Sensor assembly for detecting or identifying operation of injection device

Abstract

A sensor assembly for detecting or identifying operation of an injection device. The present disclosure relates to a sensor assembly (80) for detecting the operation of an injection device (1), the sensor assembly (80) comprising:-a sensor element (81) attachable to the injection device (1) and comprising a sensing surface (82, 83), the sensing surface (82, 83) comprising a plurality of touch-sensitive sensor segments (84, 85, 86) operable to detect the operation of a body part (112, 114, 116, 116) of a user; 117),-a processor (44) connectable to the sensor element (81) and operable to detect changes in the electrical touch signals over time and to identify operation of the injection device (1) based on the changes in the electrical touch signals over time.

Description

Technical Field

[0001] The present disclosure relates to a sensor assembly for detecting or identifying operation of an injection device. In another aspect, the present disclosure relates to an injection device equipped with such a sensor assembly. In another aspect, the present disclosure relates to an attachment configured for fastening to an injection device, wherein the attachment is provided with a sensor assembly. In another aspect, the present disclosure relates to a method for detecting or identifying operation of an injection device, and in another aspect, the present disclosure relates to a computer program. Background Art

[0002] Drug delivery devices for setting and dispensing single or multiple doses of liquid medicaments are well known in the art per se. Typically, such devices have substantially similar uses to ordinary syringes.

[0003] Drug delivery devices such as pen-type 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 weak and may also be visually impaired. Therefore, suitable drug delivery devices specifically intended for home medication need to be robust and should be easy to use. In addition, the manipulation and general handling of the device and its components should be clear and easy to understand. Such injection devices should provide for the setting and subsequent distribution of doses of equal or variable sizes. In addition, the dose setting and dose distribution procedures must be easy to operate and must be clear and unambiguous.

[0004] Patients with certain diseases may require a certain amount of medication to be injected via a pen-type syringe.

[0005] Some drug delivery devices or injection devices are capable of selecting variable-sized doses of medication and injecting a previously set dose. Other injection devices provide fixed dose setting and dispensing. In this case, the amount of medication that should be injected according to a given prescription schedule is always the same and does not change over time or cannot be changed.

[0006] Some injection devices are implemented as reusable injection devices, allowing users to replace medication containers (such as cartridges). Other injection devices are implemented as disposable injection devices. For disposable injection devices, it is intended that the entire injection device be discarded when the contents (i.e., medication) have been used up.

[0007] In order to control and monitor the administration of medicaments by users or patients themselves, it is desirable to provide automatic detection and recording of repeated and regular use of drug delivery devices. Especially for fixed dose injection devices, which typically provide a simple and fairly effective method of delivering many drug therapies, recording the dose injected by the user will provide significant advantages over manual dose recording in terms of safety and convenience.

[0008] Some injection devices or additional devices configured for use with injection devices provide electronic detection and monitoring of repeated dose injection procedures. Here, the user may need some training to correctly use such detection or monitoring functions. Therefore, a specific object is to provide intuitive and fairly easy monitoring or recording of the operation of the injection device. Summary of the invention

[0009] By way of example, the present disclosure relates to a sensor assembly for detecting, identifying, characterizing and / or measuring the operation of an injection device. The sensor assembly includes a sensor element that is attachable to an injection device and includes a one-dimensional or two-dimensional sensing surface. The sensing surface includes a plurality of touch-sensitive sensor segments. The sensor assembly further includes a processor that is connectable to the sensor element. The processor is operable to detect a sensing area on the sensing surface when the sensing surface is in contact with a body part of a user.

[0010] The processor is operable to detect changes in the sensing area over time, and the processor is further operable to identify, detect, characterize and / or measure operation of the injection device based on the detected changes in the sensing area.

[0011] The sensing area is typically defined by a portion of the sensing surface of the sensor element that is in contact with a body part of the user. In this case, the sensing area may define a contact area or touch area of ​​the sensing surface that is in contact with a body part (e.g., a user's finger) or may coincide with it.

[0012] By monitoring temporal changes in the sensing region during, for example, a single and / or predefined operation of the injection device, the processor may be operable to characterize, identify, detect and / or measure a particular operation of the injection device.

[0013] According to further examples, 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 in a non-overlapping manner. They can be arranged adjacent to each other in a regular or irregular manner. For some examples, the entire sensing surface is covered and / or occupied by multiple sensor segments. The sensor segments can have equal or unequal sizes.

[0014] For some examples, the touch-sensitive sensor segments are not coupled to each other. Each touch-sensitive sensor segment can operate independently of any other touch-sensitive sensor segment of the sensing surface. Thus, the touch-sensitive sensor segments can then be operable to individually generate electrical touch signals when touched by a body part of a user.

[0015] The sensor segments may belong to or may constitute a touch-sensitive matrix, such as a one-dimensional or two-dimensional array of touch-sensitive segments. The touch-sensitive segments may each include a capacitor or a resistor operable to generate or modify an electrical signal in response to, for example, physical contact with a body part of a user. In this case, the plurality of touch-sensitive sensor segments forms or constitutes a spatially resolved touch-sensitive sensor.

[0016] For further examples, the touch-sensitive surface or touch-sensitive matrix includes a matrix of resistive elements that change their measurable resistance when, for example, touched by a user. For other examples, the touch-sensitive surface or touch-sensitive matrix includes a matrix of capacitive elements that are operable to change their measurable capacitance when, for example, touched by a user.

[0017] For a further example, the touch-sensitive surface or touch-sensitive matrix comprises a combination of resistive sensor segments and capacitive sensor segments.Capacitive sensors exhibit a relatively low level of power consumption.

[0018] For a further example, the touch-sensitive surface or the touch-sensitive matrix is ​​based on surface acoustic wave technology relying on acoustic waves. Accordingly, the touch-sensitive surface or the touch-sensitive matrix comprises at least one pair of acoustic wave transducers and acoustic wave receivers.

[0019] For another example, the touch-sensitive surface or touch-sensitive matrix includes a plurality of optical sensors, such as photodetectors or photodiodes.

[0020] For a further example, the touch-sensitive surface or the touch-sensitive matrix comprises an ultrasonic sensor.The optical sensor and / or the ultrasonic sensor may also be implemented as a fingerprint sensor capable of distinguishing a feature fingerprint of a first user from a feature fingerprint of a second user.

[0021] For some examples, the sensor element may be attached to a user-actuable part of the injection device. It may be attachable or may be attached to a surface of an actuating element or a manipulation element that is typically touched, manipulated or actuated by a user when using or operating the injection device. The sensor element may also be integrated into the surface of the actuating element or the manipulation element. The user-actuable part may be part of at least one of a sleeve-shaped housing component, a trigger or a dose dial of the injection device.

[0022] For some examples, the processor may be operable to detect a point in time when an injection is initiated. The processor may detect a point in time when an injection procedure is terminated. The processor may further be operable to detect or measure a duration of contact of the sensor element or sensing surface with a body part of a user. In this case, the processor may be operable to measure or determine a duration of operation of the injection device. Furthermore, by evaluating and processing temporal variations of the electrical touch signal and / or by monitoring and / or evaluating temporal variations of the sensing area, the processor and therefore the sensor assembly may be operable to distinguish between different operating modes of the injection device.

[0023] Depending on the temporal variation of the electrical touch signal and / or depending on the variation of the sensing area, the processor may be operable to automatically distinguish, for example, a dose setting procedure from a dose dispensing or dose injection procedure.

[0024] For some examples, the processor may further be operable to detect or characterize a holding operation of the injection device. Here, the processor may be operable to detect and / or monitor a time interval or a specific duration at the end of a dose injection procedure during which the injection needle should remain in the patient's skin.

[0025] According to a further example, at least one of the touch-sensitive sensor segments is operable to generate a different electrical touch signal in response to a change in the pressure applied to the touch-sensitive sensor segment. In this case, the electrical touch signal to be generated by the touch-sensitive sensor segment varies with the pressure applied, for example, by a body part of a user that is touching or contacting this particular touch-sensitive sensor segment.

[0026] In response to changes in pressure applied to the touch-sensitive sensor segment, the electrical touch signal may differ in amount or amplitude. In addition, the electrical touch signal may change its sign or may change its frequency or periodicity. In response to changing pressure applied to the touch-sensitive sensor segment, the respective sensor segment may be operable to change the electrical touch signal in a measurable manner, i.e., in a manner detectable or processable by a processor connected or connectable to the touch-sensitive sensor segment.

[0027] For some examples, the plurality of touch-sensitive sensor segments are operable to generate different electrical touch signals in response to changes in pressure applied thereto. For some examples, the touch-sensitive sensor segments of the sensing surface are operable to provide and / or generate changes in corresponding electrical touch signals in response to changes in pressure applied to the corresponding touch-sensitive sensor segments.

[0028] For 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. According to a default condition, the touch-sensitive sensor segment can be operable to generate a first electrical touch signal in response to a first pressure applied to the touch-sensitive sensor segment. Here, if the first pressure applied to the touch-sensitive sensor segment is above a first predefined threshold, the first electrical touch signal can be generated.

[0029] The touch sensitive sensor segment may be further operable to generate a second electrical touch signal that is different from the first electrical touch signal in at least one of amount, amplitude, sign or frequency. The second electrical touch signal may be generated when the pressure applied to the touch sensitive sensor segment is equal to or higher than a second predefined threshold. Typically, the second threshold is higher than the first threshold.

[0030] In this case, the first electrical touch signal and the second electrical touch signal may indicate a relatively low pressure and a relatively high pressure, respectively, applied to the corresponding touch-sensitive sensor segment.

[0031] For further example, the touch-sensitive sensor segment or segments are operable to generate a variety of different electrical touch signals. It is contemplated that the touch-sensitive sensor segment is 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 indicates a respective first, second, third, fourth, fifth, sixth, or eighth pressure applied to the respective touch-sensitive sensor segment.

[0032] For further example, the touch-sensitive sensor segment may be operable to generate an electrical touch signal that gradually changes as the pressure applied to the corresponding touch-sensitive sensor segment changes. Here, the electrical touch signal may directly represent the applied pressure.

[0033] According to a further example, the touch-sensitive sensor segments of the sensing surface are operable to generate different electrical touch signals in response to changes in pressure applied to the respective touch-sensitive sensor segments. For some examples, all touch-sensitive sensor segments of the sensing surface are operable to generate different or varying electrical touch signals in response to changes in pressure applied to the respective touch-sensitive sensor segments.

[0034] For some examples, where touch-sensitive sensor segments are arranged adjacently or proximate to each other on a one-dimensional or two-dimensional sensing surface of a sensor element, the entire sensing surface may become touch-sensitive.

