Electronic system for a drug delivery device and drug delivery device

Abstract

Electronic System for Drug Delivery Device and Drug Delivery Device An electronic system (1000) for a drug delivery device (1) is provided, the electronic system comprising: at least one user interface component (1600) configured to be manipulated by a user to perform dosing operations, such as a dose setting operation for setting a dose of drug to be delivered by the drug delivery device and / or a dose delivery operation for delivering the set dose; an electronic control unit (1100) configured to control the operation of the electronic system, the electronic system having a first state and a second state, wherein the electronic system in the second state has increased power consumption compared to the first state; and an electrical signal generator. The signal transmitting unit (1300) is configured 15 to provide an electrical signal indicating that the user interface component is being manipulated, wherein the electronic control unit is configured to switch the electronic system from the first state to the second state in response to the electrical signal, and wherein the user interface component includes a first part (1603) and a second part (1604), wherein the first part is movable relative to the second part from a rest position of the first part to a signal transmitting position of the first part, wherein the signal transmitting unit is configured to provide the electrical signal in response to the movement of the first part relative to the second part from the rest position to the signal transmitting position.

Description

Background Technology

[0001] This disclosure relates to an electronic system for a drug delivery device. This disclosure further relates to a drug delivery device, which preferably includes an electronic system.

[0002] Drug delivery devices using electronic components are becoming increasingly popular in the pharmaceutical industry and for users or patients. However, the management of power resources integrated into the device is particularly important, especially if the device is designed to be stand-alone (i.e., without connectors for connecting to the external power source necessary to power the device's operation).

[0003] For example, an electronic system is described in EP 3448470 B1. Summary of the Invention

[0004] The purpose of this disclosure is to provide a novel and appropriately improved electronic system.

[0005] This objective is achieved by the subject matter as described in the independent claims. Advantageous embodiments and improvements are subject to the dependent claims. We note that this disclosure is not limited to the currently claimed content and may include the subject matter only in the description which may be bound by the claims.

[0006] One aspect of this disclosure relates to an electronic system for a drug delivery device. Another aspect of this disclosure relates to a drug delivery device, particularly a drug delivery device including an electronic system. Therefore, the features disclosed regarding the drug delivery device or its units also apply to the electronic system, and vice versa.

[0007] In one embodiment, the electronic system includes at least one user interface component. The user interface component may be arranged or configured to be manipulated by a user (e.g., a user of a drug delivery device), such as by touch and / or movement. The user interface component may be provided for performing dosing operations, such as a dose setting operation for setting a dose of drug to be delivered by the drug delivery device and / or for performing a dose delivery operation to deliver the set dose, preferably, a dose previously set during the dose setting operation. Dosing operations may be operations related to the dose to be delivered by the drug delivery device: a delivery operation or a dose setting operation. In addition to dose setting operations, dosing operations may include dose adjustment operations, wherein a previously set dose is increased or decreased by manipulating the user interface component. Dosing operations may be performed by a user of the drug delivery device (e.g., a patient). Dosing operations may require continuous contact between the user and the user interface component throughout the operation. Dosing operations may involve movement of the user interface component relative to the housing of the drug delivery device, such as the housing of the drug delivery device unit to which the electronic system is to be connected, or the housing of the drug delivery device itself. As an alternative to or supplement to dosing operations, the user interface component may be manipulated to perform activation operations. Activation operations can be provided as a substitute for or supplement to all dosing operations, that is, as a substitute for or supplement to dosing setting operations and dosing delivery operations, and, if applicable, as a substitute for or supplement to dosing adjustment or cancellation operations.

[0008] In one embodiment, the user interface component has an external operating surface arranged and configured for touch by a user. The external operating surface can be arranged and configured to be touched during operation of the system or device (such as dosing), for example, for initiating and / or performing an operation. Therefore, the external operating surface can be or may include a setting surface for setting an operation and / or a delivery surface for delivering an operation. The setting surface and the delivery surface can face different directions. The setting surface can face radially or laterally. The delivery surface can face axially (e.g., proximal). The setting surface can extend circumferentially about an axis of the user interface component. The delivery surface can be arranged obliquely or perpendicularly to the axis.

[0009] In one embodiment, the electronic system includes an electronic control unit. The electronic control unit can be configured to control the operation of the electronic system. For example, the electronic control unit can be or may include an electronic processor, such as a microcontroller or an ASIC. The electronic system can have a first state (e.g., when the system is in sleep or idle) and a second state (e.g., when the system is operable). The electronic system may have increased power consumption in the second state compared to the first state. In the first state, one or more electrical or electronic units of the electronic system may be in sleep mode or powered off, such that they have no significant power consumption or no power consumption. For example, in the second state, a motion sensing unit may be on (i.e., it can be operated), while in the first state, the motion sensing unit is not on (i.e., it cannot be operated). The motion sensing unit will be described in more detail below. Alternatively or additionally, a communication unit may be off in the first state and on in the second state. The communication unit will be described in more detail below.

[0010] In one embodiment, the electronic system includes an electrical signal transmitting unit. The unit can be configured to provide at least one electrical signal when the user interface component is manipulated. The signal can indicate that the user interface component is being manipulated. For example, at least one electrical signal can be initiated or generated when a user begins to move or attempts to move the user interface component (e.g., relative to the housing). The electrical signal can indicate a dosing operation (e.g., a dose setting operation or a dose delivery operation) or an activation operation. The signal can indicate that a dosing operation is starting or that an activation operation has been completed. The housing can be the housing of a drug delivery device or the housing of a drug delivery device unit to which the electronic system should be connected. It may be necessary to move at least a part or portion of the user interface component, or only a part or portion of the user interface component, to generate the corresponding signal. This is explained in more detail below. The signal transmitting unit can be configured to generate or provide signals indicating dosing operations and / or activation operations.

[0011] In one embodiment, the electronic control unit is configured to switch the electronic system from a first state to a second state, for example, by issuing corresponding commands or signals to other units or components of the system. The electronic control unit may be configured to switch the electronic system from the first state to the second state in response to at least one electrical signal. The signal may indicate a dosing operation or may require a dedicated operation (such as an activation operation) different from the dosing operation. For example, a signal indicating an activation operation may be used to selectively activate, for example, a communication unit without activating a motion sensing unit.

[0012] In one embodiment, the user interface component includes a first part and a second part. The first part may expose or provide an external operating surface. The second part may expose or provide an interface between the user interface component and a dosage setting and / or drive mechanism of a drug delivery device or drug delivery device unit. The interface may establish a permanent or non-releasable connection to the dosage setting and / or drive mechanism (e.g., when the system is integrated into the device), or a releasable connection to the dosage setting and / or drive mechanism (e.g., when the system is an additional module of the mechanism). The second part may provide connection features, such as snap-fit ​​features, for the connection between the user interface component and the drug delivery device unit. The system can be axially and / or steered to the dosage setting and / or drive mechanism (e.g., one of its components) via the connection. Dosing operation may require movement of the second part relative to the housing. Activation operation may require movement of the first part relative to the second part (e.g., from a rest position of the first part to a signal transmission position relative to the second part). Movement of the first part relative to the second part to the signal transmission position may be required to trigger a signal transmission unit to provide an electrical signal. During the relative movement of the first part from the rest position to the signal transmission position, the second part may be stationary. That is, the second part may, for example, not move relative to the housing. The first part may be movable relative to the second part from its rest position to a signal transmission position relative to the second part. The signal transmission unit may be configured to provide an electrical signal in response to the displacement or movement of the first part relative to the second part from its rest position to its signal transmission position. Therefore, relative movement may be required to provide an electrical signal. Completing the dosing operation may involve or require the simultaneous movement of the first and second parts, for example, after the first part has reached the signal transmission position relative to the second part. The rest position may be the position that the first part has relative to the second part when the user is not applying force or torque to the user interface member. When the first part is in the rest position, the user interface member may be in its initial position (i.e., the position before the dosing operation begins or can begin).

[0013] For example, using relative movement between the first part and the second part (both of which are components of the user interface component) will cause the generation process of a signal that switches the electronic system to the second state to be integrated into the manipulation of the user interface component, without involving another component to activate the system (such as waking the system by switching it from a dormant state to an operational state).

[0014] In one implementation, for the activation operation, the user manipulates the setting surface of the user interface component, preferably only the setting surface. The activation operation may involve a rotational movement of the first portion relative to the second portion, for example, opposite to the dose setting direction.

[0015] In one embodiment, for the activation operation, the user manipulates the delivery surface of the user interface component, preferably only the delivery surface. The activation operation may involve axial movement of the first portion relative to the second portion, for example, in the dose delivery direction.

[0016] In one embodiment, an electronic control unit (ECU) is connected (e.g., mounted) to a second part. The ECU may be fixedly connected to the second part of the user interface component. The ECU may be mounted on a conductor carrier and / or electrically connected to a conductor on the conductor carrier. The conductor carrier may be fixed to the second part of the user interface component. Therefore, during movement of the first part relative to the second part, the first part may move relative to the ECU and / or the conductor carrier. Since the ECU is mounted to the part of the user interface component that moves relative to the first part as it moves from a rest position to a signal transmission position, signal generation can occur near the ECU. This provides the possibility of a short conductive path to the ECU. Furthermore, the connection to the second part ensures that the ECU does not need to be moved by the user when the first part moves relative to the second part.

[0017] In one embodiment, the movement of the first portion relative to the second portion from a rest position to a signal transmission position involves a rotational movement of the first portion relative to the second portion, preferably only a rotational movement (that is, no axial movement of the first portion relative to the second portion). This rotational movement can occur when a user manipulates the setting surface of the user interface component for, for example, a dose setting operation or an activation operation. This manipulation typically occurs before the delivery operation (which typically involves the delivery surface being touched by the user), and thus, after switching to the second state, sufficient time is given to allow the system's electronic components or units to be awakened or made operable before the delivery operation begins.

[0018] In one embodiment, the movement of the first part relative to the second part from a rest position to a signal transmission position involves axial movement of the first part relative to the second part, preferably only axial movement (i.e., no rotational movement of the first part relative to the second part). In this case, the user can manipulate the delivery surface of the user interface component. The system can switch to the second state immediately before or during the delivery operation. Therefore, the electronic functions of the system can be provided only when needed, such as during a dose delivery operation.

[0019] In one embodiment, when the first part moves from a stationary position to a signal transmitting position, the second part remains stationary, for example, relative to the housing. Movement of the second part, for example, relative to the housing in the same direction as the first part can be prevented. This prevention can be achieved, for example, by a stop feature.

[0020] In one embodiment, for dosing operations, the first and second portions must, for example, move relative to the housing. For dosing operations, the first and second portions may need to move in a coordinated and suitable manner in both orientation and axial direction. The second portion is movable from the first portion for dosing operations.

[0021] In one embodiment, the forces that must be overcome to actuate the movement of the second part relative to the housing (e.g., for dose setting or dose delivery operations) may include frictional forces and / or other components, such as bias forces that need to be overcome to switch couplings in a drug delivery device or forces involved in activating mechanisms (i.e., before delivery operations can begin).

[0022] In one implementation, the first and second portions function as a single, integral part during dosing operations. The user interface component may function as a rigid, single component during dosing operations, i.e., there is no relative movement between these portions.

[0023] In one embodiment, the relative movement (e.g., axial and / or rotational movement) between the first and second parts of the user interface component from the rest position to the signal transmission position is restricted, for example, in one or both directions.

[0024] In one embodiment for setting a dose during a dose setting operation, the user interface component (e.g., its second portion) must be rotated relative to the housing, for example, in the dose setting direction. The rotation can be an integer multiple of a unit setting increment angle. A unit setting increment can be the minimum dose that can be set to be delivered by a drug delivery device. A unit setting increment angle can be an angle by which the user interface component (e.g., its second portion and / or its first portion) may need to be rotated relative to the housing. When the first portion moves to the signal transmission position, the angle by which the first portion rotates relative to the second portion can be less than the angle corresponding to a unit increment, i.e., the unit setting increment angle. For example, the angle separating the rest position from the signal transmission position in the angular direction can be less than or equal to half the unit setting increment angle.

[0025] In one embodiment, if the first part rotates from a stationary position to a signal transmitting position relative to the second part, the angular distance between the stationary position and the signal transmitting position is less than or equal to one of the following values: 10°, 8°, 7°, 6°, 5°, 4°, 3°, 2°, 1°. The distance may be greater than 0.5°.

[0026] In one implementation, if the first portion moves axially from its rest position to the signal transmission position relative to the second portion, this movement may be limited to a distance less than any of the following values: 1 mm, 0.5 mm, 0.3 mm. The movement may be greater than or equal to 0.2 mm.

[0027] In one embodiment, the distance of relative axial movement between the first and second portions from the rest position to the signal transmission position can be less than the distance the user interface component must move relative to the housing to switch the coupling connection in the dose setting and / or drive mechanism, for example, switching the mechanism from a dose setting configuration for dose setting operations to a dose delivery configuration for dose delivery operations. Therefore, the signal transmission position can be reached before the configuration change of the mechanism.

