (see Figure 8 、 20 and 22).

[0147] Thus, two channels 115 are formed between the jacket 107 and the peripheral wall 102. The channels 115 extend axially along the entire jacket 107. The channels 115 are symmetrical to each other with respect to plane P2, and each channel is symmetrical with respect to plane P1. Each channel 115 has an inner face 116 formed by a continuous face formed by the bottom shell peripheral wall 102, the partition wall 110, the possible jacket 107, and the side wall 112 (if present).

[0148] The sheath 107 is attached to the peripheral wall 102 by a partition wall 111 and preferably also by a first transverse wall 117 near the sheath distal end 108 and a second transverse wall 118 near the sheath proximal end 109. The first and second transverse walls 117, 118 preferably extend over an annular cross-sectional area between the sheath 107 and the peripheral wall 102, except at a location corresponding to the cross-sectional area of ​​the passageway 115.

[0149] In one embodiment, a window 119 extends parallel to plane P2 through the bottom housing 101. The window 119 may form a generally rectangular border on opposite sides of the bottom housing peripheral wall 102. The window 119 is intended to allow inspection of a medical container 2 received in the autoinjector 1.

[0150] The proximal portion of the peripheral wall 102 may be provided with two notches 120, the two notches facing each other along a direction orthogonal to P1, each notch 120 being symmetrical with respect to P2. Each notch 120 may be square and have a bottom surface substantially flush with the second transverse wall 118 and two longitudinal side edges 121. Figure 6 、 8 As shown in FIGS. 22 and 22 , proximal to the second transverse wall 118 , the perimeter wall 102 may extend circumferentially beyond the sidewall 112 of the channel 115 , thereby forming a lip 122 .

[0151] Facing each notch 120, a snap-fit ​​protrusion 123 may be provided, protruding outwardly from the sheath 107. Preferably, the snap-fit ​​protrusion 123 does not extend radially beyond the cylindrical envelope surface formed by the bottom housing peripheral wall 102.

[0152] The bottom housing 101 can further include at least one rib 124 that projects inwardly and extends axially from the peripheral wall 102. The rib 124 can extend from the open distal end 105 of the peripheral wall, with the proximal side 125 of the rib 124 spaced apart from the inner sheath distal end 108. The rib 124 can project from the peripheral wall 102 in a direction generally parallel to P1.

[0153] For example, bottom housing 101 includes two groups 126, each group including two ribs 124, and the two groups are arranged symmetrically with respect to plane P2. Within each group 126, ribs 124 can be arranged symmetrically with respect to plane P1 and can be adjacent. For example, when viewed in a plane orthogonal to axis A101, the distance between ribs 124 can be approximately equal to the width of each rib 124.

[0154] Now refer to Figure 4 and 5 The top case 150 is described.

[0155] The top case 150 may be realized as a single piece, for example by injection molding of a plastic material.

[0156] The top housing 150 includes a peripheral wall 152 that is preferably generally cylindrical and has an interior face 153 , an exterior face 154 , an open distal end 155 , and a proximal end closed by a proximal transverse wall 156 .

[0157] The distal portion of the peripheral wall 152 may be provided with two notches 159, the two notches facing each other in a direction orthogonal to P2, each notch 159 being symmetrical with respect to P1. Thus, two protrusions 160 are formed between the notches 159, the two protrusions being configured to mate with the notches 120 of the bottom shell 101. In order to provide the shell 100 with a continuous peripheral wall, the shape of the protrusions 160 preferably matches the shape of the notches 120. Thus, each protrusion 160 may be square and have two longitudinal side edges 161. In addition, as Figure 5 and 22 As shown in , the lip 162 can extend circumferentially beyond each longitudinal side edge 161 while being offset inwardly. The lip 162 of the top shell 150 is intended to mate radially with the inner face of the lip 122 of the bottom shell 101 to ensure proper positioning and attachment of the top shell 150 and the bottom shell 101. In addition, a hole 163 can be provided in each protrusion 160 for receiving the snap-fit ​​protrusion 123 and providing a secure connection between the top shell 150 and the bottom shell 101.

[0158] The top shell 150 may further include at least one rib 164 projecting inwardly from the peripheral wall 152 and extending axially. The rib 164 may project from the peripheral wall 152 in a direction generally parallel to P1. For example, the top shell 150 may include two groups 166, each group including two ribs 164, the two groups being symmetrically arranged relative to plane P2. Within each group 166, the ribs 164 may be symmetrically arranged relative to plane P1 and may be adjacent to one another. In one example, when viewed in a plane orthogonal to axis A150, the width of the group 166 of ribs 164 is approximately equal to the width of the group 126 of ribs 124 of the bottom shell 101. Each rib 164 may extend distally from the proximal transverse wall 156 to approximately the proximal edge 158 of the corresponding notch 159.

[0159] like Figure 37 , the top housing 150 can further include an inner sleeve 167 that is generally cylindrical and coaxial with the peripheral wall 152. The sleeve 167 can extend from the proximal transverse wall 156, and an open distal end 168 of the sleeve 167 can be located proximal to the proximal edge 158 of the notch 159. The diameter of the sleeve 167 can be smaller than the diameter of the sheath 107.

