WO2025195751A1

WO2025195751A1 - Medicament delivery device and medicament delivery assembly

Info

Publication number: WO2025195751A1
Application number: PCT/EP2025/055622
Authority: WO
Inventors: Staffan BURÉN; Daniel SÄLL; Daniel Carlsson
Original assignee: SHL Medical AG
Current assignee: SHL Medical AG
Priority date: 2024-03-18
Filing date: 2025-03-03
Publication date: 2025-09-25
Anticipated expiration: 2026-09-18

Abstract

The medicament delivery device (2) comprises a plunger rod device (7) proximally movable for expelling the medicament from a medicament container (3); a driver biasing member (9); and a driver assembly biased by the driver biasing member (9) and coupled to the plunger rod device (7), configured carry out, biased by the driver biasing member (9), a driver movement, the driver movement causing the expelling movement. It further comprises a dose setting mechanism for setting a dosing amount for a dose of the medicament (33) to be expelled, the dose setting mechanism comprising a dosing element (62) operable by a user by moving it relative to the driver assembly in a setting movement to set a dosing amount for a dose of the medicament to be expelled. And it further comprises an end lock mechanism comprises a locking device (10); a first coupling structure (107) comprised in the locking device (10); a second coupling structure (71) comprised in the plunger rod device (7); and a linkage structure (110) comprised in the locking device (10). The first coupling structure (107) and the second coupling structure (71) are configured - to engage when the plunger rod device (7) moving proximally reaches an axial threshold position while the locking device (10) is a non-linking position; and - when engaged, to axially couple the locking device (10) to the plunger rod device (7) to cause, in reaction to the plunger rod device (7) moving from the threshold position towards proximally into an end position, a movement of the locking device (10) from the non-linking position towards proximally into a linking position.

Description

Medicament Delivery Device and Medicament Delivery Assembly

TECHNICAL FIELD

The invention is in the field of medicament delivery devices. In particular, it relates to automatic medicament delivery devices. The invention more particularly relates to medicament delivery devices for delivering multiple doses of a medicament from one medicament container, more specifically, wherein a user can set the dosing amount to be delivered (variable dose medicament delivery device).

BACKGROUND

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 (or another seal) to be perforated immediately prior to use, or a syringe. Often, the medicament delivery device and the medicament container are pre-assembled to constitute a medicament delivery assembly for self-administration.

Automatic medicament delivery devices are known which have a pretensioned spring which stores and provides, when a dose release mechanism is activated, the energy required for expelling the medicament from the medicament container.

Furthermore, medicament delivery device are known which can expel multiple doses of a medicament from one medicament container, wherein for each dose, the user can set a desired dosing amount by means of a dose setting mechanism. Some dose setting mechanisms even make possible to correct a false setting of a dosing amount, which, e.g., can avoid having to discard a portion of the medicament if the user accidentally has set a too high dosing amount. On the one hand, re-usable medicament delivery devices are known, where the medicament container can be replaced, such that, e.g., one can replace a used, e.g., empty, medicament container by a new (completely filled) medicament container. On the other hand, there are disposable medicament delivery devices which are to be discarded after a number of expelled doses; the medicament container cannot be replaced.

SUMMARY

In case of disposable medicament delivery devices, it can be useful to inform the user that the device shall not or cannot be used anymore, i.e. that the device has reached the end of its life. And it can furthermore be useful to disable the medicament delivery device, more particularly to make it impossible for the user to further use the device.

It is an object of the present invention to provide a medicament delivery device overcoming disadvantages of prior art medicament delivery devices. The device should have a high usability and should be safe.

Especially, it is an object to provide a medicament delivery device, in particular a disposable medicament delivery device, where the user recognizes when the end of life of the device is reached. More particularly, where the device disables itself when its end of life is reached.

Another object of the invention is to provide a medicament delivery device suitable for delivering multiple doses of a medicament wherein the user can set the dosing amount for each dose,

Another object of the invention is to provide a medicament delivery device suitable for delivering multiple doses of a medicament, wherein the user can set the dosing amount for each dose and furthermore can correct a set dosing amount before delivery of the dose.

Another object of the invention is to provide a medicament delivery device suitable for delivering multiple doses of a medicament, wherein the expelling of another dose is automatically disabled at some point, in particular when the end of life of the device is reached.

Another object of the invention is to provide a medicament delivery device suitable for delivering multiple doses of a medicament, wherein the user can set the dosing amount for each dose, wherein the setting of a dosing amount is automatically disabled at some point, in particular when the end of life of the device is reached.

Another object of the invention is to provide a medicament delivery device which does not increase its length more and more with increasing dosing amounts set by the user.

At least one of these objects is achieved by the device and assembly as defined in the claims.

Further objects and various advantages emerge from the description and embodiments below.

The medicament delivery device is designed for accommodating a medicament container containing a medicament and for expelling multiple doses of the medicament from the medicament container. It comprises

- a plunger rod device which is axially movable for acting, in an expelling movement in which the plunger rod device moves towards proximally, on a plunger of the medicament container in order to expel the medicament therefrom;

- a driver biasing member; and

- a driver assembly biased by the driver biasing member and coupled to the plunger rod device, wherein the driver assembly is configured to carry out a driver movement, the driver movement causing the expelling movement.

Due to the coupling of the driver assembly to the plunger rod device, the driver movement, caused by the driver biasing member, can cause the expelling movement. The medicament delivery device may also comprise a device body to which the medicament container, when the medicament container is mounted to the medicament delivery device, is fixedly coupled. For example, the device body may form at least a portion of a housing of the medicament delivery device. The expelling movement may then more particularly be an axial, more specifically a proximal, movement of the plunger rod device relative to the device body.

The medicament delivery device further comprises a dose setting mechanism for setting a dosing amount for a dose of the medicament to be expelled. The dose setting mechanism comprises a dosing element operable by a user by moving it relative to the driver assembly (and/or relative to the device body) in a setting movement to set a dosing amount for a dose of the medicament to be expelled.

The setting movement maybe, e.g., a rotating movement, e.g. a cw (clockwise) twisting of the dosing element.

These features and corresponding medicament delivery devices are known in the art. However, the herein described medicament delivery device further comprises an end lock mechanism. The purpose of the end lock mechanism can be to indicate to a user that the medicament delivery device shall not be used anymore, e.g., that the medicament container contains a too small amount of the medicament. More particularly, the end lock mechanism can lock the dose setting mechanism, so that setting another dose is inhibited. In particular, the setting movement can be inhibited by the end lock mechanism. And accordingly, a user attempting to set a dosing amount for another dose to be expelled, will recognize that this cannot be done, when the setting movement cannot be carried out.

The end lock mechanism can be particularly useful for disposable medicament delivery devices, more particularly for medicament delivery devices which are to be used with no more than exactly one medicament container. Furthermore, when the end lock mechanism inhibits the setting movement when the medicament delivery device has reached its end of life, the provision of the end lock mechanism can be particularly useful for variable-dose medicament delivery devices, i.e. where the user can set a dosing amount to be expelled, in particular can set a dosing amount for a next dose to be expelled.

Particularly, the end lock mechanism may comprise

- a locking device;

- a first coupling structure comprised in the locking device;

- a second coupling structure comprised in the plunger rod device; and

- a linkage structure comprised in the locking device.

Therein, the first coupling structure and the second coupling structure are configured

- to engage when the plunger rod device moving proximally reaches an axial threshold position while the locking device is a non-linking position; and

- when the first and second coupling structures engaged, to axially couple the locking device to the plunger rod device to cause, in reaction to the plunger rod device moving from the threshold position towards proximally into an end position, a movement of the locking device from the non-linking position towards proximally into a linking position.