[0028] In one embodiment, the first and second portions are mechanically interconnected during dosing operations (e.g., only during dosing operations). The first and second portions may also be directly interconnected via mechanical interconnection during dosing operations. The mechanical interconnection can be configured to transmit force or torque from the first portion to the second portion during dosing operations. The mechanical interconnection can be a permanent connection (e.g., a connection that is not releasable without permanently destroying the features involved in establishing the connection) or a releasable connection. Alternatively, the mechanical interconnection can be releasable. For example, the mechanical interconnection can be released when a user performs an activation operation using a user interface component to switch the electronic system from a first state to a second state. Mechanical interconnections can be established for dosing operations (e.g., dosing setting operations and dosing delivery operations).

[0029] In one embodiment, the mechanical interconnect includes at least one connection feature. The user interface component may include multiple connection features. The connection features may be configured to provide the mechanical interconnect. The connection features may be integrally formed with the first part and / or the second part. The mechanical interconnect may include only one connection feature integrally formed with the first and second parts, or multiple connection features, each integrally formed with the first and second parts. The connection feature integrally formed with the first and second parts may be or may be included in a web extending between the first and second parts. The corresponding connection features may be radially oriented. The connection features may enable the first and second parts to be radially interconnected with each other.

[0030] In one embodiment, the transition region between the connecting feature and the first portion and / or the transition region between the connecting feature and the second portion can be rigid. The connecting feature can be flexible. In particular, the connecting feature can be flexible to allow the first portion to move relative to the second portion from a rest position to a signal transmission position. The connecting feature can be elastically deformable. The connecting feature can elastically deform as the first portion moves from the rest position to the signal transmission position.

[0031] In one embodiment, the mechanical interconnect includes at least one connecting feature of a first portion and at least one connecting feature of a second portion. These connecting features are suitably configured to interact with each other (e.g., engage with each other) to establish the mechanical interconnect. The corresponding connecting features may be rigid. The mechanical interconnect can be formed when the connecting features of the first and second portions engage. The mechanical interconnect can be released when the connecting features disengage. For example, the connecting features may be snap-fit ​​features.

[0032] In one embodiment, the first and second portions are connected via a force-sensitive coupling. The coupling can lock these portions against relative movement (e.g., against relative rotational movement) until a force exceeding a threshold force is applied to the coupling. The coupling can then be released, and the first portion can move relative to the second portion. Forces used for dosing operations (e.g., forces used to set or cancel a dose) are preferably reliably transmitted via the force-sensitive coupling. Mechanically interconnected connection features can establish the force-sensitive coupling.

[0033] In one embodiment, the system is configured such that after relative movement has been completed in a direction away from the stationary position, such as by rotation of less than one unit increment angle (e.g., entering or passing the signal transmission position), the first part is connected to the second part in a torque- and / or force-resistant manner. This can be achieved by interacting features on the first part adjacent to interacting features on the second part. Therefore, after reaching the signal transmission position, the mechanical interconnect can be transferred from the first part to the second part without additional stress.

[0034] In one implementation, the dosing operation is a dose setting operation. Alternatively, the dosing operation can be a dose delivery operation.

[0035] In one embodiment, the dose setting operation involves a rotational movement of a first portion relative to the housing (e.g., the housing of a drug delivery device) in the dose setting direction.

[0036] In one embodiment, the movement of the first part away from the stationary position involves a rotational movement in or opposite to the dose setting direction.

[0037] In one embodiment, the second part also moves together with the first part during dosage operation. The entire user interface component can move during dosage operation. During the initial phase of movement for dosage operation, the first part can move to the signal transmission position, and thereafter, the first and second parts can move together. During dosage setting operation, the entire user interface component moves relative to the housing from the initial position to the dosage setting position. In the initial position, the first part can be in its stationary position.

[0038] In one embodiment, as the movement of the first part continues from the signal transmission position in a direction away from the rest position, the first and second parts move together (e.g., rotate together), preferably moving together in unison. The direction away from the signal transmission position and the rest position can be the dose setting direction. Once the signal transmission position has been reached (e.g., by the first part adjacent to the second part), the second part can passively follow the first part.

[0039] In one embodiment, the mechanical interconnect is releasable. The mechanical interconnect can be releasable for activation. Activation may involve movement of the first portion relative to the second portion, particularly from a rest position to a signal transmission position. Activation may differ from dosing operations as discussed above. The movement may be a rotational movement opposite to the dose setting direction.

[0040] In one embodiment, the electronic system, preferably with mechanical interconnects, is configured such that the force or torque that a user must apply to the first part to perform a dosing operation (e.g., move the first and second parts) using the user interface components is less than the force or torque that a user must apply to the first part to move it from a rest position to a signal transmission position (e.g., to perform an activation operation). The force or torque required for the dosing operation can be determined by the force required to move the second part (e.g., relative to the housing and / or one or more components of the dose setting and / or drive mechanism) for the dosing operation. Because the mechanical interconnects may have to be released to move the first part from the rest position to the signal transmission position, the force or torque that a user must apply to move it to the signal transmission position may have to be greater than the force or torque used for the dosing operation (particularly the dose setting operation).

[0041] In one embodiment, the electronic system, preferably with mechanical interconnects, is configured such that the force or torque that the user must apply to the first part in order to perform a dosing operation using the user interface component (e.g., to move the second part together with the first part) is greater than the force or torque that the user must apply to the first part in order to move the first part from a stationary position to a signal transmission position.

[0042] In one embodiment, the system is configured such that the second portion is configured to abut a stop feature when the first portion moves from a rest position toward a signal transmission position. This facilitates or enables movement of the first portion relative to the second portion toward the signal transmission position. The stop feature can be arranged to block movement of the second portion in the same direction as the first portion's movement toward the signal transmission position. This helps to increase the force or torque applied by the user to the mechanical connection, for example, to flex or release the connection feature, in order to move the first portion relative to the second portion into the signal transmission position. The stop feature can be provided in or within a drug delivery device unit, for example, locked relative to the housing.

[0043] In one implementation, for the dose setting operation, the first portion moves away from the signal transmission position and away from the stationary position. In this case, the activation operation is suitably an operation different from the dose setting operation.

[0044] In one implementation, for either dose setting or dose delivery operations, the first portion moves away from the stationary position and toward the signal transmission position. In this case, signal generation can be integrated into the regular dose setting operation without requiring a separate activation operation.

[0045] In one embodiment, the signal transmitting unit is configured such that if the first part moves from the rest position to the signal transmitting position, it provides an electrical signal only when the magnitude of the currently set dose is zero. When no dose is set, the user interface component can be located closest to the housing, for example, in a dose setting configuration of the dose setting and / or drive mechanism. Alternatively, the signal transmitting unit can provide a signal independently of whether a non-zero dose is currently set.

[0046] In one implementation, the rest position is a zero-dose or no-dose setting position for the first part and / or the user interface component. That is, in the rest position, the currently set dose can be zero. The rest position can be, for example, the position of the user interface component and / or the first part as close as possible to the housing of the drug delivery device or drug delivery device unit when the mechanism is in the dose setting configuration. For example, when the first part is in the rest position relative to the housing, the user interface component can be in its initial position before the dose setting operation begins.

[0047] In one embodiment, the signal transmitting unit includes an electrical switching mechanism. The switching mechanism can be configured to be triggered when the first part moves from a rest position to a signal transmitting position relative to the second part, preferably to provide an electrical signal. The electrical switch of the switching mechanism can be disposed on a conductive carrier and / or fixed to the second part. The switch can be electrically connected to an electronic control unit. The switching mechanism can be configured such that the electronic control unit can determine the direction of rotation of the first part relative to the second part, for example, distinguishing between two opposite directions. The switching mechanism can be configured to generate a signal only for unidirectional rotation or for bidirectional rotation (e.g., by having multiple switches, one for each direction).

[0048] In one embodiment, the electronic system is configured such that when the first part is in the signal transmitting position, the first part is biased toward a rest position, for example, by a biasing mechanism of the user interface component. A user who can manipulate the user interface component can react to the bias, thereby maintaining the signal transmitting position of the first part by the user. However, once the user releases the user interface component, the biasing mechanism can be configured to re-establish the relative arrangement of the second part with the first part, such that the first part again takes a rest position relative to the second part. The biasing mechanism may include a resiliently displaceable or resiliently deformable feature that resiliently displaces or deforms and is thereby biased when the first part moves into the signal transmitting position. The resilient restoring force provided by the feature moves the first part, in particular, from the signal transmitting position back to the rest position. For example, the feature may be a flexible arm. Alternatively or additionally, the resiliently displaceable or resiliently deformable feature is a mechanically interconnected connection feature.

[0049] In one embodiment, the second portion is an internal part of the user interface component. Preferably, for example, when the electronic system is integrated into or connected to a drug delivery device unit, the second portion is inaccessible from the outside of the electronic system. In the electronic system, the second portion may be inaccessible from the lateral or proximal surface of the user interface component. It may be accessible from the distal end of the user interface component, for example, from a component used for connection to dose setting and / or drive mechanisms.

[0050] In one embodiment, the signal transmission position is offset at an angle from the rest position in a direction opposite to the dose setting direction. For example, the rotation required to rotate the first part relative to the second part into the signal transmission position may be opposite to the dose setting direction.

[0051] In one embodiment, a stop feature may be provided to prevent rotation of the first portion relative to the second portion, for example, beyond the signal transmission position. However, limited rotatability of the first portion relative to the second portion is suitably permitted.

[0052] In one implementation, in order to provide an electrical signal for switching the electronic system from a first state to a second state, the movement of the first part relative to the second part in the signal transmission position is unidirectional. This avoids complex multidirectional movements.

[0053] In one implementation, the first and second parts are rigid. The connection between these parts can be flexible.

[0054] In one embodiment, the user interface component can be moved, for example, relative to the housing (such as the housing of a system or drug delivery device) from a first position (e.g., axially) to a second position. The first position can be, for example, the initial position that the user interface component has relative to the housing before the start of a dose delivery operation and / or after the dose setting operation has been completed. The second position can be the position taken by the user interface component when a user force (e.g., a distally directed force) is applied to the user interface component and the user interface component moves away from the first position (e.g., for a dose delivery operation). The first and second positions can be axially offset. Movement from the first position to the second position may involve only axial movement.

[0055] In one embodiment, the first and second portions are operatively coupled to each other via a guide interface. The guide interface may be provided as a supplement to the connection features and / or mechanical interconnection. The guide interface may, for example, axially guide movement of the first portion relative to the second portion from a rest position to a signal transmission position. The guide interface may be configured to prevent tilting movement of the first portion relative to the second portion, for example, relative to a rotational axis of the first portion and / or the user interface component for a first operation. The rotational axis may be the axis of the user interface component and / or the rotational axis around which the user interface component rotates for dose setting operations.

[0056] In one embodiment, the electronic system or drug delivery device includes a dose setting and / or actuation mechanism. The dose setting and / or actuation mechanism may include a first component and a second component. The first and / or second components may be configured to move relative to the housing of the electronic system or drug delivery device during dose setting and / or dose delivery operations. The first component may be a dose-setting component or selector component (e.g., a selector sleeve or digital sleeve) that is moved to set a dose within the dose setting and / or actuation mechanism. The second component may be an actuation component (e.g., a component engaging a piston rod of the dose setting and / or actuation mechanism) or a device user interface component (such as a dose knob and / or injection button). The first and / or second components may be movably coupled to or held within the housing. During dose setting operations, the first and / or second components may be axially displaced relative to the housing (e.g., away from the proximal end of the housing). The distance by which the first and / or second components are displaced relative to the housing (e.g., axially) during dose setting operations may be determined by the magnitude of the set dose. In other words, the drug delivery device can be of the selectable extension type, that is, the device increases its length during the dose setting operation by an amount proportional to the size of the set dose.

[0057] In one embodiment, during dose setting and / or dose delivery operations, the first component moves (e.g., rotates and / or moves axially) relative to the second component. For example, during dose delivery operations (e.g., only during dose delivery operations), the first component may rotate relative to the second component. Both the first and second components may move axially during dose delivery operations. During dose setting and / or dose delivery operations, the first component may rotate relative to the second component and relative to the housing. During dose delivery operations, the second component may be locked or guided relative to the housing in orientation, for example, by a delivery connector. During dose setting operations, the first and second components may be locked relative to each other in orientation. Therefore, during dose setting operations, the first and second components may rotate relative to the housing. During dose setting operations, the first and second components may be coupled to each other, for example, via a coupling interface (e.g., a setting connector). During dose setting operations, the coupling interface may lock the first and second components relative to each other in orientation. When the coupling interface engages, the first and second components may lock to each other in orientation, such as through direct engagement of coupling interface features. The first and second components may include mating coupling interface features. For example, the coupling interface can be released during dose delivery operation by axially displacing the second component relative to the first component. Thus, the second component can be locked in orientation relative to the housing during dose delivery, while the first component can rotate relative to the housing during dose delivery. The coupling interface can be released when switching the dose setting and / or drive mechanism from a dose setting configuration to a dose delivery configuration. This can be achieved when the user interface component moves from a first position to a second position. In the first position, the mechanism can be in the dose setting configuration. In the second position, the mechanism can be in the dose delivery configuration.

