Electronic system for a drug delivery device

Abstract

The present invention relates to an electronic system (100) for a drug delivery device (1). The electronic system (100) can comprise 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 can comprise a first member (20, 30, 90) and a second member (11, 40, 70, 80), wherein the dose setting and drive mechanism is configured such that the first member moves relative to the second member at least in the dose delivery operation and / or in the dose setting operation. The electronic system (100) can further comprise a power source (150), e.g. a rechargeable or non-rechargeable battery, a communication unit (140) for communicating with another device, and an electronic control unit (110) configured to control the operation of the electronic system. The electronic system (100) has a first state in which the communication unit (140) is not activated and a second state in which the communication unit (140) is activated. The electronic system (100) can further comprise an electrical usage detection unit (130). The electrical usage detection unit is operatively connected to the electronic control unit (110) and configured to generate a first signal indicating that a user has started or ended a relative movement between the first member and the second member. Further, the electronic system (100) is configured such that the electronic system is switched from the first state to the second state by the electronic control unit (110) in response to the first signal, thereby causing the communication unit (140) to establish the communication with another device.

Description

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

[0002] Pen-type drug delivery devices are suitable for routine injection situations by persons without formal medical training. This can be increasingly common among patients having diabetes, for whom self-treatment enables such patients to manage their disease effectively. In practice, such drug delivery devices allow the user to individually select and dispense a number of user variable doses of a medicament.

[0003] Basically, there are two types of drug delivery devices: resettable devices (i.e. reusable) and non-resettable devices (i.e. disposable). For example, disposable pen-type delivery devices are supplied as stand-alone devices. Such stand-alone devices do not have a removable pre-filled cartridge. Rather, the pre-filled cartridge cannot be removed and replaced from these devices without destroying the device itself. Accordingly, such disposable devices do not need to have a resettable dose setting mechanism. The present invention is applicable to both disposable devices and reusable devices.

[0004] For such devices, it can be valuable for many device users to have a function to record the doses dialled and delivered from the pen as a detailed record of the dose history. Therefore, drug delivery devices using electronics are becoming more and more popular in the pharmaceutical industry and for users or patients. For example, a drug delivery device is known from EP 2 729 202 B1 comprising an electronically controlled capture system for capturing data relating to the amount of drug expelled from a reservoir by an expelling means.

[0005] WO 2020 / 035406 A1 discloses a data collection apparatus for an injection device. An axial movement of a button at the beginning of a dose dispensing is used to close an electrical switch activating the data collection apparatus. Information can be transmitted to a computer via a wireless communication interface at regular intervals.

[0006] US 2019 / 0321555 A1 discloses an injection stopper rod comprising a sensor, a transmitter and an activation component configured to activate the sensor when the injection stopper rod has completed a delivery stroke.

[0007] US 2014 / 0074041 A1 discloses a drug delivery device with multiple sensors detecting dose setting or dose dispensing. These sensors operate like electrical switches by opening / closing a connection to a conductive area.

[0008] However, the management of the power supply resources integrated into the device is particularly important especially if the device is designed to be standalone, that is to say without a connector for connecting to a power source necessary for the operation of the device.

[0009] It is therefore an object of the present disclosure to provide improvements in drug delivery devices comprising one or more electronic systems for the drug delivery device.

[0010] This object is solved by the subject matter as defined, for example, in the independent claims. Advantageous embodiments and improvements are subject to the dependent claims. However, it should be noted that the present disclosure is not limited to the subject matter defined in the appended claims. Rather, as will become apparent from the following description, the present disclosure can comprise improvements additional to or alternative to the subject matter defined in the independent claims.

[0011] In more detail, the object can be solved by an electronic system for a drug delivery device, the electronic system comprising:

[0012] - 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, the first member being a dial sleeve, e.g. a number sleeve, or a member axially and / or rotationally locked to the dial sleeve, the second member being a dose and / or injection button or a member axially and / or rotationally locked to the dose and / or injection button, wherein the dose setting and drive mechanism is configured such that, at least in the dose delivery operation and / or in the dose setting operation, the first member moves relative to the second member,

[0013] - a communication unit for communicating with another device,

[0014] - an electronic control unit configured to control the operation of the electronic system, the electronic system having a first state in which the communication unit is not activated and a second state in which the communication unit is activated,

[0015] - an electrical usage detection unit operatively connected to the electronic control unit, the electrical usage detection unit being configured to generate a first signal indicating that a user has started or ended a relative movement between the first member and the second member, wherein the electrical usage detection unit comprises at least one electrically conductive spring arm deflectable to establish or break an electrical connection with at least one electrical contact in response to the relative movement between the first member and the second member.

[0016] The electronic system can be characterized in that it comprises a linearly guided switch feature operatively coupled to the first member and / or the second member such that a predetermined axial displacement of the first member relative to the second member along the rotational axis of the dose setting and drive mechanism is converted into a radial movement transverse to the rotational axis of the dose setting and drive mechanism, wherein the electronic system is configured such that it is switched by the electronic control unit from a first state to a second state in response to the first signal, thereby causing the communication unit to establish the communication with the other device.

[0017] 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 are to be considered as disclosed for the electronic system and vice versa.

[0018] According to one aspect of the present invention, the electronic system comprises a dose setting and drive mechanism, a power source, e.g. a rechargeable or non-rechargeable battery, a communication unit for communicating with another device, an electronic control unit and an electrical usage detection unit.

[0019] In one embodiment, the dose setting and drive mechanism can be 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. For example, the dose setting and drive mechanism can comprise a first member and a second member and be configured such that the first member is moved relative to the second member at least in the dose delivery operation and / or in the dose setting operation. Further, the first member can be moved relative to the second member if the user actuates the device to initiate operation of the electronic system but does not perform a dose delivery operation and / or a dose setting operation, e.g. where the dose setting and drive mechanism is in a home position or state. Such a home position or state can be a state after dose delivery and / or before setting a new dose. In other words, the user can move the first member relative to the second member, preferably axially, to initiate operation of the electronic system only, e.g. to initiate a manual synchronization and / or pairing with another device or to initiate a mode for modifying settings of the electronic system. Modifying settings of the system can include setting or modifying audible and / or visual feedback or modifying display settings. However, such operation of the electronic system, e.g. to initiate a manual synchronization and / or pairing with another device or to initiate a mode for modifying settings of the electronic system, can also occur during a dose delivery operation and / or a dose setting operation, preferably at the end of a dose delivery operation.

[0020] 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.

[0021] The power supply can be arranged in the interior of the electronic system, like in the interior of the user interface member.

[0022] 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 cannot operate with the desired functionality assigned to the electronic system, e.g. synchronization and / or pairing. In other words, the communication unit can not be activated in this first state. In the second state, the system can be ready to operate with the desired functionality, e.g. when the system is triggered to start operation and / or when a dose setting operation and / or a dose delivery operation is performed in the second state. In comparison to the first state, the electronic system can have an increased power consumption in the second state. For example, one or more electrical or electronic units of the electronic system can switch to a state of higher power consumption (e.g. an on state) in the second state in comparison to the first state in which the respective unit can be in a state of lower power consumption, e.g. a sleep state or a state of no power consumption at all because the connection to the power supply is switched off. For example, the communication unit can be activated in this second state.

[0023] Further, in one embodiment, the electrical usage detection unit is operatively connected to the electronic control unit and configured to generate a first signal indicating that the user has started or ended a relative movement between the first member and the second member. The electrical usage detection unit can be configured to generate the first signal in response to a relative movement, e.g. a relative axial movement, between the first member and the second member.

