WO2025190656A2

WO2025190656A2 - Medicament delivery device and medicament delivery assembly

Info

Publication number: WO2025190656A2
Application number: PCT/EP2025/055079
Authority: WO
Inventors: Daniel SÄLL
Original assignee: SHL Medical AG
Current assignee: SHL Medical AG
Priority date: 2024-03-11
Filing date: 2025-02-25
Publication date: 2025-09-18
Anticipated expiration: 2026-09-11
Also published as: WO2025190656A3

Abstract

The invention relates to a medicament delivery device for expelling multiple doses of a medicament from a medicament container. it comprises a medicament delivery partial device comprising a device body (5); a container housing (4) for accommodating the medicament container; and a mounting mechanism for enabling a user to mount the container housing (4) to the device body (5). The mounting mechanism comprises a keying mechanism comprising a first key comprised in the medicament delivery partial device and a second key comprised in the container housing (4). It is a pre-condition for the mounting that the first key and the second key are matching keys. In case the first and second keys are not matching keys, the mounting is inhibited by the keying mechanism. The first key comprises a first mechanical structure comprising first keying features (K11, K12), the second key comprises a second mechanical structure comprising second keying features (K21). An engagement of the first and second mechanical structures during the mounting is a pre-condition for the mounting. The first keying features (K11, K12) and the second keying features (K21) enable the engagement in case the first key (K1) and the second key (K2) are matching keys and mechanically block the engagement otherwise.

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.

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.

For large doses, single use autoinjectors with a tensioned spring dominate the market, whereas for small doses, pen injectors containing multiple doses have been the main route. Such pen injectors are mainly operated manually, in that the user presses a button to inject the medicament with manual force. This is not a viable option for larger doses. To increase sustainability and minimize the generated waste, an autoinjector suitable for large doses and, at the same time, containing multiple doses would be desirable, even though this requires the patient to change needle before each dose.

For a re-usable multidose device, the dose volume is set by the device. A patient may start with a specific dosing amount, and depending on tolerability and effectiveness, the dosing amount may have to be increased or decreased. Some devices let the patient set the dose by means of a variable dose mechanism. This however bears a risk for human errors where the patient injects wrong dosing amounts. Fixed dose devices are safer in use in this regard, as they make it impossible for the user to set a wrong dosing amount. But in view of the re-usability of the medicament delivery device, another risk arises from the possibility that the user might couple a wrong medicament container to the medicament delivery device. Thus, for an even further increased safety, it should be ensured that the user can couple to the medicament delivery device only a suitable medicament container containing the correct medicament.

A mechanical way for inhibiting the use of a wrong medicament container is known in the art. However, in this mechanism, a part of the re-usable device has to be unmounted first, then the user inserts the medicament container into that unmounted part, and a keying takes place between that unmounted part and the medicament container when fixing the one to the other. A wrong medicament container (and thus a wrong medicament) cannot be fixed to said unmounted part. Afterwards, said part is mounted again to the rest of the medicament delivery device.

SUMMARY

It is an object of the present invention to provide a medicament delivery device overcoming disadvantages of prior art medicament delivery devices. Especially, it is an object to provide a medicament delivery device suitable for delivering multiple doses of a medicament while ensuring that only the correct medicament (and medicament container, respectively) is used with the device. The device should have a high usability and should be safe.

Another object of the invention is to provide a medicament delivery device which is particularly simple to operate, in particular involving only a small number of actions to be taken by a user.

Another object of the invention is to provide a medicament delivery device which is relatively simple to manufacture, e.g., to assemble, in particular the device consisting of a small number of separate parts only. These objects are 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 equipped for accommodating a medicament container containing a medicament and for expelling multiple doses, in particular multiple pre-defined doses, of the medicament from the medicament container, and it defines a device axis. It comprises a medicament delivery partial device comprising a device body; and a container housing for accommodating the medicament container in a stationary manner.

The medicament delivery device further comprises a mounting mechanism configured for a user to bring the container housing, in a mounting step, from an unmounted position in which the container housing is separate from the device body (and in particular: from the medicament delivery partial device) into a mounted position in which the container housing is mounted to the device body (and thus to the medicament delivery partial device).

And the mounting mechanism can be configured to bring the container housing, in an unmounting step, from the mounted position into the unmounted position.

The medicament delivery partial device further comprises a plunger rod assembly comprising a main plunger rod device configured to act, by moving in proximal direction, on a plunger of the medicament container for expelling the medicament therefrom; and a biasing member, such as a spring device, configured to force the plunger rod assembly in a proximal direction. In particular, the plunger rod assembly can be axially movable relative to the device body for interacting with the medicament container for expelling the medicament therefrom.

Furthermore, the mounting mechanism comprises a keying mechanism comprising a first key comprised in the medicament delivery partial device (more particularly: comprised in the device body) and a second key comprised in the container housing.

The first key comprises a first mechanical structure comprising one or more first keying features, and the second key comprises a second mechanical structure comprising one or more second keying features. The mounting mechanism is configured such that an engagement of the first mechanical structure and the second mechanical structure during the mounting step is a pre-condition for the mounting step; i.e. the mounting step can be carried out only if the said engagement takes place. For accomplishing this, the one or more first keying features and the one or more second keying features are configured to enable the engagement of the first mechanical structure and the second mechanical structure during the mounting step in case the first key and the second key are matching keys; and to mechanically block the engagement of the first mechanical structure and the second mechanical structure during the mounting step in case the first key and the second key are not matching keys.

In other words, the mounting step and thus bringing the container housing into the mounted position, is possible only if an engagement of the first mechanical structure (at the medicament delivery partial device) and the second mechanical structure (at the container housing) takes place; and the engagement is possible only in case the keys are matching keys - in which case the first and second keying features are structured accordingly, i.e. structured to enable the engagement. This is a simple mechanical way of embodying the keying mechanism. Accordingly, a pre-condition for the mounting step is that the first key and the second key are matching keys, wherein in case the first key and the second key are not matching keys, the mounting step is inhibited by the keying mechanism, more particularly by the mechanical blocking of the engagement as effected by the cooperation of the first and second keying features.

This way, the mounting mechanism requires, for the mounting step to be accomplished, i.e., for enabling a mounting of the container housing to the device body (and thus to the medicament delivery partial device), that the first key (of the medicament delivery partial device) and the second key (of the medicament container) are matching keys. The keying mechanism, in other words, is configured to not inhibit the mounting step in case the first key and the second key are matching keys and to inhibit the mounting step otherwise. Like a key-and-lock system, the keying mechanism enables or disables the mounting, which impedes the use of a wrong medicament container and medicament, respectively, with the medicament delivery partial device. The first key and the second key cooperate accordingly.

Such a mounting mechanism (and keying mechanism) is simple to operate, as the user does not have to carry out an additional step for accomplishing a keying, i.e., for ensuring that he/she does not use the wrong medicament. Instead, the mounting step is prevented in case it is attempted to use a wrong medicament container with the device. And furthermore, no additional part to be attached to (and/or removed from) the medicament delivery partial device is required in order to accomplish both, the mounting of the container housing and the keying ensuring the use of the correct medicament.

The first key can, more particularly, be affixed to the medicament delivery partial device and to the device body, respectively.

The second key can, more particularly, be affixed to the container housing.

In embodiments, in the mounted position, the container housing assembly and thus also the medicament container is fixed to the device body in a stationary manner, more particularly in a stationary but unmountable (removable) manner.

