A subassembly for a medicament delivery device

Abstract

A subassembly (1) for a medicament delivery device (100) having a medicament container (116), the sub-assembly comprising: a pretensioned plunger rod (200) having a proximal end portion (200a), a distal end portion 5 (200b) and a distally protruding arm (402); and an actuator (208) arranged radially outside of the plunger rod, the actuator comprising a sleeve portion (604) having a protrusion (604a) arranged to push the protruding arm radially inwards, and an engagement portion (601) having a plurality of subsequently axially arranged radial openings (602) separated by one or 0 more ribs (603). The protruding arm is operably arranged to be brought into contact with the engagement portion and move radially outwards into the radial openings and radially inwards over the one or more ribs, to impact the actuator for generating an audible feedback.

Description

[0001] A SUBASSEMBLY FOR A MEDICAMENT DELIVERY DEVICE

[0002] TECHNICAL FIELD

[0003] The present disclosure generally relates to medical devices for medicament administration.

[0004] BACKGROUND

[0005] A variety of medical conditions necessitate the reliable administration of medicament via medicament delivery devices. Such devices typically house a medicament container configured to expel medicament through a delivery member, such as a needle or nozzle, during use.

[0006] Modern medicament delivery devices, including autoinjectors, pen injectors, and on-body delivery systems, have revolutionized the management of numerous medical conditions, offering convenience and improved adherence to treatment regimens. Despite these advancements, current devices still exhibit certain limitations.

[0007] For instance, when using a medicament delivery device, it is often important to provide the user with clear indications about the operational state of the device. This is particularly crucial for automated devices where the medicament must be delivered properly and fully absorbed at the injection site before the device is removed. Such feedback ensures that the medicament delivery process is not prematurely interrupted, which could compromise treatment efficacy.

[0008] Certain known devices disclose auto -injectors that generate an audible or tactile signal to inform the user of device operation. These solutions rely on mechanical interactions between various components to produce feedback, typically signaling the start of activation or delivery. However, the audible or tactile indications provided in such devices may not be sufficient and / or may not correspond to desired phases of the medicament expulsion.

[0009] There remains a need for medicament delivery devices that provide clear and / or precise feedback. Such feedback would enhance the user’s confidence in proper device operation and ensure adherence to the intended delivery protocol.

[0010] SUMMARY

[0011] An object of the present disclosure is to provide a subassembly for a medicament delivery device which solves, or at least mitigates problems of the prior art.

[0012] There is hence provided a subassembly for a medicament delivery device having a medicament container. The sub-assembly comprises: a pretensioned plunger rod configured for expelling medicament of the medicament container, the plunger rod having a proximal end portion and a distal end portion extending along a longitudinal axis, the plunger rod comprising a distally protruding arm; an actuator arranged radially outside of the plunger rod, the actuator comprising a sleeve portion having a protrusion arranged to push the protruding arm radially inwards, and an engagement portion arranged proximally of the sleeve portion, the engagement portion having a plurality of subsequently axially arranged radial openings separated by one or more ribs; wherein the protruding arm is operably arranged to, upon movement of the plunger rod in the proximal direction, be brought into contact with the engagement portion and move radially outwards into the radial openings and radially inwards over the one or more ribs, to impact the actuator for generating an audible feedback.

[0013] Hereby, an improved audible feedback mechanism maybe provided. The audible feedback, or automatic audible feedback, may notify a user of the movement of the plunger rod and the related expulsion of medicament from the medicament container. That is, the plunger rod is typically configured to move proximally towards the dose delivery site to expel the medicament from the medicament container during a medical delivery action. Hereby, the audible feedback may notify the user of a medical delivery action. As the engagement portion comprises a plurality of subsequently axially arranged radial openings separated by one or more ribs, the protruding arm is configured for repeated impacts with the actuator generating the audible feedback. In other words, the subassembly enables audible feedback through repeated interactions between the protruding arm of the plunger rod and the engagement portion of the actuator, allowing the user to be alerted to the progress and / or completion of the medicament delivery. This provides a sensory confirmation that improves user experience and safety and / or ensuring proper delivery of medicament. The audible feedback may be referred to as an audible signal or a sound feedback.

[0014] In the present disclosure, when the term “distal direction” is used, this refers to the direction pointing away from the dose delivery site during use of the medicament delivery device. When the term “distal part / end” is used, this refers to the part / end of the delivery device, or the parts / ends of the members thereof, which under use of the medicament delivery device is / are located furthest away from the dose delivery site.

[0015] Correspondingly, when the term “proximal direction” is used, this refers to the direction pointing towards the dose delivery site during use of the medicament delivery device.

[0016] When the term “proximal part / end” is used, this refers to the part / end of the delivery device, or the parts / ends of the members thereof, which under use of the medicament delivery device is / are located closest to the dose delivery site.

[0017] Further, the term “longitudinal”, “longitudinally”, “axially” or “axial” refer to a direction extending from the proximal end to the distal end, typically along the device or components thereof in the direction of the longest extension of the device and / or component.

[0018] Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.

[0019] Further, the terms “circumference”, “circumferential”, or “circumferentially” refer to a circumference or a circumferential direction relative to an axis, typically a central axis extending in the direction of the longest extension of the device and / or component.

[0020] Similarly, “radial” or “radially” refer to a direction extending radially relative to the axis, and “rotation”, “rotational” and “rotationally” refer to rotation relative to the axis.

[0021] According to one embodiment, the protruding arm is operatively arranged to be pushed radially outwards into a first radial opening, thereafter to be pushed radially inwards by the one or more ribs, and thereafter to be pushed radially outwards into a second radial opening (the second radial opening being an adjacent opening to the first radial opening) for repeatedly impact with the actuator for generating an audible feedback. For embodiments in which the radial openings are separated by a plurality of ribs, the repeatedly impact with the actuator for generating the audible feedback will be prolonged.

