Electronic unit for attachment to an injection device

Abstract

The disclosure relates to an electronic unit (34) for attachment to an injection device (1) or for integration into an injection device (1), the electronic unit (34) comprising: - an electronic display (60) with a display surface (61), - a processor (44) connected to the electronic display (60), - a sensor assembly (80) connected to the processor (44) and comprising a touch sensitive sensor element (81), which is coupled to the display surface (61), wherein the sensor assembly (80) is operable to generate a sequence of touch control signals in response to a user touching the display surface (61) while conducting a predefined touch action (66) of a number of predefined touch actions (66, 66', 66''), and - wherein the processor (44): i) is operable to process the sequence of touch control signals, ii) is operable to recognize the predefined touch action (66) on the basis of the processing of the sequence of touch control signals, and iii) is operable to generate a display control signal on the basis of the recognition of the predefined touch action (66), the display control signal causing a modification of a visual appearance (62, 63, 64) of the display surface (61) when received and / or processed by the electronic display (60).

Description

[0001] PAT24274-WO-PCT

[0002] Electronic Unit for Attachment to an Injection Device

[0003] Description

[0004] Field

[0005] The present disclosure relates to an electronic unit for attachment to an injection device or for integration into an injection device. In some aspects the present disclosure relates to an add-on device configured for detachably fastening to an injection device and provided with an electronic unit. In other aspects the present disclosure relates to an injection device provided with an electronic unit. In other aspects the disclosure relates to an injection system comprising at least one of an add-on device and an injection device and further comprising an external electronic device. Further aspects relate to a method of modifying a visual appearance of a display surface of an electronic display of an electronic unit and a computer program for executing such a method.

[0006] Background

[0007] Drug delivery devices for setting and dispensing a single or multiple doses of a liquid medicament are as such well-known in the art. Generally, such devices have substantially a similar purpose as that of an ordinary syringe.

[0008] Drug delivery devices, such as pen-type injectors, have to meet a number of user-specific requirements. For instance, with patients suffering chronic diseases, such as diabetes, the patient may be physically infirm and may also have impaired vision. Suitable drug delivery devices especially intended for home medication therefore need to be robust in construction and should be easy to use. Furthermore, manipulation and general handling of the device and its components should be intelligible and easy understandable. Such injection devices should provide setting and subsequent dispensing of a dose of a medicament of equal or variable size. Moreover, a dose setting as well as a dose dispensing procedure must be easy to operate and has to be unambiguous.

[0009] A patient suffering from a particular disease may require a certain amount of a medicament to either be injected via a pen-type injection syringe.

[0010] Some drug delivery or injection devices provide selecting of a dose of a medicament of variable size and injecting a dose previously set. Other injection devices provide setting and dispensing of a fixed dose. Here, the amount of medicament that should be injected in accordance with a given prescription schedule is always the same and does not change or cannot be changed over time.

[0011] Some injection devices are implemented as reusable injection devices offering a user to replace a medicament container, such as a cartridge. Other injection devices are implemented as a disposable injection device. With disposable injection devices it is intended to discard the entirety of the injection device when the content, i.e. the medicament, has been used up.

[0012] Medical devices for injection of liquid drugs, like pen-typ injectors or fixed-dose injectors are quite common today, but are displaying the selected dose or status in most cases only during dial-up in a specific dose window, showing a number on a number sleeve. To record the therapy progress it is usually required to use an anolog or digital notebook to record a time stamp at together with injected dose. To increase the functionality of this kind of mechanical injection devices, it is possible to attach a digital recording device to the injection device capable to record the selected or applied dose.

[0013] Some injection device may be readily equipped with an electronic dose recording unit, which may be integrated or arranged on or inside a housing or body of the injection device.

[0014] Due to space constraints a display on the add-on device may not exceed the limited size of the add-on device. Such displays are hence comparatively small and are thus restricted to display only a limited amount of information at a time. However, in order to provide comprehensive information to a user of an electronic dose recording device it would be desirable to increase the amount of information that could be shown to a user of the dose recording device. It is therefore desirable to provide improvements to such dose recording devices in terms of providing a comparatively large amount of information on a display of limited size, which amount of information should be available for a user in a rather intuitive and straightforward and / or structured manner.

[0015] Summary

[0016] The above-mentioned drawbacks will be solved by an electronic unit, by an add-on device for an injection device, by an injection device for injecting a dose of a medicament, by an injection system, by a method of modifying a visual appearance of the display surface of an electronic display and by a respective computer program as defined by the features of the independent claims. Further examples of these solutions are subject matter of the dependent claims.

[0017] In one aspect there is provided electronic unit for attachment to an injection device or for integration into an injection device, e.g. for attachment to an injection pen or for integration into an injection pen. The electronic unit comprises an electronic display with a display surface. The electronic unit further comprises a processor, which is connected or coupled to the electronic display, e.g., in a signal transferring manner. The electronic unit further comprises a sensor assembly, which is connected to the processor.

[0018] The sensor assembly comprises a touch sensitive sensor element, which is coupled to the display surface. The sensor element may be attached or integrated into the display surface. It may overlap with the display surface. The sensor assembly is operable to generate a sequence of touch control signals in response to a user touching the display surface while conducting a predefined touch action of a number of predefined touch actions. The processor is operable to process the sequence of touch control signals that are generated by the sensor assembly. The processor is further operable to recognize the predefined touch action on the basis of the processing of the sequence of touch control signals and the processor is further operable to generate a display control signal on the basis of the recognition of the predefined touch action. The display control signal causes a modification of a visual appearance of the display surface when received and / or / when processed by the electronic display.

[0019] In this way, there can be provided a modification of the visual appearance of the display surface of the electronic display only when a user touches the display surface in a predefined manner or when the user applies a dynamic touch procedure with regards to the touch sensitive sensor element of the sensor assembly. In other words, the user has to conduct one of a predefined touch actions relative to the touch sensitive sensor element and hence relative to the sensor assembly such that a predefined sequence of touch control signals is generated in response to the predefined touch action, such that by analyzing or processing the sequence of touch control signals as generated by the sensor assembly can be recognized or assigned to one of a predefined touch action of numerous predefined touch actions.

[0020] Upon recognition of a specific predefined touch action by the processor of the electronic unit there will be generated a specific display control signal on the basis of which the electronic display is operable to modify the appearance of the display surface.

[0021] The processing of a sequence, hence a temporal sequence of touch control signals allows and supports to implement various different display configurations or different visual appearances of the display surface only when detecting a predefined touch action conducted by a user of the electronic unit while or after conducting such a predefined touch action chain.

[0022] According to some examples the display surface is a two-dimensional display surface. The sensor assembly and its touch sensitive sensor element may be also implemented to comprise a two- dimensional sensing surface, which entirely or almost entirely overlaps with the display surface of the electronic display.

[0023] The sequence of touch control signals as generated or generatable by the sensor assembly may be indicative of a predefined user gesture, that may be conducted by a user, e.g. by a body part of the user, e.g. by a finger of a user's hand touching or swiping across the display surface of the electronic display.

[0024] Accordingly, the sequence of touch control signals may be a temporal sequence. In this way, the dynamics or a dynamic evolution of a generation of one and the same or of different and / or mutually distinguishable touch control signals can be detected and processed, e.g., analyzed, to recognize the predefined touch action.

[0025] In further examples, the sequence of control signals represents a spatial sequence and / or a spatio-temporal sequence of control signals. Here, the spatial origin of the control signals may vary over time. Individual control signals may be generated in response to a user touching a certain or varying touch sensitive regions of e.g., a two-dimensional or one-dimensional display surface, each touch sensitive region may be configured to generate or to cause generation of a respective touch control signal.

[0026] In some examples the electronic display is a touch sensitive electronic display. The interaction between the processor, the electronic display and the sensor assembly may be implemented such, that recognition of a predefined touch action of a user triggers a modification of the visual appearance of the display surface. In this way the amount of information to be visually provided to a user via the electronic display can be easily increased. By conducting a predefined touch action, which triggers a modification of the visual appearance of the display surface the user gains a rather intuitive control of modifying the visual appearance of the display surface.

[0027] The touch sensitive electronic display may be configured to visualize or to display a first information part in a default configuration. The visual appearance of the display surface may be then switched to a second configuration, e.g., by conducting the predefined touch action on or across the touch sensitive sensor element. In the second configuration the display may visualize a second information part and so on. By repeatedly conducting a further touch action the visual appearance of the display surface may be modified again and again.

[0028] Hence, a comparatively large contextual information may be split into comparatively small information parts, which may be then illustrated sequentially on the display surface. Switching from one information part on the display surface to another information part on the display surface may be controlled by the user through conducting at least one of numerous predefined touch actions.

[0029] According to a further example the sensor element comprises a sensing surface. The sensing surface of the sensor assembly comprises a number of touch sensitive sensor segments. Each of the sensor segments is operable to generate or to modify an electric touch signal when touched by the body part of the user. The sensor segments are spatially separated on the sensing surface in a non-overlapping way. They may be arranged next to each other in a regular or irregular manner. With some examples the entire sensing surface is covered and / or occupied by numerous sensor segments. The sensor segments may be of equal or of unequal size.

[0030] With some examples, the touch sensitive sensor segments are decoupled from each other. Each touch sensitive sensor segment may operate independent from any other touch sensitive sensor segment of the sensing surface. Hence, then touch sensitive sensor segments may be operable to generate electric touch signals individually when touched by the body part of the user.

[0031] The sensor segments may belong to a touch sensitive matrix or may constitute a touch sensitive matrix, e.g. a one or two-dimensional array of touch sensitive segments. The touch sensitive segments may each comprise a capacitor or resistor, that is operable to generate or to modify an electrical signal in response to a physical contact, e.g. with a body part of a user. Insofar, the plurality of touch sensitive sensor segments forms or constitutes a spatially resolving touch sensitive sensor.

[0032] With further examples the touch sensitive surface or touch sensitive matrix comprises a matrix of electrically resistive elements, which change their electrical and measurable resistance when e.g. touched by a user. With other examples the touch sensitive surface or touch sensitive matrix comprises a matrix of capacitive elements operable to change their measurable electric capacitance when e.g. touched by a user.

[0033] With further examples the touch sensitive surface or touch sensitive matrix comprises a combination of electrically resistive sensor segments and capacitive sensor segments. Capacitive sensors exhibit a rather low degree of electric power consumption.

[0034] According to a further example the processor of the electronic unit is operable to distinguish between a first touch action, which is characterized by a first sequence of touch control signals and a second touch action, which is characterized by a second sequence of touch control signals. Here, the second sequence of touch control signals distinguishes from the first sequence of touch control signals, either by the signal type, by the signal strength and / or by the signal amplitude, which is recognizable or analyzable by the processor.

[0035] Accordingly, the processor is capable or operable to distinguish between a first touch action and a second touch action by processing respective first and second sequences of touch control signals. When the processor detects a first characteristic or a first predefined sequence of touch control signals the processor immediately recognizes the first touch action. Accordingly, and when the processor detects or analyzes the second sequence of touch control signals the processor may immediately recognizes the second touch action.

[0036] According to a further example the electronic unit comprises a digital memory, which is readable and / or writable by the processor. The digital memory may be configured to store a reference sequence of touch control signals. It may be operable to store a number of reference sequences of touch control signals. In some examples, a first reference sequence of control signals and a second reference sequence of control signals may be stored in the digital memory. The processor may be then operable to distinguish between the first sequence of touch control signals and the second sequence of touch control signals by comparing the sequence of touch control signals received from the sensor assembly with at least one or numerous reference sequences of touch control signals stored in the digital memory. In this way, the processor is capable to not only distinguish between a first sequence of touch control signals and a second sequence of touch control signals but to assign a sequence of touch control signals as obtained from the sensor assembly to one of the reference sequences of touch control signals as stored in the digital memory. In this way the processor is operable to distinguish between first and second touch actions that may be conducted by a user of the electronic unit.

[0037] According to a further example the processor is operable to generate a first display control signal upon recognition or when recognizing the first touch action. The processor is further operable to generate a second display control signal when recognizing the second touch action.

[0038] The first display control signal may cause a first visual appearance of the display surface. The second display control signal may cause a second visual appearance of the display surface when received and / or processed by the electronic display. The first and the second visual appearances visually distinguish from each other. The display control signals may contain a specific information or information content to be displayed on the electronic display. The information content of the first display control signal may distinguish from the information content of the second display control signal. In this way and when receiving or processing respective first and second display control signals the electronic display is configured to change its visual appearance and provides different information to the user.

[0039] According to a further example the first display control signal may cause a predefined modification of the visual appearance of the electronic display. The second display control signal may induce or may trigger another modification of the visual appearance of the electronic display. Hence, and according to some examples the first display control signal and / or the second display control signal may be indicative of a variation of the visual appearance of the display surface.

[0040] By way of different touch actions to be conducted by a user, e.g., by way of different gestures conducted by a body part of the user on the sensor assembly there can be generated different display control signals, which induce different configurations of the visual appearance of the display surface of the electronic display. According to some examples a first touch action may be translated into a first user command. Repeatedly conducting the first touch action may be interpreted as a repetition of the respective user command.

[0041] In contrast to that the second touch action, which may distinguish from the first touch action, may be interpreted as a second user command that distinguishes from the first user command. In this way and by recognizing different touch actions on the basis of different sequences of touch control signals there can be implemented a large variety of different user commands, that will be interpreted by the electronic unit accordingly.

[0042] Such different user commands may induce different appearances of the display surface for different purposes, e.g., for operating, controlling or calibrating of the electronic unit and / or for modifying the visual appearance of its display surface.

