Electronic module, assembly of an electronic module and a drug delivery device and method for switching an electronic module

Abstract

The present disclosure relates to an electronic module (100) for use with a drug delivery device (1). The electronic module comprises a displaceable component configured to be axially moved to a reference component along a longitudinal axis (I) to initiate and / or effect drug dispensing. Further, the electronic module comprises a monitoring device (106) with an electric power source (107), a processor (108) electrically connected to the electric power source, an optical sensor arrangement (103) electrically connected to the processor and comprising at least one light source (104) and at least one optical detector (105). The monitoring device (106) is configured to determine, store and / or transmit data indicative of an amount of drug dispensed from the drug delivery device based on detec- tion of rotation of a rotatable component rotationally movable about the longitudinal axis (I) relative to the displaceable component during drug dispensing. In addition, the moni- toring device is configured to switch between a sleep mode of relatively low power con- sumption and an operation mode of relatively higher power consumption. In order to pro- vide an improved electronic module with a simplified structure, the optical sensor ar- rangement (103) is configured to be axially moved relative to the reference component upon axial displacement of the displaceable component and the processor (108) is con- figured to switch the monitoring device (106) from the sleep mode to the operation mode in response to detection of said axial movement of the optical sensor arrangement (103) relative to the reference component.

Description

[0001] Description

[0002] ELECTRONIC MODULE, ASSEMBLY OF AN ELECTRONIC MODULE AND A DRUG DELIVERY DEVICE AND METHOD FOR SWITCHING AN ELECTRONIC MODULE

[0003] The present disclosure is generally directed to an electronic module and to an assembly of an electronic system, e.g. an electronic module, which is configured to be, e.g. releas- ably attached to or integrated into a drug delivery device. Further, the present disclosure is directed to a method for switching an electronic module between two different modes.

[0004] Electronic modules for releasable attachment to drug delivery devices are generally known and often used to provide further functionalities to drug delivery devices. As such for example electronic modules are known which measure relevant data with respect to dose setting and / or dose dispensing. An exemplary data collection device for attachment to an injection device is for example shown in WO 2016 / 198516 A1.

[0005] As electronic modules have a limited battery capacity, they are usually only activated on demand. This means that the electronic modules are for example only switched from sleep mode, which is a lower-power-consumption state, into operation mode, which is a higher-power-consumption state, if, for example, a dose is to be delivered or data is to be transmitted to an external device. However, during dose setting or during nonuse of the injection device the electronic module may remain in the low-power-consumption state. This has the advantage that the electronic module which may be used to determine an amount dispensed by means of a sensor arrangement is only activated when a dose is actually delivered or when it transmits data to an external device. To activate the electronic module, it is known to use switches, e.g. mechanical switches, which use axial relative movements during dose delivery to switch the electronic module in the operation mode, for example by forming an electrical contact or the like. It is further known to use optical sensor arrangements to detect relative movements of components during dose delivery, for example relative rotational movements. Detection of relative rotational movements may then be used to determine the amount of drug delivered by the drug delivery device during dose dispensing. WO 2016 / 131713 A1 , for example, discloses detection of dose amounts delivered to a user based on a change in a sensor output signal resulting from changes in received light intensities. The relative rotational movement, which is used to determine the amount of drug dispensed, is here for example provided by relative rotational movement between a number sleeve and a dose button.

[0006] Although these known modules with an optical sensor for detecting delivered dose amounts and a separate switch for activating the module from a sleep mode operate in a highly reliable manner, the provision of a separate sensor arrangement and an activation switch requires additional space in the module and results in additional costs for providing these two units of the module. This is true regardless of whether the electronic module is integrated into the drug delivery device or whether the electronic module is provided as a separate add-on module which may be releasably attached to the drug delivery device.

[0007] The object of the present disclosure is therefore to provide an improved electronic module which comprises a simplified structure without impairing its functionality. Further, the object of the present disclosure is to provide a cost-effective and reliable electronic module.

[0008] This object is solved by an electronic module according to claim 1 as well as by an assembly of a drug delivery device and an electronic module according to claim 15.

[0009] The electronic module is configured for use with a drug delivery device. In this regard, the electronic module may be a module which is releasably or removably attached to the drug delivery device, for example to a proximal end of a drug delivery device such as a dose button and / or a dose dial grip of the drug delivery device. However, the electronic module may also be permanently attached to or integrated into the drug delivery device, for example into the proximal end of the drug delivery device, for example into the dose button of the drug delivery device. The electronic module, as an integrated module, may therefore for example be housed in the dose button I and or dial grip of the drug delivery device or, as an add-on module, may be provided as an auxiliary dose button which may act on the dose button of the drug delivery device when axially moved relative to a housing of the drug delivery device.

[0010] The electronic module according to claim 1 comprises a displaceable component which is axially displaceable along a longitudinal axis of the module and a rotatable component which is rotationally movable about the longitudinal axis. The displaceable component is configured to be axially moved relative to a reference component along the longitudinal axis or vice versa to initiate and / or effect drug dispensing when used with the drug delivery device or for example in a zero dose position to power the electronic module for communication with an external device. A zero dose position may be a position prior to dose setting and / or after dose dispensing. Although not required for the present disclosure, the reference component may be an axially stationary component. The reference component may be a part of the electronic module or may also be part of the drug delivery device, e.g. its housing or number sleeve.

[0011] For example, in case where the electronic module is integrated within the drug delivery device, and wherein the displaceable component may be the dose button, the dose button may be axially moved along the longitudinal axis with respect to a reference component. The reference component may, for example be provided by an axially stationary housing of the drug delivery device. However, any other component which may not axially move before a dose dispensing is effected may be suitable as a reference component. The reference component may therefore be a sleeve, for example a number sleeve, a clutch or any other component according to the aforementioned aspects. It will be understood that it is not required that the reference component is permanently axially stationary with respect to the housing of the drug delivery device. Rather, the reference component, e.g. a number sleeve or a clutch of the drug delivery device, may move axially relative to the housing during dose setting and dose dispensing in a dial extension drug delivery device. In case the electronic module is integrated within the drug delivery device, it may be integrated in a dose button of the drug delivery device that is a single component used to set a dose as well as to actuate dose dispensing. In this embodiment, the drug delivery device does not have a separate dose dial grip. When the user presses the dose button of the drug delivery device, the electronic module moves axially into a second axial position.

[0012] Alternatively, the electronic module may be integrated within the proximal end of a drug delivery device which comprises a dose button and a dose dial grip.

[0013] In case the electronic module is an add-on module, i.e. releasably attachable to a drug delivery device, the electronic module may, for example, comprise at least two portions which are axially movable relative to each other. A first portion may thus for example be used to releasably attach the electronic module to the drug delivery device may for example be an auxiliary dose dial grip of the add-on module, which is the reference component, and a second portion may thus for example be an auxiliary dose button of the add-on module, which is the displaceable component.

[0014] Alternatively, an electronic module that is attachable to a drug delivery device may be attached to a single dose button of the drug delivery device which is a single component used to set a dose as well as to actuate dose dispensing. In this embodiment, the drug delivery device does not have a separate dose dial grip. When the user presses on the electronic module to dispense a dose, the complete electronic module may move axially, thereby moving the dose button of the drug delivery device into a second axial position.

[0015] "Reference component" may thus be understood as a component of the module or of the drug delivery device which component is axially stationary with respect to the displaceable component when the displaceable component of the electronic module is axially moved along a longitudinal axis in order to initiate and / or effect drug dispensing. However, the reference component may be axially displaceable together with the module relative to components of the drug delivery device. For example, the whole module may move axially or on a helical path relative to a stationary housing of the drug delivery device during dose setting and / or dose dispensing. Further, the electronic module comprises a monitoring device. The monitoring device comprises an electric power source, for example a battery such as a coin cell, a processor and an optical sensor arrangement. The processor is electrically connected to the electric power source and the optical sensor arrangement is electrically connected to the processor. Sensor output signals may thus be transmitted to the processor. Likewise, the electric power source may power a light source of the optical sensor arrangement and the processor.

