Medicament delivery device and medicament delivery assembly

Abstract

The medicament delivery device for accommodating a medicament container containing a medicament and for expelling multiple doses of the medicament from the medicament container defines a device axis and comprises - a plunger rod device (6) comprising at least one cooperation element (61) and being axially movable; - a biasing device (7) configured to force the plunger rod device (6) in a proximal direction; - a dosing device (8) for controlling a dosing amount for each of the doses. The dosing device (8) comprises multiple retaining structures (81a, 81b, 82a, 82b) configured to cooperate with the at least one cooperation element (61) to block a proximal movement of the plunger rod device (6). For each of the doses applies: - the retaining structures (81a, 81b, 82a, 82b) comprise a respective set comprising a respective first retaining structure (81a, 82a) and a respective second retaining structure (81b, 82b); - the dosing device (8) is rotatable relative to the plunger rod device (6) from a respective first rotational position to a respective second rotational position, in the respective first rotational position, a proximal movement of the plunger rod device (6) is blocked by cooperation of the at least one cooperation element (61) with the respective first retaining structure (81a, 82a), and in the respective second rotational position, a proximal movement of the plunger rod device (6) is blocked by cooperation of the at least one cooperation element (61) with the respective second retaining structure (81b, 82b); - an axial distance between the respective first retaining structure (81a, 82a) and the respective second retaining structure (81b, 82b) defines a respective axial movement of the plunger rod device (6).

Description

[0001] TITLE

[0002] Medicament Delivery Device and Medicament Delivery Assembly

[0003] TECHNICAL FIELD

[0004] The invention is in the field of medicament delivery devices. In particular, it relates to automatic medicament delivery devices and to medicament delivery devices for delivering multiple fixed doses of a medicament.

[0005] BACKGROUND

[0006] Medicament delivery devices for automatic delivery of a medicament by selfadministration are well-known. Especially, they may be equipped to accommodate a medicament container, for example a medicament container with a septum to be perforated immediately prior to use, or a syringe. Often, the medicament delivery device and the medicament container are preassembled to constitute a medicament delivery assembly for selfadministration.

[0007] Such medicament delivery devices and medicament delivery assemblies should generally be safe to use and easy to handle, and they should ensure delivery of the designated dose of the medicament with high accuracy.

[0008] Many such medicament delivery devices which are to deliver a single predetermined dose are "empty all", coming with a pre-filled syringe or vial as medicament container containing said pre-determined dose of the medicament. The dosing accuracy thus depends on the accuracy of the container filling equipment used for filling the container. Accordingly, the medicament delivery device in such cases is only required to empty all the medicine contained in the container.

[0009] In many applications, pre-determined (preset) medicament doses have to be delivered repeatedly. In view of environmental considerations, it is undesirable in that case to use pre-filled single-dose medicament delivery devices and dispose one of those for each dose to be delivered (disposable auto-injectors). And even when using a medicament delivery device in which the medicament container can be replaced, it is still undesirable to dispose a (single-dose) medicament container for each medicament delivery.

[0010] One way of lowering the carbon footprint here is to reduce the amount of material involved, in particular plastics. This can be accomplished by allowing for the medicament delivery device to deliver multiple doses instead of only one.

[0011] Such multi-dose medicament delivery devices (also referred to as partial doses medicament delivery devices) on the other hand, cannot depend on the filling equipment for dosing accuracy and are instead relying on the device design, i.e., the medicament delivery device has to comply with corresponding regulations such as ISO requirements for dose accuracy. Thus, the medicament delivery device has to comprise a mechanism for reliably delivering accurate medicament doses. To fulfil such requirements, for each of the doses to be delivered, the dosing amount (dose volume) should be dependent on as few components as possible to minimize the risk of tolerance stack-up possibly causing an under- or overdose. Manufacturing tolerances need to be low, and long links of assembled parts need to be avoided.

[0012] SUMMARY

[0013] Therefore, one object of the invention is to create a new medicament delivery device for delivering multiple preset doses of a medicament from a medicament container.

[0014] Another object of the invention is to create a medicament delivery device which is particularly environment-friendly and / or has a small carbon footprint.

[0015] Furthermore, the medicament delivery device should be advantageous in terms of safety, reliability, ease of use. Further objects and various advantages emerge from the description and embodiments below.

[0016] These objects are at least partially achieved by devices and assemblies according to the patent claims.

[0017] The medicament delivery device is a medicament delivery device for accommodating a medicament container containing a medicament and for expelling multiple doses of the medicament from the medicament container, in particular wherein for each of the doses, the respective dosing amount is predetermined.

[0018] The medicament delivery device defines a device axis, more particularly a proximodistal axis, and comprises a plunger rod device comprising at least one cooperation element, e.g., a protrusion, and being axially movable; a biasing device, e.g., a spring, configured to force the plunger rod device in a proximal direction; a dosing device for controlling a dosing amount for each of the doses.