[0043] According to a further example the processor is operable to display an amount of information on the display surfaces, e.g., by generating a respective display control signal, which contains the respective amount of information. The amount of information includes a first information part and a second information part and optionally also further information parts. The processor of the electronic unit is operable to display the first information part and the second information part sequentially on the electronic display, hence on the display surface of the electronic display. According to some examples the processor may be configured to generate a first display control signal being indicative of the first information part and the processor is further operable to generate a second display control signal, which is indicative of the second information part. When receiving and / or processing respective first or second display control signals the electronic display visualizes the first information part and the second information part, respectively.

[0044] Displaying or illustrating the first information part and the second information part sequentially on the electronic display may be controlled or triggered by the processor, either automatically or in response to an interaction with the user. With an automatic sequential illustration of first and second information parts the processor may be configured to display the first information part for a predefined period of time. After lapse of the predefined period of time the processor may be configured to automatically switch the visual appearance of the display surface to visualize or to show the second information part instead of the first information part.

[0045] In this way, a comparatively large amount of information can be split into numerous smaller-sized information parts, which are shown or visualized sequentially on the display surface of the electronic display. In this way, a rather long text message or other textural information can be split into smaller information parts, e.g. letters, numbers or symbols that are then illustrated sequentially on the display surface.

[0046] By way of the touch sensitive sensor elements, it is also possible to trigger a change or modification of the visual appearance of the display surface by user interaction, e.g., by conducting a predefined touch action on the sensor assembly or on the touch sensitive sensor element.

[0047] By way of a touch action conducted by a user an automated switching of first and second information parts on the electronic display can be modified. Here, e.g., a velocity of an automatic switching between different visual appearances of the display surface can be modified. Hence, a time interval between a switching of illustrating a first information part and a sequential illustration of a second information part can be modified.

[0048] In other configurations or examples, it is possible that a change of displaying the first information part provides displaying the second information part instead of the first information part. This modification of the display surface may be conducted or triggered by a distinguishable touch action of the user. Here, the user gains complete control of a variation or modification of the visual appearance of the display surface. Here, the electronic unit, specifically the processor thereof may be configured to display the first information part, e.g., by default, and to switch from illustrating the first information part towards illustrating the second information part instead of the first information part when recognizing a predefined touch action conducted by a user.

[0049] Here, it may be also provided that recognition of a first touch action of a number of predefined touch actions is interpreted by the processor as a switching command, namely to switch from illustrating the first information part to an illustrating of the second information part on the display surface. Upon recognition of a second touch action, which is distinguishable from the first touch action the processor may be operable to invert the switching of first and second information parts. Here, and upon recognizing the second touch action the processor may be configured to switch from displaying the second information part on the display surface to displaying the first information part instead of the second information part.

[0050] In this way, the user may gain a complete control of how to visualize an amount of information, which due to its size cannot be displayed or visualized on the electronic display at a time. Here and by way of conducting one or several predefined touch actions the user may be provided with a rather intuitive solution to navigate through the amount of information by illustrating or displaying only a part of the information at a time. Here and by way of the touch action to be conducted by the user the individual information parts may be displayed in response and as defined by the touch action or numerous touch actions conducted by the user of the electronic unit.

[0051] Switching from a first visual appearance to a second visual appearance may be conducted in a kind of a temporally overlapping manner. Here, replacing a first information part on the display surface by a second information part may come along with a partial or section-wise disappearing of the first information part at the benefit of a partial or section-wise appearing of the second information part. In this way, and in the course of replacing the first information part by the second information part a portion of the first information part may still appear on the display surface while only a portion of the second information part is already present on the display surface. In a subsequent step, a residual portion of the first information part may disappear from the display surface at the benefit of an appearance of the remaining portion of the second information part.

[0052] In a further example the processor is operable to switch from displaying the first information part to the second information part upon recognition of one of the predefined touch actions.

[0053] According to a further example the processor is operable to switch from displaying the first information part to the displaying of the second information part instead of the first information part when recognizing the first touch action. The processor may be further operable to switch from displaying the second information part to the displaying of the first information part instead of the second information part when recognizing the second touch action. In some examples the first touch action and the second touch action distinguish from each other. In some examples the first touch action may define a unidirectional swipe motion by way of which a user, e.g. a finger of a user, swipes along a first longitudinal direction across the display surface. The second touch action may be also a swipe motion of e.g. a finger of a user but in a direction opposite to the first direction.

[0054] With a two-dimensional electronic display there may be at least four differently directed swipe motions, e.g., pointing to the left, to the right, to the top and to the bottom, wherein each of which swipe motions may define a predefined touch action. Any of these predefined touch actions may be easily distinguishable by analyzing the respective sequence of touch control signals as generated by the touch sensitive sensor element and / or by the sensor assembly and when conducting a respective touch action on the touch sensitive sensor element and / or on the display surface.

[0055] Each of these distinguishable touch actions may be assigned to a predefined user command, which may be interpreted by the processor to provide different predefined parts of information on the display in response to detect or to recognize the respective touch action.

[0056] In some examples the amount of information to be provided on the display surface may be structured in accordance with a user menu and in accordance with one or several submenus, through which a user may browse. Browsing, and / or witching between different menu items may be derived from the predefined touch action, e.g. by differently directed swipe motions or predefined gestures conducted by the user.

[0057] According to a further example the amount of information includes a third information part. The processor is operable to switch from displaying the second information part to the third information part when recognizing a third predefined touch action. The third touch action may distinguish from the first touch action as well as from the second touch action, e.g. by a direction of movement of the touch action and / or by a geometric structure of the touch action. In some examples, touch actions may be defined by longitudinal swipe motions. In other examples touch actions may be defined by a single or by multiple taps on the touch sensitive sensor element. In still further examples a predefined touch action may be defined by a duration of a contact between a body part of the user, e.g., a finger, and the touch sensitive sensor element of the sensor assembly.

[0058] In still other examples a variation in size of a touch region of the touch sensitive sensor element which is actually touched by a body part, may be indicative of or may define a predefined touch action. This may arise when a user applies a varying pressure on the touch sensitive sensor element and hence on the sensor assembly. By varying a contact pressure or touch pressure between a body part of a user, e.g. a finger of a user, and the touch sensitive sensor element, the respective body part of the user, e.g., a finger may be subject to a slight but measurable geometric deformation thus leading to an increase of the size of the touch area on a sensing surface of the sensor assembly with an increase of touch pressure or contact pressure.

[0059] Such a variation of a size of a touch area may be also defined as a predefined touch action, which may be in turn interpreted as a user command, e.g., for operating, controlling or calibrating the electronic unit.

[0060] According to some examples it may be provided that the processor is operable to switch from displaying the second information part to the third information part when recognizing a repetition of the first touch action. In this way, and by repeatedly applying the first touch action to the sensor assembly or to the touch sensitive sensor element the processor may be configured to illustrate the first information part, the second information part, a third information part, a fourth information part and so on. In this way there can be provided a rather intuitive browsing through a comparatively large amount of information when the user repeatedly applies a first predefined touch action.

[0061] When applying a second touch action, which may be opposite or reverse compared to the first touch action the order according to which numerous information parts will be displayed on the display surface may be inverted or reversed.

[0062] According to a further example the processor is operable to generate a guiding indication on the display surface. The guiding indication is indicative of at least one predefined touch action of the numerous predefined touch actions, which in the present configuration of the electronic unit or electronic display can be applied by the user in order to enter a respective user command.

[0063] In this way the user may be intuitively guided of how to operate the electronic unit and / or which one of a variety of predefined touch actions could be applied in a specific configuration of the electronic unit in order to modify the visual appearance of the display surface and / or to enter a suitable user command. The guiding indication may comprise one of an arrow or the like indication being indicative of a direction of a touch action that could be applied in the momentary state or configuration of the electronic unit. In this way and specifically when displaying an amount of information by sequentially displaying numerous information parts of the amount of information, the user may be provided with a rather intuitively understandable guiding indication along which way or along which direction a touch action could be applied or could be interpreted by the processor to illustrate another information part or to enter a user command.

[0064] By way of example and when e.g. illustrating a first and initial information part of an amount of information it may be provided that only a first touch action can be or should be applied to the sensor assembly to switch from illustrating the first information part to the illustration of the second information part. When illustrating the second information part there may be provided numerous guiding indications. Here, a first guiding indication may be indicative of a further first touch action in order to switch from the second information part to the third information part.

[0065] A second guiding indication, e.g., pointing in an opposite direction compared to the first guiding indication, may indicate a second touch action, which when conducted by a user induces a switching of the display from the illustration of the second information part towards an illustration of the first information part.

[0066] By way of one or numerous guiding indications provided on the display surface the user may be rather intuitively guided which one of a number of predefined touch actions could or should be applied in order to obtain a visualization of a specific information part on the display surface and / or to enter a suitable user command.

[0067] According to a further example the touch sensitive sensor element comprises a number of touch sensitive sensor segments, each of which being operable to generate an electronic control signal when touched.

[0068] According to a further example the touch sensitive sensor element comprises at least one pressure sensitive sensor segment, which is operable to generate distinguishable touch control signals in response to an exposure to a varying contact pressure or touch pressure applied by a user on the sensor assembly or electronic display. In this way, different contact pressures may be distinguishable by the processor and may be interpreted as distinguishable user commands, which in turn may again invoke or trigger a modification or variation of the visual appearance of the display surface.

[0069] According to a further aspect the present disclosure also relates to an add-on device for fastening to an injection device. The add-on device comprises a device body and a fastener. The fastener is integrated into the device body or is fixed to the device body. By way of the fastener the device body and hence the entire add-on device can be detachably fastened to at least one of a housing, a dose dial grip and a dose button or trigger of an injection device. The injection device may comprise an injection pen, e.g. a handheld injection pen. The injection device may contain a medicament container and a drive mechanism, wherein the drive mechanism is operably engaged with the medicament container to expel an amount, e.g., a dose of a medicament from the medicament container.

[0070] The injection device may be further provided with an injection needle, which may be in a fluid transferring contact with an interior of the medicament container. This way, the injection device may be configured to inject a dose of the medicament via an injection needle into biological tissue of a patient.

[0071] The add-on device comprises an electronic unit as described above. Accordingly, the add-on device is provided with an electronic display with a display surface and with a processor connected to the electronic display as well as with a sensor assembly, which is connected, e.g., coupled to the processor and which comprises a touch sensitive sensor element, which is coupled or connected to the display surface. The electronic unit comprises a touch sensitive display to visualize information to a user of the add-on device or injection device.

[0072] The add-on device and hence the fastener of the add-on device may be configured for fastening the add-on device to a housing of the injection device. The housing of the injection device may comprise a tubularly-shaped housing. Here, the fastener may be configured to attach to an outside surface of the sidewall of the housing of the injection device. In another example the electronic display of the electronic unit is provided on or is integrated in an outside surface of the device body of the add-on device. In this way, the electronic display can be directly visible for users of the add-on device. It may be also directly accessible for users of the add-on device to conduct one of a number of predefined touch actions on the electronic display.

[0073] According to a further example of the add-on device the device body comprises a first portion, which is configured to be releasably attached to a dose dial grip of the injection device. The device body further comprises a second portion, which is coupled to the first portion and which is longitudinally displaceable relative to the first portion to apply pressure onto the dose button of the injection device. Here, the dose button may protrude from the dose dial grip. It may protrude in a proximal longitudinal direction from the tubularly-shaped dose dial grip.

[0074] For conducting or for initiating a dose dispensing action it may be provided that the dose button of the injection device, hence the trigger of the injection device is depressible along a longitudinal distal direction. Here and since the second portion of the add-on device is longitudinally displaceable relative to the first portion when the first portion of the device body may be firmly attached to the dose dial grip of the injection device, the second portion of the add-on device may be configured to abut or to get in contact with the dose button. Upon a distally directed displacement of the second portion of the device body relative to the first portion of the device body the dose button or trigger of the injection device may be subject to a distally directed longitudinal displacement relative to the dose dial grip, thereby initiating or triggering a dose injection procedure.

[0075] Here, the first portion of the device body may be usable as auxiliary dose dial grip to set a dose of constant or variable size. The second portion of the device body of the add-on device may be usable as an auxiliary trigger to initiate a dose dispensing or dose injection procedure conducted by the injection device when the add-on device is duly attached to the dose dial grip of the injection device. Here and with an add-on device comprising a first portion and a second portion the electronic display of the electronic unit is provided on a proximal end face of the second portion.

[0076] Alternatively, the electronic display may be integrated into the proximal end face of the second portion. The proximal end face of the second portion may be only slightly larger in circumference or cross-section compared to the dose button or trigger. Accordingly, the dose button or trigger is limited in size. It may be sized to receive an end section of a thumb or of an arbitrary finger of a user. Accordingly, and since the add-on device should not affect the general operability of the injection device it is limited in size and the proximal end face of the second portion of the add-on device is comparatively small. It may comprise a circular or oval shape. The electronic display, which may be integrated or provided on the proximal end face is of limited size. To provide a good legibility of information to be provided on the electronic display it may be provided that a comparatively large amount of information may be split into numerous information parts, that are provided on the display surface sequentially, either in an automated manner or by interaction with a user, e.g., by conducting and recognizing the numerous predefined touch actions with regard to the sensor assembly.

[0077] Since the add-on device comprises an electronic unit as described above, all features, effects and benefits as described above in connection with the electronic unit equally apply to the addon device; and vice versa.