[0058] In one embodiment, the first component and the second component rotate relative to each other during only one of the dose setting and dose delivery operations. One of the first and second components (e.g., the first component) may rotate relative to the housing during both operations. One of the first and second components (e.g., the second component) may rotate relative to the housing during only one of these operations (e.g., during dose setting or during dose delivery).

[0059] In one embodiment, a second component of the dose setting and / or drive mechanism is configured to be connected to or be connected to a second part of the user interface component.

[0060] In one embodiment, the electronic system includes at least one, any selected plurality, or all of the following units or components:

[0061] - Electrical motion sensing unit. The motion sensing unit will be explained in more detail below.

[0062] - Communication Unit. A communication unit may be provided to establish a communication interface between the electronic system and another device, such as an electronic device (e.g., a portable device), such as a portable or non-portable computer, mobile phone, or tablet computer. The communication unit may be a wireless unit, such as an RF communication unit, or a Bluetooth unit. The communication unit may be provided to transmit dose data from the electronic system to other devices, such as information about the amount of drug delivered by the device in a delivery operation.

[0063] - Memory unit. The memory unit may be provided to store executable program code and / or data regarding dose information already calculated by the electronic system, preferably dose data regarding one or more delivered doses. The dose data may be determined via a motion sensing unit. From the memory unit, the data may be retrieved for transmission to another device, for example, via a communication unit.

[0064] In one embodiment, the motion sensing unit is configured to generate one or more electrical motion signals. These motion signals may be adapted to quantify relative movement between a first component and a second component, for example, during a dose setting or dose delivery operation, to obtain dose data (such as the magnitude of the delivered dose). The first and / or second component may be components of an electronic system and / or a drug delivery device, such as dose setting and / or actuation mechanisms as further discussed above. The relative movement may be relative rotational movement. For example, during dose delivery, the first component may rotate relative to the second component.

[0065] In one embodiment, the electronic system is configured such that the motion sensing unit switches from a first state to a second state, for example, via an electronic control unit and / or in response to a signal provided by a signal transmitting unit in response to movement of the first part to a signal transmitting position. In the first state, the motion sensing unit may not operate to sense movement of the first member relative to the second member. In the second state, the motion sensing unit may operate. In the second state, the motion sensing unit may have a higher power consumption than in the first state. This increase in power consumption of the motion sensing unit may contribute to or limit the increased power consumption of the electronic system in the second state.

[0066] In one embodiment, the motion sensing unit is configured to operate during the dose delivery operation, preferably only during the dose delivery operation. The motion sensing unit can be configured to monitor the dose delivery operation, such as the rotation of the first component relative to the second component. Therefore, positional information regarding the relative position between the first and second components can be collected from the motion signal. Alternatively or additionally, positional information between the two components can also be collected during the dose setting operation. However, it is advantageous for the motion sensing unit to monitor movement during the dose delivery operation in order to calculate dose information or data regarding dose delivery during the operation.

[0067] In one embodiment, the electronic system is configured such that a communication unit and / or a motion sensing unit are activated in response to a signal. The communication unit may be activated in response to a dosage operation and / or an activation operation (e.g., only in response to an activation operation or in response to both an activation operation and a dosage operation). The communication unit may be configured to perform data transmission to another device (e.g., a telephone or laptop computer), as discussed above. When the communication unit is activated, for example, in response to an activation operation, the electronic system may attempt to transmit data (e.g., dosage data) to another device that can be paired with the electronic system, or to synchronize data with another device via the communication unit. The motion sensing unit may remain inoperable in response to the activation operation; that is, unlike the communication unit, the motion sensing unit may not be activated by the activation operation. The activation operation and / or dosage operation may be used to trigger a data transmission or synchronization process with another device. During a dosage operation, such as when performing a dosage delivery operation to deliver a previously set dose, the motion sensing unit is preferably also operable. After the dosage delivery operation has been completed, the communication unit may transmit data to or attempt to transmit data to another device.

[0068] In one embodiment, the electronic control unit or electronic system is configured to calculate dose information or data using motion signals generated by the motion sensing unit. As previously mentioned, the dose information is preferably information about the magnitude of the dose delivered in the dose delivery operation.

[0069] In one implementation, when stationary, the first part can move relative to the second part in two different directions (e.g., in opposite rotational directions). One of these directions can be toward a signal transmission location where a signal is generated to switch the electronic system to a higher power consumption state, for example, to activate the motion sensing unit, and preferably the communication unit. The other direction can be away from the signal transmission location. A signal can also be generated in this direction, for example, via a corresponding switch that, when triggered, indicates rotation in that direction. However, when the signal transmission location is detected and the corresponding signal is generated, the electronic control unit preferably switches the system to a higher power consumption state only, where the motion sensing unit is on. The other direction can be used to (only) manually activate the communication unit, for example, to perform pairing or synchronization operations with other devices. The operation of the user interface components associated with the activation of the communication unit can be an activation operation. Pairing or synchronization operations can be integrated into the operating sequence of the electronic system after the motion sensing unit has acquired dose data, for example, related to the delivery dose in a dose delivery operation.

[0070] In one implementation, the electronic system is configured such that it switches from a first state to a second state only when a first portion of the user interface component is held, maintained, or sustained away from a rest position (e.g., in a signal transmission position) for a predetermined time. The predetermined time can be 2 s, 3 s, 4 s, or 5 s. Therefore, the first portion may need to be held in the signal transmission position, for example, against a bias that tends to move the first portion into the rest position, in order for the system to be switched to the second state. This is particularly suitable for activation operations different from dose-based operations, as it requires a conscious decision by the user to switch the system, and because accidental movement of the first portion away from the rest position for a predetermined time is less likely than accidental displacement. Before the system is switched to the higher-power second state, the first portion may need to rotate or axially displace away from the rest position and remain away from said position for a predetermined time.

[0071] In one embodiment, the motion sensing unit includes one or more sensors and / or one or more transmitters, such as one or more photoelectric radiation sensors or detectors and / or one or more photoelectric radiation transmitters. The sensors may be configured to generate motion signals in response to movement of the first member relative to the second member. The transmitters may excite the sensor signals.

[0072] In one embodiment, during the dose setting operation, the dose can be set, for example, between a minimum settable dose and a maximum settable dose. The dose can be set, preferably, to an amount corresponding to an integer multiple of a unit dose increment.

[0073] In one embodiment, the separation (e.g., axial separation) between a first and second position of the user interface component (e.g., relative to the housing) is determined by, for example, equal to, a switching distance (e.g., a connector release distance). The switching distance can be the distance that the second component of the dose setting and drive mechanism must move relative to the first component of the dose setting and drive mechanism in order to switch the dose setting and drive mechanism from a dose setting configuration to a dose delivery configuration of the mechanism. In the first position, the dose setting and drive mechanism can be in the dose setting configuration. In the second position, the dose setting and drive mechanism can be in the dose delivery configuration. In the dose setting configuration or the first position, for example, the component of the dose setting and drive mechanism can be locked in steering, as discussed further above. In the dose delivery configuration or the second position, relative rotation is permitted, for example, the first component can rotate relative to the second component and the housing during dose delivery. During dose delivery operation, the second component can be locked in steering relative to the housing.

[0074] In one implementation, the axial separation between the first and second positions is greater than or equal to the distance the second member must move relative to the first member, for example, axially, to release the rotary lock. Specifically, during the movement of the user interface member from the first to the second position, the rotary lock can be released by moving the second member axially (e.g., distally) relative to the first member. The distance for releasing the rotary lock may correspond to a switching distance. When the member moves from the first position to the second position, a signal can be provided and / or the electronic system can immediately switch to the second state.

[0075] In one implementation, the electronic system includes a power source, such as a rechargeable or non-rechargeable battery.

[0076] In one embodiment, in the second state, the electronic system is configured to collect information or data related to the magnitude of the currently dispensed or delivered dose, for example via a motion sensing unit, during the delivery operation. Thus, the motion sensing unit can be configured to facilitate the retrieval of dose data regarding the dose delivered in the delivery operation (e.g., the dose currently delivered during a dose delivery operation).

[0077] In one embodiment, in the second state, the electronic system is configured to store dose data in a dose memory or memory unit of the electronic system. The memory may be temporary or non-temporary. The dose data is suitably derived using measurements or signals from the motion sensing unit.

[0078] In one implementation, in the second state, the electronic system is configured to transmit dose data (e.g., dose data retrieved from memory) to another device or system, such as a computing device, like a mobile phone or a portable or non-portable computing unit, by means of a communication unit.

[0079] In one embodiment, the electronic system includes a user interface component (e.g., a single integrated component) for dose setting and dose delivery operations, or two distinct user interface components, one for dose setting and the other for dose delivery. These two distinct components can suitably move relative to each other, for example, to switch between dose setting and dose delivery configurations. If a single interface component is used for both dose setting and dose delivery, this component may have a setting surface and a delivery surface, preferably which cannot move relative to each other, particularly not during dose delivery and / or during dose setting. If two distinct user interface components are used, the setting surface and delivery surface may be on different components and can be used or moved relative to each other during dose delivery and / or during dose setting.

[0080] In one embodiment, the electronic system includes a timer unit. The timer unit can be configured to deactivate the motion sensing unit and / or other motoring units of the electronic system after a predetermined time period has elapsed, and preferably when no motion signal has been generated during this time period. The timer unit can trigger or cause the electronic system to switch from a second state back to a first state. In other words, the electronic system can be configured to switch from a second state back to a first state, preferably when the electronic control unit has not generated and / or received a motion signal within the predetermined time period.

[0081] In one implementation, the user interface component is a drug delivery device or a dose setting and / or injection button for the drug delivery device.

[0082] In one implementation, dose setting and / or dose delivery operations require a second part of the user interface component, for example, to move relative to the housing.

[0083] In one embodiment, the electronic system includes a feedback unit. The feedback unit can be configured to generate user-perceptible feedback. The feedback enables the user to determine whether the system is in a first state or a second state. Preferably, no perceptible feedback is provided in the first state, while feedback indicates the second state. For example, the feedback can be a feedback signal, such as a light signal. The feedback signal can be provided by a light source such as a light-emitting diode (LED). The light source can operate in a pulsed or flashing manner to provide feedback.

[0084] In one implementation, the device is a manually driven device, such as a user-driven device.

[0085] 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 containing a drug. The reservoir may include sufficient doses of drug to be delivered by the drug delivery device in multiple (preferably user-configurable) doses.

[0086] In one embodiment, the drug delivery device is a pen-shaped device.

[0087] 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 respective drug delivery device unit can be a disposable drug delivery device unit, and / or the respective 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.

[0088] In one implementation, the power supply is non-replaceable.

[0089] 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.

[0090] In this document, "distal" refers 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" refers 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 face away from the distal end and / or toward the proximal end. The distal surface can face the distal end and / or face 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.

[0091] In a particularly advantageous embodiment, an electronic system for a drug delivery device includes:

[0092] - At least one user interface component configured to be manipulated by a user to perform dosing operations, such as a dosing setting operation for setting a dose of drug to be delivered by a drug delivery device and / or a dosing delivery operation for delivering the set dose.

[0093] - An electronic control unit configured to control the operation of an electronic system having a first state and a second state, wherein the electronic system in the second state has increased power consumption compared to the first state.

[0094] - An electrical signal transmitting unit, configured to provide an electrical signal indicating that a user interface component is being manipulated, wherein...

[0095] - The electronic control unit is configured to switch the electronic system from the first state to the second state in response to the electrical signal, and wherein

[0096] - The user interface component includes a first part and a second part, wherein the first part is movable relative to the second part from a stationary position to a signal transmission position, wherein the signal transmission unit is configured to provide an electrical signal in response to the movement of the first part relative to the second part from the stationary position to the signal transmission position.

[0097] Features disclosed in different aspects and embodiments can be combined with each other, even if such combinations are not explicitly discussed above or below. Further aspects, embodiments, and advantages will become apparent from the following description of exemplary embodiments in conjunction with the accompanying drawings. Attached Figure Description

[0098] Figure 1 An implementation scheme for a drug delivery device or drug delivery device unit is shown.

[0099] Figure 2 The illustration schematically shows a device for drug delivery (e.g., Figure 1 The electronic system of the drug delivery device in the middle.

[0100] Figure 3 The illustration schematically shows a device for drug delivery (e.g., Figure 1 An implementation scheme for the electronic system of a drug delivery device (in the context of a drug delivery device).

[0101] Figures 4A to 4H The illustration schematically shows a device for drug delivery (e.g., Figure 1 An implementation scheme for the electronic system of a drug delivery device (in the context of a drug delivery device).

[0102] Figure 5 Another implementation of an electronic system for a drug delivery device is shown.

[0103] Figure 6A and Figure 6B Another implementation of an electronic system for a drug delivery device is shown.

