Switch assembly for an electronic system of a drug delivery device

Abstract

The invention relates to a switch assembly (20, 30) for an electronic system of a drug delivery device (1). The switch assembly comprises a chassis (19) supporting a PCBA (110) comprising at least a first electrical contact (23a), a second electrical contact (23b), a third electrical contact (23c) and a fourth electrical contact (23d), and a ring (21) having a ratchet profile (22). During a first switch operating mode, the chassis (19) is axially moved relative to the ring (21) from a first axial position to a second axial position. The chassis (19) and the ring (21) are configured such that the ring (21) is rotated relative to the chassis (19) during a second switch operating mode. The first electrical contact (23a) and the second electrical contact (23b) are arranged such that an electrical connection between the first electrical contact (23a) and the second electrical contact (23b) is closed when the chassis (19) is axially moved towards the ring (21) during the first switch operating mode. Further, an elastically deformable arm (24) is radially interposed between the ratchet profile (22) of the ring (21) and the chassis (19) and guided over the ratchet profile (22) such that the arm (24) is elastically deformed in radial direction towards the chassis (19) at least during the second switch operating mode, thereby alternatingly opening and closing an electrical connection between the third electrical contact (23c) and the fourth electrical contact (23d) via the arm (24).

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 by persons without formal medical training. This can be increasingly common among patients having diabetes, for whom self-treatment enables them 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 (i.e. disposable). For example, disposable pen-type delivery devices are supplied as self-contained devices. Such self-contained 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 or to support 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 related to the amount of drug expelled from a reservoir by an expelling device.

[0005] However, the management of the power supply resources integrated into the device is particularly important, especially in case the device is designed as self-contained (that is to say without a connector for connecting to a power source necessary for the operation of the device).

[0006] Unpublished EP 20315066.9 and EP 20315357.2 disclose advantageous embodiments of an electronic system for a drug delivery device with improved power management. These electronic systems comprise a switch assembly for activating / deactivating the power consumption functions of the electronic system.

[0007] An alternative rotary encoder is known from WO 2019 / 173097 A1 comprising several switches selectively opened and closed by a mechanical wave generator whose data profile is in the form of a concave and convex portion engaging and actuating the switches.

[0008] Such drug delivery devices are usually manufactured on a large scale, so that an efficient and simple assembly is an important factor to keep production costs rather low.

[0009] It is an object of the present disclosure to provide improvements for a drug delivery device comprising an electronic system or an electronic system for a drug delivery device, allowing for reliable activation / deactivation of functions of the electronic system and an efficient assembly.

[0010] This object is solved, e.g., by the subject matter defined 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] One aspect of the present disclosure relates to a switch assembly for an electronic system of a drug delivery device. The switch assembly comprises a chassis supporting a PCBA, a distal surface of the PCBA comprising at least a first electrical contact, a second electrical contact, a third electrical contact, and a fourth electrical contact. The switch assembly further comprises a ring, e.g., an encoder ring of a rotary sensor, the ring comprising a ratchet profile. The ratchet profile can comprise a base section and a tooth peak section, e.g., arranged facing a radial inner side of the ring. Preferably, the chassis and the ring are arranged and adapted such that during a first switch operation mode, e.g., during a transition from a dose setting operation to a dose delivery operation of the drug delivery device or when the chassis is pressed under a 0U dialing condition of the drug delivery device, the chassis is axially moved relative to the ring from a first, e.g., more distal axial position to a second, e.g., more proximal axial position. Further, the chassis and the ring are configured such that during a second switch operation mode, e.g., during the dose delivery operation of the drug delivery device, the ring is rotated relative to the chassis. A reliable switching of the two switch modes is obtained if the first electrical contact and the second electrical contact are arranged such that during the first switch operation mode, upon the axial movement of the chassis towards the ring, an electrical connection between the first electrical contact and the second electrical contact is closed. In addition, an elastically deformable arm can be radially interposed between the ratchet profile of the ring and the chassis. Preferably, the arm is axially and rotationally constrained by the chassis and guided over the ratchet profile such that the arm is elastically deformed in radial direction towards the chassis at least during the second switch operation mode, thereby alternatingly opening and closing an electrical connection between the third electrical contact and the fourth electrical contact via the arm.

[0012] This arrangement of the switch assembly has the further advantage that the chassis, the PCBA with its contacts at the distal surface, the ring and the contacts can be mounted to each other from the same direction to form the switch assembly. This significantly improves the assembly efficiency compared to alternatives which require mounting of the components from different directions. In addition, the number of additional components required to establish the switch assembly is relatively low. For example, in a drug delivery device with an electronic system comprising a ring, a chassis and a PCBA, only a metal component comprising an arm needs to be provided. Thus, only the ring and the PCBA need to be modified to provide a switch assembly according to the present disclosure. The lower number of additional components contributes to a highly efficient assembly process.

[0013] According to a further independent aspect of the present application, a rounded metal piece is provided, which is scalable in diameter, thickness and height and thus can be adapted to various drug pens and / or their respective connection modules, in which one or more spring elements are built in. During a rotational movement of either part of the pen and / or connection module, the spring elements can interact with the respective counterpart. According to this aspect of the present application, the rounded metal part can be fixed or rotating, with the counterpart being rotating or fixed, respectively. The total force of the rotating part against the fixed part in a rotational application can be adjusted by choosing the spring accordingly. This aspect of the present application is based on the idea that if the spring element interacts with the counterpart, the spring is reversibly bent, for example by closing or opening an electrical contact, which bending can be used as a trigger signal. The rotational movement between the spring element and the counterpart can be used in both directions. As a further benefit, the relative rotational movement between the two parts can be used to generate a haptic and / or audible patient feedback signal.

[0014] In the switch assembly, the arm can comprise at least one pawl or protrusion which is adapted to engage a ratchet profile of the ring. In more detail, the pawl or protrusion can fit into a bottom section of the ratchet profile and can be able to slide over a tooth peak section of the ratchet profile upon relative rotation of the ring with respect to the chassis and the arm. The ratchet profile and the pawl can be adapted to each other to allow relative rotation in only one direction while blocking relative rotation in the opposite direction. As an alternative, the ratchet profile and the pawl can allow relative rotation in both directions.

[0015] The installation of the switch assembly can be facilitated if the arm is part of a substantially ring-shaped electrically conductive spring member which is biased to abut the ratchet profile of the ring and which is able to be at least partially deflected radially inwards into the annular space between the ring and the chassis. For example, the spring member can be a slotted ring which is clamped into the space between the ring and the chassis by elastically expanding or elastically constraining the spring member.