The container housing and, in particular, the container assembly (comprising the container housing and the medicament container) can be attachable to and detachable from the medicament delivery partial device.

In embodiments, the device body forms a part of a housing of the medicament delivery device.

In embodiments, the container housing ex-factory accommodates the medicament container. Thus, mounting the container housing to the device body (and thus to the medicament delivery partial device) means to mount the container assembly to the device body. This makes operation of the medicament delivery device particularly safe.

The medicament delivery partial device can be re-usable. In other words, it can be used for delivering a medicament from different container housings and container assemblies, respectively. Of course, all of the containers have to match the medicament delivery partial device (via the keying mechanism), but after a medicament container has been used up (no dose of the medicament remaining therein), the medicament delivery partial device does not have to be discarded but can be used with further medicament containers and container housings / assemblies, respectively.

The container housing and, in particular, the container assembly comprising the housing and the medicament container, can be disposable. I.e., after use, such as after one or more doses of the medicament have been expelled from the medicament container, the container housing and the container assembly, respectively, can be discarded.

In embodiments, the doses to be expelled from the medicament container are pre-defined doses (also referred to as preset doses). The doses are, more particularly, defined (and set) by the medicament delivery partial device. A keying mechanism is particularly valuable in this case, as the dosing amount cannot be adjusted by the user, in contrast to medicament delivery devices implementing a variable dose mechanism.

The expelling of doses of the medicament from the medicament container can be accomplished, in particular, by proximally moving the plunger of the medicament container, while a needle assembly is mounted to the medicament container, more particularly while a seal of the medicament container, e.g., a septum, is perforated by a needle device, such as by a cannula.

In embodiments, the mounting mechanism is configured such that a number and/or a size and/or a position of the first keying features and a number and/or a size and/or a position of the second keying features are matching in case the first key and the second key are matching keys, to enable the engagement; and are not matching otherwise, to block the engagement. This is a simple way of realizing the keys while enabling, also in a simply way, a large number of different pairs of matching first and second keys, where the first keys (at the medicament delivery partial device) do not match any of the second keys (at the container housing) other than the one it forms a matching pair of keys with.

In embodiments, at least one of the first keying features comprises one of: an opening and a protrusion, and at least one of the second keying features comprises the other one (i.e., the protrusion or the opening). And in the engagement, the protrusion is engaged with the opening. E.g., the protrusion can be slid into the opening for the engagement, in particular during the mounting step.

In embodiments, the mounting step comprises sliding the opening and the protrusion into one another, in particular through one another, in case the first key and the second key are matching keys.

In embodiments, the mounting mechanism is configured such that the mounting step comprises a first partial movement of the container housing during which, in case the first key and the second key are matching keys, the engagement takes place. And the mounting step comprises a second partial movement of the container housing. Therein, the first partial movement brings the container housing into an intermediate position, whereas the second partial movement brings the container housing from the intermediate position into the mounted position. This way, the second partial movement can be accomplished only in case of matching keys.

In particular, the first partial movement can be a movement (of the container housing) into a first direction, and the second partial movement can be a movement (of the container housing) into a second direction, wherein the first direction is different from the second direction. E.g., the first direction can be a distal direction, and the second direction can comprise a rotational direction or can, more particularly be a rotational direction combined with a distal direction.

In embodiments, the first mechanical structure and the second mechanical structure are configured to block the second partial movement when in the engagement. When the engagement blocks the second partial movement, the first mechanical structure and the second mechanical structure have to be disengaged (which is this case in the intermediate position) to unblock (and thus to enable) the second partial movement; accordingly, in the intermediate position the first and second mechanical structures are disengaged.

In embodiments, the first partial movement comprises a distal movement of the container housing, and the second partial movement comprises a rotational movement of the container housing combined with a (small) distal movement of the container housing.

In embodiments, the unmounting step corresponds to a time-reversed version of the mounting step.

In embodiments, the medicament delivery device comprises a plunger rod fixing mechanism configured to inhibit a rotatability of the main plunger rod device when activated. The plunger rod fixing mechanism comprises a first coupling feature comprised in, in particular affixed to, the medicament delivery partial device; and the container housing comprises a second coupling feature, in particular wherein the second coupling feature is affixed to the container housing. Furthermore, the plunger rod fixing mechanism is configured to be activated when the first coupling feature is in an inhibiting state and to be not activated when the first coupling feature is in not in the inhibiting state. And the mounting mechanism is configured such that the first coupling feature and the second coupling feature cooperate, during the second partial movement, to bring the first coupling feature into the inhibiting state and to keep the first coupling feature in the inhibiting state; and the first coupling feature and the second coupling feature, during the mounting step, do not cooperate to bring the first coupling feature into the inhibiting state before the intermediate position is reached.

This way, during the second partial movement, more particularly in an end portion thereof, a rotatability of the main plunger rod device becomes and stays inhibited. This can be valuable, e.g., in case a priming mechanism as described herein below shall be implemented, but can be valuable also in other cases.

And the blocking of the rotation of the main plunger rod device is not caused before the intermediate position is reached. This can be useful in case the main plunger rod device has to rotate during the first partial movement, such as when the main plunger rod device has to be moved distally during the first partial movement, and its rotation is coupled (e.g., by an auxiliary plunger rod device) to its distal movement, in particular such that it cannot move distally unless it rotates.

In embodiments, the first coupling feature comprises a resilient arm, and the second coupling feature comprises a sleeve-shaped distal portion of the container housing which presses a free end of the resilient arm inwardly to cause the rotational locking of the main plunger rod device, e.g., by rotationally locking a plunger rod guiding member as described below.

In embodiments, the plunger rod fixing mechanism is coupled to the mounting mechanism. In particular, they can be coupled in that bringing the container housing, in the mounting step, from the unmounted position into the mounted position, in particular during the second partial movement, activates the plunger rod fixing mechanism.

For example, the plunger rod fixing mechanism and the mounting mechanism can be coupled in that bringing the container housing, in the mounting step, from the unmounted position into the mounted position, causes the first coupling feature and the second coupling feature (in particular during the second partial movement) to cooperate to bring the first coupling feature into the intermediate position to rotationally lock the main plunger rod device, e.g., via rotationally locking a plunger rod guiding member; e.g., as follows.

In embodiments, the plunger rod fixing mechanism comprises a plunger rod guiding member comprised in, in particular affixed to, the medicament delivery partial device and rotationally fixed to the main plunger rod device, e.g., by an outer shape of the main plunger rod device cooperating with an outer shape of the plunger rod guiding member. And the plunger rod guiding member is configured to axially guide the main plunger rod device. The first coupling feature and the plunger rod guiding member cooperate to rotationally lock the main plunger rod device when the first coupling feature is in the inhibiting state, wherein the first coupling feature does not rotationally lock the main plunger rod device when it is not in the inhibiting state. Thus, the first coupling feature can, when in the inhibiting state, rotationally lock the plunger rod guiding member which again rotationally locks the main plunger rod device, because the main plunger rod device and the plunger rod guiding member are rotationally locked to one another. Accordingly, during the second partial movement, the first coupling feature can assume (and stay in) the inhibiting state as caused by cooperation with the second coupling feature, which, via the plunger rod guiding member, inhibits the rotatability of the main plunger rod device.

And if the first coupling feature is not in the inhibiting state, it does not rotationally lock the plunger rod guiding member and neither the main plunger rod device.

