Electronic module configured to correct and / or validate dose counts

Abstract

The present disclosure relates to an electronic module (100) comprising at least an electric power source (109) configured to power electronic components of the electronic module (100), a circuit board assembly (110) electrically connected to the electric power source (109), at least a first sensor arrangement (112) configured to provide a first sensor output signal (A), at least a second sensor arrangement (113) configured to provide a second sensor output signal (B), and a processor unit (114) configured to perform a first dose count by processing specific first sensor output values (Aindex) of the first sensor output signal (A) and a second dose count by processing specific second sensor output values (Bindex) of the second sensor output signal (B). In order to provide an improved electronic module (100), the processor unit (114) is further configured to correct and / or validate the first dose count and / or the second dose count and to provide a general dose count from the corrected and / or validated first and second dose counts.

Description

[0001] Description

[0002] ELECTRONIC MODULE CONFIGURED TO CORRECT AND / OR VALIDATE DOSE COUNTS

[0003] The present disclosure is generally directed to an electronic module, for example to an electronic module which is releasably attached to a drug delivery device or integrated into a drug delivery device.

[0004] Electronic modules are generally known and often used to provide further functionalities to drug delivery devices. As such for example electronic modules are known which may be releasably attached to a drug delivery device. In this regard, electronic modules are regularly used to count and / or record doses, e.g. a number of drug units which are dialed and / or dispensed. To this end, it is further known to integrate a sensor in the electronic module which senses corresponding relative movements to detect the dialed and / or dispensed dose units. In order to process and log the sensor data, it is also known to transmit corresponding sensor data to a processor unit, a storage unit and / or to use means for transmitting sensor data to a mobile device, such as a smartphone.

[0005] An exemplary data collection device for attachment to an injection device is shown in WO 2016 / 198516 A1. Further injection monitoring modules are for example known from WO 2020 / 217094 A1 , WO 2021 / 140352 A1 and WO 2021 / 214 275 A1.

[0006] When detecting movements, however, there are often inaccuracies that can be caused by inconsistent movement patterns of relevant components, e.g. due to manufacturing tolerances, wear and tear of components during use, changing environmental conditions or simply due to different handling of the drug delivery device by the user. In addition, the sensors used for detecting movements may provide incorrect information. With acoustic sensors, for example, background noise that is unrelated to dose selection or delivery may result in a sensor output signal that may lead to incorrect processing when used for dose counting.

[0007] As an example, where handling of the drug delivery device or the electronic module by the user is crucial for an accurate dose count, an injection device is considered, wherein the dose button of the injection device is allowed to rotate relative to the dose dial grip in all states, especially during dose dispensing, as is the case with the device disclosed in WO 2004 / 078239 A1. Here, rotation of the dose button is typically prevented by the user's thumb or finger

[0008] September 22, 2025 S 100 P 548 WO applying pressure onto the dose button. For the data collection device disclosed in WO 2016 / 198516 A1 it is typically assumed that the user prevents the rotation of a second portion relative to a first portion during dose dispensing by applying pressure to the second portion.

[0009] However, since rotational movement of the second portion is still possible during dose dispensing measurement inaccuracies may occur if the user cannot completely prevent rotational movement by his or her thumb or finger. Thus, even though, often the dose button or the second portion is essentially prevented from rotating by the user's thumb or finger during dose dispensing, it is impossible to fully rely on the measured data. The measured data thus may form useful information which, for example, provide a physician or user with indications for the use of the injection device. However, it would be deceptive to rely solely on these data if, for example, the dosing regimen needs to be adjusted.

[0010] In this regard, it is known to count dose units by detecting signal peaks above predetermined thresholds. It is further known to only count signal peaks when there is a certain time step to a preceding signal peak, regardless of whether the signal peak which is counted actually indicates a dose unit. Thus, dose units are also counted if, for example, a peak value is above the threshold value and if the time step to a preceding signal peak is larger than the specified time step, although the counted peak value is not associated with a dose delivery or a dose setting.

[0011] Exemplary devices which have two sensors and which perform a dose count are known from US 2021 / 236738 A1 and US 2023 / 338666 A1.

[0012] Based on the aforementioned problems, it is an object of the present disclosure to provide an improved electronic module.

[0013] This object is essentially solved by an electronic module according to claim 1.

[0014] The electronic module comprises at least an electric power source, such as a battery, configured to power electronic components of the electronic module. Electronic components may be processor units, display units, sensor arrangements, storage units, communication modules, for example wireless modules, chips, conductors or the like. The electronic module may comprise a housing in which the electric power source and / or any of the further electronic components are arranged. In this regard, the housing may comprise several parts or a single part, e.g. an injection-molded plastic part.

[0015] September 22, 2025 S 100 P 548 WO Further, the electronic module comprises a circuit board assembly electrically connected to the electric power source. The aforementioned electronic components may be electrically connected to the circuit board assembly. The electric power source may thus power the electronic components by means of the circuit board assembly. The circuit board assembly may comprise a substrate equipped with the electronic components. The circuit board assembly may comprise a printed circuit board assembly (PCB). The circuit board assembly may be arranged inside the housing.

[0016] In addition, the electronic module comprises at least a first sensor arrangement and at least a second sensor arrangement. However, according to one aspect, the electronic module may also comprise more than two sensor arrangements. The sensor arrangements may each comprise a different type of sensor or the same sensor. Sensors which may be used as a first sensor arrangement and / or a second sensor arrangement may be an accelerometer, a gyroscope, a light sensor, a sound or acoustic sensor, a pressure sensor, a temperature sensor, a proximity sensor, an infrared sensor, an ultrasonic sensor, a color sensor, a humidity sensor, a tilt sensor, a flow sensors, a Hall effect sensor, a radiation sensor, a lidar, an electrical current sensor, an optical sensors, a force or torque sensor, a strain gauge or mechanical switch, for example, sensing relative movement of components by switch activation. Preferably the sensor arrangements comprise different sensors.

[0017] The first sensor arrangement is therefore configured to provide a first sensor output signal and the second sensor arrangement is configured to provide a second sensor output signal. The sensor output signals refer to the same dose event. In other words, a single dose event, for example, a dose dialing and / or dose dispensing, may lead simultaneously to a first sensor output signal and to a second sensor output signal, wherein both sensor output signals refer to the same event for example a dose delivery event, and may provide dose incidents referring to the respective dose event.

[0018] Further, the first sensor arrangement and the second sensor arrangement may be configured to detect dose incidents which are in temporal connection. The sensor output signals may for example be a voltage pulse related to a condition detected by a specific sensor. For example, greater reflections detected by an optical sensor may cause a larger voltage pulse than fewer or no reflections. Similarly, sounds, for example click sounds from a drug delivery device, may trigger a larger voltage pulse than the ambient sounds or no sounds perceived by the acoustic sensor. Similarly, pressure applied to the dose button during dose delivery may trigger a voltage pulse and so on.

[0019] September 22, 2025 S 100 P 548 WO A processor unit is configured to perform a first dose count by processing specific first sensor output values of the first sensor output signal. Further, the processor unit is configured to perform a second dose count by processing specific second sensor output values of the second sensor output signal. In this regard, it is generally assumed that there should be specific first sensor output values referring to the first sensor arrangement and specific second sensor output values referring to the second sensor arrangement having similar time points. In other words, a specific first sensor output value should be temporally related to a specific second sensor output value since both sensor arrangements detect the same incidents during a dose event. The processor unit may be integrated within a housing of the electronic module, for example within the same housing as the sensor arrangements, or may be connected, for example wirelessly connected, to the sensor arrangements and may thus only be used to further process the sensor data and may thus be in a functional connection to the electronic module.