Therein, in the linking position, the dosing element and the driver assembly are coupled to one another by the linkage structure to inhibit the setting movement; and, in the non-linking position, the setting movement is not inhibited by the linkage structure.

This can inhibit the setting of another dosing amount when the plunger rod device has moved a predefined distance (namely up to the end position) and, accordingly, when there is only a small amount of the medicament left in the medicament container. Thus, a user has an indication (by not being able to carry out the setting movement) that the medicament delivery device has reached its end of life.

The plunger rod device thus in particular can pull the locking device towards proximally because they are coupled by the first and second coupling structures. The moving towards proximally of the plunger rod device can take place, e.g., during the expelling of a dose.

For example, during the proximal movement of the plunger rod device, the first and second coupling structures engage, which is when the plunger rod device is in the threshold position, while the locking device is in the nonlinking position. And then, during further proximal travel of the plunger rod device (which can concern a very short up to a longer axial distance, depending on the design of the medicament delivery device), the plunger rod device pulls, because of the coupling, the locking device towards and into the linking position. And in the linking position, the linking structure couples or locks the driver assembly and the dosing element to one another, such that the setting movement is inhibited, i.e. it is then, in the linking position, not possible to move dosing element relative to the driver assembly for setting a dosing amount, e.g., the two parts are rotationally coupled to one another by the linking structure where the setting movement is a rotational movement.

When the locking device, however, is in the non-linking position, the setting movement can be carried out or is, at least, not inhibited by the linkage structure.

In embodiments, the axial coupling of the locking device to the plunger rod device is a rigid coupling.

In embodiments, the linkage structure is a rigid structure.

In embodiments, in the linking position, the locking device is coupled to the driver assembly by the linkage structure to inhibit a movement of the locking device further towards proximally. This can inhibit a movement of the plunger rod device beyond the end position, i.e., further towards proximally than the end position. And the end position can be determined (or defined) by the linking position.

Accordingly, the linking structure, cooperating with the driver assembly, can provide a stop inhibiting a further proximal movement of the locking device when the locking device is in the linking position.

The plunger rod device, more particularly, cannot move further towards proximally from the end position when the locking device is in the linking position, because the plunger rod device is coupled to the locking device by the first and second coupling structures; and the locking device, because of the linking structure, cannot move further towards proximally when it is in the linking position.

In embodiments, the end lock mechanism further comprises a locking biasing member biasing the locking device towards the non-linking position, e.g., towards distally. This can enable to avoid unintended movements of the locking device from the non-linking into the linking position. Accordingly, the proximal movement of the plunger rod device has to act against the bias of the locking biasing member when pulling the locking device towards proximally on its way from the threshold position to the end position.

In embodiments, the locking biasing member is a compression spring abutting the driver assembly at one and the locking device at its other end, forcing the driver assembly and the locking device apart.

In other embodiments, the locking biasing member may be an extension spring affixed to both, the driver assembly and the locking device, to counteract proximal movements of the locking device.

In embodiments, the end lock mechanism comprises:

- a first blocking structure comprised in the linkage structure;

- a second blocking structure comprised in the dosing element;

- a third blocking structure comprised in the linkage structure;

- a fourth blocking structure comprised in the driver assembly; wherein, in the linking position,

- the first blocking structure and the second blocking structure are engaged with one another; and

- the third blocking structure and the fourth blocking structure are engaged with one another; to inhibit the setting movement.

In particular, furthermore, in the non-linking position, the third blocking structure and the fourth blocking structure are not engaged with one another. Thus, the setting movement is not inhibited in the non-linking position, at least not by the linking structure.

In embodiments, the first blocking structure and the second blocking structure (and thus also the dosing element and the locking device) are engaged with one another also in the non-linking position. This can facilitate reaching the linking position from the non-linking position, as this engagement does not have to be establish on the way from the non-locking to the locking position.

In other embodiments, however, the first blocking structure and the second blocking structure (and thus also the dosing element and the locking device) are not engaged with one another in the non-linking position.

In embodiments, the first and second blocking structures each comprise splines, forming a splined connection.

In embodiments, the third and fourth blocking structures each comprise splines, forming a splined connection.

In embodiments, the third blocking structure and the fourth blocking structure are engaged with one another (in the linking position) to furthermore inhibit a movement of the locking device further towards proximally. Caused by the engagement of the third and fourth blocking structures, a stop may be provided which defines the linking position (the locking device not being able to move any further towards proximally because of the stop), and thus also defines the end position (of the plunger rod device). This may be implemented, e.g., by wedge-shaped splines, more particularly when the third blocking structure comprises generally longitudinally aligned splines which are tapered towards proximally and/or when the fourth blocking features comprises generally longitudinally aligned splines which are tapered towards distally.

In other embodiments, however, the function of providing a stop for the proximal movement of the locking device, thus defining the linking position, is effected by separate blocking structures, such as by a fifth and a sixth blocking structure different from the third and fourth blocking structures.

In embodiments, the plunger rod device comprises a distal part having a wall structure surrounding a hollow interior, and the locking device comprises a rod-shaped proximal part extending within the hollow interior; the second coupling structure comprises, at a distal end of the hollow interior, a second stop face facing the hollow interior, the first coupling structure comprising, in a proximal portion of the rod-shaped proximal part within the hollow interior, a first stop face facing the second stop face. This is a suitable way of implementing the functionality of the first and second coupling structures. For example, the locking device maybe generally rod-shaped, partially (including the first coupling structure) inside the plunger rod device, and the hollow plunger rod device may have, at its distal end, a protrusion protruding towards its inside (usually towards the device axis) cooperating with an outwardly protruding feature at the proximal end of the locking device, so as to form two cooperating stop features, enabling the plunger rod device to pull the locking device towards proximally.

In other embodiments, it can be the other way round, i.e., the locking device being hollow and the plunger rod device extending in the interior of the locking device. More particularly, in embodiments, the locking device comprises a proximal part having wall structure surrounding a hollow interior, the plunger rod device comprises a rod-shaped distal part extending within the hollow interior. And the first coupling structure comprises, at a proximal end of the hollow interior, a first stop face facing the hollow interior, and the second coupling structure comprises, in a distal portion of the rod-shaped distal part within the hollow interior, a second stop face facing the first stop face.

These are two ways to implement the first and second coupling structures and the interaction of the locking device and the plunger rod device to activate the locking mechanism.

In particular, the first and second stop faces are abutting when the plunger rod device is in the threshold position (the locking device being in the nonlinking position); and they remain abutting until and when the plunger rod device is in the end position (the locking device moving into and being in the linking position).

The degree to which the respective rod-shaped proximal / distal part extends within the respective hollow interior depends on the axial position of the plunger rod device and decreases with increasing proximal travel of the plunger rod device and thus with decreasing amount of the medicament in the medicament container.

In embodiments, the setting movement is a rotational movement in a first sense of rotation, e.g., a cw (clockwise) rotation, and the driver movement is rotational movement in a second sense of rotation opposite the first sense of rotation, e.g., a ccw (counter clockwise) rotation. Especially in such embodiments, the first, second, third and fourth blocking structures may comprise radially protruding longitudinally extended splines distributed over a circumference.