In embodiments, a ratchet mechanism can be used to implement the rotational locking of the plunger rod guiding member by the first coupling feature in the inhibiting state. E.g., the first coupling feature can comprise a first ratchet member, e.g., facing towards the device axis, and the plunger rod guiding member can comprise a second ratchet member, e.g., facing away from the device axis. And the first and second ratchet members can cooperate to rotationally lock, when the first coupling feature is in the intermediate position, e.g., the first ratchet member being pressed against the second ratchet member, such as by cooperation with the second coupling feature.

Such embodiments can be particularly valuable when the main plunger rod device shall be rotationally fixed (relative to the device body) when the container housing is mounted to the medicament delivery partial device, such as when it has to be rotationally fixed during expelling of doses and/or during a loading process for biasing the biasing member - and when furthermore, the main plunger rod device has to be distally moved during the mounting step.

In particular, such embodiments can be valuable when furthermore the main plunger rod device has to be able to rotate in order to move distally, e.g., when the distal movement (of the main plunger rod device) is coupled to a rotational movement (of the main plunger rod device) relative to the device body, such as by means of a thread (plunger rod thread) of the main plunger rod device cooperating with a thread engaging feature of, e.g., the auxiliary plunger rod device.

In embodiments, the first partial movement comprises, in particular essentially is, a distal movement of the container housing relative to the device body, and the second partial movement comprises a rotational movement of the container housing relative to the device body. More particularly, the second partial movement in addition comprises a distal movement of the container housing relative to the device body. This can provide a convenient way of operating the medicament delivery device, in particular in conjunction with a priming mechanism as described below.

In embodiments, the medicament delivery device comprises a priming mechanism configured to cause a pre-bias of the biasing member. The priming mechanism comprises a first guiding structure comprised in, in particular affixed to, the medicament delivery partial device, and a second guiding structure comprised in, in particular affixed to, the container housing. The first guiding structure and the second guiding structure cooperate to guide the second partial movement to comprise a distal movement, and the distal movement causes the pre-tension, namely by the plunger abutting a proximal end of the main plunger rod device. This way, a pre-bias of the biasing member can be caused by the mounting of the container housing to the medicament delivery partial device, more particularly by carrying out the second partial movement. This pre-bias can be made use of for priming the medicament delivery device.

When operating the medicament delivery device, more particularly when mounting the container housing (more particularly: the container assembly) to the device body, the user mainly causes a rotational movement of the container housing (relative to the device housing), however, the cooperation of the first and second guiding structures ensures that also (at the same time) a distal movement of the container housing is carried out. The cooperation of the first and second guiding structures derives the distal movement portion of the second partial movement from the rotational movement portion of the second partial movement.

During the mounting step, the septum of the medicament container is not pierced (no needle arrangement mounted at this point), the plunger of the medicament container is stationary relative to the container housing. Furthermore, the plunger rod assembly is biased by the biasing member to proximally force the plunger rod assembly (and more particularly: the main plunger rod device). Therefore, as a consequence of the distal movement comprised in the second partial movement (as caused by cooperation of the first guiding structure and the second guiding structure), the plunger of the medicament container - abutting the proximal end of the main plunger rod device - distally moves the main plunger rod device. This distal movement of the main plunger rod device acts against the force exerted by the biasing member which forces the plunger rod assembly proximally if the main plunger rod device and the plunger rod assembly are coupled to lock their distal movements. In order to block an axial relative movement of the main plunger rod device and the plunger rod assembly (such as due to a coupling between distal movements of the main plunger rod device and rotational movements of the main plunger rod device, e.g., as described above by cooperation of a plunger rod thread and a thread engaging feature of the auxiliary plunger rod device), a rotatability of the main plunger rod device has to be inhibited. This can be accomplished by means of the plunger rod locking mechanism as described, in particular during a final portion of the second partial movement. Thus, the distal movement of the main plunger rod device caused by the distal movement part of the second partial movement causes a corresponding distal movement of the plunger rod assembly.

Accordingly, a pre-bias is caused in the biasing member, e.g., by axially compressing it. The biasing member can be, e.g., a compression spring.

When the pre-bias exists, and when in that situation the septum of the medicament container is pierced, e.g., by a cannula, all gaps in the mechanical chain for expelling a medicament dose can be eliminated and a portion of the medicament contained in the medicament container can be expelled through the cannula as forced by the pre-bias.

In embodiments, the first guiding structure and the first mechanical structure are, at least in part, identical. Thus, the same structure can be used for the keying and for ensuring the distal movement portion of the second partial movement. This can enable a space-saving design.

In embodiments, the first guiding structure comprises a protrusion comprising a sliding side face, and the second guiding structure comprises a guiding slit comprising a sliding face. The sliding face is generally circumferentially extended but slanted to cause the distal movement of the second partial movement by cooperation with the sliding side face during the second partial movement. Furthermore, the guiding slit can be aligned generally circumferentially but slanted.

This is a simple and effective way of embodying the second guiding structure and the priming mechanism, respectively.

In embodiments, the device body comprises an essentially cylindrical first guiding surface, and the container housing comprising an essentially cylindrical second guiding surface cooperating with the first guiding surface to guide the container housing relative to the device body during the mounting step, in particular during the first and the second partial movements. One of the first guiding surface and of the second guiding surface is an inner surface, the other is an outer surface. Such essentially cylindrical surfaces can provide guidance in both, rotational and axial movements. And they can provide mechanical stability of the connection established by the mounting. In addition, this can effect a centering (around the device axis) of the container housing (relative to the medicament delivery partial device).

In embodiments, the container housing comprises a sleeve-shaped distal portion, and the second guiding surface is formed on an inner side of the sleeve-shaped distal portion. And the device body comprises a proximal tubeshaped portion, wherein the first guiding surface is formed on an outer side of the tube-shaped portion.

In the mounted state, the sleeve-shaped distal portion can encompass the rod-shaped portion. In embodiments, the plunger rod assembly comprises, in addition to the main plunger rod device (also referred to as second plunger rod device), an auxiliary plunger rod device (also referred to as first plunger rod device), and the medicament delivery device further comprises a loading mechanism configured for a user to cause a distal movement of the auxiliary plunger rod device, relative to the device body and to the main plunger rod device, from an unloaded position into a loaded position and to thereby bias the biasing member. During the mounting step, the auxiliary plunger rod device usually is in the unloaded position.

The auxiliary plunger rod device may be a plunger nut, with an internal cavity that accommodates at least a portion of the main plunger rod device, and with the thread engaging feature being an interior thread of the plunger nut.

The main plunger rod device may comprise a plunger rod. In embodiments, the plunger rod thread is an exterior thread on the plunger rod.

In embodiments, the device body defines a stop for a movement of the plunger rod assembly in the proximal direction when the auxiliary plunger rod device has reached the unloaded position, wherein the loading mechanism is equipped for the user to cause another distal movement of the auxiliary plunger rod device relative to the device body and the main plunger rod device in a reloading action after the plunger rod assembly has reached the stop, whereby the medicament delivery device is configured for the loading mechanism to be activated a plurality of times. Therein, the unloaded position of the auxiliary plunger rod device and the loaded position of the auxiliary plunger rod device is the same for each dose. Loading and reloading usually takes place with the container housing in the mounted position.

In embodiments, the main plunger rod device is configured to interact with the medicament container to expel the medicament therefrom when the plunger rod assembly is moved in the proximal direction. For example, the main plunger rod device may act on the plunger of the medicament container, wherein the movement of the plunger towards proximally expels the medicament when a needle is mounted (piercing the septum).

