A detachable subassembly for a medicament delivery assembly

Abstract

A detachable subassembly (201, 301, 401) for a medicament delivery device (100) having a housing (102) and an internal metal component (118, 204, 206) arranged inside the housing. The subassembly comprises: an electrostatic sensing unit (210, 310, 410, 510) having at least one charge-sensor (212, 312, 412, 512) configured to detect variations in electric charge associated with movement of the internal metal component during an operation of the medicament delivery device, and a signal conditioning circuitry (220, 520) connected to the charge-sensor, the signal conditioning circuitry being configured to generate an output signal (O1) corresponding to the detected variations in electric charge caused by the movement of the internal metal component.

Description

[0001] A DETACHABLE SUBASSEMBLY FOR A MEDICAMENT DELIVERY ASSEMBLY

[0002] TECHNICAL FIELD

[0003] The present disclosure generally relates to medical devices for medicament administration.

[0004] BACKGROUND

[0005] Medicament delivery devices, such as autoinjectors, are commonly used to administer medications in a controlled manner. These devices often include internal mechanical components, such as springs or needle covers, that move during their operation to facilitate medicament delivery. Monitoring the operation of these devices is critical for ensuring proper usage, verifying successful delivery of the medicament, and detecting any malfunctions.

[0006] Existing solutions for monitoring medicament delivery actions typically rely on mechanical sensors or vibration-based systems. However, these approaches often require physical modifications to the delivery device, which can complicate manufacturing, increase costs, and limit compatibility across device types. Additionally, vibration-based sensors may be prone to interference from external disturbances, such as accidental knocks or environmental noise, resulting in reduced detection accuracy.

[0007] In considering these problems, the applicant has appreciated that various developments could be made to help improve the medicament delivery devices on the market today, which are set out in more detail below.

[0008] SUMMARY

[0009] An object of the present disclosure is to provide a medicament delivery assembly which solves, or at least mitigates problems of the prior art.

[0010] There is hence provided a detachable subassembly for a medicament delivery device having a housing and an internal metal component arranged inside the housing. The subassembly comprises: an electrostatic sensing unit having at least one charge-sensor configured to detect variations in electric charge associated with movement of the internal metal component during an operation of the medicament delivery device, and a signal conditioning circuitry connected to the charge-sensor, the signal conditioning circuitry being configured to generate an output signal corresponding to the detected variations in electric charge caused by the movement of the internal metal component; a mounting structure configured to attach the subassembly to the housing of the medical delivery device; and a processing circuitry operatively connected to the signal conditioning circuitry, the processing circuitry being configured to: receive and process the output signal from the signal conditioning circuitry; identify an operation of the medicament delivery device based on the output signal indicating movement of the internal metal component; and generate an indication of the operation of the medicament delivery device.

[0011] Hereby, a reliable, non-invasive detection of operations of the medicament delivery device is provided. By monitoring the movement of an internal metal component of the medicament delivery device through variations in electric charge, the operations of the medicament delivery device, such as e.g. medicament delivery actions, may be monitored unaffected by external magnetic fields or electromagnetic noise. Thus, the monitoring of the operations of the medicament delivery device can be made more reliable, in particular in environments with high electromagnetic interference (e.g., hospitals or labs with electronic equipment). Moreover, by the detachable arrangement of the subassembly relative to the housing of the medicament delivery device, and the provision of the electrostatic sensing unit, no physical modification of the medicament delivery device is required for achieving the monitoring, thus improving compatibility across various types of medicament devices while maintaining structural integrity. As the charge-sensor is configured to detect variations in electric charge associated with movement of the internal metal component, various operations and states of the medicament delivery device related to the movement of the internal metal component can be detected, not only those related to the medicament delivery action, but potentially movements prior and after the medicament delivery action. However, as the charge-sensor is configured to detect variations in electric charge associated with movement of the internal metal component, the subassembly is particularly suitable for detecting a medicament delivery action, as such action typically is related to movement of internal metal components within the medicament delivery device. Thus, the electrostatic sensing unit may be configured to detect various movements of the internal metal component, such as e.g. a movement of the needle cover preparing the medicament delivery device for the medicament delivery action, a post-medicament delivery action such as a lock-out of needle cover, and / or movements related to the discharge of the medicament during the medicament delivery action e.g. the movement of the plunger rod and / or movement of the drive spring.

[0012] For example, the technical effect of the subassembly may be related to enhanced monitoring reliability, enhanced detection accuracy of the operation of the medicament delivery device, reduced risk of electromagnetic interference, and / or increased adaptability to various medicament delivery device designs. The indication of the operation of the medicament delivery device generated by the processing circuitry may e.g. be a visual, audible, tactile or otherwise provided electronic signal. In other words, the processing circuitry may be configured to generate a visual, audible, tactile or electronic indication of the operation of the medicament delivery device, and to communicate the occurrence of such operation to a user or an external system. For example, the indication may correspond to displaying a visual indication of the operation of the medicament delivery on a display, and / or to provide an audible indication of the operation of the medicament delivery by a speaker.

[0013] It should be understood that the charge-sensor is configured to sense, or detect, variations in electric charge due to movement of the internal metal component. Thus, the electrostatic sensing unit is configured to operate based on the principle of detecting variations in electric charge induced by the movement of an internal metal component within the medicament delivery device. Metal components inherently carry free charge carriers, which, when in motion, cause fluctuations in the surrounding electric field. These fluctuations generate quasi-electrostatic potential changes that can be detected by the charge-sensor. The charge-sensor, such as a charge-sensing coil, acts as a sensitive electrode positioned in proximity to the internal metal component. As the metal component moves during operation (e.g., the expansion of a spring or the displacement of a needle cover), the resulting variations in electric field induce a measurable differential electric potential on the chargesensor. This phenomenon is commonly referred to as quasi-electrostatic charge variation (Qvar).

[0014] The signal conditioning circuitry connected to the charge-sensor processes these induced potential changes, converting them into an output signal that reflects the dynamic behavior of the internal metal component. By analyzing this output signal by the processing circuitry, the subassembly can reliably detect specific operational events of the medicament delivery device, such as e.g. preparation, priming, start, progress, end and / or post-related events of a medicament delivery action. Unlike measurement devices based on electromagnetic / inductive sensing methods, the electrostatic sensing approach does not rely on changes in magnetic flux or require the metal component to exhibit magnetic properties. Instead, it utilizes the inherent electrostatic properties of the internal metal component, enabling monitoring without susceptibility to electromagnetic interference. It should be mentioned that the signal conditioning circuitry may form a part or portion of a common control unit including both the signal conditioning circuitry and the processing circuitry. The processing circuitry may be configured to compare the output signal from the signal conditioning circuitry with a predefined list of operations of the medicament delivery device, wherein such predefined list includes at least one of: preparation, priming, start, progress, end and / or post-related events of a medicament delivery action.

