Electrode system, electronic system, drug delivery device, and method of manufacturing the electronic system

Abstract

The present disclosure relates to a sensor electrode system (1345) for an electronic system (1000), comprising: an electrically insulating flexible conductor carrier (1350); and an electrode configuration (1360) including at least two conductive electrode tracks (1362, 1364, 1378) extending along the flexible conductor carrier and electrically isolated from one another along the conductor carrier, one of the conductive electrode tracks forming an extended sensing electrode (1366, 1376) in a sensing region (1310, 1320) of the flexible conductor carrier. Further disclosed are electronic systems, drug delivery devices, and methods.

Description

[Technical Field]

[0001] The present disclosure relates to electrode systems, electronic systems, drug delivery devices, and methods of manufacturing electronic systems. [Background technology]

[0002] Electronic drug delivery devices are becoming increasingly popular not only within the industry but also among patients or users. Summary of the Invention [Problem to be solved by the invention]

[0003] It is an object of the present disclosure to facilitate improvements associated with electronic systems of drug delivery devices. [Means for solving the problem]

[0004] This object is achieved by the subject matter of the independent claims. Advantageous embodiments and improvements are the subject matter of the dependent claims. The present disclosure is not limited to the subject matter of the present claims. Rather, the present disclosure may also encompass currently unclaimed subject matter that may provide improvements to and / or be the subject matter of the claims, as would be readily apparent to one skilled in the art.

[0005] One aspect of the present disclosure relates to an electrode system of a drug delivery device or electronic system. Another aspect relates to an electronic system, preferably an electronic system including an electrode system. The electronic system can be an electronic system of a drug delivery device. Yet another aspect relates to a drug delivery device, which preferably includes an electrode system or an electronic system. Finally, the present disclosure relates to a method of manufacturing or assembling an electronic system of a drug delivery device.

[0006] In one embodiment, the electrode system includes a flexible conductor carrier. The flexible conductor carrier can be electrically insulating. The flexible conductor carrier is configured to provide a base for one or more conductive electrode tracks extending along the flexible conductor carrier. Each electrode track can also be flexible only in a region or throughout the region. The flexible conductor carrier and / or the electrode system can be deformed (e.g., folded, bent, or curved) for application in an electronic system. Thus, in the electronic system, the electrode system and / or the conductor carrier can have a second or deformed configuration, for example, as opposed to a first or undeformed configuration. In the first configuration, the conductor carrier can be flat. By having a flexible conductor carrier, the conductor carrier and / or the entire electrode system can be easily tailored to the specific requirements of the electronic system in which it is used. For example, the flexible conductor carrier can easily conform to a non-planar (e.g., curved) surface, such as a cylindrical surface. Different regions of the conductor carrier can be deflected in different directions to orient in different directions in the electronic system. Having a flexible conductor carrier is particularly suitable for electrode systems in drug delivery devices such as injection and / or pen devices, where such devices typically have limited available space, making it particularly advantageous to have a flexible conductor carrier.

[0007] In one embodiment, the electrode system includes an electrode structure. The electrode structure can extend along an electrode surface of a flexible conductor carrier. The electrode surface can be a major surface of the flexible conductor carrier. The electrode structure is limited to the electrode surface. The surface opposite the electrode surface or the surface facing away from the electrode surface can be an electrically insulating surface. The insulating surface is provided by the flexible conductor carrier. In this way, the electrode function of the electronic system is provided on one surface, the electrode surface, and the opposite surface is electrically insulated from the electrode structure, thereby facilitating application of the electrode system in a use situation (e.g., an electronic system) because the insulating properties of the flexible conductor carrier and the insulating surface it provides reduce the risk of short circuits caused by elements located on the surface of the conductor carrier facing away from the electrode surface. Alternatively, by insulating the entire surface, the surface of the conductor carrier opposite the electrode surface or the surface of the conductor carrier facing away from the electrode surface can be a surface on which one or more conductive electrode portions are exposed (i.e., two opposing surfaces of the conductor carrier can be electrode surfaces).

[0008] In one embodiment, the electrode configuration includes at least one conductive electrode track. The electrode configuration can include at least two conductive electrode tracks (e.g., two tracks, three tracks, or four tracks). Each track is formed or disposed on an electrode surface of a flexible conductor carrier. Each conductive electrode track can extend along the flexible conductor carrier. When multiple conductive electrode tracks are present, the conductive electrode tracks are electrically separated or insulated from each other along the conductor carrier. In other words, there can be no electrical interconnection between two conductive electrode tracks of the electrode configuration on the conductor carrier, preferably between any selected pair of two conductive electrode tracks.

[0009] In one embodiment, the electrode system is a sensor electrode system. The sensor electrode system is configured to operatively couple between a sensing site (e.g., an external working surface of a user interface member) and a sensor controller (see below) configured to evaluate one or more electrical properties input via the electrode system. For example, the sensor electrode system, when applicable in combination with the sensor controller, is configured to detect capacitance or a change in capacitance on or near the external working surface of a user interface member of a drug delivery device or electronic system. Specifically, the sensor electrode arrangement is configured to detect the proximity of a user's fingers (e.g., a thumb, a finger other than the thumb, and / or at least another finger, such as the thumb and index finger) to the external working surface.

[0010] In one embodiment, one of the conductive electrode tracks can form, define, or be the sensing electrode. The sensing electrode can extend in a sensing region of the flexible conductor carrier. The sensing region can be a region of the conductor carrier configured to be positioned close, preferably as close as possible, to an external actuation surface. The external actuation surface can be a setting surface, i.e., a surface that a user contacts during or for a dose-setting operation, or a delivery surface, i.e., a surface that a user contacts during or for a dose-delivery operation.

[0011] In one embodiment, the electrode tracks are configured to be coupled to or form separate channels or inputs of a sensor controller that monitors one or more electrical properties in the sensing region (e.g., capacitance between two electrode tracks) by one or more electrode tracks. Alternatively or additionally, the electrode tracks are assigned to different sensing regions of the conductor carrier.

[0012] In one embodiment, the electrode system, flexible conductor carrier, and / or electrode configuration are deformable, for example, entirely or in at least one or more regions. Preferably, the electrode system, flexible conductor carrier, and / or electrode configuration are elastically deformable, for example, entirely or in at least one or more regions. Thus, the electrode system is deformed, for example, from an undeformed configuration to a deformed configuration. As a result of the deformation, an elastic restoring force can be obtained that tends to re-establish the undeformed configuration. The elastic restoring force can be advantageously used, for example, to maintain contact of a portion of the elastically deformed flexible conductor carrier with another component, such as the inner wall of a user interface member, preferably facing away from the external actuation surface. The elastic restoring force can press a surface (e.g., electrode surface) of the flexible conductor carrier against the other component. Thus, elastic deformability facilitates conformance of the electrode system to non-planar or curved (e.g., cylindrical) surfaces. The electrode system may be elastically deformable entirely, or only in one or more regions. Other regions of the electrode system may still be deformable, but are not necessarily elastic. A deformable electrode system (eg, a flexible printed wiring board) has small space requirements and can be easily adjusted to various shapes and sizes of user interface members.

[0013] In one embodiment, one of the conductive electrode tracks of the electrode configuration is or forms a reference electrode. The reference electrode can extend along the sensing electrode in the sensing region of the flexible conductor carrier. The electrode track of the reference electrode can extend along the entire electrode track of the sensing electrode. The reference electrode and the sensing electrode are configured to be provided with different potentials. The different potentials create an electric field between the reference electrode and the sensing electrode. The electric field can be static or dynamic, for example, using an alternating potential or voltage. The electric field or its characteristics are monitored by a sensor controller of the system. A fluctuation in the electric field or its characteristics (e.g., capacitance) occurs when a user's finger approaches the sensing electrode and / or the reference electrode. The sensor controller evaluates the fluctuation and, if it meets one or more predetermined criteria, considers it to be caused by the user's finger approaching the external operating surface. For example, one of the electrodes can be provided with a high potential and the other with a low potential (e.g., ground potential). One potential can be positive and the other negative. The electrode with the low potential can be the reference electrode and the electrode with the high potential can be the sensing electrode. An electronic system (e.g., a sensor controller) is configured to monitor changes in capacitance between the reference electrode and the sensing electrode. If the change crosses a threshold level (e.g., becomes either higher or lower than a predetermined threshold), the sensor controller is configured to generate or provide a signal, e.g., to a main controller or electronic control unit of the electronic system. If a touch or proximity event occurs with respect to an external operating surface, the sensor controller issues a corresponding signal that is used in the electronic system to change the operating state of the electronic system. In response to this signal (which may be an operating signal or a proximity signal), the electronic system is configured to switch from a first state of low power consumption (e.g., a state in which only the sensor controller is operating) to a second state of high power consumption (e.g., a state in which one or more units of the electronic system that were previously inoperable are operating). These units may include a motion sensing unit and / or a communication unit.The switching operation is performed by an electronic control unit (eg, a main controller) provided in addition to the sensor controller.

[0014] In one embodiment, the sensing electrode, particularly in the sensing region of the flexible conductor carrier, has a plurality of sensing electrode portions. The sensing electrode portions are distributed, for example uniformly, across the entire sensing region. The sensing electrode portions are separated from one another in the sensing region. The sensing electrode portions are oriented parallel to one another. Alternatively or additionally, the reference electrode, particularly in the sensing region, can have a plurality of reference electrode portions. The reference electrode portions are distributed, for example uniformly, across the entire sensing region. The reference electrode portions are separated from one another in the sensing region. The reference electrode portions are oriented parallel to one another in the sensing region. Each electrode portion is formed by an associated conductive electrode track. Each electrode portion is oriented axially, for example in an electronic system, from a proximal end of the electronic system to a distal end of the electronic system. The sensing electrode portions in the sensing region are disposed equidistantly along the sensing region, i.e., two consecutive sensing electrode portions of any pair can have the same distance. Alternatively or additionally, the same can apply to the reference electrode portions. Alternatively, the distance between adjacent sensing electrode portions may vary, for example in a regular pattern. Alternatively or additionally, the same may apply to adjacent reference electrode portions.

[0015] In one embodiment, one of the reference electrode and the sensing electrode has an electrode portion. For example, the reference electrode has a reference electrode portion oriented in opposite directions (e.g., opposite axial directions) in the sensing region. The electrode portions can have ends facing in different directions (e.g., different axial directions). Some electrode portions can face proximally and other electrode portions can face distally. The other of the reference electrode and the sensing electrode (e.g., the sensing electrode) is disposed between two portions of one of the reference electrode and the sensing electrode that are oriented in opposite directions.

[0016] In one embodiment, each electrode portion, i.e., the reference electrode portion and / or the sensing electrode portion, is oriented in an axial direction, which may be perpendicular to the longitudinal direction of the main extension of the flexible conductor carrier, and each electrode portion may have a free end.

[0017] In one embodiment, the sensing electrode portions and reference electrode portions are arranged alternately in and / or along the sensing region, e.g., when viewed along a main extension direction of the sensing region, the electrode system, and / or the flexible conductor carrier, i.e., a sensing electrode portion can be followed by a reference electrode portion, which can be followed by another sensing electrode portion, which can be followed by another reference electrode portion.

[0018] In one embodiment, the electrode portions may define or have an alternating or interdigitated arrangement of the sensing and reference electrodes in the sensing region, where successive electrode portions may belong to different electrodes, i.e., reference or sensing electrodes, when viewed along the main extension direction. A first comb is formed by the sensing electrode, and a second comb, engaged with the first comb, is formed by the reference electrode. The electrode portions may form the teeth of each comb. The reference and / or sensing electrode portions are arranged sequentially along the sensing region when viewed along the main extension direction of the sensing region, e.g., the main extension direction of the flexible conductor carrier.

[0019] In one embodiment, the distance between successive sensing electrode portions can be greater than the width of the reference electrode portion located between adjacent sensing electrode portions. The same applies to the distance between successive reference electrode portions, which for convenience is greater than the width of the sensing electrode portion located between two adjacent reference electrode portions. This width can refer to the dimension perpendicular to the extension of the electrode portion, for example towards the end of the electrode portion.

[0020] In one embodiment, the sensing electrode portion and / or the reference electrode portion are oriented obliquely or perpendicularly to the main extension direction of the sensing region, the electrode system and / or the flexible conductor carrier.

[0021] In one embodiment, the sensing region is configured to be located near the external actuation surface at a distance less than, preferably at a maximum distance from, for example, one of the following values: 2 mm, 1.5 mm, 1 mm. The external actuation surface can be a circumferentially or angularly disposed surface (e.g., a setting surface of a user interface member). The main extension direction of the sensing region can be along the circumferentially disposed surface (e.g., angularly) when the electrode system is provided in an electronic system.

[0022] In one embodiment, the sensing electrode portions have the same width and / or the same length. Alternatively or additionally, the reference electrode portions can have the same width and / or the same length. The width of the reference electrode portion can be equal to the width of the sensing electrode portion. The length or axial extension of the reference electrode portion can be equal to the length or axial extension of the sensing electrode portion.

[0023] In one embodiment, the sensing electrode sections are connected to the connection sections of the sensing electrodes. Preferably, all sensing electrode sections are connected, for example directly, to a common connection section. The connection sections can conductively interconnect the sensing electrode sections. The connection sections can be part of an electrode track from which the sensing electrode sections branch off. All sensing electrode sections can branch off from the connection sections in the same direction. The transition regions between the connection sections and the sensing electrode sections are arranged sequentially along the connection sections (for example, linearly and / or along the main extension direction of the connection sections). Each sensing electrode section can have an end remote from the connection section of the sensing electrode. The sensing electrode sections can extend linearly away from the connection sections. The connection sections can extend linearly along the flexible conductor carrier.

[0024] In one embodiment, the reference electrode portions are connected to the reference electrode connection portions. Preferably, all reference electrode portions are connected, for example directly, to a common connection portion. The connection portions can conductively interconnect the reference electrode portions. The connection portions can be part of an electrode track from which the reference electrode portions branch off. All reference electrode portions can branch off from the connection portions in the same direction. The transition regions between the connection portions and the reference electrode portions are arranged sequentially (for example, linearly) along the connection portions. Each reference electrode portion can have an end remote from the reference electrode connection portion. The reference electrode portions can extend linearly away from the connection portions. The connection portions can extend linearly along the flexible conductor carrier.

[0025] In one embodiment, at least one end (e.g., a free end) of the reference electrode portion (e.g., multiple reference electrode portions or all reference electrode portions) faces the sensing electrode or electrode track of the sensing electrode, particularly when viewed along the flexible conductor carrier.

[0026] In one embodiment, at least one end (e.g., a free end) of the sensing electrode portion (e.g., multiple sensing electrode portions or all sensing electrode portions) faces the reference electrode or electrode track of the reference electrode, particularly when viewed along the flexible conductor carrier.

[0027] In one embodiment, the number of sensing electrode portions and / or the number of reference electrode portions is even or odd. The number of sensing electrode portions may be equal to the number of reference electrode portions.

[0028] In one embodiment, the number of sensing electrode portions and / or the number of reference electrode portions is one or more of the following values: 2, 3, 4, 5, 6, 7, 8.

[0029] In one embodiment, the ends of the reference electrode portion, in particular all ends of the reference electrode portion, face the connecting portion side of the sensing electrode. Alternatively or additionally, the ends of the sensing electrode portion, in particular all ends of the sensing electrode portion, face the connecting portion side of the reference electrode.

[0030] In one embodiment, each sensing electrode portion and / or each reference electrode portion extends linearly. The reference electrode portion and the sensing electrode portion are oriented to extend parallel to each other.

[0031] In one embodiment, each electrode portion, i.e., one or more of the reference electrode portion and / or sensing electrode portion, has a constant width along its extension, for example when viewed in a direction from the connecting portion connecting the respective electrode portions to the free end of the respective electrode portion. Each electrode portion can have a regular shape.

[0032] In one embodiment, each electrode portion, i.e., one or more of the reference electrode portion and / or sensing electrode portion, has a width that varies along its extension, for example, when viewed in a direction from the connecting portion connecting the respective electrode portions to the free end of the respective electrode portion. The width of the electrode portion may preferably decrease continuously in a direction toward the free end. The free end may be a pointed end or a flat end. Each electrode portion may have a triangular or trapezoidal shape.

[0033] In one embodiment, the sensing region of the flexible conductor carrier is configured to fit against and / or extend along a circumferentially or angularly disposed sensing surface of the user interface member. When the electrode system is applied to or included in an electronic system, the sensing region fits against and / or extends along the sensing surface of the user interface member. The sensing region is provided to cover the entire circumference of the sensing surface or at least an angle of 360°. The sensing surface can be a surface extending along an external operating surface of the user interface member, particularly on the interior or body of the user interface member. The sensing surface can have an angular extension of 360°. The external operating surface can be a setting surface that must be manipulated (e.g., rotated) by the user to perform a dose setting operation with the user interface member. The angular or circumferential orientation of the sensing surface can be relative to the axis of rotation of the dose setting.

[0034] In one embodiment, the sensor electrode system can be or is configured such that one reference electrode portion and one sensing electrode portion are disposed at opposite locations, particularly along the sensing surface, and / or such that, when the electrode system is mounted in an electronic system, for example, the sensing area conforms to the sensing surface. Thus, when mounted in an electronic system, one sensing electrode portion and one reference electrode portion are offset from each other by 180°. Both portions can face the sensing surface. Every sensing electrode portion can have an oppositely disposed or associated reference electrode portion, for example, offset by 180° from the sensing electrode portion. Because a user is likely to touch a user interface element at opposite locations with another finger, such as a thumb and index finger, for dose setting operations, it has been discovered that arranging the sensing electrode portion and the reference electrode portion at opposite locations causes a particularly noticeable fluctuation, perceptible to the sensor controller, due to the user's fingers when or during dose setting. For this purpose, an odd number of sensing and reference electrode portions is particularly advantageous.

[0035] In one embodiment, one of the reference and sensing electrodes (e.g., the reference or sensing electrode) in the sensing region passes through an end of the other of the sensing and reference electrodes (e.g., the sensing or reference electrode, respectively). Alternatively or additionally, the other of the sensing and reference electrodes is disposed between two portions of one of the reference and sensing electrodes. The two portions of one of the reference and sensing electrodes extend or are oriented parallel to each other, e.g., along at least a majority of the other of the sensing and reference electrodes, and / or are connected by an electrode portion that passes through an end of one of the sensing and reference electrodes.

[0036] In one embodiment, the sensing electrode is a first sensing electrode, and the sensing region is a first sensing region. One of the conductive electrode tracks of the electrode configuration can form, define, or be the second sensing electrode. The second sensing electrode can extend in the second sensing region of the flexible conductor carrier. The second sensing region and the first sensing region are separated from each other (e.g., do not overlap). The second sensing region and the first sensing region are connected by a connecting region of the flexible conductor carrier. The electrode track of the second sensing electrode extends within the connecting region so as to define the second sensing electrode in the second sensing region. In contrast to the first sensing region and / or the second sensing region, the connecting region can have smaller dimensions (e.g., smaller length and / or smaller width). The conductive electrode track of the second sensing electrode is conveniently electrically separated or insulated from the electrode track of the first sensing electrode on the flexible conductor carrier. The electrode track of the second sensing electrode is electrically separated or isolated from the electrode track of the reference electrode.

[0037] In one embodiment, the flexible conductor carrier is configured such that the first and second sensing regions are movable relative to one another. The sensing regions can be movable relative to one another so that the surfaces with the sensing electrodes, i.e., the first and second sensing electrodes, face in different directions. For example, the first and second sensing regions are configured such that the second sensing region and the first sensing region are perpendicular to one another, i.e., the normal vector of the surface of the flexible conductor carrier is perpendicular to the sensing regions. When the electrode system is provided in an electronic system, one of the sensing regions can have an essentially planar surface, while the other sensing region can have a curved surface or a radially oriented angular surface.

[0038] In one embodiment, the first and second sensing regions are configured or assignable to differently oriented external actuation surfaces. For example, the first sensing electrode is assigned to a setting surface of the user interface member. Alternatively or additionally, the second sensing electrode is assigned to a delivery surface of the user interface member.

[0039] In one embodiment, the reference electrode or its conductive electrode track extends along the first sensing electrode in the first sensing region and / or the second sensing electrode in the second sensing region, i.e., the first sensing electrode and the second sensing electrode can have a common reference electrode, so that one conductive electrode track is used as the reference electrode in two different sensing regions.

[0040] In one embodiment, a reference electrode or conductive electrode track thereof is disposed between the first sensing electrode or electrode track thereof and the second sensing electrode or electrode track thereof, so that the first and second sensing electrodes or electrode tracks thereof, when extending alongside one another, are still separated by the reference electrode. This configuration makes electrical isolation between the first and second sensing electrodes particularly easy and reliable, and can at least reduce the possibility of crosstalk between the sensing electrodes.

