Monitoring unit for a multi-dose button-activatable medicament delivery device

Abstract

The invention related to a monitoring unit (30) for a multi-dose medicament delivery device (2) having a distal activation button (13) and comprising a positioning mechanism configured to move back the activation button (13) distally after an injection and before a next injection, wherein the5 medicament delivery device extends axially between a proximal end and a distal end, the distal end being the one pointing away from a dose delivery site during use of the medicament delivery device, the monitoring unit (30) comprising: - A sheath (301) removably attachable around a distal portion of the10 medicament delivery device (2); - A knob (30a) axially moveable relative to the sheath (301) between an unpressed position and a pressed position, wherein in the unpressed position, the knob (30a) protrudes from a distal end of the sheath (301) by a longer extent than in the pressed position, wherein the knob15 (30a) comprises a support surface (303c) extending radially and configured to bias or be biased by a distal surface of the activation button (13); - An assembly (30b) axially fixed relative to the sheath (301) and distal relative to the support surface (303c), comprising a mechanical switch20 (306) configured to transition between an open state and a closed state as a result from axial movements of the activation button (13).

Description

[0001] Monitoring unit for a multi-dose button-activatable medicament delivery device

[0002] TECHNICAL FIELD

[0003] The present invention relates to a monitoring unit for a multi-dose button- activatable medicament delivery device.

[0004] BACKGROUND

[0005] There are a number of medicament delivery devices that have been developed for self-administration of a medicament by a user who is usually a non- medically trained person. For many treatments, like asthma, diabetes, hormone growth, the patient has to receive doses on a regular basis and the advantage with such devices is that the patient can administer the delivery anywhere and is not bound to visit care facilities in order to receive medication.

[0006] It is known from the prior art to use medicament delivery devices having a pre-tensioned spring which, upon pressing an activation button on the distal end of the device (that is to say the end configured to point away from the injection site), drives a plunger rod proximally (that is to say in direction of the injection site). The plunger rod thereby displaces a plunger in a medicament container, resulting in expelling said medicament from said container.

[0007] In the case of a multi-dose medicament delivery device, the activation button needs to be moved back to its initial position after-use, that is to say in a position where it protrudes distally, so that the user can press it again to activate the medicament delivery device again. For that purpose, the medicament delivery device needs to be equipped with a positioning mechanism, activatable for instance by rotating a sleeve of the device.

[0008] Many patients or elderly with motor skills difficulties may have problems with the correct and safe handling of such a medicament delivery device. Therefore, it is beneficial that the risks of wrong handling of the device are minimized.

[0009] SUMMARY

[0010] It is an object of the present invention to provide a monitoring unit able to give feedback to a user of a multi-dose button-activatable medicament delivery device, said medicament delivery device being equipped with a positioning mechanism configured to push back the button distally after an injection, before the next injection.

[0011] These objects are achieved by the device and assembly as defined in the claims.

[0012] The invention relates to a monitoring unit for a multi-dose medicament delivery device having a distal activation button and comprising a positioning mechanism configured to move back the activation button distally after an injection and before a next injection, wherein the medicament delivery device extends axially between a proximal end and a distal end, the distal end being the one pointing away from a dose delivery site during use of the medicament delivery device, the monitoring unit comprising:

[0013] - a sheath removably attachable around a distal portion of the medicament delivery device;

[0014] - a knob axially moveable relative to the sheath between an unpressed position and a pressed position, wherein in the unpressed position, the knob protrudes from a distal end of the sheath by a longer extent than in the pressed position, wherein the knob (30a) comprises a support surface extending radially and configured to bias or be biased by a distal surface of the activation button;

[0015] - an assembly axially fixed relative to the sheath and distal relative to the support surface, comprising a mechanical switch configured to transition between an open state and a closed state as a result from axial movements of the activation button. When the monitoring unit is attached to the medicament delivery unit, the user cannot directly press the activation button to trigger the injection, but can transfer force to the activation button by pressing the knob, through the support surface of the knob. When the medicament delivery device is reloaded, that is to say when the positioning mechanism brings back the activation button in a position where it can be activated, the activation button moves distally, which in turn moves the knob distally too through the support surface of the knob. During the axial movements of the activation button, the switch comes into contact or loses contact with the activation button, which opens or closes the switch.

[0016] Changes of states of the switch give indications on status of the medicament delivery device. When the switch closes, it can be detected that the medicament delivery device is loaded and ready to be activated. When the switch opens, it can be detected that an injection is on-going.