[0016] The rotational switch of the switch assembly can be established in a simple and reliable manner if the third and fourth electrical contacts are provided on a flexible tab or flexible plate section of the PCBA that extends distally from the PCBA to a position between the ring and the chassis. In other words, the third and fourth contacts can be arranged close to each other on the tab or flexible plate section such that contact of the tab or flexible plate section with the arm electrically bridges and connects the third and fourth electrical contacts. For example, the arm can alternate between contacting the contact base section and the tooth peak section of the ratchet profile and thereby elastically deflect to connect and disconnect the third and fourth electrical contacts during the second switch operating mode.

[0017] The axial switch of the switch assembly can comprise a first electrical contact, which can be a first lever having one end attached to the PCBA and an opposite free end, and a second electrical contact, which can be a second lever having one end attached to the PCBA and an opposite free end. For example, the free ends of the levers are arranged such that the electrical connection between the first and second electrical contacts is closed by deflecting at least the first lever relative to the second lever upon axial movement of the chassis towards the ring during the first switch operating mode. In more detail, the first lever can extend through the chassis with its free end protruding from the chassis to a position that is deflected by the ring or a component connected to the ring, such as a part of the dial assembly, upon axial movement of the chassis towards the ring during the first switch operating mode. In this example, the first and second levers can be located in a space formed in the chassis radially inside the ring.

[0018] As an alternative, the axial switch of the switch assembly can further comprise a housing and a dial grip or dose knob. For example, the axial movement of the chassis towards the ring during the first switch operating mode can be caused by an axial displacement of at least a part of the dial grip or dose knob relative to the housing that closes a gap between the first and second electrical contacts. In this example, the first and second electrical contacts can be arranged on a proximal side of the PCBA facing away from the ring.

[0019] According to another aspect of the present disclosure, a method for assembling a drug delivery device is provided, the drug delivery device comprising a dose setting and drive mechanism, an electronic system having a switch assembly comprising a chassis, a PCBA with its contacts at a distal surface, a ring having an annular ratchet profile, and first and second electrically conductive arms, wherein the components of the drug delivery device are mounted into and / or onto each other from a single direction, preferably from a proximal button end towards a distal dispensing end of the drug delivery device. Some of the components can be mounted as pre-assembled sub-units, which can or can not themselves be mounted from the same single direction.

[0020] Examples of the switch assembly are particularly suitable for drug delivery devices comprising an electronic system. The invention is suitable for devices which are driven manually, e.g. by a user exerting force on an injection button module, for devices which are driven by a spring or the like, and for devices which combine both concepts (i.e. spring assisted devices which still require a user to exert injection force). Spring type devices involve pre-loaded springs and springs which 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.

[0021] According to an aspect of the present disclosure, the drug delivery device can comprise an electronic system having a switch assembly as described above. For example, the drug delivery device can comprise a dose setting and drive mechanism and a button module. In more detail, 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. Preferably, the dose setting and drive mechanism comprises the ring of the switch assembly. Further, the button module can comprise an electronic control unit on the PCBA, a rotation sensor having e.g. a light source and a corresponding optical sensor, a communication unit having a wireless communication interface for communicating with another device, and a usage detection unit comprising the switch assembly. Preferably, the electronic control unit is configured to control the operation of the electronic system.

[0022] According to another aspect of the present disclosure, the button module and the dose setting and drive mechanism can be configured such that the dose dial assembly rotates relative to the button module during the dose delivery operation, but does not rotate relative to the button module during the dose setting operation, and such that the button module moves axially relative to the dose dial assembly during a transition from the dose setting operation to the dose delivery operation or when the button module is pressed in a 0U dial condition.

[0023] According to another aspect of the present disclosure, the electronic system is configured such that the communication unit is switched from the sleep mode to the operational mode, thereby causing the communication unit to initiate a manual synchronization and / or pairing with another device when the electrical connection between the first electrical contact and the second electrical contact is closed during the first switching operational mode. Additionally or alternatively, the electronic system is configured such that the rotation sensor is switched from the sleep mode to the operational mode, thereby causing the rotation sensor to initiate movement detection when the electrical connection between the second electrical contact and the third electrical contact is closed via the arm during the second switching operational mode.

[0024] The present disclosure provides advantageous implementations relating to the integration of mechanically activated electronic switches to initiate different device functions. The at least one switch assembly can form or can be part of a usage detection unit of the electronic system. Such a usage detection unit can comprise a rotationally activated electronic switch (rotation switch) to wake up an electronic coding module attached to an injection device and / or an axially activated electronic switch (axial switch) to initiate a pairing function of a coding module (e.g. a rotation sensor) attached to an injection device with another smart electronic device. The mechanically activated electronic switch can be or can constitute part of an electrical usage detection unit operably connected to an electronic control unit. The electrical usage detection unit can be configured to generate a first signal indicating that a user has started or completed a relative movement between a dose setting and drive mechanism and a button module. Thus, the present invention allows an injection device to remain in a low power state without the need to power up the coding sensor(s) or to pair, but to wake up when any of the functions are required. This is particularly suitable for devices where the module rotates relative to an axially adjacent mechanism component during dose delivery, but not during dialling, and / or for devices where the module moves axially relative to an adjacent mechanism component during the transition from dialling to dispensing state or when the button module is pressed in the 0U dialled condition (i.e. the state after completion of a dose dispensing and before a new dose is selected).

[0025] According to one aspect of the present disclosure, the electronic system comprises a dose setting and drive mechanism configured to perform a dose setting operation for setting a dose to be delivered by a drug delivery device and a dose delivery operation for delivering the set dose. The dose setting and drive mechanism comprises at least a ring which can preferably be indirectly operable by a user during the dose setting operation and / or the dose delivery operation. For example, the dose setting and drive mechanism can comprise one or more of the following components: a dial grip, a dial or display member (e.g. a number sleeve), a driver, a coupling, a piston rod, an inner housing and / or an outer housing component. The dose setting and drive mechanism of the present invention can be based on the dose setting and drive mechanism disclosed in EP 2 890 435.