The loading mechanism can be configured to allow the user to move the auxiliary plunger rod device into a distal direction relative to both, the device body and the main plunger rod device, and to thereby bias the biasing member. The step of causing the auxiliary plunger rod device towards distally and thereby biasing the biasing member by means of the loading mechanism is also called "loading step".

The described loading approach may thus comprise having an auxiliary plunger rod device that is moved into a distal direction relative to both, the device body and the main plunger rod device, to bias the biasing member. This allows the user to load the medicament delivery device prior to expelling the first dose and to re-load it prior to expelling any further dose. For each dose, the auxiliary plunger rod device may be subject to an axial movement from essentially a same initial position (loaded position) to a same end position (unloaded position). The loaded position and the unloaded position are pre-defined and may be the same for every dose, so that dispensing errors can be excluded and so that the time for expelling the medicament may be the same for each dose. Also, due to the mentioned loading approach, the biasing member does not need to store the energy for all the doses. The biasing member does not even need to store the energy for any dose until immediately before medicament delivery. Hence, the medicament delivery device does not have the problem of being under high load for a long time. The biasing member - for example a compression spring - may rather be in a low load state during storage and be supported by rigid parts. This makes possible that for the medicament delivery device no materials fulfilling high demands concerning resistance to creeping have to be used. Rather, also simpler plastic such as Polypropylene (PP) can be used, and it is possible to make most parts of the medicament delivery device - with the exception of, e.g., the compression spring - of a same material, which facilitates recycling. When the user, during loading, moves the auxiliary plunger rod device into the distal direction, the plunger rod assembly may be configured for the main plunger rod device to not participate in this movement and for example to stand essentially still.

Since the medicament delivery device is configured for expelling multiple doses of the medicament, the distance travelled by the plunger rod assembly for delivering a dose of the medicament will be less than, and only a fraction of, the distance the plunger of the medicament container travels from the initial, full state to a final, empty state. The main plunger rod device will move forward (towards proximally) together with the auxiliary plunger rod device, as part of the plunger rod assembly for expelling the medicament, whereas it is only the auxiliary plunger rod device that makes the backward (towards distally) movement during the loading step.

Mounting and unmounting of the container housing usually takes place after a dose, e.g., the last dose, has been expelled.

The loading mechanism may for example comprise the principle that the user twists a twisting element - for example a loading sleeve - relative to the device body. The loading mechanism may further comprise a conversion of the rotational movement caused by the twisting of the twisting element into the translational movement of the auxiliary plunger rod device. To this end, the twisting element may be rotationally couplable (fixedly coupled or equipped to be coupled for the loading action) to the auxiliary plunger rod device, with respect to rotations around the axis. Then, at least one of the auxiliary plunger rod device and of the device body may comprise a helical feature, whereas the other one comprises a cooperating feature cooperating with the helical feature to cause the movement towards distally upon the rotational movement of the auxiliary plunger rod device. For example, the device body or a part affixed thereto may comprise a helically running slope as the helical feature, and the auxiliary plunger rod device may comprise a matching slope or an abutting element that is in contact with the slope. According to an alternative, the auxiliary plunger rod device may comprise a thread, for example an external thread, as the helical feature, cooperating with a thread engaging protrusion, for example inward protrusion, of the device body.

In embodiments, the medicament delivery device further comprises an activation mechanism for activating the medicament delivery device by initiating the expelling step in which the resilient member forces the plunger rod assembly, comprising the main and auxiliary plunger rod devices, towards proximally. The activation mechanism may for example comprise an activation button, an activation slider or similar and may cause, when applied, unlocking of the plunger rod assembly in the loaded position.

The described loading approach makes possible that the biasing member is an element that causes a purely axial force, in contrast to for example a torsion spring. Especially, the biasing member may be a compression spring, for example a helical spring. Compression springs compared to torsion springs have substantial advantages in terms of manufacturing and assembly.

The medicament delivery assembly comprises the medicament delivery device as herein described and further comprises the medicament container accommodated in the container housing (and thus assembled with the medicament delivery device). In other words, it comprises the medicament delivery partial device to which the container assembly is mounted. In addition, it may comprise a needle assembly that is equipped to pierce a septum of the medicament container and that has a needle, e.g., a cannula, for injecting the medicament, especially subcutaneously.

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. The drawings show:

Figure 1 a medicament delivery partial device, in a perspective view;

Figure 2 a container housing mountable to the medicament delivery partial device of Fig. 1, in a perspective view;

Figure 3 a medicament container;

Figure 4A a detail of the container housing of Fig. 2;

Figure 4B the container housing of Fig. 2, in another perspective view; Figure 5A the device body of the medicament delivery partial device of Fig.

1, in a perspective view;

Figure 5B a detail of the device body of Fig. 5A;

Figures 6A-6D the medicament delivery device in different stages regarding the mounting step;

Figure 7 a detail of the medicament delivery assembly, with engaged keying structures;

Figures 8A-8C pairs of keys and of keying structures, respectively, schematically;

Figure 9 the medicament delivery assembly comprising the medicament delivery partial device of Fig. 1 and the container housing of Fig.

2, with attached needle assembly;

Figure 10 the plunger rod guiding member of the device of Fig. 1, in a perspective view;

Figures 11A, 11B the device body with mounted plunger lock spring of the device of Fig. 1 in different states, in a perspective view;

Figure 12 the plunger lock spring of the device of Fig. 1, in a perspective view;

Figure 13A a detail of the medicament delivery device, with the container housing in the intermediate position;

Figure 13B the detail of the medicament delivery device of Fig. 13A, during the second partial movement, with activated plunger rod fixing mechanism;

Figure 14 the plunger nut of the plunger rod assembly of the medicament delivery partial device of Fig. 1;

Figures 15A-15D the medicament delivery assembly in different stages regarding the priming step, in a perspective view, with the device body shown in a transparent fashion; Figure 16 a spring stop of the medicament delivery device;

Figure 17 the spring stop as shown in Fig. 16, from a different perspective;

Figure 18 a loading sleeve of the medicament delivery device;

Figure 19 an activation button of the medicament delivery device;

Figure 20 a plunger nut of a 360° embodiment of the medicament delivery device;

Figure 21 a view of a slope part of this 360° embodiment;

Figure 22 an other view of the slope part;

Figure 23 a detail of elements of the 360° embodiment, in the unloaded state;

Figure 24 a detail of elements of the 360° embodiment, half-way through the loading step; and

Figure 25 a detail of elements of the 360° embodiment, upon completion of the loading step.

DETAILED DESCRIPTION

Fig. 1 shows, in a perspective view, a medicament delivery partial device 2’ comprising a device body 5 and a plunger rod 7 (as a main plunger rod device). It has a device axis A which is a proximodistal axis and comprises a plunger rod thread 72.

Fig. 2 shows a container housing 4 for accommodating a medicament container. It is mountable to the medicament delivery partial device 2’ to form a medicament delivery device and unmountable therefrom. It comprises, at its proximal end, a needle assembly thread 42 for mounting thereto a needle assembly comprising a needle device such as a cannula. And it comprises, as an option, a housing windows 41 through which the user may see the medicament container 3 to determine how many doses are left in the container. Fig. 3 shows the medicament container 3 containing a medicament. It can be accommodated in medicament container 4 and comprises a seal 32 such as a septum, to be pierced by the needle device, and a plunger 31 to be forced proximally in order to expel portions of the medicament through a needle device piercing the seal 32.