[0160] In one embodiment, the distal portion of the sleeve 167 is provided with notches 169 extending axially from the open distal end 168 of the sleeve 167. Thus, an axially extending leg 170 is formed between the two notches 169. The leg may preferably be provided with a ridge 171 at its distal end, the ridge 171 being oriented toward the axis A150. The leg 170 may be moved from a rest position (at Figure 5 and Figure 31 ) toward the deformed position (in the Figure 31 The legs 170 are elastically deflected radially outwards (illustrated by dashed lines in FIG. 1 ). As will be explained, the legs 170 form a retainer. Two legs 170 may be provided that are arranged symmetrically with respect to the plane P1.

[0161] An elongated protrusion 175 protruding distally from the proximal transverse wall 156 extends in the sleeve 167 perpendicular to the plane P2. The elongated protrusion 175 has a small height along the axis A150. In particular, the elongated protrusion 175 is proximally offset relative to the recess 169.

[0162] Additionally, top shell 150 may include four ribs 176 projecting distally from proximal transverse wall 156 and each connecting peripheral wall 152 to sleeve 167. Ribs 176 may be spaced 90° apart from one another, with each rib 176 generally contained within one of planes P1 and P2.

[0163] Now refer to Figure 9 , which illustrates a plunger rod 300. The plunger rod 300 is intended to be installed in the housing 100, for example, in the top housing 150. The plunger rod 300 has a cylindrical wall 301 with an axis A300, which, in the installed position, generally coincides with the autoinjector axis A1. Preferably, the plunger rod 300 has two planes of symmetry, which, in the installed position, coincide with planes P1 and P2. Therefore, the reference numerals P1 and P2 are used to identify the planes of symmetry of the plunger rod 300.

[0164] At its distal end 305, the plunger rod 300 includes a collar 302 extending in a plane orthogonal to the axis A300 and oriented inwardly, the collar 302 defining an opening 303. The proximal end 306 of the plunger rod 300 is open. The cylindrical wall 301 includes a notch 304 extending axially from the proximal end 306 and configured to receive the elongated protrusion 175 of the top housing 150 to prevent the plunger rod 300 from rotating relative to the top housing 150 about the axis A150. Thus, in the aforementioned embodiment, the notches 304 face each other along a direction orthogonal to P2, with each notch 304 being symmetrical with respect to P1.

[0165] The cylindrical wall 301 also includes at least one hole 310 for receiving the protuberance 171 of one leg 170 of the top shell 150. Thus, in the aforementioned embodiment where the top shell 150 includes two legs 170, two holes 310 are provided, facing each other along a direction orthogonal to P1, each hole 310 being symmetrical with respect to P2.

[0166] Now refer to Figure 10and 11 Needle cover 200 is described.

[0167] The needle cover 200 is intended to be mounted in the housing 100. The needle cover 200 has an axis A200 which, in the mounted position, substantially coincides with the autoinjector axis A1. Preferably, the needle cover 200 has two planes of symmetry which, in the mounted position, coincide with planes P1 and P2. Therefore, the reference numerals P1 and P2 are used to identify the planes of symmetry of the needle cover 200.

[0168] The distal portion of the needle cover 200 forms a shielding portion 201 having a generally cylindrical peripheral wall 202 and serving to shield the needle 5 from injury and contamination. The peripheral wall 202 has an inner face 203 and an outer face 204. The distal end 205 of the needle cover 200 includes a bearing surface 207 extending in a plane orthogonal to the axis A200. The bearing surface 207 has a portion extending inward from the peripheral wall 202 and having a central opening 208, and a portion extending outward and forming an annular flange 209. An annular flange 210 extending outward from the peripheral wall 202 is also arranged at the proximal end of the shielding portion 201. The two flanges 209, 210 may have substantially the same outer diameter.

[0169] The needle cover 200 further comprises at least one arm 220 extending proximally from the shielding portion 201. Figure 10 In the embodiment illustrated in , the needle cover 200 comprises two arms 220 arranged symmetrically with respect to the plane P2. Preferably, the or each arm 220 is symmetrical with respect to the plane P1.

[0170] The arm 220 includes a main wall 221 having a curved cross-section, when viewed along the axis A200, that follows the cylindrical shape of the peripheral wall 202 of the shielding portion. A distal portion 222 of the main wall 221 has a longitudinal edge 223 and is extended by a proximal portion 224 having a longitudinal edge 225 that is closer to one another than the longitudinal edge 223 of the distal portion 222. In other words, when the needle cover 200 is viewed in a direction orthogonal to the plane P2, the width of the distal portion 222 is greater than the width of the proximal portion 224. As a result, a transverse edge 226 is formed between the distal portion 222 and the proximal portion 224. The proximal end 206 of the needle cover 200 is also the proximal end of the arm 220.

[0171] The arm 220 further includes at least one guide rail 230 that extends axially and projects outwardly from the main wall 221. In one embodiment, each arm 220 includes two guide rails 230. The guide rails 230 can be disposed at the longitudinal edge 225 of the proximal portion 224 of the main wall. Preferably, the guide rails 230 define an outer diameter of the needle cover 200 surrounding the arm 220 that is substantially equal to an outer diameter of the needle cover 200 surrounding the shield portion 201. For example, the guide rails 230 and the annular flange 210 at the proximal end of the shield portion 201 can form a continuous rib.

[0172] Needle cover 200 further comprises a pin 235 projecting from arm 220 towards axis A200. Pin 235 is located at main wall proximal portion 224, for example, near proximal end 206. Preferably, proximal surface 236 of pin 235 is substantially normal to axis A200, while distal surface 237 may be inclined.