[0017] The distal portion of the medicament delivery device may be a loading sleeve, the activation button being inside the loading sleeve. The loading sleeve may be rotated by the user to load / reload the drive spring of the medicament delivery device.

[0018] In the present disclosure, when the term “distal direction” is used, this refers to the direction pointing away from the dose delivery site during use of the medicament delivery device. When the term “distal part / end” is used, this refers to the part / end of the delivery device, or the parts / ends of the members thereof, which during use of the medicament delivery device is / are located furthest away from the dose delivery site. Correspondingly, when the term “proximal direction” is used, this refers to the direction pointing towards the dose delivery site during use of the medicament delivery device. When the term “proximal part / end” is used, this refers to the part / end of the delivery device, or the parts / ends of the members thereof, which during use of the medicament delivery device is / are located closest to the dose delivery site. Further, the terms “longitudinal”, “longitudinally”, “axially” and “axial” refer to a direction extending from the proximal end to the distal end and along the device or components thereof, typically in the direction of the longest extension of the device and / or component.

[0019] Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.

[0020] A mechanism or element “configured to” perform a specified function is indeed capable of performing the specified function without any alteration, rather than merely having potential to perform the specified function after further modification. In other words, the mechanism or element “configured to” perform a specified function is specifically selected, created, implemented, utilized, programmed, and / or designed for the purpose of performing the specified function. As used herein, “configured to” refers to existing characteristics of a mechanism or element which enable the mechanism or element to perform the specified function without further modification. For purposes of this disclosure, a mechanism or element described as being “configured to” perform a particular function can additionally or alternatively be described as being “adapted to” and / or as being “operative to” perform that function.

[0021] The term engagement encompasses any kind of interaction between the named features such as abutment, clamping, locking, biasing, flexing, etc.

[0022] 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. In a non-limiting embodiment, the assembly comprises a printed circuit board fixedly attached to the sheath and distal relative to the support surface, the mechanical switch being attached to the printed circuit board.

[0023] Axial movements of the knob and the activation button move the distal surface of the activation button closer or farther from the printed circuit board, hence from the switch.

[0024] In a non-limiting embodiment, the switch has an arm configured to move between an open position in which the arm does not contact the printed circuit board and the switch is the open state, and a closed position in which the arm contacts the printed circuit board and the switch is in the closed state.

[0025] The arm is configured to rotate around a point that is fixed relative to the printed circuit board. When the activation button moves distally, it comes into contact with the arm, until a distal end of the arm contacts the printed circuit board, which closes the switch.

[0026] In a non-limiting embodiment, the arm is by default in the open position.

[0027] This feature allows that when the knob is pressed and consequently the activation button moves proximally, the contact between the arm and the activation button is lost, which opens the switch.

[0028] In a non-limiting embodiment, the printed circuit board and the sheath are connected to each other through connection elements.

[0029] In a non-limiting embodiment, the knob comprises a flexible arm extending axially, having a hook at its proximal end configured to move axially along an axially-extending track of the sheath.

[0030] In a non-limiting embodiment, the track comprises a protrusion extending radially inwards, the protrusion comprising an angled surface extending distally towards the axis of the sheath. The flexible arm bends inwards, pushed radially inwards by the protrusion, when the hook is against the angled surface. The flexible arm stops bending inwards and moves back to its natural position when the hook has passed the angled surface of the protrusion, at the end of a proximal movement of the knob. When the activation button of the medicament delivery device is moved distally, pushing in turn the knob of the monitoring device distally, the flexible arm and its hook stop the distal movement of the cap holder while still in the slope of the angled surface 30 id. The effect is that the knob is always biased proximally against the activation button of the medicament delivery device.

[0031] In a non-limiting embodiment, the angled surface extends distally from a proximal end of the protrusion.

[0032] In a non-limiting embodiment, the assembly comprises a RGB sensor or a RFID reader configured to capture data on the distal surface of the activation button.

[0033] Closing the switch may activate the RGB sensor or RFID reader. The distal surface of the activation button may be of a specific colour linked to the medicament dose deliverable by the medicament delivery device. That colour may be sensed by the RGB sensor, and decoded. In another example, the distal surface of the activation surface may comprise a RFID tag in which data about the medicament delivery device are saved. That RFID tag may be read by the RFID reader. Said data may comprise the medicament dose deliverable by the medicament delivery device, the expiry date of the medicament, authentication data relative to the medicament delivery device, etc.