[0016] The optical sensor arrangement comprises at least one light source and at least one optical detector, preferably one light source and one optical detector or two light sources and two optical detectors. The at least one light source may be configured to emit light which may be detected by the at least one optical detector in order to provide a respective sensor output signal. This means that depending on the amount of light detected by the optical detector, the sensor output signal, e.g. a voltage pulse, may vary in size. The at least one light source may for example be provided by an LED. The at least one optical detector may thus be used to detect light reflected or directly transmitted from the at least one light source.

[0017] Furthermore, the monitoring device is configured to determine, store and / or transmit data indicative of an amount of drug dispensed from the drug delivery device based on detection of rotation of the rotatable component relative to the displaceable component and / or the reference component or vice versa during drug dispensing when the module is used with the drug delivery device.

[0018] The monitoring device may further comprise a communication unit for communicating with another device, e.g. a wireless communication interface for communicating with another device via a wireless network such as Wi-Fi or Bluetooth, or even an interface for a wired communications link, such as a socket for receiving a Universal Series Bus (USB), mini-USB or micro-USB connector. Preferably, the monitoring device comprises an RF, Wi-Fi and / or Bluetooth unit as the communication unit. The communication unit may be provided as a communication interface between the electronic module and the exterior, such as other electronic (external) devices, e.g. mobile phones, personal computers, laptops and so on. For example, dose data may be transmitted by the communication unit to the external device. The dose data may be used for a dose log or dose history established in the external device.

[0019] The amount of drug dispensed, which may then for example be stored by the external device, may for example be determined by detection of relative rotation of the rotatable component. The rotatable component may be a sleeve, for example a number sleeve or a portion of the electronic module such as an auxiliary dose dial grip which may rotate during dose dispensing. The displaceable component may thus comprise the optical sensor arrangement, wherein the rotatable component may for example comprise reflective and non-reflective flags or other patterns or coding which allow rotation of the rotatable component to be detected by the at least one optical detector, wherein the optical detector detects reflected light. As an alternative, the amount of drug dispensed may be determined by detection of relative rotation in a reverse configuration, i.e. where at least one sensor rotates relative to an e.g. stationary, sensed element.

[0020] The flags, pattern or coding may comprise different reflectivity due to a different color, a different material or a different surface finish or may simply be provided with different distances with respect to the optical detector and therefore allow less or more light to be detected. Light emitted from the at least one light source may thus result in reflections comprising different intensities. However, the rotatable component may also be provided with open and closed portions, i.e. with portions that comprise material and portions that do not comprise material, so that the light emitted by the at least one light source may only be reflected by the closed portions comprising material. Still, further the light may also pass through the open portions directly to the optical detector and may only be blocked by the closed portions. Other configurations using reflection or passing of light from a light source to an optical detector may also be used in order to detect an amount of drug dispensed based on detection of rotation of the rotatable component.

[0021] Further, the monitoring device is configured to switch between a sleep mode of relatively low power consumption and an operation mode of relatively higher power consumption. In other words, the monitoring device may be configured to wake up from a low-power sleep mode to a high-power operation mode before dose dispensing starts or simultaneously with the start of dose dispensing. In the operation mode, rotation of the rotatable component may be detected by the optical sensor arrangement. Additionally or alternatively, the monitoring device may be configured to wake up from a low-power sleep mode to a high-power operation mode before communicating with an external device, e.g. before sending dose data to a smart phone app.

[0022] Axial movement of the displaceable component may axially move a sensor, e.g. the optical sensor arrangement, relative to the reference component, thereby allowing detection of this relative axial movement. Alternatively, the reference component which may carry flags, teeth, a pattern or the like may be moved axially relative to the sensor arrangement with the same effect. Therefore, the processor is able to switch the monitoring device from the sleep mode to the operation mode in response to detection of said relative axial movement of the sensor and the, e.g. axially stationary, reference component.

[0023] In an example, the optical sensor arrangement may be configured to be axially moved relative to the stationary reference component upon axial displacement of the displaceable component. In one aspect, for example, when the electronic module is integrated in the dose button of the drug delivery device and the user applies pressure onto the dose button in order to dispense a drug, the dose button is axially moved (e.g. to disengage a clutch of the drug delivery device, thereby changing into a dispensing mode) and consequently the optical sensor arrangement is also axially moved together with the dose button. The relative axial movement of the optical sensor arrangement with respect to the reference component may be detected by the optical sensor arrangement, e.g. by detecting a change in light intensity of reflected light. For example, the reference component may comprise a reflective component or a light blocking element and the optical sensor arrangement may be configured to provide a change in the sensor output signal upon axial movement of the optical sensor arrangement relative to the reflective component or the light blocking element, e.g. if a light beam between a light source and an optical detector is reflected and / or blocked by the reflective component or the light blocking element upon relative axial movement of the reference component and the optical sensor arrangement. Therefore, the processor is configured to switch the monitoring device from the sleep mode to the operation mode in response to detection of said axial movement of the optical sensor arrangement relative to the reference component. Hence, powering the electronics of the monitoring device with the help of the optical sensor arrangement allows for detection of drug dispensing or for communication with an external device and at the same time eliminates the need for an additional switch, e.g. a mechanical switch. This makes the electronic module not only cost-effective but also reliable. In addition, omission of a switch also saves space. Such a power-management is especially necessary for extending the lifetime of monitoring devices having a power source (e.g. a battery) that cannot be recharged, but is also useful for devices with rechargeable power sources.

[0024] Hence, in one aspect, the optical sensor arrangement may be configured to provide a change in sensor output signal upon relative axial movement of the optical sensor arrangement and the reference component. The sensor output signal may thus be increased or reduced compared to an initial sensor output signal, i.e. a sensor output signal before the optical sensor arrangement has been axially moved. The change in sensor output signal may be temporarily. This may mean that over the distance of the axial movement of the optical sensor arrangement, the change in the sensor output signal may be changed temporarily. For example, the initial sensor output signal may have a certain value before the axial movement is initiated, wherein this initial value may be equal to a value after the axial movement, and wherein the sensor output signal is temporarily increased or reduced during the axial movement. It is also possible that the sensor output signal may be changed from a low initial value before the axial movement is initiated to a higher or lower value due to the axial movement. Other changes to the sensor output signal are also conceivable, as long as the change in sensor output signal is detectable and can be used to switch the monitoring device. For example, detection of light may be increased or reduced by axially moving the optical sensor arrangement. The change in sensor output signal may be noted by the processor and may thus wake up the monitoring device. Axial movement of the optical sensor arrangement may thus allow to reliably switch the monitoring device in operation mode.

[0025] In one aspect, the optical sensor arrangement may be configured to be located in a first axial position relative to the reference component during dose setting and / or before dose setting, in which the monitoring device is in the sleep mode. For example, the device could be activated by a user pressing the second portion (e.g. the auxiliary dose button) axially prior to dose setting e.g. for capturing a set dose with a rotation sensor during dose setting. In another example, the device could be activated by a user pressing the second portion (e.g. the auxiliary dose button) axially when initiating dose setting e.g. for capturing a dispensed dose with a rotation sensor during dose dispensing. Further, the optical sensor arrangement may be configured to be axially moved upon axial displacement of the displaceable component into a second axial position, in which the monitoring device is in the operation mode. In the first axial position, the displaceable component may not have been axially moved. Further, light emitted by the at least one light source in the first axial position may be detected by the at least one optical detector. The sensor output signal may remain constant, as the at least one light source illuminates a same region, e.g. the same region of the reference component, without any axial movement. Axial movement of the optical sensor arrangement may then cause a change in the sensor output signal, which wakes up the monitoring device in operation mode. Due to the axial movement of the displaceable component, a clutch may be released, so that the dose dispensing may be initiated. Consequently, as the monitoring device is in the sleep mode during dose setting and / or before dose setting, power consumption may be limited.

