Electronic module and drug delivery device

Abstract

The present invention relates to an electronic module (11) for releasable attachment to a drug delivery device (1) and to such a drug delivery device. The module (11) can comprise at least one module locking formation (323) adapted to mating abutment with a corresponding device locking formation (21) of a dedicated drug delivery device (1). Further, the module (11) can comprise at least one attachment element (324) for releasable attachment of the module (11) on the drug delivery device (1). Further, the module (11) can comprise at least one light pipe (325) for guiding a light beam from a light source (121) to a reflective surface (24) of the drug delivery device (1) and from said reflective surface (24) to a light detector sensor (122). Still further, the module (11) can comprise at least one light guide (321) for guiding a light beam from a light source (141) to a user feedback surface (322) of said component adapted to emit light. Further, the module (11) can comprise at least one elastically deformable switch arm (326). The component (320) can be a monolithic component part injection molded from a polycarbonate material.

Description

[0001] The present invention relates generally to an electronic system (e.g. module) for a drug delivery device, and more particularly to a component part of such a module having multiple functions. The present invention further relates to a drug delivery device, preferably comprising such an electronic module.

[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 such patients to effectively manage their disease. 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. Therefore, 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 memory aid or to support 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.

[0005] For example, from EP 2 814 545 Al a drug delivery device comprising a clip-on electronic module is known. The clip-on module comprises a battery, which powers a processor and other components controlled by the processor, such as a light source, a light meter, an acoustic sensor, an acoustic signal generator and a wireless unit, such as a transceiver, configured to transmit information to and / or receive information from another device in a wireless manner.

[0006] However, the management of the power supply resources integrated into the device is particularly important, especially if the device is designed to be stand-alone, that is to say without a connector for connecting to a power supply necessary for the operation of the device.

[0007] ​Unpublished EP 20315066.9 and EP 20315357.2 disclose advantageous embodiments of electronic systems for drug delivery devices with improved power management. These electronic systems comprise a switch assembly for activating / deactivating power consuming functions of the electronic system. For disclosure concerning the working principle of electronic systems in connection with drug delivery devices, reference is made to these two documents.

[0008] A further example of an electronic module for use with a drug delivery device is described in WO 2019 / 101962 A1. For detecting a dialled or dispensed dose, this module comprises an encoder system with two optical sensors, each consisting of a transmitting part (e.g. an LED) and a corresponding receiving part (e.g. a photodiode). Light (e.g. IR light) emitted by the transmitting part of the sensor is directed through an optical tube extending from a chassis part of the module to the vicinity of a tooth ring formed on the proximal end of a rotatable number sleeve of a drug delivery device. The light exits the optical tube at the end opposite to the sensor and depending on the rotational position of the tooth relative to the optical tube, the light can be reflected by a tooth of the number sleeve back into the optical tube which directs the reflected light beam to the receiving part of the sensor. The optical tube can be made of glass or polycarbonate. For disclosure concerning the working principle of encoder systems in connection with drug delivery devices, reference is made to this document.

[0009] Unpublished international patent applications PCT / EP2020 / 085728 and PCT / EP2020 / 085729 disclose similar modules for drug delivery devices with an encoder system comprising optical sensors, the modules having a chassis comprising an optical tube. In PCT / EP2020 / 085728 and PCT / EP2020 / 085729, the electronic module is configured for detachable attachment to a drug delivery device and comprises a respective fastening element. By providing a dedicated electronic module to a specific drug delivery device, the risk of a wrong pairing of the electronic module with the drug delivery device is minimized.

[0010] Such drug delivery devices are usually manufactured in large scale, so that efficient and simple assembly is an important issue to keep production costs reasonably low.

[0011] It is an object of the present disclosure to provide an improvement for electronic modules for use with drug delivery devices, allowing for reasonable production and assembly efforts.

[0012] This object is solved by the subject matter defined in the independent claims, for example. Advantageous embodiments and improvements are subject of 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 include improvements additional to or alternative to the subject matter defined in the independent claims.

[0013] One aspect of the present disclosure relates to an electronic module adapted for use with a drug delivery device. Such a drug delivery device 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 electronic module preferably comprises at least one processor (e.g. a microcontroller), a sensor arrangement, a communication unit with a wireless communication interface, at least one electronic user feedback generator, a memory for storing measurement data and a power supply connected to the at least one microcontroller.

[0014] According to an aspect of the present disclosure, the electronic module is adapted to be releasably attached to a drug delivery device. The module comprises a component, which can be a chassis of the module. The electronic module can further comprise a cap, a printed circuit board assembly (PCBA) and a power supply. For example, the component is a chassis rigidly attached to the cap and supporting the PCBA within the cap. This chassis component can have several different functions, thereby reducing the number of component parts required for the module. This keeps the production and assembly time and costs low. In the following, the component part will mainly be referred to as a chassis component part, however, the function of the component part as a chassis for supporting the PCBA, for example, is not mandatory. Rather, the present disclosure includes all types of component parts, regardless of the ability to have a chassis function.

[0015] Although all features and functions of the chassis component listed in the following can be implemented together in the chassis component, the present disclosure is not limited to this embodiment. Rather, according to the present disclosure, the chassis component can comprise only one, preferably at least two, of the following independent features and functions:

[0016] According to a first independent aspect of the present disclosure, the chassis component of the module can comprise at least one module locking formation adapted to matingly abut with a corresponding device locking formation of a dedicated drug delivery device. In other words, the electronic module can comprise a module locking formation as a mechanical coding feature to engage with a corresponding device locking formation as an opposite mechanical coding feature provided at the proximal end of the dedicated drug delivery device. The term "dedicated drug delivery device" is used in the present disclosure to indicate that the drug delivery device cooperates or mates with the respective module.

