Drug delivery member shield locking assembly

Abstract

The present application describes a drug delivery member shield locking assembly (58) for a drug delivery device (10), the drug delivery member shield locking assembly (58) comprising: a housing (40) extending in an axial direction (22) along an axis (20) from a proximal end (14) to a distal end (16), the housing (40) comprising a recess or slit (45); a drug delivery member shield (60) slidably arranged in the housing (40), the drug delivery member shield (60) extending from the proximal end (14) to the distal end (16); a locking member activation sleeve slidably arranged in the housing (40) at the distal end (16) of the drug delivery member shield (60); (80); and a drug delivery member shield lock (100) disposed in the housing (40) adjacent to the lock activation sleeve (80), wherein the drug delivery member shield lock (100) includes a base (102) and a flexible arm (104) pivotally attached to the base (102), wherein the flexible arm (104) includes a proximal portion (106) and a distal portion (108), wherein the flexible arm (104) is attached to the base (102) between the proximal portion (106) and the distal portion (108), and wherein the proximal portion (106) of the flexible arm (104) is disposed adjacent to a recess or slot (45) in the housing (40). A variety of related drug delivery devices, drug delivery device components, subassemblies, and methods are also described.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] The disclosure of each of the following applications is incorporated herein by reference: European Patent Application No. EP20201659.8, filed Oct. 14, 2020, and European Patent Application No. EP21172824.1, filed May 17, 2021, both by SHL Medical AG. TECHNICAL FIELD

[0003] The present invention relates to a shield locking assembly for a medicament delivery member, and more particularly to a shield locking assembly for a medicament delivery member including a housing, a medicament delivery member shield, a locking member activation sleeve, and a medicament delivery member shield locking member. BACKGROUND OF THE INVENTION

[0004] A medicament delivery device, such as an auto-injector, may include a needle shield locking member that prevents the needle shield from retracting again after use of the auto-injector, thereby reducing needle stick injuries. However, the needle shield locking member may be fragile, in which case the locking member may break if the needle shield is pushed forcefully. With this in mind, the present applicant has realized that it would be beneficial to develop a more robust needle shield locking member. SUMMARY OF THE INVENTION

[0005] The present invention is defined by the appended claims, and reference should now be made to the claims to understand the invention.

[0006] In the present disclosure, when the term "distal direction" is used, it refers to the direction away from the dose delivery site during use of the medicament delivery device. When the term "distal part / end" is used, it refers to the part / end of the delivery device or its component that is farthest from the dose delivery site when using the medicament delivery device. Correspondingly, when the term "proximal direction" is used, it refers to the direction towards the dose delivery site during use of the medicament delivery device. When the term "proximal part / end" is used, it refers to the part / end of the delivery device or its component that is closest to the dose delivery site when using the medicament delivery device.

[0007] In addition, the terms "longitudinal", "axial", or grammatical variations thereof refer to a direction that generally extends along the device or its component from the proximal end to the distal end in the longest extension direction of the device and / or component.

[0008] Similarly, the term "lateral" or grammatical variations thereof refer to a direction that is generally perpendicular to the axial direction (longitudinal direction).

[0009] A first aspect of the present invention relates to a medicament delivery member shield locking assembly for a medicament delivery device, the medicament delivery member shield locking assembly comprising: a housing extending axially in an axial direction from a proximal end to a distal end, the housing including a recess or a slit; a medicament delivery member shield slidably disposed in the housing, the medicament delivery member shield extending from the proximal end to the distal end; a locking member activation sleeve slidably disposed in the housing at the distal end of the medicament delivery member shield; and a medicament delivery member shield locking member disposed in the housing adjacent to the locking member activation sleeve. The medicament delivery member shield locking member includes a base and a flexible arm pivotally attached to the base, wherein the arm includes a proximal portion and a distal portion, wherein the arm is attached to the base between the proximal portion and the distal portion, and wherein the proximal portion of the arm is disposed adjacent to the recess or the slit in the housing. By being slidably disposed in the housing, the medicament delivery member shield can be attached to the housing and can be moved relative to the housing in the axial direction. Similarly, by being slidably disposed in the housing, the locking member activation sleeve can be moved relative to the housing in the axial direction.

[0010] The medicament delivery member shield locking assembly constructed in this way can provide a robust needle shield locking member, for example for a single-use disposable auto-injector. This is useful for any drug viscosity, but is particularly useful in devices for injecting highly viscous liquids, such as liquids above 30 centipoise, above 50 centipoise, between 30 and 150 centipoise, between 30 and 100 centipoise, or between 30 and 50 centipoise.

[0011] The medicament delivery member shield locking assembly can avoid the need to compromise between the activation force (i.e., the force required to push the medicament delivery member shield back) and the strength of the locking mechanism.

[0012] Optionally, the medicament delivery member shield includes a distally facing surface, and the locking member activation sleeve includes a corresponding proximally facing surface, and the distally facing surface of the medicament delivery member shield engages the proximally facing surface to push the locking member activation sleeve in the distal direction when the medicament delivery member shield is pushed in the distal direction.

[0013] Optionally, the locking member activation sleeve includes a radially facing surface relative to the axis, and by using the radially facing surface when the locking member activation sleeve is pushed in the distal direction, the distal portion of the flexible arm of the medicament delivery member shield locking member is pushed in the radial direction to bias the flexible arm of the medicament delivery member shield locking member against the medicament delivery member shield.

[0014] Optionally, when the medicament delivery member shield is subsequently moved back in the proximal direction, the proximal portion of the flexible arm of the medicament delivery member shield locking member moves towards or into a recess or slit in the housing.

[0015] Optionally, the medicament delivery member shield is configured to push the locking member activation sleeve in the distal direction when the medicament delivery member shield is pushed in the distal direction. Optionally, the locking member activation sleeve is configured to push the distal portion of the flexible arm of the medicament delivery member shield locking member in the radial direction relative to the axis when it is pushed in the distal direction to bias the flexible arm. Optionally, when the medicament delivery member shield is subsequently moved back in the proximal direction, the proximal portion of the arm of the medicament delivery member shield locking member moves towards or into a recess or slit in the housing.

[0016] Optionally, the proximal portion of the flexible arm of the medicament delivery member shield locking member includes a protrusion extending in the radial direction. This can assist in engaging the medicament delivery member shield locking member with a recess or slit in the housing. Optionally, the protrusion extends away from the axis.

[0017] Optionally, the base of the medicament delivery member shield locking member is tubular. Optionally, the locking member activation sleeve is tubular. Optionally, at least a portion of the arm of the medicament delivery member shield locking member is further from the axis than the base. Optionally, a pivot extends between the base of the locking member activation sleeve and the locking member activation sleeve arm.

[0018] Optionally, the medicament delivery member shield locking member includes a bellows section having a variable length in the axial direction and extending axially from the proximal end of the medicament delivery member shield locking member. Optionally, the bellows section includes a support portion spaced from the base of the medicament delivery member shield locking member and at least one arm extending from the base of the medicament delivery member shield locking member to the support portion.

[0019] Optionally, the medicament delivery member shield locking member (usually the base of the medicament delivery member shield locking member) is directly or indirectly fixed to the housing and cannot move relative to the housing. Optionally, the distal end 113 of the distal portion 108 of the arm is further from the axis 20 than the proximal end 109 of the distal portion 108 of the arm. Optionally, the distal portion 108 of the arm includes a protrusion 111. This protrusion 111 can assist in holding the locking member activation sleeve and the arm in place before injection.

[0020] Optionally, the medicament delivery member shroud includes a proximal portion and a distal portion, wherein the proximal portion is tubular and the distal portion includes an arm. Optionally, the arm of the medicament delivery member shroud includes a recess or slit extending in the axial direction. The recess or slit can receive the arm of the medicament delivery member shroud lock during injection and can reduce the strain on the arm. It can also enable a stronger arm as the arm can be bent less.

[0021] Optionally, the radially facing surface of the lock activation sleeve faces the axis 20. Optionally, the distally facing surface of the medicament delivery member shroud and the proximally facing surface of the lock activation sleeve are spaced apart in the axial direction. This can help prevent activation of the medicament delivery device if the medicament delivery device is dropped.

[0022] In a second aspect of the invention, there is provided a medicament delivery device including any of the above medicament delivery member shroud lock assemblies. Optionally, the medicament delivery member shroud lock assembly includes a medicament delivery member shroud spring, which is generally disposed between the medicament delivery member shroud and the housing or syringe holder. Optionally, the medicament delivery device includes a medicament delivery member. Optionally, the medicament delivery member is an injection needle or a jet injector. Optionally, the medicament delivery device includes a plunger rod extending through the medicament delivery member shroud lock and the lock activation sleeve. Optionally, the medicament delivery device includes a threaded drive nut, wherein the plunger rod is threaded to engage the threads on the drive nut. Optionally, the medicament delivery device includes a drive for driving the plunger rod. Optionally, the medicament delivery device is an autoinjector or a pen injector.

[0023] A third aspect of the present invention relates to a method of using a medicament delivery member shield locking assembly, the medicament delivery member shield locking assembly including a tubular housing having a recess or slit, the tubular housing extending from a proximal end to a distal end along an axis; a medicament delivery member shield slidably disposed in the tubular housing; a locking member activation sleeve slidably disposed in the tubular housing; and a medicament delivery member shield locking member disposed in the tubular housing, the medicament delivery member shield locking member including a base and a flexible arm pivotally attached to the base, wherein the flexible arm is pivotally attached to the base between a proximal portion of the flexible arm and a distal portion of the flexible arm, the method comprising the steps of: pushing the medicament delivery member shield in a distal direction relative to the tubular housing, thereby pushing the locking member activation sleeve in a distal direction relative to the tubular housing, such that the locking member activation sleeve pushes the distal portion of the flexible arm of the medicament delivery member shield locking member towards the axis and biases the proximal portion of the flexible arm of the medicament delivery member shield locking member away from the axis; and releasing the medicament delivery member shield such that the medicament delivery member shield moves in a proximal direction, thereby allowing the biased proximal portion of the medicament delivery member shield locking member to move away from the axis and towards the recess or slit in the tubular housing. The advantages of this method are similar to the advantages of the above-described medicament delivery member shield locking assembly.

[0024] Optionally, when the biased proximal portion of the medicament delivery member shield locking member moves away from the axis, a portion of the proximal portion of the medicament delivery member shield locking member moves into the recess or slit in the housing.

[0025] A fourth aspect of the present invention relates to a medicament delivery member shield locking assembly configured to perform any of the methods in the third aspect above.

[0026] A fifth aspect of the present invention relates to a medicament delivery member shield locking assembly for an auto-injector, the medicament delivery member shield locking assembly including a housing, a medicament delivery member shield, a locking member activation sleeve, and a medicament delivery member shield locking member, wherein the housing, the medicament delivery member shield, the locking member activation sleeve, and the medicament delivery member shield locking member are arranged relative to each other such that movement of the medicament delivery member shield in a distal direction pushes the locking member activation sleeve in a distal direction, which in turn pushes a portion of the medicament delivery member shield locking member in a direction perpendicular to the axial direction, and wherein when the medicament delivery member shield is subsequently moved in a proximal direction, a portion of the medicament delivery member shield locking member moves perpendicular to the axial direction to limit movement of the medicament delivery member shield in a distal direction.

[0027] The sixth aspect of the present invention relates to a medicament delivery member shield locking assembly for an autoinjector, the medicament delivery member shield locking assembly comprising: a housing extending in an axial direction from a proximal end to a distal end; a medicament delivery member shield movable relative to the housing in the axial direction from a first position to a second position and then to a third position; a locking member activation sleeve movable relative to the housing in the axial direction from a first position to a second position; and a medicament delivery member shield locking member having an arm movable relative to the housing from a first position to a second position and then to a third position, wherein in an initial state prior to use of the medicament delivery member shield locking assembly, the medicament delivery member shield is in the first position, the locking member activation sleeve is in the first position, and the arm of the medicament delivery member shield locking member is in the first position, wherein in an intermediate state, the medicament delivery member shield is in the second position, the locking member activation sleeve is in the second position, and the arm of the medicament delivery member shield locking member is in the second position, and wherein in a final state, the medicament delivery member shield is in the third position, the locking member activation sleeve is in the second position, and the arm of the medicament delivery member shield locking member is in the third position. All of the positions listed above are generally different from each other, but this is not necessary; for example, the first position and the third position of the medicament delivery member shield may be the same.

[0028] The seventh aspect of the present invention relates to a medicament delivery member shield locking assembly for a medicament delivery device, the medicament delivery member shield locking assembly comprising: a tubular housing extending in an axial direction along an axis from a proximal end to a distal end; a medicament delivery member shield slidably disposed in the proximal end of the housing, the medicament delivery member shield extending from the proximal end to the distal end, the medicament delivery member shield including a distally facing surface; a locking member activation sleeve slidably disposed in the housing, the locking member activation sleeve including a proximally facing surface configured to engage the distally facing surface of the medicament delivery member shield; and a medicament delivery member shield locking member disposed in the housing, wherein the medicament delivery member shield locking member is fixed relative to the housing, wherein the medicament delivery member shield locking member includes a base and an arm extending from a proximal end to a distal end, wherein the arm is pivotally attached to the base between the proximal end and the distal end.

[0029] The eighth aspect of the present invention relates to a medicament delivery member shield lock for a medicament delivery device, the medicament delivery member shield lock extending axially along an axis from a proximal end to a distal end, the medicament delivery member shield lock including a base and a flexible arm pivotally attached to the base, wherein the arm includes a proximal portion and a distal portion, and the arm is attached to the base between the proximal portion and the distal portion, and wherein the distal portion of the arm is configured to be biased towards the axis, and wherein the proximal portion of the arm is configured to be biased away from the axis when the distal portion of the arm is biased towards the axis. Any combination of the optional features of the medicament delivery member shield lock of the medicament delivery member shield lock assembly for the first aspect as described above may also be included in this medicament delivery member shield lock.

[0030] The ninth aspect of the present invention relates to a drive nut for a medicament delivery device, the drive nut including a base; an arm attached to the base, the arm being configured to engage a lock activation sleeve and a drive member to lock the medicament delivery device before the medicament delivery device is used; and a thread attached to the base, the thread being configured to engage a corresponding thread on a piston rod to guide the piston rod in a proximal direction during use of the medicament delivery device.

[0031] The tenth aspect of the present invention relates to an activation subassembly for a medicament delivery device, the activation subassembly including a plunger rod, the medicament delivery member shield lock of the seventh aspect, the drive nut of the ninth aspect, and a lock activation sleeve, the lock activation sleeve including a radially facing surface configured to engage the distal portion of the arm of the medicament delivery device guard lock. Optionally, the activation subassembly includes a thrust bearing attached to the proximal end of the plunger rod.

[0032] The eleventh aspect of the present invention relates to a power unit subassembly for a medicament delivery device, the power unit subassembly including a power unit housing, a drive member, a torsion spring attached to the power unit housing and the drive member, and a power unit lock, wherein in a first position, the power unit lock is rotationally locked relative to the power unit housing, and the drive member is free to rotate relative to the power unit housing to tension the torsion spring, and wherein in a second position, the power unit lock is rotationally locked relative to the power unit housing and the drive member, and the torsion spring is tensioned. Optionally, in a third position, the power unit lock is rotationally locked relative to the drive member, and the power unit lock is free to rotate relative to the power unit housing.

[0033] The twelfth aspect of the present invention relates to a rear subassembly for a medicament delivery device, the rear subassembly including the power unit subassembly of the eleventh aspect and the activation subassembly of the tenth aspect.

[0034] A thirteenth aspect of the present invention relates to a sub-assembly of a medicament delivery device, the sub-assembly of the medicament delivery device comprising a drive member and a drive nut for driving a plunger rod, wherein the drive member comprises teeth and the drive nut comprises corresponding teeth, so as to give an indication, such as an audible or tactile indication, when the drive member rotates relative to the drive nut during medicament delivery.

[0035] A fourteenth aspect of the present invention relates to a sub-assembly of a medicament delivery device, the sub-assembly of the medicament delivery device comprising a drive member for driving a plunger rod and a power unit locking member, wherein the drive member and the power unit locking member comprise corresponding protrusions engaging with each other, so as to give an indication, such as an audible or tactile indication, when the drive member rotates relative to the power unit locking member during medicament delivery.

[0036] A fifteenth aspect of the present invention relates to a sub-assembly of a medicament delivery device, the sub-assembly of the medicament delivery device comprising a rotating body, wherein the rotating body is attached to a component configured to rotate during medicament delivery, so that the rotating body rotates when the component rotates during medicament delivery to provide an indication of medicament delivery, such as a visual, audible or tactile indication. Optionally, the component rotates relative to the housing. Optionally, the component designed to rotate during medicament delivery is a plunger rod or a drive member for driving the plunger rod.

[0037] A sixteenth aspect of the present invention relates to a medicament delivery device, such as an auto-injector or a pen injector, the medicament delivery device comprising the content of one or more of the fourth to fifteenth aspects.

[0038] Another aspect relates to a locking mechanism for a medicament delivery device, the locking mechanism extending axially from a proximal end to a distal end relative to a longitudinal axis, the locking mechanism comprising a housing, a medicament delivery member shield and a cap, wherein one of the medicament delivery member shield and the housing comprises a flexible arm, the flexible arm comprising a protrusion extending in a radial direction relative to the longitudinal axis, wherein the other of the medicament delivery member shield and the housing comprises a recess or a notch, wherein a part of the flexible arm is located in the recess or the notch, wherein the flexible arm is located between the cap and the other of the medicament delivery member shield and the housing, and wherein the cap is adjacent to the flexible arm in a radial direction relative to the longitudinal axis. This can lock the medicament delivery device before removing the cap to avoid activation. This may allow the needle spring, which should be stronger to prevent the device from activating when dropped, to be weaker, possibly allowing a lower activation force, thus making it easier for the end user to deliver the medicament. For example, this is particularly important in some user groups with low grip strength.

[0039] Optionally, the housing extends around a medicament delivery member shield. Optionally, the housing includes a flexible arm, and the medicament delivery member shield includes a recess or notch. Optionally, a proximal end of the notch or recess is spaced apart from the protrusion in a longitudinal direction. This helps to reduce the force required to start moving the medicament delivery shield. Optionally, the recess or notch is a first recess or notch, and the other of the medicament delivery member shield and the housing includes a second recess or notch that is closer to the proximal end than the first recess or notch. This can reduce friction. Optionally, the second recess or notch is aligned with the first recess or notch in a direction of a longitudinal axis. Optionally, the cap, the housing, and the medicament delivery member shield are arranged such that movement of the housing in a radial direction is prevented before removal of the cap, thereby preventing the medicament delivery member shield from moving in a distal direction, and such that the housing can move in a radial direction after removal of the cap, and thus the medicament delivery member shield can push the housing in a radial direction to move the housing in a distal direction. Optionally, a portion of the arm within the recess or notch is a protrusion.

[0040] Another aspect relates to a locking mechanism for a medicament delivery device, the locking mechanism extending axially from a proximal end to a distal end relative to a longitudinal axis, the locking mechanism including a housing, a medicament delivery member shield, and a cap, wherein one of the medicament delivery member shield and the cap includes a protrusion extending in a radial direction relative to the longitudinal axis, wherein the other of the medicament delivery member shield and the cap includes a recess or notch, wherein the protrusion is located within the recess or notch, wherein the medicament delivery member shield is movable relative to the housing from a locked position to an unlocked position in a direction of the longitudinal axis, wherein in the locked position, movement of the protrusion relative to the recess or notch is restricted by a wall of the housing, and in the unlocked position, movement of the protrusion relative to the recess or notch is no longer restricted by the wall of the housing, thereby allowing the protrusion to move out of the recess or notch and allowing removal of the cap from the medicament delivery member shield. This can lock the medicament delivery device before removal of the cap to avoid activation. This may allow a needle spring, which would otherwise be stronger to prevent activation of the device upon dropping, to be weaker, potentially allowing a lower activation force and thus making it easier for a user to deliver the medicament. This is particularly important, for example, in some user groups with a lower grip strength.

