Locking mechanism for a medicament delivery device

Abstract

A locking mechanism for a medicament delivery device is described. The locking mechanism extends in an axial direction 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 guard (60) and a cap (160, 162, 170). The locking mechanism further comprises a protrusion (68, 412) extending in a radial direction relative to the longitudinal axis and a recess or cut-out (70, 172). Various related medicament delivery devices, medicament delivery device components, subassemblies and methods are also described.

Description

[0001] Related application citation

[0002] The disclosures of each of the following applications are incorporated herein by reference: European Patent Application No. EP20201659.8 filed by SHL Medical AG on 14 October 2020 and European Patent Application No. EP21172824.1 filed by SHL Medical AG on 17 May 2021. Technical Field

[0003] This invention relates primarily to pharmaceutical delivery devices, such as auto-injectors. Background Technology

[0004] Drug delivery devices such as autoinjectors may include a needle guard lock that prevents the needle guard from retracting after use, thereby reducing needlestick injuries. However, the needle guard lock may be fragile, and in such cases, it may break if the needle guard is pushed forcefully. With this in mind, the applicant recognized the benefit of developing a more robust needle guard lock. The applicant also recognized the potential to improve other drug delivery device features, such as locking mechanisms that restrict movement of the drug delivery component guard before the cap is removed. Summary of the Invention

[0005] This invention is defined by the appended claims, which are hereby referred to for understanding.

[0006] In this disclosure, the term "distal direction" refers to the direction away from the dose delivery site during use of the drug delivery device. The term "distal portion / distal end" refers to the portion / end of the delivery device or its components that is furthest from the drug delivery site when the drug delivery device is in use. Correspondingly, the term "proximal direction" refers to the direction towards the dose delivery site during use of the drug delivery device. The term "proximal portion / proximal end" refers to the portion / end of the delivery device or its components that is closest to the drug delivery site when the drug delivery device is in use.

[0007] In addition, the terms “longitudinal,” “axial,” or their grammatical variations refer to the direction in which the device or its components extend from the proximal end to the distal end, typically along the longest extension direction of the device and / or component.

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

[0009] A first aspect of the invention relates to a drug delivery component shroud locking assembly for a drug delivery device, the assembly comprising: a housing extending axially from a proximal end to a distal end along an axis, the housing including a recess or slit; a drug delivery component shroud slidably disposed within the housing, the shroud extending from the proximal end to the distal end; a locking element activation sleeve slidably disposed within the housing at the distal end of the drug delivery component shroud; and a drug delivery component shroud locking element disposed within the housing adjacent to the locking element activation sleeve. The drug delivery component shroud locking element 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 and distal portions, and wherein the proximal portion of the arm is arranged adjacent to the recess or slit in the housing. By being slidably disposed within the housing, the drug delivery component shroud can be attached to the housing and can move axially relative to the housing. Similarly, by being slidably arranged in the housing, the locking element activates the sleeve to move axially relative to the housing.

[0010] The drug delivery component shroud locking assembly constructed in this way provides a robust needle shroud locking mechanism, such as for single-use disposable autoinjectors. This is useful for any drug viscosity, but is particularly useful in devices used for injecting high-viscosity liquids, such as those above 30 centipoise, above 50 centipoise, between 30 and 150 centipoise, between 30 and 100 centipoise, or between 30 and 50 centipoise.

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

[0012] Optionally, the drug delivery component shroud includes a distally facing surface, and the locking activation sleeve includes a corresponding proximally facing surface, the distally facing surface of the drug delivery component shroud engaging with the proximally facing surface to push the locking activation sleeve distally when the drug delivery component shroud is pushed distally.

[0013] Optionally, the locking activation sleeve includes a radially facing surface relative to the axis, which, when the locking activation sleeve is pushed in a distal direction, allows the distal portion of the flexible arm of the drug delivery member shroud locking member to be pushed radially to bias the flexible arm of the drug delivery member shroud locking member onto the drug delivery member shroud.

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

[0015] Optionally, the drug delivery member shroud is configured to push the locking element activation sleeve distally when the drug delivery member shroud is pushed distally. Optionally, the locking element activation sleeve is configured to push the distal portion of the flexible arm of the drug delivery member shroud locking element radially relative to the axis when it is pushed distally, to bias the flexible arm. Optionally, when the drug delivery member shroud is subsequently moved proximally, the proximal portion of the arm of the drug delivery member shroud locking element moves toward or into a recess or slit in the housing.

[0016] Optionally, the proximal portion of the flexible arm of the drug delivery component shroud locking member includes a protrusion extending in a radial direction. This can help the drug delivery component shroud locking member engage with a recess or slit in the housing. Optionally, the protrusion extends in a direction away from the axis.

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

[0018] Optionally, the drug delivery component shroud locking member includes an accordion-style corrugated section having a variable length in the axial direction, and the accordion-style corrugated section extending axially from the proximal end of the drug delivery component shroud locking member. Optionally, the accordion-style corrugated section includes a support portion spaced apart from the base of the drug delivery component shroud locking member and at least one arm extending from the base of the drug delivery component shroud locking member to the support portion.

[0019] Optionally, the drug delivery component shroud locking member (typically the base of the drug delivery component shroud locking member) is directly or indirectly secured to the housing and cannot move relative to the housing. Optionally, the distal end 113 of the distal portion 108 of the arm is farther 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 helps to activate the locking member before injection and to hold the cannula and the arm in place.

[0020] Optionally, the drug 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 drug delivery member shroud includes a recess or slit extending in the axial direction. This recess or slit is capable of receiving the arm of the drug delivery member shroud locking member during injection and is capable of reducing strain on the arm. It also enables a stronger arm because the bending of the arm can be less.

[0021] Optionally, the radially facing surface of the locking element activation sleeve faces axis 20. Optionally, the distally facing surface of the drug delivery component shroud and the proximal facing surface of the locking element activation sleeve are spaced apart in the axial direction. This helps prevent activation of the drug delivery device should it fall.

[0022] In a second aspect of the invention, a drug delivery device is provided that includes any of the drug delivery member shroud locking assemblies described above. Optionally, the drug delivery member shroud locking assembly includes a drug delivery member shroud spring, which is generally arranged between the drug delivery member shroud and a housing or syringe holder. Optionally, the drug delivery device includes a drug delivery member. Optionally, the drug delivery member is an injection needle or a jet injector. Optionally, the drug delivery device includes a plunger rod extending through a drug delivery member shroud locking member and a locking member activation sleeve. Optionally, the drug delivery device includes a threaded drive nut, wherein the plunger rod is threaded to engage with the threads on the drive nut. Optionally, the drug delivery device includes a drive member for driving the plunger rod. Optionally, the drug delivery device is an auto-injector or a pen injector.

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

[0024] Optionally, as the biased proximal portion of the drug delivery component shroud lock moves away from the axis, a portion of the proximal portion of the drug delivery component shroud lock moves into a recess or slit in the housing.

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

[0026] A fifth aspect of the invention relates to a drug delivery component shroud locking assembly for an autoinjector, the drug delivery component shroud locking assembly comprising a housing, a drug delivery component shroud, a locking element activation sleeve, and a drug delivery component shroud locking member, wherein the housing, the drug delivery component shroud, the locking element activation sleeve, and the drug delivery component shroud locking member are arranged relative to each other such that distal movement of the drug delivery component shroud pushes the locking element activation sleeve distally, which in turn pushes a portion of the drug delivery component shroud locking member in a direction perpendicular to the axial direction, and wherein, when the drug delivery component shroud is subsequently moved proximally, a portion of the drug delivery component shroud locking member moves perpendicular to the axial direction to limit distal movement of the drug delivery component shroud.

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

[0028] A seventh aspect of the invention relates to a drug delivery member shroud locking assembly for a drug delivery device, the drug delivery member shroud locking assembly comprising: a tubular housing extending from a proximal end to a distal end along an axis in an axial direction; a drug delivery member shroud slidably disposed in the proximal end of the housing, the drug delivery member shroud extending from the proximal end to the distal end, the drug delivery member shroud 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 with a distally facing surface of the drug delivery member shroud; and a drug delivery member shroud locking member disposed in the housing, wherein the drug delivery member shroud locking member is fixed relative to the housing, wherein the drug delivery member shroud locking member includes a base and an arm extending from the proximal end to the distal end, wherein the arm is pivotally attached to the base between the proximal and distal ends.

[0029] The eighth aspect of the invention relates to a drug delivery component shroud lock for a drug delivery device, the drug delivery component shroud lock extending from a proximal end to a distal end along an axis in an axial direction. The drug delivery component shroud lock includes 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 and distal portions. The distal portion of the arm is configured to be biased toward the axis, and the proximal portion of the arm is configured to be biased away from the axis when the distal portion of the arm is biased toward the axis. This drug delivery component shroud lock may also include any combination of optional features of the drug delivery component shroud lock assembly of the first aspect as described above.

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

[0031] The tenth aspect of the invention relates to an activator assembly for a pharmaceutical delivery device, the activator assembly including a plunger rod, a pharmaceutical delivery member guard locking element (seventh aspect), a drive nut (ninth aspect), and a locking element activation sleeve including a radially facing surface configured to engage a distal portion of an arm of a pharmaceutical delivery device protective lock. Optionally, the activator assembly includes a thrust bearing attached to a proximal end of the plunger rod.

[0032] The eleventh aspect of the present invention relates to a power unit subassembly for a pharmaceutical 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 locking member, wherein in a first position, the power unit locking member is rotatably locked relative to the power unit housing, and the drive member is freely rotatable relative to the power unit housing to tension the torsion spring, and wherein in a second position, the power unit locking member is rotatably 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 locking member is rotatably locked relative to the drive member, and the power unit locking member is freely rotatable relative to the power unit housing.

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

[0034] The thirteenth aspect of the invention relates to a drug delivery device subassembly including a drive member for driving a plunger rod and a drive nut, wherein the drive member includes teeth and the drive nut includes corresponding teeth, thereby providing indication, such as audible or tactile indication, as the drive member rotates relative to the drive nut during drug delivery.

[0035] The fourteenth aspect of the invention relates to a drug delivery device subassembly including a drive member for driving a plunger rod and a power unit locking member, wherein the drive member and the power unit locking member include corresponding protrusions that engage with each other to provide indication, such as audible or tactile indication, during drug delivery when the drive member rotates relative to the power unit locking member.

[0036] The fifteenth aspect of the invention relates to a drug delivery device subassembly including a rotatable body attached to a component configured to rotate during drug delivery, such that the rotatable body rotates as the component rotates during drug delivery to provide indication of drug delivery, such as visual, auditory, or tactile indication. Optionally, the component rotates relative to a housing. Optionally, the component designed to rotate during drug delivery is a plunger rod or a drive member for driving the plunger rod.

[0037] The sixteenth aspect of the invention relates to a drug delivery device, such as an auto-injector or pen injector, which includes the contents of one or more aspects from the fourth to the fifteenth aspect.

[0038] Another aspect relates to a locking mechanism for a medication delivery device, extending axially from a proximal end to a distal end relative to a longitudinal axis. The locking mechanism includes a housing, a medication delivery member guard, and a cap. One of the medication delivery member guard and the housing includes a flexible arm with a protrusion extending radially relative to the longitudinal axis. The other of the medication delivery member guard and the housing includes a recess or cutout, a portion of which is located within the recess or cutout. The flexible arm is positioned between the cap and the other of the medication delivery member guard and the housing, and the cap is radially adjacent to the flexible arm relative to the longitudinal axis. This allows the medication delivery device to be locked to prevent activation before the cap is removed. This allows for a weaker needle spring, which would otherwise be stronger to prevent activation upon drop, potentially allowing for a lower activation force, making medication delivery easier for the end user. This is particularly important, for example, among some user groups with lower grip strength.

[0039] Optionally, the housing extends around a drug delivery member shroud. Optionally, the housing includes a flexible arm, and the drug delivery member shroud includes a recess or cutout. Optionally, the proximal end of the cutout or recess is spaced from the protrusion in the longitudinal direction. This helps reduce the force required to initiate movement of the drug delivery member shroud. Optionally, the recess or cutout is a first recess or cutout, and another of the drug delivery member shroud and the housing includes a second recess or cutout closer to the proximal end than the first recess or cutout. This reduces friction. Optionally, the second recess or cutout is aligned with the first recess or cutout in the direction of the longitudinal axis. Optionally, the cap, the housing, and the drug delivery member shroud are arranged such that the housing is prevented from moving radially before the cap is removed, thereby preventing the drug delivery member shroud from moving distally, and such that the housing can move radially after the cap is removed, thus allowing the drug delivery member shroud to push the housing radially to move the housing distally. Alternatively, the portion of the arm in the recess or cutout is a protrusion.

[0040] Another aspect relates to a locking mechanism for a drug delivery device, extending axially from a proximal end to a distal end relative to a longitudinal axis. The locking mechanism includes a housing, a drug delivery component guard, and a cap. One of the drug delivery component guard and the cap includes a protrusion extending radially relative to the longitudinal axis. The other of the drug delivery component guard and the cap includes a recess or cutout, in which the protrusion is located. The drug delivery component guard is movable relative to the housing in the longitudinal axis direction from a locked position to an unlocked position. In the locked position, the movement of the protrusion relative to the recess or cutout is restricted by the wall of the housing. In the unlocked position, the movement of the protrusion relative to the recess or cutout is no longer restricted by the wall of the housing, thereby allowing the protrusion to move out of the recess or cutout and allowing the cap to be removed from the drug delivery component guard. This allows the drug delivery device to be locked to prevent activation before the cap is removed. This allows for a weaker needle spring, which would otherwise be stronger to prevent activation upon drop, potentially allowing for a lower activation force, thus making drug delivery easier for the user. This is especially important, for example, among some user groups with lower grip strength.

[0041] Optionally, at least one of the cap and the drug delivery member cover includes a flexible portion. Optionally, the flexible portion is a flexible arm of the cap. Optionally, the recess or cutout is located in the flexible arm. Optionally, the cap includes a cap shell 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 ​​engagement that restricts the axial movement of the cap core relative to the cap body. Optionally, the 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 surface adjacent to a proximal surface of the shell. Optionally, the distal surface of the cap and the proximal surface of the shell each depict a sinusoidal pattern in the circumferential direction relative to a longitudinal axis. Optionally, the wall of the shell faces the radial direction. Optionally, the wall of the shell faces the axis.

[0042] Optionally, the protective cap includes a drug delivery component cover remover, preferably a rigid drug delivery component cover remover.

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

[0044] Another aspect relates to a locking mechanism for a drug delivery device, extending axially from a proximal end to a distal end relative to a longitudinal axis. The locking mechanism includes a housing, a needle guard (or more generally, a drug delivery component guard), and a cap. Preferably, at least one of the housing, the needle guard, and the cap body has a flexible arm. The interaction between the housing, the needle guard, and the cap restricts distal movement of the needle guard before the cap is removed, and the needle guard is freely movable distally after the cap is removed. Optionally, the flexible arm is a lever. Optionally, the cap includes a cap body and a needle guard removal element. Optionally, the proximal end of the lever includes a protrusion, and the cap includes a corresponding protrusion, such that as the needle guard moves distally relative to the cap, the protrusion of the cap engages with the protrusion of the needle guard, causing the lever to pivot. 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 surface of the housing is farther from the longitudinal axis than the proximal surface of the lever.

[0045] Another aspect relates to a locking mechanism for a drug delivery device, the locking mechanism comprising a housing, a needle guard (or more generally, a drug delivery component guard), and a cap, wherein the locking mechanism includes a recess or cutout, wherein the locking mechanism includes a protrusion extending into the recess or cutout, wherein the locking mechanism includes a flexible portion, wherein the locking mechanism is movable between a locked position and an unlocked position, wherein in the locked position, the protrusion is restricted from leaving the recess or cutout due to the restricted movement of the flexible portion, and wherein in the unlocked position, the protrusion is able to leave the recess or cutout by movement of the flexible portion. Optionally, the cap includes a cap housing and a needle guard removal component.

