Wearable electronic device and method of monitoring use of an injection device

Abstract

In one aspect the present disclosure relates to a wearable electronic device (100) for monitoring use of an injection device (1), the wearable electronic device (100) comprising: - a sensor arrangement (55) operable to detect or to measure at least one of: - a position of the wearable electronic device (100), - an orientation of the wearable electronic device (100), - an acceleration of the wearable electronic device (100) and - an acoustic signal emanating from the injection device (1) and operable to generate a first sensor signal (S1, S2, S3) being indicative of at least one of the position, the orientation, the acceleration of the wearable electronic device (100), and / or of the acoustic signal emanating from the injection device (1), - a memory (40), and - a processor (44) coupled to the sensor arrangement (55) and to the memory (40), wherein the processor (44) is operable: - to identify at least a first use pattern of the injection device (1) on the basis of the first sensor signal (S1, S2, S3).

Description

[0001] Wearable Electronic Device and Method of Monitoring Use of an Injection Device

[0002] Description

[0003] The present disclosure relates to the field of monitoring use and / or operation of injection devices, such as syringes, auto injectors, pen-type injectors and the like hand-held and user- operable injection devices. In one aspect the present disclosure relates to a wearable electronic device for monitoring use of an injection device. In another aspect the present disclosure relates to a method of monitoring use of an injection device by using or wearing a wearable electronic device. In a further aspect the present disclosure relates to a computer program for monitoring use of an injection device.

[0004] Background

[0005] Drug delivery devices for setting and dispensing a single or multiple doses of a liquid medicament are as such well-known in the art. Generally, such devices have substantially a similar purpose as that of an ordinary syringe.

[0006] Drug delivery devices, such as pen-type injectors, have to meet a number of user-specific requirements. For instance, with patients suffering chronic diseases, such as diabetes, the patient may be physically infirm and may also have impaired vision. Suitable drug delivery devices especially intended for home medication therefore need to be robust in construction and should be easy to use. Furthermore, manipulation and general handling of the device and its components should be intelligible and easy understandable. Such injection devices should provide setting and subsequent dispensing of a dose of a medicament of equal or variable size. Moreover, a dose setting as well as a dose dispensing procedure must be easy to operate and has to be unambiguous.

[0007] A patient suffering from a particular disease may require a certain amount of a medicament to either be injected via a pen-type injection syringe.

[0008] Some drug delivery or injection devices provide selecting of a dose of a medicament of variable size and injecting a dose previously set. Other injection devices provide setting and dispensing of a fixed dose. Here, the amount of medicament that should be injected in accordance to a given prescription schedule is always the same and does not change or cannot be changed over time.

[0009] Some injection devices are implemented as reusable injection devices offering a user to replace a medicament container, such as a cartridge. Other injection devices are implemented as a disposable injection device. With disposable injection devices it is intended to discard the entirety of the injection device when the content, i.e. the medicament, has been used up.

[0010] In order to control and to supervise administering of medication conducted by users or patients themselves it is desirable to provide an automated detecting and logging of a repeated and regular use of the drug delivery device. A rather automated recording of doses injected by a user would offer a significant advantage over a manual dose logging in terms of security and convenience.

[0011] There exist numerous add-on devices or auxiliary devices that are generally configured for use with injection devices and which offer an electronic detection and monitoring of single or repeated dose injection procedures.

[0012] Add-on devices or auxiliary devices can be detachably connected to an injection device. An add-on device may be operable to detect a date and / or time when the user sets or injects a dose of the medicament. Some add-on devices also provide a quantitative measurement of a size of a dose currently set or dispensed. Some add-on devices are intended for use with a series of injection devices. This may particularly apply with disposable injection devices, that are intended to become discarded after use or after the medicament located therein has been used up.

[0013] With particular types of injection devices, such as prefilled syringes or prefilled safety-syringes use and user acceptance of auxiliary devices or add-on devices is quite challenging, since prefilled syringes or prefilled safety-syringes may be intended for a single use.

[0014] In view of the above it would be beneficial to provide monitoring operation and / or use of injection devices without the necessity to attach a separate add-on device or auxiliary device to the injection device. It would be of further benefit to provide a rather automated monitoring or logging of one or repeated uses of the injection device with only a minimum of user interaction. The solution should be easy to implement and cost efficient. It should come along with a high degree of user satisfaction and user acceptance.

[0015] Summary In one aspect there is provided a wearable electronic device for monitoring use of an injection device. The wearable electronic device comprises a sensor arrangement, which is operable to detect or to measure at least one of a position of the wearable electronic device, an orientation of the wearable electronic device, an acceleration of the wearable electronic device and an acoustic signal emanating from the injection device. The sensor arrangement of the wearable electronic device is further operable to generate a first sensor signal. The first sensor signal is indicative of at least one of the position, the orientation and the acceleration of the wearable electronic device. In addition or alternatively, the first sensor signal is indicative of the acoustic signal emanating from the injection device.

[0016] The wearable electronic device further comprises a memory, e.g., a non-volatile digital memory. The wearable electronic device also comprises a processor, e.g., a microprocessor or microcontroller. The processor is coupled to the sensor arrangement and is further coupled to the memory. Moreover, the processor is operable to identify at least a first use pattern of the injection device on the basis of the first sensor signal.

[0017] Accordingly, the processor is configured to process the first sensor signal as provided by the sensor arrangement. On the basis of the signal processing the processor may identify a first use pattern of the injection device. The processor may distinguish between different use patterns of the injection device. A use pattern of the injection device may comprise one or numerous steps of use of the injection device that have to be conducted or executed by a user in the course of operating the injection device, e.g. for setting and / or injecting a dose of a medicament.

[0018] A use pattern of the injection device may be characterized by a user gesture. Such user gestures may be detected or quantitatively measured by the sensor arrangement of the wearable electronic device when the wearable electronic device is worn or carried by a user during use of the injection device. The wearable electronic device may comprise one of a smartwatch and a fitness tracker. It may be worn at an arm, hand or hand wrist of a user or patient while making use of the injection device. By way of the sensor arrangement and by way of measuring at least one of a position, an orientation and an acceleration of the wearable electronic device and / or by measuring or detecting an acoustic signal emanating from the injection device a characteristic use pattern of the injection device can be identified or detected on the basis of signal processing of the first sensor signal provided by the sensor arrangement.

[0019] In some examples, the injection device may be equipped with an add-on device, which add-on device may be configured to generate an acoustic signal upon or during operation of the injection device. This may be of particular use when the injection device should be inoperable to generate an acoustic signal during operation.

[0020] Insofar and for identifying a particular use pattern of the injection device it is no longer necessary to provide a sensor arrangement or a respective electronic circuit to the injection device. It is neither necessary to attach a separate add-on device to the injection device. The identification of the use pattern of the injection device may be exclusively provided by the wearable electronic device, which may be located in close vicinity to the injection device during the intended use of the injection device.

[0021] However, optional use of an add-on device connected or connectable to the injection device may be beneficial for identifying a use pattern of the injection device. The add-on device may be configured to generate an acoustic signal in the course of operating or using the injection device. The acoustic signal, e.g., detectable by the sensor arrangement of the wearable electronic device and generated by the add-on device during use of the injection device may be indicative of a particular use pattern of the injection device.

[0022] The wearable electronic device may provide a rather automated monitoring of the use or operation of the injection device simply on the basis of signal processing of the first sensor signal provided by the sensor arrangement. The wearable electronic device may be permanently worn by a user or patient. When the wearable electronic device is for instance implemented as a smartwatch it may be carried along by the user almost permanently. Accordingly, a user may no longer have to take care to equip the injection device with an addon device or with an auxiliary device for the purpose of monitoring use or operation of the injection device, e.g., for setting and / or or dispensing or injecting of a dose of the medicament.

[0023] The wearable electronic device and the functionality of the wearable electronic device may be provided by a suitable hardware and / or software implementation. Here, an existing wearable electronic device may be provided with a suitable software application, e.g., in form of an app to deploy the above-described functionality of the wearable electronic device. The wearable electronic device may be based on hardware of an existing or commercially available wearable electronic device.

[0024] Hence, the extended functionality of the wearable electronic device for monitoring use of the injection device may be exclusively provided by a respective software or software application. In this way, the total costs for implementing the wearable electronic device and respective expenditure to provide the functionality of the wearable electronic device might be comparatively low. In addition, many patients or users of injection devices may already comprise or possess a suitable wearable electronic device. Insofar, the wearable electronic device for monitoring use of the injection device as described herein may be easily obtained or may be easily obtainable for patients or users of the injection device.

[0025] According to a further example the processor of the wearable electronic device is operable to log and / or to record an identification of the first use pattern of the injection device in the memory of the wearable electronic device. In this way, identification of a characteristic and hence of a first use pattern of the injection device can be logged and / or recorded in the memory of the wearable electronic device.