[0019] The plunger rod device, more particularly, can be cooperating with a stopper device of the medicament container.

[0020] The at least one cooperation element, more particularly, can be axially movable relative to the medicament container; e.g., a plunger rod of the plunger rod device can comprise the cooperation element and can be axially movable relative to the medicament container.

[0021] Furthermore, the dosing device comprises multiple retaining structures configured to cooperate with the at least one cooperation element to block a proximal movement of the plunger rod device, wherein for each of the doses: the retaining structures comprise a respective set comprising a respective first retaining structure and a respective second retaining structure; the dosing device is rotatable relative to the plunger rod device from a respective first rotational position to a respective second rotational position, in the respective first rotational position, a proximal movement of the plunger rod device is blocked by cooperation of the at least one cooperation element with the respective first retaining structure, and in the respective second rotational position, a proximal movement of the plunger rod device is blocked by cooperation of the at least one cooperation element with the respective second retaining structure; an axial distance between the respective first retaining structure and the respective second retaining structure defines a respective axial movement of the plunger rod device.

[0022] Such a multi-dose fixed-dose medicament delivery device, in particular autoinjector, can enable to successively expel accurate pre-determined dosing amounts from a single medicament container. The dosing device can provide stops for inhibiting proximal movement of the plunger rod device which come into effect at different rotational positions (of the dosing device relative to the plunger rod device, more particularly to at least one cooperation element), such that the plunger rod device can move (forced by the biasing device), in reaction to a rotation (from a first to a second such rotational position), from an initial axial position taken at the beginning of a delivery of a dose to a final axial position taken at the end of a delivery of the respective dose. The plunger rod device can thus cooperate with a stopper device of the medicament container so as to proximally move the stopper device from an initial position (at the beginning of a delivery) to a final position (at the end of a delivery). For example, the plunger rod device can abut the stopper device in its initial axial position and in its final axial position. The dosing amount can be defined by the axial distance between the initial position and the final position of the stopper device which again can be defined by the axial distance between the initial axial position and the final axial position of the plunger rod device.

[0023] Said axial movement is also sometimes referred to as axial stroke and can define the respective dosing amount of the respective dose.

[0024] In embodiments, the dosing device is, relative to the plunger rod device, rotatable about the device axis or about an axis parallel thereto.

[0025] In embodiments, the dosing device describes a tubular shape, in particular wherein the tubular shape extends along the device axis. In particular, the retaining structures are present on an inner side of the tubular shaped dosing device. More particularly, the at least one cooperation element is arranged inside the tubular shaped dosing device.

[0026] In embodiments, each of the retaining structures comprises an abutting surface, more particularly the abutting surfaces cooperate with the at least one cooperation element to block the proximal movement of the plunger rod device, and said axial distance defining a respective axial movement of the plunger rod device can be an axial distance between the respective abutting surfaces.

[0027] In embodiments, said proximal movements of the plunger rod device are blocked by the at least one cooperation element abutting the abutting surface of the respective retaining structure.

[0028] In embodiments, the plunger rod device comprises a housing, and the plunger rod device is rotationally fixed relative to the housing and proximally movable relative to the housing, and the dosing device is rotatable relative to the housing and is, in particular proximodistally fixed relative to the housing.

[0029] In embodiments, the medicament delivery device comprises a clutch device, and the dosing device comprises engaging structures, the clutch device comprising first engaging structures cooperating with the engaging structures of the dosing device. And the clutch device is configured to be axially movable, in particular proximally movable, to engage, for each of the doses, the first engaging structures with the engaging structures of the dosing device to effect a rotation of the dosing device in a first sense of rotation, e.g., cw, from the respective first rotational position to the respective second rotational position.

[0030] This way, an axial movement (of the clutch device) can be used to activate the medicament delivery device. E.g., to start the medicament delivery, a user can operate an activation button by pressing, and a corresponding axial movement, e.g., proximal movement, of the activation button can be coupled to the clutch device which, accordingly, moves proximally then. The rotation of the dosing device can be derived from the proximal movement of the clutch device by the cooperation of the first engaging structures with the engaging structures of the dosing device.

[0031] In embodiments, the clutch device is blocked against rotation in a second sense of rotation, e.g., ccw, which is opposite the first sense of rotation. This way, it can be ensured that, upon engagement of the engaging structures of the dosing device and the first engaging structures, the dosing device rotates; it is avoided that upon said engagement, the clutch device rotates while the dosing device does not rotate.

[0032] In embodiments, the engaging structures of the dosing device and the first engaging structures (of the clutch device) comprise inclined sections cooperating when engaging, thus they can convert a translational relative movement into a rotational relative movement. E.g., the engaging structures of the dosing device and the first engaging structures (of the clutch device) can comprise a sawtooth-like profile, e.g., along a circumference of the respective device.