[0026] According to another aspect of the present application, the electronic system comprises a button module comprising at least an electronic control unit, e.g. consisting of or comprising a PCBA, configured to control the operation of the electronic system. The button module can be permanently or detachably attached to a trigger, a button or a dial grip, e.g. at or near the proximal end of the drug delivery device. The button module and / or the electronic control unit can have a distal surface facing towards the dose setting and drive mechanism, e.g. for providing an interface for mechanical interaction and / or electrical connection with other components of the system.

[0027] 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. The electronic control unit can have at least a first (preferably low power consumption) state and a second (preferably high power consumption) state. In the first state, the system can be in an idle state, wherein the system is not operable to use the required functionality assigned to the electronic system, e.g. use detection, motion detection, encoding, synchronization and / or pairing. In other words, in this first state, at least one functionality can not be activated. In the second state, the system can be ready to operate using the required 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. The power consumption of the electronic system can be increased in the second state compared to the first state. For example, one or more electrical or electronic units of the electronic system can be switched to a higher power consumption state (e.g. an on state) in the second state compared to the first state, wherein the respective unit can be in a low power consumption sleep state or in an off state with no power consumption at all (e.g. because the connection to the power supply is interrupted). For example, a communication unit and / or an encoding module (e.g. a rotation sensor) can be activated in this second state.

[0028] The encoding module or unit is generally adapted to detect a movement of a specific component of the dose setting and drive mechanism and to generate a signal indicative of the amount of movement of this component. For example, the encoding module or unit can detect a rotational movement of an encoder ring attached to the dial sleeve, preferably the ring of the switch assembly, during a dose setting operation and / or during a dose delivery operation. According to one aspect of the present disclosure, the encoding module comprises a rotation sensor for detecting the rotational movement. The rotation sensor can comprise a light source with a respective optical sensor, preferably two light sources with two respective optical sensors, for detecting the rotational movement of a component having a pattern. As an alternative, the rotation sensor can use other detection techniques, e.g. the rotation sensor can comprise electrical sliding contacts, a mechanical switching assembly and / or a magnetic sensor.

[0029] For example, the encoder ring can further comprise a pattern arranged at least on its outer surface, which pattern can be detected by a rotation sensor. According to one aspect, the rotation sensor comprises a primary sensor and a secondary sensor, which are configured to target a specifically adapted region at the proximal end of the dial sleeve, e.g. at the encoder ring. In this example, the primary and secondary sensors can be light reflective sensors. Thus, the specifically adapted proximal region of the dial sleeve or encoder ring can be divided into at least one reflective region and at least one non-reflective (or absorptive) region. The rotation sensor can be an optical sensor that emits light from an LED, the light of which is reflected by the reflective region(s) of the encoder ring and the reflected light is detected by the sensor. The sensor then converts the detected light into an electrical output. The encoding or motion sensing unit can comprise one or more such optical rotation sensors, e.g. two optical rotation sensors positioned circumferentially spaced around the encoder ring.

[0030] The electronic system can further comprise an encoding or motion sensing unit in a dormant mode in the first low power consumption state and activated in the second high power consumption state and / or a communication unit for communicating with another device, the communication device being in a dormant mode in the first low power consumption state and activated in the second high power consumption state. In exemplary embodiments of the present disclosure, the electronic system can comprise an encoding or motion sensing unit and a communication unit, wherein both units can be independently activated or in a dormant mode. Thus, there can be more than two power consumption states, namely a state in which both units are deactivated or in a dormant mode, a state in which only the encoding or motion sensing unit is activated, a state in which only the communication unit is activated, and a state in which both units are activated. For each of these four states, the power consumption of the electronic system can differ. However, for reasons of simplification, only the first low power consumption state and the second high power consumption state are discussed herein.

[0031] In embodiments, the electronic system can be adapted to use the encoding or motion sensing unit 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 second state of the system. In one embodiment, when activated, the encoding or motion sensing unit can be operable to collect motion data or measure data related to the movement of e.g. the dialing member, the driver and / or the piston rod. The electronic control unit can be configured to convert this data into dose data, e.g. a characteristic of the size of a dose that has been set in a respective operation or has been delivered. The encoding or motion sensing unit can be designed as described in unpublished EP 20315066.9 and EP 20315357.2, the disclosure of which is incorporated herein by reference.

[0032] The communication unit can comprise a wireless communication interface for communicating with another device, wherein the electronic system is configured such that it is switched from the first state to the second state by the electronic control unit in response to the first signal, thereby causing the communication unit to initiate a manual synchronization and / or pairing with the other device.

[0033] 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 the unit is turned on or in an operational state. The unit can be a communication unit for communicating with another device, e.g. a wireless communication interface for communicating with another 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 device, such as another electronic device, e.g. a mobile phone, a personal computer, a laptop, etc. For example, dose data can be transmitted by the communication unit to the external device. The dose data can be used in a dose log or dose history established in the external device.

[0034] In one embodiment, the communication unit comprises a wireless communication interface for communicating with another device, wherein the electronic system is configured such that it is switched from the first state to the second state by the electronic control unit in response to the first signal using at least one switch of the electrical usage detection unit, thereby causing the communication unit to initiate a manual synchronization and / or pairing with the other device or to initiate a mode for modifying settings of the electronic system.

[0035] According to one aspect of the present application, the electronic system comprises a dose setting and drive mechanism, a power source, e.g. a rechargeable or non-rechargeable battery, an electronic control unit, an electrical usage detection unit, and a coding or motion sensing unit and / or a communication unit for communicating with another device.

[0036] In one embodiment, the device or electronic system comprises an electronic control unit, e.g. comprising a microprocessor or microcontroller. The electronic control unit can be configured to control the operation of the drug delivery device or 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, such as a printed circuit board. The conductor carrier can be retained in the interior of a user interface member of the system or device. The power source can be arranged in the interior of the electronic system, as in the interior of the user interface member.

[0037] ​According to one aspect of the present disclosure, the electronic system is adapted to limit the battery capacity requirements of the injection device, wherein it is advantageous to be able to put the device in a low power state when no electronic functionality is required. This can be achieved by a mechanical switch that is activated by the relative movement between the electronic button module and the adjacent component, e.g. the encoder ring as exemplarily mentioned above as part of the dial sleeve assembly, upon demand.