[0024] 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 electric use detection unit can be configured to generate or trigger a first signal, e.g. an electrical signal. The first signal can be indicative that the user has started or finished a relative movement, preferably a relative axial movement, between the first member and the second member. In particular, the first signal can be indicative that, with the drug delivery device in an initial position or state, the user has pushed a button or trigger to start or initiate a manual synchronization and / or pairing of the electronic system with another device or to initiate a mode for modifying settings of the electronic system. Additionally or as an alternative, the first signal can be indicative that the user has started or finished a dose setting operation or a dose delivery operation. Starting and / or finishing a dose setting operation or a dose delivery operation can require a relative movement, e.g. a relative axial and / or rotational movement, between the first member and the second member. Accordingly, the first signal can only be generated after the dose delivery operation has finished or completed. In this way, it can be ensured that an energy consuming operation, such as a synchronization or pairing with another device, is only performed when required, i.e. when initiated manually by the user or when required after other data has been collected and should be transmitted, e.g. after a dose delivery operation.

[0025] Preferably, the electronic system is configured such that the electronic system is switched by the electronic control unit from the first state to the second state in response to the first signal, thereby initiating the communication unit to establish the communication, e.g. a synchronization or pairing operation, with the other device. In one embodiment, the electronic system is configured such that the electronic system is switched by the electronic control unit from the first state to the second state in response to the first signal. Accordingly, the generation of the first signal can cause and result in the electronic system switching to the second state of increased power consumption.

[0026] The electronic control unit can issue a command, e.g. a signal, to another unit of the electronic system in response to receiving the first signal, such that this unit is switched on or operable. This unit can be the communication unit for communicating with the other device, e.g. a wireless communication interface for communicating with the other device via a wireless network, such as Wi-Fi or Bluetooth, or even an interface for a wired communication link, such as a socket for receiving a Universal Serial Bus (USB), mini-USB or micro-USB connector. Preferably, the electronic system comprises an RF, WiFi and / or Bluetooth unit as the communication unit. The communication unit can be provided as a communication interface between the system or drug delivery device and an external, such as another electronic device, e.g. a mobile phone, a personal computer, a laptop, etc. For example, dose data can be transmitted to the external device via the communication unit. The dose data can be used for establishing a dose record or dose history in the external device.

[0027] ​In one embodiment, the communication unit comprises a wireless communication interface to communicate with another device, wherein the electronic system is configured such that the electronic system is switched by the electronic control unit from the first state to the second state in response to the first signal, thereby initiating a manual synchronization and / or pairing of the communication unit with another device or initiating a mode for modifying settings of the electronic system.

[0028] There are several different ways suitable to implement the electrical usage detection unit. For example, the movement between the first member and the second member can be detected by means of one or more optical sensors (e.g. comprising an electromagnetic radiation emitter (e.g. LED) and a radiation detector), and / or one or more acoustic sensors (e.g. detecting a click sound caused by the movement), and / or one or more photoelectric sensors, and / or one or more inductive sensors, and / or one or more capacitive sensors, and / or one or more contact sensors, and / or one or more non-contact sensors, and / or one or more magnetic sensors. The electrical usage detection unit can comprise at least one sensor, preferably a plurality of sensors.

[0029] In one embodiment, the electrical usage detection unit comprises at least one electrical switch as a sensor. For example, the electrical usage detection unit can comprise at least one electrically conductive spring arm deflectable in response to a relative movement (e.g. a relative axial movement) between the first member and the second member to establish or break an electrical connection with at least one electrical contact. The electrical usage detection unit can be configured to generate the first signal in response to establishing or breaking the electrical connection between the at least one electrically conductive spring arm and the at least one electrical contact.

[0030] In one embodiment, the first member is a dial sleeve (e.g. a number sleeve) or a member axially and / or rotationally locked to the dial sleeve, which is rotatable relative to a housing of the dose setting and drive mechanism, e.g. along a helical path, at least in a dose setting operation. Further, the second member can be a dose and / or injection button or a member axially and / or rotationally locked to the dose and / or injection button, which is axially displaceable relative to the first member and rotationally restricted by the housing at least in a dose delivery operation.

[0031] In one embodiment, the first member comprises an encoder ring. The encoder ring can be permanently or releasably clamped on the dial sleeve. The encoder ring can be a component integral with the dial sleeve. The encoder ring can have a first portion with a first inner diameter and a second portion with a second inner diameter different from the first inner diameter, wherein the first portion and the second portion are located at axially different positions of the encoder ring. Movement of the first member relative to the second member can cause a switch feature abutting the encoder ring to make or break an electrical connection between at least one electrically conductive spring arm and at least one electrical contact when the switch feature passes from the first portion to the second portion or vice versa. For example, a transition ramp can be axially interposed between the first portion and the second portion to facilitate smooth actuation of the switch feature. Additionally or as an alternative, the switch feature can be provided with a ramp to facilitate smooth actuation when the switch feature passes from the first portion to the second portion or vice versa.

[0032] At least one of the first portion and the second portion can have a smooth cylindrical surface. Additionally or as an alternative, one of the first portion and the second portion can be provided with radially inwardly directed ratchet teeth and / or ratchet recesses. Interaction between the switch feature and the ratchet teeth and / or ratchet recesses can occur upon further movement, e.g. relative rotation, of the first member and the second member relative to each other during a dose setting operation or a dose delivery operation. Preferably, one portion is provided with a cylindrical surface and the other portion is provided with ratchet teeth and / or ratchet recesses.

[0033] In one embodiment, 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 ratchet can be a separate member from the first member and the second member, e.g. an encoder ring. Alternatively, the ratchet can be one of the first member and the second member, e.g. the first member. The ratchet can be rotationally locked to one of the first member and the second member. The ratchet can be axially moveable relative to the member to which it is rotationally locked, e.g. rotationally locked. The ratchet can be axially locked to the other of the first member and the second member, e.g. to the second member.

[0034] In a further embodiment, the first member is a dial sleeve (e.g. a number sleeve) or a member axially and / or rotationally locked to said dial sleeve, said first member being axially displaceable relative to a housing of the dose setting and drive mechanism, e.g. along a helical path, at least in the dose delivery operation, and wherein the second member is a member (e.g. a pin) axially displaceable relative to the first member at least in the dose delivery operation when abutting the housing or a member axially locked to said housing. The second member can be guided in a dose and / or injection button or a member axially and / or rotationally locked to said dose and / or injection button such that the second member abuts the housing or a member axially locked to said housing only when the dose and / or injection button is axially displaced against the bias of a spring. This embodiment is particularly suitable in case the first signal is intended to be generated at or near an initial position or state of the dose setting and drive mechanism, i.e. a position or state at or after the end of dose delivery and / or before a new dose is set. In more detail, the pin is preferably positioned in the system such that the pin moves relative to the dial sleeve when the dial sleeve approaches its initial position at the end of dose delivery.

[0035] For example, this can be achieved by guiding the pin in a zero part that axially moves together with the dial sleeve during dose setting and dose delivery. Such a zero part can be a clutch sleeve for rotationally coupling the dial sleeve to the driver. The limited relative axial movement between this zero part and the dial sleeve can allow for example for a clutch interface between these two parts for coupling and / or decoupling. Preferably, the dial sleeve and the zero part (e.g. the clutch sleeve) approach an axial end face of the housing part at the end of dose delivery. The pin can protrude in the first state to abut this end face before abutting the dial sleeve or the clutch sleeve. This causes a relative axial movement between the pin and the dial sleeve.

