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

Abstract

Wearable Electronic Device and Method of Monitoring Use of an Injection Device In one aspect the present disclosure relates to a wearable electronic device (100) for use with an injection device (1), the wearable electronic device (100) comprising an electronic circuit (35), the electronic circuit (35) 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 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 transceiver (38) to establish a communication link (110) to a device electronic circuit (135) engaged with or attachable to the injection device (1), - a processor (44) coupled to the sensor arrangement (55) and to the transceiver (38), wherein at least one of the electronic circuit (35) and the processor (44) is switchable into one of an injection assisting mode and an injection monitoring mode on the basis of the first sensor signal received from the sensor arrangement (55).

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, autoinjectors, 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 device 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 only.

[0014] In view of the above it would be beneficial to improve monitoring operation and / or use of injection devices with the help of an auxiliary device. It is a further aim to assist users in using injection devices and to train users in operating injection devices. 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 use with an injection device. The wearable electronic device comprises an electronic circuit. The electronic circuit comprises a sensor arrangement. The electronic circuit further comprises a transceiver to communicate with a device electronic circuit engaged with or attachable to the injection device. The electronic circuit of the wearable electronic device further comprises a processor that is coupled to the sensor arrangement and to the transceiver.

[0016] At least one of the electronic circuit and the processor is switchable into one of an injection assisting mode and an injection monitoring mode on the basis of sensor signals received from the sensor arrangement. The sensor arrangement 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, e.g., in the course of operating or using the injection device. The sensor arrangement is further operable to generate 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.

[0017] The wearable electronic device may be configured for attachment or arrangement to a body portion of a user or patient making use of the injection device. By way of the sensor arrangement of the wearable electronic device and by generating respective first sensor signals as provided by the sensor arrangement there can be identified a use pattern of the injection device. By way of the use pattern the electronic circuit and / or the processor of the wearable electronic device can be switched into one of an injection assisting mode and an injection monitoring mode.

[0018] In the respective injection assisting or injection monitoring mode the wearable electronic device may either assist a user in using the injection device or may monitor operation of the injection device and / or may monitor or log data being indicative of the use of the injection device. By way of the sensor arrangement and by processing of the first sensor signal or signals obtainable from the sensor arrangement one or several user gestures can be detected or quantitatively measured by the sensor arrangement when the wearable electronic device is worn or carried by a user during use of the injection device.

[0019] In some examples the wearable electronic device comprises a smartwatch and / or a fitness tracker. It may be worn at an arm, at a hand or hand wrist of a user or patient when 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 of the wearable electronic device, which wearable electronic device is worn by the user during use of the injection device.

[0020] On the basis of the first sensor signal or sensor signals as provided by the sensor arrangement of the wearable electronic device the wearable electronic device can be automatically switched into one of an injection assisting mode and an injection monitoring mode. In this way, a user may no longer have to enter a respective command into the wearable electronic device. The wearable electronic device may trigger automatically or may be triggered autonomously to at least one of assisting a user in operating or using the injection device and monitoring use of the injection device, e.g., by switching the electronic circuit and / or the processor of the wearable electronic device into one of the injection assisting mode and the injection monitoring mode.

[0021] In some examples the transceiver of the wearable electronic device is configured to communicate with a device electronic circuit engaged with or attachable to the injection device. The device electronic circuit may be fastened or connected to the injection device and may be configured to detect or measure at least one of use or handling of the injection device prior to, during or after injecting of a dose of a medicament. In some examples the transceiver of the wearable electronic device may be configured to establish a communication link, e.g., a wireless communication link to the device electronic circuit engaged with or attachable to the injection device.

[0022] In further examples it may be the device electronic circuit, e.g. a respective transceiver of the device electronic circuit that is configured to establish a communication link with the transceiver of the electronic circuit of the wearable electronic device. The transceiver of the device electronic circuit may be configured to likewise communicate with the transceiver of the electronic circuit of the wearable electronic device.

[0023] In some examples the transceiver of the electronic circuit of the wearable electronic device is a wireless transceiver. In this way, there may be provided a wireless data exchange or communication between the transceiver of the electronic circuit of the wearable electronic device and the device electronic circuit engaged with or attached to the injection device.

[0024] According to some examples the device electronic circuit is or forms part of an add-on device configured for detachably fastening to the injection device. In other examples the device electronic circuit is integrated into the injection device. It may be inextricably linked or inextricably integrated into a drive mechanism of the injection device.

[0025] According to a further example and when in one of the injection assisting mode and the injection monitoring mode the transceiver of the electronic circuit of the wearable electronic device is operable to receive and / or to collect injection device data from the device electronic circuit, e.g., from the transceiver of the device electronic circuit that is engaged with or which is attached to the injection device. In some examples and when in one of the injection assisting mode and the injection monitoring mode the transceiver of the wearable electronic device is operable to receive and / or to collect injection device data via the communication link from the device electronic circuit that is engaged with or that is attached to the injection device.

[0026] In this way and when in one of the injection assisting mode and the injection monitoring mode the transceiver and hence the electronic circuit of the wearable electronic device is operable to collect injection-related data from the device electronic circuit that is engaged with or that is attached to the injection device. In this way there can be collected and / or logged injection- related data by the electronic circuit of the wearable electronic device.

[0027] Moreover, and when in one of the injection assisting mode and the injection monitoring mode and when receiving injection device data via the communication link and / or from the device electronic circuit the wearable electronic device, specifically its electronic circuit may be configured to generate a user-perceivable feedback, which may be directly and rather instantaneously detected or perceived by a user of the wearable electronic device and / or injection device.

[0028] Insofar, the wearable electronic device may be implemented as a feedback device that is configured to provide a perceivable user feedback before, during or after injecting of a dose of the medicament by way of the injection device. Hence, the communication link between the transceiver of the electronic circuit of the wearable electronic device and the device electronic circuit can be used to generate and / or to broadcast a user-perceivable feedback signal, which may be generated by the wearable electronic device in response to receive injection device data from the device electronic circuit engaged with or attachable to the injection device.

[0029] In some examples the wearable electronic device may be even void of a sensor arrangement as described above. It may be exclusively equipped with a transceiver to communicate with the device electronic circuit engaged with or attachable to the injection device and may further comprise a processor coupled to the transceiver. Here, the processor may be operable to generate a user feedback in response to injection device data acquired and / or collected from the device electronic circuit via the transceiver of the electronic circuit of the wearable electronic device. In this way, there can be provided an improved feedback for a user using the injection device and using the wearable electronic device.

[0030] In general, and since the wearable electronic device can be worn at a hand or wrist of a patient or user it may be easily accessible or readable by the patient or user even during conducting or executing a medicament injection process. Especially with patients or users having physical disabilities, haptic limitations and / or in limited vision the patient or user may face difficulties in detecting or realizing a particular status of the injection device.