[0035] Depending on the number and size of the touch sensitive sensor segments distributed over the sensing surface, an accurate and fairly detailed spatially resolved pressure distribution of or across the sensing surface of the sensor element can be provided. In this way, the sensor assembly is operable to detect or measure a spatially resolved pressure distribution exerted on the sensing surface by a body part of a user.

[0036] A spatially resolved pressure distribution and / or a temporal variation of such a spatially resolved pressure distribution may be indicative of a specific operation of the injection device.

[0037] According to a further example, the processor is operable to process the electrical touch signals of the plurality of touch-sensitive sensor segments to identify a sensing area of ​​the sensing surface that is touched by the body part. Typically, and when a finger is used as a body part to make contact with the sensing surface of the sensor element, the corresponding touch-sensitive sensor segment will be able to detect the pressure applied by the corresponding body part. In this way, during or for operation of the injection device, all touch-sensitive sensor segments that are in mechanical contact with the body part may generate corresponding electrical touch signals.

[0038] By processing the signals of these touch-sensitive sensor segments simultaneously, the processor can provide or confirm the sensing area on the sensing surface that is actually in contact or mechanical contact with the user's body part. In this way, the processor can be operated to detect whether the middle part or the border area of ​​the sensing surface is actually touched by the body part.

[0039] In addition, the processor may be operable to detect or measure the size of the sensing area. By identifying or determining 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 a fairly accurate and spatially resolved monitoring of how the user's body part touches the sensor element.

[0040] According to a further example, the processor is operable to detect movement of the sensing area on the sensing surface. In the event that a body part of the user itself is subjected to movement during operation of the injection device (e.g. during setting of a dose or during injection of a dose), movement of the body part, e.g. relative to a housing of the injection device, may be accompanied by measurable movement of the body part relative to the sensor element and hence relative to the sensing surface. Here, a body part of the user (e.g. a finger or thumb) may be subjected to a grinding motion or a natural rolling motion during operation of the injection device.

[0041] Such movement of the body part relative to the sensor element can cause movement of the sensing area touched by the body part on the sensing surface. Movement of the body part relative to the sensor element can cause activation and deactivation of multiple touch-sensitive sensor segments spatially distributed on the sensing surface of the sensor element. This results in a measurable change in the change of the electrical touch signal and a corresponding change in the sensing area that can be measured by the processor.

[0042] By evaluating and processing the electrical touch signals generated by the touch-sensitive sensor segments during respective operation of the injection device, the processor may detect movement of the sensing area on the sensing surface. By detecting such movement of the sensing area, the sensor assembly may identify or characterize the operation of the injection device. Here, the sensor assembly and therefore its processor may be operable to distinguish between different operating modes of the injection device by evaluating measurable movement of the sensing area on the sensing surface.

[0043] 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 caused by a change in the pressure applied by the body part to the sensor element. Since the body part may include a certain elasticity and may further include a relatively convex outwardly facing structure or surface, 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 cause an increase in the size of the sensing area on the sensing surface.

[0044] Thus, detecting a change in the size of the sensing area during operation of the injection device may indicate a change in the pressure applied by the user to the sensor element. For some examples, a change in size measurable by the processor and a change in the type, amount, amplitude, sign, or frequency of the electrical touch signal generated by the touch-sensitive sensor segment may be processed in a combined manner. In this case, a change in the pressure applied by a body part to the sensor element 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 touch-sensitive sensor segment.

[0045] Here, changes in the pressure applied by the body part can be monitored or detected in a dual manner. Thus, changes in the pressure applied to the sensor element can be measured or determined in at least two different ways, thereby increasing or providing redundancy of the measurement system provided by the sensor assembly.

[0046] According to a further example, the processor is operable to detect a change in the geometry of the sensing area on the sensing surface and / or to detect a change in the orientation of the sensing area. In this way, further operating modes may be detected and evaluated during which the user's body part undergoes movement or change relative to the sensor element. Changes in the geometry or orientation of the sensing area on the sensing surface (which are typically detected by corresponding changes in the electrical touch signals generated by the plurality of touch-sensitive sensor segments) may further indicate a specific usage scenario of the injection device.

[0047] The sensor assembly is operable to detect, identify, characterize and / or measure different operations and modes of operation of the injection device by electronically detecting and / or by electronically and quantitatively measuring at least one of movement of the sensing area, change in size of the sensing area, change in geometry of the sensing area on the sensing surface and / or change in orientation. By evaluating movement of the sensing area during operation of the injection device and / or by evaluating changes in size, geometry or orientation of the sensing area on the sensing surface when the injection device is operated by a user, the sensor assembly may automatically identify a particular mode of operation of the injection device.

[0048] According to a further example, the sensor element comprises a planar sensing surface configured for fastening to an end face of a trigger of an injection device. The planar sensing surface may comprise a plurality of touch-sensitive sensor segments positioned adjacent to each other on the planar sensing surface. For some examples, the entire planar sensing surface may be filled with or occupied by adjacently arranged sensor segments. In this case, the entire planar sensing surface may be implemented as the touch-sensitive sensing surface of the sensor element.

[0049] The planar sensing surface may cover the entire end face of the trigger of the injection device. Typically, the trigger is configured to be pressed by a user's finger to initiate and / or control an injection procedure performed by the injection device. By applying 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 integrated into the trigger of the injection device.

[0050] For another example, the planar sensing surface may be configured to be fastened to an end face of an auxiliary trigger of an attachment configured to be fastened to an injection device. The auxiliary trigger may mimic the trigger of the injection device and may be operably engaged with the trigger of the injection device when the attachment is attached or fastened to the injection device. Here, the auxiliary trigger may replace or supersede the function of the original trigger of the injection device.

[0051] The additional device may cover the trigger section of the injection device. The auxiliary trigger may be directly or indirectly operably engaged with the trigger of the injection device, so that by pressing or actuating the auxiliary trigger of the additional device, the trigger of the injection device will be actuated respectively. By implementing the sensor assembly onto or into the additional device, the planar sensing surface may be fastened or integrated to the end face of such an auxiliary trigger of the additional device.

[0052] For some examples, the planar sensing surface may be integrated into the end face of the trigger or auxiliary trigger. It may be fastened to the end face of the trigger or may be integrated into the end face of the trigger. By attaching or integrating the planar sensing surface to the end face of the trigger, a fairly integrated solution for implementing or integrating the sensor assembly into or onto an injection device or at an additional device may be provided.

[0053] According to a further example, the sensor element comprises a tubular shaped sensing surface configured for fastening to a tubular member of an injection device. For this example, the sensor element may be configured to surround or at least partially surround a tubular shaped structure or tubular member of an injection device, such as a dose dial or housing component of the injection device.

[0054] For some examples, the tubular shaped sensing surface of the sensor element is configured to encapsulate the outer surface of a tubular shaped dose dial of an injection device. A single size dose of the injection device can be set by a user by using the dose dial and rotating the dose dial relative to the body or housing of the injection device in a dose increasing direction or a dose decreasing direction. By having the tubular shaped sensing surface mounted or integrated on the outside of the dose dial, such a dose dialing program can be accurately detected, identified, characterized or even quantitatively measured by the sensor assembly.

[0055] For other examples, the tubular shaped sensing surface may be attached or securable to the outer surface of a tubular shaped housing component of an injection device. The housing component may be grasped by hand (e.g., with the palm of a hand or multiple fingers of a user of the injection device) to prepare and / or perform a dose injection procedure. Also here, and by having a sensor element on the outer surface of the tubular shaped body or housing of the injection device, manipulation or operation of the injection device by the user may be accurately detected, characterized, identified or measured.

[0056] According to a further example, the sensor element comprises a planar sensing surface and further comprises a tubular shaped sensing surface. The sensor element may comprise a cup-shaped structure comprising a planar sensing surface at a longitudinal end, the planar sensing surface adjoining the tubular shaped sensing surface, the tubular shaped sensing surface forming a side wall of the cup-shaped sensor element. Such a sensor element may be operable or configured for attachment to a dose member of an injection device, wherein the dose member is implemented as a combined dose dial and trigger. Here, by rotating the dose member, a dose of variable size may be set, and by pressing the dose member, the injection process may be triggered and / or controlled.

[0057] According to a further example, the sensor element comprises a flexible sheet configured to be wrapped around the tubular member of the injection device. The sensor element may comprise a planar substrate made of a flexible sheet, such as a flexible foil. The planar substrate may be flexible and / or foldable or rollable into a tubular shape.

[0058] The flexible sheet or substrate may be provided with a plurality of touch sensitive sensor segments. The pliable or flexible sheet can be wrapped around the tubular member of the injection device. The flexible sheet of the sensor element and the touch sensitive sensor segments attached or mounted on the flexible sheet allow the sensor element to be used with various different sized tubular members of the injection device.

[0059] The sensor element can be universally applicable to tubular members of different sizes. By means of the flexible sheet, the entire sensor element can be flexible and can be easily fixed to the tubular member of the injection device. It can be adhesively attached to the outer surface of the tubular member and can provide a spatially resolved touch-sensitive area on the outside of the tubular member, for example on the outside of the housing of the injection device.

[0060] The same applies to the attachment device, but assuming that the attachment device comprises a tubular member, for example for fastening or snapping around a housing of an injection device.

[0061] According to a further example, the tubular member of the injection device is a dose dial which is rotatable relative to the body of the injection device for setting a dose. By attaching the flexible sensor element to the dose dial, a dose dialing or dose setting operation by a user of the injection device (thereby rotating the dose dial relative to the body or housing of the injection device) may be detected, identified, characterized or quantitatively measured by the sensor assembly.

[0062] According to further examples, the tubular member is the body of the injection device. For some examples, the body of the injection device includes an elongated tubular sleeve. The size of the body can be determined to accommodate a drive mechanism for discharging or extracting a dose of medicament from a medicament container. For some examples, a medicament or medicament container (e.g., a syringe or cartridge embodied as a liquid medicament) can also be arranged inside the body or housing of the injection device.

[0063] According to a further example, the tubular member is a clip configured for detachable fastening to an injection device.Herein, the tubular member may be embodied as a part of an additional device configured for fastening to a housing of an injection device.

[0064] For a further example of the sensor assembly, the processor may be operable to detect at least 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 plurality of electrical touch signals of the plurality of touch-sensitive sensor segments over time when the sensor element is attached to the injection device or when the sensor element is indirectly attached to the injection device (e.g., via an auxiliary device or an additional device configured to be fastened to the injection device).