[0026] In some examples the wearable electronic device further comprises a clock configured to provide a clock signal or timer signal. Here, logging of the identification of the first use pattern of the injection device in the memory may include logging and / or storage of a timestamp as provided by the clock of the wearable electronic device. Here, the timestamp can be stored concurrently with the identification of the first use pattern of the injection device in the memory of the wearable electronic device. In this way, a history of use or history of operation of the injection device can be logged or monitored over time.

[0027] According to a further example the wearable electronic device comprises a signal generator coupled to the processor and operable to indicate the identification of the first use pattern of the injection device to a user. In this way, the identification of at least the first use pattern of the injection device can be perceivably indicated to a user of the wearable electronic device. The user may then confirm the identification or approve the identification of the use pattern.

[0028] The user may also decline or dismiss an identification of the at least first use pattern of the injection device. By way of the signal generator, e.g., controlled by the processor, there can be provided a feedback to the user of the wearable electronic device during and / or for an automated use pattern recognition as provided by the wearable electronic device. In this way, the precision of the use pattern identification as provided by the processor can be improved. Moreover, recording or logging of false or erroneously identified use patterns of the injection device can be effectively prevented.

[0029] According to a further example the signal generator of the wearable electronic device comprises a display to visually indicate the identification of the first use pattern of the injection device to the user. The display may comprise a touch sensitive display. It may comprise a two-dimensional display. Here, the signal generator and / or the display may be configured to provide information to the user being indicative of the identification of the at least first use pattern of the injection device. The first use pattern of the injection device may be represented on the display form of a text message, in form of symbols and / or on the basis of moving or animated text or moving or animated symbols. In this way, an identification of the at least first use pattern of the injection device can be rather intuitively provided to the user of the wearable electronic device and / or to the user of the injection device.

[0030] According to a further example the signal generator of the wearable electronic device comprises an acoustic signal generator to acoustically indicate the identification of the at least first use pattern of the injection device to the user. The acoustic signal generator may be controlled or operated by the processor. The acoustic signal generator may comprise at least one of a speaker and a sound generating device configured to produce acoustic signals that are perceivable or discernible by a user of the wearable electronic device and / or by a user of the injection device. Here, the at least first use pattern may be characterized by a distinguishable acoustic signal, such as a characteristic sound or acoustic pattern. Generation of an acoustic signal to indicate the identification of the first use pattern of the injection device is of particular benefit because acoustic signals may be discernible or perceivable by the user irrespective on a momentary orientation, position or movement of the wearable electronic device. Acoustic signals are permanently perceptible by users of the injection device or wearable electronic device.

[0031] According to a further example the signal generator comprises a haptic signal generator to haptically indicate the identification of the at least first use pattern of the injection device to the user. Generation of a haptic signal may be of particular benefit when a user should suffer from hearing loss or if a user should have switched the wearable electronic device into a silent mode. In a silent mode the wearable electronic device may be disabled to generate acoustic signals. However, a haptic signal generator, e.g. a vibration generated by the haptic signal generator may be still detectable or perceptible by a user wearing the wearable electronic device. In this way, the attention of the user can be attracted to the haptic signal generated by the haptic signal generator even if the wearable electronic device should be in a silent mode.

[0032] According to a further example the wearable electronic device comprises an actuating element, e.g., an input element, coupled to the processor and configured to receive a user command and to transfer the user command to the processor. In some examples the actuating element is actuatable by the user of the wearable electronic device. The actuating element may comprise one of a button and a switch that is actuatable by a user in order to enter a user command. In some examples the actuating element may be integrated into a display, e.g. into a touch sensitive display of the wearable electronic device. The actuating element may be even integrated into the display of the signal generator.

[0033] By way of the actuating element the user is provided with a possibility to enter at least one or several commands or to provide a feedback to a user prompt as provided to the user via the signal generator.

[0034] The actuating element may be touchable, depressible or movable by the user, e.g., by a finger of a user. By way of the actuating element a user may provide a feedback, e.g. to a processor generated identification of at least a first use pattern of the injection device.

[0035] In some examples the processor may be configured to indicate the identification of the first use pattern of the injection device to a user via the signal generator. The processor may be further configured to log and / or to store the identification of the at least first use pattern of the injection device in the memory only after receiving a respective user command or user feedback that may be entered into the wearable electronic device via the actuating element. Hence, in response to a rather automated identification of at least a first use pattern of the injection device the processor may prompt a user to confirm the identification of the at least first use pattern of the injection device.

[0036] If the user does not confirm a proposed identification of the use pattern the processor may be configured to discard the processor-generated identification of the at least first use pattern of the injection device. In further examples and when the user confirms the identification of the at least first use pattern of the injection device, e.g., by providing a respective user command via the actuating element the processor may proceed with logging or storing of the identification of the at least first use pattern of the injection device in the memory, e.g., concurrently with a timestamp.

[0037] According to a further example of the wearable electronic device the sensor arrangement is operable to detect or to measure at least one of the position of the wearable electronic device, the orientation of the wearable electronic device, the acceleration of the wearable electronic device, and of the acoustic signal emanating from the injection device over time. The sensor arrangement is further operable to generate a plurality of first sensor signals over time being indicative of a temporal evolution of at least one of the position of the wearable electronic device, the orientation of the wearable electronic device, the acceleration of the wearable electronic device, and the temporal evolution of the acoustic signal emanating from the injection device. A temporal evolution of the first sensor signal over time may be directly indicative of a particular use pattern of the injection device. By permanently or regularly detecting or measuring at least one of the position, the orientation, and the acceleration of the wearable electronic device over time and / or by permanently or regularly measuring or detecting the acoustic signal emanating from the injection device over time a rather precise identification of the at least first use pattern of the injection device can be provided.

[0038] Particular use patterns of the injection device that are conducted by a user of the injection device in the course of setting of a dose of the medicament and / or injecting of the dose of the medicament may come along with characteristic sensor signals within a predefined time interval. Now and by generating a plurality of first sensor signals over time the respective temporal evolution of the first sensor signals over time can be detected or quantitatively measured thus allowing to identify the at least use pattern of the injection device and / or to distinguish a first use pattern of the injection device from a second use pattern of the injection device; and vice versa.

[0039] In a further example the sensor arrangement and the processor are configured to detect or to measure at least one of the position, the orientation and the acceleration of the wearable electronic device over time and / or to detect or to measure an acoustic signal emanating from the injection device over time and to generate respective first sensor signals over time being indicative of at least one of the position, the orientation and the acceleration of the wearable electronic device over time and / or being indicative of the acoustic signal emanating from the injection device, e.g., during a respective time interval.

[0040] The processor connected to the sensor arrangement is further configured or operable to identify at least the first use pattern of the injection device on the basis of the temporal sequence or temporal evolution of the first sensor signal.

[0041] According to a further example the processor of the wearable electronic device is configured to identify the at least first use pattern of the injection device on the basis of a temporal correlation between the first sensor signal at a first time and the first sensor signal and a second time. Some use patterns of the injection device may be characterized by a first sensor signal at a first time and by a further first sensor signal at a second time, wherein the first and the second times may define a time interval. Some predefined use patterns of the injection device may require execution of a first step of handling the injection device followed by a second step within a predefined time interval. Both, the first step and the second step of handling of the injection device may be characterized by specific sensor signals of the sensor arrangement of the wearable electronic device when the device is worn by the user while conducting the first and second handling steps.

[0042] Now and by measuring or detecting at least one of a position of the wearable electronic device, an orientation of the wearable electronic device and an acceleration of the wearable electronic device and / or by measuring or detecting the acoustic signal emanating from the injection device such a temporal sequence of dedicated steps of using or operating the injection device can be recorded or detected by the wearable electronic device provided that the wearable electronic device is worn by a user, e.g., at a hand or wrist of the user during use of the injection device.

[0043] The identification of at least a first use pattern may require detection of at least one of a first position, a first orientation and a first acceleration of the wearable attorney device and / or detection of a first acoustic signal emanating from the injection device. It may further require detection or measuring of at least one of a second position of the wearable electronic device, a second orientation of the wearable electronic device and a second acceleration of the wearable electronic device and / or detection or measuring of a second acoustic signal emanating from the injection device within a predefined time interval. The processor may be configured to identify the at least first use pattern of the injection device on the basis of a processing of the plurality of first sensor signals over time.

[0044] According to another example the processor is operable to identify the at least first use pattern of the injection device on the basis of a temporal evolution of a first signal amplitude of the first sensor signal during a predefined time interval. The at least first use pattern of the injection device may be accompanied by a well-defined temporal evolution of a first signal amplitude of a sensor signal being indicative of at least one of the position of the wearable electronic device, an orientation of the wearable electronic device, an acceleration of the wearable electronic device, and / or of an acoustic signal emanating from the injection device. By taking into account the temporal evolution of the first signal amplitude of the first sensor signal for identifying at least the first use pattern of the injection device the precision of the rather automated identification of the at least first use pattern can be enhanced.