[0046] Another aspect of the invention relates to a locking mechanism for a medication delivery device, comprising a housing, a needle guard, and a cap. The locking mechanism extends axially from a proximal end to a distal end relative to a longitudinal axis. This allows the medication delivery device to be locked to prevent activation before the cap is removed. This allows for a weaker needle spring, which would otherwise be stronger to prevent activation upon drop, potentially allowing for a lower activation force, thus making medication delivery easier for the user. This is particularly important, for example, among some user groups with lower grip strength.

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

[0048] Optionally, one of the needle guard and the cap includes a protrusion extending radially relative to a longitudinal axis, and the other of the needle guard and the cap includes a recess or cutout, wherein a portion of the arm (e.g., the protrusion) is located in the recess or cutout, wherein the needle guard is movable relative to the housing in a longitudinal axial direction from a locked position to an unlocked position, wherein in the locked position, the movement of the protrusion relative to the recess or cutout is restricted by the wall of the housing, and in the unlocked position, the movement of the protrusion relative to the recess or cutout is no longer restricted by the wall of the housing, thereby allowing the protrusion to be removed from the recess or cutout and allowing the cap to be removed from the needle guard.

[0049] Optionally, one of the needle guard and the housing includes a flexible arm with a protrusion extending radially relative to a longitudinal axis, wherein the other of the needle guard and the housing includes a recess or cutout, wherein the arm (e.g., the protrusion of the arm) extends into the recess or cutout, wherein the flexible arm is located between the cap and the other of the needle guard 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 cutout, wherein the locking mechanism includes a protrusion extending into the recess or cutout, 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 protrusion is restricted from leaving the recess or cutout due to the restricted movement of the flexible portion, and wherein in the unlocked position, the protrusion is able to leave the recess or cutout by movement of the flexible portion.

[0051] Another aspect of the invention relates to a tool for assembling a drug delivery device, the tool comprising 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 rotate lock to a portion of the power unit of the drug delivery device, such as a power unit lock and / or a power unit housing, and wherein the proximal tool is configured to receive and rotate lock to another portion of the drug delivery device, such as a lock activation sleeve.

[0052] Another aspect of the invention relates to a method for assembling a drug delivery device, the method comprising the steps of: inserting a first power unit subassembly into a distal tool of a tool for assembling the drug delivery device; inserting a torsion spring into the first power unit subassembly; inserting a second power unit subassembly into the torsion spring; inserting a proximal tool of the tool for assembling the drug delivery device into the second power unit subassembly; and rotating the first power unit subassembly relative to the second power unit subassembly to coil the torsion spring.

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

[0054] Generally, unless otherwise expressly defined herein, all terms used in the claims shall be interpreted in accordance with their ordinary meaning in the art. Unless otherwise expressly stated, all references to “a / the element, device, component, part, apparatus, etc.” shall be interpreted in an open-ended manner as referring to at least one instance of the element, device, component, part, apparatus, etc. Attached Figure Description

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

[0056] Figure 1 A cross-sectional view of a portion of an autoinjector is shown, illustrating the configuration of the needle guard locking assembly prior to use of the autoinjector.

[0057] Figure 2 It shows Figure 1 The morphology of the components during injection.

[0058] Figure 3 It shows Figure 1 The shape of the components after injection.

[0059] Figure 4 It shows Figure 1 The shape of the component in the needle sheath when it attempts to retract after injection.

[0060] Figure 5 A cross-sectional view of a portion of an autoinjector is shown, illustrating the configuration of the needle guard locking assembly prior to use of the autoinjector.

[0061] Figure 6 It shows Figure 5 The morphology of the components during injection.

[0062] Figure 7 It shows Figure 5 The shape of the components during the return of the needle shield after injection.

[0063] Figure 8 It shows Figure 5 The shape of the components after injection.

[0064] Figure 9 It shows Figure 5 The shape of the component in the needle sheath when it attempts to retract after injection.

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

[0066] Figure 11 It shows Figure 10 An exploded side view of the front sub-assembly of an autoinjector.

[0067] Figure 12 It shows Figure 10 An exploded side view of the rear sub-assembly of an autoinjector.

[0068] Figure 13 It shows Figure 10 A perspective view of the syringe holder and needle shield.

[0069] Figure 14 It shows Figure 10 A perspective view of the front sub-assembly of an autoinjector.

[0070] Figure 15 It shows Figure 10 A perspective view of the power unit locking element and the power unit housing of the power unit subassembly of an auto-injector.

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

[0072] Figure 17 It shows Figure 10 A perspective view of the power unit locking element and power unit housing, as well as the torsion spring and drive element of the auto-injector before the drive element is attached.

[0073] Figure 18 It shows Figure 10 A perspective view of the power unit sub-assembly of an autoinjector.

[0074] Figure 19 A near-side view of a portion of the power unit locking member is shown when the power unit locking member is in the second position.

[0075] Figure 20 It shows Figure 10 A perspective view of the activation subcomponent of the autoinjector.

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

[0077] Figure 22 A near-side cross-sectional view of a portion of the locking element activation sleeve and drive nut, and a side view of the plunger rod are shown.

[0078] Figure 23 It shows the relationship with Figure 22 The view in the middle is a near-side cross-sectional view of a portion of the locking element activation sleeve and drive nut at a 90-degree angle, and Figure 20 Side view of the plunger rod.

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

[0080] Figure 25 It showsFigure 24 The shown component is a side cross-sectional view during assembly.

[0081] Figure 26 It shows Figure 20 A side-view cross-sectional view of a portion of the active sub-component.

[0082] Figure 27 It shows Figure 10 A perspective view of the power unit sub-assembly and the activator sub-assembly of an autoinjector when they are attached together.

[0083] Figure 28 It shows Figure 10 A perspective view of the power unit sub-assembly and activator sub-assembly of the autoinjector when they are attached together and located within the housing 40.

[0084] Figure 29 A perspective view of another exemplary autoinjector is shown.

[0085] Figure 30 It shows Figure 29 An exploded perspective view of the components of an autoinjector.

[0086] Figure 31 It shows Figure 29 A cross-sectional view of an auto-injector before use.

[0087] Figure 32 It shows Figure 29 A perspective and partial cross-sectional view of a portion of an autoinjector before use.

[0088] Figure 33 It shows Figure 29 Perspective and partial cross-sectional views of the housing and drive nut of an automatic injector.

[0089] Figure 34 It shows Figure 29 A perspective and partial cross-sectional view of a portion of an autoinjector before use.

[0090] Figure 35 It shows Figure 29 Side view and partial cross-sectional view of some components of an autoinjector during injection.

[0091] Figure 36 It shows Figure 29 A side view and partial cross-sectional view of a portion of an autoinjector before use.

[0092] Figure 37 It shows Figure 29 An axial view of some components of an auto-injector.

[0093] Figure 38 It showsFigure 29 A perspective view of the drive mechanism and rotating body of an automatic injector.

[0094] Figure 39 It shows Figure 29 A cross-sectional view of the distal end of an autoinjector.

[0095] Figure 40 It shows Figure 29 A perspective view of the distal end of an autoinjector.

[0096] Figure 41 It shows Figure 29 A cross-sectional view of a portion of an auto-injector before use.

[0097] Figure 42 It shows Figure 29 A cross-sectional view of a portion of an autoinjector before use but after the cap has been removed.

[0098] Figure 43 It shows Figure 29 A cross-sectional view of a portion of an autoinjector during injection.

[0099] Figure 44 It shows Figure 29 Cross-sectional views of some components of an auto-injector after use.

[0100] Figure 45 It shows Figure 29 Perspective and partial cross-sectional views of some components of an auto-injector after use.

[0101] Figure 46 It shows Figure 29 Cross-sectional view of some components of an auto-injector before use.

[0102] Figure 47 It shows Figure 46 The component is shown in a cross-sectional view after activation.

[0103] Figure 48 It shows Figure 29 A perspective view of the driver and drive nut of an automatic injector before use.

[0104] Figure 49 It shows Figure 29 An axial cross-sectional view of the drive unit and drive nut of an automatic injector before use.

[0105] Figure 50 It shows Figure 29 A perspective view of the thrust bearing of an auto-injector.

[0106] Figure 51 It shows Figure 29Another perspective view of the thrust bearing of an auto-injector.

[0107] Figure 52 A cross-sectional and perspective view of a portion of another similar exemplary autoinjector is shown, illustrating features that allow the power unit locking element and the power unit housing to interact to produce a clicking sound during injection.

[0108] Figure 53 A perspective view of an exemplary autoinjector is shown.

[0109] Figure 54 It shows Figure 53 An exploded perspective view of an autoinjector.

[0110] Figure 55 It shows Figure 54 A perspective view of the needle guard locking component.

[0111] Figure 56 It shows Figure 54 A perspective view of the drive nut.

[0112] Figure 57 It shows Figure 54 A perspective view of the locking element activating the sleeve.

[0113] Figure 58 It shows Figure 54 A perspective view of the power unit locking component.

[0114] Figure 59 It shows Figure 54 A perspective view of the driving component.

[0115] Figure 60 It shows Figure 54 A perspective view of the power unit housing.

[0116] Figure 61 It shows Figure 54 Another perspective view of the power unit housing.

[0117] Figure 62 It shows Figure 54 A perspective view of the needle shield.

[0118] Figure 63 It shows Figure 54 A perspective view of the components of the protective cap.

[0119] Figure 64 It shows Figure 53 A cross-sectional view of a portion of an autoinjector before the cap is removed.

[0120] Figure 65 It shows Figure 53A cross-sectional view of a portion of an autoinjector during cap removal.

[0121] Figure 66 It shows Figure 53 A perspective view of a portion of an auto-injector during the removal of the protective cap by twisting.

[0122] Figure 67 It shows Figure 53 A perspective view of a portion of an autoinjector during cap removal.

[0123] Figure 68 It shows Figure 53 A perspective view of the cap being removed by twisting.

[0124] Figure 69 It shows Figure 53 A perspective view of the helmet.

[0125] Figure 70 A perspective view of another exemplary autoinjector is shown.

[0126] Figure 71 It shows Figure 70 An exploded perspective view of an autoinjector.

[0127] Figure 72 It shows Figure 71 A perspective view of the power unit housing and rotating body protective cap.

[0128] Figure 73 It shows Figure 71 A perspective view of the power unit locking components and rotating parts.

[0129] Figure 74 It shows Figure 71 Perspective and partial cross-sectional views of the power unit locking component and a portion of the rotating body.

[0130] Figure 75 It shows Figure 70 A perspective view of the distal portion of an autoinjector.

[0131] Figure 76 It shows Figure 70 A cross-sectional view of an autoinjector.

[0132] Figure 77 It shows Figure 71 A perspective view of the needle guard locking component.

[0133] Figure 78 It shows Figure 71 A perspective view of the drive nut.

[0134] Figure 79 It shows Figure 71A perspective view of the locking element activating the sleeve.

[0135] Figure 80 It shows Figure 71 A perspective view of the protective cap shell.

[0136] Figure 81 It shows Figure 71 A perspective view of the near-side shell.

[0137] Figure 82 It shows Figure 70 A cross-sectional view of a portion of an auto-injector before use.

[0138] Figure 83 It shows Figure 70 A cross-sectional view of a portion of an autoinjector as the needle guard moves distally relative to the housing before the cap is removed.

[0139] Figure 84 It shows Figure 70 A cross-sectional view of a portion of an autoinjector after the cap has been removed and after the needle guard has been moved distally relative to the housing.

[0140] Figure 85 It shows Figure 84 A perspective view of the components.

[0141] Figure 86 A cross-sectional view of a portion of another exemplary autoinjector is shown.

[0142] Figure 87 It shows Figure 86 A cross-sectional view of an autoinjector as the needle guard moves distally relative to the housing before the cap is removed.

[0143] Figure 88 It shows Figure 86 A perspective view of the needle shield.

[0144] Figure 89 A perspective view of a portion of another exemplary autoinjector is shown.

[0145] Figure 90 It shows Figure 89 Side view of the cap of an autoinjector.

[0146] Figure 91 A perspective view of the remote tool, power unit locking element, and power unit housing during device assembly is shown.

[0147] Figure 92 A side view of the power unit locking member and a portion of the power unit housing during device assembly is shown.

[0148] Figure 93 A cross-sectional side view of the remote tool, power unit locking member, and a portion of the power unit housing during device assembly is shown.

[0149] Figure 94 and 95 A perspective view of the distal tool, proximal tool, and portion of the autoinjector during device assembly is shown.

[0150] Figure 96 to 98 A cross-sectional side view of a portion of the autoinjector and assembly tools during device assembly is shown.

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

[0152] Figure 100 It shows Figure 99 An exploded perspective view of an autoinjector.

[0153] Figure 101 It shows Figure 100 A perspective view of the plunger rod and thrust bearing.

[0154] Figure 102 It shows Figure 100 Another perspective view of the thrust bearing.

[0155] Figure 103 It shows Figure 100 A perspective view of the power unit locking and driving components.

[0156] Figure 104 It shows Figure 100 A perspective view of the power unit housing and rotating body protective cap.

[0157] Figure 105 It shows Figure 100 A perspective view of the needle guard locking component.

[0158] Figure 106A and 106B It shows Figure 100 Different perspective views of the drive nut.

[0159] Figure 107 It shows Figure 100 A perspective view of the locking element activating the sleeve.

[0160] Figure 108 It shows Figure 100 A perspective view of the driving component.

[0161] Figure 109 It shows Figure 100 A perspective view of the distal shell.

[0162] Figure 110It shows Figure 100 Perspective view of syringe holder 120.

[0163] Figure 111 It shows Figure 100 A perspective view of the needle shield.

[0164] Figure 112 It shows Figure 99 A cross-sectional view of a portion of an autoinjector.

[0165] Figure 113 to 115 They are shown respectively Figure 100 Two different perspective views of the components (i.e., the cap shell, the cap core, and the proximal shell).

[0166] Figure 116 and 117 It shows Figure 99 Different perspective views of the front sub-assembly of the autoinjector.

[0167] Figure 118 to 120 It shows Figure 99 A different view of the front sub-assembly of the autoinjector after the cap has been removed and after the needle guard has been pushed distally relative to the housing.

[0168] Figure 121 An exploded perspective view of the feedback mechanism sub-components is shown.

[0169] Figure 122 It shows including Figure 121 A cross-sectional perspective view of a portion of the drug delivery device of the feedback mechanism sub-component.

[0170] Figure 123 and 124 It shows Figure 121 A perspective view of the rotating body.

[0171] Figure 125 It shows Figure 121 A perspective view of the sound generator.

[0172] Figure 126A It shows Figure 121 A perspective view of the rotating protective cap.

[0173] Figure 126B It shows Figure 121 A perspective view of the power unit locking component.

[0174] Figure 127 It shows Figure 121 A perspective view of the rotating body.

[0175] Figure 128 It shows Figure 121 A perspective view of a portion of the rotating protective cap.

[0176] Figure 129 and 130 A perspective view of another feedback mechanism is shown. Detailed Implementation

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

[0178] In one aspect, a drug delivery component cover locking assembly (58) for a drug delivery device (10) is described, the drug delivery component cover 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 drug delivery component cover (60) slidably disposed in the housing (40) extending from the proximal end (14) to the distal end (16); and a locking member slidably disposed in the housing (40) at the distal end (16) of the drug delivery component cover (60) for activation. The sleeve (80); and the agent delivery member shroud lock (100) arranged in the housing (40) adjacent to the lock to activate the sleeve (80), wherein the agent delivery member shroud 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 arranged as a recess or slit (45) adjacent to the housing (40).

[0179] Figure 1 A portion of an autoinjector 10 is shown, which includes a housing 40, a needle guard (needle cover) 60, a locking activation sleeve 80, and a needle guard locking member 100.

[0180] The housing 40 includes two slits 45 that are opposite each other relative to the axis (central axis) 20. The slits 45 penetrate the housing 40 in the radial direction 26. The needle guard 60, the locking activation sleeve 80, and the needle guard locking member 100 are all located within the housing 40.

