Wearable electronic device

Abstract

The present disclosure relates to a wearable electronic device (100) comprising: - a housing (101), - a processor (140) arranged within the housing (101), - at least a first sensor (160, 180) connected to the processor (140) and configured to detect at least one of a mechanical vibration or an acoustic noise caused or generated by a click sound generator (45) of a handheld injection device (1).

Description

[0001] This disclosure relates to a wearable electronic device, particularly a smartwatch configured for wear by a user of a handheld injection device. In another aspect, this disclosure relates to a method for determining the dosage or operational status of a handheld injection device. Furthermore, this disclosure relates to computer programs for determining or detecting, for example, the dosage set or dispensed by the handheld injection device and / or for detecting or determining the operational status of the handheld injection device. Background Technology

[0002] Drug delivery devices for setting and dispensing single or multiple doses of liquid medication are well known in the art. Typically, such devices serve a purpose substantially similar to that of a conventional syringe.

[0003] Drug delivery devices (such as pen injectors) must meet many user-specific requirements. For example, patients with chronic conditions such as diabetes may be frail and visually impaired. Therefore, suitable drug delivery devices, especially those designed for home use, need to be robust in construction and easy to use. Furthermore, the operation and general handling of the device and its components should be clear and easy to understand. Such injection devices should provide the setting and subsequent dispensing of variable-sized drug doses. In addition, the dosage setting and dispensing procedures must be easy to operate and clearly defined.

[0004] For both mechanically implemented and electronically implemented drug delivery devices, such as injection devices equipped with electrically driven mechanisms, it is desirable to monitor and / or collect accurate, reliable, and semi-automated drug delivery-related data during use of the injection device. Mechanically operated drug delivery and / or injection devices may be equipped with electronically implemented electronic modules that function as add-ons or data collection devices and are configured to monitor user-induced actions of the injection device. Such electronic modules should be quite compact in their geometry. Typically, such electronic modules can be used as memory aids and for precise dose history locking.

[0005] Drug delivery devices, such as handheld injection devices, typically provide acoustic or tactile feedback during at least one of the processes of dose setting, dose dispensing, or completion of the dose dispensing procedure. Thus, when the drug delivery device or injection device is in operation, the user of the device, such as a patient, is provided with an acoustically or tactilely detectable feedback signal. For mechanically implemented handheld injection devices, such as mechanically implemented pen syringes, a click sound generator is typically provided to provide a characteristic and therefore distinguishable click sound during at least one process of dose setting, dose dispensing, or completion of the dose dispensing procedure.

[0006] For reliable monitoring of long-term or short-term treatments using such handheld injection devices, it is desirable to provide automated or semi-automatic recording or supervision for the reusability of these devices. Numerous add-ons or auxiliary devices have been reported for monitoring the operation and use of handheld injection devices (such as pen syringes). Such add-ons or auxiliary devices suitable for monitoring or recording the operation of handheld injection devices must be mechanically connected to the corresponding injection device, for example, in a predefined manner. For disposable injection devices intended to be discarded after the medication administered in them is used up, the add-on or auxiliary device must be detached from the disposable injection device and reconnected to another injection device.

[0007] Repeated disassembly and reassembly of additional or auxiliary devices to monitor the operation of a mechanically implemented injection device can be burdensome for the user or patient.

[0008] Furthermore, the components including the handheld injection device and any additional or auxiliary devices attached to it have a relatively large geometric size compared to the handheld injection device itself. The increased storage space required for handheld injection devices equipped with additional or auxiliary devices can be considered a disadvantage when the device is carried by the user or patient.

[0009] Therefore, there is a need to provide an improved system and method for monitoring the operation or detecting the operational status of handheld injection devices by avoiding the aforementioned drawbacks. The solution should be cost-effective and highly acceptable to end-users and patients. A particular objective is to utilize existing hardware components to provide effective, accurate, and reliable monitoring of at least one of the following: dose setting, dose dispensing, or operational status of the handheld injection device. Summary of the Invention

[0010] In one aspect, a wearable electronic device is provided. The wearable electronic device includes a housing and a processor disposed within the housing. The wearable electronic device also includes at least a first sensor. The first sensor is connected to the processor. The first sensor is configured to detect at least one of mechanical vibration or acoustic noise caused or generated by a click generator of a handheld injection device.

[0011] When using a handheld injection device, the wearable electronics are typically worn by the patient or user. The handheld injection device, equipped with a click generator, is usually held in the hand of the user or patient when operated. Operation of the handheld injection device is accompanied by the corresponding repetitive or periodic activation of the click generator. Typical use or operation of the handheld injection device is accompanied by at least one, typically a series, distinguishable and / or detectable mechanical vibrations or acoustic noises generated by the click generator during operation or use of the handheld injection device.

[0012] At least a first sensor of the wearable electronic device is specifically configured to detect mechanical vibrations or acoustic noise generated by a click generator during the use or operation of the handheld injection device. In this way, a processor connected to the at least first sensor and configured to process electrical signals generated and provided by the at least first sensor is able to record or monitor the recurrence of mechanical vibrations or acoustic signals caused or generated by the click generator of the handheld injection device.

[0013] In some examples, the processor is configured to count the number of mechanical vibrations or acoustic noises originating from a click generator during operation of the handheld injection device. By simply counting, for example, many instances of repeated clicks, the size of the dose setting or the size of the actually dispensed dose can be calculated. Typically, during dose setting, the click generator produces mechanical vibrations or acoustic noises detectable by at least a first sensor each time the dose size increases by a predefined increment.

[0014] Similarly, and during dose dispensing, the click generator can repeatedly produce characteristic vibrations or characteristic acoustic noises indicating the increment of the dose actually dispensed or expelled by the handheld injection device. In some examples, the click generator can be activated only or particularly, for example, at the end of the dose dispensing process, thereby tactilely or acoustically indicating that the dose expulsion process has been completed.

[0015] In some examples, the handheld injection device is equipped with at least two click generators. Here, the first click generator produces a first mechanical vibration or a first acoustic noise. The second click generator produces a second mechanical vibration or a second acoustic noise. Furthermore, the first mechanical vibration or the first acoustic noise can be distinguished from the second mechanical vibration or the second acoustic noise. The first sensor and / or processor can also be configured to distinguish between the first and second mechanical vibrations and / or can be configured to distinguish between the first and second acoustic noises. In this way, and when, for example, the first click generator is activated only during dose setting and the second click generator is activated only during dose dispensing, when the first or second mechanical vibration or acoustic noise generated by the first or second click generator is detected or recorded respectively, at least the first sensor and / or processor is able to distinguish between dose setting and dose dispensing.

[0016] In a typical use case, the click generator of the handheld injection device and at least a first sensor of the wearable electronics are mechanically connected via a carrier medium that provides the transmission of mechanical vibrations or acoustic noise from the click generator to the first sensor. The carrier medium may include at least one mechanical component of the handheld injection device and at least one housing of the wearable electronics, as well as biological tissue, such as human skeletal structure or skin.

[0017] Typically, when operating a handheld injection device, the device is held in the user's hand. Wearable electronic devices are usually carried or worn by the same hand that the user also carries or holds the injection device. To date, acoustic noise or signals caused or generated by the click generator of a handheld injection device, as well as mechanical vibrations, can lead to the generation and / or transmission of sound waves or mechanical vibrations through the housing of the handheld injection device into and through the biological tissue of the corresponding user's hand or arm in mechanical contact with the handheld injection device.

[0018] In some examples, the wearable electronics are carried or worn by the user's hand or arm, not the hand or arm that holds the handheld injection device, but the specific hand the user uses to operate the handheld injection device. For example, a user may hold the injection device with their left hand and operate it with their right hand, such as setting or dispensing a dose. Here, the wearable electronics can be worn by the user's left or right hand. For both options, mechanical vibrations and / or acoustic noise from the click generator of the handheld injection device will be mechanically transmitted to the user's right and / or left hand.

[0019] To date, skin or biological tissue from a part of a patient's body has been used as a carrier medium to transmit acoustic noise or mechanical vibration generated by the click generator of a handheld injection device during use. Wearable electronics and at least a first sensor can be specifically configured to detect such acoustic noise or mechanical vibration transmitted through the biological tissue of the patient or user via the handheld injection device.

[0020] To date, ambient background noise around or near wearable electronic devices and / or handheld injection devices can be easily eliminated or blocked. At least a first sensor of the wearable electronic device can be specifically configured to detect mechanical vibrations or acoustic noise generated by the click generator of the handheld injection device. The mechanical vibrations or acoustic noise originating from the click generator can reach the first sensor only via biological tissue, such as that of the user's hand or arm.

[0021] Typically, each area of ​​a person's or user's body is generally suited to propagating acoustic noise or mechanical vibrations; for example, skin and / or bone structures are suitable for wearing electronic devices. In a typical example, wearable electronics are configured to be worn on a user's wrist or arm. It is typically worn on the same arm or hand that the user also holds the injection device before or during the injection procedure.

[0022] Typically, and according to another example, wearable electronics are implemented as smartwatches or fitness trackers configured to be carried or worn on a user's arm or wrist. Assuming a handheld injection device is carried or held in the same hand or arm as the user, the wearable electronics are inherently close to the handheld injection device when the injection device is actually operated or used by the user.

[0023] In addition, wearable electronic devices such as smartwatches or fitness trackers are now widely used by end consumers or patients. They provide interconnectivity with other electronic devices such as smartphones or tablets, through which data indicating the time, date, and / or size of the actual injection dose, and collected or stored by the wearable electronic devices, can be easily transmitted to healthcare providers for evaluation or monitoring purposes.

