Sensor assembly for detecting or recognizing the operation of an injection device

Abstract

Sensor assembly for detecting or recognizing the operation of an injection device The present disclosure is 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 including sensing surfaces (82, 83), the sensing surfaces (82, 83) including a number of touch sensing sensor segments (84, 85, 86), the touch sensing sensor segments (84, 85, 86) being operative to generate an electrical touch signal when touched by a body part (112, 114, 116, 117) of a user; and - a processor (44) connectable to the sensor element (81), the processor (44) being operative to detect a change in the electrical touch signal over time and to recognize the operation of the injection device (1) based on the temporal change in the electrical touch signal. The present disclosure relates to the sensor assembly (80).

Description

Technical Field

[0001] The present disclosure relates to a sensor assembly for detecting or recognizing the operation of an injection device. In another aspect, the present disclosure relates to an injection device comprising such a sensor assembly. In a further aspect, the present disclosure relates to an add-on device configured to be fastened to an injection device, the add-on device comprising a sensor assembly. In another aspect, the present disclosure relates to a method for detecting or recognizing the operation of an injection device, and in a further aspect, the present disclosure relates to a computer program.

Background Art

[0002] Drug delivery devices for setting and administering single or multiple doses of a liquid medicament are themselves well known in the art. Generally, such devices have substantially the same purpose as that of a normal syringe.

[0003] Drug delivery devices such as pen-type injectors must meet a plurality of user-specific requirements. For example, in the case of a patient suffering from a chronic disease such as diabetes, the patient may be physically debilitated and may also have reduced vision. Therefore, a suitable drug delivery device, particularly for home drug treatment, should have a robust construction and should be easy to use. Further, the operation and general handling of the device and its components should be clear and easy to understand. Such an injection device should provide for the setting and subsequent administration of doses of medicaments of the same or different sizes. Further, the dose setting and dose administration procedures should be easily executable and unambiguous.

[0004] A patient suffering from a particular disease needs to inject a certain amount of medicament via a pen-type injection syringe.

[0005] Some drug delivery or infusion devices perform the selection of doses of drugs of various sizes and the infusion of pre-set doses. Other infusion devices perform the setting and administration of a fixed dose. In this case, the amount of drug to be infused according to a certain prescription schedule is always the same, does not change over time, or cannot be changed.

[0006] Some infusion devices are implemented as reusable infusion devices where the user can replace a drug container such as a cartridge. Other infusion devices are implemented as disposable infusion devices. With a disposable infusion device, it is intended that the entire infusion device be discarded when the contents, i.e., the drug, are used up.

[0007] To control and manage the administration of drugs by the user or the patient themselves, it is desirable to provide automatic detection and recording of the repeated and regular use of a drug delivery device. In particular, in a fixed-dose infusion device that typically provides a simple and fairly effective approach for delivering many drug therapies, recording the dose infused by the user provides a significant advantage over manual dose recording in terms of safety and convenience.

[0008] Some infusion devices or add-on devices configured to be used with an infusion device provide electronic detection and monitoring of repeated dosing procedures. In this case, the user may need some training to properly use such detection or monitoring functions. Therefore, it is particularly aimed at providing an intuitive and fairly simple monitoring or recording of the operation of the infusion device. Summary of the Invention Means for Solving the Problems

[0009] In one example, the present disclosure relates to a sensor assembly for detecting, recognizing, characterizing, and / or measuring the operation of an infusion device. The sensor assembly is attachable to the infusion device and includes a sensor element having a one-dimensional or two-dimensional sensing surface. The sensing surface includes a plurality of touch-sensing sensor segments. The sensor assembly further includes a processor connectable to the sensor element. The processor is operative to detect a sensing region on the sensing surface when contacted by a user's body part.

[0010] The processor is operative to detect changes in the sensing region over time, and the processor is further operative to recognize, detect, characterize, and / or measure the operation of the infusion device based on the detected changes in the sensing region.

[0011] The sensing region is typically defined by a portion of the sensing surface of the sensor element that contacts the user's body part. In such cases, the sensing region may define or coincide with a contact region or touch region of the sensing surface that contacts the user's body part, such as a finger.

[0012] For example, by monitoring temporal changes in the sensing region during a single and / or predefined operation of the infusion device, the processor is operative to characterize, recognize, detect, and / or measure a particular operation of the infusion device.

[0013] According to a further example, each of the sensor segments is operative to generate or modify an electrical touch signal when touched by a user's body part. The sensor segments are spatially separated so as not to overlap on the sensing surface. The sensor segments may be arranged adjacent to each other in a regular or irregular pattern. In some examples, the entire sensing surface is covered and / or occupied by a plurality of sensor segments. The sensor segments may be of equal size or of unequal size.

[0014] In some examples, the touch sensing sensor segments are separated from each other. Each touch sensing sensor segment can operate independently of any other touch sensing sensor segment on the sensing surface. Thus, the touch sensing sensor segments can function to individually generate an electrical touch signal when touched by a user's body part.

[0015] The sensor segments can belong to a touch sensing matrix or can form a touch sensing matrix, such as a one - dimensional or two - dimensional array of touch sensing segments. Each touch sensing segment can include, for example, a capacitor or a resistor that functions to generate or modify an electrical signal in response to physical contact with a user's body part. In such a case, a plurality of touch sensing sensor segments form or constitute a touch sensing sensor with spatial resolution.

[0016] In a further example, the touch sensing surface or touch sensing matrix includes a matrix of electrical resistance elements that change their electrical and measurable resistance when touched, for example, by a user. In other examples, the touch sensing surface or touch sensing matrix includes a matrix of capacitive elements that function to change their measurable capacitance when touched, for example, by a user.

[0017] In a further example, the touch sensing surface or touch sensing matrix includes a combination of electrical resistance sensor segments and capacitive sensor segments. Capacitive sensors exhibit a relatively low level of power consumption.

[0018] In a further example, the touch sensing surface or touch sensing matrix is based on surface acoustic wave technology that depends on sound waves. Thus, the touch sensing surface or touch sensing matrix includes at least one pair of an acoustic wave transducer and an acoustic wave receiver.

[0019] In another example, the touch sensing surface or touch sensing matrix includes several optical sensors such as photodetectors or photodiodes.

[0020] In a further example, the touch sensing surface or touch sensing matrix includes an ultrasonic sensor. The optical sensor and / or ultrasonic sensor may also be implemented as a fingerprint sensor capable of distinguishing the characteristic fingerprint of a first user from the characteristic fingerprint of a second user.

[0021] In some examples, the sensor element is attachable to a user-operable portion of the injection device. The sensor element may be attachable to or attached to the surface of an actuating element or handling element, which is typically touched, handled, or actuated by the user when using or operating the injection device. The sensor element may also be incorporated into the surface of the actuating element or handling element. The user-operable portion may be a part of at least one of the sleeve-like housing components, trigger, or dose dial of the injection device.

[0022] In some examples, the processor functions to detect when the injection is initiated. The processor may detect when the injection procedure is completed. The processor may further function to detect or measure the time during which the sensor element or sensing surface is in contact with a body part of the user. In such a case, the processor may function to measure or determine the operating time of the injection device. Further, by evaluating and processing the temporal changes of the electrical touch signal and / or by monitoring and / or evaluating the temporal changes of the sensing area, the processor, and thus the sensor assembly, may function to distinguish between different operating modes of the injection device.

[0023] In response to the temporal changes of the electrical touch signal and / or in response to the changes in the sensing area, the processor may function to automatically distinguish, for example, between a dose setting procedure and a dose administration procedure or a dose injection procedure.

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

[0025] According to a further example, at least one of the touch sensing sensor segments is configured to generate different electrical touch signals in response to a change in the pressure applied to the touch sensing sensor segment. In such a case, the electrical touch signal generated by the touch sensing sensor segment varies, for example, according to the pressure applied by the body part of the user that touches or contacts this particular touch sensing sensor segment.

[0026] In response to a change in the pressure applied to the touch sensing sensor segment, the electrical touch signal may differ in magnitude or amplitude. Further, the electrical touch signal can change its sign or change its frequency or periodicity. In response to the various pressures applied to the touch sensing sensor segment, each sensor segment is configured to vary the electrical touch signal in a measurable manner, i.e., in a manner detectable or processable by a processor connected to or connectable to the touch sensing sensor segment.

[0027] In some examples, a plurality of touch sensing sensor segments are configured to generate different electrical touch signals in response to a change in the pressure applied thereto. In some examples, the touch sensing sensor segments of the sensing surface are configured to provide and / or cause a change in each electrical touch signal in response to a change in the pressure applied to each touch sensing sensor segment.

[0028] In some examples, a touch sensing sensor segment functions to generate at least two different electrical touch signals in response to a change in the pressure applied thereto. By default, the touch sensing sensor segment may function to generate a first electrical touch signal in response to a first pressure applied to the touch sensing sensor segment. Here, the first electrical touch signal may be generated when the first pressure applied to the touch sensing sensor segment exceeds a first predetermined threshold value.

[0029] The touch sensing sensor segment may further function to generate a second electrical touch signal that is different from the first electrical touch signal in at least one of magnitude, amplitude, sign, or frequency. The second electrical touch signal may be generated when the pressure applied to the touch sensing sensor segment is equal to or greater than a second predetermined threshold value. Typically, the second threshold value is greater than the first threshold value.

[0030] In such a case, the first electrical touch signal and the second electrical touch signal may each indicate a relatively low pressure and a relatively high pressure applied to each respective touch sensing sensor segment.

[0031] In a further example, a touch sensing sensor segment or a plurality of sensor segments function to generate various different electrical touch signals. The touch sensing sensor segment functions to generate at least 3, at least 4, at least 5, at least 6, or at least 8 different electrical touch signals, and each of the different electrical touch signals may be considered to reflect or indicate each of the first, second, third, fourth, fifth, sixth, or eighth pressures applied to each respective touch sensing sensor segment.