[0173] The needle cover 200 further comprises a tab 240 arranged on each arm 220. The tab 240 has a base 241 preferably fixed to the main wall 221 of the arm between the guide rails 230, and a free distal end 242 preferably extending orthogonally to the axis A200. The tab 240 protrudes obliquely distally and outwardly from the main wall 221. More specifically, for example, Figure 10 and 18 As seen in the figures, the tab 240 can have an inner face 243 and an outer face, wherein the inner face is flush with the inner face of the arm main wall 221, and the outer face includes a ramp portion 244 and a straight portion 245, wherein the ramp portion is inclined distally and outwardly, and the straight portion is generally parallel to the outer face of the main wall 221 but offset outwardly relative to the outer face of the main wall 221.

[0174] Starting from this position, the tab 240 can be elastically deflected towards the axis A200 to allow the needle cover to be installed in the housing 100 .

[0175] Now refer to Figures 12 to 14 The blocking member 400 is described.

[0176] The blocking member 400 is intended to be mounted in the housing 100. The blocking member 400 has an axis A400 which, in the mounted position, substantially coincides with the autoinjector axis Al Preferably, the blocking member 400 has a plane of symmetry P which, in the mounted position, contains the autoinjector axis Al.

[0177] The blocking member 400 includes a body 401 having a generally cylindrical shape. The exterior surface of the body 401 has two portions 402, each having a cylindrical shape bounded by a longitudinal edge 403. The portions 402 (referred to as cylindrical portions 402) are arranged symmetrically relative to an axis A400, with each portion 402 being symmetrical relative to a plane P. Between the cylindrical portions 402, the exterior surface of the body 401 has a portion 404 that is recessed inwardly relative to the cylindrical portions 402. Thus, the exterior surface of the body 401 has two recessed portions 404. Each recessed portion 404 has an exterior surface 407 that can be generally cylindrical.

[0178] The blocking member 400 has a central bore 410 extending axially and having the same diameter as the inner diameter of the recessed portion 404. Two opposing axial slots 411 open into the central bore 410. Each axial slot 411 is arranged in the same angular sector as and inside the corresponding cylindrical portion 402. The blocking member 400 has an open distal end 405 and an open proximal end 406. At the proximal end 406, a transverse wall 408 extends from the periphery of the body 401 to the boundary of the opening formed by the combination of the central bore 410 and the axial slots 411. The central bore 410 has a generally cylindrical inner face 413 that is radially opposite the recessed portion 404, i.e., circumferentially spaced from the axial slots 411.

[0179] The blocking member 400 may include an inclined rib 435 projecting outwardly from the recessed portion exterior face 407. The inclined rib 435 has a distal end 431, which may be proximal to the blocking member distal end 405 and a longitudinal edge 403, and a proximal end 432, which may be proximal to the blocking member proximal end 406 and distal to the longitudinal edge 403. The distal side 436 of the inclined rib 435 thus forms a cam surface that is inclined relative to the axis A400 and defines an inclined or generally spiral path from the distal end 431 toward the proximal end 432. Figure 33 As shown in , when viewed normal to axis A400, the inclined ribs 435 may form an angle α between 20° and 45° relative to axis A400.

[0180] A longitudinal rib 437 protruding outward from the recessed portion outer surface 407 and extending axially is arranged in the circumferential direction between the proximal end 432 of the inclined rib 435 and the longitudinal edge 403 opposite to the longitudinal edge 403 near the distal end 431 of the inclined rib 435 .

[0181] In one example, the blocking member 400 further includes an abutment wall 438 that protrudes outward from the recessed portion exterior face 407. The abutment wall 438 extends generally axially from the blocking member distal end 405, with a proximal end of the abutment wall 438 spaced apart from the inclined rib 435 along a direction parallel to the axis A400. The abutment wall 438 is located circumferentially between the distal end 431 of the inclined rib 435 and the longitudinal rib 437. A distal rib 439 that protrudes outward from the recessed portion exterior face 407 can extend along the blocking member distal end 405 to connect the abutment wall 438 and the longitudinal rib 437.

[0182] The blocking member 400 may further include a tab 440 located in the recessed portion 404, between the abutment wall 438 and the longitudinal rib 437, and between the inclined rib 435 and the blocking member distal end 405 or the distal rib 439 (if present). The tab 440 has a base 441 fixed to the body 401 of the blocking member 400 and a free distal end 442 that preferably extends orthogonally to the axis A400. The tab 440 protrudes obliquely distally and outwardly from the body 401. More specifically, for example, Figure 12 and 14 , the tab 440 can have an exterior face including a ramped portion 444 that slopes distally and outwardly, and a straight portion 445 that is generally parallel to the recessed portion exterior face 407 but offset outwardly relative thereto. From this position, the tab 440 can be resiliently deflected toward the axis A400.

[0183] The tab 440 , the abutment wall 438 and the distal rib 439 are part of a locking device 440 of the blocking member 400 , which is configured to lock the needle cover 200 in a safety position, as will be explained below.

[0184] In one embodiment, the autoinjector 1 further comprises a cap 500, now referring to Figure 15 and 16 Describe it.

[0185] The cap 500 may be realized as a single piece, for example by injection molding of a plastic material.

[0186] The cap 500 is intended to be mounted at the distal end of the housing 100. The cap 500 has an axis A500 which, in the mounted position, generally coincides with the autoinjector axis A1. Preferably, the cap 500 has two planes of symmetry which, in the mounted position, coincide with planes P1 and P2. Therefore, the reference numerals P1 and P2 are used to identify the planes of symmetry of the cap 500.