[0104] Figures 7A to 7C Another implementation of an electronic system for a drug delivery device is shown. Detailed Implementation

[0105] In the accompanying drawings, the same features, features of the same kind, or features with the same or similar functions may have the same reference numerals.

[0106] In the following description, some concepts will be referred to in connection with insulin injection devices. The system described herein can be implemented in this device or used as an additional module of the 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.

[0107] 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 techniques (e.g., facilitating small batteries and / or enabling efficient power use).

[0108] Certain embodiments described in this document pertain to injection devices (e.g., similar to Sanofi's ALLSTAR® device) that incorporate an injection button and a grip (dose setting component or dose setter). The injection button provides a user interface component for initiating and / or performing dose delivery operations of the drug delivery device. A grip or knob provides a user interface component for initiating and / or performing dose setting operations. These components may be of the selector extension type, i.e., their length increases during dose setting. Other injection devices known to have the same kinematic behavior as selector extensions and buttons during dose setting and dose dispensing operation modes are, for example, the Kwikpen® or Savvio® devices marketed by Eli Lilly and Company and the FlexPen® or Novopen® devices marketed by Novo Nordisk. Therefore, it is straightforward to apply the general principles to these devices, and further explanation will be omitted. However, the general principles of this disclosure are not limited to the described kinematic behavior. Certain other embodiments are conceivable for application to injection devices with separate injection buttons and grip components / dose setting components, such as Sanofi's SoloSTAR®. 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 relative to each other in orientation, 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 relative to the housing in orientation 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 via the threaded connection between the piston rod and the housing.

[0109] Figure 1The injection device 1 is an injection pen, which 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 may be set on a digital sleeve or a selector sleeve 70. For example, when injection device 1 is configured to administer human insulin, the dose can be expressed 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 delivering insulin analogs or other agents. It should be noted that the selected dose can be expressed in conjunction with... Figure 1 The different methods shown in dose window 13 are also well displayed.

[0110] The dosage window 13 may be in the form of an orifice in the housing 10, or in the form of a transparent, stand-alone component inserted into an orifice in the housing, wherein the stand-alone component may be combined with a magnifying glass. The dosage window 13 allows the user to view a limited portion of the selector sleeve 70, which is configured to move when the dosage knob 12 is rotated to provide a visual indication of the currently programmed dosage. When rotated during programming, the dosage knob 12 rotates in a helical path relative to the housing 10.

[0111] 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.

[0112] 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 pressed in the axial direction, the insulin dose displayed in the display or dose window 13 is dispensed 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 of time after the dose knob 12 has been pushed to the correct position. The dispensing 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.

[0113] In this embodiment, during insulin dose delivery, the dosing knob 12 moves axially back to its initial position without rotation, while the selector sleeve 70 or 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 medication formulations.

[0114] 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).

[0115] Furthermore, before using the injection device 1 for the first time, it may be necessary to perform a so-called "preparation for injection" 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 amount expelled substantially corresponds to the injection dose, such that, for example, the amount of medication expelled from the injection device 1 is equal to the dose received by the user.

[0116] 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.

[0117] The general setup of the electronic system for the drug delivery device is disclosed below.

[0118] Figure 2 The general configuration of the components of the electronic system 1000 is shown, which can be used in or for drug delivery devices, such as the devices or device units discussed further above or other devices.

[0119] Electronic system 1000 includes electronic control unit 1100. The control unit may include a processor, such as a microcontroller or ASIC. Furthermore, 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 that, when executed by the system, controls the operation of the system and / or the electronic control unit. Control unit 1100 is suitably designed to control the operation of electronic system 1000. Control unit 1100 may communicate with other units of electronic system 1000 via a wired or wireless interface. Control unit 1100 may transmit signals containing commands and / or data to and / or receive signals and / or data from corresponding units. The connection between these units and electronic control unit 1100 is provided by… Figure 2 The lines in the diagram represent the units. However, connections may also exist between these units, which are not explicitly shown. The control unit 1100 may be arranged on a conductive carrier, such as a (printed) circuit board (see [reference]). Figure 3 (Ref. 3000). Other units of the electronic system may include one or more components that are also arranged on the conductor carrier.

[0120] 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 suitably designed to generate motion signals (such as electrical signals) indicating movement of one component of the electronic system or drug delivery device relative to another component, such as the movement of a selector sleeve or digital sleeve relative to a drive sleeve or button / knob in the device further discussed above, wherein the sensor may be fixedly connected to one of these components (e.g., a knob or button). The relative movement suitably occurs during dose delivery operation. 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, such as an optical encoder component. The radiation may be radiation reflected by the 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 including at least one sensor. One possible embodiment of the sensor is an IR sensor configured to detect infrared light. The light source and sensor can 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, such as the use of magnetic sensors. In motion sensing units having electrically operated sensors and / or electrically operated sources (such as radiating emitters and associated sensors) for stimulating 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. The motion sensing unit 1200 can be designed to detect and preferably measure or quantify the relative movement of one component of the drug delivery device or the dose setting and actuation mechanism for the drug delivery device relative to another component of the dose setting and actuation mechanism or relative to the housing 10 during 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 actuation mechanism relative to each other. Based on motion data received or calculated from the signal of unit 1200, the electronic system (e.g., a control unit) can calculate dose data, such as data regarding the currently delivered dose. The motion sensing unit 1200 is suitably 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 suitably adapted to quantify relative movement in integer multiples of a unit setting increment. The unit setting increment can be or may be defined by an angle greater than or equal to one of the following values: 5°, 10°. The unit setting increment can be or may 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 angle can be the rotation required to set the minimum settable dose to be delivered by the device. The increment can be defined, for example, by a ratchet system. As explained above, the amount or distance of relative (rotational) movement between the first and second components determined by the motion sensing unit characterizes the currently set dose in the dose setting operation or the currently 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 during the dose delivery operation.

[0121] The electronic system 1000 further includes a signal transmitting unit 1300. The signal transmitting unit may be associated with one or more user interface components (knobs 12 or buttons 11 in the devices discussed above). Via the signal transmitting unit 1300, manipulation of components for setting and / or delivering a dose can be detected. The signal transmitting unit is configured to generate an electrical signal in response to manipulation of the user interface components, preferably directly in response to manipulation (e.g., unidirectional movement). The user interface components may have a setting surface and / or a delivery surface, the setting surface being arranged for touch by a user to perform a dose setting operation, and the delivery surface being arranged for touch by a user to perform a dose delivery operation. The setting surface may face a radial direction, and the delivery surface may face an axial (e.g., proximal) direction. Signal generation may require movement of at least a portion of the user interface component, for example, relative to another portion of the user interface component and / or housing. This will be explained in further detail below. For example, the element generating the signal may be an electrical sensor or a switch, such as a micro-force switch. The signals generated by the signal transmitting unit in response to manipulation can allow differentiation of different directions of movement of the user interface component and / or different surfaces of the user interface component manipulated by the user. In this case, multiple switches may be provided. The signal transmitting unit is suitably configured such that the electrical signals(s) generated in response to manipulation allow the collection of information about the currently performed, anticipated, or already performed manipulation, such as dose setting, dose delivery, or different operations. The signals generated by the signal transmitting unit 1300 may be activation prompt signals or usage signals. For example, the signal transmitting unit 1300 is operatively connected to the electronic control unit 1100. The signals provided by the signal transmitting unit can be received and / or processed by the electronic control unit 1100.

[0122] The electronic system 1000 further includes a communication unit 1400, such as an RF, WiFi, and / or Bluetooth unit. The communication unit may be provided as a communication interface between the system or drug delivery device and an external device (such as other electronic devices, such as mobile phones, personal computers, laptops, 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 also be provided for wireless communication.

[0123] The generation of a signal by the signal transmitting unit 1300 can preferably cause the electronic control unit 1100 to switch the electronic system from a first state or idle state (e.g., the state it has when the system is not needed (e.g., in a sleep state), where the idle state is optimized in terms of power consumption) to a second state with higher power consumption, for example, by activating the motion sensing unit 1200 and / or the communication unit 1400. A single signal generated by the signal transmitting unit may be sufficient to trigger the switch to the second state. To switch the system to the second state, the control unit 1100 may send an activation signal to the corresponding unit. In the second state, the motion sensing unit and / or the communication unit may be operable. In the first state, the motion sensing unit and / or the communication unit are preferably not operable. In this way, the functionality of the electrically operated unit can be available when needed. The power consumption required for the signal transmitting unit to operate in the first state is advantageously less than the power consumption when the communication unit and / or the motion sensing unit are operable. An activation prompt or usage signal may be generated in response to manipulation of a user interface component or at least a portion thereof. The manipulation may involve only unidirectional movement. Manipulation may involve rotational or axial movement only of the user interface component or its portion. Activation of the user interface component may differ from both dose setting and dose delivery operations. For example, activation may involve an attempt to rotate a portion of the user interface component in the opposite direction to the dose setting direction, such as in the zero-dose position of the user interface component. Therefore, a dedicated activation operation may be required to switch the system to a second state. Thus, the user can decide whether electronic functionality is needed, or, for example, in an emergency or other reason, choose to use the drug delivery device without electronic functionality, which is preferable. Alternatively, signal generation can be integrated into the dose setting or dose delivery operation, for example, by using relative movement between different portions of the user interface component. This relative movement (preferably limited) is suitably not detectable by the user as necessary to activate the electronic system.

[0124] The electronic system 1000 further includes a power source 1500, such as a rechargeable or non-rechargeable battery. The power source 1500 can provide power to the corresponding units of the electronic system.

[0125] In one implementation, for example, before generating a use or activation prompt signal, the power consumption, particularly the maximum power consumption, of the electronic system in the first state may be less than or equal to one of the following values: 300 nA, 250 nA, 200 nA (nA: nanoampere). Alternatively or additionally, in the second state of the electronic system, the power consumption, particularly the minimum power consumption, may be greater than or equal to one of the following values: 0.5 mA, 0.6 mA, 0.8 mA (mA: milliampere). This difference may be caused by the power consumption of the motion sensing unit 1200 and / or the communication unit 1400, which may be activated or operable in the second state of the electronic system 1000 and deactivated or in a sleep state in the first state.

[0126] In one implementation, the power consumption P2 (e.g., minimum or maximum power consumption) in the second state can be greater than or equal to at least one of the following values: 2*P1, 3*P1, 4*P1, 5*P1, 10*P1, 20*P1, 30*P1, 40*P1, 50*P1, 100*P1, 500*P1, 1000*P1, 2000*P1, 5000*P1, 10000*P1, where P1 is the power consumption in the first state. In the second state, the motion sensing unit can be turned on and / or the communication unit can be turned on, for example, for wireless communication.

[0127] When the system is in its first state, such as when neither the motion sensing unit nor the communication unit is turned on, the current consumption can be 200 nA. When only the motion sensing unit is turned on, the power consumption can be 0.85 mA. When the communication unit (e.g., in addition to the motion sensing unit or only the communication unit) is turned on, the power consumption can be 1.85 mA.

[0128] Although not explicitly described, the electronic system preferably includes, for example, permanent and / or non-volatile storage or memory units that can store data related to the operation of the drug delivery device, such as dose (history) data.

[0129] In one embodiment, the electronic control unit 1100 is configured to reduce the power consumption of the corresponding unit, i.e., to switch the unit back to a first state. This is suitable, for example, if an event associated with the unit (e.g., a motion sensing event (motion signal) from the motion sensing unit) does not occur within a predetermined time interval after the unit has switched from the first state to the second state and / or after a use signal has been generated. Monitoring of the time interval can be achieved by a timer unit (not explicitly shown) operatively connected to the electronic control unit. After a use or activation prompt signal, if no signal is generated by the motion sensing unit within the predetermined time interval, the entire system can switch back to the first state. This time interval can be greater than or equal to one of the following values: 5 s, 10 s, 15 s, 20 s, 25 s, or 30 s. Alternatively or additionally, the time interval may be less than or equal to one of the following values: 180 s, 150 s, 120 s, 90 s, 80 s, 70 s, 60 s, 50 s, 45 s, 40 s, 35 s, or 30 s. The time interval may be between 5 seconds and 180 seconds, for example, 30 s or 180 s. If no motion signal is generated within the predetermined time interval, the entire system may switch back to the first state. The predetermined time interval is preferably constant.

[0130] In one embodiment, the electronic system includes a feedback unit (not explicitly shown). The feedback unit is configured to generate user-perceptible feedback. The feedback enables the user to determine whether the system is in a first state or a second state. Preferably, in the first state, no perceptible feedback is provided and / or feedback indicates the second state. For example, the feedback can be a feedback signal, such as a light signal. The feedback signal can be provided by a light source such as a light-emitting diode (LED). The light source can operate in a pulsed or flashing manner to provide feedback.

[0131] The corresponding units described above can be integrated into the user interface components of an electronic system, which will be discussed in further detail below in conjunction with various implementation schemes.

[0132] It goes without saying that the electronic system 1000 may include other electronic units besides those shown, such as other sensing units that sense or detect quantities or events different from the relative movement detected by the motion sensing units.

[0133] The following sections describe some more detailed implementations of the electronic system. It should be noted that the features discussed above also apply to these implementations.