[0020] The specific sensor output values of the sensor output signals may also be referred to as definite sensor output values. The sensor output values may be called specific or definite as they allow to identify dose incidents. In other words, the specific or definite sensor output values may be used to perform a dose count. In general, the specific or definite sensor output values are those sensor output values which by their characteristic, for example due to preprocessing, may be considered as a dose unit, i.e. a set and / or delivered dose unit, and are therefore in principle detected as such by the processor unit.

[0021] For example, the specific sensor output values may be peak values above a predetermined threshold value, for example a voltage limit. Furthermore, the specific sensor output values may be generated by pre-processing the sensor output signal by the processor unit before performing a dose count. For example, the sensor output signal may first be modulated, e.g. smoothed, rectified, amplified, etc. before the sensor output values may be considered as specific or definite sensor output values.

[0022] As in general, the specific or definite sensor output values are those sensor output values which may be considered as dose units, those specific sensor output values may not necessarily refer to actual dose units. In other words, the specific sensor output values may indicate a dose unit, for example, because the specific sensor output values are above a predetermined threshold value, such as a voltage limit, and for example sufficiently distanced in time to a preceding sensor output value, however, an actual event that has led to the specific sensor output value may not be related to a dose delivery or a dose setting. For example,

[0023] September 22, 2025 S 100 P 548 WO regarding an acoustic sensor, a background noise may have caused a specific sensor output value.

[0024] Therefore, since the processor unit would consider the specific sensor output values as dose units, such specific first sensor output values result in a first dose count and such specific second sensor output values result in a second dose count. In other words, an increase in specific first sensor output values may increase the first dose count and an increase in specific second sensor output values may increase the second dose count. Still, however, the first dose count and / or the second dose count may not be correct, i.e. , an actual, real dose count may differ from the first and / or second dose count. The first dose count and the second dose count may therefore also be considered as a presumed first and second dose count, for example. Ideally, however, the first dose count and the second dose count are identical.

[0025] Consequently, and according to the disclosure, the processor unit is further configured to correct and / or validate the first dose count and / or the second dose count. In this regard, a correction may be understood as a processing of the first and / or second sensor output signal comprising the specific first and / or second sensor output values which may result in a correction of one of the sensor output signals. For example, by processing the sensor output signals it may be determined that the dose count for one of the sensor output signals is smaller than the dose count for the other one of the sensor output signals. For example, the first dose count may be smaller than the second dose count. Hence, there may be either a dose unit, i.e. in other words a specific first sensor output value, missing in the first sensor output signal or there may be one specific second sensor output value too many. Respective processing may thus correct either one of the sensor output signals, for example by increasing a dose count which is missing a specific sensor output value or by decreasing a dose count if there are too many specific sensor output values.

[0026] In general terms a correction of a dose count may thus be understood as an adjustment of one of the two dose counts to the respective other one of the two dose counts. For example, the first dose count may be adjusted to the second dose count or vice versa.

[0027] Still further, for example, by comparing the first dose count with the second dose count it may be determined that the two dose counts are identical in number. It may further be possible to determine whether the specific sensor output values of the different sensor output signals are present at similar time points, i.e. that a deviation in time between a specific first sensor output value and a corresponding specific second sensor output value is below a predetermined time interval for example. Consequently, when the number of dose counts are for example identical

[0028] September 22, 2025 S 100 P 548 WO as well as the time points of the specific sensor output values are for example within predetermined thresholds, it may be assumed that the two dose counts are correct. The dose counts may thus be considered validated. Therefore, for example, either the first dose count or the second dose count may be used to assess an actual number of dose units delivered or set. In other words, in this case the dose counts would have been validated, i.e. checked for correctness, and one of the dose counts may be used as a general dose count.

[0029] In general terms a validation of a dose count may thus be understood as a verification of one of the two dose counts based on the sensor output signal of the respective other one of the two dose counts. For example, the first dose count may be verified based on the second sensor output signal or the second dose count may be verified based on the first sensor output signal. In this regard, verification is a check of the correctness of a dose count.

[0030] The processor unit is thus configured to provide a general dose count from the corrected and / or validated first and second dose counts. The general dose count, which is also the actual dose count with a greater degree of certainty, may thus be derived from the first dose count or from the second dose count as either both dose counts have been corrected and may thus be suitable to be used as the general dose count or the processor unit has determined, i.e. validated, which dose count is presumably the correct one or that both dose counts, i.e. the first dose count and the second dose count, are correct.

[0031] Consequently, the electronic module according to the disclosure provides an improved, i.e., in particular, more reliable indication of the accuracy of a dose count. In particular, at least two sensors are required for this purpose, both of which provide sensor data suitable for providing information about the delivery or setting of dose units.

[0032] The processed data from the sensors may be used to provide the user or healthcare professional with information about an amount of dose delivered, e.g. whether a dose event has occurred, a time at which a dose has been delivered and the amount of dose that has been dispensed. The corresponding information may be displayed on an external device such as a mobile device or a computer or on the electronic module or drug delivery device itself.

[0033] The drug delivery device, with which the electronic module may be used, may for example be the drug delivery device known from EP 3 164 173 A1. Other suitable working principles of drug delivery devices to be used may for example be described 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 B2, US 7,241 ,278 B2 or US 9,937,294 B2. The drug delivery

[0034] September 22, 2025 S 100 P 548 WO device may comprise a clicker arm in order to provide a click sound during dose delivery and / or dose setting.

[0035] According to one aspect, the processor unit may be configured to determine a time point referring to at least one specific second sensor output value of the second sensor output signal. The time point may thus be a point in time, for example a second time point, which is assigned to a single specific second sensor output value, wherein the single specific second sensor output value may be counted, i.e. used to increase the (presumed) second dose count. A second time point may therefore be a time point at which a specific second sensor output value is present. The processor unit may be configured to determine second time points for all specific second sensor output values. Further, the processor unit may be configured to determine first time points for all specific first sensor output values. However, the time point may also refer to two specific second sensor output values, for example, to two second time points. The time point may thus for example be a time point midway between two specific second sensor output values. Further, the processor unit may be configured to determine a number of specific first sensor output values within a first time period preceding and / or following the time point, which may for example be a second time point. Starting from this time point, the processor unit is set up to determine how many specific first sensor output values, i.e. sensor output values relevant for the first dose count and detected by the first sensor arrangement, lie within a first time period. The specific sensor output value may thus relate to a dose incident or a dose unit and may be used to provide a dose count.

[0036] The first time period that is considered may extend from the time point before, after or before and after the time point. In other words, the first time period which is considered may precede and / or follow the time point. A time period covering a time preceding and following a time point may be considered as a bi-directional time period, wherein a time period only covering a time preceding or following a time point may be considered as a uni-directional time period. A unidirectional time period preceding a time point may be considered as a negative time period, wherein a uni-directional time period following a time point may be considered as a positive time period. If no specific first sensor output value is determined within the first time period, it may be derived that a first dose count, i.e. a first specific sensor output value, has been missed. The first dose count may thus be increased by one dose unit. However, if, for example a first time period is considered starting from a time point midway between two consecutive second time points, and only one specific first dose value is detected, wherein however two specific second dose values are detected within the same time period, the first dose count may also be increased by one dose unit.

[0037] September 22, 2025 S 100 P 548 WO Conversely, the detection of too many specific first sensor output values within the first time period, i.e. for example two specific first sensor output values where only one is expected, may be used to lower the first dose count or to adapt a threshold value responsible for detection of specific sensor output values, for example a voltage limit or a voltage threshold. Considering a first time period before a time point referring to at least one specific second sensor output value, this first time period may thus be used to detect missing dose counts or to detect excessive dose counts.