[0078] According to another aspect the present disclosure also relates to an injection device for injecting a dose of a medicament. The injection device may be implemented as a pen-type injector, e.g., as a handheld injection pen. The injection device comprises a housing to accommodate a drive mechanism, which is operable to withdraw or to expel the medicament from a medicament container. The medicament container may be located or arranged inside the housing of the injection device. The injection device, e.g., the drive mechanism thereof, comprises at least one of a dose dial or dose dial grip and a trigger, e.g., implemented as a dose button. The trigger, e.g., the dose button is actuatable by a user for injecting or expelling the dose of the medicament. The injection device further comprises an electronic unit as described above. The electronic unit is attached to at least one of the housing, the dose dial grip and the trigger. It may be also integrated into at least one of the housing, the dose dial grip and the trigger.

[0079] In this way, the injection device itself may be provided with the electronic unit. The electronic unit may be of particular use for visualizing or displaying information to the user. In further examples the electronic unit may be implemented as a dose recording unit for recording dose dispensing related in formation. Since the injection device comprises an electronic unit as described above, all features, effects and benefits as described above in connection with the electronic unit equally apply to the injection device; and vice versa.

[0080] According to a further example the electronic display of the electronic unit is provided on a proximal end face of the trigger or dose button of the injection device. According to a further example the electronic display may be integrated into the proximal end face of the trigger. The trigger, hence the dose button of the injection device, comprises a comparatively small proximal end face. When arranging or integrating the electronic display of the electronic unit on the proximal end face or in the proximal end face of the trigger the respective size of the display surface of the electronic unit is comparatively small.

[0081] To provide information of sufficient size or amount and in order to provide a good legibility for the user and further to provide an intuitive control of displaying information on the display the electronic display is implemented as a touch sensitive display. It may be particularly implemented to recognize different touch actions of a user, such as swiping motions or the like user gestures by way of which the electronic circuit receives respective user commands, which in turn may be used to modify or to vary a visual appearance of the electronic display, e.g., to vary the information as displayed on the display surface.

[0082] Generally, the electronic unit is typically configured to automatically detect and set or to quantitatively measure a date, a point of time and a size of a dose actually set or dispensed, e.g., injected by an injection device when duly connected to or integrated into the injection device. Respective data may be stored locally in the digital memory of the electronic unit. By way of a communication link to an external electronic device such data may be exported or transferred to the external electronic device, such as a smartphone, a smartwatch or tablet computer. The electronic display may be implemented in accordance with various display technologies, such as electronic ink display, such as a LED display, such as an organic LED display, as a trance reflective liquid crystal display. The electronic display may be equipped with an additional illumination.

[0083] The display may be implemented as a digital display. It may be configured to show various symbols, signs, letters, numbers or indicators, such hyphens and colons.

[0084] By way of nonlimiting examples, numerous touch actions to be conducted by a user may include an activation or deactivation of the electronic unit, confirm actions like Bluetooth pairing status or presenting information on the display, by way of pressure sensitive sensor segments, the electronic unit, specifically the processor may be operable to conduct a contact force evaluation during drug injection and / or during holding the injection device after terminating the injection procedure.

[0085] Accordingly, the processor may be operable to detect an incomplete delivery of a dose of the medicament.

[0086] According to some examples, the display surface is matte or glossy.

[0087] In some examples, the display or display surface is rimless. It may flush with an outside surface of the add-on device or injection device, thus providing an advanced and rather ecstatic a design of the respective device.

[0088] According to some examples, the electronic unit and hence the display may be configured to visualize static information that is not changed due to current device handling or touch actions on the add-on device or injection device. Such type of information, which may be read from the digital storage of the electronic unit could be arranged in sequential order that can be looked through or scrolled via swiping to the next position. Examples of such static information might contain last dose, time stamp of last dose, time between doses, battery life estimation, wireless connection status and pairing, memory usage or general device state.

[0089] It may be also possible to display dynamic information as a response on device handling or touch input like dose dialed, dosing action ongoing, dose delivered, holding time after dose injection, transmitting data to another device, pairing with another device, switching light on and off. According to a further aspect the present disclosure also relates to an injection system. The injection system comprises an external electronic device. The external electronic device may be implemented as a mobile electronic device. It may comprise one of a smart phone, a smartwatch and a tablet computer. The external electronic device comprises a user interface to communicate with a user of the injection device. The external electronic device further comprises a device transceiver. The device transceiver may be configured to communicate, e.g., to exchange signals, e.g. communication signals with an electronic unit as described above.

[0090] The injection system comprises at least one of an add-on device as described above and an injection device as described above. The add-on device may be configured for fastening to another injection device. Here, the add-on device is equipped with an electronic unit as described above. The injection device of the injection system may be also equipped with an electronic unit as described above. Here and in addition to the electronic unit as described above the electronic unit of at least one of the add-on device and the injection device comprises a transceiver to communicate, e.g., to exchange communication signals with the device transceiver of the external electronic device.

[0091] In this way, information or data collected or stored, e.g., in an electronic memory of the electronic unit may be transferred to the external electronic device for further data analysis and / or for forwarding respective data to a healthcare professional or healthcare service provider. The device transceiver of the external electronic device and the transceiver of the electronic unit of at least one of the add-on device and the injection device may be configured to communicate wirelessly. The device transceiver and the transceiver of the electronic unit may be configured to establish a wireless communication link for exchanging wireless signals and data wirelessly.

[0092] The communication link between the device transceiver and the transceiver of the electronic unit may be established in accordance with standardized communication protocols, such as Bluetooth, Bluetooth low energy (BLE), UWB, NFC or any other wireless communication standard, such as any Wi-Fi communication standard.

[0093] According to a further example the present disclosure also relates to a method of modifying a visual appearance of the display surface of an electronic display of the electronic unit, which electronic unit is configured for attachment to an injection device or which electronic unit is configured for integration into an injection device, such as a handheld injection pen. The electronic unit comprises a touch sensitive sensor element, which is coupled to the display surface of the electronic display. The method comprises the steps of generating a sequence of touch control signals in response to a user touching the display surface by conducting a predefined touch action of a number of predefined touch actions.

[0094] The method further comprises the step of recognizing the predefined touch action by processing of the sequence of touch signals with a processor of the electronic unit. The method further comprises the step of generating a display control signal on the basis of the recognition of the predefined touch action and the step of modifying a visual appearance of the display surface through receiving and / or processing the display control signal by the electronic display.

[0095] In some examples the method of modifying a visual appearance of the display surface of an electronic display of an electronic unit is to be conducted with an electronic unit as described above, which may be attached to or integrated into an add-on device for fastening to an injection device or which may be attached to or integrated into an injection device as described above. Insofar, all features, effects, and benefits as described above in connection with the electronic unit may equally apply to the method of modifying a visual appearance of the display surface of the electronic display of the electronic unit.

[0096] In another aspect the present disclosure further relates to a computer program comprising computer readable instructions, which when executed by a processor of an electronic unit, which is configured for attachment to an injection device or which is configured for integration into injection device, causes the processor to receive and / or to process a sequence of touch control signals, that are generated by a sensor assembly of the electronic unit in response to a user touching a display surface while conducting a predefined touch action of a number of predefined touch actions, the processor is further caused by the computer readable instructions to recognize the predefined touch action by processing of the sequence of touch control signals and the processor is further caused by the computer readable instructions to generate a display control signal on the basis of the recognition of the predefined touch action. The display control signal in turn causes a modification of a visual appearance of the display surface when received and / or processed by the electronic display.

[0097] According to further examples the computer program is to be executed by a processor of an electronic unit as described above in order to execute or to conduct the method of modifying a visual appearance of the display surface of the electronic display of the electronic unit as described above. Insofar, all features, effects, and benefits as described above in connection with the electronic unit and the method of modifying a visual appearance of a respective display surface of the electronic display of the electronic unit equally apply to the computer program, to a respective computer readable medium; and vice versa. The computer program may be implemented in a firmware of the electronic circuit electronic unit. It may be implemented or deployed in a microcontroller of the electronic circuit.

[0098] Generally, the scope of the present disclosure is defined by the content of the claims. The disclosure is not limited to specific embodiments or examples but comprises any combination of elements of different embodiments or examples. Insofar, the present disclosure covers any combination of claims and any technically feasible combination of the features disclosed in connection with different examples or embodiments.

[0099] In the present context the term ‘distal’ or ‘distal end’ relates to an end of the injection device that faces towards an injection site of a person or of an animal. The term ‘proximal’ or ‘proximal end’ relates to an opposite end of the injection device, which is furthest away from an injection site of a person or of an animal.

[0100] The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

[0101] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0102] The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., shorter long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dual-chamber cartridge configured to store two or more components of the pharmaceutical formulation to-be- administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

[0103] The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (anti-diabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0104] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.

[0105] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0106] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega- carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(w- carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

[0107] Examples of GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB- 1023, TTP-054, Langlenatide I HM-11260C (Efpeglenatide), HM-15211 , CM-3, GLP-1 Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1 , CVX- 096, ZYOG-1 , ZYD-1 , GSK-2374697, DA-3091 , MAR-701 , MAR709, ZP-2929, ZP-3022, ZP-DI- 70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651 , ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN and Glucagon-Xten.

[0108] An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol- reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom. Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0109] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0110] Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

[0111] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

[0112] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0113] The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0114] 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).

[0115] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0116] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

[0117] An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0118] As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non- replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non- replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

[0119] Brief description of the drawings

[0120] In the following, numerous examples of a data logging device for monitoring use of an injection device as well as a respective injection device will be described in greater detail by making reference to the drawings, in which:

[0121] Fig. 1 shows a drug delivery device;

[0122] Fig. 2 shows a dose button and a dose dial grip;

[0123] Fig. 3 shows a further dose button and a dose dial grip;

[0124] Fig. 4 shows a top view of the dose button shown in Figure 3;

[0125] Fig. 5 shows a perspective view of an electronic add-on device;

[0126] Fig. 6 shows a perspective bottom view of the electronic add-on device according to Figure 5;

[0127] Fig. 7 shows an alternative bottom view of the electronic add-on device according to Figure 5;

[0128] Fig. 8 shows an exploded view of an electronic add-on device;

[0129] Fig. 9 shows an electronic add-on device, a dose dial grip and a dose button prior to assembly;

[0130] Fig. 10 shows a cross-sectional view through a third and fourth alignment structure of an assembled electronic add-on device and a drug delivery device as for example shown in Figure 9;

[0131] Fig. 11 shows an exploded view of a drive sleeve and a dose button of a drug delivery device;

[0132] Fig. 12 shows a cross-sectional view through a slot-spline engagement of the drive sleeve and the dose button shown in Figure 11 ;

[0133] Fig. 13A shows a cross-sectional view of an assembly comprising an electronic add-on device and a proximal part of a drug delivery device in a dose setting state;

[0134] Fig. 13B shows an exemplary coupling portion of an electronic add-on device;

[0135] Fig. 13C shows an exemplary sleeve portion of an electronic add-on device;

[0136] Fig. 13D shows a perspective bottom view of an engagement between the coupling portion of Figure 13B and the sleeve portion of Figure 13C;

[0137] Fig. 14 shows a cross-sectional view of the assembly according to Figure 13A in an interim state of the module;

[0138] Fig. 15 shows a cross-sectional view of the assembly according to Figure 13A and 14 in a dose dispensing state;

[0139] Fig. 16 is a simplified schematic illustration of an example of the add-on device,

[0140] Fig. 17 is a block diagram of electronic components of the add-on device,

[0141] Fig. 18 is a perspective illustration of an example of an add-on device attached to an injection device,

[0142] Fig. 19 shows a further example of an add-on device or of an integration of an electronic unit at the proximal end of an injection device,

[0143] Fig. 20 shows a schematic illustration of the electronic display provided with a spatially resolving sensor assembly,

[0144] Fig. 21 shows a longitudinal cross-section through the proximal end of the add-on device,

[0145] Fig. 22 shows an example configuration of the electronic display,

[0146] Fig. 23 shows an example of a predefined touch action conducted by a user on the touch sensitive sensor element of the sensor assembly,

[0147] Fig. 24 shows a switching of the electronic display from a first visual appearance to a second visual appearance,

[0148] Fig. 25 shows another configuration of a switching of the electronic display from a first visual appearance to a further visual appearance,

[0149] Fig. 26 shows further configurations of the reconfigurable electronic display in different visual appearances,

[0150] Fig. 27 shows an example of a predefined touch action,

[0151] Fig. 28 shows the generation of a corresponding sequence of touch control signals that correspond to the touch action as illustrated in Fig. 27,

[0152] Fig. 29 shows an example of another predefined touch action,

[0153] Fig. 30 shows a further generation of a sequence of touch control signals that correspond to the touch action of Fig. 29,

[0154] Fig. 31 shows an example of a further touch action conducted by a finger of a user and

[0155] Fig. 32 shows a corresponding generation of a sequence of touch control signals,

[0156] Fig. 33 shows an example of an injection system,

[0157] Fig. 34 shows a block diagram of an external electronic device to communicate with the electronic unit,

[0158] Fig. 35 shows a flowchart of a method of modifying a visual appearance of the display surface, and

[0159] Fig. 36 shows another example of integrating the electronic unit in an injection device.

[0160] Detailed Description

[0161] In the Figures, identical elements and components as well as identical elements and components in different examples or embodiments, i.e. elements and components acting identical or provided for the same purposes but belong to different examples, are provided with the same reference signs.

[0162] Figure 1 shows an exploded view of an exemplary medicament or drug delivery device 1. The drug delivery device 1 is a pen-type injector comprising a housing 10 in which a drive mechanism for dose setting and dose dispensing is arranged. The drug delivery device 1 extends from a distal point to a proximal direction P or from a proximal point to a distal direction D along a second longitudinal axis Y of the drug delivery device 1. In order to set a dose for delivery a user may rotate or dial a dose dial grip 12 with respect to the housing 10, wherein the dose dial grip 12 is arranged at a distal end of the housing 10. During dose setting the dose dial grip 12 may perform a helical movement, i.e. a combined axial and rotational movement, or may perform pure rotational movement.