[0034] In a non-limiting embodiment, the monitoring unit comprises a communication module with an external device, connected to the switch.

[0035] Hence, the status of the medicament delivery, and potentially other acquired data can be transmitted to an external device, for instance a smartphone. In a non-limiting embodiment, the knob comprises a cap and a cap holder connected to each other through engagement means.

[0036] This feature facilitates the mounting process of the monitoring unit.

[0037] In a non-limiting embodiment, the sheath comprises a groove extending axially distally from a proximal end of the sheath.

[0038] The groove is configured to receive a bulge of the medicament delivery device. That cooperation prevents a rotation of the sheath around the distal portion of the medicament delivery device.

[0039] In another aspect, the invention relates to a kit comprising:

[0040] - a multi-dose medicament delivery device having a distal activation button and comprising a positioning mechanism configured to move back the activation button distally after an injection and before a next injection, wherein the medicament delivery device extends axially between a proximal end and a distal end, the distal end being the one pointing away from a dose delivery site during use of the medicament delivery device;

[0041] - a monitoring unit as previously defined.

[0042] In another aspect, the invention relates to a kit comprising:

[0043] - a multi-dose medicament delivery device having a distal activation button and comprising a positioning mechanism configured to move back the activation button distally after an injection and before a next injection, wherein the medicament delivery device extends axially between a proximal end and a distal end, the distal end being the one pointing away from a dose delivery site during use of the medicament delivery device;

[0044] - a monitoring unit as previously defined, the sheath comprising a groove extending axially distally from a proximal end of the sheath; wherein the positioning mechanism comprises a loading sleeve having a bulge, the groove being configured to receive the bulge.

[0045] In a non-limiting embodiment, the positioning mechanism comprises a loading sleeve generally cylindrical, and the sheath forms a cylindrical sleeve configured to be attached to the loading sleeve.

[0046] BRIEF DESCRIPTION OF THE DRAWINGS

[0047] 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:

[0048] Fig. 1A a medicament delivery device, in an unloaded state, suitable to be monitored by a mechanism according to the invention;

[0049] Fig. 1B the medicament delivery device, in a loaded state, not activated;

[0050] Fig. 1C the medicament delivery device, activated and near the end of a first of multiple injection;

[0051] Fig. 1D the medicament delivery device, at the end of the first injection;

[0052] Fig. 2 a priming rod of the medicament delivery device;

[0053] Fig. 3 a plunger rod of the medicament delivery device;

[0054] Fig. 4 a plunger nut of the medicament delivery device;

[0055] Fig. 5A a view of a slope part of the medicament delivery device;

[0056] Fig. 5B another view of the slope part shown in Fig. 5A;

[0057] Fig. 6 a spring stop of the medicament delivery device;

[0058] Fig. 7 a drive spring of the medicament delivery device;

[0059] Fig. 8 an activation button / priming button of the medicament delivery device;

[0060] Fig. 9 a loading sleeve of the medicament delivery device; Fig. 10A a detail of elements of the medicament delivery device, in the unloaded state;

[0061] Fig. 10B a detail of elements of the medicament delivery device, half-way through a loading step;

[0062] Fig. 10C a detail of elements of the medicament delivery device, upon completion of the loading step;

[0063] Fig. n elements of a monitoring unit according to the invention, attachable for instance to the medicament delivery device of the previous drawings;

[0064] Fig. 12A shows the monitoring unit mounted onto the distal end of the medicament delivery device, having a closed switch;

[0065] Fig. 12B shows the same elements as in Fig. 12A, the switch being open;

[0066] Fig. 13A shows a perspective view of a cap holder of the monitoring unit;

[0067] Fig. 13B shows another perspective view of the cap holder;

[0068] Fig. 14 shows a perspective view of a cap of the monitoring unit;

[0069] Fig. 15 shows a cross-sectional view of a knob of the monitoring unit, made of the cap and the cap holder;

[0070] Fig. 16 shows a perspective view of a sheath of the monitoring unit;

[0071] Fig. 17A shows a cross-sectional view of the monitoring unit, the switch being closed;

[0072] Fig. 17B shows the same elements as in Fig. 17A, the switch being open;

[0073] Fig. 18A shows a side view of an assembly of the monitoring unit;

[0074] Fig. 18B shows a perspective view of the assembly.