[0015] 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 under 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.

[0016] 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 under use of the medicament delivery device is / are located closest to the dose delivery site.

[0017] Further, the term “longitudinal”, “longitudinally”, “axially” or “axial” refer to a direction extending from the proximal end to the distal end, typically along the device or components thereof in the direction of the longest extension of the device and / or component.

[0018] Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.

[0019] Further, the terms “circumference”, “circumferential”, or “circumferentially” refer to a circumference or a circumferential direction relative to an axis, typically a central axis extending in the direction of the longest extension of the device and / or component.

[0020] Similarly, “radial” or “radially” refer to a direction extending radially relative to the axis, and “rotation”, “rotational” and “rotationally” refer to rotation relative to the axis.

[0021] According to one embodiment, the subassembly is configured to be attached to an outer surface of the housing such that the electrostatic sensing unit is arranged in a non-contact configuration to the internal metal component. The non-contact configuration between the electrostatic sensing unit (the charge-sensor) and the internal metal component enables the medicament delivery device to remain unmodified during the monitoring. Moreover, by enabling attachment of the subassembly to the outer surface of the housing of the medicament delivery device, the electrostatic sensing unit, and / or the charge-sensor can be positioned in proximity to the internal metal component in an advantageous manner. For example, the mounting structure is configured to be attached to the outer surface of the housing, or another portion of the housing or medicament delivery device, such that the electrostatic sensing unit is arranged in a non-contact configuration to the internal metal component. Typically, the mounting structure is configured to attach the subassembly relative to the outer surface of the housing such that the electrostatic sensing unit is arranged in a non-contact configuration to the internal metal component with the chargesensor arranged in close proximity to the internal metal component. Proximity, or close proximity, is here referring to a distance between the charge-sensor and the internal metal component, when the subassembly is attached to the outer housing of the medicament delivery device, for which the charge-sensor can adequately measure the variations in electric charge associated with movement of the internal metal component. Such distance is known to the skilled person, but may be exemplified as being between 0.1 mm and 30 mm, such as e.g. between 0.2 mm and 20 mm or between 0.3 mm and 10 mm.

[0022] According to one embodiment, the electrostatic sensing unit is positioned in a sensor portion of the subassembly, the sensor portion being configured to face the housing of the medicament delivery device when the subassembly is attached thereto. Hereby, an advantageous arrangement of the electrostatic sensing unit for achieving a reliable detection of the variations in electric charge associated with movement of the internal metal component by the charge-sensor is provided. Hereby, the electrostatic sensing unit, and / or the charge-sensor may be aligned with the internal metal component when the subassembly is attached to the housing of the medicament delivery device. For example, by the positioning of the electrostatic sensing unit in the sensor portion, the signal sensitivity of the charge-sensor with regards to the movement of the internal metal component may be optimised or maximised.

[0023] According to one embodiment, the least one charge-sensor is configured to detect variations in electric charge associated with movement of an internal metal component being a coil spring or a needle cover during an operation of the medicament delivery device. Thus, the subassembly may be configured to monitor specific moving parts of the medicament delivery device, typically those whose motion is indicative of interesting operational states of the medicament delivery device. Moreover, both coil spring(s) and the needle cover typically constitutes large metal parts within the medicament delivery device, making them suitable for monitoring using the electrostatic sensing unit.

[0024] According to one embodiment, the electrostatic sensing unit includes a Qvar sensing circuitry configured to detect quasi-electrostatic potential changes caused by the movement of the internal metal component within the housing of the medical delivery device during the operation of the medicament delivery device, the Qvar sensing circuitry generating an output signal corresponding to variations in electric charge induced by the movement of the internal metal component. The Qvar sensing circuitry enables precise detection of even subtle electric charge variations, enhancing sensitivity to detecting movement of the internal metal component. According to one embodiment, the charge-sensor is configured to detect the quasi-electrostatic potential changes. Stated differently, the charge-sensor may be configured to detect induced differential electric potential variations between the chargesensor and the moving internal metal component.

[0025] According to one embodiment, the detachable subassembly further comprises at least one secondary sensor configured to detect a physical entity of the medicament delivery device different from variations in electric charge. That is, the secondary sensor is different to the charge-sensor. Hereby, a redundancy in the monitoring is provided and / or an increased reliability or accuracy of detecting the operation of the medicament delivery device related to movement of the internal metal component is provided. For example, the processing circuitry may be configured to combine the data from the secondary sensor with the output signal from the electrostatic sensing unit to enhance detection accuracy of the operation of the medicament delivery device. Hereby, the reliability and / or accuracy of detecting the operation of the medicament delivery device related to movement of the internal metal component may be further improved. For example, so called “false positives” of specific operation of the medicament delivery device, e.g. caused by external disturbances, can be reduced.

[0026] According to one embodiment, the secondary sensor comprises a vibration sensor configured to detect vibration generated by the medicament delivery device and to provide associated vibrational data of the medicament delivery device, wherein the processing circuitry is further configured to combine the vibrational data from the vibration sensor with the output signal from the electrostatic sensing unit to enhance detection accuracy of the operation of the medicament delivery device. The combination of vibrational and electrostatic data may enhance the reliability and / or accuracy of detecting the operation of the medicament delivery device related to movement of the internal metal component. The vibration sensor may e.g. comprise an accelerometer and / or a gyroscope. For example, the processing circuitry may be configured to filter out external disturbances by crossreferencing the vibrational data with the output signal from the electrostatic sensing unit to distinguish between internal medicament delivery device operations and external environmental vibrations. Hereby, discrimination between genuine medicament delivery actions and external disturbances can be improved.

[0027] According to one embodiment, the secondary sensor comprises an optical sensor configured to detect visual changes of the medicament delivery device to provide associated optical data of the medicament delivery device, wherein the processing circuitry is further configured to combine the optical data from the optical sensor with the output signal from the electrostatic sensing unit to enhance detection accuracy of the operation of the medicament delivery device. The combination of optical and electrostatic data may enhance the reliability and / or accuracy of detecting the operation of the medicament delivery device related to movement of the internal metal component. The optical sensor may e.g. comprise an photointerruptor sensor, a reflective optical sensor, and optical proximity sensor, and / or a camera. The optical sensor may alternatively or additionally be used to determine the proximity of the electrostatic sensing unit with regards to the internal metal component of the medicament delivery device. The at least one secondary sensor may be at least two secondary sensors, e.g. comprising the previously described vibration sensor and the optical sensor. According to one embodiment, the detachable subassembly further comprises a flexible printed circuit board, wherein the electrostatic sensing unit is comprised in the flexible printed circuit board. The integration of the electrostatic sensing unit into a flexible printed circuit board (PCB) enhances its adaptability to various types of medicament delivery devices, e.g. to various shapes of housings. Thus, the charge-sensor may be mounted on the flexible printed circuit board, and hereby be brought in close proximity to the internal metal component when the subassembly is attached to the medicament delivery device.

