Multi-dose medicament delivery device having status indicators, and monitoring unit for such device

Abstract

The invention related to 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 device body (5); - a plunger rod assembly arranged to move axially in a proximal direction relative to the device body (5) for interacting with the medicament container (3) for expelling the medicament therefrom; and - a biasing member (9) configured to bias the plunger rod assembly in a proximal direction; wherein the plunger rod assembly comprises a plunger nut (8) and a plunger rod device (6, 7), wherein the plunger rod device (6, 7) is configured to act, by moving in proximal direction, on a plunger (31) of the medicament container (3) for expelling the medicament therefrom; wherein the medicament delivery device further comprises a loading mechanism configured for a user to cause a distal helical movement of the plunger nut (8), relative to the device body (5) and to the plunger rod device (6, 7), from an unloaded position into a loaded position, and to thereby bias the biasing member (9); wherein the device body (5) comprises a status window (51), and the plunger nut (8) comprises a first symbol (260) positioned such that at the end of the distal helical movement of the plunger nut (8), the first symbol (260) is visible through the status window (51).

Description

[0001] Multi-dose medicament delivery device having status indicators, and monitoring unit for such device

[0002] TECHNICAL FIELD

[0003] The present invention relates to a multi-dose medicament delivery device having status indicators, and to a monitoring unit configured to monitor the status of such a 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 drives a plunger rod in direction of the injection site. The plunger rod thereby displaces a plunger in a medicine container, resulting in expelling said medicine from said container.

[0007] In the case of a multi-dose medicament delivery device, 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. Moreover, 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.

[0008] For these reasons, it has already been proposed to provide the medicament delivery device with a loading mechanism that re-tensions the drive spring before each injection. Besides that, there are many patients or elderly with motor skills difficulties who could have problems with the correct and safe handling of the medicament delivery device. Therefore, it is beneficial that the risks of wrong handling of the device are minimized.

[0009] There is therefore an increasing demand for feedback to the patient indicative of a loading status of the drive spring.

[0010] SUMMARY

[0011] It is an object of the present invention to provide a multi-dose medicament delivery device enabling feedback to the patient indicative of a loading status of the drive spring.

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

[0013] The invention relates to a medicament delivery device 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 defining a device axis and comprising: a device body; a plunger rod assembly arranged to move axially in a proximal direction relative to the device body for interacting with the medicament container for expelling the medicament therefrom; and a biasing member configured to bias the plunger rod assembly in a proximal direction; wherein the plunger rod assembly comprises a plunger nut and a plunger rod device, wherein the plunger rod device is configured to act, by moving in proximal direction, on a plunger of the medicament container for expelling the medicament therefrom; wherein the medicament delivery device further comprises a loading mechanism configured for a user to cause a distal helical movement of the plunger nut, relative to the device body and to the plunger rod device, from an unloaded position into a loaded position, and to thereby bias the biasing member; wherein the device body comprises a status window, and the plunger nut comprises a first symbol positioned such that at the end of the distal helical movement of the plunger nut, the first symbol is visible through the status window.

[0014] 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.

[0015] 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.

[0016] Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.

[0017] 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.

[0018] In a non-limiting embodiment, the plunger nut comprises a second symbol positioned such that at the end of the proximal movement of the plunger rod assembly, when the plunger nut has reached the unloaded position, the second symbol is visible through the status window.

[0019] In a non-limiting embodiment, the helical movement comprises a rotational component of 360 degree. This allows, when the loading mechanism is loaded again, to have again the first symbol visible through the status window.

[0020] In a non-limiting embodiment, the device body defines a stop for the proximal movement of the plunger rod assembly; the loading mechanism is equipped for the user to cause another distal helical movement of the plunger nut relative to the device body and the plunger rod device in a reloading action after the plunger rod assembly has reached the stop; the medicament delivery device is configured for the loading mechanism to be activated a plurality of times; and the unloaded position of the plunger nut and the loaded position of the plunger nut is the same for each dose.

