Medicament delivery device and medicament delivery assembly
The medicament delivery device integrates needle cover activation with dose expulsion, simplifying user interaction and enhancing safety while reducing environmental impact by enabling multiple doses from a single container.
Patent Information
- Application Number
- PCT/EP2024/088170
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-01-03
- Filing Date
- 2024-12-20
- Publication Date
- 2025-07-10
AI Technical Summary
Existing medicament delivery devices for multiple doses face challenges in simplifying user interaction, ensuring safety against needle stick injuries, and reducing environmental impact, particularly with multi-dose devices requiring needle replacement before each use.
A medicament delivery device that integrates a needle cover activation mechanism with an activation member, allowing a single movement to expel a dose, eliminating the need for a separate button activation and enabling safe, efficient use with a reusable activation member and detachable needle assembly.
The device simplifies user interaction by combining needle cover and activation movements, enhances safety through automatic dose expulsion, and reduces environmental impact by allowing multiple doses from a single container, thus minimizing waste.
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Figure EP2024088170_10072025_PF_FP_ABST
Abstract
Description
[0001] TITLE
[0002] Medicament Delivery Device and Medicament Delivery Assembly
[0003] TECHNICAL FIELD
[0004] The invention is in the field of medicament delivery devices. In particular, it relates to automatic medicament delivery devices and to medicament delivery devices for delivering multiple fixed doses of a medicament.
[0005] BACKGROUND
[0006] Medicament delivery devices for automatic delivery of a medicament by selfadministration are well-known. Especially, they may be equipped to accommodate a medicament container, for example a medicament container with a septum to be perforated immediately prior to use, or a syringe. Often, the medicament delivery device and the medicament container are preassembled to constitute a medicament delivery assembly for selfadministration.
[0007] Such medicament delivery devices and medicament delivery assemblies should generally be safe to use and easy to handle, and they should ensure delivery of the designated dose of the medicament with high accuracy. Safety in this regard can in particular comprise that unintended needle stick injuries after use are prevented.
[0008] Many such medicament delivery devices which are to deliver a single predetermined dose are "empty all", coming with a pre-filled syringe or vial as medicament container containing said pre-determined dose of the medicament.
[0009] In many applications, pre-determined (preset) medicament doses have to be delivered repeatedly. In view of environmental considerations, it is undesirable in that case to use pre-filled single-dose medicament delivery devices and dispose one of those for each dose to be delivered (disposable auto-injectors). And even when using a medicament delivery device in which the medicament container can be replaced, it is still undesirable to dispose a (single-dose) medicament container for each medicament delivery.
[0010] One way of lowering the carbon footprint here is to reduce the amount of material involved, in particular plastics. This can be accomplished by allowing for the medicament delivery device to deliver multiple doses instead of only one, thus reducing the carbon footprint per injection.
[0011] Correspondingly large volume cartridges are available and allow for multiple injections with one medicament container instead of single dose injections with a pre-filled syringe.
[0012] Auto-injectors are known which are button-activated, i.e., the user presses an activation button to cause the auto-injector to expel a dose of the medicament.
[0013] In addition, for single dose disposable auto-injectors, needle cover activation is known. In this case, the user presses the auto-injector tip against the location where the injection shall take place, thereby pushing back a needle cover which initially protects and then exposes the needle, for piercing the skin, and the pushing back of the needle cover activates the auto-injector, i.e., causes the auto-injector to expel a dose of the medicament.
[0014] For multi-dose medicament delivery devices (also referred to as partial doses medicament delivery devices), however, a new needle needs to be attached for each injection. Thus, for multi-dose medicament delivery devices, prior to each use, a needle needs to be pierced through the seal, e.g., septum, of the container.
[0015] SUMMARY
[0016] For single dose auto-injectors, a needle protection feature to prevent unintended needle stick injuries after use is known, making use of a needle cover activation sleeve. Using such a needle protection feature using a needle cover activation sleeve in case of a multi-dose medicament delivery device is likely to be possible if button activation is implemented. However, for a user, pressing an activation button is an extra action to be taken.
[0017] However, if it would be intended to create a multi-dose medicament delivery device with needle cover activation (to avoid said extra action of pressing an activation button), a needle cover activation sleeve as known in the art for protecting the needle would likely interfere with the needle during assembly or replacement.
[0018] Therefore, one object of the invention is to create a new medicament delivery device for delivering multiple doses, in particular multiple preset doses, of a medicament from a medicament container.
[0019] Another object of the invention is to create a medicament delivery device which is particularly environment-friendly and / or has a small carbon footprint.
[0020] Another object of the invention is to create a medicament delivery device which is particularly simple to use.
[0021] Another object of the invention is to create a medicament delivery device which is particularly safe to use.
[0022] Furthermore, the medicament delivery device should be advantageous in terms of safety, reliability, ease of use.