[0028] According to one embodiment, the flexible printed circuit board is configured to conform to a surface of the housing of the medicament delivery device when the subassembly device is attached thereto. The flexibility of the PCB allows the subassembly to conform closely to various shapes of medicament delivery devices. Moreover, by providing a flexible PCB which conforms to the surface of the housing, the arrangement of the electrostatic sensing unit in close proximity to the internal metal component is further enhanced. Hereby, improved signal reliability and detection accuracy may be achieved.

[0029] According to one embodiment, the processing circuitry is further configured to identify the operation of the medicament delivery device as at least one of the start and end of a medicament delivery action based on the output signal indicating movement of the internal metal component. Hereby, precise tracking of critical operational states of the medicament delivery device may be provided. The start and end of the medicament delivery device may e.g. be related to movement of a coil spring, such as a drive spring exerting a force on a plunger rod. Such drive spring typically moves during the start and end of the medicament delivery action.

[0030] According to one embodiment, the processing circuitry is further configured to calculate a duration of the medicament delivery action based on the time for the start and end of the medicament delivery action. The duration measurement may provide valuable data for evaluating the performance of the medicament delivery device. For example, the processing circuitry may be configured to calculate the duration of the medicament delivery event based on the time difference between the start and end of the medicament delivery action.

[0031] According to one embodiment, the mounting structure comprises a clip or sleeve structure. The clip or sleeve structure allows for a secure attachment of the subassembly to the housing of the medicament delivery device without requiring structural modifications of the latter. Moreover, the clip or sleeve structure allows for the subassembly to detached from the housing of the medicament delivery device in a simplified manner. Hereby, easy attachment and removal of the subassembly to the housing of the medicament delivery device is provided, improving user convenience and allow for reuse across multiple devices. For example, the mounting structure is configured to securely position the electrostatic sensing unit adjacent to the internal metal component without altering the structure of the medical delivery device.

[0032] According to one embodiment, the electrostatic sensing unit is configured to operate by detecting variations in electric charge and excludes sensing based on electromagnetic induction. The exclusion of electromagnetic induction ensures that the subassembly is less sensitive to, or even immune to, interference from magnetic fields. As previously mentioned, this results in an improved robustness in detecting operations of the medicament delivery device, particularly in environments with high electromagnetic noise.

[0033] According to one embodiment, the at least one charge-sensor is a charge-sensing coil. A charge-sensing coil provides a simple and efficient mechanism for detecting quasielectrostatic potential changes. The charge-sensing coil may be curved, or semi-circular. Hereby, the conformity of the subassembly relative to the housing of the medicament delivery device may be improved. The at least one charge-sensor may be a plurality of charge-sensors. Correspondingly, the subassembly may comprise a plurality of chargesensing coils.

[0034] According to one embodiment, the subassembly comprises a wireless communication module configured to transmit the data thereof to an external device. The transmitted data may include the generated indication of the operation of the medicament delivery device provided by the processing circuitry, and / or the output signal from the signal conditioning circuitry possibly together with any data from a secondary sensor such as e.g. vibration data or optical data.

[0035] According to a second aspect of the present disclosure, there is provided a medicament delivery device comprising the detachable subassembly of the first aspect of the present disclosure. The medicament delivery device further comprises a housing having a proximal end portion and a distal end portion extending along a longitudinal axis, and an internal metal component arranged inside the housing, the internal metal component being configured to move inside the housing during an operation of the medicament delivery device.

[0036] Effects and features of the second aspect are largely analogous to those described above in connection with the first aspect. Embodiments mentioned in relation to the first aspect are largely compatible with the second aspect. The medicament delivery device is typically configured to expel medicament from a medicament container e.g. comprised in a syringe.

[0037] According to one embodiment, the housing comprises an outer surface, wherein the subassembly is detachable arranged to the outer surface by the mounting structure such that the electrostatic sensing unit is arranged in a non-contact configuration to the internal metal component of the medical delivery device. The non-contact configuration between the electrostatic sensing unit and the internal metal component enables the medicament delivery device to remain unmodified during the monitoring, as already described with reference to the first aspect.

[0038] According to one embodiment, the medicament delivery device is an autoinjector. The adaptability of the subassembly to autoinjectors enhances its utility in widely used medicament delivery devices.

[0039] According to one embodiment, the internal metal component is a needle cover or a coil spring. By monitoring these components, the medicament delivery device and the subassembly provide detection of components highly related to operations of the device. For example, the coil spring may be a drive spring configured to expand or contract during a medicament delivery action.

[0040] According to one embodiment, related to both the first and second aspects, the detachable subassembly is formed as a plate or rectangular pad.

[0041] According to one embodiment, related to both the first and second aspects, the size of the detachable subassembly is adapted to its intended use. Moreover, the position of the detachable subassembly with regards to the internal metal component whose movement is to be detected may be adapted based on the need. Typically, detachable subassembly is positioned radially outside of the internal metal component, i.e. to cover the internal metal component.

[0042] 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, component, means, etc.” are to be interpreted openly as referring to at least one instance of the element, apparatus, component, means, etc., unless explicitly stated otherwise.

[0043] BRIEF DESCRIPTION OF THE DRAWINGS

[0044] The specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which:

[0045] Fig. 1 shows an example of a detachable subassembly for a medicament delivery device according to embodiments of the present disclosure;

[0046] Fig. 2 is a cross-sectional view of an example subassembly and medicament delivery device according to embodiments of the present disclosure; Fig. 3 is a cross-sectional view of an example subassembly and medicament delivery device according to embodiments of the present disclosure;

[0047] Fig. 4A is a perspective view of a detail of the subassembly in Fig. 3;

[0048] Fig. 4B is a perspective view of a detail of another example subassembly;

[0049] Fig. 5 is a schematic illustration of a control circuitry to be at least partly comprised in a subassembly according to embodiments of the present disclosure

[0050] Fig. 6 shows graphs of data related to various embodiments of the present disclosure.

