Electrode system, electronic system, drug delivery device and method of manufacturing an electronic system
Patent Information
- Application Number
- CN202180093056.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2020-12-16
- Filing Date
- 2021-12-15
- Publication Date
- 2026-10-20
- Estimated Expiration
- 2041-12-15
Smart Images
Figure CN116829216B_ABST
Abstract
Description
Background Technology
[0001] This disclosure relates to an electrode system, an electronic system, a drug delivery device, and a method of manufacturing an electronic system.
[0002] Drug delivery devices utilizing electronic components are becoming increasingly popular in industry and for patients or users. Summary of the Invention
[0003] The purpose of this disclosure is to promote improvements associated with electronic systems used in drug delivery devices.
[0004] This objective is achieved by means of the subject matter described in the independent claims. Advantageous embodiments and improvements are subject to the dependent claims. This disclosure is not limited to the subject matter currently claimed. Rather, this disclosure may also cover subject matter not currently claimed, however, as will be readily understood by one of ordinary skill, that such subject matter may be modified and / or made subject to the claims.
[0005] One aspect of this disclosure relates to an electrode system for a drug delivery device or for an electronic system. Another aspect relates to an electronic system, preferably an electronic system including an electrode system. The electronic system may be an electronic system for a drug delivery device. Yet another aspect relates to a drug delivery device, wherein the device preferably includes an electrode system or an electronic system. Finally, this disclosure relates to a method of manufacturing or assembling an electronic system for a drug delivery device.
[0006] In one embodiment, the electrode system includes a flexible conductor carrier. The flexible conductor carrier may be electrically insulating. The flexible conductor carrier may be configured to provide a substrate for one or more conductive electrode tracks extending along the flexible conductor carrier. The corresponding electrode tracks may also be flexible only in certain areas or entirely. When applied to an electronic system, the flexible conductor carrier and / or the electrode system can be deformable, for example, folded, bent, or flexed. Thus, in an electronic system, the electrode system and / or conductor carrier may have a second or deformable configuration (e.g., opposite to a first or non-deformable configuration). In a first configuration, the conductor carrier may be flat. Having a flexible conductor carrier allows the conductor carrier and / or the entire electrode system to be easily adapted to the specific requirements of the electronic system in which it is used. For example, the flexible conductor carrier can be easily conformed to non-planar (e.g., curved) surfaces, such as cylindrical surfaces. Different regions of the conductor carrier may be deflected in different directions, such that these regions face different directions in the electronic system. Having a flexible conductor carrier is particularly suitable for electrode systems used in drug delivery devices (such as injection devices and / or pen-type devices) because such devices typically have only limited available space, making the flexible conductor carrier particularly advantageous.
[0007] In one embodiment, the electrode system includes an electrode arrangement. The electrode arrangement may extend along an electrode surface of a flexible conductor carrier. The electrode surface may be the main surface of the flexible conductor carrier. The electrode arrangement may be confined to the electrode surface. A surface opposite to or away from the electrode surface may be an electrically insulating surface. The insulating surface may be provided by the flexible conductor carrier. In this way, the electrode functionality of the electronic system can be provided on one surface (the electrode surface), and the opposite surface may be electrically insulated from the electrode arrangement. This facilitates the application of the electrode system in use conditions (e.g., in an electronic system) because the risk of short circuits using components arranged on the side of the conductor carrier away from the electrode surface is reduced due to the insulating properties of the flexible conductor carrier and the insulating surface it provides. As an alternative to complete insulation, the surface of the conductor carrier opposite to or away from the electrode surface may be a surface with one or more exposed conductive electrode portions (that is, the two opposite surfaces of the conductor carrier may be electrode surfaces).
[0008] In one embodiment, the electrode arrangement includes at least one conductive electrode track. The electrode arrangement may include at least two conductive electrode tracks, for example, two tracks, three tracks, or four tracks. The corresponding tracks may be formed or arranged on the electrode surface of the flexible conductor carrier. The corresponding conductive electrode tracks may extend along the flexible conductor carrier. In the presence of multiple conductive electrode tracks, the conductive electrode tracks may be electrically separated or insulated from each other along the conductor carrier. In other words, there may be no electrical interconnection between two conductive electrode tracks of the electrode arrangement on the conductor carrier, preferably between any chosen pair of two conductive electrode tracks.
[0009] In one embodiment, the electrode system is a sensor electrode system. The sensor electrode system can be configured to provide an operative connection between a sensing point (e.g., an external operating surface of a user interface component) and a sensor controller (further details below), wherein the sensor controller is configured to evaluate one or more electrical characteristics input to the sensor controller via the electrode system. For example, if applicable in conjunction with a sensor controller, the sensor electrode system is configured to sense capacitance or capacitance changes on or near the external operating surface of the user interface component of a drug delivery device or electronic system. Specifically, the sensor electrode arrangement can be configured to sense the proximity of one or more of the user's fingers (e.g., the thumb, a finger different from the thumb, and / or at least the thumb and another finger such as the index finger) to the external operating surface.
[0010] In one embodiment, one of the conductive electrode tracks may form, define, or be a sensing electrode. The sensing electrode may extend into a sensing region of the flexible conductive carrier. The sensing region may be an area of the conductive carrier configured to be close to, preferably as close as possible to, an external operating surface. The external operating surface may be a setting surface (i.e., a surface touched by a user during or for the purpose of a dose setting operation) or a delivery surface (i.e., a surface arranged to be touched by a user during or for the purpose of a dose delivery operation).
[0011] In one embodiment, electrode tracks may be configured to connect to or form a separate channel or input of a sensor controller, which monitors one or more electrical characteristics in a sensing region, such as the capacitance between two electrode tracks, by means of one or more electrode tracks. Alternatively or additionally, electrode tracks may be assigned to different sensing regions of a conductive carrier.
[0012] In one embodiment, the electrode system, flexible conductor carrier, and / or electrode arrangement are deformable, for example, all or at least in one or more regions. Preferably, the electrode system, flexible conductor carrier, and / or electrode arrangement are elastically deformable, for example, all or at least in one or more regions. Thus, the electrode system can deform from a non-deformable configuration to a deformable configuration, for example. Deformation can result in an elastic restoring force that tends to re-establish the non-deformable configuration. The elastic restoring force can be advantageously used. For example, the elastic restoring force can be used to maintain contact between a portion of the elastically deformed flexible conductor carrier and another portion (such as the inner wall of a user interface component, preferably facing away from the external operating surface). The elastic restoring force can press the surface of the flexible conductor carrier (e.g., the electrode surface) against the other portion. Thus, elastic deformability helps to conform the electrode system to non-planar or curved (e.g., cylindrical) surfaces. The electrode system can be entirely elastically deformable, or only one or more regions can be elastically deformable. The remaining one or more regions of the electrode system can still be deformable, but not necessarily elastically deformable. Deformable electrode systems (e.g., flexible printed circuit boards) have minimal space requirements and can be easily adapted to different shapes and sizes of user interface components.
[0013] In one embodiment, one of the conductive electrode tracks in the electrode arrangement is or forms a reference electrode. The reference electrode can extend along the sensing electrode within the sensing region of the flexible conductive carrier. The electrode track for the reference electrode can extend along the entire electrode track for the sensing electrode. The reference electrode and the sensing electrode can be configured to be provided with different potentials. An electric field can be formed between the reference electrode and the sensing electrode by means of the different potentials. The field can be static or dynamic, for example, having an alternating potential or voltage. The electric field or its characteristics can be monitored by the system's sensor controller. Changes in the field or characteristics (e.g., capacitance) can be caused by a user's finger approaching the sensing and / or reference electrode. Therefore, changes can be evaluated by the sensor controller, and if they meet one or more predetermined criteria, they are considered to be caused by a user's finger approaching an external operating surface. For example, one of the electrodes can be provided with a high potential, while the other can be provided with a low potential (e.g., ground potential). One potential can be positive, and the other can be negative. The low-potential electrode can be the reference electrode, and the high-potential electrode can be the sensing electrode. An electronic system (e.g., a sensor controller) can be configured to monitor changes in capacitance between the reference electrode and the sensing electrode. If the change exceeds a threshold level (e.g., becomes below or above a predetermined threshold), the sensor controller can be configured to generate or provide a signal, such as to the main controller or electronic control unit of the electronic system. In the event of a touch or proximity event relative to an external operating surface, the sensor controller can cause the emission of a corresponding signal usable in the electronic system to change its operating state. In response to the signal (which may be a usage signal or a proximity signal), the electronic system can be configured to switch from a lower power consumption first state (e.g., a state where only the sensor controller is operable) to a higher power consumption second state (e.g., in which one or more previously inoperable units of the electronic system become operable). These units may include motion sensing units and / or communication units. The switching operation can be performed by an electronic control unit (e.g., the main controller) that can be provided in addition to the sensor controller.
[0014] In one embodiment, particularly in the sensing region of a flexible conductor carrier, the sensing electrode has multiple sensing electrode portions. The sensing electrode portions may be distributed (e.g., uniformly) across the sensing region. The sensing electrode portions may be separated from each other within the sensing region. The sensing electrode portions may be oriented parallel to each other. Alternatively or additionally, the reference electrode (particularly in the sensing region) may have multiple reference electrode portions. The reference electrode portions may be distributed (e.g., uniformly) across the sensing region. The reference electrode portions may be separated from each other within the sensing region. The reference electrode portions may be oriented parallel to each other within the sensing region. The corresponding electrode portions may be formed by associated conductive electrode tracks. The corresponding electrode portions may be oriented axially, for example, in an electronic system, such as from the proximal end to the distal end of the electronic system. The sensing electrode portions in the sensing region may be equidistantly arranged along the sensing region. That is, any pair of two adjacent sensing electrode portions may have the same distance. Alternatively or additionally, this may also 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, this may also 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 may have ends facing different directions (e.g., different axial directions). Some electrode portions may face proximally, while others may face distally. The other of the reference electrode and the sensing electrode (e.g., the sensing electrode) may be arranged between the two portions of the reference electrode and the sensing electrode, said portions being oriented in opposite directions.
[0016] In one embodiment, the respective electrode portions (i.e., the reference electrode portion and / or the sensing electrode portion) are axially oriented. The axis may be perpendicular to the longitudinal direction of the main extension of the flexible conductor carrier. The respective electrode portions may have free ends.
[0017] In one embodiment, sensing electrode portions and reference electrode portions are alternately disposed within the sensing region and / or along the sensing region, for example, as viewed along the main extension direction of the sensing region, the electrode system, and / or the flexible conductor carrier. That is, a sensing electrode portion may be followed by a reference electrode portion, which may be followed by another sensing electrode portion, which may again be followed by another reference electrode portion.
[0018] In one embodiment, by means of electrode portions, sensing electrodes and reference electrodes can have or define an alternating or comb-like arrangement of sensing electrodes and reference electrodes in the sensing region. Here, as viewed along the main extension direction, adjacent electrode portions can belong to different electrodes, i.e., to either the reference electrode or the sensing electrode. A first comb-like element can be formed by the sensing electrode, and a second comb-like element that can engage with the first comb-like element can be formed by the reference electrode. The electrode portions can form the teeth of the corresponding comb-like elements. The reference electrode portions and / or sensing electrode portions can be arranged sequentially along the sensing region, for example, as viewed along the main extension direction of the sensing region (such as the main extension direction of a flexible conductor carrier).
[0019] In one embodiment, the distance between consecutive sensing electrode portions can be greater than the width of a reference electrode portion disposed between adjacent sensing electrode portions. This can also apply to the distance between consecutive reference electrode portions, which conveniently is greater than the width of a sensing electrode portion disposed between these two adjacent reference electrode portions. The width can refer to the dimension perpendicular to the extension of the electrode portion (e.g., toward the end of the electrode portion).
[0020] In one embodiment, the sensing electrode portion and / or the reference electrode portion are tilted or vertically oriented relative to the main extension direction of the sensing region, the electrode system, and / or the flexible conductor carrier.
[0021] In one embodiment, the sensing area can be configured such that it is disposed close to an external operating surface, for example, at a distance (preferably the maximum distance) less than one of the following values: 2 mm, 1.5 mm, 1 mm. The external operating surface can be a circumferentially or angularly disposed surface, for example, the setting surface of a user interface component. The main extension direction of the sensing area can be the direction along the circumferentially disposed surface when the electrode system is disposed in the electronic system (e.g., an angular direction).
[0022] In one embodiment, the sensing electrode portions have the same width and / or the same length. Alternatively or additionally, the reference electrode portions may have the same width and / or the same length. The width of the reference electrode portion may be equal to the width of the sensing electrode portion. The length or axial extension of the reference electrode portion may be equal to the length or axial extension of the sensing electrode portion.
[0023] In one embodiment, the sensing electrode portions are connected to the connection portion of the sensing electrode. Preferably, all sensing electrode portions are directly connected, for example, to a common connection portion. The connection portion can electrically interconnect the sensing electrode portions. The connection portion can be part of an electrode track from which the sensing electrode portions branch. All sensing electrode portions can branch from the connection portion in the same direction. The transition region between the connection portion and the sensing electrode portion can be arranged sequentially (e.g., linearly and / or along the main extension direction of the connection portion) along the connection portion. The corresponding sensing electrode portion can have an end away from the connection portion of the sensing electrode. The sensing electrode portion can extend linearly away from the connection portion. The connection portion can extend linearly along the flexible conductor carrier.
[0024] In one embodiment, a reference electrode portion is connected to a connection portion of a reference electrode. Preferably, all reference electrode portions are directly connected, for example, to a common connection portion. The connection portion can electrically interconnect the reference electrode portions. The connection portion can be part of an electrode track from which a reference portion branches. All reference portions can branch from the connection portion in the same direction. The transition region between the connection portion and the reference portion can be arranged sequentially (e.g., linearly) along the connection portion. The corresponding reference electrode can have an end away from the connection portion of the reference electrode. The reference electrode portion can extend linearly away from the connection portion. The connection portion can extend linearly along a flexible conductor carrier.
[0025] In one embodiment, at least one end (e.g., a free end) of the reference electrode portion (e.g., a plurality of reference electrode portions or all of the reference electrode portions) faces the sensing electrode or the electrode track for the sensing electrode, particularly as viewed along a flexible conductor carrier.
[0026] In one embodiment, at least one end (e.g., a free end) of the sensing electrode portion (e.g., a plurality of sensing electrode portions or all sensing electrode portions) faces the reference electrode or the electrode track for the reference electrode, particularly as 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 either 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 greater than or equal to one of the following values: 2, 3, 4, 5, 6, 7, 8.
[0029] In one embodiment, the ends of the reference electrode portion, particularly all ends of the reference electrode portion, face the connection portion of the sensing electrode. Alternatively or additionally, the ends of the sensing electrode portion, particularly all ends of the sensing electrode portion, face the connection portion of the reference electrode.
[0030] In one embodiment, the corresponding sensing electrode portion and / or the corresponding reference electrode portion extend linearly. The reference electrode portion and the sensing electrode portion may be oriented such that they extend parallel to each other.
[0031] In one embodiment, one or more corresponding electrode portions (i.e., reference electrode portions and / or sensing electrode portions) have a constant width along their extension, for example, as viewed in a direction away from the connection portion connecting the corresponding electrode portion toward the free end of the corresponding electrode portion. The corresponding electrode portions may have a rectangular shape.
[0032] In one embodiment, one or more corresponding electrode portions (i.e., reference electrode portions and / or sensing electrode portions) have varying widths along their extension, for example, as viewed in a direction away from the connecting portion connecting the corresponding electrode portion toward the free end of the corresponding electrode portion. The width of the electrode portion may preferably decrease continuously in the direction toward the free end. The free end may be a pointed end or a flat end. The corresponding electrode portion may have a triangular shape or a trapezoidal shape.
[0033] In one embodiment, the sensing region of the flexible conductor carrier is configured to conform to and / or extend along a circumferentially or angularly positioned sensing surface of the user interface component. When an electrode system is applied to or included in an electronic system, the sensing region conforms to and / or extends along the sensing surface of the user interface component. The sensing region can be provided to cover the entire circumference of the sensing surface or at least 360° at an angle. The sensing surface can be a surface extending along an external operating surface of the user interface component (particularly on the inside of the user interface component or the user interface component body). 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 dose setting operations using the user interface component. The angular or circumferential setting of the sensing surface can be relative to a rotation axis used for dose setting.
[0034] In one embodiment, the sensor electrode system is configured such that a reference electrode portion and a sensing electrode portion can be or are positioned in opposite locations, particularly along a sensing surface and / or when the electrode system is provided in an electronic system, for example, such that the sensing area conforms to the sensing surface. Thus, when arranged in an electronic system, a sensing electrode portion and a reference electrode portion can be offset 180° relative to each other. Both portions can face the sensing surface. Each sensing electrode portion can have a relative setting or associated reference electrode portion offset from said portion, for example, by 180°. It has been found that providing the sensing electrode portion and the reference electrode portion in relative positions relative to each other can result in particularly noticeable changes perceptible to the sensor controller, caused by one or more fingers of the user for dose setting or during dose setting, since it is likely that the user will touch the user interface component in relative positions with their thumb and another finger, such as the index finger, for dose setting. It is particularly advantageous for this purpose that the number of sensing electrode portions and reference electrode portions is odd.
[0035] In one embodiment, one of the reference electrode and the sensing electrode (e.g., the reference electrode or the sensing electrode) in the sensing region passes through the end of the other of the sensing electrode and the reference electrode (e.g., the sensing electrode or the reference electrode). Alternatively or additionally, the other of the sensing electrode and the reference electrode may be arranged between two portions of one of the reference electrode and the sensing electrode. The two portions of one of the reference electrode and the sensing electrode may extend or be oriented parallel to each other (e.g., at least along a large portion of the other of the sensing electrode and the reference electrode) and / or may be connected by electrode portions passing through the end of one of the sensing electrode and the reference electrode.
[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 arrangement can form, define, or be a second sensing electrode. The second sensing electrode can extend into the second sensing region of the flexible conductor carrier. The second sensing region and the first sensing region can be separated from each other, for example, non-overlapping. The second sensing region and the first sensing region can be connected by a connection region of the flexible conductor carrier. The electrode track for the second sensing electrode can extend within the connection region such that it can define the second sensing electrode within the second sensing region. Unlike the first sensing region and / or the second sensing region, the connection region can have smaller dimensions, for example, a smaller length and / or a smaller width. The conductive electrode track for the second sensing electrode is conveniently electrically decoupled or insulated from the electrode track for the first sensing electrode on the flexible conductor carrier. The electrode track for the second sensing electrode can be electrically decoupled or insulated from the electrode track for the reference electrode.
[0037] In one embodiment, the flexible conductor carrier is configured such that a first sensing region and a second sensing region are movable relative to each other. The sensing regions can be movable relative to each other such that the surfaces having sensing electrodes (i.e., the first sensing electrode and the second sensing electrode) face different directions. For example, the first and second sensing regions can be configured such that they can be arranged relative to each other such that the second sensing region and the first sensing region are perpendicular to each other, i.e., the normal vector of the surface of the flexible conductor carrier can be perpendicular in these sensing regions. When the electrode system is provided in an electronic system, one of the sensing regions can have a substantially planar surface, and the other sensing region can have a curved surface or an angled surface facing the radial direction.
[0038] In one embodiment, the first sensing region and the second sensing region are configured to be assigned to, or be assignable to, external operating surfaces facing different directions. For example, the first sensing electrode may be assigned to a setting surface of the user interface component. Alternatively or additionally, the second sensing electrode may be assigned to a delivery surface of the user interface component.
[0039] In one embodiment, a reference electrode or a conductive electrode track therefor extends along a first sensing electrode in a first sensing region and / or along a second sensing electrode in a second sensing region. That is, the first and second sensing electrodes may share a common reference electrode. Therefore, a single conductive electrode track can be used as a reference electrode in two different sensing regions.
[0040] In one embodiment, a reference electrode or conductive electrode track therefor is arranged between the first sensing electrode or electrode track therefor and the second sensing electrode or conductive electrode track therefor. Therefore, even when the first and second sensing electrodes or electrode tracks therefor extend along each other, they remain separated by the reference electrode. This configuration makes electrical separation 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, a reference electrode or associated electrode track surrounds a sensing electrode or associated electrode track in the sensing region. The reference electrode (e.g., in the sensing region) may have a first portion and a second portion. The two portions may be oriented along the main extension direction of the flexible conductor carrier or the sensing region. These portions may extend parallel to each other. The sensing electrode may be arranged (e.g., defined) between the two portions of the reference electrode. The first and second portions may be connected by a transition portion. The transition portion may extend beyond an end of the sensing electrode as it extends from the first portion to the second portion. The end may be located away from the contact connection region (see below).
[0042] In one embodiment, the first sensing electrode and the second sensing electrode are configured to be provided with the same or different potentials during operation of the electronic system.
[0043] In one embodiment, the connection region between the first sensing region and the second sensing region has a width smaller than the width of the first sensing region and / or smaller than the width of the second sensing region. The width of the second sensing region may be smaller than the width of the first sensing region. The narrow connection region facilitates a movable connection between the first and second sensing regions. Electrode tracks for the reference electrode and the second sensing electrode may extend along the connection region. The electrode tracks may deform together with the connection region.