[0065] For some examples, the processor is operable to detect at least one of a dose setting operation, a dose dispensing operation or a holding operation of the injection device by processing a temporal change in a sensing area of ​​a sensing surface of the sensor element.

[0066] For further example, and when the dose setting operation is accompanied by a rotation of a tubular member (e.g. a dose dial) of the injection device, such rotation may be detected by a change in an electrical touch signal provided by a touch-sensitive sensor segment provided on a sensing surface of the tubular shape of the sensor element. A dispensing operation (e.g. the start, duration and / or end of a dispensing operation) may typically be detected, identified or characterized by processing the electrical touch signal generated or modified by the touch-sensitive sensor segment of a planar sensing surface, which is typically provided on an end face of a trigger of the injection device or on a corresponding end face of an auxiliary trigger of an additional device.

[0067] In addition, an end-of-dose hold operation of the injection device, i.e. a certain period of time 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 accurately monitored. Here, and during the hold operation at the end of the dose injection procedure, the electrical touch signal generated or modified by the plurality of touch-sensitive sensor segments should be fairly constant.

[0068] According to a further example, the processor is operable to distinguish between an end of a dose setting operation, a dose dispensing operation and a dose holding operation of the injection device by processing a plurality of electrical touch signals of the plurality of touch-sensitive sensor segments over time when the sensor element is attached to the injection device or an additional device (which is itself then attached to the injection device). Each operating mode of the injection device may be characterized by a temporal and / or spatial distribution of the plurality of touch-sensitive sensor segments touched by a body part of a user during the respective operating mode.

[0069] By evaluating such temporal and / or spatial distributions measurable by the sensor assembly, the sensor assembly may be operable and become operable to automatically distinguish between different operating modes of the injection device. In this case, the sensor assembly may be equipped with automatic operating mode detection of the injection device, thereby simplifying the use of the sensor assembly and improving the accuracy of continuous injection monitoring or injection recording over time.

[0070] According to a further example, the sensor assembly comprises a clock or a clock generator connected to the processor. In this way, the processor is operable to detect or measure at least one of a point in time when the user operates the injection device and a duration for which the user operates the injection device. By providing the processor with a clock, corresponding points in time or durations at which the processor detects a specific electrical touch signal or a sensing area change indicating, for example, the start or termination of at least one of a dose setting operation and a dose dispensing operation can be detected or recorded.

[0071] According to a further example, the sensor assembly comprises a memory connected or coupled to the processor. The processor is operable to store usage-related data in the memory, wherein the data comprises at least one of the following: a time point when the injection device is operated, a duration of operation of the device, and a size of a dose of a medicament set or injected by the injection device. All these parameters (time point, duration and dose size information) can be obtained from a change in the electrical touch signal, or based on a change in a sensing area detectable by a processor connected to the sensor element.

[0072] According to a further example, the processor, clock and memory may be operable to automatically store or automatically monitor and / or record a user-induced sequence of operations 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.

[0073] According to a further example, the processor may be provided with a wake-up function. Here, the processor may automatically switch to a sleep mode, for example when it is determined that the sensor element and its sensing surface have not been touched within a predefined time interval. Upon detecting an initial contact with the sensing surface of the sensor element, the processor may switch to an active mode and may wake up accordingly. By providing the processor with a sleep function, energy provided to the sensor assembly may be saved. Accordingly, the battery life of the sensor assembly may thus be extended.

[0074] 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.

[0075] For further examples, the sensor assembly is provided with a transceiver. The transceiver may be operable to communicate with an external electronic device (e.g., with a smart watch, a smart phone, or a tablet computer). The transceiver may be implemented as a wireless transceiver. The transceiver may be operable to establish a communication link with the external electronic device. For some examples, the transceiver may be operable to collect energy from the external electronic device. In this case, the transceiver may also be used as a power source for providing power to the sensor assembly.

[0076] According to a further example, the sensor assembly comprises 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. Through the signal generator, the sensor assembly may be operable to communicate directly with a user of the injection device. In this way, the sensor assembly may provide feedback such as confirmation to the user, indicating, for example, that a particular operation of the injection device caused by the user has been monitored or has not been correctly monitored. The signal generator may be operable to provide and / or generate visual signals of different colors and / or different and varying durations.

[0077] For other examples, the signal generator may be operable to generate an acoustic signal, such as an audible sound.Herein, the signal generator may be operable to provide different and distinguishable sound signals, for example, indicating successful or unsuccessful detection or measurement of a user-induced action of the injection device.

[0078] A haptically implemented signal generator may be configured to generate a vibration that is detectable, eg, perceptible, by a user.

[0079] For further example, the sensor assembly may include a reminder function. Here, the memory of the sensor assembly may be equipped with a predefined medication schedule for a specific patient. Accordingly, and when an injection may be due, the processor may prompt the signal generator to generate a user-perceivable signal to remind the user to perform or execute the injection procedure.

[0080] For further example, the sensor assembly includes a position sensor and / or an acceleration sensor. The position sensor may be integrated into the sensor assembly or may be integrated into the injection device. The position sensor may be operably connected to a component of the drive mechanism of the injection device that indicates the dose size currently set or dispensed. The position and / or orientation of the position sensor may further indicate the amount of medicament provided in the cartridge. In this way, the position sensor may provide quantitative data indicating the dose size.

[0081] For further example and when an acceleration sensor is provided, the sensor assembly can further detect or measure specific movement or acceleration of the sensor assembly, for example indicating a specific gesture made by the user when holding the sensor assembly. Through the acceleration sensor, the operation mode of the injection device can be detected accordingly.

[0082] Via the transceiver, the sensor assembly can exchange measured data with an external electronic device. The memory of the sensor assembly is typically configured to store usage-related data of the injection device. When a communication link is established with the external electronic device, the sensor assembly, and therefore the memory of the sensor assembly, can be synchronized with the external electronic device, which can provide further processing of the data and / or transmission of the data, for example, to a healthcare provider.

[0083] For some examples, the sensor assembly may be provided with a display, for example, operable to visually indicate usage-specific or user-specific information to a user of the injection device. The display may be implemented into the sensor element. In this case, the sensor element may be implemented as a touch-sensitive display.

[0084] In this case, the touch-sensitive sensor segments may represent individual pixels of the touch-sensitive display. The touch-sensitive sensor segments may coincide with pixels of the touch-sensitive display.

[0085] The sensor element, in particular its sensing surface, may be provided with a reconfigurable electronic display, for example operable to provide visual content to a user of the attachment device or injection device, respectively. In this case, the sensor element and the sensor assembly provide a dual function. It is operable to receive input from a user and to provide information to the user.

[0086] For some examples, the sensor assembly may be operable to provide a visual indication on the sensing surface, such as a number of doses actually set or a number of doses to be set. The sensor assembly may support the patient during setting the dose and during injecting the dose. The sensor assembly, in particular its touch-sensitive display, may be operable to provide visual symbols, numbers and / or text to guide and / or assist the user in using the attachment or injection device.

[0087] 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, submit data between the attachment and the external electronic device, and / or notify the user when the next injection is due.

[0088] Furthermore, the touch-sensitive display may be operable to visually indicate specific portions of the sensing surface that should be touched by the user.

[0089] The touch-sensitive display can provide static information as well as dynamic information. For some examples, the touch-sensitive display of the sensor assembly can be operable to dynamically and visually display the movement of the user's finger on the sensing surface of the sensor assembly. Here, the user can even be instructed how to touch, tap or swipe the sensing surface of the sensor element.

[0090] According to a further example, the sensor assembly includes a clock and a memory connected to a processor. The processor is operable to monitor the temporal variation of the electrical touch signal during a specific operation of the injection device. The processor is further operable to store the temporal variation of the electrical touch signal as a touch signal profile in the memory and assign the specific operation of the injection device to the touch signal profile.

[0091] Such operation of the sensor assembly or functionality of the sensor assembly may represent a training mode, wherein a user may train the sensor assembly to assign or map a measurable or derivable touch signal profile to one of a plurality of user-specific operations of the injection device.

[0092] In this case, the sensor assembly can be switched between the training mode and the sensing mode. In this way, the sensor assembly can be adapted to the respective different operating modes of different users of the injection device. Thus, the sensor assembly can be adapted to different user-specific habits and behaviors, which may be different for each user of the injection device.

[0093] According to a further example, the processor is operable to detect a temporal variation of the electrical touch signal during operation of the injection device, and to generate an operation profile based on the detected temporal variation of the electrical touch signal. The processor is further operable to compare the operation profile with a plurality of touch signal profiles previously stored in a memory. The processor is further operable to select from the memory one touch signal profile that has the best match to the actually measured operation profile, and to select the injection device-specific operation that was previously assigned the selected touch signal profile as the identified operation of the injection device.

[0094] Here, the processor and therefore the sensor assembly is operable to utilize touch signal profiles previously stored in memory. The separately trained touch signal profiles can be used to assign and map predefined operations or specific operations of the injection device to the actual measured operating profiles. In this way, the sensor assembly and / or its processor is operable to distinguish between different operating modes of the injection device simply by comparing the actual measured operating profiles with the previously stored touch signal profiles.

[0095] In another aspect, the present disclosure also relates to an injection device for injecting a dose of a medicament. The injection device comprises a body for accommodating a drive mechanism operable to extract or discharge a medicament from a medicament container. Typically, the drive mechanism is operable to inject or discharge a dose of a medicament from a medicament container. The injection device further comprises at least one of a dose dial and a trigger, which can be actuated by a user for injection and / or setting a dose.

[0096] The injection device further comprises a sensor assembly as described above. The sensor assembly is attached to or integrated into at least one of the body, the dose dial and the trigger of the injection device. By attaching or integrating the sensor assembly into at least one of the body, the dose dial and the trigger, a fairly accurate and quasi-automatic detection, identification, characterization and measurement of user-induced operation of the injection device can be provided.

[0097] The injection device may be implemented as a pen-type injector. It may be implemented as a disposable injection device or a reusable injection device. For some examples, the injection device may include a dial extension that is subjected to longitudinal and rotational or spiral motion during dose setting and at least longitudinal sliding motion during dose injection. For other examples, the injection device has no so-called dial extension. Here, the dose dial and / or the trigger may be arranged, for example, at the proximal end of the housing of the injection device. The dose member (e.g. in the form of a combined dose dial and trigger) may be rotated relative to the body or housing of the injection device for setting the dose and may, for example, be pressed by the thumb of a user for injecting the dose.

[0098] For another example, the injection device is implemented as a so-called autoinjector. Here, the user can simply hold the body of the injection device and press the body of the injection device and thus the distal end of the injection device against a portion of the skin, thereby causing a fairly automated injection procedure during which the injection needle is pushed into the skin and a dose of the medicament is subsequently dispensed or injected.