[0163] The drive mechanism of the drug delivery device 1 may comprise a plunger, a drive sleeve 13, a clutch, a clutch spring, a number sleeve, a last dose nut and so on, which may move during dose setting and / or dose dispensing. Although not all of these components are shown in detail, for example, the drive mechanisms disclosed in EP 1 570 876, EP 2 814 547, US 9,937,294 B2 or WO 2004 / 078239 A1 represent suitable drive mechanisms for the present disclosure.

[0164] Once the dose is set by means of the dose dial grip 12, the user may press a dose button 11 arranged at the proximal end of the drug delivery device 1 in the distal direction D in order to dispense the dose. When pressing the dose button 11 , the user applies a force directed towards the proximal end of the drug delivery device 1 , wherein the force moves the dose button 11 in the distal direction of the pen and parallel to the second longitudinal axis Y. This axial movement of the dose button 11 releases the drive mechanism for example by decoupling a number sleeve from the drive sleeve, wherein irrespective of which component of the drug delivery device 1 performs a rotational movement during dose delivery, the dose dial grip 12 is coupled to a respective component in order to perform a rotational movement during dose delivery.

[0165] This rotational movement of the dose dial grip 12 during dose delivery may be used to determine, for example, the actual dose delivered by means of an electronic add-on device 100 as shown in various examples in the Figures and described here below.

[0166] The exemplary drug delivery device 1 shown in Figure 1 comprises in addition to the dose dial grip 12 and the dose button 11 an optional dosage window 14, a container 15, and a needle 16. The set dose may be displayed via the dosage window 14. The container 15 may be filled directly with a drug, for example, insulin or may be configured to receive a cartridge and thus act as a cartridge holder. The needle 16 may be affixed to the container or the receptacle. During dose dispensing the drug is dispensed through the needle 16. The needle 16 may be protected by an inner needle cap 17. In addition, the needle 16 may be protected by either an outer needle cap 18 or another cap 19.

[0167] In order for an electronic add-on device 100 to be functionally attached to a drug delivery device 1 , i.e. attached and usable, either the drug delivery device 1 can be adapted to the electronic add-on device 100 or, conversely, the electronic add-on device 100 can be adapted to the drug delivery device 1. Regardless of this, the drug delivery device 1 as well as the electronic add-on device 100 may have different examples, wherein the further description with respect to the drug delivery device 1 essentially deals with the dose button 11 , the dose dial grip 12 and the drive sleeve 13.

[0168] A corresponding first example of a dose button 11 and a dose dial grip 12 is shown in Figure 2. The dose dial grip 12 comprises at least one second mechanical coupling element 20 in form of a protruding nub which may have chamfered or angled second contact surfaces 21 in the proximal direction and in the distal direction, i.e. in the direction of the dose button 11 and in the opposite direction. The second contact surfaces 21 of the second mechanical coupling element 20 are angled with respect to a direction perpendicular to the second longitudinal axis Y. The second mechanical coupling element 20 is configured for engagement with respective mechanical coupling elements of an electronic add-on device 100 as will be described later on. Although not shown, the dose dial grip 12 may comprise multiple second mechanical coupling elements 20, for example, another coupling element on the opposite site of coupling element 20. Furthermore, ribs 22 are arranged alternately around the circumferential surface of the dose dial grip 12 and a groove 23 is arranged between each two adjacent ribs 22. As soon as an electronic add-on device 100 is attached to the drug delivery device 1 , the second mechanical coupling element 20, in cooperation with corresponding first mechanical coupling elements (not shown here), is able to limit relative axial as well as rotational movement between a first portion of the electronic add-on device 100 and the dose dial grip 12 of the drug delivery device 1. In addition, the ribs 22 and grooves 23 may transfer rotational movement between the drug delivery device 12 and the electronic add-on device 100. Depending on the embodiment of the second contact surfaces 21 , in particular the angle of the chamfered surfaces, a force needed to attach or remove an electronic add-on device 100 on or from a drug delivery device 1 may be determined. In addition, the structure of the grooves 23 and ribs 22 can be used to determine the force transmission between the dose dial grip 12 and the electronic add-on device 100. The grooves 23 shown here have a larger width in the proximal area, i.e. closer to the dose button 11 , and a smaller width closer to the distal end. This configuration may facilitate attachment and alignment of corresponding counterparts of the electronic add-on device 100 to the drug delivery device 1. Therefore, the ribs 22 and grooves 23 may be seen as a second alignment structure arranged on an outer circumferential surface of the dose dial grip 12.

[0169] On the proximal end of the grooves 24, first abutment edges 24A are provided. The first abutment edges 24A are configured to abut end stops 114 of the electronic add-on device 100 which will be described below. On the distal end of the grooves 23, the grooves 23 are provided with a second abutment edge 24B configured to be in abutment with a respective counterpart of the electronic add-on device 100, when engaged with the drug delivery device 1. The second abutment edges 24B may limit the axial movement of the electronic add-on device 100 in the distal direction D, when the electronic add-on device 100 is engaged with the drug delivery device 1.

[0170] Although the second mechanical coupling element 20 is shown here as a protruding nub, the second mechanical coupling element 20 may also be formed as a recess which may engage with a corresponding counterpart of the electronic add-on device 100. The second mechanical coupling element 20 in form of a recess may then also comprise chamfered second contact surfaces, wherein the electronic add-on device 100 may comprise a counterpart in the form of a protrusion with chamfered contact surfaces configured to be engaged with the second mechanical coupling element 20. The second mechanical coupling element 20 is consequently only shown as one example. The exact configuration of the first mechanical coupling element, which is preferably arranged on a first portion 101 of an electronic add-on device 100, and the configuration of the second mechanical coupling element 20, which is preferably arranged on the dose dial grip 12 of the drug delivery device 1 and forms the counterpart to the first mechanical coupling element, should be carried out in symbiosis. The specific structure of the mechanical coupling elements may be used to define the forces required for engagement or disengagement of the mechanical coupling elements. In addition, the mechanical coupling elements may be used to determine which movements are coupled between the electronic add-on device 100 and the drug delivery device 1 during an engagement.

[0171] A further example of a dose button 11 and a dose dial grip 12 is shown in Figure 3. Here, the dose button 11 comprises a recess 25 on a proximal end surface 26 defining a fourth alignment structure configured to be engaged with a respective alignment structure of the electronic addon device 100, i.e. a third alignment structure of a second portion 102 of the electronic add-on device 100 described in more detail below. Once the third alignment structure and the fourth alignment structure are engaged, the second portion 102 is rotationally constrained to the dose button 11 of the drug delivery device 1 such that the second portion 102 does not rotate if the dose button 11 remains stationary. The recess 25 is arranged centered with respect to the proximal end surface 26 of the dose button 11. As alternatives to the depicted interface between dose button 11 and the second portion 102, a toothed interface, a friction coupling, a ratchet, a clicker or other known rotational couplings may be used to rotationally constrain the dose button 11 to the second portion 102 at least in one direction, preferably in both directions.

[0172] Further, the fourth alignment structure comprises ribs and grooves configured to engage respective counterparts of the second portion 102 of the electronic add-on device 100. The second alignment structure arranged on the dose dial grip 12 may be configured to be engaged with a corresponding first alignment structure of the electronic add-on device 100 in a first number of different engagement positions. The fourth alignment structure arranged on the dose button 11 may be configured to be engaged with a third alignment structure of the electronic add-on device 100 in a second number of different engagement positions. The first number may be less than or equal to the second number. In Figure 3, the fourth alignment structure comprises ten ribs with ten grooves arranged in between a pair of ribs.

[0173] The ribs and grooves providing the fourth alignment structure of the dose button 11 is also shown in a top view in Figure 4, wherein the fourth alignment structure is arranged centered with respect to the proximal end surface 26 of the dose button 11. In addition, an abutment surface 27 is shown at the distal end of the recess 25, which may be configured for abutment of a push element 111 , for example shown in Figures 6 to 9. An electronic add-on device 100 comprising a third alignment structure may be attached to a drug delivery device 1 comprising the dose button 11 shown in Figure 4.

[0174] A respective example of an electronic add-on device 100 comprising a first portion 101 and a second portion 102 is shown in Figure 5. The second portion 102 is retained in the first portion 101 allowing relative rotational movement about the first longitudinal axis X. In addition, relative axial movement between the first portion 101 and the second portion 102 parallel to the first longitudinal axis X is allowed. When attached to the drug delivery device 1 , the first portion

[0175] 101 of the electronic add-on device 100 defines an auxiliary dose dial grip and the second portion 102 defines an auxiliary dose button.

[0176] When the electronic add-on device 100 is attached to a drug delivery device 1 , a user may rotate the first portion 101 in order to set a dose for delivery. The first portion 101 provides an auxiliary grip 103 allowing for a controlled rotational movement of the first portion 101. Further, pressure may be applied to a proximal end surface 104 of the second portion 102, for example by a thumb of a user, in order to axially move the second portion 102 with respect to the first portion 101 along the first longitudinal axis X.

[0177] Figure 6 depicts a bottom view of the electronic add-on device 100 shown in Figure 5. The first portion 101 comprises a hollow sleeve-like body with an inner surface provided with ribs 105 and grooves 106 as a first alignment structure configured to be engaged with the second alignment structure of the dose dial grip 12, in the present example ribs 22. When the first alignment structure is engaged with the second alignment structure, i.e. when the module is attached to the drug delivery device, the first portion 101 of the module is rotationally constrained to the dose dial grip 12, such that rotation of the first portion 101 of the module may entrain the dose dial grip 12 of the drug delivery device and vice versa. The second portion

[0178] 102 is retained in the first portion 101 by means of clips 107. In addition, first mechanical coupling elements 108 are provided on the inner surface of the first portion 101 and more specifically the first mechanical coupling elements 108 extend parallel to the first longitudinal axis X closer to a distal end of the first portion 101 than the first alignment structure. The first mechanical coupling elements 108 are provided as recesses with angled or chamfered first contact surfaces 109. When the electronic add-on device 100 is releasably attached to the drug delivery device 1 , the first longitudinal axis X and the second Y are in line with one another. An assembly of the drug delivery device 1 and the electronic add-on device 100, therefore, allows rotational movement of the dose dial grip 12 and the first portion 101 about the first and second longitudinal axis X and Y during dose setting. In addition, the assembly allows axial movement of the second portion 102 and the dose button 11 parallel to the first and second longitudinal axis X and Y during dose dispensing.

[0179] Furthermore, one example of a third alignment structure is shown in Figure 6. The alignment structure is provided by a protrusion in form of a cylindrical portion provided with ribs 110 on its outer circumferential surface. The ribs 110 are configured to be aligned with the respective grooves of recess 25 depicted in Figures 3 and 4. Once the third alignment structure and the fourth alignment structure are engaged, the second portion 102 and the dose button 11 are rotationally constrained.

[0180] In addition, one example of a push element 111 is shown in Figure 6, wherein the push element 111 is elastically biased in the distal direction D by a spring 112. The push element 111 is provided by an actuation rod moveable in an axial direction relative to the second portion 102. In the shown state, the push element is maximally biased in the distal direction D, wherein the spring 112 is arranged around a portion of the rod, and wherein the spring 112 is in abutment with a distal surface of the third alignment structure and a surface of the push element 111 facing proximally. The push element 111 is provided with a push element abutment surface 113 at its distal end. When attached to the drug delivery device 1 , the push element abutment surface 113 may be in abutment with abutment surface 27 in order to push the second portion 102 of the electronic add-on device in the proximal direction P.

[0181] Furthermore, and in addition to the first mechanical coupling element 108 of the first portion 101 , the electronic add-on device 100 shown in Figure 6 comprises an end stop 114. The end stop 114 is provided as a flange portion protruding from the first portion 101 into the hollow- sleeve-like body and therefore perpendicular to the first longitudinal axis X. The end stop 114 is arranged at the proximal end of ribs 105 and grooves 106. Thus, even though the first mechanical coupling element 108 may prevent that the electronic add-on device 100 is pushed too far onto the drug delivery device 1 in the distal direction D, wherein pushing the electronic add-on device 100 too far onto the drug delivery device 1 may damage electronic components arranged inside the electronic add-on device 100, the additional end stop 114 ensures that the electronic add-on device 100 is not pushed too far. In this regard, the end stop 114 is configured to abut against a respective proximal facing surface of the drug delivery device, i.e. against the first abutment edges 24A. Although the end stop 114 in Figure 6 is represented by a circumferentially continuous ringflange, the end stop 114 may also comprise of one or more segments projecting in the direction perpendicular to the first longitudinal axis X as long as the end stop 114 is configured to limit the axial movement of the electronic add-on device 100 when attached to the drug delivery device 1.

[0182] Figure 7 shows the electronic add-on device 100 of Figure 6 in a different view, wherein the third alignment structure may be better observed. The cylindrical portion provided with ribs 110 on the outer circumferential surface provides an exemplary third alignment structure. The alignment structure comprises eight ribs 110 in total.

[0183] In Figure 8, a further example of an electronic add-on device 100 is shown. Also here, the electronic add-on device 100 comprises a push element 111 provided with spring 112 biassing the push element 111 in the distal direction D. In addition, the first portion 101 is provided with a first clutch element 115 provided by teeth and the second portion 102 is provided with a second clutch element 116 provided by teeth. When the first and second portions 101 and 102 are assembled, preferably, both clutch elements 115 and 116 are in engagement, when the electronic add-on device 100 is in the dose setting position, i.e. when the second portion 102 is in the proximal position and the clutch elements 115 and 116 are in engagement. The clutch therefore rotationally constrains the second portion 102 to the first portion 101 , wherein, when the user rotates the first portion 101 in order to set a dose, also the second portion 102 is rotated.