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

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

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

[0184] Please refer to Figures 1 to 4 The relative motion of the different components during use will now be explained. Figure 1 This shows the initial position of the autoinjector before use (and activation). This is the position the autoinjector typically maintains between final assembly and use (e.g., during transport and storage). Figure 2 The autoinjector 10 is shown in its configuration after the needle shield 60 has been moved distally (typically by the initiation of injection). This distal movement of the needle shield 60 also distally pushes the locking activation sleeve 80. This distal movement of the locking activation sleeve 80 causes the liner 86 of the locking activation sleeve to engage with the distal portion 108 of the arm 104 of the needle shield locking member, pushing the distal portion 108 of the arm 104 toward axis 20. The proximal portion 106 of the arm 104 would correspondingly pivot and move away from axis 20, but the needle shield 60 prevents this movement. As a result, the arm 104 is biased and pushes the needle shield 60 (away from axis).

[0185] Once the needle shield is allowed to move distally again (typically at the end of the injection, but this could be earlier if the needle shield was lifted too early from the injection site), the needle shield is moved proximally back to its original position. Figure 3The position shown is (in this case, the final position after injection is the same as the initial position before injection, which is optional, of course). However, the locking activation sleeve does not move back to its initial position, so the pad 86 still pushes the distal portion 108 of the arm 104 toward the axis 20. To release the tension generated in the arm 104 as described above, the proximal portion 106 of the arm 104 moves away from the axis 20 once the needle guard 60 no longer obstructs it. The proximal portion 106 of the arm 104 (or specifically, in this example, the protrusion 110 on the proximal portion of the arm 104) terminates in (or adjacent to) a slit 45 in the housing 40. The arm can remain tensioned after injection, thus holding the locking activation sleeve 80 in place by friction; of course, one or more other features at other locations on the device may additionally or alternatively hold the locking activation sleeve in place.

[0186] Figure 4 This illustrates what happens if an attempt is made to push the needle guard 60 back in a distal direction after the lock generated by the needle guard locking member 100 has been set. In this example, the needle guard 60 can move a small distance distally (e.g., ...). Figure 3 The gap between the shown arm 104 and the needle guard 60 is optional, but preferred because it allows for greater manufacturing tolerances during component manufacturing and assembly. However, it is subsequently prevented from moving further in the distal direction by the arm 104 of the needle guard locking member 100. The arm 104 is supported in the slit 45 by the protrusion 110.

[0187] Figure 5 It shows a kind of Figure 1 The autoinjector described herein is similar to an autoinjector, but with arms 62 of a different shape on the needle guard 60. In this example, each arm 62 includes a slit 66 (in... Figure 13 (This can also be seen in examples). Figures 5 to 9 The relative movement of different components during use is shown, where Figure 5 and Figure 1 correspond, Figure 6 and Figure 2 correspond, Figure 8 and Figure 3 correspond, Figure 9 and Figure 4 Corresponding. In Figure 6 and Figure 7 It can be seen from the Figures 1 to 4 The difference. In Figure 6In this process, the arm 104 of the needle shield locking member is freely moved further from 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 axis 20 by the distal end 63 of the needle shield arm, as... Figure 7 As shown. Once the needle guard has passed the arm 104 of the needle guard locking member (relative to the axial direction), the arm 104 of the needle guard locking member can move again in a direction away from the axis 20, as... Figure 8 As shown.

[0188] Figure 10 Another auto-injector 10 is shown, which includes... Figures 5 to 9 The needle guard locking assembly shown is similar to the needle guard locking assembly. Figure 10 In the middle, one can see the housing 40, the protective cap 160, the optional end cap 200 (rear cap), and the main kit 360. A small portion of the power unit housing 240 can also be seen. Figure 11 Parts of the front subassembly (proximal subassembly) 50 (i.e., syringe holder 120, needle guard spring 140, needle guard 60) and three parts of the cap 160 (i.e., cap housing 162, rigid needle guard remover 180, and cap core 170) are shown. Figure 12 Parts of the rear subassembly (far-side subassembly) 52 are shown, namely, end cap 200, optional power unit lock 220, power unit housing 240, torsion spring 260, drive element 280, plunger rod 300, lock activation sleeve 80, drive nut 320, thrust bearing 340 and housing 40. Figures 1 to 9 The parts mentioned above are not necessarily the same as the corresponding parts below, but these parts are similar and have roughly the same function.

[0189] Now we will explain in more detail Figure 11 and 12 The portion shown. Therefore, Figures 13 to 28 Various combinations of parts of the autoinjector 10 are also shown.

[0190] Figure 13 A perspective view of some components of the rear subassembly (i.e., syringe holder 120, needle guard spring 140, and needle guard 60) is shown. As described elsewhere in this specification, each component (more generally, each subassembly and each device) extends from the proximal end 14 to the distal end 16. Figure 14 The assembled rear subassembly is shown, which has Figure 13 The components and caps in the middle are 160.

[0191] The needle shield can be considered as a proximal portion and a distal portion, the proximal portion including a shield portion 64 and the distal portion including two needle shield arms 62. A needle shield slit 66 extends axially on each side of the needle shield. The shield portion is tubular, and in the assembled autoinjector, the axis of the shield portion is parallel to axis 20. The needle shield may also include protrusions 68 for engaging corresponding recesses or cutouts (not shown) on the cap, which helps to keep the cap attached to the rest of the autoinjector; of course, the cap may be attached alternatively or additionally to the housing, especially in, for example... Figures 5 to 9 In the example shown, the removal of the cap allows the needle shield to move in a proximal direction.

[0192] The needle guard spring 140 is fitted inside the needle guard 60, and the proximal end of the needle guard spring engages with an engagement feature of the needle guard, such as a protrusion or a distally facing crossbar (in... Figure 13 (Not visible in the middle). The distal end of the needle guard spring engages with the proximal-facing crossbar 122 on the syringe holder (see...). Figure 14 ).

[0193] The syringe holder 120 has a tubular shape and includes several features, including a crossbar 122, a window 124, and a protrusion 126. During assembly of the autoinjector 10, the window 124 of the syringe holder is arranged to align with window 46. The syringe holder includes a protrusion 126 on each side to engage with a corresponding slit 66 on the needle guard arm 62, thereby allowing the needle guard to remain slidably attached to the syringe holder. Figure 14 As shown, the distal side of protrusion 126 is a distally facing crossbar to engage with the distal end of slit 66. The proximal side of protrusion 126 is inclined (at an angle relative to axis 20 and radial direction 26) to allow the portion of needle guard arm 62 away from slit 66 to slide over protrusion 126 during assembly. For this purpose, needle guard arm 62 is generally flexible in the radial direction 26 to facilitate assembly; however, alternative structures can avoid the need for this flexibility (e.g., using a flexible syringe holder instead).

[0194] exist Figure 14 In the image, the protective cap 160 is shown attached to the needle shield 60. (Example) Figure 11 As shown, the cap consists of a cap housing 162, a cap core 170, and a rigid needle guard removal component 180. An optional handle 164 can be seen on the cap 160.

[0195] Now we will explain in more detail Figure 12The exemplary rear subassembly shown comprises two separate subassemblies: 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 element, and an optional power unit locking element. The mechanism subassembly includes a locking element activation sleeve, a needle guard locking element, a plunger rod, a drive nut, and an optional thrust bearing.

[0196] Figure 15 Optional power unit locking element 220 and power unit housing 240 are shown. Figure 16 The diagram shows how the power unit locking member 220 and the power unit housing 240 were initially attached to each other. Figure 17 The power unit locking member 220 and power unit housing 240 are shown, as well as torsion spring 260 and drive member 280; the drive member 280 is shown in the form before attachment.

[0197] The power unit locking member 220 includes a body 222 (in this case, a tubular body) and two protrusions 224 extending relative to the axis 20 in a direction away from the body 222 (proximal end). The protrusions are configured to fit into corresponding slots 242 in the power unit housing 240 (see details). Figure 16 To facilitate attachment of the power unit locking member 220 and the power unit housing 240 together, two protrusions 244 extend circumferentially into each slit 242. The protrusions 224 of the power unit locking member 220 have corresponding recesses to engage with the protrusions 244, which in... Figure 16 The middle part is the clearest.

[0198] exist Figure 17 The interaction between the torsion spring 260 and the power unit housing can be seen in the diagram. 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, 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 crossbar 282 on the drive member. The position of the drive member after it is in place is as follows: Figure 18 As shown. In this position, the power unit locking member 220 is in the first position, as described in more detail below, and the drive member can rotate in the circumferential direction to tension the spring.

[0199] The power unit locking member 220 is designed to take three different positions during the assembly of the autoinjector. The first position of the power unit locking member is capable of... Figure 16 and 17 As seen in the image, in this position, the power unit locking element is restricted from rotation relative to the power unit housing.

[0200] In order to reach the second position, the power unit locking member moves from the first position toward the proximal direction relative to the power unit housing. Figure 19 The image shows the power unit locking member in the second position. In this second position, the power unit locking member is rotationally restricted relative to the power unit housing and the drive unit.

[0201] To reach the third position, the power unit locking member moves proximally relative to the power unit housing from the second position. In the third position, the power unit locking member is typically still rotationally restricted relative to the drive member (e.g., this allows the power unit locking member to provide an optional clicking sound during injection, as described below), but is no longer rotationally restricted relative to the power unit housing. The power unit locking member typically moves to the third position only after the drive member has been rotationally locked to the housing (e.g., by a drive nut). (This rotational locking between the drive member and the drive nut is described in more detail in later examples, especially referring to…) Figures 46 to 49 (Note that the rotary lock operates in the same manner in this example). Therefore, the power unit locking element provides a locking mechanism that keeps the spring tensioned during a portion of the assembly process. In some examples, the power unit locking element may additionally or alternatively provide an optional click during injection, for example, protrusion 226 and a corresponding protrusion or rib on the inner side of the power unit housing (not directly shown in this example, but see [reference needed]). Figure 52 (as shown in the example). In the finished device, the power unit locking element will be in the third position. The third position can be the same as the first position, but not a different position. Alternatively, once the drive element is engaged by another part of the device (e.g., as shown in the example), Figures 46 to 49 The drive nut (shown) is locked and cannot be rotated, allowing the power unit locking component to be removed from the device instead of being moved to the third position. Therefore, the power unit locking component may not be present in the final device. The plunger rod can be fitted within the body 222 of the power unit locking component, especially in instances where the power unit locking component remains in the fully assembled device.

[0202] In another alternative, a tool that provides the function of a power unit locking element during assembly is used instead of a component containing the power unit locking element. Various features of the power unit locking element (e.g., body 222, protrusions 224, 226, and handle 228) can vary in shape. For example, in an embodiment where the third position is identical to the first position and the power unit locking element remains in the device after assembly, compared to... Figure 15 Compared to the power unit locking member 220 shown, the length of the main body needs to be shortened, and the handle needs to be arranged differently.

[0203] Figure 18 It shows the relationship with Figure 17The same part, but now with a drive member 280 attached. Once the drive member is attached, it can rotate in the circumferential direction 24 to tension the spring. Once the spring is tensioned, the power unit locking member 220 moves proximally from the first position (e.g., Figure 16 and 17 (As shown) Move to the second position (as shown) Figure 18 and 19 (As shown), to hold the drive element, and thus also to hold the tensioned spring in place relative to the power unit housing 240. This engagement for holding the spring tensioned is achieved through two different interactions. First, as... Figure 19 As shown, once the power unit locking member 220 moves proximally, the protrusion 224 of the power unit locking member moves from a state not engaged with the drive member to a state engaged with the slot 288 on the inner side of the drive member. Similar to the use of protrusion 244 to help attach the power unit locking member 220 and the power unit housing 240 together, the drive member 280 includes two protrusions 284 that engage with the same recess in the protrusion 224 of the power unit locking member.

[0204] The second interaction that keeps the spring taut is caused by Figure 16 The protrusion 224 of the power unit locking member 220 shown is provided, which is still partially retained in the slit 242 of the power unit housing in the second position, thereby rotating and locking the power unit housing 240 and the drive member 280 relative to the power unit locking member 220, thereby preventing the spring 260 from releasing tension.

[0205] Optional safety pins or safety guards may also be provided to lock the power unit locking member in a second position, such as a clamp that holds the handle 228 of the power unit locking member 220 in place relative to the distal end of the power unit housing 240.

[0206] The activation of child components by the back child components will now be explained in more detail. Figure 20 The assembled activator assembly is shown, which includes a plunger rod 300, a locking activation sleeve 80, a needle guard locking element 100, a drive nut 320, and a thrust bearing 340. Figure 21 The diagram shows a portion of the activator assembly (i.e., piston rod 300, locking activation sleeve 80, and drive nut 320) in its configuration prior to full assembly. Figure 22 and 23 The diagram illustrates how the plunger rod 300, the locking activation sleeve 80, and the drive nut 320 are attached to each other through cross-sectional features. The plunger rod 300 includes a thread 302 that engages with a corresponding thread 322 on the drive nut 320. Specifically, in Figures 21 to 23As can be seen, the plunger rod 300 has threads 302 only on a portion 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 37 ).

[0207] The drive nut 320 includes the threads 322 as described above, and also includes two arms 324. Typically, the arms 324 extend primarily in the axial direction. The arms 324 include teeth 326 on their surfaces facing axis 20, which can engage with the drive member 280, as will be described in more detail later (see, for example, [link to relevant documentation]). Figure 49 ).like Figure 23 As shown, arm 324 also includes a surface opposite to axis 20, which engages with locking activation sleeve 80. Figure 23 As can be seen, once the drive nut 320 and the locking activation sleeve 80 are assembled together, the arm 324 of the drive nut 320 is biased inward (this bias is released when the locking activation sleeve 80 is pushed distally by the needle guard 60). In this example, the drive nut 320 includes a base 332 (e.g., a tubular base), to which threads 322 and the arm 324 are attached.

[0208] The locking activation sleeve 80 includes a tubular segment 82 and two arms 84, each arm including a pad 86. A notch 88 is provided on each arm 84 to receive the distal portion 108 of the arm of the needle guard locking member 100 (see, for example, [reference needed]). Figure 27 ).

[0209] Figure 24 The plunger rod 300, locking activation sleeve 80, needle guard locking member 100, and drive nut 320 are shown, wherein the needle guard locking member 100 is not yet assembled. Figure 25 It shows Figure 24 A near-sighted side view of the components when assembled. Similarly, Figure 26 It shows Figure 24 Another near-side view of the middle section, now also including the thrust bearing 340. The various features of these sections and their interactions will now be explained, especially with reference to… Figure 26The drive nut 320 includes a base 332, and a tubular segment 102 of the needle guard locking member 100 extends around the base 332. Optional features for holding the needle guard locking member 100 in place relative to the drive nut 320 (although allowing some axial movement, as in this example) are a distally facing crossbar 114 of the needle guard locking member 100 located near a proximal crossbar 330 of the drive nut 320, and a proximal crossbar 116 of the needle guard locking member 100 located near a snap-fit ​​protrusion 329 of the drive nut 320. The tubular segment 102 of the needle guard locking member 100 can be assembled via the snap-fit ​​protrusion, but is not easily retracted via the snap-fit ​​protrusion, thus holding it in place relative to the drive nut 320.

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

[0211] Figure 27 The attached power unit sub-assembly and activation sub-assembly are shown. (Example) Figure 28 As shown, these two sub-assemblies are then fitted into housing 40, which in this case is a single outer shell, although the housing may, of course, consist of multiple parts. This combination of the power unit sub-assembly, the activation sub-assembly, and the housing constitutes the complete rear sub-assembly. An end cap (not shown) is typically also included at the distal end of the housing as part of the rear sub-assembly.

[0212] exist Figure 29 Another exemplary autoinjector is shown below, which will now be described in detail with reference to the following figures. The autoinjector and the needle guard locking assembly within it differ somewhat from those described in the examples above. However, the autoinjector in the examples described below can be used with... Figure 1 , 5 Or use the needle shield locking assembly in instance 10, and Figure 1 , 5 The auto-injector in example 10 can be used with the needle guard locking assembly described below.