[0038] In one aspect, the time point may be a second time point. Further, a duration of the first time period preceding and / or following the second time point may be a fraction of a second time interval between two consecutive specific second sensor output values. Furthermore, one of the two consecutive specific second sensor output values, i.e. one of the two consecutive specific second sensor output values used to determine the second time interval, may be the specific second sensor output value corresponding to the second time point. The fraction may thus be predetermined by a factor. In other words, the first time period may for example be derived by multiplying the second time interval with a predetermined factor. The factor may for example be three quarters. In other words, the first time period may be three quarters of the second time interval. The factor used for a time period preceding the second time point and the factor used for a time period following the second time point may also be different from one another. In one aspect, the first time period may also be predetermined. By determining a shorter (, i.e. by using a factor,) first time period, data processing may be accelerated, as a shorter first time period must be taken into account during processing. At the same time, the factor may be selected in such a way that it still allows to reliably determine missing or excessive specific sensor output values.

[0039] According to one aspect, absolute values of a duration of the first time period preceding the aforementioned time point or the second time point and of a duration of the first time period following the time point or the second time point are the same. The use or consideration of an absolute value is intended to mean that no signs of the first time periods are taken into account, as a first time period in a range preceding a time point could otherwise also be understood as a negative time period. If the first time period may be derived from a fraction of a second time interval, a factor used to determine the fraction may also be the same for a first time period preceding or following the second time point. Still, however, as aforementioned, the durations may also be different. The decision as to whether the durations of the first time periods may be the same or different may be based, for example, on whether the distances between the specific second sensor output values, which are used to determine the time point or the second

[0040] September 22, 2025 S 100 P 548 WO time point, are (similarly) the same or different between several specific second sensor output values.

[0041] In one aspect, a total duration of the first time period, i.e. a total length of the first time period, including the duration of the first time period preceding the second time point and the duration of the first time period following the second time point may be an average of two second time intervals each determined by a duration between the second time point and a corresponding preceding or a corresponding following second time point of a specific second sensor output value. In other words, the total duration of the first time period may be determined by an average of two second time intervals referring to a second time point from which the first time period is considered. Using an average of two second time intervals may be especially helpful when second time intervals between different specific second sensor output values are different, so that these differences are balanced out.

[0042] According to a further aspect, the processor unit may be configured to determine a first time interval between two consecutive specific first sensor output values, i.e. between the corresponding first time points of the two consecutive specific first sensor output values, and a corresponding closest second time interval between two consecutive specific second sensor output values, i.e. between the corresponding second time points of the specific second sensor output values. In this regard, a corresponding closest second time interval may be considered closest, when for example a second time point of the second time interval lies within the first time interval. More precisely, the second time point which may be considered for the closest second time interval, may be the second time point that precedes the later first time point of the first time interval with the smallest time difference. Still, it may be possible to consider a second time interval with a further second time point following the second time point within the first time interval as well as a further second time point preceding the second time point within the first time interval. However, this decision, which of the second time intervals should be considered, may depend on whether the sensor data may be processed directly or later on, when also second time points following the second time point within the first time interval have been detected or determined. Further, the processor unit may be configured to correct and / or validate the first dose count or the second dose count by relative comparison of the first time interval with the second time interval. In this regard, in order to provide for a relative comparison of the first time interval with the second time interval absolute values of the respective time intervals may be compared. If the first time interval may for example have a first number of seconds, i.e. a first length, and the second time interval may have a second number of seconds, i.e. a second length, the first length may be compared with the second length in order to perform a relative comparison between the two time intervals. For example,

[0043] September 22, 2025 S 100 P 548 WO if the first time interval is smaller than the second time interval, the first dose count may be reduced by one dose unit, as it may be assumed that the specific first sensor output values defining the first time interval probably comprise an incorrect measured specific first sensor output value. The dose counts may thus be corrected and / or validated, which may lead to an improved general dose count.

[0044] In one aspect, a deviation between the first time interval and the second time interval may be determined. The processor unit may be configured to correct and / or validate the first dose count or the second dose count depending on a magnitude of the deviation. For example, if the first time interval is smaller than the second time interval by a certain factor, e.g. only a quarter of the second time interval, wherein the factor may thus define the magnitude of the deviation, the first dose count may be reduced or decreased by one dose unit, as it may be assumed that the specific first sensor output values defining the first time interval probably comprise an incorrect measured specific first sensor output value. On the other hand, if, for example, the first time interval is greater than the second time interval by a certain factor, e.g. one and a half times as large as the second time interval, the first dose count may be increased by one dose unit, as it may be assumed that the specific first sensor output values defining the first time interval probably comprise a missing specific first sensor output value. Thus, and according to a further aspect, the processor unit may be configured to increase the first dose count by one dose unit when the deviation between the first time interval and the second time interval exceeds a predetermined value greater than 1 , and wherein the processor unit may be configured to decrease the first dose count by one dose unit when the deviation between the first time interval and the second time interval decreases below a predetermined value less than 1. Consequently, depending on the deviation it may be determined if there are missing dose counts or if there are too many dose counts.

[0045] According to a further aspect, the electronic module additionally comprises a switch. The switch may be configured to activate and / or deactivate electronic components of the electronic module. For example, the electronic module may be configured such that it may be switched from a first state having lower energy consumption into a second state having higher energy consumption. Switching from the first state into the second state may be performed by operating the electronic module. The first state may be a sleeping mode and the second mode may be a detection mode. Consequently, the sensor arrangements may only be configured to provide a sensor output signal, when the switch is actuated. In this regard, the processor unit may be configured to detect a switch time point at which the switch is actuated. In other words, a switch time point may be determined, wherein the switch time point may be indicative of a point in time when the switch has been actuated, i.e., when the electronic module may be

[0046] September 22, 2025 S 100 P 548 WO switched from sleeping mode to detection mode or vice versa. The switch incident may thus cause the processor unit to identify a switch time point. Further, the processor unit may be configured to determine a first switch time interval between the switch time point and a first time point at which a specific first sensor output value preceding and / or following the switch time point is detected and / or the processor unit may be configured to determine a second switch time interval between the switch time point and a second time point at which a specific second sensor output value preceding and / or following the switch time point is detected. Consequently, although at the beginning or the end of use of the electronic module there may be erroneous counts, for example an acoustic sensor may detect noise of parts contacting each other when the button is pressed or released, or a user may rotate the button when the user starts to push it or when the user stops pushing it so an optical sensor may have an additional count, i.e. one specific sensor output values too many, these dose counts may not be counted or considered if a switch time interval is considered, and wherein only dose counts are considered which comprise a time point following the switch time interval.

[0047] Further, according to one aspect, the processor unit may be configured to correct and / or validate the first dose count or the second dose count by a comparison of the first and / or second switch time interval with a predetermined switch time interval. In other words, the dose count, for example the first dose count, may for example be decreased by the number of dose counts which are within a predetermined switch time interval, for example the first switch time interval. Consequently, only dose counts after the switch time interval may be considered. If there are no dose counts, this may be seen as a validation of the dose counts, as they may then be considered correct.

[0048] In one aspect, the processor unit may be configured to correct and / or validate the first dose count or the second dose count by a comparison of the first switch time interval with the second switch time interval. For example, if the first switch time interval, i.e. the time interval after a switch time point until a first or initial specific first sensor output value or after a last or final specific first sensor output value until a switch time point, is smaller than a predetermined fraction of the second switch time interval, for example, only half the size, the first dose count may be decreased by one dose unit. Consequently, wrong dose counts at the beginning of a dose detection and at the end of a dose detection, for example a dose dialing and / or dispensing detection, may be corrected and / or validated.