[0032] In a further example, a touch sensing sensor segment may function to generate an electrical touch signal that gradually changes in response to a change in the pressure applied to each respective touch sensing sensor segment. Here, the electrical touch signal may directly represent the applied pressure.

[0033] According to a further example, the touch sensing sensor segments of the sensing surface are configured to generate different electrical touch signals in response to changes in the pressure applied to each touch sensing sensor segment. In some examples, all of the touch sensing sensor segments of the sensing surface are configured to generate different or various electrical touch signals in response to changes in the pressure applied to each touch sensing sensor segment.

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

[0035] Depending on the number and size of the touch sensing sensor segments distributed across the sensing surface, a precise and rather detailed spatially resolved pressure profile across the sensing surface of the sensor element or across the sensing surface of the sensor element can be provided. In this way, the sensor assembly is configured to detect or measure the spatially resolved pressure profile applied across the sensing surface by a user's body part.

[0036] The spatially resolved pressure profile and / or the temporal variation of such a spatially resolved pressure profile may indicate a particular operation of the infusion device.

[0037] According to a further example, the processor is configured to process the electrical touch signals of some of the touch sensing sensor segments to identify the sensing area of the sensing surface being touched by the body part. Typically, when using a finger as the body part for contacting the sensing surface of the sensor element, each touch sensing sensor segment can detect the pressure applied by each body part. In this way, all of the touch sensing sensor segments that mechanically contact the body part during or for an operation of the infusion device can generate respective electrical touch signals.

[0038] By simultaneously processing the signals of the touch sensing sensor segments, the processor can provide or confirm a sensing area on the sensing surface that is actually touched or mechanically contacted by the user's body part. In this way, the processor functions to detect whether the central part or the boundary region of the sensing surface is actually touched by the body part.

[0039] Furthermore, the processor can function to detect or measure the size of the sensing area. By confirming or determining that the sensing area on the sensing surface is actually touched or mechanically contacted by the user's body part, the sensor assembly provides a fairly precise and spatially resolved monitoring of how the user's body part touches the sensor element.

[0040] According to a further example, the processor functions to detect the movement of the sensing area on the sensing surface. During the operation of the injection device, for example, in a situation where the user's body part itself moves during dose setting or dose injection, there may be a measurable movement of the body part with respect to the sensor element, and thus with respect to the sensing surface, due to the movement of the body part with respect to the housing of the injection device. In this case, during the operation of the injection device, the user's body part, such as a finger or thumb, may perform a rubbing movement or a natural rolling movement.

[0041] Such a movement of the body part with respect to the sensor element can result in a movement of the sensing area on the sensing surface that is touched by the body part. The movement of the body part with respect to the sensor element can cause the activation and deactivation of many touch sensing sensor segments that are spatially distributed across the sensing surface of the sensor element. This results in a measurable change in the electrical touch signal and a change in each of the sensing areas measurable by the processor.

[0042] By evaluating and processing the electrical touch signals generated by the touch sensing sensor segments during the operation of each of the injection devices, the processor can detect the movement of the sensing area on the sensing surface. By detecting such movement of the sensing area, the sensor assembly can recognize or characterize the operation of the injection device. Here, the sensor assembly, and thus its processor, can function to distinguish between different operating modes of the injection device by measuring the measurable movement of the sensing area on the sensing surface.

[0043] According to a further example, the processor of the sensor assembly functions to detect a change in the size of the sensing area on the sensing surface. A change in the size of the sensing area can be due to a change in the pressure applied to the sensor elements by a body part. Since the body part can include a certain elasticity and further can include a considerably convex outer surface structure or surface, by increasing the pressure applied to the sensor elements by the body part, for example, by elastic deformation of the body part, the proportion of the body part in direct contact with the sensing surface may increase. This can result in an increase in the size of the sensing area on the sensing surface.

[0044] Therefore, the detection of a change in the size of the sensing area during the operation of the injection device can indicate a change in the pressure applied to the sensor elements by the user. In some examples, the change in size measurable by the processor, as well as the change in the type, size, amplitude, sign, or frequency of the electrical touch signals generated by the touch sensing sensor segments, can be processed in a combined manner. In such cases, the change in the pressure applied to the sensor elements by the body part can be detected by the change in the size of the sensing area simultaneously with the change in the electrical touch signals generated by the touch sensing sensor segments.

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

[0046] According to a further example, the processor functions to detect a change in the geometric shape of the sensing region on the sensing surface and / or to detect a change in the orientation of the sensing region on the sensing surface. In this way, a further operating mode can be detected and evaluated while the user's body part is making a movement or change relative to the sensor element. A change in the geometric shape or orientation of the sensing region on the sensing surface, typically detected by a change in each of the electrical touch signals generated by several touch sensing sensor segments, may further indicate a specific situation of the use of the injection device.

[0047] By electronically detecting and / or electronically and quantitatively measuring at least one of a movement of the sensing region, a change in the size of the sensing region, a change in the geometric shape of the sensing region on the sensing surface, and / or a change in orientation, the sensor assembly functions to detect, recognize, characterize, and / or measure different operations and operating modes of the injection device. By evaluating the movement of the sensing region during operation of the injection device and / or by evaluating a change in the size, geometric shape, or orientation of the sensing region on the sensing surface while the injection device is being operated by the user, the sensor assembly can automatically recognize a specific operating mode of the injection device.

[0048] According to a further example, the sensor element includes a flat sensing surface configured to be fastened to the end face of the trigger of the injection device. The flat sensing surface may include several touch sensing sensor segments located adjacent to each other and adjacent to each other on the flat sensing surface. In some examples, the entire flat sensing surface may be filled or occupied by sensor segments arranged adjacent to each other. In such a case, the entire flat sensing surface may be implemented as the touch sensing surface of the sensor element.

[0049] The flat sensing surface may cover the entire end face of the trigger of the injection device. Typically, the trigger is configured to be depressed by the user's finger to initiate and / or control the injection procedure performed by the injection device. By applying or attaching the flat sensing surface to the depressible end face of the trigger, the sensor element, and thus the entire sensor assembly, can be incorporated into the trigger of the injection device.

[0050] In another example, the flat sensing surface may be configured to be fastened to the end face of an auxiliary trigger of an add-on device configured to be fastened to the 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 add-on device is attached or fastened to the injection device. Here, the auxiliary trigger may replace or substitute for the function of the original trigger of the injection device.

[0051] The add-on device may cover the trigger portion of the injection device. The auxiliary trigger may be operably engaged directly or indirectly with the trigger of the injection device such that the trigger of the injection device is actuated respectively by depressing or actuating the auxiliary trigger of the add-on device. By implementing the sensor assembly on or into the add-on device, the flat sensing surface may be fastened or incorporated into the end face of such an auxiliary trigger of the add-on device.

[0052] In some examples, the flat sensing surface can be incorporated into the end face of the trigger or an auxiliary trigger. The flat sensing surface can be fastened to or incorporated into the end face of the trigger. By attaching or incorporating the flat sensing surface to the end face of the trigger, a fairly integrated solution can be provided for implementing or incorporating the sensor assembly into or onto the injection device or into an add-on device.

[0053] According to a further example, the sensor element includes a tubular sensing surface configured to be fastened to a tubular member of the injection device. In this example, the sensor element can be configured to surround or at least partially surround a tubular structure or tubular member of the injection device, such as a dose dial or a housing component of the injection device.

[0054] In some examples, the tubular sensing surface of the sensor element is configured to surround the outer surface of a tubular dose dial of the injection device. The dose of an individual size of the injection device can be set by the user rotating the dose dial in either an increasing dose direction or a decreasing dose direction with respect to the body or housing of the injection device using the dose dial. By having a tubular sensing surface attached to or incorporated outside the dose dial, such a dose dial procedure can be accurately detected, recognized, characterized, or even quantitatively measured by the sensor assembly.

[0055] In other examples, the tubular sensing surface can be attachable or fixable to the outer surface of a tubular housing component of the injection device. The housing component can be gripped by the hand of the user of the injection device, such as the palm or multiple fingers, to prepare and / or perform a dose injection procedure. Again, by having the sensor element on the outer surface of the tubular body or housing of the injection device, the handling or operation of the injection device induced by the user can be accurately detected, characterized, recognized, or measured.

[0056] According to a further example, the sensor element includes a flat sensing surface and further includes a tubular sensing surface. The sensor element may include a cup-shaped structure that includes a flat sensing surface at a longitudinal end adjacent to the tubular sensing surface that forms the side wall of the cup-shaped sensor element. Such a sensor element may be configured or adapted to be attached to a dosing member of an injection device, and the dosing member is implemented as a combination of a dosing dial and a trigger. Here, by rotating the dosing member, different sized doses can be set, and by pressing the dosing member, the injection process can be triggered and / or controlled.

[0057] According to a further example, the sensor element includes a flexible sheet configured to wrap around a tubular member of an injection device. The sensor element may include a flat substrate made of a flexible sheet, for example made of flexible foil. The flat substrate may be foldable or rollable into a flexible and / or tubular shape.

[0058] The flexible sheet or substrate may be provided with a plurality of touch sensing sensor segments. The flexible or bendable sheet can be wrapped around the tubular member of the injection device. The flexible sheet of the sensor element and the touch sensing sensor segments attached or mounted on the flexible sheet enable the use of the sensor element with tubular members of a wide variety of different sizes of injection devices.

[0059] The sensor element may be generally applicable to tubular members of different sizes. The flexible sheet may enable the entire sensor element to be flexible and may be easily fixable to the tubular member of the injection device. The flexible sheet may be adhesively attached to the outer surface of the tubular member and may provide a spatially resolved touch sensing area on the outside of the tubular member, for example on the outside of the housing of the injection device.

[0060] The same may apply to an add-on device, which is assumed to include, for example, a tubular member for fastening or fixing around the housing of an injection device.

