Electronic system for a drug delivery device and drug delivery device

Abstract

An electronic system (1000) for a drug delivery device (1, 2) is provided, the electronic system comprising: - a dose setting and drive mechanism (1780, 1790) configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device and a dose delivery operation for delivering the set dose, the dose setting and drive mechanism comprising a first member (1780) and a second member (1790), wherein the dose setting and drive mechanism is configured such that, in the dose delivery operation and / or in the dose setting operation, the first member moves, e.g. rotates, relative to the second member; - 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 has an increased power consumption in the second state compared to the first state; - an electrical usage detection unit (1300) operatively connected to the electronic control unit, the electrical usage detection unit being configured to generate a usage signal indicating that a user has started a dose setting operation or a dose delivery operation, wherein the electronic system is configured such that the electronic system is switched from the first state to the second state by the electronic control unit in response to the usage signal, and wherein the electrical usage detection unit is configured to generate the usage signal in response to a relative movement, preferably a relative rotational movement, between the first member and the second member, e.g. in response to a relative rotational movement therebetween, preferably during the dose delivery operation.

Description

BACKGROUND

[0001] The present disclosure relates to an electronic system for a drug delivery device. The present disclosure further relates to a drug delivery device, preferably comprising the electronic system.

[0002] Drug delivery devices using electronics are becoming more and more popular in the pharmaceutical industry as well as for users or patients. However, the management of the power supply resources integrated into the device is of particular importance, especially if the device is designed to be standalone, that is, without a connector for connecting to a power source necessary for the operation of the device. SUMMARY

[0003] It is an object of the present disclosure to provide an improvement of a drug delivery device comprising one or more electronic systems for the drug delivery device.

[0004] One aspect of the present disclosure relates to an electronic system for a drug delivery device. Another aspect of the present disclosure relates to a drug delivery device comprising the electronic system. Accordingly, features described herein in relation to a drug delivery device shall be considered as disclosed for the electronic system and vice versa.

[0005] In one embodiment, the electronic system or the drug delivery device comprises a dose setting and / or drive mechanism. The dose setting mechanism can be configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device. The dose that can be set in the drug delivery device can be a variable dose, that is, the size of the dose that can be set is not fixed by the design of the mechanism, but can be selected by the user. Preferably, the user can select the set dose between a minimum settable dose and a maximum settable dose. The drive mechanism can be configured to perform a dose delivery operation for delivering the dose, e.g., the dose that has been set previously.

[0006] In one embodiment, the electronic system of the drug delivery device comprises a housing. The housing can house components of the dose setting and / or drive mechanism and / or one or more other components of the electronic system or the drug delivery device. The housing can be an outer housing. That is, the housing can present an outer surface of the electronic system or the drug delivery device. Components described herein as moving can move relative to the housing during operation of the electronic system and / or the dose setting and / or drive mechanism.

[0007] In one embodiment, the dose setting and / or drive mechanism comprises a user interface member, e.g., a dose and / or injection button. The user interface member can be arranged to be operated by a user to operate the mechanism.

[0008] In one embodiment, the dose setting and / or drive mechanism comprises a first member and a second member. The first member and / or the second member can be configured to move relative to the electronics system or the housing of the drug delivery device during a dose setting operation and / or during a dose delivery operation. The first member can be a dose member or a dial member (e.g. a dial sleeve or a number sleeve) of the dose setting and / or drive mechanism that is moved to set a dose. The second member can be a drive member (e.g. a member that engages with a piston rod of the dose setting and / or drive mechanism) or a user interface member (e.g. a dose and / or injection button). The first member and / or the second member can be movably coupled to or held in the housing. In a dose setting operation, the first member and / or the second member can be displaced axially (e.g. away from the proximal end of the housing) relative to the housing. The distance by which the first member and / or the second member is axially displaced relative to the housing during a dose setting operation can be determined by the size of the dose set. In other words, the drug delivery device can be of the dial extension type, i.e. the device increases its length during a dose setting operation in an amount proportional to the size of the dose set.

[0009] In one embodiment, the first member moves (e.g. rotates and / or moves axially) relative to the second member in a dose setting operation and / or in a dose delivery operation. For example, the first member can rotate relative to the second member during a dose delivery operation. Both the first member and the second member can move axially during a dose delivery operation. The first member can rotate relative to the second member and relative to the housing during a dose setting operation and / or a dose delivery operation. The second member can be rotationally locked or guided relative to the housing during a dose delivery operation, e.g. by a delivery interface (e.g. a delivery clutch). The first member and the second member can be rotationally locked relative to each other during a dose setting operation. Thus, the first member and the second member can rotate relative to the housing in a dose setting operation. The first member and the second member can be coupled to each other via a coupling interface (e.g. a setting clutch) during a dose setting operation. The coupling interface can rotationally lock the first member and the second member to each other during a dose setting operation. When the coupling interface is engaged, the first member and the second member can be rotationally locked to each other, such as by a direct engagement of coupling interface features. The first member and the second member can comprise matching coupling interface features. The coupling interface can be released during a dose delivery operation. In particular, the use signal explained in more detail below can only be generated when the coupling interface (e.g. the delivery clutch and / or the setting clutch) has changed its state (e.g. from engaged to released or vice versa) and / or after the first member has been rotated relative to the second member.

[0010] In one embodiment, the first member and the second member are rotated relative to each other during only one of the dose setting operation and the dose delivery operation. One of the first member and the second member can be rotated relative to the housing during both operations. One of the first member and the second member can be rotated relative to the housing during only one of the operations, e.g. during dose setting or during dose delivery.

[0011] In one embodiment, the device or the electronic system comprises an electronic control unit, e.g. comprising a microprocessor or a microcontroller. The electronic control unit can be configured to control the operation of the drug delivery device or the electronic system. The electronic control unit can be arranged on a conductor carrier and in electrically conductive connection with the conductors on the conductor carrier. The conductor carrier can be a circuit board, like a printed circuit board. The conductor carrier can be held in the interior of a user interface member of the system or device.

[0012] In one embodiment, the device or the electronic system comprises a power supply. The power supply can be arranged in the interior of the electronic system, like in the interior of a user interface member.

[0013] In one embodiment, the electronic system has a first state and a second state. The first state and the second state can be different operational states of the electronic system. In the first state, the system can be in an idle state in which the system does not operate with the desired functionality assigned to the electronic system during dose setting and / or dose delivery operations, e.g. a dose logging functionality. In the second state, the system can be ready to operate with the desired functionality, especially when a dose setting operation and / or a dose delivery operation is being performed in the second state. The power consumption of the electronic system in the second state can be increased compared to the first state. For example, in the second state, one or more electrical or electronic units of the electronic system can be switched to a state of higher power consumption (e.g. an on state) compared to the first state in which the respective unit can be in a state of lower power consumption, e.g. a sleep state, or no power consumption at all because the connection to the power supply is switched off.

[0014] In one embodiment, the electronic system comprises an electrical use detection unit. The use detection unit can be operatively connected to the electronic control unit, e.g. in an electrically conductive manner, such as via a conductor on a conductor carrier. The electrical use detection unit can be configured to generate or trigger a use signal, e.g. an electrical signal. The use signal can be indicative of the user having started a dose setting operation or a dose delivery operation. Starting the dose setting operation or the dose delivery operation can require a relative movement, e.g. a relative rotational movement, between the first member and the second member. Accordingly, the use signal can only be generated after the dose setting operation or the dose delivery operation has been started or initiated. In this way, it can be ensured that, when the use signal is generated, the operation it is supposed to be indicative of, such as the dose setting operation or the dose delivery operation, has already started.

[0015] In one embodiment, the electronic system is configured such that the electronic system is switched from the first state to the second state by the electronic control unit in response to the use signal. Accordingly, the generation of the use signal can cause and result in the electronic system being switched to the second state of increased power consumption. The electronic control unit can issue a command, e.g. a signal, to another unit of the electronic system in response to receiving the use signal, such that this unit is turned on or made operable. This unit can be a motion sensing unit configured to measure how much the first member moves relative to the second member during a dose setting operation and / or a dose delivery operation. The movement can be indicative of the currently set or delivered dose.

[0016] In one embodiment, the use detection unit is configured to generate the use signal in response to a relative movement, e.g. a relative rotational movement, between the first member and the second member, conveniently during a dose delivery operation. Thus, the generation of the use signal can require a relative movement between the first member and the second member. This means that a dose setting or dose delivery operation is actually being performed and, thus, it is very likely that the system is being intentionally operated. This is even more so when the use signal is only generated during a dose delivery operation, e.g. when the delivery operation has been started.

[0017] In one embodiment, the first member is a member different from the user interface member. In particular, the first member can not have any surface intended to be touched by a user for operating the drug delivery device or system. The first member can be an internal member of the drug delivery device or system. The first member can be arranged within a housing of the drug delivery device.

[0018] In one embodiment, the dose setting and / or drive mechanism comprises a dose member, e.g. a number sleeve or a dial sleeve. The dose member can be rotated relative to the housing, e.g. in integer multiples of a unit dose setting increment, during a dose setting operation. During the dose setting operation, the dose member can be operatively coupled, e.g. rotationally locked, to the user interface member and / or the second member. The unit dose setting increment can be a constant angle. Thus, the unit dose setting increment can define a minimum dose that can be set with the dose setting and / or drive mechanism. One unit dose setting increment can correspond to a rotation of greater than or equal to 10° and / or a rotation of less than or equal to 20°, e.g. 15°. The electronics system can comprise an increment change setting interface defining the unit dose setting increment. The setting interface can be a ratchet interface. For example, the ratchet interface can operate between the dose member and the housing.

[0019] In one embodiment, the rotation axis about which one, more or all of the rotations discussed herein are performed can be a longitudinal axis of the housing and / or the rotation axis about which the first member and / or the second member are rotated, e.g. relative to the housing, during dose setting and / or dose delivery.

[0020] In one embodiment, one of the first member and the second member is a dose member. Alternatively, the first member and the second member are different from the dose member.

[0021] In one embodiment, at least a portion of the second member is received within the first member.

[0022] In one embodiment, the first member and / or the second member or a portion of the respective member has a sleeve-like configuration.

[0023] In one embodiment, the electronics system is configured such that the use signal is generated, preferably only after rotation of the first member relative to the housing and / or the second member has started. The use signal can be generated before the first member has been rotated by two unit dose setting increments relative to the second member and / or the housing, preferably before the first member has been rotated by more than one unit dose setting increment relative to the second member and / or the housing.

[0024] In one embodiment, the electronics system is configured such that the switching of the electronics system from the first state to the second state has been completed before the relative rotation between the first member and the second member reaches two unit dose setting increments, preferably one unit dose setting increment. Thus, the wake-up procedure for switching the system to the second state of higher power consumption can be quickly completed. This means that the motion sensing unit can be operated soon after the start of a dose setting operation or a dose delivery operation, for example.

[0025] In one embodiment, the electronic system is configured such that the switching of the system from the first state to the second state is completed within a timespan which is less than or equal to one of the following values: 5 ms, 4 ms, 3.5 ms, 3.2 ms, 3 ms, 2.8 ms, 2.7 ms, 2.5 ms (ms: millisecond). Alternatively or additionally, the electronic system is configured such that the switching of the system from the first state to the second state is completed within a timespan which is greater than or equal to one of the following values: 1 ms, 1.5 ms, 1.7 ms, 2.0 ms, 2.2 ms, 2.5 ms. In particular, the timespan required for the switching of the system from the first state to the second state can be between 1 ms and 5 ms. The timespan required for the switching can be determined from the generation of the use signal or from the movement of the user interface member for performing the dose setting operation or the dose delivery operation until the motion sensing unit and / or the communication unit has become operable.

[0026] In one embodiment, the relative rotation of the first member and the second member during the dose delivery operation can be indicative of the size of the dose which is being dispensed in the dose delivery operation or which is being set in the dose setting operation. Thus, since the use signal is generated only after the rotation has started, an offset is to be considered when the dose shall be calculated from the measured relative rotation. The offset can be one unit setting increment which has to be added to the measured dose when this dose is required to activate the electronic system and in particular its dose measuring and / or logging capability of the set and / or dispensed dose.

[0027] In one embodiment, the electronic system comprises a use signal generation interface, for example comprising a ratchet interface such as a radial ratchet interface or an axial ratchet interface. The use signal generation interface can be configured to generate one or more use signals in response to the relative rotation between the first member and the second member. The use signal generation interface can be configured to generate one (e.g. only one) or more use signals during the dose delivery operation. In case more than one use signal is generated, preferably the first use signal generated is the signal for triggering the switching of the electronic system from the first state to the second state. The use signal generation interface can be an incremental change interface. The use signal generation increment can be an angle. The use signal generation increment can be adapted to the unit setting increment. Preferably, the use signal generation increment is equal to or smaller than the unit setting increment. That is, the pitch of the use signal generation increment and the pitch of the unit setting increment can be equal or the pitch of the use signal generation increment can be finer. In case the pitch is finer, one unit setting increment rotation can cover more than one use signal generation increment.

[0028] In one embodiment, the electronic system includes a use signal generating interface member. A ratchet (e.g., having ratchet teeth and / or ratchet recesses) for the use signal generating interface can be provided on the use signal generating interface member. The ratchet teeth and / or ratchet recesses of the ratchet can be axially or radially oriented. That is, the free ends of the teeth can point in a radial direction. The use signal generating interface member can be a member separate from the first member and the second member. Alternatively, the use signal generating interface member can be one of the first member and the second member, e.g., the first member. The use signal generating interface member can be rotationally locked to one of the first member and the second member. The use signal generating interface member can be axially movable relative to the member to which it is connected, e.g., rotationally locked, e.g., in a limited manner. The use signal generating interface member can be axially locked to the other of the first member and the second member, e.g., to the second member.

[0029] In one embodiment, the electronic system or drug delivery device comprises a movable switch feature. The switch feature can be movable along a rotational axis or a main longitudinal axis of the housing and / or can be movable transverse or radial to the rotational axis or the main longitudinal axis of the housing. The switch feature can be rotationally locked to one of the first member and the second member, preferably to the second member. The switch feature can be arranged to move only radially, or only axially, or radially and axially. The switch feature can be rigid or preferably elastically deformable. The switch feature can be operatively coupled to one of the first member and the second member, e.g. via use of a signal generation interface member. For example, the switch feature can engage a ratchet, e.g. a ratchet defining a use signal generation increment. The switch feature can be operatively coupled to the first member and / or the second member such that a rotation of the first member relative to the second member causes a movement of the switch feature relative to the first member, relative to the second member and / or relative to the housing. For example, a rotation of the first member relative to the second member, relative to the switch feature and / or relative to the housing can be converted into a movement of the switch feature, e.g. by an operative coupling between the switch feature and the ratchet. Alternatively, a rotation of the first member relative to the switch feature can remove a mechanical blockage which blocks a movement of the switch feature in a direction in which the switch feature is biased. The movement of the switch feature can be used to trigger the generation of a use signal. In other words, the generation of a use signal can require a movement of the switch feature in response to a movement of the first member relative to the second member. For example, for the generation or triggering of a use signal, the movement of the switch feature can be used and / or cause a change of state of an electrical connection, e.g. from open to closed, or vice versa, and / or can trigger an electrical switch. The switch feature can be electrically insulating, e.g. plastic, or it can be electrically conductive, e.g. metallic. If the switch feature is electrically conductive, it can form part of an electrical switch, e.g. a contact feature of the switch, in electrical contact with another contact feature of the switch, in order to generate a use signal.

[0030] In one embodiment, the switch feature engages a ratchet, e.g. a ratchet which can be associated with the first member or the second member. The switch feature can be biased into engagement with the ratchet, e.g. when the switch feature has been displaced out of a ratchet recess defined between two adjacent ratchet teeth of the ratchet. The biasing force acting on the switch feature can act opposite to the direction of movement of the switch feature which causes the generation of a use signal. For the generation of a use signal, the switch feature can be moved, e.g. radially inwards. In an initial state, before starting a dose setting operation or a dose delivery operation, the switch feature can be engaged with a ratchet recess defined by adjacent ratchet teeth, such as teeth of a ratchet defining a use signal generation interface.

[0031] In one embodiment, the switch feature is elastically biased into engagement with the blocking feature under the action of a biasing force, preferably before the first member is moved relative to the second member and / or before starting a dose setting operation or a dose delivery operation. The blocking feature can block movement of the switch feature relative to the housing, the first member and / or the second member in the direction of the biasing force. The biasing force can be provided by e.g. an electrical contact feature of the switch which is elastically displaced before starting the dose setting operation and / or the dose delivery operation. The blocking feature can be provided by a ratchet tooth between two adjacent ratchet recesses. The biasing force can act in the direction of movement which causes generation of the use signal. For example, the switch feature cooperating with the blocking feature can maintain the switch in an open state. When the blocking feature is removed from the switch feature, the biasing can be released and the switch can be closed. In order to generate the use signal at the start of the dose setting operation or the dose delivery operation, for example, the switch feature can be moved in a radially outward direction.

[0032] In one embodiment, the electronic system or the drug delivery device is configured such that movement of the switch feature is used to trigger an electrical switch, for example by contacting and / or moving a trigger feature of the switch. When the switch is triggered, a use signal can be generated. In response to the use signal, the electronic control unit can switch the electronic system from a first state to a second state.