[0017] Generally, a set of multiple electronic modules can be provided which are distinguished by their respective module locking configurations (mechanical coding). A first mechanical coding of a first electronic module is distinguished from a second mechanical coding of a second electronic module. For example, the first mechanical coding or first module locking configuration comprises at least one of a first protrusion and a first recess. The second mechanical coding feature or second module locking configuration comprises at least one of a second protrusion and a second recess. The geometry of the first protrusion can be distinguished from the geometry of the second protrusion. Additionally or alternatively, the position of the first protrusion in a plane transverse to the longitudinal direction is distinguished from the position of the second protrusion in the transverse plane. The same applies to the first and second recesses of the first and second electronic modules. Further, the present disclosure also relates to a set of drug delivery devices which are distinguished by their corresponding device locking configurations or (counter-) mechanical codings. At least a first drug delivery device having a first corresponding device locking configuration or first counter- mechanical coding and a second drug delivery device having a second corresponding device locking configuration or second counter- mechanical coding can be provided. The first module locking configuration cooperates (i.e. matches) with the first corresponding device locking configuration but not with the second corresponding device locking configuration. Likewise, the second module locking configuration cooperates (i.e. matches) with the second corresponding device locking configuration only but not with the first corresponding device locking configuration. The first and second counter- mechanical codings of the first and second drug delivery devices are distinguished by at least one of the geometry and the transverse position of the respective counter-coding features, thus by the shape and / or the transverse position of their protrusions or recesses.

[0018] When the respective locking configurations match (i.e. when the mechanical coding cooperates with the counter- mechanical coding) and when the electronic module is attached to the proximal end of the drug delivery device in the predetermined fastening configuration, the mutual engagement of the mechanical coding and the counter- mechanical coding is achieved.

[0019] In examples of the first aspect of the disclosure, the at least one module locking formation comprises a profiled protrusion or seat adapted to matingly abut with a corresponding profiled seat or protrusion of a device locking formation of the dedicated drug delivery device. More specifically, in examples of the disclosure, the drug delivery device comprises a button rotatable to select a dose and axially displaceable for dispensing a dose. Such a button can be provided with a circular recess in a proximally facing end surface. This recess is adapted to receive at least one, e.g. two, protrusions, e.g. particularly chassis components, of the module. These protrusions constitute the module locking formation. The recess is not rotationally symmetrical but comprises one or more internal blocking features as a corresponding device locking formation. The design of the module locking formation(s) and the corresponding device locking formation(s) is such that, if the user attempts to fit the module to an incorrect device, it will immediately come apart as soon as the pressure is released.

[0020] In other words, the at least one module locking formation prevents the module from being attached on a non-matching drug delivery device. For example, in case of an electronic module comprising a module locking formation that does not cooperate with a corresponding device locking formation of the drug delivery device, the locking formations, coding features, can be positioned circumferentially offset. For example, in a predetermined fastened configuration in which the module is fully attached to the drug delivery device, if the fastening elements of the module are engaged with the corresponding shaped counter fastening elements of the drug delivery device, the respective locking formations can not have the appropriate counter formations to key into. Thus, they can block and hinder the correct arrangement and assembly of the electronic module on the drug delivery device.

[0021] As an alternative to such locking formations on the chassis components, keying / blocking features can be provided on separate components, e.g. on a housing or cap of the electronic module and / or on an optional adapter of the electronic module. The keying and / or blocking features can be connected to the housing and / or to the chassis components using a press fit, a form fit, a force fit or other connection means.

[0022] According to a second independent aspect of the disclosure, the chassis component of the module can comprise at least one attachment element for releasably attaching the module on the drug delivery device. For example, the at least one attachment element for releasably attaching the module on the drug delivery device comprises at least one elastically deformable arm having a snap protrusion or recess for releasably engaging with a corresponding snap recess or protrusion of the drug delivery device. Typically, the electronic module can be used with several equivalent or identical types of drug delivery devices. Thus, the assembly or fastening of the electronic module to the drug delivery device is only a temporary assembly. The mutual fastening of the electronic module and the drug delivery device can require a distally directed movement of the electronic module from a pre-assembly configuration to a final assembly configuration, which can coincide with a predetermined fastened configuration.

[0023] In other words, the electronic module can comprise a fastening or attachment element configured to mechanically engage with a complementary shaped counter fastening or attachment element of the drug delivery device in a predetermined fastening configuration. The fastening or attachment element and the counter fastening or attachment element can define the predetermined fastening configuration in which the electronic module is attachable, couplable or connectable to the drug delivery device. The position and / or geometry of the fastening or attachment element of the electronic module is typically coordinated with the geometry and / or position of the counter fastening or attachment element of the drug delivery device. The mutual assembly and thus the arrangement of the electronic module in the predetermined fastening configuration on the drug delivery device requires the fastening or attachment element to mechanically engage with the complementary shaped counter fastening or attachment element. When the fastening or attachment element and the complementary shaped counter fastening or attachment element are in mechanical engagement, the electronic module is in a predetermined orientation and in a predetermined position relative to the drug delivery device.