[0038] According to one aspect of the present disclosure, the function of manual synchronization will be initiated upon pressing the button module when the device is in 0U dial. Upon pressing the button module, the button module is translated distally relative to the dial sleeve assembly, e.g. together with the coupling, in any device state. The nominal axial travel can be limited to e.g. less than 3 mm, e.g. between 1.5 mm and 2.0 mm, the travel of the button module relative to the dial sleeve (and encoder ring), further relative axial movement is limited. An axial switch using one embodiment of the detection unit is mounted on the underside of the button module and is triggered with the relative axial displacement between the button module and the dial sleeve assembly. The duration of the button module being held in the pressed state can be used to allow initiation of multiple different functions by the same switch, e.g. short time press and release for manual synchronization, or longer time press and release for pairing.

[0039] According to another aspect of the present disclosure, e.g. the encoded function can need to be initiated only when the device is dispensing. In the device disclosed in EP 2 890 435, for example, during dose setting, the dial sleeve assembly, e.g. consisting of the dial sleeve and the encoder ring, and the button module are rotated (translated) helically from the device. Thus, during dose setting, there is no relative rotation between the button module and the dial sleeve assembly. In order to initiate dose delivery, the button module is translated distally relative to the device housing, e.g. together with the coupling. After the coupling has translated a predetermined distance, e.g. less than 2.0 mm, e.g. nominally 1.20 mm, the coupling is disengaged from the dial sleeve and the delivery mechanism enters the dispensing (dose delivery) mode. In this dispensing mode, the dial sleeve assembly is retracted along the helical path into the device, while the button module is not rotated and is retracted only with axial movement until the 0U stop is engaged and dispensing is completed. Thereby, during dispensing, there is relative rotation between the button module and the dial sleeve assembly. In an exemplary embodiment using a rotational switch of the detection unit, this rotational switch can be mounted on the underside of the button module and is triggered with the relative rotation between the button module and the dial sleeve assembly.

[0040] In this exemplary application of the device disclosed in EP 2 890 435, the axial switch will also be triggered when the button module is pressed as part of a dispensing event. However, according to the described embodiment, the relative order of the rotation and axial switch state change cannot be guaranteed. It is possible that the axial switch will not be triggered before the point where the coupling disengages (e.g. 1.2 mm of button module translation), so some rotation of the dial sleeve assembly can occur before the axial switch state changes. Using the rotation switch to initiate, for example, an optical encoding system can ensure that the delivered dose is accurately recorded, independent of the axial position of the button module. Without the need to be triggered before the coupling disengages, the maximum deflection of the axial switch contact and thus the force, stress and packaging space of this axial switch can be minimized.

[0041] According to another aspect of the present disclosure, the use detection unit comprises an axial switch and a rotation switch, wherein the electronic control unit is adapted for switching the encoding or motion sensing unit into its low power consumption state in response to a signal indicating that the axial switch switches from its first electrical state (e.g. electrically open circuit) to its second electrical state (e.g. electrically closed circuit). In more detail, when the user releases the button module at the end of a dispensing (or in the middle of a dispensing event), the button module and the coupling translate proximally relative to the device, e.g. under the force of the coupling spring. The axial switch state will change during this movement, but the rotation switch state will not. The change of state of the axial switch after a dispensing event provides the controller (electronic control unit) with the information that the user has released the button module. Without this information, an increased delay duration is needed before the reading of the dispensed dose is displayed, as the system has to wait to check for no further rotation switch signal to determine if the dose is complete. This would have a negative impact on battery life and user experience. Thus, while the use detection unit can comprise only an axial switch or only a rotation switch, the combination of an axial switch and a rotation switch provides additional benefits beyond the possibility of triggering two different functions with two different switches.

[0042] The present invention further relates to a drug delivery device comprising an electronic system as described above. The drug delivery device can comprise a container receptacle releasably attached to the dose setting and drive mechanism. As an alternative, the container receptacle can be permanently attached to the dose setting and drive mechanism. The container receptacle is adapted for receiving a container containing a drug, e.g. a cartridge.

[0043] The terms“drug” or“medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients, or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient (“API”) is a chemical structure with a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. The drug or medicament can be used for a limited period, or on a regular basis for chronic diseases.

[0044] As described below, the drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of APIs can include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0045] The drug or medicament can be contained in a primary package or“drug container” suitable for use with a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide a suitable chamber for storing (e.g., short- or long-term storage) 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 store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs) separately, 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 one another (e.g., by way of a conduit between the two chambers) and allow the user to mix the two components when desired prior to dispensing. Alternatively, or additionally, the two chambers can be configured to allow mixing as the components are being dispensed into the human or animal body.

[0046] The medicaments or pharmaceutical agents contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, for example, diabetes mellitus or complications associated with diabetes mellitus (diabetic retinopathy), thromboembolism disorders (e.g. deep vein or pulmonary thromboembolism), acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and pharmaceutical agents are those as described in, for example, the

[0047] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide 1 (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refer to a polypeptide which has a molecular structure which can formally be derived by deleting and / or exchanging at least one amino acid residue occurring in a naturally occurring peptide, and / or by adding at least one amino acid residue, from the structure of the naturally occurring peptide (e.g., the structure of human insulin). The added and / or exchanged amino acid residue can be a codable amino acid residue or other naturally occurring residue or a purely synthetic amino acid residue. Insulin analogues are also referred to as “insulin receptor ligands”. In particular, the term “derivative” refers to a polypeptide which has a molecular structure which can formally be derived from the structure of the naturally occurring peptide (e.g., the structure of human insulin), wherein one or more organic substituent (e.g., a fatty acid) is bound to one or more amino acids. Optionally, 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.

[0048] Examples of insulin analogues are Gly(A21 ), Arg(B25), Arg(B26) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0049] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detear, ); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl Lys B28Pro B29 human insulin; B28-N-palmitoyl- Lys B28Pro B29 human insulin; B30-N-myristoyl-Thr B29Lys B30 human insulin; B30-N-palmitoyl-Thr B29Lys B30 human insulin; B29-N-(N-palmitoyl-Y-glutamyl)-des(B30) human insulin, B29-N-ooxocarboxypentadecanoyl-Y-glutamyl-des(B30) human insulin (insulin degludec, ); B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; B29-N-(ooxocarboxyheptadecanoyl)-des(B30) and B29-N-(ooxocarboxyheptadecanoyl) human insulin.

[0050] Examples of GLP-1, GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixlirapen Exendin-4, a 39 amino acid peptide produced by the salivary glands of the Gila monster, Liraplutide Semaglutide, Taspoglutide, Albiglutide Dulaglutide 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.

[0051] Examples of oligonucleotides are e.g. mipomersin sodium It is a cholesterollowering antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrome.