[0051] DETAILED DESCRIPTION

[0052] The inventive concept will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplifying embodiments are shown. The inventive concept may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided by way of example so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concept to those skilled in the art. Like numbers refer to like members throughout the description.

[0053] Fig. 1 shows a first example of medicament delivery device 100 and a detachable subassembly 201 . The medicament delivery device 100 is here exemplified as an autoinjector. The detachable subassembly 201 may be a separate component to the medicament delivery device, or it may be comprised in the medicament delivery device. The detachable subassembly is interchangeably referred to as the subassembly throughout the application.

[0054] The medicament delivery device 100 comprises a housing 102 and an internal metal component 118, 206 arranged at least partly inside the housing 102. The internal metal component 118, 206 here exemplified as a needle cover 118 and a coil spring 206 (shown in dashed to indicated its position within the housing 102), is configured to move inside the housing 102 during an operation of the medicament delivery device 100. Moreover, the medicament delivery device 100 comprises a cap 103, which may be removed prior use of the medicament delivery device 100.

[0055] In more detail, and in the example of Fig. 1 , the housing 102 comprises a proximal end portion 102a and a distal end portion 102b extending along a longitudinal axis L. The housing 102 comprises an outer surface 102c. The outer surface 102c is arranged for enabling interaction with the detachable subassembly 201 . The medicament delivery device 100 is configured to expel medicament from a medicament container 116 during a medicament delivery action. The medicament container 116 typically comprises a medicament delivery member, e.g. a needle, through which the medicament is discharged during the medicament delivery action.

[0056] The subassembly 201 comprises an electrostatic sensing unit 210 having at least one charge-sensor 212 configured to detect variations in electric charge associated with movement of the internal metal component 118, 206 during an operation of the medicament delivery device 100. As previously mentioned, the internal metal component is here exemplified as a needle cover 118 and a coil spring 206, but other metal components arranged within the housing 102 and being configured to move during operation of the medicament delivery device 100 is within the scope of the inventive concept. Moreover, the charge-sensor 212 is here exemplified as a charge-sensing coil, but other suitable chargesensor elements is within the scope of the inventive concept. Typically, the electrostatic sensing unit 210 comprises a plurality of charge-sensors 212 or charge-sensing coils 212.

[0057] The subassembly 201 comprises a mounting structure 230 configured to attach the subassembly 201 to the housing 102 of the medical delivery device 100. In the example of Fig. 1 , the mounting structure 230 is formed as a clip comprises two clip structures 230a, 230b arranged on opposite sides of the mounting structure 230. Hereby, the subassembly 201 can be detachably arranged to the outer surface 102c of the housing 102 by the clip structures 230a, 230b. Typically, the subassembly 201 is configured to be attached to the outer surface 102c of the housing 102 such that the electrostatic sensing unit 210 is arranged in a non-contact configuration to the internal metal component 118, 206. For example, the electrostatic sensing unit 210 may be arranged, or positioned in a sensor portion 210a of the subassembly 201 , the sensor portion 210a being configured to face the housing 102 of the medicament delivery device 100 when the subassembly 201 is attached thereto. Hereby, the electrostatic sensing unit 210, and / or the charge-sensor 212, can be positioned in proximity to the internal metal component 118, 206 in an advantageous manner. For example, as shown in Fig. 1 , the subassembly 201 is configured to be attached to the outer surface 102c of the housing 102 in an axial position corresponding to that of the coil spring 206.

[0058] The subassembly 201 further comprises a signal conditioning circuitry 220 connected to the charge-sensor 212. The signal conditioning circuitry 220 is configured to generate an output signal corresponding to the detected variations in electric charge caused by the movement of the internal metal component 118, 206, which now will be described in further detail.

[0059] Metal components, such as e.g. the needle cover 118 and the coil spring 206 inherently carry free charge carriers, which, when in motion, cause fluctuations in the surrounding electric field. These fluctuations generate quasi-electrostatic potential changes that can be detected by the charge-sensor(s) 212. The charge-sensor(s) 212 acts as a sensitive electrode positioned in proximity to the needle cover 118 and / or coil spring 206. As the needle cover 118 and / or coil spring 206 moves during operation (e.g., the expansion of the coil spring 118 or displacement of a needle cover 118), the resulting variations in electric field induce a measurable differential electric potential on the charge-sensor(s) 212. In other words, the electrostatic sensing unit 210 and the charge-sensor(s) 212 detect variations in electric charge in response to that the needle cover 118 and / or coil spring moves within the housing 102 during operation of the medicament delivery device 100.

[0060] The subassembly 201 further comprises a processing circuitry 240 operatively connected to the signal conditioning circuitry 220. The processing circuitry 240 is configured to receive and process the output signal from the signal conditioning circuitry 220. Moreover, the processing circuitry 240 is configured to identify an operation of the medicament delivery device based on the output signal indicating movement of the internal metal component 118, 206. Based on the identification of the operation of the medicament delivery device, the processing circuitry 240 is configured to generate an indication of the operation of the medicament delivery device 100. For example, the processing circuitry 240 may be configured to identify an operation of the medicament delivery device being a medicament delivery action based on that the output signal indicates movement of the coil spring 206, or to identify a preparation, or start, of a medicament delivery action based on that the output signal indicates movement of the needle cover 118.

[0061] As shown in Fig. 1 , the subassembly 201 may comprises a casing 203. The casing 203 may e.g. house the processing circuitry 240 and / or the signal conditioning circuitry 220. Moreover, the subassembly 201 may comprise an energy source, e.g. a battery, arranged inside the casing 203. The battery may provide power to the processing circuitry 240 and / or the signal conditioning circuitry 220.

[0062] Turning to Figs. 2-3 showing cross sectional views of medicament delivery devices. The medicament delivery devices of Figs. 2-3 may in large correspond to that described with reference to Fig. 1 , except for the associated detachable subassembly. Thus, reference is made to the housing 102, the outer surface 102c of the housing 102, the medicament container 116, the needle cover 118 and the coil spring 206. Moreover, in the cross sectional views of Figs. 2-3, a plunger rod 200 and a needle cover spring 204 is shown. Typically, the coil spring 206 is a drive spring for the plunger rod 200. The plunger rod 200 is operatively configured to, upon activation, move in the proximal direction to act on the medicament container 116 for expelling medicament through the medicament delivery member 116a. The needle cover spring 204 is configured to bias the needle cover 118. The activation of the plunger rod 200 may e.g. be achieved by pushing the needle cover 118 distally further into the housing 102.