[0033] In one embodiment, the switch feature is linearly guided. For example, the switch feature can be received in a guide slot. The switch feature can only move linearly, for example radially or axially, when it is linearly guided. This provides a relatively simple type of movement when triggering the use signal. For example, the guide slot can be provided in the second member.

[0034] In one embodiment, the switch feature is axially oriented, in particular along a rotation axis, or is radially or transversely oriented, in particular relative to a rotation axis.

[0035] In one embodiment, the switch feature is pivotally mounted, in particular within the electronic system or the drug delivery device. The movement of the switch feature which causes generation of the use signal can be a pivotal movement. The switch feature can be pivotally mounted to the second member.

[0036] In one embodiment, the switch feature moves transversely to and / or along a rotation axis about which the first member rotates relative to the second member and / or relative to the housing in a dose setting operation and / or a dose delivery operation.

[0037] In one embodiment, the switch feature is pin-like and / or has a main extension direction.

[0038] In one embodiment, the switch feature has a portion of a U-shaped cross section, in particular when the cross section is taken parallel to the rotation axis.

[0039] In one embodiment, one of the first member and the second member is provided with a ratchet. The switch feature can be arranged to mechanically cooperate with the ratchet. The ratchet can be provided on the first member. The ratchet can be provided on the use signal generating interface member. The ratchet can comprise ratchet teeth provided circumferentially or angularly. The ratchet teeth can be evenly distributed in a circumferential direction or an angular direction. Two adjacent teeth can be separated by a ratchet recess. The ratchet teeth can be oriented axially (e.g. proximally) or radially (e.g. inwardly).

[0040] In one embodiment, the switch feature is biased into engagement with a ratchet recess when it attempts to disengage therefrom. The bias can be provided by an elastically displaceable feature and / or an electrical contact feature of the switch.

[0041] In one embodiment, the electronic system or drug delivery device comprises a plurality of switch features, e.g. a first switch feature and a second switch feature. The switch features can be arranged to cooperate with the ratchet. The switch features can be radially aligned (e.g. angularly offset by 180°) or can be oriented in different radial directions (e.g. angularly offset by an angle different from 180°). The switch features can be arranged to cooperate with the ratchet at different positions along the ratchet. That is, the positions at which the two switch features engage the ratchet can be angularly separated from each other, in particular by pairs of ratchet teeth and ratchet recesses between the two positions. At least one of the first switch feature and the second switch feature can be displaced relative to the first member and / or the second member when the first member is rotated relative to the second member. Preferably, both switch features are displaced. The two switch features can be displaced in the same direction or in different directions during rotation. For example, both switch features can be displaced inwardly (e.g. radially). The switch features can be displaced towards each other, e.g. such that the distance (e.g. radial distance) between the two switch features is reduced. Instead of being displaced in the same direction, one switch feature can be displaced outwardly and the other inwardly.

[0042] Having a plurality of switch features cooperating with the same ratchet at different positions has the advantage that the relative movement of the switch features relative to each other can be adjusted by choosing the type of engagement with the ratchet. The two switch features can be in phase relative to the ratchet. That is, in a given stable rotational or angular position of the first member relative to the second member, both switch features engage a ratchet recess or they both engage a ratchet tooth. This has the advantage that both teeth can contribute to the radial displacement and the height of the teeth can be reduced to achieve a particularly desired relative radial displacement of the switch features. Alternatively, the two switch features can be out of phase relative to the ratchet. That is, in a given stable rotational or angular position of the first member relative to the second member, one of the switch features engages a ratchet tooth and the other engages a ratchet recess.

[0043] In one embodiment, a deformable switch feature engages with the ratchet at different positions. The deformable switch feature can engage a radial ratchet. Rotation of the first member relative to the second member can cause a portion of the deformable switch feature to be displaced axially, e.g. due to the switch feature cooperating with the ratchet teeth of the ratchet. The axial displacement of the portion can be directed proximally. The axial displacement of the portion can be relative to the ratchet. The axial displacement can be used to trigger generation of a use signal. In particular, upon axial displacement, the portion can protrude from the ratchet. The switch feature can be elastically deformable such that, when elastically deformed, the switch feature tends to restore its original shape due to an elastic restoring force. The switch feature can bridge a free space within the member, wherein the ratchet is engaged by the switch feature. The switch feature can be continuous. Prior to initiation of a dose setting operation or a dose delivery operation, the deformable switch feature, in particular opposite ends thereof, can engage with the ratchet recesses of the ratchet. Upon rotation of the first member relative to the second member, the engagement with the ratchet teeth tends to deform (e.g. compress) the switch feature. This can result in an axial displacement of a portion (e.g. a central portion) of the switch feature. The switch feature can be configured as a fork or a toggle mechanism component. The portion of the switch feature can be axially displaced in a direction away from the ratchet.

[0044] In one embodiment, the switch feature is rotationally locked to the one of the first member and the second member which is not provided with a ratchet.

[0045] In one embodiment, the electronic system or drug delivery device comprises a motion sensing unit. The motion sensing unit can be an electronic unit. The motion sensing unit can be an optoelectronic unit. The motion sensing unit can be configured to measure and / or quantify a movement of the first member relative to the second member. The encoder component can be movable relative to the motion sensing unit, e.g. an encoder ring. The encoder component can be or can be connected to the first member or the second member, preferably the first member. The encoder component can be a signal generating interface member. The encoder component can comprise circumferentially spaced apart detection areas which trigger a signal generation in the motion sensing unit when moved into a detection position relative to the unit. The motion sensing unit can comprise at least one sensor, preferably a plurality of sensors. The respective sensors can be non-contacting. For example, the respective sensors can be radiation detectors. The motion sensing unit can comprise an electromagnetic radiation emitter, e.g. an LED, and a radiation detector. The radiation emitter can emit radiation towards the encoder component and the radiation detector can be arranged and configured to detect radiation reflected from the encoder component. In a first state, the motion sensing unit can be inoperable or switched off. In a second state of the electronic system, the motion sensing unit can be operable or switched on. Motion sensing units for measuring relative movements of members, such as for determining a currently set dose or a dose already dispensed during a dispensing operation, can have a particularly high power consumption. The currently set dose or the currently dispensed dose can depend on an amount of relative movement, e.g. rotation, between the first member and the second member from the start of the respective operation. In the present disclosure, the motion sensing unit can only be activated after the respective operation, e.g. a dose delivery operation and / or a dose setting operation, for which the motion sensing unit shall operate has started. The electronic system preferably takes into account an offset between the start or initiation of a dose setting operation or a dose delivery operation and the operability of the motion sensing unit, e.g. by adding a value, e.g. a constant value, such as one unit setting increment or two unit setting increments, to the determined dose. The electronic control unit can be configured to issue a command to make the motion sensing unit operable in response to the use signal.

[0046] In one embodiment, the switch feature is configured to move a first electrical contact feature of the electrical switch into electrical and / or mechanical contact with a second electrical contact feature of the electrical switch when the first member is rotated relative to the second member. A use signal can be generated when the first electrical contact feature is in contact with the second electrical contact feature. The switch feature can be arranged to displace the second electrical contact feature during the rotation of the first member relative to the second member. The switch feature can displace both the first and the second contact feature, particularly in the same direction, during the rotation. In this way, it can be achieved that the use signal is generated under all tolerance conditions, as both contact features move together after the contact has been established.

[0047] In one embodiment, the electronic system or drug delivery device comprises a coupling interface (e.g. an interlock) that selectively rotationally locks the first member and the second member. The coupling interface can rotationally lock the two members when established and can allow relative rotational movement when released. In a dose setting operation, the coupling interface can be established. In a dose delivery operation, the coupling interface can be released.

[0048] In one embodiment, for switching from a dose setting configuration of the dose setting and drive mechanism in which a dose setting operation can be performed to a dose delivery configuration of the dose setting and drive mechanism in which a dose delivery operation can be performed, the first member and the second member can be axially displaceable relative to each other. The axial displacement can be a displacement of the second member relative to the first member in a distal direction. During the relative axial displacement, the state of the coupling interface can be switched, e.g. from established to released, or vice versa. The relative axial displacement to change the state of the coupling interface can be mandatory before the dose delivery operation can be initiated. The relative axial displacement can be performed by a movement of a user interface member of the device or system, which can be connected to or integral with one of the first member and the second member (e.g. a dose or injection button). The axial displacement can be achieved when a user presses a surface on the button, e.g. in a distal direction. In other words, the first member and the second member can have different axial positions relative to each other in the dose setting operation and in the dose delivery operation.

[0049] In one embodiment, the ratchet (e.g. in the use signal generation interface member) is designed to allow a relative rotation between the first member and the second member in both opposite directions or only in one direction. In other words, the ratchet can be unidirectional or bidirectional. In case a unidirectional ratchet is provided, the ratchet can provide a resistance against or prevent a rotation of the first member relative to the second member in a direction that would increase a set dose when in the dose delivery configuration (e.g. when the second member has been axially displaced relative to the first member).

[0050] In one embodiment, the generation of the use signal is independent of a change of the axial position of the user interface member or the second member relative to the first member. That is, a mere pressing of the user interface member does not result in a use signal generation. Rather, a rotational movement of the first member relative to the second member is required to generate the use signal.

[0051] In the dose setting configuration and / or in the dose delivery configuration, the relative relationship or position between the switch feature and the ratchet (e.g. in the use signal generation interface member) can be different and / or varied.

[0052] For example, the switch feature can engage the ratchet only in the initial phase of the dose setting operation or the dose delivery operation, in particular before the relative axial movement between the first member and the second member is completed. In this way, after the use signal has been generated, the switch feature can disengage from the ratchet and engage a planar surface, for example, with a correspondingly smaller frictional loss, which can result in a smaller torque or force required to operate the device. Thus, the switch feature can engage the ratchet and can disengage from said ratchet after the initial relative rotation has been completed to generate the use signal, for example, after the dose delivery operation has been started. After the operation, for example, the dose delivery operation, has been completed, the switch feature can re-engage the ratchet, for example, by a spring. The spring can be a coupling spring that re-establishes the engager interface between the first member and the second member.

[0053] In one embodiment, the power consumption, in particular the maximum power consumption, in the first state, for example, before the use signal is generated, can be less than or equal to one of the following values: 300 nA, 250 nA, 200 nA (nA: nanoampere). Alternatively or in addition, in the second state, the power consumption, in particular the minimum power consumption, can be greater than or equal to one of the following values: 0.5 mA, 0.6 mA, 0.8 mA (mA: milliampere). The difference can be caused by the power consumption of the motion sensing unit and / or the communication unit, which can be active or operable in the second state of the electronic system and switched off or in a sleep state in the first state of the electronic system.

[0054] In one embodiment, the motion sensing unit, when active, for example, in the second state of the system, can be operable to collect motion data or measurement data related to the relative movement of the first member and the second member. The electronic control unit can be configured to convert such data into dose data, for example, a representation of the size of the dose that has been set in the respective operation or that has been delivered. The dose data can be calculated from the measurement data. The communication unit can be configured to transmit the dose data to an external unit, for example, a mobile phone, a tablet or a personal computer.

[0055] In one embodiment, the amount or distance of the relative movement between the first member and the second member is a representation of the dose that is currently set in the dose setting operation or of the dose that is currently dispensed in the dose delivery operation. The size of the delivered dose can be determined or correspond to the distance by which the piston rod of the dose setting and / or drive mechanism is displaced relative to the housing during the dose delivery operation.

[0056] In one embodiment, the power consumption P2 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, wherein P1 is the power consumption in the first state. In the second state, the motion sensing unit can be active and / or a communication unit (e.g. for wireless communication).

[0057] In one embodiment, the electronic system can be configured such that it is switched back to the first state with lower power consumption after a predetermined time has elapsed.

[0058] In one embodiment, the drug delivery device comprises a reservoir with a drug or a reservoir holder configured to receive a reservoir with a drug. The drug can be a liquid drug. The reservoir can comprise an amount of drug sufficient to deliver a plurality of doses. The reservoir can comprise an amount of drug sufficient to deliver a plurality of maximum settable doses. The reservoir can be a cartridge. The device can be a device for self-administration by a user (e.g. a medically trained or untrained user such as a patient). The device can be a pen-type device. The device can be a needle-based device or can be needle-free. The drug delivery device can be a reusable device and / or the electronic system can be a reusable electronic system. In particular, the electronic system is preferably designed for use with a plurality of disposable drug delivery devices or for use in a reusable drug delivery device where one or more replacement reservoirs are provided once the reservoir has been emptied. The drug delivery device can be a device that is carried on the person or portable. Thus, the device can be a device that is carried by a user to a potentially remote location and, as such, the device can not be configured to be connected to a power source.

[0059] It should be noted that features disclosed above and hereinafter in connection with different embodiments and / or aspects can be combined with each other and also with other features of other aspects or embodiments.

[0060] In one particularly advantageous embodiment, there is provided an electronic system for a drug delivery device, the electronic system comprising:

[0061] - a dose setting and drive mechanism configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device and a dose delivery operation for delivering the set dose, the dose setting and drive mechanism comprising a first member and a second member, wherein the dose setting and drive mechanism is configured such that, in the dose delivery operation and / or in the dose setting operation, the first member moves (e.g. rotates and / or moves axially) relative to the second member;

[0062] - an electronic control unit configured to control operation of the electronic system, the electronic system having a first state and a second state, wherein the electronic system has an increased power consumption in the second state compared to the first state;

[0063] - an electrical use detection unit operatively connected to the electronic control unit, the electrical use detection unit being configured to generate a use signal indicative of that the user has started a dose setting operation or a dose delivery operation, wherein

[0064] the electronic system is configured such that it is switched from the first state to the second state by the electronic control unit in response to the use signal, and wherein

[0065] the electrical use detection unit is configured to generate the use signal in response to relative movement, e.g. relative rotational movement, between the first member and the second member, preferably during a dose delivery operation.

[0066] Further aspects, embodiments, and advantages will become apparent from the following description, taken in connection with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0067] Figure 1 Embodiments of a drug delivery device are shown.

[0068] Figure 2 A proximal end of a drug delivery device according to another embodiment is shown.

[0069] Figure 3A A proximal end of an injection device is shown after actuation of the injection button Figure 2

[0070] Figure 3B A cross-sectional view of an injection device is shown after actuation of the injection button Figure 2

[0071] Figure 4 An enlarged cross-sectional view of the device Figure 2

[0072] Figure 5 An isometric side view of an encoder system of the first type is shown.

[0073] Figure 6 A plan view of the encoder system shown in Figure 5

[0074] Figure 7 A schematic block diagram of a device controller is shown.

[0075] Figure 8A ​​​​is a cross-sectional view of the proximal end of the device prior to actuation of the injection button.

[0076] Figure 8B is a cross-sectional view of the proximal end of the device during partial actuation of the injection button.

[0077] Figure 8C is a cross-sectional view of the proximal end of the device during full actuation of the injection button.

[0078] Figure 9 is an isometric side view of an encoder system of a second type.

[0079] Figure 10 is a plan view of the encoder system shown in Figure 9

[0080] Figure 11 illustrates Gray code output.

[0081] Figure 12 is a partial plan view of the encoder system.

[0082] Figure 13 is a partial plan view of the encoder system.

[0083] Figure 14 is an isometric side view of an encoder system of a third type.

[0084] Figure 15A is a partial plan view of the encoder system.

[0085] Figure 15B is a partial plan view of the encoder system.

[0086] Figure 16 is an isometric side view of an encoder system of a fourth type.

[0087] Figure 17 is an isometric side view of an encoder system of a fifth type.

[0088] Figure 18A is a plan view of an encoder system of a sixth type.

[0089] Figure 18B is a plan view of an encoder system of a seventh type.

[0090] Figure 19A is a screenshot showing an oscilloscope trace obtained from various embodiments.

[0091] Figure 19B is a close-up view of the screenshot of Figure 19A

[0092] Figure 20 ​​Embodiments of an electronic system for a drug delivery device are schematically illustrated.

[0093] Figure 21 Embodiments of an electronic system and in particular of a usage detection unit thereof for generating a usage signal are illustrated.

[0094] Figure 22 Another embodiment of an electronic system and in particular of a usage detection unit thereof for generating a usage signal is illustrated.

[0095] Figure 23 Another embodiment of an electronic system and in particular of a usage detection unit thereof for generating a usage signal is illustrated.

[0096] Figure 24 Another embodiment of an electronic system and in particular of a usage detection unit thereof for generating a usage signal is illustrated.

[0097] Figure 25A and Figure 25B Another embodiment of an electronic system and in particular of a usage detection unit thereof for generating a usage signal is illustrated.

[0098] Figure 26A and Figure 26B Another embodiment of an electronic system and in particular of a usage detection unit thereof for generating a usage signal is illustrated.

[0099] Figure 27 Another embodiment of an electronic system and in particular of a usage detection unit thereof for generating a usage signal is illustrated.

[0100] Figure 28 Another embodiment of an electronic system and in particular of a usage detection unit thereof for generating a usage signal is illustrated.