[0026] In one aspect, the optical detector is always powered when the electronics of the monitoring device are in the sleep mode, such that a change in optical signal due to an axial movement is reliably detected. Alternatively, the optical detector may conduct periodic measurements in order to detect a possible change in light intensity due to axial movement.

[0027] In one aspect, the optical sensor arrangement may be configured to detect rotation of the rotatable component in the second axial position. In other words, the optical sensor arrangement may be configured to detect relative rotation of the rotatable component when the monitoring device is in the operation mode. In the second axial position, the optical sensor arrangement is then set up to detect relative rotation of the rotatable component in order to detect the amount of drug dispensed. Switching to operation mode when required therefore extends battery life, reliably detects the amount of dose dispensed and at the same time eliminates the need for an additional switch in addition to the optical sensor arrangement. In order to detect the relative rotation of the rotatable component, the rotatable component may have a pattern or coding or the like. For example, the rotatable component may comprise alternating reflective or more reflective and non-reflective or less reflective flags as aforementioned. Instead of non-reflective or only weakly reflective flags, the rotatable component may also have alternating material-free and non-material-free areas so that reflection only occurs in the non-material-free areas. Other types of coding that allow an alternating sensor output signal of the optical sensor arrangement, which has at least one light source and at least one optical detector, are also conceivable. The sensor output data referring to the sensor output signal may be stored in a storage of the electronic module. However, the sensor output data may also be processed by the processor of the monitoring device in order to calculate the amount of dose dispensed. For example, using a rotation angle and the correlating amount of dose delivered. Further, the sensor output data or the calculated dose data may be transmitted to an external device. The external device may also store and / or process the sensor output data in order to determine an amount of drug delivered.

[0028] In one aspect, the reference component and the rotatable component may be provided by the same component. In other words, the axially stationary is the rotatable component. This one component may then simply have different functions, namely to remain axially stationary during the axial displacement of the optical sensor arrangement and to rotate during the dose delivery. This may allow to further limit the number of components needed for switching between sleep and operation mode as well as for detection of rotation. In this regard, the axially stationary and rotatable component may for example be a sleeve-like component, for example a second portion of the electronic module or a dosing sleeve of a drug delivery device. The monitoring device comprising the optical sensor arrangement may be axially moved relative to the axially stationary and rotatable component. For example, the monitoring device may be moved in the sleeve during axial movement so that the optical sensor arrangement slides axially relative to the sleeve in order to switch on the monitoring device. Further, after switching the monitoring device to the operation mode, the sleeve may rotate relative to the monitoring device during dose dispensing, i.e. after the axial relative movement has been completed. The rotation may then be detected and an amount of dose dispensed with the drug delivery device may be detected. In one aspect, the optical sensor arrangement may be configured to be axially moved relative to the reference component, thereby reducing a distance between the optical sensor arrangement and the reference component. For example, when the user presses the dose button of the drug delivery device or an auxiliary dose button of an electronic module, for example a first portion of an electronic module releasably attached to the drug delivery device, the optical sensor arrangement which may be integrated into the dose button or the auxiliary dose button may move closer to the reference component. Considering that the optical sensor arrangement has at least one light source and at least one optical detector, by bringing the optical sensor arrangement closer to the reference component, for example, more light from the at least one light source may be reflected from the reference component to the optical detector, so that a sensor output signal changes, for example, increases. The processor may then wake up the monitoring device by switching it from sleep mode to operation mode. Although it would also be possible to increase the distance or otherwise change the sensor output signal, which would trigger the switching of the monitoring device, approaching the reference component makes the best possible use of the relative movement of components of a drug delivery device, which are typically caused to move when load is applied to the dose button.

[0029] In one aspect, when the optical sensor arrangement may be axially moved from the first axial position into the second axial position, the sensor output signal provided by the optical sensor arrangement may be reduced. For example, when the optical sensor arrangement is axially moved into the second axial position, a sensor output signal is no longer present. This means, for example, that in the first axial position the at least one light source may illuminate the at least one optical detector directly, whereas in the second axial position the optical detector is no longer illuminated. The initial sensor output signal, which was caused by the direct illumination of the at least one optical detector in the first axial position, is then stopped, i.e. suspended. Reducing the sensor output signal may be particularly advantageous as, in contrast to an increase, it may be more clearly defined and therefore easier to detect.

[0030] In one aspect, the reference component may be configured to be moved at least partially into a space between the at least one light source and the at least one optical detector of the optical sensor arrangement during axial movement from the first axial position into the second axial position. Consequently, the at least one optical detector which may have been illuminated by the at least one light source in the first axial position, may no longer be illuminated in the second axial position or may at least no longer be fully illuminated in the second axial position. Therefore, the reference component may be configured to screen the at least one optical detector at least partially from the at least one light source, meaning that the light from the light source is at least partially blocked by the reference component from reaching the optical detector in the second axial position. Thus, the sensor output signal may be reduced or shut down completely. Here, the sensor arrangement may reach around at least one area of the reference component (such that the light source is positioned on one side of the reference component and the detector is positioned on the other side of the stationary component), so that the reference component moves at least partially in between the at least one light source and the at least one optical detector of the optical sensor arrangement.

[0031] In one aspect, the reference component may comprise at least one axially protruding element configured to at least partially screen the at least one optical detector from the at least one light source. However, the reference component may also comprise multiple, i.e. at least two, axially protruding elements configured to at least partially screen the at least one optical detector. In this regard, there may consequently be material-free areas between the axially protruding elements, i.e. openings, gaps, recesses or the like in areas where there are no axially protruding elements. The reference component may be a sleeve. The axially protruding elements may thus be arranged like axially extending teeth on an end face of the sleeve, for example a number sleeve or dosing sleeve of the drug delivery device. The material-free areas may therefore be located between the teeth. "Axially protruding" means in the direction of the axial movement of the optical sensor arrangement. The use of axially protruding elements has the advantage that when the reference component is rotated, a tooth that shields or screens the at least one optical detector from the light source in a first position is exposed in a second position in which the light source emits light through the material-free area. The pattern or coding provided by the axial protruding elements may therefore also be used to detect the rotation of the reference component as a rotatable component. Consequently, the reference component may also be a rotatable component. Furthermore, there may also be more than one light source and more than one optical detector provided, (preferably two light sources and two optical detectors) which are arranged offset, for example, so that when the optical sensor arrangement moves axially, it is ensured that at least one optical detector of the more than one optical detectors is at least partially screened or shielded by an axially protruding element.

[0032] In one aspect, the reference component may comprise at least one radially protruding element. Thus, instead of elements protruding in the direction of axial movement, this radially protruding element protrudes in a direction perpendicular to the direction of axial movement. The at least one radially protruding element may thus be arranged on a lateral surface of the reference component. Similar to the axially protruding elements, there may also be material-free areas between the at least two radially protruding elements. The reference component may therefore comprise multiple radially protruding elements which are like teeth arranged on the lateral surface of a sleeve. Further, the distance between the optical sensor arrangement and the at least one radially protruding element of the reference component may be reduced when the optical sensor arrangement is axially moved relative to the reference component. In this regard, the optical sensor arrangement may be moved towards the at least one radially protruding element. The light emitted by the at least one light source may therefore be more focused on a radially protruding element towards which the optical sensor arrangement moves, so that the amount of light reflected by said radially protruding element to the at least one optical detector is increased. Consequently, a larger amount of reflected light may be detected by the at least one optical detector. This increase may lead to an increased sensor output signal, i.e. to a change in sensor output signal, and consequently to switching of the monitoring device. At the same time, when the reference component is also a rotatable component and comprises multiple radially protruding elements, for example at least two, the radially protruding elements may provide a pattern or coding detectable for determination of an amount of drug dispensed. In addition, the optical sensor arrangement may comprise a purely axially extending light pipe which may allow for better focusing of the light onto the radially protruding elements.