[0041] In one embodiment, the reference electrode or associated electrode track surrounds the sensing electrode or associated electrode track in the sensing region. For example, the reference electrode in the sensing region can have a first portion and a second portion, both oriented along the main extension direction of the flexible conductor carrier or sensing region. These portions extend parallel to each other. The sensing electrode is disposed (e.g., limited) between the two portions of the reference electrode. The first and second portions are connected by a transition portion. When the transition portion extends from the first portion to the second portion, it can pass through an end of the sensing electrode. This end can be remote from the contact connection region (see below).

[0042] In one embodiment, the first and second sensing electrodes are configured to be provided with the same or different potentials during operation of the electronic system.

[0043] In one embodiment, the connecting region between the first and second sensing regions has a width smaller than the width of the first sensing region and / or the width of the second sensing region. The width of the second sensing region can be smaller than the width of the first sensing region. Having a connecting region with a small width facilitates a movable connection between the first and second sensing regions. The electrode tracks of the reference electrode and the second sensing electrode can extend along the connecting region. The electrode tracks are deformed along with the connecting region.

[0044] In one embodiment, the flexible conductor carrier includes a contact coupling region. The contact coupling region can be a coupling region, a connector region (see below), and / or a region outside the sensing region. The contact coupling region is provided to conductively couple each electrode track or associated electrode, such as the (first) sensing electrode, the reference electrode, and / or the second sensing electrode, to another component of the electronic system, such as a sensor controller. The sensor controller can have multiple channels, the number of which preferably corresponds to the number of electrodes or electrode tracks provided on the electrode system. For example, the sensor controller can have one channel if only one electrode is provided, such as a sensing electrode and a reference electrode; two channels if two electrodes are provided, such as a first sensing electrode, a second sensing electrode, and a reference electrode; or three channels if three electrodes are provided. It should be noted that, instead of having a common reference electrode, separate reference electrodes can also be provided for the first and second sensing electrodes. In this case, the sensor controller can have four channels. The contact coupling region can be movable (e.g., foldable) relative to the sensing region. The contact connection region is provided to conductively connect the electrode tracks on the flexible conductor carrier with the sensor controller and / or another conductor carrier. The sensor controller is disposed on the other (e.g., rigid) conductor carrier. The contact connection region is provided for connection with a connector (e.g., an FCC connector or a slim stack connector). The first sensing region is disposed between the contact connection region and the second sensing region or between the contact connection region and the connector region when viewed along the extension of the flexible conductor carrier (e.g., from the contact connection region to the second sensing region or connector region, respectively). Alternatively, the second sensing region or connector region is disposed between the contact connection region and the first sensing region.

[0045] In one embodiment, the reference electrode, the (first) sensing electrode, and / or the second sensing electrode, or their electrode tracks, extend from the associated sensing region to and / or are in electrical contact with the contact connection region, where each electrode can be in electrical contact with the contact connection region, and where a terminal of each electrode (or electrode track) is provided.

[0046] In one embodiment, the sensing area is configured to cover at least 270°, at least 300°, or at least 350° of angular extension of the circumferentially disposed surface of the user interface member (e.g., the sensing surface described above and / or the sensing surface if fitted to the surface). The flexible conductor carrier is configured to cover more than 360° of extension of the surface. In this way, particularly sensitive areas of the flexible conductor carrier can be shielded from the outer surface via the conductor carrier. That is, the flexible conductor carrier can cover one or more sensitive areas of the flexible conductor carrier (e.g., the connection area and / or the contact connection area).

[0047] In one embodiment, the electrode system is a flexible printed wiring board.

[0048] In one embodiment, the electrode arrangement is located internal to the user interface member, i.e., is not externally accessible.

[0049] In one embodiment, one of the conductive electrode tracks can form, define, or be a connector electrode. The connector electrode can extend in a connector region of the flexible conductor carrier. The connector electrode or connector region is provided to electrically couple another electrode (e.g., a separate sensing electrode) to the electrode configuration. The other electrode can be separate (e.g., a separate part) from the electrode configuration. The other electrode can be a metal part. The connector electrode can be exposed in the connector region of the flexible conductor carrier to enable mechanical contact of the connector electrode with the other electrode. In the electronic system, the other electrode is disposed between the flexible conductor carrier and an external actuation surface (which can be a delivery surface). The other electrode is conductively coupled to a power source via the electrode configuration. The other electrode can be elastically deformable. The other electrode is configured to act as a biasing member (see below) and / or bias one or more elements or components of the electronic system away from the external actuation surface (e.g., part of the flexible conductor carrier). The connector region is arranged in a region of the conductor carrier associated with or associated with the delivery surface. This further electrode can serve as a (second) sensing region or a (second) sensing electrode (or a sensing region / electrode associated with the delivery surface). Thus, the configurations described above and below for the (second) sensing region or electrode (or a sensing region associated with the delivery surface) also apply to the connector region, and vice versa. The first sensing region (or a sensing region associated with the setting surface) is conveniently provided in addition to the connector region and the further electrode.

[0050] In one embodiment, the electrode system (e.g., electrode arrangement) includes a terminal portion configured to be coupled, e.g., directly, to a power source. The terminal portion can be part of an electrode track forming, e.g., a reference electrode or a sensing electrode. The terminal portion can be accessible, e.g., on a face of the flexible conductor carrier facing away from the external actuation surface. A biasing member (see above or below) (e.g., another electrode) is arranged to bias the terminal portion toward (e.g., into mechanical contact with) the terminal of the power source. The terminal portion is arranged on a face of the flexible conductor carrier remote from or opposite the connector electrodes in the connector region. The terminal portion is electrically insulated from the connector electrodes.

[0051] In one embodiment, the reference electrode portion extends along the connector electrode in the connector region (e.g., along the exterior or outer edge of the connector electrode). Having one or more portions of the reference electrode associated with the connector electrode brings the reference electrode into proximity with another electrode when the electronic system is assembled. Having the reference electrode in proximity with another electrode can be advantageous even when the electrode configuration itself does not provide a sensing electrode, but rather a separate electrode does.

[0052] In one embodiment, as seen in a top or plan view of the conductor carrier, for example when the carrier is in a flat configuration, the connector electrode is located between the reference electrode portion and the terminal portion.

[0053] In one embodiment, the electronic system includes a user interface member. The user interface member has at least one external actuation surface. The external actuation surface is arranged to be manipulated by a user for a dose actuation. The dose actuation can be a dose setting actuation for setting the dose to be delivered by the drug delivery device and / or a dose delivery actuation for delivering a dose (e.g., a previously set dose). To operate the user interface member, the user must contact the external actuation surface. The external actuation surface can be a setting surface (e.g., a radially facing surface and / or a circumferentially arranged surface) for a dose setting actuation or a delivery surface, such as an axially (e.g., proximally) facing surface. The user interface member must be moved, e.g., rotationally, for a dose setting actuation. The amount of rotation can be proportional to the size of the set dose. The user interface member must be moved, e.g., axially, for a dose delivery actuation. The (respective) movement of the user interface member can be relative to the housing (e.g., the housing of the drug delivery device or drug delivery device unit).

[0054] In one embodiment, the user interface member includes a user interface member body. The user interface member body can form or define one or more external actuation surfaces. The body can have a cup-shaped configuration. The body can have a proximal end relative to the delivery surface. The distal end can be open for coupling of the user interface member to, for example, a dose-setting mechanism and a drive mechanism of or for a drug delivery device.

[0055] In one embodiment, the exterior working surface and / or the user interface member body may be electrically insulating.

[0056] In one embodiment, the electronic system includes a user proximity detection unit. The user proximity detection unit is disposed within the user interface member, particularly within the user interface member body. The user proximity detection unit is disposed and configured to detect whether a user approaches or touches the external operating surface. When the user proximity detection unit determines that the user has approached or touched the external operating surface, the user proximity detection unit can provide or trigger the generation of an electrical signal, such as a use signal or a proximity signal. This signal can indicate that the user is approaching or touching the external operating surface and / or that a dose operation (e.g., a dose setting operation or a dose delivery operation) is about to be initiated. The user proximity detection unit can include an electrode system as described above. The user proximity detection unit can further include an electronic sensor controller (e.g., a microcontroller or an ASIC). The sensor controller is conductively coupled to the electrode system, e.g., as discussed in detail above. The sensor controller can have different channels for different tracks or electrodes. A signal is provided by the user proximity detection unit in response to the user contacting the external operating surface or the user being close to but not contacting the external operating surface and being less than a predetermined distance from the external operating surface, which may be less than or equal to one of the following values: 5 mm, 4 mm, 3 mm, 2 mm, 1 mm, 0.5 mm, 0.4 mm, 0.3 mm, 0.2 mm.

[0057] In one embodiment, a (first) sensing electrode is assigned to the setting surface of the user interface member and / or a second sensing electrode is assigned to the delivery surface of the user interface member, such that the proximity of a user to different surfaces is detected via the electrode system by the same electrode system.

[0058] In one embodiment, the first sensing region is associated with the setting surface. Alternatively or additionally, the second sensing region is associated with the delivery surface.

[0059] In one embodiment, the electronic system includes a power source, such as a rechargeable or non-rechargeable battery including at least one coin cell. The power source can provide power for electrically powered components of the electronic system. The electronic system can be self-contained; that is, the power source cannot be replaceable and is therefore permanently integrated into the system. Thus, if the power source is not rechargeable, the electronic system must be discarded once the power contained in the power source is consumed.

[0060] In one embodiment, the electronic system includes an electronic control unit. The electronic control unit is provided in addition to the sensor controller. As such, the sensor controller is used to switch the electronic control unit to a high power consumption state. The electronic control unit can then similarly switch one or more other units to a high power consumption state (e.g., from inactive to active). The other units may include a motion detection unit and / or a communication unit. The motion detection unit is provided for capturing dose-related data (e.g., characteristics of the size of the delivered dose) during the dose delivery operation. The communication unit is provided for establishing a communication channel to another device (e.g., a mobile phone or a personal computer) and / or transmitting the dose-related data to another device, such as after the dose delivery operation has ended.

[0061] In one embodiment, the sensing region (e.g., the second sensing region and / or the first sensing region) is biased toward the external actuation surface, e.g., by a resilient or spring force. For example, the sensing region is biased against an inner surface of the user interface member or user interface member body that is close to the external actuation surface (e.g., disposed on a surface of a wall of the user interface member body that faces away from the external actuation surface, the wall externally defining the external actuation surface). Thus, the sensing region can be adjacent to or conform to the inner surface of the user interface member or user interface member body.

[0062] In one embodiment, the sensing region (eg, the first sensing region and / or the second sensing region) is biased toward the external actuation surface by a force resulting from elastic deformation of the electrode system or flexible conductor carrier.

[0063] In one embodiment, the electronic system includes a biasing member (e.g., a resilient member such as a spring). The biasing member is arranged to bias a region of the flexible conductor carrier against the external actuation surface and / or the user interface member body, e.g., toward or away from the user interface member body. As mentioned above, the biasing member is formed by a separate electrode that can act as a separate sensing electrode. Therefore, references to the biasing member (e.g., references to its arrangement) should be understood as references to the separate electrode, especially when the separate electrode is provided as a sensing electrode and is not realized by an electrode arrangement.

[0064] In one embodiment, the sensing region (e.g., the second sensing region) is biased toward the external actuation surface by a biasing member, i.e., a biasing member is provided in the electronic system to mechanically bias the sensing region toward the external actuation surface.

[0065] In one embodiment, the biasing member is disposed between the user interface member body and the connector portion (eg, between an external actuation surface (such as a delivery surface) and the connector portion).

[0066] In one embodiment, the biasing member is electrically conductive. The biasing member is conductively coupled to a power source. The biasing member is conductively coupled to the sensor controller and / or other electronic or electrical power unit (e.g., a power source) of a component of the electronic system.

[0067] The biasing member can help direct power from the power source to other units or components of the electronic system (such as a sensor controller or electronic control unit). The biasing member can bias the sensing region proximally relative to the user interface member body (e.g., adjacent to an inner surface of a section of the user interface member body that forms or defines the delivery surface). The sensing region is secured between the biasing member and the user interface member body that defines the outer actuation surface with which the sensing region is associated.

[0068] The biasing member ensures a conductive connection between the power source and the other carrier (e.g., its conductors or terminals) as the case may be, by biasing the flexible conductor carrier towards the power source (e.g., relative to the user interface member body) and / or biasing the power source towards the other carrier (e.g., a rigid conductor carrier). The biasing member can function as a separate sensing electrode, and is conductively connected to a connector electrode at a connector region of the flexible conductor carrier, for example, by mechanical contact between the connector electrode and the biasing member.

[0069] In one embodiment, the flexible conductor carrier has multiple sensing areas associated with the same external actuation surface (e.g., a delivery surface or a setting surface). One or more electrode tracks of an electrode configuration can extend through each sensing area. The electrode track configurations in different sensing areas can be identical. Each sensing area (e.g., each second sensing area) is connected to another carrier area (e.g., a first sensing area) of the flexible conductor carrier via a separate connecting area of ​​the flexible conductor carrier. In this case, the external actuation surface is preferably covered or monitored by multiple sensing areas, each of which has the same electrode track configuration and / or a portion of the same electrode track. Therefore, monitoring of the external actuation surface is distributed among the various sensing areas. This facilitates reducing the size and weight of each sensing area. Therefore, the inherent elasticity of the connecting area facilitates biasing each sensing area toward the external actuation surface. This facilitates the omission of separate biasing members for the above purpose or due to different dimensional requirements of the biasing members.

[0070] In one embodiment, the user proximity detection unit is configured to monitor the proximity of an object (eg, a deformable object such as a user's finger) to an external actuation surface.

[0071] In one embodiment, the external operating surface includes a surface structure. The surface structure may include one or more depressions or recesses. The depressions or recesses may be separated or connected to each other. The depressions or recesses are dimensioned so that when a user contacts the external operating surface, a deformable object, such as the skin of a user's fingers (e.g., thumb and / or index finger), is deflected into the depression or recess. In this way, the distance between the user's skin and the detection area is reduced. The closer the object to be detected is to the detection area, the more pronounced the signal will typically be. The surface structure reduces the risk that a user will mistakenly assess a non-deformable object (e.g., a metal object) as being close to the external operating surface. The surface structure of the external operating surface is defined by a user interface member body. The user interface member body may have a varying thickness. In the case of a setting surface as the external operating surface, the radial thickness of the body may vary along the axial and / or angular extension of the setting surface. In the case of a delivery surface as the external operating surface, the axial thickness of the body may vary along the radial and / or angular extension of the delivery surface. The thickness of the user interface member body, particularly in the region between the sensing area and the associated external operating surface, can define the distance between the sensing surface and the associated external operating surface, which can therefore be varied as well by, for example, surface structure.

[0072] In one embodiment, the external operating surface is configured such that the user proximity detection unit has a higher sensitivity to soft or flexible conductive objects that easily conform to the external operating surface (e.g., the skin on a user's finger or thumb) compared to hard or rigid conductive objects that do not easily conform to the external operating surface (e.g., metal and / or rigid objects), which is achieved by the surface structure described above.

[0073] In one embodiment, the sensor electrode system is configured such that the electrode configuration is adjusted, preferably set, in the sensing region to compensate for thickness variations of the user interface member body along the external working surface and / or distance variations of the external working surface from a sensing region associated with the external working surface. The thickness or distance variations can be due to the surface structure of the user interface member body. The electrode configuration is configured such that the sensitivity of a sensor including the sensor electrode system monitored by the sensor electrode system is uniform along the external working surface (e.g., a setting surface), particularly regardless of thickness variations. Thus, the proposed solution allows for smaller variations in sensor sensitivity along the external working surface (e.g., circumferentially and / or axially along a setting surface) than the sensitivity variations along an external reference surface monitored by the same sensor. The reference surface can be smooth and thus have a constant distance from the sensing region of the sensor electrode system that conforms to the inner surface or sensing surface of the user interface member body. The reference body can have the same general shape as the user interface member body, while being free of thickness variations. The reference surface is conveniently a surface of a reference body made of the same material as the user interface member body. The thickness of the reference body along the reference surface can be constant or can be between the maximum and minimum thicknesses of the user interface member body. The distance of the external reference surface from the sensing region can be between the maximum and minimum distances of the external actuation surface from the sensing region. The electrode configuration is adjusted for thickness variations by configuring one or more electrode tracks in the sensing region. For example, the reference electrodes and sensing electrodes are interleaved in the sensing region, which is believed to be particularly suitable for providing uniform sensitivity even when a structured surface is monitored by the sensor electrode system.

[0074] In one embodiment, a sensor (eg, a capacitive sensor) includes a sensor controller and a sensor electrode system.

[0075] In one embodiment, in the electronic system, the contact coupling region and the second sensing region are oriented in the same direction, or the contact coupling region and the connector region are oriented in the same direction.

[0076] In one embodiment, in the electronic system, the contact coupling region and / or the second sensing region is diagonal or perpendicular to the first sensing region.

[0077] In one embodiment, the electronic system includes a carrier, such as a conductor carrier (e.g., a rigid conductor carrier). The carrier is provided in addition to a flexible conductor carrier of the electronic system. The sensor controller, electronic control unit, and / or other units (such as a communication unit and / or a motion sensing unit) of the electronic system are disposed on the carrier and / or are conductively coupled to conductors provided on the carrier. The carrier can be a printed wiring board.

[0078] In one embodiment, the user interface member includes a user interface member part. The user interface member part is preferably axially and / or non-rotatably fixed to the user interface member body. An interior of the user interface member is defined by the user interface member body and the user interface member part. The interior is sealed, for example, against moisture and / or dust. The user interface member part is received in a distal opening of the user interface member and preferably closes said opening. The user interface member part may be a housing.

[0079] In one embodiment, the carrier is held, for example axially and / or non-rotatably, relative to the user interface member component.

[0080] In one embodiment, the electrode system (eg, sensing region) is wrapped around the user interface member component.

[0081] In one embodiment, the sensing region extends along an outer surface (e.g., a radially facing outer surface) of the user interface member piece and / or carrier. The sensing region can surround all or part of the carrier or user interface member piece, particularly in an angular or circumferential direction, for example, relative to an axis parallel to the distal direction.

[0082] In one embodiment, the contact coupling regions of the electrode system extend inward relative to the outer surface of the user interface member part, e.g., towards a (rigid) carrier, and are conductively coupled to the sensor controller, e.g., directly or via conductors on the carrier.

[0083] In one embodiment, the flexible conductor carrier is fixed or held to the user interface member part, e.g., non-rotatably and / or axially. The sensing area is fixed to the user interface member part (e.g., on its outer surface). For example, the flexible conductor carrier is fixed to the user interface member part by receiving a protrusion on the user interface member part in a notch on the flexible conductor carrier or electrode system.

[0084] In one embodiment, the power source is disposed between a portion of the flexible conductor carrier and the (rigid) carrier. The portion of the flexible conductor carrier can be a connector region. The coupling region of the flexible conductor carrier (e.g., the coupling region extending toward the contact coupling region) can extend toward the carrier from a portion of the flexible conductor and / or a face of the power source remote from the carrier. The contact coupling region is mechanically and / or electrically coupled to the carrier (e.g., a conductor or terminal on the carrier). The contact coupling region can conductively couple the flexible conductor carrier to the carrier and / or the sensor controller. The power source is held or fixed to the user interface member component and / or carrier by the flexible conductor carrier, e.g., via a coupling portion associated with the carrier on one hand and a coupling portion associated with the user interface member component on the other hand. In other words, in the present disclosure, the flexible conductor carrier can function as a retainer or holding member that holds components of a subassembly of an electronic system relative to one another. The subassembly is inserted into the user interface member body. The components can be or include: a carrier, a user interface member component, and / or a power source. In addition to these components, the subassembly may include a flexible conductor carrier.

[0085] In one embodiment, a method of manufacturing or assembling an electronic system includes providing an electrode system for a drug delivery device. The electrode system can be as described above. The electrode system can include a flexible, preferably electrically insulating, conductor carrier. The electrode system can further include an electrode configuration. The electrode configuration can include at least one conductive electrode track. The electrode track can extend along the flexible conductor carrier. The method also includes providing a component (e.g., a user interface member component).

[0086] In one embodiment, an electronic unit (eg, a sensor controller) is conductively coupled to the electrode arrangement (eg, conductive electrode tracks).

[0087] In one embodiment, the method includes deforming the electrode system, for example by folding one or more portions of the electrode system relative to other portions. The electrode configuration is deformed so that a surface of the conductor carrier extends along or conforms to the component (e.g., an outer surface of the component). The surface of the flexible conductor carrier facing the component can be the surface of the flexible conductor carrier remote from the electrode configuration. The opposite side can define a sensing region. The electrode system or the flexible conductor carrier can be deformed before or after conductively coupling the electrode tracks with the electronic unit, for example via contact coupling regions of the flexible conductor carrier.

[0088] In one embodiment, before the electrode system is deformed to extend along the outer surface of the component, other portions of the flexible conductor carrier are deflected relative to the contact coupling areas that are already coupled to the electronic unit.

