Medicament delivery device

Abstract

A medicament delivery device according is arranged to accommodate a medicament container and a power pack arranged to exert a force on said medicament container for expelling a dose of medicament. A manually operable activator (2) comprises at least one stop (23) provided at a circumferential surface thereof and a housing (1) comprises an internal locking surface (11). In a first rotational state of the manually operable activator (2), a proximally directed surface (21) of the manually operable activator (2) abuts the locking surface (11) of the housing (1) blocking proximal movement of the manually operable activator (2) with respect to the housing (1) and a blocking element (33) of an actuator (3) is configured to abut the stop (23) thus blocking proximal movement of the actuator (3) with respect to the manually operable activator (2). In a second rotational state of the manually operable activator (2), the proximally directed surface (21) of the manually operable activator (2) is configured to clear the locking surface (11) of the housing (1) and the manually operable activator (2) is free to be displaced in the proximal direction on application of a force by a user.

Description

[0001] Medicament delivery device

[0002] TECHNICAL FIELD

[0003] The present disclosure relates to a medicament delivery device and in particular, but not exclusively, to a medicament delivery device that has improved handling.

[0004] BACKGROUND

[0005] Medicament delivery devices maybe activated by depression of a medicament delivery member cover (needle cover) or a combination of a needle cover and an activation button. Although such mechanisms ensure that the device is activated on the injection site, activation, in particular depression of the needle cover, maybe challenging in case of a soft tissue at the injection site.

[0006] The present disclosure addresses such problems.

[0007] SUMMARY

[0008] The invention is specified by the independent claims. Preferred embodiments are defined in the dependent claims.

[0009] A medicament delivery device according to the present disclosure comprises a housing arranged to accommodate a medicament container and a power pack arranged to exert a force on said medicament container for expelling a dose of medicament. The power pack comprises a plunger rod, a drive spring arranged to exert a force on said plunger rod in a proximal direction, wherein the proximal direction is a direction towards a medicament delivery site, an actuator coaxial with said plunger rod and arranged with holding elements for releasably holding said plunger rod with said drive spring in an energised state and further comprising at least one blocking element provided towards a distal end of the actuator, a manually operable activator arranged at a distal end of the housing movable in the proximal direction, rotatable around a central longitudinal axis of the housing and operably connected to said actuator for releasing said plunger rod, wherein the manually operable activator comprises at least one stop provided at a circumferential surface thereof, wherein the housing comprises an internal locking surface, wherein in a first rotational state of the manually operable activator, a proximally directed surface of the manually operable activator abuts the locking surface of the housing blocking proximal movement of the manually operable activator with respect to the housing and the blocking element of the actuator is configured to abut the stop thus blocking proximal movement of the actuator with respect to the manually operable activator, and wherein in a second rotational state of the manually operable activator, the proximally directed surface of the manually operable activator is configured to clear the locking surface of the housing and the manually operable activator is free to be displaced in the proximal direction on application of a force by a user.

[0010] Various embodiments may preferably implement the following features.

[0011] Preferably, in the second rotational state, the stop is configured to clear the blocking element.

[0012] Preferably, the manually operable activator comprises at least one rotation protrusion protruding from an outer circumferential surface thereof.

[0013] Preferably, the housing comprises a recess configured to receive the rotation protrusion.

[0014] Preferably, the recess is substantially L-shaped.

[0015] Preferably, the recess is provided on an inner circumferential surface of the housing and is formed by two parallel recesses extending in the circumferential direction of the housing.

[0016] Preferably, the rotation protrusion is configured to visually indicate the first or second rotational state of the manually operable activator.

[0017] Preferably, the rotation protrusion protrudes through the recess to provide visual and tactile indication of the first or second rotational state.

[0018] Preferably, in the first rotational state, the rotation protrusion is configured to abut a proximal surface of the recess, thus blocking proximal movement of the manually operable activator. Preferably, the recess comprises a ridge extending in the circumferential direction of the housing and dividing the recess in a proximal part and a distal part.

[0019] Preferably, the rotation protrusion is a snap flexible in a radial direction with respect to the central longitudinal axis.

[0020] Preferably, in the second rotational state, the snap is configured to flex inwards in the radial direction to pass the ridge, when the manually operable activator is pushed proximally.

[0021] Preferably, the manually operable activator comprises a proximally directed contact point and the actuator comprises a corresponding distally directed contact point,

[0022] Preferably, in the second rotational state, the actuator is configured to be pushed proximally by operation of the manually operable activator via abutment of the activator contact point and the actuator contact point.

[0023] Preferably, the blocking element is a protrusion, preferably protruding radially outwards with respect to the central longitudinal axis of the housing.

[0024] Preferably, the stop is a protrusion, preferably protruding radially towards the central longitudinal axis of the housing, and more preferably the stop comprises a circular ring segment.

[0025] Preferably, the proximally directed surface of the manually operable activator is a proximal end surface of the manually operable activator.

[0026] Preferably, the internal locking surface is provided on a protrusion that preferably protrudes radially towards the central longitudinal axis of the housing, and more preferably the internal locking surface comprises a circular ring segment.

[0027] Preferably, the medicament delivery device further comprises an actuator sleeve coaxial with said actuator.

[0028] Preferably, the actuator sleeve is arranged to interact with said holding elements, said actuator sleeve being movable in a longitudinal direction in relation to the actuator and the housing. Preferably, the medicament delivery device further comprises a medicament delivery member cover protruding from the proximal end of said housing and movable in said longitudinal direction.

[0029] Preferably, the actuator is moveable in a longitudinal direction with respect to the housing and the actuator sleeve between an initial state, an activated state and an end state.

[0030] Preferably, in the initial state, the actuator is located further proximal than in the end state, and in the activated state the actuator is located further proximal than in the initial state with respect to the housing.

[0031] Preferably, the actuator sleeve comprises a first recess and a second recess on an inner circumferential surface wherein the first recess is located further towards the proximal end than the second recess.

[0032] Preferably, the holding elements of the actuator comprises two proximally directed arms that are flexible in a generally radial direction and wherein the arms are arranged with outwardly directed surfaces engaging an inner surface of said actuator sleeve.

[0033] Preferably, in the initial state, the outwardly directed surfaces are located in the first recess blocking outward movement of the arms.

[0034] Preferably, the holding elements of the actuator comprise two proximally directed arms that are flexible in a generally radial direction, wherein the arms are arranged with inwardly directed protrusions engaging corresponding recesses in said plunger rod in the initial state.

[0035] Preferably, in the activated state, the outwardly directed surfaces disengage the first recess allowing the arms to flex outwardly and the inwardly directed protrusions are configured to disengage corresponding recesses of the plunger rod allowing the plunger rod to be moved in the proximal direction by force of the drive spring.

[0036] Preferably, when a distal end of the plunger rod has passed the inwardly directed protrusions during proximal movement of the plunger rod, the arms are configured to flex radially inwards during distal movement of the actuator and the actuator is configured to be pushed in the distal direction by a residual force of the drive spring. Preferably, at the end of the distal movement of the actuator, a distally directed surface of the actuator is configured to hit a proximally directed surface of the housing, giving an audible and / or tactile signal.

[0037] Preferably, in the end state, a distally directed surface of the actuator is configured to abut a proximally directed surface of the housing.

[0038] Preferably, the actuator sleeve is moveable in a longitudinal direction with respect to the housing between an initial state and a locked state.

[0039] Preferably, in the locked state, the actuator sleeve is located further proximal with respect to the housing than in the initial state.

[0040] Preferably, the actuator sleeve comprises at least one retaining element provided towards a distal end of a flexible arm and configured to abut a distally directed surface of the housing in the initial state of the actuator sleeve, thus blocking proximal movement of the actuator sleeve with respect to the housing.