[0021] In a non-limiting embodiment, the medicament delivery device comprises a loading sleeve that is configured to be twisted by the user relative to device body to cause the distal helical movement of the plunger nut; the plunger nut is rotationally couplable to the loading sleeve; and one of the plunger nut and of the device body comprises a helical feature and the other one comprises a cooperating feature cooperating with the helical feature, whereby a rotation of the plunger nut around the axis causes a translational movement of the plunger relative to the device body.

[0022] In a non-limiting embodiment, the plunger rod device comprises a plunger rod thread; the plunger nut comprises a thread engaging feature; the plunger rod device is rotationally coupled to the device body; the plunger rod device is configured to be essentially stationary relative to the device body when the plunger nut is subject to the distal helical movement during loading; the plunger rod thread and the thread engaging feature are configured to transfer a movement of the plunger nut into the proximal direction during medicament expelling on the plunger rod device but allowing the plunger nut to be moved into the distal direction relative to the plunger rod device when subject to the distal helical movement during the loading step.

[0023] In a non-limiting embodiment, a lead of the plunger rod thread is smaller than a lead of the helical feature.

[0024] In a non-limiting embodiment, an engagement of the plunger rod thread on the one hand and the thread engaging feature on the other hand is subject to a clearance.

[0025] In a non-limiting embodiment, one of the plunger nut and of the device body comprises a pair of locking arms with locking protrusions, and the other one of the plunger nut and of the device body comprises a locking structure capable of engaging with the locking protrusions; and the medicament delivery device is configured for the locking arms to flex in a resilient manner while the user causes the distal helical movement of the plunger nut for loading and to flex back for the locking protrusions to engage the locking structure immediately before a loaded position has been reached by the plunger nut.

[0026] In a non-limiting embodiment, the medicament delivery device comprises an activation mechanism for the user to activate medicament delivery; and the activation mechanism comprises an activation button with an activation structure that, when the activation button is pressed, causes the locking arms to flex until their locking protrusions get out of engagement with the locking structure to release the plunger rod assembly so that the resilient member displaces the plunger rod assembly towards proximally.

[0027] In a non-limiting embodiment, the plunger rod device comprises a plunger rod and a priming rod, the priming rod being displaceable relative to the plunger rod in the proximal direction but not in the distal direction, and the priming rod having a proximal impact surface for acting on the plunger of the medicament container.

[0028] In a non-limiting embodiment, the activation button comprises a priming protrusion shaped to act on the priming rod for displacing the priming rod towards proximally when the activation button is pressed; and the medicament delivery device further comprises a re-set mechanism displacing the activation button back towards distally by the user to cause the distal movement of the plunger nut.

[0029] In another aspect, the invention relates to a kit comprising a medicament delivery device as defined previously, the kit further comprising a monitoring unit removably attachable to the medicament delivery device and configured to cover the status window when the monitoring unit is attached to the medicament delivery device, the monitoring unit comprising a sensor configured to detect a symbol in the status window.

[0030] In a non-limiting embodiment, the sensor is a RGB colour sensor or an optical sensor.

[0031] In a non-limiting embodiment, the medicament delivery device comprises a RFID label storing identification information related to the medicament delivery device; and the monitoring unit comprises a device identification module having a reader configured to read said RFID label when the monitoring unit is attached to the medicament delivery device.

[0032] BRIEF DESCRIPTION OF THE DRAWINGS

[0033] 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:

[0034] Fig. 1A a medicament delivery device according to the invention, in an unloaded state; Fig. 1B the medicament delivery device, in a loaded state, not activated;

[0035] Fig. 1C the medicament delivery device, activated and near the end of a first of multiple injection;

[0036] Fig. 1D the medicament delivery device, at the end of the first injection;

[0037] Fig. 2 a priming rod of the medicament delivery device;

[0038] Fig. 3 a plunger rod of the medicament delivery device;

[0039] Fig. 4 a plunger nut of the medicament delivery device;

[0040] Fig. 5A a view of a slope part of the medicament delivery device;

[0041] Fig. 5B another view of the slope part shown in Fig. 5A;

[0042] Fig. 6 a spring stop of the medicament delivery device;

[0043] Fig. 7 a drive spring of the medicament delivery device;

[0044] Fig. 8 an activation button / priming button of the medicament delivery device;

[0045] Fig. 9 a loading sleeve of the medicament delivery device;