[0089] In one embodiment, after conductively connecting the electrode tracks with the electronic unit and / or deforming the flexible conductor carrier to fit the component, the user interface member body is guided over a surface of the flexible conductor carrier facing away from the component. This positions a region of the flexible conductor carrier between the inner surface of the user interface member body and the outer surface of the (user interface member) component in the electronic system. As mentioned above, this region can be or include a sensing region (e.g., a first sensing region). The user interface member body and the user interface member component are, for example, rigidly connected to each other.

[0090] In one embodiment, the method further includes providing a biasing member and positioning a region of the flexible conductor carrier (e.g., a sensing region such as the second sensing region) such that the biasing member is positioned to bias the sensing region away from the part and / or toward an inner surface of the user interface member body. The inner surface can be a surface of the user interface member facing away from the external actuation surface (e.g., an inner surface of a wall of the user interface member body that externally defines the delivery surface).

[0091] In one embodiment, a subassembly is provided, the subassembly being arranged to be non-rotatable and / or axially held relative to the part, for example after the electrode track is coupled to the electronic unit, and the carrier, power supply, electronic unit, and / or biasing member can belong to the subassembly.

[0092] In one embodiment, the subassembly includes an orientation feature that ensures that the subassembly can be placed on or coupled to a component only in a predetermined relative orientation (e.g., relative angular orientation). The predetermined relative orientation can include only one relative orientation, thereby ensuring that the electronic unit of the subassembly is placed in a predetermined position relative to the component.

[0093] In one embodiment, the flexible conductor carrier extends along the outer edge, particularly the radially outer edge of the power source and / or component (eg, a user interface member component).

[0094] In one embodiment, the drug delivery device includes a reservoir holder that holds a reservoir (e.g., a cartridge) containing the drug, and / or the device includes a reservoir that can contain enough drug for multiple doses, preferably user-settable doses, that the drug delivery device delivers.

[0095] In one embodiment, the drug delivery device is a pen device and / or an injection device (eg, a needle injector).

[0096] In one embodiment, the electronic system is configured as a (preferably reusable) add-on to the drug delivery device unit. The system is configured to be attached to the drug delivery device unit. That is, the electronic system is configured to be used with multiple drug delivery device units. Each drug delivery device unit can be a disposable drug delivery device unit and / or each drug delivery device unit can be fully operable to perform dose setting and dose delivery operations. The drug delivery device unit can include a reservoir. The drug delivery device unit can be free of an electric unit or components for such a unit.

[0097] In one embodiment, the drug delivery device or drug delivery device unit includes a dose setting and drive mechanism. The dose setting and drive mechanism may include a first member coupled or coupleable to an electronic system. The dose setting and drive mechanism may include a second member. The first and second members are coupled (e.g., non-rotatably locked) for a dose setting actuation. For a dose delivery actuation, the first and second members are decoupled, e.g., to allow relative rotatable movement. The dose setting and drive mechanism may further include a piston rod. The first member is coupled to the piston rod, e.g., directly and / or by a screw. During a dose delivery actuation, the relative rotatable movement between the first and second members is measured by the electronic system to determine the size of the delivered dose.

[0098] In one embodiment, a drug delivery device kit includes a drug delivery device unit and an electronic system. The system can be attached to the device unit to form a drug delivery device. Features disclosed above and below with respect to the drug delivery device, particularly features not directly related to the electronic system, also apply to the drug delivery device unit and vice versa.

[0099] As used herein, "distal" is used to designate a direction, end, or surface that is positioned or arranged to face or point toward the dosing end of a drug delivery device or a component thereof, and / or a direction, end, or surface that points opposite, faces away from, or faces away from the proximal end. Meanwhile, "proximal" is used to designate a direction, end, or surface that is positioned or arranged to face or point away from the dosing end of a drug delivery device or a component thereof, and / or a direction, end, or surface that is positioned or arranged to face or point away from the distal end. The distal end can be the end closest to the dosing end and / or the end farthest from the proximal end, and the proximal end can be the end farthest from the dosing end. The proximal face can be opposite the distal end and / or facing toward the proximal end. The distal face can be facing away from the distal end and / or the proximal end. The dosing end can be, for example, the needle end at which a needle unit is attached or attached to the device.

[0100] In one advantageous embodiment, the sensor electrode system of the drug delivery device comprises: - with an electrically insulating flexible conductor carrier; - an electrode arrangement including at least two conductive electrode tracks extending along a flexible conductor carrier and electrically isolated from one another along the conductor carrier; Including, One of the conductive electrode tracks forms an extended sensing electrode in a sensing region of the flexible conductor carrier.

[0101] In one advantageous embodiment, a method of manufacturing an electronic system for a drug delivery device comprises: - providing an electrode system (e.g., the electrode system described above) comprising an electrically insulating flexible conductor carrier and an electrode arrangement comprising at least one conductive electrode track extending along the flexible conductor carrier; - providing a component (e.g., a user interface member component); - deforming the electrode system so that a surface of the flexible conductor carrier extends along the component (e.g., along the outer surface of the component); - conductively connecting at least one conductive electrode track with an electronic unit, thereby forming, for example, an electronic system; Includes:

[0102] The features disclosed in connection with the various aspects and embodiments may be combined with one another even without explicit discussion, for example, features relating to electrode systems and electronic systems may also apply to devices, methods, and kits, and vice versa.

[0103] Other aspects, embodiments, and advantages will become apparent from the following description of exemplary embodiments taken in conjunction with the drawings. [Brief explanation of the drawings]

[0104] [Figure 1] 1 illustrates an embodiment of a drug delivery device. [Figure 2] FIG. 1 illustrates one embodiment of an electronic system. [Figure 3] 3A-3C are diagrams illustrating one embodiment of an electronic system. [Figure 4] FIG. 1 illustrates one embodiment of an electrode system. [Figure 5] FIG. 1 illustrates one embodiment of an electronic system. [Figure 6] FIG. 1 illustrates one embodiment of an electrode system. [Figure 7]FIG. 1 illustrates one embodiment of an electronic system. [Figure 8] 8A-8C show an embodiment of an electrode system. [Figure 9] 9A-9C are diagrams illustrating one embodiment of an electronic system. [Figure 10-1] 10A-10D illustrate one embodiment of an electronic system and a method for assembling or manufacturing the electronic system. [Figure 10-2] Continued from Figure 10-1. [Figure 10-3] Continued from Figure 10-2. [Figure 11] FIG. 1 illustrates one embodiment of an electrode system. [Figure 12] FIG. 1 illustrates one embodiment of an electrode system. [Figure 13] FIG. 1 illustrates one embodiment of an electrode system. [Figure 14] FIG. 1 illustrates one embodiment of an electrode system. [Figure 15-1] 15A-15F illustrate one embodiment of an electrode system, electronic system, and method. [Figure 15-2] Continued from Figure 15-1. [Figure 15-3] Continued from Figure 15-2. DETAILED DESCRIPTION OF THE INVENTION

[0105] In the figures, identical elements, elements with identical functions, or elements of the same type are given the same reference numerals.

[0106] Some concepts are described below with reference to an insulin injection device in which the systems described herein are implemented, although the disclosure is not limited to such applications and may equally well be used for or in injection devices configured to expel other medicaments, i.e., drug delivery devices in general, preferably pen-type and / or injection devices.

[0107] Provided below are embodiments relating to injection devices, particularly variable dose injection devices, that record and / or track data related to the dose delivered. These data may include the selected dose size and / or the actual delivered dose size, the date and time of administration, the duration of administration, etc. The configurations described herein may include power management techniques or related concepts (e.g., to facilitate small batteries and / or enable efficient power usage).

[0108] Certain embodiments herein are illustrated with respect to an injection device that combines an injection button and a grip (dose-setting member or dose setter), similar to, for example, Sanofi's ALLSTAR® device. The injection button can provide a user interface for initiating and / or executing a dose-delivery actuation of the drug delivery device. The grip or knob can provide a user interface for initiating and / or executing a dose-setting actuation. The device can be of the dial-extension type, i.e., its length increases during dose setting. The same kinematic behavior of the dial extension and button during dose-setting and dose-extraction modes of operation is known from other injection devices, such as the Kwikpen® or Savvio® devices sold by Eli Lilly and Company, and the FlexPen®, FlexTouch®, or Novopen® devices sold by Novo Nordisk. Therefore, application of the general principles to these devices appears straightforward and will not be further described. However, the general principles of the present disclosure are not limited to such kinematic behavior. Other particular embodiments are envisioned for application to injection devices (e.g., Sanofi's SoloSTAR®) in which the injection button and grip component / dose-setting member are separate. Thus, the present disclosure also relates to systems with two separate user interface members, one for dose-setting actuation and one for dose-delivery actuation. To switch between the dose-setting and dose-delivery configurations of the device, the dose-delivery user interface member is moved relative to the dose-setting user interface member. If one user interface member is provided, it is moved distally relative to the housing. During each movement, a clutch between the two members of the device's dose-setting and drive mechanisms changes state (e.g., from engaged to disengaged, or vice versa).For example, when a clutch formed by sets of interlocking teeth on the two members is engaged, the two members are locked against rotation relative to one another, and when the clutch is disengaged or released, one of the two members is rotatable relative to the other. One of the members can be a drive member or drive sleeve that engages with a piston rod of the dose-setting and drive mechanism. The drive sleeve is designed to rotate relative to the housing during dose setting and is locked against rotation relative to the housing during dose delivery. The engagement between the drive sleeve and the piston rod can be a threaded engagement. Thus, since the drive sleeve cannot rotate during dose delivery, axial movement of the drive sleeve relative to the housing causes rotation of the piston rod. This rotation is converted into axial displacement of the piston rod by the threaded connection between the piston rod and the housing during the delivery operation.

[0109] The injection device 1 of FIG. 1 is an injection pen that includes a housing 10 and a container 14 (e.g., an insulin container) or a receptacle for such a container. The container can contain a medication (e.g., insulin). The container can be a cartridge or a cartridge receptacle, and the receptacle can contain or be configured to receive a cartridge. A needle 15 is secured to the container or receptacle. The container can be a cartridge, and the receptacle can be a cartridge holder. The needle is protected by an inner needle cap 16 and an outer needle cap 17 or another cap 18. After the insulin dose to be expelled from the injection device 1 is set, programmed, or "dialed in" by turning the dose knob 12, the currently programmed or set dose is displayed via the dose window 13, e.g., in multiples of units. The units are determined by a dose-setting mechanism that allows rotation of the knob 12 relative to the housing 10 only in integer multiples of one-unit setting increments, thereby defining one dose increment. This is achieved, for example, by a suitable ratchet system. The markings displayed in the window are provided on a number sleeve or dial sleeve 70. For example, if the injection device 1 is configured to administer human insulin, the dose is displayed in so-called international units (IU). 1 IU is the bioequivalent of approximately 45.5 micrograms of pure crystalline insulin (1 / 22 mg). In injection devices delivering similar insulins or other medications, other units are employed. Note that the selected dose may be displayed differently and equally well than shown in the dose window 13 of FIG. 1.

[0110] The dose window 13 may be in the form of an aperture in the housing 10 that allows the user to view a restriction on the dial sleeve 70 that is configured to move when the dose knob 12 is turned to provide a visual indication of the currently programmed dose. The dose knob 12 rotates in a helical path relative to the housing 10 as it is turned during programming.

[0111] In this example, the dose knob 12 includes one or more structures 71 a, 71 b, 71 c that facilitate the attachment of a data collection device or electronic system. Electronic systems that can be attached to the user interface members (knob 12 and / or button 11) or, in general, to elements or members of the dose setting and drive mechanism of the drug delivery device 1 are described in more detail below. The electronic systems can, for example, be provided within the user interface members. Also, the electronic systems described in more detail below can be configured as add-ons to the drug delivery device.

[0112] The injection device 1 is configured so that turning the dose knob 12 provides acoustic feedback to the user with a mechanical click. In this embodiment, the dose knob or dose button 12 also functions as the injection button 11. After the needle 15 is inserted into the patient's skin area, the insulin dose displayed in the display window 13 is expelled from the injection device 1 when the dose knob 12 / injection button 11 is pressed axially. After the dose knob 12 is pushed back, if the needle 15 of the injection device 1 remains in the skin area for a certain period of time, the dose is injected into the patient's body. The expulsion of the insulin dose can also produce a mechanical click, but this is different from the sound produced when the dose knob 12 is rotated while dialing the dose.

[0113] In this embodiment, during delivery of the insulin dose, the dose knob 12 is returned to its initial position in an axial movement without rotation, while the dial sleeve 70 or number sleeve 70 is rotated back to its initial position, e.g., to indicate a dose of zero units. As noted above, the present disclosure is not limited to insulin, but is intended to include any drug, particularly a liquid drug or formulation, in the drug container 14.

[0114] The injection device 1 is used for multiple injection processes until the insulin container 14 is empty or the expiry date of the medication in the injection device 1 is reached (eg, 28 days after first use).

[0115] Furthermore, before using the injection device 1 for the first time, it may be necessary to perform a so-called "prime shot" by selecting, for example, 2 units of insulin and pressing the dose knob 12 while holding the injection device 1 with the needle 15 pointing up, to ensure proper fluid flow from the insulin container 14 and the needle 15. For simplicity of presentation, it is assumed below that the discharged amount substantially corresponds to the injected dose. For example, the amount of drug discharged from the injection device 1 is equal to the dose the user receives.

[0116] Also, as explained above, the dose knob 12 also functions as the injection button 11, so the same component is used for dialing / setting the dose and dispensing / delivering the dose. It should be noted that even in this case, a configuration with two different user interface members that are movable relative to one another, preferably only in a limited way, is also possible. However, the following discussion focuses on a single user interface member that provides the functions of dose setting and dose delivery. In other words, the setting surface of the member that the user contacts for dose setting actuation and the dose delivery surface that the user contacts for dose delivery actuation are fixedly connected. Alternatively, if different user interface members are used, they can be movable relative to one another. During each actuation, the user interface member is preferably moved relative to the body or housing of the device. During dose setting, the user interface member is moved proximally and / or rotated relative to the housing. During dose delivery, the user interface member is moved axially (e.g., distally), preferably without rotating relative to the housing or body.

[0117] An embodiment of an electronic system for a drug delivery device is disclosed below.

[0118] FIG. 2 schematically illustrates one embodiment of an electronic system 1000. The system 1000 includes a user interface member 1600. The user interface member is designed to be actuated by a user during dose-setting and / or dose-delivery operations. The user interface member 1600 has various external actuation surfaces. The actuation surfaces are defined by external surfaces accessible from the exterior of the user interface member body or housing 1605. The user interface member 1600 has a setting surface 1610 arranged to be grasped by a user for dose-setting operations. Dose-setting operations, particularly when performed by rotation, typically require two points of contact with the user interface member. For example, a user typically grasps the user interface member with two fingers, such as an index finger and a thumb. The setting surfaces are surfaces that circumferentially bound the user interface member 1600 (e.g., radially facing surfaces). The user interface member 1600 also has a delivery surface 1620. The delivery surface is positioned for contact (e.g., pressing) by a user for dose delivery. The delivery surface 1620 is an axially facing surface (e.g., a proximally facing surface). In the illustrated embodiment, the user interface member 1600 has a cup-shaped configuration. As noted above, embodiments of the present disclosure can employ different user interface members for setting and delivery. A dose setting actuation can include rotation of the user interface member 1600 about a central axis, which can extend perpendicular to and through the delivery surface 1620 (not explicitly shown).

[0119] Several additional elements or units of the electronic system are housed or disposed within the user interface member 1600 (e.g., within the internal hollow defined by the user interface member body 1605). Specifically, the system includes an electrical user proximity detection unit 1330. The user proximity detection unit 1330 is configured to detect whether a user's fingers (e.g., index finger and / or thumb) are approaching or touching the setting surface 1610 and / or the delivery surface 1620. The user proximity detection unit 1330 includes a sensor controller 1340 (e.g., a controller of the Azoteq IQS 228-AS type). The sensor controller 1340 is operatively (e.g., conductively) coupled to an electrode system 1345 by an electrode configuration. The sensor controller and the sensor electrode system together form a capacitive sensor. The sensor electrode system 1345 provides or includes the setting sensing area 1310 (first sensing area). The sensor electrode system 1345 provides or includes a delivery sensing region 1320 (second sensing region). The set sensing region 1310 is associated with the set surface 1610. The set sensing region 1310 conveniently extends along most or all of the inner surface of the user interface member body 1605 facing away from the set surface (e.g., along at least 350° or 360° of angular extension of the inner surface). The set sensing region 1310 faces toward the set surface 1610. The delivery sensing region 1320 is associated with the delivery surface 1620. The delivery sensing region 1320 faces toward the delivery surface 1620. The sensing region 1320 can be planar. The sensing region 1310 can have a curved (e.g., cylindrical) configuration that wraps around or extends around a center or major axis A of the user interface member. Instead of having a set sensing region and a delivery sensing region, only one of these regions (i.e., the set sensing region or the delivery sensing region) is provided. Also, in the illustrated embodiment, both sensing regions or associated electrodes are coupled to a common sensor controller 1340. It is also contemplated that the set sensing region and the delivery sensing region may be coupled to separate sensor controllers.However, for convenience, both sensing areas are connected to the same sensor controller, preferably to different channels of the sensor controller. A preferred embodiment of the electrode system 1345 is described in more detail below. The sensor controller 1340 may be a low-power controller that monitors input capacitance or electric field from the sensing areas of the electrode system 1345 (e.g., from each channel or combination of channels) and outputs a signal when the capacitance, change in capacitance, or change in electric field detected in the sensing area meets a predetermined criterion (e.g., when the monitored quantity or value is above or below a threshold). The criterion is conveniently selected so that, when met, it characterizes the user's proximity to or contact with the respective external operating surface. The capacitive sensor is configured to output a signal when the user moves less than 0.5 mm, 0.4 mm, 0.3 mm, or 0.2 mm away from the monitoring surface. It should be noted, however, that the operating distance of the capacitive sensor may be extended or possibly shortened as required. The signal generated by the user proximity detection unit 1330 is used to affect the operating state of an electronic system or a drug delivery device including the system. Having a setup sensing area and a delivery sensing area allows for identification of whether the user is approaching one of the external actuation surfaces, i.e., the setup surface or the delivery surface, which is used for different operations in the electronic system.

[0120] The electronic system 1000 further includes an electronic control unit 1100. The control unit may include a processor (e.g., a microcontroller or an ASIC). The control unit 1100 may also include one or more memory units, such as a program memory and / or a main memory. The program memory is designed to store program code or software that, when executed by the electronic system, controls the operation of the system and / or the electronic control unit. The control unit 1100 is conveniently designed to control the operation of the electronic system 1000. The control unit 1100 may communicate with other units of the electronic system 1000 (e.g., the sensor controller 1340) via a wired or wireless interface. The control unit 1100 may transmit signals containing commands and / or data to the units and / or receive signals and / or data from the respective units. In FIG. 2, connections between units and the electronic control unit are represented by lines or arrows. However, there may also be connections between units that are not explicitly shown. Similarly, the operative or conductive connection between the electrode system 1345 and the sensor controller 1340 is indicated by an arrow.

[0121] The electronic system further includes a power source 1500, such as a battery (e.g., a coin cell or a stack of multiple coin cells). The power source is configured to provide a total charge of approximately 50-500 mAh at a voltage of approximately 1.4-3 V. The power source 1500 is conveniently conductively coupled to the sensor controller 1340 and / or the electronic control unit 1100. The power source is capable of providing all power for operation of the electronic system, preferably throughout its entire lifespan. When the power remaining in the power source is insufficient to operate the system, the system must be discarded.

[0122] The electronic system 1000 further includes a conductor carrier 3000 (e.g., a (printed) wiring board). Components of electrical or electronic units or all units of the electronic system are disposed on the conductor carrier 3000 and / or conductively coupled to conductors on the conductor carrier. The conductor carrier 3000 is rigid. That is, the conductor carrier advantageously maintains its shape under its own weight, preferably in any orientation relative to ground, even when a force is applied to the conductor carrier. The conductor carrier 3000 can be more rigid than the flexible conductor carrier 1350 of the sensor electrode system 1345, discussed in more detail below. A flexible conductor carrier may or may not maintain its shape under its own weight, but in either case, is deformable when an external force is applied. The conductor carrier 3000 is secured to the user interface member body 1605 either directly to the body or secured to another part (not explicitly shown (see user interface member part or housing 1670, described below)). The sensor controller 1340 and the electronic control unit 1100 are disposed on the conductor carrier 3000 and are preferably conductively coupled to conductors on the conductor carrier. The power source 1500 is disposed between the delivery surface 1620 and the conductor carrier 3000. This facilitates a compact design of the user interface member 1600.