[0184] The push element abutment surface 113 may push the second portion 102 in a proximal direction P by abutting against the abutment surface 27 of the drug delivery device 1 with the help of the spring force of a spring 112, so that the clutch is engaged. Therefore, when pressure is applied on the proximal end surface 104 of the second portion 102, the pressure force directed in distal direction D may have to overcome the force of the spring 112 pushing the second portion 102 proximally by abutment against the abutment surface 27 in order to disengage the clutch.

[0185] Correspondingly, when the electronic add-on device 100 is attached to the drug delivery device, the second portion 102 may be pushed in the dose setting position in which the clutch is in engagement. Hence, when the first portion 101 is rotationally moved also the second portion 102 is rotationally moved. If, in addition, the electronic add-on device 100 is attached to the dose dial grip 12 by means of mechanical coupling elements 20 and 108 and / or first and second alignment structures, rotational movement is transferred from the first portion 101 directly onto the second portion 102. Consequently, rotational movement of the first portion 101 during dose setting may rotate the dose dial grip 12 as well as the second portion 102.

[0186] However, when the second portion 102 of the electronic add-on device 100 is additionally provided with the third alignment structure, this structure may engage the fourth alignment structure of the dose button 11 , when the second portion 102 is axially moved. Thus, axial movement of the second portion 102 in the distal direction D may engage the third and fourth alignment structure, wherein disengagement of the clutch between the first portion 101 and the second portion 102 occurs after engagement of the third and fourth alignment structure. In other words, the distal travel of the second portion 102 needed to disengage the clutch may be greater than the distal travel needed to engage the third and fourth alignment structures. Therefore, during dose dispensing and when the user applies pressure onto the proximal end surface 104 of the second portion 102, the clutch is disengaged allowing relative rotational movement between the second portion 102 and the first portion 101. However, at the time of disengagement of the clutch, the second portion 102, moreover the third alignment structure is in engagement with the fourth alignment structure so that the second portion 102 is rotationally constrained to the dose button 11. The first portion 101 , i.e. the auxiliary dose dial grip, attached to the dose dial grip 12 may thus rotate during dose dispensing relative to the dose button 11 rotationally constrained to the second portion 102.

[0187] An exemplary arrangement of an electronic add-on device 100 and a drug delivery device 1 or its dose dial grip 12 and its dose button 11 prior to assembly is shown in Figure 9. The previously mentioned alignment of the first and second longitudinal axis X and Y when the electronic add-on device 100 is attached to the drug delivery device 1 may be imagined. Here, only a number sleeve 28, the dose dial grip 12 and the dose button 11 of a respective drug delivery device 1 are shown. The number sleeve 28 may comprise an outer thread 29 which may be guided in a housing thread allowing for a helical movement of the number sleeve 28 with respect to the housing of the drug delivery device 1 during dose setting, i.e. upon rotation of the dose dial grip 12 or the auxiliary dose dial grip 101 when attached to the drug delivery device 1. The dose dial grip 12 may be permanently fixed to the number sleeve 28, so that the dose dial grip 12 and the electronic add-on device 100 or the first portion 101 when attached to the drug delivery device 1 may perform a helical movement with respect to the housing of the drug delivery device 1 during dose setting and dose dispensing.

[0188] Figure 10 illustrates a cross-sectional view through the engagement of the third and fourth alignment structure of an assembled electronic add-on device 100 and a drug delivery device 1. The ribs 22 are therefore in engagement with respective grooves 106 of the third alignment structure and the ribs 110 are in engagement with respective grooves of recess 25 forming the fourth alignment structure.

[0189] Further, Figure 11 depicts an exploded view of an example of a dose button 11 and drive sleeve 13, wherein the drive sleeve 13 comprises a slot 29 configured to receive a spline 30 as part of the dose button 11. An engagement between the slot 29 and the spline 30 therefore rotationally constrains the dose button 11 to the drive sleeve 13 such that, if the drive sleeve is rotationally constrained to the housing 10 of the drug delivery device 1 during dose dispensing to perform a purely axial movement, the dose button 11 is also rotationally constrained to the housing. Still, the shown configuration of the slot 29 and spline 30 allows a relative axial movement between the dose button 11 and the drive sleeve 13 along the longitudinal axis. As alternatives to the depicted interface between dose button 11 and drive sleeve 13, a toothed interface, a friction coupling, a ratchet, a clicker or other known rotational couplings may be used to rotationally constrain the dose button 11 to the drive sleeve 13 at least in one direction, preferably in both directions.

[0190] Therefore, when the drive sleeve 13, for example, performs a helical movement upon rotation of the dose dial grip 12 during dose setting, the dose button 11 also rotates. Consequently, there is no relative rotational movement between the dose button 11 and the dose dial grip 12 during dose setting. Further, when the drive sleeve 13 performs a pure axial movement during dose dispensing, due to the slot-spline-engagement between the dose button 11 and the drive sleeve 13, also the dose button 11 does not perform rotational movement during dose dispensing. In consideration of attachment of an electronic add-on device 100 to the drug delivery device 1 , rotation of the first portion 101 attached to the dial grip 12 rotates the dial grip 12 during dose setting. When the second portion 102 is clutched to the first portion 101 as described before, the spline 30 and slot 29 engagement between the drive sleeve 13 and the dose button 11 may prevent that there is any relative rotational movement between dose button 11 , dose dial grip 12, first portion 101 and second portion 102 during dose setting. This rotational coupling, irrespective of the type of the interface providing this coupling function, may be especially relevant if a sensor arrangement forms part of the electronic add-on device 100 configured to measure relative rotational movement between the first portion 101 and the second portion 102 as no relative movement occurs between the respective components during dose setting. Further, and in order to initiate dose dispensing axial movement of the dose button 11 may disengage a clutch inside the drug delivery device 1 , so that dispensing of a drug may be initiated. Likewise, when the second portion 102 comprises a third alignment structure configured to engage a fourth alignment structure of the dose button 11 during dose dispensing as described before, i.e. when pressure is applied to the proximal end surface 104 of the second portion, the second portion 102 is rotationally constrained to the dose button 11. Due to the rotationally constrained engagement therefore also the second portion 102 does not perform a rotational movement during dose dispensing even when the clutch is disengaged. However, as the first portion 101 and the dose dial grip 12 are rotated during dose dispensing, relative rotational movement between the first portion 101 and the second portion 102 may be measured in order to determine the dispensed dose.

[0191] Figure 12 shows a respective cross-sectional view through the exemplary slot-spline engagement between the dose button 11 and the drive sleeve 13 as shown in Figure 11.

[0192] Figure 13A shows a cross-sectional view of an assembly of a further example of an electronic add-on device 100 and a proximal part of a drug delivery device 1 in a dose setting state. In the dose setting state, also called "at rest state", the first portion 101 is not rotated and no pressure is applied to the second portion 102. The proximal part of the drug delivery device 1 in Figure 13A comprises a dose button 11 with a proximal end surface 26, a dose dial grip 12, a drive sleeve 13 encompassed within a number sleeve 28. A clutch 31 is arranged between the number sleeve 28 and the drive sleeve 13. The drive mechanism of the drug delivery device 1 may be configured to perform the aforementioned relative rotational, axial and helical movements.

[0193] Further, the exemplary electronic add-on device 100 is attached to the dose dial grip 12, wherein respective first and second mechanical coupling elements 20 and 108 are engaged. The first portion 101 shown in Figure 13A is divided into a sleeve portion 117 and a coupling portion 118. The sleeve portion 117 comprises the auxiliary grip 103, wherein the coupling portion 118 comprises the first mechanical coupling element 108. The coupling portion 118 is partially arranged inside the sleeve portion 117 and the first mechanical coupling element 108 is arranged on inner surface 119 of the coupling portion 118. The coupling portion 118 is partially spaced from the sleeve portion 117 so that the coupling portion 118 is partially configured to be moved relative to the sleeve portion 117 in a direction perpendicular to the longitudinal axes X and Y.

[0194] An exemplary coupling portion 118 is shown in Figure 13B and an exemplary sleeve portion 117 is shown in Figure 13C. The sleeve portion 117 shown in Figure 13C comprises a sleeve portion clip 117A which may engage with a coupling portion clip 118A in order to couple the coupling portion 118 to the sleeve portion 117. A corresponding engagement between the coupling portion 118 shown in Figure 13B and the sleeve portion 117 shown in Figure 13C is depicted in Figure 13D. It may be noted from the perspective bottom view of Figure 13D, which also depicts the mechanical coupling elements 108 of the coupling portion 118, that the sleeve portion 117 as well as the coupling portion 118 in Figures 13B to 13D are different from the respective portions shown in Figure 13A. Further, it may be noted that the coupling portion 118 is partially spaced apart from the sleeve portion 117, especially in the region of the first contact surfaces 109 of the coupling elements 108. This may allow outwards deflection of the coupling portion 118 with respect to the sleeve portion 117. In addition, it can be seen from Figure 13D that the coupling portion 118, as already described above in respect with first portion 101 , comprises a structure with ribs 105 and grooves 106, which allows engagement with respective features of a dose button.

[0195] In Figure 13A, the first mechanical coupling element 108 extends from the inner surface 119 into a direction perpendicular to the longitudinal axes X and Y and away from the components of the drug delivery device 1 , thereby forming a recess. The first contact surfaces 109 of the first mechanical coupling element 108 are angled with respect to the direction of extension. The more proximal contact surfaces comprise a smaller angle than the more contact distal surface. This may allow for an easy attachment of the electronic add-on device 100, wherein, however, more force is required to detach the electronic add-on device 100 from the drug delivery device 1. In addition, the end stop 114 limits the movement of the electronic add-on device 100 in the distal direction D during attachment.

[0196] Therefore, it can be seen that the mechanical coupling elements 20 and 108 on the dose dial grip 12 and the first portion 101 respectively comprise surfaces 21 and 109 angled relative to the axial direction in order to provide a cam action cause the necessary deflection to both assemble and disassemble the electronic add-on device 100 and the drug delivery device 1.

[0197] The second portion 102 comprising a proximal end surface 104 is retained in the first portion 101. The second clutch element 116 of the second portion 102 is fully engaged with the first clutch element 115 of the first portion101 therefore preventing relative rotational movement between the first and second portion 101 and 102. A second portion housing 120 encompasses a battery 121 as an electrical power source, a circuit board assembly 122 electrically connected to the battery 121 and comprising a microswitch 123 operable by a lever arm 124. The battery 121 , the circuit board assembly 122, the microswitch 123 and the lever arm 124 are provided inside the second portion housing 120, wherein the housing 120 comprises a distally facing surface 125. The distally facing surface 125 may be configured to be in abutment with the dose button 11 during dose dispensing.

[0198] To initiate dose dispensing the second portion 102 is axially moved in the distal direction D so that the push element 111 , which is in abutment with the dose button 11 via the push element abutment surface 113, is further moved into the second portion 102. The push element 111 is therefore configured to act on the lever arm 124. The microswitch 123 may be, for example, directly coupled to the lever arm 124 so that a movement of the lever arm 124 operates the microswitch 123. Alternatively, the microswitch 123 may, for example, be arranged on the circuit board assembly 122 and may therefore be operated, when the lever arm 124 flips in the proximal direction and contacts the microswitch 123. Importantly, the dose button 11 does not move axially during this first axial movement of the second portion 102 and the actuation of the lever arm 124 and the microswitch 123. Rather, movement of the dose button 11 only starts after the activation / operation of the microswitch 123. This ensures that the electronic components of the electronic add-on device 100, e.g. including the circuit board assembly 122, are powered and awake, i.e. ready for detecting the amount of dose dispensed from the drug delivery device.

[0199] In other words, the sequence of activation of the electronic add-on device 100 is as follows: First, the user presses, e.g. with his or her thumb, on the proximal end surface 104 of the second portion 102 which results in an axial movement of the second portion 102 in the distal direction relative to the first portion 101 and relative to the, in this moment stationary, button 11. This relative movement causes the push element 111 to act on the lever 124 which in turn activates or operates the microswitch 123, thereby powering the electronic system of the electronic add-on device 100. If the user then continues pressing on the proximal end surface 104 of the second portion 102, the button 11 starts after this activation of the electronic addon device 100 moving axially from an initial position to an actuated position in which the dose dispensing starts.

[0200] However, for example, during dose setting, i.e. when no pressure is applied to the proximal end surface 104 of the second portion 102, the spring 112 acts to bias the push element 111 in the distal direction D preventing operation of the lever arm 124 and the microswitch 123. In the state shown here, the spring 112 maximally biases the push element 111 in the distal direction. At the same time the second portion 102 is in the most proximal position with respect to the first portion 101. Operation of the microswitch 123 may activate or deactivate the electrical power source 121 and the circuit board assembly 122. Accordingly, other electronically controlled components such as sensors can also be activated by the microswitch.

[0201] To prevent the push element 111 from sliding out of the second portion housing 120 in the distal direction D, the push element 111 has a stopper element 126 which retains the push element 111 in the second portion 102 and prevents that the action of the spring 112 causes the push element 111 from disassembling from the second portion 102. In the example shown here, the third alignment structure is in the process of entering the recess 25 of the dose button

[0202] I I and engaging with the corresponding fourth alignment structure. Additionally, the dose button 11 may be rotationally constrained to the drive sleeve 13 as shown in Figures 11 and 12.

[0203] Figure 14 shows the assembly according to Figure 13A in an interim state of the module in which the second portion 102 has been moved in the distal direction D so that the push element

[0204] I I I is pushed further into the second portion housing 120 in the proximal direction P. Due to the relative axial movement between the second portion 102 and the push element 111 , the lever arm 124 is deflected and the microswitch 123 is operated. Therefore, the interim state of the module defines a state in which the microswitch is operated, i.e. a switch point, although there may still be further relative axial movement possible, as can been seen in Figure 15.