[0031] By establishing a communication link between the transceiver of the wearable electronic device and the device electronic circuit engaged with or attachable to the injection device there can be provided an improved feedback to the wearable electronic device, e.g., from the device electronic circuit via the communication link to the transceiver of the electronic circuit of the wearable electronic device that leads to the generation of a user-perceivable feedback signal for which the patient would be more sensitive.

[0032] Moreover, this type of feedback may be much more comfortable for a user, when the wearable electronic device generates a feedback signal being indicative of a particular status of the injection device. The patient or user of the wearable electronic device and / or of the injection device may become immediately aware of the status of the injection device before, during or after conducting an injection procedure.

[0033] Moreover, the wearable electronic device may be worn rather permanently and / or over a comparatively long time, e.g. during an entire day time. The wearable electronic device may almost permanently assist a user during his daily life. Implementing the communication between the transceiver of the electronic circuit of the wearable electronic device and the device electronic circuit attached to or integrated into the injection device may easily improve and extend the functionality of the wearable electronic device, which may then become an electronic assistant for users in the course of conducting or executing an injection procedure with the injection device and / or for recording or logging operation of the injection device in a rather automated way.

[0034] According to another example the wearable electronic device, specifically, its electronic circuit comprises a memory coupled to the processor. The memory may be implemented as a digital memory. It may be implemented as a readable and writable memory, which may be readable and / or writable by the processor of the electronic circuit of the wearable electronic device. The memory may be a non-volatile memory.

[0035] When in one of the injection assisting mode and the injection monitoring mode the processor is operable to store the injection device data received via the transceiver in the memory. The memory of the wearable electronic device may be of particular use to conduct an injection monitoring and to operate the processor and / or the electronic circuit of the wearable electronic device in the injection monitoring mode. When in the injection monitoring mode injection-related data generated and / or transmitted from the device electronic circuit to the transceiver of the electronic circuit of the wearable electronic device can be stored or logged in the memory.

[0036] Storage of injection-related data may be accompanied with the generation and / or storage of a timestamp, which timestamp may be generated by a clock or clock generator of at least one of the electronic circuit of the wearable electronic device and the device electronic circuit engaged with or attachable to the injection device. By way of a concurrent storage of a timestamp with injection device data, e.g., injection-related data there can be provided and stored a dosing history, e.g., a number or sizes of doses administered or injected at particular times or time intervals during a single use or repeated uses of the injection device. Generally, and by way of the memory a repeated use or history of operation of the injection device can be logged or monitoring over time.

[0037] According to a further example the wearable electronic device comprises a signal generator coupled to the processor. The signal generator is operable to generate a user-perceivable signal on the basis of the injection device data received by the transceiver. In addition or alternative, the signal generator may be operable to generate a user-perceivable signal on the basis of the first sensor signal received from the sensor arrangement of electronic circuit. In this way, there can be provided a rather intuitive and user-perceivable feedback during use of the wearable electronic device and / or during or before use of the injection device.

[0038] According to a further example the signal generator is configured to generate at least one of a visual signal, an acoustic signal and a haptic signal. When implemented as an acoustic signal generator or when comprising an acoustic signal generator the electronic circuit of the wearable electronic device is configured to acoustically indicate at least one of switching the electronic circuit and / or the processor into one of the injection assisting mode and the injection monitoring mode and / or to indicate at least one injection device data or injection-related information to the user via the signal generator. The signal generator may be controlled or operated by the processor.

[0039] 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. By way of an acoustic signal generator there can be provided an acoustic signal to indicate to a user at least one of a momentary configuration of the electronic circuit and the processor and / or to indicate and hence to communicate to the user at least a portion of injection device data received from the device electronic circuit that is engaged with or that is attached to the injection device.

[0040] Acoustic signals are permanently perceptible by users of the injection device or wearable electronic device irrespective of a momentary orientation or position of the injection device or of the wearable electronic device relative to the user.

[0041] According to a further example the signal generator comprises a haptic signal generator to haptically indicate at least one of a configuration of the processor and the electronic circuit of the wearable electronic device and / or to indicate injection device data as received from the device electronic circuit. 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. Here, and when in a silent mode, the wearable electronic device may be disabled to generate acoustic signals. However, by way of a haptic signal generator, e.g., by way of a vibration generated by the haptic signal generator the respective signal may be still detectable or perceptible by a user when carrying or wearing the wearable electronic device. In this way, the attention of the user can be attracted to the haptic signal generated by the signal generator of the wearable electronic device even if the wearable electronic device should be in a silent mode.

[0042] According to a further example the signal generator comprises a visual signal generator operable to generate a visual signal. Here, the signal generator may comprise at least a light source, such as a LED or the like, which is operable to indicate or to generate at least one or several distinguishable visual signals, such as blinking lights.

[0043] According to a further example the signal generator of the wearable electronic device comprises a display, which is operable to visually illustrate at least a portion of the injection device data received by the transceiver. 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 a momentary configuration of at least one of the electronic circuit and the processor of the wearable electronic device.

[0044] For example, the display may be operable to visually indicate to a user if the wearable electronic device is in one of the injection assisting mode and the injection monitoring mode. The display may be controlled or operated by the processor of the electronic circuit of the wearable electronic device. It may be configured to provide a predefined information content to a user, e.g. in form of symbols, text or numbers or by way of moving or animated text or moving or animated symbols. In this way, the wearable electronic device may be configured to provide useful information to the user of the wearable electronic device rather intuitively.

[0045] 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 or to process a user command. The actuating element and its optional coupling to the processor may be configured to transfer a user command to the processor. In some examples, the actuating element is actuatable by the user of the wearable electronic device. It 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 integrated into the above-mentioned display of the signal generator.

[0046] 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 user-feedback to the wearable electronic device.

[0047] 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 direct feedback or control, e.g., for controlling operation of the wearable electronic device.

[0048] According to a further example the processor of the electronic circuit of the wearable electronic device is operable to identify at least a first use pattern of the injection device on the basis of at least one of the first sensor signal received from the sensor arrangement and the injection device data received via the communication link or received from the device electronic circuit. 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 device electronic circuit and / or by the sensor arrangement of the wearable electronic device when the wearable electronic device is worn or carried by the user during use of the injection device.

[0049] A use pattern may be characterized or may be defined by e.g., removing of a protective cap from the injection device, placing the injection device against a patient's skin, starting of an injection procedure, termination of an injection procedure, removal of the injection device from an injection site of a patient and the like user-conductor patterns executed or conducted by the user during use of an injection device. Each one of these use patterns may be distinguishable by processing of the first sensor signal(s) being indicative of at least one of the position, the orientation and the acceleration of the wearable electronic device and / or being indicative of an acoustic signal emanating from the injection device during use.

[0050] By identifying one or at least a first use pattern of the injection device and / or by distinguishing between several use patterns of the injection device the processor may either record or log identification of the at least first use pattern or the processor may distinguish between different use patterns on the basis of the first sensor signal.