[0187] The cap 500 comprises a peripheral wall 502 which is preferably generally cylindrical and has an inner face 503, an outer face 504, an open proximal end 506 and a distal end closed by a transverse wall 505. The outer face 504 may be provided with a bead 501 or equivalent for preventing the user's fingers from slipping on the peripheral wall 502 when removing the cap 500.

[0188] The cap 500 may comprise at least one protrusion 507 projecting from the peripheral wall inner face 503 towards the axis A500, in a direction orthogonal to the plane P1, at a distance from the transverse wall 505 and the proximal end 506. Preferably, two protrusions 507 are provided, diametrically opposed and symmetrically arranged relative to the plane P1.

[0189] The cap 500 may further include at least one rib 508 projecting inwardly and extending axially from the peripheral wall 502. The rib 508 may extend from the transverse wall 505, with a proximal side 509 of the rib 508 spaced apart from the proximal end 506. Preferably, the cap 500 includes several such ribs 508, such as four ribs 508 spaced 90° apart from each other, with each rib 508 being substantially contained within one of the planes P1 and P2.

[0190] In one embodiment, the inner ring 510 protrudes from the transverse wall 505 coaxially with the axis A500. Two legs 520 arranged symmetrically with respect to the plane P2 extend from the inner ring 510, each leg 520 being symmetrical with respect to the plane P1. Each leg 520 extends axially and has a curved profile that is a portion of a cylinder that follows the shape of the inner ring 510. The proximal end of the leg 520 is located proximal to the proximal end 506 of the peripheral wall 502. The proximal end of each leg 520 can be provided with a protuberance 521 that is oriented toward the axis A500. The legs 520 are preferably movable from the inner ring 510. Figure 15 and 16 The rest position illustrated in FIG is elastically deflected radially outward.

[0191] exist Figure 1 and Figures 17 to 28 The autoinjector 1 is illustrated in FIG. 1 in a storage position (ie the position where it is packaged, stored and sold to a user prior to use) and will now be described.

[0192] The medical container 2 equipped with the rigid needle shield 9 is engaged in the sheath 107 of the bottom housing 101, wherein the flange 8 is supported on the proximal end 109 of the sheath 107, as shown in FIG. Figure 20 As shown in .

[0193] The needle cover 200 is mounted in the bottom housing 101 with the arm 220 received in the channel 115 and extending proximally beyond the proximal end 106 of the bottom housing peripheral wall 102 so that the pin 235 is located proximal to the proximal end 106. The needle cover 200 is thus located between the sheath 107 and the bottom housing peripheral wall 102. Figure 18 As can be seen in FIG, the needle 5 extends distally beyond the proximal end 105 of the bottom housing. Figure 17 As shown in FIG, the annular flange 210 of the needle cover shielding portion 201 is centered relative to the bottom housing peripheral wall 102.

[0194] Once in the installed position in the storage position, the needle cover 200 is prevented from moving distally relative to the housing 100 due to the snap-fit ​​engagement between the needle cover 200 and the base housing 101. More specifically, as Figure 18 As shown in FIG, the distal end 242 of the tab 240 abuts the proximal side 125 of the rib 124 of the bottom housing 101.

[0195] Furthermore, the needle cover 200 is prevented from rotating relative to the housing 100 about the axis A1 and the arm 220 is prevented from moving tangentially and radially relative to the housing 100 because:

[0196] - The guide rail 230 of the needle cover 200 contacts or is adjacent to the inner face 103 of the bottom housing peripheral wall 102, thereby preventing or significantly limiting the outward deflection of the arm 220 ( Figures 22 to 24 );

[0197] - the guide rails 230 of the needle cover 200 are in contact with or adjacent to the ribs 124 of the bottom housing 101, for example arranged on either side of the group 126 of ribs 124, thereby preventing or significantly limiting the rotational and tangential movement of the needle cover arm 220 ( Figure 24 );

[0198] - The guide rails 230 of the needle cover 200 are in contact with or adjacent to the ribs 164 of the top housing 150, for example, arranged on either side of the group 166 of ribs 164, thereby preventing or significantly limiting the rotational and tangential movement of the needle cover arm 220 ( Figure 21 );

[0199] - The arm 220 is in contact with or adjacent to the partition wall 110 forming the interior wall of the channel 115, thereby preventing or significantly limiting the arm 220 from deflecting inwardly ( Figure 22 and 23 );

[0200] - The arm 220 is in contact with or adjacent to the side wall 112 forming the side wall of the channel 115 proximal to the second transverse wall 118, thereby preventing or significantly limiting the rotational and tangential movement of the needle cover arm 220 ( Figure 22 ).

[0201] like Figure 17 and 18 As shown in FIG, in the storage position, the needle cover 200 projects beyond the housing distal end 105 so as to shield the needle 5.

[0202] Furthermore, the autoinjector 1 includes a first biasing device for biasing the needle cover 200 distally. The first biasing device may include a first spring 250, for example, a so-called "safety spring." The first spring 250 may be a coil spring whose axis, in the installed position, substantially coincides with the autoinjector axis A1. The first spring 250 may be located within the needle cover 200, more specifically, within the shielding portion 201 and between the distal portions of the arms 220. In the illustrated embodiment, the first spring 250 bears at its distal portion against the bearing surface 207 of the needle cover distal end 205 and at its proximal portion against the partition wall 110.