[0044] In one embodiment, the flexible conductor carrier includes a contact connection region. The contact connection region can be a region outside of a connection region, a connector region (further below), and / or one or more sensing regions. The contact connection region can be provided to electrically connect corresponding electrode tracks or associated electrodes (such as a (first) sensing electrode, a reference electrode, and / or a 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, if only one electrode is provided, the sensor controller can have one channel; if two electrodes are provided (such as a sensing electrode and a reference electrode), the sensor controller can have two channels; or if three electrodes are provided (such as a first sensing electrode, a second sensing electrode, and a reference electrode), the sensor controller can have three channels. For completeness only, it should be mentioned 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 connection region can be movable (e.g., foldable) relative to one or more sensing regions. Contact connection areas can be provided to electrically connect electrode tracks on the flexible conductor carrier to a sensor controller and / or to another conductor carrier. The sensor controller can be disposed on another (e.g., rigid) conductor carrier. The contact connection areas can be provided for connection to a connector (e.g., an FCC connector or a Slimstack connector). Viewed along an extension of the flexible conductor carrier (e.g., correspondingly from the contact connection area to the second sensing area or connector area), the first sensing area can be disposed between the contact connection area and the second sensing area or between the contact connection area and the connector area. Alternatively, the second sensing area or connector area can be disposed between the contact connection area and the first sensing area.
[0045] In one embodiment, a reference electrode, a (first) sensing electrode, and / or a second sensing electrode, or an electrode track therefor, extend from an associated sensing region to a contact connection region and / or may be electrically contacted in the contact connection region. The respective electrodes may be accessible for electrical contact connections in the contact connection region. Terminals for the respective electrodes (or electrode tracks) may be provided in the contact connection region.
[0046] In one embodiment, the sensing area is configured to cover an angular extension of at least 270°, at least 300°, or at least 350° of the circumferentially positioned surface of the user interface component (e.g., the aforementioned sensing surface and / or when conforming to that surface). The flexible conductor carrier can be configured to cover a surface extension exceeding 360°. In this way, the particularly sensing area 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 sensing areas of the flexible conductor carrier, such as connection areas and / or contact connection areas.
[0047] In one implementation, the electrode system is a flexible printed circuit board.
[0048] In one implementation, the electrode arrangement is located inside the user interface component, meaning it is inaccessible from the outside.
[0049] In one embodiment, one of the conductive electrode tracks may form, define, or be a connector electrode. The connector electrode may extend into a connector region of the flexible conductor carrier. The connector electrode or connector region may be provided for electrically connecting an additional electrode (e.g., a separate sensing electrode) to the electrode arrangement. The additional electrode may be separable from the electrode arrangement, e.g., a separate portion. The additional electrode may be a metallic component. The connector electrode may be exposed in the connector region of the flexible conductor carrier to achieve mechanical contact between the connector electrode and the additional electrode. In an electronic system, the additional electrode may be arranged between the flexible conductor carrier and an external operating surface, which may be a delivery surface. The additional electrode may be conductively connected to a power source via the electrode arrangement. The additional electrode may be elastically deformable. The additional electrode may act as a biasing member (further below) and / or may be arranged to bias one or more elements or components of the electronic system away from the external operating surface (e.g., a portion of the flexible conductor carrier). The connector region may be arranged in a region of the conductor carrier associated with or to be associated with the delivery surface. The additional electrode may function as a (second) sensing region or (second) sensing electrode (or a sensing region / electrode associated with the delivery surface). Therefore, the features described above and below for the (second) sensing region or electrode (or sensing region associated with the delivery surface) also apply to the connector region, and vice versa. In addition to the connector region and the additional electrodes, a first sensing region (or sensing region associated with the setting surface) is conveniently provided.
[0050] In one embodiment, the electrode system (e.g., electrode arrangement) includes terminal portions configured for direct connection to a power source, for example. For example, the terminal portions may be part of an electrode track forming a reference electrode or sensing electrode. For example, the terminal portions may be accessible on a side of the flexible conductor carrier opposite to the external operating surface. Bias members (further see above or below) (e.g., additional electrodes) may be arranged to bias the terminal portions toward a terminal of the power source (e.g., bias them into mechanical contact with said terminal). The terminal portions may be arranged on a connector electrode on the flexible conductor carrier away from the connector region or on the opposite side of said connector electrode. The terminal portions may be electrically insulated from the connector electrode.
[0051] In one embodiment, a portion of the reference electrode extends along the connector electrode in the connector region (e.g., along the outer or outer edge of the connector electrode). Once the electronic system has been assembled, associating one or more portions of the reference electrode with the connector electrode results in the reference electrode being close to another electrode. It is advantageous to have the reference electrode close to another electrode, even if the electrode arrangement itself does not provide a sensing electrode but is provided by another electrode.
[0052] In one embodiment, as viewed in a top or plan view onto the conductor carrier (e.g., when the carrier is in a flat configuration), the connector electrodes are arranged between the reference electrode portion and the terminal portion.
[0053] In one embodiment, the electronic system includes a user interface component. The user interface component has at least one external operating surface. The external operating surface can be arranged to be manipulated by a user for dosing operations. Dosing operations can be dosing setting operations for setting a dose to be delivered by a drug delivery device and / or dosing delivery operations for delivering a dose (e.g., a previously set dose). For the user interface component to be manipulated, the external operating surface may need to be touched by the user. The external operating surface can be a setting surface (e.g., a surface oriented radially and / or circumferentially) for dosing settings or a delivery surface (e.g., a surface oriented axially (e.g., proximal)). The user interface component may need to be moved (e.g., in rotation) for dosing settings. The amount of rotation may be proportional to the magnitude of the set dose. The user interface component may need to be moved (e.g., axially) for dosing delivery operations. The (corresponding) movement of the user interface component may be relative to a housing (e.g., the housing of the drug delivery device or the drug delivery device unit).
[0054] In one embodiment, the user interface component includes a user interface component body. The user interface component body may form or define one or more external operating surfaces. The body may have a cup-shaped configuration. The body may have a closed proximal end for the delivery surface. The distal end may be open, for example, for connecting the user interface component to a drug delivery device or for a dose setting and actuation mechanism of the drug delivery device.
[0055] In one implementation, the external operating surface and / or the user interface component body may be electrically insulated.
[0056] In one embodiment, the electronic system includes a user proximity detection unit. The user proximity detection unit may be disposed within the interior of a user interface component, particularly within the body of the user interface component. The user proximity detection unit may be disposed and configured to detect whether a user is approaching or touching an external operating surface. When the user proximity detection unit has confirmed that the user is approaching or touching the external operating surface, the user proximity detection unit may provide or trigger the generation of an electrical signal (such as a usage signal or proximity signal). The signal may indicate that the user is approaching or touching the external operating surface and / or that a dosing operation (e.g., a dose setting operation or a dose delivery operation) is about to begin. The user proximity detection unit may include an electrode system as described above. The user proximity detection unit may further include an electronic sensor controller, such as a microcontroller or an ASIC. The sensor controller may be electrically connected to the electrode system, for example, as discussed further above. The sensor controller may have different channels for different tracks or electrodes. A signal may be provided by the user proximity detection unit in response to the user touching the external operating surface, or the user approaching the external operating surface but not yet touching it and being less than a predetermined distance from the external operating surface. The predetermined distance can be less than or equal to one of the following values: 5mm, 4mm, 3mm, 2mm, 1mm, 0.5mm, 0.4mm, 0.3mm, 0.2mm.
[0057] In one embodiment, a (first) sensing electrode is assigned to a setting surface of the user interface component, and / or a second sensing electrode is assigned to a delivery surface of the user interface component. Therefore, user approach relative to different surfaces can be detected using the same electrode system.
[0058] In one implementation, the first sensing area is associated with a setting surface. Alternatively or additionally, the second sensing area is associated with a delivery surface.
[0059] In one embodiment, the electronic system includes a power source, such as a rechargeable or non-rechargeable battery (e.g., including at least one coin cell). The power source can provide power to the electrically operating components of the electronic system. The electronic system can be stand-alone. That is, the power source can be non-replaceable and therefore permanently installed in the system. Therefore, when the power contained in the power source has been consumed, if the power source is not rechargeable, the electronic system may have to be disposed of.
[0060] In one embodiment, the electronic system includes an electronic control unit. In addition to a sensor controller, an electronic control unit may also be provided. In this way, the sensor controller can be used to switch the electronic control unit to a higher power consumption state. The electronic control unit can then again switch one or more additional units to a higher power consumption state, for example, from non-operation to operation. The additional units may include a motion sensing unit and / or a communication unit. The motion sensing unit may be provided to capture dose-related data during dose delivery operations, such as characteristics related to the magnitude of the delivered dose. The communication unit may be provided to establish a communication channel to another device and / or, for example, to transmit dose-related data to another device (e.g., a mobile phone or personal computer) after the dose delivery operation has ended.
[0061] In one embodiment, the sensing area (e.g., a second sensing area and / or a first sensing area) is biased toward an external operating surface, for example, by a rebound force or spring force. For instance, the sensing area may be biased against an inner surface of a user interface member or user interface member body near the external operating surface, for example, disposed on a side of a wall of the user interface member body opposite to the external operating surface, wherein the wall externally defines the external operating surface. Therefore, the sensing area may be adjacent to or conform to an inner surface of the user interface member or user interface member body.
[0062] In one embodiment, the sensing regions (e.g., a first sensing region and / or a second sensing region) are biased toward an external operating surface by forces generated by the elastic deformation of the electrode system or flexible conductor carrier.
[0063] In one embodiment, the electronic system includes a biasing member, such as a spring-like rebound member. The biasing member can be arranged such that a region of the flexible conductor carrier is biased relative to an external operating surface and / or the user interface component body, for example, toward or away from the user interface component body. As further noted above, the biasing member can be formed of additional electrodes, which can act as separate sensing electrodes. Therefore, references to a biasing member (e.g., regarding its arrangement) can be understood as references to additional electrodes, especially where the additional electrodes are provided as sensing electrodes and the electrodes are not implemented by an electrode arrangement.
[0064] In one embodiment, the sensing region (e.g., a second sensing region) is biased toward an external operating surface by a biasing member. In other words, the biasing member can be provided in the electronic system for mechanically biasing the sensing region toward the external operating surface.
[0065] In one embodiment, a biasing member is arranged between the user interface member body and the connector portion, for example, between an external operating surface (such as a delivery surface) and the connector portion.
[0066] In one embodiment, the biasing member is conductive. The biasing member may be conductively connected to a power source. The biasing member may also be conductively connected to other electronic or electrodynamic units, such as a power source, within the sensor controller and / or electronic system components.
[0067] The biasing member can be used to direct power from a power source to other units or components of an electronic system, such as a sensor controller or electronic control unit. The biasing member can bias the sensing area proximally relative to the user interface component body, for example, biasing it abutting against the inner surface of the segment of the user interface component body that forms or defines the delivery surface. The sensing area can be sandwiched between the user interface component body and the biasing member, the user interface component body defining an external operating surface associated with the sensing area.
[0068] The biasing member can bias the flexible conductor carrier toward a power source (e.g., relative to the user interface component body) and / or toward another carrier (e.g., a rigid conductor carrier), optionally thereby ensuring a conductive connection (e.g., a conductor or its terminals) between the power source and the other carrier. The biasing member can act as a separate sensing electrode and be conductively connected to the connector electrode in the connector region of the flexible conductor carrier, for example, through a mechanical contact between the connector electrode and the biasing member.
[0069] In one embodiment, the flexible conductor carrier has multiple sensing regions associated with the same external operating surface (e.g., a delivery surface or a setting surface). One or more electrode tracks of an electrode arrangement can extend in each sensing region. The configuration of the electrode tracks in different sensing regions can be identical. Each sensing region (e.g., each second sensing region) can be connected to another carrier region of the flexible conductor carrier, such as a first sensing region, via different connection regions of the flexible conductor carrier. In this case, the external operating surface can be covered or monitored by multiple sensing regions, which preferably have the same electrode track configuration and / or portions of the same electrode tracks provided in each sensing region. Thus, monitoring of the external operating surface can be distributed across the various sensing regions. This helps to reduce the size and weight of the respective sensing regions. Consequently, the connection regions are more likely to bias the respective sensing regions toward the external operating surface due to their inherent elasticity. In this case, it is easier to omit separate biasing members for this purpose or to determine the size of the biasing members differently.
[0070] In one implementation, the user proximity detection unit is configured to monitor the proximity of an object (e.g., a conformable object such as a user's finger) to an external operating surface.
[0071] In one embodiment, the external operating surface includes a surface structure. The surface structure may include one or more recesses or depressions. The recesses or depressions may be separate from or connected to each other. The dimensions of the recesses or depressions may be determined such that when a user touches the external operating surface, a conformable object (such as the skin on a user's finger (e.g., thumb and / or index finger)) may deflect into the recess or depression. In this way, the distance between the user's skin and the sensing area can be reduced. The closer the object to be sensed is to the sensing area, the more pronounced the signal generally is. The surface structure reduces the risk of non-conforming objects (e.g., metallic objects) being incorrectly assessed as the user approaching the external operating surface. The surface structure of the external operating surface may be defined by a user interface component body. The user interface component body may have a varying thickness. For a setting surface serving as the external operating surface, the radial thickness of the body may vary along the axial and / or angular extension of the setting surface. For a delivery surface serving 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 component 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. Therefore, this distance can also vary, for example, due to the surface structure.
[0072] In one embodiment, the external operating surface is configured such that the user proximity detection unit has higher sensitivity to softer or more flexible conductive objects (e.g., user skin on a finger or thumb) that are more easily conformable to the external operating surface, compared to more robust or rigid conductive objects (e.g., metals and / or rigid objects) that are not easily conformable to the external operating surface. This can be achieved through surface structures as further explained above.
[0073] In one embodiment, the sensor electrode system is configured such that the electrode arrangement, preferably in the sensing region, is adjusted, preferably configured, to compensate for thickness variations along an external operating surface in the user interface component body and / or distance variations from the external operating surface to the sensing region associated with the external operating surface. Thickness or distance variations can be attributed to the surface structure of the user interface component body. The electrode arrangement can be configured such that, particularly regardless of thickness variations, the sensitivity of the sensor, including the sensor electrode system, is uniform along the external operating surface (e.g., a setting surface) monitored by the sensor electrode system. Therefore, for the proposed solution, variations in sensor sensitivity along the external operating surface (e.g., along the circumferential and / or axial directions of the setting surface) can be smaller than variations in sensitivity along an external reference surface monitored by the same sensor. The reference surface can be smooth and therefore has a constant distance from the sensing region of the sensor electrode system conforming to the inner surface or sensing surface of the user interface component body. The overall shape of the reference body can be the same as one of the user interface component bodies, but without thickness variations. The reference surface is conveniently a surface of a reference body made of the same material as the user interface component body. The thickness of the reference body along the reference surface can be constant and can fall between the maximum and minimum thickness of the user interface component body. The distance from the external reference surface to the sensing area can fall between the maximum and minimum distance from the external operating surface to the sensing area. The electrode arrangement can be adjusted according to thickness variations by configuring one or more electrode tracks in the sensing area. For example, the reference electrode and sensing electrode can be staggered in the sensing area, which is considered particularly suitable for providing uniform sensitivity, even when the sensor electrode system is monitoring a structured surface.
[0074] In one implementation, the sensor (e.g., a capacitive sensor) includes a sensor controller and a sensor electrode system.
[0075] In one implementation, in the electronic system, the contact connection area and the second sensing area are oriented in the same direction, or the contact connection area and the connector area are oriented in the same direction.
[0076] In one embodiment, in the electronic system, the contact connection area and / or the second sensing area are tilted or perpendicular to the first sensing area.
[0077] In one embodiment, the electronic system includes a carrier, such as a conductive carrier, for example, a rigid conductive carrier. The carrier may be provided in addition to the flexible conductive carrier of the electrode system. Sensor controllers, electronic control units, and / or other units of the electronic system (such as communication units and / or motion sensing units) may be arranged on the carrier and / or electrically connected to conductors provided on the carrier. The carrier may be a printed circuit board.
[0078] In one embodiment, the user interface component includes user interface component parts. The user interface component parts may preferably be axially and / or directionally fixed to the user interface component body. The interior of the user interface component may be defined by the user interface component body and the user interface component parts. The interior may be sealed, for example, to prevent moisture and / or dirt. The user interface component parts may be received in a distal opening of the user interface component, and preferably the opening is closed. The user interface component parts may be a base frame.
[0079] In one implementation, the carrier is, for example, axially and / or in the direction of steering, fastened to the user interface component part.
[0080] In one implementation, the electrode system (e.g., the sensing area) is wound around the user interface component part.
[0081] In one embodiment, the sensing area extends along the outer surface (e.g., the radially oriented outer surface) of the user interface component part and / or the carrier. The sensing area may completely or partially surround the carrier or user interface component part, particularly in, for example, angular or circumferential directions, such as, relative to an axis parallel to the distal direction.
[0082] In one embodiment, the contact connection area of the electrode system extends inward relative to the outer surface of the user interface component (e.g., toward the (rigid) carrier). The contact connection area may be electrically connected to the sensor controller, for example, directly or via a conductor on the carrier.
[0083] In one embodiment, the flexible conductor carrier is fixed or fastened to the user interface component part, for example, in a directional and / or axial manner. The sensing area may be fixed to the user interface component part (e.g., its outer surface). For example, a protrusion of the user interface component part may be received in a cutout in the flexible conductor carrier or electrode system for securing the flexible conductor carrier to the user interface component part.
[0084] In one embodiment, a power source is disposed between a portion of a flexible conductor carrier and a (rigid) carrier. The portion of the flexible conductor carrier may be a connector region. A connection region of the flexible conductor carrier (e.g., a connection region extending toward a contact connection region) may extend toward the carrier from the portion of the flexible conductor and / or from the power source side away from the carrier. The contact connection region may be mechanically and / or electrically connected to the carrier (e.g., connected to a conductor or terminal on the carrier). The contact connection region may electrically connect the flexible conductor carrier to the carrier and / or a sensor controller. The power source may be secured or fixed to the user interface component and / or the carrier via the flexible conductor carrier (e.g., via an associated connection on one side to the carrier and on the other side to a user interface component part). In other words, in this disclosure, the flexible conductor carrier may act as a holder or fastening member to secure components of a sub-assembly of an electronic system relative to each other. The sub-assembly may be inserted into the user interface component body. Components may be or may include: a carrier, user interface component parts, and / or a power source. In addition to these components, the sub-assembly may include the flexible conductor carrier.
[0085] In one embodiment, an electrode system for a drug delivery device is provided in a method of manufacturing or assembling an electronic system. The electrode system can be the electrode system discussed above. The electrode system may include a flexible conductor carrier, which is preferably electrically insulating. The electrode system may further include an electrode arrangement. The electrode arrangement may include at least one conductive electrode track. The electrode track may extend along the flexible conductor carrier. Furthermore, in this method, components (e.g., user interface component components) may be provided.
[0086] In one embodiment, the electronic unit (e.g., a sensor controller) may be electrically connected to the electrode arrangement, for example, to a conductive electrode track.
[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 parts of the electrode system. The electrode arrangement can be deformed such that the surface of the conductor carrier extends along or conforms to the part (e.g., the outer surface of the part). The surface of the flexible conductor carrier facing the part can be the surface of the flexible conductor carrier away from the electrode arrangement. The opposite side can define a sensing area. Deformation of the electrode system or the flexible conductor carrier can occur, for example, before or after electrically connecting the electrode tracks to the electronic unit via a contact connection area of the flexible conductor carrier.
[0088] In one embodiment, before the electrode system deforms to extend along the outer surface of the part, the remainder of the flexible conductor carrier is deflected relative to the contact connection area that may have been connected to the electronic unit.
[0089] In one embodiment, after the electrode tracks are electrically connected to the electronic unit and / or after the flexible conductor carrier is deformed to conform to the part, the user interface component body can be guided on the surface of the flexible conductor carrier opposite to the part. Thus, in the electronic system, a region of the flexible conductor carrier can be arranged between the inner surface of the user interface component body and the outer surface of the (user interface component) part. This region can be or may include a sensing region (e.g., a first sensing region), as discussed further above. The user interface component body and the user interface component part can, for example, be rigidly connected to each other.
[0090] In one embodiment, the method further includes providing a biasing member and arranging the biasing member and a region of the flexible conductor carrier (e.g., a sensing region, such as a second sensing region) such that the biasing member is arranged to bias the sensing region away from the part and / or toward an inner surface of the user interface member body. The inner surface may be a surface of the user interface member that faces away from an external operating surface, for example, the inner surface of a wall of the user interface member body that defines an external delivery surface.
[0091] In one embodiment, a sub-assembly is provided. The sub-assembly may be provided to be secured to the part, for example, in a directional and / or axial manner, after the electrode rails have been connected to the electronics unit. The carrier, power supply, electronics unit, and / or biasing member may be part of the sub-assembly.
[0092] In one embodiment, the sub-assembly includes an orientation feature. The orientation feature may be provided to ensure that the sub-assembly can only be arranged on or connected to the part in a defined relative orientation (e.g., a relative angular orientation). The defined relative orientation may include only one relative orientation. This ensures that one or more electronic units of the sub-assembly are arranged in a defined position relative to the part.
[0093] In one embodiment, the flexible conductor carrier extends along the outer edge, particularly the radial outer edge, of the power supply and / or component (e.g., user interface component component).