[0033] In one aspect, the optical sensor arrangement may comprise a light pipe configured to guide light towards the reference component in a direction perpendicular to the direction of relative axial movement. Because the light pipe directs the light perpendicular to the direction of axial movement of the optical sensor arrangement, the light pipe is axially displaced when the optical sensor arrangement moves axially but may not move with its light-emitting end towards an axial stationary component. Rather, it may move axially along an axially extending component which comprises a sensed reference element. In other words, although the light pipe is moved axially as part of the optical sensor arrangement, the light-emitting end of the light pipe is independent of the axial movement of the optical sensor arrangement and may remain in a constant radial position. Thus, if the axial stationary component is a sleeve in which the light pipe moves, a radial distance of the light-emitting end of the light pipe opposite to the optical detector may not change with respect to the axial stationary component. Due to the constant radial positioning of the light pipe, the sensor output signal may be changed more precisely or accurately by the axial movement compared to cases where the distance between the sensor and the sensed portion changes. Thus, this may allow the monitoring device to be switched more reliably.

[0034] In one aspect, when the optical sensor arrangement may be axially moved from the first axial position into the second axial position, the perpendicularly oriented light pipe may be configured to be moved axially past a reflective component. The sensor output signal may be temporarily changed by the reflective component with respect to the sensor output signal in the first axial position and the second axial position. The reflexive component may e.g. be a ring or a sleeve with a reflective surface facing the end of the light pipe from which the light is directed in the direction of the surface of the reflective component. The reflective component may for example reflect a different amount of light compared for example to a flag of the axially stationary and rotatable component in the first and / or second axial position. In one aspect, the reflective component may for example be highly reflective, wherein there is no light reflected in the first axial position, and wherein more light is reflected in the second axial position than in the first axial position and less than from the reflective component. However, the reflective component may also be positioned at a different distance from the light-emitting end of the light pipe compared to the flags. For example, the reflective component may protrude radially from an inner wall of a sleeve-like component along which the light-emitting end of the light pipe moves and on which flags are arranged. The change in sensor output signal may thus be caused by a reflective component located along a path of axial movement of the optical sensor arrangement, wherein the light pipe is stationary in its radial position. By using a reflective component, the change in the sensor output signal may be more accurately. In addition, it is also highly reliable, because a reflective component formed by a closed ring or sleeve guarantees a defined change in reflection and therefore the sensor output signal during the axial movement of the light pipe into the second axial position.

[0035] Furthermore, in one aspect, the monitoring device may be configured to communicate with and / or activate an external device, when the monitoring device is switched from sleep mode to operation mode. As mentioned above, the external device may for example be a mobile phone, a tablet, a personal computer, a medical data recording device or the like. When the monitoring device is switched from sleep mode to operation mode, the monitoring device may transmit a signal to the external device in order to activate the external device and I or establish a communication link with the external device. The signal may be transmitted wired or wirelessly. The monitoring device may therefore comprise a respective communication unit. Activation of the external device may also be understood as the mere execution of a specific program function of the external device. For example, the external device may run an app based on the signal received from the electronic module, wherein the app may then support the user during dose recording or the like. Activation of the external device may also comprise switching of the external device from a lower-power-consumption mode to a higher-power-consumption mode, in which more power is consumed. In other words, during activation of the external device, the external device may be switched on or rendered operational. Using an external device may also allow calculation of the delivered dose amounts based on the sensor output data with the help of the external device, further reducing the power consumption in the electronic module. After establishing a communication link with the external device, the communication unit of the electronic module may transfer data to the external device, e.g. dose information, time of dispensing a dose of medication with the drug delivery device, temperature data, and I or information about the medication dispensed with the drug delivery device.

[0036] In one aspect, the electronic module may be configured to be releasably attached to a drug delivery device. Consequently, the electronic module may, for example be attached to the drug delivery device by a push-fit so that the electronic module is secured to the drug delivery device by pure frictional force preventing unwanted detachment of the module. However, alternative fastening means for attachment of the electronic module to the drug delivery device such as clips, snaps, belts, straps or the like may also be used in order to secure the electronic module to the drug delivery device.

[0037] The electronic module may comprise at least two portions that are movable relative to each other. For example, a first portion may be configured to be releasably attached to a dose dial grip of the drug delivery device, such that the first portion follows axial and rotational movement, for example helical movement, of the dose dial grip when attached to the drug delivery device. The first portion may thus define an auxiliary dose dial grip. Hence, when the auxiliary dose dial grip is attached to the dose dial grip of the drug delivery device and is for example rotated during dose setting, the dose dial grip of the drug delivery device is also rotated. Further, the electronic module may comprise a second portion. The second portion may be at least partially arranged inside the first portion. The second portion may be retained in the first portion allowing relative axial movement with respect to the first portion. The second portion may be retained in the first portion by clips that engage in a groove. Axial movement of the second portion may cause the dose button of the drug delivery device to be axially moved in order to dispense a dose. Therefore, the second portion may define an auxiliary dose button abutting the dose button of the drug delivery device when attached to the drug delivery device. Hence, when a user applies pressure onto the auxiliary dose button, the pressure may be directly transferred onto the dose button of the drug delivery device. Alternatively, the pressure applied to the auxiliary dose button of the electronic module may first move the second portion axially to an abutment position in which it abuts the dose button of the drug delivery device and then move further axially to apply pressure to the dose button of the drug delivery device, thereby moving the dose button of the drug delivery device axially.

[0038] Consequently, the second portion is configured to apply pressure in axial direction onto the dose button of the drug delivery device, when attached. Providing the electronic module as a separate unit allows drug delivery devices to be retrofitted. The reusable electronic modules can be used with several drug delivery devices one after another in this case. At the same time, it also ensures that the electronic modules may be easily replaced if they no longer function without having to throw away the entire drug delivery device. Furthermore, the functionality of the electronic module may be checked more easily, and, for example, a battery change or recharging may be carried out more conveniently.

[0039] The above explanations of the module comprise references to the operation of the drug delivery device, e.g. dose setting or dose dispensing or actuation of a dose button. This is to be understood in a state when the module is attached to the drug delivery device or integrated into the drug delivery device, i.e. when the module is used with the drug delivery device.

[0040] Further, the object of the present disclosure is solved by an assembly according to claim 15. The assembly comprises a drug delivery device and an electronic module according to the aforementioned aspects. Accordingly, the electronic module may either be directly integrated into the drug delivery device or may be, e.g. releasably, attached to the drug delivery device.

[0041] A drug delivery device suitable to be used with the present disclosure may for example comprise at least a dose button, a dose dial grip, a drive sleeve and a plunger. Instead of comprising a dose button and a dose dial grip, the drug delivery device may for example comprise a single dose button used for dialing and dispensing and no separate dose dial grip. Although not required in the context of the present disclosure, the drug delivery device may optionally comprise further components such as a number sleeve, a clutch, a cap, a needle, a spring, a lead screw or the like, interacting with the dose button, the dose dial grip, the drive sleeve, the plunger and / or the housing, for example as disclosed in WO 2004 / 078239 A1. However, the present disclosure is not limited to the drug delivery device of WO 2004 / 078239 A1. Other suitable drug delivery devices to be used are described e.g. in EP 1 570 876 B1 , EP 2 814 547B1 , EP 2 890 434 B1 , WO 2005 / 018721 A1 , WO 2009 / 132777 A1 , WO 2014 / 033195 A1 , US 5,693,027 A, US 6,663,602 A, US 7,241 ,278 B2 or US 9,937,294 B2.