[0099] According to another aspect, the present disclosure also relates to an attachment configured to be fastened to an injection device. The attachment comprises a device body and a fastener for fastening the device body to at least one of a body, a dose dial and a trigger of the injection device. The attachment comprises a sensor assembly as described above. In this case, the entire functionality of the sensor assembly can be integrated into the attachment. Typically, and when correctly attached to the injection device, the attachment provides for setting and / or injection of a dose, for example by providing or including at least one of an auxiliary dose dial and / or an auxiliary trigger, which can be operably engaged with the dose dial and / or trigger of the injection device when the attachment is correctly assembled or attached to the injection device.

[0100] In this case, all features, effects and benefits described above in conjunction with the sensor assembly are equally applicable to the injection device and the additional device, respectively.

[0101] According to another aspect, the present disclosure also relates to a method for identifying, detecting, characterizing and / or measuring the operation of an injection device. The method comprises the following steps: attaching or integrating a sensor element or a sensor assembly as described above to or in one of an injection device and an additional device as described above, wherein the additional device is configured to be fastened to the injection device or another injection device, such as an injection device without a sensor assembly as described above.

[0102] The method further comprises the step of generating a plurality of electrical touch signals in response to a body part of a user touching the sensing surface of the sensor element.Alternatively, the method comprises the step of detecting or confirming a sensing area of ​​the sensing surface being touched or in contact with a body part of the user.

[0103] As a further step, the method comprises detecting a change in the electrical touch signal over time, and identifying, detecting, characterizing or measuring an operation of the injection device based on the time change in the electrical touch signal(s).

[0104] Alternatively, and for another example, the method includes the steps of detecting changes in the sensing region over time, and detecting, identifying, characterizing or measuring operation of the injection device based on the temporal changes in the sensing region.

[0105] Typically, the method for detecting, identifying, characterizing and / or measuring the operation of an injection device will be performed by an injection device as described above and / or by using an additional device as described above. Specifically, the method will be performed by a sensor assembly as described above. In this case, all features, effects and benefits described above in conjunction with the sensor assembly, the injection device and / or the additional device are equally applicable to the method for detecting, identifying, characterizing or measuring the operation of an injection device; and vice versa.

[0106] In another aspect, the present disclosure also relates to a computer program, the computer program comprising computer readable instructions, which when executed by a processor of a sensor assembly as described above, causes the processor to detect changes over time in an electrical touch signal generated by a touch-sensitive sensor segment of a sensing surface of a sensor element of the sensor assembly when touched by a body part of a user. The computer program further causes the processor to detect, identify, characterize and / or measure operation of an injection device based on the temporal changes in the electrical touch signal.

[0107] According to a further example, the computer program may be configured or operable to cause the processor to detect changes in a sensing area of ​​the sensing surface touched by a body part, and detect, identify, characterize and / or measure operation of the injection device based on temporal changes in the sensing area measurable by the sensor assembly.

[0108] The present disclosure further discloses and proposes a computer program, which includes computer executable instructions for implementing the method according to the method / device / system disclosed in one or more examples contained herein when the program is executed on a processor, a computer or a computer network. In particular, the computer program can be stored on a computer-readable data carrier. Thus, in particular, one, more than one or even all of the method steps indicated above can be performed by using a computer or a computer network (typically by using a computer program).

[0109] The present disclosure further discloses and proposes a computer program product with program code means, so that when the program is executed on a computer or a computer network, the method / system disclosed in one or more embodiments contained herein is implemented. Specifically, the program code means can be stored on a computer readable data carrier.

[0110] Furthermore, the present disclosure discloses and proposes a data carrier having a data structure stored thereon, which, after being loaded into a processor, a computer or a computer network, such as loaded into a working memory or a main memory of the processor, the computer or the computer network, can execute a method according to one or more examples disclosed herein.

[0111] The present disclosure further proposes and discloses a computer program product having a program code device stored on a machine-readable carrier, so that when the program is executed on a processor, a computer or a computer network, the method or part thereof according to one or more examples disclosed herein is implemented. As used herein, the computer program product refers to the program as a tradable product. The product can generally exist in any format (such as paper format) or on a computer-readable data carrier. Specifically, the computer program product can be distributed on a data network.

[0112] For another example, a modulated data signal is proposed and disclosed in the present disclosure, and the modulated data signal contains instructions that can be read by a processor, a computer system, or a computer network, which are used to implement at least a portion of the method according to one or more examples disclosed herein. Preferably, with reference to the computer-implemented aspects of the present disclosure, one or more method steps or even all method steps of the method according to one or more examples disclosed herein can be implemented by using a processor, a computer, or a computer network. Therefore, generally, any method step including collecting, providing and / or manipulating data can be performed by using a processor, a computer, or a computer network. Generally, these method steps can include any method steps, typically except for method steps that require manual work, such as providing samples and / or performing certain aspects of actual measurement.

[0113] Specifically, the present disclosure further discloses a computer or computer network, which includes: at least one processor, wherein the processor is suitable for executing a method according to one of the examples described in this specification; a computer-loadable data structure, which is suitable for executing a method according to one of the examples described in this specification when the data structure is executed on the processor or computer; and a computer program, wherein the computer program is suitable for executing a method according to one of the embodiments described in this specification when the program is executed on a computer.

[0114] Generally, the scope of the present disclosure is defined by the content 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. In this case, the present disclosure covers any combination of claims and any technically feasible combination of features disclosed in combination with different examples or embodiments.

[0115] In this context, the term "distal" or "distal end" refers to the end of the injection device that faces the injection site of a human or animal. The term "proximal" or "proximal end" refers to the opposite end of the injection device that is farthest from the injection site of a human or animal.

[0116] The terms "drug" or "medicament" are used synonymously herein and describe a pharmaceutical preparation comprising one or more active pharmaceutical ingredients or a pharmaceutically acceptable salt or solvate thereof and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient ("API") is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used to treat, cure, prevent, or diagnose disease or to otherwise enhance physical or mental health. A drug or medicament may be used for a limited duration, or periodically for a chronic disorder.

[0117] As described below, a drug or medicament may include at least one API or a combination thereof in different types of formulations for treating one or more diseases. Examples of APIs may include small molecules (having a molecular weight of 500 Da or less); polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids (such as antisense DNA and RNA), small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems (such as vectors, plasmids, or liposomes). Mixtures of one or more drugs are also contemplated.

[0118] The drug or medicament can be included in a primary package or "drug container" suitable for use with a drug delivery device. The drug container can be, for example, a cartridge, a syringe, a reservoir or other solid or flexible vessel, which is configured to provide a suitable chamber for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chamber can be designed to store the drug for about 1 month to about 2 years. It can be stored at room temperature (e.g., about 20 ° C) or refrigerated temperature (e.g., about -4 ° C to about 4 ° C). In some cases, the drug container can be or can include a dual-chamber cartridge, which is configured to store two or more components (e.g., API and diluent, or two different drugs) of the pharmaceutical preparation to be applied separately, one of which is stored in each chamber. In such a case, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components before and / or during distribution to the human or animal body. For example, the two chambers may be configured so that they are in fluid communication with each other (e.g., via a conduit between the two chambers) and allow the user to mix the two components if desired prior to dispensing. Alternatively or additionally, the two chambers may be configured to allow mixing when dispensing the components into a human or animal body.

[0119] The drugs or medicaments contained in the drug delivery devices as described herein can be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes (such as diabetic retinopathy), thromboembolic disorders (such as deep vein or pulmonary thromboembolism). Further examples of disorders are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, tumors, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are examples as described in the following manuals: such as Rote Liste 2014 (for example, but not limited to, main group 12 (antidiabetic drugs) or 86 (oncology drugs)) and Merck Index, 15th edition.

[0120] Examples of APIs for treating and / or preventing type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixtures thereof. As used herein, the terms "analogs" and "derivatives" refer to polypeptides having a molecular structure that can be formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deleting and / or exchanging at least one amino acid residue present in a naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residues can be 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 that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Alternatively, one or more amino acids present in the naturally occurring peptide may have been deleted and / or replaced by other amino acids (including non-encodable amino acids), or amino acids (including non-encodable amino acids) have been added to the naturally occurring peptide.

[0121] Examples of insulin analogs 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 at position B28 is replaced by Asp, Lys, Leu, Val or Ala and in which the Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0122] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, ); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (degludec insulin, ); B29-N-(N-lithocholyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0123] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are e.g. lixisenatide Exendin-4 A 39-amino acid peptide produced by the salivary glands of the Gila monster), liraglutide Semaglutide, tasmoglutide, albiglutide Dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211, CM-3, GLP-1Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924 , NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA- 3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Telportide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-Xten.

[0124] Examples of oligonucleotides are: Cholesterol reducing antisense therapeutics 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.

[0125] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory activity peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, chorionic gonadotropin, tocopherol), growth hormone (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin.

[0126] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or ultra low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of a polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20 A sodium hyaluronate.

[0127] 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, which retain the ability to bind antigens. The antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized antibody or a humanized antibody, a fully human antibody, a non-human (e.g., mouse) antibody or a single-chain antibody. In some embodiments, the antibody has effector functions and can fix complement. In some embodiments, the ability of the antibody to bind to Fc receptors is reduced or there is no such ability. For example, the antibody can be an isotype or subtype, an antibody fragment or a mutant, which does not support binding to Fc receptors, for example, its Fc receptor binding region has been mutated or deleted. The term "antibody" also includes antigen binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins with cross-binding region orientation (CODV).

[0128] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule, which does not include a full-length antibody polypeptide, but still includes at least a portion of a full-length antibody polypeptide that can bind to an antigen. Antibody fragments may include cleavage portions of full-length antibody polypeptides, but the term is not limited to such cleavage fragments. Antibody fragments that can be used 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 antibodies, trivalent antibodies, tetravalent antibodies and multivalent antibodies), mini antibodies, chelated recombinant antibodies, triabodies or biabodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies and antibodies containing VHH. Other examples of antigen-binding antibody fragments are known in the art.

[0129] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the correct positioning of the CDR sequences to allow antigen binding. Although the framework region itself is typically not directly involved in antigen binding as known in the art, certain residues within the framework region of certain antibodies may be directly involved in antigen binding or may affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0130] Examples of antibodies are anti-PCSK-9 mAb (eg, alirocumab), anti-IL-6 mAb (eg, salilumab), and anti-IL-4 mAb (eg, dupilumab).