[0033] In embodiments, the medicament delivery device comprises an alignment member, the alignment member comprising engaging structures, and the clutch device comprising second engaging structures cooperating with the engaging structures of the alignment member. The clutch device is configured to be axially movable, in particular distally movable, to engage, for each of the doses, the second engaging structures with the engaging structures of the alignment device to effect a rotation of the clutch device, in particular in the first sense of rotation.

[0034] This way, it is possible to achieve that the clutch device is rotationally realigned; the first engaging structures are then not in line anymore with the engaging structures of the dosing device. And this can enable to rotate the dosing device further when afterwards the first engaging structures again engage with the engaging structures of the dosing device.

[0035] In embodiments, the alignment device is blocked against rotation.

[0036] In embodiments, the medicament delivery device comprises a rotation mechanism configured to cause, at least for a first of the doses, a rotation of the clutch device, in particular in the first sense of rotation. Said rotation can more particularly be caused after the respective engagement of the first engaging structures with the engaging structures of the dosing device and before the dosing device is in the respective second rotational position.

[0037] Such a rotation mechanism is particularly useful to ensure that a suitable rotation of the clutch device is effected by the engagement of the second engaging structures with the engaging structures of the alignment device. It can be avoided that, when said engagement takes place, a relative rotational alignment of the second engaging structures and the engaging structures of the alignment device prevails which would cause no rotation of the clutch device. E.g., it can be avoided that the second engaging structures and the engaging structures of the alignment device are in line with one another.

[0038] Said rotation mechanism in particular can be provided for all of the doses or for all of the doses except for the last one, as said rotation of the clutch device is particularly useful for a respective subsequent dose, and there is no subsequent dose for the last dose. In embodiments, the rotating mechanism is configured to cause, at least for a first of the doses, a further rotation of the dosing device in the first sense of rotation.

[0039] Said further rotation can more particularly be caused after the respective engagement of the first engaging structures with the engaging structures of the dosing device and before the dosing device is in the respective second rotational position.

[0040] Said further rotation can more particularly be caused during the respective engagement of the first engaging structures with the engaging structures of the dosing device.

[0041] Said further rotation of the dosing device can cause said rotation of the clutch device by cooperation of the engaging structures of the dosing device with the first engaging structures, in particular due to the engagement of the engaging structures of the dosing device with the first engaging structures.

[0042] In embodiments, the engaging structures of the dosing device and the first engaging structures (of the clutch device) comprise steep sections cooperating when engaged, thus they can derive a rotational movement of the clutch device from a rotational movement of the dosing device. E.g., the engaging structures of the dosing device and the first engaging structures (of the clutch device) can comprise a sawtooth-like profile, e.g., along a circumference of the respective device. The steep sections can in particular can be aligned parallel to the device axis.

[0043] Said further rotation in particular can be provided for all of the doses or for all of the doses except for the last one, as said rotation of the clutch device is particularly useful for a subsequent dose, and there is no subsequent dose for the last dose.

[0044] In embodiments, an angle between the steep sections and the device axis is smaller than an angle between the inclined sections and the device axis. This is the case, e.g., in sawtooth-like profiles. In embodiments, the rotating mechanism comprises, at least for a first of the doses, one or more portions of the retaining structures. In particular, the portions can be configured to cooperate with the at least one cooperation element to convert a proximal force exerted by the at least one cooperation element on the one or more portions into a force causing said further rotation. Said portions can in particular be inclined portions.

[0045] This way, the force exerted by the biasing device can be used to effect the further rotation (of the dosing device). And furthermore, this way, said further rotation can be effected without a need for the user to take an extra action to achieve the further rotation.

[0046] Said one or more portions of the retaining structures in particular can be provided for all of the doses or for all of the doses except for the last one, as said further rotation is particularly useful for a subsequent dose, and there is no subsequent dose for the last dose.

[0047] In embodiments, the clutch device is axially arranged between the dosing device and the alignment member.

[0048] In embodiments, the medicament delivery device comprises a first activation device configured to be operable by a user, and the clutch device and the first activation device are coupled to one another to lock their axial movements. The first activation device in particular can be an activation button.

[0049] This way, a user action, such as pressing the activation button, can proximally move the clutch device. And this again can effect the engagement of the first engaging structures with the engaging structures of the dosing device effecting the rotation of the dosing device.

[0050] In embodiments, the medicament delivery device further comprises a second force device, e.g., a spring, cooperating with the first activation device to force the first activation device, e.g., distally. This way, e.g., the medicament delivery device can present a force against the operation (e.g., pressing) of the first activation device (e.g., activation button) and can, after operation, move back, e.g., distally, (unless blocked), to be operable again.

[0051] In embodiments, the medicament delivery device further comprises a second activation device cooperating with the first activation device to selectively block a distal movement of the first activation device. This way, the first activation device can be held in an operated (e.g., pressed) position by the second activation device, in particular until operation of the second activation device lets the first activation device (and in particular also the clutch device) move back, e.g., move distally.