[0024] The fastening or attachment element can comprise a clip feature and can form a clip connection with the corresponding or complementary shaped counter fastening or attachment element. Thus, the counter fastening or attachment element of the drug delivery device can also comprise a clip feature and can facilitate a snap connection between the electronic module and the drug delivery device. For other examples, the fastening or attachment element can be configured to establish a friction fit or force fit with the complementary shaped counter fastening or attachment element of the drug delivery device.

[0025] More specifically, the chassis component can comprise two flexible clips as attachment elements protruding distally from an inner rim of the chassis component, which axially hold and direct the module on the drug delivery device. The drug delivery device can comprise a button having two orifices into which the two flexible clips snap. For example, the chassis component can have at least one (e.g. two) elastically deflectable snap hooks adapted to engage with corresponding snap recesses in the button of the drug delivery device.

[0026] As an alternative to the attachment element(s) on the chassis component, a fastening feature can be provided on a separate component, e.g. on a housing or cap of the electronic module and / or on an optional adapter of the electronic module.

[0027] According to a third independent aspect of the present disclosure, the chassis component of the module can comprise at least one light pipe for guiding a light beam from a light source to a reflective surface of the drug delivery device and from the reflective surface to a light detector sensor. For example, the at least one light pipe can be a protrusion in the shape of a truncated cone. As an alternative, the at least one light pipe can be a protrusion in the form of a truncated pyramid. Yet further alternatives can comprise a cylindrical shape or an elongated cuboid shape.

[0028] At least one light pipe can have two opposite end faces and at least one sidewall, wherein at least one of the two opposite end faces has a surface roughness that is higher than a surface roughness of the at least one sidewall. This facilitates the entry or exit of light through the end faces, while light is reflected by the at least one sidewall. In other words, at least one light pipe can comprise a boundary surface that can guide electromagnetic radiation by total reflection.

[0029] In an exemplary embodiment, one end face of a light pipe can have the same surface finish as the sidewall of the light pipe (e.g. be polished), so that only one end face has a higher roughness than the sidewall. Other surface finish combinations can be successfully used.

[0030] In an example of the present disclosure, a module can comprise at least two light pipes that axially protrude from an inner portion of a chassis component in the same direction. More specifically, the light pipes can be arranged on a circular rim or a portion thereof, such that the light pipes can be inserted into the orifice of a circular recess in a button of a drug delivery device. The light pipes can be parallel to each other and / or the respective central axes of the light pipes can be parallel to each other.

[0031] The light pipe(s) can axially extend over the module lock configuration and / or the attachment element(s). In other words, the length of the light pipe(s) in the distal direction can be such that the light pipe(s) can enter into the button of the drug delivery device when the module is fully attached to the drug delivery device (i.e. when the lock configuration is in engagement and / or the attachment element is fully connected).

[0032] As an alternative to providing light pipe(s), an optical sensor can be located in the module, such that an encoder located e.g. in the vicinity of the interface between the module and the drug delivery device can be detected by the sensor.

[0033] According to a fourth independent aspect of the present disclosure, a chassis component of a module can comprise at least one light guide for guiding a light beam from a light source to a user feedback surface of the component adapted to emit light. The user feedback surface can be a light emitting area (i.e. a surface visible from the outside of the module), such that a light signal can be used to indicate e.g. a status of the module. The user feedback surface can have a ring shape, e.g. in the form of an outwardly facing light ring of the chassis component.

[0034] For example, the at least one light guide can comprise a ring-shaped skirt having at least one entry surface and a user feedback surface facing radially outward from the ring-shaped skirt. The at least one entry surface and the user feedback surface can have a surface roughness that is higher than a surface roughness of the ring-shaped skirt. This facilitates light entry or exit through the entry surface and the user feedback surface while light is reflected by the ring-shaped skirt. In other words, the at least one light guide can comprise a ring-shaped skirt as a boundary surface that can guide electromagnetic radiation by total reflection.

[0035] The surface roughness of the light pipe(s) and / or the light guide(s) can be chosen such that the regions intended for light entry and / or light exit (e.g. the two opposite end faces of the light pipe or the entry face and the user feedback surface of the light guide) have a textured finish as surface finish, in particular a textured finish according to the D3, D2 or D1 standard of the Society of the Plastics Industry, SPI. The textured finish can be a finish with a slight roughness or diffusivity such as SPI-D3 or even finer, e.g. characterized by a feature size of about 1 pm, in particular almost equal to the center wavelength of an infrared (IR) - light emitting diode (LED) sensor package that can be used as optical sensor. In the light pipe, the encoder-side surface can have a mirror finish; the encoder-side surface can comprise an anti-reflective coating. The mirror finish and the anti-reflective coating can reflect the interference light and thus can prevent the interference light from entering the light pipe and can reduce the signal-to-noise ratio.

[0036] Further, the surface roughness of the light pipe(s) and / or the light guide(s) can be chosen such that the regions intended for guiding light (e.g. the sidewall of the light pipe or the skirt of the light guide) have a mirror finish. Such a finish can facilitate total internal reflection (TIR) and efficacy of the light pipe. The mirror finish surface can be used in combination with a textured finish of the regions intended for light entry and / or light exit, whereby the roughness of the regions intended for light entry and / or light exit is reduced compared to the mirror finish, e.g. the amount of TIR at the encoder-side surface. In further examples of optical guiding devices (e.g. the light pipe(s) and / or the light guide(s)), the regions intended for guiding light can comprise one or more coatings, wherein the outermost coating can be opaque for the guided radiation, or wherein all coatings can be transparent for the guided radiation and the optical refractive index of each transparent coating is smaller than the optical refractive index of the base part itself. This can further improve the light guiding, e.g. by the at least one light pipe, and can also reduce the influence of, e.g., interfering light from outside the light pipe. Thus, the signal-to-noise ratio can be improved.