[0023] Further objects and various advantages emerge from the description and embodiments below.
[0024] These objects are at least partially achieved by devices and assemblies according to the patent claims.
[0025] The medicament delivery device for accommodating a medicament container containing a medicament and for expelling multiple doses, in particular multiple pre-determined doses, of the medicament from the medicament container comprises: an expelling unit comprising a plunger rod device configured to be driven, for each of the doses, in an axial, in particular proximal, direction while acting on the medicament container, more particularly on a stopper, e.g., plunger, of the medicament container, to expel the respective dose; and a needle assembly comprising a needle cover device.
[0026] The needle cover device is configured to be movable, in a first movement, from a first position to a second position, wherein the first movement can in particular be a distal movement, i.e., a movement in a distal direction.
[0027] The medicament delivery device comprises an activation member; and a pre-condition for the expelling unit to expel a respective dose is an activation movement of the activation member, and the medicament delivery device is configured such that the activation member (in particular when the needle assembly is attached to the base part of the medicament delivery device, cf. below) derives the activation movement from the first movement. More precisely, for each of the doses, a pre-condition for the expelling unit to expel the respective dose is an activation movement, e.g., distal movement, of the activation member.
[0028] In other words, a conversion of the first movement (of the needle cover device) to the activation movement (of the activation device) takes place. This can be accomplished in various ways, wherein in a simple example, a distal movement (of the needle cover device) is converted into a distal movement (of the activation member). This can be accomplished, e.g., by the needle cover device abutting the activation member.
[0029] The activation member can be configured to cooperate with the needle cover device so as to cause an expelling of a respective dose in reaction to the first movement. Through this, an activation of the medicament delivery device can be derived, via the activation member, from the movement (first movement) of the needle cover device, thus simplifying the use of the medicament delivery device, e.g., rendering superfluous a pressing of an activation button.
[0030] In embodiments, the expelling unit is configured to expel a respective dose in reaction to the activation movement.
[0031] In embodiments, the activation movement of the activation member causes the expelling unit to expel a respective dose.
[0032] In embodiments, the medicament delivery device comprises a housing having a proximal end and a distal end and defining a device axis extending proximodistally.
[0033] In embodiments, the needle cover device and the activation member are distinct parts. This provides enhanced flexibility in activating the medicament delivery device, e.g., they can be configured to be rotatable with respect to one another. And, for example, the needle cover device can be a single-use disposable part, i.e., to be replaced for each dose; whereas the activation member can be used for multiple doses.
[0034] In other embodiments, the needle cover device and the activation member are one and the same part, e.g., forming different sections of one and the same part.
[0035] In embodiments, the medicament delivery device comprises a base part, wherein the needle assembly is attachable to and detachable from the base part, and more particularly, the activation member can be comprised in the base part. This way, the link between exposing the needle (by the movement of the needle cover device) and activation (by the movement of the activation member) is divided into at least two parts, providing increased flexibility.
[0036] The activation member can, in instances, be considered a linkage device, as it provides a link between, on the one hand, the needle cover device and (temporarily) suspending the needle protection, respectively, and the activation on the other hand.
[0037] In embodiments, the activation movement is an axial movement, in particular a distal movement. In a simple embodiment, this is combined with the first movement being an axial movement, in particular a distal movement.
[0038] In embodiments, in the activation movement, the activation device moves from a base position to an activation position.
[0039] In embodiments, the needle assembly comprises a needle device comprising a tip, wherein in the first position, at least the tip of the needle device is covered by the needle cover device, and in the second position at least the tip of the needle device extends outside the needle cover device.
[0040] This way, the needle cover device can protect the needle tip, e.g., the needle cover device being arranged (in the first position) inside a volume defined by the needle cover device; and in the second position, the needle tip is exposed and can pierce, e.g., skin, e.g., by being arranged outside said volume defined by the needle cover device.
[0041] In embodiments, the medicament delivery device comprises a needle cover force device configured to counteract the first movement. The needle cover force device can, more particularly, be configured to force back the needle cover device from the second position towards the first position. In particular, the needle cover force device can be configured to drive the needle cover device proximally. The needle cover force device can comprise, e.g., a spring.
[0042] In embodiments, the medicament delivery device comprises an activation member force device configured to counteract the activation movement. In particular, the activation member force device can be configured to drive the activation member proximally. The needle cover force device can comprise, e.g., a spring. In embodiments, the needle cover force device and the activation member force device are identical to one another.
[0043] In embodiments, the needle cover force device and the activation member force device are in part identical to one another. E.g., the needle cover force device can comprise two sub-devices, one of these constituting the activation member force device.
[0044] In embodiments, the activation member force device is configured to drive the activation member to abut the needle cover device.
[0045] In embodiments, the activation member is configured to be axially movable, in particular both, proximally and distally.