[0022] It should be understood that the protruding arm of the plunger rod is protruding in the distal direction. Typically, the protruding arm is flexible, typically flexible in the radial direction. Thus, the protruding arm is arranged to be flexed radially outwards and radially inwards depending on its interaction with the actuator.

[0023] According to one embodiment, the plunger rod is arranged to move a predetermined distance in the proximal direction during a medicament delivery action, wherein the protruding arm is operably arranged to be brought into contact with the engagement portion of the actuator for a proximal end portion of the predetermined distance. Hereby, the plunger rod is configured to generate audible feedback over a pre-defined proximal distance. Thus, the audible feedback is only generated during a predefined phase of the medicament delivery action corresponding to such predefined proximal distance, which e.g. is an end phase of the medicament delivery action. Hereby, sounds generated during undesired phases of the medicament delivery actions can be avoided, thereby minimizing distraction for the user. In other words, focus on the predefined phase of the medicament delivery action is enhanced, facilitating clear feedback to the user.

[0024] Additionally or alternatively, the plurality of openings separated by one or more ribs is arranged in predefined portion of the actuator, e.g. only in the predefined portion of the actuator and nowhere else. Such predefined portion may typically correspond to a position along the subassembly (or medicament delivery device) for which the protruding arm passes during the last part of the movement of the plunger rod (i.e. the last part of the proximal movement of the plunger rod causing medicament to be expelled from the medicament container). Hereby, the audible feedback is generated during the end phase of the medicament delivery action. Stated differently, the engagement portion may correspond to a portion of the actuator for which the protruding arm passes during the last part of the movement of the plunger rod.

[0025] For example, the plunger rod is, upon activation, movable between a first end position and a second end position, wherein the plunger rod is arranged in its pretensioned state in the first end position and wherein the medicament has been expelled from the medicament container in the second end position. Thus, the previously mentioned predetermined distance of the movement of the plunger rod may be defined to extend from the first end position to the second end position. Thus, the protruding arm is operably arranged to be brought into contact with the engagement portion of the actuator at, or just prior to, the second end position of the plunger rod.

[0026] According to one embodiment, the plunger rod comprises a holding structure, wherein the actuator comprises at least one holding arm engaging with the holding structure to hold the plunger rod in a pretensioned state, and wherein the plunger rod is operatively arranged to, upon activation, be released from its pretensioned state by disengagement of the holding structure from the holding arm to move in the proximal direction. Hereby, the holding structure of the plunger rod and the engagement with the holding arm of the actuator allows the subassembly to be securely held in a pretensioned state. Moreover, the holding structure of the plunger rod and the engagement with the holding arm of the actuator allows the subassembly to be released from its pretensioned state. This ensures that medicament delivery is initiated only when intended (i.e. upon activation), preventing accidental releases and enhancing the reliability and safety of the subassembly. For example, the holding structure maybe arranged at the proximal end portion of the plunger rod. The holding structure may e.g. be an indentation or receiving cut-out in the outer surface of the plunger rod, wherein the indentation or cut-out is sized and dimensioned to receive and interact with the holding arm in a locking manner.

[0027] According to one embodiment, the plunger rod comprises an axial slit adjacent the protruding arm, wherein the holding arm is configured to, upon movement of the plunger rod in the proximal direction, move radially into the axial slit. Hereby, the axial slit adjacent to the protruding arm provides a defined space for the holding arm to move in, reducing friction between the plunger rod and the actuator. Such friction could otherwise cause an undesired braking effect of the movement of the plunger rod. The axial slit may e.g. be defined the protruding arm. For example, the protruding arm is extending between two mutually arranged axial slits.

[0028] According to one embodiment, the subassembly further comprises an actuator sleeve arranged radially outside of the actuator, the actuator sleeve having an inner surface abutting the holding arm of the actuator in order to prevent the holding arm from moving radially outwards and thereby disengage from the holding structure of the plunger rod. Hereby, the inner surface of the actuator sleeve prevents the holding arm from moving radially outward prematurely, securing the plunger rod in its pretensioned state until activation. Thus, stability during storage or handling of the subassembly is improved, reducing the risk of accidental releases and unintentional triggering of the device. According to one embodiment, the actuator sleeve is arranged to, upon activation, move axially such that the inner surface thereof pass the holding arm of the actuator to thereby release the holding arm to move radially outwards and disengage from the holding structure of the plunger rod. Hereby, the axial movement of the actuator sleeve during activation releases the holding arm in a controlled manner. Thus, a smooth transition from the pretensioned state of the plunger rod to a released state of the plunger rod in which the plunger rod moves in the proximal direction for expelling medicament from the medicament container, is provided. This controlled release enhances the reliability and safety of the subassembly. The axial movement of the actuator sleeve, such that the inner surface thereof pass the holding arm of the actuator to thereby release the holding arm to move radially outwards and disengage from the holding structure of the plunger rod, may be controlled or induced by an activation component of the subassembly or medicament delivery device. Such activation component may e.g. be a needle cover or an activation button.

[0029] According to one embodiment, the actuator is loosely arranged relative to the actuator sleeve upon release of the holding arm from the inner surface of the actuator sleeve. The loose arrangement of the actuator relative to the actuator sleeve upon release may allow for freedom of movement of the actuator, which can enhance sound generation and audible feedback to the user as the actuator impacts other components of the subassembly or medicament delivery device during the medicament delivery action. Such audible feedback may e.g. be a rattling noise. As the holding arm is released, the plunger rod is released from its pretension state. The loosely arranged actuator may thus contribute to audible feedback subsequent to the release of the plunger rod. Stated differently, the actuator is freely held within the actuator sleeve upon release of the holding arm from the inner surface of the actuator sleeve. The actuator may be defined as being loosely arranged relative any component within the subassembly or medicament delivery device, such as e.g. a housing of the medicament delivery device. Thus, the actuator maybe loosely arranged (or freely held) within the housing of the subassembly or medicament delivery device.