[0131] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0132] Those skilled in the art will appreciate that modifications (additions and / or removals) may be made to the various components, formulations, apparatuses, methods, systems and embodiments of the API described herein without departing from the overall scope and spirit of the invention, and that the invention encompasses such modifications and any and all equivalents thereof.

[0133] An example drug delivery device may involve a needle-based injection system as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems can be broadly divided into multi-dose container systems and single-dose (partially or completely emptied) container systems. The container may be a replaceable container or an integral non-replaceable container.

[0134] As further described in ISO 11608-1:2014(E), a multiple-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container contains multiple doses, the sizes of which may be fixed or variable (pre-set by the user). Another multiple-dose container system may involve a needle-based injection device with an integral non-replaceable container. In such a system, each container contains multiple doses, the sizes of which may be fixed or variable (pre-set by the user).

[0135] As further described in ISO 11608-1:2014 (E), a single dose container system can relate to an injection device based on a needle with a replaceable container. In an example of such a system, each container holds a single dose, wherein the entire deliverable volume is discharged (completely emptied). In another example, each container holds a single dose, wherein a portion of the deliverable volume is discharged (partially emptied). Also as described in ISO 11608-1:2014 (E), a single dose container system can relate to an injection device based on a needle with an integral non-replaceable container. In an example of such a system, each container holds a single dose, wherein the entire deliverable volume is discharged (completely emptied). In another example, each container holds a single dose, wherein a portion of the deliverable volume is discharged (partially emptied). BRIEF DESCRIPTION OF THE DRAWINGS

[0136] In the following, several examples of data recording devices for monitoring the use of injection devices and corresponding injection devices will be described in more detail with reference to the accompanying drawings, in which:

[0137] Figure 1 An example of an injection device is schematically shown,

[0138] Figure 2 schematically illustrates an on device configured to be fastened to an injection device,

[0139] Figure 3 schematically illustrates an example of a cross section through an example of an additional device or an example of a cross section through a part of an injection device,

[0140] Figure 4 shows a block diagram of an electronic module for implementing a sensor assembly,

[0141] Figure 5 An example of a sensor assembly is schematically shown in a perspective view,

[0142] Figure 6 Shows Figure 5 A side view of the sensor assembly.

[0143] Figure 7 Shows Figure 5 A top view of the sensor assembly.

[0144] Figure 8 An example of using a sensor assembly is shown,

[0145] Fig. 9 Examples of dose and sensing areas of sensor assemblies,

[0146] Fig.10 Another example of a sensing area is shown,

[0147] Fig.11 Another example of a sensing area is shown,

[0148] Fig.12 Another example of a sensing area is shown,

[0149] Fig.13 Another example of a sensing area is shown,

[0150] Fig.14 Another example of a sensing area is shown,

[0151] Fig.15 Another example of a sensing area is shown,

[0152] Fig.16 Another example of a sensing area during use of the sensor assembly is shown,

[0153] Fig.17 Another mode of operation of the injection device is schematically shown.

[0154] Fig.18 Another example of using an injection device is shown,

[0155] Fig.19 The operation mode of the injection device for dosage matters is shown.

[0156] Fig. 20 Schematically shows how Fig.19 the sensing area of ​​the sensor assembly during operation of the illustrated injection device,

[0157] Fig.21 Shown in accordance with Fig.19 Another example of a sensing area during operation of an injection device,

[0158] Fig. 22 The user's body parts are schematically shown.

[0159] Fig.23 Another example of a sensor assembly configured to be fastened to an outer surface of a tubular member of an injection device is schematically shown,

[0160] Fig.24 Schematic showing the operation of the injection device before injecting a dose,

[0161] Fig.25 Schematically shows the Fig.24 The operating modes of the sensor assembly include multiple sensing areas,

[0162] Fig.26 schematically illustrates the use of an injection device during and / or for injecting a dose,

[0163] Fig. 27 Schematically shows the Fig.26 multiple sensing regions of the sensor assembly during an operating mode,

[0164] Fig.28 An example of an external electronic device configured to communicate with a sensor assembly is shown, and

[0165] Fig.29 A flow chart of a method for detecting, identifying, characterizing, or measuring the operation of an injection device is presented. DETAILED DESCRIPTION

[0166] Figure 1An example of a drug delivery device 1 is shown, which is implemented as a handheld injection device. The injection device 1 may include or may be implemented as a pen-type injector. It may be implemented as a disposable injection device or a reusable injection device. For some examples, the injection device 1 is implemented as an autoinjector. The injection device 1 has an elongated shape. It may extend along a longitudinal direction. Towards the longitudinal distal direction 2, the drug delivery device 1 comprises a dispensing end for dispensing or injecting a medicament 24. Towards the proximal direction 3, the injection device 1 comprises at least one of a dose member 8 and a trigger 9, by which doses of equal size or individual or different sizes can be set and dispensed, respectively.

[0167] The injection device 1 comprises a housing 10. The housing 10 may comprise a plurality of housing parts, 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 may be sized and configured to accommodate a medicament container 21, which may be implemented, for example, as a cartridge containing a liquid medicament 24. The medicament container 21 comprises a tubular barrel 22, which is sealed towards the distal end by a seal 23. The seal 23 may comprise a pierceable septum fixed to an outlet 25 of the medicament container 21. The interior of the barrel 22 is sealed towards the proximal end by a piston 18 or a stopper, which is slidably disposed in the barrel 22.

[0168] By advancing the piston 18 toward the distal direction 2, a dose of medicament 24 can be discharged from the medicament container 21. In use, the medicament container 21 is arranged inside the cartridge holder 7. The drive mechanism 20 of the injection device 1 includes a piston rod 19, which can be displaced in the distal direction 2 to advance the piston 18 toward the outlet 25 of the medicament container 21. The details of the drive mechanism are not further shown and described here. For some examples, the drive mechanism 20 can be implemented as a full mechanical drive mechanism, wherein the user must provide the entire dispensing force required to move the piston rod 19 and therefore the piston 18 in the distal direction 2. For other examples, the drive mechanism includes a mechanical energy storage device, which is configured to provide at least a portion of the dispensing force. Examples of drive mechanisms can be found in, for example, WO 2004 / 078241A1, WO 2014 / 033197 A1 or WO2014 / 033195 A1, the entire contents of which are incorporated herein by reference.

[0169] For some examples, such as in Figure 8 and 18As described or shown in , the injection device 1 and therefore the drive mechanism 20 may include a dial extension 27 that projects and moves from the proximal end of the body 6 in the proximal direction 3 when or during setting a dose, and returns to its initial distal position during the dose injection procedure. To this end, the user can use the thumb 114 of his hand 110 to exert distally directed pressure on the trigger 9, thereby pushing the dial extension 27 in the distal direction 2 during the dose injection procedure.

[0170] In order to set or dial a dose, the user may, for example, twist or rotate the dose dial 8 in a dose incrementing direction 4, thus in a clockwise direction when viewed from the proximal end. In order to correct a previously set dose, the user may also rotate the dose dial 8 in an opposite dose decrementing direction 5. The size of the dose is typically displayed in a window 26 provided in or on the body 6 of the injection device 1. Before a dose of medicament 24 is injected, the distal end of the cartridge holder 7 must be connected to the needle assembly 12. To this end, the distal end of the cartridge holder 7 comprises a connector 11, for example in the form of a threaded interface, to engage with a complementary shaped threaded mating interface of the needle assembly 12.

[0171] The needle assembly 12 can be detachably or releasably fixed to the cartridge holder 7. It includes a double-pointed injection needle 13. The proximal end of the injection needle (not shown) is configured to enter the through opening at the distal end face of the connector 11 or the cartridge holder 7 so as to pierce or penetrate the seal 23 of the medicament container 21. The distal end of the injection needle 13 is usually covered by a detachable inner needle cap 14. The entire needle assembly 12 can be covered by a detachable outer needle cap 15.

[0172] The cartridge holder 7 and thus a part of the housing 10 will be received in a protective cap 16 which can be detachably connected to the cartridge holder 7 or the body 6 .

[0173] exist Figure 2 and Figure 3 , an example of an attachment 30 configured for fastening to the proximal end of an injection device 1 is shown. The attachment 30 comprises a sensor assembly 80 having a sensor element 81 operable to detect, identify, characterize and / or measure operation of the injection device.

[0174] like Figure 2 and Figure 3 The illustrated additional device 30 is detachably connectable to the dose dial 8. It comprises a device body 60 having a tubular side wall 61. Towards the distal end, the side wall 61 defines a receiving portion 63, which is dimensioned to receive the dose dial 8 and the trigger 9 of the injection device. To this end, the inner side of the side wall 60 may comprise one or more fastening ribs 31, which are configured to provide a non-slip fastening of the additional device 32 to the dose dial 8.

[0175] The receiving portion 63 is defined by a flange portion 62 extending radially inward. The flange portion 62 divides the interior of the device body 60 into a distal receiving portion 63 and a proximal receiving portion 64. The proximal receiving portion 64 is sized to accommodate a support 70 and a cover 75 to accommodate the electronic module 34. The support 70 includes a longitudinally extending rod 71 extending through the flange portion 62 in the distal direction. The support 70 is displaceably mounted in the receiving portion 64. It can move in the distal direction 2 against the action of a return element or several return elements 65. The support 70 is connected to a cup-shaped cover 75, which protrudes from the side wall 61 of the device body 60 in the proximal direction.

[0176] The cover 75 comprises a planar end face 76 facing the proximal direction 3. The end face 76 is provided with a sensor element 81. Figure 3 As shown, the entire end face 76 can be covered by the sensor element 81. In this way, the end face 76 serves as an actuation surface to be pressed by the user (e.g., by the user's thumb 114). The user can exert a distally directed force on the end face 76, thereby pushing the cover 75 and the support 70 in the distal direction 2 against the action of the return element 65.

[0177] When the end face 76 is released, the return element 75 (for example, implemented as a return spring) is used to move the support member 70 and the cover 75 toward the proximal starting position, such as Figure 3 As shown. At least one of the cover 75 and the support 70 includes a radially outwardly extending protrusion 74, which is guided in a longitudinally extending recess 66 on the inner side of the side wall 61 of the device body 60. As seen in the longitudinal direction, the recess 66 is defined by a proximal stop surface 69 and a distal stop surface 67. Figure 3 In the illustrated initial configuration, the projection 74 is in longitudinal abutment with the proximal stop surface 69 of the recess 66 .

[0178] When the cover 75 is pressed in the distal direction 2 against the action of the return element 65, the distal position is reached when the projection 74 engages the distal stop surface 67. By means of the projection 74 guided in the groove 66, the longitudinal movement of the support 70 and the cover 75 can be limited within predetermined limits relative to the device body 60.

