Medicament delivery device and medicament delivery assembly

Abstract

This text concerns a medicament delivery device (2) for accommodating a medicament containing a medicament and for expelling multiple pre-defined doses. It comprises a base assembly to which the medicament container is mountable, a plunger rod assembly being axially movable relative to the base assembly for interacting with the medicament container to expel the medicament, and a biasing member, such as a drive spring, configured to force the plunger rod assembly in a proximal direction. The plunger rod assembly comprises a first plunger rod device and a second plunger rod device, the latter acting on the medicament container for expelling the medicament. The medicament delivery device further is configured for a user to cause a distal movement of the first plunger rod device, relative to the base assembly and to the second plunger rod device, from an unloaded position into a loaded position, and to thereby bias the biasing member.

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. The invention more particularly relates to medicament delivery devices for delivering multiple doses of a medicament from one medicament container.

[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 (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.

[0007] 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 but also containing multiple doses would be desirable, even though this requires the patient to change needle before each dose.

[0008] Devices that are for expelling multiple doses and that have a pre-tensioned spring, however, suffer from disadvantages. The spring needs to be very strong to store the energy for expelling a multitude of doses. This results in high demands on the materials used - for example, it has to be made sure that the material does not creep under storage. Besides that, the force profile differs from dose to dose, since the tension of the spring decreases dose after dose. Medicament delivery thus takes substantially more time for the last doses than for the first doses.

[0009] For these reasons, it has already been proposed to provide the medicament delivery device with a loading mechanism that re-tensions the used spring before each injection. However, such loading mechanisms come about with variable doses of the drug, and this affects safety, as the user may set a wrong dose.

[0010] SUMMARY

[0011] 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 without imposing too high requirements on the materials used. The device should have a high usability and should be safe.

[0012] These objects are achieved by the device and assembly as defined in the claims.

[0013] Further objects and various advantages emerge from the description and embodiments below.

[0014] The medicament delivery device is equipped for accommodating a medicament container containing a medicament and for expelling multiple pre-defined doses of the medicament from the medicament container. The medicament delivery device defines a device axis and comprises a base assembly and a plunger rod assembly.

[0015] The base assembly may comprise a housing, the housing for example comprising a device body and a container housing. The medicament container is mountable to the base assembly. The plunger rod assembly is axially movable relative to the base assembly and, by an axial movement into a proximal direction, interacts with the medicament container to expel the medicament therefrom. The medicament delivery device to this end further comprises a biasing member configured to bias the plunger rod assembly into the proximal direction.

[0016] The plunger rod assembly has a first plunger rod device and a second plunger rod device. In this, the second 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 second plunger rod device may act on a plunger of the medicament container, wherein the movement of the plunger towards proximally expels the medicament when a needle is mounted.

[0017] The medicament delivery device further comprises a loading mechanism configured to allow the user to move the first plunger rod device into a distal direction relative to both, the base assembly and the second plunger rod device, and to thereby bias the biasing member. The step of causing the first plunger rod device to move distally and thereby biasing the biasing member is also called "loading step" in the present text.

[0018] The plunger rod assembly may thus comprise a first plunger rod device that is moved into a distal direction relative to both, the base assembly and the second plunger rod device, to bias the biasing member. This allows the user to load the medicament delivery device prior to expelling the first dose (if not already loaded ex-factory) and to re-load it prior to expelling any further dose. For each dose, the first 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 avoided and so that the time for expelling the medicament may be the same for each dose. Also, due to the mentioned approach, the biasing member does not need to store the energy for all the doses. If not already loaded ex-factory, it 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 all parts - except the compression spring - of the medicament delivery device of a same material, which facilitates recycling. Especially, the base assembly and the plunger rod assembly (and optionally also an activation element, as described hereinafter) may be made of a same material, especially a same polymer material, for example PP.

[0019] When the user moves the first plunger rod device in the distal direction, the plunger rod assembly may be configured for the second plunger rod device to not participate in this movement and for example to stand essentially still.

[0020] 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 second plunger rod device will move forward (towards proximally) together with the first plunger rod device, as part of the plunger rod assembly for expelling the medicament, whereas it is only the first plunger rod device that makes the backward (towards distally) movement during the loading step.

[0021] The loading mechanism may for example comprise the principle that the user twists a twisting element - for example a loading sleeve - relative to the base assembly. 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 first 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 first plunger rod device, with respect to rotations around the axis. Then, at least one of the first plunger rod device and of the base assembly 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 first plunger rod device. For example, the base assembly may comprise a helically running slope as the helical feature, and the first plunger rod device may comprise a matching slope or an abutting element that is in contact with the slope. According to an alternative, the first 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 base assembly. Further alternatives include a thread (for example internal thread) of the base assembly as the helical feature, cooperating with a thread engaging protrusion, for example outward protrusion, of the first plunger rod device, etc.

[0022] In embodiments, the base assembly or the first plunger rod device comprises two helically running slopes as helical features, with a i8o° axial symmetry between them. Accordingly, the first plunger rod device or the base assembly, respectively, comprises two cooperating features, offset by i8o° with respect to each other, one for each of the helically running slopes. Thereby, the substantial axial force, to which the first plunger rod device is subject during the loading step, does not lead to any bending moment on the medicament delivery device.

