Sensor assembly for an injection device

Abstract

The present disclosure relates to a sensor assembly (80) for an injection device (1), the sensor assembly (80) including a sensor element (81) attachable to the injection device (1) and including a sensing surface (82, 83), the sensing surface (82, 83) including contact-sensitive sensor segments (84, 85, 86), the contact-sensitive sensor segments (84, 85, 86) operable to generate or modify an electrical touch signal when touched by a body part (112, 114, 116, 117) of a user; a processor (44) connected to the sensor element (81) operable to detect changes in the electrical touch signal over time and to generate a control signal based on the changes in the electrical touch signal over time; and a transmitter (38, 39) connected to the processor (44), the transmitter (38, 39) operable to transmit the control signal to an external electronic device (100).

Description

[Technical field]

[0001] The present disclosure relates to a sensor assembly for an injection device. In another aspect, the present disclosure relates to an injection device comprising such a sensor assembly. In a further aspect, the present disclosure relates to an add-on device configured for fastening to the injection device, the add-on device being provided with the sensor assembly. In another aspect, the present disclosure relates to an injection system comprising an injection device and an external electronic device. In a further aspect, the present disclosure relates to a method for assisting a user in using an injection device, and a computer program for carrying out such a method. [Background technology]

[0002] Drug delivery devices for setting and dispensing single or multiple doses of liquid medication are per se well known in the art. Generally, such devices have 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, in the case of patients suffering from chronic diseases such as diabetes, the patient may be physically debilitated and may also have poor eyesight. Therefore, a suitable drug delivery device, especially for home drug treatment, needs to be robust in construction and should be easy to use. Furthermore, the operation and general handling of the device and its components should be clear and easy to understand. Such an injection device should provide for the setting and subsequent dispensing of equal or variable sized doses of the drug. Furthermore, the dose setting and dose dispensing procedures must be easy to perform and unambiguous.

[0004] Patients suffering from certain diseases need to inject a certain amount of medication through a pen syringe.

[0005] Some drug delivery or injection devices provide for the selection of variable sized doses of medication and the injection of pre-set doses, while other injection devices provide for the setting and dispensing of fixed doses, where the amount of medication to be injected according to a given prescription schedule is always the same and does not or cannot be changed over time.

[0006] Some injection devices are implemented as reusable injection devices that provide the user with replacement drug containers, such as cartridges. Other injection devices are implemented as disposable injection devices, where the intention is to discard the entire injection device when the contents, i.e. the drug, have been used up.

[0007] It is beneficial to assist the user by utilizing an external electronic device, such as a portable electronic device implemented as, for example, a smartphone, tablet computer, or smartwatch, to control and supervise the administration of medication performed by the user or the patient himself / herself. Software applications provided on such external electronic devices may interact with the user and provide instructions or recommendations to the user on how to properly use the injection device.

[0008] The user assistance provided by the external electronic device may require input from the user, which may be somewhat complicated or cumbersome for the user, for example in the process of administering a drug by injection. There may be usage scenarios where the user holds the external electronic device in one hand and the injection device in the other. In such a situation, entering commands or confirmations on the external electronic device while holding the injection device in a particular hand that can be used to enter such commands may entail a non-negligible risk of unintentional puncture wounds. Summary of the Invention [Problem to be solved by the invention]

[0009] It is therefore desirable to provide a simple and intuitive way of how to assist a user in using an injection device when additionally using an external electronic device. It is a further object to provide an intuitive and fairly easy monitoring or logging of the operation of the injection device. [Means for solving the problem]

[0010] In one example, the present disclosure relates to a sensor assembly for an injection device. The sensor assembly includes a sensor element mountable to the injection device and including a sensing surface. The sensing surface includes a touch-sensitive sensor segment. The touch-sensitive sensor segment is operable to generate or modify an electrical touch signal when touched by a body part of a user. The sensor element typically includes a one- or two-dimensional sensing surface.

[0011] The sensor assembly further includes a processor connectable or coupled to the sensor elements, the processor operable to detect changes in the electrical touch signal over time and generate control signals based on the changes in the electrical touch signal over time.

[0012] The sensor assembly further includes a transmitter connected to the processor and operable to transmit a control signal to an external electronic device.

[0013] In this manner, the sensor assembly may be operable to detect contact with a body part of a user, generate a control signal indicative of the contact with the user, and transmit the control signal to an external electronic device. Thus, the sensor assembly, which may be attachable to or incorporated into the injection device, may provide a kind of remote control for the external electronic device.

[0014] A user holding the injection device, for example in one hand, may easily reach the contact-sensitive sensor element in order to generate a control signal and transmit the control signal to an external electronic device. In some examples, the sensor assembly is attached to a proximal end of the elongated injection device, such that the sensor assembly can be easily reached by, for example, the user's thumb while the injection device is held in the palm and / or with additional fingers of the same hand.

[0015] Typically, generation of the control signal by the processor is triggered by detection of changes in the electrical touch signal over time. Transmission of the control signal to the external electronic device may be triggered automatically upon generation of the control signal.

[0016] In practice, by touching a sensor element of the sensor assembly, a control signal is generated and automatically transmitted to an external electronic device.

[0017] According to further examples, the sensing surface of the sensor assembly includes a number of touch-sensitive sensor segments. Each of the sensor segments is operable to generate or modify an electrical touch signal when touched by a body part of a user. The sensor segments are spatially separated on the sensing surface so as not to overlap. The sensor segments may be arranged adjacent to one another in a regular or irregular manner. In some examples, the entire sensing surface is covered and / or occupied by multiple sensor segments. The sensor segments may have equal or unequal sizes.

[0018] In some examples, the touch-sensitive sensor segments are isolated from one another, and each touch-sensitive sensor segment may operate independently of any other touch-sensitive sensor segment of the sensing surface, and thus the touch-sensitive sensor segments may then be individually operable to generate an electrical touch signal when touched by a body part of a user.

[0019] The sensor segments may belong to or constitute a touch-sensitive matrix, e.g. a one- or two-dimensional array of touch-sensitive segments. Each touch-sensitive segment may comprise, for example, a capacitor or resistor operable to generate or modify an electrical signal in response to physical contact with a body part of a user. To that extent, a plurality of touch-sensitive sensor segments form or constitute a spatially resolved touch-sensitive sensor segment.

[0020] In a further example, the touch sensitive surface or matrix comprises a matrix of electrically resistive elements which change their electrical and measurable resistance when, for example, touched by a user, hi another example, the touch sensitive surface or matrix comprises a matrix of capacitive elements operable to change their measurable capacitance when, for example, touched by a user.

[0021] In a further example, the touch sensitive surface or matrix comprises a combination of electrically resistive and capacitive sensor segments. Capacitive sensors exhibit a fairly low degree of power consumption.

[0022] In a further example, the touch sensitive surface or matrix is ​​based on surface acoustic wave technology which relies on acoustic waves, and therefore comprises at least one pair of an acoustic wave transducer and an acoustic wave receiver.

[0023] In another example, the touch sensitive surface or matrix includes a number of optical sensors, such as photodetectors or photodiodes.

[0024] In a further example, the touch-sensitive surface or matrix includes an ultrasonic sensor. The optical and / or ultrasonic sensor can also be implemented as a fingerprint sensor capable of distinguishing between a characteristic fingerprint of a first user and a characteristic fingerprint of a second user.

[0025] In some examples, the sensor element is attachable to a user-actuatable portion of the injection device. The sensor element may be attachable or attached to a surface of an actuation or handling element, which is typically touched, handled or actuated by a user when using or operating the injection device. The sensor element may also be integrated into a surface of the actuation or handling element. The user-actuatable portion may be part of at least one of a sleeve-like housing component, a trigger or a dose dial of the injection device.

[0026] By providing many sensor segments on or across the sensing surface, spatially resolved touch sensing can be provided. Thus, a processor connected to each touch-sensitive sensor segment is operable to identify the sensor segment that generates or modifies an electrical touch signal in response to mechanical contact with a user's body part. In this manner, the processor is operable to determine which section or subsection of the sensing surface is actually in mechanical contact with the user's body part. This allows for providing spatially resolved touch sensing of the body part at the sensing surface of the sensor element.

[0027] According to another example, the processor of the sensor assembly is operable to generate a control signal based on a temporal change in a plurality of electrical touch signals generated or modified by a number of touch-sensitive sensor segments. In this way, the sensor is operable to detect and / or provide a spatial profile and a spatio-temporal profile of the individual touch-sensitive sensor segments touched by the body part of the user. Thus, the processor may be operable to identify and / or detect an area on the sensing surface touched by the body part. The processor may further be operable to monitor a temporal change or movement of such an area over time. Here, the area touched by the body part may also be considered and / or denoted as a sensing area of ​​the sensing surface.

[0028] According to further examples, the touch sensitive sensor segment and / or some or each of the plurality of touch sensitive sensor segments may be operable to generate different electrical touch signals in response to changes in pressure applied to the touch sensitive sensor segment, such that the electrical touch signal generated by the touch sensitive sensor segment varies depending on pressure applied by, for example, a user touching or contacting that particular touch sensitive sensor segment.

[0029] In response to changes in pressure applied to the touch-sensitive sensor segments, the electrical touch signal may vary in magnitude or amplitude. Additionally, the electrical touch signal may change its sign or change its frequency or periodicity. In response to different pressures applied to the touch-sensitive sensor segments, each sensor segment is operable to change the electrical touch signal in a measurable manner, i.e., in a manner that is detectable or processable by a processor connected or connectable to the touch-sensitive sensor segment.

[0030] In some examples, many or all of the touch-sensitive sensor segments of the sensing surface are operable to generate different electrical touch signals in response to changes in pressure applied thereto.

[0031] In some examples, the touch-sensitive sensor segment is operable to generate at least two different electrical touch signals in response to a change in pressure applied thereto. In a default configuration, the touch-sensitive sensor segment may be operable to generate a first electrical touch signal in response to a first pressure applied to the touch-sensitive sensor segment. Here, the first electrical touch signal may be generated if the first pressure applied to the touch-sensitive sensor segment exceeds a first predetermined threshold.

[0032] The touch-sensitive sensor segment may be further operable to generate a second electrical touch signal that differs in at least one of magnitude, amplitude, sign, or frequency from the first electrical touch signal. The second electrical touch signal may be generated when a pressure applied to the touch-sensitive sensor segment is equal to or greater than a second predefined threshold. Typically, the second threshold is greater than the first threshold.

[0033] To that extent, the first and second electrical touch signals may be indicative of significantly lower and significantly higher pressures applied to the respective touch sensitive sensor segments.

[0034] In a further example, the touch-sensitive sensor segment or sensor segments are operable to generate a variety of different electrical touch signals, it is contemplated that the touch-sensitive sensor segment may be operable to generate at least three, at least four, at least five, at least six, or at least eight different electrical touch signals, each of which reflects or is indicative of a respective first, second, third, fourth, fifth, sixth, or eighth pressure applied to a respective touch-sensitive sensor segment.

[0035] In a further example, the touch-sensitive sensor segments may be operable to generate an electrical touch signal that varies gradually with changes in pressure applied to the respective touch-sensitive sensor segment, where the electrical touch signal may be directly representative of the applied pressure.

[0036] Depending on the number and size of the contact-sensitive sensor segments distributed across the sensing surface, an accurate and fairly detailed spatially resolved pressure profile of or across the sensing surface of the sensor element can be provided. In this manner, the sensor assembly is operable to detect or measure a spatially resolved pressure profile applied across the sensing surface by a body part of a user.

[0037] The spatially resolved pressure profile and / or the change in time of such spatially resolved pressure profile may be indicative of a particular touch sequence or gesture performed by a user of the injection device.

[0038] In some examples, the processor is further operable to generate a variety of different control signals in response to respective electrical touch signals received from the contact-sensitive sensor segments, where the processor is operable to generate and / or transmit a first control signal upon receiving a first electrical touch signal. The processor may be further operable to generate and / or transmit a second control signal upon receiving a second electrical touch signal. The first control signal and the second control signal may be different from one another and, when received by the external electronic device, may result in a different operation or configuration of the external electronic device.