[0052] The second activation device in particular can be a rotating activation device, e.g., an activation dial.

[0053] The second activation device can be biased, e.g., spring-loaded, by a third force device, e.g., by a third spring. In particular, the third force device can be configured to counteract forces moving the second activation device out of a rest position, e.g., deflecting the second activation device. The third force device can, e.g., return the second activation device after such movements (e.g., deflections) into the rest position.

[0054] The second activation device can comprise blocking structures, e.g., protrusions, for accomplishing said blocking. The blocking structures, e.g., can cooperate with structures, e.g., protrusions, of the first activation device. In particular, said structures can be comprised in a snap fit connection formed between the first and the second activation devices.

[0055] A sequence of some subsequent steps during the operation of the medicament delivery device in a particular embodiment and of the corresponding medicament delivery device assembly can be as follows:

[0056] In a ready state in which the clutch device and the aligning device are engaged with one another (via their respective engaging structures), the plunger rod device being axially unmoved (the cooperation element cooperating with first retaining structure), the first activation device is operated, which starts a dosing phase bringing the medicament delivery device into a dosing state. By proximally moving the first activation device and the clutch device, the clutch device engages with the dosing device (via their respective engaging structures) and thus rotates the dosing device from the first into the second rotational position, the plunger rod device is thus not blocked anymore by first retaining device, thus letting the plunger rod device move proximally for a predetermined axial distance which results in expelling a predetermined amount of the medicament; and because of the rotation mechanism, e.g., through cooperation of the cooperation elements with (inclined) portions of the retaining structures, the dosing device is further rotated causing a corresponding rotation of the clutch device.

[0057] At the end of the dosing phase, proximal movement of the plunger rod device is stopped by the dosing device, more particularly by the second retaining structure (dose delivery is finished).

[0058] Then, by operation of the second activation device, the first activation device is unblocked and thus can move distally, accordingly the clutch device moves distally, until blocked by the alignment device. Because of the rotation of the clutch device, the clutch device is then still further rotated by interaction of the respective engaging structures (of the clutch device and of the alignment device, respectively), so that the first retaining structures of the clutch device are not in line anymore with the engaging structures of the dosing device.

[0059] Now, the ready state is reached again, and upon another operation of the first activation device, the clutch device can rotate the dosing device again as described to effect delivery of the next dose.

[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.

[0062] Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.

[0063] 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.

[0064] BRIEF DESCRIPTION OF THE DRAWINGS

[0065] Embodiments of the present disclosure will now be described by way of example only and with reference to the following accompanying drawings.

[0066] Figure 1A a medicament delivery device assembly;

[0067] Figure 1B a cross-sectional view of the medicament delivery device assembly of Fig. 1;

[0068] Figure 2 an exploded view of parts of the medicament delivery device assembly of Fig. 1;

[0069] Figure 3 an exploded view of parts of the medicament delivery device of Fig. 1, in a perspective view; Figure 4 a perspective view of the dosing device of the medicament delivery device of Fig. 1;

[0070] Figure 5 a wireframe-drawing (without hidden line removal) of the dosing device of the medicament delivery device of Fig. 1;

[0071] Figure 6A a perspective view of the activation button of the medicament delivery device of Fig. 1;

[0072] Figure 6B a perspective view of the clutch device of the medicament delivery device of Fig. 1;

[0073] Figure 6C a perspective view of an assembly of the clutch device and the activation button of the medicament delivery device of Fig. 1;

[0074] Figure 7 a perspective view of an assembly of the clutch device and the proximal housing part of the medicament delivery device of Fig. 1;

[0075] Figure 8 a perspective view of the activation dial of the medicament delivery device of Fig. 1;

[0076] Figures 9A - 9D the medicament delivery device of Fig. 1 in different states (some parts are not shown).

[0077] The described embodiments are meant as examples or for clarifying the invention and shall not limit the invention.

[0078] DETAILED DESCRIPTION

[0079] Fig. 1A shows a medicament delivery device assembly 1 comprising a medicament delivery device 2 and a medicament container 3. Fig. 1B shows a cross-section of the medicament delivery device assembly 1. Fig. 2 shows the medicament delivery device assembly 1 in an exploded view.

[0080] Medicament container 3 contains an amount of a medicament (not shown in the Figures) and can be a cartridge. It comprises a proximal seal 3a, such as a septum, to be pierced prior to use, and it can comprise a cap, as shown. It further comprises a stopper 3b such as a plunger, proximally movable for forcing a medicament contained in the medicament container 3 through a needle 5a, e.g., a cannula, having pierced seal 3a.

[0081] Medicament delivery device 2 is embodied as a multi-dose fixed-dose medicament delivery device. It defines an axis A (a proximodistal axis) and comprises a housing 4 which optionally can comprise a proximal housing part 4a (or container housing) and a distal housing part 4b, as shown in the figures, which can be engaged to one another. Proximal housing part 4a accommodates medicament container 3.