[0046] In embodiments, the medicament delivery device comprises a housing, the activation member being axially movable relative to the housing, in particular inside the housing, in particular both, axially and distally.
[0047] The activation member and the needle cover device can be configured to cooperate such that, during the activation movement, the needle cover device is abutting the activation member.
[0048] In particular, the needle cover device can force the activation member in an axial direction, more particularly in a distal direction.
[0049] In embodiments, the needle cover device is configured to be movable, in particular subsequently to the first movement, in a second movement, from the second position to the first position. Furthermore, the medicament delivery device can comprise a safety mechanism configured to selectively block a movement of the needle cover device from the first position to the second position after the second movement has taken place, in particular after the second movement has taken place subsequently to the first movement. This way, after delivery of a dose, the needle device, in particular its tip, can be protected again by the needle cover device. And a subsequent movement of the needle cover device back towards or into the second position can be inhibited, such that injuries involving the needle can be avoided.
[0050] In embodiments, the second movement is caused by the needle cover force device. E.g., after the user lifts the medicament delivery device off the body, the needle cover force device can drive the needle cover device from the second position to the first position.
[0051] In embodiments, in the activation movement, the activation device moves from the base position to the activation position, in particular moves axially, more particularly distally.
[0052] In embodiments, the safety mechanism can assume an unsecured state in which the movement of the needle cover device from the first position to the second position, in particular the first movement, is not blocked by the safety mechanism, and a secured state in which the movement of the needle cover device from the first position to the second position blocked. It can be configured to change from the unsecured state to the secured state, e.g., by cooperating with the needle cover device, such as in reaction to the first movement; or in reaction to the second movement; or by cooperating with the activation device, such as in reaction to the activation movement; or in reaction to a movement of the activation device from an activation position to a base position.
[0053] In embodiments, the safety mechanism is comprised in the needle assembly. This way, the tip of the needle device is protected also after removal of the needle assembly from the base part.
[0054] In embodiments, the medicament delivery device comprises a plunger force device configured to drive the plunger rod device in an axial direction, in particular in a proximal direction.
[0055] The plunger force device can be part of the expelling unit. The plunger force device can comprise a spring device, such as a mechanical spring; in other embodiments, it can comprise an electric drive. In embodiments, the expelling unit comprises a release unit cooperating with the plunger rod device and with the activation member, the release unit being configured to selectively block an axial movement, in particular a proximal movement, of the plunger rod device; and in reaction to an activation movement, unblock an axial movement, in particular a proximal movement, of the plunger rod device driven by the plunger force device.
[0056] Thus, the release unit can make possible to enable delivery of a dose in reaction to an activation movement.
[0057] In embodiments, the release unit is comprised in the expelling unit.
[0058] In embodiments, the plunger rod device comprises at least one cooperation element, and the release unit comprises retaining structures configured to cooperate with the at least one cooperation element to block an axial movement, in particular a proximal movement, of the plunger rod device when the at least one cooperation element and the retaining structures are abutting. And the release unit can be configured to derive from the activation movement a relative movement of the plunger rod device and the retaining structures, so as to unblock (and thus enable) the axial movement (more particularly: proximal movement) of the plunger rod device by interrupting or terminating said abutting.
[0059] Thus, the activation member can function so as to operate the release unit.
[0060] Said relative movement can in particular be a rotational relative movement of the plunger rod device and the retaining structures. The retaining structures can form a stepped structure.
[0061] In embodiments, the release unit comprises retaining structures for each of the doses. In embodiments, the expelling unit comprises a dosing unit for controlling a dosing amount for each of the doses. The dosing unit can comprise a dosing device. In particular, for each of the doses, the respective dosing amount is controlled by an axial distance between retaining structures of the dosing device.
[0062] In embodiments, the dosing unit and the release unit are both embodied in the dosing device.
[0063] Thus, in particular, the dosing device can control both, the release of each dose and a dosing amount for each of the doses.
[0064] In embodiments, the plunger force device comprises an electric drive, and the expelling unit comprises an activation detector for detecting the activation movement. Furthermore, the expelling unit is configured to control the electric drive to axially, in particular proximally, drive the plunger rod device for each of the doses for a predetermined distance in reaction to a detection (by the activation detector) of the activation movement.
[0065] E.g., the activation detector can comprise a switch operable by the activation member, more particularly the switch can be configured to change a switching state (of the switch) in reaction to the activation member carrying out the activation movement, more particularly in reaction to the activation member approaching the switch during the activation movement. Said change in switching state can correspond to the detection of the activation movement, which, e.g., can trigger the electric drive.
[0066] The expelling unit can control, for each of the doses, a release of the plunger rod device - thus initiating the delivery of the respective dose, namely by said driving the plunger rod device in reaction to a detection of the activation movement. Thus, the expelling unit can form a release unit.