[0061] According to a further example, the tubular member of the injection device is a dose dial that is rotatable relative to the body of the injection device for dose setting. By attaching the flexible sensor element to the dose dial, the dose dial setting or dose setting operation performed by the user of the injection device, and thus the rotation of the dose dial relative to the body or housing of the injection device, can be detected, recognized, characterized, or quantitatively measured by the sensor assembly.

[0062] According to a further example, the tubular member is the body of the injection device. In some examples, the body of the injection device includes an elongated tubular sleeve. The body can be sized to accommodate a drive mechanism for discharging or removing a dose of the medicament from the medicament container. In some examples, the medicament container implemented as a syringe or cartridge containing the medicament or, for example, a liquid medicament can also be disposed within the body or housing of the injection device.

[0063] According to a further example, the tubular member is a clip configured to be removably fastened to the injection device. Here, the tubular member can be implemented as part of an add-on device configured to be fastened to the housing of the injection device.

[0064] In a further example of the sensor assembly, the processor functions to detect at least one of a dose setting operation of the injection device, a dose administration operation of the injection device, and a holding operation of the injection device by processing a plurality of electrical touch signals of a plurality of touch sensing 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 by, for example, an auxiliary device or an add-on device configured to be fastened to the injection device.

[0065] In some examples, the processor functions to detect at least one of a dose setting operation, a dose administration operation, or a holding operation of the injection device by processing a temporal change in a sensing region of a sensing surface of the sensor element.

[0066] In a further example, when the dose setting operation involves rotation of an injection device, such as a tubular member of a dose dial, such rotation can be detected by a change in an electrical touch signal provided by a touch sensing sensor segment provided on the tubular shaped sensing surface of the sensor element. The administration operation, such as the start, duration, and / or end of the administration operation, can typically be detected, recognized, or characterized by processing an electrical touch signal generated or modified by a touch sensing sensor segment of a flat sensing surface typically provided on each end face of the trigger of the injection device or the auxiliary trigger of an add-on device.

[0067] Furthermore, after the dose holding operation of the injection device, i.e., after the end of the dose injection procedure, the user can accurately monitor the end of the time during which a specific pressure should be applied to and maintained on the trigger of the injection device. Here, during the holding operation at the end of the dose injection procedure, the electrical touch signals generated or modified by many touch sensing sensor segments should be fairly constant.

[0068] According to a further example, the processor functions to distinguish between the end of the dose setting operation, the dose administration operation, and the dose holding operation of the injection device by processing over time the many electrical touch signals of many touch sensing sensor segments when the sensor element is attached to the injection device or an add-on device and thus when this add-on device itself is attached to the injection device. Each operation mode of the injection device can be characterized by the temporal and / or spatial profile of the many touch sensing sensor segments touched by the user's body part during each operation mode.

[0069] By evaluating such temporal and / or spatial profiles measurable by the sensor assembly, the sensor assembly functions and comes to function so as to automatically distinguish between different operating modes of the injection device. In such a case, the sensor assembly can comprise automated operating mode detection of the injection device, thus simplifying the use of the sensor assembly and increasing the accuracy of continuous injection monitoring or injection recording over time.

[0070] According to a further example, the sensor assembly includes a clock or clock generator connected to the processor. In this way, the processor functions to detect or measure at least one of the time when the user operates the injection device and the time during which the user operates the injection device. By providing a clock to the processor, the processor can detect or record each time or time at which it detects a specific electrical touch signal or a change in the sensing area indicating the start or end of at least one of, for example, a dose setting operation and a dose administration operation.

[0071] According to a further example, the sensor assembly includes a memory connected or coupled to the processor. The processor functions to store usage-related data in the memory, the data including at least one of the time when the injection device was operated, the time during which the device was operated, and the size of the dose of the drug set or injected by the injection device. All of these parameters, times, times, and dose size information can be derived from changes in the electrical touch signal or changes in the sensing area detectable by the processor connected to the sensor element.

[0072] According to a further example, the processor, clock, and memory can function to automatically store or automatically monitor and / or record a series of user-induced operations of the injection device only 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 have a wake-up function. Here, the processor may automatically switch to the sleep mode, for example, when it determines that the sensor element and its sensing surface have not been touched over a predetermined time interval. When detecting an initial contact with the sensing surface of the sensor element, the processor can switch to the startup mode and accordingly can wake up. By providing the sleep function to the processor, the energy supplied to the sensor assembly can be saved. Accordingly, the battery life of the sensor assembly can be extended accordingly.

[0074] According to a further example, the sensor assembly includes a power source in the form of a power supply such as a battery.

[0075] In a further example, the sensor assembly includes a transceiver. The transceiver may function to communicate with an external electronic device such as a smartwatch, a smartphone, or a tablet computer. The transceiver may be implemented as a wireless transceiver. The transceiver may function to establish a communication link with the external electronic device. In some examples, the transceiver may function to draw energy from the external electronic device. In such a case, the transceiver may also serve as a kind of power source for supplying power to the sensor assembly.

[0076] According to a further example, the sensor assembly includes a signal generator. The signal generator may be implemented as one of a visual signal generator, an acoustic signal generator, or a tactile signal generator. By means of the signal generator, the sensor assembly may function to communicate directly with the user of the injection device. In this way, the sensor assembly can provide confirmation or similar feedback to the user, and thus indicate, for example, that a particular user-induced operation of the injection device has been monitored or not monitored correctly. The signal generator may function to provide and / or generate visual signals of different colors and / or at different times.

[0077] In other examples, the signal generator may be configured to generate an acoustic signal, such as an audible sound. Here, the signal generator may be configured to provide different and distinguishable audio signals indicating the success or failure of the detection or measurement of a user-induced action of the injection device, for example.

[0078] A haptically implemented signal generator may be configured to generate vibrations that are detectable, for example, palpable by the user.

[0079] In a further example, the sensor assembly may include a reminder function. Here, the memory of the sensor assembly may include a predefined dosing schedule for a particular patient. Thus, when an injection is to be made, the processor may prompt the signal generator to generate a signal recognizable to the user and thus remind the user to perform or execute the injection procedure.

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

[0081] In a further example, when an acceleration sensor is provided, the sensor assembly may further detect or measure a particular movement or acceleration of the sensor assembly indicative of a particular gesture, for example, performed when the user is holding the sensor assembly. Thus, the operating mode of the injection device may be detected by the acceleration sensor.

[0082] The transceiver enables the sensor assembly to exchange measurement data with an external electronic device. The memory of the sensor assembly is typically configured to store usage-related data of the infusion device. When establishing a communication link with the external electronic device, the sensor assembly, and thus 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] In some examples, the sensor assembly may comprise a display that functions to visually indicate, for example, usage-specific or user-specific information to the user of the infusion device. The display may be implemented on the sensor element. In such a case, the sensor element may be implemented as a touch-sensitive display.

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

[0085] The sensor element, particularly its sensing surface, may comprise a reconfigurable electronic display that functions to provide visual content to the user of, for example, an add-on device or an infusion device, respectively. In such a case, the sensor element and the sensor assembly provide a dual function. It functions to receive input from the user and also functions to provide information to the user.

[0086] In some examples, the sensor assembly may function to provide a visual indication, such as the actual number of administrations set or the number of administrations to be set, on the sensing surface. The sensor assembly can support the patient during dose setting and during dose infusion. The sensor assembly, particularly its touch-sensitive display, may function to provide visual symbols, numbers, and / or letters to guide and / or assist the user when using the add-on device or the infusion device.

[0087] The touch-sensitive display of the sensor assembly may further provide instructions to the user such as setting a dosage, injecting a dosage, verifying an injection, transmitting data between an add-on device and an external electronic device, and / or notifying the user of when the next injection should be made.

[0088] Furthermore, the touch-sensitive display may function to visually indicate a specific portion of the sensing surface to be touched by the user.

[0089] The touch-sensitive display may provide static and dynamic information. In some examples, the touch-sensitive display of the sensor assembly may function to dynamically and visually indicate the movement of the user's finger across the sensing surface of the sensor assembly. Here, the user may even be guided as to how to touch, chip, or swipe across the sensing surface of the sensor element.

[0090] According to a further example of the sensor assembly, it includes a clock and a memory connected to a processor. The processor functions to monitor the temporal change of an electrical touch signal during the operation of a specific injection device 1. The processor further functions to store the temporal change of the electrical touch signal in the memory as a touch signal profile and to assign the operation of a specific injection device to the touch signal profile.

[0091] This operation of the sensor assembly or the function of the sensor assembly may represent a training mode. Here, the user may train the sensor assembly to assign or associate a measurable or derivable touch signal profile to one of several user-specific operations of the injection device.

[0092] In such cases, the sensor assembly may be switchable between a training mode and a sensing mode. In this way, the sensor assembly can be individually adapted to the different operating modes of different users of the infusion device. Thus, the sensor assembly may be adaptable to different user-specific quirks and behaviors that may vary for each user of the infusion device.

[0093] According to a further example, the processor functions to detect a temporal change in an electrical touch signal during operation of the infusion device and generate an operation profile based on the detected temporal change in the electrical touch signal. The processor further functions to compare the operation profile with a plurality of touch signal profiles previously stored in the memory. The processor further functions to select from the memory the one touch signal profile that most closely matches the actually measured operation profile and select the operation of the particular infusion device previously assigned to the selected touch signal profile as the recognized operation of the infusion device.

[0094] Here, the processor, and thus the sensor assembly, functions to utilize the touch signal profiles previously stored in the memory. Using individually trained touch signal profiles, the actually measured operation profile can be assigned and associated with the default operation or a particular operation of the infusion device. In this way, the sensor assembly and / or its processor functions to distinguish between different operating modes of the infusion device simply by comparing the actually measured operation profile with the previously stored touch signal profiles.

[0095] In another aspect, the present disclosure also relates to an infusion device for injecting a dose of a medicament. The infusion device includes a body for housing a drive mechanism that functions to remove or eject the medicament from a medicament container. Typically, the drive mechanism functions to inject or eject a dose of the medicament from the medicament container. The infusion device further includes at least one of a dose dial and a trigger operable by a user to inject and / or set the dose.