[0036] Still further, embodiments can comprise that the first member is a dose and / or injection button or a top cap thereof and the second member is a chassis or skirt of a dose knob. In other words, a user interface unit, like a dose and / or injection button and a dose knob, can comprise two elements which are at least partially movable relative to each other such that this relative movement can be detected to generate the first signal. For example, the top cap can be axially displaceable and / or axially elastically deformable relative to the second member. Preferably, the electrical use detection unit comprises an axial switch (e.g. mounted on a PCB) such that an axial displacement of at least a portion of the top cap relative to the second member actuates the axial switch. Again, this embodiment is suitable in case the first signal is to be generated when the dose setting and drive mechanism is in an initial position or state, i.e. a position or state at the end of or after a dose delivery and / or before a new dose is set. Additionally or as an alternative, the force required to actuate the axial switch can be chosen such that the first signal is generated before a dose delivery, i.e. the force used to actuate the axial switch is lower than the force exerted by a dose delivery.

[0037] In embodiments, the electronic system can be adapted to collect or measure dose data, e.g. corresponding to a set dose or a dispensed dose. Such dose data can only be collected in the third state of the system. According to a further aspect of the present application, the electrical use detection unit can be configured to generate a second use signal indicating that the user has started a dose setting operation or a dose delivery operation. For example, the electronic system can be configured such that the electronic system is switched from the first state or the second state to the third state by the electronic control unit in response to the second use signal. Here, the electrical use detection unit can be configured to generate the second use signal in response to a relative movement of the two members of the dose setting and drive mechanism during a dose delivery operation, e.g. in response to a relative rotational movement between the third member and one of the first member and the second member of the dose setting and drive mechanism during a dose delivery operation. In one embodiment, the electrical use detection unit and / or the motion sensing unit can be operable to collect motion data or to measure data about the relative movement between the third member and one of the first member and the second member or the relative movement of the first member and the second member when it is activated in the third state of the system. The electronic control unit can be configured to convert this data into dose data, e.g. a feature of the size of the dose that has been set or has been delivered in the respective operation.

[0038] For example, the second use signal can indicate that the user has started a dose setting operation or a dose delivery operation. Starting a dose setting operation or a dose delivery operation can require a relative movement (e.g. a relative rotational movement) between the first member and the second member. Accordingly, the second use signal can only be generated after the dose setting operation or the dose delivery operation has been started or initiated. In one embodiment, the use detection unit is configured to generate the second use signal in response to a relative movement (e.g. a relative rotational movement) between the first member and the second member which is conveniently during the dose delivery operation. Thus, generating the second 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 the case when the second use signal is only generated during the dose delivery operation (e.g. when the delivery operation has been started).

[0039] In one embodiment, the electronic system can comprise a movable switch feature. Preferably, the switch feature is linearly guided. For example, the switch feature can be received in a guiding slot. The switch feature can only move linearly (e.g. radially or axially) when it is linearly guided. This provides a relatively simple movement type when triggering the use signal. For example, the guiding slot can be provided in the second member.

[0040] The switch feature can be operatively coupled to one or both of the first member and the second member such that an axial displacement of the first member relative to the second member causes a movement of the switch feature relative to the first member and / or the second member. Preferably, the electronic system is configured such that an axial movement of the switch feature is used to trigger the generation of the first signal. In addition, the movement of the same switch feature can be used to trigger the generation of the second use signal.

[0041] For example, the movable switch feature can be operatively coupled to the first member and / or the second member such that a predetermined axial displacement of the first member relative to the second member translates into a movement of the switch feature, e.g. into a movement perpendicular to the predetermined axial displacement of the first member relative to the second member, to cause the generation of the first signal, in particular at the end of a dose setting or dose delivery operation. A further movement (e.g. a rotation) of the first member relative to the second member can translate into a movement of the switch feature to cause the generation of the second use signal.

[0042] In one embodiment, the movable switch feature can be elastically biased into engagement with a blocking feature before the first member is axially displaced relative to the second member by a predetermined distance. When the first member is moved relative to the second member, the blocking feature can be removed from the switch feature such that the biasing force can drive a movement of the switch feature to cause the generation of the first signal.

[0043] In one embodiment, the electronic system comprises a use signal generating interface, for example comprising a ratchet interface (such as a radial ratchet interface or an axial ratchet interface). The use signal generating interface can be configured to generate one or more second use signals in response to relative rotation between the first member and the second member. The use signal generating interface can be configured to generate one (e.g. only one) or more second use signals during a dose delivery operation. Where more than one use signal is generated, preferably the first signal generated is the signal used to trigger the electronic system to switch from the first state to the second state. The use signal generating interface can be an incremental interface. The use signal generating increment can be angular. The use signal generating increment can be adjusted in accordance with the unit setting increment. Preferably, the use signal generating increment is equal to or less than the unit setting increment. That is, the pitch of the use signal generating increment can be equal to the pitch of the unit setting increment, or the pitch of the use signal generating increment can be finer. Where the pitch is finer, one rotation of a unit setting increment can cover more than one use signal generating increment.

[0044] In one embodiment, the electronic system or drug delivery device comprises a movable switch feature. The switch feature can be movable along the rotational axis or main longitudinal axis of the housing and / or can be movable transverse or radial to the rotational axis or 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 second use signal generation increment). The switch feature can be operatively coupled to the first member and / or the second member such that rotation of the first member relative to the second member causes movement of the switch feature relative to the first member, relative to the second member and / or relative to the housing. Additionally or as an alternative, the switch feature can be operatively coupled to the first member and / or the second member such that axial displacement of the first member relative to the second member causes movement of the switch feature relative to the first member, relative to the second member and / or relative to the housing. For example, rotation and / or axial displacement of the first member relative to the second member, relative to the switch feature and / or relative to the housing can be converted into movement of the switch feature, e.g. by operative coupling between the switch feature and the ratchet. Alternatively, rotation and / or axial displacement of the first member relative to the switch feature can remove a mechanical blockage which blocks movement of the switch feature in the direction in which the switch feature is biased. Movement of the switch feature can be used to trigger generation of the first signal and / or the second use signal. In other words, generation of the first signal and / or the second use signal can require movement of the switch feature in response to movement of the first member relative to the second member. For example, for generation or triggering of a use signal, movement of the switch feature can be used and / or cause a change in 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) to make electrical contact with another contact feature of the switch in order to generate a use signal.

[0045] In one embodiment, the switch feature engages a ratchet (e.g. a ratchet that 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 in a direction opposite to the movement direction of the switch feature that causes the generation of the first signal and / or the second use signal. To generate the use signal, the switch feature can be moved, e.g. radially inwards. In an initial state (e.g. 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.

[0046] In one embodiment, the switch feature is biased, preferably elastically, into engagement with the blocking feature under the action of a biasing force 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 that is elastically displaced before starting a dose setting operation and / or a dose delivery operation. The blocking feature can be provided by a ratchet tooth between two adjacent ratchet recesses. As an alternative, the blocking feature can be provided by a transition (e.g. a ramp or a step) between two axially different portions of the first member. For example, an encoder ring of the first member has a first portion with a first inner diameter and a second portion with a second inner diameter that is different from the first inner diameter, the transition between these portions forming the blocking feature. The biasing force can act in the direction of movement that causes the generation of the first signal and / or the second 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 bias can be released and the switch can close. To generate the first signal and / or the second use signal, the switch feature can be moved, e.g. in a radially outward direction or in a radially inward direction.

[0047] 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, e.g. by contacting and / or moving a trigger feature of the switch. When the switch is triggered, the first signal and / or the second use signal can be generated. In response to the use signal, the electronic control unit can switch the electronic system to a different state, e.g. to a second state or to a third state.

[0048] The present application is applicable to devices that are manually driven, e.g. by the user exerting force on an injection button, to devices that are driven by a spring or the like, and to devices that combine both concepts (i.e. spring assisted devices that still require the user to exert an injection force). Spring type devices involve pre-loaded springs and springs that are loaded by the user during dose selection. Some energy storage devices use a combination of spring pre-loading and additional energy provided by the user, e.g. during dose setting.