[0041] Preferably, the distally directed surface is a collar.

[0042] Preferably, the distally directed surface protrudes radially inwards.

[0043] Preferably, in the initial state and the activation state of the actuator, an outer circumferential surface of the actuator blocks inward movement of the retaining element.

[0044] Preferably, the actuator comprises at least one release recess corresponding to the at least one retaining element.

[0045] Preferably, in the end state, the at least one release recess is configured to allow the at least one retaining element to flex inwardly, wherein the retaining element disengages the distally directed surface thus allowing the actuator sleeve to move proximally to the locked state.

[0046] Preferably, when the actuator is in the end state and the actuator sleeve is in the locked state, the outwardly directed surfaces of the actuator engage the second recess of the actuator blocking proximal movement of the arms and thus the actuator. Preferably, an actuator sleeve spring is provided to exert a proximally directed force on the actuator sleeve.

[0047] Preferably, the medicament delivery member cover is coupled to the actuator sleeve.

[0048] Preferably, the medicament delivery device comprises an injection needle, wherein in the locked state of the actuator sleeve, the medicament delivery member cover is configured to cover the injection needle.

[0049] Preferably, the power pack comprises a guide rod provided with fastening elements at its distal end, which fastening elements engage cut-outs on the actuator.

[0050] Preferably, the drive spring is arranged between a proximal end wall of the plunger rod and the fastening elements.

[0051] Preferably, the manually operable activator further comprises at least one proximally extending leg configured to block distal movement of the manually operable activator with respect to the housing.

[0052] Preferably, the proximally extending leg comprises at least one locking protrusion configured to engage a collar provided at an inner circumferential surface of the housing.

[0053] Preferably, the collar comprises a leg recess through which the proximally extending legs extend.

[0054] Preferably, the leg recess is formed between the collar and an inner circumferential surface of the housing.

[0055] Preferably, the at least one locking protrusion is configured to engage a proximally directed surface of the collar.

[0056] Preferably, the medicament delivery device further comprises a syringe holder configured to accommodate the medicament container and a cap removably attached to the housing. Preferably, the syringe holder comprises at least one flexible syringe holder arm configured to block proximal movement of the syringe holder when the cap is attached to the housing.

[0057] Preferably, the at least one flexible syringe holder arm is configured to engage a syringe holder recess provided at an inner circumferential surface of the housing.

[0058] Preferably, the cap is configured to block an inward radial movement of the at least one flexible syringe holder arm.

[0059] Preferably, when the cap is removed from the housing, the at least one flexible syringe holder arm is configured to flex inwards towards the central longitudinal axis and is configured to clear the syringe holder recess to allow proximal movement of the syringe holder.

[0060] 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 during use of the medicament delivery device is / are located furthest away from the dose delivery site. 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. 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 during use of the medicament delivery device is / are located closest to the dose delivery site.

[0061] Further, the terms “longitudinal”, “longitudinally”, “axially” and “axial” refer to a direction extending from the proximal end to the distal end and along the device or components thereof, typically in the direction of the longest extension of the device and / or component. The direction may also be referred to as x-axis / x-direction.

[0062] Consequently, the proximal direction may be referred to as the negative x-direction and the distal direction may be referred to as the positive x-direction. Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction. The y-axis and the z-axis maybe perpendicular to the x-axis.

[0063] Further, the terms “circumference”, “circumferential”, or “circumferentially” refer to a circumference or a circumferential direction relative to an axis, typically a central (longitudinal) axis extending in the direction of the longest extension of the device and / or component. 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.

[0064] 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, member, component, means, etc. are to be interpreted openly as referring to at least one instance of the element, apparatus, member component, means, etc., unless explicitly stated otherwise.

[0065] In the figures, the same or similar elements may be denoted by the same reference numerals.

[0066] BRIEF DESCRIPTION OF THE DRAWINGS

[0067] Embodiments of the present disclosure will now be described by way of example only and with reference to the following accompanying drawings.

[0068] Figure 1 is an exploded view of some components of a medicament delivery device according to an embodiment of the present disclosure.

[0069] Figures 2A to 2F are views of different rotational and axial states of a manually operable activator according to an embodiment of the present disclosure.

[0070] Figure 3A is a perspective view of a housing according to an embodiment of the present disclosure.

[0071] Figures 3B and 3C are perspective cross-sectional views of a housing and a manually operable activator in different rotational states according to an embodiment of the present disclosure. Figure 4 is an exploded perspective view of a manually operable activator and an actuator according to an embodiment of the present disclosure.

[0072] Figure 5A is a cross sectional view of a manually operable activator and figure 5B is a cross sectional view of the manually operable activator and the actuator according to an embodiment of the present disclosure.

[0073] Figure 6A is a side view of an actuator sleeve, figure 6B is a cross sectional view of the actuator sleeve and Fig. 6C is a perspective cross sectional view according to an embodiment of the present disclosure.

[0074] Figure 7 is an exploded perspective view of an actuator sleeve, an actuator and a plunger rod according to an embodiment of the present disclosure.

[0075] Figure 8 is a cross sectional view of an actuator, an actuator sleeve and a plunger rod according to an embodiment of the present disclosure.

[0076] Figure 9 is a partial cross-sectional view of a medicament delivery device according to an embodiment of the present disclosure.

[0077] Figures 10 to 13 are cross sectional views showing an injection sequence of a medicament delivery device according to an embodiment of the present disclosure.

[0078] Figure 14 is a partial perspective view of a rear part according to an embodiment of the present disclosure.

[0079] Figure 15A is a perspective view of a manually operable activator according to an embodiment of the present disclosure.

[0080] Figure 15B is a cross sectional view of Fig. 15A.

[0081] Figures 16A and 16B are partial cross sectional views of a distal part of a medicament delivery device according to an embodiment of the present disclosure.

[0082] Figure 17 is a perspective view of a distal housing part according to an embodiment of the present disclosure.

[0083] Figure 18 is a partial perspective view of a distal part of a medicament delivery device according to an embodiment of the present disclosure. Figure 19 is an exploded perspective view of a cap and a syringe holder according to an embodiment of the present disclosure.

[0084] Figures 20 and 21 are cross sectional views of a proximal part of a medicament delivery device according to an embodiment of the present disclosure.

[0085] DETAILED DESCRIPTION

[0086] The medicament delivery device according to the present disclosure may comprise an activation mechanism similar to the one shown in WO 2020 / 143991 Al and a detailed description thereof, unless necessary, may be omitted.

[0087] A medicament delivery device as disclosed herein and as shown in the exploded view of Fig. 1 comprises a housing 1 arranged to accommodate a medicament container, e.g., a syringe 7, and a power pack arranged to exert a force on said medicament container for expelling a dose of medicament. That is, the medicament delivery device may comprise a housing 1 and a power pack and the housing 1 may be arranged to accommodate a medicament container and may be arranged to accommodate the power pack.

[0088] The housing 1 maybe provided as one housing part or subdivided in a plurality of subhousings, e.g., a front housing (proximal housing) and rear housing (distal housing). The description of the embodiments is based on a two-part housing (front housing and rear housing 1) but the present disclosure is not limited to this configuration.

[0089] A cap 8 which may also function as a needle shield remover is provided on a proximal end of the medicament delivery device and a manually operable activator 2 is provided on a distal end of the medicament delivery device. In Fig. 1, the syringe 7 is held by a syringe holder 71 and surrounded by a medicament delivery member cover 5.

[0090] The power pack comprises a plunger rod 6 (see Fig. 7) and a drive element, e.g. a drive spring, (not shown) arranged to exert a force on said plunger rod 6 in a proximal direction.