[0101] Figure 29 Another embodiment of an electronic system and in particular of a usage detection unit thereof for generating a usage signal is illustrated.

[0102] Figure 30 Another embodiment of an electronic system and in particular of a usage detection unit thereof for generating a usage signal is illustrated.

[0103] Figures 31A-31E Embodiments of an electronic system and in particular of a usage detection unit thereof for generating a usage signal are illustrated. DETAILED DESCRIPTION

[0104] In the drawings, identical or the most similar elements, elements with the same function, or elements of the same kind can be provided with the same reference signs.

[0105] In the following, some embodiments will be described with reference to an insulin injection device. However, the present disclosure is not limited to such applications and can equally well be deployed with injection devices or generally drug delivery devices, preferably pen and / or injection devices, configured to expel other medicaments.

[0106] Embodiments are provided in relation to injection devices, in particular in relation to variable dose injection devices, which record and / or track data in relation to doses delivered therefrom. These data can include the size of a selected dose and / or the size of an actually delivered dose, the time and date of administration, the duration of administration, etc. Features described herein include arrangements of sensing elements and power management techniques (e.g. to facilitate small batteries and / or to enable efficient power usage).

[0107] In relation to Sanofi's Injection devices illustrate certain embodiments in this document. An injection button can provide a user interface member for initiating and / or performing a dose delivery operation of a drug delivery device. A grip or knob can provide a user interface member for initiating and / or performing a dose setting operation. Both devices are of the dialling extension type, i.e. their length is increased during dose setting. Other injection devices with the same kinematic behaviour of dialling extension and button during dose setting and dose expelling operation mode are known as e.g. the device sold by Eli Lilly and the device sold by Novo Nordisk. Thus, it appears simple and straightforward to apply the general principles to these devices and further explanation will be omitted. However, the general principles of the present disclosure are not limited to the described kinematic behaviour. Certain other embodiments can be envisaged to apply to Sanofi's injection device, where there are separate injection button and grip parts / dose setting members. Thus, there can be two separate user interface members: one for dose setting operation; and one for dose delivery operation.

[0108] “Distal” is used herein to indicate a direction, end or surface arranged or to be arranged facing or pointing towards the dispensing end of a drug delivery device or a component thereof and / or pointing outwards, to be arranged facing away or away from the proximal end. On the other hand, “proximal” is used to indicate a direction, end or surface arranged or to be arranged facing away or away from the dispensing end and / or distal end of a drug delivery device or a component thereof. The distal end can be the end closest to the dispensing end and / or furthest away from the proximal end, and the proximal end can be the end furthest away from the dispensing end. A proximal surface can face away from the distal end and / or face towards the proximal end. A distal surface can face towards the distal end and / or face away from the proximal end. For example, the dispensing end can be the needle end at which a needle unit is mounted or to be mounted to the device.

[0109] Figure 1 is an exploded view of a medicament delivery device or drug delivery device. In this example, the medicament delivery device is an injection device 1, e.g. a pen-type injector.

[0110] Figure 1 The injection device 1 of is an injection pen comprising a housing 10 and containing a container 14, e.g. an insulin container, or a receptacle for such a container. The container can contain a medicament. A needle 15 can be attached to the container or receptacle. The container can be a cartridge and the receptacle can be a cartridge holder. The needle is protected by an inner needle cover 16 and an outer needle cover 17 or another cap 18. An insulin dose to be ejected from the injection device 1 can be set, pre-set or “dialed in” by turning a dose knob 12 and then displayed (e.g. in multiples of a unit) via a dose window 13 of the currently pre-set or set dose. The indicia displayed in the window can be provided on a number sleeve or dial sleeve. For example, in case the injection device 1 is configured to administer human insulin, the dose can be displayed in so-called International Units (IU), where one IU is the biological equivalent of about 45.5 micrograms of pure crystalline insulin (1 / 22 mg). Other units can be employed in the injection device for delivery of insulin analogues or other medicaments. It should be noted that the selected dose can be displayed in a different manner than shown in the dose window 13 in. Figure 1 The selected dose can equally well be displayed in a different manner than shown in the dose window 13 in.

[0111] The dose window 13 can be in the form of an aperture in the housing 10 which allows the user to view a limited portion of a dial sleeve 70 which is configured to move when the dose knob 12 is turned to provide a visual indication of the currently programmed dose. When turned during programming, the dose knob 12 rotates on a helical path relative to the housing 10.

[0112] In this example, the dose knob 12 comprises one or more formations 71a, 71b, 71c to facilitate attachment of a data collection device.

[0113] The injection device 1 can be configured such that turning the dose knob 12 causes a mechanical click sound to provide acoustic feedback to the user. In this embodiment, the dose knob or dose button 12 also serves as an injection button 11. Upon piercing the needle 15 into a skin portion of a patient and then pushing the dose knob 12 / injection button 11 in axial direction, the insulin dose displayed in the display window 13 is ejected from the injection device 1. The dose is injected into the patient when the needle 15 of the injection device 1 remains in the skin portion for a certain time after pushing the dose knob 12 to the correct position. The ejection of the insulin dose can also cause a mechanical click sound, however, which is different from the sound produced when rotating the dose knob 12 during dialing of the dose.

[0114] In this embodiment, during delivery of the insulin dose, the dose knob 12 is returned to its initial position in axial movement (not rotated), while the dial sleeve 70 is rotated back to its initial position, e.g. displaying a dose of zero units. As already indicated, the present disclosure is not limited to insulin, but shall encompass all medicaments in the medicament container 14, in particular liquid medicaments or medicament formulations.

[0115] The injection device 1 can be used for several injection processes until the insulin container 14 is empty or the medicament in the injection device 1 reaches the expiration date (e.g. 28 days after first use).

[0116] Furthermore, before first use of the injection device 1, a so-called “priming injection” can be required to ensure that fluid is correctly flowing from the insulin container 14 and the needle 15, e.g. by selecting two units of insulin and pressing the dose knob 12 while keeping the needle 15 of the injection device 1 pointing upwards. For the sake of presentation, in the following it will be assumed that the ejected amount substantially corresponds to the injected dose, such that e.g. the amount of medicament ejected from the injection device 1 equals the dose received by the user.

[0117] As explained above, the dose knob 12 also serves as an injection button 11, such that the same component is used for dialing / setting the dose and dispensing / delivering the dose.

[0118] Figure 2 、 Figure 3A and Figure 3B A proximal end of a device 2 according to a second embodiment is shown. The device 2 comprises a grip 205 and an injection button 210. Unlike the device 1 shown in Figure 1 The injection button 210 is separate from the grip 205, which is used to dial the dose. The dial sleeve 70 and the injection button 210 are partially located inside the grip 205. The grip 205 and the dial sleeve 70 can be regarded as elements of the same component in terms of functionality. In practice, the grip 205 and the dial sleeve 70 can only be separate components for assembly reasons. Apart from the differences described herein, Figure 2The device 2 shown in Fig. 2 operates in essentially the same way as the device 1 shown in Figure 1 Fig. 1.

[0119] Like the device 1, the dial sleeve 70, the grip 205 and the injection button 210 extend helically from the device 2. During the dose dialling mode of operation, as shown in Figure 2 Fig. 2, there is no relative rotation between the injection button 210 and the dial sleeve 70. A dose is dialled by rotating the grip 205, and thereby also the dial sleeve 70 and the injection button 210, relative to the rest of the device 2.

[0120] To initiate dispensing of medicament, as shown in Figure 3A and Figure 3B Fig. 2, the injection button 210 is axially depressed. This action changes the mode of the device 2 to the dispensing mode. In the dispensing mode, the dial sleeve 70 and the grip component 205 are retracted along the helical path into the rest of the device 2, while the injection button 210 does not rotate and is only retracted with axial motion. Thereby, in the dispensing mode, the injection button 210 is disengaged, resulting in relative rotation of the injection button 210 relative to the dial sleeve 70. This disengagement of the injection button 210 relative to the dial sleeve 70 is caused by the engager arrangement or interface described in more detail in connection with Figures 8A-8C Fig. 2.

[0121] Figure 4 Fig. 3 is a close-up cross-sectional view of the proximal end of the device 2 shown in Fig. 2 after the injection button 210 has been depressed. As shown in Figure 4 Fig. 3, the injection button 210 is configured as two separate sub-components, namely a distal or lower button portion 210a and a proximal or upper button portion 210b. The injection button 210 can be configured in this way to assist the assembly process. The distal button portion 210a and the proximal button portion 210b can be fixed together and functionally used as a single component, i.e. the injection button 210.

[0122] A sensor arrangement 215 comprising one or more sensors is mounted in the injection button 210, said sensor arrangement being configured to sense the relative rotational position of the dial sleeve 70 relative to the injection button 210. This relative rotation can be equated to the size of the dose dispensed and used for the purpose of generating and storing or displaying dose history information. The sensor arrangement 215 can comprise a primary sensor 215a and a secondary sensor 215b. In Figure 4 Fig. 3, only the secondary sensor 215b is shown. In the following discussion, these sensors are optical sensors, however, a number of alternative options are equally applicable to various embodiments, such as photoelectric sensors, inductive sensors, capacitive sensors, contact sensors, non-contact sensors, magnetic sensors, etc.

[0123] Figure 5 and Figure 6 An encoder system 500 according to certain embodiments is shown. The encoder system is configured for use with the device 2 described above. Figure 5 and Figure 6 As shown, the primary sensor 215a and the secondary sensor 215b are configured for a specially adapted region at the proximal end of the selector sleeve 70. In this embodiment, the primary sensor 215a and the secondary sensor 215b are infrared (IR) reflective sensors. Therefore, the specially adapted proximal region of the selector sleeve 70 is divided into a reflective region 70a and a non-reflective (or absorptive) region 70b. A portion of the selector sleeve 70 including the reflective region 70a and the non-reflective (or absorptive) region 70b may be referred to as an encoder ring.

[0124] To keep production costs to a minimum, it may be advantageous to form these regions 70a, 70b from injection-molded polymers. In the case of polymer materials, absorptivity and reflectivity can be controlled using additives, such as carbon black for absorptivity and titanium dioxide for reflectivity. Alternative implementations are possible, where the absorptive regions are molded polymer materials, while the reflective regions are made of metal (an additional metallic component, or selective metallization of sections of the polymer selector sleeve 70).

[0125] Having two sensors facilitates the power management techniques described below. The primary sensor 215a is arranged at a frequency corresponding to the resolution (e.g., 1 IU) required for the dose history requirements applicable to a particular drug or dosing regimen, targeting a series of alternating reflective regions 70a and non-reflective regions 70b. Compared to the primary sensor 215a, the secondary sensor 215b is arranged at a reduced frequency targeting the series of alternating reflective regions 70a and non-reflective regions 70b. It should be understood that the encoder system 500 can operate solely with the primary sensor 215a to measure the dispensed dose. The secondary sensor 215b facilitates the power management techniques described below.

[0126] exist Figure 5 and Figure 6 Two sets of coding regions 70a and 70b are shown, concentric with an outer region and an inner region, respectively. However, any suitable arrangement of the two coding regions 70a and 70b is possible. Although regions 70a and 70b are shown as crenellated regions, it should be remembered that other shapes and configurations are also possible.

[0127] Devices 1 and 2 also include a controller 700, such as Figure 7A controller 700 is shown schematically. The controller 700 comprises a processor arrangement 23 comprising one or more processors, for example microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs) and the like; and memory units 24, 25 comprising program memory 25 and main memory 24 which can store software for execution by the processor arrangement 23.

[0128] The controller 700 controls a sensor arrangement 215 comprising one or more sensors 215a, 215b.

[0129] An output 27 is provided which can be a wireless communication interface for communicating with another device via a wireless network such as Wi-Fi or Bluetooth®; or an interface for a wired communication link such as a socket for receiving a Universal Serial Bus (USB), mini USB or micro USB connector. For example, data can be output to a data collection device attached to the device 1, 2.

[0130] A power switch 28 is also provided as is a battery 29 as a power source.

[0131] It is advantageous to be able to minimise the power usage of the encoder system 500 so that the size of the battery 29 required to be packaged into the device 1, 2 can be minimised. The sensors 215a, 215b used in this embodiment require a certain amount of power to operate. The embodiment is arranged so that the sensors 215a, 215b can be switched on and off intermittently at a controlled frequency (i.e. in a gated sampling mode). A fixed limit is placed on the maximum rotational speed that can be counted by the sampled encoder system before aliasing occurs. Aliasing is the phenomenon where the sampling rate is less than the rate at which the sensed region passes the sensor, meaning that a counting error can occur when the region changes. The secondary sensor 215b, which is reduced in frequency compared to the primary sensor 215a, can tolerate a higher rotational speed before it too becomes aliased. Although the secondary sensor 215b is not able to resolve doses assigned to the same resolution as the primary sensor 215a, the output of the secondary sensor 215b remains reliable at higher speeds. Thus, the two sensors 215a, 215b are used in combination to be able to accurately determine doses delivered up to a first threshold rotational speed (assigned speed). The sensors 215a, 215b can then be used to determine an approximate dose delivered up to a second (higher) threshold assigned speed. At speeds above the second threshold speed, the sensors 215a, 215b will not be able to accurately or approximately determine the dose delivered, so the second threshold is set above a speed which is physically impossible to achieve when expelling fluid from the injection device 1, 2.

[0132] ​A first speed threshold is determined by the sampling rate of the primary sensor 215a and the frequency of encoder region switching, the frequency being fixed at the resolution required for the intended drug or dosing regimen (e.g., once per 1 IU). A second speed threshold is determined by the sampling rate of the secondary sensor 215b and the frequency of encoder region switching. The first threshold is set such that the system can cover the maximum dispensing speed range to accurately report the dispensed dose.

[0133] Figure 6 The exemplary embodiment shown has a primary sensor 215a that switches once for region switching every 1 IU dose delivered and a secondary sensor 215b that switches once for region switching every 6 IU dose delivered. Other options are also possible, including switching once every 2 IU, once every 4 IU, once every 8 IU, and once per IU unit. These options are each possible because... Figure 6 In the encoder system 500 shown, there are 24 individual regions 70a, 70b per revolution. Typically, if the number of individual regions 70a, 70b per revolution is n units, there is an option to switch every m units, where m is any integer factor greater than 1 and less than n.

[0134] The slower the sampling frequency of the two sensors 215a and 215b, the lower the power consumption required, and therefore the smaller the required battery 29. Therefore, in practical applications, minimizing the sampling frequency through design is optimal.

[0135] To further limit battery capacity requirements, it is advantageous to keep device 2 in a low-power state when power is not needed for sensors 215a and 215b. This can be achieved via a switch activated by the shifting of injection button 210.

[0136] like Figure 8A As shown, switch 800 is installed in injection button 210. Figure 8A In the configuration shown, the arm of switch 800 is deflected by the selector sleeve 70, causing switch 800 to be in the open state. In this configuration, the connector between the connector component and the selector sleeve 70 engages with device 2 in its selector mode. When injection button 210 is pressed, injection button 210 is axially displaced relative to selector sleeve 70, and therefore switch 800 is axially displaced relative to selector sleeve 70. This displacement causes a portion of the selector sleeve 70 to descend along a cam surface on switch 800, thereby allowing the switch arm to deflect to its free state. This deflection in the switch arm has the effect of changing the electrical state of switch 800 (e.g., becoming electrically closed). The design is arranged such that the change in the electrical state of switch 800 occurs before the change in the state of the connector between the connector component and selector sleeve 70. Figure 8BThe transition point of the clutch is shown, and it is shown that the switch 800 has changed state. Figure 8C The state of the device 2 when the injection button 210 is fully depressed is shown. In this case, the clutch is fully disengaged, allowing the clutch components and the dial sleeve 70 to rotate relative to each other in dispensing mode.

[0137] This sequence operates in reverse when the injection button 210 is released.

[0138] An electrical state change occurs when the injection button 210 is depressed, thereby allowing the device 2 to be powered off into a low energy consumption state when the injection button 210 is not depressed. In this state, no relative rotation between the injection button 210 and the dial sleeve 70 is possible, so the encoder system 500 is not required.

[0139] The mechanical configuration between the dial sleeve 70 and the switch 800 can operate in the opposite direction, such that the arms of the switch 800 deflect during dispensing, rather than during dialling.

[0140] The following embodiment relates to an alternative sensing technology to determine the number of medicament units that have been dispensed from the device 1, 2.

[0141] As with the above described embodiments, two sensors 215 are mounted in the injection button 210 and are configured to sense the relative rotational position of the dial sleeve 70 relative to the injection button 210 during dose dispensing. This relative rotation can be equated to the size of the dose dispensed and used for the purpose of generating and storing or displaying dose history information.

[0142] As shown in Figure 9 the two sensors 215 from this embodiment are configured to target specially adapted regions 70a, 70b of the dial sleeve 70. In this embodiment, IR reflective sensors are used, so the regions of the dial sleeve 70 are divided into reflective sections 70a and absorptive sections 70b. The sections 70a, 70b can also be referred to herein as markers or detection regions.