[0037] In the electronic module, the annular skirt can comprise at least two, for example four, entry surfaces each formed in a respective recess for receiving a light source, for example a respective LED. In examples of the present disclosure, the light guide can be used to indicate different operating states of the module. Such states can include a state in which the module attempts to synchronize with another external device via the wireless communication interface of the module, for example by means of a blinking of all LEDs on the light ring, and a state in which the module attempts to pair with another external device via the wireless communication interface of the module.

[0038] As an alternative to providing a light guide in the chassis component, the module can indicate a state by means of one or more light sources that are directly visible from the outside or through a window. Further additional feedback alternatives can include a sound generator and / or a vibration motor. Such further user signals can be provided by the module, for example to indicate operation of a sensor, start and / or end of dose dialing and / or dose dispensing, expiry of a dwell time, etc. However, the module itself need not generate user feedback. As an alternative or in addition, such feedback can further be generated by the drug delivery device.

[0039] According to a fifth independent aspect of the present disclosure, the chassis component of the module can comprise at least one elastically deformable switch arm. For example, the at least one elastically deformable switch arm can extend in a circumferential direction. Alternatively or in addition, the at least one elastically deformable switch arm can comprise a free end and can be deflectable relative to the chassis component in order to actuate an electronic switch.

[0040] The present disclosure further relates to a method of waking up an electronic coded module configured as a reusable on-cartridge module for a drug delivery device, for example an injection device. The method comprises the step of waking up the electronic module at or shortly after the start of a dose delivery. This limits the power consumption by having the capturing system active for the shortest possible time. This is particularly useful for systems such as optical encoders, where the power consumption of the IR-LED sensor accounts for a significant proportion of the total power consumption of the electronic module. The method can further comprise the step of waking up the module by actuating a switch by means of a switch arm that is deflected when a button of the injection device is axially moved relative to a stationary component part of the device, for example the housing, when starting a dose dispensing. There are multiple embodiments of such a wake-up switch.

[0041] According to a further independent aspect of the present disclosure, a switch (e.g., a low force micro switch) can be mounted onto the underside of the electronics module (e.g., on the distally facing side of the PCBA). Such micro switches can have an over-travel beyond their switch point. For example, a switch such as Panasonic ESE16J001 can be suitable. The switch can be actuated by a flexible switch arm formed in the chassis component of the module. This flexible switch arm can be configured in a manner to fit within an annular groove in the back of the button component of the injection device, which can be intended to form an interface with the electronics module. A feature on the flexible switch arm can be designed to pass through an aperture in the button and contact against a component that does not move axially during the disengagement of the mechanism's hub at the start of dose dispensing. For example, the feature on the flexible switch arm can be designed to bear against the drive sleeve component of the injection pen device.

[0042] In other words, when the top face of the electronics module is pushed axially to start dose dispensing, the button of the injection pen can move distally to disengage the hub feature. The relative motion created between the electronics module and the drive sleeve can cause the flexible switch arm of the chassis component to deflect and bear against the micro switch mounted on the underside of the PCBA. For example, the micro switch can be configured to switch and wake up the electronics module after a short travel (before the hub is fully disengaged), but also has to tolerate enough over-travel to allow the full stroke of the dose button to disengage the hub after the electronics switch has completed.

[0043] To protect against water and dirt ingress, the module can be configured with an elastomeric seal component mounted between the PCBA and the flexible switch arm. The elastomeric component forms a compression face seal between the PCBA and the chassis component, thereby preventing water and dirt ingress. The elastomeric seal component is located between the flexible switch arm (formed on the chassis component) and the micro switch (mounted on the PCBA). Due to the flexible nature of the seal component, it is able to deflect the axial load from the switch arm and transfer to the micro switch, thereby allowing the normal operation of the wake-up switch, as described above.

[0044] As an alternative to providing an elastically deformable switch arm, a switch can be located at the proximal end of the PCBA (i.e., facing away from the drug delivery device), and this switch can be actuated by an elastically deformable portion in the cap when the user presses the cap to start dose dispensing. Further alternatives include using an optical sensor or waking up the module by means of a separate switch arm mounted on another component part of the drug delivery device and / or module.

[0045] According to a sixth independent aspect of the present disclosure, the chassis component of the module can be a unitary component part injection molded from a thermoplastic polymer material that is highly transparent to light (e.g., to visible light and / or IR light) and can be subjected to elastic deformation. For example, the chassis component can be made from a polycarbonate material such as Covester Makrolon 2458 by an injection molding process.

[0046] According to a seventh independent aspect of the present disclosure, the chassis component (other than the user feedback surface) can be overmolded by a cap with a printed circuit board assembly (PCBA) and a power source interposed between the cap and the component.

[0047] According to an eighth independent aspect of the present disclosure, the chassis component can have a substantially cylindrical outer shape with a radially facing user feedback surface forming a distal end, wherein the component can comprise an inner rim with at least one module locking formation, at least one attachment element extending distally from the rim and at least one light pipe and at least one collar portion extending proximally from the rim.