[0063] In Fig. 2, the detachable subassembly 301 comprises a casing 303 (e.g. housing a processing circuitry as described with reference to Fig. 1) and an electrostatic sensing unit 310 having at least one charge-sensor 312 configured to detect variations in electric charge associated with movement of the internal metal component 118, 204, 206 during an operation of the medicament delivery device 100. In the example of Fig. 2, the internal metal component may be the needle cover 118, the drive spring 206 or needle cover spring 204. The electrostatic sensing unit 310 typically comprises a plurality of charge-sensors 312, here exemplified as a plurality of charge-sensing coils.

[0064] The subassembly 301 comprises a mounting structure 330 configured to attach the subassembly 301 to the housing 102 of the medical delivery device 100. In the example of Fig. 2, the mounting structure 330 is formed as a sleeve structure 330a (or sleeve portion) arranged to at least partly encompass, or surround, the outer surface 102c when the subassembly 301 is attached to the housing 102. The sleeve structure 330a typically comprises an opening configured to receive the outer surface 102c of the housing 102. The sleeve structure 330a is preferably flexible to allow for the opening to vary in size. For example, in an expanded state in which the sleeve structure 330a is flexed out, the opening may be large enough to receive, and be arranged around, the outer surface 102c of the housing 102, whereafter the flexible sleeve structure 330a is, in a contracted state, flexed in to securely be held around the outer surface 102c of the housing 102. Hereby, the subassembly 301 can be detachably arranged to the outer surface 102c of the housing 102 by the sleeve structure 330a. Typically, the subassembly 301 is configured to be attached to the outer surface 102c of the housing 102 such that the electrostatic sensing unit 310 is arranged in a non-contact configuration to the internal metal component 118, 204, 206. For example, as for the example of the subassembly 201 in Fig. 1 , the electrostatic sensing unit 310 may be arranged, or positioned in a sensor portion 310a of the subassembly 301.

[0065] Moreover, as shown in Fig. 2, the subassembly 301 is attached to the outer surface 102c of the housing 102 in a distal end portion thereof. Thus, the charge-sensor(s) 312 are arranged in an axial position corresponding to that of the drive spring 206. Hereby, the subassembly 301 is particularly suitable for detecting movements of the drive spring 206.

[0066] In the example of Fig. 3, the detachable subassembly 401 corresponds in large with the detachable subassembly 301 of Fig. 2. Thus, the subassembly 401 comprises a casing 403 (e.g. housing a processing circuitry as described with reference to Fig. 1) and an electrostatic sensing unit 410 having at least one charge-sensor 412 configured to detect variations in electric charge associated with movement of the internal metal component 118, 204, 206 during an operation of the medicament delivery device 100. Moreover, the subassembly 401 comprises a mounting structure 430 similar to that of the example in Fig.

[0067] 2. Thus, the mounting structure 430 is configured to attach the subassembly 401 to the housing 102 of the medical delivery device 100. In the example of Fig. 3, the mounting structure 430 comprises a sleeve structure 430a similar to the sleeve structure 330a of the example in Fig. 2. Thus, the sleeve structure 430a is arranged to at least partly encompass, or surround, the outer surface 102c when the subassembly 301 is attached to the housing 102. The sleeve structure 430a is typically flexible to allow for an opening to vary in size in order receive the outer surface 102c of the housing 102, and be detachably arranged around the outer surface 102c of the housing 102, as previously described.

[0068] However, in the example of Fig. 3, the charge-sensors 412 of the subassembly 401 are divided into first and secondary charge-sensors 412a, 412b. The first charge-sensors 412a corresponds in large to those previously described with reference to the example of Fig. 2, i.e. arranged in an axial position corresponding to that of the driver spring 206. The secondary charge-sensors 412b are arranged in an axial position corresponding to a proximal end portion of the housing 102, and an axial position of the needle cover spring 204. Hereby, the subassembly 401 is particularly suitable for detecting movements of the needle cover spring 204, in addition to being particularly suitable for detecting movements of the drive spring 206. The first and second charge sensors 412a, 412b may be associated with a common mounting structure, or may be comprised in different mounting structures. The first and second charge sensors 412a, 412b may be commonly connected to the signal conditioning circuitry.

[0069] For both embodiments in Figs. 2 and 3, the needle cover 118 may extend from the proximal end portion of the housing 102 towards, or even to, the distal end portion of the housing 102. Thus, both the subassembly 301 and subassembly 401 may be particularly suitable for detecting movements of the needle cover 118.

[0070] With additional reference to Fig. 4A, the first charge-sensors 412a comprised in a flexible printed circuit board 414 is shown. Thus, the subassembly 401 may comprise a flexible printed circuit board 414, wherein at least a part of the electrostatic sensing unit 410, such as the first charge-sensors 412a, is comprised in the flexible printed circuit board 414. The flexible printed circuit board (PCB) 414 is typically configured to conform to the outer surface 102c of the housing 102. As shown in Fig. 4, the flexible PCB 414 may be elongated, wherein a distal portion 414b has a greater width as compared to a proximal portion 414a. Moreover, as shown in Fig. 4A, the first charge sensors 412a may be divided into a first coil 413a and a second coil 413b. The first coil 413a may comprise elongated coil portions extending along the width of the distal portion 414b of the flexible PCB 414 (the width extending in the circumferential direction of the housing 102 when the subassembly 401 is attached thereto). Correspondingly, the second coil 413b may comprise elongated coil portions extending along the width of the distal portion 414b of the flexible PCB 414, but in an opposite direction as compared to the first coil 413a. Typically, the elongated portions of the first and second coils 413a, 413b are intertwined, or are formed as intertwined fingers. In the example of Fig. 4a, the first and second coils 413a, 413b also comprise a corresponding portions extending into the proximal portion 414a of the flexible PCB 414. Hereby, the first and second coils 413a, 413b may be electrically connected to other components of the subassembly 401 . Thus, the first charge-sensors 412a may extend from a first end portion 414b of the flexible PCB 414 to a second, opposite, end portion 414a of the flexible PCB 414. The second charge-sensors 412b may be comprised in a corresponding flexible printed circuit board as the first charge-sensors 412a, and may be arranged in a corresponding manner with first and second coils.

[0071] Fig. 4B shows an alternative example of first or second charge-sensors 612 comprised in a flexible PCB 614. Thus, the charge-sensors 612 may form the first or second charge-sensors in the electrostatic sensing unit 410, or subassembly 401 , of Fig. 3 or Fig. 4A. In Fig. 4B, the charge-sensors 612 comprise a first coil 613a having a plate-shaped portion and a second coil 613b also having a plate-shaped portion. The flexible PCB 614 may have a distal portion 614b in which the plate-shaped portions of the first and second coils 613a, 613b are comprised, and a proximal portion 614a in which portions of the first and second coils 613a, 613b extend into for providing electrically connectability with other components of the subassembly 401 . The subassembly 401 may comprise one or more of corresponding electrostatic sensing units 410 exemplified in Fig. 4A and Fig. 4B.