[0023] In addition, the second plunger rod device may comprise a plunger rod thread, for example an external thread, cooperating with a thread engaging feature of the first plunger rod device, for example an inward protrusion or an internal thread. The helical feature(s) and the plunger rod thread both have the same direction of rotation. Further, the lead (axial advance per turn) of the plunger rod thread of the second plunger rod device may approximately correspond to the lead of the helical feature that causes the axial displacement of the first plunger rod device towards distally during the loading step. This makes possible that the second plunger rod device remains essentially stationary while the first plunger rod device is subject to the helical movement, i.e., rotation around the axis together with a translation along the axis, for the loading step. To this end, the second plunger rod device may be mounted to be not able to rotate relative to the base assembly, i.e., it may be rotationally coupled to the base assembly.

[0024] The medicament delivery device may further be configured for the first plunger rod device to be locked in the loaded position at the end of the loading step. Thereafter, once it is unlocked by suitable activation - for example by a user pressing an activation button - the biasing member forces the first plunger rod device forward towards proximally. During this expelling step, the first plunger rod device may be rotationally locked, i.e., prevented from rotating. Thereby, the engagement of the plunger thread with the thread engaging feature causes the second plunger rod device to be moved towards proximally with the first plunger rod device, i.e., the plunger rod assembly is moved as a whole. Thereby, the second plunger rod device acts on the medicament container to expel the desired dose of the medicament.

[0025] At the end of the loading step, the engagement between the helical feature and the cooperating feature may end, so that the first plunger rod device can, upon activation, be forced towards proximally for the expelling step. For example, if the helical feature comprises a slope of the base assembly, it may be configured for the cooperating feature to reach the top (distal-most point) of the respective slope. When the loading step is about to be completed, a locking mechanism that locks the first plunger rod device until unlocking / activation, sets in. In embodiments, the transition between the engagement of the helical feature with the cooperating feature and the engagement of the locking mechanism comes about with a small movement of the first plunger rod device into the proximal direction, forced by the biasing member. This slight offset between the distal-most position during the loading movement on the one hand and the loaded position, in which the first plunger rod device is locked, on the other hand, firstly has the advantage that the locking mechanism will reliably engage. This engagement is secured even when there are some manufacturing tolerances in the parts of the medicament delivery device. Secondly, the small displacement into the proximal direction and the stopping thereof by the locking mechanism may produce audible feedback in the form of a click-like sound, indicating the user that the loading step has been successfully completed. Thirdly, if the helical feature is a slope of the base assembly, a cliff-like structure of the slope may, in the loaded position, impede a back rotation, so that the slope of the base assembly has effectively a double function. A separate limit may impede a further forward rotation once the loaded position has been reached.

[0026] In a group of embodiments, the lead of the helical feature is slightly larger than the lead of the plunger rod thread, the difference compensating for the mentioned optional small displacement into the proximal direction upon completion of the loading step. Thus, when activated, the second plunger rod device will be at the same position as it was before the loading step started, and the small displacement into the proximal direction upon completion of the loading step will not cause any medicament to be expelled.

[0027] In some embodiments, the engagement of the plunger rod thread on the one hand and the thread engaging feature (for example internal thread) of the first plunger rod device on the other hand is subject to some clearance, by the thread grooves being wider than the axial extension of the thread ridges. The axial extension of the clearance may correspond to the difference between the axial advance of the helical feature during the loading step on the one hand and the axial advance of the plunger rod thread on the other hand - and for example also to the axial distance by which the first plunger rod device travels during the above-mentioned small displacement into the proximal direction upon completion of the loading step. Thereby, the clearance makes sure that the loading step can be completed without the second plunger rod device travelling back and forth.

[0028] In alternative embodiments, the plunger rod thread and the thread engaging feature do not necessarily comprise any clearance, but the lead of the plunger rod thread is slightly smaller than the lead of the helical feature, whereby, when the first plunger rod device is moved towards distally, the second plunger rod device makes a slight movement (by the difference between the leads of the helical feature on the one hand and the plunger rod thread on the other hand, times the rotation of the first plunger rod device) towards distally during the loading step. This will leave a small air gap between the plunger rod assembly and the plunger after the loading step. This air gap will be closed upon dispensing. The dose in this is set by the lead of the plunger rod thread and the rotation, the latter being a half turn (i8o°) or a full turn (360°) in many embodiments.

[0029] Locking in the loaded position may in a group of embodiments take place as follows: One of the first plunger rod device and of the base assembly comprises a pair of locking arms with locking protrusions and the other one has a locking structure with which the locking protrusions can engage. Such locking structure may for example comprise a ridge, distally of which the respective locking protrusion can engage. Alternatively, it may comprise a hole in which the locking protrusion can engage. The locking arms are caused to flex in a resilient manner in the process of the movement of the first plunger rod device during the loading step and to flex back for the locking protrusions to engage the locking structure immediately before the loading step is completed, i.e., before the first plunger rod device reaches the loaded position.