[0042] Still further, a method for switching an electronic module between two different modes is disclosed. If the electronic module comprises an optical sensor arrangement, a monitoring device and a processor, the method may comprise the steps of axially moving a displaceable component and the optical sensor arrangement of the module relative to a reference component along a longitudinal axis, detecting the relative axial movement of the optical sensor arrangement relative to a reference component, and switching the monitoring device from the sleep mode to the operation mode by means of the processor in response to detection of said axial movement of the optical sensor arrangement relative to the reference component. The method may further comprise the step of determining the amount of drug dispensed from a drug delivery device coupled to or comprising the electronic module based on detection of rotation of a rotatable component rotationally movable about the longitudinal axis relative to the displaceable component by means of the monitoring device.

[0043] The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

[0044] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0045] The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., short- or long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dual-chamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

[0046] The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (anti-diabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0047] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.

[0048] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0049] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-pal- mitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl- LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N- palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)- des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl- des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glu- tamyl)-des(B30) human insulin; B29-N-(w-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin. Examples of GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Vic- toza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rEx- endin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211 , CM-3, GLP-1 Eligen, GRMD-0901 , NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1 , ZYD-1 , GSK-2374697, DA-3091 , MAR-701 , MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651 , ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN and Glucagon-Xten.

[0050] An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.

[0051] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Sax- agliptin, Berberine.

[0052] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutro- pin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Ter- lipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0053] Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Syn- visc®), a sodium hyaluronate. The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region anti- body-like binding protein having cross-over binding region orientation (CODV).

[0054] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full-length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and immunoglobulin single variable domains. Additional examples of antigen-binding antibody fragments are known in the art.

[0055] The term “immunoglobulin single variable domain” (ISV), interchangeably used with “single variable domain”, defines immunoglobulin molecules wherein the antigen binding site is present on, and formed by, a single immunoglobulin domain. As such, immunoglobulin single variable domains are capable of specifically binding to an epitope of the antigen without pairing with an additional immunoglobulin variable domain. The binding site of an immunoglobulin single variable domain is formed by a single heavy chain variable domain (VH domain or VHH domain) or a single light chain variable domain (VL domain). Hence, the antigen binding site of an immunoglobulin single variable domain is formed by no more than three CDRs.

[0056] An immunoglobulin single variable domain (ISV) can be a heavy chain ISV, such as a VH (derived from a conventional four-chain antibody), or VHH (derived from a heavychain antibody), including a camelized VH or humanized VHH. For example, the immunoglobulin single variable domain may be a (single) domain antibody, a "dAb" or dAb or a Nanobody® ISV (such as a VHH, including a humanized VHH or camelized VH) or a suitable fragment thereof. [Note: Nanobody® is a registered trademark of Ablynx N.V.]; other single variable domains, or any suitable fragment of any one thereof.

[0057] “VHH domains”, also known as VHHs, VHH antibody fragments, and VHH antibodies, have originally been described as the antigen binding immunoglobulin variable domain of “heavy chain antibodies” (i.e., of “antibodies devoid of light chains”; Hamers-Caster- man et al. 1993 (Nature 363: 446-448). The term “VHH domain” has been chosen in order to distinguish these variable domains from the heavy chain variable domains that are present in conventional 4-chain antibodies (which are referred to herein as “VH domains”) and from the light chain variable domains that are present in conventional 4- chain antibodies (which are referred to herein as “VL domains”). For a further description of VHH’s, reference is made to the review article by Muyldermans 2001 (Reviews in Molecular Biotechnology 74: 277-302).

[0058] For the term “dAb’s” and “domain antibody”, reference is for example made to Ward et al. 1989 (Nature 341 : 544), to Holt et al. 2003 (Trends Biotechnol. 21 : 484); as well as to WO 2004 / 068820, WO 2006 / 030220, WO 2006 / 003388. It should also be noted that, although less preferred in the context of the present invention because they are not of mammalian origin, single variable domains can be derived from certain species of shark (for example, the so-called “IgNAR domains”, see for example WO 2005 / 18629). The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0059] Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

[0060] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0061] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

[0062] An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608- 1 :2014(E), needle-based injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0063] As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).

[0064] As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

[0065] The terms “axial” or “radial” as used herein may be used with respect to a longitudinal axis of the electronic module, a first portion of the electronic module or a second portion of the electronic module, the drug delivery device, the cartridge, the housing, the cartridge holder or the assembly of the drug delivery device and the electronic module, e.g. the axis which extends through the proximal and distal ends of the cartridge.

[0066] "Distal" is used herein to specify directions, ends or surfaces which are arranged or are to be arranged to face or point towards dispensing end of the drug delivery device or components thereof and / or point away from, are to be arranged to face away from or face away from the proximal end. On the other hand, “proximal” is used to specify directions, ends or surfaces which are arranged or are to be arranged to face away from or point away from the dispensing end and / or from the distal end of the electronic module or the drug delivery device or components thereof. The distal end may be the end closest to the dispensing and / or furthest away from the proximal end and the proximal end may be the end furthest away from the dispensing end. A proximal surface may face away from the distal end and / or towards the proximal end. A distal surface may face towards the distal end and / or away from the proximal end. The dispensing end of the drug delivery device may be the needle end where a needle unit is or is to be mounted to the device, for example. Similarly, a distal element compared to a proximal element is located closer to the dispensing end than to the proximal end. Furthermore, when the electronic module is considered alone, the term "distal" may be used with regard to the more distal end of the electronic module, which is located closer to the dispensing end of the drug delivery device when a releasably attachable electronic module is considered, and the term "proximal" may be used with regard to the proximal end of the electronic module, which is located further away from the dispensing end of the drug delivery device when a releasably attachable electronic module is considered.

[0067] In the following, non-limiting examples of the electronic module, the drug delivery device and the assembly of the drug delivery device and the electronic add-on module are described in more detail by making reference to the drawings, in which:

[0068] Figure 1 shows a drug delivery device;

[0069] Figure 2 shows an exemplary electronic module releasably attached to a drug delivery device;

[0070] Figures 3A to 3C show an example of a reference component comprising axially protruding elements and an interaction between an optical sensor arrangement and the reference component;

[0071] Figure 3D shows an alternative to Figure 3A;

[0072] Figures 4A to 4E show an exemplary concept of an optical sensor arrangement comprising a light pipe configured to guide light towards an axially stationary and rotatable component in a direction perpendicular to the direction of relative axial movement;

[0073] Figure 5 shows an exemplary sensor output signal of a concept according to

[0074] Figures 4A to 4E; and Figures 6A to 6B show an example of a reference component comprising radially protruding elements and an interaction between an optical sensor arrangement and the reference component.

[0075] In the Figures, identical elements and components as well as identical elements and components in different examples or embodiments, i.e. elements and components acting identically or provided for the same purposes but belong to different examples, are provided with the same reference signs.

[0076] Figure 1 shows an exploded view of an exemplary medicament delivery device or drug delivery device 1. The drug delivery device 1 is a pen-type injector comprising a housing 10, i.e. a housing 10 of a drug delivery device 1 or a drug delivery device housing 10, in which a drive mechanism for dose setting and dose dispensing is arranged. The drug delivery device 1 extends from a distal end in a proximal direction P or from a proximal end in a distal direction D along a longitudinal drug delivery device axis I of the drug delivery device 1 , i.e. a longitudinal axis of the drug delivery device 1. In order to set or dial a dose for delivery a user may rotate or dial a dose dial grip 12 with respect to the housing 10, wherein the dose dial grip 12 is arranged at a proximal end of the housing 10. During dose setting the dose dial grip 12 may perform a helical movement, i.e. a combined axial and rotational movement in the proximal direction, or may perform pure rotational movement without moving axially.