The container housing 4 ex-factory accommodates a medicament container 3. The container housing 4 together with the container 3 is also referred to as container assembly or as cassette. The user is not enabled to separate the container 3 from the container housing 4. Mounting the container assembly, i.e., the container housing 4 including the medicament container 3, to the medicament delivery partial device 2’ forms a medicament delivery assembly.

The medicament delivery device implements a mounting mechanism for mounting the container housing to the device body.

To prevent using the medicament delivery partial device 2’ with a wrong medicament, a keying mechanism is provided (comprised in the mounting mechanism) which impedes mounting to the medicament delivery partial device 2’ a container housing 4 accommodating a container 3 containing the wrong medicament. Only medicament containers 4 which are associated with the medicament delivery partial device 2’ can be mounted to the medicament delivery partial device 2’, i.e., such container housings which accommodate a container 3 containing the associated medicament - or container housings 4 which are configured to accommodate a container 3 containing the associated medicament.

The keying mechanism is operated by operating the mounting mechanism.

Fig. 4A shows a detail of the container housing of Fig. 2. Fig. 4B shows the container housing of Fig. 2, in another perspective view.

Fig. 5A shows the device body 5 of the medicament delivery partial device 2’ in a perspective view, and Fig. 5B shows a detail thereof. The medicament delivery partial device 2’, more particularly the device body 5, comprises a first key Ki comprising a mechanical keying structure comprising two outwardly (radially) protruding protrusions K11, K12 as (first) keying features which define an opening between them. The container housing 4 comprises a second key K2 comprising a mechanical keying structure comprising a protrusion K21 as a (second) keying feature. Protrusion K21 protrudes inwardly from an arched member 46 of container housing 4.

Figs. 6A to 6D show the medicament delivery assembly 1 in different stages during mounting the container housing 4 to the medicament delivery partial device 2’ or more precisely to device body 5.

Initially, the medicament delivery partial device 2’ and the container housing 4 (and the container assembly, respectively) are separate. In the mounting step for mounting the container housing 4 to the device body, the user moves container housing 4 in a guided fashion, guided by a first guiding surface 5a of a tube-shaped portion 53 of device body 5 cooperating with a second guiding surface 4a of a sleeve-shaped distal portion 46 of container housing 4, to provide axial and rotational guiding during mounting. In a first partial movement, the user moves container housing 4 distally to reach an intermediate position.

Fig. 6A illustrates the situation when the keying takes place, about in the middle of the first partial movement. Fig. 6B illustrates the situation at the end of the first partial movement, where the container housing is in the intermediate position. As can be seen, container housing 4 is positioned further distal in Fig. 6B than in Fig. 6A.

During the keying, the structures of the keys Ki, K2 are engaged. Fig. 7 shows a detail of the medicament delivery assembly in the engagement. In this situation, the protrusion K21 protrudes into the opening between the protrusions K11 and K12. Furthermore, protrusions K11 and K12 fit between side walls K22, K23 of the arched member 47. Thus, the key Ki of the medicament delivery partial device 2’ and the key K2 of the container assembly are matching keys; they are shaped so as to enable the engagement. The keying structure of key K2 slides through the keying structure of key Ki and thus through the engagement, thus enabling to finish the first partial movement.

In case of keys Ki, K2 which are not matching keys, the engagement during the mounting step would not be possible. Accordingly, a mounting of a container housing 4 to the device body 5 would not be possible; the intermediate position would not be reached (and neither the mounted position).

Figs. 8A to 8C schematically illustrate different pairs of keys Ki, K2, more particularly of the corresponding keying structures. Hatched areas symbolize protrusions, clear areas symbolize openings. Fig. 8A illustrates approximately the example described before. The keys Ki, K2 are matching keys.

Keys Ki and K2 of Fig. 8B, however, cannot be engaged. The protrusion of key K2 is too wide for the opening of key Ki. Thus, these keys are not matching keys. They are capable of blocking the first partial movement and thus are capable of inhibiting mounting the corresponding container assembly (and thus the wrong medicament) to the device body 5. Similarly, the case of Fig. 8C, where one of the two protrusions of key K2 would be able to engage with key Ki, but key Ki lacks an opening for the other protrusion of key K2. Accordingly: no engagement of the (unmatching) keys, no completion of the first partial movement, no reaching of the intermediate position (cf. Fig. 6B) or of the mounted position.

It is obvious that a large number of different pairs of matching keys can easily be construed which, when intermixed, are unmatching keys - even based on this simple concept.

For accomplishing the mounting step, the user carries out a second partial movement, subsequently to the first, distal partial movement. This movement is guided by cooperation of the first keying structure, more particularly of the protrusions K11, K12 of device body 5, functioning as a first guiding structure 18, and a guiding slit in the container housing 4 functioning as a second guiding structure 19. More particularly, the protrusions K11, K12 comprise sliding side faces 18a (see Fig. 5B) which are guided by a sliding face 19a of the guiding slit (see Fig. 7). The guiding slit is aligned generally circumferentially, but it is slanted, best visible in Figs. 6A to 6D. More generally, structures of device body 5 other than the protrusions K11, K12 could alternatively be used as the first guiding structures.

The second partial movement, leading from the intermediate position to the mounted position (Fig. 6D), is a generally rotational movement, but it also comprises a (small) distal movement by virtue of the slope of the guiding slit and more particularly of the sliding face 19a, which forces the container housing 4 more and more distally during rotationally moving the container housing 4 during the second partial movement. Fig. 6D illustrates the mounted position, whereas Fig. 6C illustrates a situation approximately half-way between the intermediate position and the mounted position.

Fig. 9 shows the medicament delivery assembly 1 with the container housing in the mounted state (like in Fig. 6D), but with an attached needle assembly 15, a cannula thereof piercing the septum 32 of the container 3.

On the one hand, said distal movement portion of the second partial movement leads to an interference fit of the container housing 4 on the device body 4 and more particularly of a circumferential internal conical surface 48a (Fig. 4B) of an abutting sleeve 48 (Fig. 4A) formed by conical section of container housing 4 on a circumferential abutting surface 5b (Figs. 5A, 5B) present at a proximal end of device body 5.

On the other hand, the first guiding structure 18 (comprised in the device body 5) and the second guiding structure 19 (comprised in the container housing 4) are parts of a priming mechanism which effects a pre-bias of a drive spring which forces the plunger rod 7 distally. The distal movement portion of the second partial movement effects said pre-bias, as will be explained below.

The medicament delivery device 2 also comprises a plunger rod fixing mechanism for inhibiting a rotatability of the plunger rod 7. The plunger rod fixing mechanism is operated by operating the mounting mechanism.

In the described medicament delivery device 2, a distal movement of the plunger rod 7 as required for mounting the container housing 4 is possible only if the plunger rod 7 can rotate. However, in other situations, such as during expelling of a dose or during loading the drive spring 9, the plunger rod 7 must not move distally and must not rotate. This can be the case for various reasons. In particular, as in the described embodiment, it can be due to details of the plunger rod assembly and the related expelling and loading mechanism. The plunger rod assembly comprises, as the main plunger rod device, also referred to as second plunger rod device, the plunger rod; and, as an auxiliary plunger rod device, also referred to as first plunger rod device, the plunger nut. The plunger rod assembly and further parts and functions of the medicament delivery device such as a loading mechanism for repeatedly biasing the drive spring 9 (biasing member) forcing the plunger rod proximally, can be embodied, e.g., as described in the following.