[0067] Furthermore, the expelling unit can control, for each dose, a respective dosing amount (dosing volume) to be delivered; namely by said driving the plunger rod device for a corresponding predetermined distance. Thus, the expelling unit can form and a dosing unit.
[0068] In embodiments, the medicament delivery device comprises a drive unit comprising the electric drive and the activation detector, the drive unit being detachable from and re-attachable to a front part of the medicament delivery device comprising the needle assembly, and, in particular, also the activation member. Accordingly, the drive unit can be re-usable many times, thus saving energy and carbon footprint. The drive unit can also comprise an energy source, such as a source of electrical energy, for powering the electric drive, e.g., a rechargeable battery.
[0069] The medicament delivery assembly comprises the medicament delivery device as herein described and further comprises the medicament container assembled with the medicament delivery device.
[0070] 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.
[0071] 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.
[0072] 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.
[0073] BRIEF DESCRIPTION OF THE DRAWINGS
[0074] Embodiments of the present disclosure will now be described by way of example only and with reference to the following accompanying drawings.
[0075] Figure 1A a medicament delivery device according to a first embodiment, comprising a drive unit and a front part, disassembled, in a perspective view;
[0076] Figure 1B the medicament delivery device of Fig. 1A, assembled, with needle cover device in a first position, in a perspective view;
[0077] Figure 1C the medicament delivery device of Fig. 1A, assembled, with needle cover device in a second position, in a perspective view;
[0078] Figure 2 the needle cover device of the medicament delivery device of Fig. 1A, in an exploded view;
[0079] Figure 3 the drive unit of the medicament delivery device of Fig. 1A, in a perspective view;
[0080] Figure 4A parts of the medicament delivery device of Fig. 1A, with the needle cover device in the first position, in a perspective view;
[0081] Figure 4B parts of the medicament delivery device of Fig. 1A, with the needle cover device in the second position, in a perspective view; Figure 5A parts of the medicament delivery device of Fig. 1A, with the needle cover device in the first position, in a perspective view;
[0082] Figure 5B parts of the medicament delivery device of Fig. 1A, with the needle cover device in the second position, in a perspective view;
[0083] Figure 5C parts of the medicament delivery device of Fig. 1A, with the needle cover device back in the first position (after the second movement), in a perspective view;
[0084] Figure 6 the distal part of the needle cover device of the medicament delivery device of Fig. 1A, in a perspective view;
[0085] Figure 7 the first part of the safety mechanism of the medicament delivery device of Fig. 1A, in a perspective view;
[0086] Figure 8 a medicament delivery device assembly according to a second embodiment, in a perspective view, several parts not shown;
[0087] Figure 9A the medicament delivery device assembly of Fig. 8 in a first state (primed), in a perspective view;
[0088] Figure 9B the medicament delivery device assembly of Fig. 8 in a second state (ready), in a perspective view;
[0089] Figure 9C the medicament delivery device assembly of Fig. 8 in a third state (beginning delivery), in a perspective view;
[0090] Figure 9D the medicament delivery device assembly of Fig. 8 in a fourth state (during delivery), in a perspective view;
[0091] Figure 9E the medicament delivery device assembly of Fig. 8 in a fifth state (end of delivery), in a perspective view;
[0092] Figure 9F the medicament delivery device assembly of Fig. 8 in a sixth state (tip secured), in a perspective view;
[0093] Figure 10 the needle cover device of the medicament delivery device assembly of Fig. 8, in a perspective view; Figure n the plunger rod device and the plunger force device of the medicament delivery device assembly of Fig. 8, in a perspective view;
[0094] Figures 12A, 12B the dosing device of the medicament delivery device assembly of Fig. 8, in different perspective views;
[0095] Figure 13 the locking device of the medicament delivery device assembly of Fig. 8, in a perspective view;
[0096] Figure 14 the container compartment member of the medicament delivery device assembly of Fig. 8, in a perspective view;
[0097] Figure 15 the activation member of the medicament delivery device assembly of Fig. 8, in a perspective view;
[0098] Figure 16 the activation member of the medicament delivery device assembly of Fig. 8, in a perspective view;
[0099] Figure 17 the distal housing part of the medicament delivery device assembly of Fig. 8, drawn in a transparent fashion in a perspective view;
[0100] Figure 18 the distal housing part drawn in a transparent fashion and the activation member of the medicament delivery device assembly of Fig. 8, assembled, in a perspective view;
[0101] Figure 19 the distal housing part of the medicament delivery device assembly of Fig. 8, drawn in a transparent fashion in a view along the device axis;
[0102] Figure 20 the rear member of the medicament delivery device assembly of Fig. 8, in a perspective view;
[0103] The described embodiments are meant as examples or for clarifying the invention and shall not limit the invention. DETAILED DESCRIPTION
[0104] FIRST EMBODIMENT
[0105] Fig. 1A shows, in a perspective view, a first embodiment of a medicament delivery device 2. This medicament delivery device 2 comprises a drive unit 2d and a front part 2c, which are, in Fig. 1A, disassembled. It comprises an attachable and detachable needle assembly 5 comprising a needle cover 5b. Needle assembly 5 can be attached, e.g., to a container compartment member 16 (cf. Fig. 4A), e.g., by screwing, by a ratch-type connection or otherwise (not shown in the figures). Fig. 1B shows medicament delivery device 2 in an assembled state (drive unit 2d and a front part 2c attached to one another), needle cover 5b being in a first position. In Fig. 1C, needle cover 5b is in a second position, needle device 5a being exposed, more particularly its tip sal.