[0051] According to a further example identification of a first use pattern of the injection device may include a correlation of the first sensor signal or first sensor signals received from the sensor arrangement of the electronic circuit of the wearable electronic device and the injection device data received via the transceiver of the electronic circuit. In this way and for identifying a first use pattern numerous or different data sources can be used and mutually correlated. Respective data can be checked with regards to its mutual plausibility. Here, the sensor arrangement may provide a first date source and the transceiver may provide a second data source. The processor may be configured to process both data sources and hence may be configured to process the first sensor signals as obtained from the sensor arrangement of the wearable electronic device and may be further configured to process injection device data as obtained via the transceiver of the electronic circuit.

[0052] In a further example the processor is operable to log an identification of the first use pattern of the injection device in the memory. Here and for logging the identification of the first use pattern in the memory the electronic circuit and / or the processor of the wearable electronic device may be in one of the injection monitoring mode and the injection assisting mode, which mode may have been previously activated on the basis of the at least one sensor signal as obtained from the sensor arrangement of the electronic circuit.

[0053] Logging of the identification of the first use pattern of the injection device in the memory may be associated or accompanied with a user prompt or user input. Hence, the locking of the identification of the first use pattern in the memory may require a user confirmation, which may have to be entered via at least one of the signal generator and the actuating element. In this way, the wearable electronic device may be configured to automatically adjust a user to log or to store an identification of the first use pattern of the injection device in the memory, but the user may still have to confirm such logging or information storage. In this way, the quality of the data stored in the memory can be kept at a comparatively high level and a likelihood of storing false or erroneous data in the memory can be reduced to a minimum.

[0054] According to a further example the processor is further operable to trigger generation of a user perceivable signal via the signal generator. The user perceivable signal is indicative of the identification of the first use pattern of the injection device. In this way, the processor and hence the wearable electronic device is configured to provide perceivable feedback to a user, that a particular or predefined use pattern of the injection device have been detected. With the processor being operable to trigger generation of a user-perceivable signal via the signal generator there can be provided a perceivable feedback to the user which feedback being indicative of a momentary or recent use pattern of the injection device as detected by at least one of the sensor arrangement or as detected or identified on the basis of signal processing of signals obtained from the device electronic circuit engaged with or attachable to the injection device.

[0055] According to a further example the processor of the wearable electronic device is operable to process the first sensor signal and to activate at least one of the injection assisting mode and the injection monitoring mode when the first sensor signal matches with a reference sensor signal, or when a temporal sequence of first sensor signal(s) matches with a sequence of reference sensor signal(s). The reference signal or sequence of reference signals may be stored in the memory of the wearable electronic device.

[0056] 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(s) and the reference signal(s).

[0057] 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. In some examples the memory of the electronic circuit of the wearable electronic device 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 signal 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. In this way, the processor of the wearable electronic device may conduct an automated selection of a number of user 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 first sensor signal or sequence of sensor signals obtainable from the sensor arrangement of the wearable electronic device.

[0058] According to a further example the wearable electronic device comprises a housing and a strap or wrist band connected to the housing. The strap or wristband is configured to attach or to fix the wearable electronic device to a body portion of a user or patient. 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 use of the injection device.

[0059] 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 its 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. The wearable electronic device may be further configured 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.

[0060] Accordingly and as described above, the sensor arrangement may be also configured to detect or to quantitatively measure acoustic signals emanating from the injection device, e.g. during use of the injection device.

[0061] 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. According to a further example the processor of the wearable electronic device is operable to detect or to identify a movement of the wearable electronic device relative to the body portion of the user, which detection or identification is conducted on the basis of the first sensor signal or on the basis of a temporal sequence of first sensor signals received from the sensor assembly. The processor is further operable to activate or to deactivate at least one of the injection assisting mode and the injection monitoring mode upon detection or identification of a predefined movement pattern of the wearable electronic device relative to the body portion.

[0062] Here, the sensor arrangement may comprise at least one of an optical sensor, an electrostatic sensor, and a magnetic sensor, e.g. in order to detect or to identify a movement of the wearable electronic device relative to the body portion.

[0063] In some examples the sensor arrangement may comprise a position sensor, which is operable to detect a momentary or varying position of the wearable electronic device relative to the body portion of the user. In this way the sensor arrangement may be configured to detect a movement or re-positioning of the wearable electronic device relative to the body portion. In some examples the strap or wristband of the wearable electronic device may comprise a certain degree of flexibility that allows to carry or to where the wearable electronic device in at least two different configurations, orientations or positions relative to the body portion.

[0064] When the wearable electronic device is implemented as a smartwatch to be worn at a hand or wrist of a user in one configuration the wearable electronic device may be located on an outside surface of the hand or wrist. In a second configuration it may be located on an inside surface of a wrist. The user or patient may rotate or reorient the wearable electronic device relative to the body portion, e.g. in order to switch the processor or electronic circuit into one of the injection assisting mode and the injection monitoring mode. Hence, in a first configuration the wearable electronic device may be in an idle mode or sleep mode with regard to the functionality of injection assisting or injection monitoring.

[0065] It may be only and upon rotating or reorienting the wearable electronic device into a second configuration, e.g., by pivoting or rearranging the wearable electronic device from an outside surface of a user's wrist to an inside surface of a user's wrist that the sensor arrangement generates respective first sensor signals being indicative of such a movement. In response to the detectable rotation or reorientation of the wearable electronic device relative to the body portion the wearable electronic device, e.g. at least one of its electronic circuit and the processor, may automatically switch into at least one of the injection assisting mode and the injection monitoring mode. Switching of the wearable electronic device into one of the injection assisting mode and injection monitoring mode may also establish or activate the communication link between the transceiver of the wearable electronic device and the device electronic circuit that is engaged with or that is attached to the injection device. As long as the wearable electronic device may be in a first configuration and hence in a sleep mode or idle mode the communication link between the transceiver of the wearable electronic device and the device electronic circuit may be disabled. In this way energy can be saved and battery lifetime can be prolonged.

[0066] The communication link may be only enabled or set up in response to a transfer of the wearable electronic device into at least one of the injection assisting mode and the injection monitoring mode, which mode may be activated by turning or reorienting the wearable electronic device in a detectable manner relative to the body portion at which the wearable electronic device is worn.

[0067] According to a further aspect the present disclosure also relates to a system for use with an injection device. The system comprises a wearable electronic device as described above and further comprises a device electronic circuit that is integrated in or that is attachable to an injection device. The device electronic circuit comprises a device sensor arrangement configured to detect or to measure an operation or use of the injection device and is further operable to generate device sensor signals being indicative of a use or operation of the injection device.

[0068] The device electronic circuit further comprises a device processor that is coupled to the device sensor arrangement in a data transmitting manner. The device processor is operable to generate injection device data on the basis of the device sensor signals that are received from the device sensor arrangement. The device electronic circuit further comprises a device transceiver that is coupled to the device processor. The device transceiver is further configured to communicate with the transceiver of the wearable electronic device. At least one of the device transceiver and the transceiver of the wearable electronic device is configured to establish a communication link between the device transceiver and the transceiver of the wearable electronic device.