[0024] The use of at least a first sensor is configured to detect at least one of the mechanical vibrations or acoustic noises caused or generated by the click generator of the handheld injection device, and implementing such a sensor in a smartwatch provides a rather elegant alternative method for monitoring and recording operations, particularly dose setting or dosing of the handheld injection device. The use of specific additional devices or auxiliary devices requiring dedicated mechanical connection or pairing with the handheld injection device can be replaced by the aforementioned wearable electronics, provided that the wearable electronics is equipped with a suitable sensor operable to detect at least one of the mechanical vibrations or acoustic noises caused or generated by the click generator of the handheld injection device.

[0025] According to another example, the wearable electronics device includes a wristband attached to a housing and configured to attach the housing to a part of a person's body. The wristband can be implemented as a bracelet. The wristband can be securely attached to the housing. The wristband can be flexible and can be provided with a strap through which it can be wrapped around a specific part of the person's body. Typically, the wristband provides fixation to the housing and thus secures the entire wearable electronics device to the user's wrist, hand, and / or arm, which is also mechanically connected to a handheld injection device.

[0026] The wristband is particularly well-suited for attaching a wearable electronic device to the specific wrist or hand of a user who holds a handheld injection device, at least during dose setting or dispensing. In this way, and by attaching the wearable electronic device close to the user's hand that is actually carrying or holding the handheld injection device, the wearable electronic device is inherently positioned close to the handheld injection device. This close proximity between the wearable electronic device and the handheld injection device is particularly advantageous for providing sufficient signal strength or intensity of mechanical vibration or acoustic noise in the sensor area.

[0027] When the at least first sensor is configured to detect mechanical vibrations or acoustic noise transmitted by the user’s biological tissue as a carrier medium, the relatively short distance between the at least first sensor and the click generator, and therefore the relatively short distance between the wearable electronics and the handheld injection device, is particularly advantageous for providing reliable and highly accurate measurement results using the at least first sensor.

[0028] According to another example, the at least first sensor is one of a mechanical vibration sensor, an acoustic sensor, an ultrasonic sensor, a capacitive sensor, and an optical sensor. Using all these types of sensors, at least the mechanical vibration or acoustic noise transmitted through a portion of the biological tissue of a person actually holding the handheld injection device can be detected by at least the first sensor when the click generator is repeatedly activated.

[0029] When implemented as an acoustic sensor, the at least first sensor is typically implemented as a directional microphone, for example, when wearable electronics are worn on a specific part of a person's body, the directional microphone is directed onto a portion of the user's skin. In this way, the at least first sensor can detect or even quantitatively measure mechanical vibrations or acoustic noise originating from a click generator and transmitted through the person's biological tissues while holding the handheld injection device.

[0030] Each click generated by the click generator typically produces a mechanical vibration, which can be transmitted from the click generator to the housing of the handheld injection device. Furthermore, this mechanical vibration is inevitably transmitted from the housing to biological tissue, such as the skin of the person actually holding the handheld injection device. Therefore, when the wearable electronics are actually worn by the user, the mechanical vibration transmitted to or onto the person's skin or biological tissue will be transmitted through the corresponding biological tissue until it reaches at least the location of the first sensor.

[0031] Activating or using the click generator of a handheld injection device can cause detectable mechanical vibrations, such as those on the user's skin. Acoustic noise, and therefore the click sound, can also be transmitted into and through human biological tissue. Vibrations or acoustic stimuli of the carrier medium, such as those on biological tissue or the user's skin, can typically be detected by at least a first sensor, particularly when the first sensor is implemented as either a mechanical vibration sensor or an acoustic sensor.

[0032] Mechanical or acoustic excitations of the user's biological tissue can also be detected within the ultrasonic spectrum. In this way, and when implemented as an ultrasonic sensor, at least the first sensor can also be equally capable of detecting ultrasonic signals caused or generated by a click generator during the use of the handheld injection device, and that ultrasonic signals have been transmitted to and through the user's biological tissue to which the wearable electronics are attached.

[0033] In a similar manner, the at least first sensor can be implemented as a capacitive sensor. For example, acoustic or mechanical excitation of human skin can also be electrically detected by electrostatic capacitive sensing arrangements, such as by a capacitive sensor that can be in direct contact with a portion of the skin.

[0034] Furthermore, mechanical vibrations or acoustic stimuli to a portion of the user's skin can also be detected optically. Here, for example, a light source and photodetector provided by a wearable electronic device can be configured to emit electromagnetic radiation and transmit it to a portion of the user's skin. An optical sensor, i.e., an optical detector, can be configured to record or detect at least a portion of the electromagnetic radiation reflected by the skin. If the skin is subjected to mechanical vibrations caused by a click generator from a handheld injection device, such vibrations result in a measurable change in the direction and / or intensity of light reflected from a particular portion of the skin.

[0035] According to another example, the housing of the wearable electronic device includes a skin contact surface. The skin contact surface is configured to make mechanical contact with a portion of the skin of the person wearing the electronic device. The at least first sensor is embedded in the skin contact surface, or the at least first sensor is disposed on the skin contact surface. Typically, the skin contact surface is located on the outer surface of the bottom of the housing. The housing of the wearable electronic device typically includes a top or crown surface opposite the bottom. On the top, the wearable electronic device typically includes a display to visually indicate various information to the user of the wearable electronic device, such as time, date, or other health-related or physiological data, such as heart rate.

[0036] By arranging or embedding at least a first sensor in or on a skin contact surface, the first sensor is inherently oriented toward the skin, or may even be in direct contact with the skin, when the patient or user properly wears the wearable electronics. By embedding or arranging the first sensor in or on a skin contact surface, immediate skin contact can be provided to the first sensor once the user or patient wears the wearable electronics.

[0037] According to another example, at least a first sensor protrudes from the skin-contact surface. Typically, at least the first sensor is located at a predefined distance from the outer edge of the skin-contact surface, and thus at a specific distance from the side edge of the bottom of the housing or all side edges. The at least first sensor may protrude from the skin-contact surface in a direction pointing to a surface normal that is substantially parallel to the skin-contact surface of the housing. In this way, and when the wearable electronics are properly attached to a portion of the user's skin, direct contact between the at least first sensor and the user's skin is ensured to some extent.

[0038] In this way, the harmful effects that may be caused by uneven or rough parts of the skin, which could otherwise lead to slightly loose contact between the skin and at least the first sensor, can be effectively compensated. By making at least the first sensor protrude at least slightly outward from the outer surface of the bottom, and thus by making at least the first sensor protrude from the skin contact surface, full and reliable direct contact between at least the first sensor and the corresponding part of the skin can be effectively provided.

[0039] According to another example, the housing includes a recess in the skin-contact surface. The recess has a specific depth. It can extend in a direction parallel to the surface normal of the skin-contact surface. Typically, the recess is also positioned off-center from the bottom of the housing, on a side or outer edge. Furthermore, the at least first sensor is disposed within the recess. The at least first sensor is typically arranged at the bottom of the recess. In this way, the at least first sensor does not protrude outward from the skin-contact surface. Instead, the at least first sensor is disposed within the recess. In this way, when the wearable electronics are attached to the corresponding skin portion, the at least first sensor is effectively protected from direct contact with a portion of the skin.

[0040] Such a configuration can be particularly advantageous when direct contact between at least the first sensor and the skin should be avoided. For example, this could be the case where the at least first sensor comprises a combination of a light source and a photodetector. By utilizing a recessed arrangement of the at least first sensor relative to the skin contact surface, direct contact between the at least first sensor and a portion of the user's skin can be effectively avoided. This can also be particularly advantageous for implementing alternative methods of detecting vibrations of the skin portion, such as those caused by the operation of a click generator from a handheld injection device. For measuring skin vibrations, a gap between the at least first sensor and the corresponding portion of the skin can be beneficial.

[0041] According to another example, the at least first sensor includes a direction with maximum sensitivity. The direction with maximum sensitivity is substantially parallel to the surface normal of the skin-contacting surface. In this way, it can be ensured to some extent that the at least first sensor has the highest sensitivity to human skin when the wearable electronics are properly worn by a person and when the skin-contacting surface of the wearable electronics' housing is in direct contact with the corresponding portion of the skin. In this way, environmental influences, such as background noise or skin vibrations caused by other environmental or ambient influences, can be ignored or disregarded. When the at least first sensor is implemented as an acoustic sensor, it may include a directional microphone, wherein the maximum sensitivity of the directional microphone is generally oriented parallel to the surface normal of the skin-contacting surface.

[0042] Typically, the direction of maximum sensitivity of the first sensor for orientation measurement can also be slightly deviated from the direction of the surface normal of the skin contact surface. In a typical example, the angular offset between the direction of maximum sensitivity of at least the first sensor and the surface normal of the skin contact surface should be less than 45°, less than 30°, less than 20°, less than 15°, or less than 10°. When the wearable electronics are equipped with multiple sensors, the direction of maximum sensitivity of at least the first sensor can be particularly deviated from the surface normal of the skin contact surface, for example, arranged adjacent to each other in or on the skin contact surface, wherein when the wearable electronics are properly attached to the part of the user's body, at least two of the multiple sensors are effectively guided to a common virtual point or area of ​​the skin part.

[0043] According to another example, the wearable electronic device includes at least a second sensor connected to a processor. The second sensor is configured to acoustically detect mechanical vibrations or acoustic noise caused or generated by a click generator of a handheld injection device. The at least second sensor may be provided as a supplement to the at least first sensor. The at least second sensor may include a microphone. It may include a directional microphone.