[0106] Fig. 2 shows needle assembly 5 in an exploded view. It furthermore comprises a safety mechanism comprising a first part 5S1 and a second part 5S2, and a needle cover force device sf, e.g., a spring. Needle cover 5 comprises a proximal part sbi and a distal part sb2.
[0107] In the figures, proximal part sbi is illustrated in a transparent fashion.
[0108] Fig. 3 shows, in a perspective view, the drive unit 2d of the medicament delivery device 2, in a perspective view. It comprises a plunger rod 6 and a plunger force device 7 which is embodied as an electric drive, e.g., comprising an electrical stepper motor.
[0109] Fig. 4A shows, in a perspective view, parts of medicament delivery device 2, with needle cover device 5b in the first position; Fig. 4B shows, in a perspective view, parts of medicament delivery device 2, with needle cover device 5b in the second position.
[0110] Medicament delivery device 2 comprises a container compartment member 16 (cf. Fig. 4A, not shown in Fig. 4B) for accommodating a medicament container 3 (transparent and therefore not visible in Figs. 4A, 4B) containing a medicament and a stopper 3b such as a plunger.
[0111] Medicament delivery device 2, assembled with container 3, is referred to as medicament delivery device assembly.
[0112] In the first position, tip sal of needle 5a is inside a volume defined by needle cover 5b and thus is protected, whereas in the second position, tip sal is outside said volume, thus it is exposed and not protected.
[0113] The movement (“first movement”) of needle cover 5b from the first to the second position is a distal movement. It takes place when a user wants the medicament delivery device assembly to expel a dose of the medicament. The proximal end of the medicament delivery device assembly is pressed against the respective part of the body, needle cover 5b makes the first movement, and exposed needle 5a can penetrate the user’s skin.
[0114] Needle cover activation is implemented by means of activation member 17 having a proximal end 17a and a distal end 17b.
[0115] In the first position of needle cover 5b, activation member 17 is in a base position (cf. Fig. 4A) where needle cover 5b can abut activation member 17 or can, as illustrated, be distant to activation member 17; and in the second position of needle cover 5b, activation member 17 is in a position referred to as activation position (cf. Fig. 4B) which is distal relative to the base position; and needle cover 5b can abut activation member 17. During the first movement, needle cover 5b forces activation member 17 distally; this movement of activation member 17 is referred to as activation movement.
[0116] Needle cover force device sf and an activation member force device 17, e.g., a spring, have to be counteracted in order to carry out the first movement and the activation movement.
[0117] Drive unit 2d can detect the activation movement, e.g., in that activation member 17 operates a switch of drive unit 2d, e.g., by pressing it (not shown). In reaction to the activation movement, plunger rod device 6 can be forced proximally by plunger force device 7 for a pre-determined axial distance and thus proximally move stopper 3b, thus resulting in delivery of a predetermined dose of the medicament.
[0118] This process is also illustrated in Figs. 5A to 5B.
[0119] Fig. 5A shows, in a perspective view, parts of medicament delivery device 2, with needle cover device 5b in the first position, and activation member is in the base position. In Fig. 5B, needle cover device 5b is in the second position (after the first movement has taken place), and activation member is in the activation position (after the activation movement has taken place). In Fig. 5C, after a second movement of needle cover 5b, needle cover device 5b is back in the first position, and activation member is back in the base position.
[0120] In Figs. 5A to 5C, distal part sb2 of needle cover 5b is not shown for increased clarity.
[0121] After the dose has been delivered, the user lifts the medicament delivery device assembly off the body, and needle cover 5b and activation member are forced back to the first position and the base position, respectively, by needle cover force device sf and activation member force device 17. Needle cover 5b carries out the second movement.
[0122] Fig. 6 shows distal part sb2 of needle cover device 5b in a perspective view. Fig. 7 shows first part ssi of the safety mechanism in a perspective view.