[0143] Unlike the encoder system 500 described above in relation to Figure 5 and Figure 6 the two sensors 215 from this embodiment are configured to target specially adapted regions 70a, 70b of the dial sleeve 70. In this embodiment, IR reflective sensors are used, so the regions of the dial sleeve 70 are divided into reflective sections 70a and absorptive sections 70b. The sections 70a, 70b can also be referred to herein as markers or detection regions. Figure 9 10 ​The encoder system 900 shown in FIG. 6 has two IR sensors 215 for the same type of zones 70a, 70b. In other words, the sensors 215 are arranged so that they face reflective zones 70a and absorptive zones 70b on the same surface. The sensors 215 can be arranged so that at the same time, one sensor faces a reflective zone 70a and one sensor faces an absorptive zone. During dose dispensing, for each unit of medicament that has been dispensed, the dial sleeve 70 rotates 15° counterclockwise relative to the injection button 210. The alternate flag element is located in the 30° (or two unit) section. The sensors 215 are arranged out of phase with each other so that the angle between them is equal to an odd number of units (e.g., 15°, 45°, 75°, etc.), as shown in FIG. 6. Figure 10

[0144] Figure 10 The encoder system 900 shown in FIG. 6 has 12 segments per revolution, i.e., 12 alternating zones 70a, 70b. Typically, the implementation works in any multiple of four units per revolution. The angle a between the sensors 215 can be expressed with Equation 1, where m and n are any integers, and 4m units are dispensed per revolution.

[0145]

[0146] Equation 1 - Angle between sensors

[0147] Figure 11 The output of Sensor A and Sensor B as the dial sleeve 70 rotates counterclockwise during medicament dispensing is shown.

[0148] The combination of the two sensors A, B produces a 2-bit Gray code output (11, 01, 00, 10). The 2-bit code sequence repeats once every four units dispensed. This encoding output facilitates detection of positive (counterclockwise) and negative (clockwise) rotation. For example, when the sensors read "11," a change to "01" would be positive rotation, while a change to "10" would be negative rotation. This direction-sensitive system is superior to a pure incremental system in terms of its ability to accurately determine the true volume of dose dispensed in the event that negative rotation can occur. For example, a mechanism that over-rotates at the end of the dose when the user releases the injection button 210 stops before "backing up."

[0149] Reference Figure 12 ​The IR sensor 215 emits IR light from the LED. The IR reflection area 70a of the encoder system 900 reflects the light, and the sensor detects the reflected light. The sensor 215 then converts the detected light into an electrical output. The intensity of the IR light detected by the sensor 215 after reflection from the encoder ring is proportional to the proximity of the sensor and the encoder ring. Therefore, it is desirable for the sensor 215 to be as radially close to the encoder ring as possible without contacting it, which would increase frictional losses in the dispensing mechanism.

[0150] refer to Figure 13 The IR-absorbing region 70b of the selector sleeve 70 does not completely absorb all the IR light emitted from the sensor 215. Tests show that when the sensor 215 is aligned with the IR-absorbing region 70b of the selector sleeve 70, the sensor 215 has some electrical output due to the low level of IR light reflected by the selector sleeve 70. Therefore, the selector sleeve markings are designed to maximize the distance between the sensor 215 and any intentionally IR-absorbing portions of the encoder ring. This ensures high contrast and signal clarity.

[0151] During dosage dispensing, the software of devices 1 and 2 monitors the electrical output of sensor 215. The software detects the change between high and low outputs to determine when the relative rotation between the selector sleeve 70 and the injection button 210 has reached another 15° (i.e., another unit has been dispensed). Therefore, maximizing the contrast between high and low outputs is beneficial for the functionality of the devices.

[0152] According to various implementation schemes, the design of the selector sleeve 70 and encoder ring markings 70a, 70b has been developed to increase contrast. Figure 14 The design shown eliminates the absorbent selector sleeve mark 70b to leave a gap 140 between adjacent encoder ring marks 70a. This maximizes the distance between the sensor 215 and any material that can reflect any IR light emitted from the sensor.

[0153] This design increases the contrast between low and high sensor electrical output. However, as... Figure 15A As shown, the infrared light emitted by sensor 215 is not a beam, so that when the selector sleeve 70 rotates between the reflective encoder ring mark 70a and the gap 140, sensor 215 detects overlap in the positions of some of the light emitted by sensor 215. During this period, the sensor output gradually decreases from high to low, rather than changing abruptly between high and low. For a rotation determined by the software to be 15° (i.e., one dose unit dispensed), this gradual decrease is more difficult than an immediate step change.

[0154] This phenomenon occurs in various implementations of the encoder mark (e.g.)Figure 9 and Figure 14 As shown in FIG. 6, the encoder ring 70a is printed with IR-reflective material. The encoder ring 70a is mounted on a shaft 72 that is coupled to a dial sleeve 70. The dial sleeve 70 is coupled to a drive mechanism (not shown) that is coupled to a motor (not shown). The motor is coupled to a controller (not shown) that is coupled to a sensor (not shown). Figure 15B As shown in FIG. 6, the encoder ring 70a is printed with IR-reflective material. The encoder ring 70a is mounted on a shaft 72 that is coupled to a dial sleeve 70. The dial sleeve 70 is coupled to a drive mechanism (not shown) that is coupled to a motor (not shown). The motor is coupled to a controller (not shown) that is coupled to a sensor (not shown).

[0155] Accordingly, it is advantageous to reduce the thickness at the edge of the IR-reflective markings 70a on the encoder ring. Figure 16 and Figure 17 Two possible implementations are shown that reduce the thickness at the side edges of the IR-reflective markings 70a on the encoder ring, such that the reflective surface is tilted inward to prevent or reduce diffuse reflection, thereby enhancing contrast transition and signal clarity.

[0156] Figure 16 An implementation is shown in which the molded polymer encoder ring has been replaced by a shaped metal ring 160.

[0157] Figure 17 An implementation is shown in which the molded polymer encoder ring has been replaced by a portion of the dial sleeve 70 that is printed, painted, or coated with IR-reflective material.

[0158] Figure 18A and Figure 18B Two alternative modes of operation are demonstrated in accordance with various implementations. Referring to FIG. 7, sensors I and II are provided with an angular offset (δ) that is half of the periodicity (φ) of the encoding regions of the encoder ring. In this implementation, the sensors are operated to sample synchronously (i.e., at the same times (ti, t2, t3,...)). Figure 18A

[0159] An implementation is shown in which the angular offset (δ) is different from half of the periodicity (φ / 2) of the features and the sensors are operated in an interleaved manner such that there is a time offset (Δt) between the samples. This can be used to achieve a more even overall system LED power consumption compared to that available in the synchronous operation. Figure 18A In the configuration shown in FIG. 8, the amount of angular offset (δ) can be reduced below half of the periodicity (φ) of the features in order to compensate for the relative angular travel during the time offset (Δt) between the sampling operations of the different sensors.

[0160] Figure 18B The time offset (Δt) can be adjusted in accordance with an estimated value of the relative rotational speed (ω) of the encoder ring, which can be calculated from sensor measurements. In particular, the offset time (Δt) can be reduced when it is determined that the rotational speed (ω) is increasing.

[0161] The time offset (Δt) can be adjusted in accordance with an estimated value of the relative rotational speed (ω) of the encoder ring, which can be calculated from sensor measurements. In particular, the offset time (Δt) can be reduced when it is determined that the rotational speed (ω) is increasing.

[0162] ​Figure 19A An oscilloscope trace obtained by an embodiment of the present disclosure is shown. The lower trace is the LED drive signal, while the upper trace is the output of the current mirror before the Schmidt trigger.

[0163] Figure 19B is Figure 19A An expanded view of the oscilloscope trace shown in the middle. The results show that a duty cycle of close to 12 to 1 can be achieved with a sampling of 256 μβ (which means that the average current is 1 / 12 of the 4 mA LED driver, thus saving power and battery capacity. This is equivalent to a sampling rate of over 3900 Hz, and with one unit per bin and at least two samples per bin, a detection speed of over 1950 units per second is achieved without violating the Nyquist criterion. Thus, no anti-aliasing detector is needed.

[0164] While the above embodiments have been described with respect to collecting data from an insulin syringe pen, it should be noted that embodiments of the present disclosure can be used for other purposes, e.g., such as monitoring injection of other medicaments or generally drug delivery devices.

[0165] As already discussed above, managing the power consumption or resources of a power source (e.g., a rechargeable or non-rechargeable battery 29) in a drug delivery device comprising an electronic system, such as an injection device discussed further above, is a problem that needs to be solved, e.g., in order to optimize the use of the capacity of the power source and / or taking into account that drug delivery devices sometimes have a rather long shelf time before the device reaches the user or patient. It is necessary to ensure that the device comprising the electronic system still functions properly for the duration of its intended use.

[0166] The present disclosure presents various concepts that can be implemented in a drug delivery device or its electronic system or as a result thereof, e.g. for improving power management in the device. Some concepts rely on providing power to certain units of the device only when needed or when there is a high likelihood that power is needed. The device has been discussed above to, e.g., energize a motion sensing unit (sensor system) of the device only when an injection button (as a user interface member) is being pressed to perform a dose delivery (injection) operation. After the motion sensing unit has been energized, an encoder component or encoder ring can be used to collect data about movements, which are indicative of the dose that has been delivered during the delivery operation. From the measured movement data, it can be calculated how much drug has actually been delivered. For example, when a user interrupts the delivery operation before the delivery operation has actually been completed, the amount of drug that has actually been delivered does not necessarily coincide with the dose that has been previously set in a dose setting operation. It is therefore advantageous to measure the movements that occur during a dose delivery operation, which are related to the amount of drug that has been delivered, e.g. to get an insight into the current status or progress of the delivery operation. The determined delivered dose can be transmitted, preferably wirelessly, to an external or remote device, e.g. a handheld device such as a smartphone. In this way, a dose log about the doses delivered by the user can be established, which can be easily accessed by the user.

[0167] The presented concepts are applicable to a variety of drug delivery devices comprising an electronic system or to an electronic system for use with such devices, not only the devices further described above. The device can be an injection device and / or a pen-type device. The device can be configured to receive or comprise a medicament container or cartridge. The container or cartridge can be filled with a liquid medicament to be delivered by the device. The device can be designed to deliver a plurality of doses of medicament. Thus, the container or cartridge can comprise an amount of medicament sufficient to deliver several doses by the device. The device can be reusable or disposable, wherein a replacement medicament container or cartridge can be provided for a reusable device when the current container or cartridge is considered empty or needs to be replaced for different reasons. A disposable device can be a single-use device which is discarded after the medicament container has been emptied. The device can be a dial- extension type device (that is, a device whose length increases during a dose setting operation), wherein the increase in length is proportional to the size of the set dose. During an associated dose delivery operation, the length of the device can decrease again, e.g. until the device resumes its original length (i.e. the length it had before the dose setting operation has been started). Alternatively, the length of the device can be independent of the size of the set dose, e.g. constant or substantially constant during dose setting and / or dose delivery. The dose setting operation can involve a preferred rotational movement of a dose setting member (e.g. a knob, a button or a grip part (as already further discussed above)) as user interface member. The dose delivery operation can involve a preferred axial movement of a dose delivery member (e.g. a button such as an injection button as further discussed above) as user interface member. As already further discussed above, the dose setting member and the dose delivery member can be formed by a single (e.g. integral) part (wherein different surfaces of the part are preferably manipulated during the dose setting operation and the dose delivery operation), or alternatively, the dose setting member and the dose delivery member can be separate members / interface members or parts (wherein a relative movement between these members is possible, e.g. to switch a dose setting and drive mechanism between a dose setting configuration and a dose delivery configuration). There can be a relative movement between these members during dose setting or dose delivery or during both operations. During the dose setting operation, a lateral surface or side surface (i.e. a radially facing surface) of the dose setting member can be gripped by a user, e.g. with the thumb and index finger. During the dose delivery operation, an axially (e.g. proximally) facing surface of the dose delivery member can be touched by a user, e.g. with the thumb. During the dose delivery operation, the user can transmit an axial force to the dose delivery member in order to initiate and / or continuously drive the dose delivery operation using a dose setting and drive mechanism of the device, which can comprise further members besides the user interface members, e.g. a drive member and a piston rod. The drive member can engage the piston rod.In one embodiment, the dose delivery member can be a drive member that threadingly engages a piston rod, for example. The device can be a device as disclosed in, for example, WO 2015 / 028439 Al, which is incorporated herein in its entirety by reference.

[0168] The device can be a needle-based device (i.e. the drug can be delivered into the body via a needle that pierces the skin) or can be needle-free. The device can be a device with delivery assistance, e.g. a spring-assisted or spring-driven device. In such devices, the user’s dose delivery operation is energy-assisted or fully driven by energy provided by an energy storage member, such as a spring. The energy in the storage member can be increased during the user’s dose setting operation or the energy storage member can be provided by the manufacturer with all the energy required to empty a pre-stored medicament container in the member. In the latter case, the user does not need to provide energy to increase the energy stored in the energy storage member, such as during the dose setting operation.

[0169] Figure 20 The general configuration of the elements of the electronic system 1000 is shown, which can be used in a drug delivery device, such as one of the devices discussed further above or other devices.

[0170] The electronic system 1000 comprises an electronic control unit 1100. The control unit can comprise the controller 700 as discussed further above. In particular, the control unit can comprise the processor arrangement 23 as discussed further above. Also, the control unit 1100 can comprise one or more memory units, such as the program memory 25 and the main memory 24 as discussed further above. The control unit 1100 is conveniently designed to control the operation of the electronic system 1000. The control unit 1100 can communicate with further units of the electronic system 1000 via wired or wireless interfaces. It can transmit signals and / or data containing commands to the units and / or can receive signals and / or data from the respective units. The connections between the units and the electronic control unit are indicated with lines in Figure 7 However, there can also be connections between the units that are not explicitly shown. The control unit can be arranged on a conductor carrier, such as a (printed) circuit board. One or more other units of the electronic system can comprise one or more components that are also arranged on a conductor carrier. Figure 20

[0171] ​The electronic system 1000 can further comprise a motion sensing unit 1200. The motion sensing unit 1200 can comprise one or more sensors, such as the sensors 215a and 215b described further above. In case of optoelectronic sensors detecting electromagnetic radiation, such as IR sensors, the motion sensing unit can additionally comprise a radiation emitter emitting radiation to be detected by the sensor. However, it should be noted that also other sensor systems, such as magnetic sensors, can be employed. The power consumption of a motion sensing unit having electrically operated sensors and electrically operated sources for stimulating the sensors, such as radiation emitters and associated sensors, can be relatively high and, thus, its power management can have specific implications. Each sensor can have an associated radiation emitter. The motion sensing unit 1200 can be designed to detect and, preferably, measure the relative movement of two movable members of a dose setting and drive mechanism of a drug delivery device or of two movable members for said drug delivery device during a dose setting operation and / or during a dose dispensing operation. For example, the motion sensing unit can measure or detect the relative rotational movement of two movable members of a dose setting and drive mechanism relative to each other. Based on movement data received from the signals of the unit 1200 or computed therefrom, the control unit can compute dose data.

[0172] The electronic system 1000 can further comprise a use detection unit 1300. The use detection unit can be associated with one user interface member or a plurality of user interface members such that a manipulation of a member for setting and / or delivering a dose thereof can be detected. Upon detection of a manipulation, the use detection unit generates or triggers the generation of a use signal. The use signal can be transmitted to the electronic control unit 1100. The electronic control unit can issue a command or signal to one of the other electrically operated units of the system, to any selected plurality of electrically operated units, or to all electrically operated units in response to said signal. For example, the control unit can cause the respective unit to switch from a first state of lower power consumption, such as a sleep state or an idle state, or a disconnected state of no power consumption, to a second state of increased power consumption. The switching can be accomplished by a respective switching command or signal issued by the electronic control unit to the respective unit. In response to the use signal, all units can switch to the second state, or only selected units can switch to the second state. If only selected units switch to the second state of higher power consumption, it is advantageous that these units are intended to be used during an operation that the user intends to start or has started.

[0173] For example, the typical time required to switch the motion sensing unit to the second state after the generation of the use signal or the activation of the user interface member to initiate an operation of the system, such as a dose delivery operation, is between 2.5 ms and 3.2 ms.

[0174] The electronic system 1000 can further comprise a communication unit 1400, e.g. an RF, WiFi and / or Bluetooth unit. The communication unit can be provided as a communication interface between the system or drug delivery device and an external, e.g. other electronic device, e.g. a mobile phone, a personal computer, a laptop, etc. For example, dose data can be transmitted to an external device via the communication unit. The dose data can be used for a dose record or dose history established in the external device. The communication unit can be provided for wireless or wired communication.

[0175] The electronic system 1000 can further comprise a power source 1500, e.g. a rechargeable or non-rechargeable battery. The power source 1500 can provide power to the respective units of the electronic system.

[0176] When the system is in the first state, e.g. neither the motion sensing unit nor the communication unit are active, the current consumption can be 200 nA. When (only) the motion sensing unit is active, the power consumption can be 0.85 mA. When the communication unit is active (e.g. in addition to or only the communication unit), the power consumption can be 1.85 mA.

[0177] Although not explicitly depicted, the electronic system can comprise a storage unit or memory unit, preferably permanent and / or non-volatile, which can store data related to the operation of the drug delivery device, e.g. dose history data.