[0075] DETAILED DESCRIPTION

[0076] A medicament delivery device suitable for being monitored by a monitoring unit according to the invention, comprises a distal activation button. The activation button must be pressed by the end user to activate the medicament delivery device. In order for the button to be pressed, it needs to protrude distally. A medicament delivery device suitable for being monitored by a monitoring unit according to the invention, comprises a positioning mechanism for the activation button, configured to push the button distally before use. The positioning mechanism may be for instance activated by a rotation of a sleeve of the medicament delivery device.

[0077] Any kind of medicament delivery device having those features may embody the invention. However, for illustrative purposes, a non-limiting example of such a medicament delivery device is described in more details in reference to Fig. i to 10C.

[0078] Fig. 1A to Fig. 1D show a medicament delivery device 2.

[0079] The medicament delivery device 2 comprises a container housing 4, a medicament container 3 being seated in the container housing 4. The container housing 4 accommodates the medicament container 3 by having a seat open towards distally into which the medicament container 3 is insertable. The medicament container 3 may be of the kind known in the field, with a plunger 31 initially seated near its distal end, and with a septum that can be pierced by a needle and that closes off the medicament container towards proximally.

[0080] The medicament delivery device 2 comprises a device body 5. The device body 5 has the general shape of a hollow circular cylinder. The device body 5 has a status window 51, whose purpose is explained hereinafter. The container housing 4 may be 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 12, an activation button 13.

[0081] Besides that, the medicament delivery device 2 comprises, at its proximal end, a needle assembly 15. Fig. 1B shows the medicament delivery device 2 in a ready-to use state with a needle case 16 of the needle assembly 15 removed, and a needle 18 of the needle assembly 15 uncovered. The proximal end of the container housing 4 has an outer thread (not visible on the drawings) for mounting the needle assembly. By screwing the needle assembly onto the container housing 4, the needle 18 pierces a septum of the medicament container 3, whereafter the medicament can be dispensed via the needle 18 by displacing the plunger 31 of the medicament container 3 towards proximally. Needle assemblies suitable for this purpose are known in the field and are not described in any more detail here.

[0082] The medicament delivery device has a plunger rod assembly used for dispensing the medicament by being moved towards proximally and thereby acting on the plunger 31. The plunger rod assembly comprises a priming rod 6 (Fig. 2), a plunger rod 7 (Fig. 3) and a plunger nut 8 (Fig. 4).

[0083] 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 3 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.

[0084] 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 the plunger nut 8. Fig. 5A shows a view of a slope part 201. Fig. 5B depicts an enlarged view of the slope part 201 from a different perspective. The slope part 201 is mounted to be essentially immovable relative to the device body 5.

[0085] The slope part 201 comprises two helical slopes 211, 212 that extend by 360° around axis A. The two slopes 211, 212 are offset by 180° with respect to one another. The two slopes 211, 212 are at different radial positions (i.e., the second slope 212 is further inside than the first slope 211), but they otherwise have a 180° axial symmetry with respect to one another. A rotation by 180° thus transfers one slope into the other slope, but with different radial positions. The slopes 211, 212 have step features 213 that prevent unwinding. 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. The step features may be in the form of zags (as illustrated) or may be in the form of platforms, i.e., zero-inclined portions.

[0086] The plunger nut 8 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.

[0087] A distal portion of the plunger nut 8 runs inside a sleeve-like spring stop 11 (Fig. 6). The spring stop 11 has spring stop coupling structures 111 engaging with coupling holes (not visible on the figures) 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 a base assembly. A drive spring 9 (Fig. 7) - serving as biasing member - is arranged between a distally facing shoulder 145 of the plunger nut 8 and the proximal end face of the spring stop 11. The loading sleeve 12 surrounds a proximal portion of the spring stop 11, while a distal portion thereof is surrounded by the device body 5. The activation button 13 extends inside of the loading sleeve 12 and extends into an interior of the spring stop 11.

[0088] For medicament delivery, the following steps are carried out:

[0089] Step A. Needle assembly affixing: Initially, the needle assembly 15 is mounted to the pre-assembled medicament delivery device 2 with the medicament container 3 already seated in the container housing 4. This will cause the septum of the medicament container 3 to be penetrated by the needle 18, whereupon the medicament is capable of being expelled through the needle.

[0090] Step B. Priming: The user presses the activation button 13 towards proximally. The activation button 13 has a priming protrusion 131 (Fig. 8) 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 31. 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.