[0039] Thus, in some examples, the control signal sent to the external electronic device may indicate a pressure level applied to a single or multiple touch-sensitive sensor segments. In a further example, the control signal sent to the external electronic device may indicate a size of the sensing area contacting the user's body part. In a further example, the control signal sent to the external electronic device may indicate a position, movement and / or change over time of the sensing area contacting the user's body part. In a further example, the control signal may indicate a combination of the above-mentioned parameters, i.e. pressure level, size of the sensing area, and / or position and / or movement of the sensing area on the sensing surface.

[0040] In this way, a single sensing surface can generate and transmit multiple different control signals for processing by an external electronic device.

[0041] According to a further example, the processor is operable to assign the temporal changes of the electrical touch signal to one of a plurality of predefined user gestures. The processor is further operable to generate the control signal by selecting a control signal from the plurality of predefined control signals based on the user gesture assigned to the temporal changes of the electrical touch signal. In some examples, the processor may be operable to detect and / or distinguish between different user gestures.

[0042] In some examples, the processor may be operable to distinguish between a number of user gestures, such as a swipe across the sensing surface, a single tap on the sensing surface, and two or more taps on the sensing surface, etc. The processor may further be operable to distinguish between short taps on the sensing surface, e.g., taps lasting less than one second, and long taps on the sensing surface, e.g., taps lasting one or two seconds or more.

[0043] Furthermore, the processor may be operable to distinguish between a soft tap and a firm or hard tap on the sensing surface. In this way, the sensor assembly is configured to detect or recognize gestures of a body part of a user. By recognizing or detecting different user gestures by the touch-sensitive surface of the sensor assembly, it is possible to achieve significant space saving and an intuitive on-board remote control of the injection device, which is configured to control and / or interact with an external electronic device.

[0044] According to further examples, the processor is operable to recognize at least one of a swipe motion of the body part across the sensing surface, a short tap motion of the body part on the sensing surface, multiple short tap motions of the body part on the sensing surface, a long tap motion of the body part on the sensing surface, and a variable pressure applied to the sensing surface by the body part, which motions may represent a single gesture or multiple gestures made by the user's body part on or at the sensing surface.

[0045] In a further example, the processor may distinguish between different gestures performed on the sensing surface by the body parts. Each of the above-mentioned gestures may be defined by a spatial and / or temporal profile of the electrical touch signals generated by one or more contact-sensitive sensor segments. The above-mentioned gestures may be defined by a reference profile of the electrical touch signals, for example, stored in a memory of the sensor assembly.

[0046] In a recognition or sensing mode of the sensor assembly, electrical touch signals obtained from the contact-sensitive sensor segments may be compared to stored reference profiles. Here, the processor may perform a best match comparison to assign one of the stored reference profiles to a profile generated or derived based on an actual measured or detected electrical touch signal. The reference profile assigned to the profile of the actual measured electrical touch signal may then be indicative of a gesture made by a body part of a user on a sensing surface. A control signal generated by the processor and transmitted to an external electronic device may be indicative of a gesture identified or detected by the processor of the sensor assembly.

[0047] According to a further example, the processor is operable to process the electrical touch signals of the many contact-sensitive sensor segments to ascertain a sensing area of ​​the sensing surface touched by the body part. Typically, when using a finger as the body part to touch the sensing surface of the sensor element, each contact-sensitive sensor segment can detect the pressure applied by the respective body part. In this way, all contact-sensitive sensor segments that mechanically contact the body part, for example during or due to operation of the injection device, can generate a respective electrical touch signal.

[0048] By simultaneously processing the signals of the touch-sensitive sensor segments, the processor may provide or identify sensing areas on the sensing surface that actually touch or mechanically contact a body part of a user. In this manner, the processor is operable to detect whether a body part is actually touching a central or border region of the sensing surface.

[0049] Additionally, the processor may be operable to detect or measure the size of the sensing area. By identifying or identifying the sensing area of ​​the sensing surface that is actually touched or in mechanical contact with the user's body part, the sensor assembly provides fairly accurate, spatially resolved monitoring of how the user's body part touches the sensor element.

[0050] According to a further example, the processor is operable to detect a movement of the sensing area on the sensing surface. Here, the processor may detect, for example, a swipe motion of a finger across the sensing surface. In a further situation, the user's own body part may move during operation of the injection device, for example during setting of a dose or during injection of a dose, and for example the movement of the body part relative to the housing of the injection device may be accompanied by a measurable movement of the body part relative to the sensor element and thus the sensing surface. Here, the user's body part, for example a finger or thumb, may perform a milling motion or naturally roll during operation of the injection device.

[0051] Such movement of the body part relative to the sensor element may result in a movement of a sensing area on the sensing surface that the body part touches. The movement of the body part relative to the sensor element may induce activation and deactivation of multiple touch-sensitive sensor segments spatially distributed across the sensing surface of the sensor element, resulting in a measurable change in the change in the electrical touch signal and a respective change in the sensing area that can be measured by a processor.

[0052] By evaluating and processing the electrical touch signals generated by the contact-sensitive sensor segments during each operation of the injection device, the processor recognizes or characterizes a particular operation of the injection device, where the sensor assembly, and therefore the processor, may be operable to distinguish between different operation modes of the injection device by evaluating measurable movements of the sensing areas on the sensing surface.

[0053] According to a further example, the processor of the sensor assembly is operable to detect a change in the size of the sensing area on the sensing surface. The change in the size of the sensing area may be due to a change in pressure applied by the body part to the sensor element. Since the body part may include a certain elasticity and may even include a significantly convex structure or surface facing outwards, by increasing the pressure applied by the body part to the sensor element, the proportion of the body part in direct contact with the sensing surface may increase, for example due to elastic deformation of the body part. This may increase the size of the sensing area on the sensing surface.

[0054] Thus, detection of a change in the size of the sensing area during operation of the injection device may indicate a change in pressure applied to the sensor element by the user. In some examples, the size change measurable by the processor and the change in type, magnitude, amplitude, sign, or frequency of the electrical touch signal generated by the contact-sensitive sensor segment may be processed in combination. To that extent, a change in pressure applied to the sensor element by the body part may be detected by a change in the size of the sensing area simultaneously with a change in the electrical touch signal generated by the pressure-sensitive sensor segment and the contact-sensitive sensor segment.

[0055] Here, the change in pressure applied by the body part may be doubly monitored or detected: thus, the change in pressure applied to the sensor element may be measured or determined in at least two different ways, thereby enhancing or providing redundancy in the measurement system provided by the sensor assembly.

[0056] According to further examples, the processor is operable to detect a change in geometry and / or to detect a change in orientation of the sensing area on the sensing surface. In this way, further operational modes can be detected and evaluated in which a body part of the user moves or changes relative to the sensor elements during said operational modes. A change in geometry or orientation of the sensing area on the sensing surface, typically detected by a respective change in the electrical touch signals generated by the many contact-sensitive sensor segments, may further indicate a particular scenario of use of the injection device.

[0057] By electronically detecting and / or electronically and quantitatively measuring at least one of a movement of the sensing area, a change in size, a change in geometry, and / or a change in orientation of the sensing area on the sensing surface, the sensor assembly is operable to detect, recognize, characterize, and / or measure different operations and operation modes of the injection device. The sensor assembly may further be operable to detect, recognize, characterize, and / or measure different control actions or gestures made by a body part of the user on or relative to the sensing surface.

[0058] According to a further example, the sensor element includes a planar sensing surface configured to fasten to an end face of a trigger of an injection device. The planar sensing surface may include a number of contact-sensitive sensor segments located adjacent to one another on the planar sensing surface. In some examples, the entire planar sensing surface may be filled or occupied by the adjacently arranged sensor segments. To that extent, the entire planar sensing surface may be implemented as a contact-sensitive surface of the sensor element.

[0059] The planar sensing surface may cover the entire end face of the trigger of the injection device. Typically, the trigger is configured to be depressed by a user's finger to initiate and / or control an injection procedure performed by the injection device. By affixing or attaching the planar sensing surface to the depressible end face of the trigger, the sensor element, and thus the entire sensor assembly, may be incorporated into the trigger of the injection device.

[0060] By locating the sensing surface on an end face of the trigger of the injection device, the sensing surface is easily accessible, for example, to the thumb of a user's hand holding the injection device while the external electronic device may be held in the user's other hand. If the sensor assembly is implemented as a kind of remote control for the external electronic device, the user may easily provide respective control commands to the external electronic device by sending control signals to the external electronic device via the transmitter.

[0061] In another example, the planar sensing surface may be configured to fasten to an end surface of an auxiliary trigger of an add-on device configured to fasten to the injection device. The auxiliary trigger may mimic the trigger of the injection device and may operably engage with the trigger of the injection device when the add-on device is attached or fastened to the injection device. Here, the auxiliary trigger may replace or replace the function of the original trigger of the injection device.

[0062] The add-on device may cover a trigger section of the injection device. The auxiliary trigger may be in direct or indirect operative engagement with the trigger of the injection device such that depressing or actuating the auxiliary trigger of the add-on device actuates or presses, respectively, the trigger of the injection device. Depending on the implementation of the sensor assembly on or within the add-on device, a planar sensing surface may be fastened or incorporated into an end face of such auxiliary trigger of the add-on device.

[0063] In some examples, the planar sensing surface may be incorporated into an end face of the trigger or auxiliary trigger. The planar sensing surface may be fastened to or incorporated into the end face of the trigger. Attaching or incorporating a planar sensing surface to the end face of the trigger may provide a fairly integrated solution for mounting or incorporating a sensor assembly in or on an injection device or in an add-on device.

[0064] According to a further example, the sensor element comprises a tubular sensing surface configured to fasten to a tubular member of the injection device. In this example, the sensor element may be configured to surround or at least partially surround a tubular structure or member of the injection device, such as a dose dial or a housing component of the injection device.

[0065] In some examples, the tubular sensing surface of the sensor element is configured to surround the outer surface of a tubular dose dial of the injection device. The dose dial can be used by a user to set individual size doses of the injection device by rotating the dose dial relative to the body or housing of the injection device in either a dose increment direction or a dose decrement direction. By having the tubular sensing surface mounted or integrated on the outside of the dose dial, such a dose dial setting procedure can be accurately detected, recognized, characterized, or even quantitatively measured by the sensor assembly.

[0066] In another example, the tubular sensing surface can be attached or fixed to an outer surface of a tubular housing component of the injection device, which can be held by the hand, e.g. the palm or multiple fingers, of a user of the injection device for preparation and / or execution of a dose injection procedure. Again, by having a sensor element on the outer surface of the tubular body or housing of the injection device, user-induced handling or movements of the injection device can be accurately detected, characterized, recognized or measured.

[0067] Also, the sensor element provided on the outer surface of the tubular body or housing of the injection device is easily accessible, for example by the fingers or thumb of the user's hand holding the injection device. By touching and / or swiping the sensing surface, the user can generate and trigger the transmission of a control signal to an external electronic device.

[0068] According to a further example, the sensor element includes a planar sensing surface and further includes a tubular sensing surface. The sensor element may include a cup-like structure including a planar sensing surface at a longitudinal end adjacent to the tubular sensing surface forming a sidewall of the cup-like sensor element. Such a sensor element may be operable or configured to attach to a dose member of an injection device, the dose member being implemented as a combined dose dial and trigger, where by rotating the dose member a variable size dose may be set and by depressing the dose member the injection process may be triggered and / or controlled.

[0069] According to a further example, the sensor element comprises a flexible sheet configured to wrap around a tubular member of the injection device. The sensor element may comprise a planar substrate made of the flexible sheet, e.g. made of a flexible foil. The planar substrate may be flexible and / or foldable or wrapable into a tubular shape.

[0070] A flexible sheet or substrate may be provided with multiple contact-sensitive sensor segments. The soft or flexible sheet may be wrapped around a tubular member of an injection device. The flexible sheet of sensor elements and the contact-sensitive sensor segments attached or mounted to the flexible sheet allow the sensor elements to be used with a wide variety of different sized tubular members of injection devices.

[0071] The sensor element may be universally applicable to tubular members of different sizes. The flexible sheet may make the entire sensor element flexible and easily fixable to the tubular member of the injection device. The flexible sheet may be adhesively attached to the outer surface of the tubular member and may provide a spatially resolved contact sensing area on the outside of the tubular member, for example on the outside of the housing of the injection device.