[0046] Fig. 10A a detail of elements of the medicament delivery device, in the unloaded state;

[0047] Fig. 10B a detail of elements of the medicament delivery device, half-way through a loading step;

[0048] Fig. 10C a detail of elements of the medicament delivery device, upon completion of the loading step;

[0049] Fig. 11 a monitoring unit according to the invention, attachable to a medicament delivery device according to the invention; and

[0050] Fig 12 a functional representation of the monitoring unit. DETAILED DESCRIPTION

[0051] A medicament delivery device according to the invention comprises a medicament container, a plunger inside the medicament container, a plunger rod, a drive spring, a rotating plunger nut, a loading sleeve and an activation button.

[0052] In an unloaded state of the medicament delivery device, the drive spring pushes the plunger nut towards proximally.

[0053] The patient may initiate a medicament administration operation by rotating the loading sleeve provided on the medicament delivery device. This movement causes the plunger nut to have a distal helical movement, biasing distally a proximal end of an unloaded drive spring. The helical movement of the plunger nut causes the drive spring to load. Preferably, at the end of the helical movement, the plunger nut has rotated 360 degrees. During the rotation and backward movement (towards distally) of the plunger nut, the plunger rod essentially stands still.

[0054] Then the patient may operate the activation button. This movement causes the loaded drive spring to unload, biasing the plunger rod proximally towards the dose delivery site. In turn, the plunger rod acts, by moving in proximal direction, on the plunger for expelling the medicament from the medicament container.

[0055] 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. 1 to 10C.

[0056] Fig. 1A to Fig. 1D show a medicament delivery device 2.

[0057] 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.

[0058] 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 maybe 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.

[0059] 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.

[0060] 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).

[0061] 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.

[0062] 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.

[0063] 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.

[0064] 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 18 o° axial symmetry with respect to one another. A rotation by 1800thus 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 maybe in the form of zags (as illustrated) or maybe in the form of platforms, i.e., zero-inclined portions. 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.

[0065] 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.

[0066] 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.

[0067] For medicament delivery, the following steps are carried out:

[0068] 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.

[0069] 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.

[0070] 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.

[0071] 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. 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. 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.

[0072] 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).

[0073] Steps A., C., D., and E. - thus all steps except the priming step - are repeated for each one of the further doses.

[0074] It should be noted that the slope part 201 maybe 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 maybe compressed between the distally facing shoulder 145 of the plunger nut 8 and the spring bearing member instead of the spring stop 11 itself.

[0075] As visible on Fig.4, the plunger nut 8 comprises, on the outer surface of its slope extension 141, two symbols (or markings) 260, 270. In the present nonlimiting example, the first symbol 260 represents a triangle and the second symbol 270 represents a rectangle. In another embodiment, instead of a triangle and a rectangle, the symbols can be o and 1. In another embodiment shown in reference to Fig. 13A to 13F, the plunger nut 8 comprises three additional symbols 261, 262, 263 showing the progression of the loading step. Fig 13A shows the device 2 unloaded; Fig, 13B to 13D show the device 2 during the loading step; Fig. 13E shows the device 2 loaded; and Fig. 13F shows the device unloaded again, after the dose was delivered. The number, shapes and colours of those symbols maybe different in other embodiments of the invention.

[0076] 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.

[0077] 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.

[0078] In an embodiment, the invention provides a monitoring unit 30 removably attachable to the medicament delivery device 2 (Fig. 11) and configured to detect the loading status of the drive spring using the symbols 260, 270. The monitoring unit maybe attached to the device body 5 of the medicament delivery device, covering the status window 51 and possibly a RFID label attached to the medicament delivery device.

[0079] In reference to Fig. 12, the monitoring unit comprises an injection detection module 301 and a battery 302. In addition, the monitoring may comprise one or more of the following modules: a wake-up module 303, a mounting detection module 304, a device identification module 305, a wireless communication module 306, and a Human-Machine Interface (HMI) 307.

[0080] The injection detection module 301 comprises a sensor configured to detect the symbol facing the status window of the medicament delivery device. When the monitoring unit is attached to the medicament delivery device, said sensor may cover the status window. The sensor may be a RGB colour sensor or an optical sensor.