[0094] In one embodiment, the drug delivery device includes a reservoir holder for holding a reservoir (e.g., a cartridge) containing a drug, and / or the device includes a reservoir. The reservoir may contain a plurality of (preferably user-configurable) doses of drug sufficient to be delivered by the drug delivery device.
[0095] In one embodiment, the drug delivery device is a pen-type device and / or an injection device, such as a needle-based syringe.
[0096] In one embodiment, the electronic system is configured as a preferred reusable accessory for a drug delivery device unit. The system can be configured to attach to the drug delivery device unit. That is, the electronic system can be configured to be used with multiple drug delivery device units. The corresponding drug delivery device unit can be a disposable drug delivery device unit, and / or the corresponding drug delivery device unit can be fully operable to perform dose setting and dose delivery operations. The drug delivery device unit may include a reservoir. The drug delivery device unit may lack an electrical operating 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 actuation mechanism. The dose setting and actuation mechanism may include a first component connected to or connectable to an electronic system. The dose setting and actuation mechanism may include a second component. The first and second components may be coupled for dose setting operations, for example, locked in direction. For dose delivery operations, the first and second components may be decoupled, for example, thereby allowing relative rotational movement. The dose setting and actuation mechanism may further include a piston rod. The first component may be coupled to the piston rod, for example, directly and / or threadedly. During dose delivery operations, the relative rotational movement between the first and second components may be measured by the electronic system to determine the magnitude of the delivered dose.
[0098] In one embodiment, the kit for a drug delivery device includes a drug delivery device unit and an electronic system. The system may be attached to the device unit to form a drug delivery device. The features of the drug delivery device disclosed above and below, particularly those not directly related to the electronic system, should also apply to the drug delivery device unit, and vice versa.
[0099] In this document, "distal" is used to refer to a direction, end, or surface that is arranged or is to be arranged facing or toward the dispensing end of a drug delivery device or its components and / or away from, or to be arranged away from, or opposite to the proximal end. Conversely, "proximal" is used to refer to a direction, end, or surface that is arranged or is to be arranged away from or opposite to the dispensing end and / or distal end of a drug delivery device or its components. The distal end can be the end closest to the dispensing end and / or furthest from the proximal end, and the proximal end can be the end furthest from the dispensing end. The proximal surface can be away from the distal end and / or facing the proximal end. The distal surface can face the distal end and / or away from the proximal end. For example, the dispensing end can be the tip of a needle where a needle unit is mounted to or is to be mounted to the device.
[0100] In an advantageous embodiment, a sensor electrode system for a drug delivery device includes:
[0101] - An electrically insulating flexible conductor carrier; and
[0102] - An electrode arrangement comprising at least two conductive electrode tracks extending along a flexible conductor carrier, wherein the conductive electrode tracks are electrically separated from each other along the conductor carrier, wherein one of the conductive electrode tracks forms a sensing electrode, and wherein the sensing electrode extends in a sensing region of the flexible conductor carrier.
[0103] In an advantageous embodiment, a method of manufacturing an electronic system for a drug delivery device includes the following steps:
[0104] - Provide an electrode system, such as the electrode system discussed above, wherein the electrode system includes an electrode arrangement and an electrically insulating flexible conductor carrier, wherein the electrode arrangement includes at least one conductive electrode track extending along the flexible conductor carrier.
[0105] -Provide components, such as user interface component components;
[0106] - To deform the electrode system so that the surface of the flexible conductor carrier extends along the part, for example, along the outer surface of the part; and
[0107] - At least one conductive electrode track is electrically connected to the electronic unit, for example, to form the electronic unit.
[0108] Features disclosed in different aspects and implementation schemes can be combined with each other, even if such combinations are not explicitly discussed. For example, features relating to electrode systems or electronic systems can also be applied to devices, methods, or kits, and vice versa.
[0109] Other aspects, implementation methods, and advantages will become apparent from the following description of exemplary implementation methods in conjunction with the accompanying drawings. Attached Figure Description
[0110] Figure 1 illustrates an implementation scheme for a drug delivery device.
[0111] Figure 2 illustrates the implementation scheme of the electronic system.
[0112] Figures 3A to 3C illustrate the implementation scheme of the electronic system.
[0113] Figure 4 illustrates the implementation scheme of the electrode system.
[0114] Figure 5 illustrates the implementation scheme of the electronic system.
[0115] Figure 6 illustrates the implementation scheme of the electrode system.
[0116] Figure 7 illustrates the implementation scheme of the electronic system.
[0117] Figures 8A to 8C illustrate implementation schemes for the electrode system.
[0118] Figures 9A to 9C illustrate the implementation scheme of the electronic system.
[0119] Figures 10A to 10D illustrate implementation schemes of electronic systems and methods for assembling or manufacturing electronic systems.
[0120] Figure 11 illustrates the implementation scheme of the electrode system.
[0121] Figure 12 illustrates the implementation scheme of the electrode system.
[0122] Figure 13 illustrates the implementation scheme of the electrode system.
[0123] Figure 14 illustrates the implementation scheme of the electrode system.
[0124] Figures 15A to 15F illustrate implementation schemes of the electrode system, electronic system, and method. Detailed Implementation
[0125] In the accompanying drawings, the same elements, elements with the same function, or elements of the same kind may be given the same reference numerals.
[0126] In the following description, some concepts will be referred to in the context of insulin injection devices. The system described herein can be implemented in this device. However, this disclosure is not limited to this application and is equally suitable for use in injection devices or drug delivery devices generally configured to dispense other pharmaceutical agents, preferably pen-type devices and / or injection devices.
[0127] The following provides embodiments relating to injection devices, particularly variable-dose injection devices, which record and / or track data regarding the dose delivered therefrom. This data may include the size of the selected dose and / or the size of the dose actually delivered, the time and date of administration, the duration of administration, etc. Features described herein may include power management technologies (e.g., facilitating small batteries and / or enabling efficient power use) or related concepts.
[0128] Some embodiments in this document relate to injection devices that combine an injection button and a grip (dose setting component or dose setter) (e.g., similar to Sanofi's). The device is described below. An injection button can provide a user interface component for initiating and / or performing dose delivery operations of the drug delivery device. A grip or knob can provide a user interface component for initiating and / or performing dose setting operations. These devices can be of the selector extension type, i.e., their length increases during dose setting. Other injection devices with the same kinematic behavior of selector extensions and buttons during dose setting and dose dispensing operation modes are known, for example, from Eli Lilly. or The device and sold by Novo Nordisk or Devices. Therefore, applying the general principles to these devices is straightforward and further explanation will be omitted. However, the general principles of this disclosure are not limited to this kinematic behavior. Certain other embodiments are conceivable for application to injection devices with separate injection buttons and grip / dose setting components, for example, Sanofi's... Therefore, this disclosure also relates to a system having two separate user interface components, one for dose setting operations and one for dose delivery operations. To switch between the dose setting and dose delivery configurations of the device, the user interface component for dose delivery can be moved relative to the user interface component for dose setting. If a user interface component is provided, it can be moved distally relative to the housing. During the corresponding movement, the engagement between the two components of the dose setting and drive mechanism changes its state, for example, from engagement to disengagement, or vice versa. When the engagement is engaged, for example by a set of meshing teeth on the two components, the two components can be locked in direction relative to each other, and when the engagement is disengaged or released, one of these components can be allowed to rotate relative to the other of the two components. One of these components can be a drive component or a drive sleeve that engages with the piston rod of the dose setting and drive mechanism. The drive sleeve can be designed to rotate relative to the housing during dose setting and can be locked in direction relative to the housing during dose delivery. The engagement between the drive sleeve and the piston rod can be a threaded engagement. Therefore, since the drive sleeve cannot rotate during dose delivery, axial movement of the drive sleeve relative to the housing will cause the piston rod to rotate. During the delivery operation, this rotation can be converted into axial displacement of the piston rod through the threaded coupling between the piston rod and the housing.
[0129] The injection device 1 in Figure 1 is an injection pen that includes a housing 10 and contains a container 14 (e.g., an insulin container) or a receiver for such a container. The container may contain a medication, such as insulin. The container may be a cartridge or a receiver for a cartridge, which may contain a cartridge or be configured to receive a cartridge. A needle 15 may be attached to the container or the receiver. The container may be a cartridge, and the receiver may be a cartridge holder. The needle is protected by an inner needle cap 16 and an outer needle cap 17 or another cap 18. The insulin dose to be dispensed from the injection device 1 can be set, programmed, or “selected” by rotating a dose knob 12, and then displayed (e.g., in multiples of units) of the currently programmed or set dose via a dose window 13. The units may be determined by a dose setting mechanism that allows the knob 12 to be rotated relative to the housing 10 only in integer multiples of a unit setting increment, which may define a dose increment. This can be achieved, for example, by a suitable ratchet system. The markings displayed in the window can be set on the digital sleeve or the selector sleeve 70. For example, when the injection device 1 is configured to administer human insulin, the dose can be displayed in so-called International Units (IU), one IU being the biological equivalent of approximately 45.5 micrograms of pure crystalline insulin (1 / 22 mg). Other units can be used in the injection device for the delivery of insulin analogs or other agents. It should be noted that the selected dose can be displayed just as well in a manner different from that shown in the dose window 13 in Figure 1.
[0130] The dosage window 13 may take the form of an aperture in the housing 10, allowing the user to view a limited portion of the selector sleeve 70, which is configured to move when the dosage knob 12 is turned to provide a visual indication of the currently programmed dosage. When turned during programming, the dosage knob 12 rotates in a helical path relative to the housing 10.
[0131] In this example, the dosage knob 12 includes one or more configurations 71a, 71b, 71c to facilitate attachment of a data collection device or electronic system. The electronic system, which will be described in more detail below, may be attached to a user interface component (knob 12 and / or button 11), or generally to elements or components of the dosage setting and actuation mechanism of the drug delivery device 1. For example, the electronic system may be housed within the user interface component. The electronic system, which will be described in more detail below, may also be configured as an accessory to the drug delivery device.
[0132] The injection device 1 can be configured such that turning the dose knob 12 produces a mechanical click to provide acoustic feedback to the user. In this embodiment, the dose knob or dose button 12 also functions as the injection button 11. When the needle 15 is inserted into the patient's skin and then the dose knob 12 / injection button 11 is pushed in the axial direction, the insulin dose displayed in the display window 13 is expelled from the injection device 1. The dose is injected into the patient while the needle 15 of the injection device 1 remains in the skin for a certain period after the dose knob 12 has been pushed to the correct position. The expulsion of the insulin dose can also cause a mechanical click, however, it is different from the sound produced when the dose knob 12 is rotated during dose selection.
[0133] In this embodiment, during insulin dose delivery, the dosage knob 12 moves axially back to its initial position without rotation, while the selector sleeve 70 or the digital sleeve 70 rotates back to its initial position, for example, to display a zero-unit dose. As already noted, this disclosure is not limited to insulin, but should cover all medications in the medication container 14, especially liquid medications or pharmaceutical preparations.
[0134] The injection device 1 can be used for several injections until the insulin container 14 is emptied or the medication in the injection device 1 reaches its expiration date (e.g., 28 days after the first use).
[0135] Furthermore, before using the injection device 1 for the first time, a so-called "preparation injection" may be necessary to ensure that the fluid is flowing correctly from the insulin container 14 and the needle 15, for example by selecting two units of insulin and pressing the dosage knob 12 while keeping the needle 15 of the injection device 1 facing upwards. For ease of presentation, it will be assumed below that the ejection volume substantially corresponds to the injection dose, such that, for example, the dose of medication ejected from the injection device 1 is equal to the dose received by the user.
[0136] As explained above, the dosage knob 12 also functions as the injection button 11, allowing the same component to be used for selecting / setting the dosage and dispensing / delivering the dosage. Similarly, we note that a configuration with two different user interface components is also possible, these two different user interface components being preferably movable relative to each other only in a limited manner. However, the following discussion will focus on a single user interface component that provides both dosage setting and dosage delivery functions. In other words, the setting surface of the component, touched by the user for dosage setting operations, and the dosage delivery surface, touched by the user for dosage delivery operations, are immovably connected. Alternatively, in the case of using different user interface components, they can be movable relative to each other. During the respective operations, the user interface component preferably moves relative to the body or housing of the device. During dosage setting, the user interface component moves proximally and / or rotates relative to the housing. During dosage delivery, the user interface component moves axially (e.g., distally), preferably without rotating relative to the housing or body.
[0137] The following describes an implementation of an electronic system for a drug delivery device.
[0138] Figure 2 schematically illustrates an embodiment of the electronic system 1000. System 1000 includes a user interface component 1600. The user interface component is designed to be operated by a user during dose setting and / or dose delivery operations. The user interface component 1600 has different external operating surfaces. The operating surfaces may be defined by external surfaces accessible from the outside of the user interface component body or housing 1605. The user interface component 1600 has a setting surface 1610, which is arranged to be gripped by a user for dose setting operations. Dose setting operations (particularly if performed by rotation) typically require two points of contact with the user interface component. For example, a user typically grips the user interface component with two fingers (such as the index finger and thumb). The setting surface is a surface that circumferentially defines the user interface component 1600, e.g., a radially facing surface. The user interface component 1600 also has a delivery surface 1620. The delivery surface is arranged to be contacted (e.g., pressed) by a user for dose delivery. The delivery surface 1620 is an axially facing surface, e.g., a proximal-facing surface. In the depicted embodiment, the user interface component 1600 has a cup-shaped configuration. As described above, embodiments of this disclosure may employ different user interface components for setting and delivery. Dosage setting operations may involve rotation of the user interface component 1600 about its central axis, which may be perpendicular to the delivery surface 1620 and extend through the delivery surface (not explicitly shown).
[0139] Within the user interface component 1600, for example, within an internal hollow defined by the user interface component body 1605, additional components or units of an electronic system are housed or arranged. 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 finger (e.g., index finger and / or thumb) is near or touches a setting surface 1610 and / or a delivery surface 1620. The user proximity detection unit 1330 includes a sensor controller 1340, for example, a controller of the Azoteq IQS228-AS type. The sensor controller 1340 is operatively (e.g., electrically) connected to an electrode system 1345 having an electrode arrangement. The sensor controller and the sensor electrode system together form a capacitive sensor. The sensor electrode system 1345 provides or includes a setting sensing area 1310 (first sensing area). The sensor electrode system 1345 provides or includes a delivery sensing area 1320 (second sensing area). The setting sensing area 1310 is associated with the setting surface 1610. The setting sensing area 1310 conveniently extends along at least a majority or the entire inner surface of the user interface component body 1605 away from the setting surface, for example, extending at least along an angle of 350° or 360° along the inner surface. The setting sensing area 1310 faces the setting surface 1610. The delivery sensing area 1320 is associated with the delivery surface 1620. The delivery sensing area 1320 faces the delivery surface 1620. The sensing area 1320 may be planar. The sensing area 1310 may have a curved (e.g., cylindrical) configuration extending around or around the central axis or main axis A of the user interface component. Instead of having both a setting sensing area and a delivery sensing area, only one of these areas may be provided, i.e., either the setting sensing area or the delivery sensing area. Moreover, in the depicted embodiment, both sensing areas or associated electrodes are connected to a common sensor controller 1340. It is also contemplated that the setting sensing area and the delivery sensing area be connected to separate sensor controllers. However, it is convenient to connect both sensing areas to the same sensor controller, preferably to different channels of said sensor controller. A suitable embodiment of the electrode system 1345 will be described in more detail later. The sensor controller 1340 may be a low-power controller that monitors input capacitance or electric field from a sensing area of the electrode system 1345 (e.g., from a specific channel or a combination of channels), and outputs a signal if 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 rises above or falls below a threshold). The criterion is conveniently selected such that if the criterion is met, it indicates that a user is approaching or touching a corresponding external operating surface. The capacitive sensor may be configured to output a signal when the user moves away from the monitored surface by less than 0.5 mm, or 0.4 mm, or 0.3 mm, or 0.2 mm.However, we note that the operating distance of the capacitive sensor can be increased or even decreased if desired. The signal generated by the user proximity detection unit 1330 can be used to influence the operating state of the electronic system or a drug delivery device including said system. Having both setting and delivery sensing areas makes it possible to distinguish which of the external operating surfaces the user is approaching (i.e., the setting surface or the delivery surface). This can be used for different operations within the electronic system.
[0140] The electronic system 1000 further includes an electronic control unit 1100. The control unit may include a processor, such as a microcontroller or an ASIC. Furthermore, the control unit 1100 may include one or more memory units, such as program memory and / or main memory. The program memory may be 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., sensor controller 1340) via a wired or wireless interface. It can transmit signals and / or data containing commands to these units, and / or receive signals and / or data from the respective units. Connections between these units and the electronic control unit are indicated by lines or arrows in Figure 2. However, connections may also exist between these units, which are not explicitly shown. Similarly, the operational or conductive connection between the electrode system 1345 and the sensor controller 1340 is indicated by arrows.
[0141] The electronic system further includes a power source 1500, such as a battery (e.g., a coin cell or a stack of multiple coin cell cells). The power source can be configured to provide a total capacity of approximately 50-500 mAh at a voltage of approximately 1.4-3V. The power source 1500 is conveniently electrically connected to the sensor controller 1340 and / or the electronic control unit 1100. The power source can provide full power for the operation of the electronic system, preferably throughout its entire lifespan. Once the remaining power in the power source is insufficient to operate the system, the system may have to be disposed of.
[0142] The electronic system 1000 further includes a conductor carrier 3000, such as a (printed) circuit board. Components of electrical or electronic units or all units of the electronic system may be arranged and / or electrically connected to conductors on the conductor carrier 3000. The conductor carrier 3000 is rigid. That is, the conductor carrier conveniently maintains its shape in any orientation relative to the ground under its own weight, and preferably even when forces are applied to the conductor carrier. The conductor carrier 3000 may be more rigid than the flexible conductor carrier 1350 of the sensor electrode system 1345, as discussed further below. A flexible conductor carrier may or may not maintain its shape under its own weight, but in any case is deformable when an external force is applied. The conductor carrier 3000 may be directly fixed to the body relative to the user interface component body 1605 or fixed to another component, which may then be fixed to the body (not explicitly shown, see user interface component component or base 1670 discussed below). The sensor controller 1340 and the electronic control unit 1100 are arranged on a conductor on the conductor carrier 3000 and are preferably electrically connected to said conductor. A power supply 1500 is arranged between the delivery surface 1620 and the conductor carrier 3000. This contributes to the compact design of the user interface component 1600.
[0143] The electronic system 1000 further includes an electro-motion sensing unit 1200. The motion sensing unit 1200 may include one sensor (e.g., only one sensor) or multiple sensors. The motion sensing unit is conveniently designed to generate motion signals (such as electrical signals) indicating the movement of one component of the electronic system or drug delivery device relative to another component, for example, the movement of a selector sleeve or digital sleeve relative to a drive sleeve or button / knob in the device further discussed above in conjunction with FIG. 1, wherein the sensor may be fixedly connected to one of these components (e.g., a knob or button or drive sleeve). The movement is conveniently a relative rotational movement. Relative rotational movement conveniently occurs during dose delivery operations, e.g., only during delivery operations. The corresponding sensor may be a photoelectric sensor. The photoelectric sensor can sense radiation that appears from the component moving relative to the sensor and impacts the sensor to excite a sensor signal or motion signal in the sensor, e.g., an optical encoder component. The radiation may be radiation reflected by the moving component and impacting the component from a radiation source such as a photoelectric radiation source (e.g., an LED). The radiation source may be an IR source (IR-LED, infrared light-emitting diode). The radiation source may be part of a sensor arrangement that includes at least one sensor. One possible implementation of the sensor is an IR sensor configured to detect infrared light. The light source and sensor may be arranged on the same component or assembly. The general functionality of the photoelectric sensor arrangement applicable to the electronic systems 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 respect to different sensor arrangements and configurations. However, it should be noted that other sensor arrangements may also be employed, for example, using magnetic sensors. In motion sensing units having electrically operated sensors and / or electrically operated sources (such as radiating emitters and associated sensors) for stimulating the sensors, power consumption may be particularly high, and therefore, appropriate power management of the electrical power available to power the system may have specific implications. For example, a signal generated by a user proximity detection unit may be used to switch the motion sensing unit from a non-operating or off state to an operating or on state. Electronic control unit 1100 may switch the motion sensing unit to a higher power consumption operating state in response to a signal generated by the user proximity detection unit that can be fed to electronic control unit 1100 or detected by said electronic control unit. In the depicted embodiment, the motion sensing unit is arranged on the surface of the conductor carrier's back delivery surface 1620 and / or the electronic control unit 1100 or the back sensor controller 1340. This is particularly suitable if the photoelectric unit is used for motion sensing and the component whose motion should be sensed is arranged on the same side of the conductor carrier as the motion sensing unit 1200.