[0091] An actuator 3 is coaxially provided with said plunger rod 6 and arranged with holding elements 31 (see Fig. 4) for releasably holding said plunger rod 6 with said drive spring in an energised state. The holding elements 31 maybe provided towards the proximal end of the actuator 3 and will be further described later on. At least one blocking element 33 is provided towards a distal end of the actuator 3.

[0092] The manually operable activator 2 is arranged at a distal end of the housing 1 and is movable in the proximal direction, rotatable around a central longitudinal axis of the housing 1 and operably connected to said actuator 3 for releasing said plunger rod. The manually operable activator 2 maybe, e.g., a push button, activation button or the like.

[0093] The manually operable activator 2 comprises at least one stop 23 (not shown in Fig. 1, see Figs. 3B, 3C) provided at a circumferential surface thereof. The housing 1 comprises an internal locking surface 11 (not shown in Fig. 1) to be further described later on.

[0094] In a first rotational state of the manually operable activator 2, a proximally directed surface 21 (see Figs. 3B, 3c) of the manually operable activator 2 abuts the locking surface 11 of the housing 1 blocking proximal movement of the manually operable activator 2 with respect to the housing 1 and the blocking element 33 of the actuator 3 is configured to abut the stop 23 thus blocking proximal movement of the actuator 3 with respect to the manually operable activator 2. In a second rotational state of the manually operable activator 2, the proximally directed surface 21 of the manually operable activator 2 is configured to clear the locking surface 11 of the housing 1 and the manually operable activator 2 is free to be displaced in the proximal direction on application of a force by a user.

[0095] Also, in the second rotational state, the stop 23 maybe configured to clear the blocking element 33.

[0096] In Fig. 1, the actuator 3 is located coaxially inside an actuator sleeve 4 to be described later.

[0097] Figs. 2A to 2F show partial views of a distal end of the medicament delivery device according to an embodiment. In particular, Figs. 2A to 2F show different rotational states of the manually operable activator 2.

[0098] In an embodiment, the manually operable activator 2 comprises at least one rotation protrusion 22 protruding from an outer circumferential surface thereof and the housing 1 comprises a recess 12 configured to receive the rotation protrusion 22. In Figs. 2A to 2C, the rotation protrusion 22 protrudes in a radial outward direction from the manually operable activator 2 and is formed in a knob or bolt shape. Alternatively, as shown in Figs. 2D to 2F, the rotation protrusion 22 protrudes in a radial outward direction from the manually operable activator 2 and is formed as a snap. That is, the proximally directed side of the rotation protrusion maybe tapered in the radial inward direction, i.e., towards the central axis.

[0099] The recess 12 maybe substantially L-shaped. That is, the two legs of the L-shape of the recess 12 may extend in the circumferential direction and the proximal direction of the housing 1, respectively. In addition, as shown in Figs. 2D to 2F, if the rotation protrusion 22 is provided as a snap, a ridge 17 (activator ridge 17) extending in the circumferential direction of the housing 1 may be provided. The ridge 17 may divide the recess 12 in a proximal part 171 and a distal part 172.

[0100] Figs. 2A and 2D show the manually operable activator 2 in the first rotational state while Figs. 2B, 2C, 2E and 2F show the manually operable activator 2 in the second rotational state in which the manually operable activator 2 has been rotated with respect to the housing 1 around the central axis. Moreover, Figs. 2A and 2D show the medicament delivery device in a locked state (no triggering of the device possible), Figs. 2B and 2E in an unlocked state (triggering of the device possible) and Figs. 2C and 2F in an activated state (medicament delivery in process), in which the manually operable activator 2 has been pushed in the proximal direction.

[0101] The rotation protrusion 22 may be configured to visually indicate the first or second rotational state of the manually operable activator 2. The rotation protrusion 22 may protrude through the recess 12 to provide visual and tactile indication of the first or second rotational state. Similarly, the rotation protrusion 22 may give an indication of the locked state, the unlocked state and the activated state.

[0102] In Fig. 2 A, in the first rotational state, the rotation protrusion 22 is configured to abut a proximal surface of the recess 12, thus blocking proximal movement of the manually operable activator 2. This may be a further safety mechanism in addition to the proximally directed surface 21 of the manually operable activator 2 abutting the locking surface 11 of the housing 1. In Figs. 2D to 2F, the snap (rotation protrusion 22) is flexible in a radial direction with respect to the central longitudinal axis. This may also be the case for the rotation protrusion 22 shown in Figs. 2A to 2C. In particular, the rotation protrusion 22 maybe provided on a flexible bar having cut-outs around the circumference allowing flexibility in the radial direction (see Fig. 4).

[0103] In the second rotational state, the snap (rotation protrusion 22) is configured to flex inwards in the radial direction to pass the ridge 17 when the manually operable activator 2 is pushed proximally from the unlocked state to the activated state. The rotation protrusion 22 is thus pushed from the proximal part 171 to the distal part 172, passing the ridge 17. In the activated state shown in Fig. 2F, the snap may prevent distal movement of the manually operable activator 2 due to the abutment of the snap 22 on the ridge 17.

[0104] The housing recess 12 may further comprise a proximally directed protrusion 18 preventing inadvertent rotation of the manually operable activator / member 2 from the first rotational state to the second rotational state.

[0105] Alternatively, the housing recess 12 may not be cut out through the housing 1 but rather provided only on an inner circumferential surface of the housing 1 as shown in Fig. 14. Therein, the housing 1 is shown transparently allowing to view the inner circumferential surface thereof. The recess 12 may be substantially formed in an L- shape as described above or, as shown in Fig. 14, as two recesses 12 extending in the circumferential direction of the housing 1. The two recesses 12 may be separated by a ridge 17. Hence, the recess 12 maybe separated in a proximal part 171 and a distal part 172 by the ridge 17. As described above, the snap (rotation protrusion 22) may be configured to flex inwards in the radial direction to pass the ridge 17 when the manually operable activator 2 is pushed proximally from the unlocked state to the activated state.

[0106] In the configuration shown in Fig. 14, the rotation protrusion 22 (i.e., the rotational state of the manually operable activator 2) is not visible from the outside and with the manually operable activator 2 configured as in Fig. 15, the rotation protrusion is omitted altogether. That is, the visual indication and the redundant locking of the rotation protrusion 22 in the recess 12 are merely optional features and maybe omitted as will be shown with reference to Figs. 14 and 15 below. Fig. 3A shows a perspective view of a housing 1 according to an embodiment. In this case, a rear housing 1 (distal housing) is shown but the disclosure is not limited thereto and the housing 1 may also be provided as a single piece.

[0107] In an embodiment, the internal locking surface 11 is provided as a protrusion that may protrude radially towards the central longitudinal axis of the housing 1 (see Fig. 3A). The internal locking surface 11 may comprise a circular ring segment as shown in Fig. 3A. In the embodiment shown in Figs. 3A to 3C, the internal locking surface 11 is provided as four protrusions equally distributed around the inner circumference of the housing 1, i.e., each offset by 90°.

[0108] Fig. 3A further shows a distally directed surface 13 of the housing 1. The distally directed surface 13 may be provided at an inner circumferential surface of the housing

[0109] 1 and may protrude towards the central axis. The distally directed surface 13 may be a collar 13. In that case, the internal locking surface 11 may also be provided on the collar 13 and protrude in a distal direction therefrom.

[0110] Figs. 3B and 3C show a partial perspective view of the distal part of the medicament delivery device, in particular the housing 1, the manually operable activator 2 and the actuator 3. The manually operable activator 2 is shown in a cross section allowing to view the interior of the device. The cross section is perpendicular to the central axis, i.e., in the y-z-plane.