[0081] The battery 302 maybe a long-time standard battery, lasting around six months. The user may replace or recharge the battery when depleted, or the battery may not be replaceable or rechargeable.

[0082] The wake-up module 303 may comprise an accelerometer configured to detect when the monitoring unit 30 is picked up, waking up the monitoring device from a power save mode.

[0083] The mounting detection module 304 may comprise a switch configured to detect an attachment to or a removal from the medicament delivery device.

[0084] The device identification module 305 may comprise a reader for a RFID label attached to the medicament delivery device. The device identification module 305 offers the possibility of identifying the medicament delivery device to which it is attached. In addition to an identifier of the medicament delivery device, the RFID label may embed a digital signature for authenticity purposes.

[0085] The wireless communication module 306 maybe able to communicate with an external device through BLE Bluetooth, LTE, LoRa, SigFox or NB-IoT.

[0086] The HMI 307 may comprise an e-ink or a RGB-LED display. Information to convey may comprise: the loading status of the drive spring, the battery state, the number of injections performed, time passed since the last injection, a wireless broadcasting activity, information relative to the medicament delivery device, diagnostics, etc. A user sequence may be the following:

[0087] - i - The user mounts the battery 302 and charges the wireless communication module 306.

[0088] - 2 - The user attaches the monitoring unit to the medicament delivery device. The mounting detection module 304 detects said event. The RFID label on the medicament delivery device is read by the device identification module 305, and the medicament delivery device is authenticated. The user is informed via the HMI 307.

[0089] - 3 - The monitoring unit goes to the power-save mode after a certain idle time.

[0090] - 4 - The monitoring unit is woken up from the power-save mode when the wake-up module 303 detects the monitoring unit 30 is picked up.

[0091] - 5 - The injection detection module 301 monitors the status window of the medicament delivery device in case the loading sleeve is rotated to load the drive spring. In that case, the HMI 307 is updated.

[0092] - 6 - If the user stops the rotation or rotates back the loading sleeve, step 3 is performed again.

[0093] - 7 - When the user fully rotates the loading sleeve (until the drive spring is loaded), the sensor of injection detection module 301 detects the change of symbol in the status window, and an injection event is detected. The HMI 307 is updated accordingly.

[0094] The delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0095] 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, 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.

[0096] 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.

[0097] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro- apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins. Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-i (GLP-i) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Ci esterase modulators, bradykinin modulators, C-C chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene-related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modulators, tumor- associated calcium signal transducer 2 (Trop-2) modulators, cluster of differentiation 52 (CD52) modulators, B-cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor A (PDGFRA) modulators, cluster of differentiation 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed death-ligand 1 (PD-1 / PD-L1) inhibitors / modulators, B-lymphocyte antigen cluster of differentiation 19 (CD 19) 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.

[0098] 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.

[0099] 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.

[0100] 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.

[0101] 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.

[0102] 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.

[0103] 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 maybe 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.

[0104] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOXy, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini- CHOP, Maxi-CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC- EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA / CO, EMA / EP, EP / EMA, TP / TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini-BEAM, IGEV, C- MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE. Various modifications to the embodiments described are possible and will occur to those skilled in the art without departing from the invention which is defined by the following claims.

Claims

CLAIMS1. A medicament delivery device (2) for accommodating a medicament container (3) containing a medicament and for expelling multiple predefined doses of the medicament from the medicament container (3), the medicament delivery device (2) defining a device axis (A) and comprising: a device body (5); a plunger rod assembly arranged to move axially in a proximal direction relative to the device body (5) for interacting with the medicament container (3) for expelling the medicament therefrom; and a biasing member (9) configured to bias the plunger rod assembly in a proximal direction; wherein the plunger rod assembly comprises a plunger nut (8) and a plunger rod device (6, 7), wherein the plunger rod device (6, 7) is configured to act, by moving in proximal direction, on a plunger (31) of the medicament container (3) for expelling the medicament therefrom; wherein the medicament delivery device further comprises a loading mechanism configured for a user to cause a distal helical movement of the plunger nut (8), relative to the device body (5) and to the plunger rod device (6, 7), from an unloaded position into a loaded position, and to thereby bias the biasing member (9), wherein the distal helical movement comprises a rotational component of 360 degrees; wherein the device body (5) comprises a status window (51), and the plunger nut (8) comprises a first symbol (260) positioned such that at the end of the distal helical movement of the plunger nut (8), the first symbol (260) is visible through the status window (51).