[0048] The sensor arrangement can be connected to the at least one processor and operable to generate measurement data indicative of dose setting operations and / or dose delivery operations. The sensor arrangement can comprise one or more electrical switches and / or can comprise optical and / or capacitive and / or acoustic sensors for detecting movement of one or more component parts of the dose setting and drive mechanism of the drug delivery device. In one example, the sensor arrangement comprises at least one light source (e.g., an LED) and at least one light sensor (e.g., a photodetector). The sensor arrangement can be part of a coding or motion sensing unit designed and working as described in unpublished EP 20315066.9 and EP 20315357.2, the disclosures of which are hereby incorporated by reference.

[0049] The communication unit with a wireless communication interface can be connected to the at least one processor and operable to establish communication with another device and to transfer data to another device. While it is true that establishing wireless communication typically involves data transfer, with respect to the present disclosure, establishing communication (which can include, for example, the process of broadcasting advertisement packets, scanning for such advertisement packets and pairing two devices) will be distinguished from data transfer as such, which is defined to occur only after successful pairing and typically involves a significantly higher amount of data transfer compared to establishing wireless communication such as manual synchronization and / or pairing.

[0050] The communication unit for communicating with another device can comprise a wireless network interface for communicating via a wireless network such as Wi-Fi or Bluetooth®. The communication unit can be configured to establish a wireless communication link with another device and to transfer data to another device. The communication unit can be configured to establish a wireless communication link with another device and to transfer data to another device. The communication unit can be configured to establish a wireless communication link with another device and to transfer data to another device. a wireless communication interface for communication with another device. In addition, the communication unit can comprise 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 electronics system comprises an RF, WiFi and / or The communication unit can be provided as a module or as a communication interface between the drug delivery device and an external, such as another electronic device, e.g. a mobile phone, a personal computer, a laptop, etc. For example, the measurement data, i.e. the dose data, can be transferred to an external device via the communication unit. The dose data can be used for establishing a dose record or a dose history in the external device. In the following, the wireless communication interface will be described with reference to the example of a communication between the module and a smartphone. However, this should not be understood as a limitation excluding alternatives of the wireless communication described above. The communication unit can be provided as a module or as a communication interface between the drug delivery device and an external, such as another electronic device, e.g. a mobile phone, a personal computer, a laptop, etc. For example, the measurement data, i.e. the dose data, can be transferred to an external device via the communication unit. The dose data can be used for establishing a dose record or a dose history in the external device. In the following, the wireless communication interface will be described with reference to the example of a communication between the module and a smartphone. However, this should not be understood as a limitation excluding alternatives of the wireless communication described above.

[0051] The memory for storing the measurement data, e.g. the dose data, can be a separate memory or can be part of the main memory of the electronics module. These are controlled by a processor, which can be, for example, at least one microcontroller, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), etc. According to an aspect of the present disclosure, the processor executes program code (e.g. software or firmware) stored in a program memory and uses the main memory, e.g. to store intermediate results, like dose data. The main memory can also be used to store a log of expulsions / injections performed based on the measurement data. The program memory can be, for example, a read-only memory (ROM), and the main memory can be, for example, a random access memory (RAM).

[0052] A power source is connected to the processor and powers the processor and other components, like the sensor arrangement, the communication unit and the at least one electronic user feedback generator, by means of a power supply. The power source can be a non-rechargeable, non-user replaceable button cell.

[0053] A potting compound or a filling layer can be applied on the chassis and / or on the PCBA, thereby preventing dust and water from entering the conductive areas of the PCBA.

[0054] The button cell can be fastened and connected to the PCBA by means of a power clip, which can be attached to the chassis component. The clip can have a curved form in its unbiased, unstressed state and can be deformed when mounted on the chassis component. The chassis component can have corresponding snap features for attaching the clip, in particular the free end of the clip. The clip can consist of an elastically deformable and electrically conductive material, e.g. a metal.

[0055] An additional or alternative switch can be provided on the PCBA. This switch can be actuated if the module is fully and correctly assembled to the button, e.g. by contact between the distal switch surface and the proximally facing button surface. When the module is not attached to the device, such a switch can be used to activate the processor or components thereof, e.g. from a power-off or sleep mode of the module.

[0056] The present disclosure further relates to a drug delivery device comprising an electronic module as described above. According to a further independent aspect of the present disclosure, the drug delivery device can comprise a button at its proximal end. The button can be user-rotatable to dial (select) a dose. Further, the button can be axially displaceable, e.g. in a distal direction, to perform a dispensing stroke. In examples, the button is adapted to attach the electronic module to the drug delivery device. More specifically, the button can comprise attachment features, e.g. one or more snap recesses for receiving and engaging attachment features of the module. Further, the button can comprise device locking feature(s) adapted to mate with locking features of the module. This can prevent the attachment of an unsuitable module to the device. Still further, the button can be provided with one or more apertures allowing a portion of one or more light pipes and / or switch arms to enter the drug delivery device.

[0057] A drug delivery device for delivering a medicament 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, and the dose setting and drive mechanism comprises a first member. The dose setting and drive mechanism can comprise a button. The drug delivery device can further 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 to receive a container containing a medicament, e.g. a cartridge.

[0058] 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.

[0059] As described below, a 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 DNA 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.