In embodiments, the medicament delivery device further comprises a device body to which the medicament container, when the medicament container is mounted to the medicament delivery device, is fixedly coupled; and furthermore, the driver biasing member is a torsion spring having a first end and a second end, the first end being affixed to the device bod), the second end being affixed to the dosing element, and the setting movement increases a tension of the torsion spring. Thus, setting a dosing amount may comprise biasing the driver biasing member. For example, the driver biasing member may be a helical torsion spring, more particularly wherein the first end is a proximal end, and the second end is a distal end.

In embodiments, the medicament delivery device comprises a dose release mechanism comprising a trigger element, wherein the trigger element is operable by a user to release a dose by bringing dose release mechanism from an inhibiting state into a releasing state, wherein the dose release mechanism is couplable to the driver assembly to block the driver movement in the inhibiting state and to enable the driver movement in the releasing state. Operating the dose release mechanism, accordingly, can suspend the rotational locking of the driver assembly. When the dose release mechanism is in the inhibiting state (not operated), it rotationally locks the driver assembly or, in other words, rotationally couples the driver assembly to the base assembly and to the device body, respectively. Thus, thus, during expelling, the driver assembly can rotate, driven by the driver biasing member.

E.g., the dose release mechanism may for this purpose comprise a releasable (and re-engageable) splined connection between the trigger element and the driver assembly.

In embodiments, the trigger element is operable by a user to be movable from an inhibiting position in which the trigger element is coupled to the driver assembly to block the driver movement, to a releasing position in which the trigger element is decoupled from the driver assembly not to block the driver movement, the dose release mechanism further comprising a trigger biasing member biasing the activation element towards the inhibiting position. Thus, without user action, the trigger biasing member keeps the trigger element in the inhibiting position (and the release mechanism in the inhibiting state), and for moving the trigger element into the releasing position (and bringing the release mechanism in the releasing state), the user has to counteract the bias of the trigger biasing member.

In embodiments, operating the trigger element is sliding the trigger element, in particular sliding the trigger element in a longitudinal direction.

Operating the trigger element may comprise sliding the trigger element.

In embodiments, the dose setting mechanism further comprises a ratchet mechanism, in particular a releasable one-way ratchet mechanism.

The ratchet mechanism comprises a first ratchet structure which is rotationally locked to, in particular comprised in, the driver assembly, and a second ratchet structure rotationally locked to, in particular comprised in, the dosing element. In a setting state, the first and second ratchet structures are engaged with one another, and, in a correcting state, they are disengaged from one another. Furthermore, in the setting state, they

- enable a rotation of the second ratchet structure relative to the first ratchet structure in a first sense of rotation, e.g., cw; and

- inhibit a rotation of the second ratchet structure relative to the first ratchet structure in a second sense of rotation opposite the first sense of rotation, e.g., ccw.

The ratchet structures and their interaction may be implemented in a way are known in the art.

A rotation of the dosing element and thus of the second ratchet structure relative to the first ratchet structure in the first sense of rotation can be considered a setting movement.

When two parts are rotationally locked, this means that rotational movements of the two parts are locked to one another - e.g., rotational movements of the driver assembly are locked to (and thus identical to) rotational movements of the first ratchet structure; and rotational movements of the second ratchet structure are locked to (and thus identical to) rotational movements of the dosing element.

The dosing element, more specifically, is operable, in particular rotatable, by the user to set and to correct (if desired) a dosing amount.

In embodiments, in the correcting state, a rotation of the second ratchet structure relative to the first ratchet structure is, by the ratchet mechanism, inhibited neither in a first sense of rotation nor in the second sense of rotation.

In embodiments, the dose setting mechanism more specifically is dose setting mechanism for setting and correcting a dosing amount for a dose of the medicament to be expelled. The dose setting mechanism in this case may comprise

- a first dosing member;

- a set-control biasing member;

- a control mechanism.

The first dosing member and the dosing element - which can also be referred to as second dosing member - are rotationally coupled to one another and axially movable relative to one another. This is more particularly the case in both, in the setting state and in the correcting state (cf. below). An angle of rotation assumed by the first dosing member determines (defines) the dosing amount. Thus, the user can set a dosing amount by setting a said angle or rotation. More particularly, it is an angle of rotation assumed by the first dosing member at the time of starting the expelling of a dose (in particular: at the time of releasing the dose release mechanism, cf. below) which determines the dosing amount. Said angle of rotation can be an angle relative to an initial rotational position of the first dosing member.

More particularly: Said angle of rotation assumed by the first dosing member is an angle of rotation assumed by the second ratchet structure relative to an initial rotational position of the the second ratchet structure - because the first and second dosing members are rotationally locked to one another, and the second ratchet structure is comprised in the dosing element. Said angle of rotation assumed by the first dosing member can also be identified with an angle of rotation by which the dosing element (and thus the second ratchet structure) is rotated relative to the first ratchet structure (and thus relative to the driver assembly) during setting / correcting a dosing amount (using the dose setting mechanism).

The set-control biasing member is configured to bias the dosing element in a second axial direction, e.g., in a proximal direction, to bias the second ratchet structure to engage with the first ratchet structure. Thus, the biasing can bias the dosing element towards the setting state. The biasing may more specifically be a biasing relative to the base assembly.

The control mechanism is operable by a user to selectably switch between the setting state and the correcting state by the user causing a first movement of the dosing element into the first axial direction, e.g., towards distally, to switch from the setting state into the correcting state, and by the user causing a second movement of the dosing element into a second axial direction opposite the first axial direction, e.g., towards proximally, to switch from the correcting state into the setting state.

In other words, in a purely axial movement, the user can switch between the setting state and the correcting state and thus engage and disengage the first and second ratchet structures.

The dosing amount setting and correcting can this way be implemented in a user-friendly and intuitively operable way. In addition, the medicament delivery device is relatively simple to manufacture, involving a not very high number of parts which are not particularly difficult to manufacture.

Furthermore, due to the provision of the first and second dosing members, the medicament delivery device does not increase its length more and more with increasing dosing amounts set by the user. This will be come clearer from the description below. In addition, the provision of the first and second dosing members makes possible that the medicament delivery device may display an indication of a set dosing amount in a simple way. This will be come clearer from the description below.

And it may be implemented that the corrections applied to a set dosing amount are possible towards decreasing and towards increasing the set dosing amount.

The user can cause the first movement, e.g., by pulling the dosing element (the second dosing member), in particular away from the base assembly. And the user can cause the second movement, e.g., by releasing the dosing element, wherein the set-control biasing member then moves the dosing element back, e.g., towards proximally and, e.g., towards the base assembly.

The user has to counteract the set-control biasing member during the first movement and thus when switching from the setting state to the correcting state. On the other hand, to cause the second movement, the user merely has to release the dosing element, as the set-control biasing member will move the dosing element back, i.e. the set-control biasing member moves the second ratchet structure (with the dosing element) back into engagement with the first ratchet member, thus changing from the correcting state into the setting state.

Accordingly, in the setting state, a dosing amount is settable by the user by rotating the dosing element in the first sense of rotation, and, in the correcting state, a set dosing amount is correctable by a user by rotating the dosing element. The latter may in particular take place in any of the first sense of rotation and of the second sense of rotation.

Thus, when the user merely rotates the dosing element (in the first sense of rotation, as rotation in the second sense of rotation being blocked by the ratchet mechanism), the user can set a dosing amount. This corresponds to the normal case of using the medicament delivery device. However, in case a correction of a set dose is required, the user causes the first movement to disengage the first and second ratchet structures, enabling him/her to apply corrections to the dosing amount set so far. In particular, in the correcting state, the second ratchet structure is rotatable in both senses of rotation, i.e., cw as well as ccw, in the correcting state. Note that in the unusual case that the user would not initially set a dosing amount but initially already cause the first movement, a rotation of the dosing element (and of the second ratchet structure) would initially be possible only in the first sense of rotation.