[0041] Optionally, at least one of the cap and the medicament delivery member shield includes a flexible portion. Optionally, the flexible portion is a flexible arm of the cap. Optionally, the recess or notch is located in the flexible arm. Optionally, the cap includes a cap housing and a cap core, and the cap core is rotatable relative to the cap body. Optionally, the cap core is attached to the cap body by a snap fit that restricts movement of the cap core relative to the cap body in the axial direction. Optionally, rotational movement of the cap core relative to the cap body is restricted by ribs extending from the cap body. Optionally, the cap includes a distal-facing surface adjacent to the proximal-facing surface of the housing. Optionally, the distal-facing surface of the cap and the proximal-facing surface of the housing each depict a sine pattern in the circumferential direction relative to the longitudinal axis. Optionally, the walls of the housing face in the radial direction. Optionally, the walls of the housing face the axis.

[0042] Optionally, the cap includes a medicament delivery member shield removal member, preferably a rigid medicament delivery member shield removal member.

[0043] Another aspect relates to a medicament delivery device including a locking mechanism as described above. Optionally, the medicament delivery device is an autoinjector. Optionally, the medicament delivery device includes a power unit within the housing and a main kit within the housing. Optionally, the medicament delivery device includes a housing, and the protrusion and / or the flexible arm are located within the housing. Optionally, the proximal end of the protrusion and / or the proximal end of the flexible arm are remote from the proximal end of the housing.

[0044] Another aspect relates to a locking mechanism for a medicament delivery device that extends in the axial direction from a proximal end to a distal end relative to a longitudinal axis, the locking mechanism including a housing, a needle shield (or more generally a medicament delivery member shield), and a cap, wherein preferably at least one of the housing, the needle shield, and the cap body has a flexible arm, wherein the interaction between the housing, the needle shield, and the cap restricts distal movement of the needle shield until the cap is removed, and wherein the needle shield is able to move freely in the distal direction after the cap is removed. Optionally, the flexible arm is a lever. Optionally, the cap includes a cap body and a needle shield removal member. Optionally, the proximal end of the lever includes a protrusion, and the cap includes a corresponding protrusion such that when the needle shield moves distally relative to the cap, the protrusion of the cap engages the protrusion of the needle shield and pivots the lever, wherein pivoting the lever causes the distal end of the lever to move radially relative to the axis such that the proximal-facing surface of the distal end of the lever aligns with the distal-facing surface of the housing. Optionally, the distal-facing surface of the housing is further from the longitudinal axis than the proximal-facing surface of the lever.

[0045] Another aspect relates to a locking mechanism for a medicament delivery device, the locking mechanism comprising a housing, a needle shield (or more generally a medicament delivery member shield) and a cap, wherein the locking mechanism comprises a recess or notch, wherein the locking mechanism comprises a projection extending into the recess or notch, wherein the locking mechanism comprises a flexible part, wherein the locking mechanism is movable between a locked position and an unlocked position, wherein in the locked position, movement of the flexible part is restricted, thus restricting the projection from leaving the recess or notch, and wherein in the unlocked position, by movement of the flexible part, the projection is able to leave the recess or notch. Optionally, the cap comprises a cap housing and a needle shield removal member.

[0046] Another aspect of the present invention relates to a locking mechanism for a medicament delivery device, the locking mechanism comprising a housing, a needle shield and a cap. The locking mechanism extends axially from a proximal end to a distal end relative to a longitudinal axis. This enables the medicament delivery device to be locked before removing the cap to avoid activation. This may allow the needle spring, which would otherwise be stronger to prevent the device from activating upon dropping, to be weaker, potentially allowing a lower activation force and thus making it easier for the user to deliver the medicament. For example, this is particularly important in some user groups with a low grip strength.

[0047] Optionally, at least one of the housing, the needle shield and the cap body has a flexible arm, wherein the interaction between the housing, the needle shield and the cap restricts the distal movement of the needle shield before the cap is removed, and wherein the needle shield is able to move distally freely after the cap is removed.

[0048] Optionally, one of the needle shield and the cap comprises a projection extending radially relative to the longitudinal axis, wherein the other of the needle shield and the cap comprises a recess or notch, wherein a part of the arm (e.g. the projection) is in the recess or notch, wherein the needle shield is movable relative to the housing in the longitudinal axis direction from a locked position to an unlocked position, wherein in the locked position, movement of the projection relative to the recess or notch is restricted by the wall of the housing, and in the unlocked position, movement of the projection relative to the recess or notch is no longer restricted by the wall of the housing, thereby allowing the projection to move out of the recess or notch and allowing the cap to be removed from the needle shield.

[0049] Optionally, one of the needle shield and the housing includes a flexible arm, which includes a protrusion extending in a radial direction relative to the longitudinal axis, wherein the other of the needle shield and the housing includes a recess or notch, wherein the arm (e.g., the protrusion of the arm) extends into the recess or notch, wherein the flexible arm is located between the cap and the other of the needle shield and the housing, and wherein the cap is adjacent to the protrusion in the radial direction relative to the longitudinal axis.

[0050] Optionally, the locking mechanism includes a recess or notch, wherein the locking mechanism includes a protrusion extending into the recess or notch, the locking mechanism includes a flexible portion, and the locking mechanism is movable between a locked position and an unlocked position, wherein in the locked position, the movement of the flexible portion is restricted, so that the protrusion is restricted from leaving the recess or notch, and wherein in the unlocked position, the protrusion can leave the recess or notch by the movement of the flexible portion.

[0051] Another aspect of the present invention relates to a tool for assembling a medicament delivery device, the tool including a distal tool and a proximal tool, wherein the distal tool is rotatable relative to the proximal tool, wherein the distal tool is configured to receive and rotationally lock a part of a power unit locked to the medicament delivery device, such as a power unit lock and / or a power unit housing, and wherein the proximal tool is configured to receive and rotationally lock to another part of the medicament delivery device, such as a lock activation sleeve.

[0052] Another aspect of the present invention relates to a method for assembling a medicament delivery device, the method including the steps of: inserting a first power unit sub-assembly into a distal tool of a tool for assembling a medicament delivery device, inserting a torsion spring onto the first power unit sub-assembly, inserting a second power unit sub-assembly onto the torsion spring, inserting a proximal tool of the tool for assembling a medicament delivery device onto the second power unit sub-assembly, and rotating the first power unit sub-assembly relative to the second power unit sub-assembly to wind the torsion spring.

[0053] Another aspect of the present invention relates to a cap for a medicament delivery device, the cap including a cap housing, a pull strap attached to the cap housing, and an arm extending from the cap housing.

[0054] Generally, unless otherwise clearly defined herein, all terms used in the claims shall be construed in accordance with their ordinary meaning in the art to which this technology pertains. Unless otherwise clearly stated, all references to "an / the element, device, component, part, apparatus", etc. shall be construed in an open-ended manner as referring to at least one instance of the element, device, component, part, apparatus, etc. Description of the Drawings

[0055] Embodiments of the present invention will now be described by way of example with reference to the following drawings:

[0056] Figure 1 A cross-sectional view of a portion of an auto-injector is shown, showing the configuration of the needle guard locking assembly before use of the auto-injector.

[0057] Figure 2 Shows Figure 1 the configuration of the components in

[0058] Figure 3 Shows Figure 1 the configuration of the components after injection.

[0059] Figure 4 Shows Figure 1 the configuration of the components when attempting to retract the needle guard again after injection.

[0060] Figure 5 A cross-sectional view of a portion of an auto-injector is shown, showing the configuration of the needle guard locking assembly before use of the auto-injector.

[0061] Figure 6 Shows Figure 5 the configuration of the components during injection.

[0062] Figure 7 Shows Figure 5 the configuration of the components during the return of the needle guard after injection.

[0063] Figure 8 Shows Figure 5 the configuration of the components after injection.

[0064] Figure 9 Shows Figure 5 the configuration of the components when attempting to retract the needle guard again after injection.

[0065] Figure 10 A perspective view of another auto-injector including a needle guard locking assembly is shown.

[0066] Figure 11 Shows Figure 10 an exploded side view of the front sub-assembly of the auto-injector of

[0067] Figure 12 Shows Figure 10 an exploded side view of the rear sub-assembly of the auto-injector of

[0068] Figure 13 Shows Figure 10 a perspective view of the syringe holder and the needle guard of

[0069] Figure 14 shows a Figure 10 perspective view of the front sub - assembly of an auto - injector.

[0070] Figure 15 shows a Figure 10 perspective view of the power unit lock and the power unit housing of the power unit sub - assembly of an auto - injector.

[0071] Figure 16 shows a Figure 10 near - side view of a portion of the power unit lock and the power unit housing of an auto - injector after they are initially attached to each other (first position of the power unit lock).

[0072] Figure 17 shows a Figure 10 perspective view of the power unit lock, the power unit housing, the torsion spring, and the drive member of an auto - injector before the drive member is attached.

[0073] Figure 18 shows a Figure 10 perspective view of the power unit sub - assembly of an auto - injector.

[0074] Figure 19 shows a near - side view of a portion of the power unit lock when the power unit lock is in the second position.

[0075] Figure 20 shows a Figure 10 perspective view of the activation sub - assembly of an auto - injector.

[0076] Figure 21 shows a Figure 20 perspective view of the plunger rod, the lock activation sleeve, and the drive nut of the activation sub - assembly.

[0077] Figure 22 shows a near - side cross - sectional view of a portion of the lock activation sleeve and the drive nut, and a side view of the plunger rod.

[0078] Figure 23 shows a Figure 22 near - side cross - sectional view of a portion of the lock activation sleeve and the drive nut at a 90 - degree angle to the view in Figure 20 and a side view of the plunger rod of

[0079] Figure 24 shows a Figure 20 perspective view of the plunger rod, the lock activation sleeve, the needle guard lock, and the drive nut of the activation sub - assembly.

[0080] Figure 25 shows aFigure 24 Side cross-sectional view of the shown components during assembly.

[0081] Figure 26 Shows Figure 20 A side cross-sectional view of a part of the activation subassembly of

[0082] Figure 27 Shows Figure 10 A perspective view of the power unit subassembly and the activation subassembly of the auto-injector of when attached together.

[0083] Figure 28 Shows Figure 10 A perspective view of the power unit subassembly and the activation subassembly of the auto-injector of when attached together and located within the housing 40.

[0084] Figure 29 Shows a perspective view of another exemplary auto-injector.

[0085] Figure 30 Shows Figure 29 An exploded perspective view of the components of the auto-injector of

[0086] Figure 31 Shows Figure 29 A cross-sectional view of the auto-injector of before use.

[0087] Figure 32 Shows Figure 29 A perspective and partial cross-sectional view of a part of the auto-injector of before use.

[0088] Figure 33 Shows Figure 29 A perspective and partial cross-sectional view of the housing and the drive nut of the auto-injector of

[0089] Figure 34 Shows Figure 29 A perspective and partial cross-sectional view of a part of the auto-injector of before use.

[0090] Figure 35 Shows Figure 29 A side and partial cross-sectional view of some components of the auto-injector of during injection.

[0091] Figure 36 Shows Figure 29 A side and partial cross-sectional view of a part of the auto-injector of before use.

[0092] Figure 37 Shows Figure 29 An axial view of some components of the auto-injector of

[0093] Figure 38 ShowsFigure 29 Perspective view of the drive member and the rotator of the auto-injector.

[0094] Figure 39 Shows Figure 29 Cross-sectional view of the distal end of the auto-injector.

[0095] Figure 40 Shows Figure 29 Perspective view of the distal end of the auto-injector.

[0096] Figure 41 Shows Figure 29 Cross-sectional view of a part of the auto-injector before use.

[0097] Figure 42 Shows Figure 29 Cross-sectional view of a part of the auto-injector before use but after removal of the cap.

[0098] Figure 43 Shows Figure 29 Cross-sectional view of a part of the auto-injector during injection.

[0099] Figure 44 Shows Figure 29<\br >Figure 45 Cross-sectional view of some components of the auto-injector after use.

[0100] Figure 29 Shows Figure 46 Perspective and partial cross-sectional view of some components of the auto-injector after use.

[0101] Figure 29 Shows Figure 47 Cross-sectional view of some components of the auto-injector before use.

[0102] Figure 46 Shows Figure 48 Cross-sectional view of the components after activation.

[0103] Figure 29 Shows Figure 49 Perspective view of the drive member and the drive nut of the auto-injector before use.

[0104] Figure 29 Shows Figure 50 Axial cross-sectional view of the drive member and the drive nut of the auto-injector before use.

[0105] Figure 29 Shows Figure 51 Perspective view of the thrust bearing of the auto-injector.

[0106] Figure 29 Shows Figure 52Another perspective view of the thrust bearing of the auto-injector.

[0107] Figure 53 A cross-sectional view and a perspective view showing a part of another similar exemplary auto-injector, which shows features that allow the power unit lock and the power unit housing to interact to produce a clicking sound during injection.

[0108] Figure 54 A perspective view of an exemplary auto-injector is shown.

[0109] Figure 53 Shows Figure 55 An exploded perspective view of the auto-injector.

[0110] Figure 54 Shows Figure 56 A perspective view of the needle guard lock.

[0111] Figure 54 Shows Figure 57 A perspective view of the drive nut.

[0112] Figure 54 Shows Figure 58 A perspective view of the lock activation sleeve.

[0113] Figure 54 Shows Figure 59 A perspective view of the power unit lock.

[0114] Figure 54 Shows Figure 60 A perspective view of the drive member.

[0115] Figure 54 Shows Figure 61 A perspective view of the power unit housing.

[0116] Figure 54 Shows Figure 62 Another perspective view of the power unit housing.

[0117] Figure 54 Shows Figure 63 A perspective view of the needle guard.

[0118] Figure 54 Shows Figure 64 A perspective view of the parts of the cap.

[0119] Figure 53 Shows Figure 65 A cross-sectional view of a part of the auto-injector before removing the cap.

[0120] Figure 53 Shows Figure 66 Cross-sectional view of a portion of an auto-injector during cap removal.

[0121] Figure 53 Shows Figure 67 Perspective view of a portion of an auto-injector during cap removal by twisting.

[0122] Figure 53 Shows Figure 68 Perspective view of a portion of an auto-injector during cap removal.

[0123] Figure 53 Shows Figure 69 Perspective view of the cap during cap removal by twisting.

[0124] Figure 53 Shows Figure 70 Perspective view of the cap.

[0125] Figure 71 Shows a perspective view of another exemplary auto-injector.

[0126] Figure 70 Shows Figure 72 Exploded perspective view of an auto-injector.

[0127] Figure 71 Shows Figure 73 Perspective view of the power unit housing and the rotor cap.

[0128] Figure 71 Shows Figure 74 Perspective view of the power unit lock and the rotor.

[0129] Figure 71 Shows Figure 75 Perspective and partial cross-sectional view of a portion of the power unit lock and the rotor.

[0130] Figure 70 Shows Figure 76 Perspective view of the distal portion of an auto-injector.

[0131] Figure 70 Shows Figure 77 Cross-sectional view of an auto-injector.

[0132] Figure 71 Shows Figure 78 Perspective view of the needle shield lock.

[0133] Figure 71 Shows Figure 79 Perspective view of the drive nut.

[0134] Figure 71 Shows Figure 80Perspective view of the locking member activating the cannula.

[0135] Figure 71 Shows Figure 81 Perspective view of the cap housing.

[0136] Figure 71 Shows Figure 82 Perspective view of the proximal housing.

[0137] Figure 70 Shows Figure 83 Cross-sectional view of a portion of the auto-injector before use.

[0138] Figure 70 Shows Figure 84 Cross-sectional view of a portion of the auto-injector when the needle shield is moved distally relative to the housing before removing the cap.

[0139] Figure 70 Shows Figure 85 Cross-sectional view of a portion of the auto-injector after removing the cap and after the needle shield has been moved distally relative to the housing.

[0140] Figure 84 Shows Figure 86 Perspective view of the components in.

[0141] Figure 87<\br >Figure 86 Cross-sectional view of a portion of another exemplary auto-injector.

[0142] Figure 88 Shows Figure 86 Cross-sectional view of the auto-injector before removing the cap when the needle shield is moved distally relative to the housing.

[0143] Figure 89 Shows Figure 90 Perspective view of the needle shield.

[0144] Figure 89 Perspective view of a portion of another exemplary auto-injector.

[0145] Figure 91 Shows Figure 92 Side view of the cap of the auto-injector.

[0146] Figure 93 Perspective view of the distal tool, power unit locking member, and power unit housing during device assembly.

[0147] Figure 94 Side view of a portion of the power unit locking member and power unit housing during device assembly.

[0148] Figures 96 to 98 A cross-sectional side view of a distal tool, a power unit lock, and a portion of the power unit housing during device assembly is shown.

[0149] Figure 99 and 95 A perspective view of a distal tool, a proximal tool, and a portion of an autoinjector during device assembly is shown.

[0150] Figure 100 A cross-sectional side view of an autoinjector and a portion of an assembly tool during device assembly is shown.

[0151] Figure 99 A perspective view of another exemplary autoinjector is shown.

[0152] Figure 101 Shows Figure 100 An exploded perspective view of the autoinjector.

[0153] Figure 102 Shows Figure 100 A perspective view of the plunger rod and the thrust bearing.

[0154] Figure 103<\br >Figure 100 Shows Figure 104 Another perspective view of the thrust bearing.

[0155] Figure 100 Shows Figure 105 A perspective view of the power unit lock and the drive member.

[0156] Figure 100 Shows Figure 106A A perspective view of the power unit housing and the rotor cap.

[0157] Figure 100 Shows Figure 107 A perspective view of the needle guard lock.

[0158] Figure 100 and 106B Shows Figure 108 Different perspective views of the drive nut.

[0159] Figure 100 Shows Figure 109 A perspective view of the lock activation sleeve.

[0160] Figure 100 Shows Figure 110 A perspective view of the drive member.

[0161] Figure 100 Shows Figure 111 A perspective view of the distal housing.

[0162] Figure 100Shows Figure 112 a perspective view of the syringe holder 120

[0163] Figure 113 r>Figure 99 Shows Figures 113 to 115 a perspective view of the needle guard

[0164] Figure 100 Shows Figure 116 a cross-sectional view of a portion of the auto-injector

[0165] Figure 99 Respectively shows Figures 118 to 120 two different perspective views of the components (i.e., the cap housing, the cap core, and the proximal housing) in

[0166] Figure 99 and 117 Shows Figure 121 different perspective views of the front sub-assembly of the auto-injector

[0167] Figure 122 Shows Figure 121 different views of the front sub-assembly of the auto-injector after removal of the cap and after the needle guard has been pushed distally relative to the housing

[0168] Figure 123 Shows an exploded perspective view of the feedback mechanism sub-assembly

[0169] Figure 121 Shows Figure 125 a cross-sectional perspective view of a portion of the medicament delivery device including the feedback mechanism sub-assembly

[0170] Figure 121 and 124 Shows Figure 126A a perspective view of the rotator

[0171] Figure 121 Shows Figure 126B<\br >Figure 121 a perspective view of the sound generator

[0172] Figure 127 Shows Figure 121 a perspective view of the rotator cap

[0173] Figure 128 Shows Figure 121 a perspective view of the power unit lock

[0174] Figure 129 Shows Figure 1 a perspective view of the rotator

[0175] Figures 1 to 4 Shows Figure 1 a perspective view of a portion of the rotator cap

[0176] Figure 2 and 130 shows a perspective view of another feedback mechanism. Detailed Description

[0177] This application illustrates various concepts as outlined in the "Summary of the Invention" section above. First, a needle shield locking assembly will be described. Then, exemplary autoinjectors will be described. These autoinjectors can include concepts such as the needle shield locking assembly described above, thus helping to place various concepts such as the needle shield locking assembly in the context of this specification.