[0052] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0053] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and antagonists thereof, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, chorionic gonadotropin, menotropin), somatropin, desmopressin, tesamorelin, goserelin, triptorelin, leuprolide, buserelin, nafarelin and goserelin.

[0054] Examples of polysaccharides include glucosaminoglycane, hyaluronic acid, heparin, low molecular weight heparin or ultra low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g. polysulfated versions of the above polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 It is a sodium hyaluronate.

[0055] 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 an isotype or subtype that lacks the ability to bind an Fc receptor, an antibody fragment, or a mutant, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen binding portion of an immunoglobulin molecule that specifically binds an antigen, e.g., F(ab')2, Fab, Fv), or a complementarity determining region (CDR) of an immunoglobulin molecule. The term also encompasses immunoglobulin molecules with structural formulas other than the classical two- domain monomeric Y-shaped antibody structure, such as a bispecific T cell engaging (BiTE) antibody.

[0056] The term "fragment" or "antibody fragment" refers to polypeptides derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) 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 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. Other examples of antigen-binding antibody fragments are known in the art.

[0057] 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 the amino acid sequences 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.

[0058] 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).

[0059] 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.

[0060] Those of skill in the art will appreciate that modifications (additions and / or removals) of various components of the APIs, formulations, devices, methods, systems and embodiments described herein can be made that will fall within the scope of the present application and the whole range of its equivalents.

[0061] 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.

[0062] 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.

[0063] 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).

[0064] The terms "axial", "radial" or "circumferential" as used herein 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.

[0065] Non-limiting exemplary embodiments of the present application will now be described with reference to the drawings, in which:

[0066] Fig. 1 shows an embodiment of a drug delivery device;

[0067] Fig. 2a shows a perspective view of a ring of a switch assembly according to a first embodiment of the application;

[0068] Fig. 2b shows a cross-sectional view of the switch assembly in a default state according to the first embodiment;

[0069] Fig. 2c shows a cross-sectional view of the switch assembly in a first switch operation mode according to the first embodiment;

[0070] Fig. 2d shows another cross-sectional view of the switch assembly in the first switch operation mode according to the first embodiment;

[0071] Fig. 2e shows a cross-sectional view of the switch assembly in a second switch operation mode according to the first embodiment;

[0072] Fig. 3a shows a perspective view of a part of a switch assembly in a second switch operation mode according to a second embodiment;

[0073] Fig. 3b shows a perspective view of a part of the chassis of Fig. 3a; and

[0074] Fig. 4 schematically illustrates an embodiment of an electronic system for a drug delivery device.

[0075] In the drawings, identical elements, identical functions, or identical kinds of elements can be provided with the same reference signs.

[0076] In the following, some embodiments will be described with reference to an insulin injection device. However, the present disclosure is not limited to such applications and can equally well be deployed with injection devices configured to expel other medicaments or generally drug delivery devices, preferably pen devices and / or injection devices.

[0077] Embodiments are provided regarding injection devices, particularly regarding variable dose injection devices that record and / or track data regarding doses delivered therefrom. These data can include the size of a selected dose and / or the size of an actually delivered dose, the time and date of administration, the duration of administration, etc. Features described herein include arrangements of sensing elements and power management techniques (e.g., to facilitate small batteries and / or to enable efficient power usage).

[0078] Certain embodiments in this document are explained in relation to injection devices as disclosed in EP 2 890 435, wherein an injection button and a grip (dose setting member or dose setter) are combined. The injection button can provide a user interface member for initiating and / or performing a dose delivery operation of the drug delivery device. The grip or knob can provide a user interface member for initiating and / or performing a dose setting operation. These devices are all dial extension type, i.e. their length is increased during dose setting. Other injection devices having the same kinematic behavior of dial extension and button during dose setting and dose expelling operation mode are known as e.g. the HUMALOG® device sold by Eli Lilly and the NOVOLOG® 4device sold by Novo Nordisk. Thus, it appears simple and straightforward to apply the general principles to these devices and further explanations will be omitted. However, the general principles of the present disclosure are not limited to this kinematic behavior. Certain other embodiments can be envisaged to apply to the Sanofi injection device, wherein there are separate injection button and grip parts / dose setting members. Thus, there can be two separate user interface members: one for dose setting operation; and one for dose delivery operation.

[0079] “Distal” is used herein to indicate a direction, end or surface that is arranged or to be arranged to face or point towards the dispensing end of the drug delivery device or a part thereof and / or to point outwards, to be arranged to face away from or to be arranged to face away from the proximal end. On the other hand, “proximal” is used to indicate a direction, end or surface that is arranged or to be arranged to face away from or to be arranged to face away from the dispensing end and / or the distal end of the drug delivery device or a part thereof. The distal end can be the end closest to the dispensing end and / or furthest from the proximal end, and the proximal end can be the end furthest from the dispensing end. 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 or is to be mounted to the device.

[0080] Figure 1 is an exploded view of a medicament delivery device or drug delivery device. In this example, the medicament delivery device is an injection device 1 (e.g. a pen-type injector), such as the injection pen disclosed in EP 2 890 435.

[0081] The injection device 1 of Fig. 1 is an injection pen comprising a housing 10 and containing a container 14, e.g. an insulin container, or a seat for such a container. The container can contain a medicament. A needle 15 can be attached to the container or to the seat. The container can be a cartridge and the seat 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 ejected from the injection device 1 can be set, pre-set or "dialed in" by turning the dose knob 12 and then displayed (e.g. in multiples of a unit) via the 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 a 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 Fig. 1.

[0082] 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 the dial sleeve assembly which is configured to move when the dial grip 12 is turned to provide a visual indication of the currently set dose. When setting a dose, the dial grip 12 is rotated in a helical path relative to the housing 10.

[0083] In this example, the dial grip 12 comprises one or more formations to facilitate attachment of a data collection device. In particular, the dial grip 12 can be arranged to attach a button module 11 to the dial grip 12. As an alternative, the dial grip can comprise such a button module of an electronic system.

[0084] The injection device 1 can be configured such that turning the dial grip 12 causes a mechanical click sound to provide acoustic feedback to the user. In this embodiment, the dial grip 12 also serves as an injection button. Upon insertion of the needle 15 into a skin portion of a patient and then upon pushing the dial grip 12 and / or the attached button module 11 in an axial direction, the insulin dose displayed in the display window 13 is ejected from the injection device 1. Upon maintaining the needle 15 of the injection device 1 in the skin portion for a certain time after pushing the dial grip 12, the dose is injected into the patient's body. Ejection of the insulin dose can also cause a mechanical click sound which can be different from the sound produced when rotating the dial grip 12 during dialing of a dose.