[0205] In Figure 14, the clutch formed by first and second clutch element 115 and 116 between the first portion 101 and the second portion 102 is still in engagement. In addition, the third and fourth alignment structure of the second portion 102 and the dose button 11 are in engagement although the dose button 11 is moved distally to its full extent with respect to the further components of the drive mechanism. Further, distal movement of the dose button 11 may have disengaged a clutch of the drive mechanism which would, without the electronic add-on device

[0206] 100 being attached to the drug delivery device 1 , start or allow dose dispensing. However, due to the rotational constraint between the first and second portion 101 and 102 via clutch elements 115 and 116, the rotational constraint between the second portion 102 and the dose button 11 via the third and fourth alignment structures which are engaged, the rotational constraint between the dose button 11 and the drive sleeve 13, wherein the drive sleeve 13 is not rotatable during dose dispensing, and the rotational constraint between the first portion

[0207] 101 and the dose dial grip 12, no dose dispensing is yet possible.

[0208] Hence, further distal movement of the second portion 102 relative to the first portion 101 as well as the drug delivery device 1 may still be required in order to transfer the assembly into a dose dispensing state as shown in Figure 15. In this state the second portion 102 has reached its most distal position. In addition, the push element 111 has deflected the lever arm 124 beyond the interim state of the module in which the microswitch was operated, for example turned into an "on"-state. Due to the axial movement, the spring 112 has been compressed. The distally facing surface 125 abuts the proximal end surface 26 of the dose button 11. Further, the clutch between the first portion 101 and the second portion 102 is disengaged, therefore allowing relative rotational movement. The disengagement of the clutch elements 115 and 116, which allows relative rotational movement between the first portion 101 and the second portion 102, thus now permits dose dispensing. The axial movement of the second portion 102, which moves the dose button 11 axially in the distal direction D, provides for an axial movement of the drive sleeve 13 and at the same time for a helical movement of the number sleeve 28. A dose dial grip 12 permanently fixed to the number sleeve 28 thus rotates with the number sleeve 28 and relative to the dose button 11. Considering an electronic add-on device 100 releasably attached to the dose dial grip 12, the dose dial grip 12 also rotates the dial grip 12 together with the first portion 101 and relative to the second portion 102. Dose dispensing is therefore permitted, wherein at the same time the amount delivered may be determined by a sensor arrangement 48.

[0209] The add-on device 100 is also conceptually illustrated in Fig. 16 and by the block diagram of Fig. 17. It comprises a device body 90 comprising the first portion 101 and the second portion 102. The second portion comprises a tubular-shaped sidewall. Towards the distal end the sidewall confines a receptacle 92, which is sized to receive the dose dial grip 12 and the trigger or dose button 11 of the injection device 1. For this, the inside of the sidewall may comprise one or numerous fastening ribs, which are configured to provide a slip free fastening of the add-on device 100 to the dose dial grip 12.

[0210] The receptacle 92 may form or constitute a fastener 91 by way of which the device body 90 and hence the entire add-on device 100 can be detachably fastened to the dose dial grip 12.

[0211] The second portion 102 part may form or constitute a cover, which is covering and closing a proximal open end of the first portion 101. An interior of the first and second portions 101 , 102 is sized to accommodate a circuit board assembly 122, which comprises an electronic unit 23

[0212] The proximal end face 104 of the second portion 102 is of planar and circular shape. It faces in proximal direction. The electronic module 34 may comprise a printed circuit board 36. It may further comprise a transceiver 38, a memory 40, a clock 42, a processor 44, a power source 121 , a sensor arrangement 48 and a signal generator 50. The sensor arrangement 48 may be configured to detect a relative rotational movement between at least two of the following components: the first portion 101 , the second portion 102, the dose button 11 and the dose dial grip 12. The sensor arrangement 48 may be configured to detect a relative rotational movement between the first 101 portion and the second portion 102. The sensor arrangement 48 may be implemented as one of an optical sensor arrangement, a magnetic sensor arrangement, a capacitive sensor arrangement and a mechanical sensor arrangement.

[0213] In this regard, for example, a magnetic sensor arrangement may comprise a magnet which may be arranged inside the second portion 102 and a corresponding receiver which may be arranged as part of the first portion 101 , and wherein the receiver is acted upon by the magnetic field in order to detect the relative rotational movement.

[0214] Further, a mechanical sensor arrangement may comprise a piezoelectric sensing component which may be deformed upon mechanical force which may act on the piezoelectric sensing component due to the relative rotational movement. Measuring the relative rotational movement may allow for the determination of a rotation angle between the respective components. This angle may for example be used to calculate a set dose or a delivered dose. It may also be possible to measure rotational movements between multiple components in order to correlate the respective measurement values. This may help to get more precise measurement results.

[0215] With an optical sensor arrangement at least one of the first portion 101 and the second portion 102 may be provided with an encoder ring comprising radially facing first flag segments and radially facing second encoder flag segment, which distinguish optically, e.g. in color or with respect to their optical reflectivity. The first encoder flag segments may be reflective and the second encoder flag segments 130 may be non-reflective.

[0216] The encoder flag segments may be provided on an inner surface of the first portion 101. The circular encoder ring may comprise a center that correlates to a center of the first portion 101 , wherein a radius varies from the center of the encoder ring to the various radially facing encoder flag segments. Accordingly, the radially facing first encoder flag segments, which may be reflective, are arranged on a radius viewed from the center of the encoder ring that is less than a radius to the radially facing second encoder flags, which may be non-reflective.

[0217] Therefore, the radially facing first encoder flag segments may be configured to be closer to an optical sensor arrangement that emits and / or guides radiation perpendicular to the first longitudinal axis X of the first portion 101. Consequently, the radially facing first encoder flag segments may reflect more radiation, for example electromagnetic radiation such as light. The radially facing second encoder flag segments of the encoder ring may be made from black material and the radially facing first encoder flag segments may be made from white material. Additionally, or alternatively, the radially facing encoder flag segments and 130 may comprise different surface finishes to increase or decrease reflectivity. The non-reflective encoder flag segments may for example be twin-shot molded.

[0218] The fact that the radially facing encoder flag segments and are radially facing is advantageous when an optical sensor arrangement emitting and / or guiding radiation towards the encoder flag segments and is moved in an axial direction. If, for example, the optical sensor arrangement is arranged on the second portion in order to detect relative rotational movement between the first portion and the second portion, axial movement of the second portion relative to the first portion may not affect the amount of radiation which is reflected and detected.

[0219] In some examples, an optical sensor arrangement 48 may comprise one or several light-pipes configured to guide radiation in a direction perpendicular to the first longitudinal axis X to and from the encoder flag segments. The optical sensor arrangement may comprise a fixation surface comprising a normal direction which is parallel to the longitudinal axis X. The radiation may exit the light-pipe through an exit surface. The optical sensor arrangement 48 may be configured to be activated upon operation of the microswitch. However, and as described above, the sensor arrangement could also be provided by a magnetic, a mechanical or a capacitive sensor arrangement 48.

[0220] As illustrated in Fig. 16 a sidewall of the first portion 101 and / or of the second portion 102 may comprise an aperture 94 or through opening aligned with a signal generator 50 of the electronic unit 34. The signal generator 50 may be configured to generate a visual signal, such as a signal light and / or may be implemented to generate an acoustic signal. In some examples the signal generator 50 may comprise a first light source 53 and a second light source 54 operable to produce or to generate visual signals of different color and / or of variable duration. The window or aperture 94 may be provided with a light pipe or with a light guiding structure. This way, the device body 90 could be protected against ingress of dust or humidity.

[0221] As particularly illustrated in Fig. 17 the electronic unit 34 comprises an electronic circuit 35, implemented or provided on a printed circuit board 36. The electronic unit 34 comprises a processor 44, which is mounted on the printed circuit board 36.

[0222] The electronic unit 34 further comprises an electronic display 60 with a display surface 61 and a sensor assembly 80, which is connected or coupled to the display surface 61. The sensor assembly 80 may cover the display surface 61 or may be integrated into the display 60 are display surface 61. The sensor assembly 80 comprises a touch sensitive sensor element 81 comprising a touch sensitive sensing surface 82 provided with numerous sensor segments 84, 85, 86.

[0223] In general, the electronic module 34 can be mounted on the printed circuit board 36. The electronic module 34 may be configured to communicate with an external electronic device 200, as e.g. illustrated in Fig. 33.

[0224] The external electronic device 100 may be implemented as a smartwatch or smartphone. It comprises a housing 201 and a user interface 202, which may be implemented as a display or as touch sensitive display. The external electronic device 200 may further comprise a control element 203 operable or actuatable by a user of the device. On the display 202 there may be provided numerous visual items 204, in form of symbols, text or the like information by way of which the user may be assisted in using the injection device 1.

[0225] The external electronic device 200 further comprises a device processor 206, a device memory 207 and a device transceiver 208. The device transceiver 208 may be implemented as a wireless transceiver. It may establish a communication link with the transceiver or transmitter 38 of the electronic unit 34, e,g. to exchange data with the electronic unit 34. The external electronic device may further comprise a control element 203, such a button.

[0226] The electronic module 34 comprises a transceiver 38, which is configured to establish or to built- up a communication link between the external electronic device 200 and the electronic module 34. A respective communication link can be realized in a wireless or wired manner.

[0227] The electronic module 34 may be configured to exchange data with the external electronic device 200. Data being indicative of an operation of the injection device and gathered or collected by add-on device 100 may be transmitted to the external electronic device 200 via the transceiver 38. The transceiver 38 may be implemented as a Bluetooth transceiver or as a BLE transceiver. The further transceiver 38 may be also implemented as a NFC or UWB transceiver. The transceiver 38 may comprise a dual-mode transceiver 38, which is operable to communicate via a first and the second communication protocols, such as Bluetooth, BLE, UWB or and / or NFC.

[0228] Fig. 33 illustrates an example of an injection system 400 comprising the external electronic device 200 and an injection device 1 equipped with an add-on device 100. Here, a user may hold the external electronic device 200 in one hand 210' and may hold the injection device 1 in another hand 210. The external electronic device 200 may provide an indication or an instruction to the user in form of a visual item 204 on the display 202 prompting the user to confirm, e.g., the recording of a dose dispensing procedure. By way of a data exchanging pairing between the device transceiver 208 and the transceiver 38 of the electronic unit 34 the user may be prompted to conduct a touch action 66, e.g., to swipe the sensing surface 82 of the sensor assembly 80, e.g., provided at a proximal end of the add-on device 100.

[0229] The electronic module 34 comprises a digital memory 40 configured to store a plurality of information, data as well as measurement data obtained from the sensor arrangement 48. The electronic module 34 further comprises a clock 42 configured to provide each of a plurality of measurement data of sensor arrangement 48 with a time index indicating the point of time and / or date of the detection of the respective operation of the injection device 1.

[0230] The processor 44 of the electronic module 34 is configured to control operation of the add-on device 100. The electronic module 34 is further equipped with a power source, e.g., implemented as a battery 121 . The battery 121 is configured to power the processor 44, the electronic display 60 and the sensor assembly 80.

[0231] The signal generator 50, which may be implemented as a visual signal indicator, may be also implemented as a haptic signal generator, e.g. configured to generate a perceivable or palpable vibration of the electronic module 34. With further examples the signal generator 50 may comprise an audible signal generator, configured to generate an audible sound.

[0232] In a further example the electronic module 34 comprise a microphone, by way of which characteristic click noises of the injection device can be detected and processed, thereby allowing to derive or to measure a size of a dose currently set or injected by the injection device 1 .

[0233] The presently illustrated implementation of the electronic module 34 in an add-on device 100 is only exemplary. Especially with reusable injection devices it is also conceivable that the entire functionality of the add-on device 100 and hence the entire functionality of the electronic unit 34 is integrated or implemented in an injection device 1. Here, the hardware components of the electronic unit 34 may be arranged and provided inside the dose dial grip 12, which is covered or closed in proximal direction by the trigger 11 or dose button.

[0234] In Fig. 18 there is shown one example of an add-on device 100, which is attached to a sidewall of a housing 10 of an injection device 1 , which is implemented as an injection pen. The add-on device 100 is provided with a touch sensitive electronic display 60. The electronic display 60 is of limited size and is further provided with a touch sensitive sensor assembly 80 comprising a touch sensitive sensor element 81. A user may conduct a predefined touch action across or on the touch sensitive sensor element 81 to generate a sequence of touch control signals that can be processed by a processor 44 of the add-on device 100.

[0235] In Fig. 19 there is shown a further example of an integration or implementation of an electronic unit 34. Here, the add-on device 100 is attached to a proximal end of the injection device 1. It may prolong the housing 10 of the injection device 1 in proximal direction. The electronic display 60 of the electronic unit 34 may be provided on the proximal end face 104 of the add-on device 100. It may be flush with the proximal end of the sidewall of the first portion 101. The electronic display 60 may be pressure resistive. It may be subject to a distally directed pressure or actuation force applied by a user intending to trigger an injection, e.g., by depressing the second portion 102 of the electronic add-on device 100.

[0236] The electronic display 60 with its display surface 61 is of limited size and provides only limited space for illustrating information 70 on the display surface 61.

[0237] The add-on device 100 comprises an electronic unit 34, the details of which are shown and described with regards to Figs. 16 and 17. The electronic unit 34 is at least provided with an electronic display 60, a processor 44 and a sensor assembly 80, which is connected to the processor 44 and which comprises a touch sensitive sensor element 81 , which is coupled to the display surface 61 of the electronic display 60.