[0091] Step C. Loading: The drive spring 9 is compressed between the distally facing shoulder 145 of the plunger nut 8 and the spring stop 11 consequently of the plunger nut 8 moving towards distally. This loading step is caused by a loading action by the user, namely a twisting of the loading sleeve 12 relative to the device body 5 by 360°. 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 plunger rod guiding portion protruding towards the interior near the proximal end of the device body 5. 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. 9) of the loading sleeve 12. The rotation of the plunger nut 8 causes the plunger nut 8 to move backward, i.e., towards distal, against the spring force of the drive spring 9. This movement of the plunger nut 8 for loading the device can be observed through the status windows 51.

[0092] Figs. 10A to 10C show, in part, the plunger nut 8 and the slope part 201 in different stages of the loading step, namely in an initial state (Fig. 10A), after a 180° rotation (Fig. 10B), and in a final state, after a 360° rotation (Fig.

[0093] 10C). The arrow indicates the increase of the axial length a of the assembly constituted by the slope part 201 and the slope extension 141 of the plunger nut 8. In an initial phase of the rotation caused by the user twisting the loading sleeve 12, a spring stop slope 112 of the spring stop 11 acts as a reset slope and causes the activation button 13 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. 6 and 8). When the device is fully loaded, the plunger nut 8 is rotated a full turn.

[0094] Step 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. 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 slope extension 141 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.

[0095] Step E. Needle assembly removal. After delivery of a full dose, the user removes the needle assembly (if no dose is left, as an alternative, the medicament delivery assembly maybe disposed directly). Steps A., C., D., and E. - thus all steps except the priming step - are repeated for each one of the further doses.

[0096] It should be noted that the slope part 201 may be absent and the two helical slopes 211, 212 may instead be located on the inner surface of the device body 5. Besides that, the medicament delivery device may comprise an additional element, a spring bearing member, coupled to the spring stop 11, and the drive spring may be compressed between the distally facing shoulder 145 of the plunger nut 8 and the spring bearing member instead of the spring stop 11 itself.

[0097] As visible on Fig.4, the plunger nut 8 comprises, on the outer surface of its slope extension 141, two symbols 260, 270. In the present non-limiting example, the first symbol 260 represents a triangle and the second symbol 270 represents a rectangle. The number, shapes and colours of those symbols may be different in other embodiments of the invention.

[0098] The second symbol 270 is placed on the slope extension 141 in such a way that in an unloaded state of the medicament delivery device 2, the second symbol 270 is visible through the status window 51 of the device body 5. This configuration is represented on Fig. 1A. The first symbol 260 is placed on the slope rope extension 141 in such a way that in at the end of the distal helical movement of the plunger nut 8, when the drive spring is fully loaded, the first symbol 260 is visible through the status window 51 of the device body 5. This configuration is represented on Fig. 1B. As the plunger nut 8 has rotated 360 degrees during the loading step, the two symbols 260, 270 must be aligned on an axis parallel to the longitudinal axis A. At the end of an injection, following the proximal movement of the plunger nut 8 caused by the drive spring release, the plunger nut 8 is back into its initial position and the second symbol 270 is again visible through the window 51 of the device body 5. This configuration is represented on Fig. 1D.

[0099] Thus, the two symbols 260, 270 can be used as loading status indicators that the drive spring is initially unloaded, then that the drive spring has been loaded and the medicament delivery device is ready for injection, and then that the injection is finished, and the drive spring is unloaded again.

[0100] The invention provides a monitoring unit 30 removably attachable to the distal portion of the medicament delivery device 2. Elements of the monitoring unit 30 are illustrated on Fig. 11.

[0101] The monitoring unit 30 is configured to envelop the distal portion of the medicament delivery device 2, and to track events linked to usages of the medicament delivery device 2. However, as explained above, the monitoring unit suits any kind of multi-dose medicament delivery device that is activatable by pushing a distal activation button, and that comprises a positioning mechanism configured to move back the activation button distally after an injection, before a next injection.

[0102] The monitoring unit 30 comprises:

[0103] - a sheath 301,

[0104] - a knob 30a made of a cap 302 and a cap holder 303, and

[0105] - an assembly 30b having a printed circuit board 304, a battery 305, a switch 306, and other electronic components 307 such as a sensor, a reader or a communication module.

[0106] The sheath 301 forms a cylindrical sleeve configured to be attached to the loading sleeve 12 of the medicament delivery device 2, around the activation button 13 of the medicament delivery device. When the monitoring unit 30 is mounted onto the medicament delivery device, the sheath 301 is immovable relative to the loading sleeve 12. Besides that, the sheath is configured to hold, at its distal end, the knob 30a.