[0030] In some embodiments, the locking arms are locking arms of the first plunger rod device, and the locking structures each comprise an inner ramp of the base assembly. Therein, upon the combined rotational-translational movement of the first plunger rod device during the loading step, the locking protrusions slide along the inner ramp of the base assembly and thereby are caused to flex inwardly. Shortly before the loaded position is reached, the locking protrusions lose contact with the inner ramps and flex outwardly again due to their resilience. This locks the locking protrusions in front of the inner ramps and impedes a movement of the first plunger rod device towards more proximally. The first plunger rod device may be a plunger nut, with an internal cavity that accommodates at least a portion of the second plunger rod device, and with the thread engaging feature being an interior thread of the plunger nut.

[0031] The second plunger rod device may comprise a plunger rod. In embodiments, the plunger rod thread is an exterior thread on the plunger rod.

[0032] In a group of embodiments, the second plunger rod device further comprises a priming rod that is movable into the proximal direction relative to the plunger rod and that comprises an impact surface. The impact surface is in physical contact with the plunger of the medicament container for expelling the medicament. The priming rod may for example have a shaft extending in an axially running internal cavity of the plunger rod, and a proximal widening that comprises the impact surface.

[0033] Priming in these embodiments will take place before the medicament is expelled for the first time and for example also before the first time a loading step is performed: By moving the priming rod towards proximally, for example by the user pressing against an activation button, initial gaps in the medicament delivery assembly (that comprises the medicament delivery device and a medicament container mounted to it) are eliminated. If a needle is already affixed at this stage, this priming action can be performed until a small amount of the medicament is expelled through the needle so that priming includes removing any air remaining in the needle's lumen. A ratchet may be established by the plunger rod and the priming rod, whereby the priming rod can be displaced relative to the plunger rod towards proximally for the priming, but not back towards distally. Thus, once priming is established, the medicament delivery device may remain free from clearances.

[0034] In alternative embodiments, the second plunger rod device consists of the plunger rod, without any separate priming rod. It is even possible that the plunger rod also comprises the plunger, for example if the medicament container is syringe-like. In other words, it is not necessary that the plunger of the medicament container is separate from the plunger rod.

[0035] 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 first and second 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.

[0036] In embodiments that comprise the above-mentioned locking arms of the first plunger rod device or of the base assembly, the activation mechanism may comprise an activation structure that in the course of the activation acts to flex the locking arms until their locking protrusions get out of engagement with the locking structure and thereby release the plunger rod assembly so that it can be displaced towards proximally.

[0037] In embodiments, the activation mechanism comprises an activation button that is arranged at the distal end of the medicament delivery device and that can be pressed towards proximally for the activation. The activation button may for example comprise activation wings serving as activation structures and that force the locking arms to flex when the activation button is pressed towards proximally when the first plunger rod device is in the loaded position. To this end, the locking arms at onset of the locking protrusions may comprise locking arm ramps along which the proximal end of the activation wings slide to gradually force the locking arms to flex until they get out of engagement with the locking structure.

[0038] In embodiments having the priming rod, the activation button may have a double function by having, in addition to the activation wings (or similar structure for the activation), a priming structure, for example a priming protrusion, that acts to displace, when the activation button is pressed, the priming rod towards proximally for the above-described priming step. In embodiments in which the activation button has this double function, the medicament delivery device may be equipped for the activation button to be re-set (displaced towards distally in a position in which it can again be pressed for activation) by the loading action. For example, the activation button may be rotationally coupled to the loading sleeve (or other twisting element) and may interact with a re-set structure of the base assembly to be displaced towards distally when rotated during the loading step. For example, the base assembly may comprise a reset slope interacting with a protruding boss of the activation button - or vice versa.

[0039] In a group of embodiments, the medicament delivery device is configured for the loading step to be caused by a i8o° twist of the twisting element. A i8o° twist can be caused by a user without loosening the grip on the twisting element and the base assembly relative to which the twisting element is twisted. Also, it allows to implement the mentioned i8o° axial symmetry of the helical features without constraint. For example, the base assembly may comprise two identical slopes at identical axial positions, offset by i8o° with respect to each other. For most applications, the i8o° twisting movement is sufficient to sufficiently load the medicament delivery device.

[0040] However, there are applications for which very a strong biasing member, for example a very strong compression spring, is required, for example if a relatively large dose of the medicament is to be expelled through a relatively thin needle. For some users, the torque that has to be applied to load such a strong biasing member by just a i8o° twist may be too high to be convenient. Therefore, in an alternative group of embodiments, the medicament delivery device is configured for the loading step to be caused by a more-than-i8o° twist of the twisting element, especially a 360° twist.

[0041] Also in embodiments of this alternative group of embodiments, the base assembly or the first plunger rod device may comprise two helical features, especially helically running slopes, and the first plunger rod device or the base assembly, respectively, comprises two cooperating features, offset by 180° with respect to each other so that there is no substantial bending moment when the twisting element is twisted against the biasing force of the biasing member. Especially, the two helical features may be at different radial positions, one further radially-inside than the other one, but may otherwise by subject to the mentioned i8o° axial symmetry with respect to each other. The helical features extend by more than i8o° around the axis.

[0042] Especially - but not only - in embodiments of this alternative group, the helical feature(s) may be provided with one or more step features that have the function of preventing a twisting back once the twisting movement has gone beyond a certain angle defined by the step feature(s), for example beyond i8o°. Step features constitute deviations from a monotonously helical course of the helical feature(s) and may for example be formed by zags interrupting the respective slopes, or as zero-incline portions between slope portions.

[0043] The approach according to the present invention 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.