[0096] The injection device further includes a sensor assembly as described above. The sensor assembly is attached to or incorporated into at least one of the body of the injection device, the dose dial, and the trigger. By attaching or incorporating the sensor assembly to at least one of the body, the dose dial, and the trigger, or to at least one of the body, the dose dial, and the trigger, fairly precise and semi-automated detection, recognition, characterization, and measurement of user-induced operations of the injection device can be provided.

[0097] The injection device can be realized as a pen-type injector. The injection device can be realized as a disposable injection device or a reusable injection device. In some examples, the injection device can include a dial extension that moves in the longitudinal and rotational or helical directions during dose setting and at least a longitudinal sliding movement during dose injection. In other examples, the injection device does not have a so-called dial extension. Here, the dose dial and / or the trigger can be provided, for example, at the proximal end of the housing of the injection device. For example, a dose member in the form of a combination of a dose dial and a trigger can be rotatable relative to the body or housing of the injection device for dose setting and can be depressible, for example, by the user's thumb to inject the dose.

[0098] In other examples, the injection device is realized as a so-called auto-injector. Here, the user can simply hold the body of the injection device and press the body, and thus the distal end of the injection device, against a part of the skin, thereby causing a fairly automated injection procedure during which the injection needle is pushed into the skin and then the dose of the drug is administered or injected.

[0099] According to a further aspect, the present disclosure also relates to an add-on device configured to be fastened to an infusion device. The add-on device includes a device body and a fastener for fastening the device body to at least one of the body of the infusion device, the dose dial, and the trigger. The add-on device includes a sensor assembly as described above. In such a case, the entire functionality of the sensor assembly can be incorporated into the add-on device. Typically, when properly attached to the infusion device, the add-on device provides or includes at least one of an auxiliary dose dial and / or an auxiliary trigger that is operably engageable with the dose dial and / or the trigger of the infusion device when the add-on device is properly assembled or attached to the infusion device, thereby providing dose setting and / or infusion.

[0100] In such a case, all of the features, effects, and advantages described above in connection with the sensor assembly apply equally to the infusion device and the add-on device, respectively.

[0101] According to another aspect, the present disclosure also relates to a method of recognizing, detecting, characterizing, and / or measuring the operation of an infusion device. The method includes attaching or incorporating a sensor element or sensor assembly as described above to or into one of the infusion device and the add-on device as described above, where the add-on device is configured to be fastened to the infusion device or another infusion device and, for example, does not have a sensor assembly as described above.

[0102] The method further includes generating a number of electrical touch signals in response to a user's body part touching the sensing surface of the sensor element. Alternatively, the method includes detecting or identifying the sensing region of the sensing surface that is being touched or in contact with the user's body part.

[0103] As a further step, the method includes detecting a change over time of an electrical touch signal and recognizing, detecting, characterizing, or measuring the operation of the injection device based on the temporal change of the electrical touch signal.

[0104] Alternatively, in another example, the method includes detecting a change over time of a sensing area and detecting, recognizing, characterizing, or measuring the operation of the injection device based on the temporal change of the sensing area.

[0105] Generally, the method of detecting, recognizing, characterizing, and / or measuring the operation of the injection device is performed by the injection device as described above and / or by using an add-on device as described above. In particular, the method is performed by a sensor assembly as described above. In such a case, all features, effects, and advantages described above in connection with the sensor assembly, injection device, and / or add-on device equally apply to the method of detecting, recognizing, characterizing the response of, or measuring the operation of the injection device, and vice versa.

[0106] In a further aspect, the present disclosure is also a computer program including computer-readable instructions that, when executed by a processor of a sensor assembly as described above, cause the processor to detect a change over time of an electrical touch signal, where the electrical touch signal is generated by a touch sensing sensor segment of a sensing surface of a sensor element of the sensor assembly when touched by a body part of a user, and the computer program further causes the processor to detect, recognize, characterize, and / or measure the operation of the injection device based on the temporal change of the electrical touch signal.

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

[0108] The present disclosure further discloses and proposes a computer program including computer-executable instructions for implementing the method by one or more of the disclosed methods / devices / systems of the examples included herein when the program is executed on a processor, a computer, or a computer network. Specifically, the computer program can be stored in a computer-readable data carrier. Thus, specifically, one, two or more, or even all of the above method steps can be implemented 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 having program code means for implementing the method by one or more of the disclosed methods / systems of the embodiments included herein when the program is executed on a computer or a computer network. Specifically, the program code means can be stored in a computer-readable data carrier.

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

[0111] The present disclosure further proposes and discloses a computer program product having program code means stored on a machine-readable carrier for implementing a method according to one or more of the examples disclosed herein, or a part thereof, when the program is executed on a processor, computer, or computer network. As used herein, a computer program product refers to a program as a tradable product. The product may generally exist in any form, for example, in paper form, or on a computer-readable data carrier. Specifically, the computer program product may be distributed via a data network.

[0112] In another example, the present disclosure proposes and discloses a modulated data signal comprising instructions readable by a processor, computer system, or computer network for implementing at least a part of a method according to one or more of the examples disclosed herein. Preferably, referring to the computer-implemented embodiments of the present disclosure, one or more, or even all, of the method steps of the method according to one or more of the examples disclosed herein may be implemented by using a processor, computer, or computer network. Thus, generally, any of the method steps including data collection, provision, and / or manipulation may be implemented by using a processor, computer, or computer network. Generally, these method steps may include any of the method steps except those that typically require manual operations such as specific manners of providing samples and / or performing actual measurements.

[0113] Specifically, the present disclosure further discloses a computer or a computer network including at least one processor adapted to implement a method according to one of the examples described herein, a computer loadable data structure adapted to implement a method according to one of the examples described herein while the data structure is being executed on the processor, a computer, and a computer program adapted to implement a method according to one of the embodiments described herein while the program is being executed on the 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. To that extent, the present disclosure encompasses any combination of the claims and any technically feasible combination of the features disclosed in relation to different examples or embodiments.

[0115] In this context, the terms "distal" or "distal end" relate to the end of the infusion device facing the infusion site of a human or animal. The terms "proximal" or "proximal end" relate to the opposite end of the infusion device, which is furthest from the infusion site of the human or animal.

[0116] As used herein, the terms "drug" or "agent" are used synonymously and represent a pharmaceutical formulation containing one or more pharmaceutical active ingredients or pharmaceutically acceptable salts or solvates thereof and optionally a pharmaceutically acceptable carrier. A pharmaceutical active ingredient ("API") is, in the broadest sense, a chemical structure that has a biological effect on a human or animal. In pharmacology, a drug or agent is used for the treatment, cure, prevention or diagnosis of a disease, or otherwise for the improvement of physical or mental health. A drug or agent can be used over a limited period or regularly for chronic diseases.

[0117] As described below, a drug or agent can contain at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs 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 can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0118] A drug or medicament can be placed within a primary package or “drug container” adapted for use with a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of 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., from one day to at least 30 days). In some cases, the chamber can be designed to store the drug for from about one month to about two years. Storage can be carried out at room temperature (e.g., about 20° C.) or refrigerated temperature (e.g., from about -4° C. to about 4° C.). In some cases, the drug container can also be or include a dual-chamber cartridge configured to separately store, one per chamber, two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs). In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between the two or more components before and / or during dosing into a human or animal body. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., by a conduit between the two chambers), allowing the user to mix the two components if desired before dosing. Alternatively or additionally, the two chambers can be configured to allow mixing upon dosing of the components into a human or animal body.

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

[0120] Examples of APIs for the treatment and / or prevention of type 1 or type 2 true diabetes or complications of type 1 or type 2 true diabetes include insulin, such as human insulin, or 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 mixture thereof. As used herein, the terms "analog" and "derivative" refer to polypeptide having a molecular structure that can be formally obtained by deleting and / or substituting at least one amino acid residue in a naturally occurring peptide structure, such as the structure of human insulin, and / or by adding at least one amino acid residue. The amino acid residues added and / or substituted can be either codable amino acid residues or other naturally occurring residues, or purely synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure that can be formally obtained from a naturally occurring peptide structure, such as the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide may be substituted by other amino acids including non-codable amino acids and / or deleted, or amino acids containing non-codable amino acids may be 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 proline at position B28 is substituted with Asp, Lys, Leu, Val or Ala and Lys at position B29 can be substituted with 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, Levemir (registered trademark)); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba (registered trademark)); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0123] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39-amino acid peptide produced by the salivary gland of the Gila monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), r exendin-4, CJC-1134-PC, PB-1023, TTP-054, langlenatide / HM-11260C, HM-15211, CM-3, GLP-1 eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, nodexen, viadorl-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (pegapamodotide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, tildesatide (LY3298176), bamaductide (SAR425899), exenatide-XTEN, and glucagon-Xten.

[0124] An example of an oligonucleotide is, for example, mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport syndrome. Examples of DPP4 inhibitors are linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0125] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides such as gonadotropins (folitropin, lutropin, chorionic gonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadorelin, tryptorelin, leuprorelin, buserelin, nafarelin, and goserelin, and their antagonists.

[0126] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or ultra-low molecular weight heparin, or their derivatives, or sulfated forms of the above polysaccharides, such as poly-sulfated forms and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of poly-sulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), sodium hyaluronate.

[0127] As used herein, the term "antibody" refers to an immunoglobulin molecule or its antigen-binding portion. Examples of the antigen-binding portion of an immunoglobulin molecule include F(ab) and F(ab’)2 fragments that retain the ability to bind to an antigen. The antibody can be a polyclonal antibody, monoclonal antibody, recombinant antibody, chimeric antibody, deimmunized or humanized antibody, fully human antibody, non-human (e.g., mouse) antibody, or single-chain antibody. In some embodiments, the antibody has effector functions and can fix complement. In some embodiments, the antibody has reduced or no binding ability to an Fc receptor. For example, the antibody can be an isotype or subtype, antibody fragment, or mutant having a mutation or deletion in the Fc receptor-binding region that does not assist in binding to the Fc receptor. The term "antibody" also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable domain antibody-like binding proteins having a crossover binding region orientation (CODV).