[0179] When pressed in the distal direction 2, the support 70 and its rod 71 start to protrude from the flange portion 62. Since the side wall 61 is fixable to the dose dial 8 in the longitudinal direction, a distal longitudinal displacement of the support 70 and its rod 71 serves to act on the trigger 9, thereby causing a distal movement of the trigger 9 relative to the dose dial 8 or the body 6. The cover 75 is fixed to the support 70 with respect to the longitudinal direction. It can be freely rotated relative to the support 70, in particular during a dose injection procedure. During a dose injection, the dose dial 8 can be rotated in the dose decrementing direction 5, while the trigger 9 remains rotationally locked to the dial extension 27 and / or the body 6. Here, the support 70 and / or the cover 75 can form or constitute an auxiliary trigger of the additional device 30.

[0180] Here, the inner side of the side wall of the cover 75 may include at least one of a radial protrusion and a recess 68 to engage with a complementary shaped radial recess or protrusion 72 of the support 70. The cup-shaped cover 75 connected or fastened to the support 70 provides a receiving portion for the electronic module 34, which is arranged in the hollow space formed by the support 70 and the cover 75.

[0181] The sensor assembly 80 as described herein may be somewhat identical or equivalent to the electronic module 34; or vice versa. The electronic module 34 may include a printed circuit board 36. It may further include a transceiver 38, 39, a memory 40, a clock 42, a processor 44, a power supply 46, an acceleration sensor 48, a position sensor 50, a signal generator 51, 52, and, for example, a light source 53, 54. It may also include a microphone.

[0182] Additionally, the sidewall 77 of the cover 75 may include a window 55 that aligns with a corresponding window 56 in the sidewall 61 of the device body 60. In this manner, visual signals that may be generated by the different light sources 53, 54 within the hollow space of the cover 75 may be perceived and visually detected from outside the attachment 30.

[0183] The two light sources 53, 54 may belong to a visual signal generator 52, which is operable to produce or generate visual signals of different colors and / or variable duration. The windows 55, 56 may be provided with light pipes or light guides. In this way, the device body 60 may be protected from dust or moisture ingress.

[0184] exist Figure 4 , a block diagram of an example of an electronic module 34 and / or sensor assembly 80 is shown. Figure 3 As shown, the processor 44 is mounted on the printed circuit board 36 which is connected to a sensor element 81 of a sensor assembly 80 which substantially covers the end surface 76 of the cover 65 .

[0185] Typically, the electronic module 34 may be mounted on a printed circuit board 36. The electronic module 34 may be configured to communicate with an external electronic device 100, such as Fig.28 As shown in . The external electronic device 100 can be implemented as a mobile electronic device. It can include a smart watch, a smart phone or a tablet computer. The electronic module 34 includes a transceiver 38, which is configured to establish or build a communication link between the external electronic device 100 and the electronic module 34. The corresponding communication link can be implemented in a wireless or wired manner.

[0186] The electronic module 34 may be configured to exchange data with an external electronic device 100. Data indicative of the operation of the injection device and acquired or collected by the sensor assembly 80 may be transmitted to the external electronic device via the transceiver 38. The transceiver 38 may be implemented as a Bluetooth transceiver or a BLE transceiver. The further transceiver 39 may be implemented as an NFC transceiver. The two transceivers may be distinguished in terms of their communication protocols and / or their spatial range.

[0187] The electronic module 34 and therefore 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 therefore the sensor assembly 80 further comprises a clock 42 configured to provide a time index to each of the plurality of measurement data of the sensor assembly 80, the time index indicating a detection time point and / or date of a corresponding operation of the injection device 1.

[0188] The processor 44 of the sensor assembly 80 and thus the processor of the electronic module 34 is configured to control the operation of the sensor assembly 80 and thus the operation of the sensor element 81. The sensor assembly 80 and thus the electronic module 34 is further equipped with a power supply 46, which is configured to supply power to the processor 44 and the sensor assembly 80. The power supply 46 may be implemented as a battery. The sensor assembly 80 may further include an acceleration sensor 48, which is configured to detect an injection operation 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, and when implemented as an auto-injector, the acceleration sensor may detect the acceleration of the needle of the auto-injector when performing a dispensing or injection procedure.

[0189] 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 last dose nut, a piston rod 19 or the like of the drive mechanism 20, which indicates the amount of medicament located within the medicament container 21.

[0190] Furthermore, the sensor assembly 80 or the 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, for example configured to generate a perceptible vibration of the electronic module 34. For further example, the signal generator 51 may include an audible signal generator configured to generate an audible sound.

[0191] Additionally and for further example, the electronic module 34 and / or the sensor assembly 80 may include a microphone by which a characteristic clicking noise of the injection device may be detected and processed, thereby allowing the size of the dose currently set or injected by the injection device 1 to be derived or measured.

[0192] The embodiment of the electronic module 34 in the attachment 30 shown at present is only exemplary. In particular for reusable devices, it is also conceivable that the entire function of the attachment 30 and therefore the entire function of the sensor assembly 80 and the electronic module 34 is implemented in the injection device 1. Here, the receiving portion 64, which is sized to accommodate the hardware components of the electronic module 34, can be arranged inside the dose dial 8, which is covered or closed in the proximal direction by the trigger 9. Here, the trigger 9 of the injection device replaces the cover 75 and the support 70. The rod 71 of the support 70 and therefore the rod of the trigger 9 can then be operably engaged with the drive mechanism to cause or trigger its dispensing operation. The device body 60 can be provided or represented by a dial 8 of tubular shape.

[0193] exist Figure 2 , Figure 3 and Figures 5 to 8 In FIG. 1 , an example of a sensor assembly 80 is schematically shown. The sensor assembly 80 includes a sensor element 81 having a plurality 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 touch-sensitive sensor segments 84, 85, 86, such as Figure 5 and Figure 6 As shown. Each sensor segment may be comparable to a pixel of a touch-sensitive display. The sensor segments 84, 85, 86 may each include a capacity measuring device, by which mechanical contact with a body part of a user may be accurately detected.

[0194] For some examples, the sensor segments 84, 85, 86 are pressure sensitive. Thus, they are operable to generate or modify electrical touch signals when touched by a body part 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 regions 88, 89 that are actually touched by or in mechanical contact with the user's skin.

[0195] For some examples, each sensor segment 84, 85, 86 is not only touch-sensitive, but also operable to generate electrical touch signals indicating the pressure or intensity of mechanical contact with a body part of the user. Thus, the touch-sensitive sensor segments 84, 85, 86 are operable to generate different electrical touch signals indicating the magnitude of the pressure or force applied to the corresponding sensor segments.

[0196] In this case, the touch-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 may be detected by the processor 44 of the sensor assembly 80 and may be evaluated in order to detect, identify, characterize and / or measure user-induced operation of the injection device 1.

[0197] for Figures 5 to 8 In the example shown, the sensor element 81 comprises a circular planar sensing surface 82 and a tubular sensing surface 83, which is longitudinally located adjacent to the outer circumference of the sensing surface 82. In this case, the sensor element 81 comprises a cup-shaped receiving portion, which is sized to receive, for example, the trigger 9 of the injection device 1, and / or the cover 75 of the additional device 30.

[0198] For a further example, it is conceivable that the cup-shaped sensor element 81 is configured to receive a dosing element which combines the functionality of the dose dial 8 and the trigger 9 in a single component.

[0199] for Figures 5 to 7 As shown, only one sensor segment 86 of the plurality of sensor segments 84 , 85 , 86 is actually operational and detects contact with a body part of the user.

[0200] For some examples, the sensor element 81 comprises only a planar sensing surface 82, which is fastened to the proximal face of the trigger 9 or the proximal face of the cover 75 of the attachment 30. For other examples, the sensor element 81 may exclusively comprise a tubular shaped sensing surface 83, which is configured to constrain the tubular shaped member 28 of the injection device 1. The tubular shaped member 28 may be provided by the tubular shaped dose dial 8 or by the tubular shaped body 6 of the injection device 1.

[0201] exist Figure 8 , a typical usage scenario of an injection device 1 provided with a dial extension 27 is shown. To set 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, which then starts to protrude from the proximal end of the body 6 in the proximal direction 3 as increasing doses are set or dialed.

[0202] As a result, a gradually increasing number of dose indication marks appear in the dose indication window 26. To inject a dose, the user uses his hand 110 and clasps the body 6 of the injection device with his palm 112, thereby holding the body 6 of the injection device 1 with at least two fingers 116, 117. The user can then use his thumb 114 to cause a dispensing action by pressing the trigger 9 in the distal direction 2.

[0203] Since the trigger 9 and the entire dial extension 27 are longitudinally displaced distally relative to the body 6 during dose injection, the angle at which the thumb 114 is oriented relative to the trigger 9 will gradually change. Therefore, during dose dispensing, the thumb 114 performs a grinding movement or a natural rolling movement, which can be detected by the spatially resolved touch-sensitive sensing surface 82 of the sensor element 81 covering the proximal end face of the trigger 9 or the proximal end face of the cover 75 of the attachment 30.

[0204] In addition, and as will be Figures 9 to 16 As shown in more detail in FIG. 8 , the touch sensitive sensor segments 84 , 85 , 86 are operable to generate different electrical touch signals depending on the level of force or pressure applied to the respective sensor segments 84 , 85 , 86 . Figures 9 to 16 In the example of FIG. 8 , relatively high or relatively high pressure levels are indicated by darker shaded sensor segments 84, 85, 86. Lower pressure levels are indicated by relatively weak or relatively light shaded sensor segments 84, 85, 86.

[0205] In this way, not only a spatially resolved contact distribution across the one- or two-dimensional sensing surface 82 , 83 of the sensor element 81 is provided, but the pressure distribution may also indicate different pressure levels applied across the sensing surface(s) 82 , 83 .

[0206] for Fig. 9In the example of FIG. 8 , only a total of 12 sensor segments are subject to large forces or pressure effects on the sensing surface 82. Here, only the exemplary sensor segment 85 is subject to higher pressure. The sensor segments 84, 86 are located radially outside the high pressure sensing area 88. They are subject to medium or lower pressures.

[0207] The sensor sections 84, 86 that are subject to lower or medium pressures form or constitute a low or medium pressure sensing region 89. Those sensor sections 85 that are subject to higher pressures form or constitute a sensing region 88.