[0134] Figure 3An embodiment of an electronic system 1000 is illustrated schematically. 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. Preferably, when the user interface component is connected to a drug delivery device unit or integrated into, for example, a combination... Figure 1 In the arrangement of the unit or device discussed, the operating surface may be defined by an externally accessible surface from the outside of the user interface member housing or body 1605. The user interface member 1600 has a setting surface 1610, which is arranged for a user to grasp, for example, with two fingers (such as the index finger and thumb), for dose setting. The setting surface is a radially oriented surface that preferably defines the user interface member 1600 circumferentially relative to the outside. The user interface member 1600 also has a delivery surface 1620. The delivery surface is arranged for user contact (e.g., pressing and / or distal movement) for dose delivery. The delivery surface 1620 is an axially oriented surface, for example, a proximal-facing surface. As described above, embodiments of this disclosure may employ different user interface members for setting and delivery.

[0135] Within the user interface component 1600, for example within the internal hollow defined by the user interface component body 1605, additional components or units of the electronic system are housed. Specifically, the electronic system includes an electronic control unit 1100. The system also includes a conductive carrier 3000, such as a circuit board, like a printed circuit board. Conductors on the conductive carrier can electrically connect the electronic control unit to other electrical or electronic units or components of the system. The electronic control unit is arranged on the conductive carrier, for example, mounted on the carrier.

[0136] Electronic system 1000 includes a signal transmitting unit 1300. In the depicted embodiment, the signal transmitting unit has at least one sensor or switch or multiple sensors or switches 1310. In the depicted embodiment, at least one switch 1310 is associated with a setting surface 1610. Alternatively or additionally, at least one switch 1310 is associated with a delivery surface 1620. The respective switches are suitably configured to generate electrical signals or switching signals when a user interface member or a portion thereof is moved to perform a dose setting operation (the sensor or switch is suitably associated with the setting surface) or a dose delivery operation (the sensor or switch is suitably associated with the delivery surface). For example, for the dose setting operation, the user interface member 1600 may be rotatable relative to the housing 10. Multiple switches may be provided, for example, to enable the control unit to distinguish rotation in different directions. For the dose delivery operation, the user interface member may be axially moved toward the housing, for example, to switch the engagement, such as from a state where the selector sleeve and drive member are locked in direction for dose setting, to a state that allows relative rotation for dose delivery. The user interface component is preferably biased, for example, by a connector spring (not shown), to a position for dose setting that can be offset proximally by a connector switching distance to a position for dose delivery. The connector switching distance (the distance the user interface component must move to switch the connector) is, for example, greater than or equal to 1.5 mm.

[0137] The electrical signal (use or activation prompt signal) generated by the signal transmitting unit can directly trigger the electronic control unit 1100 to switch the system from the first state to the second state. The movement used to trigger the signal generation is preferably unidirectional, i.e., movement is required only in one direction. In this way, complex manipulation of the user interface component 1600 for switching the system to the second state can be avoided.

[0138] The system further includes a motion sensing unit 1200, shown only schematically, and preferably includes one or more photoelectric sensors and / or one or more associated radiation emitters, such as IR sensors and IR emitters. As indicated by the double arrows, the motion sensing unit can be electrically connected bidirectionally to the electronic control unit 1100. One direction could be the direction from which an activation signal is transmitted from the electronic control unit to the motion sensing unit. In the other direction, motion signals can be sent from the motion sensing unit to the control unit, which can further process the signals, for example, to calculate dose information or data. The motion sensing unit 1200 can be arranged on the side of the conductor carrier 3000 opposite to the control unit 1100.

[0139] Furthermore, system 1000 includes a power source 1500, such as a battery, like a button cell. The power source can be configured to provide a total capacity of approximately 25-500 mAh at a voltage of approximately 1.4-3 V. This can be achieved, for example, by stacking multiple button cells. The power source 1500 is electrically connected, or can be electrically connected, to other components of the electronic system that require power to operate. Figure 3 Conductive connections are not explicitly shown. Metal contacts may be provided for connecting the power source 1500 to the conductor carrier 3000, which can distribute power to other components via conductors on the carrier. However, the power source may be arranged to extend along a main surface of the conductor carrier 3000, as depicted. In the depicted embodiment, the power source is arranged between the conductor carrier 3000 and the delivery surface 1620. This contributes to a compact construction of the user interface component 1600.

[0140] Viewed from the outside of the component (e.g., in a top view on the delivery surface), the radial width or diameter of the user interface component 1600 may be less than or equal to one of the following values: 2 cm, 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, 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 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, 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, 0.7 cm.

[0141] The electronic system 1000 is configured to be 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 incorporated into 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 reused for another drug delivery device unit. The drug delivery device unit is preferably configured to operate entirely on its own; that is, it can be operated to set and deliver the set dose. An exemplary unit is... Figure 1The electronic system may be a purely accessory to a fully functional unit, which suitably lacks electronic or electrically operating parts. Alternatively, the drug delivery device may include an electronic system as an integral part, i.e., parts disposed together with the rest of the device and / or necessary to enable the device to operate for setting and delivering drug doses, for example, because without an electronic system, the drug delivery device unit would lack user-accessible surfaces for performing dose setting or dose delivery operations. 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.

[0142] System 1000 is suitably configured to be permanently or removably / released mechanically connected to components of the drug delivery device unit (such as components of the dose setting and drive mechanism), for example, connected to a combination Figure 1 The discussed unit includes a drive sleeve or dosage knob and / or injection button. The system (e.g., via user interface component body 1605) can be locked to components of the drug delivery device unit in both directional and axial directions. During dosage setting and / or dosage delivery, the components connected to the system can move relative to the housing 10, for example, in both directional and / or axial directions during setting, and, for example, axially only during delivery. The components can engage a piston rod, for example, via a threaded engagement. Figure 1 The dose knob and drive sleeve of the unit 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 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 that have different operating modes and / or different configurations.

[0143] The following embodiments illustrate the implementation of the signal transmitting unit 1300. In various cases, the signal transmitting unit is configured to provide or generate a signal (e.g., a usage signal or an activation prompt signal) in response to movement of a first portion of the user interface component 1600 relative to a second portion of the user interface component. The first and second portions are suitably connected or fixed to each other, thus operating as a single component except for the movement required to generate the signal and, preferably, the movement to re-establish the original relative position between the two portions. For signal generation, the limited relative movement between the portions of the user interface component is utilized.

[0144] Based on such Figures 4A to 4H The various schematic representations in the different views shown, Figures 4A to 4H An embodiment of the electronic system 1000 is shown. Generally, the system corresponds to the system previously described. Therefore, unless otherwise stated or contradicted, the features previously discussed also apply to this embodiment.

[0145] The electronic system 1000 according to this embodiment includes a signal transmitting unit 1300. The signal transmitting unit 1300 includes a setting signal transmitting unit. The setting signal transmitting unit is configured to provide a signal instructing a user to initiate or perform a dose setting operation using a user interface component 1600. The setting signal transmitting unit includes a setting switch 1660. The setting switch 1660 is associated with a setting surface 1610 of the user interface component 1600. As an alternative to or supplement to the setting signal transmitting unit, the signal transmitting unit includes a delivery signal transmitting unit. The delivery signal transmitting unit includes a delivery switch 1650. The delivery switch 1650 is associated with a delivery surface 1620 of the user interface component 1600. The delivery signal transmitting unit is provided to provide a signal in response to manipulation of the delivery surface. The setting signal transmitting unit is provided to provide a signal in response to manipulation of the setting surface. Dose setting operations can be detected via the setting signal transmitting unit. Dose delivery operations can be detected via the delivery signal transmitting unit. If only one of the delivery signal transmitting unit or the setting signal transmitting unit is provided, only one of the settings in the delivery operation can be detected; if both units are provided, both the setting operation and the delivery operation can be detected. The electronic system can be configured to operate differently in response to a signal indicating a setting operation (setting signal) and in response to a signal indicating a delivery operation (delivery signal). The corresponding switches 1650, 1660 can be electrical switches, such as microswitches, like force switches. An additional setting switch (not shown) can be provided, which enables the system to distinguish different directions of rotation.

[0146] Figure 4A An exploded view shows some parts of the user interface component 1600. We note that... Figures 4A to 4HNot all components or parts of the electronic system that have been previously discussed and will be discussed later are necessarily shown; only those most relevant to the concepts under discussion are shown.

[0147] In the depicted embodiment, the user interface component body 1605 includes a first part 1601 and a second part 1602. During operation, these two parts are suitably rigidly connected such that they function as a single component during dose setting and dose delivery operations, at least as viewed from the outside. The outer surface of the user interface component can be rigid. That is, segments of the outer surface formed by the first part and segments of the outer surface formed by the second part can be fastened to each other, for example, by welding in a directional and axial direction, such that no relative movement between these segments is possible. The first part 1601 may provide a delivery surface 1620. The second part 1602 may provide a setting surface 1610 or at least a majority thereof. As depicted, the first part 1601 may provide a radially oriented and circumferentially arranged region of the delivery surface 1620 and / or the setting surface 1610. For manufacturing reasons, multiple parts of the user interface component 1600 may be provided. An integral construction of the user interface component body 1605 is also possible.

[0148] The conductor carrier 3000 is also arranged within the user interface component body 1605. The conductor carrier 3000 can be rigidly connected to the user interface component. For illustrative purposes, in... Figures 4A to 4H The electronic control unit 1100 is not shown in the figure, but nonetheless, the electronic control unit may also be arranged in the user interface component 1600, particularly on the conductor carrier 3000, as well as the other components or units further described above.

[0149] Figures 4A to 4H The arrangement depicted further includes component 3010. User interface component body 1605 may be permanently or releasably attached to component 3010, for example. Component 3010 may be a sleeve. For example, component 3010 is a component of a drug delivery device to which an electronic system can be fastened as an add-on module, or in which the electronic system is part. Component 3010 may be, for example, a drive sleeve or dose knob for a dose setting and drive mechanism. Component 3010 may be rigidly (e.g., axially and / or directionally) connected to the user interface component, particularly to the user interface component body. For example, user interface component 1600 may be connected via connection interface 3020 (see...). Figure 4DThe connection interface 3020 is rigidly connected to component 3010 (e.g., a snap-fit ​​engagement) to prevent relative rotation and axial movement between component 3010 and user interface component 1600. Therefore, axial force and rotational torque can be transmitted from user interface component to component 3010 via connection interface 3020. Component 3010 can project distally from setting surface 1610.

[0150] Figure 4B The user interface component 1600 during assembly is shown in the perspective view. Figure 4C A top view of the delivery surface 1620 of the user interface component 1600 is shown. Figure 4D It shows along Figure 4C The cross-sectional view of line BB in the image.

[0151] User interface component 1600 includes a first portion 1603 and a second portion 1604. The first portion 1603 is the portion providing at least one outer surface of the component (e.g., a setting surface or a delivery surface, or both). The second portion 1604 provides an interface to a drug delivery device (unit), schematically represented by component 3010. Therefore, a mechanical connection to the mechanism can be performed via the portion to which the conductor carrier 3000 is fastened. The corresponding portions 1603 and 1604 can be rigid. That is, the corresponding portions can be provided to withstand mechanical loads (e.g., forces or torques) and configured to transmit the load to, for example, a dose setting and drive mechanism. The load can be a load for dose setting and / or dose delivery operations. The load can be a user-generated load acting on the delivery surface or setting surface. The first portion 1603 may have a continuous portion extending circumferentially around a central main axis of the user interface member 1600 (the continuous portion may form a setting surface), and radially extending interconnecting portions connected to the continuous portion on opposite sides of the central main axis (the interconnecting portions may form a delivery surface 1620). The second portion 1604 is radially and / or inwardly offset relative to the setting surface 1610. The second portion 1604 may be offset distally relative to the delivery surface 1620. A gap may be formed between the inner wall facing the delivery surface and the second portion. The first portion 1603 may define the internal space of the user interface member 1600 and / or define the member relative to the outside. The second portion may be arranged only partially (as depicted) or completely in the internal space. The outer radial surface of the second portion may face the radial surface of the first portion. When the user interface member 1600 is connected to the member 3010, the main axis 1613 of the user interface member may be the axis of rotation of the user interface member relative to the housing 10 of the device (not shown) about it. The first part 1603 and the second part 1604 can be oriented along axis 1613.

[0152] The first part 1603 and the second part 1604 are connected to each other via a connecting portion 1606 or a connecting feature. The connecting portion 1606 (e.g., a web) is radially oriented. The connecting portion may have a radial main extension direction. The first part 1603 or at least its parts (see further above), the connecting portion 1606 and / or the second part 1604 may be integrated into an integral structure (e.g., a plastic and / or molded structure). The connecting portion is rigidly connected to the first part and the second part.