[0072] Turning to Fig. 5 being a schematic illustration of a control circuitry 502 which at least partly may be comprised in the detachable subassemblies 201 , 301 , 401 previously described. Thus, one or more of the described features of the control circuitry 502 may form part of the detachable subassemblies 201 , 301 , 401 previously described.

[0073] The control circuitry 502 comprises an electrostatic sensing unit 510 comprising at least one charge-sensor 512 and a signal conditioning circuitry 520 as previously described. Thus, the at least one charge-sensor 512 is configured to detect variations in electric charge associated with movement of the internal metal component during an operation of the medicament delivery device, and the signal conditioning circuitry 520 (being connected to the charge-sensor 512) is configured to generate an output signal 01 corresponding to the detected variations in electric charge caused by the movement of the internal metal component. As described with reference to Figs. 1-3, the least one charge-sensor 512 is typically configured to detect variations in electric charge associated with movement of a coil spring 204, 206 or a needle cover 118 during the operation of the medicament delivery device. The electrostatic sensing unit 510 may be configured to operate by detecting variations in electric charge in a way that excludes sensing based on electromagnetic induction. In other words, the electrostatic sensing unit 510, or even the entire detachable subassembly 201 , 301 , 401 previously described, may be free of any sensor configured to detect movements of internal metal components based on electromagnetic induction.

[0074] Moreover, the control circuitry 502 comprises processing circuitry 540 operatively connected to the signal conditioning circuitry 520. As previously described, the processing circuitry 540 is configured to: receive and process the output signal 01 from the signal conditioning circuitry 520; identify an operation of the medicament delivery device based on the output signal 01 indicating movement of the internal metal component; and generate an indication 02 of the operation of the medicament delivery device. For example, the processing circuitry 540 is configured to compare the output signal 01 from the signal conditioning circuitry 520 with a predefined list of operations of the medicament delivery device. The predefined list may e.g. include predefined correlations between the output signal 01 and predefined operations of the medicament delivery device being at least one of: preparation, priming, start, progress, end and / or post-related events of the medicament delivery action. Hereby, a certain output signal 01 , e.g. being related to a movement of the drive spring 206, is correlated to the start of the medicament delivery action. Another output signal 01 , e.g. being related to a movement of the needle cover 118, is correlated to the preparation of the medicament delivery action, or a post-related event such as a lock-out event of the needle cover 118.

[0075] The generated indication 02 of the operation of the medicament delivery device may e.g. be an electrical signal to a user interface 550, such as e.g. a display or a speaker. Thus, the processing circuitry 540 may be configured to display a visual indication of the operation of the medicament delivery on a display, and / or to provide an audible indication of the operation of the medicament delivery to a speaker.

[0076] The signal conditioning circuitry 520 may include a Qvar sensing circuitry 516 configured to detect quasi-electrostatic potential changes caused by the movement of the internal metal component within the housing 102 during the operation of the medicament delivery device. The internal metal component may be anyone of those previously mentioned. The Qvar sensing circuitry 116 is configured to generate an output signal 03 corresponding to variations in electric charge induced by the movement of the internal metal component. Moreover, the signal conditioning circuitry 520 may comprise an analog to digital converter (ADC) 517 configured to covert the output signal 03 from the Qvar sensing circuitry 116 to the output signal 01 from the signal conditioning circuitry 520.

[0077] The control circuitry 502 may comprise at least one secondary sensor 518, 519, 522 configured to detect a physical entity of the medicament delivery device different from variations in electric charge. For example, the secondary sensor includes a vibration sensor 518, 519 configured to detect vibration generated by the medicament delivery device 100. The vibration sensor may be at least one of an accelerometer 518 and a gyroscope 519. The vibration sensor 518, 519 is configured to provide associated vibrational data of the medicament delivery device to the processing circuitry 540. The processing circuitry 540 may be configured to combine the vibrational data from the vibration sensor 518, 519 with the output signal 01 from the electrostatic sensing unit 510 to enhance detection accuracy of the operation of the medicament delivery device.

[0078] Additionally or alternatively, the secondary sensor includes an optical sensor 522 configured to detect visual changes of the medicament delivery device 100. The optical sensor 522 is configured to provide associated optical data of the medicament delivery device to the processing circuitry 540. The processing circuitry 540 may be configured to combine the optical data from the optical sensor with the output signal 01 from the electrostatic sensing unit 510 to enhance detection accuracy of the operation of the medicament delivery device. In a further example, processing circuitry 540 may be configured to combine the vibrational data from the vibration sensor 518, 519, the optical data from the optical sensor, and the output signal 01 from the electrostatic sensing unit 510 to enhance detection accuracy of the operation of the medicament delivery device.

[0079] Turning to Fig. 6 showing three graphs of data. In the top graph, the output signal 01 from the electrostatic sensing unit 510 is shown as a first line 1001 over time. In the middle graph, the vibrational data from the accelerometer 518 is shown as a second line 1002 over time. In the bottom graph, the vibrational data from the gyroscope 519 is shown as a third line 1003 over time.

[0080] In the graphs of Fig. 6, time t1 corresponds to an initial movement of the needle cover 118, typically a movement of the needle cover 118 in the distal direction to be received further into the housing 102. Here, the medicament delivery action is not activated, but prepared for. Time t2 corresponds to the start of the medicament delivery action, e.g. activation of the plunger rod 200 to move in the proximal direction by the force of the drive spring 206. Time t3 corresponds to the end of the medicament delivery action, e.g. as the plunger rod 200 reaches its most proximal position and the drive spring 206 its most unbiased state. Time t4 corresponds to a final movement of the needle cover 118, typically a movement of the needle cover in the proximal direction to achieve needle cover lockout.

[0081] As can be seen in the graphs, the first line 1001 corresponding to the detection of variations in electric charge associated with movement of the internal metal component has clear indications at times t1 , t2, t3 and t4. Thus, the output signal 01 can be used to detect various operations of the medicament delivery device such as movement of the needle cover 118 with regards to preparing the medicament delivery device for the medicament delivery action and a post-medicament delivery action such as a lock-out of needle cover 118, as well as movements related to the discharge of the medicament during the medicament delivery action e.g. the movement of the drive spring 206. Thus, the processing circuitry 540 may utilise the output signal 01 to determine different parameters related to the operations of the medicament delivery device, and identify the operation of the medicament delivery device as at least one of: preparation, lock-out, and start / end of a medicament delivery action.