[0072] The same flexible sheet may also be applied to an attachment device, which may comprise a tubular member, for example for fastening or clamping around the housing of an injection device.

[0073] According to a further example, the tubular member of the injection device is a dose dial rotatable relative to the body of the injection device for setting a dose. By attaching a flexible sensor element to the dose dial, a dose dialing or dose setting action performed by a user of the injection device, and thereby a rotation of the dose dial relative to the body or housing of the injection device, can be detected, recognized, characterised or quantitatively measured by the sensor assembly.

[0074] According to further examples, the tubular member is a body of an injection device. In some examples, the body of the injection device includes an elongated tubular sleeve. The body may be sized to accommodate a drive mechanism for expelling or drawing a dose of medicament from the medicament container. In some examples, the medicament or medicament container may also be disposed inside the body or housing of the injection device, for example implemented as a syringe or cartridge containing a liquid medicament.

[0075] According to a further example, the tubular member is a clip configured for releasably fastening to the injection device, where the tubular member may be implemented as part of an add-on device configured for fastening to a housing of the injection device.

[0076] According to a further example, the processor of the sensor assembly is operable to detect, recognize, characterize, and / or measure the operation of the injection device based on the temporal changes of the electrical touch signal. The processor is further operable to generate a control signal by selecting one of many predefined control signals indicative of the detected, recognized, characterized, and / or measured operation of the injection device. In this example, it is particularly advantageous if the sensor assembly, and thus the sensor element, is attached to an operational element of the injection device, such as a dose dial, a trigger, and / or a housing of the injection device. The operational element is typically activated or operated by the user to perform or trigger a specific device operation, such as setting a dose, dispensing or injecting a dose, and / or maintaining the injection device in an end state of a dose configuration, such as the injection needle remaining in the skin for a predefined time interval after the end of the injection procedure.

[0077] To that extent, the processor may be operable to detect one of a dose setting operation of the injection device, a dose dispensing operation of the injection device, and a holding operation of the injection device by processing a number of electrical touch signals of a number of contact-sensitive sensor segments over time, for example when the sensor element is attached to the injection device or the sensor element is indirectly attached to the injection device by an auxiliary or additional device configured to fasten to the injection device.

[0078] The dosing operation, e.g., the start, duration, and / or end of the dosing operation, can be detected, recognized, or characterized by processing an electrical touch signal generated or modified by a contact-sensitive sensor segment of a sensing surface, which may typically be provided on an end face of the trigger of the injection device or on a respective end face of an auxiliary trigger of an add-on device.

[0079] Furthermore, the end of the dose holding operation of the injection device, i.e. the period during which the user should apply and maintain a certain pressure on the trigger of the injection device after the end of the dose injection procedure, can be precisely monitored, where the electrical touch signals generated or modified by the multiple contact-sensitive sensor segments during the holding operation at the end of the dose injection procedure should be more or less constant.

[0080] According to a further example, the processor is operable to distinguish between end of a dose setting, dose dispensing and dose holding operation of the injection device by processing a number of electrical touch signals of a number of contact-sensitive sensor segments over time when the sensor element is attached to the injection device or the add-on device, which is itself then attached to the injection device. Each operation mode of the injection device can be characterized by a temporal and / or spatial profile of the number of contact-sensitive sensor segments touched by the user's body part during the respective operation mode.

[0081] By evaluating such temporal and / or spatial profiles measurable by the sensor assembly, the sensor assembly is operable and becomes operable to automatically distinguish between different operation modes of the injection device. To that extent, the sensor assembly can be provided with automatic operation mode detection of the injection device, which simplifies the use of the sensor assembly and increases the accuracy of continuous injection monitoring or injection logging over time.

[0082] According to a further example, the sensor assembly includes a clock or clock generator connected to the processor. In this way, the processor is operable to detect or measure the time when a user operates the injection device and / or the duration for which the user operates the injection device. By providing a clock in the processor, the processor can detect or log each time or duration that it detects a change in a particular electrical touch signal or sensing area indicating, for example, the start or end of a dose setting and / or dose dispensing operation.

[0083] According to a further example, the sensor assembly includes a memory connected or coupled to a processor. The processor is operable to store usage related data in the memory, the usage related data including at least one of the time when the injection device was operated, the duration for which the device was operated, and the size of the dose of medication set or injected by the injection device. All these parameters, time, duration, and dose size information can be derived from changes in the electrical touch signal or based on changes in the sensing area detectable by the processor connected to the sensor element.

[0084] By way of further example, the processor, clock, and memory may be operable to automatically store or automatically monitor and / or log a sequence of user-induced actions of the injection device simply by detecting or measuring changes in the electrical touch signal or changes in the sensing area of ​​the sensor element.

[0085] According to a further example, the processor may be provided with a wake-up function, where the processor may automatically switch to a sleep mode, for example when it determines that the sensor element and its sensing surface have not been touched for a predefined time interval. Upon detecting an initial contact with the sensing surface of the sensor element, the processor may switch to a wake-up mode and may wake up accordingly. By providing the processor with a sleep function, energy supplied to the sensor assembly may be saved. Thus, the battery life of the sensor assembly may be extended accordingly.

[0086] According to a further example, the sensor assembly includes a power source, for example in the form of a power source, such as a battery.

[0087] In a further example, the transmitter of the sensor assembly includes a transceiver. The transceiver may be operable to communicate bidirectionally with the external electronic device. The transceiver may provide for transmitting control signals to the external electronic device and receiving signals from the external electronic device. Thus, the sensor assembly may receive, for example, a request signal from the external electronic device, which request signal is provided to and processed by the processor. In response to receiving the request signal, the processor may generate a specific control signal and transmit the control signal to the external electronic device in response to the request signal.

[0088] The transmitter and / or transceiver may be implemented as a wireless transceiver. The transceiver may be operable to establish a communication link with an external electronic device. In some examples, the transceiver may be operable to harvest energy from the external electronic device. To that extent, the transceiver may also serve as a type of power source to provide power to the sensor assembly.

[0089] According to a further example, the sensor assembly includes a signal generator. The signal generator may be implemented as one of a visual signal generator, an acoustic signal generator, or a tactile signal generator. Via the signal generator, the sensor assembly may be operable to directly communicate with a user of the injection device. In this way, the sensor assembly may provide a confirmation or similar feedback to the user, thereby indicating, for example, that a particular user-induced action of the injection device is being monitored or is not being monitored correctly. Furthermore, the signal generator may indicate recognition of a gesture of the user's body part on the sensing surface. The signal generator may be operable to provide and / or generate visual signals of different colors and / or different and varying durations.

[0090] In other examples, the signal generator may be operable to generate an acoustic signal, such as an audible tone, where the signal generator may be operable to provide distinct, identifiable sound signals, for example, indicative of successful or unsuccessful detection or measurement of a user-induced action or gesture.

[0091] A tactilely implemented signal generator may be configured to generate a vibration that is tangible, eg, detectable, by a user.

[0092] In a further example, the sensor assembly may include a reminder function, where the memory of the sensor assembly may be provided with a predetermined dosing schedule for a particular patient, and thus, when an injection is scheduled, the processor may prompt the signal generator to generate a user-perceptible signal, thereby reminding the user to perform or execute the injection procedure.

[0093] In a further example, the sensor assembly includes a position sensor and / or an acceleration sensor. The position sensor may be incorporated into the sensor assembly or may be incorporated into the injection device. The position sensor may be operatively connected to a component of a drive mechanism of the injection device that indicates the size of the currently set or dispensed dose. Furthermore, the position and / or orientation of the position sensor may indicate the amount of medicament provided in the cartridge. In this way, the position sensor may provide quantitative data indicative of the size of the dose.

[0094] In a further example, if an acceleration sensor is provided, the sensor assembly may further detect or measure a particular movement or acceleration of the sensor assembly, e.g. indicative of a particular gesture made by a user while holding the sensor assembly. By means of the acceleration sensor, an operation mode of the injection device may be detected accordingly. In some examples, the processor may be operable to generate a control signal and transmit the control signal to an external electronic device upon receiving a characteristic, e.g. gesture-specific, signal from the acceleration sensor.

[0095] Via the transceiver, the sensor assembly may exchange measurement data with an external electronic device. The memory of the sensor assembly is typically configured to store use-related data of the injection device. Upon establishing a communication link with the external electronic device, the sensor assembly, and thus the memory of the sensor assembly, may be synchronized with the external electronic device, which may provide for further processing of the data and / or transmission of the data, for example to a healthcare provider.

[0096] In some examples, the sensor assembly may be provided with a display operable, for example, to visually show application-specific or user-specific information to a user of the injection device. The display may be implemented in the sensor element. To that extent, the sensor element may be implemented as a touch-sensitive display.

[0097] Here, the touch-sensitive sensor segments may represent individual pixels of a touch-sensitive display. The touch-sensitive sensor segments may coincide with pixels of the touch-sensitive display.

[0098] The sensor element, in particular its sensing surface, may for example be provided with a reconfigurable electronic display operable to provide visual content to a user of the add-on device or the injection device, respectively. To that extent, the sensor element and the sensor assembly provide a dual function: they are operable to receive input from a user and to provide information to the user.

[0099] In some examples, the sensor assembly may be operable to provide a visual indication to the sensing surface, such as the number of doses actually set or the number of doses to be set. The sensor assembly may support the patient during setting of the dose and during injection of the dose. The sensor assembly, and in particular its touch-sensitive display, may be operable to provide visual symbols, numbers and / or text to guide and / or assist a user in using the add-on device or the injection device.

[0100] The touch-sensitive display of the sensor assembly may further provide instructions to the user, such as to set a dose, inject a dose, confirm an injection, transmit data between the attachment device and an external electronic device, and / or notify the user when the next injection is scheduled.

[0101] Additionally, the touch-sensitive display may be operable to visually indicate a particular portion on the sensitive surface that a user should touch.

[0102] The touch-sensitive display may provide static and dynamic information. In some examples, the touch-sensitive display of the sensor assembly may be operable to dynamically and visually indicate the movement of a user's finger across the sensing surface of the sensor assembly, where the user may be guided on how to touch, tip, or even swipe the sensing surface of the sensor element.

[0103] In another aspect, the present disclosure also relates to an injection device for injecting a dose of a medicament. The injection device includes a body for housing a drive mechanism operable to draw or expel a medicament from a medicament container. Typically, the drive mechanism is operable to inject or expel a dose of the medicament from the medicament container. The injection device further includes at least one of a dose dial and a trigger operable by a user for injecting and / or setting the dose.

[0104] The injection device further includes a sensor assembly as described above. The sensor assembly is attached to or incorporated into at least one of the body, the dose dial, and the trigger of the injection device. By attaching or incorporating a sensor assembly to at least one of the body, the dose dial, and the trigger, a fairly accurate and semi-automated detection, recognition, characterization, and measurement of user-induced actions of the injection device and / or gestures performed by body parts of the user may be provided.

[0105] In addition, the functionality of the injection device can be expanded by attaching or incorporating a sensor assembly to the injection device. If the sensor assembly is implemented as a kind of remote control for an external electronic device, the user's gestures can be detected and transmitted to the external electronic device in the form of a dedicated or distinct control signal. Placing or incorporating a sensor assembly on at least one of the trigger, the dose dial, and the housing of the injection device is beneficial to provide an easy and intuitive availability for the user to generate a control signal or a feedback signal to the external electronic device. The control signal to the external electronic device, and thus the remote control, can be generated and transmitted, for example, by one finger of the hand holding the injection device.

[0106] The injection device may be implemented as a pen-type injector. The injection device may be implemented as a disposable injection device or as a reusable injection device. In some examples, the injection device may include a dial extension that is moved longitudinally and rotationally or helically during dose setting and slid at least longitudinally during dose injection. In other examples, the injection device does not have a so-called dial extension. Here, the dose dial and / or the trigger may be provided, for example, at the proximal end of the housing of the injection device. For example, a dose member in the form of a combined dose dial and trigger may be rotatable relative to the body or housing of the injection device for setting the dose and may be depressable, for example, by the thumb of the user, for injecting the dose.

[0107] In some other examples, the injection device is implemented as a so-called autoinjector, where the user can simply hold the body of the injection device and press the body and thus the distal end of the injection device against a portion of the skin, thereby triggering a largely automated injection procedure, during which the injection needle is pushed into the skin and then the dose of the medication is dispensed or injected.