[0128] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include a full-length antibody polypeptide but still includes at least a portion of a full-length antibody polypeptide capable of binding to an antigen. An antibody fragment may include a cleaved portion of a full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab’)2 fragments, scFv (single-chain Fv) fragments, linear antibodies, single-specific or multispecific antibody fragments, such as bispecific, trispecific, tetra-specific and multispecific antibodies (e.g., diabodies, tribodies, tetrabodies), monovalent or multivalent antibody fragments, such as divalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelated recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0129] The term "complementary determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that primarily play a role in mediating specific antigen recognition. The term "framework region" refers to the amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences and primarily play a role in maintaining the proper arrangement of CDR sequences so as to enable antigen binding. The framework region itself is typically not directly involved in antigen binding, but as is known in the art, specific residues within the framework region of a particular antibody can be directly involved in antigen binding or can affect the ability of one or more amino acids within a CDR to interact with an antigen.

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

[0131] Any pharmaceutically acceptable salts of the APIs described herein are contemplated for use as drugs or agents within a drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and basic salts.

[0132] Without departing from the full scope and spirit of the present invention, modifications (additions and / or deletions) may be made to the various components of the APIs, formulations, devices, methods, systems, and embodiments described herein, and it will be understood by those skilled in the art that the present invention encompasses such modified forms and all of their equivalents.

[0133] Exemplary drug delivery devices may include needle-based injection systems as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems can be broadly classified into multi-dose container systems and single-dose (partial or full discharge) container systems. The container can be a replaceable container or an integrated non-replaceable container.

[0134] As further described in ISO 11608-1:2014(E), multi-dose container systems may include needle-based injection devices with replaceable containers. In such systems, each container holds multiple doses, and its size can be fixed or variable (pre-set by the user). Other multi-dose container systems may include needle-based injection devices with integrated non-replaceable containers. In such systems, each container holds multiple doses, and its size can be fixed or variable (pre-set by the user).

[0135] As further described in ISO11608-1:2014(E), a single-dose container system may include a needle-based injection device with an interchangeable container. In one example of such a system, each container holds a single-dose amount, whereby the entire deliverable volume is discharged (full discharge). In a further example, each container holds a single-dose amount, whereby a portion of the deliverable volume is discharged (partial discharge). Also as described in ISO11608-1:2014(E), a single-dose container system may include a needle-based injection device with an integrated interchangeable container. In one example of such a system, each container holds a single-dose amount, whereby the entire deliverable volume is discharged (full discharge). In a further example, each container holds a single-dose amount, whereby a portion of the deliverable volume is discharged (partial discharge).

[0136] Examples of data logging devices for monitoring the use of an injection device and corresponding injection devices will be described in more detail below with reference to the drawings.

Brief Description of the Drawings

[0137]

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DETAILED DESCRIPTION OF THE INVENTION

[0138] FIG. 1 shows an example of a drug delivery device 1 realized as a handheld injection device. The injection device 1 may include a pen-type injector or may be realized as a pen-type injector. The injection device 1 may be realized as a disposable injection device or a reusable injection device. In some examples, the injection device 1 is realized as an auto-injector. The injection device 1 has an elongated shape. The injection device 1 may extend along the longitudinal direction. The drug delivery device 1 includes an administration end for administering or injecting the medicament 24 towards the longitudinal distal direction 2. The injection device 1 includes at least one of a dose member 8 and a trigger 9 towards the proximal direction 3, whereby doses of equal or individual or different sizes can be set and administered, respectively.

[0139] The injection device 1 includes a housing 10. The housing 10 may include many housing components such as a main body 6 and a cartridge holder 7. The main body 6 may be sized and configured to accommodate a drive mechanism 20. The cartridge holder 7 is sized and configured to accommodate a medicament container 21 realized as a cartridge for containing, for example, a liquid medicament 24. The medicament container 21 includes a tubular barrel 22 sealed towards the distal end by a seal 23. The seal 23 may include a pierceable septum fixed to the 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 slidably disposed within the barrel 22.

[0140] By advancing the piston 18 in the distal direction 2, the dose of the medicament 24 can be discharged from the medicament container 21. During use, the medicament container 21 is disposed within the cartridge holder 7. The drive mechanism 20 of the injection device 1 includes a piston rod 19, and the piston rod 19 is displaceable in the distal direction 2 to advance the piston 18 toward the outlet 25 of the medicament container 21. Details of the drive mechanism are not further illustrated or described herein. In some examples, the drive mechanism 20 can be implemented as an all-mechanical drive mechanism in which the user must provide the entire dosing force necessary to move the piston rod 19, and thus the piston 18, in the distal direction 2. In other examples, the drive mechanism includes a mechanical energy storage configured to provide at least a portion of the dosing force. Examples of drive mechanisms can be found, for example, in WO 2004 / 078241 A1, WO 2014 / 033197 A1, or WO 2014 / 033195 A1, the entireties of which are incorporated herein by reference.

[0141] In some examples, such as those described or illustrated in FIGS. 8 and 18, for example, the injection device 1, and thus the drive mechanism 20, can include a dial extension 27 that projects proximally in the proximal direction 3 from the proximal end of the body 6 during dose setting or dose setting, moves, and returns to its initial distal end position during the dose injection procedure. For this purpose, the user can use the thumb 114 of his hand 110 to apply a distal pressure to the trigger 9, thereby pushing the dial extension 27 in the distal direction 2 during the dose injection procedure.

[0142] To set or dial a dosage, the user can turn or rotate the dosage dial 8, for example, in the dosage increasing direction 4, and thus clockwise as viewed from the proximal end. To change a previously set dosage, the user can also rotate the dosage dial 8 in the opposite dosage decreasing direction 5. The size of the dosage is typically indicated in a window 26 provided within or on the body 6 of the injection device 1. Prior to injecting a dosage of the medicament 24, it is necessary to connect the distal end of the cartridge holder 7 to the needle assembly 12. For this purpose, the distal end of the cartridge holder 7 includes a connector 11 in the form of, for example, a threaded interface for engaging a complementary shaped threaded counter interface of the needle assembly 12.

[0143] The needle assembly 12 is removably or detachably fixable to the cartridge holder 7. The needle assembly 12 includes a two-ended injection needle 13. The proximal end of the injection needle (not shown) is configured to enter an opening through in the connector 11 or the distal end face of 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 typically covered by a removable inner needle cap 14. The entire needle assembly 12 can be covered by a removable outer needle cap 15.

[0144] The cartridge holder 7, and thus a part of the housing 10, will be accommodated within a protective cap 16 that is removably connectable to the cartridge holder 7 or the body 6.

[0145] Figures 2 and 3 show an example of an add-on device 30 configured to be fastened to the proximal end of the injection device 1. The add-on device 30 includes a sensor assembly 80 having a sensor element 81 that functions to detect, recognize, characterize, and / or measure the operation of the injection device.

[0146] The add-on device 30 shown in FIGS. 2 and 3 is removably connectable to the dose dial 8. The add-on device 30 includes a device body 60 having a tubular side wall 61. The side wall 61 encloses a receptacle 63 sized to receive the dose dial 8 and the trigger 9 of the infusion device towards the distal end. For this purpose, the inside of the side wall 60 may include one or a plurality of fastening ribs 31 configured to provide a non-slip fastening to the dose dial 8 of the add-on device 32.

[0147] The receptacle 63 is enclosed by a radially inwardly extending flange portion 62. The flange portion 62 separates the interior of the device body 60 into a distal receptacle 63 and a proximal receptacle 64. The proximal receptacle 64 is sized to accommodate a support 70 and a cover 75 for accommodating the electronic module 34. The support 70 includes a longitudinally extending stem portion 71 that extends distally through the flange portion 62. The support 70 is displaceably mounted within the receptacle 64. The support 70 is movable against the action of a return element or a number of return elements 65 in the distal direction 2. The support 70 is connected to a cup-shaped cover 75 that projects proximally from the side wall 61 of the device body 60.

[0148] The cover 75 includes a flat end face 76 facing in the proximal direction 3. The end face 76 is provided with a sensor element 81. As shown in FIG. 3, the entire end face 76 may be covered by the sensor element 81. In this way, the end face 76 functions as an actuating surface that is pressed by the user, for example by the user's thumb 114. The user can apply a distal force to 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.

[0149] When the end face 76 is released, a return element 75, implemented as a return spring for example, serves to move the support 70 and the cover 75 towards the proximal starting position as shown in FIG. 3. At least one of the cover 75 and the support 70 includes a radially outwardly extending protrusion 74 that is guided within a longitudinally extending recess 66 inside the side wall 61 of the device body 60. When viewed longitudinally, the recess 66 is confined by a proximal stop surface 69 and a distal stop surface 67. In the initial configuration as shown in FIG. 3, the protrusion 74 is in longitudinal abutment with the proximal stop surface 69 of the recess 66.

[0150] When the cover 75 is pressed distally in the direction 2 against the action of the return element 65, it reaches the distal end position when the protrusion 74 engages the distal stop surface 67. The guiding of the protrusion 74 within the groove 66 enables the longitudinal movement of the support 70 and the cover 75 to be restricted within a predetermined limit relative to the device body 60.

[0151] When pressed distally in the direction 2, the support 70 and its stem portion 71 begin to protrude from the flange portion 62. Since the side wall 61 can be fixed longitudinally relative to the dose dial 8, the distal longitudinal displacement of the support 70 and its stem portion 71 functions 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. The cover 75 can be rotatable freely relative to the support 70, particularly during the dose injection procedure. During dose injection, the dose dial 8 can rotate in the dose decreasing direction 5 while the trigger 9 remains rotatably locked relative 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 add-on device 30.