[0082] By comparing the first line 1001 with the second and third lines 1003, 1004, no clear indications are given at times t1 and t4. However, clear indications are given for the second and third lines at times t2 and t3. Thus, by combining the data from the vibration sensor 518, 519 with the output signal 01 from the electrostatic sensing unit 510, the detection accuracy of the operation of the medicament delivery device can be improved. For example, any false positive signals generated by the vibration sensor 518, 519 can be handled in an improved manner. Hereby, the reliability and / or accuracy of detecting operations of the medicament delivery device may be improved.

[0083] Moreover, as is clear from the graphs of Fig. 6, the processing circuitry 540 may utilise the output signal 01 to determine different parameters related to the operations of the medicament delivery device. For example, the processing circuitry 540 may be configured to calculate a duration of the medicament delivery action based on the time for the start and end t2, t3 of the medicament delivery action.

[0084] The medicament delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0085] 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, Behpet'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.

[0086] Exemplary types of drugs that could be included in the medicament container, and administrated by the medicament 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.

[0087] Exemplary drugs that could be included in the medicament container, and administrated by the medicament delivery devices described herein include, but are not limited to, immunooncology 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.

[0088] Exemplary drugs that could be included in the medicament container, and administrated by the medicament 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-1 (GLP-1) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, C1 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 arrestspecific 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, tumor-infiltrating lymphocytes (TIL) therapies, or T-cell receptor (TCR) therapies.

[0089] Exemplary drugs that could be included in the medicament container, and administrated by the medicament 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 betal a, interferon beta-1 b, peginterferon beta-1 a, 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.

[0090] Exemplary drugs that could be included in the medicament container, and administrated by the medicament 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.

[0091] Exemplary drugs that could be included in the medicament container, and administrated by the medicament 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.

[0092] Exemplary drugs that could be included in the medicament container, and administrated by the medicament 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.

[0093] Exemplary drugs that could be included in the medicament container, and administrated by the medicament 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.

[0094] Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the medicament container, and administrated by the medicament 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.

[0095] Exemplary drugs that could be included in the medicament container, and administrated by the medicament delivery devices described herein include, but are not limited to, a multimedication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mF0LF0X6, mF0LF0X7, 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.

[0096] The inventive concept has mainly been described above with reference to a few examples. However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope of the inventive concept, as defined by the appended claims.

[0097] Some aspects of this disclosure are defined by the following clauses.

[0098] 1 . A detachable subassembly (201 , 301 , 401) for a medicament delivery device (100) having a housing (102) and an internal metal component (118, 204, 206) arranged inside the housing, the subassembly comprising:

[0099] - an electrostatic sensing unit (210, 310, 410, 510) having at least one charge-sensor (212, 312, 412, 512) configured to detect variations in electric charge associated with movement of the internal metal component during an operation of the medicament delivery device, and a signal conditioning circuitry (220, 520) connected to the charge-sensor, the signal conditioning circuitry being configured to generate an output signal (01) corresponding to the detected variations in electric charge caused by the movement of the internal metal component;

[0100] - a mounting structure (230, 330, 430) configured to attach the subassembly to the housing of the medical delivery device; and

[0101] - a processing circuitry (240, 540) operatively connected to the signal conditioning circuitry, the processing circuitry being configured to: receive and process the output signal from the signal conditioning circuitry; identify an operation of the medicament delivery device based on the output signal indicating movement of the internal metal component; and generate an indication (02) of the operation of the medicament delivery device.

[0102] 2. The detachable subassembly according to clause 1 , wherein the subassembly (201 , 301 , 401) is configured to be attached to an outer surface (102c) of the housing (102) such that the electrostatic sensing unit (210, 310, 410, 510) is arranged in a non-contact configuration to the internal metal component (118, 204, 206).

[0103] 3. The detachable subassembly according to anyone of clauses 1 -2, wherein the electrostatic sensing unit (210, 310, 410, 510) is positioned in a sensor portion (210a, 310a) of the subassembly, the sensor portion being configured to face the housing (102) of the medicament delivery device (100) when the subassembly is attached thereto.

[0104] 4. The detachable subassembly according to anyone of clauses 1 -3, wherein the least one charge-sensor (212, 312, 412, 512) is configured to detect variations in electric charge associated with movement of an internal metal component (1 18, 204, 206) being a coil spring (204, 206) or a needle cover (118) during an operation of the medicament delivery device.

[0105] 5. The detachable subassembly according to anyone of clauses 1 -4, wherein the electrostatic sensing unit (510) includes a Qvar sensing circuitry (516) configured to detect quasi-electrostatic potential changes caused by the movement of the internal metal component (118, 204, 206) within the housing (102) of the medical delivery device (100) during the operation of the medicament delivery device, the Qvar sensing circuitry generating an output signal (03) corresponding to variations in electric charge induced by the movement of the internal metal component (118, 204, 206).

[0106] 6. The detachable subassembly according to anyone of clauses 1 -5, further comprising at least one secondary sensor (518, 519, 522) configured to detect a physical entity of the medicament delivery device different from variations in electric charge. 7. The detachable subassembly according to clause 6, wherein the secondary sensor comprises a vibration sensor (518, 519) configured to detect vibration generated by the medicament delivery device (100) and to provide associated vibrational data of the medicament delivery device, wherein the processing circuitry (540) is further configured to combine the vibrational data from the vibration sensor with the output signal from the electrostatic sensing unit (510) to enhance detection accuracy of the operation of the medicament delivery device.

[0107] 8. The detachable subassembly according to anyone of clauses 6-7, wherein the secondary sensor comprises an optical sensor (522) configured to detect visual changes of the medicament delivery device (100) to provide associated optical data of the medicament delivery device, wherein the processing circuitry (540) is further configured to combine the optical data from the optical sensor with the output signal from the electrostatic sensing unit (510) to enhance detection accuracy of the operation of the medicament delivery device.

[0108] 9. The detachable subassembly according to anyone of clauses 1-8, further comprising a flexible printed circuit board (414), wherein the electrostatic sensing unit (410) is comprised in the flexible printed circuit board.

[0109] 10. The detachable subassembly according to clause 9, wherein the flexible printed circuit board (414) is configured to conform to a surface (102c) of the housing (102) of the medicament delivery device (100) when the subassembly device is attached thereto.

[0110] 11 . The detachable subassembly according to anyone of clauses 1 -10, wherein the processing circuitry (240, 540) is further configured to identify the operation of the medicament delivery device as at least one of the start and end (t2, t3) of a medicament delivery action based on the output signal indicating movement of the internal metal component (118, 204, 206).