[0049] According to a further additional or alternative aspect, the processor unit may be configured to determine a first time point of an initial and / or final specific first sensor output value, i.e. of a first and / or last specific first sensor output value, and / or a second time point of an initial and / or

[0050] September 22, 2025 S 100 P 548 WO final specific second sensor output value, i.e. of a first and / or last specific second sensor output value. The initial and / or final specific sensor output values may for example be determined based on a switch time point. Further, the processor unit may be configured to determine a number of specific first sensor output values within a predetermined time period after and / or before the second time point and / or the processor unit may be configured to determine a number of specific second sensor output values within a predetermined time period after and / or before the first time point. Thus, if for example, the first or initial specific first sensor output value of the first sensor arrangement is not within a uni-directional time period before the first or initial specific second sensor output value, the first dose count may for example be decreased by one dose unit or by the number of dose units present before the uni-directional time period. Further, if for example, the last or final specific first sensor output value of the first sensor arrangement is not within a uni-directional time period after the last or final specific second sensor output value, the first dose count may for example be decreased by one dose unit or by the number of dose units present after the uni-directional time period. Consequently, specific sensor output values which are incorrect, i.e., which do not relate to an actual dose delivery incident or an actual dose dialing incident, may be ignored and the dose count may thus be corrected.

[0051] Furthermore, according to one aspect, the processor unit may be configured to correct the first dose count and / or the second dose count by increasing and / or decreasing the first dose count and / or the second dose count by increasing and / or decreasing the first dose count and / or the second dose count by at least one dose unit. Consequently, and as already described before, a correction of the dose count may be considered as a decrease or increase of a dose count by dose units, for example by one dose unit. Further, however, according to one aspect, alternatively to increasing or decreasing the dose count, a predetermined threshold value which may be responsible for deciding what can and what cannot be considered a specific sensor output value, may be amended based on the aforementioned processing of the sensor output signals. For example, an amplitude of the threshold value, may be reduced within a relevant time period or time interval, if for example no specific sensor output value is detected although a specific sensor output value should have been detected. For example, a predetermined threshold value such as a voltage limit may be reduced. Subsequently, the dose count may only be increased if a specific sensor output value is detected with the lower threshold value. This may reduce the risk of adding a dose count incorrectly, and also increases the chance of detecting a dose count if the sensor output signal is temporarily weak or low.

[0052] September 22, 2025 S 100 P 548 WO In one aspect, the electronic module may further be configured to be releasably attached to a drug delivery device. For example, the electronic module may be releasably attached to the drug delivery device by fastening means for releasable attachment, for example, interacting mechanical coupling elements or by frictional or elastic engagement. In this regard, the housing of the electronic module may comprise the aforementioned fastening means for releasable attachment to a drug delivery device. The electronic module may be configured to be releasably attached to a dose button of a drug delivery device. The electronic module may be configured to be releasably attached to a dial grip of a drug delivery device. An assembly of the drug delivery device and the electronic module may thus comprise a drug delivery device and an electronic module configured for releasable attachment to the drug delivery device. The electronic module may for example be detached when the electric power source needs to be recharged or when sensor data needs to be transferred to a further device. Further, the electronic module may be attached to the drug delivery device when dose counts are to be detected. In this regard, the electronic module may be configured to be releasably attached to a dial grip of a drug delivery device.

[0053] Further, in one aspect, the at least one first sensor arrangement may comprise an acoustic sensor. Further, the at least one second sensor arrangement may comprise at least one optical sensor. Using two types of different sensors, one of which is not affected by a relative rotational movement between the electronic module and the drug delivery device, has the advantage of a more reliable detection of dose counts. For example, using an acoustic sensor has the advantage that this type of sensor is typically only affected by sounds, wherein the optical sensor is only affected by visual impacts. Consequently, the sensors react to different effects, which are typically overlapping or occur together during dose delivery or dose dialing. The acoustic sensor may for example be configured to detect clicks, i.e. click sounds, or any other sounds which are generated when a dose is dialed and / or dispensed. The sounds, for example the click sounds or beep sounds, may be generated mechanically, electromechanically or electronically, e.g. by a physical impact, the conversion of a mechanical contact into an electronic signal or by a purely electronic signal. The acoustic sensor may for example comprise a microphone. The optical sensor may be configured to generate a signal, e.g. voltage signal, based on detection of light, e.g. light reflected or interrupted by an encoder surface.

[0054] 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

[0055] September 22, 2025 S 100 P 548 WO 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.

[0056] 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.

[0057] 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 dualchamber 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.

[0058] 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,

[0059] September 22, 2025 S 100 P 548 WO 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.

[0060] 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.

[0061] 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.

[0062] 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-palmitoyl 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-glutamyl)-des(B30) human insulin; B29-N-

[0063] September 22, 2025 S 100 P 548 WO (w-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

[0064] 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 (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-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.

[0065] 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.

[0066] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0067] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0068] 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 (Synvisc®), a sodium hyaluronate.

[0069] 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

[0070] September 22, 2025 S 100 P 548 WO antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

[0071] 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, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0072] 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. 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).

[0073] 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.

[0074] 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.

[0075] 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-

[0076] September 22, 2025 S 100 P 548 WO 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.

[0077] 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).

[0078] 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).

[0079] In the following, non-limiting, examples of the electronic module and more precisely of the corresponding sensor output signals and their processing are described in more detail by making reference to the drawings, in which:

[0080] Figure 1 shows an exemplary drug delivery device configured to be equipped with an electronic module;

[0081] Figure 2 shows an exemplary electronic module configured to be releasably attached to the drug delivery device shown in Fig. 1 ;

[0082] Figure 3 shows an exemplary voltage pulse of a sensor output signal;

[0083] Figure 4 shows an exemplary first and second sensor output signal together with corresponding switch incidents;

[0084] Figures 5A to 5D show exemplary first and second sensor output signals with a missing specific first sensor output value;

[0085] September 22, 2025 S 100 P 548 WO Figures 6A to 6C show exemplary first and second sensor output signals with excessive specific first sensor output values;

[0086] Figures 7A to 7B show exemplary first and second sensor output signals with initial switch incidents; and

[0087] Figures 8A to 8B show exemplary first and second sensor output signals with final switch incidents.

[0088] In the Figures, identical elements, especially time components referring to similar conditions in different examples or embodiments are provided with the same reference signs. In this regard, however, a first time interval tintA for example shown in Figure 5D is not the same as a first time interval tintA in Figure 6C, i.e. the time intervals have not the same lengths. Still, it may be noted that a first time interval tintA may be used to indicate a time span between two specific first sensor output values Aindex of the first sensor output signal A. Nevertheless, the two specific first sensor output values used to define a first time interval do not need to be the same, i.e. Aj and Ai+i in Figure 5D and AM and Ai in Figure 6C.

[0089] Figure 1 shows an exploded view of an exemplary medicament 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 point to a proximal direction P or from a proximal point to a distal direction D along a drug delivery device axis Y 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, or may perform pure rotational movement.

[0090] The drive mechanism of the drug delivery device 1 may comprise a plunger, a drive sleeve 13, a clutch, a clutch spring, a number sleeve, a last dose nut and so on, which may move 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 [= FlexPen], EP 2 814 547 [= UnoPen], US 9,937,294 B2 [= BD Vystra] or WO 2004 / 078239 A1 [= SoloStar] represent suitable drive mechanisms for the present disclosure.

[0091] September 22, 2025 S 100 P 548 WO Although the aforementioned drive mechanisms disclose suitable drive mechansims for the present disclosure, this does not exclude that although some of these mechanisms may for example be adapted to provide, for example a click sound during dose setting and / or delivery.