[0178] In one aspect, a medicament delivery member shield locking assembly (58) for a medicament delivery device (10) is described, the medicament delivery member shield locking assembly (58) comprising: a housing (40) extending from a proximal end (14) to a distal end (16) in an axial direction (22) along an axis (20), the housing (40) including a recess or slit (45); a medicament delivery member shield (60) slidably disposed in the housing (40), the medicament delivery member shield (60) extending from the proximal end (14) to the distal end (16); a locking member activation sleeve (80) slidably disposed in the housing (40) at the distal end (16) of the medicament delivery member shield (60); and a medicament delivery member shield locking member (100) disposed in the housing (40) adjacent to the locking member activation sleeve (80), wherein the medicament delivery member shield locking member (100) includes a base (102) and a flexible arm (104) pivotally attached to the base (102), wherein the flexible arm (104) includes a proximal portion (106) and a distal portion (108), wherein the flexible arm (104) is attached to the base (102) between the proximal portion (106) and the distal portion (108), and wherein the proximal portion (106) of the flexible arm (104) is arranged adjacent to the recess or slit (45) in the housing (40).

[0179] Figure 3 A portion of an autoinjector 10 is shown, which includes a housing 40, a needle shield (needle guard) 60, a locking member activation sleeve 80, and a needle shield locking member 100.

[0180] The housing 40 includes two slits 45 opposite each other with respect to the axis (central axis) 20. The slits 45 extend through the housing 40 in a radial direction 26. The needle shield 60, the locking member activation sleeve 80, and the needle shield locking member 100 are all located within the housing 40.

[0181] The needle shield 60 includes two arms 62 extending within the housing.

[0182] The locking member activation sleeve 80 includes a tubular section 82 and two arms 84. Each arm includes a radially facing surface, in this case the radially facing surface is a pad 86 facing the axis 20.

[0183] The needle guard locking member 100 includes a base (a tubular section 102 in this example) and two arms 104. The arms are flexible and are attached to the tubular section 102 between the proximal portion 106 and the distal portion 108 of the arm 104. The proximal portion of the proximal portion 106 of the arm (which is also the most proximal portion of the arm in this case) is shaped to engage a slit in the housing, in this case to engage a projection 110.

[0184] Please refer to Figure 4 , and now the relative movement of different components during use will be described. Figure 3 The initial position of the auto-injector before use (and before activation) is shown. This is the position that the auto-injector typically remains in between final assembly and use (e.g., during transportation and storage). Figure 5 The configuration of the auto-injector 10 after the needle guard 60 has been moved distally (typically achieved by starting an injection) is shown. The distal movement of the needle guard 60 also pushes the locking member activation sleeve 80 distally. The distal movement of the locking member activation sleeve 80 causes the pad 86 of the locking member activation sleeve to engage the distal portion 108 of the arm 104 of the needle guard locking member and to push the distal portion 108 of the arm 104 towards the axis 20. The proximal portion 106 of the arm 104 will pivot accordingly and move away from the axis 20, but the needle guard 60 prevents this movement. As a result, the arm 104 is biased and (moves away from the axis) pushes the needle guard 60.

[0185] Once the needle guard is allowed to move distally again (typically at the end of injection, although this may also be earlier in the case where the needle guard is prematurely lifted from the injection site), the needle guard moves proximally back to as Figure 1The position shown (in this case, the final position after injection is the same as the initial position before injection, although this is optional). However, the locking member activation sleeve does not move back to its initial position, so the gasket 86 still pushes the distal portion 108 of the arm 104 towards the axis 20. To release the tension generated in the arm 104 as described above, once the needle guard 60 no longer obstructs the proximal portion 106 of the arm 104, this proximal portion 106 moves away from the axis 20. The proximal portion 106 of the arm 104 (or specifically, the protrusion 110 on the proximal portion of the arm 104 in this instance) terminates in (or adjacent to) the slit 45 in the housing 40. The arm can remain tensioned after injection so that it holds the locking member activation sleeve 80 in place by friction. Of course, one or more other features at other locations on the device can additionally or alternatively hold the locking member activation sleeve in place.

[0186] Figure 13 Shows what happens if an attempt is made to push the needle guard 60 back in the distal direction after the lock created by the needle guard lock 100 has been set. In this instance, the needle guard 60 can be moved a short distance back in the distal direction (as Figures 5 to 9 The gap between the arm 104 and the needle guard 60 shown is optional but preferred as it allows for greater manufacturing tolerances during component manufacture and assembly), but is then prevented from moving further in the distal direction by the arm 104 of the needle guard lock 100. The arm 104 is supported in the slit 45 by the protrusion 110.

[0187] Figure 5 Shows an autoinjector similar to the Figure 1 autoinjector described, but with arms 62 of a different shape on the needle guard 60. In this instance, each arm 62 includes a slit 66 (also visible in the Figure 6 instance). Figure 2 Shows the relative movement of different components during use, where Figure 8 corresponds to Figure 3 , Figure 9 corresponds to Figure 4 , Figure 6 corresponds to Figure 7 , Figure 1 to 4 corresponds to Figure 6 . Differences from Figure 7 and Figure 8 can be seen in Figure 10 . In Figure 5 to 9In it, the arm 104 of the needle shield lock member is free to move further from the axis 20 by extending into (or in this case through) the slit 66 of the needle shield, rather than being tensioned and held adjacent to (and pushing) the arm 62 of the needle shield. Once the needle shield moves proximally again after injection, the arm 104 is again pushed toward the axis 20 by the distal end 63 of the needle shield arm, as Figure 10 shown. Once the needle shield passes the arm 104 of the needle shield lock member (relative to the axial direction), the arm 104 of the needle shield lock member is able to move again in a direction away from the axis 20, as Figure 11 shown.

[0188] Figure 12 Another auto-injector 10 is shown, which includes a needle shield lock assembly similar to the Figure 1 to 9 shown needle shield lock assembly. In Figure 11 it, the housing 40, the cap 160, the optional end cap 200 (rear cap), and the main kit 360 can be seen. A small part of the power unit housing 240 can also be seen. Figure 13 to 28 A part of the front sub-assembly (proximal sub-assembly) 50 is shown (i.e., the syringe holder 120, the needle shield spring 140, the needle shield 60), as well as three parts of the cap 160 (i.e., the cap housing 162, the rigid needle shield removal member 180, and the cap core member 170). Figure 13 A part of the rear sub-assembly (distal sub-assembly) 52 is shown, i.e., the end cap 200, the optional power unit lock 220, the power unit housing 240, the torsion spring 260, the drive member 280, the plunger rod 300, the lock member activation sleeve 80, the drive nut 320, the thrust bearing 340, and the housing 40. Figure 14 The above parts in

[0189] are not necessarily the same as the corresponding parts described below, but these parts are similar and have substantially the same functions.

[0189] Now the parts shown in br>Figure 13 and 12 will be described in more detail. To this end, Figures 5 to 9 various combinations of parts of the auto-injector 10 are also shown.

[0190] Figure 13 A perspective view of some parts of the rear sub-assembly (i.e., the syringe holder 120, the needle shield spring 140, and the needle shield 60) is shown. As described at other places in this specification, each part (more generally each sub-assembly and each device) extends from the proximal end 14 to the distal end 16. Figure 14 An assembled rear sub-assembly is shown, which has the Figure 14 parts in

[0191] The needle shield can be considered to have a proximal portion and a distal portion. The proximal portion includes the shield portion 64, and the distal portion includes two needle shield arms 62. Needle shield slits 66 extend along the axial direction on each side of the needle shield. The shield portion is tubular, and in the assembled auto-injector, the axis of the shield portion is parallel to axis 20. The needle shield may further include a protrusion 68 for engaging with a corresponding recess or notch (not shown) on the cap, which helps to keep the cap attached to the rest of the auto-injector. Of course, the cap may alternatively or additionally be attached to the housing, especially in, for example Figure 14 the example shown, where removal of the cap allows the needle shield to move proximally.

[0192] The needle shield spring 140 is fitted within the needle shield 60. The proximal end of the needle shield spring engages with the engagement feature of the needle shield, and such an engagement structure is, for example, a protrusion or a distally facing rung (not visible in Figure 11 ). The distal end of the needle shield spring engages with the proximally facing rung 122 on the syringe carrier (see Figure 12 ).

[0193] The syringe carrier 120 has a tubular shape and includes various features, including rungs 122, windows 124, and protrusions 126. When assembling the auto-injector 10, the window 124 of the syringe carrier is arranged to be aligned with the window 46. The syringe carrier includes protrusions 126 on each side to engage with the corresponding slits 66 on the needle shield arms 62, thereby keeping the needle shield slidably attached to the syringe carrier. As shown in Figure 15 , the distal side of the protrusion 126 is a distally facing rung to engage with the distal end of the slit 66. The proximal side of the protrusion 126 is inclined (at an angle with respect to axis 20 and the radial direction 26) to allow the portion of the needle shield arm 62 away from the slit 66 to slide over the protrusion 126 during assembly. For this purpose, the needle shield arm 62 is generally flexible in the radial direction 26 to facilitate assembly. Of course, alternative structures may avoid the need for such flexibility (such as a flexible syringe carrier instead).

[0194] In Figure 16 , the cap 160 is shown attached to the needle shield 60. As shown in Figure 17 , the cap consists of a cap housing 162, a cap core 170, and a rigid needle shield removal member 180. An optional handle 164 can be seen on the cap 160.

[0195] Now it will be described in more detail Figure 16The composition of the exemplary rear subassembly shown. The rear subassembly includes two separate subassemblies, namely, a power unit subassembly 54 and an activation subassembly 56 (activation mechanism subassembly). The power unit subassembly includes a power unit housing, a torsion spring, a drive member, and an optional power unit locking member. The mechanism subassembly includes a locking member activation sleeve, a needle shield locking member, a plunger rod, a drive nut, and an optional thrust bearing.

[0196] Figure 17 An optional power unit locking member 220 and a power unit housing 240 are shown. Figure 18 It shows how the power unit locking member 220 and the power unit housing 240 are initially attached to each other. Figure 16 The power unit locking member 220 and the power unit housing 240 are shown, as well as a torsion spring 260 and a drive member 280; the drive member 280 shown is in the form before attachment.

[0197] The power unit locking member 220 includes a body 222 (a tubular body in this case), and two protrusions 224 extending in a direction away from the body 222 (proximal end) with respect to an axis 20. The protrusions are configured to fit into corresponding slots 242 in the power unit housing 240 (see specifically Figure 19 ). To assist in attaching the power unit locking member 220 and the power unit housing 240 together, two protrusions 244 extend circumferentially into each slot 242. The protrusions 224 of the power unit locking member 220 have corresponding recesses to engage with the protrusions 244, which is most clearly seen in Figures 46 to 49 .

[0198] In Figure 52 , the interaction between the torsion spring 260 and the power unit housing can be seen. In this particular example, the torsion spring 260 includes hooks at both ends of the spring, namely, a proximal hook 262 attached to the drive member 280 and a distal hook (not shown) attached to the power unit housing, for example, attached through a cutout (not shown) in the power unit housing. The proximal hook 262 engages with the drive member by engaging with a circumferentially facing rung 282 on the drive member. The position of the drive member after being in place is as shown in Figure 46 to 49 . In this position, the power unit locking member 220 is in a first position, and as will be described in more detail below, the drive member can be rotated circumferentially to tension the spring.

[0199] The power unit locking member 220 is designed to take three different positions during the assembly of the auto-injector. The first position of the power unit locking member can be seen in Figure 15 and 17 . In this position, the power unit locking member is rotationally restricted with respect to the power unit housing.

[0200] To reach the second position, the power unit lock moves in a proximal direction relative to the power unit housing from the first position. Figure 18 The power unit lock in the second position is shown. In the second position, the power unit lock is rotationally restricted relative to the power unit housing and the drive member.

[0201] To reach the third position, the power unit lock moves in a proximal direction relative to the power unit housing from the second position. In the third position, the power unit lock generally remains rotationally restricted relative to the drive member (e.g., this allows the power unit lock to provide an optional click during injection, as described below), but is no longer rotationally restricted relative to the power unit housing. The power unit lock generally moves to the third position only after the drive member has been rotationally locked to the housing (e.g., locked by a drive nut). This rotational locking between the drive member and the drive nut is described in more detail in the following examples, especially with reference to Figure 17 description, and this rotational locking works in the same way in this example). Thus, the power unit lock provides a lock that keeps the spring tensioned during part of the assembly process. In some examples, the power unit lock can additionally or alternatively provide an optional click during injection. For example, the protrusion 226 engages with a corresponding protrusion or rib on the inner side of the power unit housing (not directly shown in this example, but can be seen in Figure 16 the example shown). In the finished device, the power unit lock will be in the third position. The third position can be the same as the first position, rather than a different position. Alternatively, once the drive member has been locked against rotation by another part of the device (e.g., a drive nut as shown in Figure 18 ), the power unit lock can be removed from the device rather than moved to the third position, so the power unit lock may not be present in the final device. The plunger rod can be fitted within the body 222 of the power unit lock, especially in instances where the power unit lock remains in the fully assembled device.

[0202] In another alternative, a tool that provides the function of the power unit lock during assembly is used instead of having a power unit lock component. The various features of the power unit lock (e.g., the body 222, the protrusions 224, 226, and the grip 228) can vary in shape. For example, in an embodiment where the third position is the same as the first position and the power unit lock remains in the device after assembly, compared to the power unit lock 220 shown in Figure 19 , the length of the body needs to be shortened and the grip needs to be arranged differently.

[0203] Figure 16 is shown in connection with Figure 20The same part, but now attached with a driving member 280. Once the driving member is attached, it can rotate circumferentially in direction 24 to tension the spring. Once the spring is tensioned, the power unit locking member 220 moves proximally from a first position (as shown in Figure 21 and 17 ) to a second position (as shown in Figure 22 and 19 ) to hold the driving member, and thus also keep the tensioned spring in place relative to the power unit housing 240. This engagement for keeping the spring tensioned is achieved through two different interactions. First, as shown in Figures 21 to 23 Once the power unit locking member 220 moves proximally, the protrusion 224 of the power unit locking member moves from a state where it does not engage with the driving member to a state where it engages with the slot 288 on the inner side of the driving member. Similar to using the protrusion 244 to help attach the power unit locking member 220 and the power unit housing 240 together, the driving member 280 includes two protrusions 284, which engage with the same recesses in the protrusions 224 of the power unit locking member.

[0204] The second interaction for keeping the spring tensioned is provided by the protrusion 224 of the power unit locking member shown in Figure 37 Once the power unit locking member 220 moves proximally, the protrusion 224 of the power unit locking member remains partially in the slit 242 of the power unit housing in the second position, thereby rotationally locking the power unit housing 240 and the driving member 280 relative to the power unit locking member 220, thus preventing the spring 260 from releasing tension.

[0205] An optional safety pin or safety guard for locking the power unit locking member in the second position can also be provided, such as a clip for keeping the handle 228 of the power unit locking member 220 in place relative to the distal end of the power unit housing 240.

[0206] Now the activation sub - assembly of the rear sub - assembly will be described in more detail. Figure 49 The assembled activation sub - assembly is shown, which includes a plunger rod 300, a locking member activation sleeve 80, a needle guard locking member 100, a drive nut 320, and a thrust bearing 340. Figure 23 A form of a part of the activation sub - assembly (i.e., the piston rod 300, the locking member activation sleeve 80, and the drive nut 320) before full assembly is shown. Figure 23 23 and Figure 27 show how the plunger rod 300, the locking member activation sleeve 80, and the drive nut 320 are attached to each other through cross - sectional features. The plunger rod 300 includes threads 302, which engage with the corresponding threads 322 on the drive nut 320. In particular, in Figure 27As can be seen, the plunger rod 300 has threads 302 only on a part of its outer periphery and also has two flat sides; the flat sides allow the plunger rod to engage with the drive member 280 (see also Figure 24 ).

[0207] The drive nut 320 includes the threads 322 as described above and also includes two arms 324. Typically, the arms 324 mainly extend along the axial direction. The arms 324 include teeth 326 on the surface facing the axis 20, and the teeth 326 can engage with the drive member 280, which will be described in more detail later (for example, see Figure 25 ). As Figure 24<\br >Figure 26 shown, the arms 324 also include a surface facing away from the axis 20, and this surface engages with the locking member activation sleeve 80. As can be seen in Figure 24 , once the drive nut 320 and the locking member activation sleeve 80 are assembled together, the arms 324 of the drive nut 320 are biased inwardly (this bias is released when the locking member activation sleeve 80 is pushed distally by the needle guard 60). In this example, the drive nut 320 includes a base 332 (such as a tubular base), and the threads 322 and the arms 324 are attached to the base 332.

[0208] The locking member activation sleeve 80 includes a tubular section 82 and two arms 84, and each arm includes a gasket 86. A notch 88 is provided on each arm 84 to accommodate the distal portion 108 of the arm of the needle guard locking member 100 (for example, see Figure 26 ).

[0209] Figure 27 Shows the plunger rod 300, the locking member activation sleeve 80, the needle guard locking member 100, and the drive nut 320, where the needle guard locking member 100 has not been assembled. Figure 28 Shows Figure 29 a near-side view of the components in Figure 1 when assembled together. Similarly, Figure 1 shows Figure 29A description will be given. The drive nut 320 includes a base 332, and the tubular section 102 of the needle guard lock 100 extends around the base 332. Optional features for holding the needle guard lock 100 in place relative to the drive nut 320 (although some axial movement may be permitted, as is the case in this example) are the distal-facing rung 114 of the needle guard lock 100 near the proximally-facing rung 330 of the drive nut 320, and the proximally-facing rung 116 of the needle guard lock 100 near the snap-fit protrusion 329 of the drive nut 320. The tubular section 102 of the needle guard lock 100 can be assembled by the snap-fit protrusion but is not easily returned through the snap-fit protrusion, thereby holding it in place relative to the drive nut 320.

[0210] The thrust bearing 340 includes a snap-fit arm 342 that engages a corresponding snap-fit rung 306 of the piston rod 300. The thrust bearing 340 can rotate about the axis 20 relative to the plunger rod 300, but is held in the axial direction relative to the plunger rod 300 (in fact, in this particular example, during use, the plunger rod rotates relative to the housing while the thrust bearing does not rotate relative to the housing).

[0211] Figure 30 The power unit subassembly and the activation subassembly attached together are shown. As Figure 10 shown, these two subassemblies are then fitted into the housing 40, which is a single outer shell in this case. Of course, the housing can consist of multiple parts. This combination of the power unit subassembly, the activation subassembly, and the housing constitutes a complete rear subassembly. A end cap (not shown) is typically also included at the distal end of the housing as part of the rear subassembly.

[0212] In Figure 29 another exemplary autoinjector is shown and will now be described in detail with reference to the subsequent drawings. The autoinjector and the needle guard locking assembly within the autoinjector are both somewhat different from those described in the above examples. However, the autoinjector in the example described below can be used with the Figure 29 , 5 or the needle guard locking assembly in the example of 10, and Figure 10 , 5 or the autoinjector in the example of 10 can be used with the needle guard locking assembly described below.