[0069] The system for use with the injection device includes a wearable electronic device as described above. Insofar, all effects, features and benefits as described above in connection with the wearable electronic device equally apply to the system for use with the injection device; and vice versa. The device electronic circuit may be integrated into the injection device. It may be integrated into a drive mechanism of an injection device. In further examples the device electronic circuit may be integrated into an add-on device configured for detachably fastening to an injection device. The device sensor arrangement may be configured to detect or to quantitatively measure an operation or use of the injection device. In some examples the device sensor arrangement may be configured to detect execution or conducting of an injection procedure. In some examples the device sensor arrangement may be configured to detect completion of a dose injection procedure. In some examples the device sensor arrangement may be configured to detect a point of time or a time interval at which or during which an injection procedure has been conducted or executed. In further examples the device sensor arrangement is configured to quantitatively measure a size of a dose actually set or injected by the injection device.

[0070] The device sensor arrangement may comprise at least one of an optical sensor, an acoustic sensor, a magnetic sensor, an electrostatic sensor or the like elements by way of which operation of the injection device can be qualitatively and / or quantitatively detected or measured.

[0071] Of course, the device electronic circuit may be equipped or may comprise a source of energy, e.g., a battery to supply electrical energy to the device electronic circuit.

[0072] The device transceiver may be configured to establish a wireless data transmission with the transceiver of the electronic circuit of the wearable electronic device. The transceiver of the wearable electronic device and the device transceiver may be configured to set up a wireless communication link or wireless data transmission link. The link between the wearable electronic device and the device electronic circuit may be implemented on the basis of a standardized communication protocol, such as an RF-based communication protocol, e.g. RFID, NFC, Bluetooth or Wi-Fi standard or any other suitable wireless communication protocol.

[0073] According to a further example the device electronic circuit is operable to transmit the injection device data to the transceiver of the wearable electronic device. The injection device data may be generated or processed by the device processor of the device electronic circuit. The injection device data may be indicative of one or several device properties or device parameters prior to or during the injection procedure. In some examples the injection device data may include information about an orientation of the injection device, e.g., relative to an injection site of a patient.

[0074] In some examples the injection device data may be indicative of an orientation of the injection device prior to or during injection of a dose. For this, the device sensor arrangement may comprise at least one of a position sensor, an orientation sensor and an acceleration sensor attached to or integrated into the injection device. By way of an orientation sensor, the injection device data may include orientation specific information being indicative of an orientation of the injection device, e.g., relative to the earth magnetic field.

[0075] Here and by transmitting the injection device data, e.g., including data being indicative of a momentary orientation of the injection device, to the wearable electronic device the wearable electronic device and hence the processor of the electronic circuit may be configured to indicate such an orientation or injection angle to the user via the signal generator.

[0076] By way of indicating an orientation of the injection device and / or an injection angle to a user the user may be provided with feedback that assists and supports the user to insert an injection needle of the injection device at a predefined and / or correct injection depth in the process of injecting of a dose of the medicament with the injection device.

[0077] In some examples, the orientation of the injection device may be reproduced on the display of the wearable electronic device thereby providing a feedback to the user about the momentary configuration of the injection device and the momentary configuration of use of the injection device.

[0078] In this way the user may be provided with useful information being indicative of certain parameters of the ongoing or planned injection process. Accordingly, the user may adapt or control execution of the injection process on the basis of such feedback signals obtainable from the device electronic circuit and transmitted to the electronic circuit of the wearable electronic device and indicated to the user via the signal generator or display of the wearable electronic device.

[0079] According to a further example the system further comprises an injection device, e.g. a handheld injection device, such as an injection pen. The injection device 1 is equipped or is equipable with the device electronic circuit 135 either directly or indirectly, e.g., by way of an add-on device 60 mountable or attachable to the injection device 1.

[0080] According to another aspect the present disclosure also relates to a method of monitoring use of an injection device. The method comprises the steps of wearing a wearable electronic device comprising an electronic circuit. The electronic circuit comprises a sensor arrangement, a transceiver and a processor. The method of monitoring use of the injection device comprises the steps of detecting or measuring with a sensor arrangement 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, prior to or immediately after use of the injection device. 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 an acoustic signal emanating from the injection device, e.g., during use of the injection device, prior use or after use of the injection device.

[0081] The method of monitoring use of the injection device further includes the step of establishing a communication link between the transceiver and a device electronic circuit engaged with or attachable to the injection device and switching of at least one of the electronic circuit and the processor of the wearable electronic device into one of an injection assisting mode and an injection monitoring mode on the basis of the first sensor signal received from the sensor arrangement.

[0082] In some examples the method of monitoring use of the injection device is conducted 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.

[0083] Switching at least one of the electronic circuit and the processor of the wearable electronic device into one of the injection assisting mode and the injection monitoring mode may provide an enhanced functionality of the wearable electronic device. It may be used to log or to monitor of injection-related data, such as a point of time at which an injection took place as well as to log or to store a size of a dose currently or recently administered.

[0084] Switching the wearable electronic device into an injection assisting mode may provide an active assistance to a user prior to, during as well as after completion of an injection process making use of the injection device. Injection device data may be generated by a device electronic circuit integrated in or attachable to the injection device and such injection device data may be generated during use of the injection device. By way of the communication link between the transceiver of the wearable electronic device and the device transceiver of the device electronic circuit injection device data collected prior to, during or after use of the injection device can be rather instantly or spontaneously transmitted via the communication link to the wearable electronic device, which in response to receiving the injection device data may generate user perceivable signals via the signal generator. In addition, the wearable electronic device may generate visible signal amplitude or audible signal to assist a user in conducting or executing an injection procedure.

[0085] According to a further example the method comprises the steps of receiving and / or collecting injection device data by a communication link when at least one of the processor and the electronic circuit of the wearable electronic device is in one of the injection assisting mode and the injection monitoring mode. The collected injection device data may be indicative of any measurable physical properties of the injection device prior to use, during use or after use of the injection device. In some examples the injection device data may be indicative of a momentary orientation of the injection device relative to the earth magnetic field and / or relative to a puncture site of a patient or user of the injection device.

[0086] According to a further aspect the present disclosure also relates to a computer program comprising computer readable instructions, which when executed by a processor of the wearable electronic device cause the processor to switch at least one of the processor and an electronic circuit of the wearable electronic device into one of an injection assisting mode and an injection monitoring mode on the basis of a first sensor signal received from a sensor arrangement of the wearable electronic device. 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, e.g., during use of the injection device.

[0087] In some examples the computer program is to be executed or deployed by a processor of the wearable electronic device as described above. Insofar, all effects, features and benefits as described above in connection with the wearable electronic device may equally apply to the computer program; and vice versa. Moreover, the computer program may be particularly configured to execute a method of monitoring use of an injection device as described above. Insofar, all effects, features and benefits as described above in connection with the method of monitoring use of the injection device may equally apply to the computer program; and vice versa. In some examples, the computer program is to be executed or deployed by the processor of the wearable electronic device for executing and / or for conducting the method of monitoring use of the injection device as described above.