[0123] The electronic system 1000 further includes an electrical motion detection unit 1200. The motion detection unit 1200 can include a sensor (e.g., only one sensor or multiple sensors). The motion detection unit is conveniently designed to generate a motion signal, such as an electrical signal, indicative of movement of one component of the electronic system or drug delivery device relative to another component (e.g., movement of a dial sleeve or number sleeve relative to a drive sleeve or button / knob in the device further described above in conjunction with FIG. 1), with the sensor fixedly coupled to one of the components (e.g., the knob or button or the drive sleeve). This movement is conveniently a relatively rotatable movement. The relatively rotatable movement conveniently occurs during a dose delivery operation (e.g., only during a delivery operation). Each sensor can be an optoelectronic sensor. The optoelectronic sensor can detect radiation emerging from a component moving relative to the sensor and impinging on the sensor to excite a sensor or motion signal within the sensor (e.g., an optical encoder component). The radiation may be radiation reflected by and impinging on a moving member from a radiation source, such as a photoelectron radiation source (e.g., an LED). The radiation source may be an IR source (an IR-LED (infrared light emitting diode)). The radiation source may be part of a sensor configuration including at least one sensor. One possible embodiment of the sensor is an IR sensor configured to detect infrared light. The light source and the sensor are located on the same component or member. The general functionality of a photoelectron sensor configuration suitable for the electronic system discussed herein is disclosed in WO 2019 / 101962 A1, the entire disclosure of which is expressly incorporated herein by reference for all purposes, particularly with regard to various sensor configurations and setups. However, it should be noted that other sensor configurations (e.g., the use of magnetic sensors) may also be employed. Power consumption is particularly high in motion detection units having electrically powered sensors and / or electrically powered sources for stimulating the sensors (e.g., radiation emitters and associated sensors), and appropriate power management of the power available to power the system can have a particular impact.For example, a signal generated by the user proximity detection unit may be used to switch the motion detection unit from an inactive or off state to an active or on state. The electronic control unit 1100 may switch the motion detection unit to a high power consumption active state in response to a signal generated by the user proximity detection unit and provided to or detected by the electronic control unit 1100. In the illustrated embodiment, the motion detection unit is disposed on a surface of the conductor carrier facing away from the delivery surface 1620 and / or the electronic control unit 1100 or the sensor controller 1340. This is particularly preferred when an optoelectronic unit is used for motion detection and the member whose motion is to be detected is disposed on the same side of the conductor carrier as the motion detection unit 1200.

[0124] The motion sensing unit 1200 is designed to detect, and preferably measure or quantify, the relative movement of a dose setting and drive mechanism of a drug delivery device or a component of a dose setting and drive mechanism for a drug delivery device relative to another component of the dose setting and drive mechanism or relative to the housing 10 during a dose delivery operation. For example, the motion sensing unit can measure or detect the relative rotatable movement of two movable components of a dose setting and drive mechanism of a drug delivery device relative to each other (e.g., movement of a dial sleeve or number sleeve relative to a drive sleeve or a button / knob of a user interface component). Based on the motion data received from the unit 100 or calculated from a signal of the unit 100, the electronic system (e.g., the control unit 1100) can calculate dose data (e.g., data related to the currently delivered dose in an ongoing or completed dose delivery operation). The motion sensing unit 1200 is conveniently configured to quantify the relative movement between a first component and a second component of the electronic system or drug delivery device. The relative movement can indicate the delivered dose. The relative movement can be a relatively rotatable movement. For example, the first member can rotate relative to the second member, such as during dose delivery. The motion detection unit is conveniently adapted to quantify the relative movement in integer multiples of one unit setting increment. The unit increment can be or be defined by one or more of the following values: 5°, 10°. The unit setting increment can be or be defined by one or less of the following values: 25°, 20°. The unit setting increment can be, for example, between 5° and 25°. The unit setting increment can correspond to, for example, a 15° relative rotation. The unit setting increment can be the rotation required to set the minimum settable dose delivered by the device. As explained above, the amount or distance of relative movement between the first and second members determined by the motion detection unit can characterize the current set dose in a dose setting operation or the current medication dose in a dose delivery operation.The size of the delivered dose may be determined by or correspond to the distance that the piston rod of the dose setting and drive mechanism is displaced distally relative to the housing 10 during the dose delivery actuation.

[0125] The motion sensing unit is preferably bidirectionally conductively coupled to the electronic control unit 1100, as suggested by the double arrow. In one direction, an activation signal can be sent from the electronic control unit to the motion sensing unit, switching it to an active state. In the other direction, a motion signal is sent from the motion sensing unit to the control unit for further processing of the signal, e.g., to calculate dose information or data.

[0126] The user interface member body 1605 is positioned between the electrode system 1345 and the exterior surface of the user interface member such that when a user touches the exterior surface in the area overlying the electrodes 1345, they do not come into contact with the electrodes 1345. However, it is contemplated that the user may still touch the electrodes. Having electrodes internally facilitates sealing the interior against external influences (e.g., moisture and / or dust). Sealing the interior of the user interface member is a preferred embodiment. To this end, the distal opening shown in FIG. 2 is closed, for example, by the user interface member part or housing 1670 described above and further below. The electrode system 1345 can provide a large sensitive surface area for a capacitive sensor formed by the controller 1340 in combination with the electrode system 1345. The sensor can be or include a (low-power) controller that monitors electrical characteristics input from the sensor electrodes 1345 to the controller. The sensor controller 1340 is conveniently configured to perform sensor management or acquire sensor signals at a certain frequency (polling frequency) or response rate. This frequency or response speed can be equal to or less than one of the following values: 10 Hz, 5 Hz, 4 Hz, 3 Hz, 2 Hz, 1 Hz. The power consumption of the sensor 1340 can be equal to or less than one of the following values: 15 μA, 10 μA, 8 μA, 7 μA, 6 μA, 5 μA, 4 μA, 3 μA. Obviously, the power consumption depends on the frequency at which measurements are taken. The more frequently the sensor is polled, i.e., measurements are taken, the higher the power consumption. The above-mentioned orders of magnitude of power consumption also apply to the above-mentioned frequencies. A frequency is particularly suitable when the user proximity detection unit 1330 monitors the proximity of a user interface member to a setting surface. A lower frequency can be sufficient because the time between dose setting and dose delivery is relatively long since the user needs to switch between two surfaces to operate the system or device, and / or because setting the dose typically takes a lot of time since the user needs to confirm and / or adjust the set dose by window inspection.If the delivery surface is monitored by a sensor, the frequency should be one or more of the following values: 40 Hz, 50 Hz, 60 Hz, 70 Hz, 80 Hz, 90 Hz, 100 Hz. This will result in higher power consumption (e.g., one or more of the following values: 30 μA, 40 μA, 50 μA, 60 μA, 70 μA, 80 μA, 90 μA, 100 μA). Higher frequencies are particularly preferred if the signal generated by the user proximity detection unit is used to switch the system to a high power consumption state, and in particular if it is used to switch the motion detection unit to an active state, as this unit needs to be active during dose delivery operations where contact with the delivery surface occurs in close proximity. If proximity to the delivery surface is monitored for another purpose (e.g., to activate another function of the system, such as in connection with the communication unit (see below)), lower frequencies or response speeds than those specified above may be preferred. The sensor controller 1340 and the control unit 1100 may be mounted on the same surface or on different surfaces of the carrier 3000 .

[0127] The radial width or diameter of the user interface member 1600 when viewed from the outside (e.g., a top view of the delivery surface 1620) can be equal to or less than one of the following values: 2.5 cm, 2 cm, 1.5 cm. Alternatively or additionally, the radial width or diameter of the user interface member can be equal to or more than one of the following values: 0.5 cm, 0.7 cm. The radial extension is determined relative to the axis of rotation of the user interface member during dose setting, or relative to the major longitudinal or central axis of the user interface member, which can be coincident. The length or axial extension of the user interface member 1600 can be equal to or less than one of the following values: 2.5 cm, 2 cm, 1.5 cm. Alternatively or additionally, the length or axial extension of the user interface member 1600 can be equal to or less than one of the following values: 0.5 cm, 0.7 cm. For example, the radial width of the user interface member can be 18 mm and the length can be 19 mm.

[0128] The electronic system 1000 further includes a communication unit 1400 (e.g., an RF, WiFi, and / or Bluetooth unit (e.g., a Bluetooth Low Energy (BLE) unit)). The communication unit 1400 is provided as a communication interface between the system or drug delivery device and external devices, such as other electronic devices (e.g., a mobile phone, a personal computer, a laptop, etc.). For example, the communication unit transmits dose data to the external device and / or synchronizes with the device. The dose data is used for a dose log or dose history established in the external device. The communication unit is provided for wireless communication. An attempt to establish communication with the external device is included in the operating routine of the electronic system, in particular, after the motion detection unit measures a relative movement indicative of a dose delivery activation, for example. The electronic system 1000 may also include functionality for the communication unit to be separately activated, for example to perform data synchronization with the external device, for example, if an attempt to establish communication with the external device fails or if such device is unavailable. This function is triggered or activated, for example, via the delivery surface, if there is no contact with the setting surface prior to a signal indicating proximity of the delivery surface within a particular predetermined time (e.g., 10 s). Dose data is stored temporarily or permanently within the electronic system, for example, only the most recent dose data associated with the most recent delivery actuation, or dose history data including dose data such as date, time, and / or size for a dose or doses (e.g., all doses) delivered.

[0129] As discussed above, the user proximity detection unit (e.g., sensor controller 1340) is configured to output a signal (e.g., a proximity signal) that is used to switch or trigger the switching of the electronic control unit 1100 or the electronic system to a high power consumption state. The proximity signal is provided to or detected by the electronic control unit 1100, which can then issue a command or signal that affects the operating state of the electronic system. In the high power consumption state, the motion detection unit 1200 and / or the communication unit 1400 can be activated. The proximity signal can be a signal indicating the user's proximity to the setting surface (setting signal). Instead of using the setting surface proximity signal to wake up the motion detection unit and / or the communication unit, this signal can be used to increase the power consumption of monitoring the delivery surface, for example, by increasing the frequency at which the sensor controller 1340 measures or polls the proximity to the delivery surface 1620. The delivery surface proximity signal indicating the user's proximity to the delivery surface (delivery signal) can be used to activate the motion detection unit and / or the communication unit. Additionally or alternatively, the delivery signal may activate the communications unit 1400 only if, for example, the configuration signal precedes the delivery signal within a predetermined time interval, or preferably only if no configuration signal precedes it within a predetermined time interval. This proximity signal is used to initiate a data synchronization event with an external device separate from dose delivery activation. Thus, the motion sensing unit may be activated whether the communications unit is activated or deactivated.

[0130] The electronic system 1000 is configured to be coupled, preferably releasably, to the drug delivery device unit as an additional unit or module. The drug delivery device unit can be non-electronic. Thus, all electronics are provided in the electronic system. The drug delivery device unit can be disposable, i.e., discarded after its reservoir is emptied by use of the drug delivery device including the unit and the system 1000. The electronic system 1000 can be removed from the drug delivery device unit and reused in another drug delivery device unit. The drug delivery device unit is preferably configured as a fully functional unit, i.e., operable to set the dose to be delivered and deliver the set dose. One exemplary unit is shown in FIG. 1. The electronic system can be a pure addition to an otherwise fully functional unit. Alternatively, the drug delivery device can include the electronic system as an integral part, i.e., a part that is discarded with the rest of the device and / or a part necessary for the operation of the device to set and deliver the drug dose. For example, without the electronic system, the drug delivery device unit would have no user-accessible surface for performing dose setting or dose delivery operations.

[0131] For coupling to the drug delivery device unit, the electronic system may include one or more coupling features 1615 (e.g., snap features). Each coupling feature is located at a distal portion of the user interface member 1600 (e.g., inside the member). As described above, the user interface member part may close the proximal end of the user interface member 1600. In this case, the coupling feature 1615 is conveniently provided on a user interface member part that is non-rotatably and / or axially held relative to the user interface member body 1605. The system 1000 is conveniently configured for permanent or removable mechanical coupling to a member of the drug delivery device unit, such as a member of the dose setting and drive mechanism (e.g., to the drive sleeve or dose knob and / or injection button of the unit discussed in conjunction with FIG. 1 ). The system is non-rotatably and axially locked to a member of the drug delivery device unit, for example via the user interface member body 1605. The members to which the system is coupled are conveniently movable relative to the housing 10 during dose setting and dose delivery (e.g., non-rotatably and / or axially during setting, and only axially during delivery). The members to which the system is coupled can be engaged with the piston rod, for example, by a thread. The dose knob and drive sleeve of the unit of FIG. 1 can be integrally formed or act as a single member during dose setting and dose delivery. For example, a clutch selectively locks the drive sleeve non-rotatably relative to the dial sleeve of the dose setting and drive mechanism during dose setting so that the dial sleeve and drive sleeve rotate at the same speed during dose setting, and the dial sleeve rotates relative to the drive sleeve during dose delivery. The dial sleeve can be a number sleeve. The relative rotation of the dial sleeve and drive sleeve during dose delivery is measured by a motion sensing unit. However, it will be readily apparent to those skilled in the art that the disclosed concepts also work with dose setting and drive mechanisms having different functions.

[0132] The electronic system 1000 shown in Fig. 2 includes a coupling detection unit 1700. The coupling detection unit 1700 is configured to detect whether the electronic system is coupled to a drug delivery device unit. The system is configured such that the electronic system switches to a high power consumption state when coupling to the drug delivery device unit is detected. When the coupling detection unit detects coupling to the drug delivery device unit, a detection signal is generated or triggered. The electronic system 1000 is configured to switch to a high power consumption state in response to the detection signal.

[0133] For example, the connection detection unit 1700 may conductively couple the power source 1500 to other components or units of the electronic system, thereby enabling these components or units to function when appropriately activated, e.g., by an electronic control unit. Specifically, if connection to a drug delivery device unit is detected, the power source may provide power to the respective component or unit. If no connection is detected, the power source is disconnected from the respective component or unit of the electronic system. Thus, the connection detection unit may be, or be coupled to, an interrupter that cuts off the power source if connection to a device unit is not detected.

[0134] Alternatively or additionally, the docking detection unit 1700 is configured to switch the user proximity detection unit 1330 to a high power consumption state (e.g., a state in which the proximity or user detection unit is activated). Before being switched to the high power consumption state by the docking detection unit, the proximity or user detection unit cannot operate in the first state. The docking detection unit can trigger activation of a capacitive sensor or associated sensor controller to sense proximity to the setting surface and / or delivery surface, for example, preferably infrequently.

[0135] Thus, the connection detection unit 1700 is coupled to the electronic control unit 1100 and activates or switches the respective units to a high-power consumption state via the electronic control unit, or is directly coupled to the respective units (e.g., the sensor controller 1340) and switches them to a high-power consumption state via the connection detection unit. The connection detection unit 1700 may include a switch 1710, such as a micro (force) switch. The switch is located on the side of the carrier 3000 facing the opening of the user interface member body 1605. The opening is designed to receive a component of the device unit when the device unit and the system are coupled. The switch 1710 is positioned to make mechanical contact with or interact with a component of the drug delivery device unit and / or be triggered by said component. This component may be the same component to which the electronic system 1000 is coupled via the coupling function 1615. When the switch is triggered, the user detection unit or user proximity detection unit can be activated. In this way, power consumption of the unit during storage is avoided or at least significantly reduced.

[0136] For example, as described above with respect to the user proximity detection unit, if the system includes a capacitive sensor, the sensor's operation to determine whether the user is near the relevant surface may require it to perform measurements periodically, e.g., at the frequencies described above. Every measurement consumes power from the power source. Therefore, when the system is not coupled to a drug delivery device unit, such power consumption is completely unnecessary, and the coupled detection unit can switch on the capacitive sensor to operate less frequently, as described above. The coupled detection unit thus improves power management, particularly during storage of the electronic system when separated from the drug delivery device unit.

[0137] It is noted that the docking detection unit 1700 as described above is suitable not only for the user proximity detection unit 1330 but also for other units of the electronic system, such as an electronic control unit, a motion sensing unit, a communication unit, or even other units. For example, the docking detection unit can also work with a setup sensor, a delivery sensor, and / or a wake-up unit, whether these are feasible in a particular situation. When the docking detection unit has not detected that the system has been docked to a device unit, it can consume zero power or less than the power consumption when only the user detection unit of the electronic system is active.

[0138] 3A-3C illustrate one embodiment of the electronic system 1000 and / or electrode system 1345. FIG.

[0139] Figure 3A is a schematic perspective view of an electronic system 1000 of a drug delivery device, such as may be incorporated into the device 1 or coupled as an add-on to the device unit 1 described above with reference to Figure 1. The overall setup has already been described above, so this description will focus on what has not yet been discussed.

[0140] 3A shows a user interface member 1600 with a setting surface 1610 and a delivery surface 1620 formed by a user interface member body 1605, preferably a plastic or electrically insulating body. The setting surface 1610 is expediently structured to facilitate the user's finger skin being as close as possible to the electrode system 1345 of the user proximity detection unit 1330. However, the user interface member body 1605 is preferably closed in the circumferential direction. In particular, the setting surface may be a continuous surface. A radially oriented and angularly extending setting surface may be free of openings. The same applies to the axially oriented and radially extending delivery surface 1620. For this reason, the user interface member body 1605 is preferably closed in the proximal direction as well. This facilitates the provision of a sealed interior within the user interface member 1600 that houses one or more electrical or electronic components, as discussed above. Furthermore, FIG. 3A shows a plane P, which visualizes the plane in which the cross section is taken in the cross-sectional perspective view of FIG. 3B.

[0141] FIG. 3B shows a user interface member body 1605. Also shown is a conductor carrier 3000 with an electronic control unit 1100. The user interface member body 1605 holds a component 1630, which is preferably non-rotatably and / or axially fixed to the body, for example. The component 1630 may be a spacer component 1510 (not shown), discussed below. The spacer component can define the (mounting) space of the electronic components on the conductor carrier 3000 within the user interface member and / or maintain the distance between the electronic components from other components, such as a power source, therein. As an alternative to a spacer component, the component 1630 may be a user interface member component or housing 1670 (not shown in this depiction), which can delimit the interior of the user interface member, for example, in the distal direction. For present purposes, it is sufficient to discuss the component 1630 in general. The component 1630 may have an outer surface that extends circumferentially and is preferably circumferentially closed. The user interface member 1605 has an inner surface opposite the outer surface of the component 1630. The inner surface can have a cylindrical configuration. The electrode system 1345 or at least one sensing area thereof (such as the set sensing area 1310) is disposed between the outer surface of the part 1630 and the inner surface of the user interface member body 1605. The electrode configuration 1360 is provided on the flexible conductor carrier 1350 of the electronic system (details of suitable electrode configurations are discussed in more detail below). The flexible conductor carrier 1350 and the electrode system 1345 can conform to the inner surface of the user interface member body 1605, in particular, the same wall surface (but opposite the set surface) that defines the set surface 1610. The circumferential extension of the flexible conductor carrier 1350 when conformed to the inner surface is conveniently one or more of the following values: 270°, 355°, 360°, 400°. Alternatively or additionally, the circumferential extension is one or less of the following values: 540°, 450°. By having a circumferential extension in a particular range (eg, greater than 270° and less than or equal to 540°), a large percentage of the actuation surface (in this case, setting surface 1610) can be provided with an electrode configuration.Having an extension of greater than 360° can facilitate protecting sensitive areas of the conductor carrier with other areas of the conductor carrier, as one area of ​​the flexible conductor carrier 1350 is radially covered (e.g., radially outward) by another area of ​​the flexible conductor carrier 1350.

[0142] The electrode system 1345 preferably includes a plurality of conductive electrode tracks extending along an electrically insulating conductor carrier 1350. The flexible conductor carrier 1350, together with the electrode configuration of the electrode tracks extending thereon, can form a sensor electrode system (e.g., a flexible printed wiring board). The electrode system 1345 can be entirely flexible. The flexible conductor carrier 1350 includes a contact coupling region 1352. The contact coupling region 1352 is provided with one or more conductive terminals, each of which can be associated with or part of a conductive electrode track of the electrode system. The contact coupling region 1352 can be configured to couple to or can include an FCC connector. Via the contact coupling region 1352, the electrode system 1345 is conductively coupled directly to the sensor controller 1340 disposed on the conductor carrier 3000, or indirectly, such as via conductors on the conductor carrier 3000 or via a connector to the sensor controller 1340. This provides an operative connection of the sensor controller 1340 to a sensor electrode system 1345 including the electrode configuration and flexible conductor carrier 1350. As already mentioned above, the sensor controller and sensor electrode system together form a capacitive sensor. The contact coupling regions 1352 of the flexible conductor carrier associated with the electrode tracks can extend inward from the outer surface of the part 1630, for example, when viewed radially and / or perpendicular to the axis of the user interface member 1600, which can extend perpendicular to the carrier 3000. The electrode system 1345 or flexible conductor carrier 1350 conveniently has a deformed configuration or shape when placed on the user interface member 1600. That is, the shape or configuration changes from an undeformed or first configuration or shape to a deformed or second configuration or shape for placing the system on the user interface member.The flexible conductor carrier 1350 and the electrode system 1345 with the electrode configuration are conveniently elastically deformable such that when the electrode system or flexible conductor carrier is applied to the user interface member 1600, it tends to return to its undeformed configuration or shape due to an inherent elastic restoring force that attempts to re-establish the undeformed configuration or shape. The elasticity can be provided by the electrode configuration, the flexible conductor carrier, or both. The elastic restoring force exerted by the electrode system or flexible conductor carrier 1350 is used to conform the electrode system, or a region thereof, to an interior surface or wall of the user interface member body 1605. In this case, the inner surface of the user interface member body 1605 opposite the setting surface 1610, particularly the radially and / or inwardly facing surface, defines the surface against which the electrode system of the flexible conductor carrier conforms. The undeformed configuration of the flexible conductor carrier can be a flat or planar configuration. That is, in the undeformed configuration, the flexible conductor carrier is oriented along a plane.