[0045] According to another example of the wearable electronic device the processor is operable to identify the at least first use pattern of the injection device on the basis of a comparison of the first sensor signal with a reference signal assigned with the at least first use pattern of the injection device. The reference signal may be stored in the memory of the wearable electronic device. In situations, wherein the first sensor signal is identical, equivalent or highly similar to the reference signal, which has been assigned with the at least first use pattern of the injection device, the processor may be operable to determine a degree of similarity between the first sensor signal and the reference signal.

[0046] The processor may be also configured to calculate or to determine a probability that the first sensor signal as provided by the sensor arrangement does indeed represent the at least first use pattern of the injection device, which is represented by the reference signal. In this way and by making use of one or several reference signals stored in the memory of the wearable electronic device the processor may conduct a processing of the first sensor signal or first sensor signals on the basis of a comparison with one or several reference signals, each of which being assigned with different use patterns of the injection device.

[0047] In some examples the memory may store numerous reference signals each of which being assigned with a respective use pattern of the injection device. In some examples the processor may be operable to determine a degree of similarity between the first sensor signal with any of the reference signals stored in the memory of the wearable electronic device. The processor may then provide a ranking of use patterns of the injection device that are assigned with the respective reference signals depending on a degree of matching between the first sensor signal as provided by the sensor arrangement and the reference signals stored in the memory.

[0048] In this way, the processor of the wearable electronic device may conduct an automatic selection of a number of use patterns of the injection device that are candidates to match with the at least first use pattern of the injection device on the basis of the sensor signal or sequence of sensor signals obtainable from the sensor arrangement of the wearable electronic device.

[0049] In some examples the processor may be operable to conduct numerous comparisons of the first sensor signal or first sensor signals with one or numerous reference signals provided in the memory and assigned with different use patterns of the injection device. By conducting numerous comparisons of the first sensor signal or of numerous first sensor signals with numerous reference signals stored in the memory the precision of the identification of the at least first use pattern of the injection device can be improved.

[0050] According to a further example the reference signal assigned with the at least first use pattern of the injection device can be stored in the memory of the wearable electronic device when switching the wearable electronic device into a training mode. Here, the processor of the wearable electronic device may be switchable between a recognition mode and a training mode. In the training mode the user may execute or conduct a use pattern of the injection device while wearing the wearable electronic device. During execution of the use pattern of the injection device, e.g., during a well-defined handling step of the injection device, the sensor arrangement detects or measures at least one of the position, the orientation, and the acceleration of the wearable electronic device and / or of an acoustic signal emanating from the injection device. The respective first sensor signal as generated by the sensor arrangement during such a training procedure may be recorded over time and may be stored in the memory of the wearable electronic device as a reference signal being indicative and being hence assigned with the particular use pattern of the injection device.

[0051] Such a training procedure can be repeatedly executed for one and the same use pattern of the injection device. Here, a temporal average of the first sensor signals detected or measured during execution of the first use pattern can be derived or calculated and / or temporal average of the respective first sensor signal can be stored as the reference signal in the memory.

[0052] In some examples, operation of the wearable electronic device in the training mode is to be conducted under supervision or assistance of a healthcare provider or healthcare professional guiding the user in conducting the at least first use pattern of the injection device. In this way, a rather precise use of the injection device can be trained and recorded as a reference signal in the memory of the wearable electronic device.

[0053] According to a further example the processor of the wearable electronic device is operable to store the first sensor signal and the reference signal in the memory. Here, the processor may be operable to overwrite the reference signal in the memory with a first sensor signal recently detected or measured by the sensor arrangement. Storing of the first sensor signal actually detected or measured by the sensor arrangement while the wearable electronic device or processor is in a recognition mode may require a user confirmation in response to the indication to the user that a first use pattern of the injection device has been identified. In this way, it can be guaranteed that only user-approved sensor signals as provided by the sensor arrangement during use of the injection device can be used as a reference signal and can be stored as a reference signal in the memory.

[0054] Overwriting a reference signal in the memory may comprise a signal averaging with one or several reference signals previously stored in the memory. In some examples the reference signal in the memory may be obtained by averaging a number of first sensor signals being indicative of the first use pattern of the injection device. Numerous previous identifications of the at least first use pattern of the injection device on the basis of the first sensor signal or sequence of first sensor signals may be then used to improve the reference signal. Hence, any or selected repeated identifications of the least first use pattern of the injection device on the basis of the first sensor signal or sequence of first sensor signals can be used to improve the reference signal in the memory. In this way, the identification of an at least first use pattern of the injection device on the basis of first sensor signal can be subject to an iterative self-learning or self-training procedure.

[0055] The more often the at least first use pattern of the injection device has been identified on the basis of the first sensor signal and / or the more often a use pattern identification has been confirmed or approved by a user, e.g. by providing a respective approval or confirmation via the actuating element, the training data or reference data to be stored in the memory can be constantly improved and / or adapted to the characteristic gestures or use pattern applied by a user in the course of using or operating the injection device.

[0056] According to a further example the sensor arrangement is operable to generate a second sensor signal, which is indicative of another one of the position, the orientation, the acceleration of the wearable electronic device, and / or of the acoustic signal emanating from the injection device. The first sensor signal and the second sensor signal may distinguish by their signal type. The first sensor signal may be indicative of at least one of the position, the orientation and the acceleration of the wearable electronic device, and / or the acoustic signal emanating from the injection device. The second sensor signal may be indicative of another one of the position, the orientation, and the acceleration of the wearable electronic device and the acoustic signal emanating from the injection device.

[0057] The processor is operable to process both, the first sensor signal and the second sensor signal. Accordingly, the processor is operable to identify the at least first use pattern of the injection device on the basis of a signal processing of the first sensor signal and by a signal processing of the second sensor signal. Here, the wearable electronic device may be operable to process different sensor signals and hence sensor signals of different type, wherein the first and second sensor signals may represent or indicate different physical states of the wearable electronic device or different acoustic signals emanating from the injection device. In one example the first sensor signal is indicative of an orientation of the wearable electronic device and the second sensor signal is indicative of an acceleration of the wearable electronic device. In other examples the first sensor signal is indicative of one of the orientation or acceleration of the wearable electronic device and the second sensor signal is indicative of an acoustic signal emanating from the injection device.

[0058] In this way different signal sources being indicative of different physical parameters of the wearable electronic device and / or of the injection device can be universally used to provide a precise identification of at least a first use pattern of the injection device.

[0059] Generally, the second sensor signal or second sensor signals may be processed or used in the same or like manner as described above in connection with the first sensor signal or first sensor signals.

[0060] Accordingly, the sensor arrangement may be further operable to detect or to measure at least one of the position, the orientation, and the acceleration of the wearable electronic device and / or the acoustic signal emanating from the injection device over time and to generate a plurality of second sensor signals over time. Furthermore and according to another example, the processor may be configured to identify the at least first use pattern of the injection device on the basis of a temporal correlation between the second sensor signal at a first time and the second sensor signal at a second time.

[0061] According to a further example the processor is operable to identify the at least first use pattern of the injection device on the basis of a first signal amplitude of the second sensor signal and a second signal amplitude of the second sensor signal during a predefined time interval. As described above already in connection with the signal processing of the first sensor signal, the processor is likewise operable to process the second sensor signal over time. It may be equally operably to process or to analyze a temporal evolution of the second sensor signal during a predefined time interval.

[0062] In some examples the sensor arrangement may be configured to generate the first sensor signal concurrently with the second sensor signal. The processor may be operable to process respective first and second sensor signals concurrently or almost simultaneously. Processing of first sensor signals and second sensor signals, wherein the first and the second sensor signals are indicative of different physical properties of the wearable electronic device or injection device, provides an improvement of an automated use pattern identification to be provided by the processor.

[0063] Moreover, also the second sensor signal or sensor signal can be stored as reference signal in the memory of the wearable electronic device. Insofar the processor is operable to identify the at least first use pattern of the injection device not only on the basis of a comparison of the first sensor signals with a reference signal but also on the basis of a comparison of the second sensor signal or second sensor signals with respective reference signals assigned with the at least first use pattern of the injection device. According to another example the processor is operable to identify the first use pattern of the injection device on the basis of a comparison of the first sensor signal and the second sensor signal.

[0064] In some examples identification of the at least first use pattern may require a rather simultaneous detection or measuring of first and second sensor signals by the sensor arrangement. Hence, some use patterns may be characterized by a rather simultaneous generation or detection of first and second sensor signals. If the sensor arrangement detects first and second sensor signals rather simultaneously this might be a direct indication of the respective use pattern of the injection device. In some examples the first use pattern may be characterized on the basis of a comparison of signal amplitudes of the first sensor signal and the second sensor signal at the same time, during overlapping time intervals or at different times that are within a predefined time interval.