[0044] The second sensor may be located at a predetermined distance from the at least first sensor. The second sensor may be arranged and located inside the housing. It may be encapsulated within the housing. The second sensor may be arranged in or adjacent to a side wall of the housing of the wearable electronic device. Alternatively, the second sensor may be located on the front of the housing of the wearable electronic device or may be embedded in the front of the housing of the wearable electronic device. The second sensor may be arranged on the front, while the first sensor may be arranged in or on the bottom of the housing of the wearable sensor.

[0045] The second sensor can be configured to detect or measure mechanical vibrations or acoustic noise transmitted through air as a carrier medium. So far, the first and second sensors can be distinguished in terms of sensing capability based on the specific type of carrier medium configured for transmitting mechanical vibrations or acoustic noise.

[0046] The at least first sensor may be configured specifically to detect mechanical vibrations or acoustic noise caused or generated by the click generator and transmitted through biological tissue. The at least second sensor may be specifically configured to detect or measure mechanical vibrations or acoustic noise generated by the click generator and transmitted through air as a carrier medium.

[0047] In this way, and by having at least first and second sensors, mechanical vibrations or acoustic noise generated or caused by the click generator can be recorded, monitored, or detected in a redundant manner. This improves detection accuracy and the sensitivity of wearable electronics to mechanical vibrations or acoustic noise.

[0048] In some examples, the wearable electronics do not have a first sensor and only include a second sensor implemented as a microphone.

[0049] According to another example, the at least first sensor is capable of detecting or measuring vibrations of the user's skin, wherein the skin vibrations are caused or generated by a click generator of the handheld injection device when the handheld injection device is in mechanical contact with the user, either by the user or through user operation. In a typical use case, the injection device is held in the user's hand when operated by the user. Operation of the injection device includes dose setting and dose dispensing, as well as initiating or completing at least one of the dose setting or dose dispensing procedures, wherein each of these actions is accompanied by the generation of mechanical vibrations or acoustic noise originating from the click generator.

[0050] Typically, and when the wearable electronics are attached to the same hand or arm of a user actually holding a handheld injection device, the spatial distance between one or more sensors of the wearable electronics and the click generator is relatively short. For such a short distance, mechanical vibrations or acoustic noise generated by the click generator and transmitted to the biological tissue at a first location can be transmitted through the biological tissue to at least a second location where at least the first sensor of the wearable electronics is located.

[0051] Within or over a relatively short distance through biological tissue, the damping or attenuation of mechanical vibrations or acoustic noise is relatively small, enabling at least a first sensor to detect the corresponding signal, for example, at a second location. In this example, at least the first sensor is typically implemented as a vibration sensor. The vibration sensor can be implemented as an acoustic sensor, an ultrasonic sensor, a capacitive sensor, or an optical sensor.

[0052] According to another example, when the handheld injection device is in mechanical contact with the user during operation, the at least first sensor is capable of detecting or measuring sound waves caused or generated by the click generator and transmitted through a part of the user's body. Here, the at least first sensor is typically implemented as an acoustic sensor or an ultrasonic sensor. The sound waves caused or generated by the click generator can propagate through biological tissue, such as through the user's skin or through the user's bone structure. In some examples, sound waves originating from the click generator can enter the user's biological tissue and can enter the bone structure at a first location. The sound waves can propagate through the bone structure to a second location on the bone structure, which is located at a distance from the first location. At the second location, the sound waves, or a portion thereof, can again propagate through the biological tissue to the at least first sensor.

[0053] Sound waves generated or produced by the click sound generator of a handheld injection device can propagate through or along at least one of the user's skeletal structure, connective tissue, dermal tissue, or muscle tissue, or through a combination thereof. Typically, the user's biological tissue can serve as a carrier medium for the sound waves originating from the click sound generator, and when attached to a part of the user's body, it can be detected by at least a first sensor of a wearable electronic device.

[0054] According to another example, the wearable electronic device includes an accelerometer and a gesture recognizer. The gesture recognizer is operable to analyze the electrical signals generated by the accelerometer. At least one of the accelerometer and the gesture recognizer is connected to or embedded in a processor. In this way, and when connected to, for example, a user's hand, wrist, or arm, and the user moves the corresponding part of their body, the gesture recognizer can identify characteristic movements of the corresponding body part. Typically, the electrical signals generated by the accelerometer are permanently analyzed by the gesture recognizer.

[0055] Characteristic postures or movements of a part of a user's body result in a sequence of characteristic electronic signals generated from an accelerometer. A posture recognizer is configured to identify such characteristic sequences in order to determine, for example, whether a person is actually grasping or holding a pen-type or handheld injection device. Typically, a posture recognizer is able to identify the posture of a user's hand or arm movements when using a handheld injection device.

[0056] Pose recognition, provided by accelerometers and / or pose recognizers, can help optimize the power consumption of wearable electronics. Pose recognition can also improve the accuracy and reliability of detecting mechanical vibrations or acoustic noise originating from click generators. Furthermore, pose recognition can trigger wake-up or activation routines for wearable electronics.

[0057] According to another example, at least one of the gesture recognizer and the processor is operable to activate at least a first sensor in response to detecting or recognizing, for example, one of a predefined gesture performed by a user. When the wearable electronics are connected to the corresponding part of the user's body, the detection or recognition of the predefined gesture is typically performed based on electrical signals generated by and obtained from an accelerometer.

[0058] In some examples, and by default, at least the first sensor can be deactivated, for example, by the processor. If, in response to gesture recognition or gesture identification provided, for example, by at least one of the gesture recognizer or the processor, the processor can execute a wake-up routine, through which at least the first sensor and / or the wearable electronics are set to an active state. In the active state, the at least first sensor exhibits an increased level of power consumption compared to the inactive or default state.

[0059] By default, when switched to the active state, at least the first sensor can remain active for a predefined time interval. During this predetermined time interval, if at least one of the first or second sensors does not detect mechanical vibration or acoustic noise, the corresponding sensor can automatically switch to a default or inactive state. It can be reactivated in response to further gesture recognition or gesture identification.

[0060] According to another example, the processor is operable to derive or determine at least one of the dose sizes set or dispensed by the handheld injection device. Optionally or additionally, the processor is operable or capable of determining or deriving the operating state of the handheld injection device. The processor can identify, for example, an idle or active state of the handheld injection device. The processor can, for example, determine the completion or start of at least one of the dose setting process and the dose dispensing process. The processor derives or determines the operating state of the handheld injection device based on an electrical signal obtained from the at least first sensor, and the derivation or determination of the operating state may further include the derivation or determination of the dose size set or dispensed.

[0061] Optionally or additionally, the derivation or determination of the operating state and / or the dose size can be based on electrical signals generated by and obtained from the at least second sensor. In some examples, the processor is configured to derive and / or determine at least one of the dose size or operating state of the handheld injection device based on a combination of electrical signals obtained from the first sensor and the second sensor.

[0062] In a further example, the processor can be configured to distinguish different operating states of the handheld injection device. For this purpose, different operating states or different operations performed with the handheld injection device may cause different types of mechanical vibrations or different acoustic noises caused or generated by click generators, or different acoustic noises caused or generated by different click generators.

[0063] Therefore, the processor and / or at least one of the first and second sensors can be configured to distinguish different types of mechanical vibrations and / or different types of acoustic noises caused or generated, such as different operating modes of the click generator, or originating from different, i.e., from at least the first and at least the second click generators of the handheld injection device.

[0064] To distinguish between different types of mechanical vibrations or acoustic noise, the electrical signals provided by at least one of the first and second sensors can be subjected to electronic filtering, such as spectral filtering. For this purpose, the respective sensors and / or processors can be equipped with suitable electronic filters operable to distinguish between the first and second types of electrical signals generated by the respective sensors in response to the detection of the first and second types of mechanical vibrations or acoustic noise.

[0065] According to another example, the wearable electronic device also includes at least one of memory and a communication interface. The communication interface is typically operable to exchange data with an external electronic device. The communication interface is typically implemented as a wireless communication interface. The communication interface of the wearable electronic device is typically configured to establish and maintain a communication link with the external electronic device. The external electronic device may include one of a portable electronic device or a fixed electronic device. In some examples, the external electronic device is a smartphone, tablet, or personal computer capable of establishing a communication link with the wearable electronic device via its communication interface.

[0066] The wearable electronic device's memory and communication interface are connected to the processor. In this way, electrical signals obtained from at least one of the first and second sensors can be directly stored in the memory or transmitted to an external electronic device. Furthermore, the wearable electronic device's processor is operable to directly process the electrical signals obtained from at least one of the first and second sensors.

[0067] The processor can be configured to directly export or determine at least one of the dose size and operating status of the handheld injection device. The dose size and / or operating status can be directly transmitted to an external electronic device or stored locally in memory.

[0068] In some examples, wearable electronics also include a clock, through which data to be stored in memory or transmitted to external electronics can be provided with a time or date indication. In this way, the processor and memory can provide monitoring and / or recording of information related to the operation and / or use of the handheld injection device.

[0069] According to another example, wearable electronic devices are implemented as smartwatches or fitness trackers. In addition to the features and functions described above, wearable electronic devices may also include heart rate sensors or pulse oximetry sensors to acquire the user's physiological data when worn by the respective user. Wearable electronic devices can provide users with information such as time and date.