[0153] The connecting portion 1606 is deformable, preferably elastically deformable, such that the first portion 1603 can move relative to the second portion 1604, for example, in a restricted manner. The connecting portion can be deformable at an angle or in a direction and / or axially deformable. Axial deformability is particularly suitable for delivering signal transmitting units, while angular or directional flexibility is particularly suitable for setting signal transmitting units. When the first portion 1603 moves relative to the second portion 1604 and the associated switch 1650 or 1660 is triggered during this movement from the rest position to the signal transmitting position, a signal indicating corresponding operation can be generated. As already discussed, in response to said signal, the electronic control unit 1100 suitably switches the electronic system to a higher power consumption state. To allow axial deformation in the distal direction, an axial gap 3030 can exist between the member 3010, particularly its proximal-facing surface, and the connecting portion 1606, such as from Figure 4D This is self-evident. Alternatively or additionally, an axial gap exists between the first and second portions for axial deformability, for example, between the distal surface of the first portion and the proximal surface of the second portion. However, other configurations may also be suitable. Angular flexibility can be facilitated by an angular gap 1607 between the regions of the connecting portion 1606 and the second portion 1604. The angular gap may be provided on both sides of the connecting portion 1606 or on only one side. This is illustrated by the following diagram along... Figure 4G The cross-sectional view of the specified line in Figure 4E and Figure 4F It is obvious. Figure 4H It shows along Figure 4D The cross-sectional view of line CC in the diagram. The connecting portion 1606 allows for restricted movement of the first portion 1603 relative to the second portion 1604.

[0154] The first portion 1603 is preferably axially guided relative to the second portion 1604, for example, to avoid tilting during (restricted) relative axial movement. For this purpose, a guide feature 1609 may be provided for the first portion 1603, such as a pin-like feature and / or preferably a feature that projects axially (distally) from the inner surface at the proximal end of the user interface member 1600. The guide feature 1609 interacts with a corresponding guide feature 1608 of the second portion 1604, which preferably defines a guide opening. The axial guide interface established between the guide features and the corresponding guide features suitably allows relative axial and / or rotational movement between the first portion 1603 and the second portion 1604. The guide features 1608 and 1609 may radially frictionally contact each other to provide guidance functionality.

[0155] User interface component 1600 is designed such that, due to the flexibility provided by connection portion 1606, before the load applied by the user is transmitted via the user interface component, particularly its second portion 1604, to other components or parts of the dose setting and drive mechanism, the first portion 1603 moves relative to the second portion 1604 due to the force or torque applied by the user to the setting surface and / or delivery surface. In the case of manipulating the setting surface 1610, the movement of the first portion is, for example, rotation in or opposite to the dose setting direction, where the dose setting direction is the direction required to increase the magnitude of the set dose. Therefore, depending on whether the setting switch 1660 or the delivery switch 1650 is triggered, the clearance between the first and second portions can be used to generate a usage signal or activation prompt signal, such as a setting signal or a delivery signal. If only the setting switch or delivery switch is present, then of course only a setting signal or a delivery signal can be generated. The corresponding signal can be used to trigger the electronic control unit to switch the electronic system to a higher power consumption state. Once the relative movement of the first part with respect to the second part from its rest position has been completed, the first and second parts can move in unison away from the rest position of the first part, for example, in the dose-setting direction to set a non-zero dose, or in the distal direction to deliver a dose. Alternatively, an activation operation different from the dose-setting operation can be used, for example, the opposite of the dose-setting operation, to generate a signal as mentioned above.

[0156] As seen along the force transmission path from user manipulation to apply force to the outer surface of component 3010, the component suitably belongs to the dosage setting and actuation mechanism, with the first portion 1603 closer to the user than the second portion 1604. A connection portion 1606 is arranged between these two portions, as seen along the force transmission path. In the depicted embodiment, the first portion provides a surface for user interaction, while the second portion provides an interface to the drug delivery device unit or the dosage setting and actuation mechanism of the drug delivery device.

[0157] The conductor carrier 3000 is axially and / or directionally fixed to the second portion 1604. Therefore, switches 1660 and 1650 are fixed to the second portion 1604. Features arranged to trigger the respective switches may be provided on the first portion 1603. In the depicted embodiment, an interface feature (e.g., a distally pointing protrusion 1655) is arranged to engage the trigger feature 1657 of the delivery switch 1650. When the delivery surface 1620 is pressed to initiate a delivery operation, a force (axial or distally pointing) is transmitted via the interface feature 1655 to the trigger feature 1657 due to the axial flexibility provided by the connecting portion 1606, and via the trigger feature to the load-sensitive element of the switch 1650, causing the switch to generate a signal (in this case, a delivery signal). The delivery signal is suitably generated before the connector interface is switched (e.g., disengaged). For example, a signal can be generated for dose delivery operations before the component 3010 disengages from the selector sleeve or digital sleeve, wherein the component 3010 and the selector sleeve or digital sleeve are locked in orientation during a dose setting operation prior to setting the dose to be delivered. The setting switch 1660 includes an interface feature 1665, such as a recess, like a radially oriented recess, disposed in the inner surface of the first portion 1603. The interface feature 1665 is arranged to engage a trigger feature 1667 of the switch 1660. When the user interface component 1600 rotates via the setting surface 1610, the initial relative movement between the first portion 1603 and the second portion 1604 can cause a load to be transmitted via the trigger feature 1667 to the load-sensitive element of the switch 1660, which causes the switch 1660 to generate a signal (in this case, a setting signal).

[0158] The relative movement between the first part 1603 and the second part 1604 required to trigger the switch can be less than the rotational movement required to set a dose of one unit increment and / or less than the axial movement required to switch the state of the connectors (e.g., disengaging or engaging two connector components in a dose setting and drive mechanism), which switches the mechanism from a dose setting configuration to a dose delivery configuration. Once the user-applied load is removed from the corresponding surface of the first part, the elasticity of the connection can re-establish the initial state, i.e., the initial or first relative position between the first and second parts.

[0159] Figures 4D to 4G The initial arrangement is depicted. This is achieved by rotating the user interface component relative to the housing. Figure 4FWhen the dose is set, the first part begins to rotate relative to the second part, for example, clockwise and / or in the dose setting direction. During this phase, a signal can be generated by switch 1660. Furthermore, gap 1607 can close or at least reduce, for example, until connecting part 1606 abuts the second part 1604. After the signal has been generated, both parts 1603 and 1604 can rotate together away from the signal transmission position until the desired dose has been set. For delivery operations, relative axial movement between the first and second parts can be triggered by switch 1650 to generate a signal.

[0160] In the depicted embodiment, the axial force during delivery is reacted by the carrier 3000. Therefore, it may be necessary for the entire distributed force to act on the carrier. This can be avoided or its impact on the carrier 3000 can be at least reduced if axial abutment is established between the first and second portions once the first portion has been displaced relative to the second portion to trigger the switch 1650. Axial abutment can be achieved, for example, by one or more protrusions that project radially from the guide feature 1609 outside the guide opening (not explicitly shown), wherein the distally facing surface of the respective protrusion is arranged to abut the proximal facing surface of the second portion 1604. Similarly, after the relative movement between the two portions for signal generation has been completed, rotational abutment can be provided between the first and second portions by means of two surfaces facing each other in the angular direction. This prevents excessive load from acting on the connecting portion, which may be particularly susceptible to damage due to its flexibility. In other words, after the relative movement (axial and / or rotational movement) between the first and second parts has been completed, in order to move further away from the rest position of the first part relative to the second part, a follower interface can be formed between the first and second parts, wherein the follower interface causes the second part to follow the first part in the direction defined by the movement of the first part toward the second part (e.g., the dose setting direction or the distal direction for dose delivery).

[0161] The relative rotation or angular movement between the first and second portions required to generate a signal (e.g., a setting signal) can be less than or equal to the angle corresponding to a unit setting increment (e.g., 15°). For example, the relative rotation or angular movement between the first and second portions required to generate the signal is less than or equal to one of the following values: 15°, 10°, 9°, 8°, 7°, 6°, 5°. Alternatively or additionally, the relative rotation or angular movement between the first and second portions required to generate the signal is greater than or equal to one of the following values: 1°, 2°, 3°, 4°. The relative axial movement between the first and second portions required to generate a signal (e.g., a delivery signal) can be less than or equal to one of the following values: 1 mm, 0.9 mm, 0.8 mm, 0.7 mm, 0.6 mm, 0.5 mm. Alternatively or additionally, the movement can be greater than or equal to one of the following values: 0.2 mm, 0.3 mm, 0.4 mm. Therefore, the angular or axial distance between adjacent features in the first part and their corresponding adjacent features in the second part can take appropriate values, especially in the initial state or arrangement between the first and second parts before relative movement begins. The relative axial movement between the first and second parts required to trigger the signal can be, for example, 0.5 mm (i.e., the axial separation between the first and second positions). The relative angular movement between the first and second parts required to trigger the signal can be, for example, 4° (i.e., the angular separation between the first or rest position and the second or signal transmission position). Making the relative rotation or angular movement between the first and second parts required to generate the signal less than half the angle corresponding to a unit setting increment (the increment angle can be 15°) has the advantage that signal generation can be easily integrated into the dosing operation. Making the relative rotation or angular movement between the first and second parts required to generate the signal more than half the angle corresponding to a unit setting increment has the advantage that the user has the impression that he is doing something important. Thus, for example, the rotation for generating the signal can be 10°. This can be particularly suitable for activation operations that are different from the dosing setting operation, such as those opposite to the dosing setting direction.

[0162] It can be advantageous to generate a signal at an angle smaller than the angle corresponding to a unit set increment, as this reduces the rotational movement of the trigger signal for the user. However, we note that rotations greater than the angle corresponding to a unit set increment (e.g., 20°) for generating the signal are also conceivable. The user can verify the set current dose via a dose display (e.g., via a digital sleeve). Therefore, a relative rotation between the first and second parts at an angle greater than the angle corresponding to a unit set increment for generating the signal is not problematic in this respect.

[0163] By integrating the connection portion 1606 into the user interface component, the user can operate the user interface component without being prompted that the relative movement between the parts of the user interface component is used to control or switch the state of the electronic system, such as switching a component or unit of the system to a higher power consumption state.

[0164] In one implementation, the first portion can move relative to the second portion in two opposite directions, such as axial and / or rotational directions. The signal transmitting unit can be configured to provide an electrical signal only in one of these directions or during movement in both opposite directions. In the case of providing signals in both opposite directions, one of these directions (e.g., the dose setting direction) can be used to provide an activation prompt signal or a use signal to switch the system to a higher power consumption state. The other direction can be used to provide a signal for a different purpose, such as initiating a synchronization process of dose data with another electronic device (such as a computing device, preferably a mobile phone or server). Synchronization can be performed via a wireless interface established between the electronic system and the electronic device via a communication unit. This can be an option for the user to manually trigger the synchronization process through an activation operation. After the dose delivery operation has been performed and the motion sensing unit has generated data, the synchronization process, or an attempt to perform such a process, can be integrated by default into the operating routine of the electronic system.

[0165] When rotation opposite to the dose setting direction is used for signal generation, for example to manually trigger a synchronization event, the first part can rotate relative to a zero-dose stop or a zero-unit stop, which can engage the second part and prevent the second part from rotating in the same direction as the first part, thereby allowing the first part to rotate away from the second part.

[0166] Using rotational movement to generate one or more signals instructing the manipulation of user interface components (wherein, in response to the corresponding signals, the electronic system performs an operation or changes its state) may be superior to using (only) axial movement for this purpose. This is because user interface components are less likely to rotate accidentally than to be accidentally axially displaced.

[0167] We note that if both a setting signal transmitting unit and a delivery signal transmitting unit are provided, the setting signal transmitting unit can be used to activate the electronic control unit, for example, to switch it from a dormant state to a higher power state, where the motion sensing unit and / or communication unit has not yet been activated. Additional units can be activated by the delivery signal transmitting unit. Of course, only either the setting signal transmitting unit or the delivery signal transmitting unit can be provided. If the system switches from the setting signal transmitting unit to the higher power state, the time between delivery operations (i.e., while the motion sensing unit must record data or generate data about the relative movement between the elements of the dose setting and drive mechanism) is greater than when the delivery signal transmitting unit is used for this purpose. However, the delivery signal transmitting unit is typically actuated closer to the delivery operation than the setting signal transmitting unit. Therefore, if the electronic system is switched to the second state using the delivery signal transmitting unit, unnecessary switching to the second state is less likely to occur, as some users might be using the setting and canceling of doses for amusement, rotating the user interface components in opposite directions without actually performing a delivery operation or manipulating the delivery surface. Signal generation is seamlessly integrated into the dose setting or dose delivery operation by utilizing the relative movement during setting or delivery.

[0168] The electronic system 1000 can be configured such that a setting event is determined, preferably within a predetermined time interval, for example, less than one of the following values, before the setting signal is transmitted via the setting signal transmitting unit, for example, the signal from the delivery signal transmitting unit is considered by the control unit: 5 min, 3 min, 2 min, 1 min, 45 s, 30 s, 20 s, 15 s. Furthermore, the delivery switch 1650 can be switched to a higher power consumption state after the switch 1660 detects the setting event. Additionally, when the user simultaneously applies a load to two surfaces (the setting surface and the delivery surface that cause the generation of the setting and delivery signals), the electronic control unit can issue a corresponding signal, record a corresponding event, or generate an alarm indicating that the system may have been improperly handled when both surfaces are simultaneously loaded.