[0238] In response to a recognition of one of a predefined touch action 66 conducted by the user the processor 44 is operable to generate a display control signal, which causes a modification of a visual appearance of the display surface 61 when received and / or processed by the electronic display 60. In this way there can be provided a rather intuitive operation and handling as well as a modification of a visual appearance 62 of the display surface 61.

[0239] The electronic display 60 is provided with the touch sensitive sensor element 81 , which according to the illustration of Figs. 20 and 21 may cover the electronic display 60. The arrangement of the electronic display 60 and the sensor assembly 80 may be located recessed with respect to a proximal end face 102A of the sidewall of the second portion 102 as shown in Fig. 21. In this way, the surface, hence the outside surface 104 of the second portion 102 may be protected, e.g., against environmental influences and / or against unintended use or touch operations.

[0240] In the illustration according to Fig. 21 the sensor assembly 80 completely covers the display surface 81. Here, the touch sensitive sensor element 81 completely covers the display surface 61 . As particularly illustrated in Fig. 20 the touch sensitive sensor element 81 comprises or forms a touch sensitive sensing surface 82, which may be partitioned into a number of sensor segments 84, 85, 86. The individual sensor segments 84, 85, 86 may be each configured to generate a touch control signal, e.g., a unique and / or segment-specific touch control signal. A user conducting a touch action 66, such as a swipe movement across the display surface 61 may induce generation of a sequence of touch control signals generated by numerous sensor segments 84, 85, 86 in a sequential or temporally overlapping order.

[0241] Moreover, and according to further examples the sensor segments 84, 85, 86 or at least one of the sensor segments may be operable to generate distinguishable touch control signals in response to an exposure to a varying contact pressure or touch pressure. For instance, in the configuration of Fig. 20 the sensor segments 84, 86 may be subject to a comparatively low contact pressure whereas the sensor segment 85 may be subject to a comparatively high contact pressure when a user presses on the sensor assembly 80 and / or on the touch sensitive electronic display 60. Accordingly, the respective sensor segments 84, 85, 86 may be each configured to generate pressure indicating and hence distinguishable touch control signals, that are processable by the processor 44. In this way, the processor 44 may recognize a first sensing area 88 as indicated in Fig. 20, in which all sensor segments forming part of the sensing area 88 are subject to a comparatively high contact pressure, e.g., a contact pressure above a predefined threshold.

[0242] The processor may be also configured to identify or to recognize a further sensing area 89, which is defined or which is provided by the sensor segments 84, that are subject to a comparatively low contact pressure, hence a contact pressure below a predefined pressure threshold.

[0243] In Fig. 23 there is illustrated another example of the sensor assembly 80 and hence of the touch sensitive sensor element 81 when subject to a predefined touch action 66 as conducted by a user. Here, a user slides along a direction as indicated by the touch action 66 across or on the touch sensitive sensor element 81 . Here, a user conducts a kind of a swipe motion from the left to the right. Accordingly, and at a beginning of this motion the sensor segment 84 may be subject to a touch action and may generate a touch control signal. As the finger of the user moves further in accordance with the touch action 66 a further sensor segment 85 makes contact with the finger of the user and starts to generate a respective touch control signal. Thereafter, the further sensor segment 86 is actually touched and generates a respective touch control signal. Since the touch control signals generated individually by the various sensor segments 84, 85, 86 can be each assigned with a respective clock signal as provided by the clock 42, processing of the variety and hence of a sequence of touch control signals as generated by the individual sensor segments 84, 85, 86 may be indicative of a predefined touch action 66, such as a sliding motion from the left to the right.

[0244] Now and since the processor 44 is operable to process the sequence of touch control signals that arise in response to a user touching the display surface 61 via conducting a predefined touch action 66 the processor is configured to analyze the sequence of touch control signals obtained from the touch sensitive sensor element 81 and hence from the individual sensor segments 84, 85, 86. The processor 44 may be then operable to recognize a predefined touch action 66 on the basis of the processing of the sequence of touch control signals as received from the sensor assembly 80.

[0245] Upon recognition of a touch action the processor 44 is then operable and configured to generate a display control signal, which causes a modification of a visual appearance of the display surface 61 when received and / or processed by the electronic display 60.

[0246] Here and by recognizing a touch action 66 on the basis of a sequence of touch control signals the processor 44 is configured to generate a specific display control signal, e.g., as a kind of display command, which, when received and / or processed by the electronic display 60 leads to a modification of a visual appearance 62 of the display surface 61 , which is apparent from Fig. 24.

[0247] There, on the left-hand side the display surface 61 of the electronic display 60 comprises a first visual appearance 62, which switches into a second visual appearance 63 as shown on the righthand side of Fig. 24. In the first visual appearance 62 the display surface 61 may show various icons or symbols as well as an information part 71 in form of a specific parameter value 76. In the second visual appearance 63, there is a second information part 72 that distinguishes from the first information part. The first visual appearance 62 may be indicative of a remaining time, until it is time to conduct a dose injection procedure. The first visual appearance 62 may be also indicative of a size of a dose of a medicament, e.g. insulin, that has been delivered or injected. In the second visual appearance 63 the electronic display 60 may indicate a particular point of time, e.g., the actual time of the day or the absolute time at which the next injection procedure may be due.

[0248] Switching from the first visual appearance 62 as shown on the left-hand side in Fig. 24 to the second visual appearance 63 of the display surface 61 as shown in the right-hand side of Fig. 24 may be induced and / or controlled by a predefined touch action 66, which may be a unidirectional swipe motion to be conducted by a finger of a user across the sensor assembly 80 and hence across the touch sensitive electronic display 60.

[0249] In the first visual appearance 62 there may be also provided a guiding indication 74, which may be indicative of a possible touch action 66 that could be conducted by a user when the display surface 61 shows the first visual appearance 62. In response to a user conducting the predefined touch action 66, e.g., a horizontal swipe motion towards the right-hand side as indicated by the arrow of the guiding indication 74 the visual appearance 62 changes to the visual appearance 63. When the display 60 is in the second visual appearance 63, there may be further provided another guiding indication 74 by way of which the user may swap the display surface 61 to show another visual appearance 62 or 63 as e.g. indicated in Fig. 25.

[0250] In the second visual appearance 63 as shown on the right-hand side of Fig. 24 there may be further provided another guiding indication 74', e.g. in form of an arrow pointing in a direction opposite to the arrow of the guiding indication 74. When in the second visual appearance 63 as shown in Fig. 24 the further guiding indication 74' is indicative to a user to swipe or to conduct a predefined touch action 66' in order to switch from the second visual appearance 63 towards and back into the first visual appearance 62.

[0251] In the further configurations of the electronic display 60 as shown in Fig. 24 there can be provided or conducted a likewise switching between different visual appearances 62, 63. By way of example and in the first visual appearance 62 there may be displayed an information part 71 of an amount of information 70, which may be indicative of an actual time or a point of time at which an injection is due. In the second visual appearance 63 of the electronic display 60 as shown in Fig. 25 there may be simultaneously shown first and second information parts 71 , 72 of a contextual information 70. Here, the information may comprise a text 77 or textual message.

[0252] As illustrated, the word "HERE" may be provided in four comparatively large letters. In situations, where the amount of information 70 may exceed such a rather short word, the respective amount of information can be split into numerous individual medium or small-sized information parts 71 , 72, which can be illustrated sequentially by the electronic display 60. Here, it is conceivable that only two letters of the illustrated word, e.g. a first information part 71 is shown at a time on the display surface 61. Upon conducting a predefined touch action 66, e.g. as indicated by the guiding indication 74 another, hence a second information part 72 may be illustrated on the display surface 61 at a later time. The symbols and 75 or information 70 may be also indicative of a battery status or signal strength of a transceiver 38.

[0253] Also here, there may be provided a guiding indication 74, 74' providing an intuitive guidance for the user to apply or to conduct one or several of generally available touch actions 66, 66' to switch between different visual appearances 62, 63 of the display surface 61 of the electronic display 60.

[0254] Generally, the electronic display 60 as e.g. shown in Fig. 22 may be configured to visualize or to illustrate all conceivable types of information, e.g. in form of guiding indications 74, 74', numerous symbols 75, 75', 75". Here, and by way of example, the symbol 75 may be indicative of a time, of an injection currently due or recently conducted, of a pairing or communication status of the injection device 1 and / or of the add-on device 100, of a battery level, of a connectivity to an external electronic 200 and further configurations or settings of the injection device number 1 and / or of the add-on device 100.

[0255] In Fig. 26 there is shown a further example of a switching behavior of the display surface 61. Here, and when starting from a first visual appearance 62, in which there is illustrated a battery status, a user may be guided by the guiding indication 74 to conduct a first touch action 66, hence a swipe down movement across the touch sensitive sensor element 81. In response to the recognition of such a touch action 66 by the processor 44, the visual appearance 62 of the display surface 61 changes to a further visual appearance 63. There may be illustrated a signal strength of a transceiver 38 in the further visual appearance. In the further visual appearance 63 there is shown another guiding indication 74 pointing downwardly again and an oppositely directed guiding indication 74' indicating to the user, that the visual appearance 63 can be switched back to the visual appearance 62 by conducting a touch action 66', e.g. an upwardly directed swiping or sliding motion.

[0256] However, and when in the second visual appearance 63 the user may repeatedly conduct another downwardly directed swipe motion, hence another predefined touch action 66 to switch to a third visual appearance 64. In the third visual appearance 64 another information 70 may be illustrated to the user together with a further guiding indication 74' and 74". Here, the guiding indication 74' points upwardly and indicates to the user that a touch action 66', hence an upwardly directed swipe motion across the sensor assembly 80 may return the display surface 61 into the second visual appearance 63.

[0257] The further guiding indication 74" points in a different direction, e.g., in a horizontal direction and may indicate to a user, to enter into a further menu or menu item of the menu-structured information 70 as provided by the electronic unit 34. Here, the information 70 as shown in the third visual appearance 64 may represent an error code. By conducting another predefined touch action 66", in accordance with the further guiding indication 74" the user may obtain supplemental information about the type of error. By the touch-controllable modification of the visual appearance 62, 63, 64 of the display surface

[0258] 61 comparatively large contextual information or any other type of information can be split into numerous information parts 71 , 72, 73, which may be then illustrated to the user in a sequential but user-controllable manner. The switching between illustrations of individual information part 71 , 72, 73 may be controlled by user interaction. An individual switching from a first visual appearance

[0259] 62 towards and into a second visual appearance 63 and further into a third visual appearance 64 may require conducting of a predefined touch action 66, such as a swipe motion across the display surface 61 and hence across the touch sensitive sensor element 81 .

[0260] In Fig. 27 it is further illustrated that a user uses a finger 216 to the conduct a predefined touch action 66, such as a bow-shaped swiping motion across the sensing surface 82 of the touch sensitive sensor element 81 of the sensor assembly 80. Accordingly, numerous sensor segments 84, 85, 86 will become active during execution of the touch action 66 and may be each and individually prompted to generate a respective touch control signal, which control signal can be evaluated and processed by the processor 44 to recognize the respective spatial movement of the finger 216 across the sensing surface 82.

[0261] In Fig. 29 a repeated tapping motion of a finger 216 on the touch sensitive sensing area 82 is illustrated. Here, and depending on the size of the finger 216 numerous sensor segments 84, 85 may be activated simultaneously thus defining a sensing area 88 while another sensor segment 86 lying outside the sensing area 88 may remain inactive because it is not touched. Here, the simultaneous touching of at least two sensor segments 84, 85 and a repeated touch action within a predefined time interval may be indicative of a double tapping of the touch sensitive sensor element 81 , which may be interpreted as a predefined control signal to induce a certain operation of the electronic unit 34.

[0262] In the further example of Figs. 31 and 32 the user applies a predefined contact pressure onto the sensing surface 82, which contact pressure is above a predefined pressure threshold. Here, the sensor segments 84, 85 located inside the sensing area 88, as defined by the geometric size of the finger 216, may be indicative of a respective contact pressure. Accordingly, the firm pressing of the sensor assembly 80 by a finger 216 of a user may be interpreted as a further control command, e.g., for operating, configuring, or calibrating the electronic unit 34. Recognition of such a control command may then also come along with a modification of the visual appearance 62, 63, 64 of the display surface 61.

[0263] In the flowchart according to Fig. 35 there is illustrated a method of modifying a visual appearance 62 of the display surface 61 of an electronic display 60 of an electronic unit 34, which is configured for attachment to an injection device 1 and / or which is configured for integration into an injection device 1 , such as a pen-type injector. In a first step 300 there is generated a sequence of touch control signals in response to a user touching the display surface 61 by conducting a predefined touch action 66 of a number of predefined available touch action 66, 66', 66". In a subsequent step 302 a predefined touch action 66 is recognized by processing the sequence of touch control signals by a processor 44 of the electronic unit 34.

[0264] In a subsequent step 304 there is generated a display control signal on the basis of the recognition of the predefined touch action 66. Finally, and in step 306 a visual appearance 62 of the display surface 61 may be modified towards another visual appearance 63 through receiving and / or through processing the display control signal by the electronic display 60. The method as described in connection with the flowchart of Fig. 35 is executable or conductible by an electronic unit 34, by an add-on device 100 as well as by an injection device number 1 , each of which being equipped with such an electronic unit 34 as described herein.