[0152] 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 for engaging with a radially concave or protruding portion 72 of a complementary shape of the support 70. The cup-shaped cover 75 connected or fastened to the support 70 provides a receptacle for the electronic module 34 disposed within the hollow space formed by the support 70 and the cover 75.

[0153] The sensor assembly 80 described herein may be somewhat identical or equivalent to the electronic module 34, and vice versa. The electronic module 34 may include a printed circuit board 36. The electronic module 34 may further include transceivers 38, 39, a memory 40, a clock 42, a processor 44, a power supply 46, an acceleration sensor 48, a position sensor 50, signal generators 51, 52, and, for example, light sources 53, 54. The electronic module 34 may also include a microphone.

[0154] Furthermore, the side wall 77 of the cover 75 may include a window 55 aligned with each window 56 of the side wall 61 of the device body 60. In this way, visual signals that can be generated by different light sources 53, 54 located within the hollow space of the cover 75 can be recognized and visually detected from outside the add-on device 30.

[0155] The two light sources 53, 54 may belong to a visual signal generator 52 that functions to generate or produce visual signals of different colors and / or at various times. The windows 55, 56 may be provided with light pipes or light guiding structures. In this way, the device body 60 can be protected from the ingress of dust or moisture.

[0156] FIG. 4 shows a block diagram of an example of the electronic module 34 and / or the sensor assembly 80. As also shown in FIG. 3, the processor 44 is mounted on the printed circuit board 36, and the printed circuit board 36 is connected to the sensor element 81 of the sensor assembly 80 that substantially covers the end face 76 of the cover 65.

[0157] Generally, the electronic module 34 can be mounted on the printed circuit board 36. The electronic module 34 can be configured to communicate with an external electronic device 100, for example, as shown in FIG. 28. The external electronic device 100 can be implemented as a mobile electronic device. The external electronic device 100 can include a smart watch, a smart phone, or a tablet computer. The electronic module 34 includes a transceiver 38 configured to establish or build a communication link between the external electronic device 100 and the electronic module 34. Each communication link can be realized by a wireless or wired method.

[0158] The electronic module 34 can be configured to exchange data with the external electronic device 100. Data indicating the operation of the injection device and collected or retrieved by the sensor assembly 80 can be transmitted to the external electronic device via the transceiver 38. The transceiver 38 can be implemented as a Bluetooth transceiver or a BLE transceiver. A further transceiver 39 can be implemented as an NFC transceiver. The two transceivers can be distinguished with respect to their communication protocols and / or their spatial ranges.

[0159] The electronic module 34, and thus the sensor assembly 80, includes a memory 40 configured to store a plurality of measurement results of the sensor assembly 80. The electronic module 34, and thus the sensor assembly 80, further includes a clock 42 configured to provide a time index indicating the detection time point and / or date of each operation of the injection device 1 for each of the plurality of measurement data of the sensor assembly 80.

[0160] The sensor assembly 80, and thus the processor 44 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, further comprises a power source 46 configured to supply power to the processor 44 and the sensor assembly 80. The power source 46 may be implemented as a battery. The sensor assembly 80 may further include an acceleration sensor 48 configured to detect the injection operation of the injection device 1 and / or to detect or classify a user gesture when using the sensor assembly 80 and / or the injection device 1. For example, when implemented as an auto-injector, the acceleration sensor may detect the acceleration of the needle of the auto-injector during the administration or injection procedure.

[0161] The sensor assembly 80 may further include a position sensor 50 that may function to detect the position or orientation of a dedicated component of the drive mechanism 20 of the injection device 1. The position sensor may function, for example, to detect the position of the piston rod 19 of the drive mechanism 20 or a similar component's last dose nut indicating the amount of drug within the drug container 21.

[0162] Furthermore, the sensor assembly 80 or the electronic module 34 includes a signal generator 52, and the signal generator 52 may be implemented as a visual signal indicator including at least one light source 53, 54. Additionally or alternatively, the signal generator 51 may be implemented as a tactile signal generator configured to generate a recognizable vibration of the electronic module 34, for example. In a further example, the signal generator 51 may include an audible signal generator configured to generate an audible sound.

[0163] In addition, in a further example, the electronic module 34 and / or the sensor assembly 80 may include a microphone, and the microphone can detect and process the characteristic click sound of the injection device, thereby making it possible to derive or measure the size of the dose currently set or being injected by the injection device 1.

[0164] The implementation of the electronic module 34 within the add-on device 30, as presently illustrated, is merely exemplary. In particular, in a reusable device, it is also conceivable that the entire functionality of the add-on device 30, and hence the entire functionality of the sensor assembly 80 and the electronic module 34, could be implemented in the infusion device 1. Here, a receptacle 64 sized to accommodate the hardware components of the electronic module 34 could be provided within the dose dial 8 that is covered or closed in the proximal direction by the trigger 9. Here, the trigger 9 of the infusion device replaces the cover 75 and the support 70. The stem portion 71 of the support 70, and hence the stem portion 71 of the trigger 9, could then be operably engaged with a drive mechanism to cause or trigger its administration operation. The device body 60 could be provided or represented by those tubular-shaped dials 8.

[0165] Examples are schematically shown in FIGS. 2, 3, and 5 - 8 of an example of a sensor assembly 80. The sensor assembly 80 includes a sensor element 81 having a plurality of touch-sensing or pressure-sensing sensor segments 84, 85, 86 on sensing surfaces 82, 83. The sensor assembly 80 could include a regular arrangement of touch-sensing sensor segments 84, 85, 86 as shown in FIGS. 5 and 6. The individual sensor segments could correspond to the pixels of a touch-sensing display. Each of the sensor segments 84, 85, 86 could include a capacitance measurement device capable of accurately detecting mechanical contact with a user's body part.

[0166] In some examples, the sensor segments 84, 85, 86 are pressure-sensitive. Hence, the sensor segments 84, 85, 86 function to generate or modify an electrical touch signal when touched by a user's body part. The sensor segments 84, 85, 86 could be spatially distributed across the sensing surfaces 82, 83 of the sensor element 81. The sensor element 81 could provide a spatially resolved detection of sensing regions 88, 89 that are actually being touched by or are in mechanical contact with the user's skin.

[0167] In some examples, the individual sensor segments 84, 85, 86 are not only touch-sensitive but also function to generate an electrical touch signal indicative of the pressure or intensity of mechanical contact with a user's body part. Thus, the touch-sensing sensor segments 84, 85, 86 function to generate different electrical touch signals indicative of the magnitude of the pressure or force applied to each sensor segment.

[0168] In such cases, the touch-sensing sensor segments 84, 85, 86 function to generate electrical touch signals that differ in at least one of magnitude, amplitude, sign, or frequency. These differences in the electrical touch signals are detectable by the processor 44 of the sensor assembly 80 and can be evaluated to detect, recognize, characterize, and / or measure a user-induced operation of the infusion device 1.

[0169] In an example such as shown in FIGS. 5-8, the sensor element 81 includes a circular flat sensing surface 82 and a tubular-shaped sensing surface 83 positioned longitudinally adjacent to the outer periphery of the sensing surface 82. In such cases, the sensor element 81 includes a cup-shaped receptacle sized to receive the trigger 9 of the infusion device 1 and / or the cover 75 of the add-on device 30.

[0170] In a further example, it is conceivable that the cup-shaped sensor element 81 is configured to receive an administration element that combines the functions of the dose dial 8 and the trigger 9 into a single component.

[0171] In the description of FIGS. 5-7, only one of the plurality of sensor segments 84, 85, 86, namely sensor segment 86, is actually active and detects contact with a user's body part.

[0172] In some examples, the sensor element 81 includes only a flat sensing surface 82 fastened to the trigger 9 of the add-on device 30 or the proximal end face of the cover 75. In other examples, the sensor element 81 may include only a tubular sensing surface 83 configured to enclose 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 the tubular shaped body 6 of the injection device 1.

[0173] FIG. 8 shows a typical situation of the use of the injection device 1 with the dial extension 27. To set the dose, the user rotates the dose dial 8 relative to the body 6. The dose dial 8 is part of the dial extension 27 and thus begins to project in the proximal direction 3 from the proximal end of the body 6 when an increasing size dose is set or dialed.

[0174] As a result, an increasing number of dose display marks are shown within the dose display window 26. To inject the dose, the user uses their hand 110 to grip the body 6 of the injection device with the palm 112 of their hand, thereby holding the body 6 of the injection device 1 using at least two fingers 116, 117. The user can then cause an administration action by using their thumb 114 to press the trigger 9 in the distal direction 2.

[0175] During dose injection, since the trigger 9 and thus the entire dial extension 27 perform a longitudinal displacement in the distal direction relative to the body 6, the angle at which the thumb 114 is oriented relative to the trigger 9 gradually changes. Thus, during dose administration, the thumb 114 performs a rubbing or natural rolling motion, which is detectable by the spatially resolved touch sensing surface 82 of the sensor element 81 covering the proximal surface of the trigger 9 or the proximal surface of the cover 75 of the add-on device 30.

[0176] Furthermore, as shown in more detail in FIGS. 9 to 16, the touch sensing sensor segments 84, 85, 86 are configured to generate different electrical touch signals in response to the force level or pressure level applied to each of the sensor segments 84, 85, 86. In FIGS. 9 to 16, high or relatively high pressure levels are indicated by the relatively dark shaded sensor segments 84, 85, 86. Relatively low pressure levels are indicated by the relatively weak or light shaded sensor segments 84, 85, 86.

[0177] In this way, not only is a spatially resolved contact profile provided across the one-dimensional or two-dimensional sensing surfaces 82, 83 of the sensor element 81, but a pressure profile indicating different pressure levels applied across the sensing surfaces 82, 83 can also be provided.