[0107] The knob 30a is configured to cover the distal face of the activation button of the medicament delivery device. The knob 30a is configured to be mounted axially moveable relative to the sheath 301, as visible on Fig. 12A and Fig. 12B. In fact, the knob 30a is configured to be actioned by the user of the medicament delivery device to trigger an injection, and when actioned, to push the activation button proximally. Said differently, when the monitoring unit 30 is attached to the medicament delivery unit, the user cannot directly press the activation button to trigger the injection, but can transfer force to the activation button by pressing the knob 30a.

[0108] As explained above, the medicament delivery device comprises a positioning mechanism configured to move back the activation button distally after an injection, before the next injection. When the activation button is moved distally, it pushes distally the knob 30a, which moves the knob 30a back to a position where it can be actuated again (the unpressed position). In an embodiment, the activation button needs to be moved distally before the first injection too, using the positioning mechanism.

[0109] Fig. 12A shows the knob 30a in the unpressed position, before the user has pressed the knob, and Fig. 12B shows the knob 30a in the pressed position, after the knob has been pressed and before the positioning mechanism has moved back the knob distally. As explained above, in the unpressed axial position, the knob 30a protrudes distally from the distal end of the sheath 301 by a longer extent than in the pressed position.

[0110] Fig. 13A and Fig. 13B show the cap holder 303 of the knob 30a. The cap holder 303 comprises:

[0111] - at least one flexible arm 303a (two in the described embodiment) extending axially, the arm having a hook 303b at its proximal end, the hook 303b being configured to move axially along a track 301a of the sheath 301 (cf. Fig. 16),

[0112] - at least one support surface 303c (two in the described embodiment) extending orthogonal to the longitudinal axis, configured to bias proximally the activation button of the medicament delivery device when the knob is pushed in the proximal direction by the end user, or to be biased distally by the activation button of the medicament delivery device when the drive spring is being loaded,

[0113] - engagement means 303d for the cap 302. The term engagement encompasses any kind of interaction between the named features such as abutment, clamping, locking, biasing, flexing, etc. The engagement means illustrated in the drawings only serve as an example.

[0114] Fig. 14 shows the cap 302 of the knob. The cap 302 comprises engagement means 302a configured to cooperate with the engagement means 303d of the cap holder 303. Fig. 15 shows the knob 30a when the cap 302 and the cap holder 303 are connected to each other.

[0115] Fig. 16 shows the sheath 301. The inner surface of the sheath 301 comprises:

[0116] - at least one track 301a (two in the described embodiment) for the flexible arm 303a of the cap holder 303, the track 301a extending in the longitudinal direction up to the distal end of the sheath 301,

[0117] - a protrusion 301b extending radially inwards in the track 301a, along a longitudinal length that is shorter that the length of the track 301a,

[0118] - connexion elements 301c for the printed circuit board 304, in a way that the assembly 30b is mounted immobile relative to the sheath 301.

[0119] The protrusion 301b comprises an angled surface 3Oid extending distally towards the longitudinal axis from the proximal end of the protrusion 301b. The flexible arm 303a bends inwards, pushed radially inwards by the protrusion 301b, when the hook 303b is against the angled surface 3Oid (Fig. 12A and Fig. 17A). The flexible arm 303a stops bending inwards and moves back to its natural position when the hook 303b has passed the angled surface 3Oid of the protrusion 301b, at the end of a proximal movement of the knob 30a (Fig. 12B and Fig. 17B). When the drive spring of the medicament delivery device is reloaded, that is to say when the activation button of the medicament delivery device is moved distally, pushing in turn the knob 30a of the monitoring device 30 distally, the flexible arm 303a and its hook 303b stop the distal movement of the cap holder 303 while still in the slope of the angled surface 30 id (see Fig. 17A). The effect is that the knob 30a is always biased proximally against the activation button of the medicament delivery device. In the non-limiting illustrated embodiment, the sheath 301 comprises a groove 30ie extending axially distally from a proximal end of the sheath 301. The groove 3Oie is configured to receive a bulge 12a of the loading sleeve 12 of the medicament delivery device 2 (cf. Fig. 1A and Fig. 9). That cooperation prevents a rotation of the sheath 301 around the loading sleeve and ensure that the sheath 301 rotates when the loading sleeve 12 is rotated by the user.