The first and second movements are, more specifically, movements relative to the base assembly and relative to the first ratchet structure.

In embodiments, the device axis is the axis about which the dosing element is rotatable.

In embodiments where the driver movement is a rotational movement, the device axis is the axis about which the driver assembly rotates in the driver movement.

In embodiments, a first end of the driver biasing member is rotationally locked (in particular is affixed) to the base assembly, and a second end of the driver biasing member is rotationally locked (in particular is affixed) to the dosing element. And thus, more specifically, because of the rotational coupling between the first and the second dosing member, the second end of the driver biasing member is rotationally locked also to the first dosing member. And furthermore, the driver biasing member is pre-tensioned such that a rotation of the second end relative to the first end in the first sense of rotation increases a bias of the driver biasing member.

Thus, the rotation of the second dosing member in the first sense of rotation increases the tension of the pre-tensioned driver biasing member.

Accordingly, the energy deposited in the driver biasing member by the user setting a dosing amount may be used for driving the plunger rod device distally (via the driver assembly), so that the time required for expelling doses of identical dosing amounts, is at least approximately identical, regardless of whether the dose is expelled when the medicament container is still full or already nearly empty.

In embodiments, one of the base assembly and of the first dosing member comprises a rotation-guiding feature, the other one comprising at least one cooperating feature cooperating with the rotation-guiding feature to guide rotational movements of the first dosing member relative to the base assembly. And in addition, the rotation-guiding feature comprises a first stop cooperating with the at least one cooperating feature to inhibit a rotation of the first dosing member in the second sense of rotation when the at least one cooperating feature abuts the first stop. Therein, the rotational position of the first dosing member in which the at least one cooperating feature abuts the first stop is the initial rotational position.

This is a way how the angle of rotation assumed by the first dosing member can determine the dosing amount.

In embodiments, the rotation-guiding feature comprises a second stop cooperating with the at least one cooperating feature to inhibit a rotation of the first dosing member in the first sense of rotation when the at least one cooperating feature abuts the second stop. This way, a maximum angle of rotation of the first dosing member and thus a maximum settable dosing amount can be implemented.

In embodiments, the rotation-guiding feature is a helical feature. This way, a rotation of the first dosing member causes an additional translational movement of the first dosing member.

In embodiments, the helical feature comprises a thread.

Also, non-helical features as rotation-guiding features are possible. E.g., if rotations only smaller than 360° are enabled (and sufficient), the rotationguiding feature may be, .e.g., a circular groove in the base assembly, e.g., in a device body of the base assembly, which provides two stops, e.g., a groove of 350°, the 10° being not grooved, thus providing, at one end, the first stop and, at its other end, the second stop.

The cooperating feature may be, e.g., a protrusion, e.g., a helical protrusion.

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.

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.

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

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. BRIEF DESCRIPTION OF THE DRAWINGS

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

Figure 1A a perspective view of a medicament delivery assembly with a needle assembly;

Figure 1B a perspective view of the medicament delivery device of the medicament delivery assembly of Fig. 1A;

Figure 2 the container housing of the medicament delivery assembly of Fig. 1A;

Figure 3 the medicament container of the medicament delivery assembly of Fig. 1A;

Figures 4 to 19 show various parts of the medicament delivery device of Figs. 1A, 1B;

Figure 4 the device body;

Figure 5A a view onto a cross-section through the medicament delivery device of Figs. 1A, 1B;

Figure 5B a view onto a cross-section of the front dosing part assembled with the device body;

Figure 6 the plunger rod;

Figure 7 the plunger nut;

Figure 8 the drive spring;

Figure 9 the driver holder;

Figure 10 the driver coupling;

Figure 11 the activation slider (trigger element);

Figure 12A the driver cap;

Figure 12B the driver cap in a different view; Figure 13A the front dosing part (first dosing member);

Figure 13B the rear dosing part (second dosing member);

Figure 14 the dose setting assembly comprising the first and second dosing members;

Figure 15A the locking device;

Figure 15B a detail of the distal end of the locking device;

Figure 16A a view onto a cross-section through the locking device assembled with the plunger rod;

Figure 16B a cross-sectional view of the plunger rod assembled with several further parts of the medicament delivery device;

Figure 17 a partial assembly of the medicament delivery device;

Figure 18 a perspective view onto a cross-section through rear dosing part;

Figure 18A shows a perspective view onto a detail of a cross-section through the medicament delivery device perpendicular to the device axis;

Figure 19 shows a perspective view onto a cross-section through a partial assembly of the medicament delivery device comprising the rear dosing part.

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

DETAILED DESCRIPTION

Fig. 1A shows a medicament delivery assembly 1 with a needle assembly 15 mounted which is shown partially transparent. The medicament delivery assembly 1 comprises a container housing 4 in which a medicament container 3 is accommodated and a medicament delivery device 2 to which the container housing 4 can be mounted, as illustrated. Fig. 1B shows the medicament delivery device 2. When the container housing 4 is mounted to the medicament delivery device 2, more particularly to a device body 5 thereof (cf. Fig. 4), container housing 4 and medicament container 3 are essentially immovable relative to the device body 5. The medicament delivery device 2 and, more particularly, its plunger rod 7 (Fig. 6) or its plunger nut 8 (Fig. 7) defines a device axis A.

Fig. 2 shows the container housing 4 in more detail, and Fig. 3 shows the medicament container 3, e.g., as known in the field, which comprises a vessel 35 containing a medicament 33, and a proximal closure comprising a septum 32 closing off the medicament container towards proximally which is to be pierced by a needle of the needle assembly 15 to expel portions of the medicament 33 therethrough. Medicament container 3 also comprises a plunger 31 initially seated near its distal end, which closes off the medicament container 4 towards distally and which can be moved towards proximally in order to dispense the medicament 33 when a needle assembly 15 is mounted.

Container housing 4 (Fig. 2) has a seat for the medicament container 3 which is open towards distally and into which the medicament container 3 is insertable. The proximal end of the container housing 4 has an outer thread 42 for mounting the needle assembly 15. Through housing windows 41, a user may see the medicament container 3 and can estimate how much of the medicament33 is left in it, with the assistance of dose indicators 43.

Figs. 4-19 illustrate the elements of the medicament delivery device 2.

Fig. 4 shows device body 5 which forms a portion of the housing of the medicament delivery device 2. Fig. 5A shows a view onto a cross-section through the medicament delivery device 2. Fig. 5B shows a view onto a cross-section of a front dosing part 61 assembled with the device body 5. Fig. 6 shows the plunger rod 7 which is to be proximally moved to move the plunger 31 proximally to expel doses of the medicament 33. Fig. 7 shows a plunger nut 8 to cooperate with plunger rod 7 to achieve the proximal movement. Fig. 8 shows a drive spring 9 which is a pre-tensioned helical torsion spring to force plunger nut 8 to rotate for the expelling of a dose. At its proximal end, drive spring 9 is affixed to a driver holder 91 (Fig. 9) which is affixed to device body 5, and at its distal end, it is affixed to a driver coupling 92 (Fig. 10). Fig. 11 shows an activation slider 13 or trigger element, which is an activation element to enable a user to initiate the expelling of a dose.