[0144] Motion sensing unit 1200 can be designed to detect, preferably measure, or quantify, the relative movement of one component of the drug delivery device or the dose setting and drive mechanism of the 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 rotational movement of two movable components of the dose setting and drive mechanism of the drug delivery device relative to each other, such as the movement of a selector sleeve, a digital sleeve, relative to a drive sleeve, or a button / knob of a user interface component. Based on the movement data received or calculated from the unit 1200, the electronic system (e.g., control unit 1100) can calculate dose data, such as data regarding the dose currently delivered during an ongoing or completed dose delivery operation. 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 relative rotational movement. For example, the first component may rotate relative to the second component, such as during dose delivery. The motion sensing unit is conveniently adapted to quantify the relative movement in integer multiples of a unit setting increment. The unit increment can be defined by an angle greater than or equal to one of the following values: 5°, 10°. The unit setting increment can be defined by an angle less than or equal to one of the following values: 25°, 20°. For example, the unit setting increment can be between 5° and 25°. For example, the unit setting increment can correspond to a relative rotation of 15°. The unit setting increment can be the rotation required to set the minimum settable dose to be delivered by the device. As explained above, the amount or distance of relative movement between the first and second components determined by the motion sensing unit can characterize the current set dose in the dose setting operation or the current dispensed dose in the dose delivery operation. The magnitude of the delivered dose can be determined by or correspond to the distance by which the piston rod of the dose setting and drive mechanism is displaced distally relative to the housing 10 during the dose delivery operation.
[0145] As indicated by the double arrows, the motion sensing unit is preferably bidirectionally conductively connected to the electronic control unit 1100. One direction may be the direction in which an activation signal is transmitted from the electronic control unit to the motion sensing unit to switch the unit to an operational state. In the other direction, motion signals may be sent from the motion sensing unit to the control unit, which may further process the signals, for example, to calculate dosage information or data.
[0146] The user interface component body 1605 is arranged between the electrode system 1345 and the outer surface of the user interface component, such that the user will not touch the electrode 1345 when touching the outer surface in the area overlapping with the electrode 1345. However, it is also conceivable that the user can touch the electrode. Having electrodes inside helps to seal the interior from external influences, such as moisture and / or dirt. A sealed interior with the user interface component is a preferred embodiment. For this purpose, the distal opening shown in FIG2 can be closed, for example, via the user interface component part or the base 1670, which will be explained further below. The electrode system 1345 can provide a large sensitivity surface area for a capacitive sensor formed by the controller 1340 in conjunction with the electrode system 1345. The sensor can be or may include a (low-power) controller that monitors the electrical characteristics input from the sensor electrode 1345 to the controller. The sensor controller 1340 is conveniently configured to perform sensor measurements or acquire sensor signals having a frequency (polling frequency) or response rate. The frequency or response rate can be less than or equal to one of the following values: 10Hz, 5Hz, 4Hz, 3Hz, 2Hz, 1Hz. The power consumption of sensor 1340 can be less than or equal to one of the following values: 15μA, 10μA, 8μA, 7μA, 6μA, 5μA, 4μA, 3μA. It should be understood that power consumption depends on the frequency of measurement. The more frequently the sensor is polled, i.e., the measurement is performed, the higher the power consumption will be. The orders of magnitude of the power consumption described above apply to the frequencies described above. These frequencies are particularly suitable if the user proximity detection unit 1330 monitors proximity to a setting surface of the user interface component. Lower frequencies may be sufficient because the time between dose setting and dose delivery is relatively high, as the user needs to switch between the two surfaces to operate the system or device, and / or because setting the dose typically takes longer, as the set dose needs to be verified through a user inspection window and / or adjustment. In cases where the delivery surface is monitored by the sensor, the frequency may have to be greater than or equal to one of the following values: 40Hz, 50Hz, 60Hz, 70Hz, 80Hz, 90Hz, 100Hz. This involves higher power consumption, for example, greater than or equal to one of the following values: 30 μA, 40 μA, 50 μA, 60 μA, 70 μA, 80 μA, 90 μA, 100 μA. Higher frequencies are particularly suitable if the signal generated by the user proximity detection unit is used to switch the system to a higher power consumption state, specifically to switch the motion sensing unit to an operational state, since the unit may need to be operational during dose delivery operations that occur at considerable proximity to the touch delivery surface. If the proximity to the delivery surface is monitored for another purpose (e.g., to activate another function of the system, such as in relation to the communication unit (see below)), then lower frequencies or response rates, as further specified above, may be appropriate.The sensor controller 1340 and the control unit 1100 can be mounted on the same surface of the carrier 3000 or on different surfaces.
[0147] Viewed from the outside of the component (e.g., in a top view onto delivery surface 1620), the radial width or diameter of the user interface component 1600 may be less than or equal to one of the following values: 2.5 cm, 2 cm, or 1.5 cm. Alternatively or additionally, the radial width or diameter of the user interface component may be greater than or equal to one of the following values: 0.5 cm or 0.7 cm. The radial extension may be determined relative to the axis of rotation of the user interface component during dose setting or relative to the main longitudinal axis or central axis of the user interface component, and these axes may coincide. The length or axial extension of the user interface component 1600 may be less than or equal to one of the following values: 2.5 cm, 2 cm, or 1.5 cm. Alternatively or additionally, the length or axial extension of the user interface component 1600 may be greater than or equal to one of the following values: 0.5 cm or 0.7 cm. For example, the radial width of the user interface component may be 18 mm, and the length may be 19 mm.
[0148] The electronic system 1000 further includes a communication unit 1400, such as an RF, WiFi, and / or Bluetooth unit (e.g., a Bluetooth Low Energy (BLE) unit). The communication unit 1400 may be provided as a communication interface between the system or drug delivery device and an external device (such as other electronic devices, e.g., a mobile phone, personal computer, laptop, etc.). For example, dose data may be transmitted to and / or synchronized with the external device by the communication unit. The dose data may be used for dose logs or dose histories established in the external device. The communication unit may be provided for wireless communication. Attempts to establish communication with the external device may be included within the operating routine of the electronic system, particularly after the motion sensing unit has measured, for example, relative movement indicating a dose delivery operation. Furthermore, the electronic system 1000 may include a function that the communication unit can be actuated independently, for example, performing data synchronization with the external device if an attempt to establish communication with the external device has failed or if such a device is not yet available. For example, this function may be triggered or actuated via a delivery surface, particularly if there is no touch on the set surface within a predetermined time (e.g., 10 seconds) prior to a signal indicating proximity to the delivery surface. Dosage data can be stored temporarily or permanently in an electronic system. For example, only the latest dose data or dose history data relating to the latest delivery operation, which contains dose data such as date, time or size for one or more doses (e.g., all doses) that have been delivered.
[0149] As already discussed, a user proximity detection unit (e.g., sensor controller 1340) is configured to output a signal (e.g., a proximity signal) that can be used to switch or trigger a switch of the electronic control unit 1100 or the electronic system to a higher power consumption state. The proximity signal can be fed to or detected by the electronic control unit 1100, which can then issue commands or signals to influence the operating state of the electronic system. In the higher power consumption state, the motion sensing unit 1200 and / or the communication unit 1400 can be operational. The proximity signal can be a signal indicating that a user is approaching a designated surface (a designated signal). Instead of using a proximity signal to a designated surface to wake up the motion sensing unit and / or the communication unit, this signal can be used to increase the power consumption for monitoring the delivery surface, for example, by increasing the frequency at which the sensor controller 1340 measures or polls for approach to the delivery surface 1620. The proximity signal (delivery signal) indicating that a user is approaching the delivery surface can be used to enable the motion sensing unit and / or the communication unit. Another or alternative possibility is that, for example, the delivery signal triggers the activation of the communication unit 1400 only if a setting signal precedes the delivery signal within a predetermined time interval, or preferably only if no preceding setting signal is present within the predetermined time interval. This proximity signal can be used to initiate a data synchronization event with an external device independent of the dose delivery operation. Therefore, the motion sensing unit can be operable when the communication unit is made operable or inoperable.
[0150] The electronic system 1000 is configured preferably releasably connected to a drug delivery device unit as an additional unit or module. The drug delivery device unit may be without electronics. Therefore, all electronics can be provided within the electronic system. The drug delivery device unit may be disposable. That is, the unit can be disposed of after its reservoir has been emptied, using the drug delivery device comprising the unit and system 1000. The electronic system 1000 can be detached from the drug delivery device unit and reused in another drug delivery device unit. The drug delivery device unit is preferably configured to operate fully on its own, i.e., it can be operated to set and deliver the set dose. An exemplary unit is the one depicted in FIG. 1. The electronic system may be a purely accessory to another fully functional unit. Alternatively, the drug delivery device may include an electronic system as an integral part, i.e., a part disposed of with the rest of the device and / or necessary to enable the device to operate to set and deliver drug doses, for example, because without the electronic system, the drug delivery device unit would lack a user-accessible surface for performing dose setting or dose delivery operations.
[0151] For connection to the drug delivery device unit, the electronic system may include one or more connection features 1615, such as snap-fit features. The corresponding connection features are arranged in the distal portion of the user interface component 1600, for example, within the component. As described above, the user interface component part can close the proximal end of the user interface component 1600. In this case, the connection feature 1615 is conveniently provided on the user interface component part, which can be directionally and / or axially fastened to the user interface component body 1605. The system 1000 is conveniently configured to be permanently or removably mechanically connected to components of the drug delivery device unit (such as components of the dose setting and drive mechanism), for example, to a drive sleeve or dose knob and / or injection button connected to the unit discussed in conjunction with FIG. 1. The system (e.g., via the user interface component body 1605) can be directionally and axially locked to the components of the drug delivery device unit. During dose setting and dose delivery, the components connected to the system are conveniently movable relative to housing 10, for example, movable in direction and / or axially during setting, and axially only during delivery, for example. The components connected to the system can engage a piston rod, for example, via a threaded engagement. The dose knob and drive sleeve of the unit in FIG1 can be integrally formed, or act as a single component during dose setting and dose delivery. During dose setting, the drive sleeve can be selectively locked in direction to the selector sleeve of the dose setting and drive mechanism, such that the selector sleeve and drive sleeve rotate together during dose setting, for example, via a coupling, and the selector sleeve rotates relative to the drive sleeve during dose delivery. The selector sleeve can be a digital sleeve. The relative rotation between the selector sleeve and the drive sleeve during dose delivery can be measured by a motion sensing unit. However, it will be apparent to those skilled in the art that the disclosed concept will also work with dose setting and drive mechanisms with different functions.
[0152] The electronic system 1000 depicted in Figure 2 includes a connection detection unit 1700. The connection detection unit 1700 is configured to detect whether the electronic system is connected to a drug delivery device unit. The system is configured such that, upon detecting a connection to the drug delivery device unit, the electronic system switches to a higher power consumption state. Upon detecting a connection to the drug delivery device unit, a detection signal can be generated or triggered. The electronic system can be configured such that, in response to the detection signal, the electronic system 1000 switches to a higher power consumption state.
[0153] For example, the connection detection unit 1700 can electrically connect the power supply 1500 to other components or units of the electronic system, thereby enabling these components or units to operate when properly activated, for example, by an electronic control unit. Specifically, when a connection to the drug delivery device unit is detected, power can be supplied from the power supply to the corresponding component or unit. When no connection is detected, the power supply can be disconnected from the corresponding component or unit of the electronic system. Therefore, the connection detection unit can be or can be connected to a circuit breaker that shuts off the power supply unless a connection to the device unit is detected.
[0154] Alternatively or additionally, the connection detection unit 1700 is configured to switch the user proximity detection unit 1330 to a higher power consumption state (e.g., a state in which the proximity or use detection unit is operable). The proximity or use detection unit may be inoperable in a first state before being switched to the higher power consumption state by the connection detection unit. The connection detection unit may trigger the activation of a capacitive sensor or associated sensor controller, for example, preferably sensing proximity to the set surface and / or delivery surface at a low frequency.
[0155] Therefore, the connection detection unit 1700 can be connected to the electronic control unit 1100 and, via the electronic control unit, activate or switch a corresponding unit to a higher power consumption state. Alternatively, it can be directly connected to a corresponding unit that should be switched to a higher power consumption state by the connection detection unit, such as the sensor controller 1340. For example, the connection detection unit 1700 may include a switch 1710, such as a micro (force) switch. The switch may be arranged on the side of the carrier 3000 facing the opening of the user interface component body 1605. The opening may be designed to receive a component of the device unit when the device unit and the system are connected. The switch 1710 may be arranged to mechanically contact or mechanically interact with a component of the drug delivery device unit and / or be arranged to be triggered by the component. The component may be the same component connected to the electronic system 1000 via one or more connection features 1615. When the switch is triggered, the use of the detection unit or user proximity detection unit can become operable. In this way, the power consumption of the unit during storage can be avoided or at least significantly reduced.
[0156] For example, when the system includes a capacitive sensor for user proximity detection, as discussed above, periodic measurements may be required when the sensor operates to check if a user is near a relevant surface, for example, at the frequency described above. Each measurement draws power from the power source. Therefore, such power consumption would be entirely unnecessary when the system is not connected to the drug delivery unit, and connecting the detection unit would enable the capacitive sensor to operate, for example, at the low frequency discussed above. Thus, connecting the detection unit improves power management, especially during storage when the electronics are separated from the drug delivery unit.
[0157] We note that the connection detection unit 1700, as discussed above, is applicable not only to the user proximity detection unit 1330, but also to other units of the electronic system, such as electronic control units, motion sensing units, communication units, or even other units. For example, the connection detection unit can also operate in conjunction with setting sensors, delivery sensors, and / or wake-up units, provided that it is feasible under certain conditions. When the connection detection unit does not detect a system connection to the device unit, the power consumption can be zero or less than the power consumption when only the electronic system's user detection unit is activated.
[0158] Figures 3A to 3C illustrate implementation schemes of electronic system 1000 and / or electrode system 1345.
[0159] Figure 3A shows a schematic perspective view of an electronic system 1000 for a drug delivery device, such as one integrated into the device or connected as an add-on to a device unit (e.g., the device or device unit 1 already discussed above in conjunction with Figure 1). The general setup has been explained above. Therefore, this specification focuses on matters not yet discussed.
[0160] Figure 3A illustrates a user interface component 1600 having a setting surface 1610 and a delivery surface 1620, both formed by a user interface component body 1605, which is preferably made of plastic or otherwise electrically insulated. The setting surface 1610 is conveniently structured to facilitate the skin of one or more user fingers being as close as possible to the electrode system 1345 of the user proximity detection unit 1330. However, the user interface component body 1605 is preferably circumferentially closed. In particular, the setting surface can be a continuous surface. Openings may be absent in the radially facing and angled-extending setting surface. This can also apply to the axially facing and radially extending delivery surface 1620. Therefore, the user interface component body 1605 is also preferably closed proximally. As already discussed, this helps to provide a sealed interior within the user interface component 1600 to accommodate one or more electrical or electronic components. Further, in Figure 3A, a plane P is shown, which visualizes the plane along which the cross-section taken in the cross-sectional perspective view of Figure 3B is located.
[0161] Figure 3B illustrates the user interface component body 1605. Further, the conductor carrier 3000 is shown having an electronic control unit 1100. A part 1630 is held within the user interface component body 1605 and is preferably (e.g., directionally and / or axially) fixed to the body. Part 1630 may be a spacer component 1510 (not shown), which will be discussed later below. The spacer component may define the (mounting) space of the electronic components on the conductor carrier 3000 within the user interface component and / or maintain the distance between the electronic components and other components (such as power supplies) within the component. Alternatively, part 1630 may be a user interface component part or a base frame 1670 (not shown here), which may, for example, define the interior of the user interface component distally. For the present purposes, it is sufficient to discuss a generic part 1630. Part 1630 may have an outer surface that extends circumferentially and is preferably circumferentially closed. The user interface component 1605 has an inner surface facing the outer surface of part 1630. The inner surface may have a cylindrical configuration. An electrode system 1345, or at least its sensing area (such as a setting sensing area 1310), is arranged between the outer surface of part 1630 and the inner surface of the user interface component body 1605. An electrode arrangement 1360 (further details regarding suitable electrode arrangements are discussed below) is provided on a flexible conductor carrier 1350 of the electrode system. The flexible conductor carrier 1350 and the electrode system 1345 may be conformable to the inner surface of the user interface component body 1605, particularly to a surface defining the same wall as the setting surface 1610 but opposite to it. When conforming to the inner surface, the circumferential extension of the flexible conductor carrier 1350 is conveniently greater than or equal to one of the following values: 270°, 355°, 360°, 40°. Alternatively or additionally, the circumferential extension is less than or equal to one of the following values: 540°, 450°. Having a circumferential extension within a specified range (e.g., greater than 270° and less than or equal to 540°) allows for electrode arrangements on a large proportion of the operating surface (in this case, setting surface 1610). An extension greater than 360° enables a region of the flexible conductor carrier 1350 to be radially (e.g., radially outward) covered by another region of the flexible conductor carrier 1350, which helps protect sensitive areas of the conductor carrier through this other region.
[0162] Electrode system 1345 preferably has a plurality of conductive electrode tracks extending along an electrically insulating conductor carrier 1350. The flexible conductor carrier 1350, together with the electrode arrangement of the electrode tracks extending thereon, can form a sensor electrode system, for example, a flexible printed circuit board. The entire electrode system 1345 can be flexible. The flexible conductor carrier 1350 has a contact connection region 1352. In the contact connection region 1352, one or more conductive terminals may be provided, each terminal being associated with or part of a conductive electrode track of the electrode system. The contact connection region 1352 may be configured to connect to or may include an FCC connector. Through the contact connection region 1352, electrode system 1345 can be electrically connected directly or indirectly (e.g., via a conductor on conductor carrier 3000 or via a connector to sensor controller 1340) to a sensor controller 1340 arranged on conductor carrier 3000. This provides an operative connection between sensor controller 1340 and sensor electrode system 1345, including the electrode arrangement and flexible conductor carrier 1350. The sensor controller and electrode system together form a capacitive sensor as described above. The contact connection area 1352 of the flexible conductor carrier with associated electrode tracks can extend inward from the outer surface of part 1630. For example, the user interface component 1600 can extend perpendicularly to the carrier 3000 when viewed in the radial direction and / or as in a direction perpendicular to the axis of the user interface component 1600. The electrode system 1345 or the flexible conductor carrier 1350 conveniently has a deformable configuration or shape when arranged in the user interface component 1600. That is, the shape or configuration has been changed from a non-deformable or first configuration or shape to a deformable or second configuration or shape for arranging the system in the user interface component. The electrode system 1345 with the flexible conductor carrier 1350 and the electrode arrangement is conveniently elastically deformable, such that when the electrode system or the flexible conductor carrier is applied in the user interface component 1600, it tends to restore its non-deformable shape due to the inherent elastic restoring force that tends to reconstruct the non-deformable configuration or shape. The elasticity can be provided by the electrode arrangement or the flexible conductor carrier or both. The elastic restoring force applied by the electrode system or flexible conductor carrier 1350 can be used to conform the electrode system or its region to the inner surface or wall of the user interface component body 160. In the present case, the inner surface of the user interface component body 1605 away from the setting surface 1610 (particularly in the radial and / or inward direction) defines the surface to which the electrode system of the flexible conductor carrier conforms. The non-deformable configuration of the flexible conductor carrier can be a flat or planar configuration. That is, in the non-deformable configuration, the flexible conductor carrier can be oriented along a plane.
[0163] Figure 3C illustrates the effect or use of elastic restoring force using two different representations (i.e., A and B). Representation A shows the state when the sensor electrode system 1345 has been introduced into the user interface component body, for example, through a distal opening. To introduce the sensor electrode system into the user interface component body, the sensor electrode system has been deformed from a first configuration (e.g., where it has an extension greater than the width of the opening in the user interface component body) to a second configuration (where the extension is less than the width). The first configuration can be a non-deformable configuration. The second configuration can be a deformable configuration and / or an intermediate configuration during the assembly of the electronic system. In the second configuration, the electrode system 1345 conveniently conforms to the outer surface of part 1630 in at least one or more regions. Thus, in the second configuration, the outer diameter of part 1630 can determine the size of the electrode system (e.g., its diameter). The contact connection region 1352 extends inward (e.g., radially inward) relative to / originating from the sensing region 1310. The contact connection region 1352 is conveniently electrically connected to the sensor controller 1340, as previously described, which is not shown in detail here.
[0164] The situation depicted in Figure 3C (represented as A) can be a situation that occurs during the assembly of the electronic system. A sub-assembly, including the electrode system and part 1630, can be introduced into the user interface component body 1605, for example, such that the sub-assembly is completely received within the user interface component body 1605. When on the outside of the user interface component body 1605, preferably also during introduction, the deformed electrode system 1345 can be maintained in contact with the outer surface of part 1630, for example, by tooling or manually. After the sub-assembly has been introduced into the interior of the user interface component body 1605, the electrode system can be allowed to relax toward its non-deformed configuration, for example, by removing the tool, and engage the inner wall of the user interface component body 1605 (e.g., the surface opposite to the set surface 1610). The situation shown in Represented as B can be a situation when the electronic system transforms from an intermediate configuration toward its final or third configuration in the assembled electronic system 1000 by means of its inherent elastic restoring force. Clearly, in representation B, the outer surface of the electrode system 1345 is conformable to the inner surface of the user interface component body 1605, particularly along the extension of the sensing region 1310, for example, at least 340° or greater, such as at least: 345°, 350°, 355°.