[0060] A 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 reservoir, syringe, reservoir, or other rigid 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 as the components are being dispensed into the human or animal body.

[0061] The drugs or medicaments contained in the drug delivery devices described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolic disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome, angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as, e.g., the "Rote Liste", for example, in the 2014 version, main groups 12 (antidiabetika) or 86 (onkologische

[0062] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide 1 (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analogue" and "derivative" refer to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, e.g. the structure of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can be a codable amino acid residue or other naturally occurring residue or a purely synthetic amino acid residue. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, e.g. the structure of human insulin, wherein one or more organic substituent, e.g. a fatty acid, is bound to one or more amino acids. Alternatively, one or more amino acids occurring in the naturally occurring peptide can have been deleted and / or replaced by other amino acids, including non-codable amino acids, or amino acids, including non-codable amino acids, have been added to the naturally occurring peptide.

[0063] Examples of insulin analogues are Gly(A21 ), Arg(B25), Arg(B27) 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.

[0064] 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- L-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.

[0065] Examples of GLP-1, GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixlentide Exendin-4, a 39 amino acid peptide produced by the salivary gland of the Gila monster), Liraglutide Semaglutide, Taspoglutide, Albiglutide Dulaglutide Ruixiangding-4, CJC-1134-PC, PB-1023, TTP-054, Langlangnatide / HM-11260C (Efpeglenatide), HM-15211, CM-3, GLP-1Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA- 3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-Xten.

[0066] Examples of oligonucleotides include, for instance, sodium mipronil. It is a cholesterol-reducing antisense agent used to treat familial hypercholesterolemia or RG012 used to treat Alport syndrome.

[0067] Examples of DPP4 inhibitors include linagliptin, vedagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0068] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, fertility-stimulating hormone), growth hormone (Somatropine), desmopressin, terlipressin, gosorelin, triptorelin, leuprorelin, buserorelin, nafarelin, and goserelin.

[0069] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or their derivatives, or sulfated polysaccharides (e.g., polysulfated forms of the above polysaccharides), and / or their pharmaceutically acceptable salts. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20. It is a type of sodium hyaluronate.

[0070] The term "antibody", as used herein, refers to an immunoglobulin molecule or an antigen binding portion thereof. Examples of antigen binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a de-immunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be of an isotype or subtype that normally does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen binding molecule based on tetravalent bispecific tandem immunoglobulin (TBTI) and / or dual variable region antibody-like binding protein with cross-over binding region orientation (CODV).

[0071] 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 disclosure include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, mono- 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 (SMIP), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0072] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable region of the heavy chain polypeptide and light chain polypeptide that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable region of the heavy chain polypeptide and light chain polypeptide that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0073] 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).

[0074] 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.

[0075] Those of skill in the art will appreciate that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein can be made that will fall within the scope of the present application and the entire scope of the disclosure.

[0076] 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.

[0077] 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.

[0078] 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).

[0079] 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.

[0080] Non-limiting exemplary embodiments of the present application will now be described with reference to the accompanying drawings, in which:

[0081] Fig. 1 shows an embodiment of a drug delivery device;

[0082] Fig. 2 schematically illustrates an embodiment of an electronics module for a drug delivery device;

[0083] Fig. 3 schematically illustrates a cross-sectional view of an embodiment of an electronics module for a drug delivery device;

[0084] Fig. 4 schematically illustrates a further cross-sectional view of the electronics module of Fig. 3 attached to a drug delivery device;

[0085] Fig. 5a schematically illustrates a perspective view of the electronics module of Fig. 3;

[0086] Fig. 5b schematically illustrates a perspective view of a further electronics module;

[0087] Figs. 6a to 6c schematically illustrate views of an embodiment of a button of a drug delivery device for attaching the electronics module of Fig. 3;

[0088] Figs. 7a, 7b schematically illustrate perspective views of a chassis component of the electronics module of Fig. 5b;

[0089] Fig. 8 is a table depicting different locking configurations;

[0090] Fig. 9 schematically illustrates a perspective view of a further detail of the electronics module;

[0091] Figs. 10a to 10d schematically illustrate a clip in an unstressed state, in a deflected (mounted) state, before attachment to a chassis and after attachment to a chassis; and

[0092] Fig. 11 schematically illustrates a cross-sectional view of a further electronics module attached to a drug delivery device.

[0093] In the drawings, identical elements, identical actions, or identical kinds of elements can be provided with identical reference signs.

[0094] In the following, some embodiments will be described with reference to an insulin injection device. However, the present disclosure is not limited to such applications and can equally well be deployed with injection devices or generally drug delivery devices, preferably pen and / or injection devices, configured to expel other medicaments.

[0095] Embodiments are provided in relation to injection devices, in particular in relation to variable dose injection devices, which record and / or track measurement data in relation to doses delivered thereby. 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 power management techniques (e.g. to facilitate small batteries and / or to enable efficient power usage).

[0096] 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 both dial extension types, i.e. their length is increased during dose setting. Other injection devices with the same kinematic behavior of dial extension and button during dose setting and dose expelling operation mode are known e.g. from the device sold by Eli Lilly and the 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.

[0097] “Distal” is used herein to designate a direction, an end or a surface which is arranged or to be arranged facing or pointing towards the dispensing end of the drug delivery device or a part thereof and / or pointing outwards, to be arranged facing away or away from the proximal end. On the other hand, “proximal” is used to designate a direction, an end or a surface which is arranged or to be arranged facing away or 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 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.