[0082] A needle assembly 5 comprising the needle 5a is attachable to and removable from proximal housing part 4a. Since medicament delivery device 2 is a multi-dose medicament delivery device, a new needle assembly 5 is attached to proximal housing part 4a each time before another dose is to be delivered.

[0083] Medicament delivery device 2 further comprises a plunger rod device 6, such as a plunger rod, for cooperating with stopper 3b to move stopper 3b in proximal direction for expelling portions of the medicament from the medicament container 3 through an attached needle 5a.

[0084] Medicament delivery device 2 comprises a biasing device, e.g., a first spring 7, configured to force plunger rod device 6 proximally. Other types of springs and other biasing devices could also be used. Further, it comprises a dosing device 8 controlling a dosing amount for each of the doses of the medicament to be expelled one after the other. Dosing device 8 is shown in more detail in Figs. 3, 4 and will be discussed in more detail further below. Furthermore, dosing device 8 can also control a release of plunger rod device 6, more particularly, the rotational position of dosing device 8 controls whether or not a proximal movement of plunger rod device 6 can take place or is blocked.

[0085] Medicament delivery device 2 further comprises an activation button 10 and an activation button force device, such as a second spring 11, an activation dial 12 and an activation dial force device, such as a third spring 13. These (and their respective functions) could also be replaced by other activation devices and respective force devices.

[0086] Furthermore, medicament delivery device 2 comprises an alignment member 14 and a clutch device 9 which cooperates with alignment member 14 and dosing device 8 to effect a step-wise rotation of dosing device 8.

[0087] For accomplishing that for each dose to be expelled, the respective dosing amount of the medicament is fixed (pre-determined), dosing device 8 and plunger rod device 6 cooperate to ensure that plunger rod device 6 has a predefined plunger stroke, i.e., movements proximally along a pre-defined path length. For this, dosing device 8 comprises multiple retaining structures which cooperate with one or, as illustrated, two cooperation elements 61 of plunger rod device 6. For increased stability and to avoid tilting, two cooperation elements 61 are provided at symmetric positions about the axis A. The cooperation elements 61 have abutting surfaces 61 which, at the beginning of the expelling of a dose, are in contact with a first retaining structure 81a, more precisely with an abutting surface constituted by first retaining structure 81a (first abutting surface), and which, at the end of the expelling of the dose, are in contact with a second retaining structure 81b, more precisely with an abutting surface constituted by second retaining structure 81b (second abutting surface). Accordingly, a start position of the proximal movement of plunger rod device 6 for the expelling of a dose is well- defined (first spring 7 forcing plunger rod device 6 proximally, the proximal movement being blocked by the first retaining structure 81a); and an end position of the proximal movement of plunger rod device 6 for the expelling of a dose is well-defined (first spring 7 forcing plunger rod device 6 proximally, the proximal movement being blocked by the second retaining structure 81b).

[0088] The proximal stroke of plunger rod device 6 is thus defined and predetermined by an axial distance of the respective first retaining structure 81a and second retaining structure 81b; in the illustrated embodiment, said distance is even identical to said proximal stroke, but however can be different in other embodiments. In Fig. 5, said axial distance is illustrated by a double arrow.

[0089] For each of the doses, a corresponding pair of retaining structures is provided. In Fig. 4, two such pairs (retaining structures 81a, 81b and retaining structures 82a, 82b) are shown. In the illustrated embodiment, there are even two such pairs for each of the doses, one for cooperating with a first one of the cooperation elements 61 and another one for cooperating with the other one of the cooperation elements 61.

[0090] Furthermore, as shown in Fig. 4, a first retaining structure 81a of a pair can be identical to a second retaining structure 82b of another pair. In other words, a final axial position of the plunger rod device for one dose (defined by retaining structure 81b) can be identical to an initial axial position of the plunger rod device for another dose, in particular for the next dose (defined by retaining structure 82a). However, other implementations are possible.

[0091] In the illustrated embodiment, the retaining structures are protrusions protruding from dosing device 8, but other embodiments are possible. E.g., the protrusions are protruding inwardly, from an inner surface of dosing device 8. In another example, they could be protruding from an outer surface of dosing device 8.

[0092] In the illustrated embodiment, dosing device 8 forms a tubular body, however other implementations are possible.

[0093] In the illustrated embodiment, the retaining structures form a shelf structure, however other implementations are possible.

[0094] Now turning to the way dosing device 8 is suitably rotated and to the operation of the medicament delivery device 2.

[0095] Alignment member 14 is fixed to distal housing part 4b, e.g., like in the illustrated embodiment, by means of a snap fit connection provided by opening 41 and part 14a (cf. Fig. 2). Thus, alignment member 14 neither rotates nor translates relative to housing 4.