2. The medicament delivery device (2) according to claim 1, wherein the plunger nut (8) comprises a second symbol (270) positioned such that at the end of the proximal movement of the plunger rod assembly, when the plunger nut (8) has reached the unloaded position, the second symbol (270) is visible through the status window (51).

3. The medicament delivery device (2) according to claim 1 or 2, wherein the distal helical movement comprises a rotational component of 360 degrees.

4. The medicament delivery device (2) according to any of claims 1 to 3, wherein the device body (5) defines a stop (57) for the proximal movement of the plunger rod assembly, wherein the loading mechanism is equipped for the user to cause another distal helical movement of the plunger nut (8) relative to the device body (5) and the plunger rod device (6, 7) in a reloading action after the plunger rod assembly has reached the stop (57), whereby the medicament delivery device is configured for the loading mechanism to be activated a plurality of times, wherein the unloaded position of the plunger nut (8) and the loaded position of the plunger nut (8) is the same for each dose.

5. The medicament delivery device (2) according to any of claims 1 to 4, comprising a loading sleeve (12) that is configured to be twisted by the user relative to drive body (5) to cause the distal helical movement of the plunger nut (8), wherein the plunger nut (8) is rotationally couplable to the loading sleeve (12), and wherein one of the plunger nut (8) and of the device body (5) comprises a helical feature and the other one comprises a cooperating feature cooperating with the helical feature, whereby a rotation of the plunger nut (8) around the axis (A) causes a translational movement of the plunger (8) relative to the device body (5).

6. The medicament delivery device (2) according to any of claim 1 to 5, wherein the plunger rod device (6, 7) comprises a plunger rod thread(72), wherein the plunger nut (8) comprises a thread engaging feature, wherein the plunger rod device (6, 7) is rotationally coupled to the drive body (5) and wherein the plunger rod device (6, 7) is configured to be essentially stationary relative to the drive body (5) when the plunger nut (8) is subject to the distal helical movement during loading, wherein the plunger rod thread (72) and the thread engaging feature are configured to transfer a movement of the plunger nut (8) into the proximal direction during medicament expelling on the plunger rod device (6, 7) but allowing the plunger nut (8) to be moved into the distal direction relative to the plunger rod device (6, 7) when subject to the distal helical movement during the loading step.

7. The medicament delivery device (2) according to claim 6, wherein a lead of the plunger rod thread (72) is smaller than a lead of the helical feature.

8. The medicament delivery device (2) according to claim 6 or 7, 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.

9. The medicament delivery device (2) according to any one of claims 1 to 8, wherein one of the plunger nut (8) and of the drive body (5) comprises a pair of locking arms (85) with locking protrusions (86), and the other one of the plunger nut (8) and of the drive body (5) comprises a locking structure 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 helical movement of the plunger nut (8) 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 plunger nut (8).

10. The medicament delivery device (2) according to claim 9, further comprising an activation mechanism for the user to activatemedicament 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 towards proximally.

11. The medicament delivery device (2) according to one of claims 1 to 10, wherein the plunger rod device (6, 7) 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).

12. The medicament delivery device (2) according to claim 11, 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 plunger nut (8).

13. A kit comprising a medicament delivery device (2) according to one of claims 1 to 12, further comprising a monitoring unit (30) removably attachable to the medicament delivery device (2) and configured to cover the status window (51) when the monitoring unit (30) is attached to the medicament delivery device (2), the monitoring unit (30) comprising a sensor configured to detect a symbol in the status window (51)-14. A kit according to claim 13, wherein the sensor is a RGB colour sensor or an optical sensor.

15. A kit according to claim 13 or 14, wherein the medicament delivery device (2) comprises a RFID label storing identification informationrelated to the medicament delivery device (2), and wherein the monitoring unit (30) comprises a device identification module (305) having a reader configured to read said RFID label when the monitoring unit (30) is attached to the medicament delivery device (2).

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