[0213] like Figure 29 As shown, the autoinjector extends from the proximal end 14 to the distal end 16 and includes a housing 40 and a cap 160. The autoinjector extends along axis 20 in the axial direction 22 and about the axis in the circumferential direction 24. Figure 30 and 31The components of an autoinjector are shown, namely, a cap 160, a rigid needle guard remover 180, a proximal housing 42, a needle guard 60, a needle guard spring 140, a syringe holder 120, a main assembly including a syringe 362 and a rigid needle guard 364, a thrust bearing 340, a plunger rod 300, a needle guard locking member 100, a drive nut 320, a locking member activation sleeve 80, a drive member 280, a distal housing 44 (rear housing), a spring holder 400, a torsion spring 260, an optional rotating body 380, and an end cap (in this case, a rotating body cap 390). In summary, unless otherwise stated below, these parts function identically to their equivalents described above, and these components are interchangeable between exemplary autoinjectors. Figure 10 The illustration of the example shown focuses on the shape of these parts and how they are assembled together; Figure 29 The examples illustrate how autoinjectors work.

[0214] Apart from some differences in the shape of the parts (e.g., in Figure 29 In the example, the needle guard locking element 100 does not have the accordion-style corrugated section 112. Figure 10 and Figure 29 The most significant difference between the examples lies in the rear subassemblies, which, for example, include a rotating body 380, a rotating body cap 390, and a spring retainer 400. The rotating body 380 is attached to the drive member and rotates as the drive member rotates. The rotating body 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 we will mainly refer to Figure 29 and 30 Examples are provided to illustrate how the device is assembled and how it operates. Unless otherwise stated, the same method of operation applies to other autoinjectors described herein.

[0216] Figure 32 The diagram illustrates the details of how the various parts of the autoinjector are assembled together. A torsion spring 260 (specifically, the distal projection 264 of the torsion spring 260) applies torque to the distal end of the drive member 280 via a spring retainer 400 and a distal housing 44. Specifically, the torsion spring is secured proximally to the spring retainer 400 (specifically, via the proximal projection of the torsion spring 260, which in this example is a hook). The spring retainer 400 is fixed to the distal housing 44 and therefore cannot rotate relative to the housing (see especially...). Figure 36 and 37The distal projection 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. Therefore, once the device is activated and the drive member is released to allow rotation, the drive member rotates (see details of drive member release). Figure 34 and 35 ).

[0217] Figure 33 Further details are shown on 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 example, an inwardly extending, longitudinally extending rib 47 on the distal housing 44 engages with a corresponding protrusion 328 on the drive nut 320 to prevent free rotation of the drive nut 320 relative to the distal housing 44; this indirectly prevents 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 a snap-fit ​​engagement 48. The drive nut may also optionally be connected to the syringe holder 120 (see [link to syringe holder]). Figure 32 For example, via hook 128 on the syringe (see details) Figure 13 and 34 ) and the corresponding hook 334 on the drive nut (see Figure 34 The hook is Figures 10 to 28 (The connection does not exist in the instance, but can be included.)

[0218] Figure 34 The connection between the portions surrounding the drive nut 320 is highlighted. Prior to the use of the device, the threaded plunger rod 300 is driven by the drive member 280 (see, for example, [reference needed]). Figure 37 The actuator is rotatably held in its initial position and axially held in place by the thread 322 in the drive nut 320, which engages with 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 axis 20) by the locking element activated sleeve 80. The inward-facing drive nut teeth 326 thus engage with the corresponding outward-facing drive teeth 286.

[0219] Figure 35 As shown Figure 34 Most of the components of the device are shown, but this time the device is shown after the needle guard 60 has been pushed back to activate the locking member and sleeve 80, thereby releasing the arm 324 of the drive nut 320 and disengaging the lock between the teeth 286 of the drive member 280 and the teeth 326 of the drive nut 320. This release of the lock allows the torsion spring 260 to rotate the drive member directly, and the plunger rod 300 is rotated directly 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 37The drive element 280 converts the rotational torque from the torsion spring 260 into a linear force. A thrust bearing 340 is preferably attached to the proximal end of the plunger rod 300. This thrust bearing preferably rotates freely and independently relative to the rotating plunger rod 300, allowing the thrust bearing to remain stationary relative to the plug 366 during injection, thus transmitting linear force only to the plug 366. Another advantage of providing a thrust bearing is that its shape facilitates a gentler transmission of force from the plunger rod to the plug, for example, through engagement with a larger surface area of ​​the plug and / or through engagement with the outer edge 367 of the distal end of the plug (see...). Figure 42 (to transmit)

[0220] Figure 36 and 37 The diagram illustrates how the spring retainer 400 is rotatably secured to the distal housing 44, and how the drive member 280 is rotatably secured to the plunger rod 300. In both cases, this is achieved through corresponding non-circular cross sections (in other words, a keyed opening in the drive member and a key of a corresponding shape in the plunger rod shape), in this example, where the non-circular cross section has a corresponding straight edge (i.e., deviating from a circular cross section), though various other shapes can also be used. In this case, the keyed opening is located in the distal housing, and a correspondingly shaped crossbar on the proximal end of the syringe retainer engages with the keyed opening. Similarly, the keyed opening in the drive 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 The arrangement details of the rotating body 380 and the rotating body cap 390 are shown. The rotating body cap 390 includes a window 392 through which the rotating body can be seen; the rotating body is typically patterned thereon to make its rotational movement easily visible to the user. The rotating body 380 is rotatably fixed to the drive member (or another part that rotates during transport) such that the rotating body rotates as the drive member rotates. The rotating body 380 (or, in the absence of a rotating body, an end cap) can support the distal end of the drive member 280 to ensure that the drive member 280 remains concentric within the housing.

[0222] Now will be used Figures 41 to 45 To explain Figure 29 The operation of the needle shield locking component in the example. Overall, Figure 30 The pin guard locking component is the same as that shown in the previous examples, so the parts are interchangeable between these examples, and the operation of the other examples is the same.

[0223] Figure 41The image shows the autoinjector in its pre-use configuration, with all components in their initial positions. A notable difference in this design is that the needle guard 60 and the needle guard locking member 100 overlap axially, while, for example, in... Figure 1 and Figure 5 In the design shown, the needle guard 60 and the needle guard locking member 100 do not overlap. This overlap is optional in all needle guard locking assembly designs. The benefit of providing overlap is that it makes it more difficult to push the locking member activation sleeve 80 in a distal direction before use, for example, in the event of a drop. This is because the proximal portion 106 of the needle guard locking member arm is prevented from moving away from the axis 20, making it more difficult for the locking member activation sleeve 80 to be pushed past the distal portion 108 of the needle guard locking member arm.

[0224] exist Figure 42 In this configuration, the protective cap (not shown) of the device has now been removed. This allows the needle guard to move proximally; however, this feature is optional, and the needle guard cannot move when the protective cap is removed.

[0225] exist Figure 43 The diagram shows the device when the needle guard 60 has been fully moved distally. Activating the device by compressing the needle guard in this manner positions the needle guard in a position that prevents the needle guard locking member 100 from bending outwards. When the needle guard 60 is compressed sufficiently (i.e., pushed sufficiently distally, i.e., as...), Figure 42 As shown at distance A), it begins to push the locking activation sleeve 80 distally. Pushing the locking activation sleeve distally causes the distal portion 108 of the needle shield locking arm to bend inward, subjecting it to internal bending stress, which causes the needle shield locking arm 104 to attempt to pivot. Because the proximal portion 106 of the needle shield locking arm cannot bend outward until the needle shield 60 re-extends (moves proximally backward), 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 distal position (in this case, after the needle shield has been pushed...). Figure 42 Distance A in the middle plus Figure 42 After a distance B in the middle), the device is activated, thereby also pushing the locking activation sleeve 80 to its farthest position (in this case, the farthest position is the position where the distal surface of the locking activation sleeve 80 faces the proximal surface of the spring retainer, although the farthest position of the locking activation sleeve 80 can be set by abutting another part (e.g., the housing), or can simply be limited by the restricted movement of the needle guard). This helps to define the depth of the injection needle insertion into the injection site, or to define the way the jet injector interacts with the injection site.

[0226] The point at which the needle shield locking member 100 is activated by the locking member activation sleeve 80 can be set by the relative shape and size of the components. For example, the injection start point (in this example, set by the locking member activation sleeve 80 releasing the arm 324 of the drive nut 320, thereby disengaging the teeth 286 of the drive member 280 from the teeth 326 of the drive nut 320) can be the same point at which the device locks if the needle shield is prematurely extended again (moved back in a proximal direction, for example, due to premature removal of the device from the injection site). This means that if the injection has begun and the device is subsequently removed (at the end of the injection or premature removal), the needle shield locking assembly will lock the needle shield, but will not lock the needle shield if the injection has not yet begun. Alternatively, the injection start point can be before or after the point at which the needle shield locking member 100 is activated by the locking member activation sleeve 80.

[0227] Figure 44 The needle guard locking assembly and drive nut are shown in their configuration after injection (or after the device has been prematurely removed from the injection site). The locking activation sleeve 80 remains in place, and the retraction of the needle guard 60 in the proximal direction allows the arms 84 of the locking activation sleeve 80 to relax their bias by moving the proximal portion 106 of the needle guard locking arm 104 away from axis 20. In this example, the proximal portion 106 of the needle guard locking arm 104 abuts against the distal housing 44 in the slit 45; however, a gap between the distal housing 44 and the proximal portion 106 of the needle guard locking arm 104 is also possible (e.g., ...). Figure 3 (As shown in the example).

[0228] Figure 45 Details of the needle guard locking member 100 and its interaction with the slit 45 in the distal housing 44 are shown. Typically, as... Figure 44 and 45 As shown, a small axial gap exists between the needle guard 60 and the needle guard locking member 100 (especially the proximal portion 106 of the needle guard locking member arm 104), which allows for a slight movement of the needle guard after injection. This is beneficial in terms of improving component dimensional tolerances.

[0229] Figure 46 and 47 The relative positions of the needle guard 60, locking activation sleeve 80, and drive nut 320 are shown before and after the device is activated. As the arm 324 of the drive nut 320 moves radially outward (away from the axis), the drive member 280 is allowed to rotate as described above. Specifically... Figure 47As shown, in this example, arm 324 is moved radially outward to a position aligned with the tubular segment 82 of the locking element activation sleeve 80, such that the distally facing surface of arm 324 engages with the proximal facing surface of the tubular segment 82 of the locking element activation sleeve. This alignment is optional but advantageous because it prevents the locking element activation sleeve from being moved proximally after the needle guard 60 has been moved back. Alternatively, the locking element activation sleeve can be prevented from being moved proximally by friction (e.g., friction between the pad 86 of the locking element activation sleeve and the distal portion 108 of the needle guard locking arm 104 when the arm 104 is biased). Alternatively, a protrusion, such as optional protrusion 111 (see...), can be provided on the distal portion 108 of the needle guard locking arm. Figure 26 or Figure 42 Such protrusions can interact with the distal portion of the liner 86, thereby helping to limit accidental distal movement of the locking activation sleeve before injection.

[0230] Figure 48 and 49 The details of the engagement between the drive member 280 and the drive nut 320 are shown. 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 contributes to pushing the arm outward, especially as... Figure 49 As shown. This angle can be designed in particular to allow the arm 324 to be pushed outward with the smallest possible force, while always with sufficient force to prevent jamming (i.e., to ensure that the injection always begins as designed). The outward pressure of the arm generates friction against the force of the activation ring, which the user must overcome to activate the device; therefore, it is advantageous to design the force to be overcome to be as small as possible. Further details of the actuators that can be used in such a device are described in EP 19211853.7, the entire contents of which are incorporated herein by reference.

[0231] Figure 50 and 51 It shows the use of Figure 29 An exemplary thrust bearing 340 is provided for an autoinjector; of course, this thrust bearing can also be used in other autoinjectors described herein. The thrust bearing includes an optional base 341; one or more for proximal engagement with the plunger rod 300 (see, for example, [link to documentation]). Figure 26 and 35The syringe comprises a snap-fit ​​arm 342 (in this case, three arms), each arm including a protrusion 344 that engages with the plunger rod and a proximal-facing protrusion 346 that engages with the plug during injection. The snap-fit ​​arms are typically flexible to facilitate assembly. Generally, the thrust bearing 340 (especially the proximal-facing protrusion 346) can be advantageously varied to correspond to different plug shapes, as a large contact area between the thrust bearing and the plug is advantageous for supporting the plug, especially when the drug is viscous and therefore requires a high spring force to be transmitted from the power unit to the plug. For some plug shapes, the proximal-facing protrusion may not be necessary at all. The thrust bearing should generally be free-rotating relative to the plunger rod, ensuring that it does not rotate with the plunger rod when in contact with the syringe plug, but only transmits linear force.

[0232] Figure 52 A portion of another exemplary autoinjector with slightly different features is shown; of course, the features shown in this example can also be provided in the examples fully described above. In this example, the protrusion 226 of the power unit locking member 220 and the corresponding rib 246 on the power unit housing 240 can be seen. Generally, the shape of the protrusion 226 and the rib 246 can vary, as can the number of protrusions 226 and ribs 246. The same number of protrusions and ribs is provided here (two in this example), but different numbers can also be provided, such as two protrusions and four ribs. The ribs can be replaced by protrusions. The number, shape, and precise location of the protrusions and ribs can be varied according to the desired number and pattern of clicks. Figure 52 As shown, rib 246 may have a bevel (a face extending in both radial and circumferential directions) on one side (specifically, the side that protrusion 226 will first reach when the power unit locking member and the power unit housing rotate relative to each other during injection) to allow protrusion 226 to ride more gently on rib 246. The other side of the rib typically has a steeper face (e.g., extending in the radial direction). Or, alternatively, as Figure 52 As shown, the protrusion may be inclined (extending radially and circumferentially, rather than extending directly outward from the axis) to allow the protrusion 226 to more gently cross over the rib 246. The beveled surface of the rib and the inclined protrusion also help reduce friction when parts pass over each other. Figure 52 In the middle, the plunger rod 300 (specifically the distal end of the plunger rod 300) inside the power unit locking member 220 can be seen.

[0233] In addition to the examples and alternatives described above, we will now refer to Figure 53Other examples and alternatives are described below. These examples focus in part on mechanisms used to prevent premature activation of the drug delivery device (i.e., before the cap is removed). This problem arises particularly when the device is dropped, in which case the momentum of the needle guard causes it to move distally relative to the housing upon impact with the ground.

[0234] Figure 53 An autoinjector 10 with components similar to those described above is shown. Figure 53 In the middle, one can see the housing 40, the protective cap 160 and the optional end cap 200, as well as small parts of the syringe holder 120, the power unit housing 240 and the main kit 360.

[0235] Figure 54 It shows Figure 53 The autoinjector 10, in its disassembled components, includes: housing 40, needle guard 60, locking activation sleeve 80, needle guard locking element 100, injector holder 120, needle guard spring 140, cap (in this example including cap housing 162, cap core 170, and rigid needle guard remover 180), optional end cap 200, power unit locking element 220, power unit housing 240, and torsion spring 260 (in... Figure 54 In the diagram, the torsion spring is not fully shown, only its two ends are shown, one untensioned and the other tensioned, to illustrate the typical diameter difference between the tensioned and untensioned states; the drive element 280; the plunger rod 300; the drive nut 320; the thrust bearing 340; and the main assembly (in this example, including a syringe 362 with an injection needle 368, a rigid needle guard 364, and a plug 366). An optional label 419 is also shown. This label may obscure features between the housing and the power unit housing, such as clips. Obscuring these features can be beneficial as it helps prevent end users from attempting to disassemble the device. The label is shown extending around the entire housing, but it could also extend only around a portion of the housing.

[0236] These components are generally interchangeable among the devices described herein. However, some components differ in shape from those described elsewhere in this document. Figures 55 to 62 Some components are shown in more detail below. Figure 55 , 56 Further details of the needle guard locking member 100, the drive nut 320, and the locking member activation sleeve 80 are shown on 57 and 58, respectively. Figure 58 More details of the power unit locking member are shown; in this example, protrusion 226 is located at the distal end of the power unit locking member, rather than, for example, as shown below. Figure 15 The ground shown is spaced apart from the far end of the power unit locking component. Figure 59 More details of the drive unit 280 are shown. 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: the cap housing 162, the cap core 170, and the rigid needle guard remover 180. Figures 64 to 69 The caps are shown in different positions to provide more detail.