[0165] Electrode system 1345 has two opposite ends: a first end 1356 and a second end 1358, for example, angled ends, especially when positioned within the user interface component body. In a second or modified configuration, when the electrode system has been incorporated into the user interface component body 1605 and / or in an intermediate configuration, a region 1354 may exist in which the electrode system overlaps with itself at an angle. That is, there exists an angular position in which, when advancing radially (e.g., outward) toward the electrode system (e.g., the flexible conductor carrier or sensing area 1310) from the interior of part 1630, the inner surface of the electrode system is followed by the outer surface of the electronic system, which is again followed by the inner surface of the electronic system, which is followed by the outer surface of the electronic system, for example, directly facing the inner surface of the user interface component body 1605. In other words, the length of the electrode system may be greater than the circumference of part 1630. In the second configuration, the electrode system or its sensing area may be wound or coiled around part 1630 to a degree greater than one loop, but preferably less than two loops. In the third or final configuration of the electronic system, an angular gap 1361 may exist between the two angled ends of the electronic system or sensing area 1310, as depicted in representation B. Alternatively, in the third or final configuration, angular overlap of the electrode system may still exist, such that area 1354 also exists in the final configuration (not shown) and not only in the intermediate configuration. When transitioning from a deformable configuration to a non-deformable configuration until reaching the final configuration which is still deformable or biased (because further movement toward the non-deformable configuration is blocked by the inner wall of the user interface component body 1605), the electronic system (particularly the sensing area 1310) may extend toward the inner wall until it impacts the inner wall of the user interface component body, as indicated by the arrow in representation A.
[0166] In this embodiment, a flat, flexible electrode system can be wound around part 1630. Subsequently, body 1605 can be assembled, thereby constraining the electrode system. The natural stiffness or resilience of conductor carrier 1350 will act to unwind the electrode system, effectively biasing it outwards into the body 1605. In this way, the electrode system can reliably conform to a range of sizes of the outer housing part, which can be anticipated from the injection molding process, for example, due to manufacturing tolerances.
[0167] Figure 4 illustrates an exemplary embodiment of an electrode system 1345 for an electronic system 1000 (e.g., the electronic system discussed above). Therefore, the following discussion focuses on aspects not yet discussed, where the features discussed above also apply to this embodiment. The electrode system 1345 is shown in its first or non-deformable configuration, e.g., a flat configuration. The flexible conductor carrier 1350 is shown having an electrode arrangement 1360 extending along the flexible conductor carrier. Two (opposite) ends 1356 and 1358 of the flexible conductor carrier 1350 or electrode system 1345 are shown, which define the electronic system, for example, along a main extension direction or length direction. The distance between the two opposite ends 1356 and 1358 may define the length L of the electrode system 1345. The length L is conveniently chosen such that at least 350° of the circumferential extension of the inner surface of the user interface component body 1605 can be covered by the electrode system when conforming to or abutting the inner surface. As already noted, the length may even be greater than the circumferential extension of the inner surface.
[0168] Electrode system 1345, and particularly its electrode arrangement 1360, further includes a plurality of conductive electrode tracks. The depicted embodiment shows two electrode tracks: a first electrode track 1362 and a second electrode track 1364. The electrode tracks may be metallic, such as copper. Electrode tracks 1362 and 1364 extend along a flexible conductor carrier 1350. Electrode system 1345 has a sensing region, in this case a defined sensing region 1310. Electrode tracks 1362 and 1364 both extend within the sensing region 1310. In the depicted configuration, the width of the sensing region 1310 (i.e., its length or extension perpendicular to the main longitudinal direction) is constant along the main longitudinal direction. The sensing region 1310 has a rectangular shape in the depicted embodiment and is highlighted by a dashed rectangle in FIG. 4. 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 depicted embodiment, electrode track 1364 forms the sensing electrode). In the sensing region, the other of the first and second electrode tracks (in the depicted embodiment, electrode track 1362) defines or forms a reference electrode 1368. It is noted that the electrode track 1362 or 1364 providing the sensing electrode and the electrode track providing the reference electrode can also be reversed.
[0169] During operation, electrodes 1366 and 1368 are configured to provide different potentials (e.g., a positive potential for the sensing electrode and a negative potential for the reference electrode, or vice versa (a potential difference with the same sign may suffice)), such that an electric field is formed due to the different potentials between the two electrodes (the sensing electrode and the reference electrode). Changes in this electric field and / or changes in the capacitance between the electrodes can be evaluated by a sensor controller 1340, to which the sensing electrode and / or the reference electrode are electrically connected.
[0170] The sensing electrode 1366 includes a plurality of sensing electrode portions 1369. These portions are arranged sequentially and spaced apart from each other along the sensing region 1310, as viewed in length or main direction. The portions 1369 are oriented in a direction perpendicular to the main extension direction of the sensing region and / or, when the electrode system is arranged in the body, along the axial extension direction of the setting surface 1610 of the user interface component body 1605. The portions 1369 are oriented parallel to each other. The portions 1369 may have the same configuration. Once the electrode system 1345 has been positioned in the user interface component body 1605, the last portion 1369 near end 1358 may also have a configuration as wide as the other portions and / or cooperate with the portion near end 1356 of the electrode track 1364 to form a combined sensing electrode portion having the same or similar width as the other continuous electrode portions 1369. The portions 1369 are electrically connected via a connecting portion 1370 of the electrode track 1364. The portions 1369 protrude from the connecting portion 1370. Therefore, in the depicted embodiment, the sensing electrode 1366 may have a comb-like configuration.
[0171] The reference electrode 1368 includes a plurality of reference electrode portions 1371. These portions are arranged sequentially and spaced apart from each other along the sensing region 1310, as viewed in length or main direction. The portions 1371 are oriented in a direction perpendicular to the main extension direction of the sensing region and / or, when the electrode system is arranged in the body, along the axial extension direction of the setting surface 1610 of the user interface component body 1605. The portions 1371 are oriented parallel to each other. The portions 1371 may have the same configuration. The portions 1371 are electrically connected via connecting portions 1372. The portions 1371 protrude from the connecting portions 1372. Therefore, in the depicted embodiment, the reference electrode 1368 may have a comb-like configuration.
[0172] Reference electrode 1368 and sensing electrode 1366 are arranged such that they are staggered. Specifically, electrode portions 1369 and 1371 may be alternately arranged along the main longitudinal direction of sensing region 1310. That is, sensing electrode portion 1369 and reference electrode portion 1371 may alternate as they travel along the main extension direction of sensing region, preferably along line C (e.g., the centerline of sensing region 1310). Specifically, a sensing electrode portion is followed by a reference electrode portion, which is then followed again by a sensing electrode portion, and so on. Sensing electrode 1366 and reference electrode 1368 may be configured such that the distance between the sensing electrode and the reference electrode (which can be measured to the nearest portion of the corresponding other electrode) within sensing region 1310 is conveniently constant or does not change significantly. However, other configurations are also possible, for example, where the distance between the sensing electrode and the reference electrode varies within sensing region 1310. The distance between the reference electrode and the sensing electrode within sensing region should ideally be selected such that a target (e.g., one or more fingers of a user) can be reliably detected.
[0173] The reference electrode portion and the sensing electrode portion are preferably configured similarly. For example, they may have the same length (the distance from which they protrude from the corresponding connecting portion) and / or the same width (the dimension of the extension perpendicular to the corresponding connecting portion). The ends of the reference electrode portion and the sensing electrode portion may face different directions or be oriented in different directions. Connecting portions 1370 and 1372 are oriented towards each other. The sensing electrode portion may be oriented proximally or distally. The reference electrode portion may be oriented in the opposite direction, for example, distally or proximally. In Figure 4, the upward direction may be the proximal direction (to which the sensing electrode portion 1369 is oriented). The connecting portions may extend parallel to each other. The reference electrode portion may be uniformly distributed along the sensing area. The sensing electrode portion may be uniformly distributed along the sensing area.
[0174] In the depicted embodiment, the contact connection region 1352 of the flexible conductor carrier 1350 is a flexible and / or foldable tab. The tab can be flexible enough to be deflected or folded relative to the sensing region 1310. A notch 1373 (e.g., a notch) may be provided in the flexible conductor carrier between the contact connection region and the sensing region. This facilitates easier bending or flexing of the tab relative to the rest of the conductor carrier 1350. In the depicted embodiment, the contact connection region 1352 is located near the end 1356 of the flexible conductor carrier 1350. Specifically, the contact connection region (e.g., the tab) may define a portion of the end of the flexible conductor carrier. However, it should be noted that other configurations of the contact connection portion 1352 may also be used, such as the contact connection portion being within or away from both ends of the sensing region 1310, or having a different configuration. In the contact connection region 1352, the width of the electrode track is narrower compared to the electrode portion and / or connection portion in the sensing region. For example, corresponding electrode tracks 1362 and 1364 can be connected via an intermediate portion to terminals 1374 and 1375 of the first electrode track 1362 and the second electrode track 1364, said intermediate portion being narrower than the portions of the associated electrodes in the sensing region (e.g., the electrode portions of sensing electrode 1364 and reference electrode 1368). Terminals 1375 and 1374 can be configured to couple to a plug-in connector, such as an FCC plug-in connector or a Slimstack connector. Electrode tracks 1362 and 1364 can be electrically connected to different terminals or channels of the sensor controller 1340 via terminals 1375 and 1374.
[0175] To achieve controlled sensitivity of the capacitive sensor, it is advantageous for the sensor controller to have a clear ground plane relative to the sensing electrode 1366. This ground plane can be provided by the reference electrode 1368. Positioning the reference electrode close to the surface to be monitored is advantageous for more uniform sensitivity of the sensor, as opposed to a reference potential or ground potential further within the system. For example, during operation, an electric field (e.g., a static or dynamic field) can be applied to both the sensing and reference electrodes. As the field changes, the capacitance of the sensor changes. The more uniform the field, the more uniform the sensitivity of the sensor. The depicted arrangement has proven particularly suitable for uniform sensitivity. For cylindrical arrangements (such as in the user interface component body 1605), it has been found that particularly good or uniform sensitivity can be achieved with staggered electrode tracks 1362 and 1364, as depicted in FIG. 4, where the reference electrode is staggered with the sensing electrode. The exact size and amount of the tracks or electrode portions in the sensing area can be varied, for example, to accommodate the detection of a small hand. When monitoring proximity to a set surface, the sensitivity of the sensor with the electrode system shown is conveniently uniform in the circumferential direction. The design depicted in Figure 4 is particularly suitable for achieving uniform sensitivity of a user interface component body with a surface structure on an external surface.
[0176] The number of reference electrode portions is preferably equal to the number of sensing electrode portions. The number of reference electrode portions and / or sensing electrode portions can be even or odd, for example, 3, 4, 5, 6, 7, or 8. Having an odd number of reference electrode portions and sensing electrode portions facilitates, in a generally cylindrical setup (e.g., when the electrode system 1345 is arranged in the user interface member body 1605), the arrangement of one reference electrode portion opposite to one sensing electrode portion (e.g., offset by 180° in the angular direction). Having sensing electrode portions uniformly distributed along the flexible conductor carrier and reference electrode portions uniformly distributed along the flexible conductor carrier 1350 facilitates such an arrangement. When a user attempts to set a dose, it is expected that when using the most natural combination of fingers (i.e., index finger and thumb) for dose setting, the user touches the setting surface 1610 of the user interface member at a diametrically opposite position. If the electrode portions (sensing electrode portions and reference electrode portions) of different potentials are offset by 180° (which is facilitated by having an odd number of sensing electrode portions and reference electrode portions), the change in electric field or capacitance is expected to be particularly noticeable. Figure 5 illustrates this using three parts in a distance manner, where each reference electrode part 1369 is diametrically opposed to a sensing electrode part 1371.
[0177] Figure 6 illustrates another embodiment of the electrode system 1345, which is very similar to the electrode system 1345 discussed in conjunction with Figure 4. Therefore, the following description will focus on the differences. One difference is that the electronic system 1345 includes two distinct sensing regions. Specifically, the electrode system includes a delivery sensing region 1320, which, in addition to the setting sensing region 1310, is also highlighted by a dashed rectangle in Figure 6. A sensing electrode 1376 is arranged in the delivery sensing region 1320. The sensing electrode 1376 may be a delivery sensing electrode. A reference electrode 1368 is associated with the sensing electrode 1376 within the sensing region 1320, but is electrically isolated 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 arranged such that the reference electrode 1368 extends at least a majority (e.g., at least 280° of the outer circumference) of the sensing electrode 1376 within the sensing region 1320. In the depicted embodiment, the sensing electrode 1376 has a circular circumference or outer contour. Other shapes are also possible. Instead of a continuous configuration without openings, the sensing electrode 1376 or the sensing region may also have an annular configuration. The flexible conductor carrier 1350 may, for example, have a hole in the middle of the sensing electrode 1376 (not explicitly shown), particularly when the sensing electrode 1376 has an annular configuration. The sensing region 1320 may have a curved and / or generally circular circumference as depicted.
[0178] Sensing electrode 1376 is formed or defined by electrode tracks 1378 of electrode arrangement 1360 extending in sensing region 1320. Electrode tracks 1378 conveniently exist in electrode arrangement 1360, except for electrode tracks 1362 and 1364. The electrode tracks of the arrangement are conveniently electrically insulated from each other along the entire flexible conductor carrier 1350. Reference electrode 1368 for sensing electrode 1366 and for sensing electrode 1376 can be formed from the same electrode track in different sensing regions. Therefore, electrode track 1364 for reference electrode 1368 can extend in different sensing regions. Electrode tracks for sensing electrodes 1366 and 1376 conveniently extend only in one sensing region (i.e., setting sensing region 1310 or delivering sensing region 1320). Alternatively or additionally, the electrode track 1362 for the reference electrode 1368 is preferably arranged continuously (as depicted in FIG. 6) between the electrode track 1378 for the sensing electrode 1376 and the electrode track 1364 for the sensing electrode 1366. Terminals 1379 for contact connection with the electrode track 1378 are formed in the contact connection region 1352. The electrode track 1378 or the sensing electrode 1320 can be electrically connected to the sensor controller 1340 (e.g., a separate channel or its input, especially a channel or input separate from the channel or input for the sensing electrode 1366 and / or the reference electrode 1368) via the terminals 1379.
[0179] Sensing region 1320 is connected to the remainder of flexible conductor carrier 1350 via connecting region 1380. The connecting region extends from the remainder of flexible conductor carrier 1350 toward the sensing region and mechanically connects sensing region 1320 to the remainder of flexible conductor carrier 1350. Connecting region 1380 may have a width less than its length (where the length is the extension from the remainder of conductor carrier 1350 to sensing region 1320). The width of connecting region may be less than the width of sensing region 1320. Together with sensing region 1320, connecting region 1380 can form a foldable tab of electrode system 1345.
[0180] In addition to the reference electrode 1368 and / or the sensing electrode 1366 (setting sensing electrode), a separate electrode track 1378 for the sensing electrode 1376 (delivery sensing electrode) improves the proximity sensing of the delivery surface due to the reference electrode and / or enables the differentiation of the proximity of the delivery surface 1620 and the setting surface 1610 of the user interface component due to the two electrically separated electrode tracks assigned to these surfaces.
[0181] In the connection region 1380, the flexible conductor carrier 1350 can be deformed particularly easily, preferably elastically, such that sensing regions 1310 and 1320 can be oriented in different directions (e.g., mutually perpendicular directions). The delivery sensing region 1320 can be adapted to an inner surface of the user interface component body 1605 opposite to or away from the delivery surface 1620. The setting sensing region 1310 can be adapted to an inner surface of the user interface component body 1605 opposite to or away from the setting surface 1610. The connection region 1380 can be elastically deformable such that, when the electrode system is applied in the user interface component, the connection region can bias the sensing region 1320 toward the inner surface of the user interface component body 1605 opposite to the delivery surface 1620. Alternatively or additionally, a biasing member can be provided in the electrode system that biases the sensing region 1320 of the flexible conductor carrier 1350 toward the delivery surface 1620 (e.g., proximal).
[0182] Figure 7 schematically illustrates a biasing member 1381, such as a spring, like a compression spring. The biasing member 1381 is provided to bias the sensing area 1320 toward the inner or internal surface of the user interface component body 1605 and the delivery surface 1620. The biasing member 1381 may be formed of a metal component (e.g., a metal press). The biasing member 1381 need not be a helical compression spring 1381 as schematically depicted. Other rebound structures may be suitable for this purpose, as will become apparent from further discussion below (see arm-shaped biasing portion 1540 of the biasing member 1520, which may simultaneously serve 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 that is axially and preferably directionally fastened relative to the user interface component body 1605, or by the body itself. The part reacting to the force may be part 1630, as discussed above.
[0183] It is advantageous if the electrode system 1345 is adjusted according to the user interface component body such that, when the electrode system is arranged in the electronic system, the connection region 1380 conforms to the inner surface of the transition region 1618 between the delivery surface and the setting surface. The transition region 1618 can be externally curved to connect the radially oriented delivery surface with the axially oriented setting surface. For the user, the likelihood of acting on the transition region to manipulate the user interface component 1600 is less than on the delivery surface and the setting surface. Therefore, a dedicated sensing area is not necessarily required in the transition region of the user interface component body 1605.
[0184] It should be noted that the following is also within the scope of this disclosure: having an electrode system 1345 having only one sensing region, wherein the corresponding sensing region of the electrode system is a delivery sensing region or a delivery sensing region associated only with a delivery surface.
[0185] Providing a wound electrode system (e.g., a flexible printed circuit board) as described in conjunction with Figures 3A to 4 will offer sensitivity to touch on a setting surface (e.g., a cylindrical "grip" surface). Adding a foldable tab for delivering the sensing area can also extend this sensitivity to the delivery surface or top surface. Additional electrode tracks provide differentiation between the two touch points (setting surface and delivery surface). Crosstalk between the two channels or tracks is minimized in several ways. First, the proximity between the two electrode tracks for the sensing area is minimized as much as possible. Second, a ground track or reference electrode track 1362 shared by the two channels is always present between the two sensing electrodes. Finally, the electrode system or sensing area 1310 can extend or wound more than 360° along the inner surface of the user interface component body and / or the outer surface of the part 1630, for example, covering any areas where the delivery sensing electrodes and / or contact connection area 1352 may be vulnerable.
[0186] The electrode system 1345 is not limited to having one or more sensing electrodes and / or associated one or more reference electrodes. Instead, other electrodes, such as electrodes for antennas or other structures with conductive features or tracks, can be implemented on the flexible conductor carrier 1350. Thus, the electrode system may include electrode tracks for antennas (e.g., for communication unit 1400), such as Bluetooth communication units, preferably Bluetooth Low Energy (BLE) communication units.
[0187] Figures 8A to 8C schematically illustrate another embodiment of the electrode system 1345 for the electronic system 1000. Overall, system 1345 is similar to the system further described above in conjunction with Figures 4 and 6. Therefore, this description focuses on the differences.
[0188] As previously discussed in Figures 4 and 6, the electrode system 1345 is shown in a first configuration or flat configuration, i.e., before it has been incorporated into the user interface component body 1605 and before deformation. The electrode arrangement 1360 is not explicitly shown in this embodiment. Generally, it is envisioned that the electrode tracks be provided in the same manner as in the embodiment of Figure 6. Therefore, three electrode tracks are provided, one for sensing electrode 1366, one for sensing electrode 1376, and one for reference electrode 1368. Specific track configurations are not shown, as discussed above. In the respective sensing regions 1310 or 1320, the associated sensing electrode 1366 or 1376 is preferably disposed together with the associated reference electrode 1368, which again can be formed by a common track or electrode for sensing regions 1310 and 1320.
[0189] In the depicted embodiments, sensing regions 1320 and / or sensing regions 1310 may be distributed across multiple individual sensing regions of the flexible conductor carrier 1350. As depicted in FIG8A, multiple individual regions, for delivering sensing regions 1320, are provided, for example, three regions. In other words, the conductor carrier 1350 has multiple delivery sensing regions 1320. Each of these delivery sensing regions is connected to the remainder of the conductor carrier 1350 via an associated connection region 1380, wherein preferably, a different connection region 1380 is associated with each sensing region 1320. Particularly in the first configuration, the connection region 1380 is oriented at an angle or perpendicular to the main extension direction of the flexible conductor carrier 1350. Conveniently, the different delivery sensing regions 1320 are similarly configured. Electrode tracks 1378 and 1362 may define electrodes within the delivery sensing regions.
[0190] As an alternative to or supplement to the plurality of delivery sensing regions 1320, a plurality (e.g., four) of separate regions for setting sensing regions 1310 may be provided along the main extension direction of the flexible conductor carrier 1350. In other words, the flexible conductor carrier has a plurality of setting sensing regions 1310. Each connection region 1380 emerges from an associated setting sensing region 1310. The setting sensing regions 1310 are arranged sequentially, for example, in a linear manner, along the main extension direction or length direction of the flexible conductor carrier 1350 or the electrode system 1345. The setting sensing regions 1310 preferably have equal lengths, that is, their extensions along the main extension direction may be equal. The widths may also be equal for at least the plurality of regions 1310. A region may have a different width (e.g., the contact connection region 1352 emerges from said width), which facilitates contact connection with the sensor controller at locations offset from but radially overlapping the delivery sensing regions 1320 or the delivery surface 1620 (distally). The corresponding connection regions 1380 may emerge from the sensing region 1310 at different locations within the different sensing regions 1310. For example, the rightmost sensing region 1320 with the emerging connection region 1380, or the sensing region closest to the contact connection region 1352, has a connection region 1380 at the beginning of the sensing region 1310 (as viewed from the contact connection region 1352), the connection regions 1380 for subsequent sensing regions 1310 are arranged in the middle of the sensing region 1310, and the connection regions 1380 for the last sensing region, or the sensing region furthest from the contact connection region 1352, are arranged at the ends of the sensing region 1310 (as viewed along the length direction away from the contact connection region). The different connection regions 1380 can be conveniently connected to different set sensing regions 1310. The corresponding connection regions 1380 are preferably foldable to allow the corresponding delivery sensing region 1320 to be repositioned, for example, relative to one or more set sensing regions. For example, when folded, the corresponding connection regions 1380 may exhibit resilience or elastic deformability. The corresponding connection area 1380 can be strip-shaped.