[0049] The present application further relates to a drug delivery device comprising an electronic system as described above. The drug delivery device can comprise a cartridge containing a medicament.

[0050] 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 that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament can be used for a limited period, or on a regular basis, for chronic disorders.

[0051] 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 API 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.

[0052] A drug or medicament can be contained within a primary package or "drug container" suitable for use with a drug delivery device. The drug container can be, for example, a cartridge, a syringe, a 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 preparation 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 the user to mix the two components prior to dispensing, if desired. Alternatively, or additionally, the two chambers can be configured to allow mixing upon dispensing of the components into the human or animal body.

[0053] The drug or medicament contained in the drug delivery devices described herein can be used for therapy and / or prophylaxis in a number of different types of medical treatment. Examples of diseases to be treated include, for example, diabetes or complications associated with diabetes such as diabetic retinopathy, thromboembolic diseases such as deep vein or pulmonary thromboembolism. Further examples of diseases to be treated are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in, for example, the

[0054] Examples of APIs used in the treatment and / or prophylaxis of diabetes mellitus type 1 or type 2 or complications associated with diabetes mellitus type 1 or type 2 include an insulin (e.g., human insulin, or a human insulin analogue or derivative, glucagon-like peptide-1, a GLP-1 analogue or a GLP-1 receptor agonist, 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 can formally be derived from the structure of a naturally occurring peptide, such as 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 natural 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 can formally be derived from the structure of a naturally occurring peptide, such as the structure of human insulin, in which one or more organic substituent, such as 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.

[0055] Examples of insulin analogues are Gly(A21 ), Arg(B31 ), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, 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.

[0056] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, ); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N- palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N- palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N- palmitoyl-Y-glutamyl)-des(B30) human insulin, B29-N-ooxypentadecanoyl-Y-L- glutamyl-des(B30) human insulin (insulin degludec, ); B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; B29-N-(ooxycar- boxyheptadecanoyl)-des(B30) human insulin and B29-N-(ooxycarboxyhepta- decaoyl) human insulin.

[0057] Examples of GLP-1, GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixliraptid 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 (Efpeglenatide), HM-15211, CM-3, GLP-1 Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR 709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN and Glucagon-Xten.

[0058] Examples of oligonucleotides are e.g. mipomersin sodium It is a cholesterollowering antisense therapeutic agent for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrome.

[0059] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0060] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Turopin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonal- F, Buserelin, Nafarelin, and Goserelin.

[0061] Examples of polysaccharides include glucosaminoglycane, hyaluronic acid, heparin, a low molecular weight heparin or ultra-low molecular weight heparin or a derivative thereof, or a sulfated polysaccharide (e.g. a polysulfated version of the above mentioned polysaccharides), and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a 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.

[0062] 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 portion of an antibody.

[0063] 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.

[0064] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences and that 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.

[0065] 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).

[0066] 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.

[0067] 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.

[0068] Example drug delivery devices can involve needle-based injection systems as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needle-based injection systems can be broadly distinguished into multi-dose container systems and single-dose (with partial or full discharge) container systems. The containers can be replaceable containers or integrated non-replaceable containers.

[0069] As further described in ISO 11608-1 :2014(E), multi-dose container systems can involve needle-based injection devices with replaceable containers. In such systems, each container holds multiple doses, which can be of fixed or variable (pre-set by the user) size. Another multi-dose container system can involve needle-based injection devices with integrated non-replaceable containers. In such systems, each container holds multiple doses, which can be of fixed or variable (pre-set by the user) size.

[0070] As further described in ISO 11608-1 :2014(E), single-dose container systems can involve needle-based injection devices with replaceable containers. In one example of such systems, each container holds a single dose, whereby the entire deliverable volume is discharged (full discharge). In another example, each container holds a single dose, whereby a portion of the deliverable volume is discharged (partial discharge). As also described in ISO 11608-1 :2014(E), single-dose container systems can involve needle-based injection devices with integrated non-replaceable containers. In one example of such systems, each container holds a single dose, whereby the entire deliverable volume is discharged (full discharge). In another example, each container holds a single dose, whereby a portion of the deliverable volume is discharged (partial discharge).

[0071] As used herein, the terms "axial", "radial" or "circumferential" can be used in relation to a main longitudinal axis of the device, the cartridge, the housing or the cartridge holder (e.g. an axis extending through the proximal and distal ends of the cartridge, cartridge holder or drug delivery device).

[0072] Non-limiting exemplary embodiments of the present application will now be described with reference to the accompanying drawings, in which:

[0073] Figure 1 shows an embodiment of a drug delivery device;

[0074] Figure 2 shows a perspective view of an encoder of the system of the first embodiment;

[0075] Figure 3 shows a cross-sectional view of a part of the system of the first embodiment;

[0076] Figures 4a to 4c show cross-sectional views of a part of the system of the second embodiment in different states;

[0077] Figure 5 shows a cross-sectional view of a part of the system of the second embodiment;

[0078] Figure 6 shows a sketch of the system of the third embodiment;

[0079] Figures 7a to 7c show a part of the system of the third embodiment in different states;

[0080] Figure 8 shows an encoder ring of the third embodiment;

[0081] Figures 9a to 9b show cross-sectional views of a part of the system of the fourth embodiment in different states;

[0082] Figures 10a to 10b show cross-sectional views of a part of the system of the fourth embodiment in different states;

[0083] Figure 11 shows a perspective view of a part of the system of the fourth embodiment;

[0084] Figure 12 shows a cross-sectional view of a part of the system of the fourth embodiment;

[0085] Figure 13 shows a top view of a part of the system of the fourth embodiment;

[0086] Figure 14 shows a perspective view of a part of the system of the fifth embodiment with the cap removed;

[0087] Figure 15 shows a perspective view of the system of Figure 14 with the cap partially sectioned;

[0088] Figure 16 shows a perspective view of the cap of the system of Figure 15;

[0089] Figure 17 shows a cross-sectional view of a portion of the system according to the fifth embodiment; and

[0090] Figure 18 schematically illustrates an implementation scheme for an electronic system used in a drug delivery device.

[0091] In the accompanying drawings, the same elements, elements with the same function, or elements of the same kind may be given the same reference numerals.

[0092] In the following description, some embodiments will be illustrated with reference to insulin injection devices. However, this disclosure is not limited to such applications and can be equally well deployed with injection devices configured to dispense other medications or, in general, drug delivery devices (preferably pen-type devices and / or injection devices).

[0093] Implementations of injection devices, particularly variable-dose injection devices, are provided that record and / or track data regarding the dose delivered therefrom. This data may include the size of the selected dose and / or the size of the dose actually delivered, the time and date of administration, the duration of administration, etc. Features described herein include the arrangement of sensing elements and power management techniques (e.g., to facilitate small batteries and / or achieve efficient power usage).

[0094] Regarding the Sanofi's combination of injection button and grip (dose setting component or dose setter) The injection device illustrates certain embodiments described in this document. An injection button provides a user interface element for initiating and / or performing dose delivery operations of the drug delivery device. A grip or knob provides a user interface element for initiating and / or performing dose setting operations. Both devices are of the selector extension type, i.e., their length increases during dose setting. Other injection devices with the same kinematic behavior of selector extensions and buttons during dose setting and dose dispensing operation modes are referred to, for example, those sold by Eli Lilly. Device and sold by Novo Nordisk 4. Apparatus. Therefore, applying the general principles to these apparatuses is straightforward and self-evident, and further explanation will be omitted. However, the general principles of this disclosure are not limited to the described kinematic behavior. Certain other embodiments are conceivable for application to Sanofi. The injection device includes a separate injection button and a grip / dose setting component. Therefore, there can be two separate user interface components: one for dose setting operations and one for dose delivery operations.