[0143] FIG. 3C illustrates the effect or use of elastic restoring forces using two different depictions, A and B. Depiction A shows the sensor electrode system 1345 being introduced into the user interface member body, e.g., through a distal opening. To introduce the sensor electrode system into the user interface member body, the sensor electrode system is deformed from a first configuration, e.g., extending beyond the width of the opening in the user interface member body, to a second configuration, e.g., extending less than the width. The first configuration can be an undeformed configuration. The second configuration can be a deformed configuration and / or an intermediate configuration in the assembly of the electronic system. In the second configuration, the electrode system 1345 conveniently conforms to the outer surface of the component 1630 in at least one or more regions. Thus, the outer diameter of the component 1630 can determine the dimensions (e.g., its diameter) of the electrode system in the second configuration. The contact coupling region 1352 extends inward (e.g., radially inward) relative to and / or from the sensing region 1310. Contact coupling region 1352 is conveniently conductively coupled to sensor controller 1340, as described above, but is not shown in detail here.

[0144] The situation shown in depiction A of FIG. 3C may represent a situation that occurs during assembly of the electronic system. A subassembly including the electrode system and component 1630 is introduced into the user interface member body 1605, for example, so that the subassembly is fully received in the user interface member body 1605. While outside the user interface member body 1605, the deformed electrode system 1345 is preferably maintained in contact with the outer surface of the component 1630 during the introduction process, for example, by a tool or manually. After the subassembly is introduced inside the user interface member body 1605, the electrode system is allowed to relax to its undeformed configuration, for example, by removing the tool, and can engage with the inner wall of the user interface member body 1605 (e.g., the surface opposite the setting surface 1610). The situation shown in depiction B may represent a situation in which the electronic system transitions from an intermediate configuration to a final or third configuration in the assembled electronic system 1000 due to inherent elastic restoring forces. In expression B, it is clear that the outer surface of the electrode system 1345 conforms to the inner surface of the user interface member body 1605, particularly along the extension of the sensing region 1310, for example over at least 340° or more (e.g., at least: 345°, 350°, 355°).

[0145] The electrode system 1345, particularly when located within the user interface member body, has two opposing ends, a first end 1356 and a second end 1358 (e.g., angular ends). In the second or modified configuration, when the electrode system is introduced into the user interface member body 1605 and / or in the intermediate configuration, there is a region 1354 where the electrode system angularly overlaps itself. That is, when proceeding radially (e.g., outward) from the interior of the part 1630 toward the electrode system (e.g., flexible conductor carrier or sensing region 1310), there is an angular position where the inner surface of the electrode system is followed by the outer surface of the electronics system, which in turn is followed by the inner surface of the electronics system, e.g., directly facing the inner surface of the user interface member body 1605. In other words, the length of the electrode system can be greater than the circumference of the part 1630. In the second configuration, the electrode system, or its sensing region, is wound or wrapped around the part 1630 by more than one turn, preferably less than two turns. In the third or final configuration of the electronic system, there is angular clearance 1361 between the two angular ends of the electronic system or sensing region 1310, as shown in depiction B. Alternatively, in the third or final configuration, there is still angular overlap of the electrode system, such that region 1354 is present not only in the intermediate configuration, but also in the final configuration (not shown). Upon transitioning from the deformed configuration to the undeformed configuration until the final configuration is reached that maintains the deformation or bias (because the inner wall of the user interface member body 1605 prevents further movement toward the undeformed configuration), the electronic system, and in particular the sensing region 1310, can expand toward the inner wall of the user interface member body until it hits the inner wall, as suggested by the arrow in depiction A.

[0146] In this embodiment, a flat, flexible electrode system is wrapped around part 1630. The body 1605 is then assembled, constraining the electrode system. The natural stiffness or resilience of the conductor carrier 1350 acts to unwind the electrode system, effectively biasing it outward into the body 1605. In this way, the electrode system can reliably fit a wide range of outer casing section sizes expected in an injection molding process due to, for example, manufacturing tolerances.

[0147] FIG. 4 illustrates one exemplary embodiment of an electrode system 1345 of the electronic system 1000 (e.g., as described above). Accordingly, the following discussion focuses on what has not yet been discussed, and the configurations described above also apply to this embodiment. The electrode system 1345 is shown in its first or undeformed configuration (e.g., a flat configuration). A flexible conductor carrier 1350 is shown with an electrode configuration 1360 extending therealong. Two (opposite) ends 1356 and 1358 of the flexible conductor carrier 1350 or electrode system 1345 are shown, delimiting the electronic system, e.g., along a primary extension or length. The distance between the two opposite ends 1356 and 1358 can define a length L of the electrode system 1345. The length L is conveniently selected so that at least 350° of the circumferential extension of the inner surface of the user interface member body 1605 is covered by the electrode system conforming to or adjacent to the inner surface. As already mentioned, this length can also be greater than the circumferential extension of the inner surface.

[0148] The electrode system 1345, and in particular its electrode configuration 1360, further includes a plurality of conductive electrode tracks. The illustrated embodiment shows two electrode tracks, a first electrode track 1362 and a second electrode track 1364. The electrode tracks may be made of metal (e.g., copper). The electrode tracks 1362 and 1364 extend along the flexible conductor carrier 1350. The electrode system 1345 has a sensing area (in this case, the set sensing area 1310). Both electrode tracks 1362 and 1364 extend within the sensing area 1310. In the illustrated configuration, the width of the sensing area 1310 (i.e., the length or extension perpendicular to the main longitudinal direction of the sensing area 1310) is constant along the main longitudinal direction. In the illustrated embodiment, the sensing area 1310 has a rectangular shape, highlighted in FIG. 4 by a dashed rectangle. In the sensing region 1310, one of the first and second electrode tracks (e.g., second track 1364 or first track 1362) defines or forms a sensing electrode 1366 (in the illustrated embodiment, electrode track 1364 forms the sensing electrode), and in the sensing region, the other of the first and second electrode tracks (in the illustrated embodiment, electrode track 1362) defines or forms a reference electrode 1368. Note that the electrode tracks 1362 or 1364 providing the sensing and reference electrodes may also be reversed.

[0149] In operation, electrodes 1366 and 1368 are configured to have different potentials (e.g., a positive potential on the sensing electrode and a negative potential on the reference electrode, or vice versa) such that an electric field is created by the different potentials between the two electrodes (sensing electrode and reference electrode) (although a potential difference with potentials of the same sign may also suffice). Variations in this electric field and / or variations in capacitance between the electrodes are evaluated by sensor controller 1340, to which the sensing electrode and / or reference electrode are conductively coupled.

[0150] The sensing electrode 1366 includes a plurality of sensing electrode portions 1369. These portions are spaced apart from one another and arranged sequentially along the sensing region 1310 when viewed in the longitudinal or main direction. The portions 1369 are oriented perpendicular to the main extension of the sensing region and / or along the axial extension of the setting surface 1610 of the user interface member body 1605 when the electrode system is disposed in the body. The portions 1369 are oriented parallel to one another. The portions 1369 can have the same configuration. Also, the last portion 1369 near the end 1358 can have a similar width configuration to the other portions and / or cooperate with the portion of the electrode track 1364 near the end 1356 to form a combined sensing electrode portion of the same or similar width as the other continuous electrode portions 1369 after the electrode system 1345 is positioned in the user interface member body 1605. The portions 1369 are conductively connected by a connecting portion 1370 of the electrode track 1364. Portion 1369 protrudes from coupling portion 1370. Thus, in the illustrated embodiment, sensing electrode 1366 can have a comb-like configuration.

[0151] The reference electrode 1368 includes a plurality of reference electrode portions 1371. These portions are sequentially spaced apart from one another along the sensing region 1310 when viewed in the length or main direction. The portions 1371 are oriented perpendicular to the main extension of the sensing region and / or along the axial extension of the setting surface 1610 of the user interface member body 1605 when the electrode system is disposed on the body. The portions 1371 are oriented parallel to one another. The portions 1371 can have the same configuration. The portions 1371 are conductively connected by connecting portions 1372. The portions 1371 protrude from the connecting portions 1372. Thus, in the illustrated embodiment, the reference electrode 1368 can have a comb-like configuration.

[0152] The reference electrode 1368 and the sensing electrode 1366 are arranged so as to be interleaved with one another. In particular, the electrode portions 1369 and 1371 are arranged alternately along the main longitudinal direction of the sensing area 1310. That is, when moving along the main extension of the sensing area, preferably along line C (e.g., the centerline of the sensing area 1310), the sensing electrode portions 1369 and the reference electrode portions 1371 alternate. Specifically, a sensing electrode portion is followed by a reference electrode portion, which is followed by a sensing electrode portion, and so on. The sensing electrodes 1366 and the reference electrodes 1368 are configured so that the distance between the sensing electrode and the reference electrode (measured to the nearest portion of each other electrode) in the sensing area 1310 is conveniently constant or does not vary significantly. However, other configurations are possible, for example, where the distance between the sensing electrode and the reference electrode in the sensing area 1310 varies. The distance between the reference electrode and the sensing electrode in the sensing area should ideally be selected to ensure that a target (e.g., a user's finger) is detected reliably.

[0153] The reference electrode portion and the sensing electrode portion are preferably configured similarly. For example, they can have the same length (distance protruding from their respective connectors) and / or width (dimension perpendicular to extension away from their respective connectors). The ends of the reference electrode portion and the sensing electrode portion can face different directions or be oriented in different directions. Connectors 1370 and 1372 are oriented along one another. The sensing electrode portion is oriented in a proximal or distal direction. The reference electrode portion is oriented in the opposite direction (e.g., distal or proximal). In FIG. 4, the upward direction can be the proximal direction (the direction in which sensing electrode portion 1369 is oriented). The connectors can extend parallel to one another. The reference electrode portion is uniformly distributed along the sensing region. The sensing electrode portion is uniformly distributed along the sensing region.

[0154] In the illustrated embodiment, the contact connection region 1352 of the flexible conductor carrier 1350 is a flexible and / or foldable tab. The tab can be flexible so that it can deflect or fold relative to the sensing region 1310. A notch 1373 (e.g., a cutout) is provided in the flexible conductor carrier between the contact connection region and the sensing region. This facilitates easier bending or folding of the tab relative to the remainder of the conductor carrier 1350. In the illustrated embodiment, the contact connection region 1352 is near the end 1356 of the flexible conductor carrier 1350. Specifically, the contact connection region (e.g., tab) can define a portion of the end of the flexible conductor carrier. However, it should be noted that other configurations of the contact connection region can also be used, such as a configuration in which the contact connection region 1352 is within the sensing region 1310, a configuration remote from both ends, or a different configuration. In the contact connection region 1352, the width of the electrode track is narrower than the electrode portion and / or connection portion in the sensing region. For example, each electrode track 1362 and 1364 is coupled to terminals 1374 and 1375 of the first electrode track 1362 and the second electrode track 1364 via an intermediate portion that is narrower than the portion of the associated electrode in the sensing region (e.g., the electrode portion of the sensing electrode 1366 and the reference electrode 1368). The terminals 1375 and 1374 are configured to be coupled to a plug-in connector, such as an FCC plug-in connector or a slim stack connector. Via the terminals 1375 and 1374, the electrode tracks 1362 and 1364 are conductively coupled to different terminals or channels of the sensor controller 1340.

[0155] To control the sensitivity of the capacitive sensor, it is advantageous for the sensor controller to have a distinct ground plane relative to the sensing electrode 1366. The ground plane is provided by the reference electrode 1368. Having a reference electrode close to the surface to be monitored, as opposed to a reference or ground potential deeper within the system, is advantageous for more uniform sensitivity of the sensor. For example, during operation, an electric field (e.g., an electrostatic or dynamic electric field) is applied to the sensing and reference electrodes. As the electric field changes, the capacitance of the sensor also changes. The more uniform the electric field, the more uniform the sensitivity of the sensor. The illustrated configuration has been found to be particularly suitable for uniform sensitivity. For cylindrical configurations (such as the user interface member body 1605), it has been found that particularly good or uniform sensitivity is achieved with alternating electrode tracks 1362 and 1364, as shown in FIG. 4, with alternating reference and sensing electrodes. The exact dimensions and amount of tracks or electrode portions in the sensing area may vary, for example, for applications involving the detection of smaller hands. The sensitivity of the sensor with the illustrated electrode system is conveniently uniform in the circumferential direction when monitoring proximity to a set surface. The design shown in Figure 4 is particularly suited to achieving uniform sensitivity for a user interface member body having a surface structure on its exterior surface.

[0156] Preferably, the number of reference electrode portions is equal to the number of sensing electrode portions. The number of reference and / or sensing electrode portions can be even or odd (e.g., three, four, five, six, seven, or eight). Having an odd number of reference and sensing electrode portions facilitates placing one reference electrode portion opposite (e.g., angularly offset by 180°) one sensing electrode portion in a typical cylindrical configuration (e.g., when the electrode system 1345 is disposed on the user interface member body 1605). This configuration is also facilitated by uniformly distributing the sensing electrode portions along the flexible conductor carrier 1350 and uniformly distributing the reference electrode portions along the flexible conductor carrier. When a user attempts to set a dose, it is expected that the user will contact the setting surface 1610 of the user interface member at diametrically opposed locations if they use the most natural finger combination for dose setting (i.e., index finger and thumb). The electric field or capacitance variation is expected to be particularly pronounced when electrode portions (sensing and reference electrode portions) at different potentials are offset by 180°, which is easily achieved by having an odd number of sensing and reference electrode portions. Figure 5 shows this as an example, using three reference electrode portions 1369, each diametrically opposed to one sensing electrode portion 1371.

[0157] FIG. 6 illustrates another embodiment of an electrode system 1345 that is similar to the electrode system 1345 discussed in conjunction with FIG. 4 . Accordingly, the following description will focus on the differences. One difference is that the electrode system 1345 includes two distinct sensing regions. Specifically, the electrode system includes a set sensing region 1310 as well as a delivery sensing region 1320, highlighted by a dashed rectangle in FIG. 6 . A sensing electrode 1376 is disposed in the delivery sensing region 1320. The sensing electrode 1376 may be a delivery sensing electrode. In the sensing region 1320, a reference electrode 1368 is associated with the sensing electrode 1376 but is electrically separated or insulated from the sensing electrode 1376, particularly along the flexible conductor carrier 1350. The reference electrode 1368 and the sensing electrode 1376 are conveniently positioned in the sensing region 1320 such that the reference electrode 1368 extends along at least a majority of the sensing electrode 1376 (e.g., at least 280° of the circumference). In the illustrated embodiment, the sensing electrode 1376 has a circular perimeter or outline. Other shapes are possible as well. Also, the sensing electrode 1376 or sensing region has a ring-like configuration instead of a continuous configuration without an opening. The flexible conductor carrier 1350 can have a hole (not explicitly shown), for example, in the middle of the sensing electrode 1376, particularly when the sensing electrode 1376 has a ring-like configuration. The sensing region 1320 can have a curved perimeter and / or a large circular perimeter, as shown.

[0158] The sensing electrode 1376 is formed or defined by an electrode track 1378 of the electrode configuration 1360 that extends in the sensing region 1320. The electrode track 1378 is conveniently present in the electrode configuration 1360 in addition to the electrode track 1362 and the electrode track 1364. The electrode tracks of the configuration are conveniently electrically insulated from one another along the entire flexible conductor carrier 1350. The sensing electrode 1366 and the reference electrode 1368 of the sensing electrode 1376 are formed by the same electrode track in different sensing regions. Thus, the electrode track 1364 of the reference electrode 1368 can extend in different sensing regions. The electrode tracks of the sensing electrodes 1366 and 1376 conveniently extend in only one sensing region (i.e., the set sensing region 1310 or the delivery sensing region 1320). Alternatively or additionally, the electrode track 1362 of the reference electrode 1368 is preferably disposed contiguously (as shown in FIG. 6 ) between the electrode track 1378 of the sensing electrode 1376 and the electrode track 1364 of the sensing electrode 1366. A terminal 1379 for contact coupling to the electrode track 1378 is formed in the configured sensing region 1352. Via the terminal 1379, the electrode track 1378 or the sensing electrode 1376 is conductively coupled to the sensor controller 1340 (e.g., to a separate channel or input thereof, in particular to a separate channel or input from one for the sensing electrode 1366 and / or the reference electrode 1368).

[0159] The sensing region 1320 is connected to the remainder of the conductor carrier 1350 by a connecting region 1380 of the flexible conductor carrier 1350. The connecting region may extend from the remainder of the flexible conductor carrier 1350 toward the sensing region and mechanically connect the sensing region 1320 to the remainder of the flexible conductor carrier 1350. The connecting region 1380 may have a width that is less than its length (where the length is the extension from the remainder of the conductor carrier 1350 to the sensing region 1320). The width of the connecting region may be less than the width of the sensing region 1320. The connecting region 1380, together with the sensing region 1320, may form a foldable tab of the electrode system 1345.

[0160] Having a separate electrode track 1378 for the sensing electrode 1376 (delivery sensing electrode) in addition to the reference electrode 1368 and / or sensing electrode 1366 (setting sensing electrode) provides improved delivery surface proximity detection by the reference electrode and / or enables differentiation of proximity to the delivery surface 1620 and setting surface 1610 of the user interface member by two electrically separated electrode tracks assigned to these surfaces.

[0161] At the coupling region 1380, the flexible conductor carrier 1350 is particularly easily deformed, preferably elastically, so that the sensing regions 1310 and 1320 are oriented in different directions (e.g., mutually perpendicular). The delivery sensing region 1320 can conform to an inner surface of the user interface member body 1605 opposite the delivery surface 1620 or facing away from the delivery surface 1620. The setting sensing region 1310 can conform to an inner surface of the user interface member body 1605 opposite the setting surface 1610 or facing away from the setting surface 1610. The coupling region 1380 can be elastically deformable so that the sensing region 1320 can be urged toward the inner surface of the user interface member body 1605 opposite the delivery surface 1620 when the electrode system is applied to the user interface member. Alternatively or additionally, the electrode system is provided with a biasing member that biases the sensing region 1320 of the flexible conductor carrier 1350 toward (eg, proximally) the delivery surface 1620 .

[0162] FIG. 7 shows a schematic representation of a biasing member 1381 (e.g., a spring such as a compression spring). The biasing member 1381 is provided to bias the sensing region 1320 toward the inner or internal surface of the user interface member body 1605 and the delivery surface 1620. The biasing member 1381 is formed of a metal part (e.g., a metal stamping). The biasing member 1381 does not have to be a spiral compression spring 1381 as shown schematically. Other elastic structures are suitable for this purpose, as will become clear from the following discussion (see the arm-like biasing portion 1540 of the biasing member 1520, which can simultaneously act as a power electrode or electrode / biasing member 1390). The biasing member may be grounded, or its force may be reacted by a part or component of the electronic system 1000 held axially, preferably non-rotatably, relative to the user interface member body 1605, or by the body itself. The part reacting to the force may be part 1630, as already described above.

[0163] It is advantageous if the electrode system 1345 is adjusted to the user interface member body such that when the electrode system is placed in the electronic system, the coupling region 1380 fits onto the inner surface of the transition region 1618 between the delivery surface and the setting surface. The transition region 1618 is curved externally to couple the radially oriented delivery surface with the axially oriented setting surface. A user has less chance of acting on the transition region than on the delivery and setting surfaces to operate the user interface member 1600. Therefore, a dedicated sensing region is not necessarily required in the transition region of the user interface member body 1605.

[0164] It is also within the scope of this disclosure to have an electrode system 1345 with only one sensing region, each sensing region of the electrode system being a delivery sensing region, or an electrode system 1345 with only a delivery sensing region associated with the delivery surface.

[0165] Providing a wrapped electrode system (e.g., a flexible printed wiring board) as described in conjunction with FIGS. 3A-4 provides sensitivity to contact with the setting surface (e.g., a cylindrical "grip" surface). The addition of a foldable tab in the delivery sensing region can extend this sensitivity to the delivery or top surface as well. Additional electrode tracks differentiate between the two contact sites (setting and delivery surfaces). Crosstalk between the two channels or tracks is minimized in several ways. First, the proximity between the two electrode tracks for the sensing region is minimized as much as possible. Second, there is always a ground or reference electrode track 1362 between the two sensing electrodes, common to both channels. Finally, the electrode system or sensing region 1310 can extend or wrap more than 360° along the interior surface of the user interface member body and / or the exterior surface of the part 1630, for example, to cover any areas where the delivery sensing electrodes and / or contact coupling region 1352 are vulnerable.