The medicament delivery partial device 2’ has a plunger rod assembly for dispensing the medicament by being moved towards proximally and thereby acting on the plunger 31. The plunger rod assembly comprises the plunger rod 7 and a plunger nut 8 (Fig 20).

The plunger rod 7 has a plunger rod thread 72 being an exterior thread running along a substantial portion of its axial extension. It is seated, at least partially (depending on the state of the medicament delivery device) in an interior of a plunger nut 8. The plunger nut 8 has an internal thread 82 (cf. Fig. 14) that engages with the plunger rod thread 72 of the plunger rod 7. The plunger nut 8 further comprises an outwardly protruding, flange-like circumferential ridge 81. A distal portion of the plunger nut 8 runs inside a sleeve-like spring stop 11 (Fig. 16 and Fig. 17). The spring stop 11 has spring stop coupling structures 111 engaging with second coupling holes 56 of the device body 5 and fixedly connecting the spring stop 11 to the device body 5 when assembled. The device body 5, the medicament container 4, and the spring stop 11 are therefore fixed to each other.

A drive spring 9 - serving as the biasing member - is arranged between the circumferential ridge 81 of the plunger nut 8 and the proximal end face of the spring stop 11. The medicament delivery device further comprises a loading sleeve 12 (Fig. 18) that is distally of the device body 5 and surrounds a proximal portion of the spring stop 11, while a distal portion thereof is surrounded by the device body 5.

Inside of the loading sleeve 12 and extending into an interior of the spring stop 11, the medicament delivery device further has an activation button 13 (Fig. 19).

For medicament delivery, the following steps are carried out (after mounting the container assembly, which can include actions of the priming described further below):

• A. Needle assembly affixing: The needle assembly 15 is mounted to the medicament delivery device (container assembly being mounted to the medicament delivery partial device. This will cause the septum 32 of the medicament container to be penetrated by the needle, whereupon the medicament is capable of being expelled through the needle. With the priming mechanism described further below implemented, the medicament delivery device is already primed at this point.

• B. Loading: The drive spring 12 is compressed between the circumferential ridge 81 of the plunger nut 8 and the needle stop 11 by causing the plunger nut 8 to move towards distally. This loading step is caused by a loading action by the user, namely a twisting of the loading sleeve 12 relative to the device body 5 by 360° (or, cf. below, by i8o°). In this, the container assembly, the plunger rod guiding member 54 and the spring stop 11 are fixedly connected to the device body 5. The plunger rod 7 is prevented from rotating by the shape of the outer geometry of the plunger rod 7 (flat sides f) cooperating with the plunger rod guiding member 54 (Fig. 10). The rotation of the loading sleeve 12 is, however, transferred to the plunger nut 8 and to the activation button 13 by an inwardly protruding structure, namely by inwardly protruding ledges 121 (Fig. 18). The rotation of the plunger nut 8 causes the plunger nut 8 to move backward, i.e., towards distal, against the spring force of the drive spring 9.

• C. Expelling. When the medicament delivery device is in the loaded state, the medicament delivery step may be initiated by pressing the activation button 13. Upon activation, the plunger rod assembly comprising the plunger nut 8 and the plunger rod 7 is allowed to travel towards distally, driven by the drive spring 9 that expands from the compressed state to a relaxed state and thereby acts on the circumferential ridge 81 of the plunger nut 8. This causes a dose of the medicament to be expelled through the needle, the dose being defined by the axial distance the assembly travels from the loaded state back into the unloaded state.

• D. Needle assembly removal. After delivery of a full dose, the user removes the needle assembly. In this state, the medicament delivery device (with the container assembly mounted) can be stored away awaiting further use. If no dose is left, as an alternative, the container assembly may be unmounted and disposed directly, cf. step E.

• E. Unmounting. Typically after the last dose has been expelled, but alternatively also already after expelling an earlier dose, the container assembly is unmounted (from the medicament delivery partial device) and can be discarded. The medicament delivery partial device (with the container assembly unmounted) can be stored away awaiting further use, typically with a new container assembly (full medicament container) or with a container assembly from which one or more doses have been expelled while still containing medicament for one or more doses.

• Steps A., B., C. and D., optionally also step E. (typically only in case of the last dose) are repeated for each one of the further doses.

The embodiment described so far and below is configured for a rotation by 360° for the loading step. Alternatively, e.g., a rotation of 180° for the loading step could be implemented. The advantage of a greater rotation is that more energy can be stored in the biasing member (drive spring 9) for a given torque, or less torque is required for a given energy. This may especially be an issue if the user wants to use a comparably thin needle to minimize pain during injections. A thin needle comes about with the need for a higher plunger force and hence a higher energy stored in the biasing member for a given dosage.

In Figs. 20 to 25, Fig. 20 shows a view of the plunger nut 8 and Fig. 21 a view of a slope part 201. The slope part 201 is mounted to be essentially immovable relative to the device body 5. Fig. 22 depicts an enlarged view of the slope part 201 from a different perspective. The plunger nut 8 has slopes 142, 143 cooperating with the slopes of slope part 201, namely: an outer slope 142 cooperating with the first slope 211 of the slope part 201 and an inner slope 143 cooperating with the second slope 212 of the slope part 201. The outer slope 142 and the inner slope 143 both have steps 144 matching with the step features 213 of the slope part 201. The outer slope 142 and the inner slope 143 belong to a slope extension 141 of the plunger nut 8 a distally facing shoulder 145 of which also serves as face against which the drive spring 9 presses.

Figs. 23-25 show, in part, the plunger nut 8 and the slope part 201 in different stages of the loading step, namely in an initial loading state (Fig. 23), after a 180° rotation (Fig. 24), and in a final loading state, after a 360° rotation (Fig. 25). The arrow indicates the increase of the axial length of the assembly constituted by the slope part 201 and a slope extension 141 of the plunger nut 8. In contrast to an embodiment with i8o° rotation, such as with two helical slopes of i8o° offset with respect to one another by a rotation of i8o° around the device axis, the helical slopes extend by 360° around axis A, instead of only 180°. To this end, the following measures are taken in the 360° embodiment, in particular compared to the 180° embodiment:

• In order for there not being any bending force on plunger rod 7 and plunger nut 8 when the latter is subject to the rotation during the loading step, the device has two slopes, offset by 180° with respect to one another. In the 180° embodiment, this is readily possible by arranging the two slopes (of a corresponding slope part) at the same axial position, offset by 180° with respect to one another. This solution, however, does not work for slopes that extend by more than 180° around the axis. In the 360° embodiment, the two slopes 211, 212 are at different radial positions (i.e., the second slope 212 is further inside than the first slope 211), but they otherwise have a 180° axial symmetry with respect to one another. A rotation by 180° thus transfers one slope into the other slope, but with different radial positions.

• The slopes 211, 212 of the 360° embodiment have step features 213 that prevent unwinding. The user usually cannot twist a full turn (360°) but has to change grip between partial rotations. The step features define stops for any unwinding movement. In the depicted 360° embodiment, the step features are arranged at 90°, 180°, and 270°. However, it would be sufficient if one step feature per slope, arranged at 180°, was present. Alternatives include step features at 120° and 240°, or more step features arranged with regular or also irregular spacings. In 180° rotation embodiments, step features may be dispensed with, but alternatively, they could be used in that case, too.