[0265] In the cross-section of Fig. 36 there is shown an example of a proximal end of an injection device 1 , which is likewise implemented as a pen-type injector. The injection device number 1 is provided with an electronic circuit 35 and hence with an electronic unit 34 as described above. Here, the electronic unit 34 is integrated into the proximal end of the injection device 1. It may be integrated in a dose dial grip 12, which may be covered and closed in proximal direction by a trigger 11 and hence by a dose button 11. The proximal end face 11A of the trigger or dose button 11 may be provided with the touch sensitive electronic display 60 as described above. The electronic display 60 is coupled or connected to a spatially resolving sensor assembly 80 comprising a touch sensitive sensor element 81 with a number of non-overlapping touch sensitive sensor segments 84, 85, 86.

[0266] The electronic unit 34 as shown in Fig. 36 is generally implemented in a way as described above in connection with Figs. 16 and 17. It is equipped with a processor 44, with a clock 42 and with a sensor arrangement 48, which may be implemented as an optical sensor arrangement configured to detect and / or to quantitatively measure a degree of rotation of one component of the injection device 1 relative to another component of the injection device 1 during one of setting of a dose and dispensing or injecting of a dose of a medicament.

[0267] The electronic unit 34 comprises a sensor arrangement 48 comprising one of more sensors, which may be optical sensors, e.g. for detecting light or infrared radiation reflected from a surface. The radiation source generating the light or the radiation, e.g. an LED, may be integrated into the sensor arrangement, which, in addition to the radiation source, may comprise a detector chip for receiving reflected radiation.

[0268] The printed circuit board 36 may likewise serve as mounting section 37. It may comprise an almost circular shape. The longitudinal axis L runs through the mounting section 37 and perpendicularly to the main extension plane of the mounting section 37 and / or perpendicularly to the front side of a carrier in the mounting section 37.

[0269] The processor 44 and / or or a real-time clock 42 may be arranged on a front side of the mounting section 37. Moreover, one or more further electric elements, like capacitors, inductors and / or lightemitting diodes, are arranged on the mounting section 37, e.g. on the front side and / or on the back side.

[0270] As can be seen in Fig. 36, the electronic unit 34 is mounted on a mounting member 10A of the housing 10. The mounting member 10A may be a chassis lower comprising a top side 10B and a lateral side 10C. The mounting section 37 is mounted on the top side 10B and the sensor arrangement 48 is in its sensing position so that a sensor section 49 thereof axially overlaps with the lateral surface side 10C or surface.

[0271] Furthermore, it can be seen that the further mounting section 37A is arranged axially offset with respect to the mounting section 37 and a battery 121 is arranged between the mounting section 37 and the further mounting section 37A in axial direction.

[0272] The drug delivery device 1 shown in Fig. 36 also comprises a movable member 32. The movable member 32 is arranged within the sensing region, i.e. axially below the mounting section 37 and axially overlapping or aligned with the sensor arrangement 48. Particularly, the region of the movable member 32 axially overlapping with the sensor arrangement 48 or sensors may comprise a surface structure and / or alternating reflective and less reflective regions, e.g. alternating dark and bright regions or recessed and non-recessed regions. The sensor arrangement 48 may comprise numerous optical sensors for detecting radiation reflected from the surface structure and for sending associated measurement signals to the processor 44. If the region reflects more radiation to the sensor, e.g. as it is closer to the associated sensor and / or more reflective, the measurement signal is higher than if the region reflects less radiation to the sensor, e.g. as it is further away from the associated sensor and / or less reflective.

[0273] The movable member 32 is particularly rotatable with respect to the sensors. The movable member 32 may be or may comprise a dial sleeve and / or an encoder ring. The movable member may move, e.g. rotate, relative to the sensor(s) during the dose delivery operation e.g. only during the dose delivery operation. During the dose setting operation, the sensor(s) and the movable member 32 may move together, e.g. rotationally and / or axially, relative to a housing 10 of the drug delivery device 1.

[0274] The injection device 1 according to Fig. 36 is an example of an integration of an electronic unit 34 at or in a proximal end of an injection device, the proximal end face 11A of the trigger 11 is provided with the electronic display 60 and with the sensor assembly 80 as described above. Here, a user may conduct numerous predefined touch actions 66 on the electronic display 62 controlled the electronic unit 34 and / or to modify the visual appearance 62, 63, 64 of the display surface 61 .

[0275] Furthermore, the electronic unit 34 as described in connection with Fig. 36 is implemented as a dose recording device as described above, which is configured to quantitatively measure a size of a dose, to provide the measured or detected dose injection with a timestamp and to store the dose recording in a digital memory 40. It may likewise wirelessly pair with an external electronic device 200 as described above.

[0276] Further details of the pen-type injector as shown in Fig. 34 may be apparent from WO 2023 / 046798 A1 , the entirety of which being incorporated herein by reference.

[0277] Reference Numbers

[0278] I drug delivery device

[0279] 10 housing

[0280] 10A mounting member

[0281] 10B top side

[0282] 10C lateral side

[0283] I I dose button

[0284] 11A end face

[0285] 12 dose dial grip

[0286] 13 drive sleeve

[0287] 14 display window

[0288] 15 container

[0289] 16 needle

[0290] 17 inner needle cap

[0291] 18 outer needle cap

[0292] 19 cap

[0293] 20 second mechanical coupling element

[0294] 21 second contact surface

[0295] 22 ribs

[0296] 23 groove

[0297] 24A first abutment edge

[0298] 24B second abutment edge

[0299] 25 recess

[0300] 26 proximal end surface

[0301] 27 abutment surface

[0302] 28 number sleeve

[0303] 29 slot

[0304] 30 spline

[0305] 31 clutch

[0306] 32 movable member

[0307] 34 electronic unit

[0308] 35 electronic circuit

[0309] 36 printed circuit board

[0310] 37 mounting section

[0311] 37A mounting section

[0312] 38 transceiver 40 memory

[0313] 42 clock

[0314] 44 processor

[0315] 48 sensor arrangement

[0316] 49 sensor section

[0317] 50 signal generator

[0318] 53 light source

[0319] 54 light source

[0320] 60 electronic display

[0321] 61 display surface

[0322] 62 visual appearance

[0323] 63 visual appearance

[0324] 64 visual appearance

[0325] 66 touch action

[0326] 70 information

[0327] 71 information part

[0328] 72 information part

[0329] 73 information part

[0330] 74 guiding indication

[0331] 75 symbol

[0332] 76 value

[0333] 77 text

[0334] 80 sensor assembly

[0335] 81 sensor element

[0336] 82 sensing surface

[0337] 84 sensor segment

[0338] 85 sensor segment

[0339] 86 sensor segment

[0340] 88 sensing area

[0341] 89 sensing area

[0342] 90 device body

[0343] 91 fastener

[0344] 92 receptacle

[0345] 94 aperture

[0346] 100 electronic add-on device

[0347] 101 first portion

[0348] 102 second portion 102A end face

[0349] 103 auxiliary grip

[0350] 104 end face

[0351] 105 ribs

[0352] 106 grooves

[0353] 107 clips

[0354] 108 first mechanical coupling element

[0355] 109 first contact surfaces

[0356] 110 ribs

[0357] 111 push element

[0358] 112 spring

[0359] 113 push element abutment surface

[0360] 114 end stop

[0361] 115 first clutch element

[0362] 116 second clutch element

[0363] 117 sleeve portion 117A sleeve portion clip

[0364] 118 coupling portion 118A coupling portion clip

[0365] 119 inner surface

[0366] 120 second portion housing

[0367] 121 battery 121 A battery clip

[0368] 122 circuit board assembly

[0369] 123 microswitch

[0370] 124 lever arm

[0371] 125 distally facing surface

[0372] 126 stopper element

[0373] 200 external device

[0374] 201 housing

[0375] 202 user interface

[0376] 203 control element

[0377] 204 visual item

[0378] 206 device processor

[0379] 207 device memory

[0380] 208 device transceiver

[0381] 210 hand 216 finger

[0382] 400 injection system

Claims

57PAT24274-WO-PCTClaims1 . An electronic unit (34) for attachment to an injection device (1) or for integration into an injection device (1), the electronic unit (34) comprising: an electronic display (60) with a display surface (61), a processor (44) connected to the electronic display (60), a sensor assembly (80) connected to the processor (44) and comprising a touch sensitive sensor element (81), which is coupled to the display surface (61), wherein the sensor assembly (80) is operable to generate a sequence of touch control signals in response to a user touching the display surface (61) while conducting a predefined touch action (66) of a number of predefined touch actions (66, 66', 66"), and wherein the processor (44): i) is operable to process the sequence of touch control signals, ii) is operable to recognize the predefined touch action (66) on the basis of the processing of the sequence of touch control signals, and iii) is operable to generate a display control signal on the basis of the recognition of the predefined touch action (66), the display control signal causing a modification of a visual appearance (62, 63, 64) of the display surface (61) when received and / or processed by the electronic display (60).

2. The electronic unit (34) according to claim 1 , wherein the processor (44) is operable to distinguish between a first touch action (66), which is characterized by a first sequence of touch control signals and a second touch action (66'), which is characterized by a second sequence of touch control signals.

3. The electronic unit (34) according to claim 2, wherein the processor (44) is operable to generate a first display control signal upon recognition of the first touch action (66) and wherein the processor (44) is operable to generate a second display control signal upon recognition of the second touch action (66'), the first display control signal causing a first visual appearance (62) of the display surface (61) and the second display control signal causing a second visual appearance (63) of the display surface (61) when received and / or processed by the electronic display (60).

4. The electronic unit (34) according to any one of the preceding claims, wherein the processor (44) is operable to display an amount of information (70) on the display surface (61),58 the amount of information (70) including a first information part (71) and a second information part (72), and wherein the processor (44) is operable to display the first information part (71) and the second information part sequentially on the electronic display (60) .

5. The electronic unit (34) according to claim 4, wherein the processor (44) is operable to switch from displaying the first information part (71) to the second information part (72) upon recognition of one of the predefined touch actions (66, 66', 66").

6. The electronic unit (34) according to claim 3 and any one of the claims 4 or 5, wherein the processor (44) is operable: to switch from displaying the first information part (71) to the second information part (72) when recognizing the first touch action (66) and to switch from displaying the second information part (72) to the first information part (71) when recognizing the second touch action (66').

7. The electronic unit (34) according to any one of the preceding claims 4-6, wherein the amount of information (70) includes a third information part (73) and wherein the processor (44) is operable to switch from displaying the second information part (72) to the third information part (73) when recognizing a third predefined touch action (66").

8. The electronic unit (34) according to any one of the preceding claims, wherein the processor (44) is operable to generate a guiding indication (74; 74', 74") on the display surface (61) being indicative of at least one predefined touch action (66) of the numerous predefined touch actions (66; 66', 66").

9. The electronic unit (34) according to any one of the preceding claims, wherein the injection device (1) is implemented as an injection pen.

10. An add-on device (100) for fastening to an injection device (1), the add-on device comprising: a device body (90), a fastener (91) integrated into the device body (90) or fixed to the device body (90) and configured to detachably fasten the device body (90) to at least one of a housing (10), a dose dial grip (12) and a dose button (11) of the injection device (1), and an electronic unit (34) according to any one of the preceding claims.5911 . The add-on device (100) according to claim 10, wherein the electronic display (60) of the electronic unit (34) is provided on or integrated in an outside surface (104) of the device body (90).

12. The add-on device according to claim 10 or 11 , wherein the device body (90) comprises: a first portion (101) configured to be releasably attached to the dose dial grip (12) of the injection device (1), and a second portion (102) coupled to the first portion (101), longitudinally displaceable relative to the first portion (101) to apply pressure onto the dose button (11) of the injection device, and wherein the electronic display (60) of the electronic unit (34) is provided on a proximal end face (104) of the second portion (102) or is integrated into the proximal end face (104) of the second portion (102).

13. An injection device (1) for injecting a dose of a medicament, the injection device comprising: a housing (10) to accommodate a drive mechanism operable to withdraw or to expel the medicament from a medicament container (21), at least one of a dose dial grip (12) and a trigger (11) actuatable by a user for injecting the dose and an electronic unit (34) according to any one of the preceding claims 1 to 11 attached to or integrated into at least one of the housing (10), the dose dial grip (12) and the trigger (11).

14. The injection device (1) according to claim 13, wherein the electronic display (60) of the electronic unit (34) is provided on or is integrated into a proximal end face (11 A) of the trigger (11).

15. The injection device (1) according to claim 13 or 14, wherein the injection device (1) is implemented as an injection pen.

16. A method of modifying a visual appearance (62, 63, 64) of a display surface (61) of an electronic display (60) of an electronic unit (34) for attachment to an injection device (1) or for integration into an injection device (1), wherein the electronic unit (34) comprises a touch sensitive sensor element (81) coupled to the display surface (61), the method comprising the steps of: generating a sequence of touch control signals in response to a user touching the display surface (61) by conducting a predefined touch action (66) of a number of predefined touch actions (66, 66', 66"),60 recognizing the predefined touch action (66) by processing of the sequence of touch signals with a processor (44) of the electronic unit (34), generating a display control signal on the basis of the recognition of the predefined touch action (66), and modifying a visual appearance (62, 63, 64) of the display surface (61) through receiving and / or processing the display control signal by the electronic display (60).

17. A computer program comprising computer readable instructions, which when executed by a processor (44) of an electronic unit (34) configured for attachment to an injection device (1) or for integration into an injection device (1) cause the processor (44): to receive a sequence of touch control signals generated by a sensor assembly (80) of the electronic unit (34) in response to a user touching a display surface (61) of an electronic display (60) of the electronic unit (34) while conducting a predefined touch action (66) of a number of predefined touch actions (66, 66', 66"), to recognize the predefined touch action (66) by processing of the sequence of touch control signals, and to generate a display control signal on the basis of the recognition of the predefined touch action (66), the display control signal causing a modification of a visual appearance (62, 63, 64) of the display surface (61) when received and / or processed by the electronic display (60).

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