[0108] According to a further aspect, the present disclosure also relates to an add-on device configured to fasten to an injection device. The add-on device includes a device body and a fastener for fastening the device body to at least one of the body, the dose dial, and the trigger of the injection device. The add-on device includes a sensor assembly as described above. To that extent, all functions of the sensor assembly may be incorporated into the add-on device. Typically, when properly attached to the injection device, the add-on device provides dose setting and / or injection, for example by providing or including at least one of an auxiliary dose dial and / or an auxiliary trigger operably engageable with the dose dial and / or the trigger of the injection device when the add-on device is properly assembled or attached to the injection device.

[0109] To that extent, all the features, advantages and benefits described above in relation to the sensor assembly apply equally to the injection device and the add-on device, respectively, and in particular, all the advantages, features and benefits described above in relation to the injection device apply equally to the add-on device, especially when the add-on device is properly attached, for example, to the dose dial of the injection device.

[0110] According to a further aspect, the present disclosure also relates to an injection system including an electronic device and an injection device. The electronic device, shown as an external electronic device, is located at a location remote from the injection device. The electronic device may be implemented as a portable external electronic device. The electronic device may include one of a smartphone, a smartwatch, a fitness tracker, or a tablet computer. In some examples, the electronic device may be implemented as a mobile computer, such as a laptop computer, or a non-mobile computer, such as a desktop computer.

[0111] An injection system typically includes an injection device as described above. The external electronic device includes a user interface for communicating with a user of the injection device. The external electronic device further includes a device processor connected to the user interface. The device processor is further operable to provide at least one of an indication and a user instruction to the user via the user interface. The electronic device further includes a device transceiver configured to receive a control signal from a transmitter of a sensor assembly of the injection device.

[0112] Here, the device transceiver of the external electronic device is configured to receive control signals generated by the sensor assembly of the injection device and transmitted by the transmitter of the sensor assembly to the electronic device, and the sensor assembly may act as a kind of remote control for the external electronic device and provide a kind of remote control.

[0113] The implementation of the sensor assembly of the injection device as a kind of remote control for the external electronic device is particularly beneficial when the sensor assembly is attached to or integrated into a component or part of the injection device that is easily accessible, for example, by the thumb or by the fingers of the user's hand that actually holds the injection device. In this way, the external electronic device can provide user interaction to assist the user in properly handling or preparing the injection device. The user can easily respond to requests of the external electronic device with the hand that actually holds the injection device. In particular, the user can hold the external electronic device in one hand and the injection device in the other hand.

[0114] When initiating an interaction with an external electronic device, the user simply touches the sensing surface of the sensor element provided on the injection device, rather than directly interacting with the external electronic device. Thus, providing or mounting the sensor assembly directly on the injection device increases user acceptance and simplifies auxiliary use of the injection device.

[0115] An injection system typically utilizes an injection device as described above. In some examples, the injection system may be implemented with an injection device without the sensor assembly described above. Here, the injection device may include an add-on device, which is provided with a sensor assembly as described above. To that extent, all of the advantages, features, and benefits as described above in relation to the sensor assembly, the injection device, and the add-on device apply equally to the injection system.

[0116] Moreover, since the external electronic device includes a device processor, it is also contemplated that at least some or substantially all of the functions of the processor of the sensor assembly may be transferred to the device processor of the external electronic device. In one example, the processor of the sensor assembly may be limited to simply recording the electrical touch signals generated by the touch-sensitive sensor segments over time and transmitting the raw or pre-processed electrical touch signals as control signals to the external electronic device via the transmitter. Further processing of the electrical touch signals or control signals received from the sensor assembly may then be performed by the device processor of the external electronic device. In this manner, the computational demands on the processor of the sensor assembly may be minimized, thereby reducing production and manufacturing costs of the sensor assembly.

[0117] In effect, in some examples, the device processor of the external electronic device may be operable to assign temporal changes in the electrical touch signal to one of a plurality of predefined user gestures and further process such user gesture. Additionally, the device processor of the external electronic device may be operable to detect, recognize, characterize, and / or measure motion of the injection device based on temporal changes in the electrical touch signal detected by one or more contact-sensitive sensor segments of the sensing surface, the electrical touch signal being further transmitted from the sensor assembly to the external electronic device via the transmitter.

[0118] To that extent, all of the features, benefits, and advantages discussed above in relation to the processor of the sensor assembly may be equally applied to the device processor of the external electronic device.

[0119] According to another aspect, the present disclosure further relates to a method of assisting a user in using an injection device by utilizing an injection system, the injection system typically including an injection system as described above. The injection system includes an external electronic device and an injection device. In some examples, the injection system includes the external electronic device, the injection device, and an add-on device configured to fasten to the injection device. In some examples, at least one of the injection device and the add-on device is provided with a sensor assembly as described above.

[0120] The method includes prompting a user to operate the injection device via a user interface of the external electronic device. For example, the user interface of the external electronic device may include a display. An indication to the user may appear on the display prompting the user to set a dose of a predetermined size.

[0121] The user simply needs to confirm the indication provided by the user interface, for example by tapping or otherwise touching a sensitive surface of a sensor element attached to the injection device.

[0122] To this end, the method includes detecting a change over time in an electrical touch signal caused by a user touching a sensing surface of a sensor element of a sensor assembly of the injection device. In response to detecting the change in the electrical touch signal, a control signal is generated. The control signal is then transmitted to the external electronic device via a transmitter of the sensor assembly. Typically, the control signal, transmitted, for example wirelessly, to the external electronic device is received by a transceiver of the external electronic device and further processed by a device processor of the external electronic device.

[0123] In this way, a sensor assembly attached to or incorporated in the injection device can be used as a kind of remote control, for example to wirelessly transmit control signals to an external electronic device, which can be particularly useful and beneficial in situations where the user is already holding the injection device in the palm of one hand.

[0124] In an optional and further method step, it is further contemplated that the external electronic device provides further information or indication to the user after receiving the control signal from the sensor assembly. The user may then perform another or further device action and may confirm the execution of such a device action, for example, by touching a sensing surface of a sensor element of a sensor assembly attached to or incorporated in the injection device.

[0125] In this way, the external electronic device may provide assistance to the user for performing individual steps, e.g., setting a dose and / or injecting a dose. The user may see control signals or commands or return control signals or commands to the external electronic device while still holding the injection device in his / her hand. Since the sensor assembly is part of the injection device and easily accessible by the fingers of the user's hand that actually holds the injection device, communication and / or signal or data exchange between the user and the external electronic device may be simplified.

[0126] According to a further aspect, the present disclosure also relates to a computer program comprising computer readable instructions that, when executed by one or multiple processors of an injection system as described above, cause the processor to, for example, prompt a user via a user interface of an external electronic device to operate the injection device, detect changes over time in an electrical touch signal caused by a user touching a sensing surface of a sensor element of a sensor assembly of the injection device, generate a control signal based on the changes over time in the electrical touch signal, and transmit the control signal to the external electronic device via a transmitter of the sensor assembly.

[0127] Typically, the computer program is configured to implement the method of assisting a user in using the injection device as described above. The computer program or parts thereof are configured to be executed by the processor of the sensor assembly and / or by a device processor of the external electronic device. To that extent, the computer program may include a first software application and a second software application, one of which is implemented and executed by the processor of the sensor assembly and the other of which is implemented and executed by the device processor of the external electronic device.

[0128] The present disclosure further discloses and proposes a computer program comprising computer executable instructions for performing the method according to the disclosed method / device / system in one or more of the examples contained herein when the program is executed on a processor, computer, or computer network. In particular, the computer program may be stored in a computer readable data carrier. Thus, in particular, one, more than one, or even all of the method steps as shown above may be performed using a computer or computer network, typically using a computer program.

[0129] The present disclosure further discloses and proposes a computer program product having program code means for performing the method according to the disclosed method / system in one or more of the embodiments contained herein when the program is executed on a computer or computer network. In particular, the program code means may be stored on a computer readable data carrier.

[0130] Furthermore, the present disclosure discloses and proposes a data carrier having stored thereon a data structure which, after being loaded into a processor, computer or computer network, e.g. a working memory or main memory of a processor, computer or computer network, can execute a method according to one or more of the examples disclosed herein.

[0131] The present disclosure further proposes and discloses a computer program product having program code means stored in a machine-readable carrier for performing a method or part thereof according to one or more of the examples disclosed herein when the program is executed on a processor, computer, or computer network. As used herein, a computer program product refers to a program as a tradeable product. The product may generally be in any form, such as in paper form, or on a computer-readable data carrier. In particular, the computer program product may be distributed over a data network.

[0132] In another example, the present disclosure proposes and discloses a modulated data signal that includes instructions readable by a processor, computer system, or computer network for performing at least a portion of a method according to one or more of the examples disclosed herein. Preferably, with reference to computer-implemented aspects of the present disclosure, one or more of the method steps of the method according to one or more of the examples disclosed herein, or even all of the method steps, can be performed using a processor, computer, or computer network. Thus, generally, any of the method steps including data collection, provision, and / or manipulation can be performed using a processor, computer, or computer network. Generally, these method steps can include any of those method steps, except for those method steps that typically require manual labor, such as providing a sample, and / or certain aspects of performing the actual measurement.

[0133] In particular, the present disclosure further discloses a computer or computer network including at least one processor, the processor adapted to perform a method according to one of the examples described herein, and a computer-loadable data structure adapted to perform a method according to one of the examples described herein while the data structure is running on the processor, the computer, a computer program, the computer program adapted to perform a method according to one of the embodiments described herein while the program is running on the computer.

[0134] Generally, the scope of the present disclosure is defined by the contents of the claims. The present disclosure is not limited to specific embodiments or examples, but includes any combination of elements of different embodiments or examples. To that extent, the present disclosure covers any combination of the claims and any technically feasible combination of features disclosed in relation to different examples or embodiments.

[0135] In the present context, the term "distal" or "distal end" refers to the end of the injection device that points towards the injection site of a person or animal. The term "proximal" or "proximal end" refers to the opposite end of the injection device that is furthest from the injection site of a person or animal.

[0136] The terms "drug" or "medicament" are used synonymously herein to refer to a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharma- ceutically acceptable salts or solvates thereof, and, optionally, a pharma- ceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in the broadest sense, is a chemical structure that exerts a biological effect on humans or animals. In pharmacology, drugs or agents are used to treat, cure, prevent, or diagnose disease, or to otherwise improve physical or mental health. Drugs or agents may be used for a limited duration or periodically for chronic diseases.

[0137] As described below, drugs or agents can include at least one API or combinations thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs can include small molecules with molecular weights of 500 Da or less, polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, 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 can be incorporated into molecular delivery systems such as vectors, plasmids or liposomes. Mixtures of one or more drugs are also contemplated.

[0138] The drug or agent may be contained within a primary package or "drug container" adapted for use with a drug delivery device. The drug container may be, for example, a cartridge, a syringe, a reservoir, or other sturdy or flexible vessel configured to provide a suitable chamber for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber may be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber may be designed to store the drug for about one month to about two years. Storage may be at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., about -4°C to about 4°C). In some cases, the drug container may be or include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent or two different drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during administration into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with one another (e.g., by a conduit between the two chambers) and may allow a user to mix the two components if desired prior to administration. Alternatively or additionally, the two chambers may be configured to allow mixing upon administration of the components into the human or animal body.

[0139] The drugs or agents contained in the drug delivery device as described herein can be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes mellitus or complications associated with diabetes mellitus, such as diabetic retinopathy, thromboembolism, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders include 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 listed in handbooks such as the Rote Liste 2014, for example, but not limited to, main groups 12 (antidiabetic drugs) or 86 (oncology drugs) and the Merck Index, 15th edition.

[0140] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include insulin, e.g. human insulin or a human insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or a GLP-1 receptor agonist or an analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor or a pharma- ceutically acceptable salt or solvate thereof or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g. the structure of human insulin, by deletion and / or replacement of at least one amino acid residue present in the naturally occurring peptide and / or addition of at least one amino acid residue. The added and / or replaced amino acid residues can be either codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from that of a naturally occurring peptide, such as the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide may be deleted and / or substituted by other amino acids, including non-codable amino acids, or amino acids, including non-codable amino acids, may be added to the naturally occurring peptide.