[0166] The electrode system 1345 is not limited to having one or more sensing electrodes and / or associated reference electrodes. Rather, other electrodes (e.g., electrodes for antennas or other structures with conductive features or tracks) are mounted on the flexible conductor carrier 1350. Thus, the electrode system can include an electrode track for an antenna (e.g., a communication unit 1400 (e.g., a Bluetooth communication unit, preferably a BLE: Bluetooth Low Energy communication unit)).

[0167] 8A-8C schematically illustrate another embodiment of an electrode system 1345 of electronic system 1000. In general, system 1345 is similar to the systems described above with respect to Figures 4 and 6. Therefore, this description will focus on the differences.

[0168] As with the previously described embodiments of FIGS. 4 and 6, the electrode system 1345 is shown in a first or flat configuration, i.e., not yet introduced or deformed into the user interface member body 1605. In this embodiment, the electrode configuration 1360 is not explicitly shown. Generally, it is assumed that electrode tracks are provided similarly to the embodiment of FIG. 6. Thus, three electrode tracks are provided: one track for the sensing electrode 1366, one track for the sensing electrode 1376, and one track for the reference electrode 1368. The specific track configuration is not shown, as already described above. In each sensing region 1310 or 1320, an associated sensing electrode 1366 or 1376 is disposed, preferably along with an associated reference electrode 1368 (again, formed by a track or electrode common to the sensing regions 1310 and 1320).

[0169] In the illustrated embodiment, the sensing regions 1320 and / or 1310 are distributed across multiple distinct sensing regions of the flexible conductor carrier 1350. As shown in FIG. 8A , multiple distinct regions (e.g., three regions) are provided for the delivered sensing region 1320. In other words, the conductor carrier 1350 has multiple delivered sensing regions 1320. Each of these delivered sensing regions is connected to other portions of the conductor carrier 1350 via an associated connecting region 1380, preferably with a separate connecting region 1380 associated with each sensing region 1320. The connecting regions 1380 are oriented diagonally or perpendicularly to the primary elongation direction of the flexible conductor carrier 1350, particularly in the first configuration. For convenience, the different delivered sensing regions 1320 are similarly configured. Electrode tracks 1378 and 1362 can define electrodes in the delivered sensing regions.

[0170] Alternatively or in addition to the multiple delivery sensing regions 1320, multiple (e.g., four) separate regions for the set sensing regions 1310 are provided along the main extension direction of the flexible conductor carrier 1350. In other words, the flexible conductor carrier has multiple set sensing regions 1310. Each connecting region 1380 emerges from one associated set sensing region 1310. The set sensing regions 1310 are arranged consecutively, for example, linearly, along the main extension direction or length direction of the flexible conductor carrier 1350 or electrode system 1345. The set sensing regions 1310 are preferably of equal length, i.e., can have equal extension along the main extension direction. Furthermore, the widths of at least multiple regions 1310 can also be equal. A region (e.g., the region where the contact linking region 1352 appears) can have a different width, which facilitates contact linking to the sensor controller at a location that is offset (distally) from the delivery sensing region 1320 or delivery surface 1620 but radially overlaps. Each linking region 1380 can emerge from the sensing region 1310 at a different location in the different sensing regions 1310. For example, the right-most sensing region 1320 where a linking region 1380 appears, i.e., the sensing region 1320 closest to the contact linking region 1352, has the linking region 1380 at the beginning of the sensing region 1310 (as viewed from the contact linking region 1352), the linking region 1380 of the subsequent sensing region 1310 is located in the middle of the sensing region 1310, and the linking region 1380 of the last sensing region, i.e., the linking region 1380 farthest from the contact linking region 1352, is located at the end of the sensing region 1310 (as viewed lengthwise away from the contact linking region). Different connecting regions 1380 are conveniently connected to different set sensing regions 1310. Each connecting region 1380 is preferably foldable, for example, to allow for repositioning of each delivery sensing region 1320 relative to the set sensing region. Each connecting region 1380 can exhibit resilience or elastic deformation, for example, when folded. Each connecting region 1380 can be strip-shaped.

[0171] The set sensing regions 1310 are interconnected by connecting regions 1382. The connecting regions 1382 are oriented along the main extension direction of the flexible conductor carrier 1350. Two adjacent set sensing regions are connected by one connecting region 1382. The connecting regions 1382 can facilitate the conformance of the electrode system, preferably the sensing regions, to a circumferentially extending (e.g., cylindrical) surface, since they reduce the stiffness of the electrode system against bending. However, the connecting regions 1382 can be omitted, for example, if a large elastic restoring force is required to bias the sensing region toward the set surface. The connecting regions 1382 are expediently narrower than the sensing regions 1310. The width, i.e., the extension perpendicular to the main longitudinal direction, of the flexible conductor carrier 1350 can be narrower in the connecting regions 1382 than in the sensing regions 1310 connected by the connecting regions 1382. All electrode tracks (e.g., three electrode tracks) of the electrode configuration 1360 can extend along each of the connecting regions 1382. Each of the connecting regions 1382 is strip-shaped.

[0172] Cuts or slits between two adjacent sensing regions 1310 (e.g., on either side of a connecting region 1382 connecting the sensing regions) can be advantageous, for example, for conformance to curved surfaces and / or for manufacturing purposes, as discussed in more detail below. Specifically, they can serve, for example, to non-rotatably lock the electrode configuration against the outer surface of the part 1630 and / or to receive sections of a subassembly during manufacturing.

[0173] Each delivery sensing region 1320 has an end 1383 remote from, for example, a connecting region 1380 that connects the delivery sensing region to the remainder of the conductor carrier 1350. The ends 1383 are aligned with one another in a first or undeformed configuration. When viewed from the connecting region 1380 toward the end 1383, the sensing region 1320 can vary in width toward the end. Initially, the width increases; that is, the sensing region 1320 can widen, for example, until it reaches a maximum width. Thereafter, the sensing region 1320 can narrow toward the end 1383. The outer contour of the sensing region 1320 can have a curved portion, for example, in a region proximate the connecting region 1380. The curved portion can be followed by a straight portion. The straight portion can connect the curved portion to the end 1383. The end 1383 can be pointed.

[0174] The sensing electrodes of sensing area 1310 are conveniently formed by respective continuous electrode tracks (not shown). The same applies to the sensing electrodes of sensing area 1320, which are conveniently electrically isolated from the electrode tracks of sensing area 1310. The reference electrodes in each sensing area may belong to a common electrode track, as already described in conjunction with FIG. 6. This track is conveniently electrically isolated from the other tracks. All tracks are conveniently accessible at contact coupling area 1352 for coupling to sensor controller 1340, for example via terminals (not shown).

[0175] The electrode system 1345 is provided with mechanical portions 1359 for securing or aligning the electrode system 1345, for example, to the user interface member body or a part of the user interface member. An exemplary portion 1359 is shown at the bottom left of the end 1358 of the electrode arrangement 1360. Alternatively or additionally, the arrangement 1359 may define the flexible conductor carrier 1350 or the end 1358 of the electrode system 1345.

[0176] When the electrode system is disposed in the user interface member body 1605, the configured sensing regions 1310 are disposed circumferentially along the inner surface of the user interface member body, as previously discussed. The ends 1383 of the delivery sensing regions 1320 are oriented or pointed toward each other and / or radially inward. This is shown in FIG. 8B, which schematically illustrates the electrode system as deformed for insertion or already inserted into the user interface member body, but does not show the body. The contact coupling region 1352 is also shown, which is folded and / or bent radially inward and, in this configuration, couples to a sensor controller 1340 (not shown) that will be located inside the user interface member when the electronic system is assembled or manufactured.

[0177] Having multiple delivery sensing regions 1320 facilitates the distribution of electrode surfaces responsible for monitoring the delivery surface on different regions of the flexible conductor carrier and / or the use of multiple linking regions 1380. This facilitates the use of elastic forces provided by the flexible conductor carrier and / or linking regions 1380 to bias the sensing regions 1320 toward the delivery surface 1620. Thus, when folded into the configuration shown in FIG. 8B , the sensing regions provide a single, continuous sensitive area for the user proximity detection unit 1330. Each tab or sensing region 1320 can feature the same electrode track configuration and, when folded, acts as a single touch-sensitive area. This allows for better utilization of the rigidity of the carrier 1350, for example, during manufacturing, particularly when compared to the embodiment of FIG. 6 , and multiple flexions (at the linking regions) result in larger and / or more uniformly spread forces (e.g., elastic restoring forces acting on the user interface member body 1605).

[0178] 8C, a cross-sectional view along plane AA of FIG. 8B, illustrates the biasing force tending to maintain region 1320 in contact with the interior wall of the user interface member body opposite delivery surface 1620. As can be seen, in the deflected configuration in which set sensing region 1310 is oriented along the cylindrical surrounding surface, delivery sensing region 1320 pivots or moves relative to set sensing region 1310 due to the flexibility and / or resilience provided by linking region 1380. Linking region 1380 may form a pivot axis across its width. When user interface member body 1605 maintains the linking region and / or sensing region in the deflected configuration, the associated resilient restoring force biases the sensing region toward the delivery surface.

[0179] 9A-9C illustrate another embodiment of the electronic system 1000. FIG. 9A shows a perspective view of a user interface member 1600 including a setting surface 1610 and a delivery surface 1620. The setting surface is provided with a surface structure 1617. To this end, the setting surface 1610 is profiled. The structural elements 1616 or recesses of the surface structure are oriented generally axially, i.e., from the proximal end to the distal end. A plurality of consecutive structural elements 1616 or recesses are sequentially arranged along an angular or circumferential direction. The angular surface of the structural elements 1616 can have a wavy, knurled, or undulating shape. The bottom surface of each recess can also have a wavy, knurled, or undulating shape.

[0180] The delivery surface 1620 has a surface structure 1617. This structure is preferably different from the structure of the setting surface. For example, the structural elements 1616 (e.g., recesses) can have different dimensions, such as different lengths and / or different widths. In contrast, the structural elements 1616 of the structure of the setting surface 1610 can have equal lengths, widths, and / or equal configurations.

[0181] The surface structures 1617 on the external actuation surface have the advantage that a compliant object, such as a finger, has a larger surface contact area than a non-compliant object, such as a rigid, planar object (e.g., a coin or metal table). The surface structuring also allows the compliant object to get closer to the electrode configuration 1360 than a non-compliant object. This is illustrated by FIG. 9B, which contrasts a finger or thumb that clearly has a larger contact area with the setting surface 1610 and / or is closer to the electrode configuration 1360 than the planar object 4000. FIG. 9C illustrates the effect of the structures 1617 on the contact area with a compliant object for a structured delivery surface.

[0182] This embodiment features an electrode system 1345 as described in the previous embodiment. Additionally, small recesses are formed in the external actuation surface to allow a compliant object (e.g., a finger) to approach the sensing electrodes more closely than a rigid object (e.g., a metal table). This entails a greater change in electric field or capacitance with a compliant object than with a rigid, non-compliant object. On the cylindrical or setting surface, the recesses can be provided as ridges, for example, in any pattern (e.g., knurled), to help the user achieve grip or grasp of the surface. On the top or delivery surface, the recessed areas can simultaneously act as embossed designs or branding irons.

[0183] 10A-10D illustrate, in some aspects, more specific embodiments of electronic system 1000 and methods of assembling or manufacturing the electronic system than those discussed in conjunction with the preceding figures, although all features disclosed in conjunction with the preceding figures also apply to system 1000, and vice versa.

[0184] FIG. 10A is a schematic cross-sectional view of electronic system 1000. Again, the system includes a user interface member 1600 having a user interface member body 1605 defining a setting surface 1610 and a delivery surface 1620. A conductor carrier 3000 is provided within the user interface member body 1605 and carries one or more electronic units as described above (e.g., sensor controller 1340, motion sensing unit 1200, coupling detection unit 1700, and / or electronic control unit 1100). Conductor carrier 3000 is held axially and non-rotatably in the user interface member, for example, relative to housing 1670, described below. Not all of the above units are explicitly shown in the cross-sectional view of FIG. 10A, although they may be present.

[0185] The power source 1500 and its contact coupling arrangement for the electrical power components are shown in more detail than in the schematic representations of FIGS. 2 and 3. The power source 1500 is disposed between the carrier 3000 and the proximal or delivery surface 1620 of the user interface member 1600. A spacer component 1510 is disposed between the carrier 3000 and the power source. The power source 1500 is thus supported on the carrier 3000 via the spacer component 1510. The spacer component 1510 may have a curved inner surface so as to extend circumferentially along the (electronic) components mounted on the carrier 3000. The spacer component 1510 conveniently defines a hollow space between the power source and the surface of the carrier 3000 facing the spacer component. In this hollow space, electronic units or components on the carrier 3000 may be positioned without risk of direct contact with the power source 1500. The spacer component also helps to prevent excessive mechanical loads (eg, loads exerted by a user on the delivery surface during a dose delivery actuation) from being transferred directly to the electronic units or components on the carrier 3000 .

[0186] FIG. 10A further illustrates a power supply electrode 1520. The electrode 1520 is conductively coupled to the power supply 1500 and one or more electrical or electronic components, particularly via a conductor carrier 3000. The electrode 1520 has a contact portion 1530 that conductively couples the electrode to the conductor carrier 3000 (see FIG. 10B). The electrode 1520 extends from a side of the carrier 3000 facing the power supply 1500 to a side of the carrier 3000 facing away from the power supply 1500. The contact portion 1530 is located on the latter side. However, different configurations of the contact coupling between the power supply and the electronic component are also contemplated. The electrode 1520 has one or more (three in the illustrated embodiment) biasing portions 1540. The biasing portions 1540 are resiliently deflectable. Each biasing portion 1540 can be, for example, a flexible arm with a free end. Each biasing portion 1540 can extend in a proximal direction oblique to the major axis of the user interface member. Each biasing portion is provided so that applying a force to the power source 1500 biases the power source toward the carrier 3000 and / or spacer (e.g., distally). Alternatively or additionally, the biasing portion is provided to bias one or more sensing regions of the electrode system 1345 (see FIG. 10B (in FIG. 10A , the sensing regions 1310 and 1320 are only shown very diagrammatically)) toward an external actuation surface of the user interface member body 1605 to be monitored by the user proximity detection unit. The biasing portion 1540 can bias the power source 1500 toward the carrier 3000 and the sensing region 1320 toward the delivery surface 1620. The biasing portions 1540 are connected by the ring portion 1560 and extend axially away from and inward relative to the ring portion 1560 (see FIG. 10B ). The ring portion 1560 is conductively coupled to the power source 1500 (e.g., at one terminal thereof). The electrode 1520 has a retaining portion 1550. The retaining portion 1550 is designed to retain the power source 1500 to the spacer component 1510, thereby forming a subassembly or unit that may be manipulated, for example, during assembly of an electronic system.In the illustrated embodiment, this is achieved by securing a spacer component and power source between regions of the electrodes 1520 (not explicitly shown).

[0187] In addition to the user interface member body 1605, the system 1000 also includes a user interface member part or housing 1670. References herein to a housing shall be understood to refer to a user interface member part, and vice versa. The housing 1670 is preferably non-rotatably and axially locked (e.g., snap-fit ​​or welded) to the user interface member body 1605 (in this embodiment, a snap-fit ​​is shown, e.g., with a snap feature 1681 near the distal end of the user interface member). The housing, together with the user interface member body, may define the interior of the user interface member 1600. The interior is preferably sealed (e.g., dust-tight and / or fluid-tight). To this end, one or more seals (e.g., O-rings) are provided between the user interface member body and the housing (not explicitly shown). The housing 1670 closes the distal opening of the user interface member body 1605. The housing preferably includes a rigid portion 1672 and / or a deformable portion (e.g., an elastically deformable portion) 1674. The housing 1670 can be a part formed in a 2K molding process. The coupling features 1615 that couple the system to the drug delivery device unit can be provided on the housing (e.g., on its outer surface (not explicitly shown)) and face radially inward.

[0188] The housing 1670 defines a receiving space 1675 for the user interface member 1600, the space being open in the distal direction. The receiving space 1675 is provided to receive a member of the drug delivery device unit to which the system 1000 is to be coupled. A deformable portion 1674 of the housing, which can restrict the receiving space in the proximal direction, is preferably designed to interact with the member of the drug delivery device unit, and when the unit is coupled to the system, the deformable portion 1674 is preferably elastically deformed by the member compared to a situation when the system is not coupled to the device unit. The movement of the deformable portion 1674 during deformation (in the proximal direction) is used to trigger a switch 1710 of the coupling detection unit 1700. This allows the coupling of the electronic system to the device unit to be electronically detected and the system to be switched to a high-power consumption state, for example by activating the user proximity detection unit 1330. When the system is disconnected from the device unit, portion 1674 resiliently resumes its undeformed shape, allowing the coupling detection unit 1700 to detect the disconnection from the device unit, e.g., by switch 1710 changing its state. Because portion 1674 is part of the housing 1670, no direct contact is required between components of the drug delivery device unit and switch 1710 or coupling detection unit 1700, facilitating sealing of the interior of the user interface member 1600, e.g., for the electronics and electrode system. The housing 1670 also preferably includes one or more light guides 1676. The light guides are operatively coupled to radiation emitters and radiation sensors provided in the motion detection unit 1200 when radiation is used for motion detection. As a result, movement of a component (e.g., an encoder component) moving from the interior of the user interface member 1600 relative to an end face of the light guide 1676 remote from the end face causes fluctuations in the radiation (intensity) reflected back to the radiation sensors. This reflected radiation is preferably guided through a light guide to a radiation sensor and / or the radiation is generated by a radiation emitter.In this way, movement of a member (e.g., dial sleeve or number sleeve) relative to the user interface member 1600 or dose knob or button is quantified, such as during a dose delivery actuation. The light guide and / or corresponding sensor can be out of phase with respect to the reflective portion of the encoder component (see WO2019 / 101962A1), which has several advantages.

[0189] FIG. 10B illustrates the housing 1670 and electrode system 1345. The electrode system 1345 is similar to that described above in conjunction with FIG. 8A. However, it should be noted that any other electrode system may be used as well, particularly as described herein. The electrode system 1345 includes multiple sequentially arranged sensing regions 1310 connected by connectors 1382. Not all of these portions or regions are highlighted in FIG. 10B. The electronic system 1000 also includes a delivery sensing region 1320. In contrast to the embodiment of FIG. 8A, only one delivery sensing region 1320 is provided, similar to the embodiment shown in FIG. 6. In this embodiment, the electrode configuration 1360 is not shown in detail but is incorporated into the design of the electrode system 1345. The electrode tracks are intended to provide functionality or proximity sensing relative to an external actuation surface. For example, when viewed along the width direction, the slits 1384 on the face of the flexible conductor carrier 1350 positioned remotely from the delivery sensing region 1320 or the face of the flexible conductor carrier 1350 positioned remotely from the delivery sensing region 1320 are configured to align with or receive the ridges 1678 on the outer surface of the housing 1670, particularly when the flexible conductor carrier 1350 is wrapped around the outer surface of the housing 1670. The ridges 1678 are oriented axially, for example along the proximal direction. The ridges 1678, in cooperation with the slits 1384, can maintain the relative angular position between the housing 1670 and the electrode system 1345 after the flexible conductor carrier 1350 or electrode system is wrapped around the outer surface of the housing 1670. For example, at the distal end, a flange 1680 is provided that protrudes radially outward around the periphery of the user interface member component or housing 1670. The flange 1680 can provide a seat for the distal end of the user interface member and / or the user interface member body 1605. Offset proximally from the flange, i.e., towards the delivery face 1620, one or more snap features 1681 are provided.

[0190] The surface of the housing 1670 facing the proximal end or delivery face 1620 includes a recess 1682 that may, for example, accommodate a switch 1710. The bottom or distal surface of the recess is defined by a deformable portion 1674. The side walls are defined by a rigid portion 1672 of the housing.

[0191] For assembly or manufacturing of the electronic system 1000, the electrode system 1345 is provided with a carrier 3000 on which an electronic unit or component is mounted. The sensor controller (not shown) is mounted on a surface of the carrier facing the housing 1670 or a surface of the carrier facing the delivery face 1620 (i.e., proximally). The contact coupling region 1352 is conductively coupled to the sensor controller 1340, for example, directly or via a conductor on the conductor carrier 3000. Preferably, after establishing the coupling, the contact coupling region 1352 is positioned relative to the housing 1670 so that the contact coupling region 1352 is offset inward relative to the outer surface of the housing 1670. Alternatively, the contact coupling region 1352 is first positioned as shown in FIG. 10B , and then the contact coupling with the sensor controller 1340 is established. An FCC plug is used for the contact coupling. As an alternative to an FCC plug, a connector for vertical coupling, such as a slim stack connector, is used. The housing 1670 conveniently includes slots, eg, radially and / or inwardly oriented, to receive the contact coupling regions 1352 .

[0192] 10B, it may be advantageous, for example from a manufacturing standpoint, to provide a subassembly including multiple components or units, preferably a carrier 3000 (e.g., with sensor controller 1340, electronic control unit 1100, communication unit 1400, and / or motion sensing unit 1200), a spacer component 1510, a power source 1500, and / or a power electrode 1510. Carrier 3000 may be conveniently positioned to confine the subassembly on a surface facing and / or towards the housing side.