[0096] Activation dial 12 comprises a set of blocking structures comprising blocking structures 12a and 12b (cf. Fig. 8). Activation button 10 comprises protrusions 10c which can be formed at an end of a lever arm lod (cf.

[0097] Fig. 6A) and which cooperate with said blocking structures 12a, 12b as will be explained below.

[0098] Clutch device 9 is locked to activation button 10, such that their axial movements (proximally and distally) are fixedly coupled to one another, e.g., like in the illustrated embodiment, by means of two snap fit connections, such as provided by protrusions 9a of clutch device 9 cooperating with openings 10b of activation button 10 on the one hand and by protrusions 10a of activation button 10 cooperating with opening 9b of clutch device 9 on the other hand; cf. Figs. 6A, 6B, 6C. Clutch device 9 and activation button 10 could alternatively be embodied as a unitary part or be integrally formed - if assembly of the medicament delivery device 2 is then still possible.

[0099] Furthermore, in the illustrated embodiment, a rotation (about axis A) of clutch device 9 in a (second) sense of rotation, such as ccw (counterclockwise), is blocked, e.g., as illustrated, by blocking elements 9c of clutch device 9 (cf. Figs. 6B, 6C) cooperating with blocking elements 42, e.g., ribs, of housing 40 (more particular of proximal housing part 4a), cf.

[0100] Figs. 6B, 6C and 7.

[0101] Clutch device 9 comprises first engaging structures 91 cooperating with engaging structures 83 of dosing device 8, and further comprises second engaging structures 92 cooperating with engaging structures 141 of alignment member 14.

[0102] While alignment member 14 is locked versus rotation relative to housing 4 (by the snap fit connection provided by opening 41 and part 14a mentioned above), both, clutch device 9 and dosing device 8 are rotatable (about axis A). The cooperation between engaging structures 141 and engaging structures 92 enables to derive a rotation of clutch device 9 from a translation of clutch device 9 (at least when these engaging structure are not in line). And the cooperation between engaging structures 83 and engaging structures 91 enables to effect (i) a rotation (cw; clockwise) of dosing device 8 from a translation (proximally) of clutch device 9, and (ii) a rotation of clutch device 9 (cw) from a rotation of dosing device 8 (cw).

[0103] Activation of the medicament delivery device 2 requires two steps.

[0104] In a first activation step (which can be considered a preparatory step), which precedes a second activation step (at least after the first dose has been expelled), clutch device 9 is re-positioned (rotation-wise) with respect to dosing device 8, and at the same time, activation button 10 is released, i.e. is distally moved, by the force exerted by second spring 11, from a first position (inner position; Figs. 9A, 9D) to a second position (outer position; Fig. 9C). This is accomplished by turning (rotating) activation dial 12 (no matter whether cw or ccw) against the force exerted by third spring 13 (from a rest position to a deflected position), such that protrusions 10c (cf. Fig. 6A) of activation button 10, which, in cooperation with blocking structures 12a (cf. Fig. 8), did initially block a distal movement of activation button 10 (forced by second spring 11), can move distally to reach an intermediate position. In the intermediate position, a further distal movement of activation button 10 is blocked by cooperation of protrusions 10c and blocking structures 12b (cf. Fig. 8). As explained above, said distal movement of activation button 10 will effect a corresponding distal movement of clutch device 9.

[0105] When then activation dial 12 is released (and allowed to return into its rest position), a further distal movement of activation button 10 is not blocked anymore (not blocked anymore by cooperation of protrusions 10c and blocking structures 12b), and activation button 10 can move distally to reach said second position (outer position; Fig. 9C) in which it is ready to be operated (pressed) again, so as to be ready for the second activation step. As explained above, the distal movement of activation button 10 will effect a corresponding distal movement of clutch device 9. At the beginning of the first activation step, clutch device 9, more particularly its first engaging structures 91, are engaged with engaging structures 83 of dosing device 8. By said corresponding distal movement of clutch device 9, clutch device 9, more particularly its second engaging structures 92, are brought into contact with (and are engaged with) engaging structures 141 of alignment member 14. And first engaging structures 91 and engaging structures 83 are disengaged.

[0106] The engaging structures (83, 91, 92, 141) comprise steep sections, which in particular can be aligned parallel to axis A, and inclined sections, as is exemplarily shown in Fig. 6B for engaging structures 92 of clutch device 9, indicating inclined sections 92a and steep sections 92b; cf. also inclined sections 91a and steep sections 91b in Fig. 6C.

[0107] The inclined sections 92a can be sloped portions. The engaging structures (83, 91, 92, 141) can describe, as in the illustrated embodiment, a sawtoothlike profile.

[0108] Since, at the beginning of the first activation step, the steep sections of engagement structures 92 are not in line with the steep sections of engagement structures 141, the distal movement of clutch device 9 effects a rotation of clutch device 9, more particularly in the ccw rotation, as alignment member 14 cannot rotate. Clutch device 9 is this way reset to its original position.