[0085] In this embodiment, during delivery of an insulin dose, the dial grip 12 is returned to its initial position in axial movement (without rotation) while the dial sleeve assembly is rotated back to its initial position, e.g. to display zero units of dose. Fig. 1 shows the injection device 1 in this 0U dial condition. As already indicated, the present disclosure is not limited to insulin, but shall cover all medicaments in the medicament container 14, in particular liquid medicaments or medicament formulations.

[0086] 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.

[0087] Further, prior to first use of the injection device 1, a so-called "priming shot" 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 dial grip 12 while holding the needle 15 of the injection device 1 upwards. For presentation, in the following it will be assumed that the priming shot substantially corresponds to the injection dose, such that e.g. the amount of medicament expelled from the injection device 1 equals the dose received by the user. However, a difference (e.g. loss) between the priming shot and the injection dose can need to be considered.

[0088] As explained above, the dial grip 12 also serves as an injection button, using the same component for dialing / setting a dose and dispensing / delivering a dose. As an alternative (not shown), a separate injection button can be used, which is at least axially displaceable relative to the dial grip 12 for a limited distance to enable or trigger dose dispensing.

[0089] In the following, an electronic system 100 according to the present application will be described with reference to exemplary embodiments and with reference to Fig. 4. 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, e.g. a rechargeable or non-rechargeable battery as shown in Fig. 4. The electronic system 100 further comprises an electronic control unit 110, e.g. comprising or consisting of or being part of a PCBA, which is configured to control the operation of the electronic system 100 having a first state and a second state, wherein the electronic system 100 has an increased power consumption in the second state compared to the first state. The electronic system 100 further comprises an encoding and motion sensing unit 120, e.g. a rotary sensor, and an electrical usage detector unit 130, which is operably 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 said operation is the user of the injection device and / or the electronic system entering a manual synchronization or pairing mode of the electronic system 100 and / or the user starting a dose dispensing. The electronic system 100 is configured such that in response to said first signal it switches from the first state to the second state by means of the electronic control unit 110. The electronic system further comprises a communication unit 140 for communicating with another device. The electronic system 100 is in its second state when the communication unit 140 is in an active state to perform the manual synchronization or pairing mode. The PCBA of the electronic control unit 110 can be arranged on and / or in the module chassis 19 of the button module 11 (see Figs. 2b and 3b).

[0090] Although not explicitly depicted, the electronic system 100 can comprise a storage device or memory unit, which is preferably permanent and / or non-volatile, which can store e.g. data related to the operation of the drug delivery device, such as dose history data.

[0091] Unless otherwise specifically disclosed in the following, the electronic system 100 can have and can be arranged and / or designed according to the functionalities as described in the unpublished EP 20315066.9 and EP 20315357.2, the disclosure of which is incorporated herein by reference.

[0092] A first embodiment of the switch assembly 20 is depicted in Figs. 2a to 2e.

[0093] In the switch assembly 20, the button module 11 is arranged in the dial grip 12 and comprises a module chassis 19 on which a PCBA of an electronic control unit 110 is located. The module chassis 19 has an outer annular portion that is held in the dial grip 12 and an inner tubular portion that extends into an encoder ring 21 of the dial sleeve assembly. In the depicted embodiment, the encoder ring 21 is a separate zero part that is fixed at the proximal end of the dial sleeve as shown in Fig. 2a. As an alternative, the encoder ring 21 can be an integral part of the dial sleeve.

[0094] The encoder ring 21 comprises a ratchet profile 22 facing the radially inner side of the ring 21. The ratchet profile 22 comprises teeth forming a bottom section and a tooth peak section. The substantially cylindrical portion of the chassis 19 is located in the circular step defined by the ring 21.

[0095] The distal surface of the PCBA of the electronic control unit 110 comprises a first electrical contact 23a, a second electrical contact 23b, a third electrical contact 23c (Fig. 3b) and a fourth electrical contact 23d (Fig. 3b). In the depicted exemplary embodiment, each of the electrical contacts 23a, 23b is formed as an elastically deflectable bar having one end permanently attached and connected to the PCBA 110 and an opposite, deflectable free end. The free end of the first bar forming the first contact 23a protrudes through an opening in the chassis 19 towards the ring 21 and the dose dial component attached to the ring 21.

[0096] Between the ring 21 and the chassis 19, a substantially annular spring member is interposed, which comprises a free end forming an arm 24 with a pawl 25 or protrusion. The pawl 25 is shape-fitted to the ratchet profile 22 such that the pawl 25 can enter into the bottom section of the ratchet profile 22 and can slide over the tooth peak section. The annular spring member is axially and rotationally limited by the chassis 19 such that the arm maintains its position relative to the chassis 19 when the ring 21 and the ratchet profile 22 are rotated relative to the chassis 19.

[0097] The third electrical contact 23c and the fourth electrical contact 23d are arranged on a flexible board section 26 (Fig. 3b) of the PCBA 110, which extends into the space between the ring 21 and the chassis 19 in the distal direction. On this flexible board section 26, the third electrical contact 23c and the fourth electrical contact 23d are arranged side by side but isolated from each other.

[0098] In the default state of the drug delivery device, i.e. when the drug delivery device is not operated or manipulated by a user, the chassis 19, the ring 21, the arm 24 and the bars are arranged in the state depicted in Fig. 2b. In this default state, both the axial switch and the rotational switch of the switch assembly 20 are open, as will be explained in the following.

[0099] In the depicted embodiment, in the default position, the first and second electrical contacts 23a, 23b are spaced apart from each other such that the electrical circuit between the first and second electrical contacts 23a, 23b is open. Further, the third and fourth electrical contacts 23c, 23d are isolated from each other and from the arm 24 such that the electrical circuit between the third and fourth electrical contacts 23c, 23d is open.