[0203] The plunger rod 300 is mounted in the top housing 150 in the sleeve 167, with the elongated protrusion 175 of the top housing 150 receiving the recess 304 of the plunger rod 300 and the protuberance 171 of each leg 170 engaging in a corresponding hole 310 of the plunger rod 300. The plunger rod 300 is thus in its initial position.

[0204] Furthermore, the autoinjector 1 includes a second biasing device for biasing the plunger rod 300 distally relative to the top housing 150. The second biasing device may include a second spring 260, for example, referred to as an "injection spring." The second spring 260 may be a coil spring whose axis, in the installed position, substantially coincides with the autoinjector axis A1. The second spring 260 may be located within the plunger rod 300. In the illustrated embodiment, the second spring 260 is supported at its distal portion on the collar 302 of the plunger rod 300 and at its proximal portion on the transverse wall 156 of the top housing 150.

[0205] The blocking member 400 is installed in the housing 100 formed by the top housing 150 and the bottom housing 101 assembled to each other. The sleeve 167 of the top housing 150 is received in the central hole 410 of the blocking member 400.

[0206] In the storage position, along the longitudinal direction, the blocking member 400 is located between the rib 176 and the flange 8 of the medical container 2. The blocking member 400 can abut the rib 176 and can be held in this position by friction with the inner face 153 or lip 162 of the top shell peripheral wall 152, or by an outward force exerted by the legs 170 due to the force of the second spring 260.

[0207] With respect to the angular position of the blocking member 400 about the axis A1 in the storage position, it is such that the pin 235 arranged on each arm 220 of the needle cover 200 is located longitudinally between the blocking member distal end 405 and the distal side 436 of the inclined rib 435, and circumferentially between the abutment wall 438 and the distal end 431 of the inclined rib 435, as shown in FIG. Figure 29 As shown by the dotted line in .

[0208] In this angular position, one longitudinal edge 225 of the proximal portion 224 of the arm 220 can abut a longitudinal edge 403 of the corresponding cylindrical portion 402 of the blocking member body 401, near the distal end 431 of the inclined rib 435. This prevents the blocking member 400 from rotating in an undesired direction about the axis A1. In addition, the arm 220 preferably does not radially oppose the tab 440. For example, the opposing longitudinal edge 225 of the proximal portion 224 of the arm 220 is circumferentially located between the abutment wall 438 and the tab 440.

[0209] Furthermore, in this angular position, the legs 170 of the top shell 150 abut against the substantially cylindrical inner face 413 of the central hole 410 of the blocking member 400, i.e. offset circumferentially relative to the axial groove 411, as shown in FIG. Figure 17 As shown in .

[0210] Thus, in the stored position, the legs 170 are in their rest position and are prevented from deflecting radially outward by the blocking member 400. Without the blocking member 400, the distal force applied by the second spring 260 would cause the protuberance 171 of the legs 170 to disengage from the aperture 310 of the plunger rod 300, with the plunger rod 300 thus free to move distally. Thus, each leg 170 forms a retainer for retaining the plunger rod 300 in its initial position against the action of the second spring 260, the retainer being held in the rest position by the blocking member 400. Thus, in the stored position of the needle cover 200, the blocking member 400 is in a blocking position.

[0211] Finally, the cap 500 is mounted at the distal end of the autoinjector. More specifically, the cap 500 is not mounted on the housing 100, but rather on the needle cover 200, for example, due to the action of a protrusion 507 that cooperates with the annular flange 209. The protrusion 507 is designed to be able to clamp and release the cap 500 without manual operation and to prevent the needle cover from moving during the drop test. In the storage position, the rib 508 of the cap 500 cooperates with the distal end 105 of the housing 100 to prevent the cap 500 from moving proximally toward the bottom housing 101. In addition, as Figure 17 and 18 As seen in FIG, the ridge 521 of the leg 520 is located proximal to the proximal end of the rigid needle shield 9 of the medical container 2.

[0212] Now refer to Figures 27 to 34 Describe the operation of the autoinjector when in use.

[0213] Starting from the storage location, first, such as Figure 27 As illustrated in , the user removes the cap 500 by pulling it distally away from the housing 100 (arrow S1 ). Due to the presence of the ridge 521 engaging the proximal end of the rigid needle shield 9, removal of the cap automatically causes removal of the rigid needle shield.

[0214] Then, the user places the autoinjector 1 on the injection site and, while holding the housing 100, pushes the autoinjector 1 toward the injection site. As a result, the needle cover 200 is pushed ( Figure 28 As the needle cover 200 can move axially inside the housing 100, it overcomes the force applied by the second spring 260 and moves proximally in the housing until the needle cover 200 is in the housing. Figure 31 In the retracted position, the needle cover 200 at least partially exposes the needle 5 and the first spring 250 is compressed.

[0215] like Figure 29 As shown in FIG, when the needle cover 200 moves from the storage position to the retracted position, the pin 235 arranged on each arm 220 of the needle cover 200 first contacts the distal side 436 of the corresponding inclined rib 435 of the blocking member 400. Due to the engagement between the pin 235 and the inclined rib distal side 436, further proximal movement of the needle cover 200 causes the pin 235 to travel along a path along the distal side 436 (arrow S3).

[0216] Since the autoinjector 1 includes means for guiding axial movement of the needle cover 200 relative to the housing 100 (i.e., the arms 220 and guide rails 230 on the needle cover 200, and the channels 115 and ribs 124, 164 on the housing 100), the needle cover 200, and in particular the arms 220, are prevented from rotating relative to the housing 100. In contrast, the blocking member 400 is rotatable relative to the housing 100 about the axis A1. Thus, the proximal movement of the needle cover 200 from its storage position to its retracted position causes the blocking member 400 to rotate from the blocking position to the released position ( Figure 29 The blocking member 400 can be rotated through an angle between 20° and 45° from its blocking position to its releasing position.