[0191] The set sensing areas 1310 are interconnected via connecting areas 1382. Connecting areas 1382 are oriented along the main extension direction of the flexible conductor carrier 1350. Two adjacent set sensing areas are connected via a connecting area 1382. Connecting areas 1382 can reduce the stiffness of the electrode system against bending and thus can help conform the electrode system (particularly the sensing areas) to a circumferentially extending (e.g., cylindrical) surface. However, connecting areas 1382 can also be omitted, for example, where a higher elastic restoring force is required to bias the sensing areas toward the set surface. The width of connecting areas 1382 is conveniently smaller than that of sensing areas 1310. The width of the flexible conductor carrier 1350 (i.e., its extension perpendicular to the main longitudinal direction) can be smaller in connecting areas 1382 than in sensing areas 1310 connected via connecting areas 1382. All electrode tracks of the electrode arrangement 1360 (e.g., three electrode tracks) can extend along each of the connecting areas 1382. The corresponding connecting areas 1382 are strip-shaped.
[0192] For example, regarding the conformability of curved surfaces and / or for manufacturing purposes, providing notches or slits between two adjacent sensing regions 1310 (e.g., on opposite sides of the connecting region 1382 connecting the sensing regions) can be advantageous, as will be discussed further below. Specifically, for example, they can be used to lock the electrode arrangement in a directional manner relative to the outer surface of part 1630, and / or to receive segments of sub-assemblies during manufacturing.
[0193] For example, away from the connection region 1380 that connects the delivery sensing region to the conductor carrier 1350, the corresponding delivery sensing region 1320 has an end 1383. In a first or non-deformable configuration, the ends 1383 can be aligned with each other. As viewed from the connection region 1380 toward the end 1383, the sensing region 1320 can vary in width toward the end. First, the width increases, i.e., the sensing region 1320 can widen, for example, up to a maximum width. Thereafter, the sensing region 1320 can narrow toward the end 1383. For example, in the region closer to the connection region 1380, the outer contour of the sensing region 1320 can have a curved portion. 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 sharp.
[0194] The sensing electrodes for sensing region 1310 are conveniently formed from corresponding continuous electrode tracks (not shown). The same applies to the sensing electrodes for sensing region 1320, where this electrode track is conveniently electrically insulated from the electrode track for sensing region 1310. As already described in conjunction with FIG. 6, reference electrodes in the respective sensing regions may belong to a common electrode track. This track is conveniently electrically insulated from other tracks. All tracks are conveniently accessible in contact connection region 1352 for connection, for example, via terminals (not shown), to sensor controller 1340.
[0195] Mechanical portions 1359 may be provided in the electrode system 1345, for example for securing or aligning the electrode system 1345 relative to the user interface component body or parts of the user interface component. An exemplary portion 1359 is depicted to the lower left of the end 1358 of the electrode arrangement 1360. Alternatively or additionally, feature 1359 may define the flexible conductor carrier 1350 or the end 1358 of the electrode system 1345.
[0196] When the electrode system is arranged in the user interface component body 1605, as already discussed, the sensing area 1310 is circumferentially positioned along the inner surface of the user interface component body. The ends 1383 of the delivery sensing area 1320 may face each other and / or be radially inwardly oriented or pointing. This is illustrated in Figure 8B, which schematically shows the electrode system in a state where it is deformed for insertion into or has been inserted into the user interface component body, although the body is not shown. A contact connection area 1352 is also shown. It is folded and / or bent (radially) inwardly. In this configuration, it can be connected to a sensor controller 1340 (not shown), which may be arranged inside the user interface component when the electronic system has been assembled or manufactured.
[0197] Multiple delivery sensing regions 1320 will have electrode surfaces responsible for monitoring the delivery surface distributed across different areas of the flexible conductor carrier and / or using multiple connection regions 1380. This facilitates the use of the elastic force provided by the flexible conductor carrier and / or the connection regions 1380 to bias the sensing regions 1320 toward the delivery surface 1320. Thus, when folded into the configuration shown in FIG. 8B, the sensing regions will provide a continuous sensitive area for user proximity detection unit 1330. Each tab or sensing region 1320 may feature a configuration with the same electrode track and will act as a touch-sensitive area when folded. This allows, for example, better utilization of the stiffness of the carrier 1350 during manufacturing, where multiple bends (in the connection regions) generate larger and / or more uniformly distributed forces (e.g., elastic restoring forces acting on the user interface component body 1605), particularly when compared to the embodiment of FIG. 6.
[0198] Figure 8C (showing a cross-sectional view along plane AA in Figure 8B) illustrates the biasing force that tends to maintain contact between the holding region 1320 and the inner wall of the user interface component body opposite the delivery surface 1620. It can be seen that in the deformed configuration where the setting sensing region 1310 is oriented along the cylindrical covering surface, one or more delivery sensing regions 1320 can pivot or move relative to the setting sensing region 1310 due to the flexibility and / or elasticity provided by the connecting region 1380. The connecting region 1380 can form a pivot axis in its width direction. When the user interface component body 1605 holds the connecting region and / or sensing region in the deflection configuration, the associated elastic restoring force biases the sensing region toward the delivery surface.
[0199] Figures 9A to 9C illustrate another embodiment of the electronic system 1000. Figure 9A shows a perspective view of a user interface component 1600 having a setting surface 1610 and a delivery surface 1620. The setting surface is provided with a surface structure 1617.
[0200] Therefore, surface 1610 is shaped. The structural elements 1616 or recesses in the surface structure can be generally axially oriented (i.e., in the direction from the proximal end to the distal end). Multiple successive structural elements 1616 or recesses can be arranged sequentially along an angular or circumferential direction. The angled surfaces of the structural elements 1616 can have a corrugated, knurled, or undulating shape. Furthermore, the bottom surface of the corresponding recess can also have a corrugated, knurled, or undulating shape.
[0201] The delivery surface 1620 has a surface structure 1617. This structure is preferably different from the structure of the setting surface. For example, structural elements 1616 (e.g., recesses) may have different dimensions, such as different lengths and / or different widths. Conversely, structural elements 1616 of the setting surface 1610 may have equal lengths, widths, and / or equal configurations.
[0202] The surface structure 1617 on the external operating surface has the advantage that a compliant object, similar to a finger, will have a larger contact area with the surface than a non-compliant object, similar to a rigid planar object (e.g., a coin or metal platform). Furthermore, due to the structured surface, the compliant object can be positioned closer to the electrode arrangement 1360 than a non-compliant object. This is illustrated in Figure 9B, which compares a finger or thumb, showing a significantly larger contact area with the set surface 1610 and / or closer to the electrode arrangement 1360 compared to the planar object 4000. Figure 9C illustrates the effect of the structure 1617 on the contact surface, where the compliant object is used to structure the delivery surface.
[0203] This embodiment features the electrode system 1345 as described in the previous embodiment. Furthermore, the external operating surface is formed with small recesses to allow compliant objects (e.g., fingers) to approach the sensing electrodes closer than rigid objects (e.g., metal platforms). This requires a more significant change in electric field or capacitance between the compliant object and the rigid non-compliant object. On cylindrical or set surfaces, the recesses can be provided as ridges, for example, in any pattern (e.g., knurled), and can also be used to assist the user in achieving a grip or hold on the surface. On top or delivery surfaces, the recessed areas can simultaneously serve as an embossed design or trademark.
[0204] Figures 10A to 10D illustrate embodiments of the electronic system 1000 and methods for assembling or manufacturing the electronic system, which are more specific in some respects than the embodiments discussed in conjunction with the preceding figures. However, all the features disclosed in conjunction with the preceding figures also apply to system 1000, and vice versa.
[0205] Figure 10A shows a schematic cross-sectional view of the electronic system 1000. The system again includes a user interface component 1600, wherein a user interface component body 1605 defines a setting surface 1610 and a delivery surface 1620. A conductor carrier 3000 is provided inside the user interface component body 1605 and carries one or more electronic units as described above, such as a sensor controller 1340, a motion sensing unit 1200, a connection detection unit 1700, and / or an electronic control unit 1100. The conductor carrier 3000 is axially and directionally secured in the user interface component, for example, to a base frame 1670 described further below. While not all the units discussed above are explicitly shown in the cross-sectional view of Figure 10A, they may still be present.
[0206] Compared to the schematic diagrams in Figures 2 and 3, the arrangement of the power supply 1500 and its contact connection with the electrical components are shown in more detail. The power supply 1500 is arranged between the carrier 3000 and the proximal surface (i.e., delivery surface 1620) of the user interface component 1600. A spacer component 1510 is arranged between the carrier 3000 and the power supply. Thus, the power supply 1500 is supported on the carrier 3000 via the spacer component 1510. The spacer component 1510 may have a curved internal surface to extend circumferentially along the (electronic) components mounted on the carrier 3000. The spacer component 1510 conveniently defines a hollow portion between the surface of the carrier 3000 facing the spacer component and the power supply. In this hollow portion, electronic units or components on the carrier 3000 can be arranged without the risk of direct contact with the power supply 1500. The spacer component also helps to prevent excessive mechanical loads (e.g., loads applied to the delivery surface by the user during dose delivery operations) from being directly transferred to the electronic units or components on the carrier 3000.
[0207] Further, Figure 10A shows a power electrode 1520. Electrode 1520 is conductively connected to a power source 1500 and to one or more electrical or electronic components, particularly via a conductor carrier 3000. Electrode 1520 has a contact portion 1530 (see Figure 10B) that conductively connects the electrode to the conductor carrier 3000. Electrode 1520 extends from the side of the carrier 3000 facing the power source 1500 to the side of the carrier 3000 facing away from the power source 1500. The contact portion 1530 is arranged on the side mentioned later. However, different configurations of the contact connection between the power source and one or more electronic components are also conceivable. Electrode 1520 has one or more bias portions 1540 (three in the depicted embodiment). The bias portions 1540 are resiliently deflectable. A corresponding bias portion 1540 may be, for example, a flexible arm with a free end. A corresponding bias portion 1540 may extend in a proximal direction inclined to the main axis of the user interface component. A corresponding bias portion is provided to apply force to the power supply 1500, such that the power supply is biased distally toward the carrier 3000 and / or the spacer. Alternatively or additionally, one or more bias portions are provided to bias one or more sensing areas of the electrode system 1345 (see FIG. 10B; sensing areas 1310 and 1320 are shown only very schematically in FIG. 10A) toward the external operating surface of the user interface component body 1605, which should be monitored by the user proximity detection unit. The bias portion 1540 can bias the power supply 1500 toward the carrier 3000 and the sensing area 1320 toward the delivery surface 1620. The bias portion 1540 is connected by a ring portion 1560 and extends axially away from and inwardly relative to the ring portion (see FIG. 10B). The ring portion 1560 can be electrically connected to the power supply 1500, for example, to one of its terminals. The electrode 1520 has a fastening portion 1550. The fastening portion 1550 can be designed to fasten the power supply 1500 to the spacer component 1510, for example, to form a sub-assembly or unit that can be handled during the assembly of the electronic system. In the depicted embodiment, this is achieved by clamping the spacer component and the power supply between the regions of the electrodes 1520 (not explicitly shown).
[0208] System 1000, in addition to the user interface component body 1605, also includes a user interface component part or base 1670. References to the base herein should be understood as references to the user interface component part, and vice versa. The base 1670 is preferably steerably and axially locked to the user interface component body 1605, for example, by snap-fit or welding (a snap-fit with one or more snap features 1681 is shown in this embodiment, for example, near the distal end of the user interface component). The base, together with the user interface component body, may define the interior of the user interface component 1600. The interior is preferably sealed, for example, dustproof and / or fluid-tight. For this purpose, one or more seals, such as O-rings (not explicitly shown), may be provided at the interface user interface component body / base. The base 1670 closes the distal opening of the user interface component body 1605. The base preferably includes a rigid portion 1672 and / or a deformable (e.g., elastically deformable) portion 1674. The base frame 1670 may be a part formed using a 2K molding process. Connection features 1615 for connecting the system to the drug delivery device unit may be provided on the base frame, for example, on its outer surface (not explicitly shown), which may face radially inward.
[0209] The base frame 1670 defines a receiving space 1675 for the user interface component 1600, which may be open in the distal direction. The receiving space 1675 is provided for receiving components of a drug delivery device unit to which the system 1000 should be connected. A deformable portion 1674 of the base frame (which may proximally limit the receiving space) is preferably designed to interact with components of the drug delivery device unit, and when the unit is connected to the system, the deformable portion 1674 is preferably elastically deformed by the components compared to the state when the system is not connected to the device unit. Movement during the deformation of the deformable portion 1674 can be used to trigger a switch 1710 of the connection detection unit 1700. This will cause the connection from the electronic system to the device unit to be electronically detected, and the system can be switched to a higher power consumption state, for example, by activating the user proximity detection unit 1330. When the system is disconnected from the device unit, due to elasticity, the portion 1674 can return to its undeformed shape, causing the connection detection unit 1700 to detect the disconnection from the device unit, for example, by changing its state via the switch 1710. Since part 1674 is part of the base frame 1670, direct contact between the components of the drug delivery device unit and the switch 1710 or connection detection unit 1700 is not required. This facilitates providing a sealed interior for the user interface component 1600, for example, for electronics and electrode systems. The base frame 1670 preferably also includes one or more light guide portions 1676. In the case of radiation used for motion sensing, one or more light guide portions can be operatively coupled to a radiation emitter and a radiation sensor provided in the motion sensing unit 1200. Thus, movement of a component (e.g., an encoder component) relative to the end face of the light guide 1676, which is away from the interior of the user interface component 1600, can result in a change in the radiation (intensity) reflected back to the radiation sensor, wherein this reflected radiation can be guided to the radiation sensor via the light guide portion and / or said radiation is preferably generated by the radiation emitter. In this way, such as during dose delivery operations, the movement of a component (e.g., a dial or digital sleeve) relative to the user interface component 1600 or a dose knob or button can be quantified. The light guide portion and / or the corresponding sensor can be out of phase with respect to the reflective portion of the encoder component (see WO 2019 / 101962 A1), which has some advantages.
[0210] Figure 10B shows the base frame 1670 and the electronic system 1345. The electrode system 1345 is very similar to the electrode system described above in conjunction with Figure 8A. However, we note that any other electrode system can also be used, especially the one described herein. The electrode system 1345 has a plurality of set sensing areas 1310 arranged sequentially and connected by a connecting portion 1382. Not all portions or areas are highlighted in Figure 10B. The electronic system 1000 also has a delivery sensing area 1320. In contrast to the embodiment of Figure 8A, similar to the embodiment depicted in Figure 6, only one delivery sensing area 1320 is provided. The electrode arrangement 1360 is not depicted in detail in this embodiment; however, the electrode arrangement is incorporated into the design of the electronic system 1345 when the electrode track provides functionality or proximity sensing to an external operating surface. For example, a slit 1384 on the side of the flexible conductor carrier 1350 that is away from or about to be away from the delivery sensing area 1320 (e.g., viewed in the width direction) can be configured to align with or receive a ridge 1678 on the outer surface of the base 1670, particularly when the flexible conductor carrier 1350 is wound around the outer surface of the base 1670. The ridge 1678 can be axially oriented, for example, in a proximal direction. Once the flexible conductor carrier 1350 or the electrode system has been wound around the outer surface of the base 1670, the ridge 1678 can cooperate with the slit 1384 to secure the angular relative position between the base 1670 and the electrode arrangement 1345. For example, at the distal end, a radially outwardly projecting flange 1680 can be provided around the (entire) circumference of the user interface component part or the base 1670. The flange 1680 can provide the distal end of the user interface component and / or a support for the user interface component body 1605. Offset from the flange toward the proximal side (that is, toward the delivery surface 1620), providing one or more snap-fit features 1681.
[0211] A recess 1682 is provided in the surface of the base 1670 facing the proximal end or the delivery surface 1620, for example, to accommodate a switch 1710. The bottom or distal surface of the recess may be defined by a deformable portion 1674. Sidewalls may be defined by a rigid portion 1672 of the base.
[0212] To assemble or manufacture the electronic system 1000, an electrode system 1345 and a carrier 3000 may be provided, on which electronic units or components are mounted. A sensor controller (not shown) may be mounted on a surface of the carrier positioned facing the base 1670, or on a side of the carrier positioned facing the delivery surface 1620 (i.e., proximal). A contact connection region 1352 may be electrically connected to the sensor controller 1340, for example, directly or via a conductor on the conductor carrier 3000. Preferably, after a connection has been established, the contact connection region 1352 is arranged relative to the base 1670 such that the region 1352 is offset inward relative to the outer surface of the base 1670. Alternatively, the contact connection region 1352 may first be arranged as depicted in FIG. 10B, and then a contact connection with the sensor controller 1340 may be established. For the contact connection, an FCC plug may be used. As an alternative to the FCC plug, a connector for vertical connection, such as a slimstack connector, may be used. The base frame 1670 conveniently includes, for example, radially and / or inwardly oriented slots to receive the contact connection area 1352.
[0213] For example, from a manufacturing perspective, it is advantageous to provide a sub-assembly comprising multiple components or units, preferably a carrier 3000 (e.g., having a sensor controller 1340, an electronic control unit 1100, a communication unit 1400, and / or a motion sensing unit 1200), a spacer component 1510, a power supply 1500, and / or power electrodes 1510, as depicted in FIG10B. The carrier 3000 is conveniently arranged to face the base frame and / or to constrain the sub-assembly on the side facing the base frame.
[0214] When the sensor controller is already part of the subassembly, contact connection with the sensor controller 1340 is conveniently made. The subassembly is configured to be arranged on top of (e.g., placed on) the base, such as to its proximal surface. The subassembly can be secured to the base, for example, axially and / or in a directional manner. The subassembly and the base 1670 are configured such that the subassembly cannot be arranged on the base in any relative rotational orientation. Rather, in the depicted embodiment, the subassembly can be arranged on the base in only one predetermined relative rotational orientation. The subassembly (spacer component 1510 in the depicted embodiment (but other implementations are possible)) includes one or more rotational locking or orientation features 1515. When a desired rotational orientation is given to allow the subassembly to be arranged on the base (e.g., by contacting a surface on the base), feature 1515 is conveniently configured to cooperate with a corresponding feature 1684 on the base 1670. If the subassembly and the base frame are not in a predetermined orientation, one or more features 1515 may cooperate with the base frame (e.g., its surface) to prevent the subassembly from being positioned on the base frame or supported on the base frame by a support surface (e.g., the surface of the carrier 3000 that contacts the base frame).
[0215] Corresponding feature 1684 may include a recess in the base frame, the recess being configured to receive feature 1515 when the base frame and the subassembly are in a predetermined rotational orientation relative to each other. Corresponding feature 1684 may be defined by a wall of a defining recess (e.g., recess 1682) of the base frame 1670. Recess 1682 may extend inwardly from an outer surface of the base frame 1670, and thus provide a corresponding feature and space for switch 1710. The bottom of the distal surface of the recess or the recess defining corresponding feature 1684 may be partially or completely formed by deformable portion 1674. As an alternative to or supplement to the orientation function, one or more features 1515 may lock the subassembly in a directional manner relative to the base frame when the subassembly has been mounted to the base frame 1670. When the base and subassemblies are in the correct rotational orientation, the motion sensing unit 1200 can be operatively coupled to one or more light guide portions 1676, for example, the motion sensing unit can face one or more light guide portions 1676 and / or the switch 1710 can be triggered by deformation of the deformable portion 1674. The subassemblies can be axially locked to the base 1670, for example, by a snap-fit engagement (not explicitly shown), or clamped in place by the user interface component body 1605 and the base 1670 when axially locked. After the contact connection areas of the electrode system have been electrically connected to the sensor controller 1340 or the carrier 3000, the subassemblies are conveniently arranged on the base in the correct orientation. Contact connection areas 1352 can be arranged between the subassemblies or carrier 3000 and the base 1670.
[0216] During the assembly of the electronic system 1000, preferably after electrical contact has been established between the electrode system 1345 and the sensor controller 1340 and / or after the sub-assemblies have been correctly oriented on the chassis, one or more pre-defined sensing regions 1310 may be folded relative to the contact connection region 1352, for example, such that one or more pre-defined sensing regions are axially oriented. One or more pre-defined sensing regions may be folded downwards or distally, for example, to be tilted or perpendicular to the contact connection region 1352. The flexible conductor carrier 1350 may be wound around the chassis on its outer surface such that one or more sensing regions face radially and / or circumferentially surround the chassis. Then, one or more sensing regions 1310 are arranged along the outer surface of the chassis 1670 (e.g., a surface with a cylindrical configuration). The process may continue to arrange sensing regions 1320 such that they are radially oriented and / or extend along the proximal surfaces of the contact connection region 1352, carrier 3000, power supply 1500, and / or chassis 1670. This can be achieved by appropriately folding the connection region 1380 and / or the sensing region 1320. When the sensing region 1320 has been moved into the desired portion (e.g., facing the proximal direction and / or facing the delivery surface 1620), the sensing region, for example through the distal surface of the region, can be supported on one or more biasing members 1540, preferably formed by the power supply electrode 1520. This configuration is depicted in FIG10C.