[0111] The proximally directed surface 21 of the manually operable activator 2 may be a proximal end surface of the manually operable activator 2. In the first rotational state shown in Fig. 3B, the proximally directed surface 21 of the manually operable activator

[0112] 2 abuts the internal locking surface 11 thus preventing the manually operable activator 2 from being moved in the proximal direction (i.e., to the activated state). In the second rotational state as shown in Fig. 3C, the proximally directed surface 21 of the manually operable activator 2 clears the locking surface 11 of the housing 1 and the manually operable activator 2 is free to be displaced in the proximal direction on application of a force by a user.

[0113] The manually operable activator 2 may also comprise an activation recess 26 corresponding to the internal locking surface 11. The activation recess 26 may be recessed from a proximal surface, e.g., a proximal end surface, of the manually operable activator 2 in the distal direction. Hence, when the manually operable activator 2 is in the second rotational state, the proximally directed surface 21 clears the internal locking surface 11 and the activation recess 26 receives the internal locking surface 11 when the manually operable activator 2 is moved in the proximal direction for activation of the medicament delivery device (see Fig. 3C).

[0114] In Figs. 3B and 3C, the blocking element 33 abutting the stop 23 and thus blocking proximal movement of the actuator 3 with respect to the manually operable activator 2 can also be seen and will be further described below.

[0115] Fig. 4 is an exploded perspective view of the manually operable activator 2 and the actuator 3 according to an embodiment. Some of the features of the manually operable activator 2 has already been described above and will not be repeated.

[0116] The manually operable activator 2 according to an embodiment further comprises a proximally directed contact point 25 and the actuator 3 comprises a corresponding distally directed contact point 35. The distally directed contact point 35 is provided on the inside of the actuator 3 and not shown in Fig. 4 but will be further described below (see Fig. 5B). In the second rotational state, the actuator 3 is configured to be pushed proximally by operation of the manually operable activator 2 via abutment of the activator contact point 25 and the actuator contact point 35.

[0117] In an embodiment, the actuator’s 3 blocking element 33 is a protrusion which may protrude radially outwards with respect to the central longitudinal axis of the housing 1. In the locked state of the manually operable activator 2, the blocking element 33 abuts the stop 23 of the manually operable activator 2 to prevent proximal movement of the actuator.

[0118] The actuator 3 further comprises a release recess 34 interacting with the actuator sleeve 4 as described below.

[0119] Towards the proximal end of the actuator 3, at least one holding element 31 is provided. In an embodiment, two or four equally distributed holding elements 31 may be provided. The holding elements 31 may be formed as flexible arms capable of flexing in the radial direction with respect to the central axis. Towards the proximal end of the holding elements 31, outwardly directed surfaces 312 may be provided interacting with the actuator sleeve 4. Moreover, inwardly directed protrusions 311 interacting with the plunger rod 6 may be provided towards the proximal end of the holding elements 31. At the proximal end of the holding elements 31, a proximal (end) surface 313 maybe provided.

[0120] The actuator 3 may further comprise a feedback protrusion 36. The feedback protrusion 36 may protrude in a radial outward direction from a centre portion of the actuator 3. After medicament delivery, the feedback protrusion 36 hits a corresponding surface of the housing 1 to generate an audible and / or tactile signal that medicament delivery is completed. The housing 1 surface maybe, e.g., the proximal side of the collar 13 (see Fig. 12) or the proximal side of the distally directed surface 13, respectively.

[0121] Fig. 5A is a perspective cross sectional view of the manually operable activator 2 along the central longitudinal axis and Fig. 5B is a perspective cross sectional view of the manually operable activator 2 in interaction with the actuator 3 along the central longitudinal axis.

[0122] In an embodiment as shown in Figs. 5A and 5B, the stop 23 is a protrusion. Said protrusion may protrude radially towards the central longitudinal axis of the housing 1. The stop 23 may comprise a circular ring segment. That is, the stop 23 may not extend around the complete inner circumference of the manually operable activator 2. The blocking element 33 is located at a position corresponding to the stop 23 and is in contact therewith to block relative proximal movement between the actuator 3 and the manually operable activator 2. The stop 23 and the blocking element 33, respectively may be provided in plural.

[0123] Further, the activator contact point 25 may be provided on one or more proximally extending legs 251. The legs maybe provided coaxially with an outer circumference of the manually operable activator 2. The legs 251 may be flexible in the radial direction. In the initial state (locked / unlocked state), i.e., before medicament delivery, the plunger rod 6 prevents the proximally extending legs 251 having the contact points 25 from flexing radially inwards.

[0124] As outlined above, the corresponding actuator contact point(s) 35 are provided on an inner circumferential surface of the actuator 3. The contact points 25, 35 may be in contact with each other in the first and second rotational state as well as the locked state, the unlocked state and the activated state. Through this contacting surface, and since the proximally extending legs 251 cannot flex radially, a proximal movement of the manually operable activator 2 with respect to the housing 1 is transferred to the actuator 3 and both elements can be moved together in the proximal direction. Both contact points 25, 35 may be tapered.

[0125] In an embodiment, it is not necessary that the blocking element 33 fully clears the stop 23 in the second rotational state since there is no proximal relative movement of the actuator 3 with respect to the manually operable activator 2 in the activated state. However, after medicament delivery, the actuator 3 can move in the distal direction, e.g., for generating a feedback signal to be described below.

[0126] The medicament delivery device according to an embodiment further comprises an actuator sleeve 4 as shown in Fig. 6A coaxial with said actuator 3. Towards the distal end of the actuator sleeve 4, at least one retaining element 43 is provided. The retaining element 43 may be located at or towards a distal end of a flexible arm 431 extending from the actuator sleeve 4 in the distal direction. The retaining element 43 may be configured to abut a distally directed surface 13 (see Figs. 3A, 9) of the housing 1 to block proximal movement of the actuator sleeve 4 relative to the housing 1.

[0127] The actuator sleeve 4 is arranged to interact with said holding elements 31 (see Fig. 4). The actuator sleeve 4 is movable in a longitudinal direction in relation to the actuator 3 and the housing 1.

[0128] A first recess 41 and a second recess 42 may be provided at an inner circumferential surface of the actuator sleeve 4. As can be seen from the cross sectional view of the actuator sleeve 4 in Fig. 6B, the first recess 41 and the second recess 42 may also be formed between at least one longitudinally extending ridge 45 and may be recessed in the radial outward direction with respect to said ridge 45. The first recess 41 is located further towards the proximal end of the actuator sleeve 4 than the second recess 42. Thus, the first recess 41 may be formed as a proximal inner surface of the actuator sleeve 4 and the second recess 42 maybe formed as a distal inner surface of the actuator sleeve 4. Fig. 7 is an exploded perspective view of the actuator sleeve 4 and the actuator 3 as described above as well as the plunger rod 6. The plunger rod 6 may comprise a plunger rod recess 611 interacting with the inwardly directed protrusion 311 of the actuator 3.

[0129] Fig. 8 is a cross sectional view along the central longitudinal axis of the medicament delivery device showing the plunger rod 6, the actuator 3 and the actuator sleeve 4 in an assembled and locked state according to an embodiment. The actuator 3 is moveable in a longitudinal direction (x-direction) with respect to the housing 1 and the actuator sleeve 4 between an initial state, an activated state and an end state. In the initial state, the actuator 3 is located further proximal than in the end state, and in the activated state the actuator 3 is located further proximal than in the initial state with respect to the housing 1. In Fig. 8, the initial state is shown.

[0130] As outlined above, the actuator sleeve 4 comprises a first recess 41 and a second recess 42 on an inner circumferential surface wherein the first recess 41 is located further towards the proximal end than the second recess 42.