[0193] Contact coupling to the sensor controller 1340 is conveniently performed when the sensor controller is already part of the subassembly. The subassembly is configured to be placed on the housing, for example, on its proximal surface. The subassembly is held in the housing, for example, axially and / or non-rotatably. The subassembly and housing 1670 are configured so that the subassembly cannot be placed on the housing in any relatively rotatable orientation. Rather, in the illustrated embodiment, the subassembly is placed on the housing in only one predetermined relatively rotatable orientation. The subassembly (in the illustrated embodiment, the spacer component 1510, although other implementations are possible) includes one or more anti-rotation locking or orientation features 1515. The features 1515 are conveniently configured to cooperate with corresponding features 1684 on the housing 1670 when a desired rotatable orientation is provided to allow placement of the subassembly on the housing, for example, by contact with a surface on the housing. If the subassembly and housing are not in the predetermined orientation, configuration 1515 can cooperate with the housing (e.g., its surface) to prevent the subassembly from being placed or carried on the housing with the bearing surface (e.g., the surface of carrier 3000) in contact with the housing.

[0194] The corresponding feature 1684 can include a recess in the housing configured to receive the feature 1515 when the housing and subassembly are in a predetermined rotational orientation relative to one another. The corresponding feature 1684 is defined by a wall of the housing 1670 that defines a recess (e.g., recess 1682). The recess 1682 extends inward from the outer surface of the housing 1670 and can provide space for the corresponding feature as well as the switch 1710. A bottom of the recess in the corresponding feature 1684 or a distal surface defining the recess can be formed in part or in whole by the deformable portion 1674. Alternatively or in addition to the orientation feature, the feature 1515 can non-rotatably lock the subassembly relative to the housing 1670 when the subassembly is mounted in the housing. When the housing and subassembly are in the correct rotational orientation, the motion sensing unit 1200 is operatively coupled to the light guide 1676. For example, the switch 1710 can be triggered by facing the motion sensing unit against the light guide portion 1676 and / or by deformation of the deformable portion 1674. The subassembly is axially locked to the housing 1670, for example by a snap fit (not explicitly shown), or is fixed in place by the user interface member body 1605 and the housing 1670 when they are axially locked. The subassembly is conveniently placed on the housing in the correct orientation after the contact coupling regions of the electrode system are conductively coupled with the sensor controller 1340 or carrier 3000. The contact coupling regions 1352 are located between the subassembly or carrier 3000 and the housing 1670.

[0195] During assembly of the electronic system 1000, preferably after the electrical contacts of the electrode system 1345 and the sensor controller 1340 have been established and / or the subassembly has been placed on the housing in the correct orientation, the configured sensing region 1310 is folded relative to the contact coupling region 1352, e.g., so that the configured sensing region is axially oriented. The configured sensing region is folded downward or distally, e.g., diagonally or perpendicularly relative to the contact coupling region 1352. The flexible conductor carrier 1350 is wrapped around the exterior surface of the housing so that the sensing region is oriented radially and / or circumferentially surrounds the housing. The sensing region 1310 is then positioned along the exterior surface of the housing 1670 (e.g., a surface in a cylindrical configuration). This process can continue by positioning the sensing region 1320 so that the sensing region 1320 is radially oriented and / or extends along the proximal surface of the contact coupling region 1352, the carrier 3000, the power source 1500, and / or the housing 1670. This is achieved by appropriately folding the connecting region 1380 and / or the sensing region 1320. When the sensing region 1320 is moved to the desired position, e.g., proximally and / or facing the delivery surface 1620, the sensing region faces distally, e.g., and is supported by a biasing member 1540 preferably formed by the power electrode 1520. This configuration is shown in Figure 10C.

[0196] 10C , sensing regions 1310 and 1320 are appropriately positioned to detect proximity to setting surface 1610 or delivery surface 1620 of user interface member 1600. One or more portions of the power electrodes may extend into or be angularly aligned with notches or slits in flexible conductor carrier 1350. The slits or notches are formed in the region of coupling region 1382. Correct alignment of the components is visually inspected at the stage shown in FIG. 10C . The process continues by introducing the unit including flexible conductor carrier 1350, subassembly, and housing 1670 into the user interface member body, and securing housing 1670 to user interface member body 1605, for example by the snap fit described.

[0197] Prior to introduction into the user interface member body, for example, a mounting fixture (not shown) responds to a resilient force that tends to re-establish the first or flat configuration of the electrode system 1345. Once the force response ceases, for example, upon removal of the mounting fixture, the resilient restoring force can press the electrode system, and in particular the sensing region 1310, against the interior wall of the user interface member body 1605. This can improve the operational coupling between the electrode system and the external actuation surface. If the electrode system is not resilient or is insufficiently resilient, this force can be provided by a (separate) biasing member that biases the sensing region 1310 toward the setting surface 1610.

[0198] FIG. 10D illustrates a structure including the housing 1670, electrode system 1345 (electrode tracks not shown), and carrier 3000, with the contact coupling region 1352 conductively coupled to the sensor controller 1340, either directly or via conductors on the carrier 3000. Also shown are the spacer component 1510, power source 1500, and power electrode 1540. In contrast to the depiction in FIG. 10C, the delivery sensing region 1320 is a continuous region, not formed by a continuously arranged area. However, it should be understood that the illustrated configuration may also be employed in any other embodiment discussed herein. In the electrode system 1345, the contact coupling region 1352 and the coupling region 1380 are adjacent to each other, for example, by an angular distance less than one of the following values: 90°, 45°, 30°, 25°, 20°, or 15°. In this embodiment, the opposing ends 1356 and 1358 face each other, leaving a small gap between them through which the housing 1670 is visible. It is understood that the flexible conductor carrier may be lengthened, e.g., to protect contact coupling region 1352 and / or coupling region 1380, such that contact coupling region 1352 and / or coupling region 1380 are covered by the flexible conductor carrier, in which case the flexible conductor carrier may wrap more than 360° around the housing.

[0199] FIG. 11 illustrates another embodiment of an electrode system 1345. This embodiment is very similar to the one discussed in conjunction with FIG. 6 . Therefore, the following discussion will focus on the differences. The most notable difference is the configuration of the electrode track 1362 of the reference electrode 1368. This electrode track 1362 extends in the sensing region 1310 on either side of the electrode track 1364 of the sensing electrode 1366. The electrode track 1362 extends along the electrode track 1364 in a first direction, e.g., when viewed from the contact coupling region 1352 and / or toward the end 1358, and in a second direction opposite and preferably parallel to the first direction. The electrode track 1362 can surround the electrode track 1364. For example, at a transition portion near end 1358, electrode track 1362 can extend from one side of electrode track 1364 to the other, for example, by passing through the end of track 1364 closest to end 1358 of system 1345 or flexible conductor carrier 1350. This configuration also allows reference electrode portions 1371 to have ends facing different directions. When applied to electronic system 1000, some portions 1371 would point distally and some portions would point proximally. The ends of each portion preferably point toward the electrode track 1364 side of sensing electrode 1366. Electrode portions 1371 point in the same direction on each side of electrode track 1362. Sensing electrode portion 1369 and reference electrode portion 1371 are disposed equidistant along sensing region 1310. Electrode portions 1371 branching off from electrode track 1362 protrude into recesses defined by electrode track 1362. This electrode track configuration facilitates having many alternating sensing and reference electrode portions along the length of sensing region 1310. In joining region 1380, electrode track 1378 of sensing electrode 1376 in sensing region 1320 extends between two portions of electrode track 1364 of reference electrode 1362.

[0200] It should be noted that having an electrode track for a reference electrode on the flexible conductor carrier in addition to electrode tracks for one or two different sensing electrodes is not necessary to implement the disclosed concepts. For example, the electrode track of one sensing electrode (e.g., a sensing electrode for the delivery surface) can act as a reference electrode when proximity to a surface is to be monitored by another sensing electrode (e.g., a sensing electrode for the setting surface). The reference electrode can also be internal and remote from the flexible conductor carrier. Nevertheless, having a dedicated electrode track for the reference electrode in the electrode system can be advantageous. However, having a reference electrode on the flexible conductor carrier along with the sensing electrode facilitates or enhances increased sensitivity of the sensor, including the sensor controller and electrode system. Furthermore, when two different sensing electrodes (e.g., for the setting surface and delivery surface) are provided, the reference electrode can provide some isolation between the sensing electrodes, particularly if the reference electrode extends between the sensing electrodes and / or is electrically isolated from both sensing electrodes along the flexible conductor carrier.

[0201] FIG. 12 illustrates one embodiment of an electrode system. This embodiment is very similar to that discussed in conjunction with FIGS. 6 and 11. Therefore, the following discussion will focus on configurations that facilitate explanation of differences. However, as with the above embodiments, configurations not explicitly disclosed in conjunction with this embodiment may also be implemented. The electrode system 1345 has a configured sensing region 1310. The electrode system has a delivered sensing region 1320. Again, as with the above embodiments, one of the regions (e.g., the configured sensing region or the delivered sensing region) may be sufficient. In this embodiment, the delivered sensing region 1320 is configured similarly to FIG. 6. However, a configuration such as that of FIG. 11 is also possible. The delivered sensing region 1320 and the configured sensing region 1310 are connected by a connecting region 1380 of the flexible conductor carrier 1350. The connecting region 1380 facilitates moving the delivered sensing region 1320 relative to the configured sensing region 1310, for example, to accommodate the sensing regions on two differently oriented surfaces (e.g., surfaces extending perpendicular to each other). Similar to the above embodiment, the set sensing region 1310 is configured to conform to a curved (e.g., cylindrical) surface of the user interface member body 1605 (e.g., a sensing surface associated with the set surface 1610). The delivery sensing region 1320 is configured to conform to a flat surface of the user interface member body 1605 (e.g., a sensing surface associated with the delivery surface 1620). In the set sensing region 1310, the electrode configuration 1360 includes two electrode tracks, namely, tracks 1362 and 1364. Again, the electrode track 1362 defines a reference electrode 1368, and the electrode track 1364 defines a sensing electrode 1366. Each electrode track extends along the length of the sensing region 1310 between ends 1356 and 1358 of the flexible conductor carrier 1350, or preferably continuous sensing region 1310. Electrode tracks 1362 and 1364 extend alongside one another in the sensing region, e.g., generally away from (longitudinal) end 1356 and towards (longitudinal) end 1358. Sensing electrode 1366 and reference electrode 1368 extend along opposite ends of the sensing region (e.g., ends that bound the region widthwise or axially or perpendicular to the longitudinal direction).

[0202] The reference electrode portion 1371 and / or the sensing electrode portion 1369 of the associated electrode extend obliquely or perpendicularly to the longitudinal or length direction of the defined sensing area 1310. The reference and sensing electrode portions overlap each other, particularly along the center and / or strip-shaped area R of the sensing area 1310 extending between the ends 1356 and 1358. Area R is visualized by a dashed line in FIG.

[0203] Each electrode portion, i.e., the detection electrode portion 1369 and / or the reference electrode portion 1371, has a (free) end. One of the electrode portions (the detection electrode portion and / or the reference electrode portion) may have an overlapping area with the other electrode portion (the reference electrode portion or the detection electrode portion). Alternatively, one of the electrode portions may have a non-overlapping area with the other electrode portion. The non-overlapping area may be closer to a connecting area connecting one of the electrode portions than the end of the other electrode portion is to the same connecting area. The main extension directions of the detection electrode portion and / or the reference electrode portion are conveniently parallel to each other. The detection electrode portion 1369 extends away from the connecting portion 1370 that conductively connects the detection electrode portion and / or toward the connecting portion 1372 that conductively connects the reference electrode portion. The reference electrode portion 1371 extends away from the connecting portion 1372 that conductively connects the reference electrode portion and / or toward the connecting portion 1370. The (free) end of each electrode portion is remote from the connecting portion connecting the respective electrode portions. The end of an electrode portion can be the region located furthest from the associated connecting portion, for example, when viewed perpendicular to the main longitudinal extension of the sensing region or in the axial or width direction. The connecting portions 1370 and 1372 extend along opposite ends of the flexible conductor carrier 1350 or the sensing region 1310.

[0204] The (free or protruding) ends of the reference electrode portion 1371 are aligned with each other. The (free or protruding) ends of the sensing electrode portion 1369 are aligned with each other. When viewed in the width direction, the aligned ends can be at the same location or substantially the same location. The ends of the reference electrode portion 1371 and the ends of the sensing electrode portion 1369 are offset from each other, for example, in the width direction or axial direction and / or longitudinal direction. Thus, the reference electrode portion 1371 and the sensing electrode portion 1369 have an alternating configuration, similar to the above embodiment.

[0205] However, in the above-described embodiments, the width of the sensing electrode portions, i.e., the dimension perpendicular to their main direction of extension, i.e., away from the connecting portion toward the (free) end, was constant along the extension to the end of the electrode portion. Thus, each electrode portion had an essentially rectangular shape when viewed from above on the portion. In the illustrated embodiment, the reference electrode portion 1371 has a reduced width when viewed away from the connecting portion 1372 and / or toward the end of the reference electrode portion. Alternatively or additionally, the same applies to the sensing electrode portion relative to the connecting portion 1370 and its associated end of the portion. Each electrode portion is preferably symmetrical about an axis extending through the free end and / or an axis parallel to the main direction of extension of the electrode portion along the flexible conductor carrier. This axis can extend between the proximal and distal ends of the system or device, for example, when the electronic system is applied to a device.

[0206] In the illustrated configuration, the region of the flexible conductor carrier 1350 separating the reference electrode 1368 and the sensing electrode 1366 has a wave-like or sinusoidal shape, as opposed to the serpentine shape of the previous embodiment. Thus, at a given location (e.g., any or all locations) in the region where the reference and sensing electrode portions overlap, the respective electrode portions can have different longitudinal extensions. For example, in the region near the junction connecting the reference electrode portions, the reference electrode portion can be wider than the sensing electrode portion. This configuration can be beneficial for the uniformity of sensitivity of a sensor including the electrode configuration, or it can allow the sensitivity of the sensor to be tuned to a desired sensitivity characteristic.

[0207] Figures 13 and 14 show schematic diagrams of other embodiments of the electrode system. The embodiments are similar to those shown in Figure 12. In particular, the electrode portions can decrease in width in a direction away from the associated connector. Figure 13 shows a sinusoidal configuration of the electrode portions (in particular, the area separating electrode portions 1369 and 1371 associated with different electrode tracks has a sinusoidal shape). Figure 14 shows a zigzag or sawtooth configuration of the electrode portions (in particular, the area separating electrode portions 1369 and 1371 associated with different electrode tracks has a zigzag or sawtooth shape).

[0208] As noted above, the layout of the electrode tracks (of the reference and sensing electrodes) can feature a wide range of electrode patterns or shapes of electrode portions, such as rectangular ( FIGS. 4 , 6 , and 11 ), zigzag or sawtooth ( FIG. 14 ), or sinusoidally repeating ( FIGS. 12 and 13 ). The layout of the electrode portions or the configuration of the electrode tracks is conveniently selected (e.g., by appropriately adjusting the placement and / or configuration of the electrode portions) to provide a more reliable and / or improved response to a user's grasp, for example by increasing the likelihood that a user's finger or thumb will cover both tracks or portions (the reference electrode and the (respective) sensing electrode) when grasping the user interface member.

[0209] 15A-15F illustrate an embodiment of an electrode system, an embodiment of an electronic system using the electrode system, and an embodiment of a method, and features described in the context of this embodiment also apply to other embodiments described herein, and vice versa.

[0210] Figures 15A and 15B show electrode system 1345 from opposite sides, with Figure 15B rotated 180 degrees relative to Figure 15A. In general, electrode system 1345 is similar to the systems described above, for example, with respect to Figures 4, 6, 11, and 12. Therefore, this description will focus on the differences.

[0211] The electrode system 1345 includes a set sensing area 1310. The set sensing area extends between two ends 1356 and 1358 of the electrode system. The ends 1356 and 1358 may be two opposite or remote ends of a strip-like area of ​​the flexible conductor carrier 1350. In the set sensing area 1310, a (set) sensing electrode 1366 is provided by an electrode track 1364 of the electrode configuration 1360. The sensing electrode 1366 has a connecting portion 1370. Extending away from the connecting portion 1370 and / or towards the reference electrode 1368 are a number of different sensing electrode portions 1369. The same applies to the reference electrode portion 1371, which extends towards the sensing electrode 1366 and / or away from the connecting portion 1372. The electrode portion 1371 is formed by the electrode track 1362. The arrangement of electrode portions 1366 and 1371 can establish the illustrated serpentine shape of the area of ​​flexible conductor carrier 1350 that separates reference electrode 1368 and sensing electrode 1366 in the designated sensing region 1310. The sensing and reference electrodes can form the illustrated comb-like structure in sensing region 1310.

[0212] In the sensing region 1310, the electrode system 1345 includes a plurality of notches or slits 1384. The notches or slits 1384 extend throughout the electrode system so as to be accessible from two opposing ends of the electrode system 1345. The notches or slits 1384 are provided for convenience in attaching or coupling the electrode system, and in particular the sensing region 1310, to a user interface member component or housing 1670 of the associated electronic system 1000 (see, for example, FIG. 15C ). The notches or slits 1384 are disposed equidistantly along the extension of the sensing region 1310, for example, from the first end 1356 to the second end 1358. The notches or slits 1384 are bounded along the entire periphery by a flexible conductor carrier and / or one or more electrode tracks. The notches or slits can have different lengths or equal lengths (in the illustrated embodiment, the lengths are different; preferably, any two adjacent notches have different lengths, measured perpendicular to the main direction of extension of the sensing region 1310). The notches or slits 1384 are oriented such that, after the electrode system is applied to the electronic system 1000, their main direction of extension is oriented along an axis extending from the proximal end to the distal end. One or more of the notches or slits 1384 are positioned so as to be confined to a subregion of the sensing region 1310 where no electrode portion is located and / or where one of the electrode portions 1369 and 1371 is located. The notch or slit is surrounded and / or bounded in whole or in part by one of the electrode portions 1369 and 1371. In the illustrated embodiment, a notch or slit through the sensing electrode portion 1369 is only partially surrounded by the electrode portion 1369 (e.g., between two adjacent electrode portions 1369), while a notch or slit through the reference electrode portion 1371 is completely surrounded by the associated electrode portion 1371. This can be reversed, or both electrode portions can partially or completely surround the respective notch or slit 1384.

[0213] The electrode system 1345 further includes a connector region 1386. The connector region 1386 is connected to the sensing region 1310 via a connecting region 1380, which is conveniently flexible. The connector region 1386 is movable relative to the sensing region 1310. The electrode track 1362 and / or the electrode track 1364 extend from the sensing region 1310 to the connector region 1386 via the connecting region 1380. The connecting region 1380 has a width that is smaller than the width of the sensing region 1310 and / or the width of the connector region 1386. The periphery of the connector region 1386, or a section thereof, can have a fully or partially circular shape or can define a circular enveloping curve.

[0214] The connector region 1386 is disposed between the sensing region 1310 and the contact coupling region 1352 (when viewed along the flexible conductor carrier 1350). The contact coupling region 1352 is coupled to the connector region 1386 via another coupling region 1382 of the electrode system 1345. The other coupling region 1382 can extend away from the connector region 1386 at a point diametrically opposite the coupling region 1380. The connector region 1386, or the coupling region 1380 coupling the connector region 1386 to the sensing region 1310, is located between the ends 1356 and 1358, for example, centrally or midway and / or remotely from both ends. A separate electrode track 1378 is disposed in the connector region 1386. The electrode track 1378 is accessible at the contact coupling region 1352. Electrode tracks 1362 and 1364 are likewise accessible in contact coupling region 1352, thereby facilitating contact coupling with an electrode configuration in only one contact coupling region. However, electrode track 1378 does not extend into sensing region 1310. Rather, track 1378 is limited to connector region 1386, contact coupling region 1352, and coupling region 1382.

[0215] The electrode track 1378 provides a connector electrode 1388. The connector electrode 1388 serves as an interface for the electrode system to a separate sensing electrode. In the illustrated embodiment, the electrode is provided by a separate electrode or a spring 1390 (see FIG. 15C ) (e.g., a power spring). The connector electrode 1388 is disposed such that when the electrode system 1345 is placed in the electronic system, the wall faces the distally oriented side of the wall of the user interface member body 1605 that proximally bounds the user interface member body 1605. The size of the connector region 1386 and / or the size of the connector electrode 1388 are tailored to the size of the power source 1500 (e.g., a coin cell).