[0077] The drive mechanism of the drug delivery device 1 may comprise a plunger, a drive sleeve, a clutch, a clutch spring, a number sleeve, a last dose nut and so on, which may move relative to the drug delivery device housing 10 during dose setting and / or dose dispensing. Although not all of these components are shown in detail, for example, the drive mechanisms disclosed in EP 1 570 876, EP 2 814 547, US 9,937,294 B2 or WO 2004 / 078239 A1 represent suitable drive mechanisms for the present disclosure. An electronic module 100 according to the present disclosure (not visible in figure 1) may either be integrated within the drug delivery device 1 , for example within the dose button 11 and I or the dial grip 12 of the drug delivery device 1 or may for example be a separate module that is releasably attached thereto as for example shown in Figure 2. The components of the exemplary drug delivery device 1 shown in Figure 1 comprise in addition to the dose dial grip 12 and the dose button 11 a display window 13, a needle 15, and a container 14. The set dose may be displayed via the dosage window 13 through which a number sleeve may be visible. The container 14 may be filled directly with a drug, for example with insulin, or may be configured to receive a cartridge filled with the drug and thus the container 14 may act as a cartridge holder.

[0078] The needle 15 may be affixed to the distal end of the container 14 which may include a needle hub. During dose dispensing the drug is dispensed through the needle. The needle may be protected by an inner needle cap 16 and / or an outer needle cap 17. In addition, the container (with or without the needle 15) may be protected by a drug delivery device cap 18.

[0079] Once a dose is set (e.g. by turning the dose dial grip 12), the user may press the dose button 11 arranged at the proximal end of the drug delivery device 1 axially in the distal direction D in order to dispense a dose. When pressing the dose button 11 , the user applies an axial force, for example on a proximal end surface 19 of the dose button 11 , directed towards the proximal end of the drug delivery device 1 , wherein the force moves the dose button 11 in the distal direction D of the pen and parallel to a longitudinal axis I of the drug delivery device 1. This axial movement of the dose button 11 releases the drive mechanism for example by de-coupling a number sleeve from the drive sleeve. Irrespective of which component of the drug delivery device 1 performs a rotational movement during dose delivery, the dose dial grip 12 may be coupled to the respective rotating component in order to perform a rotational movement during dose delivery.

[0080] The rotational movement of a rotatable component of the drug delivery device and / or of at least portion of the electronic module about a longitudinal axis I relative to another component of the electronic module or of the drug delivery device may be detected by an optical sensor arrangement 103. The rotatable component may be provided by a number sleeve 20, which may form part of a dose dispensing mechanism of a drug delivery device 1 , or by a second portion 101 of an electronic module 100. The number sleeve 20 may be rotated about the longitudinal axis I of the drug delivery device 1 with respect to an axially displaceable component, for example the dose button 11 or at least a portion of the electronic module. In case of a releasably attachable electronic module 100, the displaceable component may also be provided, for example, by a first portion 102. A rotatable component may then be provided by a second portion 101 rotatable relative to the first portion 102 during dose dispensing. The relative rotational movement may be detected by the optical sensor arrangement 103. The optical sensor arrangement 103 may be configured to detect relative rotation of a pattern or coding or flags.

[0081] When the displaceable component is axially moved, for example when the dose button 11 or the first portion 102 of the electronic module 100 or the complete electronic module 100 are pressed by a user e.g. to initiate and / or effect dose dispensing, the displaceable component may be moved axially relative to a reference component. This relative axial movement is detected by the optical sensor arrangement 103 in order to cause a monitoring device 106 of the electronic module 100 to switch from a sleep mode to an operation mode.

[0082] The displaceable component may be provided by the dose button 11 or the first portion 102 which are moved axially relative to the reference component upon user depression when a user wants to set or dispense a dose or transmit data to an external device . Axial movement of the displaceable component may thus axially move the optical sensor arrangement 103. Alternatively, the reference component carrying the flags, teeth, pattern or the like may be moved axially relative to the optical sensor arrangement with the same effect. The reference component may be provided by the number sleeve 20 or the second portion 101. Consequently, in case the displaceable component is a dose button 11 , the dose button 11 may axially move relative to the number sleeve 20. However, in case the displaceable component is provided by a first portion 102, the first portion 102 may for example axially move relative to the second portion 101.

[0083] The optical sensor arrangement 103 comprises at least one light source 104 and at least one optical detector 105 configured to detect light emitted from the at least one light source 104. The optical sensor arrangement 103 forms part of a monitoring device 106 with an electric power source 107, for example a battery, and a processor 108 electrically connected to the electric power source 107. In Figure 2, the electronic module 100 is releasably attached to the dose dial grip 12 of the drug delivery device 1. In this regard, fastening means 109 are provided which secure the electronic module 100 to the drug delivery device 1. The optical sensor arrangement 103, the electric power source 107 and the processor 108 are arranged within housing elements 110 of the electronic module 100. Further, the electric power source 107 is provided distally with respect to a circuit board assembly 111. The circuit board assembly 111 may electrically connect the electric power source 107 with the processor 108. Further, a communication unit 112 configured to transmit and / or receive data from an external device such as a mobile phone is provided proximally with respect to the circuit board assembly 111.

[0084] When a user applies pressure onto a proximal end surface 113 of the first portion 102 in order to move this first portion 102 axially along the longitudinal axis I to apply pressure onto the dose button 11 of the drug delivery device 1 , and therefore in order to dispense a dose, the first portion 102 moves axially relative to the second portion 101 and thus to a portion of the housing element 110. A distance d between the portion of the housing element 110 and the optical sensor arrangement 103 may thus be reduced. Since the optical detector 105 (not shown in Figure 2) of the optical sensor arrangement 103 thereby comes closer to a surface 114 illuminated by the at least one light source 104 (not shown in Figure 2), the at least one optical detector 105 detects a greater amount of light reflected from the illuminated surface 114, so that a sensor output signal of the optical sensor arrangement 103 changes, in this case increases.

[0085] Based on this change in sensor output signal the processor 108 may switch the monitoring device 106 from a sleep mode into an operation mode. In other words, the processor 108 may switch the monitoring device 106 from sleep mode to operation mode in response to the optical detection of said axial movement of the optical sensor arrangement 103 relative to the reference component, here the surface 114 of the second portion 101.

[0086] As shown in Figures 3A to 3C, the reference component may also be provided by a number sleeve 20, which may form part of a dose dispensing mechanism of a drug delivery device 1 . However, instead of a number sleeve 20, the component shown in Figure 3A could also be another component of a drug delivery device 1 as long as the component allows relative axial movement of the optical sensor arrangement 103 according to the present disclosure. Here, the number sleeve 20 comprises axially protruding elements 21 , wherein material-free portions are provided in between two axially protruding elements 21. In Figure 3A, the protruding elements 21 protrude like teeth from an axial end face 22 of the number sleeve 20.

[0087] The axially protruding elements 21 thus differ from radially protruding elements 23, which are shown in Figures 6A and 6B and which protrude in a direction perpendicular to the direction of axial movement, i.e. in a radial direction. The radially protruding elements 23 may protrude from a lateral surface 24 of a clutch element 25. As described below, the reference component is therefore provided here by a clutch element 25.

[0088] To indicate that the use of the axially protruding elements 21 is not limiting for an electronic module 100 integrated in a drug delivery device 1 , it is pointed out that the axially protruding elements 21 could also be arranged on the (illuminated) surface 114 shown in Figure 2. In this regard, the optical sensor arrangement 103 may then be used as subsequently described with reference to Figures 3B and 3C. It may be noted that the use of radially protruding elements 23 on a clutch element 25 is not limited either to the sole use with the clutch element 25 or for the use of an integrated electronic module 100.

[0089] In the case of the example of Figures 3A to 3C, the optical sensor arrangement 103 moves axially towards the axially protruding elements 21 , for example due to a load applied on the dose button 11 or the proximal end surface 113. Figure 3B shows a state before a load by the user has been applied. Consequently, the optical detector 105 is still able to detect the light emitted from the light source 104. In Figure 3C, the optical sensor arrangement 104 was axially moved so that the axially protruding element 21 now at least partially screens the optical detector 105 from the light source 104. Due to the axial movement of the optical sensor arrangement 103, the sensor output signal may thus be reduced or no longer be present. This change in sensor output signal may thus switch the monitoring device 106 into an operation mode.