[0095] “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 away from or facing away from the proximal end. On the other hand, “proximal” is used to indicate a direction, end or surface arranged or to be arranged away from or facing 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.

[0096] 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, for example a pen-type injector, such as Sanofi’s Fiasp®.

[0097] The injection device 1 of figure 1 is an injection pen comprising a housing 10 and containing a container 14, for example a cartridge of insulin, 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 cap 16 and an outer needle cap 17 or another cap 18. An insulin dose to be expelled from the injection device 1 can be set, pre-set or “dialed in” by turning a dose knob 12 and then displayed (for example 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 equally well be displayed in a different manner than shown in the dose window 13 in figure 1.

[0098] 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 20 which is configured to move when the dose knob 12 is turned to provide a visual indication of the currently set dose. In setting the dose, the dose knob 12 is rotated in a helical path relative to the housing 10.

[0099] In this example, the dose knob 12 comprises one or more formations to facilitate attachment of a data collection device.

[0100] 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 skin portion with the needle 15 and then pushing the dose knob 12 / injection button 11 in axial direction, the insulin dose displayed in the display window 13 is expelled from the injection device 1. The dose is injected into the patient when the needle 15 of the injection device 1 remains in the skin portion for a certain time after pushing the dose knob 12. The expelling of the insulin dose can also cause a mechanical click sound, which can be different from the sound produced when rotating the dose knob 12 during dialing of the dose.

[0101] In this embodiment, during delivery of the insulin dose, the dose knob 12 is returned in axial movement to its initial position (not rotated) while the dial sleeve 20 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.

[0102] 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 expiry date (e.g. 28 days after first use). In case of a reusable device, the insulin container can be replaced.

[0103] Further, before first use of the injection device 1, a so-called “priming injection” can be required to remove air from the insulin container 14 and the needle 15, e.g. by selecting two units of insulin and pressing the dose knob 12 while holding the needle 15 of the injection device 1 pointing upwards. For the sake of presentation, it will be assumed in the following that the selected amount substantially corresponds to the injection dose, such that e.g. the amount of medicament selected from the injection device 1 equals the dose received by the user.

[0104] 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.

[0105] In the following, an electronic system 100 according to the present application will be described with respect to several different exemplary embodiments. The electronic system 100 comprises a dose setting and drive mechanism, which can be part of an injection device 1 as depicted in Fig. 1, and a power source 150, such as a rechargeable or non-rechargeable battery, as shown in Fig. 18. The electronic system further comprises an electronic control unit 110 configured to control the operation of the electronic system, the electronic system having a first state and a second state, wherein the power consumption in the second state of the electronic system is increased compared to the power consumption in the first state. The electronic system further comprises an electrical usage detector unit 130 operatively connected to the electronic control unit 110 and configured to generate at least a first signal indicative of a user performing an operation. An example of such an operation is a user of the injection device and / or the electronic system entering a manual synchronization or pairing mode of the electronic system. 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 110 in response to the first signal. The electronic system further comprises a communication unit 140 for communicating with another device. When the communication unit is activated to perform the manual synchronization or pairing mode, the electronic system is in its second state.

[0106] The present application comprises several alternatives for generating the first signal by means of the electrical usage detector unit 130. In more detail, these embodiments are based on detecting an axial movement of a first member of the dose setting and drive mechanism relative to a second member of the dose setting and drive mechanism.

[0107] A first embodiment is depicted in Figs. 2 to 4. In this embodiment, a relative axial movement of the button 11 relative to the dose dial sleeve 20 causes the generation of the first signal. Fig. 2 shows the proximal end of the dose dial sleeve 20 provided with an encoder ring 30, which can be a single part integral with the dose dial sleeve 20 or can be a separate part rigidly constrained onto the dose dial sleeve 20. In other words, the dose dial sleeve 20 and the encoder ring 30 correspond to a single part. As can be seen in Fig. 2, the encoder ring 30 is provided with a series of radially oriented ratchet teeth 31 arranged between ratchet recesses 32. Towards its distal end, the encoder ring 30 is provided with a transition ramp 33, which terminates in a cylindrical portion 34 having a continuous cylindrical inner surface. The inner diameter of the cylindrical portion 34 substantially corresponds to the inner diameter of the tip of the ratchet teeth 31. The inner diameter of the cylindrical portion 34 is smaller compared to the inner diameter defined by the ratchet recesses 32.

[0108] Fig. 3 shows the encoder ring 30 and the dose dial sleeve 20 in a cross-sectional view through a plane in the transition ramp 33. Further, Fig. 3 shows a chassis 40 arranged within a space defined by the encoder ring 30 and the dose dial sleeve 20. The chassis 40 can be held in or can be part of the button 11 or of a driver of the dose setting and drive mechanism.

[0109] The chassis 40 has a substantially circular outer shape and is provided with a guide groove 41 extending in a direction perpendicular to the axis of rotation of the dose dial sleeve 20. Further, the chassis 40 is provided with two electrical contacts 42, 43 in the form of metal pressings fixed within the chassis 40. The electrical contacts 42, 43 form a switch which is open in the absence of a force acting on the electrical contacts 42, 43. The switch can be closed by elastically deflecting the electrical contact 42 towards the electrical contact 43.

[0110] A switch feature in the form of a shuttle 50 is guided in the guide groove 41 of the chassis 40 such that the shuttle 50 is allowed to displace axially within the guide groove 41. A radially outwardly facing tip of the shuttle 50 is formed as a ratchet tooth 51 which cooperates with the ratchet teeth 31 and the ratchet recesses 32 of the encoder ring 30. The length of the shuttle 50 is chosen such that the electrical contact 42 biases the shuttle 50 into one of the ratchet recesses 32 depending on the relative rotational position of the chassis 40 with respect to the encoder ring 30. However, upon relative rotation between the encoder ring 30 and the chassis 40 (e.g. during dose delivery), the shuttle 50 is pushed inwards by engagement with the respective ratchet tooth 31 against the bias of the electrical contact 42 which is deflected to close the switch by contact with the electrical contact 43 as shown in Fig. 3.

[0111] During dose setting operation of the injection device 1, the relative axial position of the chassis 40 with respect to the encoder ring 30 is such that the shuttle 50 is aligned with the proximal portion of the encoder ring 30, allowing interaction between the shuttle 50 and the ratchet teeth 31 and ratchet recesses 32. Upon actuation of the button 11, however, the chassis 40 can be axially displaced with respect to the encoder ring 30 such that the shuttle 50 is guided along the transition ramp 33 to engage the cylindrical portion 34. This relative axial movement between the chassis 40 and the encoder ring 30 can only occur at the end of dose delivery. As shown in Fig. 3, the shuttle 50 is pushed radially inwards upon engagement of the cylindrical portion 34, thereby closing the switch formed by the electrical contacts 42, 43. In contrast to the dose setting or dose delivery operation, when the shuttle 50 repeatedly opens and closes the switch formed by the electrical contacts 42, 43 due to the wobbling of the dose dial sleeve 20 with the encoder ring 30 relative to the chassis 40 upon rotation, the switch will permanently close when the shuttle 40 has been axially moved with respect to the encoder ring 30 such that the shuttle 50 engages the cylindrical portion 34. The electrical system 100, more specifically the use detection unit 130, detects the permanent closing of the switch and generates a first signal which can activate the manual synchronization or pairing mode.

[0112] As is apparent from Fig. 3, the first signal can not only be generated at the end of dose delivery, but also in case the injection device is in an initial state or position, i.e. before dose setting. In this initial state, the manual synchronization or pairing mode of the electrical system can be activated by simply pressing the button 11.