Figs. 12A, 12B show a driver cap 85 which is affixed to plunger nut 8, the two forming a driver assembly. The driver assembly is rotatable but cannot move towards proximally, because its proximal end abuts the device body 5 (cf. the thick arrow in Fig. 5A). Driver cap 85 cooperates with a dose setting assembly 6 (Fig. 14) comprising a front dosing part 61 (Fig. 13A) and a rear dosing part 62 (Fig. 13B). The front dosing part 61 can also be referred to as first dosing member; and the rear dosing part can also be referred to as second dosing member or as dosing element. Fig. 15A shows a locking device 10, and Fig. 15B shows its distal portion. Locking device 10 cooperates with plunger rod 7 to prevent the setting of another dose when an amount of the medicament 33 remaining in medicament container 3 is below a threshold amount (and thus is assumed to be too small for continuing to use the medicament container 3), as inferred from an axial position (and from a length of a proximal travel so far) of the plunger rod 7. Fig. 16A shows a view onto a cross-section through the locking device 10 assembled with the plunger rod 7, prior to reaching said threshold amount. Fig. 16B shows a cross-sectional view of the plunger rod 7 assembled with the locking device 10, the rear dosing part 62, the driver cap 85, the driver coupling 92 and a locking spring 11 (also referred to as locking biasing member) after reaching the threshold amount. Other elements are not shown in Fig. 16B.

Fig. 17 shows a partial assembly of the medicament delivery device 2 comprising the plunger rod 7, the plunger nut 8, a trigger spring 14 cooperating with the activation slider 13 to force the latter towards distally relative to the container housing 4 and to the device body 5, the driver cap 85, the locking device io and the locking spring n to force the latter towards distally relative to the driver cap 85 and to the device body 5. Other elements are not shown in Fig. 17.

Fig. 18 shows a perspective view onto a cross-section through rear dosing part 62. Fig. 19 shows a perspective view onto a cross-section through a partial assembly of the medicament delivery device 2 comprising rear dosing part 62, driver cap 85, locking device 10 and locking spring 11 when the device termination mechanism of the medicament delivery device 2 is activated.

To set a dosing amount for a dose to be expelled (also more briefly referred to as dose setting or setting a dose), the user turns the rear dosing part 62 in a clockwise direction (cw). Rear dosing part 62 (Figs. 13B, 14) has a generally barrel-like configuration. It has a knob-part 62a at its distal end, and towards its proximal end, it has a generally tubular shape. Knob-part 62a is knurled, having a plurality of ridges distributed over its circumference, which are aligned generally parallel to the device axis A, i.e. they are longitudinally aligned. A distal travel of rear dosing part 62 (relative to device body 5) is limited by cooperation of a flange-like circumferential ridge 62b and a corresponding abutting surface (not shown in the figures) in the interior of device body 5, e.g., a surface of a groove or of a ridge at the interior surface of device body 5. And it is rotatably mounted in device body 5 by ridge 62b, too. When distally pulling the rear dosing part 62 for correcting a set dosing amount, the axial distance by which rear dose drum 62 can travel is limited by flange-like circumferential ridge 62b abutting said corresponding abutting surface of, e.g., said groove. The circumferential ridge 62b can provide guidance for movements (axial and rotational) of the rear dosing part 62 relative to the device body 5. Ridge 62b’ may also have one or both of the functions of flange-like circumferential ridge 62b, i.e. provide guidance for movements (especially a rotational mounting) and provide a limitation for movements of the rear dosing part 62 towards distally. Furthermore, rear dosing part 62 is rotationally locked to front dosing part 61 and, at the same time, these two are axially moveable relative to one another. This is the case because rear dosing part 62 is in splined connection with front dosing part 62, as by cooperation of longitudinal splines 62c in the interior of rear dosing part 62 with longitudinal grooves 61c in the exterior of front dosing part 61. Thus, rotating rear dosing part 62 causes a corresponding rotation of front dosing part 61. The two parts are rotationally locked.

Front dosing part 61 (Figs. 13A, 14) has a generally tubular configuration, with helical features 61a close to its proximal end, to cooperate with interior threads 51 of device body 5 (Fig. 4). Fig. 5B shows a view onto a crosssection of front dosing part 61 assembled with device body 5.

Thus, cw turning rear dosing part 62 results in cw turning of front dosing part 61 combined with a distal movement of front dosing part 61.

On the exterior of rear dosing part 62, markings, such as signs S (symbolically illustrated in Fig. 14), may be provided along a circumference of rear dosing part 62 which may be visible through a body window 52 of device body 5. E.g., an indication of a set dosing amount may be provided by the markings. However, if rear dosing part 62 can be rotated and is rotated by more than 360°, the markings will repeat. Accordingly, they cannot correctly represent the set dosing amount in such cases. But if only rotations smaller than 360° are enabled, e.g., by implementation of a suitable stop structure in interior threads 51, the signs S can correctly correspond to (and indicate) set dosing amounts.

However, providing signs on the front dosing part 61 can reflect dosing amounts also beyond 360° (possibly beyond multiples of 360°) because of the distal movement of front dosing part 61 which is linked to the rotational (cw) movement of front dosing part 61. Providing another window in device body 5 and, e.g., using other signs, distributed along a helical path on the exterior of front dosing part 61, a user can be informed about the set dosing amount also beyond 360° even without further signs such as the signs S on the rear dosing part 62; or, in another implementation, signs distributed along a longitudinal path on the exterior of front dosing part 61 can be used in a combined fashion together with signs S on the exterior of rear dosing part 62 to inform the user about the set dosing amount also beyond 360°. In the latter case, e.g., the signs on the exterior of the front dosing part 61 can indicate the number of completed 360° turns (or, rather, the corresponding dosing amount), and the signs S on the exterior of the rear dosing part 62 can indicate the number of fractions of a 360° turn that have taken place before reaching the next 360° turn, thus indicating the number of smaller units that add up to the completed 360° turns.

Furthermore, since the front dosing part 61 and the rear dosing part 62 are axially moveable relative to one another, the rear dosing part 62 can (and does) maintain its axial position, even if front dosing part 61 moves distally during dosing amount setting. Accordingly, it does not move distally further and further out of the device body 5 when increasing the set dosing amount. The medicament delivery device 2 thus does not increase its length during dose setting.

In an initial state, the helical features 61a can be in an end position of the threads 51, in which no further ccw (counterclockwise) rotation is possible, but only cw rotation. Accordingly, after having set a dose (by cw rotation) and expelling that dose (ccw rotation), the threads 51 may provide a stop for the helical movement (rotation, combined with axial movement) of the front dosing part 61, thus providing a stop and a reference for the setting of the dosing amount. And it defines also the rotational (initial) position of the rear dosing part 62 in the initial state.

Furthermore, the cw turning of rear dosing part 62 results in a cw rotation of driver coupling 92, because the two are rotationally locked to one another. This is because they are in splined connection with one another. Driver coupling 92 has spline grooves 92d cooperating with the longitudinal splines 62c. Drive spring 9 is, at its proximal end, affixed to drive holder 91 and thus also to device body 5, as snap fit arms 9ie of drive holder 91 cooperate with snap fit openings 59 of device body 5. And at its distal end, drive spring 9 is affixed to driver coupling 92. Already in the initial state, drive spring 9 is pretensioned to force the dose setting assembly 6 to rotate in a ccw direction.

Thus, when cw rotating the dose setting assembly 6, additional tension of drive spring 9 is produced. However, a ratchet mechanism inhibits an immediate ccw returning of the dose setting assembly 6 to the initial state.