[0213] As Figure 29 shown, the autoinjector extends from a proximal end 14 to a distal end 16 and includes a housing 40 and a cap 160. The autoinjector extends in the axial direction 22 along the axis 20 and extends circumferentially around the axis. Figure 29 and 31Shows the components of an auto-injector, namely, a cap 160, a rigid needle shield removal member 180, a proximal housing 42, a needle shield 60, a needle shield spring 140, a syringe holder 120, a main kit including a syringe 362 and a rigid needle shield 364, a thrust bearing 340, a plunger rod 300, a needle shield lock 100, a drive nut 320, a lock activation sleeve 80, a drive member 280, a distal housing 44 (rear housing), a spring retainer 400, a torsion spring 260, an optional rotator 380, and an end cap (in this case a rotator cap 390). Generally speaking, unless otherwise specified hereinafter, the functions of these parts are the same as those of the equivalent parts described above, and these components are interchangeable between exemplary auto-injectors. Figure 32 The description of the example shown in Figure 36 focuses on the shapes of these parts and how they fit together;

[0214] Except for some differences in the shapes of the components (e.g., in the Figure 34 example, there is no bellows section 112 on the needle shield lock 100), Figure 33 and Figure 32 the biggest difference between the

[0215] examples lies in the rear sub-assembly. For example, it is provided with a rotator 380, a rotator cap 390, and a spring retainer 400. The rotator 380 is attached to the drive member and rotates when the drive member rotates. The rotator cap 390 is attached to the distal housing 44 and can be considered an end cap. The spring retainer 400 is an example of a power unit housing and holds the torsion spring 260 and engages with the drive member 280.

[0215] Now will mainly refer to ​ and 30 to illustrate how the device fits together and how it works. Unless otherwise specified, the same operating methods also apply to other auto-injectors described herein.

[0216] ​ Shows the details of how the multiple parts of the auto-injector fit together. Torque is applied to the distal end of the drive member 280 by the loaded torsion spring 260 (specifically, the distal protrusion 264 of the torsion spring 260) through the spring retainer 400 and the distal housing 44. Specifically, the torsion spring is fixed to the spring retainer 400 at the proximal end (specifically, by the proximal protrusion of the torsion spring 260, which is a hook in this example). The spring retainer 400 is fixed to the distal housing 44 and thus cannot rotate relative to the housing (see especially ​ and 37)。The distal protrusion 264 of the torsion spring 260 is connected to the distal end of the drive member 280, thereby transmitting the torque of the torsion spring 260 to the drive member 280. Thus, once the device is activated and the drive member is released to be able to rotate, it causes the drive member to rotate (for the release of the drive member, see specifically ​ and 35 ).

[0217] ​ Shows more details of how the drive nut 320 is attached to the distal housing 44. Typically, the movement of the drive nut relative to the housing is largely or completely restricted. In this particular instance, the inwardly and longitudinally extending rib 47 on the distal housing 44 engages the corresponding protrusion 328 on the drive nut 320 to prevent the drive nut 320 from freely rotating relative to the distal housing 44; this indirectly prevents the rotation of the torsion spring 260 before the device is activated. The axial movement of the drive nut relative to the distal housing 44 is also restricted by the snap fit 48. The drive nut is optionally also connected to the syringe holder 120 (see ​ ), for example by a hook 128 on the syringe (see specifically Figure 13 and 34 ) and the corresponding hook 334 on the drive nut (see Figure 34 , this hook does not exist in the instance of Figures 10 to 28 but can be included).

[0218] Figure 34 Highlights the connection between parts around the drive nut 320. Before the device is used, the threaded plunger rod 300 is rotationally held in its starting position by the drive member 280 (see for example Figure 37 ), and is axially held in place by the thread 322 in the drive nut 320, which engages the thread 302 of the plunger rod 300. Before the device is used, the arm 324 of the drive nut 320 is biased inward (towards the axis 20) by the lock activation sleeve 80. The inward-facing drive nut teeth 326 thus engage the corresponding outward-facing drive member teeth 286.

[0219] Figure 35 Shows most of the components of the device as shown in Figure 34 , but this time the device shown is after the needle guard 60 has been pushed back to unlock the lock activation sleeve 80, thereby releasing the arm 324 of the drive nut 320 and unlocking the engagement between the teeth 286 of the drive member 280 and the teeth 326 of the drive nut 320. This unlocking allows the torsion spring 260 to directly rotate the drive member, and the plunger rod 300 is directly rotated by the drive member 280. The rectangular cross-section of the rotating plunger rod interacts with the corresponding inner cross-section of the drive member 280 (see especially Figure 37), the driving member 280 converts the rotational torque from the torsion spring 260 into a linear force. At the proximal end of the plunger rod 300, a thrust bearing 340 is preferably attached. The thrust bearing is preferably free to rotate independently relative to the rotating plunger rod 300, which allows the thrust bearing to remain stationary relative to the stopper 366 during injection, thereby transmitting only a linear force to the stopper 366. Another advantage of providing the thrust bearing is that the shape of the thrust bearing helps to transmit the force from the plunger rod to the stopper more gently, for example by engaging a larger surface area of the stopper and / or by engaging the outer edge 367 of the distal end of the stopper (see Figure 42 ) for transmission.

[0220] Figure 36 and 37 show how the spring retainer 400 is rotatably fixed to the distal housing 44 and how the driving member 280 is rotatably fixed to the plunger rod 300. In both cases, this is achieved by corresponding non-circular cross-sections (in other words, keyed openings in the driving member and corresponding shaped keys of the plunger rod shape). In this example, the non-circular cross-sections are provided with corresponding straight edges (i.e., deviating from the circular cross-section). Of course, various other shapes can also be used. In this case, the keyed opening is located in the distal housing, and the correspondingly shaped rung on the proximal end of the syringe retainer engages with the keyed opening. Similarly, the keyed opening in the driving member receives the plunger rod. The longitudinal movement of the syringe retainer relative to the housing is also preferably restricted, in this example by engaging with a slit in the distal housing.

[0221] Figures 38 to 40 shows the arrangement details of the rotator 380 and the rotator cap 390. The rotator cap 390 includes a window 392 through which the rotator can be seen; the rotator typically has a pattern thereon such that the user can easily see the rotational movement of the rotator. The rotator 380 is rotatably fixed to the driving member (or another part that rotates during delivery) such that the rotator rotates when the driving member rotates. The rotator 380 (or, in the case of no rotator, the end cap) can support the distal end of the driving member 280 to ensure that the driving member 280 remains concentric within the housing.

[0222] Now, Figures 41 to 45 will be used to illustrate Figure 29 the operation of the needle guard locking assembly in the example of Figure 30 . Generally speaking,

[0223] Figure 41Shows the configuration of the auto-injector before use, where all parts are in their starting positions. A significant difference in this design is that the needle shield 60 and the needle shield lock 100 overlap axially, while in, for example, Figure 1 and Figure 5 In the shown design, the needle shield 60 and the needle shield lock 100 do not overlap. This overlap is optional in all needle shield lock assembly designs. The benefit of providing the overlap is that it makes it more difficult to push the lock activation sleeve 80 distally before use, for example in the case where the device drops. This is because the proximal part 106 of the needle shield lock arm is prevented from moving away from the axis 20, making it more difficult to push the lock activation sleeve 80 past the distal part 108 of the needle shield lock arm.

[0224] In Figure 42 the cap (not shown) of the device has now been removed. This allows the needle shield to move proximally. Of course, this feature is optional and the needle shield may not move when the cap is removed.

[0225] In Figure 43 the device is shown when the needle shield 60 has moved fully distally. Compressing the needle shield in this way to activate the device places the needle shield in a position that prevents the needle shield lock 100 from bending outwards. When the needle shield 60 is compressed far enough (i.e., pushed distally far enough, i.e., the distance A as shown in Figure 42 ), it starts to push the lock activation sleeve 80 distally. Pushing the lock activation sleeve distally causes the distal part 108 of the needle shield lock arm to bend inwards, subjecting it to internal bending stress, which causes the needle shield lock arm 104 to attempt to pivot. Since the proximal part 106 of the needle shield lock arm cannot bend outwards until the needle shield 60 retracts (moves proximally), the arm 104 remains in a biased state during injection. The intention is for the user to push the needle shield all the way to its most distal position (in this case, this is after the needle shield has been pushed the distance A in Figure 42 plus the distance B in Figure 42 ), thereby activating the device, and also pushing the lock activation sleeve 80 to its most distal position (in this case, the most distal position is when the distal-facing surface on the lock activation sleeve 80 faces the proximal-facing surface on the spring retainer, although the most distal position of the lock activation sleeve 80 can be set by abutting against another part (such as the housing), or can simply be limited by the restricted movement of the needle shield). This helps to define the depth at which the injection needle penetrates the injection site, or the way in which the jet injector interacts with the injection site.

[0226] The point at which the needle shield lock 100 is activated by the lock activation sleeve 80 can be set by the relative shapes and dimensions of the components. For example, the point at which injection begins (in this instance, the point at which the arm 324 of the lock activation sleeve 80 releases the drive nut 320, causing the teeth 286 of the drive member 280 to disengage from the teeth 326 of the drive nut 320) can be the same as the point at which the device would lock in the event that the needle shield prematurely extends again (is moved back in the proximal direction, e.g., caused by premature removal of the device from the injection site). This means that in the event that injection has begun and the device is subsequently removed (at the end of injection or prematurely), the needle shield lock assembly will lock the needle shield, but if injection has not yet begun, the needle shield will not be locked. Alternatively, the point at which injection begins can be before or after the point at which the needle shield lock 100 is activated by the lock activation sleeve 80.

[0227] Figure 44 Illustrates the configuration of the needle shield lock assembly and the drive nut after injection is complete (or after the device has been prematurely removed from the injection site). The lock activation sleeve 80 remains in place, and the retraction of the needle shield 60 in the proximal direction allows the arms 84 of the lock activation sleeve 80 to relax their biasing force by moving away from the axis 20 through the proximal portion 106 of the needle shield lock arm 104. In this instance, the proximal portion 106 of the needle shield lock arm 104 abuts the distal housing 44 in the slit 45. Of course, it is also possible to have a gap between the distal housing 44 and the proximal portion 106 of the needle shield lock arm 104 (as shown in the instance of Figure 3 ).

[0228] Figure 45 Illustrates details of the needle shield lock 100 and its interaction with the slit 45 in the distal housing 44. Typically, as shown in Figure 44 and 45 , there is a small gap in the axial direction between the needle shield 60 and the needle shield lock 100 (particularly the proximal portion 106 of the needle shield lock arm 104), which allows for a small amount of movement of the needle shield after injection. This is beneficial in terms of improving component dimensional tolerances.

[0229] Figure 46 and 47 Illustrates the relative positions of the needle shield 60, the lock activation sleeve 80, and the drive nut 320 before and after the device is activated. When the arm 324 of the drive nut 320 moves radially outward (away from the axis), it allows the drive member 280 to rotate as described above. Specifically, as shown in Figure 47As shown, in this example, the arm 324 moves radially outward to a position aligned with the tubular section 82 of the lock activation sleeve 80 such that the distally facing surface of the arm 324 engages the proximally facing surface of the tubular section 82 of the lock activation sleeve. This alignment is optional but beneficial as it prevents the lock activation sleeve from being moved proximally after the needle shield 60 has been moved back in the proximal direction. Alternatively or additionally, the lock activation sleeve is prevented from moving proximally by friction (e.g., friction between the gasket 86 of the lock activation sleeve and the distal portion 108 of the needle guard lock arm 104 when the arm 104 is biased). Alternatively or additionally, a protrusion, such as the optional protrusion 111 (see Figure 26 or Figure 42 ), can be provided on the distal portion 108 of the needle shield lock arm such that the protrusion can interact with the distal portion of the gasket 86 to help limit accidental distal movement of the lock activation sleeve prior to injection.

[0230] Figure 48 and 49 show details of the cooperation between the drive member 280 and the drive nut 320. Preferably, not only does the internal bending stress of the arm 324 of the drive nut 320 cause the arm to swing outward when permitted, but the inclined interface of the teeth of the drive member 280 and the arm 324 also helps to push the arm outward, especially as Figure 49 shown. This angle can in particular be designed such that the arm 324 is pushed outward with as little force as possible, although of course it should always be pushed with sufficient force to prevent jamming (i.e., such that injection always starts as designed). The force with which the arm presses against the activation ring creates friction that the user must overcome to activate the device, so it is beneficial to design the force to be overcome to be as small as possible. More details of the drive member that can be used in such a device are described in EP 19211853.7, the entire content of which is incorporated herein by reference.

[0231] Figure 50 and 51 show an exemplary thrust bearing 340 for use in an Figure 29 auto-injector, although of course the thrust bearing can also be used in other auto-injectors described herein. The thrust bearing includes an optional base 341; one or more for engaging the proximal end of the plunger rod 300 (e.g., see Figure 26 and 35) snap - fit arms 342 (in this case three arms), each arm including a projection 344 that engages the plunger rod; and a proximally - facing projection 346 that engages the stopper during injection. The snap - fit arms are generally flexible to facilitate assembly. In general, the thrust bearing 340 (especially the proximally - facing projection 346) can advantageously be varied to correspond to different - shaped stoppers, since it is advantageous to have a large area of contact between the thrust bearing and the stopper to support the stopper, especially in cases where the medicament is viscous and thus a high spring force needs to be transmitted from the power unit to the stopper. For some stopper shapes, the proximally - facing projection may not be needed at all. The thrust bearing should generally be free to rotate relative to the plunger rod, which ensures that it does not rotate with the plunger rod when the thrust bearing contacts the syringe stopper, but only transmits a linear force.

[0232] Figure 52 A portion of another exemplary auto - injector with slightly different features is shown. Of course, the features shown in this instance can also be provided in the instance described in detail above. In this instance, the projection 226 of the power - unit lock 220 and the corresponding rib 246 on the power - unit housing 240 can be seen. In general, the shapes of the projection 226 and the rib 246 can vary, and the number of the projection 226 and the rib 246 can also vary. The same number of projections and ribs (two each in this instance) are provided here, but different numbers can also be provided, for example, two projections and four ribs. The rib can be replaced by a projection. The number, shape, and precise location of the projections and ribs can vary according to the desired number and pattern of clicks. As Figure 52 shown, the rib 246 can have a bevel (a surface extending in the radial and circumferential directions) on one side (specifically, this is the side where the projection 226 will first reach when the power - unit lock and the power - unit housing rotate relative to each other during injection) to allow the projection 226 to ride more smoothly on the rib 246. The other side of the rib generally has a steeper surface (e.g., extending along the radial direction). Alternatively or additionally, as Figure 52 shown, the projection can be inclined (extending in the radial and circumferential directions rather than extending directly outwards from the axis) to allow the projection 226 to straddle the rib 246 more smoothly. The bevel of the rib and the inclined projection also help to reduce the friction when the parts pass over each other. In Figure 52 the distal end of the plunger rod 300 (specifically, the plunger rod 300) within the power - unit lock 220 can be seen.

[0233] In addition to the instances and alternatives described above, reference will now be made to Figure 53Describe other examples and alternatives. These examples focus in part on mechanisms for preventing premature activation of a medicament delivery device (i.e., before the cap is removed). This problem can occur especially when the device is dropped, at which time, when the medicament delivery device hits the ground, the momentum of the needle shield causes the needle shield to move distally relative to the housing.

[0234] Figure 53 An autoinjector 10 is shown having components similar to those described above. In Figure 53 , a small portion of the housing 40, the cap 160, and an optional end cap 200, as well as the syringe holder 120, the power unit housing 240, and the main kit 360 can be seen.

[0235] Figure 54 Shown is Figure 53 the autoinjector 10 with its components disassembled, namely, the housing 40, the needle shield 60, the locking member activation sleeve 80, the needle shield locking member 100, the syringe holder 120, the needle shield spring 140, the cap (which in this example includes a cap housing 162, a cap core 170, and a rigid needle shield removal member 180), an optional end cap 200, a power unit locking member 220, a power unit housing 240, a torsion spring 260 (in Figure 54 , the torsion spring is not fully shown, only the two ends are shown, one end is untensioned and the other end is tensioned to show the typical diameter difference between the tensioned and untensioned states), a drive member 280, a plunger rod 300, a drive nut 320, a thrust bearing 340, and a main kit (which in this example includes a syringe 362 with an injection needle 368, a rigid needle shield 364, and a stopper 366). An optional label 419 is also shown. This label may cover features between the housing and the power unit housing, such as a clip. Covering these features may be beneficial as it helps prevent the end user from attempting to disassemble the device. The label is shown as extending around the entire housing, but it can also extend around only a portion of the housing.

[0236] These components are generally interchangeable between the devices described herein. However, some components are different in shape from those described elsewhere herein. Some components are shown in more detail in Figures 55 to 62 . Figure 55 , 56 and 57 show more details of the needle shield locking member 100, the drive nut 320, and the locking member activation sleeve 80, respectively. Figure 58 shows more details of the power unit locking member; in this example, the protrusion 226 is located at the distal end of the power unit locking member, rather than being spaced apart from the distal end of the power unit locking member as shown, for example, in Figure 15 . Figure 59 shows more details of the drive member 280, Figure 60 and61 More details of the power unit housing 240 are shown. Figure 62 More details of the needle shield 60 are shown.

[0237] Figure 63 Three components of an exemplary cap 160 are shown, namely, a cap housing 162, a cap core 170, and a rigid needle shield removal member 180. Figures 64 to 69 Caps in different positions are shown to provide more details.

[0238] Figure 64 A cap of a medicament delivery device and adjacent components are shown for context. The focus here is on the locking mechanism provided by the combination of the cap 160, the needle shield 60, and the housing 40. Here, the main kit 360, the optional needle shield spring 140, and the syringe holder 120 are also visible. The cap 160 includes a cap housing 162, a cap core 170, and a rigid needle shield removal member 180. In this case, the cap housing 162 provides the outer shell of the cap. The cap housing 162 is generally a tubular body, as Figure 63 shown, and includes an optional grip 164 and a slot 166 through which a cap core arm 171 extends, for example as Figure 69 shown. The cap core 170 includes a cap core arm 171, and the cap core arm 171 includes a notch 172 (which could also be a recess, of course). The cap core 170 also includes a snap-fit projection 174, for example as Figure 69 shown. The rigid needle shield removal member 180 is disposed between the cap core 170 and the cap housing 162, and a rigid needle shield removal member flange 182 extends between the cap housing 162 and the cap core 170 to hold the rigid needle shield removal member flange 182 in place.

[0239] Movement of the cap core 170 relative to the cap housing 162 in the axial direction 22 is restricted by the snap-fit projection 174 of the cap core 170, which abuts a proximally facing surface of the cap housing 162, for example as Figure 69 shown. The snap-fit allows rotational movement of the cap housing 162 relative to the cap core 170; optionally, this rotational movement is restricted by ribs 168 of the cap housing 162 (see, for example, Figure 69), the rib 168 can engage with the circumferentially facing surface of the cap core member arm 171 to limit the rotational movement of the cap core member 170 relative to the cap housing 162. In this example, the rib extends from the inner surface of the cap body, but it can also extend outwardly from an additional outwardly facing surface disposed within the cap body. Providing a snap fit may be beneficial since it is easy to assemble, but the snap fit is optional and can be replaced by various other structural features configured to achieve the same axial movement restriction, such as protrusions, ribs, or arms.