[0131] In addition or alternatively, a distally directed surface of the outwardly directed surface 312 may abut the ridge 45 shown in Fig. 6B (which is hidden in the view of Fig. 8), i.e., a proximally directed surface of the ridge 45. The recesses 41 and 42 may also be formed by an inner circumferential surface of the actuator sleeve 4 and thus be recessed in the radial outward direction with respect to the ridge 45 as described above.

[0132] As described above, the holding elements 31 of the actuator 3 may comprise two or more proximally directed arms that are flexible in a generally radial direction and the arms may be arranged with the outwardly directed surfaces 312 engaging an inner surface of said actuator sleeve 4. Thus, radial outward movement of the holding elements 31 / arms is blocked. Said inner surface of the actuator sleeve 4 may be the first recess 41. Hence, in the initial state shown in Fig. 8, the outwardly directed surfaces 312 may be located in the first recess 41 blocking outward movement of the arms.

[0133] The two or more proximally directed arms may further be arranged with the inwardly directed protrusions 311 engaging corresponding recesses 611 in said plunger rod 6 in the initial state. Furthermore, in the initial state and the first rotational state of the manually operable activator 2, the blocking element 33 is in engagement with the stop 23 and the retaining element 43 is in engagement with the distally directed surface 13.

[0134] Fig. 9 is a partial cross sectional view of a medicament delivery device according to an embodiment of the disclosure. In the figure, the proximal part of the device is not depicted. Fig. 9 shows the device in the first rotational state of the manually operable activator 2 and the initial state of the actuator 3. The device is thus locked and a medicament delivery has not yet been performed. Reference is made to the above description explaining the features and their interactions. As shown in the figure, the power pack comprises a plunger rod 6 and a drive spring 63 arranged to exert a force on said plunger rod 6. A guide rod 62 is coaxially provided in the plunger rod 6, wherein the drive spring 63 is arranged around said guide rod 62. The guide rod 62 is provided with fastening elements 621 at the distal end of the guide rod 62. The fastening elements 621 fix the guide rod 62 relative to the actuator 3. E.g., the fastening elements 621 may engage respective cut-outs of the actuator 3. The drive spring 63 is arranged between a proximal end wall of the plunger rod 6 and the fastening elements 621.

[0135] In the depicted state, the plunger 6 having a stopper 64 at the proximal end to deliver a drug provided in the syringe is pushed in the proximal direction by the force of the drive spring 63 but held by the engagement of the inwardly directed protrusion 311 and the plunger rod recess 611 preventing relative proximal movement of the plunger rod 6 with respect to the actuator 3. The syringe 7 comprises a needle (medicament delivery member) for injecting a drug into a patient.

[0136] The medicament delivery device further comprises a medicament delivery member cover 5 protruding from the proximal end of the housing 1 and being movable in the longitudinal direction.

[0137] The process of medicament delivery will be described with reference to Figs. 10 to 13 showing an embodiment. The disclosed medicament delivery device is provided particularly for soft tissue, i.e., a soft injection surface. Since it may be difficult to compress a medicament delivery member cover spring on a soft injection site, the present medicament delivery device is triggered only by the manually operable activator 2. In order to prevent inadvertent activation of the device, the rotating manually operable activator 2 as described above is provided which can only be actuated after turning it into the second rotational state.

[0138] The views of Figs. 10 to 12 are rotated 90 degrees around the central longitudinal axis with respect to Fig. 9. Some parts such as the proximal housing, the syringe 7, the stopper 64, the medicament delivery member cover 5, etc. have been omitted in the following figures 10 to 13. The figures also show a syringe driver 72 which functions similarly as described in WO 2020 / 143991 Al.

[0139] In Fig. 10, the manually operable activator 2 has been turned into the second rotational state (unlocked state) and the actuator 3 is still in the initial state. The device is ready to be triggered by pushing the manually operable activator 2 in the proximal direction through a force of a user. The force exerted on the manually operable activator 2 is transferred to the actuator 3 via the contact points 25, 35 and the actuator 3 is pushed in the proximal direction the same distance the manually operable activator 2 is moved. At the same time, the syringe holder 71 together with the syringe 7 (not shown) are moved proximally to pierce a patient’s skin. The syringe 7 may be axially fixed with respect to the syringe holder 71.

[0140] After pushing the manually operable activator 2 proximally, i.e., in the activated state as shown in Fig. 11, the outwardly directed surfaces 312 of the actuator 3 disengage the first recess 41 allowing the arms to flex outwardly. Consequently, the inwardly directed protrusions 311 disengage the corresponding recesses 611 of the plunger rod 6 allowing the plunger rod 6 to be moved in the proximal direction by force of the drive spring 63. The plunger rod 6, together with the stopper 64, pushes the medicament out of the syringe 7 for delivery into a patient’s tissue.

[0141] When a distal end of the plunger rod 6 has passed the inwardly directed protrusions 311 during proximal movement of the plunger rod 6, the actuator 3 is pushed in the distal direction by a residual force of the drive spring 63 and the arms are configured to flex radially inwards during distal movement of the actuator 3. Hence, the outwardly directed surface 312 is able to pass the first recess 41 (proximal inner surface 41) or the ridge 45, respectively, since the plunger rod 6 does not hinder the arms from flexing radially inwards. Since the contact points 25 of the manually operable activator 2 and the corresponding contact points 35 of the actuator 3 maybe tapered, the distal movement of the actuator

[0142] 3 forces the proximally extending legs 251 having the contact points 25 radially inwards. Moreover, during distal movement of the actuator 3, since the distal end of the plunger rod 6 has also passed the contact points 25, the plunger rod 6 does not prevent the proximally extending legs 251 having the contact points 25 from flexing radially inwards.

[0143] At the end of the distal movement of the actuator 3, a distally directed surface of the actuator 3 is configured to hit a proximally directed surface of the housing 1, giving an audible and / or tactile signal. The distally directed surface of the actuator 3 maybe the feedback protrusion 36 described above and the proximally directed surface of the housing may be a proximal side of the distally directed surface 13, e.g., the collar 13. The actuator 3 is in the end state.

[0144] Further, in the end state of the actuator 3, the distally directed surface of the actuator 3, e.g., the feedback protrusion 36, may abut the proximally directed surface of the housing 1, e.g., the collar 13. Thus, the actuator 3 is pushed in the distal direction by the force of the drive spring 63 and held in contact with the collar 13 after medicament delivery.

[0145] Fig. 12 is an angled cross sectional view and shows the configuration after the plunger rod 6 has been fully extended, i.e., moved proximally. Moreover, the proximally extending legs 251 having the contact points 25 have been flexed radially inwards allowing the actuator 3 to be fully moved in the distal direction as described above.

[0146] The actuator sleeve 4 is moveable in a longitudinal direction with respect to the housing 1 between an initial state and a locked state. Before and during medicament delivery (locked / unlocked / activated state of the actuator 3), the actuator sleeve 4 is in the initial state. After medicament delivery, the actuator sleeve 4 can be moved to the locked state. In the locked state, the actuator sleeve 4 is located further proximal with respect to the housing 1 than in the initial state. An actuator sleeve spring 44 is provided to exert a proximally directed force on the actuator sleeve 4. In other words, the actuator

[0147] 4 is biased in the proximal direction by the force of the actuator sleeve spring 44. The actuator sleeve spring 44 may also be referred to as a medicament delivery member cover spring or needle cover spring.

[0148] As described above, in an embodiment, the actuator sleeve 4 comprises at least one retaining element 43 provided towards the distal end of a flexible arm and configured to abut the distally directed surface 13 of the housing 1 in the initial state of the actuator sleeve 4 (see Fig. 9). Thereby, proximal movement of the actuator sleeve 4 with respect to the housing 1 is blocked.