[0030] According to one embodiment, the protruding arm is operably arranged to, upon movement of the plunger rod in the proximal direction, be brought into contact with the protrusion of the sleeve portion to radially push the actuator outwards for generating an audible feedback. Hereby, the interaction between the protruding arm of the plunger rod and the protrusion of the actuator enables a radial outward push of the actuator, which may generate additional sound for the audible feedback. The actuator may e.g. impact other component(s) of the subassembly or medicament delivery device.

[0031] According to one embodiment, the protruding arm is operably arranged to be brought into contact with the protrusion of the sleeve portion to radially push the actuator outwards to impact the actuator sleeve or a housing of the medicament delivery device for generating an audible feedback. Hereby, the protruding arm of the plunger rod impacts the actuator sleeve upon radial outward movement of the actuator, generating a distinct sound for the audible feedback.

[0032] According to one embodiment, the protruding arm of the plunger rod comprises a radially extending lip arranged in the distal end portion of the plunger rod. Hereby, the radially extending lip on the protruding arm of the plunger rod enhances engagement with other components. For example, the previously mentioned engagement between the protruding arm and the engagement portion of the actuator is enhanced. That is, upon movement of the plunger rod in the proximal direction, the lip of the protruding arm of the plunger rod is arranged be brought into contact with the engagement portion and move radially outwards into the radial openings and radially inwards over the one or more ribs, to impact the actuator for generating the audible feedback. In other words, the lip is arranged to be brought radially inwards by the one or more rib, and then be released into the radial opening(s). The radially extending lip may be described as extending further radially as the other portions of the protruding arm. For example, the plunger rod may have an intermediate portion between distal end portion and proximal end portion of the plunger rod, wherein the radially extending lip extends further radially as compared to a diameter of the intermediate portion of the plunger rod.

[0033] According to one embodiment, the protruding arm of the plunger rod is a protruding first arm, and the subassembly further comprises a distally protruding second arm, wherein the protruding second arm is shorter compared to the protruding first arm. Hereby, tailored interactions with the actuator to generate multiple distinct sounds as audible feedback and / or or to enable alternative engagement patterns maybe achieved. The variation in arm length of the protruding first and second arms may provide nuanced and / or adapted audible feedback depending on the phase of medicament delivery action.

[0034] According to one embodiment, the protruding arm of the plunger rod is a protruding first arm, and the subassembly further comprises a distally protruding second arm. Thus, the protruding second arm may be shorter, longer or of the same lengths as compared to the protruding first arm. For example, the protruding first and the second arms maybe separated by the previously mentioned axial slit, and / or by the previously mentioned at least two axial slits.

[0035] It should be understood that the protruding second arm maybe identical with the protruding first arm, except for the potential difference in arm length. For example, the protruding second arm maybe mirrored relative to a centre longitudinal axis of the subassembly. The protruding first and second arms maybe divided by the previously mentioned axial slit(s). For example, two mutually arranged axial slits may divide the protruding first and second arms.

[0036] According to one embodiment, the subassembly further comprises a drive spring operably arranged to act on the plunger rod to exert a force in the proximal direction, wherein the plunger rod is arranged radially outwards of the drive spring. Hereby, the drive spring, acting on the plunger rod in the proximal direction, may be arranged to supply a reliable force for medicament expulsion. Moreover, as the drive spring is arranged radially inwards of (i.e. internally of) the plunger rod, the drive spring is not interfering, or hindering, with the interaction between the protruding arm of the plunger od and the actuator. The drive spring may e.g. be biased between the plunger rod and a distal end part or portion of the subassembly or medicament delivery device.

[0037] According to one embodiment, the protruding arm of the plunger rod is arranged to, upon movement of the plunger rod in the proximal direction, be brought into contact with the drive spring for generating the audible feedback. The interaction between the protruding arm and the drive spring may provide an enhanced sound or audible feedback. Moreover, as the drive spring contributes to the movement of the plunger rod, the interaction between the protruding arm of the plunger rod and the drive spring may be characterised thereof, and thus further improve the audible feedback to the user.

[0038] According to one embodiment, the subassembly further comprises a medicament container having a distal end cap and being arranged to expel medicament upon movement of the plunger rod in the proximal direction, wherein the actuator is operably arranged to, upon contact of the protruding arm with the engagement portion of the actuator, be brought into contact with the end cap of the medicament container for generating an audible feedback. Hereby, the contact between the actuator and the end cap of the medicament container during interaction between the protruding arm of the plunger rod and the engagement portion of the actuator, provides an additional sound source, further improving the audible feedback to the user. For example, the sound generated by the contact, or impact, of the actuator (typically a proximal portion of the actuator) and the end cap of the medicament container may indicate the nearing or completion of medicament expulsion from the medicament container. According to one embodiment, the protruding arm is flexible. Typically, the protruding arm is flexibly arranged to impact the actuator. That is, the protruding arm is arranged to flex in the radial direction.

[0039] According to one embodiment, the protruding arm is formed as a radially resilient tongue. Hereby, the construction of the protruding arm facilitates the radial movement, or radial flex, during interactions with the actuator.

[0040] It should be noted that the subassembly maybe configured to provide all, or some, of the structures for enabling the different sounds used as the audible feedback described herein.

[0041] According to a second aspect of the present disclosure, there is provided a medicament delivery device comprising the subassembly of the first aspect of the present disclosure.

[0042] Effects and features of the second aspect are largely analogous to those described above in connection with the first aspect. Embodiments mentioned in relation to the first aspect are largely compatible with the second aspect. The medicament delivery device is typically configured to expel medicament from the medicament container in response to a proximal movement of the plunger rod during a medicament delivery action.