For this purpose, rear dosing part 62 forms a first ratchet structure Ri cooperating with a second ratchet structure R2 of the driver cap 85. Driver cap 85 is affixed to plunger nut 8 by a snap fit connection, as snap fit arms 85c of driver cap 85 cooperate with snap fit openings 8e of plunger nut 8.

Instead of forming a unitary part with rear dosing part 62, first ratchet structure Ri could also be a separate part which however is affixed to rear dosing part 62.

The first ratchet structure Ri comprises a plurality of ratchet teeth 8sr, e.g., an array of ratchet teeth 8sd, each having a stop surface Ris and an inclined surface Rii.

The second ratchet structure R2 comprises a plurality of ratchet teeth 62d, e.g., an array of ratchet teeth 62d, each having a stop surface and an inclined surface.

The teeth 62d, 8sd are generally radially aligned. And they axially protrude from respective surfaces which are aligned perpendicularly to the device axis A. However, the teeth 62d, 8sd could also protrude from conical surfaces, a convex conical surface facing a corresponding concave conical surface.

As generally known for ratchets, the teeth 62d and 82d cooperate to facilitate a cw rotation of the rear dosing part 62 relative to the driver cap 85, namely by the respective inclined surfaces sliding along one another and thus causing a slight distal movement of the rear dosing part 62 and letting the teeth 62d pass over the teeth 8sd; and a ccw rotation of the rear dosing part 62 relative to the driver cap 85 is inhibited by an abutting of the stop surfaces - unless further measures are taken, as described below. Thus, a user can set a dosing amount by cw turning the read dosing part 62, whereas - unless said further measures are made use of - he/she cannot turn the read dosing part 62 in a ccw direction for achieving a reduction of the set dosing amount.

Of course, in other embodiments, the cw and ccw rotations can be interchanged.

Fig. 18A shows a perspective view onto a detail of a cross-section through the medicament delivery device 2 perpendicular to the device axis A, approximately at the position indicated by the thick dashed lines in Fig. 18.

The first and second ratchet structures Ri, R2 are present on surfaces aligned perpendicularly to the device axis A. The teeth 62d protrude towards proximally from a proximally facing surface of rear dosing part 62, and the teeth 82d protrude towards distally from a distally facing surface of driver cap 85. In alternative embodiments, teeth 62d could protrude towards distally from a distally facing surface of rear dosing part 62, and the teeth 82d could protrude towards proximally from a proximally facing surface of driver cap 85. However, in still other embodiments, the surfaces could be conical surfaces, as mentioned above already.

Rear dosing part 62 is proximally biased. A force exerted by user is required to cause a moving of rear dosing part 62 towards distally. The proximal bias is caused by means of a setting spring 69 which can be integrally formed with rear dosing part 62, cooperating with a stop-forming feature affixed to the device body 7, such as with a flange-like circumferential ridge protruding inwardly from an interior surface of device body 5 (not shown in the figures). Setting spring 69 can be an elastic bar affixed at its ends and describing an arc having an apex towards distally, as illustrated (Fig. 14). Of course, other ways of producing the proximal bias on rear dosing part 62 are possible, e.g., based on a flexible bar at the device body 5 or based on a separate spring.

The setting spring 69 not only enables the setting of a dose by enabling the slight distal movement of the rear dosing part 62 required for operating the ratchet mechanism (letting the teeth 62d pass over the teeth 8sd) when cw turning the rear dosing part 62. But further enables a user to disengage the ratchet mechanism (and thus to override the ratchet mechanism) by pulling the rear dosing part 62 towards distally, counteracting the bias of setting spring 69.

When the ratchet mechanism is disengaged this way, the user can correct a setting made just before (former setting); the medicament delivery device 2 and the dose setting mechanism, respectively, can be considered in a correction state then. In the correction state, the user can selectively turn the rear dose part 62 ccw to reduce the former setting or turn the rear dose part 62 cw to further increase the former setting. Thus, the user can correct a setting he/she made.

In said alternative embodiments, the user would press the rear dosing part 62 towards proximally in order to disengage the ratchet mechanism for changing (correcting) a setting. In case of said still other embodiments, the user would either pull or press the rear dosing part 62 to disengage the ratchet mechanism for changing a setting, depending on whether the conical surface of the first ratchet part faces partially towards proximally or partially towards distally.

When disengaging the ratchet mechanism, the driver coupling 92 continues to be rotationally locked to rear dosing part 62, as does the front dosing part 61, and thus, the user can freely select, by rotating the rear dosing part 62 whether to increase the dose setting (and to which extent) or to reduce the dose setting (and to which extent), wherein the reduction to zero is possible, but not below zero, because when a reduction to zero is selected (by the ccw rotation), the helical features 61a are in an end position of the threads 51, in which no further ccw rotation is possible; the helical features 61a abut a stop at the end of the threads 51. While in the correction state, the user not only counteracts (in axial direction) the setting spring 69, but the rear dosing part 62 also is biased towards ccw rotation by drive spring 9. Thus, for further increasing the dosing amount (by cw rotation), the user has to counteract the torsion force of drive spring 9, whereas when decreasing a dose setting, the corresponding ccw rotation is facilitated by drive spring 9.

When the user decides to have reached a desired dose setting, he/she causes the ratchet mechanism to engage again (back into the setting state), by discontinuing the pulling of the read dosing part 62. Then, expelling of the set (corrected) dose can take place. Even if the user, after discontinuing the pulling of the rear dosing part 62 and thus engaging the ratchet mechanism, is not content with the set corrected dosing amount, he/she can further increase the dosing amount in the setting state (by cw rotation of the rear dosing part) and/or carry out a further correction step (by pulling, rotating, discontinuing pulling); and this can be done one or more times - before finally causing the expelling of the multiply corrected dose setting.

Expelling of a set dose (irrespective of whether corrected or not corrected) is caused by the user by moving (sliding) the activation slider 13 towards proximally. Activation slider 13 is mounted to device body 5 in a longitudinally slidable way: A protrusion 13a cooperates with a guiding slit in device body 5 (not shown); and guiding features 13b cooperating (i) with cooperating slit rims 46 of container housing 4 and (ii) with features 56 of device body 5. Activation slider 13 is mounted to device body 5 in a rotationally locked way.

The trigger spring 14 (or trigger biasing member; Fig. 17), e.g., a helical compression spring, forces activation slider 13 towards distally. In the activated (proximal) position, a rotation lock structure 13c of activation slider 13 disengages a cooperating rotation lock structure 83 of plunger nut 8, whereas these are engaged with one another in the initial (distal; not activated) position, so as to rotationally lock the plunger nut 8 to activation slider 13 and thus to device body 5. Both rotation lock structures 13c, 83 may comprise longitudinally aligned splines which are distributed over a circumference, as illustrated in Figs. 7, 11.

Plunger nut 8 has an interior thread 82 (plunger nut thread) cooperating with an exterior thread 72 (plunger rod thread) of plunger rod 7. The two threads 72, 82 are engaged with one another, so that a ccw rotation of plunger nut 8 causes a proximal movement of plunger rod 7. Towards its proximal end, plunger nut 8 is rotatably supported by an interior bore 91a of driver holder 91, and towards its distal end, plunger nut 8 is rotatably supported by an interior bore 92a of driver coupling 91. Device body 5 has a plunger rod guiding portion 54 comprising an opening through which plunger rod 7 extends. The plunger rod guiding portion 54 comprises two guiding protrusions 57 which rotationally lock plunger rod 7 by cooperating with two longitudinal guiding faces 75 of plunger rod 7.