[0149] In the initial state and the activation state of the actuator 3, an outer circumferential surface of the actuator 3 blocks inward movement of the retaining element 43. The actuator sleeve 4 thus remains axially locked. As described above in the context of Fig. 4 and as further shown in Fig. 7, the actuator 3 comprises at least one release recess 34 corresponding to the at least one retaining element 43. The release recess 34 is located further proximal than the outer circumferential surface of the actuator 3 blocking inward movement of the retaining element 43.

[0150] In the end state of the actuator 3 as shown in Fig. 12, the actuator 3 has been moved distally and the release recess 34 is on the same axial height as the retaining element 43. Thus, the at least one release recess 34 is configured to allow the at least one retaining element 43 to flex inwardly. Consequently, the retaining element 43 disengages the distally directed surface 13. The actuator sleeve 4 is able to be moved proximally to the locked state by the force of the actuator sleeve spring 44. The contact surfaces of the retaining element 43 and the distally directed surface 13 (or collar 13) may be tapered.

[0151] In other words, after the actuator 3 stops at the hard stop by abutment of the feedback protrusion 36 on the collar 13, the actuator sleeve retaining elements 43 are aligned with the release recess 34 on the actuator 3. The actuator sleeve retaining elements 43 flex in and release the actuator sleeve 4. As the actuator sleeve spring 4 extends, the actuator sleeve 4 moves forward and pushes the medicament delivery member cover 5 out. The retaining elements 43 on the actuator sleeve 4 allow the medicament delivery member cover 5 to be locked till the end of the dose and the feedback signal / click.

[0152] Fig. 13 is a cross sectional view of an end state of the medicament delivery device, i.e., after medicament delivery, according to an embodiment. The manually operable activator 2 is in the activated state, the actuator 3 is in the end state and the actuator sleeve 4 is in the locked state.

[0153] When the actuator 3 is in the end state and the actuator sleeve 4 is in the locked state, the outwardly directed surfaces 312 of the actuator 3 engage the second recess 42 of the actuator sleeve 4 blocking proximal movement of the arms and thus the actuator

[0154] 3. In the embodiment shown in Fig. 13, the ridge 45 as described above is provided on the inner circumferential surface of the actuator sleeve 4, the outwardly directed surface 312 contacts the distal inner surface 42 and the proximal (end) surface 313 of the actuator 3 abuts or engages a distal end of the ridge 45. The proximal (end) surface 313 of the actuator 3 and the distal end of the ridge 45 maybe reversely tapered to lock the actuator sleeve 4 in place. The actuator 3 is locked inside the actuator sleeve 4.

[0155] Moreover, the medicament delivery member cover 5 may be coupled to the actuator sleeve 4. Thus, after medicament delivery, delivery member cover 5 is moved proximally together with the actuator sleeve 4. Due to the resulting proximal extension of the medicament delivery member cover 5, in the locked state of the actuator sleeve

[0156] 4, the medicament delivery member cover 5 covers the injection needle to prevent a user from reaching or touching the needle. Hence, injuries after injection may be provided.

[0157] As noted above, the manually operable activator 2 may be provided without the rotation protrusion and thus the recess of the housing 1, formed as a cut-out or internal recess, may be omitted. The functionality is not altered and the locking mechanism between the manually operable activator 2 and the housing 1 is provided as outlined above.

[0158] A manually operable activator 2 without rotation protrusion is shown in Figs. 15A and 15B, wherein Fig. 15B is a cross section of Fig. 15A. The stop 23, the proximally directed surface 21, the activation recess 26 and the legs 251 having the activator contact point 25 are provide as explained above and further description will be omitted.

[0159] According to an embodiment, the manually operable activator 2 may further comprise at least one second leg 27. The at least one second leg 27 may extend proximally. For example, the at least one second leg 27 may extend from an outer circumferential surface of the manually operable activator 2 in a proximal direction. The at least one second leg 27 may extend parallel to the at least one leg 251 and may for example be offset by 90 degrees with respect to the at least one leg 251 in a circumferential direction. The at least one second leg 27 may extend into the housing 1 as will be shown below. The at least one leg 27 may be flexible. Further, it may be biased towards the central longitudinal axis. In the following, two second legs 27 are shown for exemplary purposes.

[0160] The distally directed surface (collar) 13 maybe substantially disk-shaped and provided extending from an internal circumferential surface of the housing 1. The collar 13 may further have leg recesses 131 through which the second legs 27 extend. That is, the number of leg recesses 131 corresponds to the number of second legs 27. The leg recesses 131 maybe provided as a circumferential cut-out in the collar 13. The second legs 27 may thus extend between the collar 13 and an internal circumferential surface of the housing 1. The leg recesses 131 may extend in a circumferential direction allowing rotational movement of the manually operable activator 2.

[0161] The second legs 27 may further comprise a first locking protrusion 271 and a second locking protrusion 272. The first and second locking protrusions 271, 272 may be formed as hooks or the like. For example, the first and second locking protrusions 271, 272 may comprise a proximally directed chamfered surface and a flat distally directed surface.

[0162] Figs. 16A and 16B show cross sections of the manually operable activator 2 and the housing 1 (with the other elements being omitted), wherein Fig. 16A depicts the second rotational state (unlocked state) of the manually operable activator and Fig. 16B depicts the activated state (medicament delivery in process), in which the manually operable activator 2 has been pushed in the proximal direction.

[0163] As can be seen from Fig. 16A, the second legs 27 extend through the corresponding leg recesses 131 of the housing 1, wherein the first locking protrusion 271 abuts a proximally directed surface of the collar 13. That is, the flat distally directed surface of the first locking protrusion 271 may abut the collar 13. The first locking protrusion 271 may therefore prevent distal movement of the manually operable activator 2.

[0164] When the manually operable activator 2 is moved in the proximal direction as shown in Fig. 16B, the second locking protrusion 272 snaps onto the proximally directed surface of the collar 13. That is, the flat distally directed surface of the second locking protrusion 272 may about the collar 13. The chamfered surface of the second locking protrusion 272 may aid in overcoming the collar 13. As noted above, the legs 27 may be biased towards the central longitudinal axis and thus lock the manually operable activator 2 in the activated, i.e., pushed position. This may provide any indication that the device has been used. The housing 1 may comprise an internal recess in which the second legs 27 may move in the longitudinal direction as well as the rotational direction.

[0165] Fig. 17 shows a perspective view of the housing 1 corresponding to the view of Fig. 3A. In addition to the configuration of Fig. 3A, the housing 1 as shown in Fig. 17 comprises the leg recess 131 described above. Optionally, a leg stop 132 may be provided inside the leg recess 131 which may be configured to prevent inadvertent rotation of the manually operable activator 2.

[0166] In order to move the manually operable activator 2 from the first rotational position to the second rotational position, the (flexible) legs 27 need to overcome the leg stop 132. Functionally, the leg stop 132 corresponds to the proximally directed protrusion 18 shown in Fig. 2.

[0167] Fig. 18 shows a perspective view of the medicament delivery device without the rotation protrusion and the corresponding housing recess as described above.

[0168] Fig. 19 shows a perspective exploded view of a syringe holder 71 and a cap 8. The cap 8 may comprise a substantially tubular member 81 extending in the distal direction. In an embodiment, the syringe holder 71 (cartridge carrier) of the medicament delivery device may further comprise at least one flexible syringe holder arm 711. The flexible syringe holder arm 711 may extend in an outward direction, i.e., in a radial direction with respect to the central longitudinal axis. The flexible syringe holder arm 711 may be flexible in the radial direction. The flexible syringe holder arm 711 may be provided at or towards a proximal end of the syringe holder 71.