[0092] Once the dose is set by means of the dose dial grip 12, the user may press a dose button 11 arranged at the proximal end of the drug delivery device 1 in the distal direction D in order to dispense the dose. When pressing the dose button 11 , the user applies a force directed towards the proximal end of the drug delivery device 1 , wherein the force moves the dose button 11 in the distal direction of the pen and parallel to the second longitudinal axis Y. This axial movement of the dose button 11 releases the drive mechanism for example by decoupling a number sleeve from the drive sleeve, wherein irrespective of which component of the drug delivery device 1 performs a rotational movement during dose delivery, the dose dial grip 12 is coupled to a respective component in order to perform a rotational movement during dose delivery.

[0093] This rotational movement of the dose dial grip 12 during dose delivery may be used to determine, for example, the actual dose delivered by means of an electronic module 100 and more precisely by processing corresponding sensor output signals. In this regard, the drug delivery device 1 may comprise a clicker arm in order to provide a click sound during dose delivery and / or dose setting. Hence, the drug delivery device 1 may emit, produce or generate a sound, e.g. a click sound, when the dose dial grip 12 is rotated to set a dose, when the button 11 is pressed to dispense a dose, when components, for example the drive sleeve 13, inside the drug delivery device move relative to other components, e.g. rotate, when an end position is reached, e.g. an end position during a dose delivery, etc. The sound may be triggered, for example, by a deflected arm, e.g. a deflected clicker arm, inside the drug delivery device 1 , which may be deflected due to relative movements of components of the drug delivery device 1. However, providing a click sound is not necessarily required.

[0094] The exemplary drug delivery device 1 shown in Figure 1 comprises in addition to the dose dial grip 12 and the dose button 11 a display window 14, a needle 15 to which a container may be attached and a needle. The set dose may be displayed via the dosage window 14. The container may be filled directly with a drug, for example, insulin or may be configured to receive a cartridge and thus act as a cartridge holder.

[0095] The needle 16 may be affixed to the container or the receptacle. During dose dispensing the drug is dispensed through the needle 16. The needle 16 may be protected by an inner needle

[0096] September 22, 2025 S 100 P 548 WO cap 17. In addition, the needle 16 or the inner needle cap 17 may be protected by an outer needle cap 18.

[0097] For example, in order for an electronic module 100 to be functionally attached to a drug delivery device 1 , i.e. attached and usable, either the drug delivery device 1 can be adapted to the electronic module 100 or, conversely, the electronic module 100 can be adapted to the drug delivery device 1. Regardless of this, the drug delivery device 1 as well as the electronic module 100 may have different examples, wherein the further description with respect to the drug delivery device 1 essentially deals with the dose button 11 , the dose dial grip 12 and the drive sleeve 13. However, according to one aspect, the electronic module could also be integrated within the drug delivery device 1.

[0098] Figure 2 shows an example of an electronic module 100 releasably attached to a distal end of a drug delivery device 1. In this regard, especially, a dose button 11 , a dose dial grip 12, a drive sleeve 13 and a number sleeve 19 of the drug delivery device 1 are shown. The electronic module 100 shown in Figure 2 comprises a first portion 101 configured to releasably attach the electronic module 100 to the dose dial grip 12 of the drug delivery device 1. The first portion 101 may thus define an auxiliary dose dial grip 102, wherein the first portion 101 follows the movement of the dose dial grip 12 and vice versa.

[0099] Further, the electronic module 100 has a first longitudinal axis X and comprises a second portion 103 coupled to the first portion 101 allowing relative rotational movement about the first longitudinal axis X and relative axial movement parallel to the first longitudinal axis X with respect to the first portion 101. In the example of Figure 2, the first longitudinal axis X and the second longitudinal axis Y are in line. Relative axial movement of the second portion 103 may thus apply pressure onto the dose button 11 . The second portion 103 may thus be considered an auxiliary dose button configured to apply pressure onto the dose button 11 of the drug delivery device 1.

[0100] In this regard, a user may apply pressure onto a proximal end surface 104 of the second portion 103 in order to move the second portion 103 axially with respect to the first portion 101. Axial movement of the second portion 103 may thus apply pressure onto a push element 105 biased by a spring element 106 to return the second portion 103 to its initial position as shown in Figure 2 after being loaded. However, when the second portion 103 is axially moved towards the dose button 11 , the spring element 106 is compressed and push element 105 is configured to actuate a lever arm 107. Actuation of the lever arm 107 may thus actuate a switch 108, for

[0101] September 22, 2025 S 100 P 548 WO example a microswitch, which may wake up electronic components of the electronic module 100.

[0102] In this respect, the electronic module 100 comprises an electric power source 109, here a battery, configured to power electronic components of the electronic module 100, a circuit board assembly 110 electrically connected to the electric power source 109. Thus, when the proximal end surface 104 is loaded and the second portion 103 is moved, thereby moving a distal surface 111 of the second portion 103 towards the dose button 11 , the switch 108 is activated and power is supplied to the electronic components, such as processor units, display units, sensor arrays, memory units, communication modules, such as wireless modules, chips, traces, or the like, connected to the circuit board assembly 110 or the electric power source 109.

[0103] Upon a correspondingly induced dose delivery by the drug delivery device 1 , the first portion 101 subsequently rotates relative to the second portion 103. A click sound may be generated for each delivered dose unit by a clicker arm within the drug delivery device 1 , for example. Accordingly, a first sensor arrangement 112, for example an acoustic sensor, may detect the click sound to provide a first sensor output signal A. Furthermore, a second sensor arrangement 113, for example an optical sensor, may detect the relative movement, for example a rotation between the first portion 101 and the second portion 103, and thereby provide a second sensor output signal B. More precisely, the first and second sensor arrangements 112 and 113 may detect a click sound as well as a relative movement and may provide a sensor signal which is transmitted to a processor unit 114.

[0104] The processor unit 114 may then further process the first and second sensor output signals A and B as described with reference to Figures 3 to 8B below in order to correct and / or validate the first dose count and / or the second dose count and to provide a general dose count from the corrected and / or validated first and second dose counts. In this regard, Figure 3 shows an example of a voltage pulse of a sensor output signal of a single sensor plotted over time. The voltage pulse may for example belong to the sensor output signal of an acoustic sensor configured to detect click sounds which occur during dose dialing and / or dose delivery. The voltage pulse shown in Figure 3 exceeds a predetermined threshold value for the voltage V|imit at two points. In other words, the voltage pulse comprises two voltage peaks, a first voltage peak Vp1 and a second voltage peak Vp2.

[0105] At the first voltage peak Vp1 , the voltage pulse only exceeds the predetermined threshold value for the voltage VIM slightly and for a very short period of time. At the second voltage

[0106] September 22, 2025 S 100 P 548 WO peak Vp2, the voltage pulse exceeds the predetermined threshold value for the voltage VIM for a longer period of time. Still, in order to determine a number of doses that has been delivered or dialed, the voltage peaks Vp1 and Vp2 that exceed the predetermined threshold value for the voltage VIM are counted. Here, the count would be two. Consequently, and according to the voltage pulse, there may for example be two dose units that have been dispensed. However, this dose count only depends on a sensor output signal of a single sensor and may therefore be wrong. For example, the first voltage peak Vp1 may correspond to an unintended click sound at the beginning of the dose delivery and only the second voltage peak Vp2 may correspond to a delivered dose. Thus, although the presumed dose count would be two, the actual or general dose count should be one.

[0107] Further, although additionally a predetermined threshold value for the time tiimit may be considered, wherein voltage peaks Vp1 and Vp2 above the predetermined threshold value for the voltage VIM are combined when these peak values are withing the predetermined threshold value for the time tiM, here the dose count is still two.