[0044] The medicament delivery assembly comprises the medicament delivery device as herein described and further comprises the medicament container assembled with the medicament delivery device.

[0045] In addition, it may comprise a needle assembly that is equipped to pierce a septum of the medicament container and that has a needle for injecting the medicament, especially subcutaneously.

[0046] 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.

[0047] 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.

[0048] Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.

[0049] 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.

[0050] BRIEF DESCRIPTION OF THE DRAWINGS

[0051] 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:

[0052] Figure 1 a medicament delivery device with a medicament container, in a perspective view;

[0053] Figure 2 a medicament delivery assembly comprising the medicament delivery device of Fig. 1 assembled with a needle assembly; Figure 3 the medicament delivery assembly of Fig. 2, with a needle case removed;

[0054] Figure 4 a container housing of the medicament delivery device;

[0055] Figure 5 the medicament container;

[0056] Figure 6 a device body of the medicament delivery device;

[0057] Figure 7 the device body as shown in Fig. 6, shown transparent to illustrate structures in its interior;

[0058] Figure 8 a priming rod of the medicament delivery device;

[0059] Figure 9 a plunger rod of the medicament delivery device;

[0060] Figure 10 a plunger nut of the medicament delivery device;

[0061] Figure 11 the plunger nut of Fig. 10, shown transparent to illustrate structures in its interior;

[0062] Figure 12 a drive spring of the medicament delivery device;

[0063] Figure 13 a spring stop of the medicament delivery device;

[0064] Figure 14 the spring stop as shown in Fig. 13, from a different perspective;

[0065] Figure 15 a loading sleeve of the medicament delivery device;

[0066] Figure 16 an activation button of the medicament delivery device;

[0067] Figure 17 a view of the plunger rod assembly after the priming step;

[0068] Figure 18 the medicament delivery device of Figs. 1-3 with the medicament container during different stages of its use;

[0069] Figure 19 a detail of a section through the medicament delivery device of Figs. 1-3;

[0070] Figure 20 a detail of the device body, which is shown transparent;

[0071] Figure 21 a detail of a distal portion of the medicament delivery device without the loading sleeve; Figure 22 schematically, the working principle of the locking arms and the inner ramp:

[0072] Figure 23 a detail of a section through the medicament delivery device of Figs. 1-3 when the plunger nut is in the loaded position and the medicament delivery device is in the locked state;

[0073] Figure 24 another detail of the section through the medicament delivery device of Figs. 1-3 when the plunger nut is in the loaded position;

[0074] Figure 25 a plunger nut of an alternative embodiment of the medicament delivery device;

[0075] Figure 26 a view of a slope part of this alternative embodiment;

[0076] Figure 27 an other view of the slope part;

[0077] Figure 28 a detail of elements of the alternative embodiment, in the unloaded state;

[0078] Figure 29 a detail of elements of the alternative embodiment, half-way through the loading step;

[0079] Figure 30 a detail of elements of the alternative embodiment, upon completion of the loading step; and

[0080] Figure 31 sections through an alternative embodiment of the medicament delivery assembly in three different states.

[0081] DETAILED DESCRIPTION

[0082] Fig. 1 shows a medicament delivery device 2 and a medicament container 3 of a medicament delivery assembly., the medicament container 3 being seated in the container housing 4. The medicament delivery device 2 comprises a device body 5 with body window 51 and a container housing 4 with housing windows 41. The container housing 4 is fastened to the device body 5 by a click connection and is, in the assembled state, essentially immovable relative to the device body 5. Distally of the device body 5, the medicament delivery device has a loading sleeve 12 and, inside the loading sleeve, an activation button.

[0083] Fig. 2 depicts the medicament delivery assembly 1, which comprises in addition to the medicament delivery device 2 and the medicament container 3 also a needle assembly 15 couplable to a proximal end (a fore end) of the medicament delivery device, namely to a needle assembly thread 42 of the container housing 4. Fig. 3 shows the medicament delivery assembly 1 in a ready-to use state with a needle case 16 removed. In addition to the needle case 16 (that may comprise an inner and an outer needle cap), the needle assembly comprises a needle hub 17 and the needle 18. By screwing the needle assembly onto the container housing, the needle is caused to pierce a septum of the medicament container, whereafter the medicament can be dispensed via the needle by displacing a plunger 31 of the medicament container towards proximally. Needle assemblies suitable for this purpose are known in the field and are not described in any more detail here.

[0084] Figs. 4-16 illustrate, in addition to the medicament container 3 (Fig. 5), the elements of the medicament delivery device. The container housing 4 (Fig. 4) accommodates the medicament container 3 by having a seat open towards distally into which the medicament container 3 is insertable. The proximal end of the container housing 4 has an outer thread 42 for mounting the needle assembly. Through the housing windows 41, the user may see the medicament container 3 and can determine how many doses are left in it, with the assistance of dose indicators 43.

[0085] The container housing is, in the assembled state of the medicament delivery device, affixed to the device body 5 by container housing coupling structures 44 engaging into first coupling holes 52 of the latter.