[0240] The cap 160 (specifically, the arm 171 of the cap housing 162) is located within the housing 40 (specifically, at the proximal end of the housing 40). The needle shield 60 is located within the cap 160 (specifically, within the cap core member arm 171). The needle shield 60 includes a protrusion 68 that extends radially away from the axis and extends into the cap core member notch 172.

[0241] During use, the cap is first pulled away from the housing, thereby causing the medicament delivery device to move from the Figure 64 position shown to the Figure 65 position shown. The cap and the needle shield are moved proximally relative to the housing (e.g., the movement of the needle shield may be caused by the cap pulling the needle shield and / or the needle spring pushing the needle shield proximally when the cap no longer restricts the proximal movement of the needle shield). As a result, the cap core member arm 171, which was initially restricted from moving radially due to the presence of the housing 40, can now move freely in the radial direction, allowing the cap core member arm 171 (and the rest of the cap) to continue moving proximally relative to the housing 40 and the needle shield 60, thereby moving the protrusion 68 of the needle shield 60 out of the cap core member notch 172.

[0242] In this particular example, the cap is designed such that continued pulling of the cap in the axial direction will remove the cap from the auto-injector (medicament delivery device) ( Figure 67 ). Rotation of the cap relative to the housing can be additionally or alternatively performed to remove the cap (see Figure 66 ). Specifically, as Figure 66 shown, the proximally facing surface 49 of the housing extends circumferentially around the housing in the circumferential direction 24 and faces the corresponding distally facing surface 169 of the cap 160 (specifically, the cap housing 162 in this example). Both the proximally facing surface 49 of the housing 40 and the distally facing surface 169 of the cap housing 162 extend in the axial direction, and their axial positions vary around the circumference, in this case in a sinusoidal pattern. Of course, other shapes are possible. Varying the axial position in the circumferential direction like this is optional, but it may be beneficial since it may mean that initiating the removal of the cap by twisting the cap relative to the housing will naturally cause the cap to also move axially relative to the housing.

[0243] The cap and locking mechanism referred to above in Figures 63 to 69 is an example of a more general cap and corresponding locking mechanism, and this particular design can be modified in various ways in addition to the options already mentioned above. Some other exemplary modifications will now be described. For example, the above-described cap includes three parts, but a cap consisting of a different number of parts or even a single integral part can also be used. The cutout does not necessarily have to be in the arm, although this may contribute to flexibility and make it easier to remove the protrusion from the cutout during cap removal. In the above example, the protrusion is provided on the needle shield and the cutout is provided on the cap, but this can also be reversed, i.e., the cutout is provided on the needle shield rather than on the cap. The rotational function of the cap housing 162 relative to the cap core 170 is optional; when providing such a function, it may be beneficial for both the cap housing 162 and the cap core 170 to be tubular to allow rotational movement relative to each other. Alternatively, the housing can be closer to the axis than the arms of the needle shield and the cap, rather than the housing being farther from the axis than the arms of the needle shield and the cap; in this case, the mechanism is effectively inverted in the radial direction 26.

[0244] Figure 70 Another auto-injector 10 is shown having components similar to those described above. In Figure 70 it, the housing 40, the cap 160 and the optional rotator cap 390, as well as a small portion of the syringe holder 120 and the main kit 360 can be seen. A distinct difference compared to the previous design is the design of the cap 160, which will be described in more detail below.

[0245] Figure 71 Shown is Figure 70 the auto-injector 10 in disassembled components, i.e., the housing (divided into a proximal housing 42 and a distal housing 44), the needle shield 60, the locking member activation sleeve 80, the needle shield locking member 100, the syringe holder 120, the needle shield spring 140, the cap (including two cap housings 162), the optional rotator 380 and the rotator cap 390, the power unit locking member 220, the power unit housing 240, the torsion spring 260 (in Figure 71 it, the torsion spring is not fully shown either, only the two ends are shown, one end being untensioned and the other end being tensioned to show the typical diameter difference between the tensioned and untensioned states), the drive member 280, the plunger rod 300, the drive nut 320, the thrust bearing 340 and the main kit (in this example including the syringe 362 with the injection needle 368, the rigid needle shield 364 and the stopper 366). Also shown is the optional label 419.

[0246] These components are generally interchangeable between the devices described herein. However, some components differ in shape from those described elsewhere herein. Some components are shown in more detail in Figures 72 to 81 . Figure 72 More details of the power unit housing 240 and the corresponding rotator cap 390 are shown, which can be joined together by snap fit. Figure 73 More details of the power unit lock 220 and the corresponding rotator 380 are shown, and an example of how the power unit lock 220 and the rotator 380 are attached together is shown, i.e., by engaging the rotary ribs 382 of the rotator 380 with a pair of distal notches 230 (the second notch is not visible) of the power unit lock 220. During drug delivery, the rotation of the rotator 380 can provide a visual indication that drug delivery is in progress. Figures 74 to 76 Details of the mating at the distal end of the auto-injector are shown, with emphasis on the power unit lock 220, the power unit housing 240, the rotator 380, and the rotator cap 390. In Figure 76 , the relative positions of the protrusion 226 of the power unit lock 220 and the corresponding rib 246 of the power unit housing 240 can be seen. During drug delivery, the rotation of the power unit lock 220 relative to the power unit housing 240 causes an interaction between the protrusion 226 and the rib 246, which can produce an audible indication that drug delivery is in progress. To allow the protrusion 226 and the rib 246 to pass each other, one or both of the protrusion 226 and the rib 246 can be flexible. Vibration of the device can also produce a tactile indication, especially in cases where the ribs 246 and / or protrusions 226 are spaced irregularly (as opposed to the regular spacing shown in the illustrated example). Such an audible indication can be provided as an alternative or supplement to other audible, visual, or tactile indications (e.g., as an alternative or supplement to a visual scheme, a rotator-based scheme as shown in this particular embodiment can be employed). To enhance the visual effect of the rotator, a pattern can be provided on the rotator (e.g., by printing, by adding one or more stickers, or by engraving) to make the rotation of the rotator more intuitive. The rotator can be an integral part of the power unit lock rather than a separate component. As an alternative or supplement to the above feedback signals, the plunger rod 300 can include a whistle hole. The whistle hole can produce an audio signal (usually a continuous audible signal) during drug delivery. A whistle hole can also be provided in other plunger rods described herein.

[0247] Figure 77 , 78 and 79 show more details of the needle guard lock 100, the drive nut 320, and the lock activation sleeve 80, respectively.

[0248] Figures 80 to 85Shows the cap and adjacent parts of a medicament delivery device for a context. The focus here is on the locking mechanism provided by the combination of the cap 160, the needle shield 60, and the housing 40 (more specifically the proximal housing 42 in this particular case). In this case, as Figure 80 shown, the cap includes two cap housings 162. Of course, the locking mechanism can also work in the case where the cap is a single integral piece. Optionally, each cap housing 162 includes a flange 163 that extends from the tubular shape of the cap and may be provided with a portion to assist in gripping the cap during cap removal. The cap housings 162 can be attached to each other by snap fit. Of course, other attachment mechanisms (such as gluing) are also possible. A rigid needle shield removal member 180 is arranged between the cap housings 162. Figure 81 Shows the proximal housing 42, including an arm 410 and an optional cap guide 411 (in this case a rib extending along the axial direction); this cap guide can assist in aligning the cap relative to the proximal housing and / or assist in fixing the cap relative to the proximal housing in the circumferential direction. Figure 82 and 83 Shows the part of the auto-injector that includes the locking mechanism. The cap 160, the needle shield 60, and the housing 40 (especially the proximal housing 42) are shown in the figure. Here, the main kit 360, the optional needle shield spring 140, and the syringe holder 120 are also visible. Additionally, the distal housing 44 can also be seen.

[0249] The proximal housing 42 includes an arm 410. The arm includes a protrusion 412; the protrusion 412 extends towards the axis 20 in the radial direction. In this example, the arm extends along the axial direction 22. Of course, it can also extend along another direction, such as the circumferential direction 24. In this instance, the arm is attached to the rest of the proximal housing at its proximal end. Of course, the distal end of the arm can optionally be attached to the proximal housing. The protrusion 412 extends into a notch (or recess) 70 of the needle shield 60. The needle shield 60 also includes an optional recess (or notch) 72; this recess is arranged closer to the proximal end of the needle shield 60 than the notch 70 and can reduce the friction of the protrusion 412 of the arm 410 of the proximal housing on the needle shield 60 during cap removal from the auto-injector and during subsequent use of the device.

[0250] On the side of the arm 410 of the proximal housing 42 opposite to the protrusion 412, the arm is adjacent to the surface of the cap (in this case a part of the cap housing 162), which prevents (or at least restricts) the radial movement of the arm when the cap is attached to the auto-injector. As Figure 83As shown, this limits movement of the needle shield 60 in the distal direction because the protrusion 412 of the arm 410 of the proximal housing cannot escape the path of the needle shield 60. This can prevent premature activation of the autoinjector (for example, if the autoinjector is dropped) because this can limit the movement of the needle shield 60 so that it cannot move far enough in the distal direction to activate the device. Alternatively, the arm can be tilted inwardly (or biased inwardly) so that the arm is in the path of the needle shield 60 rather than the protrusion, and the protrusion is on the side of the arm facing away from the axis rather than on the side of the arm facing the axis. Alternatively, the protrusion can be provided by a wedge-shaped end of the arm, the flexible end of the arm being radially wider than the attachment end of the arm.

[0251] When the cap has been removed from the autoinjector (by twisting or pulling relative to the autoinjector), the needle shield 60 can move to its maximum extent in the distal direction (relative to the housing 42, 44) because the arms 410 of the proximal housing 42 can move in a radial direction, thereby allowing the needle shield 60 to move in the distal direction past the protrusions 412. As the needle shield 60 moves in the distal direction, the protrusions 412 of the arms 410 of the proximal housing leave the cutouts 70 of the needle shield 60 and subsequently enter the recesses 72 of the needle shield 60. The final position of the needle shield 60 relative to the proximal housing 42 can be Figure 84 and 85 See.

[0252] Refer to above Figures 80 to 85 The cap and locking mechanism described are an example of a more general cap and corresponding locking mechanism, and this particular design may be modified in various ways in addition to the options already mentioned above (described below in Figures 111 to 120 The example shown in is only one alternative. Many alternatives are possible along the lines of the above design, especially with reference to the design of the cap and locking mechanism. For example, the cap 160 is furthest from the axis, the housing (in this case the arm 410 of the proximal housing 42) is between the needle shield and the cap, and the locking mechanism can be effectively reversed, with the cap (or at least a portion of the cap) closest to the axis, the needle shield furthest from the axis, and the proximal housing (e.g., the arm) between them, rather than as Figure 82 As shown, the needle shield 60 is closest to the axis. The above-mentioned shield comprises three parts, but shields composed of other numbers of parts or even a single integral part can also be used.

[0253] Now will refer to Figures 86 to 88 A third alternative locking mechanism is described. The general design of the autoinjector herein may be based on one of the autoinjectors described herein and will not be described in detail. In particular, the general design of the protective cap may also be based on the design of other protective caps described herein and will not be described in detail either. Figure 86 and 87 ​The shape of the cap shown is similar to that of Figure 80 shown, and of course, other shapes can also be used.

[0254] The focus here is also on the locking mechanism provided by the combination of the cap 160, the needle guard 60, and the housing 40 (more specifically, the proximal housing 42 in this particular case). Here, the main kit 360, the optional needle guard spring 140, and the syringe holder 120 are also visible (see especially Figure 87 ).

[0255] In this alternative locking mechanism, the needle guard 60 includes a double-ended arm 420 (which can also be referred to as a rocker or lever). The double-ended arm 420 of the needle guard 60 extends from the proximal portion 426 to the distal portion 427. As can be seen from Figure 88 , the double-ended arm 420 is attached to the rest of the needle guard 60 by a rocker 422, and the double-ended arm 420 can pivot around the rocker 422. A protrusion 424 extends from the proximal end of the double-ended arm 420 in a direction away from the axis (of course, in a locking mechanism design where the part of the cap providing the locking mechanism is closer to the axis than the part of the needle guard providing the locking mechanism, effectively reversing the locking mechanism, the protrusion 424 can also extend towards the axis, in the same manner as has been described in more detail above for other locking mechanisms).

[0256] The cap includes a protrusion 440 (e.g., attached to the cap housing 162). The protrusion 440 extends towards the axis. The protrusion 440 is further from the proximal end of the auto-injector than the protrusion 424. The protrusion 424 includes an inclined surface at an angle to the radial direction 26 and the axial direction 22, which is away from the proximal end and away from the axis. The protrusion 440 preferably includes a surface facing the inclined surface of the protrusion 424. The inclined surfaces on the protrusions 424 and 440 are not necessary, but can reduce the friction generated when the protrusions 424 and 440 come into contact.

[0257] The distal end of the double-ended arm 420 includes a distally facing surface 430. The housing (in this case, the proximal housing 42) includes a corresponding proximally facing surface 445 of the proximal housing 42. The proximally facing surface 445 of the proximal housing 42 is further from the proximal end of the auto-injector than the distally facing surface 430 of the distal portion 427 of the double-ended arm. The proximally facing surface 445 of the proximal housing 42 is further from the axis than the distally facing surface 430 of the distal portion 427 of the double-ended arm.

[0258] As Figure 86 and 87 shown, when the cap is still on the auto-injector, the locking mechanism restricts the distal movement of the needle guard 60 relative to the housing. If the needle guard 60 moves distally relative to the housing (as in Figure 87As shown, the protrusion 424 of the double-ended arm 420 of the needle guard 60 will be pushed against the protrusion 440 of the cap 160. As a result, the protrusion 424 is pushed towards the axis, which causes the double-ended arm 420 to pivot about the rocker 422, resulting in the proximal portion 426 of the double-ended arm moving towards the axis and the distal portion 427 of the double-ended arm moving away from the axis. As a result, the distally facing surface 430 of the distal portion of the double-ended arm moves away from the axis, aligning it with the proximally facing surface 445 of the proximal housing 42, as Figure 88 shown. The alignment of the distally facing surface 430 of the distal portion of the double-ended arm with the proximally facing surface 445 of the proximal housing 42 prevents further distal movement of the needle guard 60 relative to the housing.

[0259] When removing the cap from the auto-injector, the double-ended arm 420 pivots to allow the protrusion 440 of the cap 160 to pass through the protrusion 424 of the double-ended arm. When the protrusion 440 has passed through the protrusion 424, the double-ended arm 420 of the needle guard 60 pivots back to its original position, thus allowing the needle guard 60 to move distally relative to the proximal housing 42 without the distally facing surface 430 of the distal portion of the double-ended arm moving away from the axis. As a result, the distally facing surface 430 can move into the proximal housing 42 without engaging the proximally facing surface 445 of the proximal housing 42.

[0260] Figure 89 and 90 shows another alternative cap design that can be used in combination with a medicament delivery device, such as the auto-injector described herein. Figure 89 shows the cap 160 in an auto-injector, which includes a housing 40 having an optional window 46, a needle guard 60, and a cap 160. The cap 160 is within the needle guard 60. Figure 90 shows the cap 160, which includes a cap housing 162, a pull strap 176, and arms 177 (two arms in this example); the arms 177 include optional protrusions 179. The pull strap can be provided to allow the user to remove the cap; alternatively, another type of cap removal portion, such as a handle, can be provided. The arms 177 extend from the cap housing 162. As Figure 89As shown, an arm (in this case, the projection 179 of arm 177) extends into the incision of the needle shield 60, thereby holding the cap in place within the needle shield 60. The arm 177 is flexible, allowing the projection to move toward the axis and pass through the needle shield 60 during removal of the cap from the needle shield. After the cap is removed, the arm 177 bends outward again, making it difficult to replace the cap onto the device because the arm extends too far away from the axis to fit back into the needle shield. This can be advantageous as it prevents replacement of the cap on an activated or used device. Two arms are shown in this example; only one arm can also be provided. Three or more arms can also be provided; this can be advantageous as it makes it more difficult to replace the cap in place (e.g., more arms make it more difficult to push all the arms back toward the axis while pushing the cap back into the needle shield).

[0261] In the description referred to above Figures 15 to 19 the assembly of the power unit was discussed. Figures 91 to 98 The power unit assembly is similarly shown and a full explanation of the above functions will not be repeated. Figures 91 to 98 Parts of slightly different shapes are shown, but the process is generally the same, with the power unit moving from a first position (wound position) to a second position (power unit locked position), and then to a third position (power unit unlocked position). In addition to the auto-injector parts, Figure 91 、 94 and 95 also show tool parts that can be used to assist in the assembly. As a general introduction to this concept, it can be understood that while torsion springs typically provide an economical and efficient source of rotational energy, they also present the challenge of a decreasing spring diameter as the spring is wound up.

[0262] Especially from Figure 94 and 95 it can be seen that the tool for assisting in the assembly (spring winding tool) includes two parts that can rotate relative to each other, namely, the distal tool 460 and the proximal tool 470. The distal tool 460 is configured to receive and rotationally lock the power unit lock 220 such that the power unit lock 220 cannot rotate relative to the distal tool 460. In this example, this is achieved by providing a groove 461 that receives the projection 226 of the power unit lock 220, as Figure 91 shown. Optionally, the distal tool 460 includes a support portion 462 (in this case, a tubular section) to help support the power unit housing 240, which can also rotationally lock the power unit housing 240 relative to the distal tool 460 if additional stability is needed. The proximal tool 470 is configured to receive and rotationally lock a component that is rotationally locked to the proximal end of the torsion spring 260, and this component can be various components, such as components of the activation subassembly 56. In the example shown (e.g., seeFigure 94 ), the proximal tool 470 is configured to receive and rotatably lock to the locking member activation sleeve 80. The specific shapes of the distal tool 460 and the proximal tool 470 can vary greatly depending on the shape of the associated auto-injector components and the shapes of other tools used to assist in the assembly of the auto-injector.

[0263] Now, the method of using the spring winding tool (including the distal tool 460 and the proximal tool 470) will be described. As Figure 91 shown, first, the power unit locking member 220 is inserted into the distal tool 460, and then the power unit housing 240 is attached to the power unit locking member 220. At this time, the power unit locking member 220 and the power unit housing 240 are attached to each other through the protrusion 224 of the power unit locking member 220 and the corresponding recess in the power unit housing 240, as described above with reference to Figure 16 and as Figure 92 shown. Figure 93 The position of the distal tool 460 relative to the power unit locking member 220 and the power unit housing 240 is shown.

[0264] Next, the torsion spring 260, the drive member 280, the activation subassembly (in this particular instance, including the locking member activation sleeve 80, the needle guard locking member 100, the drive nut 320, and the thrust bearing 340), and the plunger rod (not shown) and the proximal tool 470 are added to the power unit housing 240, as Figure 94 shown. Then, the proximal tool 470 can be rotated relative to the distal tool 460 to wind the torsion spring 260, at which time the drive member can rotate freely relative to the power unit locking member. The rotation step can optionally be carried out in two steps. The first step is a limited rotation (e.g., rotating the distal tool 460 a quarter turn or a half turn (i.e., 90 or 180 degrees) relative to the proximal tool 470) to engage the proximal protrusion 262 of the spring 260 with the circumferentially facing rung 282, which allows checking whether the spring and the drive member are properly engaged, and then rotating the distal tool 460 relative to the proximal tool 470 to wind the torsion spring 260 to the desired amount). It should be noted that Figure 94 and 95 also only show a part of the torsion spring 260. For ease of understanding, a small section of the unwound spring and a small section of the wound spring are shown (the diameter of the wound spring is smaller than the diameter of the unwound spring).