In reaction to an activation (sliding the activation slider 13 towards proximally, as described) - of course, with a non-zero dose set - plunger nut 8 is free to rotate (guiding protrusions 54 and 57 disengaged) and will rotate in a ccw sense of rotation, because drive spring 9 is biased by cw rotation (cw-pre-tensioned, and in addition, by the setting of a dosing amount by cw rotation), and the distal end of drive spring 9 is affixed to driver coupling 92 which again is rotationally locked to rear dosing part 62, and rear dosing part 62 is, via the ratchet mechanism, rotationally locked to driver cap 85 which again is affixed to plunger nut 8.

Accordingly, when expelling a dose, plunger rod 7 is moved towards proximally, as driven by the ccw rotation of plunger nut 8 which is driven by drive spring 9. And this ccw rotation is carried out, too, by the distal end of drive spring 9, by driver coupling 92, by driver cap 5, by rear dosing part 62 and by front dosing part 61, wherein the latter also stops the ccw rotation (as described above, in the end position) and thus determines the end of the expelling. The medicament delivery device 2 not only has the described dose setting mechanism but has furthermore a device termination mechanism which can also be referred to as end lock mechanism.

The described dose setting mechanism may also be implemented without the device termination mechanism. And the device termination mechanism may also be implemented with a different dose setting mechanism, e.g., with a dose setting mechanism which does not allow corrections of a set dosing amount, at least for corrections which shall decrease the set dosing amount. E.g., the device termination mechanism may be implemented with a dose setting mechanism corresponding with the described one, but without the correction possibility and/or with merely a single dose setting part (e.g., as if the front and rear dosing parts were one and the same or completely locked to one another).

The device termination mechanism ensures that the medicament delivery device 2 is locked after the plunger rod 7 has proximally moved a predetermined maximum length. In other words, the device termination mechanism shall ensure that the device 2 is locked when a predetermined maximum amount of the medicament 33 has been expelled from the medicament container 3 and, accordingly, when only a predetermined minimum amount (threshold amount) of the medicament 33 still remains in the medicament container 3, respectively.

For locking the medicament delivery device 2, the ratchet mechanism is locked in the engaged position. This is accomplished by means of locking device 10 interacting on the one hand with plunger rod 7 and on the other hand, with both, the driver cap 85 and the rear dosing part 62. Furthermore, medicament delivery device 2 is locked in that a further movement towards proximally of plunger rod 7 is inhibited.

To activate the device termination mechanism, a coupling structure 107 at the proximal end 10a of locking device 10 engages with, more particularly abuts, a coupling structure 71 at the distal end 7b of plunger rod 7. This takes place, e.g., when the plunger rod 7 moves proximally. The locking device 10 is still in a non-linking position, but plunger rod device 7, while moving proximally has reached an axial threshold position. When the coupling structure 107 and the coupling structure 71 are engaged, and plunger rod 7 moves further proximally, plunger rod 7 pulls the locking device 10 towards proximally, until plunger rod device 7 reaches an end position and the locking device 10 reaches a linking position.

The plunger rod 7 moves proximally in particular during an expelling of a last dose or of a partial dose.

Fig. 16A shows the locking device 10 assembled with the plunger device 7 in a perspective view onto a cross-section, before the threshold amount is reached. The proximal end 10a of locking device 10 is far more proximal than the distal end 7b of plunger rod 7.

In Fig. 16B, the threshold amount is reached, and the two coupling structures 71, 107 are engaged by abutting one another. Fig. 19 also shows this state, when the device terminating mechanism is activated, but in a perspective view onto a cross-section of a partial assembly of the medicament delivery device 2.

Locking device 10 is biased towards distally by locking spring 11, e.g., a helical compression spring, abutting driver cap 85 at its proximal end and abutting an abutting structure 109 of locking device 10 near its distal end 10b (e.g., comprised in a spline structure 106’, cf. below).

Near its distal end 10b, locking device 10 has a blocking structure 108’ cooperating with a blocking structure 81’ of driver cap 85 when the two blocking structures 81’, 108’ are engaged, which is the case when the device termination mechanism is activated, as then, locking device 10 is moved towards proximally. The blocking structure 81’ as well as the blocking structure 108’ comprise blocking features 81 and 108, respectively, which may be, as illustrated, generally longitudinally aligned wedge-shaped splines, tapered towards distally in case of blocking features 81 and tapered towards proximally in case of blocking features 108. When engaged, the two blocking structures 81’, 108’ are rotationally fixed to one another, as their respective blocking features 8, 108 abut, coupling rotational movements of driver cap 85 and rotational movements of locking device 10. In addition, plunger rod 7 cannot move further towards proximally because of its coupling to the locking device 10, while locking device 10 cannot move further towards proximally because of the wedge-shape of the blocking features 108 of the locking device 10 and of the blocking features 81 of the driver cap 85, and driver cap 85 cannot move further towards proximally because it is part of the driver assembly, and plunger nut 8 abuts the device body 5 inhibiting proximal movements (cf. the arrow in Fig. 5A).

Also, near its distal end 10b, locking device 10 furthermore has a spline structure 106’ with splines 106 embodied as longitudinal, outwardly protruding splines distributed over a circumference. These cooperate with a spline structure 68’ with splines 68 of rear dosing part 62, embodied as longitudinal, inwardly protruding splines distributed over a circumference. These two spline structures 68’, 108’ are engaged with one another at any time during normal operation of the medicament delivery device 2, for rotationally locking the locking device 10 to the rear dosing part 62, while they are axially movable relative to one another. Fig. 18 shows rear dosing part 62 in a perspective view onto a cross-section.

Before activation of the device termination mechanism, locking spring 11 is in an expanded state, and the blocking structure 108’ is distant and disengaged from the blocking structure 81’, and blocking structure 106’ is distant and disengaged from the blocking structure 68’. But by activation of the device termination mechanism, it is brought into a compressed state, as locking device 10 is moved towards proximally, and the two blocking structures 81’, 108’ as well as the two blocking structures 68’, 106’ engage.

The blocking structure 108’ and the spline structure 106’ together form a linkage structure 110. The linkage structure may link to one another, at least rotation-wise, the rear dosing member 62 and the driver cap 85. When the device termination mechanism is activated, locking device io is rotationally locked (or even affixed) to driver cap 85 and rotationally locked to rear dosing part 62. Accordingly, it is not possible anymore in that state (the locking device 10 in the linking position) to rotate rear dosing part 62 relative to driver cap 85, and thus, it is not possible then to set a dosing amount. And it is not possible to expel another dose. If no dosing amount can be set (because rear dosing part 62 cannot be rotated relative to driver cap 85), no dose of the medicament 33 can be expelled. This can be useful in particular when the medicament delivery device 2 is a disposable device, i.e. a device to be used with only one medicament container 3, thus with no provision to replace the medicament container 3, at least not once that a first dose has been expelled from the medicament container 3.

Accordingly, a user cannot set another dosing amount and cannot expel another dose when the threshold amount is reached, i.e. when it can be assumed that the amount of the medicament 33 in the container is too small for another dose.

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

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.

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.

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.

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.

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.

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.

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.

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, loo 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.

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.

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 following claims.