[0108] Figure 4 thus shows two exemplary sensor output signals, a first sensor output signal A referring to a signal, for example a modulated voltage pulse, of a first sensor and a second sensor output signal B referring to a signal, for example a modulated voltage pulse, of a second sensor. The sensor output signals A and B are plotted over time and each signal comprises specific sensor output values Aindex and Bindex, wherein the respective index describes the relative position in time to another specific sensor output value of the same sensor output signal. For example, the specific first sensor output value AM is earlier in relation to the specific first sensor output value Aj. In addition, the specific first sensor output value Ai+i is later than the specific first sensor output value A and the specific first sensor output value Aj.

[0109] Further, the index relates to a respective dose incident during a dose event, for example delivered dose units during dose dispensing. For example, the first sensor output signal A comprises multiple specific first sensor output values Aindex which together provide for a first dose count, i.e. a presumed number of dose units delivered. Hence, each of the specific first sensor output values Aindex refer to a dose incident. As such, for example, the first specific first sensor output value Ai refers to a first dose incident, the first specific first sensor output value A2 refers to a second dose incident and the last first specific first sensor output value Anrefers to the last first dose incident.

[0110] Since the electronic module 100 comprises two sensor arrangements which are both active simultaneously in order to detect a dose incident and accordingly provide a sensor output

[0111] September 22, 2025 S 100 P 548 WO signal, a first sensor arrangement 112 with an acoustic sensor, for example, detects a click sound which may indicate dispense of a dose unit, wherein in temporal connection to the click sound an optical sensor of a second sensor arrangement 113 may also detect for example a change in light. In other words, normally the number of specific first sensor output values Aindex and the number of specific second sensor output values Bindex should be the same. Thus, normally a first dose incident, for example Aj, is normally also associated with a specific second sensor output value, for example Bj , in a temporal connection. Index i and j may thus comprise the same numerical value.

[0112] However, there may be some cases in which there is no corresponding specific sensor output value for a sensor arrangement or there are too many specific sensor output values for a sensor arrangement. In other words, there may for example be a case in which Bj-i, Bj and Bj+i exist, however, there may only be Aj and Aj+i so that A is missing. Further, there may be a case in which Bj-i , Bj and Bj+i exist and in addition A , Aj, Aj+i and Aj+2 exist. In other words, there may be more first dose incidents than second dose incidents. These cases are discussed with respect to Figures 5A to 8B.

[0113] Further, the index n or m stands for the last or final specific sensor output value and the index 1 stands for the first or initial specific sensor output value. For example, Bi is the first or initial specific second sensor output value of the second sensor output signal B and Bmis the last or final specific second sensor output value of the second sensor output signal B. Likewise Ai is the first or initial specific first sensor output value of the first sensor output signal A and Anis the last or final specific first sensor output value of the first sensor output signal A. This, however, does not mean that the last or final specific second sensor output value Bmcomprises a second time point t(Bm) which is identical to a first time point t(An) of the last or final specific first sensor output value of the first sensor output signal A.

[0114] For example, in Figure 4 the final specific first sensor output value Anand thus the corresponding first time point t(An) are following the final specific second sensor output value Bmand thus the corresponding second time point t(Bm). In other words, the first time point t(An) is later than the second time point t(Bm). More precisely, in Figure 4 all specific second sensor output values Bindex are before the corresponding specific first sensor output values Aindex, i.e. specific second sensor output values Bindex occur earlier than the corresponding specific first sensor output values Aindex.

[0115] Furthermore, the first sensor output signal A and the second sensor output signal B both show an initial switch incident Si and a final switch incident S2. Both switch incidents Si and S2 refer

[0116] September 22, 2025 S 100 P 548 WO to a switch time point, wherein the initial switch incident Si refers to a first switch time point t(Si) and final switch incident S2 refers to a second switch time point t(S2).

[0117] It should be noted that the switch incidents Si and S2, i.e. operation of a switch, do not necessarily lead to a sensor output signal, i.e. a click sound is not necessarily generated when the switch is actuated. Consequently, the switch incidents Si and S2 plotted on the time axes are to be understood less as sensor output signals and more as incidents which comprise a temporal connection to the specific sensor output values. In other words, the depicted switch incidents Si and S2 may for example refer to the actuation of a switch at the beginning and at the end of a dose event, for example at the beginning and at the end of a dose dispensing event, wherein the switch incidents Si and S2 occur before and after actual detection of dose incidents by the sensor arrangements. The switch incidents Si and S2 are therefore plotted at the same time points on the two corresponding time axes. Nevertheless, one of the sensor arrangements could also be used as a switch. In this regard, if for example the first sensor arrangement would be used as the switch, the switch incidents Si and S2 would still occur at the same points in time with respect to the sensor output signals A and B as only one switch incident Si occurs at the beginning and only one switch incident S2 occurs at the end of a dose event.

[0118] Figures 5A to 5D show the same sensor output signals A and B. In this regard, the first sensor output signal A comprises only two specific first sensor output values Aj and Aj+1. The second sensor output signal B comprises three specific second sensor output values Bj-1, Bj and Bj+1. However, as both sensor output signals A and B are signals of respective sensor arrangements detecting same dose incidents, the sensor output signals should show the same number of specific sensor output values Aindex and Bindex, i.e. the same number of dose incidents.

[0119] Considering that the second sensor output signal B is correct, there is one specific first sensor output value missing in Figure 5A. To be more precise, the specific first sensor output value corresponding to Bj is missing.

[0120] However, when the processor unit 114 is confronted with the respective sensor output signals A and B, the processor unit 114 does not know whether the sensor output signals are correct or not. Therefore, the processor unit 114 is configured to correct and / or validate the respective sensor output signals using different routines.

[0121] According to one aspect as shown in Figure 5B, the processor unit 114 may for example determine a first time period tPdA, which may for example be a bi-directional first time period

[0122] September 22, 2025 S 100 P 548 WO comprising a negative portion -tPdA and a positive portion +tPdA- However, the first time period tpdA may for example also be a uni-directional time period as shown in Figure 5C. In this regard, the processor unit 114 may thus be configured to determine a number of specific first sensor output values Aindex within a first time period tPA preceding and / or following the second time point t(Bj) . The first time period -tPdA is thus preceding the second time point t(Bj) and the first time period +tPdA is following the second time point t(Bj).

[0123] In Figures 5B and 5C no specific first sensor output value Aindex is present within the first time period tPdA. Consequently, it is assumed here that a specific first sensor output value Aindex is missing in the first sensor output signal A. The first dose count which is two for the first sensor output signal A depicted in Figures 5A to 5D may thus be increased by one dose unit.

[0124] Further, the first time period tPA in Figures 5B and 5C may for example be a fraction of a second time interval tints, i.e. a time interval between two specific second sensor output values, for example, between specific second sensor output values Bj-i and Bj. However, the first time period tPdA, i.e. the negative and / or positive portion -tPdA and / or +tPdA, may also be an average of the second time intervals tints, i.e. the second time interval tints between the specific second sensor output values Bj-i and Bj and the second time interval tints between the specific second sensor output values Bj-i and Bj.

[0125] In one aspect, a first time interval tintA between two specific first sensor output values Aj and Ai+i may be compared with a second time interval tints between two specific second sensor output values Bj and Bj+i in order to determine whether a specific first sensor output value is missing as shown in Figure 5D. In this regard, the processor unit 114 may be configured to determine a first time interval tintA between two consecutive specific first sensor output values Ai and Aj+i, i.e. between the corresponding first time points t(Aj) and t(Aj+i) of the two consecutive specific first sensor output values Ai and Aj+i , and a corresponding closest second time interval tints between two consecutive specific second sensor output values Bj and Bj+i, i.e. between the corresponding second time points t(Bj) and t(Bj+i) of the specific second sensor output values Bj and Bj+i .