[0043] Generally, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to "a / an / the element, apparatus, component, means, etc.” are to be interpreted openly as referring to at least one instance of the element, apparatus, component, means, etc., unless explicitly stated otherwise.

[0044] BRIEF DESCRIPTION OF THE DRAWINGS

[0045] The specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which: Fig. 1 shows an example of a medicament delivery device according to embodiments of the present disclosure;

[0046] Fig. 2 shows an exploded view of the medicament delivery device in Fig. 1;

[0047] Fig. 3 is a perspective, partially cut-away view of a subassembly of a medicament delivery device according to embodiments of the present disclosure;

[0048] Fig. 4 is an enlarged view of details in the subassembly of Fig. 3;

[0049] Fig. 5 is an enlarged view of details in the subassembly of Fig. 3;

[0050] Fig. 6 is a cross sectional view of the subassembly of Fig. 3;

[0051] Figs. 7A-7G are cross sectional views showing various positions of the plunger rod as it moves proximally and interacts with the actuator for generating an audible feedback according to embodiments of the present disclosure.

[0052] DETAILED DESCRIPTION

[0053] The inventive concept will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplifying embodiments are shown. The inventive concept may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided by way of example so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concept to those skilled in the art. Like numbers refer to like members throughout the description.

[0054] Fig. 1 shows an example of a medicament delivery device 100 configured to expel medicament from a medicament container 116. The medicament delivery device 100 comprises a proximal end 100a and a distal end 100b relative to a longitudinal axis A. The medicament container 116 comprises a medicament delivery member 108, here exemplified as a needle. The medicament delivery device 100 comprises a housing 102. The housing 102 has a proximal end 102a and a distal end 102b. The housing 102 maybe divided into an upper, or distal, housing and a lower, or proximal, housing. Moreover, the housing 102 may comprises a window 114 through which at least a part of the medicament container 116 can be viewed. The housing 102 may also comprise a distal end cap no. As an alternative, the distal end cap is a separate component compared to the housing 102.

[0055] The medicament delivery device 100 of Fig. 1 further comprises a delivery member cover 118. The delivery member cover 118 is arranged in the housing 102 and extends proximally from the proximal end 102a of the housing 102. The delivery member cover 118 is configured to be moved linearly relative to the housing 102 from a protracted position (shown in Fig. 1) to a retracted position in which the delivery member cover 118 is received further in the housing 102. The delivery member cover 118 may e.g. be biased in the proximal direction towards the protracted position. In examples in which the delivery member is a needle, the delivery member cover 118 may be referred to as a needle cover and will be referred to as such from this point onward. The needle cover 118 maybe biased by a needle cover spring (shown in Fig. 2).

[0056] Fig. 2 shows an exploded view of the medicament delivery device 100. Here, perspective views of the distal end cap no, the housing 102, the medicament container 116 and the needle cover 1118 are shown. The medicament container 116 may comprise a distal end cap 116b opposite to the needle 108. Moreover, from top to bottom, the medicament delivery device 100 comprises an actuator sleeve 210, an actuator 208, a drive spring 206, a guiding rod 202 for the drive spring 206, a needle cover spring 204, a plunger rod 200 and a plunger 212, which will be further elucidated in the following.

[0057] The inventive concept will now be described with further reference to Figs. 3 and 4. Fig. 3 is a perspective, partially cut-away view of a subassembly 1 of a medicament delivery device, and Fig. 4 presents an enlarged view detailing the subassembly i depicted in Fig. 3. The subassembly of Figs 3 and 4 maybe a subassembly of the medicament delivery device 100 of Figs. 1 and 2. Accordingly, components previously described in Figs. 1 and 2 will also be referenced with like reference numbers in relation to Fig. 3

[0058] The subassembly 1 comprises a plunger rod 200. The plunger rod 200 is pretensioned by means of a drive spring 206 arranged radially inwards of the plunger rod 200. Thus, the plunger rod 200 may at least partly tubular for housing the internally arranged drive spring 206.

[0059] The drive spring 206 maybe arranged radially outside of the guiding rod 202 and may be biased between the plunger rod 200 and the distal end cap no or an internal part of the housing 102. The drive spring 206 is thus arranged to act on the plunger rod 200 in the proximal direction. Upon activation of the plunger rod 200, the drive spring 206 is arranged to move the plunger rod 200 in the proximal direction. Hereby, the plunger rod 200 may act on the medicament container 116, e.g. via plunger 212, for expelling medicament. Thus, the plunger rod 200 maybe configured to act on the plunger 212 during its movement in the proximal direction. In other words, the plunger rod 200 is configured for expelling medicament of the medicament container 116 by moving in the proximal direction as a result of the force applied by the drive spring 206. Such action maybe referred to as a medicament delivery action.

[0060] The plunger rod 200 has a proximal end portion 200a and a distal end portion 200b extending along the longitudinal axis A. Moreover, as shown in Fig. 3, the plunger rod comprises at least one distally protruding arm 402. That is, the protruding arm 402 extends from an intermediate portion 200c arranged between distal end portion 200b and the proximal end portion 200a of the plunger rod 200, in the distal direction. The plunger rod 200 may further comprises an axial slit 502 adjacent the protruding arm 402. The axial slit 502 may e.g. be at least partly defined the protruding arm 402. For example, the protruding arm 402 may extend along, and adjacent to the axial slit 502. The protruding arm 402 is thus flexibly arranged, at least in the radial direction. Typically, the protruding arm 402 is flexibly arranged to impact the actuator 208. For example, the protruding arm maybe formed as a radially resilient tongue.