[0169] It should be noted that instead of an integral part connecting the first and second parts with the user interface component, all parts are integrally formed with each other in a monolithic structure. Signal generation can also be achieved by two separate parts with the user interface component that are movable relative to each other, for example, before setting the first unit increment, before delivering the dose, and / or before switching the connector interface. These parts can be spring-biased to allow the relative movement required for signal generation. However, the monolithic structure is preferred because it makes it less likely for the user to notice the multi-part construction when operating the user interface component.

[0170] Figure 5Another embodiment of an electronic system for a drug delivery device is shown. In this embodiment, as in the previously described embodiment, a setting signal transmitting unit (represented by switch 1660) is provided, which generates a signal when a setting surface is manipulated (rotated), involving relative rotation between a first part and a second part. This signal can preferably directly trigger an electronic control unit 1100 to switch the electronic system to a second state. Because this embodiment is very similar to the previously discussed embodiments, the following description focuses on the differences.

[0171] A rotational trigger signal is generated in one rotational direction relative to the second part and the switch 1660 (which may again be a force or torque switch that operates by rotation). We note that when the first part 1603 rotates in the first rotational direction (clockwise in this case), the trigger feature 1667 preferably immediately transfers the load (force or torque) to the switch 1660 due to the angular adjacency between the first part 1603 and the trigger feature 1667. Rotation of the first part relative to the first part in a second rotational direction opposite to the first rotational direction does not result in signal generation because the load is not transferred to the trigger feature 1667, for example, because the interface feature 1665 allows relative rotation before establishing angular adjacency with the trigger feature 1667. Therefore, an angular gap exists in the second rotational direction. Preferably, the second part is driven by the first part in the direction of rotation in the second direction before a signal can be generated. We note that, in addition to the rotational gap, various other measures can be taken to prevent signal generation in the direction opposite to the first direction. The first rotational direction for generating the signal may be the dose setting direction, i.e., the direction in which the user interface component rotates when the set dose increases. Alternatively, the first rotation direction can also be the opposite rotation direction. In this case, it may also be advantageous to use an activation operation for signal generation that differs from the dose setting and dose delivery operations.

[0172] Therefore, in this embodiment, the user interface component 1600 can selectively generate signals, that is, only when the user interface component rotates in the first rotational direction. This directional selectivity can also be applied to the previously discussed embodiments.

[0173] Figure 6A and Figure 6B Another implementation of the electronic system is shown. Overall, this implementation is very similar to the one already combined. Figures 4A to 4HThe proposed implementation is discussed below. Therefore, the following discussion focuses on the differences. This implementation also employs two parts 1603 and 1604 of the user interface component 1600, which are connected to each other via a connecting part 1606. In contrast to the previously described implementation, the connecting part 1606 has multiple regions 1670 and 1680. Each region extends radially and / or connects the first part 1603 to the second part 1604. The region may be a web. The regions are axially offset from each other. Regions 1670 and 1680 are axially separated from each other by a gap or aperture 1675. Figure 6B The details shown illustrate the (axial) flexibility of the connecting portion 1606, which involves deformation in both regions. The void or aperture 1675 may have a cross-section shaped according to a rectangular or non-rectangular parallelogram (e.g., cut along the main axis of the user interface component). This helps to prevent undesirable tilting movement of the user interface component 1600 relative to the axis and / or relative to the component 3010 in the radial and axial directions. Therefore, this embodiment does not require the guiding functions further described above. Consequently, guiding features 1608 and 1609 are not provided in the depicted representation.

[0174] Figures 7A to 7C Another embodiment of the electronic system is illustrated. Generally, this embodiment is similar to the previously described embodiment, such that the features disclosed in this context can also be applied to this embodiment, especially if these features do not contradict those discussed below. In the previously described embodiment, signal generation by the signal transmitting unit is sometimes associated with manipulation or action directly associated with and / or integrated into dose setting and / or dose delivery operations, for example, into unidirectional movement of user interface components required for these operations. In this embodiment, for example when the motion sensing unit and / or communication unit are operable, different user actions (i.e., activation operations different from dose setting and dose delivery operations) are required to generate signals, particularly switching the electronic system to a higher power consumption state.

[0175] exist Figure 7AThe user interface component 1600 is depicted based on a schematic cross-sectional view. Again, the user interface component 1600 has a first portion 1603 and a second portion 1604. A conductor carrier 3000 is disposed within the user interface component 1600. An electrical switch 1685 (e.g., a microswitch such as a force switch) for a signal transmitting unit 1300 is arranged on the carrier 3000. The switch 1685 has a trigger feature 1687 that triggers the switch to generate a signal when force is applied. Again, the carrier may be a printed circuit board or other conductor carrier. The switch 1685 is arranged below a delivery surface 1620. The signal transmitting unit 1300 is configured to generate a signal when the first portion 1603 rotates relative to the second portion 1604. The switch 1685 is operatively coupled to an electronic control unit 1100, which is also housed within the user interface component body 1605. In the depicted configuration, the control unit 1100 and the signal transmitting unit (particularly switch 1685) are electrically connected to and / or mounted on different conductor carriers; that is, unit 1100 is connected to another conductor carrier 3005 other than switch 1685. Conductor carrier 3005 is also mounted inside the user interface component body 1605. Conductor carriers 3000 and 3005 are suitably electrically interconnected, for example, by conductors (such as pressed metal parts). The conductor carriers can be arranged in a stacked and / or parallel manner. In this way, a signal triggered by switch 1685 can be detected or processed by control unit 1100. Power supply 1500 (e.g., button cell battery) is arranged on the side of the conductor carrier opposite to the delivery surface 1620 and / or between the two conductor carriers 3000 and 3005. The respective carriers are suitably fastened to a second portion 1604 of user interface component 1600. The second portion 1604 may have multiple parts fixedly fastened to each other (as shown) or only one part. The same applies to the first portion (not shown). In the case where the second part is formed from different components, one carrier can be fixed to one of these components, and another carrier can be fixed to another of these components. However, it should be noted that the electronic control unit 1100 and the signal transmitting unit 1300 or switch 1685 can also be arranged on the same carrier. When switch 1685 is triggered, the motion sensing unit (not explicitly shown, for example on the same carrier as the control unit and / or on a carrier closer to the distal end of the user interface component, the distal end being...) Figure 7A The lower end of the system (or another electric unit) can be woken up and / or switched to a higher power state to switch the system to a second higher power state, as discussed further above.

[0176] In the depicted embodiment, the first part 1603 and the second part 1604 are formed from separately manufactured parts assembled to each other. In the depicted embodiment, the first and second parts are connected to each other via a force-sensitive coupling 1690. The force-sensitive coupling 1690 preferably locks the first and second parts together such that they move (e.g., rotate) together unless a force greater than a predetermined threshold force (e.g., the maximum force that the coupling can stabilize) is applied to the coupling. In the present case, the threshold force may be greater than the conventional forces that occur during dose setting and dose delivery. That is, the force-sensitive coupling may be stable and transmit force or torque during conventional movement of the user interface component relative to the housing 10, for example, for dose setting and / or for dose delivery. In particular, if a force or torque below the threshold force or torque is applied, the first and second parts act as a single component. However, if a force or torque greater than the threshold force or torque is applied to the coupling, the coupling is released, and the first part can move relative to the second part. The force-sensitive coupling is suitably configured such that the first portion 1603 and the second portion 1604 rotate together unless the force or torque acting on the coupling exceeds a threshold force or torque. When this threshold force or torque is exceeded, the coupling can be released, and relative rotation can exist between the first portion 1603 and the second portion 1604. Specifically, the first portion 1603, which exposes the setting surface 1610, can then rotate relative to the second portion 1604. This relative rotation can be used to trigger the signal transmitting unit 1300 to provide a signal to switch the electronic system to a higher power consumption state. The force-sensitive coupling 1690 can be formed by connection features of the first portion and connection features of the second portion, which interact (e.g., engage) to establish the force-sensitive coupling. The force-sensitive coupling 1690 in Figure 7B The image is depicted very schematically by a protrusion on the first portion 1603 that engages a notch on the second portion 1604. However, it should be understood that other configurations are possible, and this implementation is merely an example.

[0177] The force-sensitive coupling is suitably sized such that the force or torque occurring during a normal setting event is transmitted via the coupling from the user interface component 1600 to the dose setting and drive mechanism, for example, to a previously described component 3010 to which the user interface component can be connected (see, for example, see...). Figure 4AThe force or torque transmitted via the force-sensitive coupling can be the force or torque required to rotate the user interface member 1600 in the dose setting direction, which, in the depicted setting, will be clockwise (as seen in the top view on the delivery surface 1620) until the dose is set. Furthermore, the force or torque used to cancel or reduce a previously set dose (which involves rotation in the direction opposite to the dose setting direction) is suitably transmitted via the force-sensitive coupling. That is, for dose setting and for canceling or reducing a previously set dose, the first portion 1603 and the second portion 1604 are locked in direction due to the force-sensitive coupling. For activation, the force-sensitive coupling is released.

[0178] Force-sensitive couplings can transmit forces or associated torques less than or equal to 0.05 Nm or less than or equal to 0.04 Nm. Torques can be greater than 0.005 Nm. These forces or torques are typically used for dosage setting operations, such as setting, adjusting, or canceling a dosage setting. For example, for combinations... Figure 1 The device (unit) under discussion typically has a selection or setting force or torque ranging from 0.014 Nm to 0.03 Nm. Therefore, if a force or torque is applied to the setting surface within a specified area or range, this force or torque can be transmitted via the force-sensitive connection without involving relative rotational movement between the first and second parts. Applying a larger force or torque will result in relative movement between the first and second parts.

[0179] The force-sensitive coupling 1690 can be released to allow relative rotation between the first part 1603 and the second part 1604. The coupling can only be released when a force or associated torque greater than or equal to one of the following values ​​is applied to the force-sensitive coupling: 0.05 Nm, 0.06 Nm, 0.07 Nm, 0.08 Nm, 0.09 Nm, or 0.1 Nm.

[0180] In the initial position of the user interface component (where the user has not set a dose (zero-dose position)), rotation of the user interface component 1600 relative to the housing 10 and / or another part or component of the drug delivery device in a direction opposite to the dose setting direction can be prevented by means of a stop engagement. This engagement is commonly referred to as a zero-unit stop or a zero-dose stop. In this embodiment, the stop engagement can be achieved or is achieved via a second portion 1604 of the user interface component 1600 or a component connected to said portion (e.g., component 3010 of the dose setting and drive mechanism). Figure 7CThe stop engagement is illustrated schematically. Here, during dose setting or at least at the start of dose setting, a stop feature of portion 1604 or component 3010 abuts against a corresponding stop feature to resist rotation in the direction opposite to the dose setting direction. This corresponding stop feature may be located on housing 10 or on another component of the device that is locked to housing 10 in rotation. In this arrangement, the dose setting direction is clockwise, meaning portion 1604 / component 3010 will rotate away from the corresponding stop feature on the housing. The stop engagement can be established in the rest position of the first portion. When the user attempts to rotate the user interface component in the direction opposite to the dose setting direction (i.e., counterclockwise in the depicted configuration), the second portion 1604 will be prevented from following this rotation due to the stop engagement. Therefore, if the user applies a force or torque via setting surface 1610, and the force or torque applied by the user exceeds a threshold force or torque that can be transmitted via force-sensitive connection 1690, the first portion 1603 will rotate relative to the second portion. This rotation can be used to trigger switch 1685. Rotation of the first portion relative to the second portion, for example, away from a rest position or zero-dose position and / or opposite to the dose setting direction, can be limited, for example, by a rotation stop engagement, which can be formed by a feature on the first portion engaging a feature on the second portion in a direction of rotation (not explicitly shown). Because the second portion cannot rotate in a direction opposite to the dose setting direction, the first portion can no longer rotate in that direction when the rotation stop engagement is established.

[0181] The first portion 1603 of the user interface component 1600 includes a trigger feature 1689. In the depicted embodiment, this feature is implemented as a protrusion, such as an axially oriented protrusion, like a protrusion with a free distal end. When the first portion moves relative to the second portion, this trigger feature can move relative to a switch 1685 and interact directly (not shown) or indirectly via another feature to trigger the switch 1685. The first portion can be coupled to the second portion such that a relative rotational movement of the first portion relative to the second portion is converted into an axial movement of another feature to trigger the switch.

[0182] In the depicted embodiment, a flexible arm 1688 (e.g., a trigger arm) is provided to trigger the switch 1685. The arm may be the additional feature described above, whose axial displacement triggers the switch. In the depicted embodiment, the arm is fixedly connected to or integrated into the second portion 1604. The arm may be oriented at an angle. For example, via contact with the trigger feature 1687, the arm 1688 may be suitably moved or deformed (e.g., axially) to trigger the switch. The arm 1688 has a free end that defines the arm in the direction of rotation (e.g., opposite to the dose setting direction) of the first portion 1603 relative to the second portion 1604 from a rest position to a signal transmission position. The arm 1688 is preferably designed to interact with the trigger feature 1687 of the switch 1685. If the first portion 1603 rotates toward the free end of the arm (counterclockwise in the depicted configuration), the arm 1688 will deflect axially (e.g., distally), thereby causing the switch 1685 to be triggered.