[0126] In this regard, the corresponding closest second time interval tints is the second time interval tints between two specific second output values Bindex when for example a second time point t(Bin ex) of the second time interval tints lies within the first time interval tintA. More precisely, the second time point t(Bin ex) which may be considered in Figure 5D for the closest second time interval tints, may be the second time point t(Bj+i) that precedes the later first time point t(Aj+i) of the first time interval tintA with the smallest time difference. However, the second time interval

[0127] September 22, 2025 S 100 P 548 WO tints which is considered could also be determined between the specific second sensor output value Bj+i and Bj+2.

[0128] Thus, if for example in Figure 5D the processor unit compares the first time interval tintA with the second time interval tints, wherein the processor unit 114 determines that the first time interval tintA is greater than the second time interval tints, the processor unit 114 may increase the first dose count by one dose unit. However, the processor unit may also be configured to determine a deviation between the first time interval tintA and the second time interval tints. For example, the processor unit 114 may determine a factor by which the first time interval tintA is bigger than the second time interval tints. The processor unit 114 may then be configured to determine based on a magnitude of the deviation whether a first dose count is missing or not.

[0129] Contrary to Figures 5A to 5D, wherein a specific first sensor output value Aindex was missing, Figures 6A to 6C show sensor output signals A and B, wherein there is one specific first sensor output value Aindex too many. To be more precise, the double count of the specific first sensor output values AH and Aj is incorrect, when compared with the specific second sensor output values Bj. In this regard, the first dose count would incorrectly be four, wherein the correct second dose count would be three.

[0130] Similar to the principle shown in Figure 5B, also in Figure 6B a first time period tPdA is considered. The first time period tPdA is a bi-directional time period comprising equal negative and positive portions. The processor unit 114 is consequently configured to determine a second time point t(Bj) referring to at least one specific second sensor output value Bj of the second sensor output signal B. Further, the processor unit 114 is configured to determine a number of specific first sensor output values Aindex within a first time period tPdA preceding and / or following the second time point tPBj. Here the number of specific first sensor output values Aindex is two, namely AM and Ai. Consequently, and in order to determine a correct first dose count, the processor unit 114 may decrease the previously determined first dose count of four dose units to three dose units.

[0131] As mentioned with respect to Figures 5B and 5C, the first time periods -tPdA and +tPdA in Figure 6B may be equal or different. The first time periods may also be determined using an average of second time intervals tints.

[0132] Further, in Figure 6C a first time interval tintA is compared with a second time interval tints. In this regard, if the first time interval tintA between adjacent counts for specific first sensor output values Aindex, here AM and Ai, is smaller than the second time interval tints for the nearest specific

[0133] September 22, 2025 S 100 P 548 WO second sensor output value Bindex, here Bj , the first dose count is decreased by one dose unit. The nearest specific sensor output value Bindex may be determined as the closest specific second sensor output value, i.e. the second sensor output value with the least time difference from the last specific first sensor output value of the first time interval tintA, here Aj.

[0134] Here too, as described above in relation to missing dose counts, it is possible to determine a size of the difference between the first time interval tintA and the second time interval tints. For example, the first dose count may only be reduced by one dose unit if the deviations exceed a certain predetermined factor.

[0135] Furthermore, in Figures 7A and 7B an initial switch incident Si is taken into account before any specific sensor output values Aindex and Bindex are recorded and in Figures 8A and 8B a final switch incident S2 at the end of the sensor output signals A and B is taken into account. The switch incidents Si and S2 may, for example, be triggered by actuating a switch 108 at the beginning and / or the end of a dose delivery, which may lead to a corresponding time marker, such as a time stamp. A corresponding switch time point t(Si) or t(S2) may thus for example be provided at the beginning and / or the end of the dose delivery, i.e. before the initial specific first or second sensor output value A1 or Bi or the final specific first or second sensor output value Anor Bm. Taking into account the switch time points t(Si) and t(S2) as well as corresponding time intervals may allow to identify missing specific sensor output values or specific sensor output values which do not belong to an actual dialed or dispensed dose unit, i.e. to a real dose incident.

[0136] The processor unit 114 may thus for example be configured to determine a first switch time interval tmtsA between the switch time point t(Si) and a first time point t(Ai) or t(An) at which a specific first sensor output value A1 or Anpreceding and / or following the switch time point t(Si) or t(S2) is detected. In addition, or as an alternative, the processor unit 114 may be configured to determine a second switch time interval tintss between the switch time point t(Si) and a second time point t(Bi) or t(Bm) at which a specific second sensor output value Bi or Bmpreceding and / or following the switch time point t(S1) or t(S2) is detected. Further, the processor unit 114 may be configured not to take any dose units into account which fall within the respective first switch time interval tintsAor the second switch time interval tintss-

[0137] Furthermore, the processor unit 114 may be configured to correct and / or validate the first dose count or the second dose count by a comparison of the first and / or second switch time interval tintsA or tintss with a predetermined switch time interval. If the first switch time interval tintsA or the second switch time interval tintss is longer or greater than the predetermined switch time

[0138] September 22, 2025 S 100 P 548 WO interval, there may be a dose unit missing which did not lead to a specific sensor output value. Accordingly, the respective dose count may be either increased or a threshold value for example for the voltage may be reduced. A corresponding predetermined switch time interval tints* is for example shown in Figure 7B. Here the first time interval tmtsA is shorter than the predetermined switch time interval tints*.

[0139] In one aspect, the processor unit 114 may also be configured to compare the first switch time interval tintsA with the second switch time interval tintsB- If the first switch time interval tjntsA is smaller than the second switch time interval tintsB or for example a certain fraction thereof, the first dose count may for example be decreased by one dose unit. In Figure 7B, for example, the initial specific first sensor output value Ai seems incorrect as it is too close to the switch time point t(Si). In addition, the first switch time interval tjntsA is too small compared to the second switch time interval tintsB- Consequently, the first dose count may for example be decreased by one dose unit.

[0140] According to a further aspect, also a first time period tPdA starting from an initial specific second sensor output value Bi may be considered, wherein specific first sensor output values Aindex before this first time period tpdA are not considered for the first dose count. In this regard, the processor unit 114 may for example be configured to determine a number of specific first sensor output values Aindex within a predetermined time period, for example a first time period tpdA, after and / or before the second time point t(Bi) or t(Bm) and / or the processor unit 114 may be configured to determine a number of specific second sensor output values Bindex within a predetermined time period, for example a second time period tPdB after and / or before the first time point t(Ai) or t(An).

[0141] In Figure 7B, the processor unit 114 may thus be configured with the aforementioned procedures to identify the specific first sensor output value Ai as incorrect and may thus decrease the first dose count by one dose unit. In Figure 8B, the processor unit 114 may be configured to identify the final specific first sensor output value Anas incorrect any may thus decrease the first dose count by one dose unit.

[0142] The electronic module 100 comprising two sensor arrangements 112 and 113 and a processor unit 114 configured to determine the dose counts dependent on both sensor output signals A and B may thus be configured to improve, i.e. correct and / or validate, the first dose count and / or the second dose count. Since the first dose count and the second dose count subsequently provide basis for the general dose count, the general dose count may also be improved. In summary, the electronic module 100 may thus be improved.