[0086] The medicament container 3 (Fig. 5) may be of the kind known in the field, with the plunger 31 initially seated near its distal end, and with a septum 32 that can be pierced by a needle and that closes off the medicament container towards proximally. The device body 5 (Fig. 6, Fig. 7) comprises a reload status window 51, which is also visible in Figs. 2 and 3. The purpose of this reload status window 51 is explained hereinafter. The device body 5 has the general shape of a hollow circular cylinder, with a plunger rod guiding portion 54 protruding towards the interior near the proximal end of the device body 5. Distally thereof, the device body 5 has helical slopes 55 formed by distally facing shoulders of protrusions along the interior surface of the hollow circular cylinder. The two helical slopes are offset with respect to each other by a rotation of 180° around the device axis A (see Fig. 1).

[0087] The medicament delivery device has a plunger rod assembly that for dispensing the medicament by being moved towards proximally and thereby acting on the plunger. The plunger rod assembly comprises a priming rod 6 (Fig. 8), a plunger rod 7 (Fig. 9) and a plunger nut 8 (Fig 10 and Fig. 11). The priming rod 6 has a priming rod shaft 61 seated inside the plunger rod 7 and a proximal impact surface 62 proximally of the plunger rod 7. The impact surface 62 is configured to be brought into physical contact with the plunger 31 of the medicament container to move the plunger 31 towards proximally for expelling the medicament. The priming rod 6 is, to some extent, movable relative to the plunger rod 7 into the proximal direction. A ratchet made up of priming rod ratchet structures 63 and plunger rod ratchet ridges 71 engaging into the grooves of the ratchet structures 63 allows a movement of the priming rod 6 towards proximally relative to the plunger rod 7 but prevents movements towards distally so that any movement of the plunger rod 7 towards proximally is transferred to the priming rod 6 and its impact surface 62.

[0088] 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 has an internal thread 82 that engages with the plunger rod thread 72 of the plunger rod. 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. 13 and Fig. 14). 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 in the assembled state. The device body 5, the medicament container 4, and the spring stop 11 are therefore fixed to each other and together constitute the base assembly.

[0089] 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. 15) 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.

[0090] 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.

[0091] Fig. 17 shows the plunger rod assembly 101 with the plunger nut 8, the plunger rod 7 and the priming rod 6. The priming rod 6 proximally slightly protrudes out of the mouth of the axially running internal cavity in the plunger rod 7, as is may be the case after the priming step.

[0092] For medicament delivery, the following steps are carried out:

[0093] • A. Needle assembly affixing: Initially, the needle assembly 15 is mounted to the pre-assembled medicament delivery device with the medicament container 3 already seated in the container housing 4. This will cause the septum of the medicament container to be penetrated by the needle, whereupon the medicament is capable of being expelled through the needle. In Fig. 18, panels I and II illustrate the needle assembly affixing step.

[0094] • B. Priming (panel III in Fig. 18): The user presses the activation button 13 towards proximally. The activation button 13 has a priming protrusion 131 that acts to transfer this movement towards proximally on to the priming rod 6 so that the latter moves towards proximally until its impact surface 62 is in physical contact with the plunger. A small amount of medicament may thereby be caused to be expelled if the user exerts sufficient pressure. This indicates to the user that the assembly is ready for medicament delivery. The ratchet prevents the priming rod 6 from being moved back towards distally in all further steps. Either before priming (preferable in most cases) or at the latest before medicament delivery, the needle case 16 is removed. Panel III in Fig. 18 shows the assembly with the needle case removed.

[0095] • C. 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 180°. In this, the container housing 4 (with the medicament container 3) and the spring stop 11 are fixedly connected to the device body 5. The plunger rod 7 with the priming rod 6 is prevented from rotating by the shape of the outer geometry of the plunger rod 7 cooperating with the plunger rod guiding portion 54. 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. 15). The rotation of the plunger nut causes the plunger nut 8 to move backward, i.e., towards distal, against the spring force of the drive spring 9. This movement of the plunger nut 8 for loading the device can be observed through the reload status windows 51. For example, the outer surface of the circumferential ridge 81 may have a distinct colour, and its backward movement may be well visible through the reload status windows 51. In Fig. 18, the progress of the loading step is illustrated in panels IV through VII.

[0096] • D. Expelling. When the medicament delivery device is in the loaded state, the medicament delivery step may be initiated by pressing the activation button 13 again. This is illustrated in panel VIII of Fig. 18. Upon activation, the plunger rod assembly comprising the plunger nut 8, the plunger rod 7, and the priming rod 6 is allowed to travel towards distally, driven by the drive spring that expands from the compressed state to a relaxed state and thereby acts on the circumferential ridge 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.

[0097] The user may view the resulting position of the plunger 31 through the housing windows 41. Thereby, she / he can see how many doses are left, aided by the dose indicator 43.

[0098] • E. Needle assembly removal. After delivery of a full dose (panel IX), the user removes the needle assembly (if no dose is left, as an alternative, the medicament delivery assembly may be disposed directly). Panel X of Fig. 18 illustrates the medicament delivery device with the medicament container in this state, in which state the medicament delivery device with the medicament container can be stored away awaiting further use.

[0099] • Steps A., C., D., and E. - thus all steps except the priming step - are repeated for each one of the further doses.

[0100] Fig. 19 illustrates a detail of the medicament delivery device in the unloaded state in a section. The drive spring 9 presses the plunger nut 8 towards proximally, with the proximal end face of the plunger nut abutting against a stop shoulder 57 of the device body 5.