[0098] 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.

[0099] The injection device 1 of figure 1 is an injection pen comprising a housing 10 and containing e.g. a container 14 (e.g. an insulin container) or a receptacle for such a container. The container can contain a drug. 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, programmed or "dialed in" by turning a button or dial grip (dose knob) 12 and then displayed (e.g. in multiples of a unit) via a dose window 13 of the currently programmed or set dose. The indicia displayed in the window can be provided on a number sleeve 23 or dial sleeve (partially depicted with a tooth ring 24 in figure 4). 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 microgram 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.

[0100] 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 button or dial grip 12 is turned to provide a visual indication of the currently set dose. The button or dial grip 12 is rotated in a helical path relative to the housing 10 when setting a dose.

[0101] In this example, the button or dial grip 12 comprises one or more configurations to facilitate attachment of a data collection device. In particular, the button or dial grip 12 can be arranged to attach or integrate an electronic (button) module 11 onto the button or dial grip 12. As an alternative, the dial grip can comprise such a button module of an electronic system.

[0102] The injection device 1 can be configured such that a turning of the button or dial grip 12 causes a mechanical click sound to provide acoustic feedback to the user. In this embodiment, the button or dial grip 12 also serves as an injection button. Upon piercing of the needle 15 into a skin portion of a patient and then pushing the button or dial grip 12 and / or the attached module 11 in axial direction, the insulin dose shown in the display window 13 is expelled from the injection device 1. Upon pushing the button or dial grip 12 and the needle 15 of the injection device 1 remaining in the skin portion for a certain time, the dose is injected into the patient. The expulsion of the insulin dose can also cause a mechanical click sound, which can be different from the sound produced when rotating the button or dial grip 12 during dialing of the dose.

[0103] In this embodiment, during delivery of the insulin dose, the button or dial grip 12 is returned in axial movement to its initial position (not rotated) while the dial sleeve assembly is rotated back to its initial position, e.g. to display a dose of zero units. 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 encompass all medicaments in the medicament container 14, in particular liquid medicaments or medicament formulations.

[0104] 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 an expiration date (e.g. 28 days after first use). In case of a reusable device, the insulin container can be replaced.

[0105] Further, prior to 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 a dose of two units of insulin and pushing the button or dial grip 12 while holding the needle 15 of the injection device 1 pointing upwards. For the sake of presentation, in the following it will be assumed that the expelled amount substantially corresponds to the injected 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 expelled amount and the injected dose can need to be considered.

[0106] As explained above, the button or dial grip 12 also serves as an injection button, using the same component for dialing / setting a dose and dispensing / delivering the 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.

[0107] In the following, an electronic module 11 according to the present disclosure will be described with respect to exemplary embodiments and with reference to Figs. 1-6. In Fig. 1, the electronic module 11 is depicted as integrated in the proximal end of the injection device 1, in particular in the dial grip / dose button 12. As an alternative, the electronic module 11 can be a separate component part which can be permanently or releasably attached to the injection device 1, e.g. to the grip / dose button 12.

[0108] As depicted in Fig. 2, the exemplary electronic module comprises a processor 110, a sensor arrangement 120, a communication unit 130, an electronic user feedback generator 140, a memory 150 and a power source 160.

[0109] In the example depicted in Fig. 2, the sensor arrangement 120 is connected to the processor 110 and is operable to generate measurement data indicative of a dose setting operation and / or a dose delivery operation. To this end, the sensor arrangement comprises an LED 121 and a photodetector 122 which together form an optical sensor. In addition to or as an alternative to the LED 121 and the photodetector 122, alternative sensor types can be implemented. Such alternative sensor types can include, but are not limited to, optical sensors, acoustic sensors, capacitive sensors, electrical switches.

[0110] The communication unit 130 comprises a wireless communication interface connected to the processor 110 and operable to establish communication with another (external) device, e.g. a smartphone 200. Further, the communication unit 130 is operable to transmit data, e.g. measurement data, to said another device 200.

[0111] The electronic user feedback generator 140 is connected to the processor 110 and is operable to generate feedback signals to a user. In the exemplary arrangement of Fig. 2, the electronic user feedback generator 140 comprises an LED 141 for generating optical feedback signals. In addition to or as an alternative to the LED 141, the electronic user feedback generator 140 can comprise a sound emitter and / or a vibration motor.

[0112] The memory 150 is adapted to store measurement data and is connected to or integrated into the processor 110. The power source 160 is connected to the processor 110. For example, the power source 160 is a non-rechargeable, non-user replaceable button cell.

[0113] Turning now to Figs. 3-7b, the electronic module 11 comprises a cap 310, an inner component part 320, e.g. a chassis component, a printed circuit board assembly (PCBA) 330 and a power source 160 in the form of a button cell.

[0114] The cap 310 can be a cup-shaped part having a closed proximal end (upper end in Figures 3 and 4), a closed skirt (which can have a saw-toothed or similar surface structure), and an open distal end facing the drug delivery device 1. The cap forms the outer shell of the module 11 and houses the PCBA 330, the coin cell battery 160, and at least a portion of the part 320.