[0088] 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.

[0089] 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.

[0090] 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.

[0091] 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.

[0092] 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.

[0093] 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.

[0094] 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.

[0095] 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.

[0096] 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.

[0097] 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, ORMD-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.

[0098] 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.

[0099] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0100] 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. 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.

[0101] 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).

[0102] 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.

[0103] 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.

[0104] 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.

[0105] “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).

[0106] 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).

[0107] 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.

[0108] 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).

[0109] 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.

[0110] 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.

[0111] 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.

[0112] 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).

[0113] 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).

[0114] Brief description of the drawings

[0115] In the following, further details of the wearable electronic device, the system as described above 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:

[0116] Fig. 1 shows an example of a handheld injection device during use,

[0117] Fig. 2 shows a further example of an injection device during use,

[0118] Fig. 3 shows another example of an injection device,

[0119] Fig. 4 shows a further example of an injection device,

[0120] Fig. 5 shows an external electronic device,

[0121] Fig. 6 shows an example of a wearable electronic device,

[0122] Fig. 7 is a block diagram of components of the wearable electronic device and a device electronic circuit engaged with or attachable to the injection device and configured to communicate with the wearable electronic device,

[0123] Fig. 8 shows an exemplary step of using the wearable electronic device ,

[0124] Fig. 9 shows a further exemplary step of using the wearable electronic device in connection with the injection device,

[0125] Fig. 10 shows a further step of using the wearable electronic device,

[0126] Fig. 11 shows an exemplary configuration of the wearable electronic device,

[0127] Fig. 12 shows a further exemplary configuration of the wearable electronic device,

[0128] Fig. 13 shows a further exemplary configuration of the wearable electronic device,

[0129] Fig. 14 shows a further exemplary configuration of the wearable electronic device,

[0130] Fig. 15 shows a further exemplary configuration of the wearable electronic device,

[0131] Fig. 16 shows a further exemplary configuration of the wearable electronic device, and

[0132] Fig. 17 shows a flowchart of a method of monitoring operation or use of the injection device with a wearable electronic device.

[0133] Detailed description

[0134] 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.

[0135] 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.

[0136] 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.

[0137] 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.

[0138] 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.

[0139] The example of an injection device 1 according to Fig. 2 may comprise a so-called autoinjector. 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.

[0140] 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.

[0141] 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.

[0142] 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.

[0143] 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.

[0144] 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 a device electronic circuit 135 of the add-on device 60, an example of being described in greater detail with regard to Fig. 7. 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 device transceiver 138 configured to communicate with the wearable electronic device 100 and / or to exchange data with the wearable electronic device 100 as described below.

[0145] The add-on device 60 is one example of engaging or attaching a device electronic circuit 135 to an injection device 1. The add-on device 60 may comprise one or numerous parts of the device electronic circuit 135 that will be described in greater detail with respect to Fig. 7. The add-on device 60 may comprise a device sensor arrangement 155 by way of which at least one of setting of a dose and injecting of a dose of the medicament can be detected and / or quantitatively measured.

[0146] In some examples the device sensor arrangement 155 is configured to detect a movement of the movable part 70 relative to the device body 61 of the add-on device. In some examples the device sensor arrangement 155 is configured to detect at least one of a longitudinal and a rotational movement of the movable part 70 relative to the device body 61. In some examples the device sensor arrangement 155 may be configured to quantitatively measure a degree or a distance of a movement of the movable part 70 relative to the device body 61.

[0147] In Fig. 6 there is illustrated an example of a wearable electronic device 100 that comprises a housing 101. The wearable electronic device 100 may comprise a smartwatch 106 or may be implemented as 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

[0150] 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.

[0151] 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.

[0152] 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.

[0153] 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.

[0154] 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.

[0155] 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.

[0156] 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.

[0157] 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.

[0158] The wearable electronic device 100 further comprises the transceiver 38, which 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.

[0159] As particularly indicated in Fig. 7 the wearable electronic device 100 is configured for communication with a device electronic circuit 135 that is engaged with or that is attachable to the injection device 1. The device electronic circuit 135 comprises a printed circuit board 136 on which numerous electronic components of the device electronic circuit 135 are arranged and / or fixed.

[0160] In some examples the device electronic circuit 135 is located inside an add-on device 60. In other examples the device electronic circuit 135 may be integrated into an injection device 1. It may be e.g. implemented or integrated into a pen-type injector.

[0161] The device electronic circuit 135 comprises a device memory 140 implemented as a digital memory. The device, electronic circuit 135 further comprises a device transceiver one 138, a device memory 140, a device clock 142 and a device processor 144. It may further comprise a device actuator element 146, a signal generator 148 and a power source 150 as well as the device sensor arrangement 155. The device sensor arrangement 155 may comprise a number of individual sensors 152, 154, 156.

[0162] In the example as shown in Fig. 7 the sensor 152 may comprise an orientation sensor by way of which an orientation of the device electronic circuit 135 and hence of the injection device 1 can be precisely detected or quantitatively measured, e.g., in relation to the earth magnetic field.

[0163] The sensor 154 may be implemented as an acceleration sensor by way of which an acceleration and hence a force effect acting on the device sensor arrangement 155 and hence on the injection device 1 can be detected and measured or quantitatively measured.

[0164] A further sensor 156 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. By way of the sensor 156 acoustic signals, e.g., generated during operation of the injection device 1 may be detected and / or quantitatively measured. The device sensor arrangement 155 is connected or coupled to the device processor 144. The device processor 144 is particularly configured to process the signals from the device sensor arrangement 155.

[0165] The processor 144 as well as the further component of the device electronic circuit 135 can be supplied with electrical energy from the power source 150, e.g., implemented as a battery, which may be rechargeable or replaceable.

[0166] The device processor 144 is coupled to the device sensor arrangement 155 and to the device memory 140. The device memory 140 may comprise a non-volatile digital memory. The device processor 144 may be configured to read data from the device memory 140 and / or to write data into the memory 140. The device electronic circuit 135 and hence the injection device 1 may be equipped with an own signal generator 148. The signal generator 148 may include at least one of a display, an acoustic signal generator as well as a haptic signal generator to generate respective user perceptible signal, e.g., visual signals, acoustic signal and / or haptically perceptible signal, which are suitable to attract the user's attention.

[0167] In addition, the signal generator 148 may comprise a light source, by way of which respective visual signal, e.g. a blinking light or a persistent light of a particular or of varying color may be generated thereby indicating to a user that a particular device configuration is active or inactive. The device clock 142 may provide a clock signal on the basis of which the device processor 144 may generate a timestamp to be concurrently stored with the data in the device memory 140. In addition or alternatively, the clock signal may be concurrently transmitted to the transceiver 38 of the wearable electronic device 100.