[0141] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline in position B28 can be replaced by Asp, Lys, Leu, Val or Ala and in position B29 Lys can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0142] Examples of insulin derivatives are e.g. B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl-LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin. B29-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0143] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flatfish), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C (efpegrenatide), HM-15211, C M-3, GLP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexene, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, Z P-3022, ZP-DI-70, TT-401 (pegapamoditide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, tirzepatide (LY3298176), bamadutide (SAR425899), exenatide-XTEN and glucagon-Xten.

[0144] Examples of oligonucleotides are, for example, mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport syndrome. Examples of DPP4 inhibitors are linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0145] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides such as gonadotropins (folitropin, lutropin, chorionic gonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadorelin, tryptorelin, leuprorelin, buserelin, nafarelin and goserelin, and antagonists thereof.

[0146] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or ultra-low molecular weight heparin, or derivatives thereof, or sulfated polysaccharides, such as poly-sulfated forms of the above polysaccharides, and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of poly-sulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc (registered trademark)), sodium hyaluronate.

[0147] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind to an antigen. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., mouse) antibodies, or single-chain antibodies. In some embodiments, the antibody has effector functions and can fix complement. In some embodiments, the antibody has reduced or no ability to bind to an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or a mutant that does not assist in binding to an Fc receptor, e.g., having a mutation or deletion in the Fc receptor-binding region. The term "antibody" also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable domain antibody-like binding proteins having a crossover binding region orientation (CODV).

[0148] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to an antigen. An antibody fragment may include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0149] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences in the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences in the variable regions of both heavy and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the proper arrangement of the CDR sequences to allow antigen binding. Although the framework region itself typically does not directly participate in antigen binding, as is known in the art, certain residues in the framework region of a particular antibody can directly participate in antigen binding or affect the ability of one or more amino acids in the CDR to interact with the antigen. 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).

[0150] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use with the drug or medicament in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0151] It will be understood by those skilled in the art that modifications (addition and / or deletions) may be made to the various components of the APIs, formulations, devices, methods, systems and embodiments described herein without departing from the full scope and spirit of the invention, and that the invention encompasses such modifications and any and all equivalents thereof.

[0152] Exemplary drug delivery devices may include needle-based injection systems as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems may be broadly divided into multi-dose container systems and single-dose (partial or full discharge) container systems. The container may be a replaceable container or may be an integrated non-replaceable container.

[0153] As further described in ISO 11608-1:2014(E), a multi-dose container system may include a needle-based injection device with replaceable containers. In such systems, each container holds multiple doses and the size may be fixed or variable (pre-set by the user). Other multi-dose container systems may include a needle-based injection device with integrated non-replaceable containers. In such systems, each container holds multiple doses and the size may be fixed or variable (pre-set by the user).

[0154] As further described in ISO 11608-1:2014(E), the single-dose container system may include a needle-based injection device with a replaceable container. In one example of such a system, each container holds a single dose, which expels the entire deliverable amount (full expulsion). In a further example, each container holds a single dose, which expels a portion of the deliverable amount (partial expulsion). As also described in ISO 11608-1:2014(E), the single-dose container system may include a needle-based injection device with an integrated replaceable container. In one example of such a system, each container holds a single dose, which expels the entire deliverable amount (full expulsion). In a further example, each container holds a single dose, which expels a portion of the deliverable amount (partial expulsion).

[0155] In the following a number of examples of data logging devices for monitoring injection device usage and respective injection devices are described in more detail with reference to the drawings. [Brief description of the drawings]

[0156] [Figure 1] 1 illustrates a schematic diagram of an example of an injection device. [Diagram 2] 1 illustrates diagrammatically an attachment device configured for fastening to an injection device; [Diagram 3] 1A and 1B show schematic cross-sectional views of an example of an add-on device or a cross-sectional view of a portion of an injection device. [Figure 4] FIG. 1 shows a block diagram of an electronic module for implementing the sensor assembly. [Diagram 5] 1 illustrates a schematic perspective view of an example sensor assembly; [Figure 6] 6 shows the sensor assembly of FIG. 5 in side view. [Figure 7] 1 shows an example of a sensitive surface that has been lightly touched by a user's finger. [Figure 8] This shows the sensitive surface when firmly touched by the user's finger. [Figure 9]1 illustrates an example of a user using an injection device with a sensor assembly. [Figure 10] 1 shows the sensor assembly in the first stage of the dose dialing procedure. [Figure 11] 13 shows the sensor assembly in a second stage of the dose dialing procedure. [Figure 12] 1 shows an example of an external electronic device in a first stage to assist a user in using an injection device. [Figure 13] 1 shows an external electronic device in a second stage assisting a user. [Figure 14] 1 shows an external electronic device in a third stage assisting a user. [Figure 15] 1 shows an external electronic device in a fourth stage assisting a user. [Figure 16] 1 illustrates a first gesture made by a user's finger relative to a sensitive surface. [Figure 17] 17 shows the configuration of the sensing surface of the caster during energization according to FIG. 16. [Figure 18] 4 illustrates a second gesture of the user's finger relative to the sensitive surface. [Figure 19] 13 illustrates the configuration of the sensing surface during a second gesture. [Figure 20] 13 illustrates a user's finger performing a third gesture. [Figure 21] 13 illustrates the configuration of the sensing surface during a third gesture. [Figure 22] 1 illustrates a schematic diagram of an injection system including an external electronic device and an injection device. [Diagram 23] FIG. 2 shows a block diagram of an example of an external electronic device. [Figure 24] 1 shows a flowchart of a method for assisting a user in using an injection device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0157] FIG. 1 shows an example of a drug delivery device 1 implemented as a handheld injection device. The injection device 1 may include or be implemented as a pen injector. The injection device 1 may be implemented as a disposable injection device or as a reusable injection device. In some examples, the injection device 1 is implemented as an autoinjector. The injection device 1 has an elongated shape. The injection device 1 may extend along a longitudinal direction. The drug delivery device 1 includes a dosing end for dosing or injecting a medicament 24 in a longitudinal distal direction 2. The injection device 1 includes at least one of a dose member 8 and a trigger 9 in a proximal direction 3, by which equal or individual or different sized doses can be set and dispensed, respectively.

[0158] The injection device 1 includes a housing 10. The housing 10 may include a number of housing components, such as a body 6 and a cartridge holder 7. The body 6 may be sized and configured to accommodate a drive mechanism 20. The cartridge holder 7 is sized and configured to accommodate a drug container 21, implemented as a cartridge containing, for example, a liquid drug 24. The drug container 21 includes a tubular barrel 22 sealed towards its distal end by a seal 23. The seal 23 may include a pierceable septum secured to an outlet 25 of the drug container 21. At its proximal end, the interior of the barrel 22 is sealed by a piston 18 or stopper slidably disposed within the barrel 22.

[0159] By advancing the piston 18 in the distal direction 2, a dose of the medicament 24 can be expelled from the medicament container 21. In use, the medicament container 21 is disposed inside the cartridge holder 7. The drive mechanism 20 of the injection device 1 includes a piston rod 19, which is displaceable in the distal direction 2 to advance the piston 18 towards the outlet 25 of the medicament container 21. Details of the drive mechanism are not further shown and described here. In some examples, the drive mechanism 20 may be implemented as an all-mechanical drive mechanism, and the user must provide the entire dosing force required to move the piston rod 19, and thus the piston 18, in the distal direction 2. In other examples, the drive mechanism includes a mechanical energy store configured to provide at least a portion of the dosing force. Examples of drive mechanisms can be found, for example, in WO 2004 / 078241 A1, WO 2014 / 033197 A1, or WO 2014 / 033195 A1, the entireties of which are incorporated herein by reference.

[0160] 9 , the injection device 1, and thus the drive mechanism 20, may include a dial extension 27 that moves protrudingly in the proximal direction 3 from the proximal end of the body 6 at or during dose setting and returns to an initial distal end position during the dose injection procedure. To this end, a user may use the thumb 114 of their hand 110 to exert distally directed pressure on the trigger 9, thereby biasing the dial extension 27 in the distal direction 2 during the dose injection procedure.

[0161] To set or dial a dose, the user may twist or rotate the dose dial 8, for example in the dose increment direction 4, thus clockwise as viewed from the proximal end. To modify a previously set dose, the user may rotate the dose dial 8 in the opposite dose decrement direction 5. The size of the dose is typically indicated in a window 26 provided in or on the body 6 of the injection device 1. Before injecting a dose of medicament 24, the distal end of the cartridge holder 7 must be connected to the needle assembly 12. For this purpose, the distal end of the cartridge holder 7 includes a connector 11, for example in the form of a threaded interface for engaging with a complementary threaded counter interface of the needle assembly 12.

[0162] The needle assembly 12 is detachably or removably fastenable to the cartridge holder 7. The needle assembly 12 includes a double-ended injection needle 13. A proximal end (not shown) of the injection needle is configured to enter a through opening in a distal end face of the connector 11 or cartridge holder 7 to puncture or penetrate a seal 23 of the drug container 21. The distal end of the injection needle 13 is typically covered by a removable inner needle cap 14. The entire needle assembly 12 may be covered by a removable outer needle cap 15.

[0163] The cartridge holder 7 , and thus part of the housing 10 , is received within a protective cap 16 , which is removably connectable to the cartridge holder 7 or to the body 6 .

[0164] 2 and 3 show an example of an add-on device 30 configured to fasten to the proximal end of the injection device 1. The add-on device 30 includes a sensor assembly 80 with a sensor element 81 operable to detect, recognize, characterize and / or measure a motion of the injection device. The sensor assembly 80 may further be operable to detect and / or characterize a user gesture on a sensing surface 82, 83 of the sensor element 81 of the sensor assembly 80.

[0165] The attachment device 30 illustrated in Figures 2 and 3 is removably connectable to the dose dial 8. The attachment device 30 comprises a device body 60 with a tubular side wall 61. At a distal end, the side wall 61 defines a receptacle 63 sized to receive the dose dial 8 and trigger 9 of an injection device. To this end, the inside of the side wall 60 may include one or multiple fastening ribs 31 configured to provide a slip-free fastening of the attachment device 32 to the dose dial 8.

[0166] The receptacle 63 is defined by a radially inwardly extending flange portion 62. The flange portion 62 divides the interior of the device body 60 into a distal receptacle 63 and a proximal receptacle 64. The proximal receptacle 64 is sized to receive a support 70 and a cover 75 for housing the electronic module 34. The support 70 includes a longitudinally extending stem 71 that extends distally through the flange portion 62. The support 70 is displaceably mounted inside the receptacle 64. The support 70 is movable in the distal direction 2 against the action of a return element or elements 65. The support 70 is connected to a cup-shaped cover 75 that protrudes proximally from the side wall 61 of the device body 60.

[0167] The cover 75 includes a planar end surface 76 facing in the proximal direction 3. The end surface 76 is provided to a sensor element 81. As shown in FIG. 3, the entire end surface 76 may be covered by the sensor element 81. In this way, the end surface 76 serves as an actuation surface to be pressed by a user, for example by the user's thumb 114. The user may apply a distally directed force to the end surface 76, thereby urging the cover 75 and the support 70 in the distal direction 2 against the action of the return element 65.

[0168] Upon release of the end face 76, a return element 75, for example implemented as a return spring, serves to move the support 70 and the cover 75 towards a proximal start position, as illustrated in Fig. 3. At least one of the cover 75 and the support 70 comprises a radially outwardly extending projection 74 guided in a longitudinally extending recess 66 on the inside of the side wall 61 of the device body 60. Viewed longitudinally, the recess 66 is defined by a proximal stop surface 69 and a distal stop surface 67. In the initial configuration as illustrated in Fig. 3, the projection 74 abuts longitudinally against the proximal stop surface 69 of the recess 66.

[0169] The distal end position is reached when the projections 74 engage the distal stop faces 67 when the cover 75 is pressed in the distal direction 2 against the action of the return elements 65. The projections 74 guided in the grooves 66 make it possible to define the limits of the longitudinal movement of the support 70 and the cover 75 within a predefined range relative to the device body 60.