[0265] Once the torsion spring 260 is wound, the power unit locking member 220 is moved to the second position, as Figures 95 to 97 shown ( Figure 97 corresponding to Figure 19 in the above description)) This can be achieved by moving the distal tool 460 towards the proximal tool 470. As described above, this locks the power unit by rotating the power unit lock and the drive member such that the torque from the spring cannot be released as the drive member and the power unit housing are rotationally locked to each other by the power unit lock. Then, the resulting subassembly can be removed from the tool and inserted into the housing 40, which rotationally locks the activation subassembly and the power unit housing relative to the housing. At this point, the power unit lock 220 can be moved to a third position, as Figure 98 shown.

[0266] Overall, this scheme of winding the spring before assembly completion is beneficial as it allows for a smaller diameter housing to be used for the spring without the need for other means - winding the spring first would reduce its size. The above tool allows the spring to be wound externally and then transferred to the housing. This allows the inner diameter of the housing (or at least the inner diameter at the housing entry point) to be smaller than the diameter of the unwound spring.

[0267] Figure 99 Another autoinjector 10 is shown having components similar to the above-described assembly. In Figure 99 , the housing 40, the cap 160 and the optional rotator cap 390, as well as a small portion of the syringe holder 120 and the main kit 360 can be seen. A distinct difference compared to previous designs is the design of the cap 160, which will be described in more detail below.

[0268] Figure 100 Shown is Figure 99 the autoinjector 10 in disassembled parts, namely, the housing (divided into a proximal housing 42 and a distal housing 44), the needle shield 60, the lock activation sleeve 80, the needle shield lock 100, the syringe holder 120, the needle shield spring 140, the cap housing 162, the cap core 170, the optional rotator 380 and rotator cap 390, the power unit lock 220, the power unit housing 240, the torsion spring 260 (in Figure 10 , the torsion spring is shown fully in the tensioned and untensioned states to show the diameter difference between the tensioned and untensioned states), the drive member 280, the plunger rod 300, the drive nut 320, the thrust bearing 340 and the main kit (in this instance, including the syringe 362 with the injection needle 368, the rigid needle shield 364 and the stopper 366). Also shown is the optional label 419.

[0269] These components are generally interchangeable between the devices described herein. However, some components are different in shape from those described elsewhere in this document. Some components are shown in more detail in Figures 101 to 115 . Figure 101The plunger rod 300 and the thrust bearing 340 are shown. Figure 102 More details of the thrust bearing 340 are shown. In this particular example, the thrust bearing 340 has four snap-fit arms 342. Of course, in this example and other thrust bearing examples described herein, other numbers of snap-fit arms 342 may also be provided. Figure 103 More details of the power unit lock 220 and the corresponding rotator 380 are shown. Additional protrusions 226 (four additional protrusions in this example) can be seen. In this example, these protrusions are curved in a plane perpendicular to the longitudinal axis, as opposed to Figure 73 the protrusions 226 shown, for example, Figure 73 the protrusions 226 shown are straight in a plane perpendicular to the longitudinal axis (and are also conical in the specific example of Figure 73 , which is optional, of course). Figure 104 More details of the power unit housing 240 and the corresponding rotator cap 390 are shown. They can be joined together by snap-fit. Figure 105 , 106, and 107 respectively show more details of the needle guard lock 100, the drive nut 320 ( Figure 106A and 106B shown at different angles), and the lock activation sleeve 80. Figure 108 The drive member 280 is shown. Figure 109 The distal housing 44, which is part of the housing 40, is shown. Figure 110 The syringe holder 120 is shown; the various features of the housing 40 and the syringe holder 120 are as described in other examples herein and will not be repeated. However, a significant difference lies in the optional attachment (snap-fit in these examples) between the syringe holder 120 and the drive nut 320. In Figure 34 the example, this attachment is achieved by a hook 128 of the syringe holder 120 (the hook extends in the radial direction (specifically, away from the axis in the radial direction, which can of course be in the opposite form) and a hook 334 of the drive nut 320. In Figure 110 and FIG. 106 (especially Figure 106B ), an alternative example is shown, where the snap-fit is achieved by snapping together by bending in the circumferential direction rather than the radial direction. Of course, these attachments are interchangeable in the examples described herein. In particular, two pairs of snap-fit arms 132 are provided on the syringe holder 120. Each pair of snap-fit arms includes two arms 132, and each arm includes a protrusion 133 that extends in the circumferential direction. For example, as Figure 110As shown, two protrusions 133 in a pair of snap-fit arms extend away from each other. The drive nut 320 includes corresponding snap-fit holes 336 (or recesses) configured to receive the protrusions 133 for snap-fitting.

[0270] Now, Figures 111 to 120 will be used to describe the front subassembly 50 of the exemplary auto-injector in more detail. In this example, the front subassembly 50 includes the syringe holder 120, the needle shield spring 140, the needle shield 60, the proximal housing 42, and three parts of the cap 160, namely, the cap housing 162, the rigid needle shield removal member 180, and the cap core member 170. Figure 111 , 113 , 114 and 115 respectively show the needle shield 60, the cap housing 162, the cap core member 170, and the proximal housing 42. Figure 112 , 116 and 117 show how these components are assembled together. In Figure 112 , it is shown that the front subassembly 50 is arranged side by side with other components of the exemplary auto-injector. Of course, the front subassembly can also be used in combination with other auto-injectors. Figure 118 , 119 and 120 show how these components are assembled together after the cap is removed and the needle shield is pushed distally.

[0271] Similar to the example shown in Figures 80 to 85 , the locking mechanism is provided by the combination of the cap 160, the needle shield 60, and the housing 40 (more specifically, the proximal housing 42 in this particular case). Due to the similar functions, the components and functions of the front subassembly in Figures 111 to 120 will not be described repeatedly. Reference should be made to the explanation given for the example in Figures 80 to 85 .

[0272] One difference from the example in Figures 80 to 85 is that the arm 410 is attached to the rest of the proximal housing 42 at the distal end of the arm. Of course, the proximal end of the arm can alternatively be attached to the proximal housing.

[0273] Another difference from the example in Figures 80 to 85 is that the proximal end of the distal housing 44 is closer to the proximal end of the front subassembly than the proximal end of the arm 410 (for example, see Figures 118 to 120 ). This can protect the arm 410 within the distal housing 44 in the assembled device; this can prevent the user from manipulating the arm 410, which might otherwise cause the user to interfere with the function of the assembled device.

[0274] Similar to Figures 80 to 85Another difference in the examples herein is that there is provided a surface that allows the rotation of the cap 160 relative to the housing 40 to be converted into an axial movement of the cap relative to the housing (for example, a similar function is provided by the examples in Figure 10 and Figure 67 . In this example, the cap core 170 includes a distal surface 173 (instead of using the distally facing surface 169 of the cap housing 162, although these designs can be interchanged), and this distal surface 173 can interact with the corresponding proximally facing surface 49 of the housing 40 (in this particular example, the proximally facing surface 49 is provided by the ribs on the proximal housing 42). Alternative solutions described in other examples herein (such as in Figure 10 and 67 ) can also be used in this example.

[0275] The cap housing 162 and the cap core 170 are rotationally fixed relative to each other (or at least their rotation is restricted). In this example, this is achieved by the engagement of the protrusion 175 of the cap core 170 (in this example, the protrusion 175 extends from the proximal face of the cap core) with the slot 165 of the cap housing 162. There are also provided a protrusion 159 of the cap housing 162 and a notch 178 (or recess) of the cap core 170 to attach the cap housing 162 to the cap core 170 (as previously mentioned, the rigid needle shield remover 180 is arranged between the cap core 170 and the cap housing 162). Of course, the notch can also be located on the cap housing, and the protrusion on the cap core. The protrusion 159 and the notch 178 also help to limit or prevent the rotational movement of the cap housing relative to the cap core.

[0276] Now, another method of providing feedback will be described using Figures 121 to 128 , which can be used as an alternative or supplement to the other feedback options provided herein. In this way, this feedback mechanism can be implemented in many of the devices described herein, such as the devices in Figure 100 . More generally, this type of feedback mechanism can also be used in a medicament delivery device in which two components rotate relative to each other.

[0277] As shown in Figure 121 , the feedback mechanism sub - assembly includes a power unit lock 220, a power unit housing 240, a rotator 380, a rotator cap 390, and a sound generator 500. Figure 122 Shows how the components of the feedback mechanism sub - assembly are fitted together, and also shows the housing 40 and the plunger rod 300 for reference.

[0278] At the distal end of the device, the rotator cap 390 extends around the rotator 380, as shown in Figure 122As shown. The rotating body 380 and the rotating body cap 390 interact with each other through the combination of the follower structure 388 and the guiding structure 394 (which can be considered as a cam follower and a cam), which will be described in more detail below.

[0279] The rotating body 380 is arranged between the rotating body cap 390 and the sound generator 500. The rotating body 380 includes a pair of protrusions 384 that interact with the sound generator 500; this will also be described in more detail below.

[0280] The sound generator 500 is arranged between the power unit housing 240 and the rotating body 380. The proximally facing surface 502 of the sound generator 500 abuts against the distally facing surface of the power unit housing 240, and the distally facing surface 504 of the sound generator 500 abuts against the proximally facing surface of the rotating body 380 (in this instance, the proximal end of the protrusion 384).

[0281] The rotating body 380 is attached to the part of the medicament delivery device that rotates relative to the rotating body cap 390, and in this case, this part is the power unit lock 220.

[0282] Also shown here is the housing 40 that is generally immovably attached to the power unit housing 240 and the rotating body cap 390. The power unit housing 240 and the rotating body cap 390 can be considered as part of the housing.

[0283] Now will refer to Figure 127 and 128 The connection between the rotating body cap and the rotating body will be described in more detail. The general idea is that the rotating body cap (or more generally the housing) includes the guiding structure 394, and the rotating body includes the follower structure 388. This can convert the rotational motion into a linear motion. As a result, when the rotating body rotates relative to the housing (as described in more detail below), the interaction between the cam and the cam follower causes the linear movement of the rotating body relative to the housing. There are many guiding structures and follower structures that can be used to achieve this effect, but first, a more detailed description will be given taking the specific shapes shown in the drawings as an example. As Figure 127 shown, the follower structure 388 of the rotating body 380 includes four inclined surfaces 389. Each inclined surface extends 90 degrees around the axis. Each inclined surface is inclined with respect to the plane perpendicular to the axis. As a result, each inclined surface extends from the proximal end to the distal end. The proximal end of each inclined surface is adjacent to the proximal end of the adjacent inclined surface. The distal end of each inclined surface is adjacent to the distal end of the adjacent inclined surface. This causes the follower structure to provide a surface that extends 360 degrees around the axis.

[0284] The guide structure 394 is a mirror image of the follower structure in its design and has four inclined surfaces 395 with the same arrangement as in the guide structure. That is, each inclined surface extends 90 degrees around the axis. Each inclined surface is inclined with respect to a plane perpendicular to the axis. As a result, each inclined surface extends from the proximal end to the distal end. The proximal end of each inclined surface is adjacent to the proximal end of the adjacent inclined surface. The distal end of each inclined surface is adjacent to the distal end of the adjacent inclined surface. This causes the follower structure to provide a surface that extends 360 degrees around the axis.

[0285] Optionally, the follower structure and the guide structure are mirror images of each other in their design. For example, for Figure 127 the follower structure shown, part or the entire guide structure can be just a protrusion extending along the axial direction, and the distal end of the protrusion abuts against the surface of the follower structure. Or, the guide structure can be as Figure 128 shown, while Figure 127 part or the entire follower structure is replaced by a protrusion.

[0286] Another alternative is to provide a single inclined surface 389 instead of four inclined surfaces. If the guide structure 394 is replaced by a protrusion as described above, then the single inclined surface can extend 90 degrees around the axis, as Figure 127 shown, or it can also extend less or more around the axis, such as 180 degrees, 270 degrees, or 360 degrees. In this instance, when the protrusion passes the farthest distal end of the inclined surface 389, the rotator will be suddenly pushed back in the distal direction by the sound generator relative to the rotator cap. This sudden movement may be beneficial because it can provide a louder click sound. Due to the sudden movement of the components relative to each other, this sudden movement can also provide tactile feedback.

[0287] Now the interaction between the rotator 380 and the sound generator 500 will be described. Two protrusions 384 (such as Figure 123 ) abut against the distally facing surface 504 of the sound generator. The sound generator is a plate, and the plate is slightly deformed so that when the rotator is in the distal position, the distally facing surface 504 of the sound generator is convex (i.e., the center of the distally facing surface 504 is farther from the proximal end of the device than the edge of the distally facing surface 504). As a result, the proximally facing surface 502 is concave. When the rotator moves in the proximal direction, the power unit lock 220 restricts the movement of the outer edge (i.e., the edge farthest from the center) of the sound generator in the proximal direction, while the rest of the sound generator is pushed in the proximal direction by the protrusions of the rotator. As a result, the sound generator deforms and transforms from the first shape to the second shape, and the distally facing surface 504 transforms from convex to concave (so the proximally facing surface 502 transforms from concave to convex).

[0288] In as Figure 121During use of the device incorporating the feedback mechanism subassembly shown, activation of the device causes the power unit lock 220 to rotate relative to the housing 40 (usually while delivering a medicament from the device). Since the rotator 380 is rotationally locked to the power unit lock 220 and the housing 40 is immovably attached to the power unit housing 240 and the rotator cap 390, the rotator 380 rotates relative to the rotator cap 390. As a result, the follower structure of the rotator rotates relative to the guiding structure of the rotator cap. Due to the respective shapes of the follower structure and the guiding structure, this rotation pushes the rotator along the longitudinal axis relative to the rotator cap (i.e., pushes in the axial direction 22 and thus proximally in the proximal direction towards the proximal end of the device). In the particular design shown in the figures, a 90-degree rotation causes the rotator to move from its furthest position to its closest position. As the rotator moves proximally, the sound generator deforms because the rotator pushes a portion of the sound generator proximally, but another portion of the sound generator cannot move proximally because the power unit housing 240 blocks this movement. This causes the sound generator to deform (i.e., potential energy accumulates in the sound generator). When the sound generator deforms from its initial, more relaxed (or relaxed) state to its deformed state, the sound generator is capable of making a clicking sound.

[0289] Another 90-degree rotation moves the rotator back from its closest position to its furthest position. This movement is driven by the release of the potential energy accumulated in the sound generator, which pushes the rotator distally once the interaction between the follower structure and the guiding structure allows it. When the sound generator relaxes back from its deformed state, it is capable of making a clicking sound.

[0290] In the example shown herein, the design of the guiding structure and the follower structure causes the rotator to move from its closest position to its furthest position and to return every 180 degrees, so that the rotator returns twice for each full 360-degree rotation. However, for other guiding structure and follower structure designs, the rotator can move from its closest position to its furthest position and return a different number of times for each 360-degree rotation, such as once or three times or more. This can be used to vary the frequency and / or pattern of the sound generated by the sound generator. The angles of the inclined surfaces 389, 395 can be constant relative to the axis along the length of the inclined surface, or can vary (e.g., vary in a sinusoidal pattern).

[0291] Figure 121The feedback sub-component shown is capable of providing repeated clicks (successive clicks) (e.g., more than 5 clicks, more than 10 clicks, or more than 20 clicks) during the delivery of the medicament from the device, thereby providing an audible indication to the user that the injection is in progress. This type of feedback sub-component can also be used to generate a single click (e.g., an end click indicating the end of the medicament delivery, a start click indicating the start of the medicament delivery, and / or a pre-injection click indicating the completion of the pre-injection). Although the examples given herein typically use multiple rotations of a rotating body relative to a housing to provide repeated clicks, this type of feedback sub-component can also operate by a single 360-degree rotation of one component relative to another, or can also operate by a partial rotation of one component relative to another, especially when one or more independent clicks rather than successive clicks are required during the medicament delivery. This type of feedback sub-component can be used alone or in combination with other visual, audible, and / or tactile feedback mechanisms.

[0292] In this particular design, it is the power unit lock 220 that rotates relative to the housing and is attached to the rotating body, thereby providing the rotation required for the rotating body to rotate relative to the housing. The rotation lock 229 on the power unit lock 220 and the rotation lock 386 on the rotating body 380 rotationally lock the power unit lock 220 and the rotating body 380 together; a particular shape of the lock is shown herein, but the shape can vary.

[0293] In Figure 121 In the example shown, the rotating body 380 is attached to the power unit lock 220. Generally speaking, the rotating body 380 can be rotatably attached to any component that rotates relative to another component, such as a plunger rod that rotates relative to the housing in a medicament delivery device, where the plunger rod rotates relative to the housing of the medicament delivery device. The rotating body can also be an integral part of a component (e.g., an integral part of the power unit lock 220 or the plunger rod), rather than an independent component.

[0294] In Figure 121In the illustrated example, the rotating body has two protrusions 384, but it may also have one, three or more protrusions. These two protrusions 384 are opposite to each other with respect to the longitudinal axis; this is optional, of course, symmetry may be preferred, for example, to maintain the force balance within the device, and providing more protrusions (two or more) can produce a louder click sound. The protrusions may be located on the surface of the sound generator 500 instead of on the rotating body; the proximal-facing surface of the rotating body interacts with the protrusions of the sound generator. In another alternative, one or more protrusions on the sound generator (for example, protrusions extending distally from the distal-facing surface 504 of the sound generator) and the protrusions 384 on the rotating body 380 are provided simultaneously. As the rotating body 380 rotates, the protrusions of the rotating body interact with the protrusions of the sound generator, thereby pushing the sound generator (in the proximal direction) and generating a click sound (the protrusions may optionally have inclined ends to reduce the friction caused by the interacting protrusions). In this alternative, a guiding structure as shown in Figure 127 and 128 is not required because the rotating body does not need to move in the proximal direction to cause the sound generator to produce a click sound.

[0295] In Figure 121 the illustrated example, the rotating body cap 390 is described as an independent component. However, the rotating body cap can be considered as part of the housing 40. Similarly, the power unit housing 240 can be considered as part of the housing 40. Therefore, more generally, the combination of the housing 40, the power unit housing 240 and the rotating body cap 390 can be simply considered as the housing (which can also be a single integral part or the sum of two or more independent parts). Therefore, the rotating body cap can be simply described as the housing or a housing part.

[0296] For example, the sound generator 500 can be made of plastic or metal. In the described example, the sound generator is a disc (with an optional smaller hole 506 in the middle), but it can also be of another shape, such as annular, rectangular or square. As described above, the hole 506 is optional. This allows the rotating body (and / or the power unit locking member 220) to extend through the sound generator. This is required in the specific design shown in the figure because the sound generator is located between the power unit locking member 220 and the rotating body 380, but it may not be required for different shapes of the sound generator. If the positions of the rotating body and the sound generator are reversed, then this hole 506 may no longer be needed.