[0061] The protruding arm 402 maybe equipped with a radially extending lip 400 or radially extending protrusion 400. In other words, the distally end portion 200b of the plunger rod 200 maybe equipped with the radially extending lip 400. The lip 400 is typically extending radially outwards from the protruding arm 402. The lip 400 may be chamfered or bevelled along the longitudinal axis A.

[0062] The subassembly 1 further comprises an actuator 208 arranged radially outside of the plunger rod 200. The actuator comprising a sleeve portion 604 housing at least a part the protruding arm 402 of the plunger rod 200. The sleeve portion 604 comprises a protrusion 604a extending radially inwards and will be referred to as a radial protrusion 604a from this point onward.

[0063] The interaction of the plunger rod 200 and the actuator 210 for generating an audible feedback will now be described with further reference to Fig. 5 showing an enlarged view detailing the subassembly 1 depicted in Fig. 3.

[0064] The actuator 208 comprises an engagement portion 601 arranged proximally of the sleeve portion 604, and proximally of the radial protrusion 604a. The engagement portion comprises a plurality of subsequently axially arranged radial openings 602 separated by a plurality of subsequently axially arranged ribs 603. In the example shown in Fig. 5, a total number of four radial openings 602 separated by three ribs 603 are comprised in the engagement portion 601. Thus, each rib 603 is arranged adjacent two subsequent radial openings 602. Stated differently, the radial openings 602 are formed as the space, or as a gap, between two subsequently arranged ribs 603, or between a rib 603 and a base part of the actuator 208. However, it should be mentioned that other numbers of the radial openings and separating ribs are within the scope of the inventive concept, as long at least two radial openings are separated by one rib. The plunger rod 200 is configured to, upon activation, move in the proximal direction such that the protruding arm 402 is guided by the sleeve portion 604 of the actuator 208. The proximal direction is indicated in Fig. 5 with a first arrow Pi. As the radially protruding lip 400 reaches the radial protrusion 604a, the protruding arm 402 is pushed radially inwards, indicated with a second arrow P2. However, it should be noted that the protruding arm 402 may be arranged such that it is pushed radially inwards by the radial protrusion 604a, without the presence of the radially extending lip 400. For example, the protruding arm 402 maybe angled, or oriented tilted in the radial direction (e.g. by extending radially outwards from the intermediate portion 200c of the plunger rod 200).

[0065] Upon further movement of the plunger rod 200 in the proximal direction, the protruding arm 402 is operably arranged to be brought into contact with the engagement portion 601 and move radially outwards into the radial openings 602 and radially inwards over the ribs 603, to impact the actuator 208 for generating an audible feedback. In the example shown in Fig. 5, the lip 400 will be brought into contact with the engagement portion 601 and move radially outwards into the radial openings 602 and radially inwards over the ribs 603, to impact the actuator 208 for generating the audible feedback. Hereby, a user maybe notified of the movement of the plunger rod 200 and the related expulsion of medicament from the medicament container 216. As the engagement portion 601 comprises a plurality of subsequently axially arranged radial openings 602 separated by a plurality of subsequently axially arranged ribs 603, the protruding arm 402, or lip 400, is configured for repeated impacts with the actuator 208 for generating the audible feedback. Depending on the arrangement of the drive spring 206, the protruding arm 402 maybe arranged to, upon movement of the plunger rod 200 in the proximal direction, be brought into contact with the drive spring 206 via for generating the audible feedback.

[0066] Typically, the plunger rod 200 is arranged to move a predetermined distance in the proximal direction during the medicament delivery action. By arranging the engagement portion 601 and the protruding arm 402 (and / or lip 400 of the protruding arm 402) such that the protruding arm 402 is brought into contact with the engagement portion 601 for a proximal end portion (or end portion) of such predetermined distance, the user maybe notified of the movement of the plunger rod 200 for a specific, or predefined, portion of the proximal distance. Thus, the user maybe notified of the related expulsion of medicament from the medicament container 216 corresponding to such specific, or predefined portion of the proximal distance. For example, by the arrangement of the engagement portion 601 and the protruding arm 402 (and / or lip 400 of the protruding arm 402) in Fig. 5, the audible feedback will be generated during an end phase of the medicament delivery action.

[0067] It should be noted that the activation of the plunger rod 200 maybe carried out in various ways and depending on the specific medicament delivery device. In the example of Figs. 1 and 2, as well as the subassembly 1 of Figs. 3- 5, it is assumed that the activation of the plunger rod 200 is initiated by pushing the needle cover 118 into its retracted position. The needle cover 118 may e.g. be pushed into its retracted position by pushing the subassembly 1 or medicament delivery device 100 against the dose delivery site. This procedure will now be described in further detail.

[0068] The plunger rod 200 may comprise a holding structure 700 (shown in Figs. 2 and 3). Correspondingly, the actuator 208 may comprises at least one holding arm 500. The holding arm 500 is arranged to lockingly engage with the holding structure 700 to hold the plunger rod 200 in a pretensioned state. Thus, by means of the drive spring 206, the holding structure 700 and the at least one holding arm 500, the plunger rod 200 is pretensioned within the housing 102.

[0069] The lockingly engagement between the holding structure 700 and the at least one holding arm 500 may be secured by the actuator sleeve 210 arranged radially outside of the actuator 208. For example, the actuator sleeve 210 may comprise an inner surface 211 (shown in Fig. 4) abutting the holding arm 500 of the actuator 208 in order to prevent the holding arm 500 from moving radially outwards and thereby disengage from the holding structure 700 of the plunger rod 200. However, by inducing an axial movement of the actuator sleeve 210 in the distal direction, typically by pushing the needle cover 118 into its retracted position (and to thereby initiate activation of the subassembly 1), the inner surface 211 will be moved passed the holding arm 500 of the actuator 208. Hereby, the holding arm 500 is released radially outwards and may thus disengage from the holding structure 700 of the plunger rod 200. As the holding arm 500 is released, the plunger rod 200 will be pushed in the proximal direction by the drive spring 206 as previously described. In other words, the plunger rod 200 is operatively arranged to, upon activation, be released from its pretensioned state by disengagement of the holding structure 700 from the holding arm 500 to move in the proximal direction.