[0123] Structures inside needle cover device 5b, more particularly in its distal part 52b (cf. Fig. 6) cooperating with first part ssi of the safety mechanism (cf. Fig. 7) during the first and during the second movement of needle cover device 5b cause a rotation of first part ssi relative to second part 5S2 and optionally a subsequent locking in of part ssi in second part 5S2. This brings the safety mechanism from an initial state (unsecured state) into a secured state. In the secured state, the structures inside needle cover device 5b (cf. Fig. 6) cooperate with first part 5S1 so as to inhibit another axial movement of needle cover device 5b from the first position towards the second position. Accordingly, after the second movement, tip sal remains inside the volume defined by needle cover device 5b and is thus protected. And since the safety mechanism is implemented in needle assembly 5, tip sal remains protected even after removal of needle assembly 5 from base part 2b.
[0124] In addition to needle cover force device sf, activation member force device iyf is present, such that it is ensured that also after a removal of needle assembly 5 from base part 2b, activation member 17 is in the base position, in particular for the case that another needle assembly is attached, which would be the case for the next dose.
[0125] After mounting another needle assembly to base part 2b, the medicament delivery device assembly is ready for expelling a subsequent dose in the same way as described.
[0126] SECOND EMBODIMENT
[0127] The second embodiment can work purely mechanically, without a need for electric power. Same or analogous features, in the first and the second embodiment, generally bear same reference signs.
[0128] Fig. 8 shows, in a perspective view, a medicament delivery device assembly 1 according to the second embodiment defining a device axis A, wherein several parts not shown for increased clarity. Medicament delivery device assembly 1 comprises a base part 2b and a needle assembly 5 attachable to base part 2b and detachable therefrom. Needle assembly 5 can be embodied similar as in the first embodiment or identically. In particular, the safety mechanism can be identical to the one of the first embodiment.
[0129] Needle cover device 5b (not shown in Fig. 8) is (optionally) a single part, cf. Fig. 10; but it could be two-part, as in the first embodiment. Activation member 17 (cf. Figs. 15, 16) is proximally biased by activation member force device iyf (cf. Fig. 8) which at the same time functions as needle cover force device (item sf in the first embodiment), via activation member 17 and needle cover device 5b abutting one another.
[0130] Medicament delivery device assembly 1 further comprises a plunger rod device 6 and a plunger force device 7 (cf. Fig. 11), a dosing device 8 (Figs. 12A, 12B), a locking member 18 (cf. Fig. 13) and a rear member (or rear cap) 19 (cf. Fig. 20). It also comprises, not shown in Fig. 8, the needle cover device 5b, a housing comprising a proximal housing part 4a (cf. Fig. 9A) and a distal housing part 4b (cf. Fig. 17), and a container compartment member 16 (cf. Fig. 14) accommodating a medicament container 3 (transparent and therefore not visible in Figs. 9A to 9F) containing a medicament and a stopper such as a plunger. Medicament container 3 can be embodied like described for the first embodiment.
[0131] In Figs. 9A to 9F, the medicament delivery device assembly 1 is shown in a perspective view, in various states, wherein container 3 is not visible, because it is transparent, and distal housing part 4b is not visible, as it is illustrated in a transparent fashion.
[0132] Fig. 9A illustrates a first state in which the medicament delivery device is primed, i.e., the plunger rod device abuts a stopper of container 3, so that a well-defined relation between a proximal travel of the plunger rod and the expelled dose volume can be assumed to exist. In this state, needle cover device 5b is in a first position, proximally biased by activation member force device 17 which forces locking member 18 distally which abuts distal end 17b of activation member 17; activation member 17, at its proximal end 17a, abutting needle cover device 5b. Thus, activation member force device 17 also functions as needle cover force device (item sf in the first embodiment).
[0133] Protrusions 161 of container compartment member 16 (cf. Fig. 14) cooperate with inner grooves 173 of activation member 17 (cf. Fig. 16) to enable a limited axial movement of activation member 17 while also allowing for a (rather) limited rotation of activation member 17. Ridges 85 of dosing device 8 (cf. Figs. 12A, 12B) cooperate with inner slits 18a of locking member 18 (cf. Fig. 13) so as to inhibit rotation of dosing device 8.
[0134] Rotation of locking member 18 is inhibited by outer slits 18b of locking member 18 cooperating with inner ridges 19a of rear member 19 (cf.
[0135] Fig. 20).
[0136] Fig. 9B illustrates a second state of the medicament delivery device in which some preparation is taken for delivery of a dose. The user, in this state, has pushed in the needle cover device 5b about halfway. Activation member force device 17 is partially compressed (by the user action of pressing needle cover device 5b against the body), activation member 17 and locking member 18 are distally moved together with needle cover device 5b, so that rotation of dosing device 8 is not inhibited anymore (ridges 85 are outside slits 18a). Thus, dosing device 8 can rotate.
[0137] Fig. 9C illustrates a third state in which the medicament delivery device is activated and can start to deliver a dose. And Fig. 9D illustrates a fourth state in which the medicament delivery device is actually delivering a dose.