[0065] In a further example of the wearable electronic device, the processor is operable to identify the first use pattern of the injection device on the basis of at least one of a comparison of the first sensor signal received at a first time with the second sensor signal received at the first time and / or received at a second time. In this way, and by comparing first and second sensor signals of different type at the same or at different times there can be provided an improved identification of the at least first use pattern of the injection device.

[0066] According to another example the processor of the wearable electronic device is operable to identify at least a second use pattern of the injection device on the basis of the first sensor signal and to distinguish between the first use pattern and the second use pattern of the injection device. Insofar, the wearable electronic device is not limited to the identification of only one use pattern of the injection device. It may be configured to identify a variety of use patterns of the injection device, which use patterns may be typically conducted in the course of using or operating the injection device.

[0067] The second use pattern of the injection device may be identified or detected in the same or like manner as described above in connection with the first use pattern. Insofar, all features, effects, and benefits as described above in connection with the identification of the first use pattern of the injection device may equally apply to the identification or detection of the second use pattern of the injection device.

[0068] The processor may be further operable to distinguish between the first and the second use patterns. The respective first and second use patterns may be identified and may be logged or stored, e.g., concurrently with a timestamp, in the memory of the wearable electronic device. In this way, the wearable electronic device may provide a rather comprehensive recording or monitoring of different use patterns of the injection device, wherein each use pattern may be indicative of a particular step of using or operating the injection device.

[0069] In addition and according to a further example, the sensor arrangement may be operable to generate a third sensor signal being indicative of another one of the position, the orientation, the acceleration of the wearable electronic device and / or being indicative of the acoustic signal emanating from the injection device. Hence, the sensor arrangement may be configured to generate a rather large number of different sensor signals each of which representing a different physical parameter of the wearable electronic device and / or of the injection device.

[0070] Accordingly, the processor coupled to the sensor arrangement may be configured to provide a respective signal processing of the first sensor signal, the second sensor signal and the third sensor signal. The generation and processing of the third sensor signal may be provided in the same or like manner as described above in connection with any of the first sensor signal and the second sensor signal. Insofar, all effects, features and benefits as described above in connection with the generation and processing of the first sensor signal may equally apply to the second sensor signal and the third sensor signal.

[0071] Moreover, by having a comparatively large number of different sensor signals, e.g. by having at least two or three different types of sensor signals there can be provided a multidimensional correlation of sensor signals of different type to identify at least a first or second use pattern of the injection device. The more sensor signal will be used by the processor to identify at least the first use pattern of the injection device the more precise the identification may become.

[0072] According to a further example the sensor arrangement of the wearable electronic device comprises at least one of a position sensor to detect or to measure the position of the wearable electronic device, an orientation sensor to detect or to measure the orientation of the wearable electronic device, an acceleration sensor to detect or to measure an acceleration of the wearable electronic device and a microphone to record or to detect an acoustic signal emanating from the injection device.

[0073] In some examples the wearable electronic device comprises a smartwatch, which is readily equipped with a position sensor, an orientation sensor, an acceleration sensor and a microphone. Any one of the position sensor, the orientation sensor, the acceleration sensor and the microphone may be configured to generate respective sensor signals, e.g., a first sensor signal, a second sensor signal, a third sensor signal and a fourth sensor signal, wherein each one of the respective sensor signals is indicative of one of the position, the orientation, the acceleration of the wearable electronic device and / or of the acoustic signal emanating from the injection device.

[0074] According to a further example the wearable electronic device comprises a housing and a strap or wrist band connected to the housing. The strap is configured to attach the wearable electronic device to a body portion of a user. In some examples the housing and the strap of the wearable electronic device are configured to attach or to fix the wearable electronic device to a wrist of a user's arm or hand. In this way, the wearable electronic device can be worn by a user, e.g. by a hand or arm of the user that is also used throughout his use of the injection device.

[0075] In other examples the wearable electronic device is configured to be worn at a wrist or arm of a user that assists the other arm or hand of a user in using the injection device. In both cases, the wearable electronic device with a sensor arrangement is particularly configured to detect and / or to measure at least one of a position, an orientation, and an acceleration of the wearable electronic device during use of the injection device and to identify at least a first use pattern of the injection device on the basis of respective sensor signals generated by the sensor arrangement during use of the injection device.

[0076] According to a further example the wearable electronic device comprises a smartwatch or a fitness tracker that is permanently or regularly worn by a user of the injection device.

[0077] In another aspect the present disclosure also relates to a method of monitoring use or monitoring operation of an injection device. The method comprises the steps of wearing a wearable electronic device, e.g., a wearable electronic device as described above. The wearable electronic device comprises a sensor arrangement. The method further comprises the step of detecting or measuring at least one of a position of the wearable electronic device, an orientation of the wearable electronic device, an acceleration of the wearable electronic device and an acoustic signal emanating from the injection device, e.g., during use or operation of the injection device. Detecting or measuring of the at least one of the position, the orientation, the acceleration, and the acoustic signal is typically conducted with the sensor arrangement of the wearable electronic device.

[0078] The method further comprises the step of generating a first sensor signal being Indicative of at least one of the position, the orientation, the acceleration of the wearable electronic device, and / or of the acoustic signal emanating from the injection device, typically, during use or operation of the injection device. The method further comprises a step of identifying at least a first use pattern of the injection device on the basis of the first sensor signal.

[0079] The method of monitoring use of the injection device may be conducted or executed with a wearable electronic device as described above. Insofar, all features, effects, and benefits as described above in connection with the wearable electronic device equally apply to the method of monitoring use of the injection device; and vice versa, wherein method includes wearing of the wearable electronic device and operating the wearable electronic device in a recognition mode.

[0080] According to a further example of the method of monitoring use of the injection device identifying at least the first use pattern of the injection device includes the step of comparing of the first sensor signal with a reference signal assigned with the at least first use pattern of the injection device. The first reference signal may be stored in a memory or storage of the wearable electronic device. The reference signal may be obtained during a training mode of the wearable electronic device. When in the training mode the wearable electronic device may detect or record the first sensor signal during use of the injection device while the wearable electronic device is worn by a user of the injection device. The first sensor signal or first sensor signal generated by the sensor arrangement during a dedicated use or reference use of the injection device may be stored in the memory during the training mode of the wearable electronic device. In this way, there can be generated and / or provided training data or reference signals that are assigned with the at least first use pattern of the injection device. Of course, there may be also generated and stored a second or further reference signals assigned with a second or further use pattern of the injection device.

[0081] When in a recognition mode the sensor signals generated by the sensor arrangement can be processed by the processor. The respective signal processing may include a comparison between the sensor signals obtained from the sensor arrangement with reference signals stored in the memory of the wearable electronic device. Depending on a degree of matching between detected or measured signals as provided by the sensor arrangement and the stored reference signals assigned with particular use patterns of the injection device there can be provided a best matching or an identification of a first use pattern or of further use patterns of the injection device.

[0082] In another aspect the present disclosure also relates to a computer program for monitoring use of an injection device. The computer program comprises computer readable instructions, which when executed by a processor of a wearable electronic device causes the processor to identify at least a first use pattern of the injection device on the basis of a first sensor signal, wherein the first sensor signal is indicative of at least one of a position, an orientation, an acceleration of the wearable electronic device and / or of an acoustic signal emanating from the injection device.

[0083] In some examples the computer program is to be executed or deployed by a processor of the wearable electronic device as described above. In a further example the computer program is particularly configured to be executed or deployed by a wearable electronic device as described above for executing and / or for conducting the method of monitoring use of the injection device as described above. Insofar, all features, effects and benefits as described above in connection with any one of the wearable electronic device and the method of monitoring use of the injection device equally apply to the computer program for monitoring use of the injection device. In some examples the computer program is a non-transitory computer program executable by the processor of the wearable electronic device. The computer program may be provided as a downloadable computer program via a communication network.

[0084] The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

[0085] 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.

[0086] The medicament container as described and defined herein is particularly configured to hold or to accommodate a pharmaceutical product inside a container cavity either in a liquid lyophilizable state, in a lyophilized reconstitutable state or in a liquid reconstituted state. The medicament container is particularly suitable for conducting a lyophilization process, for longterm storage of the lyophilized pharmaceutical product and for reconstituting the lyophilized pharmaceutical product.

[0087] 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., shorter 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 dualchamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

[0088] The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0089] 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.

[0090] 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.

[0091] 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-(w- carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

[0092] 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.

[0093] 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.

[0094] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0095] 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.

[0096] 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.

[0097] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

[0098] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and immunoglobulin single variable domains. Additional examples of antigen-binding antibody fragments are known in the art.