[0070] According to another aspect, this disclosure relates to a method for determining at least one of a dose size or an operational state of a handheld injection device. The method includes attaching a wearable electronic device to a part of a user's body, causing the handheld injection device to mechanically contact the user's body, wherein the handheld injection device includes a click generator. The method further includes the step of detecting at least one of mechanical vibration or acoustic noise caused or generated by the click generator of the handheld injection device when the injection device is operated by the user. The mechanical vibration or acoustic noise originating from the click generator may be provided during at least one of the dose setting, dose dispensing, or when at least one of the dose dispensing or dose setting processes is started or terminated.

[0071] The method also includes detecting at least one of mechanical vibration or acoustic noise originating from the click generator. Detection of mechanical vibration or acoustic noise may include detection after the vibration or acoustic noise has been propagated through biological tissue (e.g., the skin or bone structure of a user's or patient's body).

[0072] In addition, the method may also include determining or deriving at least one of the dose size and operating status of the handheld injection device based on signals obtained from at least a first sensor in response to the detection of mechanical vibration or acoustic noise.

[0073] Typically, methods for determining at least one of the dose size or operating status of a handheld injection device are implemented using wearable electronic devices as described above. All the features, effects, and benefits associated with wearable electronic devices described above apply equally to methods for determining at least one of the dose size and operating status of a handheld injection device; and vice versa.

[0074] According to another aspect, this disclosure also relates to a computer program for determining at least one of the magnitude of a set or dispensed dose and the operational state of a handheld injection device. Here, the handheld injection device includes a click generator configured to generate mechanical vibration or acoustic noise during dose setting, dose dispensing, or operation of the handheld injection device, for example, during the start or completion of at least one of the dose setting or dose dispensing processes.

[0075] When implemented in a processor of the wearable electronic device as described above, the computer program includes computer-readable instructions operable to analyze electrical signals obtained from the at least first sensor during user-induced or user-controlled operation of the injection device, such as setting or dispensing a dose. The computer-readable instructions are also operable to determine or derive the magnitude of the dose currently set or dispensed by the handheld injection device and / or determine or derive the operational state of the handheld injection device. Based on the analysis of the electrical signals obtained from the at least first sensor, further computer-readable instructions provide the derivation or determination of the operational state and / or dose magnitude.

[0076] Typically, the computer program is configured to be deployed in the wearable electronic device described above. It is generally configured to be executed by the processor of the wearable electronic device. In particular, the methods described above are executable with the assistance of the computer program. All the features, effects, and benefits described above relating to the methods for determining at least one of the wearable electronic device and the dosage and operational status of the handheld injection device also apply to the computer program; and vice versa.

[0077] In general, the scope of this disclosure is defined by the claims. The injection device is not limited to the specific embodiments or examples, but includes any combination of elements from different embodiments or examples. For this purpose, this disclosure covers any combination of claims and any technically feasible combination of features disclosed in different examples or embodiments.

[0078] In this article, the term "distal" or "far end" refers to the end of the injection device facing the injection site in a human or animal. The term "proximal" or "proximal end" refers to the opposite end of the injection device, which is furthest from the injection site in a human or animal.

[0079] The terms "drug" or "pharmaceutical preparation" are used synonymously herein and describe pharmaceutical preparations containing one or more active pharmaceutical ingredients or their pharmaceutically acceptable salts or solvates, and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient ("API") is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or pharmaceutical preparation is used to treat, cure, prevent, or diagnose a disease or to otherwise enhance physical or mental health. Drugs or pharmaceutical preparations may be used for a limited period of time or periodically for chronic diseases.

[0080] As described below, a drug or pharmaceutical agent may include at least one API or combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs 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, namely double-stranded 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.

[0081] Drugs or pharmaceutical preparations may be contained in primary packaging or "drug containers" suitable for use with drug delivery devices. Drug containers may be, for example, cartridges, syringes, reservoirs, or other robust or flexible vessels configured to provide suitable chambers for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chambers may be designed to store the drug for at least one day (e.g., from 1 day to at least 30 days). In some cases, the chambers may be designed to store the drug for about one month to about two years. Storage may be carried out at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, drug containers may be or may include dual-chamber cartridges configured to separately store two or more components of the drug formulation to be administered (e.g., API and diluent, or two different drugs), one component in each chamber. In these cases, the two chambers of the dual-chamber cartridge may be configured to allow mixing of the two or more components before and / or during administration to a human or animal. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., through a conduit between the two chambers), allowing the user to mix the two components before dispensing if needed. Alternatively or additionally, the two chambers can be configured to allow mixing during dispensing of the components into a human or animal body.

[0082] Drugs or agents contained in drug delivery devices as described herein can be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes or diabetes-related complications (such as diabetic retinopathy), thromboembolic disorders (such as deep vein or pulmonary thromboembolism). Other examples of disorders are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those described in the following manuals: such as Rote Liste 2014 (e.g., but not limited to, main group 12 (antidiabetic drugs) or 86 (oncology drugs)) and Merck Index, 15th edition.

[0083] Examples of APIs used to treat and / or prevent type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide-1 (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture thereof. As used herein, the terms “analyte” and “derivative” refer to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deletion and / or exchange of at least one amino acid residue present in a naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues may be encoding amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. Specifically, the term "derivative" refers to a polypeptide having a molecular structure that can be formally derived from the structure of a naturally occurring peptide, such as human insulin, wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in a naturally occurring peptide may have been omitted and / or substituted with other amino acids (including non-coding amino acids), or amino acids (including non-coding amino acids) may have been added to a naturally occurring peptide.

[0084] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (glargine insulin); Lys(B3), Glu(B29) human insulin (glutamate insulin); Lys(B28), Pro(B29) human insulin (lispro insulin); Asp(B28) human insulin (aspart insulin); human insulin wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala and wherein Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0085] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (detemir insulin, 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-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (degludec insulin) ); B29-N-(N-lithochyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0086] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixilatin. Exenatide (Exendin-4, Liraglutide, a 39-amino acid peptide produced by the salivary glands of the Gila monster. Semaglutide, Taspoglutide, Albiglutide Dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langelatide / HM-11260C (Efpeglenatide), HM-15211, CM-3, GLP-1Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYO G-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, tezapatide (LY3298176), bamadotide (SAR425899), exenatide-XTEN, and glucagon-XTEN.

[0087] Examples of oligonucleotides include, for instance, sodium mipronil. It is a cholesterol-reducing antisense agent used to treat familial hypercholesterolemia or RG012 used to treat Alport syndrome.

[0088] Examples of DPP4 inhibitors include linagliptin, vedagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0089] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, fertility-stimulating hormone), growth hormone (Somatropine), desmopressin, terlipressin, gosorelin, triptorelin, leuprorelin, buserorelin, nafarelin, and goserelin.

[0090] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or their derivatives, or sulfated polysaccharides (e.g., polysulfated forms of the above polysaccharides), and / or their pharmaceutically acceptable salts. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20. It is a type of sodium hyaluronate.

[0091] As used herein, the term "antibody" refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigens. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized antibodies or humanized antibodies, fully human antibodies, non-human (e.g., mouse) antibodies, or single-chain antibodies. In some embodiments, antibodies have effector function and can fix complement. In some embodiments, antibodies have reduced or no ability to bind Fc receptors. For example, antibodies can be isotypes or subtypes, antibody fragments, or mutants that do not support binding to Fc receptors, for example, they have a mutagenic or missing Fc receptor-binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or antibody-like binding proteins with bivariate cross-binding domain orientation (CODV).

[0092] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not contain the full-length antibody polypeptide but still contains at least a portion of the full-length antibody polypeptide capable of binding an antigen. Antibody fragments may contain cleaved portions of the full-length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that can be used in this 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., double-chain, triple-chain, and quadruple-chain antibodies)), monovalent or multivalent antibody fragments (such as bivalent, trivalent, quadruvalent, and multivalent antibodies), microantibodies, chelated recombinant antibodies, tri- or bispecific antibodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camel-derived antibodies, and antibodies containing VHH. Further examples of antigen-binding antibody fragments are known in the art.

[0093] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term "frame region" refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides; it is not a CDR sequence and is primarily responsible for maintaining the correct positioning of the CDR sequence to allow antigen binding. Although frame regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the frame region of some antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0094] Examples of antibodies are anti-PCSK-9 mAbs (e.g., alirocumab), anti-IL-6 mAbs (e.g., sarilumab), and anti-IL-4 mAbs (e.g., dupilumab).

[0095] Pharmaceutically acceptable salts of any API described herein are also intended for use in drugs or pharmaceutical preparations in drug delivery devices. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0096] Those skilled in the art will understand that various components of the APIs, formulations, instruments, methods, systems, and embodiments described herein can be modified (added and / or removed) without departing from the full scope and spirit of the invention, which covers such modifications and any and all equivalents thereof.

[0097] It will be apparent to those skilled in the art that various modifications and variations can be made to this disclosure without departing from its scope. Furthermore, it should be noted that any reference numerals used in the appended claims should not be construed as limiting the scope of this disclosure. Attached Figure Description

[0098] In the following sections, examples of wearable electronic devices that can be used in conjunction with handheld injection devices will be described in more detail with reference to the accompanying drawings, wherein:

[0099] Figure 1 schematically illustrates an example of a handheld injection device.

[0100] Figure 2 schematically shows many components of the handheld injection device in an exploded view.

[0101] Figure 3 shows a block diagram of the logic components of a wearable electronic device.

[0102] Figure 4 is a schematic diagram of a user holding a handheld injection device in their hand, with wearable electronics attached to the wrist of the corresponding hand.