[0168] In the same or like manner as described above in connection with the electronic circuit 35 of the wearable electronic device 100 the operation of the device processor 144 and / or of the device electronic circuit 135 may be controllable by the actuating element 146. The actuating element 146 may comprise a user actuatable element, which can be operated by touching or tapping or which may be operated by voice commands of a user. The actuating element 146 may be integrated in one of the sensors 152, 154, 156 of the device sensor arrangement 155.

[0169] The device electronic circuit 135 comprises the device transceiver one 138, which is implemented as a wireless transceiver. The device transceiver 138 is particularly configured to establish a communication link 110 with the transceiver 38 of the electronic circuit 35 of the wearable electronic device 100. The communication link 110 between the transceiver 38 and the device transceiver 138 can be based on a standardized wireless communication protocol, e.g. on a RF-based communication protocols, such as RFID, NFC, Bluetooth or Wi-Fi standard or some other suitable wireless communication protocol.

[0170] As becomes immediately apparent from a comparison of Figs. 8 and 9 the wearable electronic device 100 can be worn in at least two different configurations at a dedicated body portion, e.g. at a wrist 7 of a hand 4 of a user.

[0171] In the illustration according to Fig. 8 the wearable electronic device 100 is in a second configuration, wherein the housing 110 of the wearable electronic device is located at an inside facing side of the wrist 7 of the user. Compared to the second configuration as shown in Fig. 8, Fig. 9 shows a first configuration of wearing the wearable electronic device 100. There, the housing 101 of the wearable electronic device is located on an outside surface of the wrist 7 of the hand 4 of the user. Here, another hand 4' of the user is used to conduct the injection procedure. The other hand 4' holds the injection device 1 and the hand 4 is provided with the wearable electronic device 1.

[0172] The wearable electronic device 100 may be transferred from the second configuration as shown in Fig. 8 into the first configuration as shown in Fig. 9 and vice versa from the first configuration as shown in Fig. 9 into the second configuration as shown in Fig. 8 by twisting the wearable electronic device 100 with its strap 105 relative to the wrist 7 of the user's hand 4. For this it may be of particular benefit when the band or the strap 105 is of a certain flexibility or elasticity that allows for a rather straightforward and easy twisting of the wearable electronic device 100 from one configuration into the other.

[0173] Twisting operation or movement of the wearable electronic device 100 relative to the respective body portion 4, 7 of the user may be detected and / or quantitatively measured by the sensor arrangement 55 of the electronic circuit 35 of the wearable electronic device 100. By transferring the wearable electronic device 100 from a first configuration as shown in Fig. 9 into the second configuration as shown in Fig. 8 the processor 44 and / or the electronic circuit 35 may be switched into one of an injection assisting mode and an injection monitoring mode.

[0174] Once and when in at least one of the injection assisting mode and the injection monitoring mode the electronic circuit 35 and / or the transceiver 38 may be switched into a communication mode, in which the communication link 110 with the device transceiver 138 is activated or re-activated. Then and in the course of a subsequent dose setting or dose injection process injection device data may be acquired, collected or stored by the device electronic circuit 135 and / or can be transmitted via the communication link 110 to the wearable electronic device 100.

[0175] In the following, some user scenarios of using the wearable electronic device 100 and the system 250 are schematically illustrated. The system 250 comprises the wearable electronic device 100 and the device electronic circuit 135, which may be either attached to or integrated into the injection device 1. In some examples, the system 250 also comprises or includes one of the injection devices 1 as illustrated in any of the Figs. 1-4.

[0176] The wearable electronic device 100 may be worn or carried at wrist 7 of a user's hand 4 in one of the two configurations as shown in Figs. 8 or 9. It may be twisted or transferred between these two or further configurations as indicated by the arrow as shown in Fig. 10. By way of a twisting or rotative motion of the wearable electronic device 100 relative to the skin of the patient or relative to a body portion 4, 7 of the patient or user the sensor arrangement 55 of the wearable electronic device 100 may generate at least a first sensor signal being indicative of at least one of the position, the orientation and the acceleration of the wearable electronic device 100.

[0177] In some examples the sensor arrangement 55 may comprise an optical sensor or the like position detection sensors by way of which a position or movement of the wearable electronic device 100 relative to the body portion 4, 7 could be qualitatively or quantitatively detected or measured. Respective sensor signals generated by the sensor arrangement 55, e.g., in the course of transferring the wearable electronic device 100 from a first configuration into a second configuration or vice versa, from the second configuration into the first or any further configuration is detectable by processing the respective sensor signals as generated by the sensor arrangement 55.

[0178] The processor 44 processing respective sensor signals may then switch into at least one of an injection assisting mode and an injection monitoring mode. In at least one of these two modes or in both modes the transceiver 38 of the wearable electronic device 100 may be activated and may be triggered to start communicating with the device transceiver 138, which is either attached to or which is integrated into the injection device 1.

[0179] By way of a communication link 110 between the device transceiver 138 and the transceiver 38 there can be transferred injection device data from the device transceiver 138 to the transceiver 38. Injection device data may be acquired and / or provided by the device electronic circuit 135. The device sensor arrangement 155 may be likewise operable to acquire and / or to provide injection device data, i.e. injection device-related data.

[0180] The injection device data may include information about an ongoing, intended or past use or operation of the injection device 1. The injection device data received by the communication link 110 may be indicative of at least one of the following device configurations: detaching or removal of a protective cap 16 from an injection end of the injection device 1 , placing or arranging the injection device 1 at or against an injection site 80 of the skin 82 of a patient, starting of an injection procedure, an ongoing injection procedure, termination of an injection procedure or holding of the injection device 1 in a fixed position relative to the puncture site 80 after termination of the injection procedure.

[0181] The injection device data collected or acquired by the device electronic circuit 135 is transferable and is typically transferred via the communication link 110 to the wearable electronic device 100. The wearable electronic device 100, in particular its electronic circuit 35 and / or its processor 44 is particularly configured to process injection device data received via the communication link 110 and to provide respective information or feedback to a user as illustrated by way of example in any of the Figs. 11-16.

[0182] In all these configurations as illustrated in Figs. 11-16 the display 104 of the wearable electronic device 100 provides a specific and different information content. Hence, in the configuration of Fig. 11 the display 104 informs about a momentary status of the injection device 1. Here, it may be indicated by a graphical display feature 108 on the display 104 that the injection device 1 is ready to use.

[0183] In a further configuration as indicated in Fig. 12 and upon receipt of respective injection device data via the communication link 110 the wearable electronic device 100 may indicate another display feature 108'. The display feature 108' may be indicative that an injection procedure is currently taking place and / or the user should wait for a particular period of time until the needle of the injection device 1 can or should be withdrawn or removed from the injection site 80.

[0184] In a further configuration of the display 104 as illustrated in Fig. 13 another display feature 108" indicates to a user, that an injection procedure has been successfully completed.