[0170] When pressed in the distal direction 2, the support 70 and its stem 71 start to protrude from the flange portion 62. As the side wall 61 is longitudinally fixable relative to the dose dial 8, a distal longitudinal displacement of the support 70 and its stem 71 serves to act on the trigger 9, thereby inducing a distal movement of the trigger 9 relative to the dose dial 8 or the body 6. The cover 75 is longitudinally fixed to the support 70. The cover 75 may be freely rotatable relative to the support 70, in particular during a dose injection procedure. During a dose injection, the dose dial 8 may undergo a rotation in the dose decrement direction 5, while the trigger 9 remains rotationally locked relative to the dial extension 27 and / or the body 6. Here, the support 70 and / or the cover 75 may form or constitute an auxiliary trigger of the add-on device.

[0171] Here, the inside of the sidewall of the cover 75 may include at least one of a radial protrusion and recess 68 for engaging a complementary radial recess or protrusion 72 of the support 70. The cup-shaped cover 75 connected or fastened to the support 70 provides a receptacle for the electronic module 34 to be disposed within the hollow space formed by the support 70 and the cover 75.

[0172] The sensor assembly 80 described herein may be to some extent the same or equivalent to the electronic module 34, or vice versa. The electronic module 34 may include a printed circuit board 36. The electronic module 34 may further include transceivers 38, 39, a memory 40, a clock 42, a processor 44, a power supply 46, an acceleration sensor 48, a position sensor 50, signal generators 51, 52, and, for example, light sources 53, 54. The electronic module 34 may also include a microphone.

[0173] Additionally, the side walls 77 of the cover 75 may include windows 55 aligned with respective windows 56 in the side walls 61 of the device body 60. In this manner, visual signals producible by the different light sources 53, 54 located within the hollow space of the cover 75 may be perceived and visually detected from outside the add-on device 30.

[0174] The two light sources 53, 54 may belong to a visual signal generator 52 operable to generate or generate visual signals of different colours and / or variable duration. The windows 55, 56 may be provided with light guides or light guiding structures. In this way the device body 60 may be protected against the ingress of dust or moisture.

[0175] 4 shows a block diagram of one example of electronic module 34 and / or sensor assembly 80. As also shown in FIG. 3, processor 44 is mounted on printed circuit board 36, which is connected to sensor element 81 of sensor assembly 80, which substantially covers end face 76 of cover 65.

[0176] Generally, the electronic module 34 may be implemented on a printed circuit board 36. The electronic module 34 may be configured to communicate with an external electronic device 100, for example as illustrated in FIG. 28. The external electronic device 100 may be implemented as a portable electronic device. The external electronic device 100 may include a smart watch, a smartphone, or a tablet computer. The electronic module 34 includes a transceiver 38 configured to establish or create a communication link between the external electronic device 100 and the electronic module 34. The respective communication link may be realized in a wireless or wired manner.

[0177] The electronic module 34 may be configured to exchange data with an external electronic device 100. Data collected or gathered by the sensor assembly 80, indicative of the operation of the injection device, may be transmitted to the external electronic device via the transceiver 38. The transceiver 38 may be implemented as a Bluetooth transceiver or as a BLE transceiver. The further transceiver 39 may be implemented as an NFC transceiver. The two transceivers may be distinguished with respect to their communication protocol and / or with respect to their spatial range.

[0178] The electronic module 34, and thus the sensor assembly 80, comprises a memory 40 configured to store a plurality of measurement results of the sensor assembly 80. The electronic module 34, and thus the sensor assembly 80, further comprises a clock 42 configured to impart to each of the plurality of measurement data of the sensor assembly 80 a time index indicative of the time and / or date of detection of the respective movement of the injection device 1.

[0179] The processor 44 of the sensor assembly 80, and thus of the electronic module 34, is configured to control the operation of the sensor assembly 80, and thus of the sensor element 81. The sensor assembly 80, and thus the electronic module 34, further comprises a power source 46 configured to provide power to the processor 44 and the sensor assembly 80. The power source 46 may be implemented as a battery. The sensor assembly 80 may further include an acceleration sensor 48 configured to detect an injection action of the injection device 1 and / or to detect or classify a user's gesture when using the sensor assembly 80 and / or the injection device 1. For example, when implemented as an autoinjector, the acceleration sensor may detect the acceleration of a needle of the autoinjector when performing a medication or injection procedure.

[0180] The sensor assembly 80 may further include a position sensor 50, which may be operable to detect the position or orientation of a dedicated component of the drive mechanism 20 of the injection device 1. The position sensor may be operable to detect, for example, the position of a final dose nut, a piston rod 19 or a similar component of the drive mechanism 20, which is indicative of the amount of medicament located in the medicament container 21.

[0181] Additionally, the sensor assembly 80 or electronic module 34 includes a signal generator 52, which may be implemented as a visual signal indicator including at least one light source 53, 54. Additionally or alternatively, the signal generator 51 may be implemented as a tactile signal generator configured to generate, for example, a perceptible vibration of the electronic module 34. In a further example, the signal generator 51 may include an audible signal generator configured to generate an audible sound.

[0182] Additionally, in a further example, the electronic module 34 and / or the sensor assembly 80 may include a microphone that can detect and process the characteristic clicking noise of the injection device, thereby deriving or measuring the size of the dose currently set or injected by the injection device 1.

[0183] The currently illustrated implementation of the electronic module 34 in the add-on device 30 is merely exemplary. It is also conceivable that the full functionality of the add-on device 30, and thus the sensor assembly 80 and the electronic module 34, is implemented in the injection device 1, especially in reusable devices. Here, a receptacle 64, sized to accommodate the hardware components of the electronic module 34, may be provided inside the dose dial 8, which is covered or closed proximally by the trigger 9. Here, the trigger 9 of the injection device replaces the cover 75 and the support 70. The stem 71 of the support 70, and thus of the trigger 9, may then be operatively engaged with a drive mechanism to induce or trigger the dosing action. The device body 60 may be provided or represented by the tubular one of the dial 8.

[0184] An example of a sensor assembly 80 is illustrated generally in Figures 2, 3 and 5-8. The sensor assembly 80 includes a sensor element 81 with a number of touch-sensitive or pressure-sensitive sensor segments 84, 85, 86 on a sensing surface 82, 83. The sensor assembly 80 may include a regular arrangement of the touch-sensitive sensor segments 84, 85, 86 as illustrated in Figures 5 and 6. The individual sensor segments may correspond to pixels of a touch-sensitive display. The sensor segments 84, 85, 86 may each include a capacitance measuring device capable of accurately detecting mechanical contact with a body part of a user.

[0185] In some examples, the sensor segments 84, 85, 86 are pressure sensitive. Thus, the sensor segments 84, 85, 86 are operable to generate or modify an electrical touch signal when touched by a body portion of a user. The sensor segments 84, 85, 86 may be spatially distributed across the sensing surfaces 82, 83 of the sensor element 81. The sensor element 81 may provide spatially resolved detection of sensing areas 88, 89 where the user's skin actually touches or where the sensor element 81 mechanically contacts the user's skin.

[0186] In some examples, each sensor segment 84, 85, 86 is not only touch-sensitive, but also operable to generate an electrical touch signal indicative of the pressure or intensity of mechanical contact with a user's body part. Thus, the touch-sensitive sensor segments 84, 85, 86 are operable to generate different electrical touch signals indicative of the amount of pressure or force applied to the respective sensor segment.

[0187] To that extent, the contact-sensitive sensor segments 84, 85, 86 are operable to generate electrical touch signals that differ in at least one of magnitude, amplitude, sign, or frequency. These differences in the electrical touch signals can be detected by the processor 44 of the sensor assembly 80 and evaluated to detect, recognize, characterize, and / or measure at least one of a user-induced action of the injection device 1 and a gesture performed by a body part of the user.

[0188] 5-8, the sensor element 81 comprises a circular, planar sensing surface 82 and a tubular sensing surface 83 located longitudinally adjacent the periphery of the sensing surface 82. To that extent, the sensor element 81 comprises a cup-shaped receptacle sized to receive, for example, the trigger 9 of the injection device 1 and / or the cover 75 of the add-on device 30.

[0189] In a further example, it is envisaged that the cup-shaped sensor element 81 may be configured to receive a dose element that combines the functions of the dose dial 8 and trigger 9 into a single part.

[0190] In the illustrations of Figures 5 and 6, only one sensor segment 86 of the multiple sensor segments 84, 85, 86 is actually active and detects contact with a body part of a user.

[0191] In some examples, the sensor element 81 only comprises a planar sensing surface 82 fastened to the proximal end face of the trigger 9 or to the proximal end face of the cover 75 of the add-on device 30. In other examples, the sensor element 81 may exclusively comprise a tubular sensing surface 83 configured to confine the tubular member 28 of the injection device 1. The tubular member 28 may be provided by the tubular dose dial 8 or by the tubular body 6 of the injection device 1.

[0192] In Fig. 9 a typical usage scenario of an injection device 1 provided with a dial extension 27 is shown. For setting a dose, the user rotates the dose dial 8 relative to the body 6. The dose dial 8 is part of the dial extension 27 and then starts to protrude in the proximal direction 3 from the proximal end of the body 6 as doses of increasing size are set or dialed in.

[0193] As a result, an indexed increasing dose number appears in the dose display window 26. For injecting a dose, the user uses his / her hand 110 to grasp the body 6 of the injection device firmly in the palm 112, thereby holding the body 6 of the injection device 1 using at least two fingers 116, 117. The user may then use the thumb 114 to trigger the dosing action by depressing the trigger 9 in the distal direction 2.

[0194] As the trigger 9 and thus the entire dial extension 27 is displaced longitudinally in the distal direction relative to the body 6 during dose injection, the angle at which the thumb 114 is oriented relative to the trigger 9 changes gradually. Thus, during dose dispensing, the thumb 114 undergoes a milling motion or natural rolling which is detectable by the spatially resolved contact sensitive surface 82 of the sensor element 81 covering the proximal face of the trigger 9 or the proximal face of the cover 75 of the add-on device 30.

[0195] 7 and 8, the touch sensitive sensor segments 84, 85, 86 are operable to generate different electrical touch signals in response to force or pressure levels applied to the respective sensor segments 84, 85, 86. In FIG 8a, a fairly high or relatively high pressure level is illustrated by the relatively darkly shaded sensor segments 84, 85, 86. In FIG 7, a relatively low pressure level is illustrated by the relatively weaker or lighter shaded sensor segments 84, 86, while sensor segment 85 is subject to a relatively high pressure level.

[0196] In this way, not only is a spatially resolved contact profile provided across the one or two dimensional sensing surface 82,83 of the sensor element 81, but a pressure profile may also be provided indicative of the different pressure levels applied across the sensing surfaces 82,83.

[0197] 7, there are only a total of 12 sensor segments on sensing surface 82 that experience relatively large force or pressure effects. Here, only exemplary sensor segment 85 experiences relatively high pressure. Sensor segments 84, 86 are located radially outward of high pressure sensing region 88. Sensor segments 84, 86 experience moderate or relatively low pressure.

[0198] Those sensor segments 84, 86 that are subjected to relatively low or moderate pressure form or constitute a low or moderate pressure sensing area 89. Those sensor segments 85 that are subjected to relatively high pressure form or constitute a sensing area 88.

[0199] As illustrated in FIG. 8, the sensing area 88 is located approximately in the center of the sensing surface 82. The sensing area 88 is surrounded by a relatively low pressure sensing area 89. This example may represent a case where a user applies a moderate pressure to the sensing surface 82, for example with the thumb 114. Because the thumb 114 has a convex shape and has a certain degree of elasticity with increasing pressure, the user's thumb 114 undergoes a respective deformation, thereby increasing the lateral extent of the high pressure sensing area 88. Those sensor segments 84, 86 that previously received only a relatively low pressure, as illustrated in FIG. 7, now receive a relatively high pressure, as illustrated in FIG. 8.

[0200] The change in pressure profile from the example of Figure 7 to the example of Figure 8 can be accurately detected and monitored by processor 44, which is configured to individually process the electrical touch signals generated or modified by each of sensor segments 84, 85, 86. To that extent, processor 44 is configured to detect or recognize an increase or modification in sensitive area 88.

[0201] It should be noted that, generally, the sensor segments 84, 85, 86 specifically referred to herein for illustrative purposes represent the entirety of the sensor segments provided on the sensing surfaces 82, 83. The spatial resolution of the sensor assembly 18 may depend on the total number and arrangement of the sensor segments 84, 85, 86 on the sensing surfaces 82, 83.