[0169] The syringe holder 71 may further comprise syringe holder ribs 712 configured to engage with the medicament delivery member cover 5. Fig. 20 shows a cross sectional view of a proximal part of a medicament delivery device according to an embodiment in an assembled state. In the assembled state, the flexible syringe holder arms 711 (two arms in the depicted example) abut respective syringe holder recesses 14 in the housing 1, thus blocking proximal movement of the syringe holder 71. The syringe holder recesses 14 may comprise respective shoulders provided on an inner circumferential surface of the housing 1 which the flexible syringe holder arms 711 abut. Moreover, when the cap 8 is still in place, i.e., placed on a proximal part of the housing 1, the flexible syringe holder arms 711 are prevented from flexing inwards by the cap 8. In particular, the tubular member 81 may be provided inside of the housing 1 and the syringe holder 71 (i.e., radially inwards with respect to the central longitudinal axis) and may thus hinder the flexible syringe holder arms 711 from flexing inwards and clearing the syringe holder recesses 14. Therefore, the syringe holder 71 cannot be moved in the proximal direction and the device cannot be activated. Hence, as long as the cap 8 is attached to the medicament delivery device, the flexible syringe holder arms 711 prevent premature device activation. In other words, it is not possible to activate the device without first removing the cap 8.

[0170] In a normal, untensed / relaxed state, when the cap 8 is removed, the flexible syringe holder arms 711 maybe flexed inwards or they maybe flexed inwards by the chamfered syringe holder recess 14 when the syringe holder 71 is moved proximally for drug delivery.

[0171] Fig. 21 shows the proximal part of the medicament delivery device after injection and lock out of the device (needle not depicted). Locking of the medicament delivery member cover 5 after injection has been described above and will not be repeated. As shown in Fig. 15, the flexible syringe holder arms 711 remaining flexed in to allow drug delivery and lock out of the device.

[0172] Corresponding elements such as the internal locking surface 11 and the proximally directed surface 21, the housing recess 12 and the rotation protrusion 22, the distally directed surface 13 and the retaining element 43, etc. may all be provided in plural and in corresponding numbers.

[0173] All figures and embodiments described above are, unless indicated otherwise, compatible with each other. The present disclosure thus provides a secure and simple to use medicament delivery device which is particularly suitable for injection in soft tissue. By having only one triggering mechanism via the manually operable activator with the rotation lock, use of the device is facilitated while maintaining a safe operation.

[0174] The delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0175] 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.

[0176] Exemplary types of drugs that could be included in the 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.

[0177] Exemplary drugs that could be included in the 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.

[0178] Exemplary drugs that could be included in the 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-1 / PD-L1) 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 domain-containing protein (PVRIG) modulators, lymphocyteactivation 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 (CD80) 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.

[0179] Exemplary drugs that could be included in the 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.

[0180] Exemplary drugs that could be included in the 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, fam-trastuzumab 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.

[0181] Exemplary drugs that could be included in the 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.

[0182] Exemplary drugs that could be included in the 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.

[0183] Exemplary drugs that could be included in the 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.

[0184] Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the 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 may be 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.

[0185] Exemplary drugs that could be included in the 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, mFOLFOX6, 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, MAID, AIM, VAC-IE, ADOC, or PE.

[0186] Various modifications to the embodiments described are possible and will occur to those skilled in the art without departing from the invention which is defined by the claims.

Claims

CLAIMS1. A medicament delivery device comprising a housing (1) arranged to accommodate a medicament container and a power pack arranged to exert a force on said medicament container for expelling a dose of medicament, the power pack comprising: a plunger rod; a drive spring (63) arranged to exert a force on said plunger rod in a proximal direction, wherein the proximal direction is a direction towards a medicament delivery site; an actuator (3) coaxial with said plunger rod and arranged with holding elements (31) for releasably holding said plunger rod with said drive spring (63) in an energised state and further comprising at least one blocking element (33) provided towards a distal end of the actuator (3); a manually operable activator (2) arranged at a distal end of the housing (1) movable in the proximal direction, rotatable around a central longitudinal axis of the housing (1) and operably connected to said actuator (3) for releasing said plunger rod, wherein the manually operable activator (2) comprises at least one stop (23) provided at a circumferential surface thereof, wherein the housing (1) comprises an internal locking surface (11), wherein in a first rotational state of the manually operable activator (2), a proximally directed surface (21) of the manually operable activator (2) abuts the locking surface (11) of the housing (1) blocking proximal movement of the manually operable activator (2) with respect to the housing (1) and the blocking element (33) of the actuator (3) is configured to abut the stop (23) thus blocking proximal movement of the actuator (3) with respect to the manually operable activator (2), and wherein in a second rotational state of the manually operable activator (2), the proximally directed surface (21) of the manually operable activator (2) is configured to clear the locking surface (11) of the housing (1) and the manually operable activator (2) is free to be displaced in the proximal direction on application of a force by a user.

2. The medicament delivery device according to clause 1, wherein in the second rotational state, the stop (23) is configured to clear the blocking element (33).

3. The medicament delivery device according to claim 1 or 2, wherein the manually operable activator (2) comprises at least one rotation protrusion (22) protruding from an outer circumferential surface thereof, wherein the housing (1) comprises a recess (12) configured to receive the rotation protrusion (22).

4. The medicament delivery device according to claim 3, wherein the recess (12) is substantially L-shaped, or wherein the recess (12) is provided on an inner circumferential surface of the housing (1) and is formed by two parallel recesses extending in the circumferential direction of the housing (1).

5. The medicament delivery device according to claim 3 or 4, wherein the rotation protrusion (22) is configured to visually indicate the first or second rotational state of the manually operable activator (2).

6. The medicament delivery device according to any one of claims 3 to 5, wherein the rotation protrusion (22) protrudes through the recess (12) to provide visual and tactile indication of the first or second rotational state.

7. The medicament delivery device according to any one of claims 4 to 6, wherein in the first rotational state, the rotation protrusion (22) is configured to abut a proximal surface of the recess (12), thus blocking proximal movement of the manually operable activator (2).

8. The medicament delivery device according to any one of claims 4 to 6, wherein the recess (12) comprises a ridge (17) extending in the circumferential direction of the housing (1) and dividing the recess (12) in a proximal part (171) and a distal part (172).

9. The medicament delivery device according to claim 8, wherein the rotation protrusion (22) is a snap flexible in a radial direction with respect to the central longitudinal axis,wherein in the second rotational state, the snap is configured to flex inwards in the radial direction to pass the ridge (17), when the manually operable activator (2) is pushed proximally.

10. The medicament delivery device according to any one of claims 1 to 9, wherein the manually operable activator (2) comprises a proximally directed contact point (25) and the actuator (3) comprises a corresponding distally directed contact point (35), wherein, in the second rotational state, the actuator (3) is configured to be pushed proximally by operation of the manually operable activator (2) via abutment of the activator contact point (25) and the actuator contact point (35).

11. The medicament delivery device according to any one of claims 1 to 10, wherein the blocking element (33) is a protrusion, preferably protruding radially outwards with respect to the central longitudinal axis of the housing (1).

12. The medicament delivery device according to any one of claims 1 to 11, wherein the stop (23) is a protrusion, preferably protruding radially towards the central longitudinal axis of the housing (1), and more preferably wherein the stop (23) comprises a circular ring segment.

13. The medicament delivery device according to any one of claims 1 to 12, wherein the proximally directed surface (21) of the manually operable activator (2) is a proximal end surface of the manually operable activator (2).