[0178] In one embodiment, the electronic control unit 1100 can be configured to reduce the power consumption of the respective unit, i.e. to switch the unit back to the first state. This can be appropriate, e.g. if an event related to the unit, e.g. a motion sensing event for the motion sensing unit, does not occur within a predetermined time interval after the unit has been switched from the first state to the second state and / or after the use signal has been generated. The monitoring of the time interval can be achieved by a timer unit (not explicitly shown) operatively connected to the electronic control unit. In case no signal is generated by the motion sensing unit within the predetermined time interval after the use signal, the entire system can be switched to the first state again. This time interval can be greater than or equal to one of the following values: 0.2 s, 0.5 s, 1 s, 5 s, 10 s, 15 s, 20 s, 25 s, 30 s.

[0179] Without being named, the electronic system 1000 can comprise further electronic units in addition to the depicted electronic units, such as other sensing units, which sense or detect quantities or events different from the relative movement detected by the motion sensing unit.

[0180] In the user interface member 1600 can be integrated a respective unit, e.g. a dose setting and / or delivery button of an electronic system, e.g. the knob 12 of the device discussed previously, which is discussed in more detail below in connection with Figure 31A and Figure 31B embodiments described in more detail below but preferably present in any of the embodiments discussed below.

[0181] The use detection unit 1300 has conveniently lower power consumption than the motion sensing unit 1200 when operable to generate a use signal, e.g. a set signal and / or a delivery signal, at its activity.

[0182] When studying the operation of the trigger switch arrangement with the switch 800 discussed further above, it has been noted that it is challenging to design such a trigger switch arrangement, e.g. because axial movement is used to trigger the switch. For example, it is required to ensure that the switching is triggered before the start of a delivery operation, e.g. before the engager is disengaged. Furthermore, the switch can be subjected to considerable axial displacement, because the engager needs to be disengaged by relative axial movement after the switch is triggered, which can put considerable load on the switch. These considerations make the design of an axial trigger switch rather complex and potentially unreliable.

[0183] In the following, some embodiments are discussed which can address the shortcomings of existing systems. Also, it can be desirable to provide other embodiments of systems configured to wake up other electronic components of the system only when operation of the respective component is required. Generally, systems having a configuration allowing to wake up one or more other electronic components from a low power state or sleep state will be discussed in the following.

[0184] Figure 21Embodiments of an electronic system during operation of a device making use of the electronic system are illustrated based on four different representations A to D. In this embodiment, upon generation of a use signal, it is determined that a respective operation (in this example a dose delivery operation, but equally a dose setting operation) has been initiated or started. This is advantageous over triggering a wake-up procedure of a motion sensing unit via an axial movement of a user interface member (e.g. an injection button). An axial trigger movement of a user interface member can occur unintentionally, e.g. due to a part in a handbag hitting and moving the button while the user is walking around, whereas the relative movement required to actually perform the desired operation is less likely to occur unintentionally. The present embodiment uses the relative movement of two members occurring during a dose delivery operation to switch the electronic system from a first state of lower power consumption to a second state of higher power consumption (where e.g. the motion sensing unit and / or the communication unit are powered up). Integrating the switching procedure into the dose delivery operation has the advantage that the activation of the motion sensing unit can occur immediately when needed (in fact only after the operation it shall monitor has started) in case the currently dispensed dose shall be monitored via the motion sensing unit. Of course, it is to be understood that similar switching operations or the same switching operations can be performed during a dose setting operation as well. However, the following description focuses on the dose delivery operation. Figure 21 In the upper part a perspective view of the members of the electronic system in relation to the disclosed concept is shown, and in the lower part a top view of these members is shown. The different representations A to D illustrate different relative positions of the members during a dose delivery operation.

[0185] Representation A illustrates the situation when a dose has been set and before the start of a dose delivery operation. Schematic illustrations of the housing 10, the first member 1780 and the second member 1790 are depicted. Instead of a part of the housing 10, the outer portion can also be a part of the first member and / or a part of the user interface member 1600 as will become clear from a brief look at the representations in Figure 31A and Figure 31B . The first member and the second member are part of a dose setting and drive mechanism of or for a drug delivery device. For example, the first member 1780 can be a dial sleeve or a number sleeve or a member axially and / or rotationally locked thereto, and the second member 1790 can be a drive sleeve or a user interface member (e.g. a dose and / or injection button). At least one section of the second member 1790 can be received in the first member 1780.

[0186] To perform dose delivery, the first member 1780 is moved (e.g., rotated) relative to the second member 1790. The second member can directly or indirectly engage with the piston rod to drive the dose delivery operation. During dose setting, the first member 1780 and the second member 1790 can be co-rotated relative to the housing 10. These members can thus be rotationally locked relative to each other, such as by an engager interface established during dose setting (e.g., via matching teeth on these two members, not shown). The engager interface can be released during dose delivery and / or to perform dose delivery. By the first member and / or the second member protruding from the housing during the dose setting procedure, the length of the device can increase by an amount that is proportional to the size of the set dose. However, the disclosed concept will also work without such dial extension during dose setting. During dose setting, the dose setting member (e.g., a user interface member 1600 that can be integrated into the second member) can be rotated relative to the housing 10, e.g., in an incremental change manner (e.g., in integer multiples of a unit setting increment). This can be achieved via a dose setting interface (e.g., a ratchet interface (not explicitly shown)) that sets a pitch according to the unit setting increment. Such an interface can be formed between the first member 1780 and the housing, or between another member that is stationary during the dose setting procedure and a member that is movable (e.g., rotatable) relative to the stationary member during setting. The dose setting interface can define stable positions of the respective members relative to the housing that are separated by one unit setting increment in angular direction. For example, one unit setting increment can correspond to a rotational angle of 15°. Thus, two stable rotational positions can be separated by 15° in angular direction.

[0187] To switch the electronic system from the first state to the second state, this concept makes use of a use signal generating interface that generates a use signal before the first member and the second member are rotated one unit increment relative to each other, which will be discussed further below. The use signal generating interface is also an incremental change interface and preferably increments the interval or sets the interval in the same way as the dose setting interface, or can have a more fine grained interval or smaller increments. In the depicted embodiment, the first member 1780 is provided with circumferentially arranged ratchet recesses 1800. Two adjacent ratchet recesses are separated by a ratchet tooth 1805. The respective teeth 1805 are circumferentially arranged. In the depicted embodiment, the ratchet recesses 1800 define 24 stable positions distributed over 360°, i.e. two stable positions are separated by an angle of 15°. The respective ratchet recesses or the teeth 1805 defining these recesses can be radially oriented, i.e. the teeth can have a radially free end. The teeth can point inwards. Instead of the first member comprising a ratchet, the use signal generating interface member 1880 can be provided with a ratchet that is rotationally locked to the first member 1780, e.g. the first member can be a dial sleeve or a number sleeve. In the depicted embodiment, two adjacent ratchet recesses are delimited by differently inclined surfaces (a steep surface and a less steep surface). This ratchet interface is arranged to define a unidirectional interface, wherein relative rotation between the two parts is only possible in one rotational direction. Thus, the interface can be used to block rotation in the other direction, which can increase the safety of a device employing the system. In the present configuration, rotation of the first member 1780 relative to the second member 1790 in a counter clockwise direction is allowed. Conveniently, the allowed rotation is the rotation that occurs during a dose delivery operation. Thus, the engager interface must be released before the system is switched to the second state, and a part of the dose delivery operation must have been performed.

[0188] Further, the system comprises a switch feature 1810, e.g. a pin-like member. The switch feature 1810 is movable, e.g. radially, relative to the ratchet recess 1800 in response to a rotation of the first member 1780 relative to the second member 1790. The switch feature is conveniently shuttled between two different positions. In a first position, e.g. a radially outward position, the feature is in engagement with the ratchet recess 1800, and in a second position, e.g. an inward position, the feature is in engagement with an end face of a ratchet tooth. If the first member 1780 is rotated relative to the second member 1790, the switch feature 1810 is displaced inwardly, e.g. radially inwardly, from the first position to the second position due to the inclined surface delimiting the ratchet recess in an angular direction opposite to the direction of rotation. The switch feature 1810 can be guided such that, in response to a rotation of the first member 1780, it only moves linearly, e.g. in a radial direction or predominantly in a radial direction. For this purpose, a guide slot 1820, e.g. a linear slot, is provided in the second member 1790. A free end of the switch feature can have a complementary shape to the ratchet recess. The switch feature 1810 can be tightly received in the respective ratchet recess 1800. The switch feature 1810 can be rotationally locked to the second member 1790. The switch feature can be radially oriented or arranged such that it defines an angle to the radial direction. The switch feature can be electrically insulating, e.g. be plastic.

[0189] The system further comprises a first electrical contact feature 1830, e.g. an elastically displaceable feature. The feature 1830 can be a metallic feature and / or a contact strip. The system further comprises a second electrical contact feature 1840, e.g. an elastically displaceable feature. The feature 1840 can be a metallic feature and / or a contact strip. The respective contact features can be fixed to the second member 1790. The respective features can have a free end and / or a portion displaceable relative to a portion of the respective feature fixed to the second member 1790. The first contact feature 1813 is arranged to move towards the second feature 1840 when the switch feature 1810 is displaced inwardly.

[0190] In the situation depicted in representation A, the first electrical contact feature 1810 can push the switch feature 1810 outwardly to maintain the switch feature in engagement with the ratchet recess 1800 it is currently engaged with. Thus, in representation A, the switch feature 1810 and the first electrical contact feature are abutting. However, the contact features 1840 and 1830 are separated and not electrically connected.

[0191] When starting a dose dispensing operation involving a relative rotation of the first member with respect to the second member from the situation in representation A, the switch feature 1810 will be displaced inwardly. The switch feature 8010 carries with it the first electrical contact feature 1830 and moves it towards a portion of the second electrical contact feature 1840 until these contact features are in mechanical and electrical contact with each other (as depicted in representation B). By this contact, a use signal can be generated which can be used to trigger a switching of the electronic system to a second state of higher power consumption as already discussed above. For example, both contact features can be electrically connected to the power source 1500 and a current as a use signal only flows in case these contact features are electrically connected. The use signal is preferably generated when the first member has been rotated with respect to the second member by less than one unit increment, as depicted in representation B. Preferably, before the use signal is generated, the piston rod of the dose setting and drive mechanism has been displaced (e.g. driven by a user force transferred to the piston rod from the user via the second member 1790) to start dispensing a first unit increment of medicament from the container of the device. The abutting portions of the first contact feature 1830 and the second contact feature 1840 are displaced together by the switch feature 1810 as depicted in representation C. This ensures that the use signal is generated under all tolerance conditions. When the rotation is continued, the switch feature 1810 is again allowed to move outwardly into engagement with the next ratchet recess 1800. This movement is driven by the spring force provided by the first contact feature 1830. Thus, after having completed the rotation of one unit increment (signal generation increment), the switch feature 1810 is again resting in a ratchet recess. Also, the second contact feature 1840 is returned to its initial position so that after having completed the rotation of one unit increment, the system is in the situation depicted in representation D which corresponds to the situation in representation A except for the relative rotation of one unit increment. When the dose delivery continues, these features are again brought into contact during the next increment where again a signal is generated.

[0192] Thus, the use signal can be generated in an incrementally changing manner depending on the relative rotation between the two members 1780 and 1790. Also, it is ensured that the use signal has been generated before a full unit increment of rotation is completed. Thus, if the motion sensing unit 1200 has been switched to a sensing state in which the components of the motion sensing unit, such as the LED(s) and sensor(s), are powered and detect the relative rotation between the first member and the second member during further course of the dose delivery operation, an offset of one unit increment can be taken into account, for example, by adding an angle corresponding to one unit increment of the use signal generation interface to the result of the calculation of the rotation angle from the signals of the motion sensing unit. Advantageously, the dose setting interface and the use signal generation interface are incrementally changed in the same way as already discussed above. However, different increments are also possible in case the use signal generation interface is preferably more finely spaced than the dose setting interface, i.e. has a smaller increment in the angular direction. However, it is also possible to make the increment spacing of the use signal generation interface coarser than the increment spacing of the dose setting interface.

[0193] In the portions of the first and second electrical contact features that are designed to abut to trigger the use signal generation, a protrusion or a bump can be arranged that points from one portion to the other portion. In the depicted embodiment, such a protrusion 1850 is provided on the second electrical contact feature 1840. This can also help to guarantee the use signal even under extreme tolerance conditions. However, such a protrusion need not be present. Alternatively, both contact features can be provided with such a protrusion 1850. Further, it is also conceivable to use a separate biasing member to drive the respective movement of the switch feature and / or any movement of the respective contact feature, wherein the biasing member is biased when these contact features abut and / or move together.

[0194] Having radially oriented ratchet features (recesses and teeth) and radially / laterally oriented switch features facilitates axial relative movement between the first member and the second member, which can be necessary for releasing / establishing the adapter interface and / or for switching between the dose setting operation and the dose delivery operation. However, there can also be systems that do not involve such switching of the adapter interface. To allow for the relative axial movement, the ratchet recesses can have an axial extension sufficient to allow for such movement. That is, the switch features can be axially guided within the ratchet recesses over a distance that corresponds to the distance needed to switch the state of the adapter interface, e.g. from the connected or established state to the uncoupled state or release state or vice versa.

[0195] Advantageously, the force needed to operate the switch established by the first and second electrical contact features is as small as possible in order to avoid that the user has to exert too much force during the dose delivery operation.

[0196] In the depicted situation, a use signal is generated throughout the dose delivery operation, whenever the switch feature 1810 is displaced inwardly as it changes position from one ratchet recess into the next ratchet recess.

[0197] In one embodiment, the first member 1780 or use signal generating interface member 1880 can be axially coupled (e.g., locked) relative to the second member 1790 (e.g., dose button and / or drive sleeve). This configuration avoids relative axial movement of the member with the ratchet feature (1800, 1805) relative to the member whose rotation should be monitored and / or the switch feature 1810. In this case, the ratchet can be axially displaced relative to the member whose rotation should be monitored. The relative axial position of the switch feature 1810 and the ratchet can be constant. Alternatively, the switch feature is axially displaced relative to the ratchet when the dose delivery operation is being initiated or started.

[0198] In addition to generating one or more use signals, the disclosed configurations can be used in order to generate audible and / or tactile feedback during a dispensing operation and / or to prevent relative rotation between the first member and the second member in an undesired direction.

[0199] In the present configuration, the generation of a use signal can be triggered without direct contact from the user, i.e. without a switch that has to be mechanically contacted by the user. Moreover, the event that causes the generation of a use signal is integrated into the regular operation program of the drug delivery device, in particular into the dose delivery operation (after the user interface member / button has been moved into the position required for this operation and when the user interface member has reached this position), the relative movement between the first member and the second member has already started. For switching the electronic system into the second state, a separate user action is not necessary. Moreover, the use signal increment can match the dose unit increment, which is advantageous because the switching of the state of the electronic system can be precisely tuned to the dose unit increment.

[0200] In an alternative design, the switch feature can be pivotally mounted to the first member such that a rotation of the first member causes a pivotal movement in a plane perpendicular to the axis of rotation.

[0201] Figure 22 Another embodiment of an electronic system is illustrated based on two representations A and B. As will readily be appreciated, this embodiment is very similar to the embodiment discussed in connection with Figure 21 However, in this embodiment, the situation is slightly different with respect to the engagement of the switch feature 1810 with the ratchet, which is defined by ratchet recesses 1800 separated by ratchet teeth 1805. As already further discussed above, in connection with Figure 21In the embodiment described, the switch feature 1810 can engage with the ratchet recess and / or ratchet teeth in a first axial relative position of the first member 1780 and the second member 1790, and in a second axial position of these movable members. The first and second axial positions can be two extreme positions that the first and second members can have relative to each other. For example, starting from an initial position, the second member 1790 can move axially (e.g., distally) relative to the first member 1780 until it has reached a termination position. Therefore, in Figure 21 In the terminated position, switch feature 1810 also engages with ratchet teeth and / or ratchet recesses. Because there is relative rotational movement between the first member 1780 and the second member 1790 during dose delivery operation, a force or torque (e.g., by the user when the device is driven by the user) is required to continuously increment the ratchet. However, after the initial use signal is generated, further use signals may no longer be necessary because the electronic system has switched to a higher power consumption state, allowing dose recording via the dose recording or motion sensing unit to be performed.

[0202] Therefore, reducing the force can be advantageous. Therefore, in Figure 22 In the illustrated embodiment, in a first relative axial position of the first member 1780 and the second member 1790, the switch feature 1810 engages the ratchet, and relative rotation between the first and second members causes the switch feature to be displaced to generate a use signal. However, when the first member 1780 and the second member 1790 have reached a second relative axial position, the switch feature 1810 has disengaged from the ratchet. The use signal is still generated by the relative rotation of the first and second members. The first relative axial position can be a normal position of the two members, for example, maintained by a biasing member such as an engagement spring. When in the second relative position, removing, for example, the reaction force generated by the user, can re-establish the first relative position via the spring.