[0103] Figure 5 schematically illustrates the propagation of mechanical vibrations and / or acoustic noise from a click generator of a handheld injection device, detected and / or measured by at least a first sensor of a wearable electronic device.

[0104] Figure 6 schematically illustrates another example of a wearable electronic device.

[0105] Figure 7 shows another example of a wearable electronic device.

[0106] Figure 8 shows a partial enlarged view of the example in Figure 7.

[0107] Figure 9 schematically illustrates an example of a click sound generator, and

[0108] Figure 10 shows a flowchart of a method for determining at least one of the dose size and operating status of a handheld injection device. Detailed Implementation

[0109] Figures 1 and 2 show only one of many examples of handheld injection devices, which are typically used in conjunction with wearable electronics. The device shown in Figures 1 and 2 is a pre-filled, disposable injection device comprising a housing 10 to which an injection needle 15 can be secured. The injection needle 15 is protected by an inner needle cap 16 and an outer needle cap 17 or protective cap 18, which is configured to surround and protect the distal segment of the housing 10 of the injection device 1. The housing 10 may include and form a main housing portion configured to house the drive mechanism 8 and / or dose setting mechanism 9 as shown in Figure 2. The injection device 1 may further include a distal housing component labeled cartridge holder 14. The cartridge holder 14 may be permanently or releasably attached to the main housing 10. The cartridge holder 14 is typically configured to contain a cartridge 6 filled with a liquid medication. The cartridge 6 includes a cylindrical or tubular body 25 sealed in the proximal direction 3 by a stopper 7 located within the body 25. The stopper 7 can be displaced in the distal direction 2 relative to the barrel 25 of the cartridge 6 via the piston rod 20. The distal end of the cartridge 6 is sealed by a punctureable seal 26, which is configured as a diaphragm and can be punctured by the proximal tip of the injection needle 15. The cartridge retainer 14 includes a threaded port 28 at its distal end for threaded engagement with a corresponding threaded portion of the injection needle 15. By attaching the injection needle 15 to the distal end of the cartridge retainer 14, the seal 26 of the cartridge 6 is penetrated, thereby establishing a fluid delivery pathway into the interior of the cartridge 6.

[0110] When the injection device 1 is configured to administer, for example, human insulin, the dose set by the dose dial 12 at the proximal end of the injection device 1 can be displayed in so-called International Units (IU, where 1 IU is the bioequivalent of approximately 45.5 μg of pure crystalline insulin (1 / 22 mg)). The dose dial 12 may include or may form a dose scale.

[0111] As further shown in Figures 1 and 2, the housing 10 includes a dose window 13, which may be in the form of an aperture in the housing 10. The dose window 13 allows a user to view a limited portion of a digital sleeve 80, which is configured to move when the dose dial 12 is rotated to provide a visual indication of the currently set dose. When rotated during setting and / or dispensing or discharging of a dose, the dose dial 12 rotates in a helical path relative to the housing 10.

[0112] The injection device 1 can be configured such that turning the dosage knob 12 produces a mechanical click to provide acoustic feedback to the user. The click is typically generated by a click generator 45. The click generator 45 can be implemented in various different ways. The digital sleeve 80 interacts mechanically with the piston in the insulin cartridge 6. The dose displayed in the display window 13 is dispensed from the injection device 1 when the needle 15 is inserted into the patient's skin and when the trigger 11 or injection button is actuated. The dose is actually injected into the patient while the needle 15 of the injection device 1 remains in the skin for a period of time after the trigger 11 is actuated. The dispensing of a dose of liquid medication may also cause a mechanical click, however, this is different from the click produced when using the dosage selector 12. For this purpose, the injection device 1 may include a separate, i.e., a second click generator (not shown).

[0113] In this embodiment, during insulin dose delivery, the dose dial 12 rotates to its initial position in axial motion, that is, without rotating, while the digital sleeve 80 rotates back to its initial position, for example, displaying a dose of zero units.

[0114] The injection device 1 can be used for several injection processes until the cartridge 6 is emptied or the drug in the injection device 1 reaches its expiration date (e.g., 28 days after the first use).

[0115] Figure 2 shows an example of the drive mechanism 8 in more detail. It comprises several mechanically interacting components. The flange-like support of the housing 10 includes a threaded axial through opening that threadedly engages with the first thread or distal thread 22 of the piston rod 20. The distal end of the piston rod 20 includes a support 21 on which a pressure foot 23 is freely rotatable about the longitudinal axis of the piston rod 20. The pressure foot 23 is configured to axially abut against the proximal thrust receiving surface of the stopper 7 of the cartridge 6. During the dispensing action, the piston rod 20 rotates relative to the housing 10, thereby undergoing a distally propulsive movement relative to the housing 10 and therefore relative to the barrel 25 of the cartridge 6. As a result, due to the threaded engagement of the piston rod 20 with the housing 10, the stopper 7 of the cartridge 6 is displaced by a defined distance in the distal direction 2.

[0116] The piston rod 20 also has a second thread 24 at its proximal end. The distal thread 22 and the proximal thread 24 have opposite directions of rotation.

[0117] A drive sleeve 30 is also provided, having a hollow interior to receive the piston rod 20. The drive sleeve 30 includes an internal thread that engages with the proximal thread 24 of the piston rod 20. Furthermore, the drive sleeve 30 includes an externally threaded section 31 at its distal end. The threaded section 31 is axially constrained between a distal flange portion 32 and another flange portion 33 located at a predetermined axial distance from the distal flange portion 32. Between the two flange portions 32, 33, a final dose limiter 35 in the form of a semi-circular nut is provided, having an internal thread that mates with the threaded section 31 of the drive sleeve 30.

[0118] The final dose limiter 35 further includes a radial recess or protrusion at its outer circumference to engage with a complementary recess or protrusion at the inner sidewall of the housing 10. In this way, the final dose limiter 35 is splined to the housing 10. During continuous dose setting, rotation of the drive sleeve 30 in the dose increment direction 4 or clockwise causes cumulative axial displacement of the final dose limiter 35 relative to the drive sleeve 30. An annular spring 40 is also provided, axially abutting the proximal surface of the flange portion 33. Additionally, a tubular connector 60 is provided. At a first end, the connector 60 has a series of circumferentially oriented serrations. A radially inward flange is positioned at the second opposite end of the connector 60.

[0119] In addition, a dosage scale sleeve, also known as a digital sleeve 80, is provided. The digital sleeve 80 is disposed outside the spring 40 and the connector 60, and radially inside the housing 10. A helical groove 81 is provided around the outer surface of the digital sleeve 80. The housing 10 is provided with a dosage window 13 through which a portion of the outer surface of the number 80 can be seen. The housing 10 further has helical ribs on the inner sidewall portion of the insert 62, which will seat in the helical groove 81 of the digital sleeve 80. The tubular insert 62 is inserted into the proximal end of the housing 10. It is rotatably and axially fixed to the housing 10. A first stop and a second stop are provided on the housing 10 to limit the dosage setting procedure during which the digital sleeve 80 rotates helically relative to the housing 10.

[0120] A dose dial 12, in the form of a dose selection handle, is disposed around the outer surface of the proximal end of the digital sleeve 80. The outer diameter of the dose dial 12 generally corresponds to and matches the outer diameter of the housing 10. The dose dial 12 is fixed to the digital 80 to prevent relative movement therebetween. The dose dial 12 has a central opening.

[0121] Trigger 11, also known as the dosage button, is essentially T-shaped. It is located at the proximal end of the injection device 10. The handle 64 of trigger 11 extends through an opening in the dosage dial 12, through the inner diameter of the extension of the drive sleeve 30, and into a receiving recess at the proximal end of the piston rod 20. The handle 64 is held to allow restricted axial movement within the drive sleeve 30 and to prevent rotation relative to the drive sleeve. The head of trigger 11 is generally rounded. A trigger sidewall or skirt extends from the periphery of the head and is further adapted to be positioned in a proximal accessible annular recess of the dosage dial 12.

[0122] To select a dose, the user rotates the dose dial 12. With the spring 40 also acting as a clicker 45 and the coupling 60 engaged, the drive sleeve 30, spring 40, coupling 60, and digital sleeve 80 rotate together with the dose dial 12. Auditory and tactile feedback for dose selection is provided by the spring 40 and coupling 60. Torque is transmitted via a serration between the spring 40 and coupling 60. The helical groove 81 on the digital sleeve 80 and the helical groove on the drive sleeve 30 have the same lead. This allows the digital sleeve 80 to extend from the housing 10 and the drive sleeve 30, climbing the piston rod 20 at the same speed. At the limit of travel, a radial stop on the digital sleeve 80 engages with a first or second stop provided on the housing 10 to prevent further movement in the first rotational direction (e.g., in the dose increment direction 4). Rotation of the piston rod 20 is prevented due to the opposite directions of the integral thread and the drive thread on the piston rod 20.

[0123] As the drive sleeve 30 rotates, the final dose limiter 35, bonded to the housing 10, advances along the threaded section 31. Upon reaching the final dose dispensing position, a radial stop formed on the surface of the final dose limiter 35 abuts against a radial stop on the flange portion 33 of the drive sleeve 30, preventing further rotation of the final dose limiter 35 and the drive sleeve 30.

[0124] If the user accidentally selects an excessive dose, the injection device 1, configured as a pen injector, allows for the dispensing of a smaller dose without dispensing medication from the cartridge 6. This is accomplished simply by rotating the dosage dial 12 in the reverse direction. This causes the system to run in reverse. The flexible arm of the spring or pawl 40 acts as a ratchet, preventing the spring 40 from rotating. The torque transmitted through the coupling 60 causes the serrations to overlap, producing a clicking sound corresponding to the reduction in the selected dose. Typically, the serrations are arranged such that the circumferential extension of each serration corresponds to a unit dose. Here, the coupling can function as a ratchet mechanism.