[0070] The previously mentioned axial slit 502 of the plunger rod 200 is arranged to receive the holding arm 500. Thus, upon movement of the plunger rod 200 in the proximal direction, the holding arm 500 is configured to move radially into the axial slit 502, indicated by a third arrow P3 in Fig. 5. Hereby, friction between the plunger rod 200 and the actuator 208 is reduced.

[0071] Turning to Fig. 6 and Figs. 7A-7G, the generation of audible feedback will be described in more detail. Fig. 6 and Figs. 7A-7G show various positions of the plunger rod 200 as it moves proximally after activation.

[0072] According to one embodiment, the subassembly 1 may be configured to generate the audible feedback based on more than one sound source. For example, the actuator 208 maybe loosely arranged relative to the actuator sleeve 210 upon release of the holding arm 500 from the inner surface 211 of the actuator sleeve 210. Hereby, the actuator 208 may move both axially and radially within subassembly 1, as indicated by a cross Ci in Fig. 6. Thus, as the plunger rod 200 moves in the proximal direction, and as the protruding arm 402 (and / or the lip 400 of the protruding arm 402) interacts with the engagement portion 601, the actuator 208 may move both axially and radially to impact other components of the subassembly 1 or medicament delivery device 100. Such audible feedback may e.g. be a rattling noise caused by the movement of the actuator 208 and its interaction with other components (e.g. the actuator sleeve 210). According to another example, the actuator 208 is operably arranged to, upon contact of the protruding arm 402 with the engagement portion 601 of the actuator 208, be brought into contact with the end cap 116b of the medicament container 116 for generating an audible feedback.

[0073] In Fig. 7A, the plunger rod 200 is released and has begun its proximal movement. The protruding arm 402 is guided by the actuator 208 and its sleeve portion. The lip 400 of the protruding arm 402 has not yet reached the radial protrusion 604a or the radial openings 602 or ribs 603 of the engagement portion 601.

[0074] In Fig. 7B, the plunger rod 200 has moved further in the proximal direction, and the lip 400 of the protruding arm 402 is brought into contact with the radial protrusion 604a. As previously mentioned, the lip 400 maybe chamfered for enhanced interaction with the radial protrusion 604a. As shown in Fig. 7B, the radial protrusion 604a maybe correspondingly chamfered for enhanced interaction with the lip 400. In this state, the protruding arm 402 will be pushed radially inwards by the radial protrusion 604a as previously described. However, the actuator 208, and the sleeve portion thereof, maybe arranged to be pushed radially outwards by the protruding arm 402 (and / or the lip 400 of the protruding arm 402).

[0075] In Fig. 7C, the protruding arm 402 has reached its most radially inwardly flexed state as it is axially aligned with the protrusion 604a of the sleeve portion 604. Here, the protruding arm 402 and the lip 400 thereof push the actuator 208 radially outwards for generating an audible feedback. For example, the actuator 208 is pushed radially outwards to impact the actuator sleeve 210. By the impact between the actuator 208 and the actuator sleeve 210, an audible feedback is generated. In Fig. 7D, the protruding arm 402 has reached the engagement portion 601. Here, the lip 400 of the protruding arm 402 is released into a radial opening 602 of the engagement portion 601. In other words, the protruding arm 402 flexes radially inwards. Thus, the protruding arm 402 is moved radially outwards and into the radial opening 602 to impact the actuator 208 for generating the audible feedback.

[0076] In Fig. 7E, the protruding arm 402 is moved further proximally over the engagement portion 601. Here, the lip 400 of the protruding arm 402 is encountering a rib 603 of the engagement portion 601, the rib 603 being adjacent the previously encountered radial opening 602. Thus, the protruding arm 402 is moved radially inwards over the rib 603. During the movement, from the radial opening 602 onto the rib 603, the protruding arm 402 again impacts the actuator 208 for generating the audible feedback.

[0077] In Fig. 7F, the protruding arm 402 has again reached its most radially inwardly flexed state as it is axially aligned with the rib 603 of the engagement portion 601. As the protruding arm 402 is moved from a radial opening 603 onto a rib 603 of the engagement portion 601, the protruding arm 402 maybe brought into contact with the drive spring 206 for generating a sound of the audible feedback.

[0078] Thereafter, the protruding arm 402 maybe moved further proximally over the engagement portion 601 whereafter the lip 400 of the protruding arm 402 maybe released into another, subsequent, radial opening 602 of the engagement portion 601. This procedure of generating the audible feedback may thus be repeated for the remining radial openings 602 and ribs 603 of the engagement portion 601 and for repeated impacts with the actuator 208 generating the audible feedback.

[0079] In Fig. 7G, the plunger rod 200 as reached its final position within the medicament delivery device, i.e. its most proximal position. As shown in Fig. 7G, this position may correspond to an axial alignment with the engagement portion 601 (either a radial opening 602 or a rib 603). Hereby, it is ensured that the audible feedback is generated in an end phase of the medicament delivery action.

[0080] As shown in Figs. 6 and 7A-7G, the subassembly 1 may comprise at least two protruding arms 402, 403 (only indicated by reference number in Figs. 7A and 7D). Thus, the previously described protruding arm 402 of the plunger rod 200 maybe referred to as a protruding first arm, and the other distally protruding arm 403 may be referred to as a protruding second arm. The protruding second arm 403 may be shorter as compared to the protruding first arm 402, this is particularly clear when studying Fig. 7D. Here, the lip 400 of the protruding first arm 402 has been released into the opening 603 of the engagement structure 601, while the corresponding lip 400 of the protruding second arm 403 has not, as it still rests on the radial protrusion 604a. Hereby, tailored interactions with the actuator 208 to generate multiple distinct sounds as audible feedback may be achieved. The variation in arm length of the protruding first and second arms 402, 403 may thus provide a nuanced audible feedback depending on the phase of medicament delivery action.