[0120] Fig. 18A and Fig. 18B show the assembly 30b. The printed circuit board 304 holds, on one side, the battery 305, and on the other side, the switch 306 and the other electronic components 307. The printed circuit board 304 comprises connexion elements 304a that are configured to engage the connexion elements 301c of the sheath 301 in a way that the printed circuit board 304 is immobile relative to the sheath 301.

[0121] The switch 306 is a mechanical switch, with an arm 306a configured to move from an open position (Fig. 12 B) in which the arm 306a is angled relative to the printed circuit board 304 to a closed position (Fig. 12A) in which the arm 306a is in contact with the printed circuit board 304. In the open position of the arm 306a, the switch 306 is open, and in the closed position of the arm 306a, the switch 306 is closed. By default, the arm 306a is in the open position, that is to say the switch 306 is open, unless a pressure is applied to the arm 306, said pressure bringing it in the closed position.

[0122] The other components 307 comprise a RGB sensor or a RFID reader, a communication module such as a Bluetooth Low Energy (BLE) capable microcontroller with a BLE antenna. The assembly may optionally comprise a UI lightguide too (not visible on the drawings).

[0123] The assembly of the elements of the monitoring unit 30 follows the following process.

[0124] First, the printed circuit board 304, carrying the switch 306 and the electronic components 307, is fitted into the cap holder 303. The printed circuit board 304 is assembled by positioning it at the centre of the cap holder 303. Then, the battery 305 is mounted onto the printed circuit board 304, which wakes the monitoring unit 30 up. The monitoring unit 30 will stay on as long as the battery is connected.

[0125] Then, the cap holder 303, printed circuit board 304 and battery 305 are inserted into the sheath 301. The printed circuit board 304 is connected to the sheath 301 by using the connection elements 301c and 304a (for instance, using a snap-fit connection). The cap holder 303 is enabled to move axially relative to the sheath 301.

[0126] Finally, the cap 302 is connected to the cap holder 303 (by a snap-fit connection, for instance).

[0127] The monitoring of the medicament delivery device by the monitoring unit 30 works the following way.

[0128] In a first step, the monitoring unit 30 is mounted onto the distal end of the medicament delivery device (by a snap-fit connection, for instance), on top of the sleeve and the activation button of the medicament delivery device. The resulting configuration is the one illustrated on Fig. 12B.

[0129] In a second step, the medicament delivery device is prepared for injection by rotating the sleeve, which loads the drive spring. As a consequence, the activation button pops axially out in the distal direction from the housing of the medicament delivery device. In doing so, the distal surface of the activation button biases the support surface 303c of the cap holder 303, pushing the knob 30a distally. The resulting configuration is the one illustrated on Fig. 12A. In the course of the second step, the distal surface of the activation button of the medicament delivery device comes into contact with the arm 306a of the switch 306. This movement moves the arm 306a from the open to the closed position, closing the switch 306. Closing the switch 306 activates the RGB sensor or RFID reader, and it can be determined and recorded that the medicament delivery unit is “ready for injection”. In a third step, information relative to the medicament delivery device is acquired by the RGB sensor or RFID reader. For instance, the distal surface of the activation button may be of a specific colour linked to the medicament dose deliverable by the medicament delivery device. That colour may be sensed by the RGB sensor, and decoded. In another example, the distal surface of the activation surface may comprise a RFID tag in which data about the medicament delivery device are saved. That RFID tag may be read by the RFID reader. Said data may comprise the medicament dose deliverable by the medicament delivery device, the expiry date of the medicament, authentication data relative to the medicament delivery device, etc.

[0130] In a fourth step, the user activates the medicament delivery device by pressing the knob 30a of the monitoring unit 30, which in turn pushes the activation button of the medicament delivery device proximally. The arm 306a of the switch 306 loses contact with the support surface 303c of the cap holder 303, opening the switch 306. It can be determined and recorded that a medicament injection has happened.

[0131] In an alternative embodiment, instead of having a monitoring unit 30 always on after mounting the battery 305, the battery may be electrically connected only when the switch 306 closes. This would extend the battery life. To prevent the monitoring unit 30 to be shut down when the switch 306 reopens, an electronic hold circuit may keep the monitoring unit 30 awake until it decides to shut itself off or until next activation (after a certain data communication period, for instance).

[0132] The monitoring unit 30 may store different events and their related data in a non-volatile memory, allowing to not lose information in case of a battery change. The stored events and data are meant to be transmitted wirelessly to a receiver (for instance a hub or a smartphone) when possible, by using the communication module. A broadcast only or a two-way communication may be used. The delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0133] 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, hi dradenitis 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, Behqet'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.