[0099] The term “immunoglobulin single variable domain” (ISV), interchangeably used with “single variable domain”, defines immunoglobulin molecules wherein the antigen binding site is present on, and formed by, a single immunoglobulin domain. As such, immunoglobulin single variable domains are capable of specifically binding to an epitope of the antigen without pairing with an additional immunoglobulin variable domain. The binding site of an immunoglobulin single variable domain is formed by a single heavy chain variable domain (VH domain or VHH domain) or a single light chain variable domain (VL domain). Hence, the antigen binding site of an immunoglobulin single variable domain is formed by no more than three CDRs.

[0100] An immunoglobulin single variable domain (ISV) can be a heavy chain ISV, such as a VH (derived from a conventional four-chain antibody), or VHH (derived from a heavy-chain antibody), including a camelized VH or humanized VHH. For example, the immunoglobulin single variable domain may be a (single) domain antibody, a "dAb" or dAb or a Nanobody® ISV (such as a VHH, including a humanized VHH or camelized VH) or a suitable fragment thereof. [Note: Nanobody® is a registered trademark of Ablynx N.V.]; other single variable domains, or any suitable fragment of any one thereof.

[0101] “VHH domains”, also known as VHHs, VHH antibody fragments, and VHH antibodies, have originally been described as the antigen binding immunoglobulin variable domain of “heavy chain antibodies” (i.e. , of “antibodies devoid of light chains”; Hamers-Casterman et al. 1993 (Nature 363: 446-448). The term “VHH domain” has been chosen in order to distinguish these variable domains from the heavy chain variable domains that are present in conventional 4- chain antibodies (which are referred to herein as “VH domains”) and from the light chain variable domains that are present in conventional 4-chain antibodies (which are referred to herein as “VL domains”). For a further description of VHH’s, reference is made to the review article by Muyldermans 2001 (Reviews in Molecular Biotechnology 74: 277-302).

[0102] For the term “dAb’s” and “domain antibody”, reference is for example made to Ward et al. 1989 (Nature 341: 544), to Holt et al. 2003 (Trends Biotechnol. 21: 484); as well as to WO 2004 / 068820, WO 2006 / 030220, WO 2006 / 003388. It should also be noted that, although less preferred in the context of the present invention because they are not of mammalian origin, single variable domains can be derived from certain species of shark (for example, the so-called “IgNAR domains”, see for example WO 2005 / 18629).

[0103] 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.

[0104] 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).

[0105] 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.

[0106] 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. 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), needlebased 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.

[0107] 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).

[0108] 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).

[0109] Brief description of the drawings

[0110] In the following, further details of the wearable electronic device and the method of monitoring use of an injection device will become apparent by the following detailed description by making reference to the drawings, in which:

[0111] Fig. 1 shows an example of a handheld injection device during use, Fig. 2 shows a further example of an injection device during use, Fig. 3 shows another example of an injection device, Fig. 4 shows a further example of an injection device, Fig. 5 shows an external electronic device, Fig. 6 shows an example of a wearable electronic device,

[0112] Fig. 7 is a block diagram of components of the wearable electronic device and the external electronic device,

[0113] Fig. 8 shows an exemplary step of using the injection device,

[0114] Fig. 9 shows a further exemplary step of using the injection device,

[0115] Fig. 10 shows a further step of using the injection device,

[0116] Fig. 11 shows a further step of using the injection device,

[0117] Fig. 12 shows a further step of using the injection device,

[0118] Fig. 13 shows a further step of using the injection device,

[0119] Fig. 14 shows a further step of using the injection device,

[0120] Fig. 15 shows a further step of using the injection device,

[0121] Fig. 16 shows a diagram illustrating a temporal evolution of numerous sensor signals over time during use of the injection device and

[0122] Fig. 17 shows a flowchart of a method of monitoring operation or use of the injection device with a wearable electronic device.

[0123] Detailed description

[0124] In Figs. 1-4 there are illustrated numerous examples of injection devices 1. The injection devices 1 are of elongated shape. They extend along a longitudinal axis. Towards or near a distal longitudinal end and hence towards a distal direction 2 there is provided and outlet 14 for expelling an injectable medicament. In some examples, the outlet 14 is provided with an injection needle 15, which is configured to pierce or to puncture biological tissue of a patient for injecting a dose of the liquid medicament into the biological tissue.

[0125] In the opposite proximal direction 3 and hence at the proximal end some of the injection devices 1 may comprise one of a trigger 23 and a plunger flange 21 , which is depressible or operable and hence actuatable by a user of the injection device 1. For injecting of a dose of the medicament a user may have to apply a distally directed pressure onto the trigger 23 or plunger flange 21 in order to induce or to trigger a dispensing or injecting operation to be conducted with the injection device 1.

[0126] For executing or triggering a process of dose injection a user may hold the injection device 1 in his hand 4. He may apply a distally directed pressure onto the proximal end of the injection device 1 , e.g. by making use of a thumb 5 of the respective hand 4 while one or several fingers 6 of the same hand grip or firmly hold a housing 11 of the injection device. The injection device 1 may be implemented as an injection pen as shown in the examples of Figs. 1 and 2.

[0127] The injection device 1 according to Fig. 1 comprises a dial extension 25, which is configured to move in proximal direction 3 relative to the housing 11 in the course of setting of a dose. Here, a user may set a dose of individual or fixed size by rotating a dose dial 24, by way of which a proximally directed helical motion of the dose dial 24 and / or of the entire dial extension 25 is induced relative to the housing 11.

[0128] The process of dose injecting may require applying an actuation force in distal direction 2 onto the trigger 23, which is located at the proximal end of the injection device 1. The dial extension 25 may then return into an initial position in distal direction. The force applied by user may transition into a driving motion of a stopper 9 relative to a barrel 10 of a medicament container, which may be implemented as a cartridge.

[0129] The example of an injection device 1 according to Fig. 2 may comprise a so-called auto-injector. This injection device 1 may also comprise a housing 11 , which is to be firmly held or gripped by numerous fingers 6 of a hand 4 of a user. Also here, a user may optionally apply a distally directed pressure onto the housing 11 either by his thumb 5 or with any one or several of his fingers 6.

[0130] The injection device 1 further comprises a shield 12, e.g. in form of a tubular sleeve that sheaths an injection needle 15 pointing with its tipped end in distal direction 2. In an initial or idle configuration of the injection device 1 the injection needle 15 way be completely enclosed by the shield 12. For injecting of a dose, the distal end of the shield 12 may be placed against the skin of a patient. A user may then apply a distally directed force effect or movement of the housing 11 relative to the shield 12, by way of which expelling of a dose of the medicament may be triggered. Here, the trigger 23 of the injection mechanism 22 may be located inside the housing 11 and may be actuated by inducing a distally directed displacement of the housing 11 relative to the shield 12.

[0131] In the further example of an injection device 1 as shown in Figs. 3 and 4 the injection device 1 may comprise a safety syringe, with a syringe carrier 13 and with a protective cap 16 covering the needle 15 of the injection device 1. The injection device 1 comprises the syringe carrier 13, which is configured to house or to fix an ordinary syringe as shown in Fig. 4 therein. The syringe as shown in Fig. 4 comprises a tubularly-shaped barrel 10 with an outlet 14 at its distal end. The outlet 14 is provided with an injection needle 15. Inside the barrel 10 there is provided a movable stopper 9. Between the outlet 14 and the stopper 9 there is located an injectable medicament 8. By moving the stopper 9 relative to the barrel 10 in distal direction 2, a dose of the medicament 8 can be expelled through the outlet 14 and hence through the injection needle 15 into biological tissue. For inducing a distally directed dispensing motion the stopper 9 is mechanically connected to a plunger 20, which protrudes in proximal direction 3 from a proximal end of the barrel 10. The plunger 20 is provided with a radially widened plunger flange 21 at or near the proximal end, which allows to induce a respective dispensing or actuation force onto the plunger 20 and hence onto the stopper 9 for urging the stopper 9 in distal direction 2.

[0132] The barrel 10 may be provided with a flange portion 17 at or near its proximal end, which allows to fasten the injection device 1 in a syringe carrier 13 as shown in Fig. 3. The syringe carrier 13 may be further provided with a flange portion 18 that allows or supports gripping of the flange portion 17 by a user, e.g. by a middle finger and an index finger of a user when the user applies a distally directed pressure onto the plunger flange 21 for urging the stopper 9 in distal direction 2.

[0133] In the example of Fig. 3 there is further shown an add-on device 60 that can be detachably connected to the plunger flange 21. The add-on device 60 comprises a device body 61 for attachment to the plunger flange 21. The add-on device 60 comprises a movable part 70 that is movable relative to the device body 61. The movement of the movable part 60 relative to the device body 61 can be electronically recorded by an electronic circuit of the add-on device 60.

[0134] Generally, such add-on devices 60 may comprise a receptacle 63 configured to engage with the dose dial 24 of the injection device 1 as shown in Fig. 1. Here, the movable part 70 may mechanically engage with the trigger 23. The add-on device 60 may comprise a transceiver configured to communicate with the wearable electronic device 100 and / or to exchange data with the wearable electronic device 100 as described below.