[0217] After the blocking member 400 is rotated relative to the housing 100, the autoinjector 1 is in Figure 30 and 31 In the configuration shown in the example.

[0218] The legs 170 of the top housing 150 no longer radially face the inner face 413 of the blocking member central hole 410, but now face the axial slot 411. Therefore, the blocking member 400 no longer forms a radial abutment for the legs 170, but allows the legs 170 to deform outwardly.

[0219] Due to the force of the second spring 260, the plunger rod 300 is pushed distally relative to the top housing 150. This tends to disengage the protuberance 171 from the hole 310, which was previously impossible because it would require the legs 170 to deflect outwardly, which would be prevented by the inner face 413 of the central hole 410 of the abutting member. As a result, the legs 170 deflect outwardly into the axial slots 411 ( Figure 30 and 31 Arrow S5 in the figure). Figure 31 In the deformed position, shown in phantom in FIG, the legs 170 permit distal movement of the plunger rod 300 relative to the housing 100.

[0220] The plunger rod 300 then moves distally from its initial position within the housing 100 to Figure 32 During this movement, the plunger rod 300 pushes the stopper 7 to expel the medical product from the barrel 3 through the needle 5. In one example, if the legs 7 are no longer pushed outward by the plunger rod 300, the legs will elastically return to their rest position.

[0221] Once the injection is completed, the user can remove the autoinjector 1 from the injection site. At this time, since the needle cover 200 is not against the injection site and since the first spring 250 is compressed, the needle cover 200 is moved distally relative to the housing 100 by the first spring 250 toward the safety position, in which the needle cover 200 protrudes beyond the distal end of the housing to shield the needle 5 again. Figure 34 The safety position is illustrated in FIG. 1. In the safety position, the distal end 242 of the tab 240 may again abut the proximal side 125 of the rib 124 of the bottom housing 101. Alternatively, the position of the needle cover relative to the housing 100 may be different in the safety position and the storage position.

[0222] like Figure 33 As shown in FIG, when the needle cover 200 moves from the injection position to the safety position, the pin 235 arranged on each arm 220 of the needle cover 200 moves distally, as illustrated by arrow S6.

[0223] The autoinjector 1 is designed so that the positioning of the pin 235 in the injection position is longitudinally aligned with the tab 440 of the blocking member 400. Therefore, the pin 235 reaches the tab 440 and moves further distally until the pin 235 is located distal to the tab 440, this movement being limited by the distal rib 439 arranged on the blocking member 400. Providing the pin 235 with an inclined distal surface 237 can facilitate engagement with the tab 440 and inward deflection of the tab during distal movement of the needle cover 200 from the retracted position toward the safety position.

[0224] In the safety position, the needle cover 200 is prevented from moving proximally by the engagement between the pin 235 and the tab 440. More precisely, the pin proximal surface 236 abuts the tab distal end 442. Preferably, the pin proximal surface 236 and / or the tab distal end 442 are substantially orthogonal to the axis A1 to enhance the locking effect. Thus, the distal end 442 of the tab 440 forms a first stop for engaging with the needle cover 200 in the safety position to prevent axial movement of the needle cover in the proximal direction.

[0225] Furthermore, in the safety position, the blocking member 400 can be prevented from rotating back towards the blocking position, which rotation could cause the needle cover 200 to move freely back to its retracted position. This is achieved by an abutment wall 438 arranged on the blocking member, which forms an abutment for the pin 235. Thus, the abutment wall 438 forms a second stop for cooperating with the needle cover 200 in the safety position.

[0226] The first and second stops (here the distal end 442 of the tab 440 and the abutment wall 438) are part of a locking device 450 arranged on the blocking member 400 for locking the needle cover 200 in a safety position. In one embodiment, the locking device 450 is configured to cooperate with an operating portion arranged on the needle cover, which here comprises the pin 235.

[0227] The locking device ensures that the needle remains shielded, thereby increasing the safety of the autoinjector.Arranging the locking device on the blocking member has advantages in terms of design simplicity, compactness, material saving and reliability.

[0228] Now refer to Figure 35 、 36 and 38, which show another embodiment of the autoinjector according to the present invention.

[0229] Only the differences from the first embodiment will be described below. In addition, since the operation of this automatic injector is the same or similar to that of the previous embodiment, no further description will be given.

[0230] In this embodiment, Figure 36, the top housing 150 is mostly disposed inside the bottom housing 101, with substantially only its proximal transverse wall 156 being located outside the bottom housing 101. Furthermore, the snap-fit ​​arrangement is reversed in that the portion containing the snap-fit ​​protrusions 180 is the top housing 150, while the apertures 140 that receive the snap-fit ​​protrusions 180 are provided on the bottom housing 101.

[0231] The top housing 150 may also be provided with a collar 185 configured to mate with a hook 485 provided on the blocking member 400. The hook 485 may protrude proximally from the proximal end 406 of the blocking member body 401. This enables axial movement of the blocking member 400 in both the proximal and distal directions to be prevented because the collar 185 is sandwiched between the hook 485 and the transverse wall 408 at the proximal end 406 of the blocking member body 401.