[0101] In Fig. 19, one also sees that the thread grooves 73 of the plunger rod thread 72 are broader than the width of the thread ridge of the plunger nut's internal thread 82 so that there is some clearance between the plunger rod thread 72 and the internal thread 82.

[0102] In the loading step (step C.), the user twists the loading sleeve by 180° in case of the embodiment of Figs. 1-22. The rotation of the plunger nut 8 caused by the twisting of the loading sleeve 12 causes the movement of the plunger nut 8 towards distally by plunger nut ledges 84 sliding against the helical slopes 55 of the device body 5. Initially, in the unloaded state, the plunger nut ledges 84 rest at the bottom 58 of the respective helical slopes 55 (Fig. 20). Shortly before the i8o° rotation is completed, the plunger nut ledges 84 reach the top 59 of the respective slopes and, upon completion of the 180° rotation, get beyond the top 59 of the slopes and 'fall off the cliff, i.e., are subject to a small movement towards proximally so that the edges of the slopes prevent an unintended unwinding rotation. A rotation beyond 180° is prevented by limit ledges 87 (Fig. 10, Fig. 11) of plunger nut 8 abutting against spring stop tabs 114 of the immovable spring stop 11.

[0103] In an initial phase of the rotation caused by the user twisting the loading sleeve, a spring stop slope 112 of the spring stop also acts as a reset slope as described above and causes the activation button to be pushed out towards distally by cooperating with a protruding boss 132 that slides up the spring stop slope 112 when the activation button 13 is rotated (Fig. 21).

[0104] The plunger nut 8 has two locking arms 85 (Fig. 10) that are capable of being flexed inwardly in a resilient manner and that each comprise a locking protrusion 86. Towards the end of the 180° rotation, the locking protrusions, which are subject to a helical movement when the plunger nut 8 is rotated and thereby displaced towards distally, each glide over an inner ramp 113 (Fig. 14) of the spring stop 11, the inner ramp being shaped to gradually flex the locking arms 85 inwardly. Fig. 22 schematically depicts the principle of the inner ramp 113 flexing the locking arm 85 inwardly. The arrow in Fig. 22 indicates the movement of plunger nut 8 towards distally. Shortly before plunger nut 8 reaches the position in which the plunger nut ledges 84 get beyond the top 59 of the slopes, the locking protrusions 86, due to the movement of the plunger nut 8 towards distally, lose contact with the inner ramps 113, and the locking arms 85 are allowed to spring back into their relaxed position, so that their proximal stop faces 89 lie distally of the respective inner ramp 113. When the plunger nut ledges 84 get beyond the top 59 of the slopes, the drive spring 9 causes the plunger nut 8 to move proximally until the proximal stop faces 89 hit against the inner ramps 113, thereby generating a click sound indicating to the user that the loading action has been completed. Fig. 23, showing a cross section of the distal-most portion of the medicament delivery device 2, depicts the situation at the end of the loading step.

[0105] During the rotation and backward movement (towards distally) of the plunger nut 8, the plunger rod 7 essentially stands still. It cannot rotate due to the non-round cross section of the plunger rod guiding portion 54. Also, the plunger nut's internal thread 82 and the plunger rod thread 72 have a thread lead (the thread lead is the axial advance per turn, being an integer multiple of the thread pitch) allowing the plunger nut 8 to travel without displacing the plunger rod 7 axially. More particularly, the lead of the helical slopes 55 is slightly larger than the thread lead, so that the plunger nut 8 travels a small extra distance, this extra distance corresponding to the clearance between the plunger rod thread 72 and the internal thread 82. This extra distance allows the plunger rod to make the before-mentioned movement towards proximally until the proximal stop faces 89 hit against the inner ramps 113. Because of the clearance between the plunger rod thread 72 and the internal thread 82, this is possible without plunger rod 7 moving back or forth during the loading step. A movement of plunger rod 7 forward during the reloading could cause the expelling of some of the medicament upon reloading, this being undesired.

[0106] For activation, to initiate step D., the user pushes the activation button 13 after reloading. At the end of the rotation, the activation button 13 is in the orientation relative to the spring stop 11 as shown in Fig. 21, in which the protruding boss 132 allows a movement of the activation button 13 towards proximally when the user pushes it. This movement will cause activation wings 133 (Figs. 16 and 22) of the activation button 13, the distal ends of which slide along locking protrusion ramps 90 of the locking protrusions when the activation button is pushed proximally, to flex the locking arms 85 again inwardly. As a consequence, the drive spring 9 can push the plunger nut 8 proximally. The internal thread 82 of the plunger nut 8 transfers this movement to the plunger rod 7 (Fig. 24) and thereby to the priming rod. The dosing ends when the plunger nut 8 hits the stop face 57 (Fig. 19) of the device body 5. It is thus the interplay between the plunger nut 8, the device body 5 and the spring stop 11 (that is fixedly connected to the device body 5) that determines the distance by which the plunger assembly -comprising the plunger nut 8, the plunger rod 7 and the priming rod 6 - travels towards proximally for dosing and thus determines the dosing amount. Both, the dosing amount and the time it takes to expel it are the same for every dose.