[0297] Figure 129 and Figure 130 show another feedback mechanism that can be used with the solutions described herein (such as Figure 74 or Figure 121)Used in combination, or in combination with other devices where one component rotates relative to another. In this mechanism, a gear mechanism is provided that converts the number of rotations required to complete an injection (in this case, the number of rotations of the power unit lock 220, e.g., 1800 degrees) into a reduced amount of rotation, e.g., a rotation of less than 360 degrees of a disk (display wheel) 520 with a visual graphic conveying the injection status. The view of the display wheel may be partially blocked by a cap 540 (or an opaque portion of the cap), such that only a portion of the display wheel (e.g., some text or color) is shown to the user through a gap 542. For example, an optional label at other locations on the device including such a feedback mechanism may indicate that a green color shown in the gap indicates that the device is ready for use. For example, once injection begins and the power unit starts to rotate, the gear drive mechanism rotates the display wheel such that the green color is no longer shown but instead a yellow color is shown. A label on the device may indicate that yellow indicates that injection is in progress. When the power unit reaches the end of injection, the display wheel has rotated enough to show a red color indicating the final end-of-injection status. A label on the device may indicate that the red graphic indicates that injection has been completed, and / or that the user should wait a few seconds before removing the device, and / or that the device has now been used / is not ready for use. The gear drive means that the display wheel does not move continuously, but instead moves in a stepwise manner after the rotating component (e.g., the power unit lock or the plunger rod) has rotated a certain angle (in this case, every 180 degrees). This can create a clear boundary between changes in text and / or colored graphics. The mechanism is characterized by having a drive gear 522 directly coupled to a rotational power source (not shown), a reduction gear 524 driven by the drive gear every 180 degrees in this instance, and a display wheel characterized by having inward-facing teeth 526 and being driven by the reduction gear, as Figure 129 and 130 shown.

[0298] Alternatively, rather than producing a stepwise motion, the gear drive rotates the display wheel continuously. This requires that the interface gear has no missing teeth. Alternatively, the disk may provide an auditory feedback instead of (or in addition to) the visual feedback. The visual feedback may be provided in various ways, including text, color, and / or graphic images, to convey such as the device not being used, the device being ready for use, injection being in progress, injection being completed, and / or the device having been used. The number of rotations required from the start to the end of injection can be adapted to the needs of the device by adjusting the ratio between the gears.

[0299] In addition to any other audible clicks that may be provided, a distinctive click, such as an end click, can be provided by a rigid rib (or rigid protrusion) proximal to the display wheel, which rib (or protrusion) contacts and bends a flexible arm during a final step rotation (e.g., moving from yellow to red), and the flexible arm makes a clicking sound once released by the rotating display wheel rib (or protrusion). The positions of the flexible arm and the rigid rib can be interchanged. This method can alternatively or additionally be used for other clicks, such as a start click.

[0300] A variety of different exemplary autoinjectors are illustrated herein. There are various differences between the illustrated autoinjectors, but generally the different features of different autoinjectors are interchangeable, particularly at the level of functional sub-assemblies such as the power unit, the needle guard locking assembly, or the locking mechanism.

[0301] One or more of the cap, the housing, and the needle guard are typically (but not necessarily) tubular because this helps these components provide other functions in addition to the function of providing a locking mechanism.

[0302] Typically, the above-described locking mechanisms are used in autoinjectors (or more generally, drug delivery devices) that are (at least partially) activated by the distal movement of the needle guard because these locking mechanisms can be used to prevent premature activation (activation before the cap is removed, e.g., when the autoinjector drops). However, such locking mechanisms are also useful in devices activated in other ways. Another benefit of such locking mechanisms is that they limit the movement of components relative to each other, which can also be used to secure the device. For example, this can minimize the chance of damage during transportation.

[0303] Instances of autoinjectors with injection needles are emphasized in this application. However, the concepts illustrated herein can also be implemented in more general pen injectors or drug delivery devices. For example, the needle guard locking assembly illustrated herein can be used in an autoinjector with an injection needle, an autoinjector with a jet injector, or a pen injector. An autoinjector is generally defined as an injection device in which at least a portion of the process (e.g., drug injection, injection needle insertion, or needle guard retraction) is performed by the autoinjector and thus does not need to be performed by the user.

[0304] The relative positions of the features in this application are generally described with reference to an axis (central axis) 20 and the corresponding axial direction (longitudinal direction) 22, circumferential direction 24, and radial direction 26. The device as a whole (and each component) can be described as extending from a proximal end 14 to a distal end 16. For example, in Figure 29These terms are shown in FIG. When not specifically indicated, the movement of each component is generally described relative to the housing (such as housing 40). Each part described herein is generally an integral part. Of course, they can also be composed of two or more independent parts (such as the housing shown in Figure 29 ).

[0305] Generally speaking, the housing (outer shell) 40 can be a single-piece (such as Figure 10 ), or a two-piece or multi-piece (such as the proximal housing 42 and the distal housing 44 in Figure 29 ); these variations in housing design are also interchangeable between the illustrated examples. The illustrated housing is tubular, more specifically cylindrical. However, other shapes are possible without compromising the function of the device (such as the housing shown in Figure 99 having a rounded square cross-section perpendicular to the axis instead of a circular cross-section). When placed on a surface, a non-cylindrical design also helps to reduce the rollability of the device. Although the housing is usually the outermost component, it can also support the device as an internal component. Optionally, a window 46 is provided in the housing, for example, for drug inspection before using the device. The housing optionally includes a neck 39 (such as Figure 53 ; Figure 70 and 99 also shows a less obvious neck); the neck is usually a ring around the housing, whose outer diameter is smaller than the rest of the housing (or at least smaller than the outer diameters of the housing immediately adjacent to the ring on the proximal and distal sides of the ring), and helps to hold the housing more easily.

[0306] In this application, the needle guard locking assembly is emphasized, where the proximal part of the arm of the needle lock is biased away from the axis to interact with the slit or recess. This mechanism can also be reversed, that is, the slit is closer to the axis than the proximal part of the arm of the needle lock, and the proximal part of the arm is biased towards the axis to interact with the slit or recess. In this case, the slit or recess can still be located in the outer shell as described herein (especially in the instance where the syringe holder or the power unit housing is an integral part of the outer shell), or the housing including the slit can be part of another component (such as the syringe holder) fixed to the outer shell.

[0307] Many of the features described herein are shown in pairs, typically with two of each feature spaced 180 degrees apart in the circumferential direction 24 about an axis 20 (i.e., two-fold rotational symmetry). However, such symmetry is not required and generally only one of each feature need be provided to achieve the functional effect (e.g., an arm, a projection, a slit, a recess). However, by providing two, three, or more of any particular feature, preferably evenly distributed about the axis, benefits such as ease of manufacture, ease of assembly, reliability and / or device stability during use can be obtained.

[0308] The slit 45 in the housing extends through the housing in the radial direction. Alternatively, the slit may be replaced by a recess that only penetrates a portion of the housing in the radial direction.

[0309] Generally, the devices described herein can be divided into various sub-assemblies. At the highest level, an auto-injector can be divided into a front sub-assembly, a main kit, and a rear sub-assembly. The front sub-assembly typically includes a cap, a housing, a needle shield, and a syringe holder. The main kit typically includes a needle shield (e.g., a rigid needle shield and / or a flexible needle shield), a syringe including an injection needle, a medicament in the syringe, and a stopper. The composition of the rear sub-assembly can generally be more diverse, but typically includes some kind of power unit and optionally also includes various other features. Figure 18 An example of a power unit assembly is shown, which includes a drive member, a power unit lock, a torsion spring, and a power unit housing. The device can also be divided into various interacting sub-assemblies, including a medicament delivery member locking assembly, such as a needle shield locking assembly 58, which includes a needle shield 60 from the front sub-assembly, and a lock activation sleeve 80, a needle shield lock 100, and a housing 40 (or a portion of the housing, such as the distal housing 44) from the rear sub-assembly, which together constitute the components required to lock the needle shield after use. Another sub-assembly is an activation sub-assembly (e.g., Figure 20 ), which includes a lock activation sleeve, a needle shield lock, a plunger rod, and a drive nut. Other sub-assemblies are possible, and the sub-assemblies and components described herein are not limited to use in the specific devices described herein. For example, the power unit sub-assembly described herein can be used in a device that does not include the activation sub-assembly described herein, and the locking mechanism described herein can be used in a device that does not include the power unit sub-assembly. In fact, generally, the various sub-assemblies described herein can be included in completely different devices and can be used in devices different from the specific examples described herein. Typically, the various sub-assemblies and components in the different examples described herein are interchangeable. For example, Figure 1 and Figure 5 the needle shield locking assembly shown can be used in Figure 10 andFigure 29 in the auto - injector shown, and Figure 40 the rotator shown can be used in any of the auto - injectors described above.

[0310] In the case of providing the needle shield locking assembly described herein, it is necessary to provide a needle shield (needle guard) 60 (or more generally a medicament delivery device shield), but more generally, this is optional. The description herein focuses on examples of devices with injection needles; however, the injection needle can also be replaced by another medicament delivery member, such as a jet injector. Thus, any discussion of the injection needle herein can be extended to the medicament delivery member. By extension, any discussion of the needle shield herein can be extended to the medicament delivery member shield.

[0311] The needle shield generally includes a proximal tubular portion (such as shield portion 64) and one or more arms (such as needle shield arms 62) extending distally from the tubular section, the tubular portion forming the needle shield, and the one or more arms interacting with other parts of the device as required, such as interacting with the locking member activation sleeve 80. Optionally, the one or more arms include a slit 66. Alternatively or additionally, the slit 66 extends into the shield portion 64 (for example, see Figure 13 ). Recesses can also be provided instead of the slit 66.

[0312] The locking member activation sleeve 80 can have different shapes, depending on the device and the required function. In the above example, the locking member activation sleeve 80 includes a tubular section 82, an arm 84 with a gasket 86, and a notch 88 for the distal portion 108 of the arm of the needle shield locking member 100. As Figure 21 shown, the notch 88 extends through the arm 84 and the tubular section 82, and of course, they can also extend only through the arm or only through the tubular section. Recesses can be provided instead of the notch. Generally speaking, the arm is also optional, and the gasket 86 can be located on the tubular section 82; the function of the arm 84 of the locking member activation sleeve is that it allows the arm 324 of the drive nut 320 to extend radially outwards (for example, see Figure 47 ), while the tubular section 82 of the locking member activation sleeve does not interfere. The locking member activation sleeve is generally arranged in the housing at the distal end of the needle shield locking member, and before use of the device, most or all of the locking member activation sleeve is further away from the proximal end than the needle shield.

[0313] The gasket 86 shown in the examples herein includes a protrusion extending from the arm 84 towards the axis. The protrusion extends further in the axial direction than in the radial direction, and its shape corresponds to the arm 104 of the needle shield locking member, for example, by including angled segments at the proximal and distal ends of the gasket (for example, see Figure 25) is implemented, where the proximal end of the gasket is angled towards the proximal end and the distal end of the gasket is angled towards the distal end. The shape of the gasket 86 can vary greatly and still provide a working locking member activation sleeve. The main requirement is that the gasket pushes the distal portion 108 of the arm 104 towards the axis when the locking member activation sleeve moves in the distal direction. Thus, the gasket can be merely a protrusion on the arm 84 of the locking member activation sleeve or even a flat surface of the arm 84 of the locking member activation sleeve.

[0314] The needle guard locking member 100 includes a base (such as the tubular section 102) and at least one arm. The function of the base is generally to support the arm and hold the needle guard locking member in place relative to another component (such as the housing 40, the distal housing 44, and / or the syringe holder). The base is generally rigid. Of course, in some cases, the base can also be flexible and bend with the arm. In the examples described herein, a pivot 105 extends between the base of the locking member activation sleeve and the locking member activation sleeve arm. This pivot is optional, and the arm can be directly attached to the tubular section, especially when the tubular section is also flexible. The arm can also take various shapes. Generally, the protrusion 110 on the arm is optional. Ribs 107 can also be provided that extend in the radial and axial directions to support the arm, such as as Figure 24 shown. Optional slits 119 (see Figure 24 ) can also be provided to lock the locking member activation sleeve in rotation relative to the drive nut 320. Functionally, the needle guard locking member arm is used to pivot such that when the device is in use, the distal portion 108 of the arm moves towards the axis, biasing the proximal portion 106 of the arm in a direction away from the axis. Preferably, the distal end of the distal portion 108 is farther from the axis 20 than the proximal end of the distal portion 108 to assist in engaging the activation sleeve with the distal portion 108. As described above, the optional protrusion 110 can assist in engaging the proximal portion 106 of the arm with the housing.

[0315] The needle guard locking member can be a separate component, as shown in the examples herein, or can be an integral part of another component (such as the housing or the syringe holder).

[0316] As Figure 24 in the example shown, the needle guard locking member 100 can have other features, in Figure 24It includes a bellows corrugated section 112 configured to vary in length in the axial direction. During assembly, the bellows corrugated section can reduce its length in the axial direction, allowing the components to fit tightly together without making abnormal noises. The bellows corrugated section has a support part (in this case, the support ring 117) and two arms 118 that extend from the tubular section 102 of the needle guard lock to the support ring 117, and the arms extend along the longitudinal and circumferential directions, so that when the needle guard lock is compressed in the axial direction, the arms are allowed to bend and occupy less space in the axial direction. The support ring 117 is optional (in the case of no support part, the end of the arm 118 away from the base of the needle guard lock can be considered as the support part because the end of the arm 118 will abut against the adjacent component), but it is beneficial for better engagement with the adjacent component (in the example herein, it is the syringe). One, three or more arms can be provided instead of two arms. The shape of the arm can also be changed, for example, into a serrated shape. In the assembled medicament delivery device, the support part generally abuts against the syringe. Of course, it can also abut against another component, such as a syringe holder or a housing.

[0317] The provision of the syringe holder 120 is generally optional, and the syringe can also be held by other components, such as a housing or a clip. The syringe holder described herein includes a variety of optional features, including a proximally facing rung 122, a window 124, a protrusion 126, and a hook 128. Optionally, a proximally facing arm 129 can also be provided, as well as a radially outward protrusion 130 on the arm 129 and a radially inward protrusion 131 on the arm 129. The radially outward protrusion 130 extends through the slit 66 of the needle guard arm (see Figure 14 ). The arm 129 can be bent outward to allow the needle guard of the syringe (such as the rigid needle guard 364) to subsequently pass over the radially inward protrusion 131 during assembly. However, subsequently when the device is fully assembled, the radially outward protrusion 130 abuts against (in the radial direction) the housing, such as the housing 40, thereby preventing the radially outward protrusion 130 (as well as the arm 129 and the radially inward protrusion 131) from moving radially away from the axis, which means that during injection, the syringe (such as the shoulder 363 of the syringe 362) can be supported by the radially inward protrusion 131. The syringe holder is generally tubular. The proximally facing rung 122 can extend around the syringe holder along the circumferential direction for a section, or for a full circle, or can be multiple independent parts, or can be replaced by one or more protrusions.

[0318] The needle guard spring 140 is optional, and the needle guard can also be manually pulled out again after use. The needle guard spring is usually provided between the needle guard and the syringe holder, but can also be provided between other components, such as between the needle guard and the housing.

[0319] The cap 160 is also typically optional and may include one or more parts. The cap typically includes a rigid needle shield removal member. In the examples herein, a cap that is removed by pulling axially is shown. Other types of caps may also be provided, such as a screw cap or a cap removed by twisting.

[0320] The end cap 200 may have various alternatives. The end cap may be integrated into the housing and is thus an optional component. The rotator cap 390 is a type of end cap that can be used in place of the end cap 200, or vice versa.

[0321] The power unit housing 240 is another optional component, and its function may be provided by other components (such as the housing). Various modifications can be made to the power unit housing. For example, the spring retainer 400 (especially see Figure 30 ) is another example of the power unit housing.

[0322] In the examples given herein, torsion springs are used, and the examples are designed especially with torsion springs in mind because they are designed in a way that allows the spring to be wound during manufacturing and also in a way that allows the components to withstand the stress exerted on them by the torsion springs. However, many of the features described herein (including the collection of components, such as the front subassembly, activation subassembly, and / or needle shield locking assembly) can also be used in other medicament delivery devices, such as in an autoinjector having a compression spring or an electric power unit. The attachment structure of the torsion spring (such as the proximal protrusion (hook) 262 and the distal protrusion 264) can also be modified according to the shape of the component to which the torsion spring is attached.

[0323] By comparison Figure 17 and 30 of the drive members in, it can be clearly seen that the drive member 280 can also be modified in various ways according to the shape of the surrounding components. For example, the shape and length of the teeth 286 can vary according to the shape and length of the corresponding drive nut teeth 326. Alternatively, instead of having multiple teeth on both sides, one or more teeth can be provided on the drive member or the drive nut, and corresponding recesses or holes can be provided on the other of the drive member and the drive nut. In another alternative of the teeth, corresponding flat segments can be provided on the drive member and the drive nut, which is similar to the interaction between the plunger rod and the drive member shown in Figure 37 .

[0324] The plunger rod 300 described herein includes two flat sides 304, however, like features that are typically provided in pairs herein, only one flat side is necessary. Broadly speaking, the plunger rod does not need to have flat sides at all, but only needs to have a non-circular cross-section at the location where it engages with the driving member so that it can be rotated by the driving member. Threads are typically located on the portion of the plunger that does not engage with the driving member and are typically engaged by a drive nut 320. The snap-fit rung 306 is optional and is an example of achieving engagement between the plunger rod and the thrust bearing when a thrust bearing is provided; alternatively, the proximal end of the plunger rod can be shaped to directly engage with the plug member.

[0325] Significant variations in the shape of the drive nut 320 are also possible, which can be clearly seen from the differences in the shape of the drive nut in the examples described herein. The drive nut is also optional in some examples, especially in those examples that use a compression spring rather than a torsion spring. Like various other components, some features are also interchangeable between the examples described herein, for example, Figure 26 the optional drive nut protrusion 328 in Figure 35 can also be included in the drive nut of

[0326] The thrust bearing 340 is optional because the plunger rod can directly engage with the plug member, however, providing the thrust bearing 340 is beneficial for distributing the load on the plug member and for transmitting only axial (rather than rotational) force from the plunger rod to the plug member. Typically, the thrust bearing engages with the interior of the plug member (such as the cavity 369 of the plug member) and / or the distal end of the plug member (such as the outer edge 367 of the plug member) (see, for example, Figure 42 ). The shape of the thrust bearing can be modified according to the shape of the plug member (especially the shape of the plunger rod).

[0327] The provision of the rotator 380 is optional and the rotator 380 can also be provided in the examples of Figure 10 and 53 . The rotator can be attached to any part of the device that rotates during injection, such as the plunger rod and / or the driving member. Generally speaking, a rotator can be used on any autoinjector or medicament delivery device having a component (such as a plunger rod or a driving member) that rotates during medicament injection, not limited to the autoinjector described herein. In addition to or as an alternative to the rotator, audible or tactile feedback (or other visual feedback) can be provided as feedback indicating the start of injection, the end of injection, and / or indicating that injection is in progress. To make the rotator visible, a window 392 (or two or more windows) can be provided in the end cap (such as the rotator cap 390). Each window can be a cutout or a transparent portion in the rotator cap 390 (or more generally the end cap). Figure 40The shape of the exemplary window shown is generally similar to a sector, but other shapes are possible. The entire rotor cap or end cap can be made of a transparent material instead of providing a window.

[0328] Another additional or alternative example of feedback indicating that an injection is in progress can be the interaction between the power unit lock and the power unit housing to provide a sound during injection; this is one benefit of the power unit lock being part of the device rather than just a tool for locking the power unit during an intermediate step of the manufacturing process. Another example of feedback indicating that an injection is in progress can be the interaction between the drive nut and the drive member, such as the interaction between the teeth of the drive nut and the teeth of the drive member. Although the drive member can rotate freely when the teeth of the drive nut extend freely away from the axis (see, for example, Figure 35 ), the teeth of the drive nut are optionally held biased towards the drive member (rather than being biased away from the drive member), which means that the teeth of the drive nut and the teeth of the drive member will pass freely by each other, but will continue to interact as the drive member rotates, thereby providing a clicking sound as the injection progresses.