[0203] Indicate A shows an intermediate state during the relative movement between the first and second axial positions of components 1780 and 1790 when the generation of the use signal has been triggered (indicated by adjacent contact features 1830 and 1840). Specifically, Figure 22 The state in A corresponds to Figure 21 The state in C is represented. However, at the end of the relative axial movement, the switch feature 1810 has disengaged from the ratchet. For example, the switch feature can be axially offset from the ratchet (e.g., offset distally). This situation occurs in... Figure 22The diagram is shown in representation B. Here, a second relative axial position between the first member 1780 and the second member 1790 is shown. As immediately apparent, the switch feature 1810 now engages (particularly radially) surface 1860. This surface may be smooth, particularly compared to the area where the ratchet recess 1800 and ratchet teeth 1805 are disposed. Surface 1860 may be cylindrical. A ramp 1870 is arranged between surface 1860 and the corresponding ratchet recess 1800 or ratchet teeth 1805. The ramp may be defined in the end portion of the corresponding ratchet recess 1800, which engages the switch feature 1810 during relative movement of the first and second members from the first axial position to the second axial position. When viewed along the direction of movement of the switch feature 1810 relative to the ratchet recess 1800, the ramp may be inclined in the axial direction (e.g., inward) to disengage the switch feature 1810 from the recess. When engaged by switch feature 1810, the ramp can guide switch feature 1810 in a radially inward direction until ratchet recess 1800 disengages. Switch feature 1810 can then engage surface 1860. Surface 1860 can respond to residual forces provided by the elastically deformable first contact feature 1830 and / or second contact feature 1840. Therefore, in a second relative axial position between the first and second components, the contacts can continuously close, and a usage signal can be generated.

[0204] Contact features 1830 and 1840 do not necessarily engage with each other in the second relative axial position of the first and second components. This can be achieved by widening the interior of the system (e.g., the first component 1780) in the region where the switch feature 1810 is located in the second relative axial position of the first and second components. This is not explicitly shown. In this case, an outwardly inclined ramp, viewed along the direction of movement, can be axially positioned between the ratchet recess 1800 and the switch feature 1810. This ramp can be used to re-engage the switch feature with the ratchet recess 1800 when the first relative position between the first and second components is re-established after the delivery operation has been completed. Here, the radial width of the portion of the first component in which the switch feature is axially arranged in the second relative axial position of the first and second components is preferably greater than the radial width defined between the free ends of the ratchet teeth.

[0205] In this embodiment, the axial extension of the ratchet recess and / or teeth can be greater than the distance required to release the connector interface to rotatably disengage the first and second components from each other. The axial extension of the ratchet recess is conveniently chosen to allow the use signal to be triggered even under extreme tolerance conditions. The user interface component / button can be moved distally from an initial position to a dose delivery position. This distance can be greater than the distance required to release the connector interface.

[0206] In this embodiment, the contact features are in contact in a second relative axial position (as in representation B of Figure 22 The user interface member can be used to generate the use signal without relative rotation, as the contact is closed in the second position. Thus, the option of the contact not being closed in the second relative axial position can be advantageous in terms of power consumption.

[0207] Figure 23 A yet another embodiment of an electronic system is presented based on three different representations A to C. The overall setup of the system is very similar to the system disclosed above in connection with Figure 21 and Figure 22 The further disclosed system is very similar to the system disclosed above in connection with the representations A to C. Thus, the following discussion will focus on the differences.

[0208] As in the previous embodiments, a first member 1780 (e.g. a number sleeve, a dial sleeve and / or components rotationally and / or axially attached thereto) and a second member 1790 (e.g. a drive sleeve or a dose and / or injection button) are provided. Also depicted is a housing 10. During a dose setting operation, the first member and the second member can be rotationally locked to each other, but during a dose delivery operation, there is a relative rotation. For example, during dose delivery, the first member 1780 can rotate relative to the second member 1790 and relative to the housing 10. The second member 1790 can be rotationally locked to the housing during dose delivery. As in the already discussed embodiments, the angle of rotation of the first member relative to the second member can be indicative of the size of the dose that has been dispensed.

[0209] In this embodiment, again, a relative rotation between the first member 1780 and the second member 1790 is used to trigger the use signal generation. For this purpose, as in the further described embodiments above, a switch feature 1810 is provided. The switch feature 1810 is generally configured in the same way as previously discussed. However, its orientation is different, as it is axially oriented (as visible in representation A), which presents an inclined view on the described elements of the system, which of course can have further elements. The switch feature 1810 moves axially in order to generate the use signal by triggering a sensor or a switch, which is not explicitly shown in contrast to the previously discussed embodiments. The sensor or the switch can be realized via an electrical contact feature or via a force sensor or a pressure sensor, which is mechanically contacted by the switch feature in order to trigger the generation of the use signal. The use signal can be fed to the electronic control unit and can be used to trigger by the control unit the switching of the system to the second state.

[0210] The switch feature 1810 is again operatively coupled or engaged with the ratchet recess 1800 and / or the ratchet teeth 1805. The ratchet teeth and the ratchet recess together define a ratchet. In contrast to the previous embodiments, the ratchet recess 1800 and / or the ratchet teeth are axially oriented. For example, the free end of the ratchet teeth 1805 can be oriented in an axial direction, such as in a proximal direction. The ratchet teeth can have a helical configuration. That is, when viewed in an overhead view along the axis of rotation, for example in a distal direction, the inclined side of the teeth can extend helically. When there is relative rotation between the ratchet teeth 1805 and the switch feature 1810, the switch feature can be displaced axially, for example away from the teeth and / or outward relative to the ratchet recess, relative to the ratchet recess and / or the ratchet teeth. This axial movement can be used to trigger a use signal.

[0211] In the present embodiment, in contrast to the previous embodiments, a (separate) signal generation interface member 1880 is explicitly shown. Such a member can also be provided in the previous embodiments or can be omitted. The signal generation interface member 1880 or at least a portion thereof can be arranged radially or axially between the first member 1780 and the second member 1790. A ratchet can be provided on the signal generation interface member 1880. The signal generation interface member 1880 can be mechanically coupled to the first member 1780 and / or the second member 1790. For example, the signal generation interface member 1880 can be rotationally locked to the one of the members that rotates relative to the housing and relative to the other member. For example, the signal generation interface member can be rotationally locked to the first member 1780. The signal generation interface member can be axially locked or coupled to the other member, which is preferably not rotating relative to the housing 10, for example during dose delivery. For example, the member 1880 can be axially coupled to the second member 1790. The one of the first and second members to which the signal generation interface member 1880, which can have a ring-like configuration, is axially secured, locked or coupled to can be the member carrying the sensor or switch triggered by the movement of the switch feature 1810. When axially coupled to one of the members, for example the second member 1790, the signal generation interface member 1880 can follow the axial movement of this member, in particular in the distal direction and / or in the proximal direction.

[0212] When the signal generation interface member 1880 is rotationally locked to the other one of the members, for example the first member 1780, it can rotate with this member relative to the housing and / or relative to the other member, for example relative to the second member 1790.

[0213] In the depicted embodiment, the signal generating interface member 1880 is preferably rotationally locked to the first member 1780 and can be axially locked to the second member 1790. Thus, when the interface between the first and second members is released, e.g. by axially (e.g. distally) displacing the second member 1790 relative to the first member 1780, the rotational lock of the member 1880 to the first member 1780 can be maintained and the signal generating interface member moves with the second member relative to the first member in axial direction. The rotational lock can be achieved by splines providing a rotational lock between the interface member 1880 and the first member 1780 (not explicitly shown). The axial lock can be achieved by a circumferential groove in the second member 1790.

[0214] The first member 1780 or the signal generating interface member 1880 can be provided with an encoder surface or detection area 1890 for a motion sensing unit, such as the reflective surface or area 70a already described previously. The area between the detection areas can be a non-reflective area 70b. In the depicted embodiment, the detection areas 1890 are formed by radially outwardly protruding protrusions, wherein other configurations are possible. The areas are circumferentially, preferably uniformly, provided and / or axially aligned (i.e. arranged at the same axial position), wherein the axis is conveniently the longitudinal axis of the system or the rotational axis of the first member 1780 relative to the housing 10. In other words, the areas 1890 can be uniformly distributed. All areas 1890 can have the same configuration (e.g. angular width and / or shape).

[0215] Figures B and C again show different stages during relative movement of the first member 1780 relative to the second member 1790. As will be readily appreciated, when the first member 1780 is rotated, in particular in clockwise direction, the switch feature 1810 will be axially displaced out of the ratchet recess 1800 it is currently in in figure B due to interaction with the inclined side surface of the ratchet tooth 1805 until it disengages from the ratchet recess 1800 (see figure C). With continued rotation, the switch feature 1810 re-engages a subsequent ratchet recess 1800, e.g. due to a biasing member and / or a resiliently deformable contact feature (not explicitly shown) biasing the switch feature into engagement with the ratchet recess 1800, e.g. by a biasing member providing an axially (e.g. distally) directed force onto the switch feature 1810. In the situation in figure C, a use signal is generated, e.g. by the feature 1810 triggering a switch, such as a micro switch. Preferably, the operating force of the switch is small to keep the overall increase of force required for the drive system at a reasonable level. When rotation is continued from figure C, a subsequent ratchet recess is engaged by the switch feature.

[0216] Figure 24Another embodiment of an electronic system is shown. Figure 24 A cross-sectional view is shown, again showing a first member 1780 and a second member 1790, the first member rotating relative to the second member during dose delivery. Essentially, this embodiment corresponds to the previous embodiment, which is why the description in this respect also applies to this embodiment, as will be apparent to the skilled person. Thus, the following description focuses on the differences.

[0217] Again, the first member 1780 can be a use signal generation interface member 1880 having a ratchet with ratchet recesses and ratchet teeth 1800 / 1805 or another member to which the use signal generation interface member 1880 is connected, preferably rotationally locked. Limited relative axial movement between the use signal generation interface member 1880 and the first member, if they are separate components, can be allowed. Alternatively or additionally, the use signal generation interface member 1880 can be axially locked to the second member 1790. Again, the switch feature 1810 is movably held in the second member 1790. The switch feature 1810 is linearly, e.g. transversely and / or radially, guided relative to the axis of rotation, which in this embodiment is perpendicular to the plane represented in the shown cross-sectional view. A guide slot 1820 can receive the switch feature in order to guide the linear movement of the switch feature.

[0218] Figure 24 A situation is shown when the first member 1780 and the second member 1790 are co-rotating, e.g. due to an engagement coupling between the first member 1790 and the second member, such as during dose setting. In this situation, the switch feature 1810 maintains the distance between the contact features 1830 and 1840. Specifically, the contact feature 1830 can elastically displace or deform in the situation depicted in Figure 24 such that the switch feature 1810 is biased towards the ratchet teeth 1805, radially outwards in the depicted situation. A radial end face, e.g. a radially outwards end face, of the switch feature abuts a radial end face of the ratchet teeth 1805. The end face of the teeth can be flat. When relative rotation between the first member 1780 and the second member 1790 is allowed, the bias of the contact feature 1830 causes the switch feature 1810 to move radially and close the electrical connection with the contact feature 1840. As rotation of the member 1780 continues, the switch feature 1810 again displaces the contact feature 1830 away from the contact feature 1840. In this way, a use signal is generated during dose delivery increments that are determined by the pitch of the teeth 1805.

[0219] In comparison to the previously discussed embodiments, this embodiment has the advantage that the switch feature 1810 does not have to displace the contact features 1830 and 1840 into contact with each other, preferably both contact features together have a small displacement in order to accommodate tolerances. Rather, the switch feature 1810 is used to keep the contact features apart during dose setting. Also, only one of the contact features 1830 and 1840 has to be displaced during dose dispensing, e.g. to break the electrical contact again, and the respective force has to be provided, e.g. by the user.

[0220] The teeth 1805 can in this embodiment be configured symmetrically, in particular with respect to a radially oriented axis. Because during dose setting the switch feature does not engage the ratchet recess 1800, there is no option that this feature can be used to provide a resistance during dose setting. Likewise, in the dose dispensing configuration, when the first member and the second member are rotatable relative to each other, the interface between the feature 1810 and the ratchet cannot provide any significant resistance to reduce the resistance of setting a dose, which other embodiments with a one-way coupling can provide.

[0221] The symmetric configuration of the teeth facilitates the re-engagement of the radially facing end surface of the switch feature 1810 with the radially facing end surface of the teeth after the dose dispensing operation has been completed. The side surface of the teeth can define an angle with the radial direction and / or an axis perpendicular to the rotational axis of less than or equal to 30°. Thus, the teeth can be steeper than in the previous embodiments in order to reliably break the connection between the contact features 1830 and 1840. When the first member and the second member are rotationally locked to each other, such as during dose setting, the point of contact between the switch feature 1810 and the respective ratchet tooth 1805 can be between the inclined side surfaces of the respective teeth. The point of contact can be in the flat area of the respective teeth. If the switch feature engages the free end of the teeth after the dose delivery operation has been completed, the force required to re-engage the clutch after dose delivery does not need to take into account the force required to slightly, e.g. radially, displace the switch feature. Such a slight displacement can be necessary when the re-engagement of the clutch requires a small rotational movement of the ratchet, wherein after the dose delivery movement of the piston rod has been completed, the switch feature is arranged between two adjacent teeth.

[0222] It is noted that this concept can of course also be applied to an axially oriented switch feature 1810. In this case, the switch feature can be axially biased into engagement with the ratchet.

[0223] Figure 25A and Figure 25BAnother embodiment of an electronic system is schematically illustrated. The representation in the drawing is very schematic and the main features should be understood as the embodiment as previously described with respect to the first member 1780 and the second member 1790. Since the main functionality is very similar to one of the previously disclosed embodiments, the following description focuses on the differences, but is not limited thereto. The first contact feature 1830 and the second contact feature 1840 are connected to the second member 1790 and / or are configured such that they can be moved into mechanical contact with each other. The contact features are preferably elastically deflectable. Protrusions 1850, e.g. bumps, are provided on the respective contact features, wherein the protrusions 1850 of the contact features 1830 and 1840 face each other such that they can be in mechanical and electrically conductive contact with each other. The protrusions can facilitate defining different mechanical contact points between the contact features, but can also be omitted. The contact features can be metallic, e.g. strips that are bent into a desired shape. When the contact features are electrically conductively connected, a use signal can be generated. The contact features can be electrically conductively connected to the power supply 1500 as previously discussed.

[0224] In the depicted embodiment, a plurality of switch features 1810 is provided. One of the switch features is associated with the first contact feature 1830, while the other switch feature 1810 is associated with the second contact feature 1840. Both switch features cooperate with a ratchet that comprises ratchet teeth 1805 and ratchet recesses 1800. Of course, as in the previously discussed embodiments, the ratchet extends circumferentially, only the portion of the ratchet that is engaged by the switch features 1810 is shown in the drawing. The switch features are "in phase" with respect to the ratchet. That is, both switch features engage either the ratchet recesses or cooperate with the ratchet teeth.

[0225] From the arrangement depicted in Figure 25A When the first member 1780 starts rotating relative to the second member 1790, such as during dose delivery, the first member rotates relative to the switch features and, due to their cooperation with the teeth, the switch features are displaced radially, in particular inwards. This displaces the contact features relative to each other such that they can cooperate mechanically with each other to generate a use signal. Figure 25BThe middle depiction illustrates the situation when the use signal is generated and the contact features (e.g. their protrusions 1850) contact each other. When both features are displaced such that the contact features move towards each other, the absolute displacement of the respective contact feature relative to the ratchet can be smaller than the distance between the first contact feature 1830 and the second contact feature 1840 that has to be covered in order to establish mechanical contact between these features. This is because two switch features are provided that cooperate with the ratchet and that are both moved in phase with each other (e.g. both inwards or both outwards) relative to the ratchet. The displacement can be converted into a movement of the contact features towards each other. The two switch features 1810 can also move towards each other when cooperating with the ratchet teeth. The switch features 1810 can for example be aligned radially. The switch features can be oriented along a common axis, e.g. such that the axis is radially offset from or intersects the rotation axis of the first member 1780. The respective switch feature 1810 is preferably linearly guided. This is not explicitly shown in the drawings. When cooperating with the associated ratchet teeth, the respective switch feature is biased radially outwards such that when the rotation of the first member 1780 continues, the respective switch feature is driven by the biasing force to re-engage the ratchet recess. Conveniently, the biasing is provided by the displaced contact feature(s).

[0226] The protrusion 1850 or the contact zone with the other contact feature can be provided close to the free end of the respective contact feature.

[0227] From the mounting portion to which the respective contact feature is connected with the second member 1790, the respective contact feature can have the following portions:

[0228] - a first contact feature portion that extends away from the mounting portion towards the free end of the respective contact feature;

[0229] - a second contact feature portion that extends along the first contact feature portion (e.g. towards the mounting portion);

[0230] - a bend or curved portion that connects the first contact feature portion and the second contact feature portion.

[0231] The free end can be the end of the second contact feature portion. The protrusion 1850 can be provided in the second contact feature portion.