[0100] During dose setting, i.e. when the user selects a higher or lower dose to be dispensed from the drug delivery device 1, the user rotates the dial grip 12 relative to the housing 10. This causes a simultaneous rotation of the chassis 19 and the encoder ring 21, which are rotationally coupled in the dose setting mode of the drug delivery device 1 via a coupling (not shown) of the dose setting and drive mechanism. Since the chassis 19 and the encoder ring 21 are moved in simultaneous rotation, the relative arrangement of the chassis 19, the ring 21 and the rods and arms relative to each other remains the same as in the default state depicted in Fig. 2b. During dose setting, the dial grip 12 travels on a helical path together with the chassis 19 and the encoder ring 21, thereby unwinding from the housing 10 as the selected dose increases.

[0101] After dialing in a dose, the user can start dose dispensing by axially pushing the proximal end of the dial grip 12. This causes the coupling to disengage such that the chassis 19 and the encoder ring 21 are rotationally decoupled, and such that the dial grip 12 is rotationally coupled to the housing 10 of the drug delivery device 1 together with the chassis 19. This axial movement comprises a limited relative axial movement of the chassis 19 relative to the encoder ring 21. Fig. 2c shows the switch assembly 20 after this limited relative axial movement.

[0102] Due to this limited relative axial movement of the chassis 19 relative to the encoder ring 21, the first rod with the first electrical contact 23a abuts the zero part coupled to the ring 21, and, as a consequence, the free end of the first rod is deflected proximally (upwards in the drawing). The second rod of the second electrical contact 23b remains in its position. The relative movement of the rods causes the rods to abut each other, thereby closing the electrical circuit by connecting the first electrical contact 23a and the second electrical contact 23b.

[0103] The axial movement alone does not change the position of the arm 24 relative to the third and fourth electrical contacts 23c, 23d. Thus, the rotary switch remains open.

[0104] The axial switch of the on / off switch assembly 20 can occur not only during the transition from the dose setting operation to the dose delivery operation of the drug delivery device 1 but also under the 0U dialing condition of the drug delivery device 1, i.e. before dose setting when the dial grip 12 and thus the chassis 19 is pressed to be axially moved relative to the encoder ring 21.

[0105] This first switch operation mode is preferably used to wake up the communication unit 140, i.e. to switch the communication unit 140 from a sleep mode to an operation mode, thereby prompting the communication unit 140 to initiate a manual synchronization and / or pairing with another device. This can occur by means of the electronic control unit 110 in response to a signal generated by the axial switch between the shafts closing the first contact 23a and the second contact 23b.

[0106] Further pressing of the dial grip 12 causes the dial grip 12 with the chassis 19 to be axially pushed back into the housing 10, while the encoder ring 21 is spirally rotated back into the housing 10. In other words, the dose dispensing causes a relative rotational movement of the encoder ring 21 relative to the chassis 19. During this rotational movement, the first contact 23a and the second contact 23b remain connected. However, during this rotation, the rotational switch changes between an open state, in which the arm 24 does not contact the flexible plate segment 26 carrying the third and fourth electrical contacts 23c, 23d, and a closed state, in which the arm 24 is deflected radially inwards towards the flexible plate segment 26 thereby connecting the third and fourth electrical contacts 23c, 23d via the arm 24. As the ring 21 rotates relative to the chassis 19, the pawl 25 of the arm alternately engages with the bottom section of the ratchet profile 22 (thereby opening the rotational switch) or with the tooth peak section of the ratchet profile 22 (thereby closing the rotational switch by deflecting the arm 24 to bridge the third and fourth electrical contacts 23c, 23d). This constitutes a second switch operation mode of the switch assembly 20. The pawl 25 snapping back into the bottom section of the ratchet profile 22 can generate a tactile and / or audible feedback to the user during this dose dispensing operation.

[0107] The electronic system is preferably configured such that the rotational sensor 120 is switched from a sleep mode to an operation mode, thereby prompting the rotational sensor 120 to initiate motion detection when the electrical connection between the third and fourth electrical contacts 23c, 23d is closed via the arm 24 during this second switch operation mode. This can occur by means of the electronic control unit 110 in response to a signal generated by the rotational switch alternatingly being closed. The axial switch remains continuously engaged throughout the rotational movement of the encoder ring 21.

[0108] The axial switch and the rotational switch of the switch assembly 20 are both open as the user releases the dial grip 12, which causes the above described actions to be reversed in succession.

[0109] A second embodiment of the switch assembly 30 is depicted in Figs. 3a-3b.

[0110] In the switch assembly 30, the arrangement of the button module 11, the dial grip 12, and the module chassis 19 with the PCBA having the electronic control unit 110, as well as the arrangement of the encoder ring 21 relative to the ratchet profile 22 and the arm 24, are identical to the switch assembly 20. However, the lever forming the first and second contact 23a, 23b is removed from the distal surface of the PCBA 110 to the proximal surface (not shown) of the PCBA 110. An axial switch is formed at or near the proximal end of the dial grip 12.

[0111] It will be appreciated that the operation of the switch assembly 30 is essentially identical to that described above for the switch assembly 20. In other words, the axial switch and the rotary switch are both open in the default state and during dose setting.

[0112] Further, during the transition from the dose setting operation to the dose delivery operation of the drug delivery device 1 or in the 0U dial condition of the drug delivery device 1, i.e. before dose setting, the dial grip 12 and thus the chassis 19 is pressed to move axially relative to the encoder ring 21, the axial switch is closed, although the rotary switches 23c, 23d, 24 remain open. This first switch operation mode is preferably used to wake up the communication unit 140, i.e. to switch the communication unit 140 from the sleep mode to the operational mode, thereby prompting the communication unit 140 to initiate a manual synchronization and / or pairing with another device.

[0113] Still further, during the dose delivery operation, the rotary switches are alternately open and closed, although the axial switch remains closed. The electronic system is preferably configured such that the rotary sensor 120 is switched from the sleep mode to the operational mode, thereby prompting the rotary sensor 120 to initiate motion detection when the electrical connection between the third and fourth electrical contacts 23c, 23d is closed during this second switch operation mode.

[0114] Although mainly described with respect to a drug delivery device having a similar working principle as the device disclosed in EP 2 890 435, the electronic system is applicable to any other type of drug delivery device having a zero-part that performs a relative axial and / or rotary movement under defined conditions or states.