[0208] like Fig. 9 As shown, the sensing area 88 is located almost in the middle of the sensing surface 82. It is surrounded by the sensing area 89 of lower pressure. This example may represent a situation where a user applies a moderate pressure to the sensing surface 82, for example, with his thumb 114. Since the thumb 114 has a convex shape and has a certain elasticity by increasing the pressure, the user's thumb 114 will experience a corresponding deformation, thereby increasing the lateral range of the high-pressure sensing area 88. Fig.10 As indicated, those sensor sections 84 , 86 that were previously only subjected to lower pressures are now subjected to higher pressures.

[0209] The processor 44 can accurately detect and monitor the Fig. 9 Example orientation Fig.10 The processor is configured to individually process the electrical touch signals generated or modified by each of the sensor segments 84, 85, 86. In this case, the processor 44 is configured to detect or identify an increase or modification of the sensing area 88.

[0210] In general, it should be noted that the sensor segments 84, 85, 86 specifically mentioned herein exemplarily represent the entirety of the sensor segments disposed on the sensing surfaces 82, 83. The spatial resolution of the sensor assembly 18 may depend on the total number of sensor segments 84, 85, 86 and their arrangement on the sensing surfaces 82, 83.

[0211] like Figure 8 The operation of the injection device 1 shown in Fig.11 and Fig.12 . Here, the user has some lateral contact with the trigger 9. At the start of the dose injection operation, the user's thumb 114 touches or contacts a lateral portion of the sensing surface 82. Towards the center of the sensing surface 82, the contact intensity or pressure decreases, as shown by the sensing area 89 and the sensor segment 85. As the dispensing procedure continues, the dial extension 27 undergoes a distal movement, causing the thumb 114 to perform a somewhat natural rolling motion on the surface of the sensing surface 82.

[0212] like Fig.12 The displayed and Fig.11 Compared to the example of FIG. 8 , the sensing area 88 representing substantial mechanical contact is moved toward the center of the sensing surface 82. Accordingly, in Fig.11 The sensor section 85 which detects a relatively low pressure in the configuration of Fig.12 The greater pressure in the configuration.

[0213] like Fig.17 The configuration shown is similar to Fig.13 and Fig.14 Here, from the beginning of the injection until the end, the thumb 114 is located almost in the center of the sensing surface 82. As the injection procedure continues or progresses, the different sensing areas 88, 89 representing medium and high contact pressures only slightly increase or change their size, only moderately change their position, and only slightly change their geometry, such as from Fig.13 and Fig.14 becomes apparent in the comparison.

[0214] For example Fig.18 As shown in Fig.15 and Fig.16 As another example, as represented by the pressure distribution of , the user can completely cover the sensing surface 82 with his thumb 114 even at the beginning of the dose dispensing action. Fig.15 As shown, different sensing areas 88, 89 of variable pressure can be provided on the sensing surface 82. When the user applies gradually increasing pressure, such as Fig.15 The pressure distribution shown can be oriented as Fig.16 The pressure distribution shown is varied: In this case, the central region of the sensing surface 82 and equipped with the sensor section 85 can be varied from a medium pressure level to a higher pressure level.

[0215] The sensor assembly 80 is particularly configured to detect and monitor the temporal variation of the contact pressure applied to the various sensor segments 84, 85, 86. In this way, the sensor assembly 80 and, therefore, the processor 44 are operable to identify sensing regions 88, 89. The processor may be operable to detect and / or distinguish between different sensing regions 88, 89, each sensing region including one or more sensor segments 84, 85, 86.

[0216] The various sensing regions 88, 89 may be distinguished from one another by the level of pressure applied to the respective sensing regions 88, 89. The processor 44 and / or sensor assembly 80 may further be configured to detect or characterize movement of the sensing regions 88, 89 during, for example, a dose setting or dose dispensing procedure.

[0217] Additionally, the processor 44 and / or the sensor assembly 80 may be configured to detect or characterize changes in the size of the sensing regions 88, 89, such as by comparing Fig. 9 and Fig.10 or Fig.15 and Fig.16 And displayed.

[0218] Furthermore, the sensor assembly 80 and / or the processor 44 may be operable to detect or characterize changes in the geometry or orientation of the sensing regions 88 , 89 of the sensing surfaces 82 , 83 .

[0219] like Fig. 9 and Fig.10 , Fig.11 and Fig.12 , Fig.13 and Fig.14 and / or Fig.15 and Fig.16 The indicated temporal changes in the pressure distribution or contact distribution may indicate the same or a different operating mode of the injection device 1 .

[0220] The sensor assembly 80 and / or the processor 44 may be switchable to a training mode, whereby touch signal profiles are recorded or captured over time, and such touch signal profiles are assigned specific operations of the injection device 1. In this way, the sensor assembly 80 and / or the processor 44 may be trained for a specific (e.g., user-specific) touch signal profile associated with or assigned a specific operation of the injection device.

[0221] Later during use of the injection device 1, the sensor assembly 80 may be operable to detect temporal changes in the electrical touch signal resulting from user-induced operation of the injection device. Temporal changes in the electrical touch signal acquired or captured by the sensor assembly 80 during operation of the injection device 1 may be used to generate an operational profile. The operational profile may then be compared to a number of touch signal profiles previously stored in the memory 40 of the sensor assembly 80.

[0222] The processor 44 may then be configured to select from the memory one touch signal profile that has the best match to the operating profile, and select the injection device specific operation assigned the selected touch signal profile as the identified operation of the injection device. In this way, and by analyzing and evaluating the temporal variation of the electrical touch signal as provided by the sensor element 81, the sensor assembly 80 and / or the electronic module 34 may autonomously distinguish between different operating modes of the injection device.

[0223] As combined Fig.19 exist Fig. 20 and Fig.21As specifically shown in FIG. 1 , the user can use the thumb 114 and the index finger 116 to rotate the dose dial 8, which can also be provided with a tubular-shaped sensing surface 83 of the sensor element 81. Fig. 20 In the embodiment, only sensor section 85 is subjected to a substantially high pressure, while sensor section 84 is subjected to a lower or medium pressure, and sensor section 86 is not subjected to any pressure at all. By rotating the dose dial 8, for example, clockwise, the pressure distribution along or across the sensing surface 83 gradually changes. Fig. 20 In the configuration, a sensing area 88 coinciding with the location of the thumb 114 and index finger 116 is circumferentially framed or surrounded by a sensing area 89 of relatively low pressure or force.

[0224] By rotating the dose dial 8, the sensor segment 84 is exposed to an increase in contact pressure. As shown, the sensing areas 88, 89 move in a circumferential direction with respect to the position of the sensor segments 84, 85, 86. This movement of the sensing areas 88, 89 can be detected and tracked by the processor 44 and quantitatively measured. In this way, the sensing surface 83 and the individual sensor segments 84, 85, 86 also allow and support quantitative measurement of the degree of rotation of the dose dial 8 relative to the body 6.

[0225] exist Figure 22 to Figure 27 In further illustration of , the sensor assembly 80 includes a flexible sheet 79 configured to be buckled around or wrapped around the body 6 of the injection device 1. In this case, the injection device 1 may be implemented as an automatic injector. The injection device 1 may not have a separate trigger to be pressed, for example, by the user's thumb 114. Instead, the dose dispensing or dose injection operation may be simply triggered by bringing the distal dispensing end of the injection device 1 into contact with the skin and applying moderate pressure to the skin via the housing 10 or body 6 of the injection device 1.

[0226] The injection device 1 may then automatically start the dispensing procedure by pushing the injection needle into the skin followed by delivery or injection of the medicament into the actually punctured skin portion.

[0227] As in Figure 22 to Figure 25 As shown in FIG, in a typical usage scenario and before applying distal pressure to the body 6 of the injection device, the user may buckle around the body 6 of the injection device 1, which is provided with a sensor assembly 80 as previously described. The sensor assembly 80 may include a flexible sheet 79 or foil having a plurality of sensor segments 84, 85, 86, allowing accurate and 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.

[0228] When the user simply holds the injection device 1 in his hand 110, the contact area between the palm 112 and the sensor element 81 may be represented by the sensing area 88, as shown in FIG. Fig.25 As shown. The contact between the index finger 116 and the sensor element 81 can be reflected in the sensing area 88'. The contact area between the middle finger 117 and the sensor element 81 can be represented by the sensing area 88", and the contact area between the ring finger of the hand 110 and the sensor element 81 can be reflected by the sensing area 88'".

[0229] Now and when the user brings the dispensing end of the injection device 1 into contact with the skin and begins to push the injection device 1 against the skin, a slight but measurable deformation will occur in the contact area between the hand 110 and the sensor element 81. As the hand 110 flexes distally along the longitudinal direction on the sensing surface 82, the sensor assembly 80 is operable to record the corresponding movement of the sensing regions 88, 88', 88", 88'" towards the sensing regions 89, 89', 89", and 89'"'. The temporal changes and / or movement of the sensing regions 88, 89 may be recorded by the processor 44.

[0230] In addition, and at the end of the dose dispensing procedure, the processor 44 may be further operable to measure the duration for which the sensing areas 89, 89', 89", 89'" remain substantially constant. In the same manner, the sensor assembly 80 may be configured to detect how long the user keeps the thumb 114 pressed firmly on the trigger 9, for example at the end of the dose dispensing procedure. In this way, the sensor assembly 80 is configured to automatically detect and record a prescribed holding time during which the injection needle 13 should remain in the pierced tissue after the dose injection of the medicament is terminated.

[0231] When the dosage injection procedure is terminated, the sensor assembly 80 and / or the electronic module 34 can be configured to provide a perceptible feedback to the user in a visual, acoustic or perceptible manner. To this end, these onboard signal generators 51, 52 can be used or activated by the processor 44. Alternatively, and when the sensor assembly 80 is in a communication mode with the external electronic device 100, a corresponding feedback signal can also be generated by the external electronic device 100.

[0232] When reaching the end of the injection procedure, the user may have to maintain pressure on the trigger 9. This may result in a rather constant electrical touch signal provided by the plurality of touch-sensitive sensor segments 84, 85, 86. In this case, a rather constant and unmodified pressure profile is measured by the sensor assembly 80, and the subsequent simple complete release of the sensing surface 82 (wherein the body part is disconnected from the sensing surfaces 82, 83 and is therefore no longer in contact) is a direct indication to the user that the prescribed grip of the injection device is being adhered to after the termination of the dose injection procedure.

[0233] Here, the sensor assembly is configured to automatically distinguish between different operating modes of the injection device. It can automatically record the time and / or duration of these different operations of the injection device.

[0234] In this way, the accuracy and quality of data collected by the sensor assembly may be improved.