[0090] If the number sleeve 20 now rotates during dose dispensing, the material-free areas between the axially protruding elements 21 allow again light to pass from the light source 104 to the optical detector 105. Therefore, rotation of the number sleeve 20 may provide a distinct signal sequence of the sensor output signal which may be used to infer the amount of dose delivered. For example, the processor 108 or an external device may perform calculation based on the angle of rotation of the number sleeve 20 that can be determined using the sensor output signal which may directly be linked to the dispensed dose. Consequently, the pattern or coding provided by the axial protruding elements 32 may therefore be used to detect the rotation of the reference component as a rotatable component. In other words, the number sleeve 20 here may be an axially stationary as well as a rotatable component.

[0091] An alternative to the example of Figure 3A is shown in Figure 3D. Again, the number sleeve 20 comprises axially protruding elements 21 , wherein material-free portions are provided in between two axially protruding elements 21. However, an additional ringshaped portion forms the axial end face 22' of the number sleeve 20. In other words, an, e.g. reflective, closed annular portion is provided at the proximal end followed by a pattern of openings and closed regions 21 a little bit further distally. This alternative example may avoid using two detectors to make sure that the axial movement is detected.

[0092] The optical sensor arrangement 103 may be designed as shown in Figures 3B and 3C and moves axially towards the axially protruding elements 21 , for example due to a load applied on the dose button 11 or the proximal end surface 113. However, the light source 104 and the optical detector 105 first pass the ring-shaped axial end face 22' of the number sleeve 20 such that the light is blocked during the axial movement and the sensor output signal is thereby changed as the light source 104 and the optical detector 105 pass the ring-shaped axial end face 22'. The optical sensor arrangement 103 may then move axially further towards the elements 21 until the optical sensor arrangement 103 is positioned as shown in Figure 3C, i.e. with elements 21 interposed between the light source 104 and the optical detector 105. As in the example of Figures 3A to 3C, if the number sleeve 20 now rotates during dose dispensing, the material-free areas between the axially protruding elements 21 allow again light to pass from the light source 104 to the optical detector 105. Therefore, rotation of the number sleeve 20 may provide a distinct signal sequence of the sensor output signal which may be used to infer the amount of dose delivered. Furthermore, more than one light source 104 and more than one optical detector 105 may also be provided, which are arranged offset, such that when the optical sensor arrangement 103 moves axially, it is ensured that at least one optical detector 105 is at least partially screened or shielded by an axially protruding element 21. For example, two light sources 104 and two optical detectors 105 may be arranged offset in view of the circumference of the number sleeve for this purpose.

[0093] In Figures 4A to 4E further aspects of an electronic module 100 are shown. Similar to the electronic module 100 shown in Figure 2, also the electronic module shown in Figure 4A comprises a first portion 102 and a second portion 101. When pressure is applied to the proximal end surface 113, the first portion 102 is configured to be axially moved along the longitudinal axis I with respect to the second portion 101. Axial movement of the first portion 102 also moves the optical sensor arrangement 103 axially. The optical sensor arrangement 103 in Figure 4A comprises a light pipe 115 configured to guide light in a direction perpendicular to the direction of axial movement, i.e. in a radial direction. Exemplary light beams running through the light pipe 115 are shown by arrows in Figures 4C to 4E.

[0094] Before pressure is applied to the proximal end surface 113, the light pipe 115 and more precisely a light-emitting end 116 of the light pipe 115 may be directed towards an area which may not be reflective (or only slightly reflective). Therefore, as shown in Figure 4C the light beams may exit the light pipe 115 but are not returned (or only minimally returned) to the optical sensor arrangement 103. This is depicted by an arrow in Figure 4C compared to a double-headed arrow as shown in Figures 4D and 4E. The double-headed arrow may indicate that light is reflected and returned to the optical detector. In this initial position, before pressure is applied, there may be no (or only a very small) sensor output signal.

[0095] When the optical sensor arrangement 103 and thus the light pipe 115 are moved axially as shown in Figure 4D, the light pipe 115 may pass a reflective component 117. The light reflected by the reflective component 117 is detected by the optical detector 105 of the optical sensor arrangement 103 and used to switch the monitoring device 106 into an operational state. At this time, a clutch 118 comprising first clutch features 119 as part of the second portion 101 may still be engaged. Consequently, the first portion 102 may perform a purely axial movement with respect to the second portion 101.

[0096] When the light pipe 115 reaches the position depicted in Figure 4E, the light-emitting end 116 of the light pipe 115 may now face a reflective flag 120. Flag 120 may thus also reflect light, but to a different amount than the reflective component 117, for example less. In this position, the clutch 118 may be disengaged and the second portion 101 may be rotated with respect to the first portion 102 about the longitudinal axis I . The alternating arrangement of reflective flags 120 and non-reflective flags 121 or flags with different levels of reflection can then be used to determine the angle of rotation of the second portion and based thereon the amount of dose emitted.

[0097] Figure 4B shows a perspective view of the second portion 101 also shown in Figure 4A. A push element 122 may bias the first portion 102 proximally.

[0098] A sensor output signal 124 which may correspond to the sequence of movement shown in Figures 4C to 4E, is shown in Figure 5. The amplitude of the sensor output signal 124 in the vertical direction may, for example, correspond to a voltage pulse that changes depending on the amount of light detected by the optical detector 105.

[0099] In a first time period t1 , which may correspond to the position shown in Figure 4C, wherein the optical sensor arrangement 103 may be in a first axial position, there may be no sensor output signal present as no light may be reflected and therefore no light may be detected by the optical detector 105 of the optical sensor arrangement 103. However, when the optical sensor arrangement 103 and therefore the light pipe 115 are axially moved, at a certain axial position of the light pipe 115 the reflective component 117 may be illuminated. Consequently, in a second time period t2 corresponding to a period of time in which the light-emitting end 116 of the light pipe 115 passes the reflective component 117 as shown in Figure 4D, a high sensor output signal HA during the axial movement of the light pipe along the reflective component 117 may be provided. This high sensor output signal HA may cause the monitoring device 106 to switch from sleep mode to operation mode. Assuming that the reflective component 117 comprises a higher reflectivity than the reflective flag 120, a signal strength of the sensor output signal decreases to a low sensor output signal resulting from axial movement LA when the lightemitting end 116 is directed towards the reflective flag 120 as shown in Figure 4E, i.e. when the optical sensor arrangement 103 reaches the position depicted in Figure 4E.

[0100] In this position shown in Figure 4E, which may correspond to a position in which the optical sensor arrangement 103 may be in a second axial position, rotation of the second portion 101 during dose dispensing may cause the light-emitting end 116 of the light pipe 115 to alternately illuminate a reflective flag 120 being more reflective and a flag 121 being less reflective. The sensor output signal 124 may thus alternate between a high sensor output signal resulting from rotational movement HR and a low sensor output signal resulting from rotational movement LR. The resulting sensor output signal in this third period of time t3 may then be used to determine the amount of dose dispensed.

[0101] Figures 6A and 6B show an example of a portion of a drug delivery device 1 comprising a clutch element 25 with radially protruding elements 23. A purely axially extending light pipe 125 may be used to guide light from the optical sensor arrangement 103 to the radially protruding elements 23.

[0102] In the position shown in Figure 6A, the optical sensor arrangement 103 may be located in a second axial position, i.e. closest to the radially protruding element 24. As can be noted, the first portion 102 of the module has been axially moved and is shown in a depressed state. The clutch element 25 may be disengaged. The monitoring device 106 may thus be switched to operation mode. In an example, the module is configured to be switched into the operation mode shortly before the clutch element is fully disengaged, thereby switching the electronics of the electronic module into the operation mode before dispensing of a dose starts such that the electronic module is ready to capture the rotational movement of the relevant rotatable component during dose dispensing. This may be achieved by respective configuration and location of the optical sensor arrangement and the clutch.