[0134] 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.

[0135] 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.

[0136] 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 (CDW123) 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.

[0137] 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.

[0138] 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.

[0139] 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.

[0140] 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.

[0141] 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.

[0142] 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.

[0143] 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,

[0144] 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.

[0145] 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 monitoring unit (30) for a multi-dose medicament delivery device (2) having a distal activation button (13) and comprising a positioning mechanism configured to move back the activation button (13) distally after an injection and before a next injection, wherein the medicament delivery device extends axially between a proximal end and a distal end, the distal end being the one pointing away from a dose delivery site during use of the medicament delivery device, the monitoring unit (30) comprising:- A sheath (301) removably attachable around a distal portion of the medicament delivery device (2);- A knob (30a) axially moveable relative to the sheath (301) between an unpressed position and a pressed position, wherein in the unpressed position, the knob (30a) protrudes from a distal end of the sheath (301) by a longer extent than in the pressed position, wherein the knob (30a) comprises a support surface (303c) extending radially and configured to bias or be biased by a distal surface of the activation button (13);- An assembly (30b) axially fixed relative to the sheath (301) and distal relative to the support surface (303c), comprising a mechanical switch (306) configured to transition between an open state and a closed state as a result from axial movements of the activation button (13).

2. A monitoring unit (30) according to the previous claim, wherein the assembly (30b) comprises a printed circuit board (304) fixedly attached to the sheath (301) and distal relative to the support surface (303c), the mechanical switch (306) being attached to the printed circuit board (304).

3. A monitoring unit (30) according to the previous claim, wherein the switch (306) has an arm (306a) configured to move between an open position in which the arm (306a) does not contact the printed circuit board (304) and the switch (306) is the open state, and a closed position in which the arm (306a) contacts the printed circuit board (304) and the switch (306) is in the closed state.

4. A monitoring unit according to the previous claim, wherein the arm (306a) is by default in the open position.

5. A monitoring unit (30) according to any of claims 2 to 4, wherein the printed circuit board (304) and the sheath (301) are connected to each other through connexion elements (304a, 301c).

6. A monitoring unit (30) according to any of the previous claims, wherein the knob (30a) comprises a flexible arm (303a) extending axially, having a hook (303b) at its proximal end configured to move axially along an axially extending track (301a) of the sheath (301).

7. A monitoring unit (30) according to the previous claim, wherein the track (301a) comprises a protrusion (301b) extending radially inwards, the protrusion (301b) comprising an angled surface (3Oid) extending distally towards the axis of the sheath (301).

8. A monitoring unit (30) according to the previous claim, wherein the angled surface (30 id) extends distally from a proximal end of the protrusion (301b).

9. A monitoring unit (30) according to any of the previous claims, wherein the assembly (30b) comprises a RGB sensor or a RFID reader (307) configured to capture data on the distal surface of the activation button10. A monitoring unit (30) according to any of the previous claims, comprising a communication module (307) with an external device, connected to the switch (306).

11. A monitoring unit (30) according to any of the previous claims, wherein the knob (30a) comprises a cap (302) and a cap holder (303) connected to each other through engagement means (302a, 303d).

12. A monitoring unit (30) according to any of the previous claims, wherein the sheath (301) comprises a groove (3Oie) extending axially distally from a proximal end of the sheath (301).

13. A kit comprising:- a multi-dose medicament delivery device (2) having a distal activation button (13) and comprising a positioning mechanism configured to move back the activation button (13) distally after an injection and before a next injection, wherein the medicament delivery device extends axially between a proximal end and a distal end, the distal end being the one pointing away from a dose delivery site during use of the medicament delivery device;- a monitoring unit (30) according to any of the previous claims.

14. A kit comprising:- a multi-dose medicament delivery device (2) having a distal activation button (13) and comprising a positioning mechanism configured to move back the activation button (13) distally after an injection and before a next injection, wherein the medicament delivery device extends axially between a proximal end and a distal end, the distal end being the one pointing away from a dose delivery site during use of the medicament delivery device;- a monitoring unit (30) according to claim 12,wherein the positioning mechanism comprises a loading sleeve (12) having a bulge (12a), the groove (301a) being configured to receive the bulge (12a).

15. A kit according to claim 13 or 14, wherein the positioning mechanism comprises a loading sleeve (12) generally cylindrical, and the sheath (301) forms a cylindrical sleeve configured to be attached to the loading sleeve (12).

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