[0238] Figure 64 A cap and adjacent components for a drug delivery device for use in this context are shown. The focus here is on the locking mechanism provided by the combination of the cap 160, needle guard 60, and housing 40. The main assembly 360, optional needle guard spring 140, and syringe holder 120 are also visible. The cap 160 includes a cap housing 162, a cap core 170, and a rigid needle guard remover 180. In this case, the cap housing 162 provides the outer shell of the cap. The cap housing 162 is typically tubular, such as… Figure 63 As shown, and including an optional handle 164 and a slot 166 through which the cap core arm 171 extends, for example as... Figure 69 As shown. The hood core 170 includes a hood core arm 171, and the hood core arm 171 includes a cutout 172 (of course, the cutout can also be a recess). The hood core 170 also includes a snap-fit ​​protrusion 174, for example, as Figure 69 As shown. A rigid needle guard removal member 180 is disposed between the cap core member 170 and the cap housing 162, and a rigid needle guard removal member flange 182 extends between the cap housing 162 and the cap core member 170 to hold the rigid needle guard removal member flange 182 in place.

[0239] The movement of the cap core 170 relative to the cap housing 162 in the axial direction 22 is restricted by the snap-fit ​​protrusion 174 of the cap core 170. This snap-fit ​​protrusion 174 abuts against the proximal surface of the cap housing 162, for example... Figure 69 As shown. The snap-fit ​​engagement 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, see...). Figure 69Rib 168 can engage with the circumferentially facing surface of the cap core arm 171 to restrict rotational movement of the cap core 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 outward from an additional outward-facing surface disposed within the cap body. While snap-fit ​​engagement may be advantageous due to its ease of assembly, it is optional and can be replaced by various other structural features configured to achieve the same restriction of axial movement, 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, the proximal end of the housing 40). The needle guard 60 is located within the cap 160 (specifically, within the cap core arm 171). The needle guard 60 includes a protrusion 68 extending radially away from the axis and into the cap core cutout 172.

[0241] During use, first pull the cap off the housing, which causes the drug delivery device to... Figure 64 Move to the position shown Figure 65 The position is shown. The cap and needle guard are moved proximally relative to the housing (e.g., the movement of the needle guard may be caused by the cap pulling the needle guard proximally and / or by the needle spring pushing the needle guard proximally when the cap no longer restricts its movement). As a result, the cap core arm 171, which was initially restricted from moving radially due to the presence of the housing 40, can now move freely radially, allowing the cap core arm 171 (and the rest of the cap) to continue moving proximally relative to the housing 40 and the needle guard 60, thereby removing the protrusion 68 of the needle guard 60 out of the cap core cutout 172.

[0242] In this particular instance, the cap is designed such that pulling the cap further along the axial direction will remove it from the autoinjector (drug delivery device). Figure 67 The cap can be rotated relative to the housing, either additionally or alternatively, to remove it (see [link]). Figure 66 ). Specifically, as follows Figure 66 As shown, the proximal surface 49 of the housing extends around the housing in the circumferential direction 24 and faces the corresponding distal surface 169 of the cap 160 (specifically, the cap housing 162 in this example). Both the proximal surface 49 of the housing 40 and the distal surface 169 of the cap housing 162 extend in the axial direction, their axial positions varying around the circumference, in this case a sinusoidal pattern; other shapes are also possible. Making the axial position vary in the circumferential direction in this way is optional, but may be advantageous, as it may mean that inducing the removal of the cap by twisting it relative to the housing would naturally cause the cap to also move axially relative to the housing.

[0243] Refer to the above text Figures 63 to 69 The illustrated cap and locking mechanism are examples 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 cap described above comprises three parts, but caps consisting of other numbers 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 provide flexibility and make the protrusion easier to remove from the cutout during cap removal. In the example above, the protrusion is located on the needle guard and the cutout is located on the cap, but this can also be reversed, i.e., the cutout is located on the needle guard instead of the cap. The rotational function of the cap housing 162 relative to the cap core 170 is optional; when providing this function, it may be advantageous 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 may be closer to the axis than the arm of the needle guard and cap, rather than the housing being further away from the axis than the arm of the needle guard and cap; in this case, the mechanism is effectively inverted in the radial direction 26.

[0244] Figure 70 Another autoinjector 10 with components similar to those described above is shown. Figure 70 In the image, one can see the housing 40, the cap 160 and optional rotating cap 390, as well as small portions of the syringe holder 120 and the main assembly 360. A notable difference compared to previous designs is the design of the cap 160, which will be explained in more detail below.

[0245] Figure 71 It shows Figure 70 The autoinjector 10, in its disassembled components, includes: a housing (divided into a proximal housing 42 and a distal housing 44), a needle guard 60, a locking activation sleeve 80, a needle guard locking element 100, an injector holder 120, a needle guard spring 140, a cap (including two cap housings 162), an optional rotating body 380 and a rotating body cap 390, a power unit locking element 220, a power unit housing 240, and a torsion spring 260 (in...). Figure 71 The torsion spring is not fully shown, only its two ends are shown, one untensioned and the other tensioned, to illustrate the typical diameter difference between the tensioned and untensioned states; drive element 280; plunger rod 300; drive nut 320; thrust bearing 340; and main assembly (in this example, including syringe 362 with injection needle 368, rigid needle guard 364, and plug 366). Optional label 419 is also shown.

[0246] These components are generally interchangeable among the devices described herein. However, some components differ in shape from those described elsewhere in this document. Figures 72 to 81 Some components are shown in more detail below. Figure 72 More details are shown of the power unit housing 240 and the corresponding rotating body cap 390, which can be joined together by snap-fit. Figure 73 Further details of the power unit locking member 220 and the corresponding rotating body 380 are shown, along with an example of how the power unit locking member 220 and the rotating body 380 are attached together, namely, by means of a rotating rib 382 of the rotating body 380 engaging with a pair of distal recesses 230 of the power unit locking member 220 (the second recess is not visible). During drug delivery, rotation of the rotating body 380 can provide a visual indication that drug delivery is in progress. Figures 74 to 76 The details of the distal engagement of the autoinjector are shown, focusing on the power unit locking member 220, the power unit housing 240, the rotating body 380, and the rotating body cap 390. Figure 76 The relative positions of the protrusion 226 of the power unit locking member 220 and the corresponding rib 246 of the power unit housing 240 can be seen. During drug delivery, rotation of the power unit locking member 220 relative to the power unit housing 240 causes 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 rib 246 to pass through each other, one or both of the protrusion 226 and rib 246 can be flexible. Vibration of the device can also produce a tactile indication, especially when the ribs 246 and / or protrusions 226 are irregularly spaced (rather than the regular spacing shown in the illustrated example). Such audible indications 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 rotating body-based scheme shown in this particular embodiment can be adopted). To enhance the visual effect of the rotating body, patterns can be provided on the rotating body (e.g., by printing, by adding one or more stickers, or by engraving) to make the rotation of the rotating body more intuitive. The rotating body may be an integral part of the power unit locking mechanism, rather than a separate component. As an alternative to or supplement to the aforementioned feedback signal, the plunger rod 300 may include a whistle hole. This whistle hole is capable of generating an audio signal (typically a continuous audible signal) during drug delivery. Whistle holes may also be provided in other plunger rods described herein.

[0247] Figure 77 , 78 Further details of the needle guard locking member 100, drive nut 320, and locking member activation sleeve 80 are shown in 79 and 79, respectively.

[0248] Figures 80 to 85The cap and adjacent parts of the drug delivery device for context are shown. The focus here is 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). In this case, as... Figure 80 As shown, the cap includes two cap housings 162; however, the locking mechanism can also function if the cap is a single, integral piece. Optionally, each cap housing 162 includes a flange 163 extending from the tubular shape of the cap and may have a portion to aid in holding the cap during removal. The cap housings 162 can be attached to each other via snap-fit, although other attachment mechanisms (such as adhesive) are also possible. A rigid needle guard remover 180 is arranged between the cap housings 162. Figure 81 The proximal housing 42 is shown, including an arm 410 and an optional cap guide 411 (in this case, a rib extending in the axial direction); the cap guide can help align the cap relative to the proximal housing and / or help secure the cap relative to the proximal housing in the circumferential direction. Figure 82 and 83 The portion of the autoinjector including the locking mechanism is shown. The cap 160, needle guard 60, and housing 40 (especially the proximal housing 42) are shown. The main assembly 360, optional needle guard spring 140, and syringe holder 120 are also visible here, as is the distal housing 44.

[0249] The proximal housing 42 includes an arm 410. This arm includes a protrusion 412 extending radially toward axis 20. In this example, the arm extends along axial direction 22, but it could also extend in another direction, such as circumferential direction 24. In this example, the arm is attached at its proximal end to the remainder of the proximal housing; alternatively, the distal end of the arm could also be attached to the proximal housing. The protrusion 412 extends into a cut (or recess) 70 in the needle shield 60. The needle shield 60 also includes an optional recess (or cut) 72; this recess is arranged closer to the proximal end of the needle shield 60 than the cut 70 and is designed to reduce friction between the protrusion 412 of the arm 410 of the proximal housing and the needle shield 60 during removal of the cap from the autoinjector 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, part of the cap housing 162), which prevents (or at least restricts) radial movement of the arm when the cap is attached to the autoinjector. Figure 83As shown, this restricts the distal movement of the needle guard 60 because the protrusion 412 of the arm 410 of the proximal housing cannot disengage from the path of the needle guard 60. This prevents premature activation of the autoinjector (e.g., in the event of an autoinjector drop) because it limits the movement of the needle guard 60 so that it cannot move distally far enough to activate the device. Alternatively, the arm can be tilted (or biased) inward so that the arm is in the path of the needle guard 60 rather than the protrusion, which is on the side of the arm opposite to 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 which is radially wider than the attachment end of the arm.

[0251] When the needle cap has been removed from the autoinjector (by twisting or pulling relative to the autoinjector), the needle guard 60 can move distally to its maximum extent (relative to housings 42, 44) because the arm 410 of the proximal housing 42 can move radially, allowing the needle guard 60 to move distally past the protrusion 412. As the needle guard 60 moves distally, the protrusion 412 of the arm 410 of the proximal housing exits the cutout 70 of the needle guard 60 and subsequently enters the recess 72 of the needle guard 60. The final position of the needle guard 60 relative to the proximal housing 42 is... Figure 84 and 85 I saw it in the middle.

[0252] Refer to the above text Figures 80 to 85 The described cap and locking mechanism are an example of a more general cap and corresponding locking mechanism. In addition to the options already mentioned above, this particular design can be modified in various ways (see below). Figures 111 to 120 The example shown is merely one alternative. Following the design principles described above, and especially considering the design of the cap and locking mechanism, many alternatives are possible. For example, with the cap 160 furthest from the axis, the housing (in this case, the arm 410 of the proximal housing 42) positioned between the needle guard and the cap, the locking mechanism can be effectively reversed, with the cap (or at least a portion of the cap) closest to the axis, the needle guard furthest from the axis, and the proximal housing (e.g., the arm) positioned between them, instead of as shown... Figure 82 As shown, the needle guard 60 is closest to the axis. The aforementioned guard consists of three parts, but guards composed of other numbers of parts or even a single integral part can also be used.

[0253] Now refer to Figures 86 to 88 A third alternative locking mechanism is described. The overall design of the autoinjector described herein can be based on one of the autoinjectors described herein, and therefore will not be described in detail. In particular, the overall design of the cap can also be based on other cap designs described herein, and will not be described in detail thereafter. Figure 86 and 87The shape of the hat shown is similar to Figure 80 The shapes shown are similar, but other shapes can also be used.

[0254] The focus here is also on the locking mechanism provided by the combination of the cap 160, needle guard 60, and housing 40 (more specifically, the proximal housing 42 in this particular case). Here, the main assembly 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 (also referred to as a rocker arm or lever). The double-ended arm 420 of the needle guard 60 extends from the proximal portion 426 to the distal portion 427. Figure 88 As can be seen, the double-ended arm 420 is attached to the rest of the needle guard 60 via a rocker arm 422, and the double-ended arm 420 can pivot about the rocker arm 422. The 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 portion of the cap providing the locking mechanism is closer to the axis than the portion of the needle guard providing the locking mechanism, thus effectively reversing the locking mechanism, the protrusion 424 can also extend toward the axis, as is the case with respect to other locking mechanisms described in more detail above).

[0256] The cap includes a protrusion 440 (e.g., attached to the cap housing 162). The protrusion 440 extends toward the axis. The protrusion 440 is further from the proximal end of the autoinjector than the protrusion 424. The protrusion 424 includes a ramp at an angle to the radial direction 26 and the axial direction 22, the ramp being away from the proximal end and away from the axis. The protrusion 440 preferably includes a surface facing the ramp of the protrusion 424. The ramps on the protrusions 424 and 440 are not necessary, but can reduce friction arising from contact between the protrusions 424 and 440.

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

[0258] like Figure 86 and 87 As shown, when the needle guard is still on the autoinjector, 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 (e.g.) Figure 87As shown), the protrusion 424 of the double-ended arm 420 of the needle guard is pushed against the protrusion 440 of the cap 160. As a result, the protrusion 424 is pushed towards the axis, causing the double-ended arm 420 to pivot about the rocker arm 422, resulting in the proximal portion 426 of the double-ended arm moving towards the axis, while the distal portion 427 of the double-ended arm moves away from the axis. Consequently, the distal-facing surface 430 of the distal portion of the double-ended arm moves away from the axis, aligning it with the proximal-facing surface 445 of the proximal housing 42, as shown. Figure 88 As shown. Aligning the distal surface 430 of the distal portion of the double-ended arm with the proximal surface 445 of the proximal housing 42 prevents the needle guard 60 from moving further distally relative to the housing.

[0259] When the cap is removed from the autoinjector, 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. Once 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, thereby allowing the needle guard 60 to move distally relative to the proximal housing 42, while the distal-facing surface 430 of the distal portion of the double-ended arm does not move away from the axis. As a result, the distal-facing surface 430 can move into the proximal housing 42 without engaging with the proximal-facing surface 445 of the proximal housing 42.

[0260] Figure 89 and 90 An alternative cap design is shown that can be used in conjunction with a drug delivery device, such as the autoinjector described herein. Figure 89 A cap 160 is shown in an autoinjector, which includes a housing 40 with an optional window 46, a needle guard 60, and a cap 160. The cap 160 is located within the needle guard 60. Figure 90 A cap 160 is shown, 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 configured to allow a user to remove the cap; alternatively, another type of cap removal component, such as a handle, can be provided. Arms 177 extend from the cap housing 162. Figure 89As shown, an arm (in this case, a protrusion 179 of arm 177) extends into a cutout in the needle guard 60, thereby holding the cap in place within the needle guard 60. Arm 177 is flexible, allowing the protrusion to move toward the axis and across the needle guard 60 during cap removal from the needle guard. After the cap is removed, arm 177 bends outward again, making it difficult to put the cap back onto the device because the arm extends too far away from the axis to be reattached to the needle guard. This can be advantageous because it prevents cap replacement on activated or used devices. Two arms are shown in this example; however, only one arm may be provided. Three or more arms may also be provided; this can be advantageous because it makes it more difficult to put the cap back in place (e.g., more arms make it more difficult to push all the arms back toward the axis while simultaneously pushing the cap back into the needle guard).

[0261] Refer to the above text Figures 15 to 19 The given description discusses the assembly of the power unit. Figures 91 to 98 The power unit components are similarly shown, and a full explanation of the aforementioned functions will not be repeated. Figures 91 to 98 A slightly different shape is shown, but the process is largely the same: the power unit moves from a first position (winding position) to a second position (power unit locked position), and then to a third position (power unit unlocked position). This applies to components other than the autoinjector. Figure 91 , 94 Figures 95 and 95 also show tooling components that can be used to aid assembly. As a general introduction to the concept, it is understandable that while torsion springs typically provide cost-effective rotational energy, they also present the challenge of a reduction in spring diameter when the spring is coiled up.