The step features may be in the form of zags (as illustrated, see Figs. 20-25) or may be in the form of platforms, i.e., zero-inclined portions. It is usually required to distally move the plunger rod 7 when mounting a container housing 4, because typically all or most doses have been expelled from the medicament container 3 at that point, and plunger rod 7 thus has moved far proximally, typically sticking far out of device body 5, such as visible in Fig. 1. Therefore, during mounting, the proximal end of plunger rod 7 abuts the distal end of the plunger 31 which pushes plunger rod 7 distally. Due to the coupling between rotation and distal movements of plunger rod 7, a rotation of plunger rod 7 may not be blocked at that point, whereas during other processes, in particular during a loading step for biasing the drive spring and during expelling the doses of the medicament, rotation of the plunger rod 7 has to be blocked.

Plunger rod 7 is axially guided by and rotationally locked to plunger rod guiding member 54 (also referred to as plunger rod guiding portion) which is accommodated in device body 5. Fig. 10 shows the plunger rod guiding member 54 in a perspective view. Plunger rod 7 is prevented from rotating relative to plunger rod guiding member 54 by the shape of the outer geometry of the plunger rod 7 cooperating with shape of the inner geometry of the plunger rod guiding member 54, the flat sides yf of plunger rod 7 (cf. Fig. 1) slide along the flat sides 54f of plunger rod guiding member 54 (Fig. 10) during distal plunger rod movements.

In order to selectively enable and disable rotation of plunger rod 7, plunger rod guiding member 54 is selectively rotatable. For accomplishing this, device body 5 comprises resilient arms 25 which are circumferentially extended and are spring-loaded by a plunger lock spring 20 towards outwardly, see Figs. 11A and 11B showing device body 5 with plunger lock spring 20 mounted therein, and Fig. 12 showing plunger lock spring 20, embodied as a sheet metal spring, in a perspective view. More particularly, spring arms 21 are pretensioned and abut resilient arms 25 to force them outwardly.

Resilient arms 25 comprise, at their free end, a protrusion 25a protruding outwardly and a first ratchet member 25b facing inwardly, i.e., towards the device axis A. During mounting the container housing 4, more particularly, during the second partial movement, the free ends of the resilient arms 25 are pushed inwardly (towards the device axis A) by the sleeve-shaped distal portion 46 of the container housing 4, so as to enter a state referred to as inhibiting state, shown in Fig. 11B. More particularly, portions 45 of the sleeve-shaped distal portion 46, as second coupling features, cooperate with the protrusions 25a, as first coupling features, so that the arms 25 enter the inhibiting state, as their free ends are pushed inwardly. This way, the first ratchet members 25b engage with a second ratchet member 54b present on the outside of plunger rod guiding member 54, resulting in a rotational locking of plunger rod guiding member 54, i.e., plunger rod guiding member 54 is rotationally blocked relative to device member 5 in this state; the resilient arms 25 (first coupling features) are in the inhibiting state and the plunger rod fixing mechanism is activated.

Fig. 13A shows a detail of the medicament delivery device 2, with the container housing 4 in the intermediate position. The plunger rod rotation is not yet fixed at this point.

Then, the second partial movement is carried out, and quite in the beginning thereof, protrusion 25a is pressed down by portion 45 of sleeve-shaped distal portion 46. Fig. 13B shows the situation at that point during the second partial movement, with activated plunger rod fixing mechanism; plunger rod rotation is fixed, the resilient arms 25 are in the inhibiting state, first ratchet members 25b and second ratchet member 54b are engaged.

The plunger rod fixing mechanism stays activated up to and also in the mounted state.

As described above, plunger rod 7 is part of a plunger rod assembly which in addition comprises a plunger nut 8 (as an auxiliary plunger rod device) which is shown in Fig. 14 in a transparent fashion to make better visible internal thread 82 which engages with the plunger rod thread 72 of the plunger rod 7. At the end of an expelling movement during which both, plunger rod 7 and plunger nut 8 move proximally, forced by drive spring 9, the plunger rod assembly (and thus plunger rod 7 and plunger nut 8) is still proximally forced by drive spring 9.

However, with the container housing 4 unmounted, plunger rod 7 can rotate relative to plunger nut 8, which is made use of during mounting of another container housing 4, more particularly during the first partial movement. But when, during the second partial movement, the plunger rod fixing mechanism is activated as described above, it blocks a rotatability of plunger rod 7 (relative to the device body 5). In this situation, with the rotation of plunger rod 7 locked, the above-explained distal movement portion of the second partial movement takes place (by virtue of the slope of the guiding slit). Accordingly, said distal movement portion causes the medicament container 3 and thus also the plunger 31 to move distal (medicament container 3 is stationary in container housing 4), and thus, plunger 31, abutting the proximal end of plunger rod 7, forces plunger rod 7 and therewith also plunger nut 8 to move distally - against the force exerted by drive spring 9. And, as a consequence, the pre-bias of drive spring 9, which has been mentioned above already, is caused, cf. Fig. 15C.

Therefore, as soon as the septum 32 is perforated by a needle device (cf. step A above), such as a cannula of the needle assembly 15, drive spring 9 moves the plunger rod assembly proximally, causing plunger rod 7 to move plunger 31 proximally. Thus, clearances are removed, and a small portion of the medicament is expelled. In other words, a priming takes place.

The medicament delivery partial device can furthermore comprise an additional spring inside the plunger rod 7 for pushing the plunger rod 7 distally when the container assembly is unmounted. The proximal end of plunger rod 7 can thus proximally protrude from device body 5, like shown in Fig. 1. This additional spring can be, e.g., a compression spring, and can be a much weaker spring than drive spring 9. E.g,. the additional spring can, at its proximal end, internally abut a proximal end face of plunger rod 7 and, at its distal end, internally abut a distal end face of the activation button 13. The additional spring can ensure contact between the plunger rod 7 and plunger 31 already (briefly) before the plunger rod guiding member 54 is rotationally blocked. A user can thus mount a container assembly regardless of the orientation of the partial medicament delivery device in the gravity field. And also, mounting a container assembly with a merely partially filled medicament container 3 is facilitated, the plunger rod 7 being located at a corresponding axial position (less proximal than in case of a completely used- up medicament container 3), thus facilitating mounting partially used container assemblies.

The embodiments described herein can furthermore have the property that an engagement of the plunger rod thread 72 on the one hand and the internal thread 82 on the other hand is subject to a clearance.

Figs. 15A to 15D illustrate this priming mechanism showing the medicament delivery assembly 1 in different stages regarding the priming step. For better visibility, device body 5 is shown in a transparent manner.

In Fig. 15A, the container housing 4 is in the intermediate position. In Fig. 15B, the second partial movement has started, but the plunger rod fixing mechanism is not yet activated. In Fig. 15C, the container housing 4 is in the mounted position, i.e., the second partial movement is terminated. The open arrow in Fig. 15C points at a gap between the plunger nut 8 and a slope part 201 which is affixed to device body 5, indicating that a compression (prebias) of drive spring 9 has been built up. in Fig. 15 D, the needle assembly 15 is mounted to container housing 4, piercing the septum 32 of container 3 with a needle device - thus enabling expelling of a small portion of the medicament from the medicament container 3. Accordingly, the pre-bias has vanished by proximally moving the plunger rod assembly which accordingly has proximally moved the plunger 32.

For unmounting the container housing 4 (after a dose, e.g., the last dose, has been expelled), the mounting movements are carried out in a time-reversed fashion. I.e., container housing 4 is rotated back from the mounted position to the intermediate position, including a small proximal movement, and then it is proximally moved and finally separated from device body 5.