[0329] Various modifications to the described embodiments are possible and would be apparent to those skilled in the art, and these do not depart from the invention as defined by the appended claims.

[0330] Some aspects of the invention are summarized in the following items.

[0331] 1. A medicament delivery member shroud locking assembly (58) for a medicament delivery device (10), the medicament delivery member shroud locking assembly (58) comprising:

[0332] A housing (40) extending in an axial direction (22) along an axis (20) from a proximal end (14) to a distal end (16), the housing (40) including a recess or slit (45);

[0333] A medicament delivery member shroud (60) slidably disposed in the housing (40), the medicament delivery member shroud (60) extending from the proximal end (14) to the distal end (16);

[0334] A lock activation sleeve (80) slidably disposed in the housing (40) at the distal end (16) of the medicament delivery member shroud (60); and

[0335] A medicament delivery member shroud lock (100) disposed in the housing (40) adjacent to the lock activation sleeve (80),

[0336] The medicament delivery member shroud locking member (100) includes a base (102) and a flexible arm (104) pivotally attached to the base (102), where the flexible arm (104) includes a proximal portion (106) and a distal portion (108), where the flexible arm (104) is attached to the base (102) between the proximal portion (106) and the distal portion (108), and where the proximal portion (106) of the flexible arm (104) is arranged to be adjacent to a recess or slit (45) in the housing (40).

[0337] 2. The medicament delivery member shroud locking assembly according to item 1, wherein the medicament delivery member shroud includes a distally facing surface, and the locking member activation sleeve includes a corresponding proximally facing surface, and the distally facing surface of the medicament delivery member shroud engages the proximally facing surface to push the locking member activation sleeve in the distal direction when the medicament delivery member shroud is pushed in the distal direction,

[0338] wherein the locking member activation sleeve includes a radially facing surface relative to an axis, and when the locking member activation sleeve is pushed in the distal direction, the distal portion of the flexible arm of the medicament delivery member shroud locking member is pushed in the radial direction using the radially facing surface to bias the flexible arm of the medicament delivery member shroud locking member against the medicament delivery member shroud, and

[0339] wherein when the medicament delivery member shroud is subsequently moved back in the proximal direction, the proximal portion of the flexible arm of the medicament delivery member shroud locking member moves towards or into a recess or slit in the housing.

[0340] 3. The medicament delivery member shroud locking assembly according to item 1 or item 2, wherein the medicament delivery member shroud is configured to push the locking member activation sleeve in the distal direction when the medicament delivery member shroud is pushed in the distal direction,

[0341] wherein the locking member activation sleeve is configured to push the distal portion of the flexible arm of the medicament delivery member shroud locking member in the radial direction relative to the axis when it is pushed in the distal direction to bias the flexible arm, and

[0342] wherein when the medicament delivery member shroud is subsequently moved back in the proximal direction, the proximal portion of the flexible arm of the medicament delivery member shroud locking member moves towards or into a recess or slit in the housing.

[0343] 4. The medicament delivery member shroud locking assembly according to any of the preceding items, wherein the proximal portion of the flexible arm of the medicament delivery member shroud locking member includes a protrusion extending in the radial direction.

[0344] 5. A medicament delivery member shield locking assembly as described in any of the foregoing items, wherein at least a portion of the flexible arm of the medicament delivery member shield lock is further from the axis than the base.

[0345] 6. A medicament delivery member shield locking assembly as described in any of the foregoing items, wherein the medicament delivery member shield lock includes a bellows section having a variable length in the axial direction and extending axially from the proximal end of the medicament delivery member shield lock.

[0346] 7. The medicament delivery member shield locking assembly as described in item 6, wherein the bellows section includes a support portion spaced from the base of the medicament delivery member shield lock and at least one arm extending from the base of the medicament delivery member shield lock to the support portion.

[0347] 8. A medicament delivery member shield locking assembly as described in any of the foregoing items, wherein the distal end 113 of the distal portion 108 of the flexible arm is further from the axis 20 than the proximal end 109 of the distal portion 108 of the flexible arm.

[0348] 9. A medicament delivery member shield locking assembly as described in any of the foregoing items, wherein the medicament delivery member shield includes a proximal portion and a distal portion, wherein the proximal portion is tubular and the distal portion includes an arm.

[0349] 10. The medicament delivery member shield locking assembly as described in item 9, wherein the arm of the medicament delivery member shield includes a recess or slit extending in the axial direction.

[0350] 11. The medicament delivery member shield locking assembly as described in any one of items 2 to 10, wherein the radially facing surface of the lock activation sleeve faces the axis 20.

[0351] 12. The medicament delivery member shield locking assembly as described in any one of items 2 to 10, wherein the distally facing surface of the medicament delivery member shield and the proximally facing surface of the lock activation sleeve are axially spaced apart.

[0352] 13. A medicament delivery device comprising a medicament delivery member shield locking assembly as described in any of the foregoing items.

[0353] 14. A locking mechanism for a medicament delivery device, the locking mechanism extending axially from a proximal end to a distal end relative to a longitudinal axis, the locking mechanism including a housing, a medicament delivery member shield, and a cap,

[0354] wherein one of the medicament delivery member shield and the cap includes a protrusion extending radially relative to the longitudinal axis,

[0355] One of the medicament delivery member shield and the cap includes a recess or notch,

[0356] wherein the protrusion is located in the recess or notch,

[0357] wherein the medicament delivery member shield is movable relative to the housing in the direction of the longitudinal axis from a locked position to an unlocked position, wherein in the locked position, movement of the protrusion relative to the recess or notch is restricted by a wall of the housing, and in the unlocked position, movement of the protrusion relative to the recess or notch is no longer restricted by the wall of the housing, thereby allowing the protrusion to move out of the recess or notch and allowing the cap to be removed from the medicament delivery member shield.

[0358] 15. The locking mechanism according to article 14, wherein at least one of the cap and the medicament delivery member shield includes a flexible portion.

[0359] 16. The locking mechanism according to article 15, wherein the flexible portion is a flexible arm of the cap.

[0360] 17. The locking mechanism according to article 16, wherein the recess or notch is located in the flexible arm.

[0361] 18. The locking mechanism according to any one of articles 14 to 17, wherein the cap includes a cap housing and a cap core, and the cap core is rotatable relative to the cap body.

[0362] 19. The locking mechanism according to article 18, wherein the cap core is attached to the cap body by a snap fit that restricts movement of the cap core relative to the cap body in the axial direction.

[0363] 20. The locking mechanism according to article 18 or 19, wherein rotational movement of the cap core relative to the cap body is restricted by ribs extending from the cap body.

[0364] 21. The locking mechanism according to any one of articles 14 to 20, wherein the cap includes a distal surface that abuts a proximal surface of the housing, and wherein the distal surface of the cap and the proximal surface of the housing each depict a sine pattern in the circumferential direction relative to the longitudinal axis.

[0365] 22. The locking mechanism according to any one of articles 14 to 21, wherein the wall of the housing faces in the radial direction.

[0366] 23. A locking mechanism as described in any of the foregoing items, wherein the cap includes a shield removal member for the medicament delivery member.

[0367] 24. A medicament delivery device comprising a locking mechanism as described in any one of Articles 1 to 23.

[0368] 25. The medicament delivery device as described in Article 24, wherein the medicament delivery device is an auto-injector.

[0369] 26. The medicament delivery device as described in Article 24 or 25, wherein the medicament delivery device includes a power unit within a housing and a main kit within the housing.

[0370] 27. The medicament delivery device as described in any one of Articles 24 to 26, wherein the medicament delivery device includes a housing, and wherein the protrusion and / or the flexible arm are located within the housing.

[0371] 28. The medicament delivery device as described in Article 27, wherein the proximal end of the protrusion and / or the proximal end of the flexible arm are remote from the proximal end of the housing.

[0372] 29. A feedback mechanism sub-assembly for a medicament delivery device, the feedback mechanism sub-assembly comprising a housing, a sound generator, and a rotating body,

[0373] wherein the rotating body is disposed between the housing and the sound generator,

[0374] wherein the housing includes a guiding structure that engages a corresponding driven structure of the rotating body, such that when the rotating body rotates relative to the housing, the engagement of the driven structure with the guiding structure causes a linear movement of the rotating body relative to the housing,

[0375] wherein the proximally facing surface of the sound generator abuts the distally facing surface of the housing, and the distally facing surface of the sound generator abuts the proximally facing surface of the rotating body, such that when the rotating body rotates relative to the housing, the sound generator is capable of deforming from a first shape to a second shape during the linear movement of the rotating body relative to the housing.

[0376] 30. The feedback mechanism sub-assembly as described in Article 29, wherein when the sound generator is in the first shape, the distally facing surface of the sound generator is convex, and wherein when the sound generator is in the second shape, the distally facing surface of the sound generator is concave.

[0377] 31. The feedback mechanism sub-assembly as described in Article 29 or 30, wherein the sound generator is in a relaxed state in the first shape and in a tensioned state in the second shape.

[0378] 32. A feedback mechanism sub-assembly as described in any one of Articles 29 to 31, wherein the proximally facing surface of the rotator is the proximal end of the protrusion of the rotator.

[0379] 33. A feedback mechanism sub-assembly as described in any one of Articles 29 to 32, wherein the distally facing surface of the sound generator is the distal end of the protrusion of the sound generator.

[0380] 34. A feedback mechanism sub-assembly as described in any one of Articles 29 to 33, wherein the proximally facing surface of the rotator is closer to the axis than the distally facing surface of the housing.

[0381] 35. A feedback mechanism sub-assembly as described in any one of Articles 29 to 34, wherein the sound generator has a hole passing through the center in the axial direction.

[0382] 36. A feedback mechanism sub-assembly as described in any one of Articles 29 to 35, wherein the sound generator is a plate.

[0383] 37. A feedback mechanism sub-assembly as described in any one of Articles 29 to 36, wherein the housing includes a rotator cap.

[0384] 38. A feedback mechanism sub-assembly as described in any one of Articles 29 to 37, wherein the feedback mechanism sub-assembly extends in the axial direction along the axis, and the movement of the rotator relative to the housing is in the axial direction.

[0385] 39. A feedback mechanism sub-assembly as described in any one of Articles 29 to 38, wherein the proximally facing surface of the sound generator that abuts the housing is farther from the longitudinal axis than the distally facing surface of the sound generator that abuts the rotator.

[0386] 40. A feedback mechanism sub-assembly as described in any one of Articles 29 to 39, wherein the proximally facing surface of the rotator is on the protrusion of the rotator.

[0387] 41. A feedback mechanism sub-assembly as described in any one of Articles 29 to 40, wherein at least one of the guiding structure and the driven structure includes an inclined surface that surrounds the axis and extends in the axial direction.

[0388] 42. A feedback mechanism sub-assembly as described in any one of Articles 29 to 41, wherein at least one of the guiding structure and the driven structure includes a protrusion that extends in the axial direction.

[0389] 43. A medicament delivery device comprising a feedback mechanism sub-assembly as described in any one of Articles 29 to 42.

[0390] 44. A locking mechanism for a medicament delivery device, the locking mechanism extending axially from a proximal end to a distal end relative to a longitudinal axis, the locking mechanism comprising a housing (40, 42, 44), a medicament delivery member shield (60) and a cap (160),

[0391] wherein one of the medicament delivery member shield (60) and the housing (40, 42, 44) comprises a flexible arm (410), the flexible arm (410) comprising a protrusion (412) extending in a radial direction relative to the longitudinal axis,

[0392] wherein the other of the medicament delivery member shield (60) and the housing (40, 42, 44) comprises a recess or notch (70),

[0393] wherein a portion of the flexible arm (410) is located in the recess or notch (70),

[0394] wherein the flexible arm (410) is located between the cap (160) and the other of the medicament delivery member shield (60) and the housing (40, 42, 44), and

[0395] wherein the cap (160) is adjacent to the flexible arm (410) in a radial direction relative to the longitudinal axis.

[0396] 45. The locking mechanism according to article 44, wherein the housing extends around the medicament delivery member shield, and wherein the housing comprises a flexible arm, and the medicament delivery member shield comprises a recess or notch.

[0397] 46. The locking mechanism according to article 44 or 45, wherein a proximal end of the notch or recess is spaced apart from the protrusion in a longitudinal direction.

[0398] 47. The locking mechanism according to any one of articles 44 to 46, wherein the recess or notch is a first recess or notch, and the other of the medicament delivery member shield and the housing comprises a second recess or notch closer to the proximal end than the first recess or notch, and wherein the second recess or notch is aligned with the first recess or notch in a direction of the longitudinal axis.

[0399] 48. The locking mechanism according to any one of articles 44 to 47, wherein the cap, the housing and the medicament delivery member shield are arranged such that movement of the housing in a radial direction is prevented before removal of the cap, thereby preventing the medicament delivery member shield from moving distally, and such that the housing is capable of moving in a radial direction after removal of the cap, and thus the medicament delivery member shield is capable of pushing the housing in a radial direction to move the housing distally.

[0400] 49. A locking mechanism as described in any one of Articles 44 to 48, wherein the portion of the arm in the recess or notch is a protrusion.

[0401] 50. A locking mechanism for a medicament delivery device, the locking mechanism extending axially from a proximal end to a distal end relative to a longitudinal axis, the locking mechanism comprising a housing (40), a medicament delivery member shield (60) and a cap (160, 162, 170),

[0402] wherein one of the medicament delivery member shield (60) and the cap (160, 162, 170) comprises a protrusion (68) extending in a radial direction relative to the longitudinal axis,

[0403] wherein the other of the medicament delivery member shield (60) and the cap (160, 162, 170) comprises a recess or notch (172),

[0404] wherein the protrusion (68) is located in the recess or notch (172),

[0405] wherein the medicament delivery member shield (60) is movable relative to the housing (40) in the direction of the longitudinal axis from a locked position to an unlocked position, wherein in the locked position, the movement of the protrusion (68) relative to the recess or notch (172) is restricted by the wall of the housing (40), and in the unlocked position, the movement of the protrusion (68) relative to the recess or notch (172) is no longer restricted by the wall of the housing (40), thereby allowing the protrusion (68) to move out of the recess or notch (172) and allowing the removal of the cap (160, 162, 170) from the medicament delivery member shield (60).

[0406] 51. The locking mechanism as described in Article 50, wherein at least one of the cap and the medicament delivery member shield comprises a flexible portion.

[0407] 52. The locking mechanism as described in Article 51, wherein the flexible portion is a flexible arm of the cap.

[0408] 53. The locking mechanism as described in Article 52, wherein the recess or notch is located in the flexible arm.

[0409] 54. The locking mechanism as described in any one of Articles 50 to 53, wherein the cap comprises a cap housing and a cap core, and the cap core is rotatable relative to the cap body.

[0410] 55. A locking mechanism as described in any one of Articles 50 to 54, wherein the cap includes a distal-facing surface adjacent to the proximal-facing surface of the housing, and wherein the distal-facing surface of the cap and the proximal-facing surface of the housing respectively depict a sinusoidal pattern in the circumferential direction relative to the longitudinal axis.

[0411] 56. A medicament delivery device comprising a locking mechanism as described in any one of Articles 44 to 55.

[0412] 57. The medicament delivery device as described in Article 56, wherein the medicament delivery device includes a housing, and wherein the protrusion and / or the flexible arm are located within the housing.

[0413] 58. The medicament delivery device as described in Article 57, wherein the proximal end of the protrusion and / or the proximal end of the flexible arm are remote from the proximal end of the housing.

Claims

1. A drug delivery member shield locking assembly (58) for a drug delivery device (10), the drug delivery member shield locking assembly (58) comprising: a housing (40) extending in an axial direction (22) along the axis (20) from the proximal end (14) to the distal end (16), the housing (40) including a recess or slot (45); a medicament delivery member shield (60) slidably disposed in the housing (40) and extending along an axial direction (22); a lock activating sleeve (80) slidably disposed in the housing (40) at the distal end (16) of the housing (40); and a medicament delivery member shield lock (100) disposed in the housing (40) adjacent the lock activation sleeve (80), wherein the medicament delivery member shield lock (100) comprises a base (102) and a flexible arm (104) pivotally attached to the base (102), wherein the flexible arm (104) comprises a proximal portion (106) and a distal portion (108), wherein the flexible arm (104) is attached to the base (102) between the proximal portion (106) and the distal portion (108), and wherein the proximal portion (106) of the flexible arm (104) is arranged adjacent to a recess or slot (45) in the housing (40), wherein the medicament delivery member shield includes a distally facing surface and the lock activation sleeve includes a corresponding proximally facing surface, the distally facing surface of the medicament delivery member shield engaging the proximally facing surface to push the lock activation sleeve in the distal direction when the medicament delivery member shield is pushed in the distal direction, wherein the lock activation sleeve comprises a radially facing surface relative to the axis, and when the lock activation sleeve is pushed in the distal direction, the distal portion of the flexible arm of the drug delivery member shield lock is pushed in the radial direction by the radially facing surface to bias the flexible arm of the drug delivery member shield lock against the drug delivery member shield, and Wherein when the medicament delivery member shroud is subsequently moved back in the proximal direction, the proximal portion of the flexible arm of the medicament delivery member shroud lock moves towards or into the recess or slit in the housing.

2. The drug delivery member shield locking assembly of claim 1, wherein the drug delivery member shield is configured to push the lock activation sleeve in the distal direction when the drug delivery member shield is pushed in the distal direction, wherein the lock activation sleeve is configured to push the distal portion of the flexible arm of the drug delivery member shield lock in a radial direction relative to the axis to bias the flexible arm when the lock activation sleeve is pushed in a distal direction, and Wherein when the medicament delivery member shroud is subsequently moved back in the proximal direction, the proximal portion of the flexible arm of the medicament delivery member shroud lock moves towards or into the recess or slit in the housing. 3 . The medicament delivery member shroud locking assembly of claim 1 , wherein the proximal portion of the flexible arm of the medicament delivery member shroud locking piece comprises a protrusion extending in a radial direction.

4. The medicament delivery member shroud locking assembly of claim 1 or 2, wherein at least a portion of the flexible arm of the medicament delivery member shroud locking piece is further from the axis than the base.

5. A drug delivery member shield locking assembly as described in claim 1 or 2, wherein the drug delivery member shield locking piece includes an accordion-type corrugated segment having a variable length in the axial direction, and the accordion-type corrugated segment extends along the axial direction from the proximal end of the drug delivery member shield locking piece.

6. The drug delivery member shield lock assembly of claim 5, wherein the accordion-type corrugated section includes a support portion spaced apart from the base of the drug delivery member shield lock and at least one arm extending from the base of the drug delivery member shield lock to the support portion.

7. A drug delivery member shield locking assembly as described in claim 1 or 2, wherein the distal end (113) of the distal portion (108) of the flexible arm is farther from the axis (20) than the proximal end (109) of the distal portion (108) of the flexible arm.

8. The drug delivery member shield locking assembly of claim 1 or 2, wherein the drug delivery member shield comprises a proximal portion and a distal portion, wherein the proximal portion is tubular and the distal portion comprises arms.

9. The medicament delivery member shield locking assembly of claim 8, wherein the arm of the medicament delivery member shield comprises a recess or a slit extending in an axial direction.

10. The medicament delivery member shield lock assembly of claim 2, wherein the radially facing surface of the lock activation sleeve faces the axis (20).

11. The medicament delivery member shield lock assembly of claim 2, wherein the distally facing surface of the medicament delivery member shield and the proximally facing surface of the lock activation sleeve are spaced apart in an axial direction.

12. A medicament delivery device comprising a medicament delivery member shield locking assembly as claimed in any preceding claim.

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