[0135] However, optional use of an add-on device 60 connected or connectable to the injection device 1 may be beneficial for identifying a use pattern of the injection device 1. With some examples the add-on device 60 may be configured to generate an acoustic signal in the course of operating or using the add-on device 60 when attached to or engaged with the injection device 1. Such an acoustic signal may be detectable by the sensor arrangement 55 of the wearable electronic device 100. It may be generated by the add-on device 60 during use of the injection device 1 and may be indicative of a particular use pattern of the injection device 1.

[0136] In some examples, moving of the movable part 70 relative to the device body 61 of the add-on device 60 may generate an acoustic signal that is detectable by the sensor arrangement 55 of the wearable electronic device 100. In this way, and when the injection device 1 as such should be inoperable to generate an acoustic signal, use of the add-on device 60 concurrent with the injection device 1 may provide an acoustic detection and hence a detection and identification of a use pattern of a respective operation of the add-on device 60 concurrent with the injection device 1.

[0137] Figs. 8-15 illustrate different steps of using an injection device 1. In the example of Fig. 8 the injection device 1 comprises a housing 11 which is provided with a protective cap 16. Prior use or in the course of using the injection device 1 it is required to detach the protective cap 16 from the housing 11 of the injection device. Here, the user may hold the injection device 1 in one hand 4 and may grip the protective cap 16 with the other hand 4'. By exerting a detachment force to the protective cap 16 relative to the housing 11 the fastening mechanism that keeps the protective cap 16 secured to the housing 11 may release and may allow a detachment or disassembly of the housing 11 and the protective cap 16.

[0138] Depending on the specific fastening or fixing mechanism between the housing 11 and the protective cap 16 the detachment motion conducted by at least one of the hands 4, 4' of the user may be characterized by a respective movement of at least one of the hands 4, 4' or by both of the hands 4, 4'. Such hand movements and hence a measurable acceleration of at least one of the hands for, 4' of the user can be qualitatively and / or quantitatively detected or measured by the sensor arrangement 55 of the wearable electronic device 100 when attached or fixed to one of the user's hands 4, 4'.

[0139] With the example of Fig. 8 detachment of the protective cap 16 from the housing 11 may require a longitudinal displacement of the protective cap 16 relative to the housing 11. The respective movement may be accompanied by a rather abrupt acceleration of one hand 4, relative to the other hand 4' in one of the longitudinal distal direction 2 and the longitudinal proximal direction 3.

[0140] In the example according to Fig. 9 detachment of the protective cap 16 from the housing 11 of the injection device 1 may require a twisting or helical motion of the protective cap 16 relative to the housing. As indicated by the arrows in Fig. 9 and when the user wears a wearable electronic device 100 in close vicinity to one of his hands 4, 4', or rotating or twisting motion of one hand 4 relative to the other hand 4' can be precisely detected by the sensor arrangement 55 of the wearable electronic device 100.

[0141] In Fig. 10 there is illustrated a further step of placing the injection device 1 to an injection site 80 of a user or patient. Positioning of the injection device 1 to the injection site, and e.g. an abutment of the distal end of the injection device 1 with the patient's skin 82 may be also precisely detectable by the sensor arrangement 55.

[0142] In Fig. 11 triggering or start of an injection to be conducted or executed by the injection device 1 is schematically indicated. The injection process may be accompanied with at least one of a well-defined noise or sound generated by the injection device 1 and / or by a well-defined movement of components of the injection device 1 , which movement may induce a respective shock applied to one of hands 4 holding the injection device 1 or to a hand 4' being in contact with the injection site 80 or skin 82.

[0143] Termination of the injection process may be accompanied by a further acoustic noise or acoustic signal that may be detected by an acoustic sensor 56 of the sensor arrangement 55 of the wearable electronic device 100. After completion of the dose injection procedure, it may be required that the injection device 1 is kept still to the injection site 80, e.g. for some seconds. Thereafter, the injection device 1 may be removed from the injection site 80 as indicated in Fig. 12.

[0144] Such a removal may be again detectable by the sensor arrangement 55 of the wearable electronic device 100, e.g., worn by that hand of the user which holds and moves the injection device 1.

[0145] In Figs. 13-15 there are illustrated further user steps to be conducted by a user in the course of injecting a dose of a medicament into an injection site 80. Here, the user may hold the injection device and 1 in one of his hands 4 and may use his other hand 4’ to assist or accompany the injection process. In Fig. 13 it is illustrated that the other hand 4’ is used to support or to hold a skin portion 82 during and / or before conducting the injection procedure. In the scenario as depicted in Fig. 14 the further hand 4’ is used to pinch a portion of the skin 82 before, during or after injection and in the example of Fig. 15 the further hand 4’ is used to supply or to guide the injection device in the course of the process of dose setting or dose injection.

[0146] Also here, and when the wearable electronic device 100 is worn at a wrist 7 of the further hand 4’ of the user there can be still detected characteristic signals from the sensor arrangement 55 of the wearable electronic device 100 that are indicative of for particular steps of using the injection device 1.

[0147] The wearable electronic device 100 comprises a housing 101 as illustrated in Fig. 6. The wearable electronic device 100 may comprise a smartwatch 106. The wearable electronic device 100 comprises a display 104, which may cover a major portion of an upper side of the housing 101. The wearable electronic device 100 may further comprise a strap 105 or wrist band connected to the housing 101. By way of the strap 105 or wristband 105 the wearable electronic device 100 can be fixed or attached to a particular body portion of a user, e.g. to a wrist 7 of a hand 4 of the user.

[0148] As further indicated in Fig. 6 the wearable electronic device 100 comprises an actuating element 46 by way of which a user may enter selected commands by actuating the actuating element 46. In further examples the display 104 may comprise a touch sensitive display. This way, the user may enter respective confirmations or commands by touching or wiping on or across the display 104.

[0149] The wearable electronic device 100 may communicate with a further external electronic device 200 as illustrated in Fig. 5. The external electronic device 200 may also comprise a housing 201 and a device processor 202 as well as an actuating element 203 which is actuatable from outside the external electronic device 200. The external electronic device 200 further comprises a display 204, which may be implemented as a touch sensitive display. User commands or user feedback may be processed via the touch sensitive display 204.

[0150] The electronic device 200 comprises a communication unit 206, e.g. implemented as a wireless communication unit to wirelessly communicate with the wearable electronic device 100. Also, the external electronic device 200 may comprise a device memory 208. The external electronic device 200 may be implemented as a smart phone or as a tablet computer. It may establish a frequent or permanent communication link with the wearable electronic device. The external electronic device 200 and the wearable electronic device 100 may mutually synchronize in regular time intervals and / or upon establishing a communication link.

[0151] In the block diagram of Fig. 7 numerous components of the wearable electronic device 100 are schematically illustrated. The wearable electronic device 100 comprises an electronic circuit 35. The electronic circuit 35 may comprise a printed circuit board 36. The electronic circuit 35 comprises a transceiver 38, a memory 40, a clock 42, a processor 44, the actuator element 46, a signal generator 48, a power source 50 and a sensor arrangement 55. The sensor arrangement 55 may comprise a number of individual sensors 52, 54, 56. In the example as illustrated in Fig. 7 the sensor 52 may comprise an orientation sensor by way of which an orientation of the electronic circuit 35 and hence of the sensor arrangement 55 can be precisely detected or quantitatively measured, e.g., in relation to the earth magnetic field. The sensor 54 may be implemented as an acceleration sensor by way of which an acceleration and hence a force effect acting on the sensor arrangement 55 can be detected and / or quantitatively measured.

[0152] The further sensor 56 may be Implemented as an acoustic sensor, e.g., as a microphone, by way of which acoustic signals can be detected and / or quantitatively measured. The sensor arrangement 55 is connected or coupled to the processor 44 and the processor 44 is particularly configured to process the sensor signals or numerous sensor signals as provided by the sensor arrangement 55 and by its individual sensors 52, 54, 56.

[0153] The processor 44 as well as the further components of the electronic circuit 35 can be supplied with electrical energy from the power source 50, e.g. implemented as a battery, which may be rechargeable or replaceable.

[0154] The processor 44 is coupled to the sensor arrangement 55 and to the memory 40. The memory 40 may comprise a non-volatile digital memory. The processor 44 may be configured to read data from the memory 40 and / or to write data into the memory 40. The electronic circuit 35 and hence the wearable electronic device 100 comprises a signal generator 48. The signal generator 48 may include at least one of the display 104 as described above and an acoustic signal generator as well as a haptic signal generator to generate respective user perceptible signals, e.g., visual signals, acoustic signals and / or haptically perceptible signals, which are suitable to attract the user's attention.

[0155] The clock 42 may provide a clock signal on the basis of which the processor 44 may generate a timestamp to be concurrently stored with the data in the memory.