[0262] Especially from Figure 94 and 95 As can be seen, the tool used for auxiliary assembly (spring winding tool) comprises two parts rotatable relative to each other: a distal tool 460 and a proximal tool 470. The distal tool 460 is configured to receive and rotate the locking power unit locking member 220, preventing the power unit locking member 220 from rotating relative to the distal tool 460. In this example, this is achieved by providing a groove 461 for receiving the protrusion 226 of the power unit locking member 220, as shown... Figure 91 As shown. Optionally, the distal tool 460 includes a support portion 462 (in this case, a tubular segment) to help support the power unit housing 240, which can also be rotationally locked relative to the distal tool 460 if additional stability is required. The proximal tool 470 is configured to receive and rotate-lock a component to the proximal end of the torsion spring 260, which can be various components, such as the component of the activating subassembly 56. In the example shown (see, for example, see...) Figure 94 The proximal tool 470 is configured to receive and rotate to lock into the locking element activated sleeve 80. The specific shapes of the distal tool 460 and the proximal tool 470 can vary considerably, depending on the shape of the relevant autoinjector components and the shape of other tools used to assist in the assembly of the autoinjector.

[0263] The method of using the spring winding tool (including the distal tool 460 and the proximal tool 470) will now be explained. Figure 91 As shown, first, the power unit locking member 220 is inserted into the remote 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 referred to above. Figure 16 The above and such Figure 92 As shown. Figure 93 The position of the remote tool 460 relative to the power unit locking member 220 and the power unit housing 240 is shown.

[0264] Next, a torsion spring 260, a drive element 280, an activator assembly (in this particular instance, including a locking activation sleeve 80, a needle guard locking element 100, a drive nut 320, and a thrust bearing 340), a plunger rod (not shown), and a proximal tool 470 are added to the power unit housing 240, as follows: Figure 94 As shown. Then, the proximal tool 470 can be rotated relative to the distal tool 460 to wind the torsion spring 260, at which point the drive member can rotate freely relative to the power unit locking member. The rotation step can optionally be performed in two steps: the first step is a limited rotation (e.g., rotating the distal tool 460 a quarter turn or half a turn relative to the proximal tool 470 (i.e., 90 or 180 degrees) to engage the proximal protrusion 262 of the spring 260 with the circumferentially facing crossbar 282, which allows checking that the spring and drive member are properly engaged), followed by 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 Only a portion of the torsion spring 260 is shown. 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 up, the power unit locking member 220 is moved to the second position, such as Figures 95 to 97 As shown ( Figure 97 Equivalent to the explanation above Figure 19This can be achieved by moving the distal tool 460 toward the proximal tool 470. As described above, this locks the power unit by rotating the power unit locking member and the drive member, preventing the torque from the spring from being released because the drive member and the power unit housing are rotated and locked together by the power unit locking member. The resulting sub-assembly can then be removed from the tool and inserted into the housing 40, which will activate the rotational locking of the sub-assembly and the power unit housing relative to the housing. At this point, the power unit locking member 220 can be moved to a third position, such as... Figure 98 As shown.

[0266] Overall, this method of winding the spring before assembly is advantageous because it allows for the use of a smaller diameter housing for the spring, without resorting to other methods—firstly, winding the spring would reduce its size. The aforementioned tool allows the spring to be wound externally and then transferred into the housing. This allows the inner diameter of the housing (or at least the inner diameter of the housing inlet point) to be smaller than the diameter of the unwound spring.

[0267] Figure 99 Another autoinjector 10 with components similar to those described above is shown. Figure 99 In the image, one can see the housing 40, the cap 160 and optional rotating cap 390, as well as small portions of the syringe holder 120 and the main assembly 360. A notable difference compared to previous designs is the design of the cap 160, which will be explained in more detail below.

[0268] Figure 100 It shows Figure 99 The autoinjector 10, after disassembly, comprises the following components: housing (divided into proximal housing 42 and distal housing 44), needle guard 60, locking activation sleeve 80, needle guard locking element 100, injector holder 120, needle guard spring 140, cap housing 162, cap core 170, optional rotating body 380 and rotating body cap 390, power unit locking element 220, power unit housing 240, and torsion spring 260 (in... Figure 10 The diagram fully illustrates the torsion spring in both tensioned and untensioned states (to show the diameter difference between the tensioned and untensioned states), drive element 280, plunger rod 300, drive nut 320, thrust bearing 340, and main assembly (in this example, including syringe 362 with injection needle 368, rigid needle guard 364, and plug 366). Optional label 419 is also shown.

[0269] These components are generally interchangeable among the devices described herein. However, some components differ in shape from those described elsewhere in this document. Figures 101 to 115 Some components are shown in more detail below. Figure 101The plunger rod 300 and 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, other numbers of snap-fit ​​arms 342 may be provided in this example and in other thrust bearing examples described herein. Figure 103 More details of the power unit locking member 220 and the corresponding rotating body 380 are shown. Additional protrusions 226 (four additional protrusions in this example) can be seen, in which these protrusions are curved in a plane perpendicular to the longitudinal axis. Figure 73 The protrusion 226 shown is the opposite, for example, Figure 73 The protrusion 226 shown is straight in a plane perpendicular to the longitudinal axis (in... Figure 73 In certain instances, it is also conical, though this is optional. Figure 104 More details are shown of the power unit housing 240 and the corresponding rotating body cap 390, which can be joined together by snap-fit. Figure 105 106 and 107 respectively show the needle guard locking member 100 and the drive nut 320. Figure 106A and 106B (Different angles are shown) and more details of the locking activation sleeve 80. Figure 108 The drive unit 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; various features of the housing 40 and syringe holder 120, as described in other examples herein, will not be repeated. However, a significant difference lies in the optional attachment (in these examples, a snap-fit ​​engagement) between the syringe holder 120 and the drive nut 320. Figure 34 In this example, the attachment is achieved by a hook 128 of the syringe holder 120 (which extends radially (specifically, radially away from the axis, though this could also be the opposite) and a hook 334 of the drive nut 320. Figure 110 And Figure 106 (especially) Figure 106B An alternative example is shown in the diagram, where the snap-fit ​​is engaged by bending along the circumferential direction rather than the radial direction; of course, these attachments are interchangeable in the examples described herein. Specifically, two pairs of snap-fit ​​arms 132 are provided on the syringe holder 120. Each pair of snap-fit ​​arms includes two arms 132, each arm including a protrusion 133 extending along 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 a corresponding snap-fit ​​hole 336 (or recess) configured to receive the protrusions 133 to achieve snap-fit ​​engagement.

[0270] Now will be used Figures 111 to 120 To illustrate the exemplary autoinjector front subassembly 50 in more detail. In this example, the front subassembly 50 includes three parts: an injector holder 120, a needle guard spring 140, a needle guard 60, a proximal housing 42, and a cap 160, namely, a cap housing 162, a rigid needle guard remover 180, and a cap core 170. Figure 111 , 113 114 and 115 show the needle guard 60, the cap housing 162, the cap core 170, and the proximal housing 42, respectively. Figure 112 , 116 Figures 117 and 117 illustrate how these components are assembled together. Figure 112 The diagram shows the front sub-assembly 50 arranged side-by-side with other components of an exemplary autoinjector; of course, the front sub-assembly can also be used in conjunction with other autoinjectors. Figure 118 , 119 Figures 1 and 120 show how these components are assembled after the cap has been removed and the needle guard has been pushed to the distal direction.

[0271] and Figures 80 to 85 The example shown is similar; the locking mechanism is provided by a combination of a cap 160, a needle guard 60, and a housing 40 (more specifically, a proximal housing 42 in this particular case). Due to their similar function, further details will not be provided. Figures 111 to 120 The components and functions of the front sub-assembly will be described again; please refer to the description of... Figures 80 to 85 The explanation provided by the examples in the text.

[0272] and Figures 80 to 85 One difference in the example is that the arm 410 is attached at its distal end to the rest of the proximal housing 42, although the proximal end of the arm may alternatively be attached to the proximal housing.

[0273] and Figures 80 to 85 Another difference in the example 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 (see, for example, [link to example]). Figures 118 to 120 This allows the arm 410 to be protected within the distal housing 44 in the assembled device; this prevents the user from manipulating the arm 410, which could otherwise interfere with the function of the assembled device.

[0274] and Figures 80 to 85Another difference in the example is that it includes a surface that allows rotation of the cap 160 relative to the housing 40 to be converted into axial movement of the cap relative to the housing (e.g., a similar function is provided by...). Figure 10 and Figure 67 (As provided in the example). 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 are interchangeable), which can interact with the corresponding proximal facing surface 49 of the housing 40 (in this particular example, the proximal facing surface 49 is provided by ribs on the proximal housing 42). Refer to other examples herein (e.g. in... Figure 10 and 67 The alternative described in the text can also be used in this example.

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

[0276] Now will be used Figures 121 to 128 To illustrate another method of providing feedback, this method can serve as an alternative to or supplement to the other feedback options presented herein. Thus, this feedback mechanism can be implemented in many of the devices described herein, such as... Figure 100 The device in the middle. More generally, this type of feedback mechanism can also be used in drug delivery devices in which two components rotate relative to each other.

[0277] like Figure 121 The feedback mechanism sub-assembly shown includes a power unit locking member 220, a power unit housing 240, a rotating body 380, a rotating body protective cap 390, and a sound generator 500. Figure 122 The diagram shows how the components of the feedback mechanism subassembly are assembled together, and also shows the housing 40 and plunger rod 300 for reference.

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

[0279] A rotating body 380 is arranged between a rotating body cap 390 and a 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 disposed between the power unit housing 240 and the rotating body 380. The proximal surface 502 of the sound generator 500 abuts against the distal surface of the power unit housing 240, and the distal surface 504 of the sound generator 500 abuts against the proximal surface of the rotating body 380 (in this example, the proximal end of the protrusion 384).

[0281] The rotating body 380 is attached to the portion of the drug delivery device that rotates relative to the rotating body cap 390, in this case, the portion being the power unit locking member 220.

[0282] Also shown is a housing 40, which is generally non-removably 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 refer to Figure 127 and 128 The connection between the rotating body cap and the rotating body is explained in more detail. The general idea is that the rotating body cap (or more generally, the housing) includes a guide structure 394, and the rotating body includes a driven structure 388. This converts rotational motion into linear motion. As a result, when the rotating body rotates relative to the housing (as explained in more detail below), the interaction between the cam and the cam follower causes the rotating body to move linearly relative to the housing. Many guide and follower structures can be used to achieve this effect, but a more detailed explanation is given first using a specific shape shown in the accompanying drawings. Figure 127 As shown, the driven structure 388 of the rotating body 380 includes four inclined planes 389. Each inclined plane extends 90 degrees about the axis. Each inclined plane is inclined relative to a plane perpendicular to the axis. As a result, each inclined plane extends from its proximal end to its distal end. The proximal end of each inclined plane is adjacent to the proximal end of the adjacent inclined plane. The distal end of each inclined plane is adjacent to the distal end of the adjacent inclined plane. This results in the driven structure providing a surface extending 360 degrees about the axis.

[0284] The guide structure 394 is a reflection of the driven structure in its design, having four inclined planes 395 arranged in the same manner as in the guide structure. That is, each inclined plane extends 90 degrees around the axis. Each inclined plane is inclined relative to a plane perpendicular to the axis. As a result, each inclined plane extends from its proximal end to its distal end. The proximal end of each inclined plane is adjacent to the proximal end of the adjacent inclined plane. The distal end of each inclined plane is adjacent to the distal end of the adjacent inclined plane. This results in the driven structure providing a surface extending 360 degrees around the axis.

[0285] Optionally, the driven structure and the guiding structure are mirror images of each other in their design. For example, for Figure 127 The driven structure shown may consist of a portion or the entire guiding structure, which may be simply a protrusion extending along the axial direction, the distal end of which abuts against the surface of the driven structure. Alternatively, the guiding structure may be as follows: Figure 128 As shown, and Figure 127 Part or all of the driven structure is replaced by a protrusion.

[0286] Another alternative is to provide a single ramp 389 instead of four ramps. If the guide structure 394 is replaced by a protrusion as described above, then the single ramp can extend 90 degrees around the axis, as... Figure 127 As shown, or it may extend less or more around the axis, such as 180 degrees, 270 degrees, or 360 degrees. In this example, as the protrusion passes the farthest end of the ramp 389, the rotating body is suddenly pushed back distally by the sound generator relative to the rotating body cap. This sudden movement can be beneficial because it can provide a louder click. This sudden movement can also provide tactile feedback due to the sudden movement of the parts relative to each other.

[0287] The interaction between the rotating body 380 and the sound generator 500 will now be explained. Two protrusions 384 (e.g.) Figure 123 The sound generator abuts against the distal surface 504 of the sound generator. The sound generator is a plate, and this plate is slightly deformed so that when the rotating body is in the distal position, the distal surface 504 of the sound generator is convex (i.e., the center of the distal surface 504 is farther from the proximal end of the device than the edge of the distal surface 504). As a result, the proximal surface 502 is concave. As the rotating body moves in the proximal direction, the power unit locking member 220 restricts the movement of the outer edge of the sound generator (i.e., the edge farthest from the center) in the proximal direction, while the rest of the sound generator is pushed in the proximal direction by the protrusion of the rotating body. As a result, the sound generator deforms and changes from a first shape to a second shape, and the distal surface 504 changes from convex to concave (therefore the proximal surface 502 changes from concave to convex).

[0288] In such Figure 121During use of the device including the feedback mechanism sub-assembly, activation of the device causes the power unit locking member 220 to rotate relative to the housing 40 (typically while delivering medication from the device). Since the rotating body 380 is rotationally locked to the power unit locking member 220, and the housing 40 is immovably attached to the power unit housing 240 and the rotating body cap 390, the rotating body 380 rotates relative to the rotating body cap 390. As a result, the driven structure of the rotating body rotates relative to the guide structure of the rotating body cap. Due to the respective shapes of the driven and guide structures, this rotation pushes the rotating body relative to the rotating body cap along the longitudinal axis (i.e., along the axial direction 22, thus towards the proximal end of the device). In the particular design shown in the figures, a 90-degree rotation causes the rotating body to move from its furthest position to its closest position. As the rotating body moves towards the proximal direction, the transmitter deforms because the rotating body pushes a portion of the transmitter towards the proximal direction, but another portion of the transmitter cannot move towards the proximal direction because the power unit housing 240 obstructs this movement. This causes the sound generator to deform (i.e., potential energy accumulates in the sound generator). As the sound generator deforms from its initial, more relaxed (or relaxed) state to its deformed state, it is able to produce a clicking sound.

[0289] Another 90-degree rotation moves the rotating body from its closest position back to its furthest position. This movement is driven by the release of potential energy accumulated in the sound generator, which pushes the rotating body back towards the farthest side once the interaction between the driven and guiding structures allows. The sound generator is able to produce a clicking sound as it relaxes from its deformed state.

[0290] In the example shown in this paper, the design of the guiding and driven structures causes the rotating body to move from its nearest to its farthest position and return every 180 degrees, thus returning twice for each complete 360-degree rotation. However, for other guiding and driven structure designs, the rotating body can move from its nearest to its farthest position and return a different number of times for each 360-degree rotation, such as once, three times, or more. This can be used to change the frequency and / or mode of the sound generator. The angles of the ramps 389 and 395 relative to the axis along the length of the ramp can be constant or can be varied (e.g., varying in a sinusoidal pattern).

[0291] Figure 121The feedback sub-component shown provides repetitive clicking sounds (continuous clicking sounds) (e.g., more than 5 clicks, more than 10 clicks, or more than 20 clicks) during drug delivery from the device, thus providing the user with an auditory indication that injection is in progress. This type of feedback sub-component can also be used to generate single clicking sounds (e.g., an end-of-delivery click indicating the end of drug delivery, a start-of-delivery click indicating the start of drug delivery, and / or a pre-injection click indicating pre-injection completion). While the example given here typically uses multiple rotations of a rotating body relative to the housing to provide repetitive clicking sounds, this type of feedback sub-component can also operate via a single 360-degree rotation of one component relative to another, or via partial rotation of one component relative to another, particularly when one or more independent clicking sounds are required instead of continuous clicking sounds during drug delivery. This type of feedback sub-component can be used alone or in conjunction with other visual, auditory, and / or tactile feedback mechanisms.