[0111] 12. The detachable subassembly according to clause 11 , wherein the processing circuitry (240, 540) is further configured to calculate a duration of the medicament delivery action based on the time for the start and end of the medicament delivery action.

[0112] 13. The detachable subassembly according to anyone of clauses 1 -12, wherein the mounting structure (230, 330, 430) comprises a clip (230a, 230b) or sleeve structure (330a, 430a).

[0113] 14. The detachable subassembly according to anyone of clauses 1-13, wherein the electrostatic sensing unit (210, 310, 410, 510) is configured to operate by detecting variations in electric charge and excludes sensing based on electromagnetic induction. 15. The detachable subassembly according to anyone of clauses 1 -14, wherein the at least one charge-sensor (212, 312, 412, 512) is a charge-sensing coil.

[0114] 16. A medicament delivery device (100) comprising the detachable subassembly (201 , 301 , 401) according to any one of clauses 1 -15, wherein the medicament delivery device further comprises a housing (102) having a proximal end portion (102a) and a distal end portion (102b) extending along a longitudinal axis (L), and an internal metal component (118, 204, 206) arranged inside the housing (102), the internal metal component being configured to move inside the housing during an operation of the medicament delivery device.

[0115] 17. The medicament delivery device according to clause 16, wherein the housing (102) comprises an outer surface (102c), and wherein the subassembly is detachable arranged to the outer surface by the mounting structure (230, 330, 430) such that the electrostatic sensing unit (210, 310, 410, 510) is arranged in a non-contact configuration to the internal metal component of the medical delivery device (100).

[0116] 18. The medicament delivery device according to any one of clauses 16-17, wherein the medicament delivery device (100) is an autoinjector (100).

[0117] 19. The medicament delivery device according to any one of clauses 16-18, wherein the internal metal component (118, 204, 206) is a needle cover (118) or a coil spring (204, 206).

Claims

26CLAIMS1 . A detachable subassembly (201 , 301 , 401) for a medicament delivery device (100) having a housing (102) and an internal metal component (118, 204, 206) arranged inside the housing, the subassembly comprising:- an electrostatic sensing unit (210, 310, 410, 510) having at least one charge-sensor (212, 312, 412, 512) configured to detect variations in electric charge associated with movement of the internal metal component during an operation of the medicament delivery device, and a signal conditioning circuitry (220, 520) connected to the charge-sensor, the signal conditioning circuitry being configured to generate an output signal (01) corresponding to the detected variations in electric charge caused by the movement of the internal metal component;- a mounting structure (230, 330, 430) configured to attach the subassembly to the housing of the medical delivery device; and- a processing circuitry (240, 540) operatively connected to the signal conditioning circuitry, the processing circuitry being configured to: receive and process the output signal from the signal conditioning circuitry; identify an operation of the medicament delivery device based on the output signal indicating movement of the internal metal component; and generate an indication (02) of the operation of the medicament delivery device.

2. The detachable subassembly according to claim 1 , wherein the subassembly (201 , 301 , 401) is configured to be attached to an outer surface (102c) of the housing (102) such that the electrostatic sensing unit (210, 310, 410, 510) is arranged in a non-contact configuration to the internal metal component (118, 204, 206).

3. The detachable subassembly according to anyone of claims 1-2, wherein the electrostatic sensing unit (210, 310, 410, 510) is positioned in a sensor portion (210a, 310a) of the subassembly, the sensor portion being configured to face the housing (102) of the medicament delivery device (100) when the subassembly is attached thereto.

4. The detachable subassembly according to anyone of claims 1-3, wherein the least one charge-sensor (212, 312, 412, 512) is configured to detect variations in electric charge associated with movement of an internal metal component (118, 204, 206) being a coil spring (204, 206) or a needle cover (118) during an operation of the medicament delivery device.

5. The detachable subassembly according to anyone of claims 1-4, wherein the electrostatic sensing unit (510) includes a Qvar sensing circuitry (516) configured to detectquasi-electrostatic potential changes caused by the movement of the internal metal component (118, 204, 206) within the housing (102) of the medical delivery device (100) during the operation of the medicament delivery device, the Qvar sensing circuitry generating an output signal (03) corresponding to variations in electric charge induced by the movement of the internal metal component (118, 204, 206).

6. The detachable subassembly according to anyone of claims 1-5, further comprising at least one secondary sensor (518, 519, 522) configured to detect a physical entity of the medicament delivery device different from variations in electric charge.

7. The detachable subassembly according to claim 6, wherein the secondary sensor comprises a vibration sensor (518, 519) configured to detect vibration generated by the medicament delivery device (100) and to provide associated vibrational data of the medicament delivery device, wherein the processing circuitry (540) is further configured to combine the vibrational data from the vibration sensor with the output signal from the electrostatic sensing unit (510) to enhance detection accuracy of the operation of the medicament delivery device.

8. The detachable subassembly according to anyone of claims 6-7, wherein the secondary sensor comprises an optical sensor (522) configured to detect visual changes of the medicament delivery device (100) to provide associated optical data of the medicament delivery device, wherein the processing circuitry (540) is further configured to combine the optical data from the optical sensor with the output signal from the electrostatic sensing unit (510) to enhance detection accuracy of the operation of the medicament delivery device.

9. The detachable subassembly according to anyone of claims 1-8, further comprising a flexible printed circuit board (414), wherein the electrostatic sensing unit (410) is comprised in the flexible printed circuit board.

10. The detachable subassembly according to claim 9, wherein the flexible printed circuit board (414) is configured to conform to a surface (102c) of the housing (102) of the medicament delivery device (100) when the subassembly device is attached thereto.11 . The detachable subassembly according to anyone of claims 1 -10, wherein the processing circuitry (240, 540) is further configured to identify the operation of the medicament delivery device as at least one of the start and end (t2, t3) of a medicament delivery action based on the output signal indicating movement of the internal metal component (118, 204, 206).

12. The detachable subassembly according to claim 11 , wherein the processing circuitry (240, 540) is further configured to calculate a duration of the medicament delivery action based on the time for the start and end of the medicament delivery action.

13. The detachable subassembly according to anyone of claims 1-12, wherein the mounting structure (230, 330, 430) comprises a clip (230a, 230b) or sleeve structure (330a, 430a).

14. The detachable subassembly according to anyone of claims 1-13, wherein the electrostatic sensing unit (210, 310, 410, 510) is configured to operate by detecting variations in electric charge and excludes sensing based on electromagnetic induction.

15. The detachable subassembly according to anyone of claims 1-14, wherein the at least one charge-sensor (212, 312, 412, 512) is a charge-sensing coil.

Images