[0156] Operation of the processor 44 and / or of the electronic circuit 35 may be controllable by the actuating element 46. The actuating element 46 may comprise a user actuatable element, which can be operated by touching or tapping and / or by voice commands of a user. The actuating element 46 may be integrated into the display 104 and / or it may comprise microphone, e.g. implemented in the sensor 56. The display 104 may be implemented as a touch sensitive display.

[0157] The wearable electronic device 100 further comprises the transceiver 38. It may be implemented as a wireless transceiver. The transceiver 38 may be configured to establish a communication link with the communication unit 206 of the external electronic device 200. The communication link between the transceiver 38 and the communication unit 206 of the external electronic device 200 may be based on a standardized wireless communication protocol, e.g. on a RF-based communication protocol, such as RFID, NFC, Bluetooth or Wi-Fi standard or some other suitable wireless communication protocol.

[0158] In the diagram according to Fig. 16 numerous sensor signals S1, S2, and S3 are illustrated over time. A first sensor signal S1 may be indicative of an acceleration of the wearable electronic device 100. A second sensor signal S2 may be indicative of an acoustic signal emanating from the injection device 1 and the further and hence a third sensor signal S3 may indicate an orientation of the wearable electronic device 100, e.g., relative to the earth magnetic field.

[0159] The individual sensor signals S1 , S2, S3 comprise numerous peaks or amplitudes A1 , A2, A3 over time. For instance, at a time t1 a protective cap 16 may be detached from the housing 11 of the injection device 1. Such a detachment may be accompanied with a rather abrupt motion of one or of the hands’4, 4' of the user. When the user wears the wearable electronic device 100 on one of his hands 1 or at a respective wrist 7 a respective acceleration can be detected at the time t1.

[0160] In some examples and when the protective cap 16 is connected or fastened to the housing 11 of the injection device 1 the detachment of the protective cap 16 may be further accompanied with a characteristic sound, such as a click noise or clip noise. Such a characteristic sound may reflect in a first amplitude AT in the second sensor signal S2. It may be further detectable by the acceleration sensor 54 and may reflect in a signal amplitude A1 of the first sensor signal S1.

[0161] In the time interval between t1 and 12 the injection device 1 may be prepared for conducting an injection procedure. At the time t2 the injection device 1 may be placed against an injection site 80. This procedure may be void of any acoustic noise. The injection device 1 and hence a hand 4 holding the injection device 1 and hence the wearable electronic device 100 may be then subject to measurable acceleration or reorientation, which may reflect in respective signal amplitudes of the first sensor signal S1 and the third sensor signal S3.

[0162] At the time t3 the injection device 1 may be held still against the skin 82 of the patient. At the point of time t3 an injection procedure may be initiated or triggered. Specifically, and with an injection device 1 implemented as an auto injector, injecting of a dose may be triggered by urging the injection device 1 firmly to the skin 82 of the puncture site 80. The triggering of the injection process may be accompanied with a measurable acceleration of the wearable electronic device 100 as well as by detection of a characteristic noise, e.g. a click sound generated by the injection device 1. Respective signal amplitudes A2 a’d A2' may be present at time t3 in the sensor signals S1 and S3. At the end of the injection procedure at time t4, a likewise signal or signal amplitude A’, A3' may be detectable or quantitatively measurable. Also, the process of injection termination may be accompanied with a measurable acceleration, e.g., when a plunger or piston rod of a firing or injection mechanism of the injection device 1 reaches a stop figuration by way of which the movement of the advancing stopper 9 is promptly stopped. Also, the end of the injection procedure may be accompanied with a particular acoustic sound, such as a further click noise reflecting in a signal amplitude A3' in the second sensor signal S2.

[0163] In the subsequent time interval between t4 and t5 the injection device 1 may be held still against the skin 82 of the patient before at t5 the injection device 1 is removed from the injection site 80. Such a removing motion may reflect in a further signal aptitude A4 of the first sensor signal S1.

[0164] As indicated in the example of Fig. 16 a process of preparing an injection device 1 for injection and conducting of an injection procedure with the injection device 1 may be accompanied with a number of characteristic signals or signal amplitudes of numerous sensor signals S1 , S2, S3.

[0165] The processor 44 of the wearable electronic device 100, which is worn by a user during conducting of the injection procedure, is particularly configured to process any of these sensor signals S, S2 and / or S3 and may be further operable to conduct a plausibility check if the occurrence of individual signal amplitudes over time or if particular temporal evolutions of signal amplitudes of the individual sensor signals S1, S2 and / or S3 correspond or indicate conducting of an injection procedure.

[0166] Here, identifying at least a first use pattern, e.g. removing of a protective cap from the injection device, placing the injection device against the patient's skin, start of an injection procedure, termination of an injection procedure, removal of the injection device from the injection site, may be each characterized by at least one or by a combination of individual sensor signals S1, S2 and / or S3 as provided or generated by the sensor arrangement 55 of the wearable electronic device 100.

[0167] A use pattern may be identified on the basis of an analysis of the signal amplitude of a single or of a combination of the sensor signals S1 , S2 and / or S3. The identification of a use pattern of the injection device 1 may be also conducted on the basis of detecting or quantitatively measuring a temporal evolution of a single sensor signal or of numerous sensor signals S1 , S2, S3. Moreover, identification of a particular use pattern of the injection device 1 may be conducted on the basis of a correlation of characteristic signal amplitudes A1, A2, A3 of the first signal S1 at a first time and signal amplitudes of the first sensor signal S1 at a second time. Moreover, correlations between different sensor signals S1 , S2, S3 at the same point of time, at or during overlapping time intervals or at different points of time may be indicative of a respective use pattern.

[0168] The identification of one of a plurality of use patterns on the basis of at least one or on the basis of several sensor signals S1, S2, S3 may be conducted by way of a comparison of at least one or several sensor signals S1, S2, S3 with reference signals stored in the memory 40 of the wearable electronic device 100.

[0169] In the flowchart of Fig. 17 numerous steps of conducting a method of monitoring use or operation of the injection device 1 are indicated. In a first step 300 the user takes the injection device 1 and e.g. detaches the protective cap 16 from the injection device 1. The detachment of the protective cap 16 from the injection device 1 leads to the generation of a measurable sensor signal S1 in step 302. In a subsequent step 304 the sensor signal S1 is compared with a reference signal as stored in the memory 40.

[0170] In step 306 it is determined if the sensor signal S1 actually obtained from the sensor arrangement 55 suitably matches with a respective reference signal as obtained from the memory 40. If there is a sufficient degree of matching, the procedure continues with step 308. Here, one of a plurality of use patterns of the injection device 1 is identified and the identified use pattern is stored or logged in step 310, e.g., concurrently with a timestamp receivable from the clock 42 of the electronic circuit 35 of the wearable electronic device 100.

[0171] If it should be determined in step 306 that the matching between the sensor signal actually obtained from the sensor arrangement 55 does not match with any of the reference signals stored in the memory 40 the procedure may continue with step 312. Here, a use pattern assigned with a reference signal providing the best match with the sensor signal S1 actually provided by the sensor arrangement 55. may be preliminarily selected and presented to a user in step 312, e.g. via the display 204 and / or via the signal generator 48.

[0172] In the subsequent step 314 the user is prompted by the wearable electronic device 100 to confirm or to decline the preliminarily identified use pattern. If the user confirms the preliminarily selected or identified use pattern, then the procedure continues with step 308. Otherwise, and if the user declines the preliminarily selected or identified use pattern the procedure continues with step 316. Here, the method may provide numerous options on how to proceed.

[0173] According to one option the measurement or detection as provided by the sensor arrangement may be discarded. According to another option, the method may return to step 312 and may propose another candidate of a use pattern based on the comparison between the sensor signal S1 as provided by the sensor arrangement and any available reference signal stored in the memory 40. Then, the procedure may continue with step 314 in a manner as described above.

[0174] It should be noted that the wearable electronic device 100 may be either configured to be worn at an operating hand 4 or at an accompanying hand 4' of a user and during use or operation of the injection device. The operating hand 4 of the user is that particular hand, which holds and / or operates the injection device during operation or use of the injection device. The accompanying hand 4' is the other hand of the user, which may be used to assist or to guide the injection process. The accompanying hand may be in contact with the skin 82 of an injection site 80 of the patient before, during or after the injection process.

[0175] In either scenario, the individual steps of using or operating the injection device 1 may be characterized by specific motions of the wearable electronic device 100, which can be recognized by the generation of at least a first sensor signal S1 by the sensor arrangement 55 and by a subsequent signal processing provided by the processor 44 of the wearable electronic device 100.

[0176] In the following, numerous use patterns that are generally detectable or quantitatively measurable with a wearable electronic device 100, e.g., with a smartwatch 106 worn by a user during use or operation of the injection device 1 are schematically described.