[0081] The subassembly 1 described herein maybe comprised in, or be referred to, as a medicament delivery device 100.

[0082] The medicament delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0083] Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis), hypercholesterolaemia and / or dyslipidemia, cardiovascular disease, diabetes (e.g. type 1 or 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hidradenitis suppurativa, Sjogren's syndrome, migraine, cluster headache, multiple sclerosis, neuromyelitis optica spectrum disorder, anaemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anaemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behqet's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetic macular edema), uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplant, acute hypoglycaemia, obesity, anaphylaxis, allergies, sickle cell disease, Alzheimer’s disease, Parkinson’s disease, dementia with Lewy bodies, systemic infusion reactions, immunoglobulin E (IgE) -mediated hypersensitivity reactions, cytokine release syndrome, immune deficiencies (e.g., primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy), enzyme deficiencies (e.g., Pompe disease, Fabry disease, Gaucher disease), growth factor deficiencies, hormone deficiencies, coagulation disorders (e.g., hemophilia, von Willebrand disease, Factor V Leiden), and cancer.

[0084] Exemplary types of drugs that could be included in the medicament container, and administrated by the medicament delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, enzymes, vaccines, anticoagulants, immunosuppressants, antibodies, antibody-drug conjugates, neutralizing antibodies, reversal agents, radioligand therapies, radioisotopes and / or nuclear medicines, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, nucleotides, protein analogues, protein variants, protein precursors, protein derivatives, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies.

[0085] Exemplary drugs that could be included in the medicament container, and administrated by the medicament delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins. Exemplary drugs that could be included in the medicament container, and administrated by the medicament delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-i (GLP-i) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Ci esterase modulators, bradykinin modulators, C-C chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene-related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modulators, tumor-associated calcium signal transducer 2 (Trop-2) modulators, cluster of differentiation 52 (CD52) modulators, B-cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor A (PDGFRA) modulators, cluster of differentiation 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed death-ligand 1 (PD-i / PD- Li) inhibitors / modulators, B-lymphocyte antigen cluster of differentiation 19 (CD19) inhibitors, B-lymphocyte antigen cluster of differentiation 20 (CD20) modulators, cluster of differentiation 3 (CD3) modulators, cytotoxic T- lymphocyte-associated protein 4 (CTLA-4) inhibitors, T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) modulators, T cell immunoreceptor with Ig and ITIM domains (TIGIT) modulators, V-domain Ig suppressor of T cell activation (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators, poliovirus receptor-related immunoglobulin domaincontaining protein (PVRIG) modulators, lymphocyte-activation gene 3 (LAG3; also known as cluster of differentiation 223 or CD223) antagonists, cluster of differentiation 276 (CD276 or B7-H3) antigen modulators, cluster of differentiation 47 (CD47) antagonists, cluster of differentiation 30 (CD30) modulators, cluster of differentiation 73 (CD73) modulators, cluster of differentiation 66 (CD66) modulators, cluster of differentiation W137 (CDW137) agonists, cluster of differentiation 158 (CD158) modulators, cluster of differentiation 27 (CD27) modulators, cluster of differentiation 58 (CD58) modulators, cluster of differentiation 80 (CD 80) modulators, cluster of differentiation 33 (CD33) modulators, cluster of differentiation 159 (CD159 or NKG2) modulators, glucocorticoid-induced TNFR-related (GITR) protein modulators, Killer Ig-like receptor (KIR) modulators, growth arrest-specific protein 6 (GAS6) / AXL pathway modulators, A proliferation-inducing ligand (APRIL) receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B-lymphocyte cell adhesion molecule modulators, cluster of differentiation W123 (CDW123) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cellular receptor 2 (HAVCR2) antagonists, cancer-testis antigen (CTA) modulators, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4 or 0X40) modulators, adenosine receptor modulators, inducible T cell co-stimulator (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumor-infiltrating lymphocytes (TIL) therapies, or T-cell receptor (TCR) therapies.

[0086] Exemplary drugs that could be included in the medicament container, and administrated by the medicament delivery devices described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-ia, interferon beta-ib, peginterferon beta-ia, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-tmca, certolizumab pegol, satralizumab, denosumab, romosozumab, benralizumab, emicizumab, tildrakizumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-rzaa, ixekizumab, and immune globulins.

[0087] Exemplary drugs that could be included in the medicament container, and administrated by the medicament delivery devices described herein may also include, but are not limited to, oncology treatments such as ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, famtrastuzumab deruxtecan-nxki, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-Yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab.

[0088] Exemplary drugs that could be included in the medicament container, and administrated by the medicament delivery devices described herein include “generic” or biosimilar equivalents of any of the foregoing, and the foregoing molecular names should not be construed as limiting to the “innovator” or “branded” version of each, as in the non-limiting example of innovator medicament adalimumab and biosimilars such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.

[0089] Exemplary drugs that could be included in the medicament container, and administrated by the medicament delivery devices described herein also include, but are not limited to, those used for adjuvant or neoadjuvant chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid. Exemplary chemotherapy drugs include, by way of example but not limitation, 5 -fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine. Exemplary drugs that could be included in the medicament container, and administrated by the medicament delivery devices described herein also include, but are not limited to, analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g. hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g., diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% Normal Saline, 0.45% normal saline, 5% dextrose in water, 5% dextrose in 0.45% normal saline, Lactated Ringer’s solution, Heparin Lock Flush solution, 100 U / mL Heparin Lock Flush Solution, or 5000 U / mL Heparin Lock Flush Solution.