[0138] The user, in the third state (and in the fourth state), has fully pushed in the needle cover device 5b which now is in a second position, and needle tip sat is exposed. Inner structures 171 of activation member 17 (cf. Fig. 15) engage with outer structures 86 of dosing device 8 (cf. Figs. 12A, 12B), so as to derive a rotation of dosing device 8 from the distal movement of activation member 17 (inclined sections of outer structures 86 cooperating with inclined sections of inner structures 171). In the fourth state, this rotation has taken place. This rotation effects that a dose is released by cooperation of proximally biased plunger rod device 6 with dosing device 8. And dosing device 8 also effects that the dosing amount is controlled, cf. below.
[0139] Initially and also in the third state still, a proximal movement of plunger rod device 6 which is proximally biased by plunger force device 7, e.g., a spring inside plunger rod device 6 as illustrated in Fig. 11 (visible at the distal, open end of plunger rod device 6; the closed, proximal end not visible in Fig. n), is blocked by cooperation elements 61, e.g., outer ridges, of plunger rod device 6 abutting one of a number of retaining structures 81 on the inside of dosing device 8, cf. Fig. 12B. By rotating dosing device 8, plunger rod device 6 can move proximally for a pre-determined length which is defined by the axial distance between two neighbouring ones of the retaining structures 81. Accordingly, the corresponding proximal length by which the stopper device is controlled, and thus also the correspondingly expelled amount of medicament is controlled by dosing device 8.
[0140] Furthermore, the retaining structures 81 comprise inclined portions 84 (cf. Fig. 12B) which, by cooperation with the cooperation elements 61, in reaction to the rotation caused by the activation member 17, effect an additional rotation (quasi an “over-rotation”) of dosing device 8, as plunger rod device 6 is proximally biased. Also this additional rotation has taken place in the fourth state. This additional rotation again effects, via cooperation of outer structures 86 with inner structures 171, more particularly of approximately axially aligned sections of outer structures 86 with approximately axially aligned sections of inner structures 171, a rotation of activation member 17.
[0141] This rotation of activation member 17 is carried out against forces provided by force elements 172 of activation member 17 (cf. Figs. 15, 16) which initially were strongly bent and now are elastically deformed to be rather straight by cooperation with protrusions 4bi on the inside of distal housing part 4b (cf. Fig. 18). Protrusions 4bi protrude into slits 174 of activation member 17 (cf. Fig. 15).
[0142] Fig. 9E illustrates a fifth state in which the dose has been delivered. Needle cover device 5b is still in the second position, the user is still pushing needle cover device 5b against the body. Plunger rod device 6 has moved proximally as far as defined by dosing device 6. Force elements 172 of activation member 17 are still rather straight, thus storing deformation energy. Fig. 9F illustrates a sixth state in which tip sat is secured by needle cover device 5b. The user has lifted off medicament delivery device assembly from the body, such that needle cover device 5b is back in the first position and also activation member 17 and locking member 18 are axially and rotationally back in the positions they had in the first state. The proximal movement is effected by activation member force device tyf, and the rotation back of activation member 17 from the position in the fourth and fifth state to the position in the first state is accomplished by cooperation of force elements 172 of activation member 17 with protrusions 4bi of distal housing part 4b. The energy stored therein in the fourth and fifths state provides the energy for the rotation taking place during the proximal movement, so that force elements 172 are bent again, and activation member 17 is in its initial position.
[0143] Since, in the sixth state, dosing device 8 is rotated relative to the initial state, e.g., the first state, activation member 17 can cause another rotation of dosing device 6 when another dose is to be delivered, involving the first movement of needle cover device 5b from the first to the second position. This, of course after detaching needle assembly 5 and attaching a new needle assembly.
[0144] Fig. 18 shows, in a perspective view, activation member 17 and, drawn in a transparent fashion, distal housing part 4b engaged to one another, in the third state, protrusions 4bi abutting force element 172.
[0145] Fig. 19 shows distal housing part 4b, drawn in a transparent fashion, in a view along device axis A. Protrusions 4bi cooperating with activation member 17 are shown, as are structures 4b2 cooperating with cooperation elements 61 (cf. Fig. 11) of plunger rod device 6 as explained.
[0146] The delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.
[0147] 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.
[0148] 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.
[0149] 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.
[0150] 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.
[0151] 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.
[0152] 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.
[0153] 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.
[0154] 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.