[0216] The reference electrode portion 1371 of the electrode track 1362 extends along (e.g., around) the connector electrode 1388. The reference electrode portion 1371 can have a width greater than adjacent portions of the electrode track 1362 and / or extend to a different (e.g., opposite) side of the connector electrode 1388. Portions of the electrode track other than the connector electrode 1388 in the connector region 1386 are covered with an insulating material (e.g., the material of the flexible conductor carrier 1350). Thus, only the connector electrode 1388 is exposed in the connector region 1386 (e.g., the side of the electronic system 1000 facing the user interface member body 1605). Exposing only the connector electrode avoids the risk of short circuits between different electrode tracks, for example, due to a separate sensing electrode 1390. For this reason, the connector electrode 1388 is shown hatched in FIG. 15A to emphasize that (only) this electrode is accessible or exposed. In the illustrated embodiment, the connector electrode 1388 has a ring-like shape (although, in general, other shapes are possible). The ring has two ends that can face each other. The ring can also extend circumferentially over more than 300° (e.g., more than 350°). The ends of the ring can define a passage for a portion of another electrode track (e.g., the electrode track 1362 that defines the reference electrode 1368) from the interior to the exterior bounded by the connector electrode. Having a connector electrode that defines an interior and defines a passage for another electrode track from the interior to the exterior is not limited to a ring-like shape.

[0217] On the side of the connector region 1380 remote from the connector electrodes 1388, terminal portions 1392 of the electrode arrangement (e.g., electrode tracks 1362) are exposed. Preferably, only the terminal portions 1392 are exposed, e.g., to reduce the risk of short circuits. In the electronic system 1000, the terminal portions 1392 can, for example, directly contact the power source 1500 (see FIG. 15C ). The connector electrodes 1388 are covered by an electrically insulating material on the side of the connector region 1386 where the terminal portions 1392 are exposed (hence, the terminal portions 1392, rather than the connector electrodes 1388, are hatched in FIG. 15B , which shows a top view of the connector electrodes 1388 and / or the side of the connector region 1386 remote from the proximal end of the user interface member body 1605 in the electronic system). The terminals of the electrode tracks in the contact connection region 1352 are accessible or exposed on the same side of the flexible conductor carrier 1350 as the terminal portion 1392 (for this reason, the electrode tracks 1362, 1364, and 1378 are also hatched in the contact connection region 1352).

[0218] 15C is a schematic cross-sectional view of an assembled electronic system 1000 that generally corresponds to the system discussed in conjunction with FIGS. 10A-10D, except for adjustments for the electronic system discussed in conjunction with FIGS. 15A and 15B. The configured sensing region 1310 wraps around or extends around the exterior of a housing or user interface member component 1670. Additionally, protrusions or ridges 1678 on the housing protrude through slits 1684 to hold or attach the sensing region 1310 to the housing 1670. The protrusions or ridges and notches or slits are configured to allow the housing 1670 to attach to the sensing region 1310, for example, by guiding the protrusions or ridges into the slits or notches. In other words, the form-fit coupling (e.g., provided by a preferably axially extending undercut in each protrusion or ridge 1678) can prevent radial movement of the sensing region 1310 away from the housing 1670 and / or axial movement of the sensing region relative to the housing when the sensing region 1310 is attached to the housing 1670. The contact coupling region 1352 is conductively coupled to a connector 3002 on the conductor carrier 3000, e.g., on a side of the conductor carrier 3000 remote from the power source 1500 or on a distal side of the conductor carrier 3000. The electrical contact coupling between the contact coupling region 1352 and the connector 3002 is formed, e.g., by a plug-in connector and / or solder.

[0219] The housing 1670, to which the electrode system 1345 is coupled, is guided into the user interface member body 1605 and / or conveniently non-rotatably and / or axially fixed relative to the body 1605 (e.g., by snap fit or welding). A separate sensing electrode or biasing member 1390 biases the connector region 1386 and / or terminal portion 1392 toward one contact (e.g., a ground contact) of the power source. The associated force can act distally and / or away from the proximal end face of the user interface member body. The sensing surface of the electrode 1390 can also conform to and / or contact an inner wall of the user interface member body 1605 at its proximal end. The biasing member or separate sensing electrode 1390 biases a contact (e.g., its negative contact) on the electrode 1500 toward an electrical terminal 3004 on the conductor carrier 3000. In this manner, the contact of the power source is coupled to the conductor carrier and the electrode system 1345. A spacer component 1510 is disposed between the conductor carrier 3000 and the power source 1500 (alternatively, the spacer can be omitted). Of course, in this embodiment, a motion sensing unit 1200, an electronic control unit 1100, and / or a sensor controller 1340 are also provided, as are other configurations of the electronic system embodiments described above.

[0220] 15D shows the subassembly of electronic system 1000 prior to insertion into user interface member body 1605. The subassembly includes electrode system 1345, housing 1670, and power source 1500, and optionally spacer 1510 and / or carrier 3000 (not explicitly shown). With electrode system 1345 also coupled to housing and carrier 3000, power source 1500 is securely held in the subassembly by coupling portions 1380 and 1382, which may extend axially across the outer lateral surfaces of power source 1500, for example. A connector portion 1386 covers the top surface of the power source, and a terminal portion couples the power source's contacts to the electrode system.

[0221] 15E and 15F show one embodiment of an electrode 1390 (biasing member) for use in an electronic system. The electrode 1390 has an electrode coupling portion 1394. The electrode coupling portion 1394 is provided for coupling the electrode to the sensor controller 1340 and / or the electrode system 1345, for example, by being carried by the connector electrode 1388. In the illustrated embodiment, the electrode coupling portion 1394 is formed by multiple (e.g., three) arms or legs. Three legs are particularly advantageous from a stability standpoint. The arms are uniformly distributed in the circumferential direction. The arms are inclined. The arms extend axially (e.g., distally) and / or radially (e.g., radially inward). The arms are configured to be carried by the connector electrode 1388. The electrode 1390 includes an electrode sensing portion 1396. The electrode sensing portion 1396 is positioned to contact and / or conform to the inner surface of a wall that proximally bounds the interior of the user interface member body 1605. The electrode sensing portion 1396 is positioned to enable, facilitate, or improve detection of a user's proximity to the delivery surface 1620 of the user interface member 1600. The sensing portion 1396 has a structured (e.g., circumferentially serpentine) surface to maximize the surface area available for (capacitive) sensing. A plurality of circumferentially arranged recesses (e.g., radially oriented recesses) can separate a plurality of circumferentially arranged protruding electrode portions (e.g., radially protruding electrode portions). The angular extension of the recesses can be less than the angular extension of the electrode portions. Each electrode coupling portion 1394 can originate and / or extend from an end (e.g., a radially outer end) of the sensing portion 1396, preferably from a protruding portion thereof.

[0222] 15C , providing a restoring force directed in, for example, a distal direction. Thus, components disposed distally from the biasing member or electrode 1390 can be biased to enhance mechanical contact or mechanical and / or electrical contact with each other. For example, the biasing member or electrode 1390 can bias one or more or all of the following pairs of components into mechanical contact with each other: - terminal portion 1392 and power source 1500 (e.g., at the proximal side of the power source, such as a ground or positive contact); - power source 1500 (e.g., at the distal side of the power source, such as the negative contact) and electrical terminal 3004; - conductor carrier 3000 and its seat or bearing surface in housing 1670 (not explicitly shown); - the motion sensing unit 1200 (e.g., its light transition surface) and the light guide 1676 (e.g., its light transition surface, which may include a light beam shaping portion shaped like a lens), which may improve the optical coupling between the light guide 1676 and the motion sensing unit 1200 and may possibly be activated.

[0223] The electrode system 1345, for example at one end (not shown in FIGS. 15A and 15B) or at both end regions 1356 and 1358 (as shown), has one or more cutouts 1398. When the sensing region 1310 is coupled to a housing, the cutouts can define or separate a passageway for the contact coupling region 1352 into the interior of the housing for coupling to, for example, a connector 3002 (see FIG. 15D).

[0224] 15D has the advantage that a dedicated clip is not required to hold the power source in the subassembly. Rather, the power source 1500 is held to the housing / user interface member part 1670 via the electrode system 1345.

[0225] 15A-15F also apply to systems that do not use separate sensing electrodes. In this case, the biasing member is conveniently located distally from the region 1386 that functions as the delivery sensing region, rather than as a connector region. Similarly, the layout of the electronic system of FIGS. 10A-10D is adjusted to employ a separate sensing electrode for monitoring proximity of the user interface member 1600 to the delivery surface 1620.

[0226] The terms "drug" or "medicament" are used interchangeably herein to 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 its broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or medications are used to treat, cure, prevent, or diagnose disease or otherwise improve physical or mental well-being. Drugs or medications can be used for a limited duration or periodically for chronic disorders.

[0227] As described below, drugs or pharmaceutical agents may contain at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs include small molecules with 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, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids, such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0228] The drug or agent can be contained in a primary package or "drug container" adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber can be designed to store the drug for about one month to about two years. Storage can occur at room temperature (e.g., about 20°C) or refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, the drug container can be or include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components prior to and / or during administration to the human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and to allow mixing of the two components by a user, if desired, prior to administration. Alternatively or additionally, the two chambers can be configured to allow mixing upon administration of the components to the human or animal body.

[0229] The drugs or agents contained in the drug delivery devices described herein can be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, and thromboembolic disorders, such as deep vein thromboembolism or pulmonary embolism. Further examples of disorders include 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 listed in handbooks such as Rote Liste 2014 (e.g., but not limited to, Main Group 12 (antidiabetic agents) or 86 (oncology agents)) and the Merck Index, 15th edition.

[0230] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin, e.g., human insulin, or a human insulin analog or derivative; glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, or an analog 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 "analog" and "derivative" refer to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deletion and / or replacement of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or replaced amino acid residue can be either a codable amino acid residue, another naturally occurring residue, or a purely synthetic amino acid residue. Insulin analogs are also referred to as "insulin receptor ligands." In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, for example, the molecular structure of human insulin in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide are deleted and / or replaced by other amino acids, including non-codable amino acids, or amino acids, including non-codable ones, are added to the naturally occurring peptide.

[0231] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and the Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0232] 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-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin. B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0233] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flathead monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rexendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C (efpegrenatide). , HM-15211, CM-3, GLP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexene, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, 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.

[0234] Examples of oligonucleotides are, for example, the cholesterol-lowering antisense therapeutic mipomersen sodium (Kynamro®) for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport syndrome.

[0235] Examples of DPP4 inhibitors are linagliptin, vidagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0236] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropine (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0237] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low-molecular-weight heparin or ultra-low-molecular-weight heparin or derivatives thereof, or sulfated polysaccharides, such as the polysulfated forms of the aforementioned polysaccharides, and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low-molecular-weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives include Hylan G-F20 (Synvisc®) and sodium hyaluronate.

[0238] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain antigen-binding ability. An antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single-chain antibody. In some embodiments, an antibody has effector function and is capable of fixing complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, antibody fragment, or mutant that does not support Fc receptor binding, e.g., has a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable region antibody-like binding proteins (CODVs) with a crossover binding region orientation.

[0239] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to antigen. Antibody fragments can include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, e.g., bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, e.g., bivalent, trivalent, tetravalent, and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0240] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences and that are primarily responsible for maintaining the proper orientation of the CDR sequences to enable 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 a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids within the CDRs to interact with the antigen.

[0241] 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).

[0242] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use as drugs or medicaments in drug delivery devices. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0243] Those skilled in the art will appreciate that modifications (addition and / or removal) of the various components of the APIs, formulations, devices, methods, systems, and embodiments described herein may be made without departing from the full scope and spirit of the invention, which encompasses such modifications and any and all equivalents thereof.

[0244] Exemplary drug delivery devices can include needle-based injection systems such as those described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems are broadly classified into multi-dose container systems and single-dose (with partial or full ejection) container systems. The container can be an exchangeable container or a non-exchangeable one-piece container.

[0245] As further described in ISO 11608-1:2014(E), a multi-dose container system can include a needle-based injection device with replaceable containers. In such a system, each container holds multiple doses of fixed or variable (user-preset) size. Another multi-dose container system can include a needle-based injection device with a non-replaceable, one-piece container. In such a system, each container holds multiple doses of fixed or variable (user-preset) size.

[0246] As further described in ISO 11608-1:2014(E), a single-dose container system can include a needle-based injection device with replaceable containers. In one example of such a system, each container holds a single dose, thereby discharging the entire deliverable volume (full discharge). In another example, each container holds a single dose, thereby discharging a portion of the deliverable volume (partial discharge). Also, as described in ISO 11608-1:2014(E), a single-dose container system can include a needle-based injection device with a non-replaceable, one-piece container. In one example of such a system, each container holds a single dose, thereby discharging the entire deliverable volume (full discharge). In another example, each container holds a single dose, thereby discharging a portion of the deliverable volume (partial discharge).

[0247] The scope of protection is not limited to the examples described above: any invention disclosed herein is embodied in each and every novel feature and each combination of features, and includes in particular all combinations of any and all features set out in the claims, even if this feature or combination of features is not explicitly set out in the claims or examples. [Explanation of symbols]

[0248] 1. Injection device, drug delivery device, or device unit 10. Housing 12 Dosage Knob 11 Injection button 13 Windows 14 Container 15 needles 16 Inner needle cap 17 Outer needle cap 18 Cap 70 sleeve 71a-c structure 1000 Electronic Systems 1100 Electronic Control Unit 1200 Motion Detection Unit 1310 Setting detection area 1320 Delivery detection area 1330 User Proximity Detection Unit 1340 Sensor Controller 1345 Electrode System 1350 Flexible Conductor Carrier 1352 Contact connection area 1354 parts 1356 End 1358 End 1359 Mechanical parts 1360 electrode configuration 1361 Angular Clearance 1362 Electrode Track 1364 Electrode Track 1366 Sensing electrode 1368 Reference electrode 1369 Detection electrode part 1370 Connection section 1371 Reference electrode section 1372 Connecting part 1373 Cutout 1374 terminal 1375 terminal 1376 Sensing electrode 1378 Electrode Track 1379 terminal 1380 Concatenated area 1381 biasing member 1382 Connected area 1383 End 1384 Slit 1386 Connector Area 1388 Connector Electrode 1390 Electrode 1392 Terminal section 1394 Electrode connection part 1396 Electrode detection unit 1398 notch 1400 Communication Unit 1500 power supply 1510 Spacer Component 1515 Orientation Configuration 1520 Power electrode 1530 Contact point 1540 energizing unit 1550 Ring section 1600 User interface components 1605 User interface member body 1610 Setting screen 1615 Connecting Function 1617 Surface structure 1616 Structural Elements 1618 Transition area 1620 Delivery surface 1630 parts 1670 case 1672 Rigid part 1674 Transformable part 1675 Receptive Space 1676 Light guide section 1678 Ridge 1680 flange 1681 Snap function 1682 recess 1683 Slots 1684 corresponding configurations 1700 Linked Detection Unit 1710 Switch 3000 Conductor Carrier 3002 Connector 3004 terminal 4000 objects A-axis C line L length R Area P plane

Claims

1. A sensor electrode system (1345) of an electronic system (1000): - an electrically insulating flexible conductor carrier (1350); an electrode arrangement (1360) extending along a flexible conductor carrier and including at least two conductive electrode tracks (1362, 1364, 1378) electrically isolated from one another along the conductor carrier; Including, The sensor electrode system, wherein one of the conductive electrode tracks forms an extending sensing electrode (1366, 1376) in a sensing region (1310, 1320) of the flexible conductor carrier.

2. The sensor electrode system of claim 1 , wherein the sensor electrode system (1345) is elastically deformable.

3. 3. A sensor electrode system as described in claim 1 or 2, wherein one of the conductive electrode tracks (1362) of the electrode configuration forms a reference electrode (1368) extending along the sensing electrodes (1366, 1376) in the sensing region (1310, 1320) of the flexible conductor carrier (1350), wherein the reference electrode and the sensing electrodes (1366, 1376) are configured to be given different potentials when the sensor electrode system is operated.

4. In the detection region (1310), the reference electrode (1368) has a plurality of reference electrode portions (1371) and the detection electrode (1366) has a plurality of detection electrode portions (1369), where the detection electrode portions and the reference electrode portions are arranged alternately; 4. A sensor electrode system as described in claim 3, optionally wherein an end of at least one detection electrode portion (1369) faces the reference electrode (1368) side, and wherein an end of at least one reference electrode portion (1371) faces the detection electrode (1366) side.

5. a) the sensing region (1310) is configured to fit against and / or extend along a circumferentially disposed sensing surface of a user interface member (1600) of the electronic system (1000), where the sensor electrode system and / or a system (1345) configured such that, when the system (1345) is installed in an electronic system, one reference electrode portion (1371) and one detection electrode portion (1369) are disposed at opposing locations; b) the sensing electrode (1366) is a first sensing electrode and the sensing region (1310) is a first sensing region, and wherein one of the conductive electrode tracks (1378) of the electrode configuration (1360) forms a second sensing electrode (1376) extending in a second sensing region (1320) of a flexible conductor carrier (1350), and wherein the flexible conductor carrier is configured such that the first sensing region and the second sensing region are movable relative to each other. A sensor electrode system as described in any one of claims 1 to 4.

6. A sensor electrode system as described in claims 3 and 5 and any one of claims dependent on claims 3 or 5, wherein the reference electrode (1368) extends along the first sensing electrode (1366) in the first sensing region (1310) and along the second sensing electrode (1376) in the second sensing region (1320).

7. a) the flexible conductor carrier (1350) includes a contact coupling region (1352), where the reference electrode (1368), the sensing electrode (1366), and / or the second sensing electrode (1376) are in electrical contact at the contact coupling region; and / or A sensor electrode system as described in any one of claims 1 to 6, wherein b) one of the conductive electrode tracks (1378) forms a connector electrode (1388) extending in a connector region (1386) of the flexible conductor carrier (1350), wherein the connector region is configured to conductively couple a separate sensing electrode (1390) to the electrode configuration.

8. 1. An electronic system for a drug delivery device, comprising: a user interface member (1600) having at least one external actuation surface (1610, 1620) arranged to be manipulated by a user for dosing actuation; a user proximity detection unit (1330) comprising a sensor electrode system (1345) according to any one of claims 1 to 7 and an electronic sensor controller (1340) conductively coupled to said sensor electrode system, said user proximity detection unit (1330) arranged and configured to detect whether a user approaches or touches an external operating surface; The electronic system.

9. a) the sensing region (1320) is biased towards an external actuation surface (1620), and a biasing member (1381, 1520) is provided in the electronic system (1000) for biasing the sensing region towards the external actuation surface, wherein preferably the biasing member (1520) is conductively coupled to a power source (1500) of the electronic system and / or the sensor controller (1340); and / or 10. The electronic system of claim 8, wherein the sensor controller (1340) is disposed on a carrier (3000), e.g., a rigid conductor carrier, secured to a user interface member part (1605, 1670) of the user interface member (1600), wherein the sensing region (1310) extends along an outer surface of the user interface member part and the contact connection region (1352) extends inwardly, e.g., toward the carrier, and is conductively connected to the sensor controller.

10. 10. The electronic system of claim 9, including a power source (1500) disposed between the carrier (3000) and a portion of a flexible conductor carrier (1350) secured to a user interface member component (1670), wherein a coupling region (1382) of the flexible conductor carrier extends from a portion of the flexible conductor on a remote power source side of the carrier toward the carrier, the coupling region being mechanically and / or electrically coupled to the carrier.

11. a) the sensing electrodes (1366) are assigned to a setting surface (1610) of the user interface member (1600) and / or the sensing electrodes (1376) are assigned to a delivery surface (1620) of the user interface member; and / or b) The sensor electrode system is the sensor electrode system of claim 7, wherein a first sensing electrode (1366) is assigned to a setting surface (1610) of the user interface member (1600) and a second sensing electrode (1376) is assigned to a delivery surface (1620) of the user interface member. An electronic system according to any one of claims 8 to 10.

12. a) the sensor electrode system is a sensor electrode system according to claim 7, wherein the first and second sensing areas are adapted to be assigned to external actuation surfaces facing in different directions; and / or An electronic system according to any one of claims 8 to 11, wherein b) the external actuation surface is a setting surface for dose setting actuation and faces radially.

13. The electronic system of any one of claims 8 to 12, wherein the external operating surface is configured such that the user proximity detection unit (1330) is more sensitive to soft or flexible conductive objects that conform to the external operating surface than to hard or rigid conductive objects that do not easily conform to the external operating surface.

14. A drug delivery device (1), comprising: A sensor electrode system (1345) according to any one of claims 1 to 7 and / or An electronic system (1000) according to any one of claims 8 to 13, and / or A container (14) or a receptacle configured to receive a container, the container containing a drug. The drug delivery device comprising:

15. A method of manufacturing an electronic system (1000) of a drug delivery device, such as the system according to any one of claims 8 to 13, comprising the steps of: - providing an electrode system (1345), which is a sensor electrode system according to any one of claims 1 to 7, comprising an electrically insulating flexible conductor carrier (1350) and an electrode arrangement (1360) comprising at least one conductive electrode track (1362, 1364, 1378) extending along the flexible conductor carrier; - providing a component (1670), for example a user interface member component; - deforming the electrode system so that a surface of the flexible conductor carrier extends along the component, for example along the outer surface of the component; - conductively connecting at least one conductive electrode track with an electronic unit (1340), thereby forming, for example, an electronic system; The method comprising:

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