[0217] Therefore, in FIG10C, sensing regions 1310 and 1320 are appropriately positioned such that they can sense the approach of the setting surface 1610 or delivery surface 1620 of the user interface component 1600. One or more portions of the power electrodes may extend within or be angled to a notch or slit in the flexible conductor carrier 1350. The slit or notch may be formed in the region of the connection region 1382. The correct positioning of the components can be visually checked during the stage shown in FIG10C. The process continues by introducing the unit, including the flexible conductor carrier 1350, the sub-assembly, and the base frame 1670, into the user interface component body and securing the base frame 1670 to the user interface component body 1605 (e.g., by the snap-fit engagement discussed).
[0218] Before being incorporated into the user interface component body, the elastic force tending to re-establish the first or flat configuration of the electrode system 1345 can be reacted, for example, by an installation tool (not shown). Once the force is no longer reacted (e.g., when the installation tool is removed), the elastic restoring force can press the electrode system (particularly one or more sensing areas 1310) against the inner wall of the user interface component body 1605. This can improve the operative connection between the electrode system and the external operating surface. If the elasticity of the electrode system is not provided or is insufficient, a force can be provided by biasing one or more sensing areas 1310 toward (another) biasing member biasing the setting surface 1610.
[0219] Figure 10D illustrates a structure with a base frame 1670, an electrode system 1345 (electrode tracks not shown), and a carrier 3000, wherein the contact connection area 1352 is electrically connected to the sensor controller 1340 via a conductor on the carrier 3000 or directly. Similarly, a spacer component 1510, a power supply 1500, and a power electrode 1540 are shown. Contrary to the representation in Figure 10C, the delivery sensing area 1320 is a continuous region and is not formed by successively arranged areas. However, it should be understood that the depicted features can also be used in any other embodiment addressed herein. In the electrode system 1345, the contact connection area 1352 and the connection area 1380 are close to each other, for example, having an angular distance less than one of the following values: 90°, 45°, 30°, 25°, 20°, 15°. In this embodiment, the opposing ends 1356 and 1358 face each other, forming a small gap between them, at which the base frame 1670 is visible. It should be understood that, for example, to protect the contact connection area 1552 and / or the connection area 1380, the flexible conductor carrier can be made longer, for example, such that the contact connection area 1352 and / or the connection area 1380 is covered by the flexible conductor carrier. In this case, the flexible conductor carrier can be wound around the base frame for more than 360°.
[0220] Figure 11 illustrates another embodiment of the electrode system 1345. This embodiment is very similar to the embodiment discussed in conjunction with Figure 6. Therefore, the following discussion focuses on the differences. The most significant difference is the configuration of the electrode track 1362 for the reference electrode 1368. This electrode track 1362 extends on two opposite sides of the electrode track 1364 for the sensing electrode 1366 in the sensing region 1310. The electrode track 1362 extends along the electrode track 1364 in a first direction (e.g., as seen from the contact connection region 1352) and / or toward the end 1358 and in a second direction opposite to and preferably parallel to the first direction. The electrode track 1362 may surround the electrode track 1364. In transitional portions, for example near the end 1358, the electrode track 1362 may extend from one side of the electrode track 1364 to the other, for example, through the end of the track 1364 closest to the end 1358 of the system 1345 or the flexible conductor carrier 1350. This configuration also results in the reference electrode portion 1371 pointing in a different direction with its end. When applied in electronic system 1000, some portions 1371 will point distally, and some portions will point proximally. The end of each portion preferably points towards the electrode track 1364 for the sensing electrode 1366. The electrode portions 1371 point in the same direction on each side of the electrode track 1362. The sensing electrode portion 1369 and the reference electrode portion 1371 are equidistantly arranged along the sensing region 1310. The electrode portions 1371 branching from the electrode track 1362 protrude into the recess defined by the electrode track 1362. This configuration of the electrode track facilitates having a large number of alternating electrode portions and reference electrode portions along the length of the sensing region 1310. In the connection region 1380, the electrode track 1378 for the sensing electrode 1376 in the sensing region 1320 extends between the two portions of the electrode track 1364 for the reference electrode 1362.
[0221] It should be noted that, in addition to one or more electrode tracks for one or two different sensing electrodes, having an electrode track for a reference electrode on the flexible conductor carrier is not necessary to realize the disclosed concept. For example, when the approach to a surface is to be monitored by another sensing electrode (e.g., a sensing electrode for setting the surface), an electrode track for one sensing electrode (e.g., an electrode track for delivering the surface) can serve as a reference electrode. Moreover, the reference electrode can be located away from the flexible conductor carrier inside. However, 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 helps to improve or enhance the sensitivity of the sensor, including the sensor controller and the electrode system. Moreover, if two different sensing electrodes (e.g., for setting the surface and for delivering the surface) are provided, the reference electrode can provide a degree of isolation between the sensing electrodes, especially if the reference electrode extends between the sensing electrodes and / or is electrically isolated from the two sensing electrodes along the flexible conductor carrier.
[0222] Figure 12 illustrates an embodiment of the electrode system. This embodiment is very similar to the embodiment discussed in conjunction with Figures 6 and 11. Therefore, the following discussion focuses on features that facilitate description of the differences. However, features not explicitly disclosed in this embodiment can also be implemented, as in the previous embodiments. Electrode system 1345 has a setting sensing region 1310. Electrode system has a delivery sensing region 1320. Again, as in the previous embodiments, one region may be sufficient, for example, a setting or delivery sensing region. In this embodiment, the delivery sensing region 1320 is configured in the same manner as in Figure 6. However, the configuration shown in Figure 11 is also possible. The delivery sensing region 1320 and the setting sensing region 1310 are connected by a connection region 1380 of the flexible conductor carrier 1350. The connection region 1380 facilitates the movement of the delivery sensing region 1320 relative to the setting sensing region 1310, for example, to adapt these sensing regions to two surfaces with different orientations (e.g., surfaces extending perpendicularly to each other). As in a previous embodiment, the setting sensing region 1310 is adapted to conform to a curved (e.g., cylindrical) surface of the user interface component body 1605 (e.g., the sensing surface associated with the setting surface 1610). The delivery sensing region 1320 is adapted to conform to a planar surface of the user interface component body 1605 (e.g., the sensing surface associated with the delivery surface 1620). In the setting sensing region 1310, the electrode arrangement 1360 includes two electrode tracks, namely tracks 1362 and 1364. Electrode track 1362 again defines a reference electrode 1368, and electrode track 1364 defines a sensing electrode 1366. The respective electrode tracks extend along the longitudinal direction of the sensing region 1310 between the ends 1356 and 1358 of the flexible conductor carrier 1350, or along the preferably continuous sensing region 1310. Electrode tracks 1362 and 1364 extend along each other in the sensing region, for example, generally away from (longitudinal) end 1356 and toward (longitudinal) end 1358. Sensing electrode 1366 and reference electrode 1368 extend along opposite ends of the sensing region, for example, at the ends that define the region in the width direction, axial direction, or perpendicular to the longitudinal direction.
[0223] The reference electrode portion 1371 and / or sensing electrode portion 1369 of the associated electrodes 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 central and / or strip-shaped region R extending between the ends 1356 and 1358 of the sensing area 1310. Region R is visualized by a dashed line in FIG12.
[0224] The corresponding electrode portions (i.e., sensing electrode portion 1369 and / or reference electrode portion 1371) have (free) ends. One of the electrode portions (sensing electrode portion and / or reference electrode portion) may have an area overlapping with the other electrode portion (correspondingly, the reference electrode portion or sensing electrode portion) and an area in which one of the electrode portions does not overlap with the other electrode portion. The non-overlapping area may be closer to the connection area of one of the electrode portions compared to the end of the other electrode portion to the same connection area. The main extension directions of the sensing electrode portion and / or reference electrode portion are conveniently parallel to each other. Sensing electrode portion 1369 extends away from connection portion 1370 (which conductively connects to the sensing electrode portion) and / or toward connection portion 1372 (which conductively connects to reference electrode portion 1371). Reference electrode portion 1371 extends away from connection portion 1372, which conductively connects to the reference electrode portion, and / or toward connection portion 1370. The (free) ends of the corresponding electrode portions are away from the connection portions connecting the corresponding electrode portions. The ends of the electrode portions can be located in the regions furthest from the associated connection portions, for example, as perpendicular to the longitudinal main extension direction of the sensing region or viewed in the axial or width direction. Connection portions 1370 and 1372 extend along the opposite ends of the flexible conductor carrier 1350 or the sensing region 1310.
[0225] 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. Viewed in the width direction, the aligned ends may be in the same or substantially the same position. 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 or axial direction and / or in the longitudinal direction. Thus, the reference electrode portion 1371 and the sensing electrode portion 1369 again have the same staggered arrangement as in the previous embodiment.
[0226] However, in the previously described embodiments, the width of the sensor electrode portion (that is, its dimension perpendicular to its main extension direction (i.e., away from the connecting portion toward the (free) end)) is constant along the extension of the electrode portion toward its end. Thus, the corresponding electrode portion has a substantially rectangular shape when viewed in top view toward said portion. In the currently described embodiments, the width of the reference electrode portion 1371 decreases as viewed away from the end of the connecting portion 1372 and / or toward the end of the reference electrode portion. Alternatively or additionally, this also applies to the sensing electrode portion with respect to the associated end of the connecting portion 1370 and said portion. The corresponding electrode portion is preferably symmetrical with respect to an axis extending through the free end and / or parallel to the main extension direction of the electrode portion along the flexible conductor carrier. For example, when an electronic system is used in a device, this axis may extend from the proximal end to the distal end of the system or device.
[0227] In the depicted configuration, the region of the flexible conductor carrier 1350 that separates the reference electrode 1368 from the sensing electrode 1366 has a wavy or sinusoidal shape. This is the opposite of the zigzag shape in previous embodiments. Therefore, at a given location in the overlapping region of the reference electrode portion and the sensing electrode portion (e.g., at any location or at all locations except one), the respective electrode portions can have different extensions along the longitudinal direction. For example, in the region closer to the connection portion connecting the reference electrode portion, 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 arrangement or for tuning the sensor's sensitivity to desired sensitivity characteristics.
[0228] Figures 13 and 14 schematically illustrate other embodiments of the electrode system. These embodiments are similar to the embodiment shown in Figure 12. In particular, the width of the electrode portions in the direction away from the associated connection portions can be reduced. Figure 13 shows a sinusoidal arrangement 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 arrangement 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).
[0229] As described above, the layout of the electrode tracks (for the reference electrode and the sensing electrode) can be characterized by a range of electrode patterns or shapes of the electrode portions, such as linear (Figures 4, 6, and 11), zigzag or sawtooth (Figure 14), or sinusoidal repetition (Figures 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 arrangement and / or configuration of the electrode portions) to provide a reliable and / or improved response to the user's grip, for example by increasing the likelihood that the user's finger or thumb will cover both the track or portion (reference electrode and (corresponding) sensing electrode) when gripping the user interface component.
[0230] Figures 15A to 15F illustrate implementation schemes of the electrode system, electronic systems using the electrode system, and methods. The features described in the context of these implementation schemes can also be applied to other implementation schemes described herein, and vice versa.
[0231] Figures 15A and 15B show the electrode system 1345 from opposite sides. Figure 15B is rotated 180° relative to Figure 15A. Overall, the electrode system 1345 is similar to the system further described above, for example, in conjunction with Figures 4, 6, 11, and 12. Therefore, this description focuses on the differences.
[0232] Electrode system 1345 includes a setting sensing region 1310. The setting sensing region extends between two ends 1356 and 1358 of the electrode system. Ends 1356 and 1358 may be two opposite or distant ends of a strip-shaped region of flexible conductor carrier 1350. In the setting sensing region 1310, a (setting) sensing electrode 1366 is provided by electrode tracks 1364 of electrode arrangement 1360. The sensing electrode 1366 has a connection portion 1370. A plurality of different sensing electrode portions 1369 extend away from the connection portion 1370 and / or toward a reference electrode 1368. This also applies to a reference electrode portion 1371 extending toward the sensing electrode 1366 and / or away from the connection portion 1372. Electrode portions 1371 are formed by electrode tracks 1362. The arrangement of electrode portions 1366 and 1371 can create the tortuous shape shown in the region of the flexible conductor carrier 1350 that separates the reference electrode 1368 and the sensing electrode 1366 in the defined sensing region 1310. The sensing electrode and the reference electrode can form the comb-like structure shown in the sensing region 1310.
[0233] In the sensing region 1310, the electrode system 1345 includes a plurality of cuts or slits 1384. The cuts or slits 1384 extend throughout the electrode system such that they are accessible from two opposite sides of the electrode system 1345. The cuts or slits 1384 are conveniently provided to attach or connect the electrode system, and particularly the sensing region 1310, to a user interface component or base 1670 of the associated electronic system 1000 (e.g., see FIG. 15C). The cuts or slits 1384 may be equidistantly arranged along the extension of the sensing region 1310 (e.g., from a first end 1356 to a second end 1358). The cuts or slits 1384 may be defined by a flexible conductor carrier and / or by one or more electrode tracks along their entire circumference. The cuts or slits may have varying or equal lengths (in the described embodiments, the length varies; preferably, any two arbitrarily adjacent cuts have different lengths, wherein the length can be measured perpendicular to the main extension direction of the sensing region 1310). The notch or slit 1384 can be oriented such that, once the electrode system is applied in the electronic system 1000, the main extension direction of the notch or slit is oriented along an axis extending from the proximal end to the distal end. One or more of the notches or slits 1384 can be arranged such that they are confined to a sub-region of the sensing region 1310 where no electrodes are disposed and / or to a sub-region where one of the electrode portions 1369 and 1371 is disposed. The notch or slit can be wholly or partially surrounded and / or defined by one of the electrode portions 1369 and 1371. In the depicted embodiment, the 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 the notch or slit through the reference electrode portion 1371 is wholly surrounded by the associated electrode portion 1371. This can also be reversed, or the two electrode portions can partially or completely surround a corresponding one of the notches or slits 1384.
[0234] The electrode system 1345 further includes a connector region 1386. The connector region 1386 is connected to the sensing region 1310 via a conveniently flexible connection region 1380. The connector region 1386 is movable relative to the sensing region 1310. Electrode tracks 1362 and / or electrode tracks 1364 extend from the sensing region 1310 to the connector region 1386 via the connection region 1380. The connection region 1380 has a width smaller than the width of the sensing region 1310 and / or smaller than the width of the connector region 1386. The outer circumference of the connector region 1386 or a segment thereof may have a fully or partially circular shape or may define a circular wrapping curve.
[0235] Connector region 1386 is arranged between sensing region 1310 and contact connection region 1352 (as viewed along flexible conductor carrier 1350). Contact connection region 1352 is connected to connector region 1386 via additional connection region 1382 of electrode system 1345. Additional connection region 1382 may extend away from connector region 1386 at a position opposite to connection region 1380 in diameter. Connector region 1386, or connection region 1380 connecting connector region 1386 to sensing region 1310, is positioned between ends 1356 and 1358 (e.g., centrally located or in the middle and / or away from both ends). Additional electrode tracks 1378 are arranged in connector region 1386. Electrode tracks 1378 may be accessible in contact connection region 1352. Electrode tracks 1362 and 1364 may also be accessible in contact connection region 1352 to facilitate contact connection with electrodes arranged in only one contact connection region. However, the electrode track 1378 does not extend into the sensing region 1310. Instead, the track 1378 is confined to the connector region 1386, the contact connection region 1352, and the connection region 1382.
[0236] Electrode track 1378 provides connector electrode 1388. Connector electrode 1388 is provided as an interface between the electrode system and individual sensing electrodes. In the depicted embodiment, the electrode is provided by a separate electrode or spring 1390 (e.g., a power spring) (see FIG. 15C). When electrode system 1345 is arranged in an electronic system, connector electrode 1388 is provided as a distally pointing surface facing the wall of user interface component body 1605, wherein the wall proximally defines the user interface component body. The size of connector region 1386 and / or connector electrode 1388 can be adjusted according to the size of power supply 1500 (e.g., a coin cell).
[0237] The reference electrode portion 1371 of electrode track 1362 extends along connector electrode 1388 (e.g., along its outer circumference). Reference electrode portion 1371 may have a wider width than adjacent portions of electrode track 1362 and / or extend on different (e.g., opposite) sides of connector electrode 1388. In addition to connector electrode 1388, portions of the electrode tracks in connector region 1386 may be covered with an insulating material, such as the material covering flexible conductor carrier 1350. Therefore, in connector region 1386, for example, on the side facing user interface component body 1605 in electronic system 1000, only connector electrode 1388 may be exposed. Exposing only the connector electrode avoids the risk of short circuits between different electrode tracks, such as those caused by the individual sensing electrode 1390. This is why connector electrode 1388 is shown in shaded lines in FIG. 15A, which should emphasize that (only) this electrode is accessible or exposed. In the depicted embodiment, connector electrode 1388 has a ring-shaped shape (while other shapes are generally possible). The ring has two ends that can face each other. The ring can extend more than 300° in the circumferential direction, for example, more than 350°. The ends of the ring can define a channel from the inside to the outside defined by the connector electrode for a portion of another electrode track (e.g., electrode track 1362 defining reference electrode 1368). The connector electrode having an interior that defines a channel from the inside to the outside for another electrode track is not limited to a ring shape.
[0238] On the side of connector region 1380 away from connector electrode 1388, terminal portion 1392 of the electrode arrangement (e.g., electrode track 1362) may be exposed. Preferably, only terminal portion 1392 is exposed, for example to reduce the risk of short circuits. In electronic system 1000, terminal portion 1392 may, for example, be in direct contact with power supply 1500 (see FIG. 15C). Connector electrode 1388 may be covered with an electrically insulating material on the side of connector region 1386 where terminal portion 1392 is exposed (therefore, terminal portion 1392, rather than connector electrode 1388, is shown in shaded lines in FIG. 15B, which shows a top view on the side of connector region 1386 away from connector electrode 1388 and / or away from the proximal end of user interface component body 1605 in electronic system). The terminals of the electrode tracks in the contact connection area 1352 are accessible or exposed on the same side of the flexible conductor carrier 1350 as the terminal portion 1392 (which is why electrode tracks 1362, 1364 and 1378 are also shown in shaded lines in the contact connection area 1352).
[0239] Figure 15C shows a schematic cross-sectional view of the assembled electronic system 1000, which, apart from the adjustments to the electrode system discussed in conjunction with Figures 15A and 15B, primarily corresponds to the system discussed in conjunction with Figures 10A to 10D. A sensing area 1310 is positioned to wrap around or extend around the exterior of a chassis or user interface component part 1670. A protrusion or ridge 1678 of the chassis protrudes through a slit 1684 to secure or attach the sensing area 1310 to the chassis 1670. The protrusion or ridge and the cutout or slit can be configured such that the chassis 1670 can hook into the sensing area 1310 (e.g., by guiding the protrusion or ridge into the slit or cutout). In other words, a form-fit connection (e.g., provided by a preferred axially extending undercut in the corresponding protrusion or ridge 1678) prevents radial movement of the sensing area 1310 away from the base 1670 and / or axial movement of the sensing area relative to the base when the sensing area 1310 is attached to the base 1670. For example, on the side of the conductor carrier 3000 away from the power source 1500 or on the far side of the conductor carrier 3000, a contact connection area 1352 is electrically connected to a connector 3002 on the conductor carrier 3000. The electrical contact connection between the contact connection area 1352 and the connector 3002 can be formed, for example, by a plug-in connector and / or by soldering.
[0240] A base 1670 with a connected electrode system 1345 can be guided into the user interface component body 1605 and / or conveniently secured to the body 1605 in a directional and / or axial manner (e.g., by snap-fit or soldering). A separate sensing electrode or biasing member 1390 biases the connector region 1386 and / or terminal portion 1392 to a contact of the power supply (e.g., a ground contact). The associated force can act in a distal direction and / or away from the proximal surface of the user interface component body. The sensing surface of the electrode 1390 can conform to and / or contact the inner wall of the user interface component body 1605 located proximal to the body. The biasing member or separate sensing electrode 1390 biases a contact on the power supply 1500 (e.g., its negative contact) to an electrical terminal 3004 on the conductor carrier 3000. In this way, the contacts of the power supply can be connected to the conductor carrier and the electrode system 1345. A spacer component 1510 may be arranged between the conductor carrier 3000 and the power supply 1500 (or the spacer may be omitted). Of course, in this embodiment, a motion sensing unit 1200, an electronic control unit 1100, and / or a sensor controller 1340 may also be provided, as well as the remaining features of the previously described electronic system embodiments.
[0241] Figure 15D illustrates a sub-assembly for the electronic system 1000 prior to insertion into the user interface component body 1605. The sub-assembly includes the electronic system 1345, a base frame 1670, and a power supply 1500, and optionally a spacer 1510 and / or a carrier 3000 (not explicitly shown). When the electrode system 1345 is connected to the base frame and also to the carrier 3000, the power supply 1500 can be reliably held in the sub-assembly, for example, by connection portions 1380 and 1382, which can extend axially across the lateral outer surface of the power supply 1500. A connector portion 1386 covers the top surface of the power supply, and a terminal portion connects another contact of the power supply to the electrode system.