[0090] Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the medicament container, and administrated by the medicament delivery devices described herein, for example pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier. Such formulations may include one or more other active ingredients (e.g., as a combination of one or more active drugs), or maybe the only active ingredient present, and may also include separately administered or co-formulated dispersion enhancers (e.g. an animal-derived, human-derived, or recombinant hyaluronidase enzyme), concentration modifiers or enhancers, stabilizers, buffers, or other excipients.

[0091] Exemplary drugs that could be included in the medicament container, and administrated by the medicament delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mF0LF0X6, mFOLFOXy, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini-CHOP, Maxi-CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA / CO, EMA / EP, EP / EMA, TP / TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini-BEAM, IGEV, C-MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD,

[0092] MAID, AIM, VAC-IE, ADOC, or PE.

[0093] The inventive concept has mainly been described above with reference to a few examples. However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope of the inventive concept, as defined by the appended claims.

Claims

28CLAIMS1. A subassembly (i) for a medicament delivery device (100) having a medicament container (116), the sub-assembly comprising: a pretensioned plunger rod (200) configured for expelling medicament of the medicament container, the plunger rod having a proximal end portion (200a) and a distal end portion (200b) extending along a longitudinal axis (L), the plunger rod comprising a distally protruding arm (402); an actuator (208) arranged radially outside of the plunger rod, the actuator comprising a sleeve portion (604) having a protrusion (604a) arranged to push the protruding arm radially inwards, and an engagement portion (601) arranged proximally of the sleeve portion, the engagement portion having a plurality of subsequently axially arranged radial openings (602) separated by one or more ribs (603); wherein the protruding arm is operably arranged to, upon movement of the plunger rod in the proximal direction, be brought into contact with the engagement portion and move radially outwards into the radial openings and radially inwards over the one or more ribs, to impact the actuator for generating an audible feedback.

2. The subassembly (1) according to claim 1, wherein the plunger rod (200) is arranged to move a predetermined distance in the proximal direction during a medicament delivery action, and wherein the protruding arm (402) is operably arranged to be brought into contact with the engagement portion (601) of the actuator (208) for a proximal end portion of the predetermined distance.

3. The subassembly (1) according to any one of claims 1-2, wherein the plunger rod (200) comprises a holding structure (700), and wherein the actuator (208) comprises at least one holding arm (500) engaging with the holding structure to hold the plunger rod in a pretensioned state, and wherein the plunger rod is operatively arranged to, upon activation, bereleased from its pretensioned state by disengagement of the holding structure from the holding arm to move in the proximal direction.

4. The subassembly (1) according to claim 3, wherein the plunger rod (200) comprises an axial slit (502) adjacent the protruding arm (402), and wherein the holding arm (500) is configured to, upon movement of the plunger rod in the proximal direction, move radially into the axial slit.

5. The subassembly (1) according to any one of claims 3-4, further comprising an actuator sleeve (210) arranged radially outside of the actuator (208), the actuator sleeve having an inner surface (211) abutting the holding arm (500) of the actuator (208) in order to prevent the holding arm from moving radially outwards and thereby disengage from the holding structure (700) of the plunger rod (200).

6. The subassembly (1) according to claim 5, wherein the actuator sleeve(210) is arranged to, upon activation, move axially such that the inner surface(211) thereof pass the holding arm (500) of the actuator (208) to thereby release the holding arm to move radially outwards and disengage from the holding structure (700) of the plunger rod (200).

7. The subassembly (1) according to claim 6, wherein the actuator (208) is loosely arranged relative to the actuator sleeve (210) upon release of the holding arm (500) from the inner surface (211) of the actuator sleeve (210).

8. The subassembly (1) according to any one of claims 1-7, wherein the protruding arm (402) is operably arranged to, upon movement of the plunger rod (200) in the proximal direction, be brought into contact with the protrusion (604a) of the sleeve portion (604) to radially push the actuator (208) outwards for generating an audible feedback.

9. The subassembly (1) according to any one of claims 5-7 and claim 8, wherein the protruding arm (402) is operably arranged to be brought into contact with the protrusion (604a) of the sleeve portion (604) to radiallypush the actuator (208) outwards to impact the actuator sleeve (210) for generating an audible feedback.

10. The subassembly (1) according to any one of claims 1-9, wherein the protruding arm (402) of the plunger rod (200) comprises a radially extending lip (400) arranged in the distal end portion of the plunger rod.

11. The subassembly (1) according to any one of claims 1-10, wherein the protruding arm (402) of the plunger rod (200) is a protruding first arm, and the subassembly further comprises a distally protruding second arm, wherein the protruding second arm is shorter compared to the protruding first arm.

12. The subassembly (1) according to any one of claims 1-11, further comprising a drive spring (206) operably arranged to act on the plunger rod (200) to exert a force in the proximal direction, wherein the plunger rod is arranged radially outwards of the drive spring.

13. The subassembly (1) according to claim 12, wherein the protruding arm (402) of the plunger rod (200) is arranged to, upon movement of the plunger rod in the proximal direction, be brought into contact with the drive spring (206) for generating the audible feedback.

14. The subassembly (1) according to any one of claims 1-13, further comprising a medicament container (116) having a distal end cap (116b) and being arranged to expel medicament upon movement of the plunger rod (200) in the proximal direction, wherein the actuator (208) is operably arranged to, upon contact of the protruding arm (402) with the engagement portion (601) of the actuator, be brought into contact with the end cap of the medicament container for generating an audible feedback.

15. The subassembly (1) according to any one of claims 1-14, wherein the protruding arm (402) is formed as a radially resilient tongue.

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