[0125] Alternatively or additionally, the ratchet mechanism 90 may include at least one ratchet feature 91, such as a flexible arm on the sidewall of the tubular connector 60. At least one ratchet feature 91 may include, for example, a radially outwardly extending protrusion on the free end of the flexible arm. The protrusion is configured to engage with a correspondingly shaped reverse ratchet structure on the inner side of the digital sleeve 80. The inner side of the digital sleeve 80 may include longitudinally shaped grooves or protrusions characterized by a serrated profile. During tossing or dose setting, the ratchet mechanism 90 allows and supports rotation of the digital sleeve 80 relative to the connector 60 in a second rotational direction 5, the rotation accompanied by a regular clicking sound from the flexible arm of the connector 60. The angular momentum applied to the digital sleeve 80 along the first rotational direction is transmitted unchanged to the connector 60. Here, the corresponding ratchet features of the ratchet mechanism 90 provide torque transmission from the digital sleeve 80 to the connector 60.

[0126] Once the desired dose has been selected, the user can simply dispense the set dose by pressing trigger 11. This causes the connector 60 to axially displace relative to the digital sleeve 80, disengaging its teeth. However, the connector 60 remains engaged with the drive sleeve 30 during rotation. The digital sleeve 80 and the dose dial 12 are now free to rotate according to the helical groove 81.

[0127] Axial movement deforms the flexible arm of spring 40 to ensure that the teeth are not overturned during dispensing. This prevents drive sleeve 30 from rotating relative to housing 10, although it can still move freely axially relative to housing. This deformation is then used to push spring 40 and coupling 60 back along drive sleeve 30 to restore the connection between coupling 60 and digital sleeve 80 when dispensing pressure toward the distal side is removed from trigger 11.

[0128] The longitudinal axial movement of the drive sleeve 30 causes the piston rod 20 to rotate through the through opening in the support of the housing 10, thereby advancing the stopper 7 in the cartridge 6. Once the selected dose has been dispensed, further rotation of the digital sleeve 80 is prevented by contact between at least one stop extending from the dosing dial 12 and at least one corresponding stop in the housing 10. The zero-dose position can be determined by the abutment of the axially extending edge of the digital sleeve 80 or one of the stops with at least one or more corresponding stops in the housing 10.

[0129] The discharge mechanism or drive mechanism 8 described above is merely an example of one of many different configurations of drive mechanisms that are typically implemented in disposable pen syringes. The drive mechanism described above is explained in more detail in, for example, WO 2004 / 078239 A1, WO2004 / 078240 A1 or WO 2004 / 078241 A1, the entire contents of which are incorporated herein by reference.

[0130] Wearable electronic device 100 includes a housing 101 and a wristband 102. The wristband 102 is attached to the housing 101 and provides attachment of the housing 101, and thus the entire wearable electronic device 100, to a dedicated or selected portion 204 of the user's body 202. Typically configured as a wristband and typically including a flexible band, the wristband 102 is used to detachably secure the wearable electronic device 100 to the user's body portion 204, such that the housing 101 is in mechanical contact with at least the user's skin 200.

[0131] As shown in the sequence of Figures 5-8, the housing 101 of the wearable electronic device 100 includes a skin contact surface 103. The skin contact surface 103 may be disposed on the bottom 105 of the housing 101. The skin contact surface 103 may coincide with the bottom 105 of the housing 101. The housing 101 also includes a top 106 opposite to the bottom 105. The top 106 and the bottom 105 may be integrally formed, or they may be interconnected through the sidewalls 107 of the housing 101. At least a first sensor 160 is embedded or disposed in the skin contact surface 103. The at least first sensor is connected to a processor 140 disposed inside the housing 101.

[0132] At least a first sensor 160 is configured to detect at least one of mechanical vibration or acoustic noise caused or generated by the click generator 45 of the handheld injection device 1. Mechanical vibration or acoustic noise is typically generated during operation of the handheld injection device 1. The acoustic noise or mechanical vibration is typically transmitted via the housing 10 of the handheld injection device 1 to the skin 200 and / or to the user's body 202. The mechanical vibration or acoustic noise can then be transmitted to at least the first sensor 160 via the user's body 202 and / or skin 200. At least the first sensor 160 is capable of detecting at least one of the mechanical vibration or acoustic noise originating from the click generator 45 after transmission through or via the body 202.

[0133] The first sensor is specifically configured to detect mechanical vibrations or acoustic noise transmitted through the user's body 202. Specifically, the first sensor 160 is operable to detect or quantify at least one of the mechanical vibrations or acoustic noise transmitted through the skin 200. In particular, the first sensor may be sensitive only to mechanical vibrations or acoustic noise transmitted through at least one of the user's skin 200 or body 202. It may be substantially insensitive to background noise around or near the wearable electronics. This allows irrelevant background noise to be effectively suppressed or ignored. Therefore, the electrical signal generated by the first sensor 160 can exhibit an excellent signal-to-noise ratio in response to the detection of acoustic noise or mechanical vibration transmitted through the user's body 202.

[0134] The first sensor is typically implemented as one of a mechanical vibration sensor 161, an acoustic sensor 162, an ultrasonic sensor 163, a capacitive sensor 164, and an optical sensor 165. The combination and interaction between the first sensor 160 and the processor 140 can also provide a count of the subsequent series of mechanical vibrations or acoustic noises originating from the click generator 45. For a typical handheld injection device, a click is generated for each incremental step during dose setting or dose dispensing. In this way, and by counting the number of characteristic mechanical vibrations or acoustic noises transmitted through the body 202 and originating from the click generator 45, the magnitude of the currently set or dispensed dose can be quantitatively determined.

[0135] Typically, when the wearable electronics 100 is attached to a corresponding portion 204 of the body 202, at least the first sensor 160 faces the surface of the skin 200. As shown in FIG5, when the wearable electronics 100 is attached to the body portion 204, the direction D of the first sensor 160 having maximum sensitivity is generally oriented towards and / or pointed toward the skin 200. Typically, the direction D of at least the first sensor having maximum sensitivity extends substantially parallel to the surface normal of the skin contact surface 103. In some examples, it may extend at an angle of less than 45°, less than 30°, less than 20°, less than 15°, or less than 10° relative to the surface normal of the skin contact surface 103 of the wearable electronics 100.

[0136] Typically, the wearable electronic device 100 also includes a display 118. The display 118 is usually located on the top of the housing 101. The display can provide the user with information such as time and date information, as well as information about the user's own physiological parameters, such as heart rate. When the first sensor 160 actually detects mechanical vibration or acoustic noise originating from the click generator 45, the processor 140 and the display 118 can be configured to provide corresponding visual feedback to the user, for example, even in real time. In this way, and when the user sets a dosage using a handheld injection device, the corresponding click sound generated by the click generator can be recorded or detected by at least the first sensor 160.

[0137] When the processor 140 is properly calibrated to the specific type of handheld injection device currently in use, the processor has knowledge of the dose magnitude increment associated with each click sound generated by the click sound generator. In this way, once the first sensor 160 has detected characteristic mechanical vibrations or acoustic noise originating from the handheld injection device 1, the processor can calculate and visualize the dose magnitude on the display 118.

[0138] As further shown in Figure 5, the wearable electronic device 100 may also be equipped with at least a second sensor 180. The at least second sensor 180 is also connected to the processor 140. The second sensor 180 is specifically configured to acoustically detect mechanical vibrations or acoustic noise caused or generated by a click generator. The second sensor 180 may be implemented as a microphone 181, such as a directional microphone. The second sensor 180 may also allow processing of voice commands from the user. When implemented as, for example, a smartwatch 110, a conventional wearable electronic device 100 can be inherently provided.

[0139] By having first and second sensors 160 and 180, mechanical vibrations or acoustic noise caused or generated by the click generator of the handheld injection device 1 can be redundantly recorded or monitored. This significantly improves the measurement accuracy and reliability of click detection. The signal obtainable from the first sensor 160 and the signal simultaneously obtainable from the second sensor 180 can be correlated by the processor 140 to, for example, distinguish between mechanical vibrations and acoustic noise originating from the click generator or from other sources.

[0140] As shown in Figure 5, the second sensor 180 can be positioned at a spatial offset from the first sensor 160. In this way, the time difference between the electrical signals generated by the first sensor 160 and the second sensor 180 can also be used to determine whether the electrical signals from the first sensor 160 and the second sensor 180 originate from a common source, such as a click generator. Here, the relatively limited speed of sound propagation or mechanical vibration propagation through biological tissue can be considered. The measurable time difference between the electrical signals generated by the first sensor 160 and the second sensor 180 may be due to the corresponding sound or vibration signals traveling along or through different lengths of transmission or different carrier media.

[0141] The second sensor 118 may be located outside and offset from the skin contact surface 103 of the housing 101. The second sensor 180 may be located inside the housing 101. It may be located near the side wall 107 or near the top 106.

[0142] In some examples, particularly when the wearable electronics 100 is implemented as a smartwatch 110 or a fitness tracker, the wearable electronics 100 may include only one sensor operable to detect mechanical vibrations or acoustic noise. Here, the first sensor 160 may include a microphone, such as a directional microphone. The first sensor 160 may be positioned offset from the skin contact surface 103. It may, for example, coincide with the position of the second sensor 180 shown in FIG. 5. Here, particularly when implemented as a body-worn electronics device, at least the first sensor 160 includes a microphone configured to detect mechanical vibrations or acoustic noise originating from the click generator 45 and transmitted primarily through the air as a carrier medium.