[0202] As particularly illustrated in Figures 9-11, in a further configuration, the user may use thumb 114 and index finger 116 to rotate the dose dial 8, which may also be provided with a tubular sensing surface 83 of the sensor element 81. In Figure 10, only the sensor segment 85 is subjected to substantially high pressure, whereas the sensor segment 84 is subjected to lower or moderate pressure, and the sensor segment 86 is subjected to no pressure at all. By rotating the dose dial 8, for example clockwise, the pressure profile along or across the sensing surface 83 is gradually changed. In the configuration of Figure 10, the sensing area 88, which coincides with the position of the thumb 114 and index finger 116, is circumferentially framed or surrounded by a sensing area 89 of significantly lower pressure or low force.

[0203] By rotating the dose dial 8, the sensor segments 84 are subjected to an increasing contact pressure. As shown, the sensing areas 88, 89 move circumferentially relative to the positions of the sensor segments 84, 85, 86. Such movement of the sensing areas 88, 89 can be detected, tracked, and quantitatively measured by the processor 44. In this manner, the sensing surface 83 and the individual sensor segments 84, 85, 86 also enable and facilitate a quantitative measurement of the degree of rotation of the dose dial 8 relative to the body 6.

[0204] In a further example, for example illustrated in Fig. 22, the sensor assembly 80 comprises a flexible sheet 79 configured to be fastened around or wrapped around the body 6 of the injection device 1. Here, the injection device 1 may be implemented as an autoinjector. The injection device 1 may not have a separate trigger, for example pressed by the user's thumb 114. Rather, the dose dispensing or dose injection action may be triggered simply by contacting the distal dispensing end of the injection device 1 to the skin and applying moderate pressure to the skin via the housing 10 or body 6 of the injection device 1.

[0205] The injection device 1 may then automatically initiate the dosing procedure by pushing the injection needle into the skin and subsequently delivering or injecting the medication into the portion of the skin that is actually punctured.

[0206] Here, in a typical use scenario, before applying a distally directed pressure to the body 6 of the injection device, a user may grasp the body 6 of the injection device 1, which is provided with a sensor assembly 80 as already described. The sensor assembly 80 may comprise a flexible sheet 79 or foil with a number of sensor segments 84, 85, 86 that allow for precise spatially resolved recording and detection of the holding force or pressure applied by the fingers 114, 116, 117 and palm 112 of the user's hand 110.

[0207] When a user simply holds the injection device 1 in his / her hand 110, the contact area between the palm 112 and the sensor element 81 can be detected as a sensing area 88. When a user brings the dispensing end of the injection device 1 into contact with the skin and begins to urge the injection device 1 against the skin, a small but measurable deformation occurs in the contact area between the hand 110 and the sensor element 81. As the hand 110 bends longitudinally over the sensing surface 82 towards the distal end, the sensor assembly 80 is operable to record the movement of each of the sensing areas 88. The changes over time and / or the movement of the sensing areas 88, 89 can be detected and / or recorded by the processor 44.

[0208] Additionally, at the end of a dose dispensing procedure, the processor 44 may further be operable to measure the duration for which the sensing area 88 remains substantially constant. Similarly, the sensor assembly 80 may be configured to detect how long the user keeps the thumb 114 firmly pressed against the trigger 9, for example, at the end of a dose dispensing procedure. In this manner, the sensor assembly 80 is configured to automatically detect and record a defined retention time that the injection needle 13 should remain within the punctured tissue following the end of a dose injection of a medicament.

[0209] Upon completion of the dose injection procedure, the sensor assembly 80 and / or the electronic module 34 may be configured to provide perceptible feedback to the user visually, acoustically or tactilely. For this purpose, the on-board signal generators 51, 52 may be used or activated by the processor 44. Alternatively, the respective feedback signal may also be generated by the external electronic device 100 when the sensor assembly 80 is in a communication mode with the external electronic device 100.

[0210] When the end of the injection procedure is reached, the user may be forced to maintain pressure on the trigger 9. This may result in a more or less constant electrical touch signal provided by the multiple contact-sensitive sensor segments 84, 85, 86. To that extent, a more or less constant and unmodified pressure profile measured by the sensor assembly 80 and merely followed by a complete release of the sensing surfaces 82, 83, where the body part is detached from and thus no longer in contact with the sensing surfaces 82, 83, directly indicates that the user has complied with the prescribed retention of the injection device after the end of the dose injection procedure.

[0211] Here, the sensor assembly is configured to automatically distinguish between different operation modes of the injection device and may automatically record the time and / or duration when such different operation modes of the injection device occur.

[0212] In this manner, the accuracy and quality of the data collected by the sensor assembly can be improved.

[0213] A number of examples of the external electronic device 100 are illustrated diagrammatically in Figures 12 to 15, 22 and 23. The external electronic device 100 may be implemented as a smartwatch or a smartphone. The external electronic device 100 comprises a housing 101 and a user interface 102, which may be implemented as a display or as a touch-sensitive display. The external device 100 may further comprise a control element 103 operable or actuable by a user of the device. The external electronic device 100 may be attached to a user's wrist 111 by a wristband 115. A number of visual items 104 in the form of symbols, text or similar information may be provided on the display 102 that may assist the user in using the injection device 1.

[0214] The communication link between the sensor assembly 80 and the electronic module 34 may eliminate the need for a user to manually check a particular operational mode of the injection device 1 with the external electronic device 100. The communication link, for example a wireless communication link between the external electronic device 100 and the sensor assembly 80, may automatically provide the external electronic device 100 with information such as the setting of a dose at a particular time and the dispensing of a dose at a particular time.

[0215] Moreover, the sensor assembly 80 may be further configured to detect or quantitatively measure the size of the dose actually set by the user of the injection device. Upon detection of a dosing procedure, by distinguishing the dosing procedure from, for example, a dose setting procedure, the sensor assembly 80 and the electronic module 34 may automatically provide the relevant information to the external electronic device 100, which may provide further data processing or data analysis. Furthermore, the external electronic device 100 may be configured to transmit the acquired data to a healthcare provider for further data analysis and to control the user's compliance with the prescribed dosing schedule.

[0216] The user interface 102 may include at least one of a display, e.g., a touch-sensitive display, an audible and / or tactile or tactile signal generator, by which the external electronic device 100 may communicate with a user of the injection device 1. The external electronic device 100 further includes a device processor 106, a device memory 107, and a device transceiver 108. The device transceiver 108 may be implemented as a wireless transceiver. The device transceiver 108 may establish a communication link with the transceiver or transmitter 38, 39 of the sensor assembly 80.

[0217] In figures 16 to 21 a number of gestures 1 performed by a user of an injection device are illustrated diagrammatically. In figure 16 the user uses his index finger 116 to slide over the sensing surface 82 of the sensor element 81. The sliding movement is indicated by a curved arrow. In figure 16 the corresponding configuration of the sensing surface 82 when integrated over time while the finger 116 swipes over the sensing surface 82 is illustrated. The contact sensitive sensor segments 84, 85 located on the path followed by the index finger 116 while swiping over the sensing surface 82 are shown in a shaded design. The contact sensitive sensor segments 86 not touched by the finger 116 remain white.

[0218] The sliding motion of the index finger can be dynamically tracked and sensed over time by processing and / or evaluating the electrical touch signals generated by the individual sensor segments 84, 85 that finger 116 touches as finger 115 swipes across sensing surface 82.

[0219] The processor 44 of the sensor assembly 80 is configured to detect and process individual electrical touch signals generated by those sensor segments 84, 85 that are within a sensing area 88 as shown in Figure 17. Here, the processor 44 is operable to derive a spatial and / or temporal profile of the electrical touch signals generated by the multiple touch-sensitive sensor segments 84, 85, 86. Thus, the processor 44 is operable to recognize a swipe motion of the finger 116.

[0220] Another gesture is shown in Fig. 18, where the finger 116 performs multiple short tapping movements on the sensing surface 82. Here, a sensing area 88 following the outline of the finger 116 is visibly marked on the representation of the sensing surface 82 in Fig. 19. The sensor segment 86 is located within the sensing area 88, whereas the sensor segments 84, 85 are located outside the sensing area 88. The processor 44 is configured to detect single and multiple short tapping movements of the body part or finger 116 on the sensing surface 82.

[0221] 20 and 21, a user's finger 116, and thus a body part, applies a particular intensity of pressure to the sensing surface 82 of the sensor element 81. Thus, the processor may be provided with a sensing signal indicative of a relatively high pressure applied by the body part or finger 116, as indicated by the dark shaded sensing area 88 and the dark shaded contact sensitive sensor segment 86. Typically, the contact sensitive sensor segments 84, 85, 86 may be sensitive to the applied pressure and operable to modify or generate a discernable electrical touch signal indicative of the magnitude of pressure currently being applied.

[0222] Processor 44 may be operable to distinguish electrical touch signals indicative of pressure above a predetermined threshold, and to that extent, in all examples such as those illustrated in Figures 16-21, processor 44 is operable to distinguish between these characteristic user gestures.

[0223] 16 may be used to generate and transmit a control signal from the sensor assembly to the external electronic device 100. The control signal generated based on the swipe gesture may be interpreted as a confirmation, for example, by the device processor 106, when received by the external electronic device 100.

[0224] Multiple short taps as illustrated in Fig. 18 may be used to generate and send another control signal to the external electronic device 100, which may be interpreted, for example, in a user interaction, as a delete or reset signal. Further gestures as illustrated in Fig. 20, which may include longer lasting and / or higher pressure gestures, may cause the processor of the sensor assembly to generate and send a further control signal to the external electronic device, thereby indicating that the injection device is currently being used to inject a dose of medication.

[0225] In an injection system 200 as illustrated in Fig. 22, a user may hold the external electronic device 100 in his left hand 110' and the injection device 1 in his right hand 110. The external electronic device 100 may provide indications or instructions to the user in the form of visual items 104 on the display 102, prompting the user to, for example, check the record of the dose dispensing procedure. As shown on the display 102, the user is prompted to swipe the sensing surfaces 82, 83 of a sensor element 81 attached to or incorporated into the injection device 1.

[0226] A user may perform a respective swipe motion using, for example, thumb 114. The swipe motion causes contact-sensitive sensor segments 84, 85, 86 of sensor element 81 to generate or modify electrical touch signals that are processed by processor 44. Processor 44 may process the electrical touch signals and recognize particular gestures of the user's respective body parts and may generate control signals based on such gesture recognition.

[0227] The processor 44 may then transmit the respective control signals to the external electronic device 100. In this manner, the sensor assembly 80 attached or attachable to the injection device 1 provides an effective remote control over the external electronic device 100. The sensor assembly 80 serves to enhance and facilitate assistance to the user in using the injection device 1 while being instructed by a software application provided or executed by the external electronic device 100.

[0228] 12-15 illustrate an exemplary scenario of a method for assisting a user to utilize an injection device 1 by using an injection system 200 as described herein. The external electronic device 100 is implemented, for example, as a smart watch worn on the wrist 111 of a user's hand 110. The user may wear the electronic device 100, for example, on the left hand 110' while holding the injection device 1 in the right hand 110. The electronic device 100 may be configured to execute user assistance instructions, for example to execute a software application that assists the user to use the injection device 1 correctly. In an initial configuration as illustrated in FIG. 12, the user interface 102, for example implemented as a display, may show the user that, for example, a dose of 30 units is currently scheduled to be set.

[0229] The user may then use the injection device 1 to set or dial a dose of the required size. To this end, the user may for example dial the dose dial 8 in a clockwise direction. During the setting of the dose, the sensor assembly 80 may detect the dialing action by a time-dependent change in the signal, for example from the sensor segments 84, 85, 86, provided on a tubular sensing surface 83 attached to the outer circumference of the dose dial 8. Here, as explained in relation to Figs. 10 and 11, the sensor assembly 80 may further be configured to quantitatively determine or quantitatively measure the size of the currently set dose. Upon detecting or determining that a dose of the required size has been set, the processor 44 of the sensor assembly 80 may be operable to generate a respective control signal and to transmit the control signal to the external electronic device 100.