[0292] In this particular design, the power unit locking member 220 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. Rotary locking members 229 on the power unit locking member 220 and 386 on the rotating body 380 rotatably lock the power unit locking member 220 and the rotating body 380 together; a specific shape of the locking member is shown here, but this shape can vary.

[0293] exist Figure 121 In the example shown, the rotating body 380 is attached to the power unit locking member 220. Generally, 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 of a drug delivery device. The rotating body can also be an integral part of a component (e.g., an integral part of the power unit locking member 220 or the plunger rod) rather than a separate component.

[0294] exist Figure 121In the example shown, the rotating body has two protrusions 384, but it can also have one, three, or more protrusions. These two protrusions 384 are opposite each other relative to the longitudinal axis; this is optional, although symmetry may be preferred, for example, to maintain force balance within the device, and providing more protrusions (two or more) can produce a louder clicking sound. The protrusions may be located on the surface of the sound generator 500, rather than on the rotating body; the proximal surface of the rotating body interacts with the protrusions of the sound generator. In another alternative, one or more protrusions are provided on the sound generator (e.g., protrusions extending distally from the distal surface 504 of the sound generator) and protrusions 384 on the rotating body 380 are simultaneously provided. 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 (proximally) and producing a clicking sound (the protrusion may optionally have an angled end to reduce friction caused by the interacting protrusions). In this alternative, it is not necessary to... Figure 127 and 128 The guide structure shown does not require the rotating body to move towards the proximal direction to produce a clicking sound from the sound generator.

[0295] exist Figure 121 In the example shown, the rotating body cap 390 is described as a separate 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 housing 40, power unit housing 240, and rotating body cap 390 can be simply considered as a housing (or a single integral part or the sum of two or more separate parts). Thus, the rotating body cap can be simply described as a housing or a housing portion.

[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 center), but it could also be another shape, such as annular, rectangular, or square. As mentioned 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 necessary 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; however, it may not be necessary for different sound generator shapes. If the positions of the rotating body and the sound generator are reversed, then the hole 506 may no longer be needed.

[0297] Figure 129 and Figure 130 Another feedback mechanism is shown, which can be used with the scheme described herein (e.g.) Figure 74 or Figure 121This mechanism can be used in conjunction with other devices that allow one component to rotate relative to another. In this mechanism, a gear mechanism is provided that converts the number of rotations required to complete the injection (in this case, the number of rotations of the power unit locking member 220, e.g., 1800 degrees) into a reduced amount of rotation, such as less than 360 degrees of rotation of a disc (display wheel) 520 with a visual shape conveying the injection status. The view of the display wheel may be partially obscured by a cap 540 (or an opaque portion of the cap), so 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 in another location on the device including such a feedback mechanism could indicate that green in the gap indicates the device is ready for use. For example, once the injection begins and the power unit starts rotating, the gear mechanism rotates the display wheel, so that instead of green, yellow is displayed. A label on the device could indicate that yellow indicates the injection is in progress. When the power unit reaches the end of the injection, the display wheel has rotated sufficiently to display red, indicating the final injection completion status. Labels on the device can indicate that a red graphic signifies that the injection has been completed, and / or that the user should wait a few seconds before removing the device, and / or that the device is now in use / not yet ready for use. The geared mechanism means that the display wheel does not move continuously, but rather in steps after a rotating component (e.g., a power unit locking element or plunger rod) rotates a certain angle (in this case, every 180 degrees). This allows for a clear distinction between changes in text and / or color graphics. The mechanism is characterized by a drive gear 522 directly coupled to a rotating power source (not shown), a reduction gear 524 driven by the drive gear every 180 degrees in this example, and a display wheel characterized by having inward-facing teeth 526 and being driven by the reduction gear, such as... Figure 129 and 130 As shown.

[0298] Alternatively, instead of generating stepping motion, the gear transmission mechanism causes the display wheel to rotate continuously. This requires that the interface gears have no missing teeth. Alternatively, the disc can provide auditory feedback instead of (or simultaneously provide) visual feedback. Visual feedback can be provided in various ways, including text, color, and / or graphic images, to convey messages such as the device is not in use, the device is ready for use, injection is in progress, injection is complete, and / or the device has been used. The number of rotations required from the start to the end of injection can be adjusted to suit the device's needs by regulating the ratio between the gears.

[0299] In addition to any other audible clicking sounds that may be provided, a distinctive clicking sound, such as an ending click, can be provided by a rigid rib (or rigid protrusion) near the display wheel that contacts and bends the flexible arm during the final step rotation (e.g., from yellow to red), producing a click once the flexible arm is 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 be used alternatively or additionally for other clicking sounds, such as an initiation click.

[0300] This document describes several different exemplary autoinjectors. Various differences exist between the autoinjectors described, but generally the different features of different autoinjectors are interchangeable, especially at the level of functional sub-components such as the power unit, needle guard locking assembly, or locking mechanism.

[0301] One or more of the cap, housing, and needle guard are usually (but not necessarily) tubular, as this helps these components to provide functions other than the locking mechanism.

[0302] Typically, the aforementioned locking mechanisms are used in autoinjectors (or more generally, drug delivery devices) that are (at least partially) activated by distal movement of the needle guard, as these mechanisms can prevent premature activation (activation before the cap is removed, e.g., when the autoinjector is dropped). However, such locking mechanisms are also useful in devices activated in other ways. Another benefit of such locking mechanisms is that they restrict movement of components relative to each other, which can also be used to secure devices, for example, minimizing the chance of damage during transport.

[0303] This application focuses on examples of autoinjectors with injection needles. However, the concepts described herein can also be implemented in more general pen injectors or drug delivery devices. For example, the needle guard locking assembly described herein can be used in autoinjectors with injection needles, autoinjectors with jet injectors, or pen injectors. An autoinjector is generally defined as an injection device in which at least some of the processes (e.g., drug injection, needle insertion, or needle guard retraction) are performed by the autoinjector and therefore do not require user intervention.

[0304] The relative positions of the features in this application are generally described with reference to the axis (central axis) 20 and the corresponding axial direction (longitudinal direction) 22, circumferential direction 24, and radial direction 26. The device, in general (and in its individual components), can be described as extending from the proximal end 14 to the distal end 16. For example, in Figure 29These terms are shown herein. Unless otherwise specified, the movement of individual components is generally described relative to the housing (e.g., housing 40). The various parts described herein are generally integral parts, but they may also consist of two or more separate parts (e.g., such as...). Figure 29 (The casing shown).

[0305] Generally speaking, the housing (outer shell) 40 can be a single piece (e.g. Figure 10 ), or two-piece or more (e.g. Figure 29 (The proximal housing 42 and the distal housing 44 in the example); these variations in housing design are interchangeable between the examples described. The housing shown is tubular, more specifically cylindrical, but other shapes are possible without impairing the function of the device (e.g., Figure 99 The housing shown has a rounded square cross-section perpendicular to the axis, rather than a circular cross-section. The non-cylindrical design also helps reduce the device's rollability when placed on a surface. While the housing is typically the outermost component, it can also serve as an internal component to support the device. Optionally, a window 46 is provided in the housing, for example, for checking reagents before use of the device. The housing may optionally include a neck 39 (e.g., Figure 53 ; Figure 70 and 99 The neck, which is less obvious, is also shown; this neck is usually a ring around the housing with an outer diameter smaller than the rest of the housing (or at least smaller than the outer diameter of the housing immediately adjacent to the ring on both the proximal and distal sides), and helps to make the housing easier to grip.

[0306] This application focuses on a needle guard locking assembly in which the proximal portion of the arm of the needle lock is biased away from the axis to interact with a slit or recess. The mechanism can also be reversed, i.e., the slit is closer to the axis than the proximal portion of the arm of the needle lock, and the proximal portion of the arm is biased toward the axis to interact with the slit or recess. In this case, the slit or recess can still be located within the housing as described herein (especially in instances where the syringe holder or power unit housing is an integral part of the housing), or the housing including the slit can be part of another component (e.g., a syringe holder) fixed to the housing.

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

[0308] A slit 45 extends through the housing in the radial direction. Alternatively, the slit may be replaced by a recess that extends only through 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, autoinjectors can be divided into a front sub-assembly, a main assembly, and a rear sub-assembly. The front sub-assembly typically includes a cap, a housing, a needle guard, and a syringe holder. The main assembly typically includes a needle guard (e.g., a rigid needle guard and / or a flexible needle guard), a syringe containing the injection needle, the medication in the syringe, and a stopper. The composition of the rear sub-assembly can be more diverse, but it typically includes some kind of power unit and optionally various other features. Figure 18 An example of a power unit assembly is shown, which includes a drive element, a power unit locking element, a torsion spring, and a power unit housing. The device can also be divided into various interacting sub-assemblies, including a drug delivery component locking assembly, such as a needle guard locking element assembly 58, which includes a needle guard 60 from a front sub-assembly, and a locking element activation sleeve 80, a needle guard locking element 100, and a housing 40 (or a portion of the housing, such as a distal housing 44) from a rear sub-assembly, together forming the components required to lock the needle guard after use. Another sub-assembly is an activation sub-assembly (e.g., Figure 20 This includes a locking activation sleeve, a needle guard locking element, a plunger rod, and a drive nut. Other sub-assemblies are also possible, and the sub-assemblies and components described herein are not limited to use in the specific device 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 speaking, 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 guard locking assembly shown can be used in Figure 10 and Figure 29 In the auto-injector shown, and Figure 40 The rotating body shown can be used in any of the described autoinjectors.

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

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

[0312] The locking element activation sleeve 80 can have different shapes depending on the device and the required function. In the example above, the locking element activation sleeve 80 includes a tubular segment 82, an arm 84 with a pad 86, and a cutout 88 for the distal portion 108 of the arm for the needle guard locking element 100. Figure 21 As shown, the cutouts 88 extend in the arm 84 and the tubular segment 82; of course, they may also extend only in the arm or only in the tubular segment. Recesses may be provided instead of cutouts. Generally, the arm is also optional, and the gasket 86 may be located on the tubular segment 82; the function of the locking member activating the sleeve arm 84 is that it allows the arm 324 of the drive nut 320 to extend radially outward (see, for example, [reference needed]). Figure 47 The tubular segment 82 of the locking element activation sleeve does not obstruct the movement. The locking element activation sleeve is typically arranged in the housing at the distal end of the needle guard locking element, with most or all of the locking element activation sleeve further away from the proximal end than the needle guard before the device is used.

[0313] The pad 86 shown in the examples herein includes a protrusion extending axially from arm 84. This protrusion extends further in the axial direction than in the radial direction, and its shape corresponds to arm 104 of the needle guard locking member, for example by including angled segments at the proximal and distal ends of the pad (see, for example, see...). Figure 25This is achieved by angulating the proximal end of the pad towards the proximal end and angulating the distal end of the pad towards the distal end. The shape of the pad 86 can vary considerably while still providing a working locking element activation sleeve. The main requirement is that the pad pushes the distal portion 108 of the arm 104 toward the axis as the locking element activation sleeve moves distally. Thus, the pad can be simply a protrusion on the arm 84 of the locking element activation sleeve, or even a flat surface of the arm 84 of the locking element activation sleeve.

[0314] The needle guard locking member 100 includes a base (e.g., a tubular segment 102) and at least one arm. The base typically functions to support the arm and hold the needle guard locking member in place relative to another component (e.g., housing 40, distal housing 44, and / or syringe holder). The base is typically rigid, although in some cases it can be flexible and bend along with the arm. In the example 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 segment, especially if the tubular segment is also flexible. The arm can also take various shapes. Generally, a protrusion 110 on the arm is optional. Ribs 107 extending radially and axially to support the arm can also be provided, for example, as shown in the image. Figure 24 As shown. An optional slit 119 can also be set (see...). Figure 24 The locking member is rotated relative to the drive nut 320 to activate the sleeve. Functionally, the needle guard locking arm is pivoted such that, during use of the device, the distal portion 108 of the arm moves toward 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 help activate the sleeve to engage with the distal portion 108. As described above, an optional protrusion 110 can help engage the proximal portion 106 of the arm with the housing.

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

[0316] like Figure 24 As shown in the example, the needle guard locking member 100 may have other features, in Figure 24The assembly includes an accordion-style corrugated section 112 configured to vary in length in the axial direction. During assembly, this accordion-style corrugated section reduces its length in the axial direction, allowing the components to fit together tightly without rattling. The accordion-style corrugated section has a support portion (in this case, a support ring 117) and two arms 118 extending from the tubular section 102 of the needle guard lock to the support ring 117. These arms extend in both the longitudinal and circumferential directions, allowing them to bend and occupy less space in the axial direction when the needle guard lock is compressed. The support ring 117 is optional (in the absence of a support portion, the end of the arm 118 away from the base of the needle guard lock can be considered the support portion, as the end of the arm 118 abuts against an adjacent component), but it is advantageous for better engagement of adjacent components (in this example, a syringe). One, three, or more arms can be provided instead of two. The shape of the arms can also be changed, for example, becoming serrated. In an assembled drug delivery device, the support portion typically abuts against the syringe; however, it can also abut against another component, such as the syringe holder or housing.

[0317] The syringe holder 120 is typically optional, and the syringe is also held by other components, such as a housing or clip. The syringe holder described herein includes a variety of optional features, including a proximal crossbar 122, a window 124, a protrusion 126, and a hook 128. A proximal arm 129, and radially outward protrusions 130 and 131 on the arm 129 may also be optionally provided. The radially outward protrusion 130 extends through a slit 66 in the needle guard arm (see...). Figure 14 Arm 129 can bend outward to allow the syringe needle guard (e.g., 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 housing 40, thereby preventing the radially outward protrusion 130 (as well as arm 129 and radially inward protrusion 131) from moving radially away from the axis. This means that during injection, the syringe (e.g., shoulder 363 of syringe 362) can be supported by the radially inward protrusion 131. The syringe holder is typically tubular. The proximal crossbar 122 may extend a portion around the syringe holder in the circumferential direction, or extend a full circle, or may be multiple separate sections, or may be replaced by one or more protrusions.

[0318] The needle guard spring 140 is optional, and the needle guard can also be manually removed after use. The needle guard spring is typically located between the needle guard and the syringe holder, but it can also be located between other components, such as between the needle guard and the housing.

[0319] The protective cap 160 is also typically optional and may include one or more parts. The protective cap typically includes a rigid needle guard removal element. An example shown herein is a protective cap that is removed by pulling along the axial direction. Other types of protective caps may also be provided, such as spiral protective caps or protective caps that are removed by twisting.

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

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

[0322] In the examples given herein, torsion springs are used, and these examples are designed specifically with torsion springs in mind, as they are designed to allow the spring to be wound during manufacturing and to allow the components to withstand the stresses exerted on them by the torsion spring. However, many of the features described herein (including the assembly of components, such as the front subassembly, the activation subassembly, and / or the needle guard locking assembly) can also be used in other drug delivery devices, such as in autoinjectors with compression springs or electro-powered units. The attachment structures of the torsion spring (e.g., proximal protrusions (hooks) 262 and distal protrusions 264) can also be modified depending on the shape of the component to which the torsion spring is attached.

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

[0324] The plunger rod 300 described herein includes two flat sides 304; however, as is typically the case here with features arranged in pairs, only one flat side is required. More broadly, the plunger rod does not need to have flat sides at all, but only a non-circular cross-section at its engagement point with the drive member, allowing it to be rotated by the drive member. Threads are typically located on the portion of the plunger not engaging with the drive member, and are typically engaged by the drive nut 320. A snap-fit ​​crossbar 306 is optional and is an example of how the plunger rod engages with a thrust bearing when a thrust bearing is provided; alternatively, the proximal end of the plunger rod may be shaped to engage directly with the plunger.

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

[0326] Thrust bearing 340 is optional because the plunger rod can directly engage with the plug; however, providing thrust bearing 340 helps to distribute the load on the plug and transmit axial (rather than rotational) forces only from the plunger rod to the plug. Typically, the thrust bearing engages with the interior of the plug (e.g., the cavity 369 of the plug) and / or the distal end of the plug (e.g., the outer edge 367 of the plug) (see, for example, [reference needed]). Figure 42 The shape of the thrust bearing can be modified according to the shape of the plug (especially the shape of the plunger rod).