[0143] Figure 6 illustrates another example of the wearable electronics 100. There, at least a first sensor 160 protrudes from the skin contact surface 103 at the bottom 105 of the housing 101. In this way, it is ensured to some extent that when the wearable electronics 100 is attached to the corresponding portion 204 of the user's body 202, at least the first sensor 160 is in direct contact with the skin 200. Direct skin contact of the first sensor 160 can provide higher accuracy and reliability of the corresponding measurements.

[0144] In another example of Figure 7, at least the first sensor 160 is located in a recess 104 disposed in the skin contact surface 103. Using this example, direct contact between at least the first sensor 160, for example, disposed at the bottom of the recess 140, and the surface of the skin 200 can be effectively avoided. Here, and as shown in the enlarged view of Figure 8, the first sensor 160 can be implemented as an optical sensor 165. The optical sensor 165 may include a light source 166 that generates light or electromagnetic radiation directed toward and guided onto the surface of a portion 204 of the skin 200. The optical sensor 165 also includes an optical detector 167, by which at least a portion of the electromagnetic radiation generated by the light source 166 and reflected from the surface of the skin 200 can be detected. Changes in the reflected light and the detected light directly indicate, for example, vibrations of the skin 100, which may be caused by a click generator 45 directly or indirectly mechanically coupled to a corresponding portion 204 of the user's body 202.

[0145] Typically, as shown in Figures 5 and 6, sensor 160 can be implemented as one of a vibration sensor 161, an acoustic sensor 162, an ultrasonic sensor 163, a capacitive sensor 164, or an optical sensor 165. Only one example of the wearable electronics 100 in Figure 6 schematically illustrates some of the many alternative implementations of the first sensor 160. It is self-evident that many wearable electronics can be provided, distinguished from each other by the type and specific implementation of the first sensor 160 or the second sensor 180.

[0146] Figure 9 schematically illustrates an example of a click generator 45. The click generator 45 typically includes a flexible or resilient member 46 with a protrusion 47. The protrusion 47 is configured to audibly and mechanically engage with the structure of a second member 48. The second member may include a toothed structure 49 that engages with the protrusion 47 of the first member when the first member 46 and the second member 48 move or rotate relative to each other.

[0147] Typically, during at least one step in the dosage setting or dosage dispensing process, any two parts 46, 48 of the drive mechanism 8 of the injection device 1 can move relative to each other to form or constitute a click generator 45.

[0148] Figure 10 shows a flowchart of a method for determining or estimating at least one of the dosage and operational status of a handheld injection device 1. In a first step 300, the wearable electronics 100 is attached to a portion 204 of the user's body 202. Typically, the wearable electronics 100, implemented as a smartwatch, is attached or secured to the wrist of the user's hand 201. In the next step 302, the handheld injection device is removed by the user. It is typically held in the same hand to connect the wearable electronics 100.

[0149] In subsequent step 304, the user operates the handheld injection device 1. The user may induce or trigger at least one of a dose setting process, a dose dispensing process, or some other type of procedure, such as a check of the handheld injection device. User-initiated operation of the handheld injection device results in at least one of mechanical vibration or acoustic noise originating from the click generator 45 of the handheld injection device 1.

[0150] In step 306, the corresponding mechanical vibration or acoustic noise is transmitted through the body 202, for example, through the user's skin 200. In the subsequent step 308, the mechanical vibration or acoustic noise transmitted through the body 202 is detected by the first sensor 160. In step 310, the processor 140 of the wearable electronics 100 determines or estimates the operating status of the handheld injection device 1 and / or determines or estimates the magnitude of the dose actually set or dispensed by the handheld injection device. Optionally, the operating status and / or the magnitude of the dose are visually displayed on the display 118 of the wearable electronics 100.

[0151] Figure 3 schematically illustrates a block diagram of a wearable electronic device 100. The wearable electronic device 100 includes a housing 101. The wearable electronic device 100 also includes one or more processors 140, such as a microprocessor, digital signal processor (DSP), application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), etc., and a memory 114. The memory 114 may include program memory and main memory, which may store software executed by the processors 140 and data generated or captured during use of the wearable electronic device 100, such as counted pulses, derived dose magnitudes, timestamps, etc. An optional switch 122 connects a power supply 120 to the electronic components of the wearable electronic device 100. A display 118 may or may not be present.

[0152] Wearable electronic devices 100, typically implemented as smartwatches 110, include an interface 124 connected to a processor 140. The interface 124 may be for communication via, for example, Wi-Fi or... RFID, NFC (Near Field Communication) or BLE ( A wireless communication interface that communicates with another external electronic device 65, such as a portable electronic device, using a low-energy wireless communication protocol or network. The wireless communication interface can be operable in the radio frequency range. For example, the wireless communication interface can be based on radio frequency identification technology (called RFID), which allows compatible hardware to power and communicate with otherwise unpowered and passive electronic tags using radio waves. Therefore, it can be used for identification, authentication, and tracking.

[0153] In other examples, interface 124 is implemented as a wired communication link, such as a jack for receiving a Universal Serial Bus (USB), mini-USB, or micro-USB connector. For this purpose, interface 124 includes a transceiver 126 configured to transmit and receive data. Figure 3 depicts an example of a wearable electronic device 100 connected to, or connectable to, an external electronic device 65 for data transmission via communication link 66. Data connection 66 can be of wired or wireless type.

[0154] For example, processor 140 may store the determined delivery dose and timestamp of an injection performed by the user, and then transmit the stored data to external electronic device 65. Device 65 maintains a treatment log and / or forwards treatment history information to a remote location, such as for review by medical personnel.

[0155] Wearable electronic device 100 can act as a data collection device and can be configured to store data such as delivered drug doses and timestamps of numerous injection events, such as 35 or more injection events. For a once-daily injection therapy, this would be sufficient to store approximately one month's treatment history. Data storage 114 can be organized in a first-in, first-out (FIFO) manner to ensure that the most recent injection events are always present in the memory of wearable electronic device 100. Once transferred to external electronic device 65, the injection event history in wearable electronic device 100 can be deleted. Alternatively, data can remain in wearable electronic device 100, with the oldest data automatically deleted once new data is stored. In this way, a log in the data collection device is built up over time during use and will always include the most recent injection events. Alternatively, other configurations may contain storage capacity for 70 injection events (twice daily), 100 injection events (3 months), or any other suitable number, depending on the user's treatment needs and / or preferences.

[0156] In another embodiment, interface 124 may be configured to transmit information using a wireless communication link and / or processor 140 may be configured to periodically transmit such information to external electronic device 65.

[0157] The processor 140 can control an optional display 118 to show determined drug dosage information and / or show the time elapsed since the last drug dose was delivered. For example, the processor 140 can cause the display 118 to periodically switch between displaying the most recently determined drug dosage information and the elapsed time.

[0158] Power source 120 may be a battery. Power source 120 may be a button cell battery or multiple button cells arranged in series or parallel. A timer or clock 115 may also be provided. In addition to turning the wearable electronics 100 on and off, or instead of turning the wearable electronics 100 on and off, switch 122 may be arranged to trigger clock 115 upon engagement and / or disengagement. For example, if timer or clock 115 is triggered on both engagement and disengagement of the first and second electrical contacts of the switch, or on both operation and deactivation of switch 122, processor 140 may use the output from timer 115 to determine the length of time trigger 11 is pressed, for example, to determine the duration of an injection.

[0159] Alternatively or additionally, processor 140 may use a timer or clock 115 to monitor the length of time elapsed since the injection was completed, as indicated by the disengagement time of the corresponding switching element or the cessation of operation of switch 122. Optionally, the elapsed time may be displayed on display 118. Also optionally, when switch 122 is subsequently operated, processor 140 may compare the elapsed time with a predetermined threshold to determine whether the user will attempt to administer another injection prematurely after the previous injection, and if so, generate an alarm such as an audible signal and / or warning message on display 118 or via output 116. Output 160 may be configured to generate an audible sound or induce vibration, thus generating a tactile signal, for example, to alert the user.

[0160] Wearable electronics may also be equipped with a sensor arrangement 150. As illustrated in FIG. 3, the sensor arrangement 150 includes a combination of a first sensor 160 and a second sensor 180. As described above, the first sensor 160 is implemented as one of a vibration sensor 161, an acoustic sensor 162, and an ultrasonic sensor 163. The first sensor 160 may also include a capacitive sensor 164 or an optical sensor 165. The second sensor 180 is typically implemented as a microphone 181. At least one or both of the sensors 160 and 180 may be connected to or coupled to an electronic filter 182. The electronic filter 182 can be used to distinguish different characteristic signals received or generated by at least one of the first or second sensors 160 and 180. The electronic filter 182, which may also be integrated into the processor 140, can help distinguish different types of mechanical vibrations or acoustic noise detected by at least one of the first sensor 160 and the second sensor 180.