[0235] Fig.28 Schematically an example of an external electronic device 100 is shown. The external electronic device 100 is implemented as a smartwatch. It comprises a housing 101 and a display 102, which may be implemented as a touch-sensitive display. The external device 100 may further comprise a control element 103, which is operable or actuatable by a user of the device. By means of a wristband 115, the external electronic device 100 may be attached to a user's wrist 111. On the display 102, a plurality of visual items 104 in the form of symbols, texts or similar information may be provided, by means of which the user may be assisted in using the injection device 1.

[0236] In case there is a communication link between the sensor assembly 80 and the electronic module 34, the user may no longer need to manually confirm a certain operation mode of the injection device 1 with the external electronic device 100. Due to the communication link, such as a wireless communication link, between the external electronic device 100 and the sensor assembly 80, the external electronic device 100 may be automatically provided with information such as setting a dose at a certain time point and dispensing a dose at a certain time point.

[0237] In addition, the sensor assembly 80 can be further configured to detect or quantitatively measure the size of the dose actually set by the user of the injection device. Upon detecting a dispensing procedure and by distinguishing the dispensing procedure from, for example, a dose setting procedure, the sensor assembly 80 and the electronic module 34 can automatically provide relevant information to the external electronic device 100, which can provide further data processing or data analysis. In addition, the external electronic device 100 can be configured to transmit the acquired data to a healthcare provider for further data analysis and for controlling whether the user complies with the prescribed medication schedule.

[0238] Fig.29The flowchart of FIG. 2 shows a method for identifying, detecting, characterizing or measuring the operation of an injection device by using a sensor assembly 80 as described above. In a first step 200, a sensor element 81 of the sensor assembly 80 is attached to or integrated into the injection device 1 or the additional device 30 as described above. In a subsequent step 202, a plurality of electrical touch signals are generated or modified in response to a user's body part touching the sensing surface 82, 83 of the sensor element 81. In a subsequent step 204, changes in the electrical touch signals over time are detected and / or recorded. In a subsequent step 206, the operation of the injection device 1 is detected, recorded, characterized or quantitatively measured based on the time changes of the electrical touch signals.

[0239] Reference numerals

[0240] 1 Injection device

[0241] 2 Distal direction

[0242] 3 Proximal direction

[0243] 4 Dose escalation direction

[0244] 5 Dose reduction direction

[0245] 6 body

[0246] 7 Cartridge holder

[0247] 8-dose dial option

[0248] 9 Triggers

[0249] 10 Housing

[0250] 11 Connectors

[0251] 12-pin assembly

[0252] 13. Injection needle

[0253] 14 Inner needle cap

[0254] 15 Outer needle cap

[0255] 16 Protective cap

[0256] 18 Piston

[0257] 19 Piston rod

[0258] 20 Driving mechanism

[0259] 21 Medicine Container

[0260] 22 Cylinder

[0261] 23 Seals

[0262] 24 Pharmacy

[0263] 25 Exit

[0264] 26 Window

[0265] 27 Dial extension

[0266] 28 Tubular components

[0267] 30 Additional devices

[0268] 34 Electronic modules

[0269] 36 Printed Circuit Board

[0270] 38 Transceiver

[0271] 39 Transceiver

[0272] 40 Memory

[0273] 42 clock

[0274] 44 Processor

[0275] 46 Power Supply

[0276] 48 Acceleration Sensor

[0277] 50 Position Sensor

[0278] 51 Signal Generator

[0279] 52 Signal Generator

[0280] 53 Light Source

[0281] 54 Light Source

[0282] 55 Window

[0283] 56 Window

[0284] 60 Device body

[0285] 61 Sidewall

[0286] 62 flange part

[0287] 63 Reception Department

[0288] 64 Reception Department

[0289] 65 Return element

[0290] 66 recess

[0291] 67 Stop surface

[0292] 68 recess

[0293] 69 stop surface

[0294] 70 Support

[0295] 71 shots

[0296] 72 Protrusion

[0297] 74 protrusion

[0298] 75 Cover

[0299] 76 End face

[0300] 77 Sidewall

[0301] 79 pieces

[0302] 80 Sensor assembly

[0303] 81 sensor element

[0304] 82 Sensing Surface

[0305] 83 Sensing Surface

[0306] 84 Sensor section

[0307] 85 Sensor section

[0308] 86 Sensor section

[0309] 88 Sensing area

[0310] 89 Sensing area

[0311] 100 External devices

[0312] 101 Housing

[0313] 102 Display

[0314] 103 Control elements

[0315] 104 visual items

[0316] 110 hands

[0317] 111 Wrist

[0318] 112 Palm

[0319] 114 Thumb

[0320] 116 fingers

[0321] 117 fingers

Claims

1. A sensor assembly (80) for detecting operation of an injection device (1), the sensor assembly (80) comprising: a sensor element (81) attachable to the injection device (1) and comprising a sensing surface (82, 83) comprising a plurality of touch-sensitive sensor segments (84, 85, 86) operable to generate an electrical touch signal when touched by a body part (112, 114, 116, 117) of a user, - a processor (44) connectable to the sensor element (81) and operable to detect changes in the electrical touch signals over time and to identify an operation of the injection device (1) based on the time changes in the electrical touch signals.

2. The sensor assembly (80) according to claim 1, wherein: At least one of the touch sensitive sensor segments (84, 85, 86) is operable to generate different electrical touch signals in response to changes in pressure applied to the touch sensitive sensor segment (84, 85, 86).

3. The sensor assembly (80) according to claim 1 or 2, wherein: Each of these touch sensitive sensor segments (84, 85, 86) is operable to generate or modify an electrical touch signal when touched by a body part (112, 114, 116, 117) of a user.

4. The sensor assembly (80) according to any one of the preceding claims, wherein: The processor (44) is operable to process electrical touch signals of a plurality of touch-sensitive sensor segments (84, 85, 86) to identify a sensing area (88, 89) of the sensing surface (82, 83) that is touched by the body part (112, 114, 116, 117).

5. The sensor assembly (80) according to claim 4, wherein: The processor (44) is operable to detect movement of the sensing region (88, 89) on the sensing surface (82, 83).

6. The sensor assembly (80) according to claim 4 or 5, wherein: The processor (44) is operable to detect a change in the size of the sensing area (88, 89) on the sensing surface (82, 83).

7. The sensor assembly (80) according to any one of the preceding claims 4 to 6, wherein: The processor (44) is operable to detect a change in the geometry or orientation of the sensing region (88, 89) on the sensing surface (82, 83).

8. The sensor assembly (80) according to any one of the preceding claims, wherein: The sensor element (81) comprises a planar sensing surface (82) configured to be fastened to an end face of a trigger (9) of the injection device (1).

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

10. The sensor assembly (80) according to claim 9, wherein: The sensor element (81) comprises a flexible sheet (79) configured to be wrapped around a tubular member (28) of the injection device (1).

11. The sensor assembly (80) according to any one of the preceding claims, wherein: The processor (44) is operable to detect at least one of a dose setting operation of the injection device (1), a dose dispensing operation of the injection device (1) and an end-of-dose holding operation of the injection device (1) by processing a plurality of electrical touch signals of a plurality of touch-sensitive sensor segments (84, 85, 86) over time when the sensor element (81) is attached to the injection device (1).

12. The sensor assembly (80) of claim 11, wherein: The processor (44) is operable to distinguish between a dose setting operation, a dose dispensing operation and an end-of-dose holding operation of the injection device (1) by processing a plurality of electrical touch signals of a plurality of touch-sensitive sensor segments (84, 85, 86) over time when the sensor element (81) is attached to the injection device (1).

13. The sensor assembly (80) of any preceding claim, further comprising a clock (42) connected to the processor (44), wherein: The processor (44) is operable to detect or measure at least one of a point in time when a user operates the injection device (1) and a duration of time that the user operates the injection device (1).

14. The sensor assembly (80) according to any one of the preceding claims, further comprising a memory (40) connected to the processor (44), wherein: The processor (44) is operable to store usage-related data in the memory (40), wherein the data comprises at least one of the following: a point in time when the injection device is operated, a duration of operation of the device, and a dose size of a medicament group injected by the injection device (1).

15. The sensor assembly (80) of claim 14, wherein: The processor (44) is operable to: - detecting temporal variations of the electrical touch signal during operation of the injection device (1) and generating an operating profile based on the detected temporal variations of the electrical touch signal, - comparing the operating profile with a plurality of touch signal profiles stored in the memory (40), - selecting from the memory (40) a touch signal profile that best matches the operating profile, and - selecting a specific operation of the injection device (1) assigned with the selected touch signal profile as the identified operation of the injection device (1).

16. The sensor assembly (80) of any preceding claim, further comprising a clock (42) and a memory (40) connected to the processor (44), wherein: The processor (44) is operable to: - monitoring the temporal variation of the electrical touch signal during a specific operation of the injection device (1), and - storing the temporal variation of the electrical touch signal as a touch signal profile in the memory (40), and - Assigning a specific operation of the injection device (1) to the touch signal profile.

17. An injection device (1) for injecting a dose of a medicament (24), the injection device comprising: - a body (6) for housing a drive mechanism (20) operable to extract or expel the medicament (24) from the medicament container (21), - at least one of a dose dial (8) and a trigger (9) which is actuatable by a user for injecting the dose, and - A sensor assembly (80) according to any one of the preceding claims, attached to or integrated into at least one of the body (6), the dose dial (8) and the trigger (9).

18. An attachment device (30) configured to be fastened to an injection device (1), the attachment device (30) comprising a device body (60) and a fastener (31) for fastening the body (60) to at least one of a body (6), a dose dial (8) and a trigger (9) of the injection device, wherein: The attachment device (30) comprises a sensor assembly (80) according to any one of the preceding claims 1 to 16.

19. A method for identifying the operation of an injection device (1), the method comprising the following steps: - attaching or integrating a sensor element (81) of a sensor assembly (80) according to any of the preceding claims 1 to 16 to one of an injection device (1) and an additional device (30) configured to be fastened to the injection device (1), - generating a plurality of electrical touch signals in response to a user's body part (112, 114, 116, 117) touching a sensing surface (82, 83) of the sensor element (81), - detect changes in electrical touch signals over time, and - identifying the operation of the injection device based on the temporal variation of the electronic touch signal.

20. A computer program comprising computer readable instructions which, when executed by a processor (44) of a sensor assembly (80) according to any one of the preceding claims 1 to 16, cause the processor (44) to: - detecting changes over time in electrical touch signals generated by touch-sensitive sensor segments (84, 85, 86) of a sensing surface (82, 83) of a sensor element (81) of the sensor assembly (80) when touched by a body part (112, 114, 116, 117) of a user, and - identifying the operation of the injection device (1) based on the temporal variation of the electronic touch signal.

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