[0327] The setting of the rotating body 380 is optional, and... Figure 10 and 53 A rotating body 380 may also be provided in the example. The rotating body can be attached to any part of the device that rotates during injection, such as a plunger rod and / or a drive. Generally, a rotating body can be used on any autoinjector or drug delivery device having a component that rotates during drug injection (e.g., a plunger rod or drive), not limited to the autoinjectors described herein. In addition to or as an alternative to a rotating body, auditory or tactile feedback (or other visual feedback) may be provided as feedback indicating the start, end, and / or ongoing injection. To make the rotating body visible, a window 392 (or two or more windows) may be provided in the end cap (e.g., rotating body cap 390). Each window may be a cutout or transparent portion in the rotating body cap 390 (or more generally, the end cap). Figure 40The exemplary window shown is typically fan-shaped, but other shapes are possible. The entire rotating body cap or end cap may be made of transparent material instead of providing a window.

[0328] Another additional or alternative example of feedback indicating that injection is in progress could be the interaction between the power unit locking member and the power unit housing to provide sound during injection; this is an advantage of the power unit locking member being part of the device rather than merely a tool for locking the power unit during an intermediate step in the manufacturing process. Another example of feedback indicating that injection is in progress could 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. While the drive member can rotate freely as the teeth of the drive nut extend freely in a direction away from the axis (see, for example, see...). Figure 35 However, the teeth of the drive nut can optionally remain biased toward the drive (rather than being biased away from the drive), which means that the teeth of the drive nut and the teeth of the drive will pass freely over each other, but will continue to interact as the drive rotates, thus providing a clicking sound as the injection proceeds.

[0329] Various modifications are possible to the embodiments described, and those skilled in the art will be able to conceive of such modifications without departing from the invention as defined by the appended claims.

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

[0331] 1. A drug delivery component cover locking assembly (58) for a drug delivery device (10), the drug delivery component cover locking assembly (58) comprising:

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

[0333] A drug delivery component shroud (60) is slidably arranged in the housing (40) and extends from the proximal end (14) to the distal end (16);

[0334] A locking element activation sleeve (80) is slidably arranged in the housing (40) at the distal end (16) of the drug delivery component shroud (60); and

[0335] The drug delivery component guard locking element (100) is arranged in the housing (40) adjacent to the locking element activation sleeve (80).

[0336] The drug delivery component shroud 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 as a recess or slit (45) adjacent to the housing (40).

[0337] 2. The drug delivery component shroud locking assembly as described in Clause 1, wherein the drug delivery component shroud includes a distally facing surface, and the locking element activation sleeve includes a corresponding proximally facing surface, the distally facing surface of the drug delivery component shroud engaging with the proximally facing surface to push the locking element activation sleeve distally when the drug delivery component shroud is pushed distally.

[0338] The locking activation sleeve includes a radially facing surface relative to the axis. When the locking activation sleeve is pushed distally, the distal portion of the flexible arm of the drug delivery component shroud locking member is pushed radially using this radially facing surface to bias the flexible arm of the drug delivery component shroud locking member onto the drug delivery component shroud.

[0339] When the drug delivery component cover is subsequently moved back in the proximal direction, the proximal portion of the flexible arm of the drug delivery component cover locking member moves toward or into a recess or slit in the housing.

[0340] 3. The drug delivery component cover locking assembly as described in Clause 1 or 2, wherein the drug delivery component cover is configured to activate the sleeve by pushing the locking member in a distal direction when the drug delivery component cover is pushed in a distal direction.

[0341] The locking activation sleeve is configured to push the distal portion of the flexible arm of the drug delivery member shroud locking member radially relative to the axis when it is pushed distally, to bias the flexible arm, and

[0342] When the drug delivery component cover is subsequently moved back in the proximal direction, the proximal portion of the flexible arm of the drug delivery component cover locking member moves toward or into a recess or slit in the housing.

[0343] 4. The drug delivery member shield locking assembly as described in any of the preceding entries, wherein the proximal portion of the flexible arm of the drug delivery member shield locking member includes a protrusion extending in a radial direction.

[0344] 5. A drug delivery component shroud locking assembly as described in any of the preceding entries, wherein at least a portion of the flexible arm of the drug delivery component shroud locking member is further off the axis than the base.

[0345] 6. The drug delivery component shroud locking assembly as described in any of the preceding entries, wherein the drug delivery component shroud locking member includes an accordion-like corrugated section having a variable length in the axial direction and extending in the axial direction from the proximal end of the drug delivery component shroud locking member.

[0346] 7. The drug delivery component shroud locking assembly as described in Section 6, wherein the accordion-style corrugated section includes a support portion spaced apart from the base of the drug delivery component shroud locking member and at least one arm extending from the base of the drug delivery component shroud locking member to the support portion.

[0347] 8. The drug delivery component guard locking assembly as described in any of the preceding entries, 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.

[0348] 9. A drug delivery member shield locking assembly as described in any of the preceding entries, wherein the drug 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 drug delivery component shroud locking assembly as described in Section 9, wherein the arm of the drug delivery component shroud includes a recess or slit extending in the axial direction.

[0350] 11. A drug delivery component shroud locking assembly as described in any one of Articles 2 to 10, wherein the locking element activates the radially facing surface of the sleeve facing axis 20.

[0351] 12. The drug delivery member shroud locking assembly as described in any one of Articles 2 to 10, wherein the distal-facing surface of the drug delivery member shroud and the proximal-facing surface of the locking activation sleeve are spaced apart in the axial direction.

[0352] 13. A pharmaceutical delivery device comprising a pharmaceutical delivery component guard locking assembly as described in any of the preceding entries.

[0353] 14. A locking mechanism for a pharmaceutical 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 pharmaceutical delivery component guard, and a cap.

[0354] One of the drug delivery component shroud and the cap includes a protrusion extending radially relative to the longitudinal axis.

[0355] The other of the drug delivery component shroud and the cap includes a recess or cutout.

[0356] The protrusion is located in the recess or cut.

[0357] The drug delivery component cover is movable from a locked position to an unlocked position relative to the housing in the direction of the longitudinal axis. In the locked position, the movement of the protrusion relative to the recess or cut is restricted by the wall of the housing, while in the unlocked position, the movement of the protrusion relative to the recess or cut is no longer restricted by the wall of the housing, thereby allowing the protrusion to be removed from the recess or cut and allowing the cap to be removed from the drug delivery component cover.

[0358] 15. The locking mechanism as described in Section 14, wherein at least one of the cap and the agent delivery member shield includes a flexible portion.

[0359] 16. The locking mechanism as described in Section 15, wherein the flexible portion is the flexible arm of the cap.

[0360] 17. The locking mechanism as described in Section 16, wherein the recess or cutout is located in the flexible arm.

[0361] 18. The locking mechanism as described in 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 as described in Section 18, wherein the cap core is attached to the cap body by a snap-fit ​​engagement that restricts the axial movement of the cap core relative to the cap body.

[0363] 20. The locking mechanism as described in Section 18 or 19, wherein the rotational movement of the cap core relative to the cap body is restricted by a rib extending from the cap body.

[0364] 21. The locking mechanism as described in any one of Articles 14 to 20, wherein the cap includes a distal surface adjacent to a proximal surface of the housing, and wherein the distal surface of the cap and the proximal surface of the housing are respectively depicted in a sinusoidal pattern in the circumferential direction relative to a longitudinal axis.

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

[0366] 23. The locking mechanism as described in any of the preceding entries, wherein the cap includes a drug delivery component shield removal element.

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

[0368] 25. The drug delivery device as described in Section 24, wherein the drug delivery device is an autoinjector.

[0369] 26. A pharmaceutical delivery device as described in Section 24 or 25, wherein the pharmaceutical delivery device comprises a power unit within a housing and a main assembly within a housing.

[0370] 27. A drug delivery device as described in any one of Articles 24 to 26, wherein the drug delivery device comprises a housing, and wherein the protrusion and / or the flexible arm is located within the housing.

[0371] 28. The drug delivery device as described in Section 27, wherein the proximal end of the protrusion and / or the proximal end of the flexible arm is located away from the proximal end of the housing.

[0372] 29. A feedback mechanism subassembly for a pharmaceutical delivery device, the feedback mechanism subassembly comprising a housing, a sound generator, and a rotating body.

[0373] The rotating body is arranged between the housing and the sound generator.

[0374] The housing includes a guide structure that engages with 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 guide structure results in linear motion of the rotating body relative to the housing.

[0375] The proximal surface of the sound generator abuts against the distal surface of the housing, and the distal surface of the sound generator abuts against the proximal surface of the rotating body, so that the sound generator can deform from a first shape to a second shape during the linear motion of the rotating body relative to the housing when the rotating body rotates relative to the housing.

[0376] 30. The feedback mechanism subassembly as described in Article 29, wherein when the sounder is in the first shape, the distal surface of the sounder is convex, and wherein when the sounder is in the second shape, the distal surface of the sounder is concave.

[0377] 31. The feedback mechanism subassembly as described in Section 29 or 30, wherein the sound generator is in a relaxed state in a first shape and in a tensile state in a second shape.

[0378] 32. The feedback mechanism subassembly as described in any one of Articles 29 to 31, wherein the proximal surface of the rotating body is the proximal end of the protrusion of the rotating body.

[0379] 33. The feedback mechanism subassembly as described in any one of Articles 29 to 32, wherein the distal surface of the sound generator is the distal end of the protrusion of the sound generator.

[0380] 34. The feedback mechanism subassembly as described in any of Articles 29 to 33, wherein the proximal surface of the rotating body is closer to the axis than the distal surface of the housing.

[0381] 35. The feedback mechanism subassembly 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. The feedback mechanism sub-assembly as described in any one of Articles 29 to 35, wherein the sound generator is a plate.

[0383] 37. The feedback mechanism subassembly as described in any one of Articles 29 to 36, wherein the housing includes a rotating body cap.

[0384] 38. The feedback mechanism subassembly as described in any one of Articles 29 to 37, wherein the feedback mechanism subassembly extends in the axial direction along an axis, and the movement of the rotating body relative to the housing is in the axial direction.

[0385] 39. The feedback mechanism subassembly as described in any one of Articles 29 to 38, wherein the proximal surface of the abutment housing of the sounder is further away from the longitudinal axis than the distal surface of the abutment rotating body of the sounder.

[0386] 40. The feedback mechanism subassembly as described in any one of Articles 29 to 39, wherein the proximal surface of the rotating body is on the protrusion of the rotating body.

[0387] 41. The feedback mechanism subassembly as described in any one of Clauses 29 to 40, wherein at least one of the guiding structure and the driven structure includes an inclined plane extending about an axis and in the axial direction.

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

[0389] 43. A pharmaceutical 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 pharmaceutical 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 pharmaceutical delivery component guard (60), and a cap (160),

[0391] One of the drug delivery component shroud (60) and the housing (40, 42, 44) includes a flexible arm (410) comprising a protrusion (412) extending radially relative to a longitudinal axis.

[0392] The other of the drug delivery component shroud (60) and the housing (40, 42, 44) includes a recess or cutout (70).

[0393] A portion of the flexible arm (410) is located within the recess or cutout (70).

[0394] The flexible arm (410) is located between the cap (160) and another of the drug delivery component shroud (60) and the housing (40, 42, 44), and

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

[0396] 45. The locking mechanism as described in Section 44, wherein the housing extends around a drug delivery member shroud, and wherein the housing includes a flexible arm, and the drug delivery member shroud includes a recess or cutout.

[0397] 46. ​​The locking mechanism as described in Section 44 or 45, wherein the proximal end of the cut or recess is spaced apart from the protrusion in the longitudinal direction.

[0398] 47. The locking mechanism as described in any one of Articles 44 to 46, wherein the recess or cut is a first recess or cut, and another of the drug delivery member shroud and the housing includes a second recess or cut closer to the proximal end than the first recess or cut, and wherein the second recess or cut is aligned with the first recess or cut in the direction of the longitudinal axis.

[0399] 48. The locking mechanism as described in any one of Articles 44 to 47, wherein the cap, the housing, and the agent delivery member shield are arranged such that the housing is prevented from moving radially before the cap is removed, thereby preventing the agent delivery member shield from moving distally, and the housing is allowed to move radially after the cap is removed, such that the agent delivery member shield can push the housing radially to move the housing distally.

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

[0401] 50. A locking mechanism for a pharmaceutical 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 pharmaceutical delivery component guard (60), and a cap (160, 162, 170),

[0402] One of the drug delivery component shroud (60) and the cap (160, 162, 170) includes a protrusion (68) extending radially relative to the longitudinal axis.

[0403] The other of the drug delivery component shroud (60) and the cap (160, 162, 170) includes a recess or cutout (172).

[0404] The protrusion (68) is located in the recess or cut (172).

[0405] The drug delivery component shroud (60) is movable from a locked position to an unlocked position relative to the housing (40) in the direction of the longitudinal axis. In the locked position, the movement of the protrusion (68) relative to the recess or cutout (172) is restricted by the wall of the housing (40), while in the unlocked position, the movement of the protrusion (68) relative to the recess or cutout (172) is no longer restricted by the wall of the housing (40), thereby allowing the protrusion (68) to be removed from the recess or cutout (172) and allowing the caps (160, 162, 170) to be removed from the drug delivery component shroud (60).

[0406] 51. The locking mechanism as described in Section 50, wherein at least one of the cap and the diaphragm of the drug delivery component includes a flexible portion.

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

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

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

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

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

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

[0413] 58. The drug delivery device as described in Section 57, wherein the proximal end of the protrusion and / or the proximal end of the flexible arm is located away from the proximal end of the housing.

Claims

1. A locking mechanism for a medicament delivery device, the locking mechanism extending in an axial direction from a proximal end to a distal end with respect to a longitudinal axis, the locking mechanism comprising a housing (40, 42, 44), a medicament delivery member guard (60) and a cap (160), wherein one of the medicament delivery member guard (60) and the housing (40, 42, 44) comprises a flexible arm (410) comprising a protrusion (412) extending in a radial direction with respect to the longitudinal axis, wherein the other of the medicament delivery member guard (60) and the housing (40, 42, 44) comprises a recess or cut-out (70) extending in an axial direction parallel to the longitudinal axis, wherein a portion of the flexible arm (410) is located in the recess or cut-out (70), wherein the flexible arm (410) is located between the cap (160) and the other of the medicament delivery member guard (60) and the housing (40, 42, 44), and wherein the cap (160) is adjacent the flexible arm (410) in a radial direction with respect to the longitudinal axis, wherein the recess or cut-out is a first recess or first cut-out and the other of the medicament delivery member guard and the housing comprises a second recess or second cut-out closer to the proximal end than the first recess or first cut-out, and wherein the second recess or second cut-out is aligned with the first recess or first cut-out in the direction of the longitudinal axis.

2. The locking mechanism of claim 1, wherein the housing extends around the medicament delivery member guard, and wherein the housing comprises the flexible arm and the medicament delivery member guard comprises the recess or cut-out.

3. The locking mechanism of claim 1 or 2, wherein a proximal end of the cut-out or recess is spaced apart from the protrusion in the longitudinal direction.

4. The locking mechanism of claim 1 or 2, wherein the cap, the housing and the medicament delivery member guard are arranged such that the housing is prevented from moving in the radial direction before the cap is removed, thereby preventing the medicament delivery member guard from moving in the distal direction, and such that the housing is enabled to move in the radial direction after the cap is removed, whereby the medicament delivery member guard is able to push the housing in the radial direction to move the housing in the distal direction.

5. The locking mechanism of claim 1 or 2, wherein the portion of the arm in the recess or cut-out is the protrusion.

6. A medicament delivery device comprising the locking mechanism of any one of claims 1 to 5.

7. The medicament delivery device of claim 6, wherein the medicament delivery device comprises a housing, and wherein the protrusion and / or the flexible arm is located within the housing.

8. The medicament delivery device of claim 7, wherein a proximal end of the protrusion and / or a proximal end of the flexible arm is distal from a proximal end of the housing.

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