[0232] The autoinjector 1 can further include means for limiting the range of rotational movement of the barrier member 400. To this end, the transverse wall 408 can include a notch 490 adjacent the recessed portion 404, the notch 490 being defined by a first edge 491 and a second edge 492. The first edge can coincide with the longitudinal edge 403 adjacent the distal end 431 of the inclined rib 435, and the second edge can be adjacent the proximal end 432 of the inclined rib 435. Additionally, the top housing 150 can include a tongue 190 that, in the installed position, extends distally beyond the barrier member transverse wall 408. Thus, the tongue 190 can abut the first edge 491 or the second edge 492 of the notch 490, thereby limiting rotational movement of the barrier member 400 relative to the housing 100 about the axis A1.

[0233] Now refer to Figure 39 and 40 , which illustrates an embodiment in which the start moment of retainer release and the trigger period of the actual injection are controlled.

[0234] Thus, the autoinjector 1 can be configured to set the starting point of the injection relative to the puncture depth to ensure that all of the medical product will be expelled from the medical container and injected into the injection site. More specifically, the axial groove 411 can be configured to allow the retainer 170 to begin deforming when the needle cover 200 has moved axially along a predetermined length, and preferably, to control the deformation speed of the retainer 170 toward its deformed position.

[0235] The longitudinal edge between the inner face 413 of the blocking member body 401 and the axial groove 411 is referred to as the activation edge 414 , which is the last contact portion between the retainer 170 and the inner face 413 before the retainer 170 is allowed to deform after the blocking member 400 rotates.

[0236] The axial groove 411 comprises a control surface 415 which extends from the activation edge 414 towards the interior space of the axial groove 411 and away from the housing axis A100. Figure 40 As shown in FIG, the control surface 415 is inclined at an angle α relative to the radial line segment 195 of the housing 100 passing through the activation edge 414. The angle α may be between 25° and 50°, preferably between 35° and 45°. This ensures a fast start of the injection, but a smooth transition from the initial position of the plunger rod to its end-of-injection position.

[0237] The invention is not limited to the embodiments described above by way of example, but comprises all technical equivalents and variants of the means described, as well as combinations thereof.

[0238] It should be understood that the present invention is not limited to the embodiments described above and illustrated 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. An automatic injector (1) for automatically injecting a product into an injection site, the automatic injector (1) comprising: a housing (100) having an axis (A100) defining a longitudinal direction, said housing (100) being configured to receive a medical container (2) comprising a barrel (3) defining a reservoir for containing a medical product, said barrel (3) having a distal end (4) provided with a needle (5) and an open proximal end (6), said open proximal end being configured to receive a plunger rod (300) for pushing a stopper (7) arranged inside said barrel (3); an inner sleeve (167) arranged axially inside the housing (100) and fixed to the housing (100); a needle cover (200) coupled to the housing (100), the needle cover (200) being rotationally fixed relative to the housing (100) and being axially movable inside the housing (100) between a storage position, in which the needle cover (200) projects beyond the housing distal end (105) so as to shield the needle (5), a retracted position, in which the needle cover (200) is moved proximally relative to the housing (100) from the storage position so as to at least partially expose the needle (5), and a safety position, in which the needle cover (200) is moved distally back relative to the housing (100) from the retracted position and projects beyond the housing distal end (105) so as to shield the needle (5); - guiding means (103, 115, 124, 164) fixedly arranged on the housing (100) for guiding the axial movement of the needle cover (200) relative to the housing (100); - first biasing means (250) for biasing the needle cover (200) distally; a plunger rod (300) which is axially movable inside the housing (100) between an initial position and an injection end position distal to the initial position, the plunger rod (300) being configured to push the stopper (7) to expel the medical product; - a second biasing means (260) for biasing the plunger rod (300) distally; a retainer (170) for retaining the plunger rod (300) in the initial position against the action of the second biasing means (260), the retainer (170) being arranged at a distal portion of the inner sleeve (167), the retainer (170) being elastically deformable between a rest position and a deformed position, in which the retainer (170) abuts axially against the plunger rod (300) to block the plunger rod (300) in the initial position, and in which the retainer (170) deflects radially to allow the plunger rod (300) to move distally; - a blocking member (400) arranged inside the housing (100), the blocking member (400) being axially fixed relative to the housing (100) and being rotatable relative to the housing (100) about the axis (A100) between a blocking position and a release position, in which the blocking member (400) prevents deformation of the retainer (170) and thus retains the retainer (170) in the rest position, and in which the blocking member (400) allows deformation of the retainer (170), the rotation of the blocking member (400) from the blocking position to the release position being caused by the movement of the needle cover (200) from the storage position to the retracted position, the blocking member (400) comprising a locking device (450) configured to lock the needle cover (200) in the safety position.

2. The automatic injector according to claim 1, wherein The locking device (450) comprises a first stop (442), which preferably extends substantially orthogonally to the axis (A100) and is adapted to cooperate with the needle cover (200) in the safety position so as to prevent axial movement of the needle cover (200) in the proximal direction.

3. The automatic injector according to claim 2, wherein: The blocking member (400) comprises a body (401), and the locking device (450) comprises a tab (440) having a free distal end (442) and a base (441) fixed to the body (401), the tab (440) protruding obliquely from the body (401) in the distal direction toward the needle cover (200), the tab (440) being elastically deflectable toward the body (401) by movement of the needle cover (200) from the retracted position to the safety position, the distal end (442) of the tab (440) forming the first stop.