[0178] In the example of FIG. 9, there are only 12 sensor segments in total on the sensing surface 82 that are affected by a relatively large force or pressure. Here, only the exemplary sensor segment 85 is subject to a relatively high pressure. The sensor segments 84, 86 are located radially outside the high-pressure sensing region 88. The sensor segments 84, 86 are subject to medium or relatively low pressure.

[0179] The sensor segments 84, 86 that are subject to relatively low or medium pressure form or constitute a low or medium pressure sensing region 89. These sensor segments 85 that are subject to relatively high pressure form or constitute the sensing region 88.

[0180] As shown in FIG. 9, the sensing region 88 is located substantially at the center of the sensing surface 82. The sensing region 88 is surrounded by a relatively low-pressure sensing region 89. This example may represent a case where a user applies a moderate pressure on the sensing surface 82, for example, with his or her thumb 114. Since the thumb 114 has a convex shape and a certain elasticity, as the pressure is increased, the user's thumb 114 undergoes respective deformations, and thus the lateral range of the high-pressure sensing region 88 increases. As shown in FIG. 10, those sensor segments 84, 86 that previously received only relatively low pressure are now receiving relatively high pressure.

[0181] The change in the pressure profile from the example of FIG. 9 to the example of FIG. 10 can be accurately detected and monitored by a processor 44 configured to individually process the electrical touch signals generated or modified by each of the sensor segments 84, 85, 86. In such a case, the processor 44 is configured to detect or recognize an increase or change in the sensing region 88.

[0182] It should be noted that generally, the sensor segments 84, 85, 86 specifically referred to herein exemplarily show the entirety of the sensor segments provided on the sensing surfaces 82, 83. The spatial resolution of the sensor assembly 18 may depend on the total number of the sensor segments 84, 85, 86 and their arrangement on the sensing surfaces 82, 83.

[0183] The operation of the injection device 1 shown in FIG. 8 can result in two examples of touch profiles as shown in FIGS. 11 and 12. Here, the user is in slight lateral contact with the trigger 9. At the start of the dose injection operation, the user's thumb 114 touches or is in contact with the lateral portion of the sensing surface 82. As indicated by the sensing region 89 and the sensor segment 85, the contact intensity or pressure decreases towards the center of the sensing surface 82. As the administration procedure continues, the dial extension 27 moves in the distal direction, thus causing a somewhat natural rolling movement of the thumb 114 across the surface of the sensing surface 82.

[0184] As shown in FIG. 12 and compared with the example of FIG. 11, the sensing region 88 indicating substantial mechanical contact moves towards the center of the sensing surface 82. Therefore, the sensor segment 85 that detected a relatively low pressure in the configuration of FIG. 11 detects a relatively high pressure here in the configuration of FIG. 12.

[0185] A configuration as shown in FIG. 17 is consistent with the contact or touch profile as shown in FIGS. 13 and 14. Here, from the beginning to the end of the injection, the thumb 114 is located approximately in the center of the sensing surface 82. As the injection procedure continues or progresses, the different sensing regions 88, 89 indicating medium contact pressure and high contact pressure only slightly increase or change in their size, only moderately change in their position, and only slightly change in their geometric shape, as is apparent from the comparison between FIGS. 13 and 14.

[0186] In another example shown in FIG. 18, for example, and as indicated by the pressure profiles of FIGS. 15 and 16, the user can completely cover the sensing surface 82 with his or her thumb 114 even at the start of the dosing action. As shown in FIG. 15, different sensing regions 88, 89 with different pressures can be provided across the sensing surface 82. As the user applies increasing pressure, the pressure profile shown in FIG. 15 can change to a pressure profile as shown in FIG. 16. Here, the central region of the sensing surface 82 with the sensor segment 85 can change from a medium pressure level to a relatively high pressure level.

[0187] The sensor assembly 80 is specifically configured to detect and monitor the temporal changes in the contact pressure applied to the individual sensor segments 84, 85, 86. In this way, the sensor assembly 80, and thus the processor 44, functions to identify the sensing regions 88, 89. The processor can function to detect and / or distinguish between different sensing regions 88, 89, each including one or more of the sensor segments 84, 85, 86, respectively.

[0188] The various sensing regions 88, 89 can be distinguished from each other by the pressure levels applied to each of the sensing regions 88, 89. The processor 44 and / or the sensor assembly 80 can be further configured to detect or characterize the movement of the sensing regions 88, 89, for example, during a dosing setting or a dosing administration procedure.

[0189] Furthermore, the processor 44 and / or the sensor assembly 80 can be configured to detect or characterize changes in the size of the sensing regions 88, 89, as shown by the comparison of FIGS. 9 and 10 or FIGS. 15 and 16.

[0190] Furthermore, the sensor assembly 80 and / or the processor 44 can function to detect or characterize changes in the geometric shape or orientation of the sensing regions 88, 89 on the sensing surfaces 82, 83.

[0191] The temporal changes in the pressure profile or the contact profile shown by FIGS. 9 and 10, FIGS. 11 and 12, FIGS. 13 and 14 and / or FIGS. 15 and 16 can indicate the same or different operating modes of the injection device 1.

[0192] The sensor assembly 80 and / or the processor 44 may be switchable to a training mode, whereby a touch signal profile is recorded or captured over time and such a touch signal profile is assigned to a specific operation of the infusion device 1. In this way, the sensor assembly 80 and / or the processor 44 can be trained on a specific, e.g., user-specific, touch signal profile associated with or assigned to a specific operation of the infusion device.

[0193] Thereafter, during use of the infusion device 1, the sensor assembly 80 may function to detect temporal changes in the electrical touch signals caused by user-induced operations of the infusion device. The temporal changes in the electrical touch signals collected or captured by the sensor assembly 80 during operation of the infusion device 1 may be used to generate an operation profile. Thereafter, the operation profile may be compared with a number of touch signal profiles previously stored in the memory 40 of the sensor assembly 80.

[0194] Thereafter, the processor 44 may be configured to select from the memory one touch signal profile that most closely matches the operation profile and select the specific operation of the infusion device to which the selected touch signal profile is assigned as the recognized operation of the infusion device. In this way, by analyzing and evaluating the temporal changes in the electrical touch signals provided by the sensor element 81, the sensor assembly 80 and / or the electronic module 34 can autonomously distinguish between different operation modes of the infusion device.

[0195] As particularly shown in FIGS. 20 and 21 in connection with FIG. 19, the user can rotate the dose dial 8 using the thumb 114 and index finger 116, and the dose dial 8 can similarly comprise a tubular sensing surface 83 of the sensor element 81. In FIG. 20, only the sensor segment 85 is substantially under high pressure, the sensor segment 84 is under low or medium pressure, and the sensor segment 86 is not under any pressure at all. By rotating the dose dial 8, for example, clockwise, the pressure profile along or across the sensing surface 83 will gradually change. In the configuration of FIG. 20, the sensing region 88 corresponding to the positions of the thumb 114 and index finger 116 is circumferentially edged or surrounded by a sensing region 89 of considerably lower pressure or force.

[0196] By rotating the dose dial 8, the sensor segment 84 is exposed to an increasing contact pressure. As shown, the sensing regions 88, 89 move circumferentially with respect to the positions of the sensor segments 84, 85, 86. This movement of the sensing regions 88, 89 can be detected and tracked and can be quantitatively measured by the processor 44. In this way, the sensing surface 83 and the individual sensor segments 84, 85, 86 also enable and support a quantitative measurement of the degree of rotation of the dose dial 8 with respect to the body 6.

[0197] In a further description of FIGS. 22 - 27, the sensor assembly 80 includes a flexible sheet 79 configured to wrap around or enclose the body 6 of the injection device 1. Here, the injection device 1 can be implemented as an auto - injector. The injection device 1 may not have a separate trigger, for example, pressed by the user's thumb 114. Rather, the dosing or injection operation can be simply initiated by bringing the distal dosing end of the injection device 1 into contact with the skin and applying a medium pressure to the skin through the housing 10 or body 6 of the injection device 1.

[0198] Thereafter, the injection device 1 can automatically start the administration procedure by pushing the injection needle into the skin, and subsequently deliver or inject the drug into the actually punctured skin portion.

[0199] As shown in FIGS. 22 to 25, in a typical usage situation, before applying a distal pressure to the body 6 of the injection device, the user can grasp the periphery of the body 6 of the injection device 1 provided with the sensor assembly 80 as described above. The sensor assembly 80 may include a flexible sheet 79 or foil having a plurality of sensor segments 84, 85, 86 that enable precise and spatially resolved recording and detection of the holding force or pressure applied by the fingers 114, 116, 117 and the palm 112 of the user's hand 110.

[0200] The contact area between the palm 112 and the sensor element 81 when the user simply holds the injection device 1 with his own hand 110 can be represented by a sensing area 88 as shown in FIG. 25. The contact between the index finger 116 and the sensor element 81 can be reflected in the sensing area 88'. The contact zone between the middle finger 117 and the sensor element 81 can be represented by the sensing area 88'', and the contact zone between the ring finger of the hand 110 and the sensor element 81 can be reflected by the sensing area 88'''.

[0201] Here, when the user brings the administration end of the injection device 1 into contact with the skin and starts pressing the injection device 1 against the skin, a measurable deformation occurs in the contact area between the hand 110 and the sensor element 81. Since the hand 110 bends longitudinally along the distal end on the sensing surface 82, the sensor assembly 80 functions to record the movement of each of the sensing areas 88, 88', 88'', 88''' toward the sensing areas 89, 89', 89'', 89'''. The temporal change and / or movement of the sensing areas 88, 89 can be recorded by the processor 44.

[0202] Furthermore, at the end of the dosing procedure, the processor 44 may further function to measure the time during which the sensing regions 89, 89', 89'', 89''' remain substantially constant. Similarly, the sensor assembly 80 may be configured to detect, for example, the time that the user keeps the thumb 114 firmly pressed against the trigger 9 at the end of the dosing procedure. In this way, the sensor assembly 80 is configured to automatically detect and record a predetermined holding time that the injection needle 13 should remain in the punctured tissue after the end of the drug dosing injection.