[0185] In another configuration as shown in Fig. 14 the injection device data as provided by the device electronic circuit 135 and transmitted via the communication link 110 to the wearable electronic device 100 may be indicative of a particular orientation of the injection device during or before conducting an injection procedure. Here, an injection angle of 75° may be in the catered by the display feature 108'". In a further configuration of the wearable electronic device 100 and as shown in Fig. 15 the display 104 illustrates another display feature 108"", which is indicative of an injection angle of the injection device 1 relative to the puncture or injection site 80 by about 89°. Such an angle of inclination may be measured or detected by the device sensor arrangement 155 of the device electronic circuit 135 that is integrated in or that is attached to the injection device 1.

[0186] By establishing a respective communication link 110 between the device electronic circuit 135 and the electronic circuit 35 of the wearable electronic device 100 such injection device data or respective information about the current status of the injection device 1 can be transferred from the device electronic circuit 135 to the wearable electronic device 100 for illustration or presentation to a user or patient of the wearable electronic device 100.

[0187] In the further configuration of the display 104 as shown in Figs.16 the user may be provided with numerous information 109, e.g. representing a point of time at which an injection took place. A further information content 109' may indicate a name of the medicament that has been administered and a further information content 109" may indicate a size of a dose of the medicament that has been dispensed or injected with the injection device 1.

[0188] The information 109, 109', 109" as visually provided on the display 104 may be stored in the memory 40 of the wearable or portable electronic device 100. The wearable electronic device 100 may regularly synchronize with another external electronic device 200, e.g. implemented as a smart phone or tablet computer. Here, a complete medication history may be stored and may be further communicated to a healthcare provider.

[0189] The illustration of the numerous configurations of the wearable electronic device 100 and provided in Figs. 11-16 is only exemplary. The presentation of injection device data or feedback is in no way limited to a graphical or visual presentation. Likewise, the wearable electronic device 100 may be configured to provide respective information also in any other format, e.g. audibly or by way of haptic signals, e.g. by way of a vibration of the housing 101 of the wearable electronic device 100. Here, the duration and frequency of vibrations or acoustic signals may vary in order to indicate different and distinguishable configurations of the injection device 1, e.g. in response to a transfer of such information via the communication link 110.

[0190] The wearable electronic device may automatically switch into one of an injection assisting mode, as e.g. illustrated by the sequence of Figs. 11-13, or into an injection monitoring mode, e.g. illustrated by Figs. 13 or 16. In both operating modes of the wearable electronic device 100 the wearable electronic device 100 is configured to receive and / or to process injection device data received via the communication link 110 from the device electronic circuit 135.

[0191] Activating of at least one of the injection assisting mode and the injection monitoring mode may be triggered by a user using the actuating element 46 of the wearable electronic device 100 and / or by a user gesture that may be automatically detected by the sensor arrangement 55 of the wearable electronic device. Here, at least one of a position sensor, an orientation sensor and an acceleration sensor of the sensor arrangement 55 of the wearable electronic device 100 may be configured to detect or to quantitatively measure one of a number of predefined gestures conducted by a user moving the wearable electronic device 100 in accordance to a particular use pattern. In this way, a predefined and detectable swiping motion or tapping motion with a hand or arm of a user actually wearing the wearable electronic device may be identified by the processor 44 upon processing of the at least first sensor signal as provided by the sensor arrangement 55 of the wearable electronic device 100 in response to a respective characteristic movement.

[0192] In some examples a rotation or twisting motion of the wearable electronic device 100 relative to a body portion 4, 7 of a user actually provided with the wearable electronic device 100 may automatically switch the wearable electronic device 100 into one of the injection assisting mode and the injection monitoring mode. In any of these modes, communication with the device electronic circuit 135 is established, e.g., in order to provide a rather direct feedback to the user with regard to injection device data collected or acquired by the device electronic circuit 135 and / or to record or to store injection device data.

[0193] In some examples the sensor arrangement 55 of the wearable electronic device 100 comprises an acoustic sensor 56 by way of which a characteristic noise or sound emanating from the injection device 1 in the course of using the injection device 1 can be detected and / or quantitatively measured. Here, the wearable electronic device 100 may be directly configured to acquire or to evaluate injection device data from the injection device 1.

[0194] In some examples the wearable electronic device 100, in particular the processor 44, the memory 40 and the display 104 may mutually interact to guide a patient through a typical or intended use of the injection device 1. Here, a user may be provided with visual, audible or haptic information via the wearable electronic device 100 about individual steps of correctly using the injection device 1. By way of the communication link 110 and by way of injection device data acquisition conducted by the device electronic circuit 135 a correct execution of such individual user steps may be detected.

[0195] Such detection may be communicated as injection device data via the communication link 110 to the wearable electronic device 100, which in response to such injection device data may be configured to provide a respective feedback or information to the user via the signal generator 48 or display 104.

[0196] In the flowchart of Fig. 17 one of several methods of using an injection device and monitoring use of the injection device is illustrated. In a first step 300 the wearable electronic device 100 is attached to a dedicated body portion of a patient or user. For instance, the wearable electronic device 100 may be attached to a hand 4 or wrist 7 of a user. In a subsequent step 302 the sensor arrangement 55 of the wearable electronic device starts to generate first sensor signals being indicative of at least one of the position, the orientation, the acceleration of the wearable electronic device 100 and / or being indicative of an acoustic signal emanating from the injection device 1.

[0197] In step 304 such signals are evaluated by the processor 44. Here, the first sensor signal may be compared with reference data, e.g., stored in the memory 40 of the electronic circuit 35. In the further step 306 it is checked if the sensor signal(s) as obtained from the sensor arrangement 55 match(es) with predefined reference signal(s) of reference data by way of which a characteristic use pattern or movement pattern of the wearable electronic device 100 could be identified. If the comparison conducted in step 306 reveals that the wearable electronic device 10 has been moved from a first configuration, e.g. as shown in Fig. 9, into a second configuration as e.g. shown in Fig. 8 the processor 44 and / or the electronic circuit 35 as a whole may switch into at least one of an injection assisting mode and an injection monitoring mode in step 308.

[0198] In a subsequent step 310 and as long as in the injection assisting mode or injection monitoring mode is active a communication link 110 with the device transceiver 138 of the device electronic circuit 134 is established. Furthermore, and in step 310, the wearable electronic device starts to receive injection device data via the communication link 110, which injection device data is either used to provide a feedback to the user, e.g., via the signal generator 48. In addition or alternative, the wearable electronic device 100 may store injection device data being indicative of a completion of a dose injection event in the storage 40.

[0199] When and as long as the method as conducted in step 306 does not identify a particular use pattern or movement of the wearable electronic device 100 the method returns to step 302 and the loop of steps 302, 304 and 306 is continued until a predefined use pattern or movement of the wearable electronic device 100 is detected by way of which the wearable electronic device 100 is switched into one of an injection assisting mode and an injection monitoring mode.