[0242] Figures 15E and 15F illustrate embodiments of an electrode 1390 (biasing member) that can be used in an electronic system. Electrode 1390 has an electrode connection portion 1394. The electrode connection portion 1394 is provided to connect the electrode to a sensor controller 1340 and / or an electrode system 1345 (e.g., by support on a connector electrode 1388). In the depicted embodiment, the electrode connection portion 1394 is formed by a plurality of (e.g., three) arms or legs. Three legs are particularly advantageous from a stability perspective. The arms are evenly distributed in the circumferential direction. The arms are inclined. The arms extend in the axial (e.g., distal) direction and / or in the radial direction (e.g., radially inward). The arms are configured to be supported on the connector electrode 1388. Electrode 1390 includes an electrode sensing portion 1396. The electrode sensing portion 1396 is arranged to contact and / or conform to the inner surface of a wall that proximally defines the interior of the user interface member body 1605. Electrode sensing portions 1396 are arranged to enable, facilitate, or improve the detection of user proximity to the delivery surface 1620 of the user interface component 1600. Sensing portions 1396 have structured surfaces (e.g., a zigzag shape in the circumferential direction) to maximize the surface area available for (capacitive) sensing. Multiple circumferentially arranged recesses (e.g., radially oriented recesses) can separate multiple equally circumferentially arranged protruding electrode portions (e.g., radially protruding electrode portions). The angular extension of the recesses can be smaller than the angular extension of the electrode portions. Corresponding electrode connection portions 1394 can originate from and / or extend from an end of the sensing portion 1396 (e.g., a radially outer end), preferably at and / or from its protrusion.
[0243] In the configuration shown in Figure 15C, the electrode or biasing member 1390 readily undergoes elastic deformation, for example, to provide a restoring force pointing distally. Therefore, it can bias components disposed distally from the biasing member or electrode 1390 into mechanical contact with each other or enhance mechanical and / or electrical contact. For example, one or more components of the following pair of components can be biased into mechanical contact with each other by the biasing member or electrode 1390:
[0244] - Terminal portion 1392 and power supply 1500 (e.g., near the power supply, such as ground or positive contact);
[0245] - Power supply 1500 (e.g., at the far side of the power supply, such as a negative contact) and electrical terminal 3004;
[0246] - Conductor carrier 3000 and support or bearing surfaces (not explicitly shown) for the carrier in base frame 1670;
[0247] - Motion sensing unit 1200 (e.g., its light conversion surface) and light guide 1676 (e.g., its light conversion surface, which may include a beam shaping portion similar to that formed by a lens)). This can improve the optical coupling between light guide 1676 and motion sensing unit 1200, which can operate optically.
[0248] The electrode system 1345 (e.g., in an end region at one end (not depicted in Figures 15A and 15B) or at both ends 1356 and 1358 (as depicted)) has one or more cutouts 1398. When the sensing region 1310 has been connected to the chassis, the one or more cutouts may define or delineate a passage for access to the connection region 1352 into the chassis interior, for example, for connection to the connector 3002 (see Figure 15D).
[0249] Extending the electrode system over the power supply in the sub-assembly depicted in Figure 15D has the advantage of eliminating the need for dedicated clamps to secure the power supply within the sub-assembly. Instead, the power supply 1500 is secured to the base / user interface component 1670 via the electrode system 1345.
[0250] We note that the layout of the electrode system or electronic system and / or the arrangement of the electrode system in the electronic system presented in Figures 15A to 15F can also be applied to systems that do not use separate sensing electrodes. In this case, the biasing member is conveniently positioned distally from region 1386, which then serves as a delivery sensing region instead of a connector region. Similarly, the layout of the electronic system in Figures 10A to 10D can also be adjusted to employ separate sensing electrodes to monitor proximity to the delivery surface 1620 of the user interface member 1600.
[0251] The terms “drug” or “pharmaceutical” are used synonymously herein and describe pharmaceutical preparations comprising one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally pharmaceutically acceptable carriers. In the broadest sense, an active pharmaceutical ingredient (“API”) is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or pharmaceutical preparation is used to treat, cure, prevent, or diagnose a disease, or to otherwise enhance physical or mental health. Drugs or pharmaceutical preparations may be used for a limited duration or periodically for chronic disorders.
[0252] As described below, a drug or pharmaceutical preparation may include at least one API or combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules (having a molecular weight of 500 Da or less); polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids (such as antisense DNA and RNA), small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems (such as vectors, plasmids, or liposomes). Mixtures of one or more drugs are also contemplated.
[0253] Drugs or pharmaceutical preparations may be contained in a primary package or "drug container" adapted for use with a drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chamber may be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chamber may be designed to store the drug for about one month to about two years. Storage may occur at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, the drug container may be or may include a dual-chamber cartridge configured to separately store two or more components of the pharmaceutical preparation to be administered (e.g., an API and a diluent, or two different drugs), one component in each chamber. In this case, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components before and / or during administration to a human or animal. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., by means of a conduit between the two chambers) and allow the user to mix the two components before dispensing if needed. Alternatively or additionally, the two chambers can be configured to allow mixing during dispensing of the components into a human or animal body.
[0254] 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 diabetes-related complications (such as diabetic retinopathy), thromboembolic disorders (such as deep vein or pulmonary thromboembolism). Other examples of disorders are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those described in the following manuals: such as the 2014 German Medical Doctor's Drug Handbook (Rote Liste), for example, but not limited to main group 12 (antidiabetic drugs) or 86 (oncology drugs); and the 15th edition of the Merck Index.
[0255] Examples of APIs used to treat and / or prevent type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide-1 (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture thereof. As used herein, the terms “analyte” and “derivative” refer to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deletion and / or exchange of at least one amino acid residue present in a naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues may be encoding amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. Specifically, the term "derivative" refers to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in a naturally occurring peptide may have been deleted and / or substituted with other amino acids (including non-coding amino acids), or amino acids (including non-coding amino acids) may have been added to a naturally occurring peptide.
[0256] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (glargine insulin); Lys(B3), Glu(B29) human insulin (glutamate insulin); Lys(B28), Pro(B29) human insulin (lispro insulin); Asp(B28) human insulin (aspart insulin); human insulin wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala and wherein Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.
[0257] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (detemir insulin, B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (degludec insulin) ); B29-N-(N-lithochyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.
[0258] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixilatin. Exenatide (exocetide-4, Liraglutide, a 39-amino acid peptide produced by the salivary glands of the Gila monster. Semaglutide, Taspoglutide, Albiglutide Dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langelatide / HM-11260C (Efpeglenatide), HM-15211, CM-3, GLP-1Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GS K-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.
[0259] Examples of oligonucleotides include, for instance, sodium mipronil. It is a cholesterol-reducing antisense agent used to treat familial hypercholesterolemia or RG012 used to treat Alport syndrome.
[0260] Examples of DPP4 inhibitors include linagliptin, vedagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.
[0261] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, fertility-stimulating hormone), growth hormone (Somatropine), desmopressin, terlipressin, gosorelin, triptorelin, leuprorelin, buserorelin, nafarelin, and goserelin.
[0262] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or their derivatives, or sulfated polysaccharides (e.g., polysulfated forms of the above polysaccharides), and / or their pharmaceutically acceptable salts. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20. It is a type of sodium hyaluronate.
[0263] As used herein, the term "antibody" refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigens. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., murine) antibodies, or single-chain antibodies. In some embodiments, antibodies have effector function and can fix complement. In some embodiments, antibodies have reduced or no ability to bind Fc receptors. For example, antibodies can be isotypes or subtypes, antibody fragments, or mutants that do not support binding to Fc receptors, for example, they have a mutagenic or missing Fc receptor-binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or antibody-like binding proteins with bivariate cross-binding domain orientation (CODV).
[0264] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule, excluding full-length antibody polypeptides but still including at least a portion of a full-length antibody polypeptide capable of binding antigens. Antibody fragments may include cleaved portions of full-length antibody polypeptides, although the term is not limited to such cleaved fragments. Antibody fragments that can be used in this invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (such as bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., double-chain, triple-chain, and quadruple-chain antibodies)), monovalent or multivalent antibody fragments (such as bivalent, trivalent, quadruvalent, and multivalent antibodies), microantibodies, chelated recombinant antibodies, tri- or bivalent antibodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camel-derived antibodies, and antibodies containing VHH. Further examples of antigen-binding antibody fragments are known in the art.
[0265] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term "frame region" refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides that is not a CDR sequence, and is primarily responsible for maintaining the correct positioning of the CDR sequence to allow antigen binding. Although the frame region itself does not typically participate directly in antigen binding, as is known in the art, certain residues within the frame region of some antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDR to interact with the antigen.
[0266] Examples of antibodies are anti-PCSK-9 mAbs (e.g., alirocumab), anti-IL-6 mAbs (e.g., sarilumab), and anti-IL-4 mAbs (e.g., dupilumab).
[0267] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in drugs or pharmaceutical preparations in drug delivery devices. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.
[0268] Those skilled in the art will understand that various modifications (additions and / or removals) can be made to the APIs, formulations, devices, methods, systems, and embodiments described herein without departing from the full scope and spirit of the invention, which covers such variations and any and all equivalents.
[0269] Example drug delivery devices may involve needle-based injection systems as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems can be broadly categorized into multi-dose container systems and single-dose (with partial or full discharge) container systems. Containers may be replaceable containers or integrated, non-replaceable containers.
[0270] As further described in ISO 11608-1:2014(E), a multi-dose container system can relate to a needle-based injection device with replaceable containers. In such a system, each container holds multiple doses, the size of which can be fixed or variable (preset by the user). Another multi-dose container system can relate to a needle-based injection device with an integrated, non-replaceable container. In such a system, each container holds multiple doses, the size of which can be fixed or variable (preset by the user).
[0271] As further described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device with replaceable containers. In one example of such a system, each container contains a single dose, thereby discharging the entire deliverable volume (complete discharge). In another example, each container contains a single dose, thereby discharging a portion of the deliverable volume (partial discharge). As also described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device with an integrated, non-replaceable container. In one example of such a system, each container contains a single dose, thereby discharging the entire deliverable volume (complete discharge). In another example, each container contains a single dose, thereby discharging a portion of the deliverable volume (partial discharge).
[0272] The scope of protection is not limited to the examples given above. Any invention disclosed herein is embodied in each novel feature and each combination of features, particularly including each combination of any feature described in the claims, even if that feature or combination of features is not expressly stated in the claims or embodiments.
[0273] Figure Labels
[0274] 1. Injection device, drug delivery device or device unit
[0275] 10. Shell
[0276] 12 Dosage knobs
[0277] 11. Injection button
[0278] 13 windows
[0279] 14 Containers
[0280] 15 stitches
[0281] 16 Inner needle cap
[0282] 17 Outer pin cap
[0283] 18 hats
[0284] 70 sleeve
[0285] 71a-c construction
[0286] 1000 Electronic Systems
[0287] 1100 Electronic Control Unit
[0288] 1200 motion sensing units
[0289] 1310 Set the sensing area
[0290] 1320 Delivery Sensing Area
[0291] 1330 User Proximity Detection Unit
[0292] 1340 Sensor Controller
[0293] 1345 Electrode System
[0294] 1350 Flexible Conductor Carrier
[0295] 1352 Contact Connection Area
[0296] Part 1354
[0297] 1356 end
[0298] 1358 end
[0299] 1359 Mechanical Part
[0300] 1360 Electrode Arrangement
[0301] 1361 angular clearance
[0302] 1362 Electrode Track
[0303] 1364 Electrode Track
[0304] 1366 sensing electrode
[0305] 1368 Reference Electrode
[0306] 1369 Sensing Electrode Section
[0307] 1370 Connection Part
[0308] 1371 Reference Electrode Section
[0309] 1372 Connection Part
[0310] 1373 Incision
[0311] 1374 terminal
[0312] 1375 terminal
[0313] 1376 Sensing Electrode
[0314] 1378 Electrode Track
[0315] 1379 terminal
[0316] 1380 Connection Area
[0317] 1381 Offset component
[0318] 1382 Connection Area
[0319] 1383 end
[0320] 1384 Slit
[0321] 1386 Connector Area
[0322] 1388 connector electrodes
[0323] 1390 electrode
[0324] 1392 Terminal Section
[0325] 1394 Electrode Connection Section
[0326] 1396 Electrode Sensing Section
[0327] 1398 incision
[0328] 1400 communication units
[0329] 1500 power supply
[0330] 1510 Spacer Component
[0331] 1515 Orientation Characteristics
[0332] 1520 power supply electrode
[0333] 1530 Contact Part
[0334] 1540 bias portion
[0335] 1550 ring section
[0336] 1600 User Interface Components
[0337] 1605 User Interface Component Body
[0338] 1610 Setting Surface
[0339] 1615 Connection Features
[0340] 1617 Surface Structure
[0341] 1616 Structural Components
[0342] 1618 Transition Zone
[0343] 1620 Delivery Surface
[0344] 1630 parts
[0345] 1670 base frame
[0346] 1672 Rigid Part
[0347] 1674 Deformable Part
[0348] 1675 receiving space
[0349] 1676 Optical Guide
[0350] 1678 Ridge
[0351] 1680 flange
[0352] 1681 Buckle Features
[0353] 1682 Depression
[0354] 1683 Slot
[0355] 1684 Corresponding Features
[0356] 1700 Connection Detection Unit
[0357] 1710 switch
[0358] 3000 Conductor Carrier
[0359] 3002 connector
[0360] 3004 terminal
[0361] 4000 objects
[0362] Axis A
[0363] C line
[0364] L length
[0365] R area
[0366] P plane
Claims
1. An electronic system (1000) for a drug delivery device, the electronic system (1000) comprising: - User interface component (1600), the user interface component having at least one external operating surface (1610, 1620) arranged for manipulation by a user for dose operation. as well as - Sensor electrode system (1345) for electronic system (1000). The sensor electrode system (1345) includes: - Electrically insulated flexible conductor carrier (1350); and - An electrode arrangement (1360) comprising at least two conductive electrode tracks (1362, 1364, 1378), wherein the conductive electrode tracks extend along the flexible conductor carrier, wherein the conductive electrode tracks are electrically separated from each other along the conductor carrier, wherein the conductive electrode tracks form a first sensing electrode (1366) and a second sensing electrode (1376), and wherein the sensing electrodes extend in sensing regions (1310, 1320) of the flexible conductor carrier. The first sensing electrode (1366) is assigned to the setting surface (1610) of the user interface component (1600), and The second sensing electrode (1376) is assigned to the delivery surface (1620) of the user interface component (1600).
2. The electronic system according to claim 1, in, The sensor electrode system (1345) is elastically deformable.
3. The electronic system (1000) according to any one of the preceding claims. in, One of the conductive electrode tracks (1362) of the electrode arrangement forms a reference electrode (1368), wherein the reference electrode extends 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 provided with different potentials when the sensor electrode system is operated.
4. The electronic system (1000) according to claim 3. in, In the sensing region (1310), the reference electrode (1368) has a plurality of reference electrode portions (1371), and the sensing electrode (1366, 1376) has a plurality of sensing electrode portions (1369), wherein the sensing electrode portions and the reference electrode portions are alternately arranged.
5. The electronic system (1000) according to claim 4. in, At least one end of a sensing electrode portion (1369) faces the reference electrode (1368), and at least one end of the reference electrode portion (1369) faces the sensing electrode (1366).
6. The electronic system (1000) according to any one of the preceding claims. a) wherein the sensing region (1310) is configured to conform to a circumferentially arranged sensing surface of a user interface component (1600) of the electronic system (1000) and / or extend along the circumferentially arranged sensing surface, and wherein the sensor electrode system is configured such that when the sensor electrode system (1345) is provided in the electronic system, a reference electrode portion (1371) and a sensing electrode portion (1366) are disposed at opposite positions, and / or b) Among them, The first sensing electrode (1366) extends along the first sensing region (1310), wherein one of the conductive electrode tracks (1378) of the electrode arrangement (1360) forms the second sensing electrode (1376), the second sensing electrode extends in the second sensing region (1320) of the 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.
7. The electronic system (1000) according to any one of the preceding claims. in, One of the conductive electrode tracks (1362) of the electrode arrangement forms a reference electrode (1368), wherein the reference electrode extends 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 provided with different potentials when the sensor electrode system is operated. 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).
8. The electronic system (1000) according to any one of the preceding claims. in, One of the conductive electrode tracks (1362) of the electrode arrangement forms a reference electrode (1368), wherein the reference electrode extends 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 provided with different potentials when the sensor electrode system is operated. a) wherein the flexible conductor carrier (1350) includes a contact connection region (1352), wherein the reference electrode (1368), the first sensing electrode (1366), and / or the second sensing electrode (1376) are capable of electrical contact in the contact connection region, and / or b) wherein one of the conductive electrode tracks (1378) forms a connector electrode (1388), the connector electrode extending in a connector region (1386) of the flexible conductor carrier (1350), wherein the connector region is configured to conductively connect a separate sensing electrode (1390) to the electrode arrangement.
9. The electronic system (1000) according to any one of the preceding claims, the electronic system comprising - A user proximity detection unit (1330), arranged and configured to detect whether a user is near or touches the external operating surface, wherein the user proximity detection unit includes the sensor electrode system (1345) and An electronic sensor controller (1340) is electrically connected to the sensor electrode system.
10. The electronic system (1000) according to claim 9. in, The flexible conductor carrier (1350) includes a contact connection area (1352), and a) wherein the sensing area (1320) is biased toward the external operating surface (1620), and wherein biasing members (1381, 1520) are provided in the electronic system (1000) for biasing the sensing area toward the external operating surface, and / or b) wherein the sensor controller (1340) is arranged on a carrier (3000), wherein the carrier is fastened to a user interface component part (1605, 1670) of the user interface component (1600), wherein the sensing area (1310) extends along the outer surface of the user interface component part, and wherein the contact connection area (1352) extends inward and is electrically connected to the sensor controller.
11. The electronic system (1000) according to claim 10. a) wherein the biasing member (1520) is electrically connected to the power supply (1500) of the electronic system and / or the sensor controller (1340), and / or b) Among them, The sensor controller (1340) is arranged on a rigid conductor carrier, and the contact connection area (1352) extends inward toward the carrier (3000).
12. The electronic system (1000) according to claim 10 or 11. in, The electronic system includes a power supply (1500) disposed between the carrier (3000) and a portion of the flexible conductor carrier (1350), wherein the flexible conductor carrier is fastened to the user interface component part (1670), wherein a connection area (1382) of the flexible conductor carrier extends from the portion of the flexible conductor toward the carrier from the side of the power supply away from the carrier, and wherein the connection area is mechanically and / or electrically connected to the carrier.
13. The electronic system (1000) according to any one of claims 9 to 12. a) wherein the first sensing electrode (1366) extends in a first sensing region (1310) and the second sensing electrode (1376) extends in a second sensing region (1320), and wherein the first sensing region (1310) and the second sensing region (1320) are configured to be assigned to external operating surfaces (1610, 1620) facing different directions, and / or b) Among them, The setting surface (1610) is configured to be manipulated for dose setting operations and is oriented in the radial direction.
14. The electronic system (1000) according to any one of claims 9 to 13. in, The external operating surface is configured such that the user proximity detection unit (1330) has higher sensitivity to softer or more flexible conductive objects that conform to the external operating surface, relative to more robust or rigid conductive objects that are not easily conformable to the external operating surface.
15. A drug delivery device (1) comprising the electronic system (1000) of any one of the preceding claims.
16. The drug delivery device (1) according to claim 15, wherein the drug delivery device includes a reservoir holder for holding the reservoir, or the drug delivery device includes a reservoir.
17. The drug delivery device (1) according to claim 16, the drug delivery device comprising a reservoir, wherein the reservoir comprises a drug.
18. The drug delivery device (1) according to any one of claims 15 to 17, wherein the drug delivery device is a pen-type device and / or an injection device.
19. The drug delivery device (1) according to claim 18, wherein the drug delivery device (1) is a needle-based syringe.
20. A method of manufacturing an electronic system (1000) for a drug delivery device, the method comprising the steps of: - Provides a user interface component (1600) and a sensor electrode system (1345), the user interface component having at least one external operating surface (1610, 1620). The sensor electrode system (1345) includes: Electrically insulated flexible conductor carrier (1350) and electrode arrangement (1360), wherein the electrode arrangement includes at least one conductive electrode track (1362, 1364, 1378) extending along the flexible conductor carrier (1350). - Deform the sensor electrode system (1345) such that the surface of the flexible conductor carrier (1350) extends along the outer surface of the user interface component (1600); - Assign the first sensing electrode (1366) of the sensor electrode system (1345) to the setting surface (1610) of the user interface component (1600). - Assigning the second sensing electrode (1376) of the sensor electrode system (1345) to the delivery surface (1620) of the user interface component (1600); and - The at least one conductive electrode track is electrically connected to the electronic unit (1340) to form the electronic system.
21. The method of claim 20, wherein the electronic system is the electronic system (1000) of any one of claims 1 to 14.
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