[0109] In the second activation step, the user operates, more particularly presses, activation button 10, thus proximally moving clutch device 9, which again effects that clutch device 9 and dosing device 8 engage (with their respective engaging elements 91, 83); and engaging elements 92 and 141 disengage. A cw rotation of dosing device 8 is this way effected (as will be described below; ccw rotation of clutch device 9 is prevented, cf. above), moving dosing device 8 out of a first rotational position, which again effects that plunger rod device 6 is not anymore blocked from moving proximally by a respective first retaining structure, such that first spring 7 can move plunger rod device 6 proximally, such that a respective fixed dose is expelled, wherein expelling the dose ends when plunger rod device 6 is blocked from moving further proximally by a respective second retaining structure; as described above.

[0110] In Figs. 9A to 9D, show the medicament delivery device 2 in different states, wherein some parts of medicament delivery device 2 are not shown, such as housing 4.

[0111] Fig. 9A illustrates the situation at the beginning of the first activation step (activation button 10 in the first (inner) position; activation dial 12 in the rest position).

[0112] Fig. 9B illustrates the situation during the first activation step, with activation button 10 in the intermediate position, and with activation dial 12 in the deflected position.

[0113] Fig. 9C illustrates the situation at the end of the first activation step, with activation button 10 in the second (outer) position, and with activation dial 12 again in the rest position.

[0114] Fig. 9D illustrates the situation at the end of the second activation step, with activation button 10 again in the first (inner) position, and with activation dial 12 still in the rest position. This situation can correspond to the situation illustrated in Fig. 9A, but for the next dose.

[0115] In order to ensure that clutch device 9 is in a suitable rotational position at the start of the first activation step, a mechanism should be present which effects this, i.e., a mechanism which rotates clutch device 9, e.g., further cw, after clutch device 9 has disengaged from alignment member 14 and before it re-engages alignment member 14 at the end of the first activation step. Various mechanisms can be used to accomplish this. In the illustrated embodiment, a particular elegant mechanism is implemented. This mechanism involves inclined portions 84 of the retaining structures, cf. Fig. 4. One can say it creates an “over-rotation” of dosing device 8. When engaging structures 91 have engaged engaging structures 83 and effected the corresponding cw rotation of dosing device 8 provided by the interaction of clutch device 9 and dosing device 8, dosing device 8 will move out of the first rotational position towards a second rotational position and let plunger rod device 6 movement proximally (dosing device 8 discontinues blocking of the proximal movement). However, during this, cooperation elements 61 of plunger rod device 6 (biased by first spring 7) will effect an additional cw rotation of dosing device 8, namely when they cooperate with the inclined portions 84 of dosing device 8, as dosing device 8 is rotatable, whereas plunger rod device 6 is not. And, since engaging structures 91 are engaged with engaging structures 83, this extra cw-rotation will cause a corresponding extra cw rotation of clutch device 9 (which cannot rotate ccw). Thus, the interaction of plunger rod device 6, spring 7 and dosing device 8 causes an extra ccw rotation of clutch device 9, so that at the beginning of the first activation step, clutch device 9, more particularly its engaging structures 92 are not in line with engaging structures 141 of alignment member 14 (which they would be in case there were no rotation mechanism). Accordingly, when clutch device 9 and alignment member 14 engage (towards the end of the first activation step), the cooperation between engaging members 91 and 141 leads to a further cw rotation of clutch device 9 (alignment member 14 does not rotate).

[0116] Therefore, when clutch device 8 and dosing device 7 engage the next time (for the next dose), their engaging members 91 and 83 are not in line, such that dosing device 8 is further cw rotated (out of the respective first rotational position for the next dose towards the respective second rotational position for said next dose) , so as to let plunger rod device 6 move proximally for said next dose, involving the next pair of retaining structures.

[0117] Of course, the medicament delivery device can as well be embodied with the senses of rotation (cw; ccw) inverted (to ccw; cw). Besides, embodiments with merely cw rotations are possible, and embodiments with merely ccw rotations are possible too. As will have become clear, the illustrated medicament delivery device 2 (and medicament delivery device assembly 1) is suitable for multi-dose, fixed-dose injection in a safe way, such that medically trained personnel and also not specifically medically trained people such as a patient himself / herself can apply it, as an autoinjector.

[0118] Due to the functioning of the medicament delivery device, the plunger rod device, e.g., an abutting surface of a plunger rod of the plunger rod device, can be operating a stopper device of the medicament container continuously from the beginning of the delivery of the first dose until the end of the delivery of the last dose. No mechanical play (or, at most, a negligible mechanical play) is present during that between the plunger rod device and the stopper device. Thus, the medicament delivery device can be operated without a need for priming after start of the delivery of the first dose.

[0119] Dosing amounts can be delivered with high accuracy.

[0120] The delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0121] 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, Behget’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.

[0122] 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.

[0123] 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.