[0113] The switch formed by the electrical contacts 42, 43 can further be part of a motion sensing unit 120 of the electrical system 100 which detects the relative rotation between the dose dial sleeve 20 and the chassis 40 during dose delivery when the shuttle 50 is repeatedly opening a second switch formed by the electrical contacts 42 and 43. This second use signal can turn on the encoder function of the electrical system.

[0114] A second embodiment is depicted in Figs. 4a to 5 which is similar to the first embodiment. Again, the dose dial sleeve 20 is provided with an encoder ring 30 having ratchet teeth 31 and ratchet recesses 32. Further, the chassis 40 is provided with a guide groove 41 guiding a shuttle 50 adapted to engage the ratchet teeth 31 and ratchet recesses 32.

[0115] In contrast to the first embodiment, the second embodiment comprises two switches formed by the electrical contacts 42, 43 and 44. Further, the axial position between the chassis 40 and the encoder ring 30 is such that in the initial state or position of the injection device 1 (i.e. before dose setting), the shuttle 50 is positioned spaced apart proximally from the encoder ring 30 as shown in Fig. 5. This position is further depicted in Fig. 4a, wherein the shuttle 50 is shown pushed radially outwardly by the electrical contact 44. In this case (i.e. before the button 11 is pressed), both switches are not closed since the electrical contacts 42, 43 and 44 are not deflected by the shuttle 50.

[0116] Fig. 4b shows the situation when the button 11 is pressed such that the chassis 40 is axially displaced relative to the encoder ring 30. This causes the shuttle 50 to be pushed radially inwardly to the large diameter of the ratchet (i.e. the diameter defined by the ratchet recess 32). Due to this displacement of the shuttle 50, the first switch between the electrical contact 44 and the electrical contact 42 is closed. By closing this first switch, a first signal is generated, thereby switching on the manual synchronization and pairing function of the electrical system.

[0117] Fig. 4c shows the situation when the dose dial sleeve 20 starts to rotate relative to the chassis 40, e.g. during dose delivery. Due to this rotation, the shuttle 50 is repeatedly pushed radially inwardly to the small diameter of the ratchet (i.e. the inner diameter defined by the tip of the ratchet teeth 31), thereby repeatedly closing the second switch formed by the electrical contacts 42 and 43 as described above with respect to the first embodiment. This situation can generate a second use signal which can switch on the encoder function of the electrical system.

[0118] The third embodiment is depicted in Figs. 6 to 8 and is similar to the first embodiment. Again, the dose dial sleeve 20 (not shown) is provided with an encoder ring 30 having ratchet teeth 31 and a ratchet recess 32. Further, the chassis 40 (not shown) is provided with a guide groove 41 guiding a shuttle 50 adapted to engage the ratchet teeth 31 and the ratchet recess 32.

[0119] In contrast to the first embodiment, the third embodiment comprises a cylindrical portion 34 of the encoder ring 30, which is located at the proximal end of the encoder ring 30. Thus, the ratchet formed by the ratchet teeth 31 and the ratchet recesses 32 is located distally of the cylindrical portion 34. In addition, the design of the electrical contacts 42, 43 is modified such that the switch formed by the electrical contacts 42, 43 is open when the shuttle 50 abuts the cylindrical portion 34 or is pushed radially inwards by contact with the ratchet teeth 31. On the other hand, the switch formed by the electrical contacts 42, 43 is closed when the shuttle 50 is allowed to enter into the ratchet recesses 32 due to the bias of the electrical contacts 42 acting on the shuttle 50. In other words, the operation of the third embodiment is essentially the opposite compared to the first embodiment.

[0120] In a similar manner as in the first embodiment, the encoder ring 30 of the third embodiment can be provided with a transition ramp 33 between the cylindrical portion 34 and the ratchet portion 31, 32. In addition or as an alternative, the shuttle 50 can be provided with a corresponding ramp at the ratchet teeth 51.

[0121] In the third embodiment, in the initial position or state (i.e. before dose setting), the shuttle 50 is held on the cylindrical portion 34 of the encoder ring 30. In this case, the switch 42, 43 is open. When the user rotates the dose dial sleeve 20 by means of the dose knob 12, the switch 42, 43 remains open during dose setting. Upon pressing the button 11 by the user (i.e. causing the relative axial movement of the button 11 (together with the chassis 40) relative to the dose dial sleeve 20 (together with the encoder ring 30), the shuttle 50 is biased by the electrical contacts 42 to fall into the ratchet recesses 32, thereby closing the switch 42, 43. This closure of the switch is detected and causes the generation of a first signal, thereby switching on the manual synchronization and pairing function of the electrical system.

[0122] During dose delivery operation, the shuttle 50 is repeatedly pushed radially inwards by the interaction of the ratchet teeth 51 with the ratchet teeth 31 against the bias of the electrical contacts 42. Thus, the switch 42, 43 is repeatedly opened and closed (when a ratchet tooth 51 falls into one of the ratchet recesses 32). This can be detected and can cause the generation of a second use signal, thereby switching on the encoder function of the electrical system.

[0123] A fourth embodiment is depicted in Figs. 9a to 13. Again, the dose dial sleeve 20 is provided with an encoder ring 30 having ratchet teeth 31 and ratchet recesses 32. Further, the chassis 40 is provided with a guide groove 41 guiding the shuttle 50 adapted to engage the ratchet teeth 31 and the ratchet recesses 32. In addition, electrical contacts 42, 43 are provided in a similar configuration as in the first embodiment, i.e. if the ratchet teeth 51 of the shuttle 50 engage the ratchet recesses 32, a switch formed by the contacts 42, 43 is open and when the ratchet teeth 51 pass one of the ratchet teeth 31 and are pushed radially inwards against the bias of the electrical contact 42, the switch is closed.

[0124] In contrast to the first to third embodiments, the encoder ring 30 is not provided with a cylindrical portion intended to engage the shuttle 50. Thus, the encoder ring 30 can be shorter in axial direction compared to the first to third embodiments. The dose setting and drive mechanism of the fourth embodiment further comprises a clutch sleeve 60 and an inner housing 70. The clutch sleeve 60 can be provided with a ring of clutch teeth 61 provided on a flange-like portion 62 to engage a corresponding ring of clutch teeth 21 provided on the dose dial sleeve 20. A clutch spring (not shown) can be provided acting on the clutch sleeve 60 to urge the clutch teeth 21 into engagement with the clutch teeth 61. When the user presses the button 11, e.g. for a dose delivery operation, the clutch teeth 21, 61 can disengage against the bias of the clutch spring, thereby axially displacing the clutch sleeve 60 relative to the dose dial sleeve 20. The dose dial sleeve 20 can be threadedly engaged with the inner housing 70 such that the dose dial sleeve 20 is guided along a helical path during dose setting and dose delivery operations. Further, the inner housing 70 is provided with a proximal end face 71 abutting the flange-like portion 62 of the clutch sleeve 60. When the button 11 is pressed, the distal side of the flange-like portion 62 abuts the proximal end face 71 at the end of a dose delivery. Upon release of the button 11 by the user, the clutch spring lifts the flange-like portion 62 away from the proximal end face 71, thereby re-engaging the clutch teeth 21, 61.

[0125] The dose setting and drive mechanism of the fourth embodiment further comprises a pin 80 guided in the chassis 40 such that relative axial movement of the pin 80 relative to the chassis 40 is allowed. The pin 80 comprises a finger 81 passing through a cut-out in the flange-like portion 62 of the clutch sleeve 60 and protruding distally through the flange-like portion 62 as shown in Figs. 9a and 10a. Further, the pin 80 comprises a ramp 82 on the proximal side of the pin 80. This ramp 82 engages a corresponding ramp 52 of the shuttle 50 through a cut-out in the guide groove 41 of the chassis 44.