[0107] Elements of a further, second embodiment are described referring to Figs. 25 to 30. The second embodiment is distinct from the first embodiment of Figs. 1 to 24 in that it is configured for a rotation by 360° instead of 180° for the loading step. The advantage of a greater rotation is that more energy can be stored in the biasing member (drive spring) 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.

[0108] In Figs. 25 to 30, Fig. 25 shows a view of the plunger nut and Fig. 26 a view of a slope part 201. Fig. 27 depicts an enlarged view of the slope part 201 from a different perspective. Figs. 28-30 show, in part, the plunger nut and the slope part 201 in different stages of the loading step, namely in an initial state (Fig. 28), after a 180° rotation (Fig. 29), and in a final state, after a 360° rotation (Fig. 30). 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.

[0109] In contrast to the first embodiment, the helical slopes extend by 360° around axis A. To this end, the following measures are taken in the second embodiment compared to the first embodiment:

[0110] 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 i8o° with respect to one another. In the first embodiment, this is readily possible by arranging the two slopes 55 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 second 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.

[0111] • The slopes 211, 212 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 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.

[0112] The step features may be in the form of zags (as illustrated, see Figs. 25-30) or may be in the form of platforms, i.e., zero-inclined portions.

[0113] The following features of the second embodiment are distinct from the first embodiment but do not necessarily depend on the twisting-by-36o°-concept and do also not depend on each other. In other words, they are optional modifications of the first embodiment, too, and also the second embodiment could be modified to be implemented without them:

[0114] • The first and second slopes 211, 212 are present on a separate part, namely a slope part 201 instead of being features of the device body 5 itself. The slope part 201 is mounted to be essentially immovable relative to the device body 5.

[0115] • The plunger nut 8 instead of having a plunger nut ledge 84 of a relatively limited extension in circumferential direction (the ledge cooperating with the slopes) has slopes 142, 143, too, 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, whereby the slope extension 141 also has the function that in the first embodiment is fulfilled by the circumferential ridge 81.

[0116] The embodiments described hereinbefore have the property that an engagement of the plunger rod thread 72 on the one hand and the thread engaging feature on the other hand is subject to a clearance, as described referring to Fig. 19 showing the clearance between the plunger rod thread 72 and the internal thread 82. Fig. 31 shows a variant, in which the plunger rod 7 is allowed to back from the plunger 31 during loading. This has the advantage of eliminating axial tolerances.

[0117] Fig. 31 shows, in section the medicament delivery assembly immediately after the priming step (panel I), after in a loaded state, i.e. after a first loading step (panel II), and after the first delivery of a first dose (panel III), respectively. Auxiliary lines extend vertically across the panels for illustrating the relationship between different axial displacements.

[0118] When the medicament delivery device is primed (panel I), the plunger nut 8 is at its most proximial position and the thread engagement between plunger rod 7 and plunger nut 8 has no gaps. This position of the plunger nut 8 prior to loading is the same for all doses.

[0119] When the device is loaded, the plunger nut 8 is rotated half or a full turn, depending on mechanism type. The variant shown in Fig. 31 is an example of an embodiment, similarly to the one of Figs. 1-25, where loading comprises a 180° twisting movement, for eample with the plunger nut or the base assembly comprising two slopes, offset by i8o° with respect to each other, as the helical features. The principles explained referring to Fig. 31, however, are also applicable to embodiments where loading requires a full, 360° turn, for example based on the principle described referring to Figs. 25-30

[0120] By the half turn (or full turn) of the plunger nut 8, the plunger nut is moved towards distally, on account of the helical feature cooperating with the cooperating feature, as explained for both embodiments described hereinbefore. In the embodiment of Fig. 31, however, the lead of the plunger rod thread 72 and the internal thread 82 is slightly smaller than the lead of the helical feature that causes the movement of the plunger nut 8 towards distally. At the same time, the base assembly, as in the previous embodiments, prevents any rotation of the plunger rod 7. Thereby ,the plunger rod 7 is slightly retracted during the loading step, the movement of the plunger rod 7 towards distally corresponding to the difference between the leads of the helical feature on the one hand and the plunger rod thread and internal thread on the other hand, times the rotation (i.e., half of the difference between the leads if the rotation is a half turn and the full difference if the rotation is a full turn, for example).

[0121] This retraction of the plunger rod 7 - and thus also of the priming rod 6 - will lead to an air gap 301 between the plunger rod (or, to be precise the priming rod 6) on the one hand and the plunger 31 on the other hand. In panel II the axial extension of the air gap 301 is denoted by G. This air gap 301 does not affect the dosing, as the dosing (defined by the dose axial extension D) is equal to the axial movement of the plunger rod 7 during loading, being the plunger rod lead half L (or the plunger rod lead in 'full turn' embodiments). The air gap axial extension G is thus the difference between the plunger nut stroke S and the plunger rod lead half L. Upon activation, firstly the air gap 301 will be closed and then the plunger rod assembly travels by a distance corresponding to the dose axial extension D (=L). The delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0122] 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.

[0123] 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.

[0124] 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.

[0125] 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.

[0126] 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.

[0127] 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.

[0128] 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.

[0129] 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.

[0130] 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.

[0131] 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.

[0132] 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,

[0133] 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.