[0230] When the sensor assembly 80 detects that a dose of the required size has been set, e.g. when the external electronic device 100 receives a respective control signal from the sensor assembly 80, the user interface 102 may switch to a configuration as illustrated in Fig. 13. Here, the user may be prompted to confirm the dose setting. The user may be prompted to confirm the dose setting by swiping a particular portion, e.g. the planar sensing surface 82 of the sensor assembly 80. This swiping action, and thus the confirmation that a dose of the required size has indeed been set, may be performed by the fingers 114, 116, 117 of the user's right hand 110.

[0231] Regardless of the quantitative measurement, upon setting a dose of the required size, the user may confirm the setting of the dose, for example, by performing a swiping motion across at least one of the sensing surfaces 82, 83. The swiping motion is typically recorded or detected by the sensor assembly 80, which in response to such detection generates and transmits a further control signal to the external electronic device 100.

[0232] After confirming the setting of the dose by making a gesture with respect to the sensor assembly 80 and / or upon receiving a further control signal, the user interface 102 may switch to a configuration as illustrated in FIG. 14. Here, the user may be prompted to start the injection procedure. The user may then apply pressure to the trigger 9 in a distal direction. Alternatively, with an autoinjector, the user may urge the body 6 against a portion of the skin. The application of pressure to the trigger 9 and the urging of the body 6 against the portion of the skin may be detected qualitatively and quantitatively by the sensor assembly 80. The dispensing or injection of the dose may be accompanied by a gesture as described in relation to FIGS. 20 and 21. The sensor assembly may record the application of pressure above the first and / or second thresholds over a time interval of characteristic duration.

[0233] If the trigger 9 is displaced slowly longitudinally during the dose injection process, a recordable milling motion or natural rolling of the user's thumb 114 against the planar sensing surface 82 covering the trigger 9 may occur. This applies in particular when the trigger 9 is provided at the proximal end of the dial extension 27 of the injection device 1. The rolling of the thumb 114 may be detectable and / or recordable by the sensor assembly 80. Here, the sensing area 88 may undergo a temporal change, for example a movement and / or a measurable geometric change. At the end of the injection procedure, the user may have to hold the injection needle 13 in the skin for a certain time interval, also indicated as the holding time. During this time interval, the sensor assembly 80 may only record a somewhat constant and therefore unchanging sensing area 88. By analyzing the touch signals generated by the individual sensor segments 84, 85, 86, the start and end of the injection procedure, as well as the start and end of the holding procedure, may be accurately detected.

[0234] After the end of the injection procedure and / or after the holding time has elapsed, the user may remove the thumb 114 from the trigger 9. This removal is immediately recorded by the sensor assembly 80, which is operable to generate and transmit a respective control signal to the electronic device 100. Thus, the electronic device 100 may provide the user with an indication that the injection procedure is completed, for example in the form of a visual item 104. The injection-related data recorded during the dose setting and / or dose injection process may be summarized on the user interface 102, for example as illustrated in FIG. 22. The user may then finally confirm to store the acquired data locally, for example in the device memory 107, and / or to transmit the acquired data, for example to a healthcare provider. This confirmation may require another swipe action, for example as illustrated in FIG. 16 or 17. Alternatively, if the user wants to decline or not approve the storage and / or transmission of the data, the user may perform a double tap, as illustrated in FIG. 18 and FIG. 19.

[0235] As further illustrated in the flow chart of FIG. 24, the method of assisting a user to use an injection device includes a step 200 of prompting a user to operate the injection device 1 via a user interface 102 of the external electronic device 100, for example as illustrated in FIG. 12. In a next step 202, typically when the sensor assembly 18 is attached or fixed to the injection device 1, a change in an electrical touch signal over time caused by the user touching the sensing surface 82, 83 of the sensor element 81 of the sensor assembly 80 is detected. Proceeding in step 204, the sensor assembly 80 generates a control signal based on the change in the electrical touch signal over time, and in step 206, the touch control signal is transmitted to the external electronic device via the transmitter or transceiver 38, 39 of the sensor assembly 80. To that extent, the sensor assembly provides a remote control of the external electronic device and helps the user to input different user comments to the electronic device 100 without having to directly input commands to the electronic device 100 by tapping the device 100. [Explanation of symbols]

[0236] 1. Injection device 2 Distal direction 3 Proximal direction 4 Dose Increment Direction 5 Dose decrement direction 6 Main unit 7 Cartridge holder 8 Dose Dial 9 Triggers 10. Housing 11 Connectors 12 Needle Assembly 13 Syringe needle 14 Inner needle cap 15 Outer needle cap 16 Protective Cap 18 Piston 19 Piston rod 20 Drive mechanism 21 Drug containers 22 barrels 23 Seal 24 Drugs 25 Outlet 26 Windows 27 Dial extension 28 Tubular Members 30 Additional Devices 34 Electronic Module 36 Printed Circuit Board 38 Transmitter / Receiver 39 Transmitter / Receiver 40 Memory 42 Clock 44 processors 46 Power supply 48 Acceleration Sensor 50 Position Sensor 51 Signal Generator 52 Signal Generator 53 Light source 54 Light source 55 Windows 56 Windows 60 Device body 61 Side wall 62 Flange part 63 Receptacle 64 Receptacle 65 Return element 66 Recess 67 Stop surface 68 Recess 69 Stopping surface 70 Support 71 Stem 72 Protrusion 74 Protrusion 75 Cover 76 End face 77 Side wall 79 sheets 80 Sensor Assembly 81 Sensor Element 82 Sensing surface 83 Sensing surface 84 sensor segments 85 Sensor Segments 86 Sensor Segments 88 Sensing area 89 Sensing area 100 External Devices 101 Housing 102 User Interface 103 Control Elements 104 Visual Inspection Items 105 Wristbands 106 Device Processors 107 Device Memory 108 Device body 110 Hands 111 Wrist 112 Palm 114 Thumb 116 fingers 117 fingers

Claims

1. A sensor assembly (80) for an injection device (1), comprising: a sensor element (81) attachable to the injection device (1) and comprising a sensing surface (82, 83), the sensing surface (82, 83) comprising contact-sensitive sensor segments (84, 85, 86), the contact-sensitive sensor segments (84, 85, 86) operable to generate or modify an electrical touch signal when touched by a body part (112, 114, 116, 117) of a user; a processor (44) coupled to the sensor elements (81) and operable to detect changes in the electrical touch signals over time and generate control signals based on the changes in the electrical touch signals over time; a transmitter (38, 39) connected to the processor (44), the transmitter (38, 39) operable to transmit the control signal to an external electronic device (100); A sensor assembly (80).

2. 2. The sensor assembly (80) of claim 1, wherein the sensing surface (82, 83) includes a number of contact-sensitive sensor segments (84, 85, 86), each of which is operable to generate or modify an electrical touch signal when touched by a body part (112, 114, 116, 117) of a user.

3. 3. The sensor assembly (80) of claim 2, wherein the processor (44) is operable to generate the control signal based on the temporal variations in a plurality of electrical touch signals generated or modified by a number of contact-sensitive sensor segments (84, 85, 86).

4. The sensor assembly (80) of any one of claims 1 to 3, wherein the contact-sensitive sensor segments (84, 85, 86) are operable to generate different electrical touch signals in response to changes in pressure applied to the contact-sensitive sensor segments (84, 85, 86).

5. 5. The sensor assembly of claim 1, wherein the processor is operable to assign the temporal changes in the electrical touch signals to one of a plurality of predefined user gestures, and the processor is further operable to generate the control signal by selecting the control signal from a plurality of predefined control signals based on the user gesture assigned to the temporal changes in the electrical touch signals.

6. The processor (34) a swiping motion of said body part (112, 114, 116, 117) across said sensing surface (82, 83); a brief tapping motion of said body part (112, 114, 116, 117) on said sensing surface (82, 83); a plurality of short tapping movements of said body part (112, 114, 116, 117) on said sensing surface (82, 83); a prolonged tapping motion of said body part (112, 114, 116, 117) on said sensing surface (82, 83); Variable pressure applied to the sensing surfaces (82, 83) by the body parts (112, 114, 116, 117). The sensor assembly (80) of claim 5, operable to recognize at least one of:

7. The sensor assembly (80) of any one of claims 1 to 6, wherein the processor (44) is operable to process electrical touch signals of a number of contact-sensitive sensor segments (84, 85, 86) to ascertain a sensing area (88, 89) of the sensing surface (82, 83) touched by the body part (112, 114, 116, 117).

8. A sensor assembly (80) according to any one of claims 1 to 7, wherein the sensor element (81) comprises a planar sensing surface (82) configured for fastening to an end surface of a trigger (9) of the injection device (1).

9. The sensor assembly (80) of any one of claims 1 to 8, wherein the sensor element (81) comprises a tubular sensing surface (83) configured for fastening to a tubular member (28) of the injection device (1).

10. The sensor assembly (80) of any one of claims 1 to 9, wherein the sensor element (81) comprises a flexible sheet (79) configured to wrap around the tubular member (28) of the injection device (1).

11. The sensor assembly (80) of any one of claims 1 to 10, wherein generation of the control signal is triggered by the detection of a change in the electrical touch signal over time.

12. The sensor assembly (80) of any one of claims 1 to 11, wherein the transmission of the control signal to the external electronic device (100) is triggered automatically upon generation of the control signal.

13. The sensor assembly (80) of any one of claims 1 to 12, wherein the processor (44) is operable to detect, recognize, characterize and / or measure a motion of the injection device (1) based on the temporal changes of the electrical touch signal, and the processor (44) is operable to generate the control signal by selecting one of a number of predefined control signals indicative of the detected, recognized, characterized and / or measured motion of the injection device (1).

14. The sensor assembly (80) of any one of claims 1 to 13, wherein the processor (44) is operable to distinguish between end of a dose setting operation, a dose dispensing operation and a dose holding operation of the injection device (1) by processing multiple electrical touch signals of multiple contact-sensitive sensor segments (84, 85, 86) over time when the sensor element (81) is attached to one of the injection device (1) and an add-on device (30) attached to the injection device (1).

15. The sensor assembly (80) of any one of claims 1 to 14, further comprising a clock (42) and a memory (409) connected to the processor (44), wherein the processor (44), the clock (42) and the memory (409) are operable to automatically store or automatically monitor and / or log a sequence of user-induced actions of the injection device (1) by detecting or measuring changes in an electrical touch signal of the sensor element (81).

16. An injection device (1) for injecting a dose of a medicament (24), comprising: a body (6) for housing a drive mechanism (20) operable to draw or expel said medicament (24) from a medicament container (21); a dose dial (8) and / or a trigger (9) operable by a user to inject said dose; A sensor assembly (80) according to any one of claims 1 to 15, attached to or integrated with at least one of the body (6), the dose dial (8) and the trigger (9); An injection device (1).

17. An injection system (200) comprising an external electronic device (100) and an injection device (1) according to claim 16, said external electronic device (100) comprising: a user interface (102) for communicating with a user of the injection device (1); a device processor (106) coupled to the user interface (102), the device processor (106) operable to provide at least one of an indication and a user instruction to the user via the user interface (102); a device transceiver (108) configured to receive control signals from the transmitter (38, 39) of the sensor assembly (80) of the injection device (1); An injection system (200).

18. A method for assisting a user in using an injection device (1) by utilizing an injection system (200) according to claim 17, comprising the steps of: prompting the user via the user interface (102) of the external electronic device (100) to operate the injection device (1); detecting a change over time in an electrical touch signal caused by the user touching the sensing surface (82, 83) of the sensor element (81) of the sensor assembly (80) of the injection device (1); generating a control signal based on the temporal variation of the electrical touch signal; transmitting said control signal to said external electronic device (100) via said transmitter (38, 39) of said sensor assembly (80); A method comprising:

19. When executed by one or more processors (44, 106) of the injection system (200) of claim 17, prompting the user via the user interface (102) of the external electronic device (100) to operate the injection device (1); detecting a change over time in an electrical touch signal caused by the user touching the sensing surface (82, 83) of the sensor element (81) of the sensor assembly (80) of the injection device (1); generating a control signal based on the temporal variation of the electrical touch signal; Transmitting said control signal to said external electronic device (100) via said transmitter (38, 39) of said sensor assembly (80). A computer program comprising computer readable instructions for causing the processor (44, 106) to:

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