[0126] When the finger 81 of the pin 80 protrudes distally through the flange-like portion 62, the distal end of the finger 81 abuts the proximal face 71 of the inner housing 70 at the end of dose delivery (i.e. when the dose dial sleeve 20 and the clutch sleeve 60 are moved distally relative to the inner housing 70). This causes the pin 80 to be axially displaced relative to the chassis 40 such that the ramp 82 engages the ramp 52 of the shuttle 50 and pushes the shuttle 50 radially inwards against the bias of the electrical contact 42, thereby closing the switch formed by the electrical contacts 42, 43. By closing this switch, a first signal is generated, thereby switching on the manual synchronization and pairing function of the electrical system.

[0127] During a dose delivery operation, the shuttle 50 is repeatedly pushed radially inwards against the bias of the electrical contact 42 by the interaction of the ratchet teeth 51 with the ratchet teeth 31, as explained above with respect to the first embodiment. Thus, the switch 42, 43 is repeatedly opened and closed (when a ratchet tooth 51 falls into one of the ratchet recesses 32). This can be detected and can cause the generation of a second use signal, thereby switching on the encoder function of the electrical system.

[0128] A fifth embodiment is depicted in Figs. 14 to 17. In this fifth embodiment, an electrical use detection unit 130 for detecting a first signal causing the switching on of the manual synchronization and pairing function of the electrical system is located in the dose knob 12 below the button 11. In contrast to the other embodiments, in which the dose knob 12 and the button 11 can be a single integral part, the button 11 is formed as a separate cap that is attached to the skirt of the dose knob 12 during assembly of the system or device. A printed circuit board (PCB) 90 is located within the dose knob 12 below the button 11, on which an axial switch 91 is provided, e.g. centrally. The PCB 90 can further comprise other electronic components, such as LEDs 92.

[0129] In the fifth embodiment, the cap-like button 11 is elastically deformable, e.g. by means of a skeleton as depicted in Fig. 16. Preferably, this skeleton is covered by a skin made of a softer material, such that the skin can form a circumferential seal by means of an engaging lip of a corresponding groove in the skirt of the dose knob 12, as shown in Fig. 17. The skin can further comprise a translucent portion, such that a backlit logo or the like can be provided on the button 11, which can indicate the operation of the electrical system (e.g. the manual synchronization and pairing function of the electrical system).

[0130] The force required to actuate the axial switch 91 can be selected in dependence of the intended function. Thus, the axial switch 91 can be actuated by a relatively low force, such that the axial switch 91 is activated before the clutch (e.g. the clutch formed by the clutch teeth 21 of the dose dial sleeve 20 and the clutch teeth 61 of the clutch sleeve 60) disengages. As an alternative, the force required to actuate the axial switch 91 can be relatively high (e.g. exceeding the force of the clutch spring acting on the clutch sleeve 60). This results in the axial switch 91 being actuated during or at the end of a dose delivery operation.

[0131] Although not depicted in Figs. 14 to 17, a second use signal can be generated during dose delivery, thereby switching on the encoder function of the electrical system. The generation of the second use signal can be identical or similar to the generation of the second use signal in the first to fourth embodiments, i.e. by the interaction of the shuttle 50 with the ratchets 31, 32 of the encoder ring 30.

[0132] The electronic system 100 comprises an electronic control unit 110. The control unit can comprise a controller. In particular, the control unit can comprise a processor arrangement. Moreover, the control unit 110 can comprise one or more memory units, like a program memory and a main memory. The control unit 110 is conveniently designed to control the operation of the electronic system 100. The control unit 110 can communicate with further units of the electronic system 100 via a wired or wireless interface. The control unit 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 by lines in Fig. 18. However, there can also be connections between the units which are not explicitly shown. The control unit can be arranged on a conductor carrier (e.g. a (printed) circuit board, like the PCB 90 shown in Figs. 14, 15 and 17). One or more other units of the electronic system can comprise one or more components which are also arranged on the conductor carrier.

[0133] The electronic system 100 can further comprise a motion sensing unit 120. The motion sensing unit 120 can comprise one or more sensors, such as the sensor switches 42, 43, 44 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 120 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 120 or calculated therefrom, the control unit can calculate dose data.

[0134] The electronic system 100 can further comprise a use detection unit 130. The use detection unit can be associated with one user interface member, such as the button 11, 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. When a manipulation is detected, the use detection unit generates or triggers the generation of a use signal. The use signal can be transmitted to the electronic control unit 110. The electronic control unit can issue a command or signal to one of the other electrically operated units of the system, to a plurality of electrically operated units arbitrarily selected, or to all electrically operated units in response to said signal. For example, the control unit can cause the respective units 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 respective switching commands or signals issued by the electronic control unit to the respective units. 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 already started.

[0135] The electronic system 100 can further comprise a communication unit 140, e.g. an RF, WiFi and / or Bluetooth unit. The communication unit can be arranged 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 establishing a dose record or dose history in the external device. The communication unit can be arranged for wireless or wired communication.

[0136] The electronic system can further comprise a power source 150, e.g. a rechargeable or non-rechargeable battery. The power source 150 can provide power to the respective units of the electronic system.

[0137] 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.

[0138] Still further, in embodiments, the electrical usage detection unit 130 can comprise a capacitive sensor instead of the axial switch 91.

[0139] In general, according to the present disclosure, the electrical usage detection unit 130 can be able to detect contact to one face of the electronic system, e.g. the top face of the electronic module, which means that dose synchronization with an application of a further electronic device, e.g. a mobile phone, a personal computer, a laptop, etc. or setting the electronic module into Bluetooth advertising mode can be initiated using this system. In case the dose button 11 is pressed (but no dose is selected) for a time greater than ti (e.g. 1 second) but less than t2(e.g. 5 seconds), only one channel of the two IR-LEDs 92 is observed to enter the "high" state. This characteristic signal can be used to initiate a dose synchronization sequence with an application.

[0140] Similarly, if the dose button 11 is pressed (but no dose is selected) for a time greater than t2(e.g. 5 seconds), the characteristic optical signal can be used to initiate a Bluetooth advertising sequence.

[0141] Thus, if the switch remains closed for a specified time period (e.g. 3 to 5 seconds) to initiate synchronization and / or more than 5 seconds to initiate Bluetooth pairing, dose synchronization and Bluetooth pairing can be implemented with the top mounted switch 91 of the electrical usage detection unit 130 or other alternatives as described above.

[0142] Reference signs

[0143] 1 device 100 electronic system

[0144] 10 housing 110 control unit

[0145] 11 injection button 120 motion sensing unit

[0146] 12 dose knob 130 use detection unit

[0147] 13 dose window 140 communication unit

[0148] 14 container / container receptacle 150 power source

[0149] 15 needle

[0150] 16 inner needle cap

[0151] 17 outer needle cap

[0152] 18 cap

[0153] 20 dose dial sleeve

[0154] 21 clutch teeth

[0155] 30 encoder ring

[0156] 31 ratchet teeth

[0157] 32 ratchet recess

[0158] 33 transition ramp

[0159] 34 cylindrical portion

[0160] 40 chassis

[0161] 41 guide groove

[0162] 42 electrical contact

[0163] 43 electrical contact

[0164] 44 electrical contact

[0165] 50 shuttle (switch feature)