[0203] After the end of the dosing procedure, the sensor assembly 80 and / or the electronic module 34 may be configured to provide recognizable feedback to the user in any of a visual, acoustic, or tactile manner. For this purpose, the on-board signal generators 51, 52 can be used or activated by the processor 44. Alternatively, when the sensor assembly 80 is in a communication mode with the external electronic device 100, each feedback signal can also be generated by the external electronic device 100.

[0204] Upon reaching the end of the injection procedure, the user may have to maintain the pressure applied to the trigger 9. This can result in a fairly constant electrical touch signal provided by the many touch sensing sensor segments 84, 85, 86. In such a case, the complete release of the sensing surface 82 that the body part has separated from the sensing surfaces 82, 83 and is thus no longer in contact, simply following a fairly constant and unchanging pressure profile measured by the sensor assembly 80, directly indicates that the user has complied with the predetermined hold of the injection device after the end of the dosing procedure.

[0205] Here, the sensor assembly is configured to automatically distinguish between different operating modes of the injection device. The sensor assembly may automatically record the times and / or durations at which such different operations of the injection device were performed.

[0206] In this way, the accuracy and quality of the data collected by the sensor assembly can be improved.

[0207] An example of an external electronic device 100 is schematically shown in FIG. 28. The external electronic device 100 is realized as a smartwatch. The external electronic device 100 includes a housing 101 and a display 102 that can be implemented as a touch-sensitive display. The external device 100 may further include control elements 103 that can be operated or actuated by a user of the device. By means of a wristband 115, the external electronic device 100 can be attached to a user's wrist 111. On the display 102, many visual items 104 in the form of information such as symbols, characters, etc. can be provided, whereby the user can be assisted when using the injection device 1.

[0208] Due to the communication link between the sensor assembly 80 and the electronic module 34, it may no longer be necessary for the user to manually confirm a specific operating mode of the injection device 1 on the external electronic device 100. By means of a communication link, for example a wireless communication link between the external electronic device 100 and the sensor assembly 80, information such as the setting of the dose at a specific point in time and the administration of the dose at a specific point in time can be automatically provided to the external electronic device 100.

[0209] Furthermore, 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. By detecting the administration procedure and distinguishing the administration procedure from, for example, the dose setting procedure, the sensor assembly 80 and the electronic module 34 can automatically provide relevant information to the external electronic device 100, and the external electronic device 100 can provide further data processing or data analysis. Furthermore, the external electronic device 100 can be configured to transmit the acquired data to a healthcare provider for further data analysis and management of compliance with a predetermined user's dosing schedule.

[0210] The flowchart of FIG. 29 illustrates a method of recognizing, detecting, characterizing, or measuring the operation of an injection device by utilizing the sensor assembly 80 described above. In a first step 200, the sensor element 81 of the sensor assembly 80 is attached or incorporated to or within the injection device 1 or the add-on device 30 as described above. In the next step 202, several electrical touch signals are generated or modified in response to a user's body part touching the sensing surfaces 82, 83 of the sensor element 81. In the next step 204, changes in the electrical touch signals over time are detected and / or recorded. In the next step 206, the operation of the injection device 1 is detected, recorded, characterized, or quantitatively measured based on the temporal changes in the electronic touch signals.

Explanation of Signs

[0211] 1 Injection device 2 Distal direction 3 Proximal direction 4 Dose increase direction 5 Dose decrease direction 6 Body 7 Cartridge holder 8 Dose dial 9 Trigger 10 Housing 11 Connector 12 Needle assembly 13 Injection needle 14 Inner needle cap 15 Outer needle cap 16 Protective cap 18 Piston 19 Piston rod 20 Drive mechanism 21 Drug container 22 Barrel 23 Seal 24 Drug 25 Outlet 26 Window 27 Dial extension 28 Tubular member 30 Add-on device 34 Electronic module 36 Printed circuit board 38 Transceiver 39 Transceiver 40 Memory 42 Clock 44 Processor 46 Power supply 48 Acceleration sensor 50 Position sensor 51 Signal generator 52 Signal generator 53 Light source 54 Light source 55 Window 56 Window 60 Device body 61 Side wall 62 Flange portion 63 Receptacle 64 Receptacle 65 Return element 66 Recess 67 Stop surface 68 Recess 69 Stop surface 70 Support 71 Stem portion 72 Protrusion 74 Protrusion 75 Cover 76 End face 77 Side wall 79 Sheet 80 Sensor assembly 81 Sensor element 82 Sensing surface 83 Sensing surface 84 Sensor segment 85 Sensor segment 86 Sensor segment 88 Sensing region 89 Sensing region 100 External device 101 Housing 102 Display 103 Control element 104 Visual item 110 Hand 111 Wrist 112 Palm 114 Thumb 116 Finger 117 Finger

Claims

1. A sensor assembly (80) for detecting the operation of an injection device (1), - A sensor element (81) that can be attached to the injection device (1), includes sensing surfaces (82, 83), and the sensing surfaces (82, 83) include several touch-sensing sensor segments (84, 85, 86). The touch-sensing sensor segments (84, 85, 86) are configured 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), which is configured to detect changes in the electrical touch signal over time and recognize the operation of the injection device (1) based on the temporal changes of the electrical touch signal, The sensor assembly (80) comprising the above.

2. The sensor assembly (80) according to claim 1, wherein at least one of the touch-sensing sensor segments (84, 85, 86) is configured to generate different electrical touch signals in response to changes in the pressure applied to the touch-sensing sensor segments (84, 85, 86).

3. The sensor assembly (80) according to claim 1 or 2, wherein each of the touch-sensing sensor segments (84, 85, 86) is configured to generate or modify an electrical touch signal when touched by the body part (112, 114, 116, 117) of the user.

4. The sensor assembly (80) according to any one of claims 1 to 3, wherein the processor (44) is configured to process the electrical touch signals of several touch-sensing sensor segments (84, 85, 86) to identify the sensing areas (88, 89) of the sensing surfaces (82, 83) being touched by the body part (112, 114, 116, 117).

5. The sensor assembly (80) according to claim 4, wherein the processor (44) is configured to detect the movement of the sensing areas (88, 89) on the sensing surfaces (82, 83).

6. The sensor assembly (80) according to claim 4 or 5, wherein the processor (44) is configured to detect changes in the size of the sensing areas (88, 89) on the sensing surfaces (82, 83).

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

8. The sensor assembly (80) according to any one of claims 1 to 7, wherein the sensor element (81) includes a flat 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 claims 1 to 8, wherein the sensor element (81) includes a tubular sensing surface (83) configured to be fastened to a tubular member (28) of the injection device (1).

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

11. The sensor assembly (80) according to any one of claims 1 to 10, wherein the processor (44) functions to detect at least one of an end of a dose setting operation, a dose administration operation, and a dose holding operation of the injection device (1) by processing a plurality of electrical touch signals of a plurality of touch sensing sensor segments (84, 85, 86) over time when the sensor element (81) is attached to the injection device (1).

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

13. The sensor assembly (80) according to any one of claims 1 to 12, further including a clock (42) connected to the processor (44), wherein the processor (44) functions to detect or measure at least one of a time point when a user operates the injection device (1) and a time during which the user operates the injection device (1).

14. It further includes a memory (40) connected to the processor (44), and the processor (44) functions to store usage-related data in the memory (40), and the data includes at least one of the time when the injection device was operated, the time the device was operated, and the size of the dose of the drug set or injected by the injection device (1). The sensor assembly (80) according to any one of claims 1 to 13.

15. The processor (44) - Detect the temporal change of the electrical touch signal during the operation of the injection device (1), and generate an operation profile based on the detected temporal change of the electrical touch signal, - Compare the operation profile with a plurality of touch signal profiles stored in the memory (40), - Select one touch signal profile that most matches the operation profile from the memory (40), - Select a specific operation of the injection device (1) to which the selected touch signal profile is assigned as the recognized operation of the injection device (1) The sensor assembly (80) according to claim 14, which functions as follows.

16. It further includes a clock (42) and a memory (40) connected to the processor (44), and the processor (44) - Monitor the temporal change of the electrical touch signal during a specific operation of the injection device (1), - Store the temporal change of the electrical touch signal in the memory (40) as a touch signal profile, - Assign the specific operation of the injection device (1) to the touch signal profile The sensor assembly (80) according to any one of claims 1 to 15, which functions as follows.

17. An injection device (1) for injecting a dose of a drug (24), the injection device comprising: - A main body (6) for accommodating a drive mechanism (20) that functions to take out or discharge the drug (24) from a drug container (21), - At least one of a dose dial (8) and a trigger (9) that can be actuated by a user to inject the dose, - The sensor assembly (80) according to any one of claims 1 to 16 attached to or incorporated in at least one of the main body (6), the dose dial (8), and the trigger (9), An injection device (1) comprising.

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

19. A method of recognizing the operation of an injection device (1), comprising: - attaching or incorporating a sensor element (81) of a sensor assembly (80) according to any one of claims 1 to 16 to or into one of the injection device (1) and an add-on device (30) configured to be fastened to the injection device (1); - generating a number of electrical touch signals in response to a user's body part (112, 114, 116, 117) touching the sensing surface (82, 83) of the sensor element (81); - detecting a change in the electrical touch signals over time; - recognizing the operation of the injection device based on the temporal change of the electronic touch signals. A method comprising the above steps.

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 claims 1 to 16, cause the processor (44) to: - detect a change over time in electrical touch signals, the electrical touch signals being generated by touch-sensing sensor segments (84, 85, 86) of a sensing surface of a sensor element (81) of the sensor assembly (80) when touched by a user's body part (112, 114, 116, 117); - recognize the operation of the injection device (1) based on the temporal change of the electronic touch signals. A computer program.

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