[0103] In this position, rotation of the optical sensor arrangement 103 relative to the clutch element 25 may cause light to be directed alternately towards the radially protruding elements 23 and the material-free areas between two radially protruding elements 23. As a result, the rotation alternately causes light to be reflected by the radially protruding elements 23 and not to be reflected by the material-free areas. Similar to the axially protruding elements 21 or the flags 120, 121 , the resulting sensor output signal may thus alternate between higher and lower values and may thus be used to determine the amount of dose dispensed.

[0104] In summary, the disclosure therefore eliminates the need for a switch to be provided for switching an electronic module for a drug delivery device between sleep mode and operation mode in addition to an optical sensor arrangement. In other words, the disclosure allows to realize by means of the monitoring device and the respective optical sensor arrangement both the switch function and the determination function for determining the amount of drug dispensed with the drug delivery device.

[0105] Reference Numerals

[0106] 1 drug delivery device

[0107] 10 housing (of the drug delivery device)

[0108] 11 dose button

[0109] 12 dose dial grip

[0110] 13 display window

[0111] 14 container

[0112] 15 needle

[0113] 16 inner needle cap

[0114] 17 outer needle cap

[0115] 18 cap

[0116] 19 proximal end surface (of the dose button)

[0117] 20 number sleeve

[0118] 21 radially protruding elements

[0119] 22, 22' axial end face

[0120] 23 radially protruding elements

[0121] 24 lateral surface

[0122] 25 clutch element

[0123] 100 electronic module

[0124] 101 second portion

[0125] 102 first portion

[0126] 103 optical sensor arrangement

[0127] 104 light source

[0128] 105 optical detector

[0129] 106 monitoring device

[0130] 107 electric power source

[0131] 108 processor

[0132] 109 fastening means

[0133] 110 housing elements

[0134] 111 circuit board assembly

[0135] 112 communication unit 113 proximal end surface

[0136] 114 (illuminated) surface

[0137] 115 light pipe

[0138] 116 light-emitting end

[0139] 117 reflective component

[0140] 118 clutch

[0141] 119 first clutch feature

[0142] 120 (reflective or high reflective) flag

[0143] 121 (non-reflective or less reflective) flag

[0144] 122 push element

[0145] 124 sensor output signal

[0146] 125 purely axially extending light pipe

[0147] I longitudinal axis d distance

[0148] D distal direction

[0149] P proximal direction t1 first time period t2 second time period t3 third time period

[0150] HA high sensor output signal resulting from axial movement

[0151] LA low sensor output signal resulting from axial movement

[0152] HR high sensor output signal resulting from rotational movement R low sensor output signal resulting from rotational movement

Claims

Claims1. An electronic module (100) for use with a drug delivery device (1), wherein the electronic module comprises a displaceable component configured to be axially moved relative to a reference component along a longitudinal axis (I) to initiate and / or effect drug dispensing, and a monitoring device (106) with an electric power source (107), a processor (108) electrically connected to the electric power source, an optical sensor arrangement (103) electrically connected to the processor and comprising at least one light source (104) and at least one optical detector (105), wherein the monitoring device (106) is configured to determine, store and / or transmit data indicative of an amount of drug dispensed from the drug delivery device based on detection of rotation of a rotatable component rotationally movable about the longitudinal axis (I) relative to the displaceable component during drug dispensing, and wherein the monitoring device is configured to switch between a sleep mode of relatively low power consumption and an operation mode of relatively higher power consumption, characterized in that the optical sensor arrangement (103) is configured to be axially moved relative to the reference component upon axial displacement of the displaceable component and to detect this relative movement based on a change in sensor output signal, and in that the processor (108) is configured to switch the monitoring device (106) from the sleep mode to the operation mode in response to detection of said axial movement of the optical sensor arrangement (103) relative to the reference component.

2. The electronic module (100) according to claim 1 , wherein the reference component comprises a reflective component (22', 117) or a light blocking element (21) and wherein the optical sensor arrangement (103) is configured to provide a change in thesensor output signal upon axial movement of the optical sensor arrangement relative to the reflective component (22', 117) or the light blocking element (21).

3. The electronic module (100) according to claim 1 or 2, wherein the optical sensor arrangement (103) is configured to be located in a first axial position relative to the reference component, in which the monitoring device (106) is in the sleep mode, and wherein the optical sensor arrangement is configured to be axially moved upon axial displacement of the displaceable component into a second axial position, in which the monitoring device is in the operation mode.

4. The electronic module (100) according to claim 3, wherein the optical sensor arrangement (103) is configured to be located in the first axial position relative to the reference component during dose setting or in a zero dose position.

5. The electronic module (100) according to claim 3 or 4, wherein the optical sensor arrangement (103) is configured to detect rotation of the rotatable component when in the second axial position.

6. The electronic module (100) according to any one of the preceding claims, wherein the reference component is the rotatable component.

7. The electronic module (100) according to any one of the preceding claims, wherein the optical sensor arrangement (103) is configured to be axially moved relative to the reference component thereby reducing a distance (d) between the optical sensor arrangement (103) and the reference component.

8. The electronic module (100) according to any one of claims 3 to 7, wherein, when the optical sensor arrangement (103) is axially moved from the first axial position into the second axial position, the sensor output signal provided by the optical sensor arrangement is reduced.

9. The electronic module (100) according to claim 8, wherein the reference component is configured to be moved at least partially between the at least one light source(104) and the at least one optical detector (105) of the optical sensor arrangement (103) during axial movement from the first axial position into the second axial position, and wherein the reference component is configured to screen the at least one optical detector at least partially from the at least one light source.

10. The electronic module (100) according to claim 9, wherein the reference component comprises at least one axially protruding element (21) configured to at least partially screen the at least one optical detector (105) from the at least one light source (104).

11. The electronic module (100) according to any one of the preceding claims, wherein the reference component comprises at least one radially protruding element (23), and wherein the distance between the optical sensor arrangement (103) and the at least one radially protruding element of the reference component is reduced when the optical sensor arrangement is moved axially relative to the reference component.

12. The electronic module (100) according any one of the preceding claims, wherein the optical sensor arrangement (103) comprises a light pipe (115) configured to guide light towards the reference component.

13. The electronic module (100) according to claim 12, wherein the light pipe (115) is configured to guide light towards the reference component in a direction perpendicular to the direction of relative axial movement, and wherein, when the optical sensor arrangement (103) is axially moved from the first axial position into the second axial position, the light pipe (115) is configured to be moved past a reflective component (117), and wherein the sensor output signal is temporarily changed by the reflective component with respect to the sensor output signal in the first axial position and / or the second axial position.

14. The electronic module (100) according to any one of the preceding claims, wherein the monitoring device (106) is configured to activate and / or communicate with and / or transmit data to an external device, when the monitoring device is switched from sleep mode to operation mode.

15. The electronic module (100) according to any one of the preceding claims, wherein the electronic module is configured to be releasably attached to a drug delivery device (1).

16. An assembly comprising a drug delivery device (1) and an electronic module (100) according to any one of the preceding claims.

17. A method for switching an electronic module (100) between two different modes, wherein the electronic module comprises an optical sensor arrangement (103), a monitoring device (106) and a processor, the method comprising: axially moving a displaceable component and the optical sensor arrangement (103) of the module (100) relative to a reference component along a longitudinal axis (I), detecting the relative axial movement of the optical sensor arrangement (103) and the reference component, switching the monitoring device (106) from the sleep mode to the operation mode by means of the processor in response to detection of said relative axial movement of the optical sensor arrangement (103) and the reference component.

18. The method of claim 17, further comprising the step of determining the amount of drug dispensed from a drug delivery device (1) coupled to or comprising the electronic module (100) based on detection of relative rotation of a rotatable component rotationally movable about the longitudinal axis (I) and the displaceable component by means of the monitoring device (106).

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