[0124] 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, 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 (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 (CDwi23) 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, tumorinfiltrating lymphocytes (TIL) therapies, or T-cell receptor (TCR) therapies.

[0125] 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.

[0126] 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. 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.

[0127] 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.

[0128] 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. 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.

[0129] 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, 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, MAID, AIM, VAC-IE, ADOC, or PE.

Claims

CLAIMS1. A medicament delivery device (2) for accommodating a medicament container (3) containing a medicament and for expelling multiple doses of the medicament from the medicament container (3), the medicament delivery device (2) defining a device axis (A) and comprising a plunger rod device (6) axially movable, comprising at least one cooperation element (61); a biasing device (7) configured to force the plunger rod device (6) in a proximal direction; a dosing device (8) for controlling a dosing amount for each of the doses, the dosing device (8) comprising multiple retaining structures (81a, 81b, 82a, 82b) configured to cooperate with the at least one cooperation element (61) to block a proximal movement of the plunger rod device (6); wherein for each of the doses: the retaining structures (81a, 81b, 82a, 82b) comprise a respective set comprising a respective first retaining structure (81a, 82a) and a respective second retaining structure (81b, 82b); the dosing device (8) is rotatable relative to the plunger rod device (6) from a respective first rotational position to a respective second rotational position; in the respective first rotational position, a proximal movement of the plunger rod device (6) is blocked by cooperation of the at least one cooperation element (61) with the respective first retaining structure (81a, 82a); and in the respective second rotational position, a proximal movement of the plunger rod device (6) is blocked by cooperation of the at least one cooperation element (61) with the respective second retaining structure (81b, 82b);an axial distance between the respective first retaining structure (8ia, 82a) and the respective second retaining structure (81b, 82b) defines a respective axial movement of the plunger rod device (6).

2. The medicament delivery device (2) according to claim 1, comprising a clutch device (9), the dosing device (8) comprising engaging structures (83), the clutch device (9) comprising first engaging structures (91) cooperating with the engaging structures (83) of the dosing device (8), the clutch device (9) being configured to be axially movable, in particular proximally movable, to cause, for each of the doses, an engagement of the first engaging structures (91) with the engaging structures (83) of the dosing device (8) to effect a rotation of the dosing device (8) in a first sense of rotation from the respective first rotational position to the respective second rotational position, in particular wherein the clutch device (9) is blocked against rotation in a second sense of rotation which is opposite the first sense of rotation.

3. The medicament delivery device (2) according to claim 2, comprising an alignment member (14), the alignment member (14) comprising engaging structures (141), the clutch device (9) comprising second engaging structures (92) cooperating with the engaging structures (141) of the alignment member (14), the clutch device (9) being configured to be axially movable, in particular distally movable, to engage, for each of the doses, the second engaging structures (92) with the engaging structures (141) of the alignment device (14) to effect a rotation of the clutch device (14), in particular a rotation of the clutch device (14) in the first sense of rotation; in particular wherein the alignment device (14) is blocked against rotation.

4. The medicament delivery device (2) according to claim 2 or claim 3, comprising a rotation mechanism configured to cause, at least for a first of the doses, a rotation of the clutch device (9), in particular in the first sense of rotation, after the respective engagement of the first engaging structures (91) with the engaging structures (83) of the dosing device (8) and before the dosing device (8) is in the respective second rotational position.

5. The medicament delivery device (2) according to claim 4, the rotating mechanism being configured to cause, at least for a first of the doses, a further rotation of the dosing device (8) in the first sense of rotation after the respective engagement of the first engaging structures (91) with the engaging structures (83) of the dosing device (8) and before the dosing device (8) is in the respective second rotational position.

6. The medicament delivery device (2) according to claim 5, the rotating mechanism comprising, at least for a first of the doses, one or more inclined portions (84) of the retaining structures (84), in particular wherein the inclined portions (84) are configured to cooperate with the at least one cooperation element (61) to convert a proximal force exerted by the at least one cooperation element (61) on the one or more inclined portions (84) into a force causing said further rotation.

7. The medicament delivery device (2) according to one of claims 2 to 6, the clutch device (9) being axially arranged between the dosing device (8) and the alignment member (14).

8. The medicament delivery device (2) according to one of claims 2 to 7, comprising a first activation device (10), in particular an activation button (10), configured to be operable by a user, axial movements of the first activation device and of the clutch device being locked to one another.

9. The medicament delivery device (2) according to claim 8, further comprising a second force device (11) cooperating with the first activation device (10) to distally force the first activation device (10).

10. The medicament delivery device (2) according to claim 9, further comprising a second activation device (12), in particular an activation dial (12), cooperating with the first activation device (10) to selectively block a distal movement of the first activation device (10).

11. A medicament delivery assembly (1), comprising the medicament delivery device (2) according to one of claims 1 to 10, further comprising themedicament container (3) assembled with the medicament delivery device (2).

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