[0232] Figure 26A and Figure 26B Another embodiment of an electronic system is shown. This embodiment mainly corresponds to the embodiment shown in Fig. 1 1 and described above. Figure 25A and Figure 25BThe implementation discussed. Thus, the following description focuses on the differences. The most important difference is that this implementation does not use separate switch features 1810 in place of the contact features 1830, 1840. Rather, the respective contact features 1830, 1840 comprise a ratchet interaction portion 1832, 1842. The interaction portion directly engages the ratchet teeth and / or recesses.

[0233] Starting from the mounting portion to which the respective contact feature 1830, 1840 is connected with the second member 1790, the respective contact feature can have the following portions:

[0234] - a first contact feature portion (1844, 1834) which extends away from the mounting portion, preferably towards and / or outwards the ratchet;

[0235] - an interaction portion (1842, 1832) for interacting with the ratchet, in which interaction portion the contact feature can be bent or kinked, thereby enhancing the engagement with the ratchet recesses and / or mimicking the shape of the ratchet recesses;

[0236] - a second contact feature portion (1846, 1836) which extends away from the ratchet (e.g. inwards);

[0237] - a third contact feature portion (1848, 1838) which follows the second contact feature portion and / or which extends up to the free end of the contact feature, the third contact feature portion can extend along the first contact feature portion, along the interaction portion and / or the second contact feature portion. The third contact feature portion can comprise a free end and / or a contact area which is designed to be contacted by another contact feature.

[0238] Each of these portions can be preferably elastically deflectable relative to the mounting portion and / or relative to the other portions. The third contact feature portions of the contact features 1840 and 1830 can face each other, especially in the area which is designed to make mechanical contact (e.g. the area with the protrusions 1850).

[0239] When the first member is rotated relative to the second member, the contact features are deflected such that they contact each other. For example, the contact areas in the third area (e.g. the protrusions 1850) can contact each other. Figure 26B This situation is depicted in Fig. 18. As the rotation continues, the contact features return to their original position, e.g. due to their elasticity. Figure 26A The arrangement in Fig. 19.

[0240] Figures 25A-26BThe embodiment depicted in Fig. 18 uses two different engagements with the ratchet in order to achieve a displacement in a synchronized manner, that is, if one of the switch features or contact features is displaced towards the other, the other contact feature or associated switch feature is likewise displaced. This means that the depth of the ratchet recesses can be reduced, since two different ratchet recesses or ratchet teeth contribute to the relative movement. Within the constraints of using a uniform outer diameter of the signal generating interface member, the reduced depth of the ratchet recesses can allow for a smaller ramp angle of the ramped surface of the teeth, especially at the surface delimiting the teeth in the direction in which the first member should be rotated. This can be advantageous for further reducing the dispensing force or torque required to be exerted by the user. Moreover, if two engagements with the ratchet are used and the relative movement of the switch features or contact features towards each other is used for generating the use signal, the tolerance requirements can be lower and / or the overall stability and integrity of the system can be improved.

[0241] Furthermore, having two different positions of engagement with the ratchet can also improve the resistance provided by the ratchet against a rotation in the opposite direction during dose delivery. This can improve the safety of the device. In terms of the click function of the ratchet, where the element engaging the ratchet, such as the contact feature or switch feature, is considered, having two engagements potentially increases the risk that if the re-engagement with the ratchet recess does not happen exactly simultaneously, a separate click noise or haptic feedback is generated, although only one feedback should be apparent. If one of the switch features or contact features is designed to generate a smaller or less apparent feedback, for example by rounding the edges of the part engaging the ratchet recess, this risk can be reduced. Then, the feedback will be dominated by the re-engagement of the other switch feature with the ratchet recess. In summary, the feedback generated at the two positions can be designed to be different, for example, one feedback is more apparent than the other, which is preferably almost or not apparent.

[0242] Figure 27 Another embodiment of an electronic system is shown. Again, the basic functionality corresponds to the embodiments already discussed previously, where the following description focuses on the differences. Generally, this embodiment is very similar to the embodiments depicted in Figure 25A and Figure 25B However, in this embodiment, the two contact positions between the ratchet and the switch features 1810 are out of phase. That is, before the relative movement between the first member 1780 and the second member 1790 starts, one of the switch features 1810 interacts with the ratchet teeth in said position, while the other one of the switch features 1810 interacts with or is arranged in the ratchet recess in said position. Of course, if the contact features themselves engage the ratchet as in Figure 26A and Figure 26B In this arrangement, the switch features 1810 can also be dispensed with, if the contact features themselves engage the ratchet.

[0243] Each switch feature 1810 is respectively associated with one contact feature 1830. Thus, if the switch feature 1810 is displaced, the contact feature can follow this displacement in one direction (e.g. radially and / or inwardly) and / or can elastically bias the switch feature 1810 in the other direction (e.g. radially, such as radially outwardly) and / or due to its inherent elasticity or due to a biasing member (such as a spring) transmitting a biasing force to the switch feature 1810 via the contact feature 1830. In Figure 27 In the situation depicted in Fig. 18, the upper switch feature 1810 cooperating with the ratchet tooth 1805 can be biased towards the ratchet tooth, e.g. by the contact feature 1830 or a biasing member (e.g. a spring).

[0244] In addition to the contact features 1830 which are displaced relative to the second member 1790 when the first member 1780 is rotated relative to the second member, in this embodiment at least one further contact feature 1840 is provided. The further contact feature 1840 can be stationary or immovable, in particular relative to the second member 1790. In the depicted embodiment, two further contact features 1840 are provided. Depending on the state of the switch feature 1810 or the engagement state of the ratchet, one of the contact features 1830 (preferably only one of these contact features) mechanically contacts the further contact feature 1840. Preferably, one further contact feature 1840 is associated with each contact feature 1830. In the depicted situation, the lower contact feature 1830 mechanically contacts the associated lower further contact feature 1840.

[0245] In the depicted embodiment, the contact features 1830 associated with the switch features 1810 and / or the switch features are mechanically coupled to each other via coupling members 1855. The coupling members 1855 can be arranged between the contact features 1830. In this way, movement of a contact feature 1830 or one of the switch features 1810 and / or a force acting thereon can be transmitted to the other contact feature 1830 or switch feature 1810. The coupling features 1855 can be rigid or elastic members, such as the biasing members mentioned above. The elastic members can be springs, such as compression springs and / or micro springs. The coupling members 1855 can be configured to exert a laterally or radially directed biasing force relative to an axis of rotation, which in this embodiment is directed perpendicular to the plane of the illustration as in the previous embodiments. The system can be designed such that in each stable relative rotational position between the first member and the second member, one contact feature 1830, preferably only one, is electrically conductively connected to the associated further contact feature 1840. As depicted, this pair of contact features 1830 can shuttle between two different further contact features 1840. The respective switch features 1810 are preferably guided, e.g. linearly, such as by respective guide slots 1820, wherein the respective guide slots can be rotationally and / or axially locked to the second member 1790.

[0246] When, from the situation depicted in Figure 27 , the first member 1780 is rotated, e.g. in a counterclockwise direction, the lower switch feature 1810 is displaced radially, in particular inwardly. This disengages the lower contact feature 1830 from the associated further contact feature 1840 and transmits a load via the coupling member 1855 towards the upper contact feature 1830, conveniently after biasing this coupling member. Since the upper switch feature 1810 can then engage a subsequent ratchet recess 1800 which adjoins the ratchet teeth 1805 counter to the direction of rotation, the upper contact feature 1830 can move into contact with the associated further contact feature 1840, e.g. via the relaxed coupling member 1855.

[0247] In the depicted embodiment, in each stable rotational position, there is a closed contact connection between a pair of one contact feature 1830 and one further contact feature 1840. Conveniently, the electronic system is configured such that a use signal is generated when the contact features 1830 and further contact features 1840 are in mechanical contact with each other. Thereafter, the electrical connection between the power supply and this pair can be interrupted in order to avoid excessive power consumption. The power supply can be electrically conductively connected to the pair of contact features 1830 and further contact features 1840 which are not currently electrically conductively connected. This can be achieved by appropriate switching circuits in the electronic control unit, for example.

[0248] This embodiment can be designed such that only after a rotation corresponding to a multiple of a unit setting increment (e.g. two unit setting increments) each end of the shuttle formed by the switch feature and the contact feature 1830 together with the coupling member 1855 changes its position relative to the ratchet (i.e. the teeth and / or recesses). However, one of the two ends changes its position relative to the ratchet every unit setting increment, so that the two ends can be incrementally moved in an alternating fashion. In this case, the resilient coupling member 1855 is preferred, because in this way the overall length change in the shuttle during each unit setting increment or even in a finer spacing than a unit increment is larger than the overall length change when both ends of the shuttle change their position relative to the ratchet (e.g. from engaging a tooth to engaging a recess or vice versa).

[0249] Figure 28 Another embodiment of an electronic system is shown. This embodiment is very schematically represented by its key components, which are a switch feature 1810 interacting at its two extremities 1815 with a ratchet (not explicitly shown). The switch feature 1810 is conveniently elastically deformable, so that a rotational movement of a first member 1780 relative to a second member 1790 is converted into an axial movement of a portion 1812 (e.g. a central portion) of the switch feature. The axially displaced portion 1812 of the switch feature can be axially guided, e.g. in a guiding slot (not explicitly shown). The switch feature 1810 converts the rotational movement into an axial deformation of the switch feature, which is sometimes also designated as a fork or toggle mechanism component. The rotational movement of the first member 1780 (not explicitly shown) moves the extremities 1815 closer to each other from their respective positions of engaging a ratchet recess (along the respective ratchet teeth). This results in an axial displacement of the portion 1812 of the switch feature 1810.

[0250] This axial displacement can be used to trigger a use signal. Figure 28 Two configurations of the switch feature 1810 are shown. One configuration which the switch feature has before the first member starts to rotate is designated 1810a, while in the second configuration 1810b the portion 1812 has been axially displaced relative to the ratchet and / or the extremities 1815. In the configuration 1810b, the portion 1812 can contact a switch 1857 (such as a micro switch) which when triggered can cause the generation of a use signal with a motion sensing unit or a corresponding wake-up procedure of the electronic system. The switch 1857 can be mounted on a conductor carrier (e.g. a circuit board) which can be arranged within a user interface member (e.g. an injection or dose knob) which can be rigidly connected to or integral with the second member 1790.

[0251] Figure 29Another embodiment of an electronic system is schematically illustrated. Essentially, the electronic system corresponds to the electronic system described in connection with the previous embodiments shown in Figure 28 Contrary to having a switch 1857 that is contacted or triggered by the portion 1812, here, the portion 1812 bridges an area between two electrically separated contacts, e.g. contact pads. The portion 1812 is conveniently electrically conductive on its side facing the contacts 1859, such that by means of the portion 1812 being axially displaceable relative to the ratchet teeth (not explicitly shown), an electrically conductive connection between the contacts 1859 can be established. This electrically conductive connection can trigger the generation of a use signal, e.g. via a current flow from one contact to the other contact through an electrically conductive portion 1812 or an electrically conductive layer provided on the portion 1812 (then the portion can be electrically insulating). Contrary to using a switch 1857, this embodiment can facilitate meeting tighter tolerances.

[0252] Figure 30 Another embodiment of an electronic system is illustrated. As in the previously described embodiments, a use signal generation interface member 1880 is provided. This member 1880 comprises a ratchet recess 1800 and ratchet teeth 1805 defining an incremental change interface that cooperates with a switch feature 1810 to generate a use signal, as has been discussed previously. Adjacent teeth can be separated by an angle corresponding to one unit setting increment. Thus, the unit setting increment can be equal to a use signal generation increment, as is further discussed above. Thus, for some angles, the following uses the unit setting increment as a reference. However, it is noted that also a use signal generation increment (in case it is different from the unit setting increment) can be used.

[0253] The use signal generation interface member 1880 is conveniently rotationally fastened to the first member 1780 and axially fastened relative to the second member 1790, as has been further discussed above. The interface rotationally fastening the member 1880 to the first member 1780 is implemented by a spline feature 1900, e.g. axially oriented ribs. The spline feature 1900 can be provided on the first member 1780. A corresponding feature on the use signal generation interface member 1880 can be arranged to engage the spline feature 1900. Of course, the positions of the spline feature and the corresponding feature engaging the spline feature can also be reversed, such that the spline feature is provided on the member 1880 and the corresponding feature is provided on the first member 1780. The use signal generation interface member can engage the first member 1780 in a proximal region thereof. The proximal region of the first member 1780 can be received within the use signal generation interface member 1880.

[0254] The use signal generation interface member 1880 is axially movable relative to the first member 1780 between a first position and a second position, wherein the first position is distal of the second position.Figure 30 The member 1880 can be rotationally locked in both or only one of these positions relative to the first member 1780. The second position can be offset distally relative to the first position, wherein Figure 30 The distal direction in the second position is a downward direction. In the second position, an axially oriented engagement feature 1910 of the use signal generation interface member can engage a corresponding feature 1920 (e.g. a slot) in the first member 1780. The engagement can establish a rotational lock between the first member and the use signal generation interface member or can stabilize the relative angular position between the first member 1780 and the use signal generation interface member 1880. This can increase the accuracy of motion sensing and / or determination of the delivered dose, because the rotational orientation between the first member, which rotates in a dose delivery operation and whose rotation is to be monitored or measured via a motion sensing unit, and the use signal generation interface member 1880, which can carry a detection area 1890 for monitoring the rotational or angular position of the first member in a dose delivery operation, is stabilized. The interface formed during movement of the use signal generation interface member 1880 from the first position to the second position can be self-centering, which can be achieved by a beveled surface of one of the engagement features 1910 and 1920. In the depicted embodiment, the feature 1910, which can be a crenellation, has a beveled surface.

[0255] The angular distribution of the engagement features 1910 and / or 1920 can have a pitch determined by an angle corresponding to one use signal generation increment and / or one unit setting increment, wherein, as already discussed, the angle corresponding to one use signal generation increment and one unit setting increment can be identical. The distance of the axial movement of the use signal generation interface member relative to the first member 1780 can be determined by the engager release distance (e.g. d c ) already further discussed above.

[0256] In the depicted embodiment, the use signal generation interface member 1880 provides a use signal generation interface for determining the amount of relative rotation during dose delivery by a ratchet tooth and a ratchet recess and also a detection area 1890. This is advantageous from a manufacturing point of view, because the structure for generating the use signal and the structure for monitoring the movement can be integrated into one component, which can be more easily integrated into the device than separate components. The detection area 1890 can be provided on an outer surface and the use signal generation interface can be provided on an inner surface of the member 1880.

[0257] Of course, this embodiment can be combined with any of the remaining embodiments set forth in the present disclosure.

[0258] Figures 31A-31EAnother embodiment of an electronic system is shown. Two figures show schematic cross-sectional views during different phases of operation of the electronic system. This embodiment is similar to the previously described embodiments, which is why the present description focuses on the differences. Also, features disclosed herein can be applied to other embodiments.

[0259] Figure 31A A first member 1780 and a second member 1790 are shown. As in the previous embodiments, the first member is rotatable relative to the second member during dose delivery. Both members are co-rotated for dose setting operation. During dose delivery operation, the second member can be rotationally locked relative to the housing. In contrast to the previously described embodiments, the second member 1790 is shown in more detail in these figures. The second member 1790 and the user interface member 1600 (e.g. dose or injection knob) can be integrated into a common part or rigidly fastened to each other. However, the second member and the user interface member 1600 can also be separate parts which can be movably or immovably connected to each other. Again, the user interface member for interaction with the user for dose setting can be different from the user interface member during dose delivery. In the present embodiment, the user interface member 1600 provides a surface which is contacted by the user for dose setting operation, i.e. a setting surface 1610. The setting surface can be a lateral surface of the user interface member 1600 and / or face in radial direction. Alternatively or additionally, the user interface member provides a delivery surface 1620. The delivery surface can be a surface which faces in axial direction, e.g. proximally. After a dose has been set, the delivery surface 1620 can be contacted by the user for initiating dose delivery operation. The second member 1790 can have an interaction portion 1792 (e.g. a hollow or sleeve-like portion) which is arranged to receive and / or interact with (e.g. engage, in particular threadedly engage) a piston rod which is arranged to be driven by the second member during dose delivery operation. The setting surface 1610 can be radially outwardly offset relative to the interaction portion 1792.

[0260] A signal generation interface member 1880 is operatively connected to the first member 1780 (e.g. rotationally locked to the first member) and can be axially movable or fixed relative to the first member, as previously discussed for example in connection with the embodiment of Figures 1 1 and 12. Figure 30 The signal generation interface member has been discussed. The signal generation interface member conveniently comprises a ratchet, e.g. ratchet teeth and ratchet recesses 1800, 1805, respectively, as previously discussed.

[0261] The electronic system further comprises a switch feature 1810. The switch feature 1810 has an interaction portion 1811 that engages the ratchet as previously described. Due to the ratchet being oriented radially, as in previous embodiments, the cooperation with the ratchet results in a radial force being transmitted to the switch feature 1810. In this embodiment, however, the switch feature is mounted in the electronic system in such a way that it can pivot. In particular, the switch feature 1810 is mounted to the first member 1790 and / or the user interface member 1600, especially inside thereof, with a pivot portion 1814. The pivot portion 1814 is expediently offset axially, e.g. proximally, from the interface between the use signal generation interface member 1880 and the switch feature 1810. In this way, the radial force can be converted into a pivoting movement of the switch feature, in particular involving an axial component in the proximal direction, for example when the switch feature 1810 is displaced inwardly relative to the interface member 1880. Thus, during rotation of the first member 1780 and / or the member 1880 relative to the second member 1790 and / or the housing 10 (not explicitly shown in this embodiment), the switch feature 1810 pivots relative to the first member 1780 and / or the second member 1790.