[0155] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOXy, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini- CHOP, Maxi-CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC- EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA / CO, EMA / EP, EP / EMA, TP / TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini-BEAM, IGEV, C- MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE. 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
CLAIMS1. A medicament delivery device (2) for accommodating a medicament container (3) containing a medicament and for expelling multiple doses of the medicament from the medicament container (3), the medicament delivery device (2) comprising an expelling unit comprising a plunger rod device (6) configured to be driven, for each of the doses, in an axial direction while acting on the medicament container (3) to expel the respective dose; and a needle assembly (5) comprising a needle cover device (5b); wherein the needle cover device (5b) is configured to be movable, in a first movement, from a first position to a second position, wherein the medicament delivery device (2) comprises an activation member (17); wherein a pre-condition for the expelling unit to expel a respective dose is an activation movement of the activation member (17), and wherein the medicament delivery device (2) is configured such that the activation member (17) derives the activation movement from the first movement.
2. The medicament delivery device (2) according to claim 1, comprising a base part (2b), the needle assembly (5) being attachable to and detachable from the base part (2b), and the activation member being comprised in the base part (2b).
3. The medicament delivery device (2) according to claim 1 or claim 2, the needle assembly (5) comprising a needle device (5a) comprising a tip (sat), wherein in the first position, the tip (sat) of the needle device (5a) is covered by the needle cover device (5b), and in the second position, the tip (sat) of the needle device (5a) extends outside the needle cover device (5b).
4. The medicament delivery device (2) according to one of claims 1 to 3, further comprising a needle cover force device (sf) configured to counteract the first movement and an activation member force device (tyf) configured to counteract the activation movement, wherein the needle cover force device (sf) and the activation member force device (17O are optionally fully or in part identical to one another.
5. The medicament delivery device (2) according to one of claims 1 to 4, comprising a housing (4), the activation member (17) being axially movable inside the housing (4), the activation member (17) and the needle cover device (5b) being configured to cooperate such that, during the activation movement, the needle cover device (5b) is abutting the activation member (17), in particular the needle cover device (5b) forcing the activation member (17) in a distal direction.
6. The medicament delivery device (2) according to one of claims 1 to 5, wherein the needle cover device (5b) is configured to be, in particular subsequently to the first movement, movable, in a second movement, from the second position to the first position, the medicament delivery device (2) comprising a safety mechanism (ssi, 5S2) configured to selectively block a movement of the needle cover device (5b) from the first position to the second position after the second movement has taken place, in particular after the second movement has taken place subsequently to the first movement.
7. The medicament delivery device (2) according to claim 6, wherein the safety mechanism (ssi, 5S2) is comprised in the needle assembly (5).
8. The medicament delivery device (2) according to one of claims 1 to 7, comprising a plunger force device (7) configured to drive the plunger rod device (6) in an axial direction, in particular in a proximal direction.
9. The medicament delivery device (2) according to claim 8, the expelling unit comprising a release unit cooperating with the plunger rod device (6) and with the activation member (17), the release unit being configured to selectively block an axial movement, in particular a proximal movement, of the plunger rod device (6); and in reaction to an activation movement, unblock an axial movement, in particular a proximal movement, of the plunger rod device (6) driven by the plunger force device (7).
10. The medicament delivery device (2) according to claim 9, the plunger rod device (6) comprising at least one cooperation element (61), and the release unit comprising retaining structures (81) configured to cooperate with the at least one cooperation element (61) to block an axial movement, in particular a proximal movement, of the plunger rod device (6) when the at least one cooperation element (61) and the retaining structures (81) are abutting, and wherein the release unit is configured to derive from the activation movement a relative movement of the plunger rod device (6) and the retaining structures (81) to unblock the axial movement, more particularly the proximal movement, of the plunger rod device (6) by interrupting said abutting; in particular wherein the relative movement is a rotational relative movement of the plunger rod device (6) and the retaining structures (81).
11. The medicament delivery device (2) according to one of claims 1 to 10 the expelling unit comprising a dosing unit for controlling a dosing amount for each of the doses, the dosing unit comprising a dosing device (8), in particular wherein for each of the doses, the respective dosing amount is controlled by an axial distance between retaining structures (81) of the dosing device (8).
12. The medicament delivery device (2) according to claim 11 AND one of claims 9 to 10, the dosing unit and the release unit being both embodied in the dosing device (8).
13. The medicament delivery device (2) according to claim 8, the plunger force device (7) comprising an electric drive, and the expelling unit comprising an activation detector for detecting the activation movement, the expelling unit being configured to control the electric drive to axially, in particular proximally, drive the plunger rod device (6) for each of the doses for a predetermined distance in reaction to a detection, by the activation detector, of the activation movement.
14. The medicament delivery device (2) according to claim 13, comprising a drive unit comprising the electric drive and the activation detector, the drive unit being detachable from and re-attachable to a front part (2c) of the medicament delivery device (2) comprising the needle assembly (5), and, in particular, also the activation member (17).
15. A medicament delivery assembly (1), comprising the medicament delivery device according to one of claims 1 to 14, further comprising the medicament container (3a) assembled with the medicament delivery device (2).
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