14. The medicament delivery device according to any one of claims 1 to 13, wherein the internal locking surface (11) is provided on a protrusion that preferably protrudes radially towards the central longitudinal axis of the housing (1), and more preferably wherein the internal locking surface (11) comprises a circular ring segment.

15. The medicament delivery device according to any one of claims 1 to 14, further comprising an actuator sleeve (4) coaxial with said actuator (3).

16. The medicament delivery device according to claim 15, wherein the actuator sleeve (4) is arranged to interact with said holding elements (31), said actuator sleeve (4) being movable in a longitudinal direction in relation to the actuator (3) and the housing (1).

17. The medicament delivery device according to any one of claims 1 to 16, further comprising a medicament delivery member cover (5) protruding from the proximal end of said housing (1) and movable in said longitudinal direction.

18. The medicament delivery device according to any one of claims 15 to 17, wherein the actuator (3) is moveable in a longitudinal direction with respect to the housing (1) and the actuator sleeve (4) between an initial state, an activated state and an end state.

19. The medicament delivery device according to claim 18, wherein in the initial state, the actuator (3) is located further proximal than in the end state, and in the activated state the actuator is located further proximal than in the initial state with respect to the housing (1).

20. The medicament delivery device according to any one of claims 15 to 19, wherein the actuator sleeve (4) comprises a first recess (41) and a second recess (42) on an inner circumferential surface wherein the first recess (41) is located further towards the proximal end than the second recess (42).

21. The medicament delivery device according to any one of claims 15 to 20, wherein the holding elements (31) of the actuator (3) comprises two proximally directed arms that are flexible in a generally radial direction and wherein the arms are arranged with outwardly directed surfaces (312) engaging an inner surface of said actuator sleeve (4).

22. The medicament delivery device according to any one of claims 18 to 21, wherein in the initial state, the outwardly directed surfaces (312) are located in the first recess (41) blocking outward movement of the arms.

23. The medicament delivery device according to any one of claims 1 to 22, wherein the holding elements (31) of the actuator (3) comprise two proximally directed arms that are flexible in a generally radial direction, wherein the arms are arranged with inwardly directed protrusions (311) engaging corresponding recesses (611) in said plunger rod (6) in the initial state.

24. The medicament delivery device according to any one of claims 21 to 23, wherein in the activated state, the outwardly directed surfaces (312) disengage the first recess (41) allowing the arms to flex outwardly, and wherein the inwardly directed protrusions (311) are configured to disengage corresponding recesses (611) of the plunger rod (6) allowing the plunger rod (6) to be moved in the proximal direction by force of the drive spring (63).

25. The medicament delivery device according to claim 24, wherein, when a distal end of the plunger rod (6) has passed the inwardly directed protrusions (311) during proximal movement of the plunger rod (6), the arms are configured to flex radially inwards during distal movement of the actuator (3) and the actuator (3) is configured to be pushed in the distal direction by a residual force of the drive spring (63).

26. The medicament delivery device according to claim 25, wherein at the end of the distal movement of the actuator (3), a distally directed surface of the actuator (3) is configured to hit a proximally directed surface of the housing (1), giving an audible and / or tactile signal.

27. The medicament delivery device according to any one of claims 18 to 26, wherein in the end state, a distally directed surface of the actuator (3) is configured to abut a proximally directed surface of the housing (1).

28. The medicament delivery device according to any one of claims 15 to 27, wherein the actuator sleeve (4) is moveable in a longitudinal direction with respect to the housing (1) between an initial state and a locked state.

29. The medicament delivery device according to claim 28, wherein in the locked state, the actuator sleeve (4) is located further proximal with respect to the housing (1) than in the initial state.

30. The medicament delivery device according to any one of claims 28 or 29, wherein the actuator sleeve (4) comprises at least one retaining element (43) provided towards a distal end of a flexible arm and configured to abut a distally directed surface (13) of the housing (1) in the initial state of the actuator sleeve (4), thus blocking proximal movement of the actuator sleeve (4) with respect to the housing (1).

31. The medicament delivery device according to claim 30, wherein the distally directed surface (13) is a collar.

32. The medicament delivery device according to any one of claim 30 or 31, wherein the distally directed surface (13) protrudes radially inwards.

33. The medicament delivery device according to any one of claim 30 to 32, wherein in the initial state and the activation state of the actuator (3), an outer circumferential surface of the actuator (3) blocks inward movement of the retaining element (43).

34. The medicament delivery device according to any one of claims 30 to 33, wherein the actuator (3) comprises at least one release recess (34) corresponding to the at least one retaining element (43).

35. The medicament delivery device according to claim 34, wherein in the end state, the at least one release recess (34) is configured to allow the at least one retaining element (43) to flex inwardly, wherein the retaining element (43) disengages the distally directed surface (13) thus allowing the actuator sleeve (4) to move proximally to the locked state.

36. The medicament delivery device according to any one of claims 28 to 35, wherein when the actuator (3) is in the end state and the actuator sleeve (4) is in the locked state, the outwardly directed surfaces (312) of the actuator (3) engage thesecond recess (42) of the actuator sleeve (4) blocking proximal movement of the arms and thus the actuator (3).

37. The medicament delivery device according to any one of claims 15 to 36, wherein an actuator sleeve spring (44) is provided to exert a proximally directed force on the actuator sleeve (4).

38. The medicament delivery device according to any one of claims 17 to 37, wherein the medicament delivery member cover (5) is coupled to the actuator sleeve (4).

39. The medicament delivery device according to any one of claims 28 to 38, wherein the medicament delivery device comprises an injection needle, wherein in the locked state of the actuator sleeve (4), the medicament delivery member cover (5) is configured to cover the injection needle.

40. The medicament delivery device according to any one of claims 1 to 39, wherein the power pack comprises a guide rod (62) provided with fastening elements (621) at its distal end, which fastening elements (621) engage cut-outs on the actuator (3), and wherein the drive spring (63) is arranged between a proximal end wall of the plunger rod (6) and the fastening elements (621).

41. The medicament delivery device according to any one of claims 1 to 40, wherein the manually operable activator (2) further comprises at least one proximally extending leg (27) configured to block distal movement of the manually operable activator (2) with respect to the housing (1).

42. The medicament delivery device according to claim 41, wherein the proximally extending leg (27) comprises at least one locking protrusion (271, 272) configured to engage a collar (13) provided at an inner circumferential surface of the housing (1).43- The medicament delivery device according to claim 42, wherein the collar (13) comprises a leg recess (131) through which the proximally extending legs (27) extend, wherein the leg recess (131) is formed between the collar (13) and an inner circumferential surface of the housing (1).

44. The medicament delivery device according to claim 42 or 43, wherein the at least one locking protrusion (271, 272) is configured to engage a proximally directed surface of the collar (13).

45. The medicament delivery device according to any one of claims 1 to 44, further comprising a syringe holder (71) configured to accommodate the medicament container and a cap (8) removably attached to the housing (1), wherein the syringe holder (71) comprises at least one flexible syringe holder arm (711) configured to block proximal movement of the syringe holder (71) when the cap (8) is attached to the housing (1).

46. The medicament delivery device according to claim 45, wherein the at least one flexible syringe holder arm (711) is configured to engage a syringe holder recess (14) provided at an inner circumferential surface of the housing (1), and wherein the cap (8) is configured to block an inward radial movement of the at least one flexible syringe holder arm (711).

47. The medicament delivery device according to claim 46, wherein, when the cap (8) is removed from the housing (1), the at least one flexible syringe holder arm (711) is configured to flex inwards towards the central longitudinal axis and is configured to clear the syringe holder recess (14) to allow proximal movement of the syringe holder (71).

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