[0115] Reference signs

[0116] 1 device

[0117] 10 housing

[0118] 11 button module

[0119] 12 dial grip

[0120] 13 dose window

[0121] 14 container / container receptacle

[0122] 15 needle

[0123] 16 inner needle cap

[0124] 17 outer needle cap

[0125] 18 cap

[0126] 19 module chassis

[0127] 20 switch assembly

[0128] 21 encoder ring

[0129] 22 ratchet profile

[0130] 23a-d electrical contacts

[0131] 24 arm

[0132] 25 pawl

[0133] 26 flexi-plate segment

[0134] 30 switch assembly

[0135] 100 electronics system

[0136] 110 electronic control unit (PCBA)

[0137] 120 encoding and motion sensing unit

[0138] 130 use detection unit

[0139] 140 communication unit

[0140] 150 power supply

Claims

1. A switch assembly for an electronic system of a drug delivery device (1), the switch assembly comprising: A base frame (19) supporting a printed circuit board assembly (PCBA) (110), the PCBA including at least a first electrical contact (23a), a second electrical contact (23b), a third electrical contact (23c), and a fourth electrical contact (23d). Ring (21), which has an annular ratchet profile (22). During the first switch operation mode or when the base frame (19) is pressed under the condition that the drug delivery device (1) is switched to 0 units, the base frame (19) moves axially from a first axial position to a second axial position relative to the ring (21), and wherein the base frame (19) and the ring (21) are configured such that the ring (21) rotates relative to the base frame (19) during the second switch operation mode. The first electrical contact (23a) and the second electrical contact (23b) are arranged such that during the first switch operation mode, when the base frame (19) moves axially toward the ring (21), the electrical connection between the first electrical contact (23a) and the second electrical contact (23b) is closed. Furthermore, it is characterized in that an elastically deformable arm (24) is radially inserted between the ratchet profile (22) of the ring (21) and the base (19), is restricted in the axial and rotational direction by the base (19), and is guided on the ratchet profile (22), such that the arm (24) elastically deforms in the radial direction toward the base (19) at least during the second switching operation mode, thereby alternately opening and closing the electrical connection between the third electrical contact (23c) and the fourth electrical contact (23d) via the arm (24).

2. The switch assembly according to claim 1, wherein the first axial position is a more distant axial position, wherein the second axial position is a more recent axial position, wherein the first switch operation mode is a switch from a dose setting operation of the drug delivery device (1) to a dose delivery operation, and wherein the second switch operation mode is the dose delivery operation of the drug delivery device (1).

3. The switch assembly according to claim 1 or 2, wherein, The arm (24) includes a pawl (25) or protrusion adapted to engage the ratchet profile (22) of the ring (21).

4. The switch assembly according to claim 1 or 2, wherein, The arm (24) is part of a substantially annular conductive spring member that is biased to abut the ratchet profile (22) of the ring (21) and is at least partially radially inwardly deflected into the annular space between the ring (21) and the base frame (19).

5. The switch assembly according to claim 1 or 2, wherein, The third electrical contact (23c) and the fourth electrical contact (23d) are disposed on the flexible wing or flexible plate section (26) of the PCBA (110), the flexible wing or flexible plate section extending distally from the PCBA (110) to the position between the ring (21) and the base frame (19).

6. The switch assembly according to claim 5, wherein, The arm (24) alternates between the contact bottom section and the tooth peak section of the ratchet profile (22) and thereby elastically deflects to connect and disconnect with the third electrical contact (23c) and the fourth electrical contact (23d) during the second switch operation mode.

7. The switch assembly according to claim 1 or 2, wherein, The first electrical contact (23a) is a first rod having one end attached to the PCBA (110) and an opposite free end, wherein the second electrical contact (23b) is a second rod having one end attached to the PCBA (110) and an opposite free end, and wherein the free ends of the first rod and the free ends of the second rod are arranged such that during the first switch operation mode, when the base frame (19) moves axially toward the ring (21), the electrical connection between the first electrical contact (23a) and the second electrical contact (23b) is closed by deflecting at least the first rod relative to the second rod.

8. The switch assembly according to claim 7, wherein, The first rod extends through the base frame (19) as its free end protrudes from the base frame (19) to a position where the ring (21) or a component connected to the ring (21) deflects the first rod at that position when the base frame (19) moves axially toward the ring (21) during the first switch operation mode.

9. The switch assembly according to claim 7, wherein, The first rod and the second rod are located in the space formed in the base frame (19) radially inside the ring (21).

10. The switch assembly according to claim 1 or 2, further comprising a housing (10) and a toggle grip (12), wherein, The axial movement of the base frame (19) toward the ring (21) during the first switch operation mode is caused by the axial displacement of at least a portion of the selector grip (12) relative to the housing (10), which closes the gap between the first electrical contact (23a) and the second electrical contact (23b).

11. The switch assembly according to claim 10, wherein, The first electrical contact (23a) and the second electrical contact (23b) are arranged on the proximal side of the PCBA (110) opposite to the ring (21).

12. A drug delivery device comprising an electronic system (100) having a switch assembly (20, 30) according to any one of claims 1-11, the drug delivery device (1) 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 including the ring (21). - A button module (11) comprising an electronic control unit (110) on the PCBA, a rotation sensor (120), a communication unit (140) having a wireless communication interface for communicating with another device, and a usage detection unit (130) including the switch assembly, wherein the electronic control unit (110) is configured to control the operation of the electronic system. The button module (11) and the dose setting and drive mechanism are configured such that the dose selection assembly rotates relative to the button module (11) during the dose delivery operation but does not rotate relative to the button module (11) during the dose setting operation, and that the button module (11) moves axially relative to the dose selection assembly when the button module (11) is pressed during the transition from the dose setting operation to the dose delivery operation or when the drug delivery device (1) is selected to 0 units. The electronic system is configured to cause the communication unit (140) to switch from a sleep mode to an operating mode, thereby prompting the communication unit (140) to initiate manual synchronization and / or pairing with another device when the electrical connection between the first electrical contact (23a) and the second electrical contact (23b) is closed during the first switch operating mode. Furthermore, the electronic system is configured to cause the rotation sensor (120) to switch from a sleep mode to an operating mode, thereby prompting the rotation sensor (120) to initiate motion detection when the electrical connection between the third electrical contact (23c) and the fourth electrical contact (23d) is closed via the arm (24) during the second switch operating mode.

13. The drug delivery device according to claim 12, wherein the rotation sensor (120) has a light source and a corresponding optical sensor.

14. The drug delivery device according to claim 12 or 13, wherein, The rotation sensor (120) includes an encoder ring (21).

15. The drug delivery device according to claim 12 or 13, further comprising a container receiving seat (14) which is permanently or releasably connected to the dosage setting and drive mechanism and adapted to receive a container containing a drug.

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