[0143] September 22, 2025 S 100 P 548 WO Reference Numerals

[0144] 1 drug delivery device

[0145] 10 housing

[0146] 11 dose button

[0147] 12 dose dial grip

[0148] 13 drive sleeve

[0149] 14 display window

[0150] 15 container

[0151] 16 needle

[0152] 17 inner needle cap

[0153] 18 outer needle cap

[0154] 19 number sleeve

[0155] 100 electronic module

[0156] 101 first portion

[0157] 102 auxiliary dose dial grip

[0158] 103 second portion

[0159] 104 proximal end surface

[0160] 105 push element

[0161] 106 spring element

[0162] 107 lever arm

[0163] 108 switch

[0164] 109 electric power source

[0165] 110 circuit board assembly

[0166] 111 distal surface

[0167] 112 first sensor arrangement

[0168] 113 second senor arrangement

[0169] 114 processor unit first sensor output signal initial specific first sensor output value specific first sensor output value final specific first sensor output value first time point first time period first time period preceding a time point (negative time period)

[0170] September 22, 2025 S 100 P 548 WO +tpdA first time period following a time point (positive time period) tintA first time interval

[0171] B second sensor output signal

[0172] Bi initial specific second sensor output value

[0173] Bindex specific second sensor output value

[0174] Bmfinal specific second sensor output value t(Bjndex) second time point tints second time interval

[0175] 51 first switch incident

[0176] 52 second switch incident tintsA first switch time interval tintsB second switch time interval t(Si) switch time point (of a first switch incident) t(S2) switch time point (of a second switch incident) tints* predetermined switch time interval tiimit predetermined threshold value for the time

[0177] Viimit predetermined threshold value for the voltage

[0178] Vp1 first voltage peak

[0179] Vp2 second voltage peak

[0180] September 22, 2025 S 100 P 548 WO

Claims

Claims1. An electronic module (100) for a drug delivery device (1) comprising at least• an electric power source (109) configured to power electronic components of the electronic module (100),• a circuit board assembly (110) electrically connected to the electric power source (109),• at least a first sensor arrangement (112) configured to provide a first sensor output signal (A),• at least a second sensor arrangement (113) configured to provide a second sensor output signal (B), and• a processor unit (114) configured to perform a first dose count by processing specific first sensor output values (Aindex) of the first sensor output signal (A) and a second dose count by processing specific second sensor output values (Bindex) of the second sensor output signal (B), characterized in that the processor unit (114) is further configured to correct and / or validate the first dose count and / or the second dose count and to provide a general dose count from the corrected and / or validated first and second dose counts.

2. The electronic module (100) according to claim 1 , wherein the processor unit (114) is configured to determine a time point referring to at least one specific second sensor output value (Bindex) of the second sensor output signal (B), and wherein the processor unit (114) is configured to determine a number of specific first sensor output values (Aindex) within a first time period (tPdA) preceding and / or following the time point.

3. The electronic module (100) according to claim 2, wherein the time point is a second time point (t(Bindex)), wherein a duration of the first time period (tPdA) preceding and / or following the second time point (t(Bindex)) is a fraction of a second time interval (tints) between two consecutive specific second sensor output values (Bindex, Bindex±i), and wherein one of the two consecutive specific second sensor output values (Bindex, Bindex±i) is the specific second sensor output value (Bindex) corresponding to the second time point (t(Bindex)).

4. The electronic module (100) according to anyone of claims 2 or 3, wherein absolute values of a duration of the first time period (-tPdA) preceding the time point or the second time point (t(Bindex)) and of a duration of the first time period (+tPdA) following the time point or the second time point (t(Bindex)) are the same.September 22, 2025 S 100 P 548 WO5. The electronic module (100) according to claim 4, wherein a total duration of the first time period (tpdA) including the duration of the first time period (-tpA) preceding the second time point (t(Bjnex)) and the duration of the first time period (+tpdA) following the second time point (t(Bin ex)) is an average of two second time intervals (tints) each determined by a duration between the second time point (t(Bjnex)) and a corresponding preceding or a corresponding following second time point (t(Bjn ex-i, t(Bjn ex+i)) of a specific second sensor output value (Bjndex) ■6. The electronic module (100) according to any one of the preceding claims, wherein the processor unit (114) is configured to determine a first time interval (tintA) between two consecutive specific first sensor output values (Ajndex, Ajndex±i) and a corresponding closest second time interval (tints) between two consecutive specific second sensor output values (Bjndex, Bindex±i) , and wherein the processor unit (114) is configured to correct and / or validate the first dose count or the second dose count by relative comparison of the first time interval (tintA) with the second time interval (tints) .

7. The electronic module (100) according to claim 6, wherein a deviation between the first time interval (tintA) and the second time interval (tints) is determined, and wherein the processor unit (114) is configured to correct and / or validate the first dose count or the second dose count depending on a magnitude of the deviation.

8. The electronic module (100) according claim 7, wherein the processor unit (114) is configured to increase the first dose count by one dose unit when the deviation between the first time interval (tintA) and the second time interval (tints) exceeds a predetermined value greater than 1 , and wherein the processor unit (114) is configured to decrease the first dose count by one dose unit when the deviation between the first time interval (tintA) and the second time interval (tints) deceeds below a predetermined value less than 1.

9. The electronic module (100) according to any one of the preceding claims, wherein the electronic module (100) additionally comprises a switch (108) configured to activate and / or deactivate electronic components of the electronic module (100), wherein the processor unit (114) is configured to detect a switch time point (t(Si), t(S2)) at which the switch (108) is actuated, andSeptember 22, 2025 S 100 P 548 WOwherein the processor unit (114) is configured to determine a first switch time interval (tmtsA) between the switch time point (t(Si), t(S2)) and a first time point (t(Ai), t(An)) at which a specific first sensor output value (Ai, An) preceding and / or following the switch time point (t(Si), t(S2)) is detected, and / or wherein the processor unit (114) is configured to determine a second switch time interval (tintsB) between the switch time point (t(Si), t(S2)) and a second time point (t(Bi), t(Bm)) at which a specific second sensor output value (Bi , Bm) preceding and / or following the switch time point (t(Si), t(S2)) is detected.

10. The electronic module (100) according to claim 9, wherein the processor unit (114) is configured to correct and / or validate the first dose count or the second dose count by a comparison of the first and / or second switch time interval (tmtsA, tintss) with a predetermined switch time interval (tints*).

11. The electronic module (100) according to claim 9 or 10, wherein the processor unit (114) is configured to correct and / or validate the first dose count or the second dose count by a comparison of the first switch time interval (tintsA) with the second switch time interval (tintss) .

12. The electronic module (100) according to any one of the preceding claims, wherein the processor unit (114) is configured to determine a first time point (t(Ai), t(An)) of an initial and / or final specific first sensor output value (Ai, An) and / or a second time point (t(Bi), t(Bm)) of an initial and / or final specific second sensor output value (Bi , Bm), for example based on a switch time point (t(Si), t(S2)), and wherein the processor unit (114) is configured to determine a number of specific first sensor output values (Aindex) within a predetermined time period (tPdA) after and / or before the second time point (t(Bi), t(Bm)) and / or wherein the processor unit (114) is configured to determine a number of specific second sensor output values (Bindex) within a predetermined time period (tPdA) after and / or before the first time point (t(Ai), t(An)).

13. The electronic module (100) according to any one of the preceding claims, wherein the processor unit (114) is configured to correct the first dose count and / or the second dose count by increasing and / or decreasing the first dose count and / or the second dose count by at least one dose unit.September 22, 2025 S 100 P 548 WO14. The electronic module (100) according to any one of the preceding claims, wherein the electronic module (100) is configured to be releasably attached to a drug delivery device (1).

15. The electronic module (100) according to any one of the preceding claims, wherein the at least one first sensor arrangement (112) comprises an acoustic sensor, and wherein the at least one second sensor arrangement (113) comprises at least one optical sensorSeptember 22, 2025 S 100 P 548 WO

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