[0262] The switch feature 1810 further comprises a use signal triggering portion 1816. The use signal triggering portion 1816 can be radially spaced apart from the pivot portion 1814. The pivot portion 1814 can be connected to the triggering portion 1816 via a connecting portion 1818. The connecting portion can be axially offset, e.g. distally, from the triggering portion 1816 and the pivot portion. The pivot portion and the triggering portion can be oriented axially and radially separately. The connecting portion can extend transversely, in particular relative to the axis of rotation. The pivot portion 1814, the connecting portion 1818 and the triggering portion 1816 can be part of a switch feature portion having a U-shaped cross section. The interaction portion 1811 can extend along a main direction defined by the connecting portion 1818. The pivot portion 1814 and the triggering portion 1816 can be separated by free space. In the depicted embodiment, the triggering portion 1816 is designed to displace a contact feature 1830 in order to trigger or generate a use signal. In the case of a use signal being generated, the contact feature 1830 can contact another contact feature on a conductor carrier 1550, such as a circuit board, e.g. a printed circuit board. Of course, instead of contacting another electrically conductive feature via an electrically conductive connection to establish a use signal, a switch can also be provided that can be mechanically contacted by the triggering portion 1816. Figure 31A In the case of a use signal being generated, the contact feature 1830 can contact another contact feature on a conductor carrier 1550, such as a circuit board, e.g. a printed circuit board. Of course, instead of contacting another electrically conductive feature via an electrically conductive connection to establish a use signal, a switch can also be provided that can be mechanically contacted by the triggering portion 1816.

[0263] The conductor carrier 1550 can be held in the interior of the user interface member 1600 and can conductively connect to and / or mechanically support or carry one or more electrical or electronic components of the electronic system, such as a member of the electronic control unit 1100 (e.g., a microprocessor or microcontroller) or the motion sensing unit. After a use signal has been generated, for example due to the elasticity of the contact feature 1830 (as has been discussed previously) or another elastic feature implemented in the electronic system, the switch feature 1810 can be displaced back to its initial position. Figure 31B This situation is shown in Fig. 18. The control unit 1100 can be mounted on the side of the conductor carrier distal to the switch feature 1810.

[0264] The space defined by the switch feature between the trigger portion 1816 and the pivot portion 1814 can be designed to receive an electrical component 1555 of the electronic system, such as a capacitor. The electrical component 1555 can be mounted on the conductor carrier 1550 on the side facing away from the electronic control unit 1100. Thus, the U-shaped cross-section of the switch feature 1810 allows for a space-saving arrangement within the user interface member. The interior space of the user interface member can have an inner diameter that is larger than the inner diameter of the first member and / or the second member.

[0265] Compared to the switch features that have been described previously, the increase in the distribution force can be particularly small for this configuration in which the switch feature pivots in the axial direction.

[0266] Figures 31C-31E Three embodiments of a switch feature are shown that can be implemented in connection with the embodiments discussed above in place of the switch feature 1810 employed therein. Figure 31A and Figure 31B Three embodiments of a switch feature are shown that can be implemented in connection with the embodiments discussed above in place of the switch feature 1810 employed therein.

[0267] Figure 31CA switch feature 1810 is shown, wherein the U-shaped portion is provided with an electrical contact feature 1830 for electrically connecting two contacts 1859, e.g. on a conductor carrier (not explicitly shown). The depicted situation shows a situation before a use signal is generated. That is, one connection to a lower right contact 1859 is open, while the other contact 1859 can be electrically connected to the contact feature 1830. The contact feature 1830 can be formed as a leaf spring and connected to the trigger portion 1816 of the switch feature 1810. The contact feature 1830 can be resilient such that once an electrically conductive connection between the contacts 1859 is established by the contact feature, the resilience removes this electrically conductive connection when the switch feature engages the ratchet recess again. The contact feature 1830 can protrude radially from the switch feature with respect to an axis defined by the connection portion 1818. The contact feature can have a U-shaped cross-section, especially when seen in a plane perpendicular to the axis defined by the connection portion 1818. The contact feature 1830 can be connected to the tip of the trigger portion 1816.

[0268] Figure 31D Another embodiment of a switch feature 1810 is shown, wherein the contact feature 1830 is oriented along an axis defined by the connection portion 1818 and has two different regions, each provided for contacting one of the contacts 1859. A use signal is generated when both contacts 1859 are electrically connected to the contact feature 1830. The contact feature 1830 is connected to a fastening portion 1817 provided at an end of the connection portion distal to the pivot portion 1814. For example, the switch feature 1810 can be molded around the contact feature 1830 or the contact feature can be fastened to the switch feature in a different way, e.g. by a snap fit.

[0269] Figure 31E Another embodiment of a switch feature 1810 is shown. This embodiment is very similar to the embodiment in Figure 31D . However, the connection portion 1818 of the switch feature 1810 is omitted and replaced by a portion of the contact feature 1830. However, the overall geometry of the structure comprising the switch feature and the associated contact feature is very similar to the one depicted in Figure 31D .

[0270] The terms "drug" or "medicament" are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient ("API") is a chemical structure with a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. The drug or medicament can be used for a limited period, or on a regular basis for chronic diseases.

[0271] As described below, the drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of APIs can include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0272] The drug or medicament can be contained in a primary package or "drug container" suitable for use with a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., short- or long-term storage) of one or more drugs. For example, in some cases, the chamber can be designed to store a drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chamber can be designed to store a drug for about 1 month to about 2 years. Storage can occur at room temperature (e.g., about 20°C) or refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, the drug container can be or can include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., by means of a conduit between the two chambers) and allow a user to mix the two components prior to dispensing, if desired. Alternatively, or additionally, the two chambers can be configured to allow mixing as the components are being dispensed into the human or animal body.

[0273] The drugs or medicaments contained in the drug delivery devices described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolic disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome, angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as "Rote Liste", e.g. in Version 2014, such as those in sections 12 (Anti-diabetic drugs) or 86 (Tumor drugs); and the "Merck Index" 15th Edition.

[0274] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide 1 (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analogue" and "derivative" refer to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, e.g. the structure of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can be a codable amino acid residue or other naturally occurring residue or a purely synthetic amino acid residue. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, e.g. the structure of human insulin, wherein one or more organic substituent, e.g. a fatty acid, is bound to one or more amino acids. Alternatively, one or more amino acids occurring in the naturally occurring peptide can have been deleted and / or replaced by other amino acids, including non-codable amino acids, or amino acids, including non-codable amino acids, have been added to the naturally occurring peptide.

[0275] Examples of insulin analogues are Gly(A21 ), Arg(B25), Arg(B26) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0276] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detear, ); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl Lys B28Pro B29 human insulin; B28-N-palmitoyl- Lys B28Pro B29 human insulin; B30-N-myristoyl-Thr B29Lys B30 human insulin; B30-N-palmitoyl-Thr B29Lys B30 human insulin; B29-N-(N-palmitoyl-Y-glutamyl)-des(B30) human insulin, B29-N-ooxocarboxypentadecanoyl-Y-glutamyl-des(B30) human insulin (insulin degludec, ); B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; B29-N-(ooxocarboxyheptadecanoyl)-des(B30) and B29-N-(ooxocarboxyheptadecanoyl) human insulin.

[0277] Examples of GLP-1, GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixlirapid Exendin-4, a 39 amino acid peptide produced by the salivary glands of the Gila monster, Liraplutid Semaglutid, Taspoglutid, Albiglutid Dulaglutid rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C, CM-3, GLP-1 Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR 709, ZP-2929, ZP-3022, TT-401, BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Exenatide-XTEN and Glucagon-Xten.

[0278] Examples of oligonucleotides are e.g. mipomersin sodium It is a cholesterol-reducing antisense therapeutic agent for the treatment of familial hypercholesterolemia.

[0279] Examples of DPP4 inhibitors are Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0280] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and antagonists thereof, such as gonadotropins (follitropin, luteinizing hormone, chorionic gonadotropin, menotropin), somatropine (growth hormone), desmopressin, tesidol, goserelin, triptorelin, leuprolide, buserelin, nafarelin and goserelin.

[0281] Examples of polysaccharides include glucosaminoglycane, hyaluronic acid, heparin, low molecular weight heparin or ultra low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g. 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 G-F 20 It is a sodium hyaluronate.

[0282] The term "antibody", as used herein, refers to an immunoglobulin molecule or an antigen binding portion thereof. Examples of antigen binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a de-immunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be of an isotype or subtype that normally does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen binding molecule based on tetravalent bispecific tandem immunoglobulin (TBTI) and / or dual variable region antibody-like binding protein with cross-over binding region orientation (CODV).

[0283] The term "fragment" or "antibody fragment" refers to polypeptides (e.g., antibody heavy and / or light chain polypeptides) derived from antibody polypeptides molecules that do not comprise a full-length antibody polypeptide but that still comprise at least a portion of a full- length antibody polypeptide that is capable of binding to antigen. Antibody fragments can comprise a cleaved portion of a full-length antibody polypeptide, although the term as used herein is not limited to such cleaved fragments. Antibody fragments that are useful in the present application include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0284] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable region of the heavy chain polypeptide and light chain polypeptide that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable region of the heavy chain polypeptide and light chain polypeptide that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0285] 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).

[0286] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in the drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0287] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein can be made without departing from the full scope and spirit of the present application, which encompass such modifications and any and all equivalents thereof.

[0288] The scope of protection is not limited to the examples given here above. Any of the inventions disclosed herein are contemplated to be embodied within each new and novel feature and combination of features, particularly each and every combination of features recited in the claims, even if that feature or combination of features is not expressly disclosed in the claims or examples.

[0289] Reference Signs

[0290] 1 device

[0291] 2 device

[0292] 10 housing

[0293] 12 dose knob

[0294] 11 injection button

[0295] 13 dose window

[0296] 14 container or container receptacle

[0297] 15 needle

[0298] 16 inner needle cap

[0299] 17 outer needle cap

[0300] 18 cap

[0301] 27 output

[0302] 28 switch

[0303] 29 power source

[0304] 70 dial sleeve

[0305] 70a segment

[0306] 70b section

[0307] 71a Construction

[0308] 205 grip

[0309] 210 Injection Button

[0310] 210a Button Section

[0311] 210b Button Section

[0312] 215 Sensor Arrangement

[0313] 215a sensor

[0314] 215b sensor

[0315] 500 encoder system

[0316] 700 Controller

[0317] 800 switch

[0318] 900 Encoder System

[0319] 1000 Electronic Systems

[0320] 1100 Electronic Control Unit

[0321] 1200 motion sensing units

[0322] 1300 Using detection unit

[0323] 1400 communication units

[0324] 1500 power supply

[0325] 1550 Conductor Carrier

[0326] 1555 electrical components

[0327] 1600 User Interface Components

[0328] 1610 Setting Surface

[0329] 1620 Delivery Surface

[0330] 1780 First Component

[0331] 1790 Second component

[0332] 1792 Interaction Part

[0333] 1800 ratchet recess

[0334] 1805 ratchet teeth

[0335] 1810 switch feature

[0336] 1810a configuration

[0337] 1810b configuration

[0338] 1811 interaction portion

[0339] 1812 portion

[0340] 1814 pivot portion

[0341] 1815 end

[0342] 1816 use signal triggering portion

[0343] 1817 securement portion

[0344] 1818 connection portion

[0345] 1820 guide slot

[0346] 1830 first contact feature

[0347] 1832 interaction portion

[0348] 1834 contact feature portion

[0349] 1836 contact feature portion

[0350] 1838 contact feature portion

[0351] 1840 second contact feature

[0352] 1842 interaction portion

[0353] 1844 contact feature portion

[0354] 1846 contact feature portion

[0355] 1848 contact feature portion

[0356] 1850 protrusion

[0357] 1855 link member

[0358] 1857 switch

[0359] 1859 contact

[0360] 1860 surface

[0361] 1870 ramp

[0362] 1880 use signal generating interface member

[0363] 1890 detection zone

[0364] 1900 spline feature

[0365] 1910 engagement feature

[0366] 1920 engagement feature

[0367] d c engager release distance

Claims

1. An electronics system (1000) for a drug delivery device (1, 2), the electronics system comprising: - a dose setting and drive mechanism (1780, 1790) configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device and a dose delivery operation for delivering the set dose, the dose setting and drive mechanism comprising a first member (1780) and a second member (1790), wherein the dose setting and drive mechanism is configured such that, in the dose delivery operation and / or in the dose setting operation, the first member moves relative to the second member, - an electronic control unit (1100) configured to control operation of the electronics system, the electronics system having a first state and a second state, wherein the electronics system has an increased power consumption in the second state compared to the first state, - an electrical use detection unit (1300) operatively connected to the electronic control unit, the electrical use detection unit being configured to generate a use signal, the use signal indicating that a user has started the dose delivery operation, wherein the electronics system is configured such that the electronics system is switched from the first state to the second state by the electronic control unit in response to the use signal, wherein the electrical use detection unit is configured to generate the use signal in response to a relative rotational movement between the first member and the second member during the dose delivery operation, and wherein the second member is directly engaged with a piston rod to drive the dose delivery operation, wherein the electronics system (1000) comprises a movable switch feature (1810) operatively coupled to one or both of the first member (1780) and the second member (1790) such that rotation of the first member relative to the second member causes movement of the switch feature relative to the first member and / or the second member, and wherein the electronics system is configured such that movement of the switch feature is used to trigger generation of the use signal.

2. The electronics system of claim 1, wherein the dose setting and drive mechanism comprises a dose member that is rotatable relative to a housing (10) in integer multiples of a unit setting increment in the dose setting operation, and wherein one of the first member and the second member is the dose member, or wherein the first member and the second member are different from the dose member.

3. The electronics system of claim 2, wherein the electronics system comprises a use signal generation interface, wherein the use signal generation interface is configured to generate one or more use signals during the dose delivery operation, and wherein the use signal generation interface is an incremental change interface, wherein the use signal generation increment is adjusted to the unit setting increment.

4. The electronic system of any of claims 1-3, wherein the electronic system is configured such that the use signal is generated after rotation of the first member (1780) has started and before the first member has rotated more than one unit dose increment relative to the second member (1790).

5. The electronic system of claim 1, wherein the movable switch feature (1810) is operatively coupled to the first member and / or the second member such that rotation of the first member relative to the second member translates into movement of the switch feature to cause generation of the use signal, in particular at the start of the dose setting operation or the dose delivery operation.

6. The electronic system of claim 1, wherein the movable switch feature (1810) is elastically biased into engagement with a blocking feature (1805) before rotation of the first member (1780) relative to the second member (1790), wherein the blocking feature is removed from the switch feature when the first member is rotated relative to the second member such that a biasing force can drive movement of the switch feature to cause generation of the use signal.

7. The electronic system of claim 1, wherein the switch feature (1810) is linearly guided.

8. The electronic system of claim 1, wherein the switch feature (1810) is pivotally mounted, and wherein movement of the switch feature is a pivotal movement.

9. The electronic system of claim 1, wherein one of the first member (1780) and the second member (1790) is provided with a ratchet having circumferentially arranged ratchet teeth, and wherein the switch feature (1810) is arranged to cooperate with the ratchet.

10. The electronic system of claim 9, wherein the switch feature (1810) is rotationally locked to the one of the first member and the second member which is not provided with the ratchet.

11. The electronic system of claim 9, wherein the electronic system (1000) comprises a first switch feature (1810) and a second switch feature (1810), wherein the first switch feature and the second switch feature are arranged to cooperate with the ratchet.

12. The electronic system of claim 9, wherein one deformable switch feature (1810) engages with the ratchet at different positions at which rotation of the first member (1780) relative to the second member (1790) causes a portion of the deformable switch feature to be axially displaced.

13. The electronic system of any of claims 1-3, wherein the electronic system comprises a motion sensing unit (1200), wherein the motion sensing unit is operable in the second state of the electronic system (1000) and is inoperable in the first state of the electronic system, wherein the electronic control unit is configured to issue a command to make the motion sensing unit operable in response to the use signal.

14. The electronic system according to any of the claims 1-3, wherein the first member and the second member are configured to move relative to a housing of the electronic system or the drug delivery device during the dose setting operation and / or during the dose delivery operation.

15. The electronic system according to any of the claims 1-3, wherein in the first state of the electronic system, the electronic system is in an idle state.

16. The electronic system according to claim 1, wherein the first member and the second member are configured to move relative to a housing of the electronic system or the drug delivery device during the dose setting operation and during the dose delivery operation.

17. A drug delivery device (1, 2) comprising an electronic system (1000) according to any of the preceding claims and a reservoir with a drug and / or a reservoir holder for holding a reservoir with a drug in the drug delivery device.

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