Claims

1. A medicament delivery device (2) for accommodating a medicament container (3) containing a medicament and for expelling multiple doses of the medicament (33) from the medicament container (3), the medicament delivery device (2) comprising

- a plunger rod device (7) axially movable for acting, in an expelling movement in which the plunger rod device (7) moves towards proximally, on a plunger (31) of the medicament container (3) for expelling the medicament therefrom;

- a driver biasing member (9);

- a driver assembly biased by the driver biasing member (9) and coupled to the plunger rod device (7), configured to carry out a driver movement, the driver movement causing the expelling movement;

- a dose setting mechanism for setting a dosing amount for a dose of the medicament (33) to be expelled, the dose setting mechanism comprising a dosing element (62) operable by a user by moving it relative to the driver assembly in a setting movement to set a dosing amount for a dose of the medicament to be expelled;

- an end lock mechanism comprising o a locking device (10); o a first coupling structure (107) comprised in the locking device (10); o a second coupling structure (71) comprised in the plunger rod device (7); and o a linkage structure (110) comprised in the locking device (10); wherein the first coupling structure (107) and the second coupling structure (71) are configured

- to engage when the plunger rod device (7) moving proximally reaches an axial threshold position while the locking device (10) is a nonlinking position; and - when engaged, to axially couple the locking device (io) to the plunger rod device (7) to cause, in reaction to the plunger rod device (7) moving from the threshold position towards proximally into an end position, a movement of the locking device (10) from the non-linking position towards proximally into a linking position; wherein in the linking position, the dosing element (62) and the driver assembly are coupled to one another by the linkage structure (110) to inhibit the setting movement; and wherein in the non-linking position, the setting movement is not inhibited by the linkage structure (110).

2. The medicament delivery device (2) according to claim 1, wherein in the linking position, the locking device (10) is coupled to the driver assembly by the linkage structure (110) to inhibit a movement of the locking device (10) further towards proximally.

3. The medicament delivery device (2) according to claim 1 or claim 2, the end lock mechanism further comprising a locking biasing member (11) biasing the locking device (10) towards the non-linking position.

4. The medicament delivery device (2) according to one of claims 1 to 3, the end lock mechanism comprising:

- a first blocking structure (106’) comprised in the linkage structure;

- a second blocking structure (68’) comprised in the dosing element (62);

- a third blocking structure (108’) comprised in the linkage structure;

- a fourth blocking structure (81’) comprised in the driver assembly; wherein in the linking position, the first blocking structure (106’) and the second blocking structure (68’) are engaged with one another; and the third blocking structure (108’) and the fourth blocking structure (81’) are engaged with one another; to inhibit the setting movement.

5. The medicament delivery device (2) according to one of claims 1 to 4, wherein either

- the plunger rod device (7) comprises a distal part having a wall structure surrounding a hollow interior, the locking device (10) comprising a rod-shaped proximal part extending within the hollow interior, the second coupling structure (71) comprising, at a distal end of the hollow interior, a second stop face facing the hollow interior, the first coupling structure (107) comprising, in a proximal portion of the rod-shaped proximal part within the hollow interior, a first stop face facing the second stop face; or

- the locking device (10) comprises a proximal part having wall structure surrounding a hollow interior, the plunger rod device (7) comprising a rod-shaped distal part extending within the hollow interior, the first coupling structure (107) comprising, at a proximal end of the hollow interior, a first stop face facing the hollow interior, the second coupling structure (71) comprising, in a distal portion of the rod-shaped distal part within the hollow interior, a second stop face facing the first stop face.

6. The medicament delivery device (2) according to one of claims 1 to 5, wherein the setting movement is a rotational movement in a first sense of rotation, and the driver movement is rotational movement in a second sense of rotation opposite the first sense of rotation.

7. The medicament delivery device (2) according to one of claims 6, the medicament delivery device (2) further comprising a device body (5) to which the medicament container (3), when the medicament container (3) is mounted to the medicament delivery device (2), is fixedly coupled; the driver biasing member (9) being a torsion spring having a first end and a second end, the first end being affixed to the device body (5), the second end being affixed to the dosing element (62), the setting movement increasing a tension of the torsion spring, in particular wherein the driver biasing member (9) is a helical torsion spring, the first end being a proximal end, the second end being a distal end.

8. The medicament delivery device (2) according to one of claims 1 to 7, further comprising a dose release mechanism comprising a trigger element (13), wherein the trigger element (13) is operable by a user to release a dose by bringing dose release mechanism from an inhibiting state into a releasing state, wherein the dose release mechanism is couplable to the deriver assembly to block the driver movement in the inhibiting state and to enable the driver movement in releasing inhibiting state.

9. The medicament delivery device (2) according to claim 8, wherein the trigger element (13) is operable by a user to be movable from an inhibiting position in which the trigger element (13) is coupled to the driver assembly to block the driver movement to a releasing position in which the trigger element (13) is decoupled from the driver assembly not to block the driver movement, the dose release mechanism further comprising a trigger biasing member (14) biasing the activation element (13) towards the inhibiting position.

10. The medicament delivery device (2) according to one of claims 1 to 9, the dose setting mechanism further comprising

- a ratchet mechanism with a first ratchet structure (Ri) rotationally locked to, in particular comprised in, the driver assembly and a second ratchet structure (R2) rotationally locked to, in particular comprised in, the dosing element (62), which, in a setting state, are engaged with one another and which, in a correcting state, are disengaged from one another, and which, in the setting state, o enable a rotation of the second ratchet structure (R2) relative to the first ratchet structure in a first sense of rotation; and o inhibit a rotation of the second ratchet structure (R2) relative to the first ratchet structure (Ri) in a second sense of rotation opposite the first sense of rotation;

11. The medicament delivery device (2) according to claim 10, wherein the dose setting mechanism for setting and correcting a dosing amount for a dose of the medicament (33) to be expelled; the dose setting mechanism comprising

- a first dosing member (61) which is rotationally coupled to and axially movable relative to the dosing element (62), wherein an angle of rotation assumed by the first dosing member (61) determines the dosing amount;

- a set-control biasing member (69) configured to bias the dosing element (62) in a second axial direction to bias the second ratchet structure (R2) to engage with the first ratchet structure (Ri);

- a control mechanism operable by a user to selectably switch between the setting state and the correcting state, by the user causing a first movement of the dosing element (62) into the first axial direction to switch from the setting state into the correcting state, and by the user causing a second movement of the dosing element (62) into a second axial direction opposite the first axial direction to switch from the correcting state into the setting state.

12. The medicament delivery device (2) according to one of claims 1 to 11, wherein a first end of the driver biasing member (9) is rotationally locked to the base assembly and a second end of the driver biasing member (9) is rotationally locked to the dosing element (62); wherein the driver biasing member (9) is pre-tensioned such that a rotation of the second end relative to the first end in the first sense of rotation increases a bias of the driver biasing member (9).

13- The medicament delivery device (2) according to one of claims 1 to 12, one of the base assembly and of the first dosing member (61) comprising a rotation-guiding feature (51), the other one comprising at least one cooperating feature (61a) cooperating with the rotation-guiding feature (51) to guide rotational movements of the first dosing member relative to the base assembly, wherein the rotation-guiding feature (51) comprises a first stop cooperating with the at least one cooperating feature (61a) to inhibit a rotation of the first dosing member (61) in the second sense of rotation when the at least one cooperating feature (61a) abuts the first stop, wherein the rotational position of the first dosing member (61) in which the at least one cooperating feature (61a) abuts the first stop is the initial rotational position.

14. A medicament delivery assembly (1), comprising the medicament delivery device (2) according to one of claims 1 to 13, further comprising the medicament container (3) assembled with the medicament delivery device (2).