Later, a new container housing and container assembly, respectively, can be mounted in the same manner as described.

The drug 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, 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. 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) comprising a plunger (31) and 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 medicament delivery partial device (2’) comprising a device body (5); a container housing (4) for accommodating the medicament container (3) in a stationary manner; a mounting mechanism configured for a user to bring the container housing (4), in a mounting step, from an unmounted position in which the container housing (4) is separate from the device body (5) into a mounted position in which the container housing (4) is mounted to the device body (5); the medicament delivery partial device (2') further comprising: a plunger rod assembly (101) comprising a main plunger rod device (7) configured to act, by moving in proximal direction, on a plunger (31) of the medicament container (3) for expelling the medicament therefrom; and a biasing member (9) configured to force the plunger rod assembly (101) in a proximal direction; characterized in that the mounting mechanism comprises a keying mechanism comprising a first key (Ki) comprised in the medicament delivery partial device (2') and a second key (K2) comprised in the container housing (4), the first key (Ki) comprising a first mechanical structure comprising one or more first keying features (K11, K12), the second key (K2) comprising a second mechanical structure comprising one or more second keying features (K21), wherein the mounting mechanism is configured such that an engagement of the first mechanical structure and the second mechanical structure during the mounting step is a pre-condition for the mounting step, and wherein the one or more first keying features (K11, K12) and the one or more second keying features (K21) are configured to enable the engagement of the first mechanical structure and the second mechanical structure during the mounting step in case the first key (Ki) and the second key (K2) are matching keys; and to mechanically block the engagement of the first mechanical structure and the second mechanical structure during the mounting step in case the first key (Ki) and the second key (K2) are not matching keys.

2. The medicament delivery device (2) according to claim 1, wherein the mounting mechanism is configured such that one or more of: a number; a size; a position; of the first keying features (K11, K12) and one or more of: a number; a size; a position; of the second keying features (K21) are matching in case the first key (Ki) and the second key (K2) are matching keys, to enable the engagement, and are not matching otherwise, to block the engagement.

3. The medicament delivery device (2) according to claim 1 or claim 2, wherein at least one of the first keying features (K11, K12) comprises one of: an opening and a protrusion, and at least one of the second keying features (K21) comprises the other one, wherein in the engagement, the protrusion is engaged with the opening.

4. The medicament delivery device (2) according to claim 3, the mounting step comprising, in case the first key (Ki) and the second key (K2) are matching keys, sliding the opening and the protrusion into one another, in particular through one another.

5. The medicament delivery device (2) according to one of claims 1 to 4, wherein the mounting mechanism is configured such that the mounting step comprises a first partial movement of the container housing (4) during which, in case the first key (Ki) and the second key (K2) are matching keys, the engagement takes place, and a second partial movement of the container housing (4), the first partial movement bringing the container housing (4) into an intermediate position, the second partial movement bringing the container housing (4) from the intermediate position into the mounted position, in particular wherein the first mechanical structure and the second mechanical structure are configured to block the second partial movement when in the engagement.

6. The medicament delivery device (2) according claim 5, comprising a plunger rod fixing mechanism configured to inhibit a rotatability of the main plunger rod device (7) when activated, the plunger rod fixing mechanism comprising a first coupling feature (25) comprised in the medicament delivery partial device (2'), the container housing (4) comprising a second coupling feature (45), wherein the plunger rod fixing mechanism is configured to be activated when the first coupling feature (25) is in an inhibiting state and to be not activated when the first coupling feature (25) is in not in the inhibiting state, wherein the mounting mechanism is configured such that the first coupling feature (25) and the second coupling feature (45) cooperate, during the second partial movement, to bring the first coupling feature (25) into the inhibiting state and to keep the first coupling feature (25) in the inhibiting state, and such that the first coupling feature (25) and the second coupling feature (45), during the mounting step, do not cooperate to bring the first coupling feature (25) into the inhibiting state before the intermediate position is reached.

7. The medicament delivery device (2) according claim 6, the plunger rod fixing mechanism comprising a plunger rod guiding member (54) comprised in the medicament delivery partial device (2') and rotationally fixed to the main plunger rod device (7) and configured to axially guide the main plunger rod device (7); the first coupling feature (25) and the plunger rod guiding member (54) cooperating to rotationally lock the main plunger rod device (7) when the first coupling feature (25) is in the inhibiting state, the first coupling feature (25) not rotationally locking the main plunger rod device (7) when not in the inhibiting state.

8. The medicament delivery device (2) according to one of claims 5 to 7, the first partial movement comprising a distal movement of the container housing (4) relative to the device body (5), and the second partial movement comprises a rotational movement of the container housing (4) relative to the device body (5).

9. The medicament delivery device (2) according to claim 8, comprising a priming mechanism configured to cause a pre-bias of the biasing member (9) and comprising a first guiding structure (18) comprised in the medicament delivery partial device (2') and a second guiding structure (19) comprised in the container housing (4); the first guiding structure (18) and the second guiding structure (19) cooperating to guide the second partial movement to comprise a distal movement, the distal movement causing the pre-tension, by the plunger (31) abutting a proximal end of the main plunger rod device (7).

10. The medicament delivery device (2) according to claim 9, the plunger rod assembly (101) comprising, in addition to the main plunger rod device (7), an auxiliary plunger rod device (8), and the medicament delivery device further comprising a loading mechanism configured for a user to cause a distal movement of the auxiliary plunger rod device (8), relative to the device body (5) and to the main plunger rod device (7), from an unloaded position into a loaded position, and to thereby bias the biasing member (9), and wherein the device body (5) defines a stop (57) for a movement of the plunger rod assembly (101) in the proximal direction when the auxiliary plunger rod device (8) has reached the unloaded position, wherein the loading mechanism is equipped for the user to cause another distal movement of the auxiliary plunger rod device (8) relative to the device body (5) and the main plunger rod device (7) in a reloading action after the plunger rod assembly (101) has reached the stop (57), whereby the medicament delivery device (2) is configured for the loading mechanism to be activated a plurality of times, wherein the unloaded position of the auxiliary plunger rod device (8) and the loaded position of the auxiliary plunger rod device (8) is the same for each dose.

11. The medicament delivery device (2) according to claim 9 or claim 10, wherein the first guiding structure (18) and the first mechanical structure are, at least in part, identical.

12. The medicament delivery device (2) according to one of claims 9 to 11, wherein the first guiding structure (18) comprises a protrusion comprising a sliding side face (18a), the second guiding structure (19) comprising a guiding slit comprising a sliding face (19a), wherein the sliding face (19a) is generally circumferentially extended but slanted to cause the distal movement of the second partial movement by cooperation with the sliding side face during the second partial movement.

13. The medicament delivery device (2) according one of claims 1 to 12, the device body (5) comprising an essentially cylindrical first guiding surface (5a), and the container housing (4) comprising an essentially cylindrical second guiding surface (4a) cooperating with the first guiding surface (5a) to guide the container housing (4) relative to the device body (5) during the mounting step, one of the first guiding surface (5a) and of the second guiding surface (4a) being an inner surface, the other being an outer surface, in particular wherein the container housing (4) comprises a sleeve-shaped distal portion (46), the second guiding surface (4a) being formed on an inner side of the sleeve-shaped distal portion (46), and the device body comprises a proximal tube-shaped portion (53), the first guiding surface (5a) being formed on an outer side of the tube-shaped portion (53). 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) accommodated in the container housing.