[0161] Typically, the electronic components of the wearable electronic device 100 are interconnected via electronic circuitry 112. Electronic circuitry 112 may be disposed on a printed circuit board. Furthermore, the wearable electronic device 100 may also include an accelerometer 190 and a posture recognizer 192. Posture recognizer 192 may also be implemented or integrated into processor 140. Accelerometer 190 can provide a measurement of the acceleration force present in the wearable electronic device 100. In conjunction with processor 140 or posture recognizer 192, signals obtained from accelerometer 190 in response to characteristic movements of the wearable electronic device 100 can be used to identify or recognize specific postures. This posture recognition or identification can be further used to activate and / or deactivate sensor arrangement 150. For example, if accelerometer 190 detects that the wearable electronic device 100 is not in motion, sensor arrangement 150 can be switched to an idle or sleep mode. When movement of the wearable electronic device 100 is detected, processor 140 can be configured to wake up sensor arrangement 150 or at least one of sensors 160, 180.

[0162] Figure Labels

[0163] 1. Injection device

[0164] 2. Distal direction

[0165] 3. Proximal direction

[0166] 4. Direction of dose escalation

[0167] 5. Direction of dose reduction

[0168] 6 medicine cartridges

[0169] 7. Plugs

[0170] 8. Drive mechanism

[0171] 9. Dosage setting mechanism

[0172] 10. Shell

[0173] 11 Triggers

[0174] 12 Dosage dial

[0175] 13 Dosage window

[0176] 14. Cartridge Holder

[0177] 15 injection needles

[0178] 16 Inner needle cap

[0179] 17 Outer pin cap

[0180] 18 Protective Helmet

[0181] 20 Piston Rod

[0182] 21 Support components

[0183] 22 First Thread

[0184] 23 Pressure feet

[0185] 24 Second Thread

[0186] 25 cylinder

[0187] 26. Seals

[0188] 28 Threaded socket

[0189] 30 drive sleeve

[0190] 31 Threaded Section

[0191] 32 flange

[0192] 33 Flange

[0193] 35. Last dose limiter

[0194] 36 Shoulder platform

[0195] 40 springs

[0196] 41. Depression

[0197] 45 Clicking sound generator

[0198] 46 Part One

[0199] 47. Protrusion

[0200] 48 Part Two

[0201] 49. Tooth-shaped structure

[0202] 60 connector

[0203] 62 Inserts

[0204] 64 strokes

[0205] 80 digital sleeve

[0206] 81 Groove

[0207] 90. Ratchet Mechanism

[0208] 91. Razor tooth characteristics

[0209] 65 Electronic devices

[0210] 66 Data Connection

[0211] 100 wearable devices

[0212] 101 Casing

[0213] 102 Wristband

[0214] 103 Skin contact surface

[0215] 104 Depression

[0216] 105 button

[0217] 106 Top

[0218] 107 Sidewall

[0219] 110 Smartwatch

[0220] 112 Electronic Circuits

[0221] 114 Memory

[0222] 115 Clock

[0223] 116 Output

[0224] 118 monitor

[0225] 120 power supply

[0226] 122 switch

[0227] 124 interface

[0228] 126 transceiver

[0229] 140 processor

[0230] 150 Sensor Arrangement

[0231] 160 sensors

[0232] 161 Vibration Sensor

[0233] 162 Acoustic Sensors

[0234] 163 Ultrasonic Sensor

[0235] 164 Capacitive Sensor

[0236] 165 Optical Sensor

[0237] 166 Light Source

[0238] 167 Photodetector

[0239] 180 sensor

[0240] 181 Microphone

[0241] 182 Electronic Filter

[0242] 190 Accelerometer

[0243] 192 Pose Recognizer

[0244] 200 skins

[0245] 201 lots

[0246] 202 Body

[0247] Part 204

Claims

1. A wearable electronic device (100), comprising: -Shell (101) - A processor (140) disposed within the housing (101), - At least a first sensor (160), which is connected to the processor (140) and configured to detect at least one of mechanical vibration or acoustic noise caused or generated by the click generator (45) of the handheld injection device (1), wherein when the handheld injection device is in mechanical contact with the user during operation, the at least first sensor (160) is capable of detecting or measuring at least one of the following: i) Vibrations of the user's skin (200) caused or generated by the click generator (45), and ii) Sound waves caused or generated by the click generator (45) and transmitted through a part (204) of the user's body (202).

2. The wearable electronic device (100) according to claim 1, wherein the operation of the handheld injection device (1) is accompanied by repeated or periodic activation of the click generator (45).

3. The wearable electronic device (100) according to claim 1 or 2, wherein the processor (140) is configured to count the number of mechanical vibrations or acoustic noises originating from the click generator (45) during operation of the handheld injection device (1).

4. The wearable electronic device (100) according to claim 1 or 2, wherein the processor (140) is operable to calculate the size of the set dose or the size of the dispensed dose of the handheld injection device (1) by counting a plurality of instances of repeated clicking sounds.

5. The wearable electronic device (100) according to claim 1 or 2 further includes a wristband (102) which is connected to the housing (101) and configured to attach the housing (101) to a portion (204) of a person's body (202).

6. The wearable electronic device (100) according to claim 1 or 2, wherein the at least first sensor (160) is one of a mechanical vibration sensor (161), an acoustic sensor (162), an ultrasonic sensor (163), a capacitive sensor (164), and an optical sensor (165).

7. The wearable electronic device of claim 6, wherein the at least first sensor (160) includes a directional microphone.

8. The wearable electronic device (100) according to claim 1 or 2, wherein the housing (101) includes a skin contact surface (103) configured to mechanically contact a portion of the skin (200) of a person wearing the electronic device (100), wherein the at least first sensor (160) is embedded in the skin contact surface (103), or wherein the at least first sensor (160) is disposed on the skin contact surface (103).

9. The wearable electronic device (100) according to claim 8, wherein the at least first sensor (160) protrudes from the skin contact surface (103).

10. The wearable electronic device (100) according to claim 8, wherein the housing (101) includes a recess (104) in the skin contact surface (103), and wherein the at least first sensor (160) is disposed in the recess (104).

11. The wearable electronic device (100) according to claim 8, wherein the at least first sensor (160) includes a direction (D) having maximum sensitivity, the direction (D) having maximum sensitivity being substantially parallel to the surface normal orientation of the skin contact surface (103).

12. The wearable electronic device (100) according to claim 1 or 2 further includes at least a second sensor (180) connected to the processor (140) and configured to acoustically detect mechanical vibrations or acoustic noise caused or generated by the click generator.

13. The wearable electronic device (100) according to claim 12, wherein the first sensor (160) is configured specifically to detect mechanical vibrations or acoustic noise caused or generated by the click generator (45) and transmitted through biological tissue, and wherein the second sensor (180) is configured to detect or measure mechanical vibrations or acoustic noise generated by the click generator (45) and transmitted through air as a carrier medium.

14. The wearable electronic device (100) according to claim 1 or 2, wherein the handheld injection device (1) is equipped with at least two click generators (45), wherein the first click generator (45) generates a first mechanical vibration or a first acoustic noise, and wherein the second click generator generates a second mechanical vibration or a second acoustic noise, the second mechanical vibration or the second acoustic noise being distinguishable from the first mechanical vibration or the first acoustic noise, and wherein at least one of the first sensor (160) and the processor (140) is configured to distinguish between the first mechanical vibration and the second mechanical vibration and / or to distinguish between the first acoustic noise and the second acoustic noise.

15. The wearable electronic device (100) according to claim 1 or 2 further includes an accelerometer (190) and a posture recognizer (192), the posture recognizer (192) being operable to analyze electrical signals generated by the accelerometer (190), wherein at least one of the accelerometer (190) and the posture recognizer (192) is connected to or embedded in the processor (140).

16. The wearable electronic device (100) according to claim 15, wherein the posture recognizer (192) is capable of recognizing the posture of the user’s hand or arm movements when using the handheld injection device (1).

17. The wearable electronic device (100) according to claim 1 or 2, wherein the processor (140) is operable to derive or determine at least one of the dose size and operating state of the handheld injection device (1) based on an electrical signal obtained from the at least first sensor (160).

18. The wearable electronic device (100) according to claim 1 or 2, wherein the wearable electronic device (100) is implemented as a smartwatch (110).

19. A method for determining at least one of a dose size or an operating state of a handheld injection device (1), the handheld injection device (1) including a click generator (45) configured to generate mechanical vibration or acoustic noise during operation of the handheld injection device (1), the method comprising the steps of: - The wearable electronic device (100) according to any one of the preceding claims is attached to a part (204) of the user's body (202), - To bring the handheld injection device (1) into mechanical contact with the user's body (202), - Detect at least one of mechanical vibration or acoustic noise caused or generated by the click generator (45) through at least a first sensor (160) of the wearable electronic device (100), and - In response to the detection of mechanical vibration or acoustic noise, determine or derive at least one of the dose size and operating status of the handheld injection device (1) based on the signal obtained from the at least first sensor (160).

20. The method of claim 19, wherein skin or biological tissue of a portion of the patient's or user's body is used as a carrier medium for transmitting acoustic noise or mechanical vibration generated by the click generator (45) during use of the handheld injection device (1), and the method includes detecting the acoustic noise or mechanical vibration transmitted via the biological tissue of the patient or user through the handheld injection device.

21. A processor (140) for a wearable electronic device (100) according to any one of claims 1-18, wherein the processor (140) implements a computer program for determining at least one of a dose size and an operating state of a handheld injection device (1), the handheld injection device (1) including a click generator (45) configured to generate mechanical vibration or acoustic noise during a set dose or during a dose dispensing, wherein, when implemented in the processor (140), the computer program includes computer-readable instructions operable to: -Analyze the electrical signals obtained from at least the first sensor (160) during operation of the handheld injection device, and - Based on the analysis of the electrical signal obtained from the at least first sensor (160), determine or derive at least one of the dose size or operating state of the handheld injection device.

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