4. The automatic injector according to any one of claims 1 to 3, wherein The locking device (450) comprises a second stop (438), which preferably extends in a plane substantially parallel to the axis (A100) for cooperating with the needle cover (200) in the safety position so as to prevent the blocking member (400) from rotating back towards the blocking position.

5. The automatic injector according to claim 4, wherein The second stop (438) includes a wall extending generally axially and projecting toward the needle cover (200).

6. The autoinjector according to any one of claims 1 to 5, wherein The blocking member (400) includes a cam surface (436) that projects toward the needle cover (200) and is inclined relative to the axis (A100), the cam surface (436) being configured to cooperate with the needle cover (200) so that movement of the needle cover (200) from the storage position to the retracted position causes the blocking member (400) to rotate from the blocking position to the released position.

7. An autoinjector according to any one or more of claims 2 to 6, wherein The needle cover (200) comprises an operating portion (235) for cooperating with the first stop (442) and / or the second stop (438) and / or the cam surface (436), the operating portion (235) comprising at least one pin protruding toward the blocking member (400).

8. The autoinjector according to any one of claims 1 to 7, wherein The needle cover (200) includes guiding means (220, 230), the guiding means of the needle cover being configured to cooperate with the guiding means (103, 115, 124, 164) fixedly arranged on the housing (100), thereby guiding the axial movement of the needle cover (200) relative to the housing (100), and preferably limiting the radial or tangential movement of the needle cover (200) relative to the housing (100).

9. The autoinjector according to any one of claims 1 to 8, wherein The needle cover (200) has a distal portion including a shielding portion (201) and at least one needle cover arm (220) extending proximally from the shielding portion (201), the shielding portion (201) being generally cylindrical.

10. The automatic injector of claim 9, wherein: The housing (100) includes a channel (115) extending axially and receiving the needle cover arm (220), with at least a portion of a side end of the needle cover arm (220) abutting against an inner surface (116) of the channel (115).

11. The automatic injector according to claim 9 or 10, wherein The needle cover arm (220) has a main wall (221) and includes at least one guide rail (230) extending axially and protruding outwardly from the main wall (221), the guide rail (230) being configured to abut against an inner peripheral wall (103) of the housing (100).

12. The automatic injector of claim 11, wherein: The needle cover arm (220) includes a tab (240) having a free distal end (242) and a base (241) fixed to the main wall (221) of the needle cover arm, the tab (240) protruding obliquely from the main wall (221) in the distal direction toward the housing (100), the tab (240) being elastically deflectable toward the axis (A100) to allow the needle cover (200) to be installed in the housing (100), and wherein, in the storage position and the safety position, the distal end (242) of the tab (240) is configured to abut against at least one rib (124) protruding inwardly from the housing (100) and extending axially so as to prevent the needle cover (200) from moving distally relative to the housing (100).

13. An autoinjector according to any one of claims 9 to 12, wherein The needle cover arm (220) has a main wall (221) and includes at least one guide rail (230) extending axially and projecting outwardly from the main wall (221), the guide rail (230) being configured to abut at least one rib (124, 164) projecting inwardly from the housing (100) and extending axially.

14. An autoinjector according to any one of claims 9 to 13, wherein In the stored position, a portion of the side end (225) of the needle cover arm (220) abuts a face (403) of the blocking member (400), the face of the blocking member extending in a plane generally parallel to the axis (A100).

15. An autoinjector according to any one of claims 1 to 14, wherein The blocking member (400) comprises a main body (401) comprising: a central hole (410) in which the inner sleeve (167) is received, the central hole (410) having an inner face (413); - at least one axial groove (411) opening into the central hole (410); wherein, in the blocking position, the blocking member (400) is positioned such that the retainer (170) radially faces the inner face (413) of the central hole (410), and in the releasing position, the blocking member (400) is positioned such that the retainer (170) radially faces the axial groove (411); Wherein, the axial groove (411) is configured to allow the retainer (170) to begin to deform when the needle cover (200) has moved axially along a predetermined length, and preferably, is configured to control the deformation speed of the retainer (170) towards its deformed position.

16. An autoinjector according to any one of claims 1 to 15, wherein The blocking member (400) comprises a main body (401), the main body comprising: a central hole (410) in which the inner sleeve (167) is received, the central hole (410) having an inner face (413); - at least one axial groove (411) opening into the central hole (410); wherein, in the blocking position, the blocking member (400) is positioned such that the retainer (170) radially faces the inner face (413) of the central hole (410), and in the releasing position, the blocking member (400) is positioned such that the retainer (170) radially faces the axial groove (411); wherein the longitudinal edge between the inner face (413) and the axial groove (411) is the last contact portion between the retainer (170) and the inner face (413) before the retainer (170) is deformed after being allowed to rotate the blocking member (400), and the longitudinal edge is referred to as an activation edge (414); Wherein, the axial groove (411) includes a control surface (415) extending from the activation edge (414) toward the inner space of the axial groove (411) and away from the axis (A100) of the shell, and the control surface (415) is inclined at an angle (α) relative to the radial line segment (195) of the shell passing through the activation edge, and the angle (α) is between 25° and 50°, preferably between 35° and 45°.

17. A medical device comprising a medical container (2) and an automatic injector (1) according to any one of the preceding claims, the medical container comprising a barrel (3) defining a reservoir for containing a medical product, the barrel (3) having a distal end (4) provided with a needle (5) and an open proximal end (6), the open proximal end being configured to receive a plunger rod (300) for pushing a stopper (7) arranged inside the barrel (3), the medical container (2) being received in the housing (100) of the automatic injector (1).

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