[0166] 51 ratchet teeth

[0167] 52 ramp

[0168] 60 clutch sleeve

[0169] 61 clutch teeth

[0170] 62 flange-like protrusion

[0171] 70 inner housing

[0172] 71 proximal face

[0173] 80 pin

[0174] 81 finger

[0175] 82 ramp

[0176] 90 PCB

[0177] 91 axial switch

[0178] 92 LED

Claims

1. An electronics system for a drug delivery device (1), the electronics system comprising: - 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 (20, 30, 90) being a dial sleeve (20) or a member (30) axially and / or rotationally locked to the dial sleeve, and a second member (11, 40, 70, 80) being a dose and / or injection button (11) or a member (40) axially and / or rotationally locked to the dose and / or injection button, wherein the dose setting and drive mechanism is configured such that the first member moves relative to the second member at least in the dose delivery operation and / or in the dose setting operation, - a communication unit (140) for communicating with another device, - an electronic control unit (110) configured to control the operation of the electronics system, the electronics system having a first state in which the communication unit (140) is not activated and a second state in which the communication unit (140) is activated, - an electrical usage detection unit (130) operatively connected to the electronic control unit, the electrical usage detection unit being configured to generate a first signal indicating that a user has started or ended a relative movement between the first member (20, 30, 90) and the second member (11, 40, 70, 80), 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 (110) in response to the first signal, thereby causing the communication unit (140) to establish the communication with another device, wherein the electronics system comprises a movable switch feature and wherein the movable switch feature is elastically biased into engagement with a blocking feature before the first member moves axially relative to the second member by a predetermined distance, wherein the blocking feature is removed from the switch feature when the first member moves relative to the second member, such that a biasing force can drive movement of the switch feature to cause generation of the first signal.

2. The electronics system according to claim 1, wherein the communication unit (140) comprises a wireless communication interface to communicate with another device, 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 first signal, thereby causing the communication unit (140) to initiate a manual synchronization and / or pairing with another device.

3. The electronic system of claim 1 or 2, wherein the electrical use detection unit (130) is configured to generate a second use signal, the second use signal being indicative of the user having started the dose setting operation or the dose delivery operation, wherein the electronic system is configured such that the electronic system is switched by the electronic control unit (110) from the first state or the second state to a third state in response to the second use signal, wherein dose data is collected in the third state, and wherein the electrical use detection unit (130) or the motion sensing unit (120) is configured to generate the second use signal in response to a relative movement of two components of the dose setting and drive mechanism during the dose delivery operation.

4. The electronic system of claim 1 or 2, wherein the electrical use detection unit (130) is configured to generate a second use signal, the second use signal being indicative of the user having started the dose setting operation or the dose delivery operation, wherein the electronic system is configured such that the electronic system is switched by the electronic control unit (110) from the first state or the second state to a third state in response to the second use signal, wherein dose data is collected in the third state, and wherein the electrical use detection unit (130) or the motion sensing unit (120) is configured to generate the second use signal in response to a relative rotational movement between a third component of the dose setting and drive mechanism and one of the first component and the second component during the dose delivery operation.

5. The electronic system of claim 1 or 2, wherein the moveable switch feature is a linearly guided switch feature, the switch feature being operatively coupled to one or both of the first component (20, 30, 90) and the second component (11, 40, 70, 80) such that an axial displacement of the first component relative to the second component causes a movement of the switch feature (50) relative to the first component and / or the second component, and wherein the electronic system is configured such that an axial movement of the switch feature (50) is used to trigger the generation of the first signal.

6. The electronic system of claim 5, wherein the linearly guided switch feature is a shuttle (50).

7. The electronic system of claim 1 or 2, wherein the moveable switch feature (50) is operatively coupled to the first component and / or the second component such that a predetermined axial displacement of the first component relative to the second component translates into a movement of the switch feature to cause the generation of the first signal, in particular at the end of the dose setting operation or the dose delivery operation.

8. The electronic system of claim 1 or 2, wherein the movable switch feature (50) is operatively coupled to the first member and / or the second member such that a predetermined axial displacement of the first member relative to the second member translates into a movement perpendicular to the predetermined axial displacement of the first member relative to the second member to cause generation of the first signal, in particular at the end of the dose setting operation or the dose delivery operation.

9. The electronic system of claim 1 or 2, wherein the electrical usage detection unit (130) comprises at least one electrically conductive spring arm (42, 44) deflectable in response to relative movement between the first member and the second member to establish or break an electrical connection with at least one electrical contact (43), wherein the electrical usage detection unit (130) is configured to generate the first signal in response to establishing or breaking the electrical connection between the at least one electrically conductive spring arm (42, 44) and the at least one electrical contact (43).

10. The electronic system of claim 1 or 2, wherein the electrical usage detection unit (130) comprises at least one electrically conductive spring arm (42, 44) deflectable in response to relative axial movement between the first member and the second member to establish or break an electrical connection with at least one electrical contact (43), wherein the electrical usage detection unit (130) is configured to generate the first signal in response to establishing or breaking the electrical connection between the at least one electrically conductive spring arm (42, 44) and the at least one electrical contact (43).

11. The electronic system of claim 1 or 2, wherein, The first member is rotatable relative to a housing (70) of the dose setting and drive mechanism at least in the dose setting operation, and wherein the second member is axially displaceable relative to the first member and rotationally constrained by the housing (70) at least in the dose setting operation.

12. The electronic system of claim 1 or 2, wherein, The first member is rotatable relative to a housing (70) of the dose setting and drive mechanism along a helical path at least in the dose setting operation, and wherein the second member is axially displaceable relative to the first member and rotationally constrained by the housing (70) at least in the dose setting operation.

13. The electronic system of claim 1 or 2, wherein the first member comprises an encoder ring (30) having a first portion (32) with a first inner diameter and a second portion (34) with a second inner diameter different from the first inner diameter, wherein the first portion and the second portion are located at axially different positions of the encoder ring (30).

14. The electronic system of claim 13, wherein a transition ramp (33) is axially interposed between the first portion and the second portion.

15. The electronic system of claim 13, wherein one of the first part (32) and the second part (34) is provided with radially inwardly directed ratchet teeth (31) and / or ratchet recesses (32).

16. The electronic system of claim 1 or 2, wherein the first member is axially displaceable relative to a housing (70) of the dose setting and drive mechanism at least in the dose delivery operation, and wherein the second member is a member that is axially displaceable relative to the first member at least in the dose delivery operation when in abutment with the housing (70) or a member axially locked to the housing.

17. The electronic system of claim 1 or 2, wherein the first member is axially displaceable along a helical path relative to a housing (70) of the dose setting and drive mechanism at least in the dose delivery operation, and wherein the second member is a pin (80) that is axially displaceable relative to the first member at least in the dose delivery operation when in abutment with the housing (70) or a member axially locked to the housing.

18. The electronic system of claim 16, wherein the second member (80) is guided in a dose and / or injection button (11) or a member (40) axially and / or rotationally locked to the dose and / or injection button such that the second member (80) abuts the housing (70) or a member axially locked to the housing only when the dose and / or injection button (11) is axially displaced against a bias of a spring.

19. The electronic system of claim 1 or 2, wherein the first member is a dose and / or injection button (11) and the second member is a chassis or skirt of a dose knob (12), wherein the dose and / or injection button (11) is axially displaceable and / or axially elastically deformable relative to the second member, and wherein the electrical use detection unit (130) comprises an axial switch (91) such that axial displacement of at least a portion of the dose and / or injection button (11) relative to the second member actuates the axial switch (91).

20. The electronic system of claim 1 or 2, wherein the first member is a dose and / or injection button (11) and the second member is a chassis or skirt of a dose knob (12), wherein the dose and / or injection button (11) is axially displaceable and / or axially elastically deformable relative to the second member, and wherein the electrical use detection unit (130) comprises an axial switch (91) mounted on a PCB (90) such that axial displacement of at least a portion of the dose and / or injection button (11) relative to the second member actuates the axial switch (91).

21. The electronic system of claim 1 or 2, wherein the dial sleeve (20) is a digital sleeve.

22. A drug delivery device comprising the electronic system of any of claims 1-21 and further comprising a cartridge containing a medicament.

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