[0177] An identifiable use pattern to be identified by the wearable electronic device 100 and / or by the method of monitoring use of the injection device 1 as described herein may include taking of the injection device 1 , e.g. removing the injection device 1 from a package, from a storage box or other compartments. Such a use pattern may be detectable at both hands 4, 4' of a user and may be further detectable by at least one of the position, the orientation and the acceleration of the wearable electronic device 100.

[0178] Also, the process of transferring the injection device 1 from one hand 4 to the other hand 4' and hence change of the device handling may be detectable with the wearable electronic device 1, provided that the wearable electronic device 100 is provided at one of the hands 4, 4' of the user. Also here, a use pattern may be equally detectable by at least one of a position, an orientation, and an acceleration of the wearable electronic device 100.

[0179] Another use pattern to be recognized by the wearable electronic device is removing of the protective cap 16 from the housing 11 of the injection device 1. Here, the removal may include a well-defined detachment of the cap, e.g. release of a snap fit connection, which may be characterized by a particular acceleration or reorientation of the wearable electronic device 100.

[0180] Also, twisting of the protective cap 16 may be easily recognizable on the basis of the sensor signals obtainable from the sensor arrangement 55 of the wearable electronic device 100

[0181] Further use patterns to be recognized or recognizable by the wearable electronic device 100 include take off the cap 16 from the injection device 1 and disposal of the protective cap 16, taking or lifting the injection device 1 for injection, supplying the injection device 1 to the injection site 80 of a user's body, starting of the injection, e.g., by applying a force effect to the injection device 1.

[0182] Also, the start of the injection procedure may be accompanied by a measurable or detectable click sound as well as by a measurable mechanical shock emanating from the injection device 1. Also, termination or completion of an injection procedure may be detectable by the acoustic sensor of the sensor arrangement of the wearable electronic device 100.

[0183] The removal of the injection device 1 from the injection site 80 may be equally captured and may be identified as a further use pattern. Also, disposal of the injection device 1, e.g., in case of a single dose injection device 1 or disposable injection device 1 may be detected or measured by the sensor arrangement 55.

[0184] Generally, each of the above-described use patterns, which may typically be conducted during, after or prior use of the injection device 1 can be detected or measured with the wearable electronic device 100 when attached to one of the two hands 4, 4’ of the user. Reference Numbers

[0185] 11 injection device

[0186] 2 distal direction

[0187] 3 proximal direction

[0188] 4 hand

[0189] 5 thumb

[0190] 6 finger

[0191] 7 wrist

[0192] 8 medicament

[0193] 9 stopper

[0194] 10 barrel

[0195] 11 housing

[0196] 12 shield

[0197] 13 syringe carrier

[0198] 14 outlet

[0199] 15 needle

[0200] 16 protective cap

[0201] 17 flange portion

[0202] 18 flange portion

[0203] 20 plunger

[0204] 21 plunger flange

[0205] 22 injection mechanism

[0206] 23 trigger

[0207] 24 dose dial

[0208] 25 dial extension

[0209] 35 electronic circuit

[0210] 36 printed circuit board

[0211] 38 transceiver

[0212] 40 memory

[0213] 42 clock

[0214] 44 processor

[0215] 46 actuating element

[0216] 48 signal generator

[0217] 50 power source

[0218] 52 sensor

[0219] 54 sensor sensor arrangement sensor add-on device device body receptacle movable part injection site skin wearable electronic device housing display strap smartwatch electronic device housing device processor actuating element display communication unit device memory

Claims

Claims1. A wearable electronic device (100) for monitoring use of an injection device (1), the wearable electronic device (100) comprising: a sensor arrangement (55) operable to detect or to measure at least one of: a position of the wearable electronic device (100), an orientation of the wearable electronic device (100), an acceleration of the wearable electronic device (100) and an acoustic signal emanating from the injection device (1) and operable to generate a first sensor signal (S1 , S2, S3) being indicative of at least one of the position, the orientation, the acceleration of the wearable electronic device (100), and / or of the acoustic signal emanating from the injection device (1), a memory (40), and a processor (44) coupled to the sensor arrangement (55) and to the memory (40), wherein the processor (44) is operable: to identify at least a first use pattern of the injection device (1) on the basis of the first sensor signal (S1, S2, S3).

2. The wearable electronic device (100) according to claim 1 , wherein the processor (44) is operable to log an identification of the first use pattern of the injection device (1) in the memory (40).

3. The wearable electronic device (100) according to any one of the preceding claims, further comprising a signal generator (48) coupled to the processor (44) and operable to indicate the identification of the first use pattern of the injection device (1) to a user.4 The wearable electronic device (100) according to claim 3, wherein the signal generator (48) comprises a display (104) to visually indicate the identification of the first use pattern of the injection device (1) to the user.

5. The wearable electronic device (100) according to any one of the preceding claims, further comprising an actuating element (46) coupled to the processor (44) and configured to receive a user command and to transfer the user command to the processor (44).

6. The wearable electronic device (100) according to any one of the preceding claims, wherein the sensor arrangement (55) is operable: to detect or to measure at least one of the position of the wearable electronic device (100), the orientation of the wearable electronic device (100), the acceleration of the wearable electronic device (100), and the acoustic signal emanating from the injection device (1) over time and to generate a plurality of first sensor signals (S1 , S2, S3) over time.

7. The wearable electronic device (100) according to claim 6, wherein the processor (44) is configured to identify the at least first use pattern of the injection device (1) on the basis of a temporal correlation between the first sensor signal (S1; S2, S3) at a first time (t1) and the first sensor signal (S1 , S2, S3) at a second time (t2).

8. The wearable electronic device (100) according to claim 6 or 7, wherein the processor (44) is operable to identify the at least first use pattern of the injection device (1) on the basis of a temporal evolution of a first signal amplitude (A1) of the first sensor signal (S1 , S2, S3) during a predefined time interval.

9. The wearable electronic device (100) according to any one of the preceding claims, wherein the processor (44) is operable to identify the at least first use pattern of the injection device (1) on the basis of a comparison of the first sensor signal (S1 , S2, S3) with a reference signal assigned with the at least first use pattern of the injection device (1).

10. The wearable electronic device (100) according to claim 9, wherein the processor (44) is operable to store the first sensor signal (S1 , S2, S3) as the reference signal in the memory (40).

11. The wearable electronic device (100) according to any one of the preceding claims, wherein the sensor arrangement (55) is operable to generate a second sensor signal (S1 , S2, S3) being indicative of another one of the position, the orientation, the acceleration of the wearable electronic device (100), and / or of the acoustic signal emanating from the injection device (1).

12. The wearable electronic device (100) according to claim 11, wherein the processor (44) is configured to identify the at least first use pattern of the injection device (1) on the basis of a temporal correlation between the second sensor signal (S1 ; S2, S3) at a first time (t1) and the second sensor signal (S1 , S2, S3) at a second time (t2).

13. The wearable electronic device (100) according to claim 11 or 12, wherein the processor (44) is operable to identify the first use pattern of the injection device (1) on the basis of a comparison of the first sensor signal (S1 , S2, S3) and the second sensor signal (S1 , S2, S3).

14. The wearable electronic device (100) according to any one of the preceding claims 11 - 13, wherein the processor (44) is operable to identify the first use pattern of the injection device (1) on the basis of at least one of a comparison of the first sensor signal (S1 , S2, S3) received at a first time (t1) with the second sensor signal (S1 , S2, S3) received at the first time (t1) and / or received at a second time (t2).

15. The wearable electronic device (100) according to any one of the preceding claims, wherein the processor (44) is operable to identify at least a second use pattern of the injection device (1) on the basis of the first sensor signal (S1, S2, S3) and to distinguish between the first use pattern and the second use pattern of the injection device (1).

16. A method of monitoring use of an injection device (1), the method comprising the steps of: wearing a wearable electronic device (100) comprising a sensor arrangement (55), detecting or measuring at least one of a position of the wearable electronic device (100), an orientation of the wearable electronic device (100), an acceleration of the wearable electronic device (100) and an acoustic signal emanating from the injection device (1) with the sensor arrangement (55), generating a first sensor signal (S1 , S2, S3) being indicative of at least one of the position, the orientation, the acceleration of the wearable electronic device (100), and / or of the acoustic signal emanating from the injection device (1), and identifying at least a first use pattern of the injection device (1) on the basis of the first sensor signal (S1 , S2, S3).

17. The method according to claim 16, wherein identifying at least the first use pattern of the injection device includes the step of: comparing of the first sensor signal (S1 , S2, 3) with a reference signal assigned with the at least first use pattern of the injection device (1).

18. A computer program comprising computer readable instructions, which when executed by a processor (44) of a wearable electronic device (100) cause the processor (44) to:identify at least a first use pattern of the injection device (1) on the basis of a first sensor signal (S1 , S2, S3), wherein the first sensor signal (S1 , S2, S3) is indicative of at least one of a position, an orientation, an acceleration of the wearable electronic device (100) and / or of an acoustic signal emanating from the injection device (1).

Images