[0183] Arm 1688 is preferably elastically displaceable such that when the user releases the user interface component, the elastic restoring force can be used to re-establish its original position and / or re-establish the force-sensitive connection. That is, for example, when the user releases the setting surface 1610, biasing can move the first portion relative to the second portion into its rest position, thereby re-establishing the initial state of the user interface component. Alternatively, another biasing mechanism, such as a separate spring mechanism, can be provided for re-establishing the force-sensitive connection or the initial state. Moreover, the triggering of the switch can be achieved by different mechanisms, such as directly via a triggering feature of the first portion interacting with the switch (such as its triggering feature 1687). It will be understood that a configuration in which arm 1688 is fixedly connected to or integrated into the first portion 1603 can also be implemented.

[0184] Once switch 1685 has been triggered, the corresponding signal can be detected by electronic control unit 1100, which can then issue a command to switch the motion sensing unit to a higher power consumption state, for example, because a dose setting and / or dispensing operation is expected soon. That is, in this case, attempting to rotate the user interface component in the opposite direction to the dose setting direction when it is in its initial position can be used to generate an activation prompt or usage signal. If, within a predetermined time interval (e.g., within 30 seconds), the motion sensing unit does not detect movement after it has switched to the higher power consumption state, the electronic system can revert to its previous state, for example, it can be turned off again to avoid unnecessary power consumption.

[0185] In one implementation, the electronic system is switched to a higher-power second state only when the first part remains away from the stationary position (e.g., in the signal transmission position) for a duration longer than a predetermined time (e.g., 3 s or more, or more than 5 s). Therefore, the electronic control unit or another unit of the system can evaluate the temporal characteristics of the signals(s) generated by the signal transmission unit, such as signal duration or the time between two consecutive signals. If the temporal characteristics meet the criteria indicating that the first part has remained away from the stationary position for a duration longer than the predetermined time, the system can switch to the second state. Using a predetermined time is particularly suitable for characterizing activation operations. The electronic control unit can issue a signal or command to switch the system to the second state, for example, by activating the communication unit and / or motion sensing unit only when the evaluation of the temporal characteristics indicates that the first part has been away from the stationary position and / or has remained in the signal transmission position for a duration exceeding the predetermined time. For example, the predetermined time can be used to distinguish between activation operations and dosage operations. If a predetermined time is used, it is beneficial that the force required for activation operations can be similar to or even less than the force required for dosage operations, such as the force used for dosage setting operations. In this embodiment, the force that the user must apply to release the force-sensitive coupling by rotating it in the opposite direction to the dose setting direction can be the same as or less than the force required to set the dose by moving the first and second parts in the dose setting direction (in... Figures 7A to 7C In this context, the direction setting refers to the direction in which the first and second parts move away from the signal transmission position. The activation operation can be used to manually trigger the synchronization operation using the communication unit.

[0186] It should be noted that the described time-based method is not limited to this embodiment, but can also be applied to other embodiments, especially if an activation operation different from the dose operation is used to trigger the system to switch to a higher power state. For example, when a zero dose is set or the force is less than that required to initiate a dose delivery operation, the activation operation may be in which the delivery surface 1620 (e.g., in) Figures 4A to 4H The operation shown in the setting is pressed and held for a predetermined time. This also applies to rotation in the opposite direction to the dose setting used for activation, where the first part needs to be held away from the stationary position for a predetermined time before the system switches to the second state. Alternatively or additionally, if in Figures 4A to 4H In this process, rotation opposite to the dose setting direction is used to generate the signal (e.g., for activation operation and / or in the zero dose setting position), and the force used to do so can be similar to the force used for dose setting. The rotation angle required for signal generation can be greater than the angle corresponding to a unit set increment and / or greater than or equal to 10°, 15°, 17°, or 20°. Larger rotation angles make it less likely that a signal will be generated accidentally.

[0187] 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.

[0188] 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 envisioned.

[0189] 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., from 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 20ºC) or at refrigerated temperatures (e.g., from about -4ºC to about 4ºC). In some cases, the drug container may be or may include a dual-chamber cartridge configured to separately store two or more components (e.g., an API and a diluent, or two different drugs) of a pharmaceutical preparation to be administered, 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.

[0190] 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 barriers. Examples of barriers include, for example, diabetes or diabetes-related complications (such as diabetic retinopathy), thromboembolic barriers (such as deep vein or pulmonary thromboembolism). Other examples of barriers 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 (RoteListe), for example, but not limited to main group 12 (antidiabetic drugs) or 86 (oncology drugs); and the 15th edition of the Merck Index.

[0191] 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 mixtures 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 omitted 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.

[0192] 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 in which the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala and the 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.

[0193] Examples of insulin derivatives include, for instance, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (detemir®); 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-ThrB29Lys B30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (insulindegludec, Tresiba®); 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.

[0194] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include lixumia®, exenatide (Byetta®, Bydureon®, a 39-amino acid peptide produced by the salivary glands of the gila monster), liraglutide (Victoza®), semaglutide, taspoglutide, syncria®, dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (efpeglenatide), HM-15211, CM-3, and GLP-1. Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-Xten.

[0195] Examples of oligonucleotides include, for instance, mipomethasone sodium (Kynamro®), a cholesterol-reducing antisense agent used to treat familial hypercholesterolemia, or RG012 used to treat Alport syndrome.

[0196] Examples of DPP4 inhibitors include linagliptin, vedagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0197] 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.

[0198] Examples of polysaccharides include glucosaminoglycane, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (such as the polysulfated forms of the above polysaccharides), and / or pharmaceutically acceptable salts thereof. 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 (Synvisc®), a sodium hyaluronate.

[0199] 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 dual variable region antibody-like binding proteins with cross-binding region orientation (CODV).

[0200] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule, which does not include full-length antibody polypeptides but still includes 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.

[0201] 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.

[0202] Examples of antibodies are anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0203] 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.

[0204] 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.

[0205] 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. The container may be a replaceable container or an integrated, non-replaceable container.

[0206] 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).

[0207] 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).

[0208] 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.

[0209] Figure Labels

[0210] 1. Injection device, drug delivery device or device unit

[0211] 10 housing

[0212] 12 Dosage Knob

[0213] 11 Injection Button

[0214] 13 windows

[0215] 14 containers

[0216] 15 stitches

[0217] 16 Inner Pin Cap

[0218] 17 outer pin cap

[0219] 18 hats

[0220] 70 dial or digital sleeve

[0221] 71a-c construction

[0222] 1000 Electronic Systems

[0223] 1100 Electronic Control Unit

[0224] 1200 motion sensing units

[0225] 1300 signal transmission unit

[0226] 1310 switch

[0227] 1400 communication units

[0228] 1500 power supply

[0229] 1600 User Interface Component

[0230] 1601 parts

[0231] 1602 parts

[0232] Part 1603

[0233] Part 1604

[0234] 1605 User Interface Component Body

[0235] 1606 connection part

[0236] 1607 gap

[0237] 1608 guiding features

[0238] 1609 guiding features

[0239] 1610 Setting Surface

[0240] 1613 axis

[0241] 1615 Connection Features

[0242] 1620 delivery surface

[0243] 1650 delivery switch

[0244] 1655 Interface Features

[0245] 1657 trigger feature

[0246] 1660 Setting Switch

[0247] 1665 Interface Features

[0248] 1667 trigger feature

[0249] Area 1670

[0250] 1675 gap

[0251] Area 1680

[0252] 1685 switch

[0253] 1687 trigger feature

[0254] 1688 arms

[0255] 1689 trigger feature

[0256] 1690 Force-Sensitive Connector

[0257] 3000 conductor carrier

[0258] 3005 conductor carrier

[0259] 3010 components

[0260] 3020 interface

[0261] 3030 gap

Claims

1. An electronic system (1000) for a drug delivery device (1), said electronic system comprising: - At least one user interface component (1600) configured to be manipulated by a user to perform dosing operations, said dosing operations including a dosing setting operation for setting a dose of drug to be delivered by the drug delivery device and a dosing delivery operation for delivering the set dose. - An electronic control unit (1100) configured to control the operation of an electronic system having a first state and a second state, wherein the electronic system in the second state has increased power consumption compared to the first state. - An electrical signal transmitting unit (1300), the signal transmitting unit being configured to provide an electrical signal indicating that the user interface component is being manipulated, wherein... - The electronic control unit is configured to switch the electronic system from the first state to the second state in response to the electrical signal, and wherein - The user interface component includes a first part (1603) and a second part (1604), wherein the first part is movable relative to the second part from a rest position of the first part to a signal transmission position of the first part, wherein the signal transmission unit is configured to provide the electrical signal in response to the movement of the first part relative to the second part from the rest position to the signal transmission position. The first portion (1603) and the second portion (1604) are permanently and directly mechanically interconnected during the dosing operation via mechanical interconnects (1606, 1690).

2. The electronic system according to claim 1, in, The movement of the first part (1603) from the stationary position to the signal transmission position involves a rotational movement of the first part relative to the second part.

3. The electronic system according to claim 1, in, The electronic control unit (1100) is connected to the second part.

4. The electronic system according to claim 1, in, The mechanical interconnection includes at least one connection feature (1606) integrally formed with the first portion and the second portion.

5. The electronic system according to claim 4, in, The connection feature (1606) is flexible to allow the first portion (1603) to move relative to the second portion (1604) from the rest position to the signal transmission position.

6. The electronic system according to claim 1, in, The mechanical interconnect includes at least one connection feature (1689) of the first portion (1603) and at least one connection feature (1688) of the second portion (1604) that interact with each other to establish the mechanical interconnect (1690).

7. The electronic system according to claim 6, in, The mechanical interconnect (1690) is releasable for activation, which involves the movement of the first portion (1603) from the rest position to the signal transmission position, and the activation is different from the dosing operation.

8. The electronic system according to claim 6, in, The mechanical interconnect (1690) is configured such that the force or torque that the user must apply to the first part (1603) in order to perform the dosage operation with the user interface component (1600) is less than the force or torque that the user must apply to the first part in order to move the first part from the rest position to the signal transmission position.

9. The electronic system according to claim 6, in, The mechanical interconnect (1690) is releasable for activation, the activation involving movement of the first portion (1603) from the rest position to the signal transmission position, the activation being distinct from the dosing operation, and wherein the mechanical interconnect (1690) is configured such that the force or torque that the user must apply to the first portion (1603) to perform the dosing operation with the user interface component (1600) is less than the force or torque that the user must apply to the first portion to move it from the rest position to the signal transmission position.

10. The electronic system according to any one of claims 1-9, in, The second part (1604) is configured to abut a stop feature when the first part moves from the stationary position toward the signal transmission position.

11. The electronic system according to any one of claims 1-9, in, The resting position is the dose-free setting position.

12. The electronic system according to any one of claims 1-9, in, The signal transmitting unit (1300) includes an electrical switching mechanism configured to be triggered to provide the electrical signal when the first portion (1603) moves relative to the second portion (1604) from the rest position to the signal transmitting position.

13. The electronic system according to any one of claims 1-9, in, The electronic system (1000) is configured such that the electronic system switches from the first state to the second state only when the first portion of the user interface component remains away from the stationary position for more than a predetermined time.

14. The electronic system according to any one of claims 1-9, in, When the first part (1603) is in the signal transmission position, the first part is biased toward the stationary position by the biasing mechanism (1688) of the user interface component (1600).

15. The electronic system according to any one of claims 1-9, in, The electronic system (1000) is configured as an additional module for the drug delivery device unit (1).

16. The electronic system according to any one of claims 1-9, wherein the first part and the second part are connected via a force-sensitive coupling.

17. The electronic system according to any one of claims 1-9, wherein the system is configured such that, after relative movement has been completed in a direction away from the stationary position, the first portion is connected to the second portion in a manner resistant to torque and / or force.

18. The electronic system according to any one of claims 1-9, wherein the system is configured such that, after relative movement has been completed in the direction of entering or exceeding the signal transmission position, the first portion is connected to the second portion in a manner resistant to torque and / or force.

19. The electronic system according to any one of claims 1-9, wherein the electronic system comprises at least one of the following elements: - Electro-motion sensing unit; - Communication unit; and - Memory unit.

20. The electronic system according to any one of claims 1-9, wherein when in a stationary position, the first part is capable of moving relative to the second part in two different directions.

21. The electronic system according to any one of claims 1-9, wherein when in a stationary position, the first part is capable of moving relative to the second part in opposite rotational directions.

22. A drug delivery device comprising a reservoir containing a drug and an electronic system according to any one of claims 1-21.

23. The drug delivery device of claim 22, wherein the drug delivery device is a pen-type device and / or an injection device.

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