[0200] Reference Numbers

[0201] 11 injection device

[0202] 2 distal direction

[0203] 3 proximal direction

[0204] 4 hand

[0205] 5 thumb

[0206] 6 finger

[0207] 7 wrist

[0208] 8 medicament

[0209] 9 stopper

[0210] 10 barrel

[0211] 11 housing

[0212] 12 shield

[0213] 13 syringe carrier

[0214] 14 outlet

[0215] 15 needle

[0216] 16 protective cap

[0217] 17 flange portion

[0218] 18 flange portion

[0219] 20 plunger

[0220] 21 plunger flange

[0221] 22 injection mechanism

[0222] 23 trigger

[0223] 24 dose dial

[0224] 25 dial extension

[0225] 35 electronic circuit

[0226] 36 printed circuit board

[0227] 38 transceiver

[0228] 40 memory

[0229] 42 clock

[0230] 44 processor

[0231] 46 actuating element

[0232] 48 signal generator

[0233] 50 power source

[0234] 52 sensor

[0235] 54 sensor 55 sensor arrangement

[0236] 56 sensor

[0237] 60 add-on device

[0238] 61 device body

[0239] 63 receptacle

[0240] 70 movable part

[0241] 80 injection site

[0242] 82 skin

[0243] 100 wearable electronic device

[0244] 101 housing

[0245] 104 display

[0246] 105 strap

[0247] 106 smartwatch

[0248] 108 display feature

[0249] 109 information content

[0250] 110 communication link

[0251] 135 device electronic circuit

[0252] 136 printed circuit board

[0253] 138 device transceiver

[0254] 140 device memory

[0255] 142 device clock

[0256] 144 device processor

[0257] 146 actuating element

[0258] 148 signal generator

[0259] 150 power source

[0260] 152 sensor

[0261] 154 sensor

[0262] 155 sensor arrangement

[0263] 156 sensor

[0264] 200 electronic device

[0265] 201 housing

[0266] 202 device processor

[0267] 203 actuating element

[0268] 204 display

[0269] 206 communication unit

[0270] 208 device memory

[0271] 250 system

Claims

Claims1. A wearable electronic device (100) for use with an injection device (1), the wearable electronic device (100) comprising an electronic circuit (35), the electronic circuit (35) 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 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 transceiver (38) to establish a communication link (110) to a device electronic circuit (135) engaged with or attachable to the injection device (1), a processor (44) coupled to the sensor arrangement (55) and to the transceiver (38), wherein at least one of the electronic circuit (35) and the processor (44) is switchable into one of an injection assisting mode and an injection monitoring mode on the basis of the first sensor signal received from the sensor arrangement (55).

2. The wearable electronic device (100) according to claim 1 , wherein when in one of the injection assisting mode and the injection monitoring mode, the transceiver (38) is operable to receive and / or to collect injection device data via the communication link (110).

3. The wearable electronic device (100) according to claim 2, further comprising a memory (40) coupled to the processor (44) and wherein when in one of the injection assisting mode and the injection monitoring mode the processor (44) is operable to store the injection device data received via the transceiver (38) in the memory (40).

4. The wearable electronic device (100) according to claim 2 or 3, further comprising a signal generator (48) coupled to the processor (44), wherein the signal generator (48) is operable to generate a user-perceivable signal on the basis of the injection device data received via the transceiver (38).

5. The wearable electronic device (100) according to claim 4, wherein the signal generator (48) is configured to generate at least one of a visual signal, an acoustic signal and a haptic signal.

6. The wearable electronic device (100) according to claim 4 or 5, wherein the signal generator (48) comprises a display (104) operable to visually illustrate at least a portion of the injection device data received via the transceiver (38).

7. The wearable electronic device (100) according to any one of the preceding claims 2 to 6, wherein the processor (44) is operable to identify at least a first use pattern of the injection device (1) on the basis of at least one of the first sensor signal received from the sensor arrangement (55) and the injection device data received via the communication link (110).

8. The wearable electronic device (100) according to claim 3 and 7, wherein the processor (44) is operable to log an identification of the first use pattern of the injection device (1) in the memory (40).

9. The wearable electronic device (100) according to claim 4 and any one of the claims 7 or 8, wherein the processor (44) is operable to trigger generation of a user-perceivable signal via the signal generator (48) wherein the user-perceivable signal is indicative of the identification of the first use pattern of the injection device (1).

10. The wearable electronic device (100) according to any one of the preceding claims, wherein the processor (44) is operable to process the first sensor signal and to activate at least one of the injection assisting mode and the injection monitoring mode when: the first sensor signal matches with a reference sensor signal, or when a temporal sequence of first sensor signals matches with a sequence of reference sensor signals.

11. The wearable electronic device (100) according to any one of the preceding claims, further comprising a housing (101) and a strap (105) connected to the housing (101) and wherein the strap (105) is configured to attached or to fix the wearable electronic device (100) to a body portion (4, 7) of a user.

12. The wearable electronic device (100) according to claim 10 and 11 , wherein the processor (44) is operable:to detect or to identify a movement of the wearable electronic device (100) relative to the body portion (4, 7) of the user on the basis of the first sensor signal or on the basis of a temporal sequence of first sensor signals received from the sensor assembly (55), and to activate or to deactivate at least one of the injection assisting mode and the injection monitoring mode upon detection or identification of a pre-defined movement pattern of the wearable electronic device (100) relative to the body portion (4, 7).

13. A system (250) for use with an injection device (1), the system (250) comprising: a wearable electronic device (100) according to any one of the preceding claims, and a device electronic circuit (135) integrated in or attachable to the injection device (1), the device electronic circuit (135) comprising: a device sensor arrangement (155) configured to detect or to measure an operation or use of the injection device (1) and to generate device sensor signals being indicative of a use or operation of the injection device (1), a device processor (144) coupled to the device sensor arrangement (155) and operable to generate injection device data on the basis of the device sensor signals received from the device sensor arrangement (155), a device transceiver (138) coupled to the device processor (144) and configured to establish the communication link (110) to the transceiver (38) of the wearable electronic device (100).

14. The system (250) according to claim 13, wherein the device electronic circuit (135) is operable to transmit the injection device data to the transceiver (38) of the wearable electronic device (100).

15. A method of monitoring use of an injection device (1), the method comprising the steps of: wearing a wearable electronic device (100) comprising an electronic circuit (35), the electronic circuit (35) comprising a sensor arrangement (55), a transceiver (38) and a processor (44), the method comprising the steps of: 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), establishing a communication link (110) between the transceiver (38) and a device electronic circuit (135) engaged with or attachable to the injection device (1), and switching of at least one of the electronic circuit (35) and the processor (44) into one of an injection assisting mode and an injection monitoring mode on the basis of the first sensor signal received from the sensor arrangement (55).

16. The method according to claim 15, further comprising the step of: receiving and / or to collecting injection device data via the communication link (110) when at least one of the processor (44) and the electronic circuit (35) is in one of the injection assisting mode and the injection monitoring mode.

17. 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: switch at least one of the processor (44) and an electronic circuit (35) of the wearable electronic device (100) into one of an injection assisting mode and an injection monitoring mode on the basis of a first sensor signal received from a sensor arrangement (55), wherein the first sensor signal 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