[0134] 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 pre-defined doses of the medicament from the medicament container (3), the medicament delivery device (2) defining a device axis (A) and comprising: a base assembly to which the medicament container (3) is mountable; a plunger rod assembly (101) axially movable relative to the base assembly for interacting with the medicament container (3) for expelling the medicament therefrom; and a biasing member configured to bias the plunger rod assembly (101) in a proximal direction; wherein the plunger rod assembly (101) comprises a first plunger rod device and a second plunger rod device, wherein the second plunger rod device is configured to act, by moving in proximal direction, on a plunger (31) of the medicament container (3) for expelling the medicament therefrom; and wherein the medicament delivery device further comprises a loading mechanism configured for a user to cause a distal movement of the first plunger rod device, relative to the base assembly and to the second plunger rod device, from an unloaded position into a loaded position, and to thereby bias the biasing member.

2. The medicament delivery device (2) according to claim 1, wherein the base assembly defines a stop (57) for a movement of the plunger rod assembly in the proximal direction when the first plunger rod device has reached the unloaded position, wherein the loading mechanism is equipped for the user to cause another distal movement of the first plunger rod device relative to the base assembly and the second plunger rod device in a reloading action after the plunger rod assembly has reached the stop (57), whereby the medicament delivery device isconfigured for the loading mechanism to be activated a plurality of times, wherein the unloaded position of the first plunger rod device and the loaded position of the first plunger rod device is the same for each dose.

3. The medicament delivery device according to claim 1 or 2, wherein the base assembly and the plunger rod assembly (101) are made of a same material.

4. The medicament delivery device according to one of claims 1 to 3, comprising a twisting element that is configured to be twisted by the user relative to the base assembly to cause the movement of the first plunger rod device into the distal direction.

5. The medicament delivery device according to claim 4, wherein the first plunger rod device is rotationally couplable to the twisting element, and wherein one of the first plunger rod device and of the base assembly comprises a helical feature and the other one comprises a cooperating feature cooperating with the helical feature, whereby a rotation of the first plunger rod device around the axis (A) causes a translational movement of the first plunger rod device relative to the base assembly.

6. The medicament delivery device according to claim 5, comprising two helical slopes (55; 211, 212) as the helical features, and one cooperating feature for each of the helical slopes (55; 211, 212), the helical slopes (55; 211, 212) being offset by 180° with respect to one another, and the cooperating features being offset by 180° with respect to one another.

7. The medicament delivery device according to claim 6, wherein each helical slope (211, 212) runs around the axis (A) by more than 180°, wherein the helical slopes (211, 212) are arranged at different radial positions, and wherein at least one of the helical slopes (211, 212) has a step feature (213) preventing a twisting back of the first plunger rod device once the rotation has gone beyond a certain angle.

8. The medicament delivery device according to claim 6 or 7, wherein the second plunger rod device comprises a plunger rod thread (72), wherein the first plunger rod device comprises a thread engaging feature, wherein the second plunger rod device is rotationally coupled to the base assembly and wherein the second plunger rod device is configured to be essentially stationary relative to the base assembly when the first plunger rod device is subject to the rotation around the axis (A) accompanied by the translational movement into the distal direction during loading, wherein the plunger rod thread (72) and the thread engaging feature are configured to transfer a movement of the first plunger rod device into the proximal direction during medicament expelling on the second plunger rod device but allowing the first plunger rod device to be moved into the distal direction relative to the second plunger rod device when subject to the rotation during the loading step.

9. The medicament delivery device according to claim 8, wherein a lead of the plunger rod thread (72) is smaller than a lead of the helical feature.

10. The medicament delivery device according to claim 8 or 9, wherein an engagement of the plunger rod thread (72) on the one hand and the thread engaging feature on the other hand is subject to a clearance.

11. The medicament delivery device according to any one of claims 1 to 10, wherein one of the first plunger rod device and of the base assembly comprises a pair of locking arms (85) with locking protrusions (86), and the other one of the first plunger rod device and of the base assembly comprises a locking structures capable of engaging with the locking protrusions (86), wherein the medicament delivery device is configured for the locking arms (85) to flex in a resilient manner while the user causes the distal movement of the first plunger rod device for loading and to flex back for the locking protrusions (86) to engage the locking structure immediately before a loaded position has been reached by the first plunger rod device.

12. The medicament delivery device according to claim 11, further comprising an activation mechanism for the user to activate medicament delivery, the activation mechanism comprising an activation button (13) with an activation structure that, when the activation button is pressed, causes the locking arms (85) to flex until their locking protrusions (86) get out of engagement with the locking structure to release the plunger rod assembly so that the resilient member displaces the plunger rod assembly (101) towards proximally.

13. The medicament delivery device according to one of claims 1 to 12, wherein the second plunger rod device comprises a plunger rod (7) and a priming rod (6), the priming rod (6) being displaceable relative to the plunger rod (7) in the proximal direction but not in the distal direction, and the priming rod (6) having a proximal impact surface (62) for acting on the plunger (31) of the medicament container (3).

14. The medicament delivery device according to claim 13, comprising the activation button (13), wherein the activation button (13) comprises a priming protrusion (131) shaped to act on the priming rod (6) for displacing the priming rod towards proximally when the activation button (13) is pressed, the medicament delivery device further comprising a re-set mechanism displacing the activation button (13) back towards distally by the user to cause the distal movement of the first plunger rod device.

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

Images