[0115] The part 320, depicted in Figures 7a and 7b from different sides, is made of a transparent material, for example, injection molded from a polycarbonate material. The part 320 has an outer skirt 321 which is substantially cylindrical and fits into the space defined by the cap 310. The skirt 321 can be provided with a circumferential outer bead and / or a circumferential outer groove for rigid attachment with a corresponding bead and / or groove structure of the cap 310. The annular distal end face of the skirt 321 forms a user feedback surface 322 which is adapted to emit light into the part 320, for example, from LEDs 141 provided on the PCBA 330. Thus, the skirt 321 acts as a light guide. As mentioned above, the surface roughness of the skirt 321 and the user feedback surface 322 can be adapted to enhance or allow the light guiding function. The user feedback surface 322 extends axially beyond the distal end of the cap 310 and can have an outer diameter similar to the outer diameter of the cap 310. Thus, the user feedback surface 322 is visible from the outside of the module 11. The inner surface of the skirt 321 can be provided with information related to the module 11 itself and / or the device 1 to be used with the module 11.

[0116] Figures 3 and 4 show that the part 320 is provided with a rim 328 facing inwards from the skirt 321. This rim 328 supports the PCBA 330 and the coin cell battery 160. For this purpose, at least one collar portion 329 can extend proximally from the rim 328. Further, this rim 328 can comprise one or more recesses for receiving LEDs 141 mounted on the PCBA 330.

[0117] Figures 5a, 5b, 7a and 7b illustrate the module locking formation 323 of the component 320, which comprises a profiled protrusion adapted to matingly abut with a corresponding contoured seat of the device locking formation 21 of the dedicated drug delivery device 1, in particular the button 12 of the drug delivery device 1. From the table of Figure 8, the functionality of the module locking formation 323 becomes apparent, which depicts three different types of module locking formation 323 in combination with three different types of corresponding device locking formation 21 of the button 12. The respective locking formations 323 and 21 are designed such that only one specific module locking formation 323 matches with a specific corresponding device locking formation 21, thereby allowing the module 11 to be attached on the respective button 12 of the dedicated drug delivery device 1. However, if the user tries to attach the module 11 to an incorrect drug delivery device 1, the complete attachment is prevented by the non-matching module locking formation 323 and corresponding device locking formation 21. While Figure 8 illustrates three types of modules 11 and three types of drug delivery devices 1, different numbers of matching pairs of modules 11 and dedicated drug delivery devices 1 can be chosen.

[0118] The module 11 can be releasably secured on the drug delivery device 1 by means of attachment elements 324 formed on the component 320. Figures 5a, 5b, 7a and 7b illustrate a pair of these attachment elements 324 in the form of elastically deformable snap hooks, which can engage with corresponding recesses 22 formed in the distally facing recess 25 of the button / dial grip 12. The attachment elements 324 extend distally from the rim 328 of the component 320. The module 11 is rigidly attached to the button 12, which means that it always moves rotationally and axially together with the button 12. Thus, during dialing, when the button 12 moves outwards on a helical path together with the drive sleeve and the number sleeve 23, the module moves helically on the same path with the button 12, the drive sleeve and the number sleeve 23 during this phase.

[0119] The component 320 further comprises two light pipes 325, which are elongated cuboid shaped protrusions extending distally from the rim 328. The light pipes 325 have two opposite end faces adapted to allow light in and light out. The side walls of the light pipes 325 form a boundary surface that guides electromagnetic radiation by total reflection. When the module 11 is attached to the button 12 of the drug delivery device 1, the light pipes 325 extend through the apertures 19 in the recess 25 in the distal end face of the button 12 (see Figures 6a, 6b), as illustrated in Figure 4.

[0120] A sensor arrangement 120 with an LED 121 and a photodetector 122 is located at or near the proximal end face of each light pipe 325 on the PCBA 330. Thus, a light beam emitted from the LED 121 can enter the light pipe 325, be guided distally, exit the light pipe 325 at its distal end, be reflected by a tooth 24 of the digital sleeve 23 (depending on the rotational position of the digital sleeve 23), enter back into the light pipe 325 and exit the light pipe at its proximal end to be detected by the photodetector 122. On the other hand, if the digital sleeve 23 is in a rotational position such that no reflecting tooth 24 is located underneath the distal end of the respective light pipe 325, the light beam exiting the light pipe 325 is not reflected and thus not detected by the photodetector 122. The time-shifted emission of the light signal from the LED 121 can be used to detect the rotation of the digital sleeve 23, which is indicative of the amount of dose dispensed from the drug delivery device 1. Thus, depending on the relative rotational position of the teeth, the teeth 24 of the digital sleeve 23 act as an encoder that either reflects or does not reflect light.

[0121] Still further, the component 320 comprises a resiliently deformable switch arm 326 having an elongated, distally extending free end 327. Two different designs of the free end 327 are depicted in Figs. 5a and 5b. The switch arm 326 extends substantially circumferentially on the diameter on which the light pipes 325 are arranged. As depicted in Figs. 5a and 5b, the switch arm 326 can have the form of an open ring, the two ends of which are hinged to a rim 328. The free end 327 can be located in the middle of the open ring, at a position substantially opposite to the light pipes 325.

[0122] This arrangement allows that the switch arm 326 can be received in the groove 25 when the switch arm 326 is deflected in a state in which the module 11 is mounted to the button 12 of the drug delivery device 1. In this state, the free end 327 extends through the further aperture 20 in the button 12 into the drug delivery device 1. Thus, if components within the drug delivery device 1 move relative to the button 12, the free end 327 and the switch arm 326 can be deflected. More specifically, at the beginning of dose dispensing, the user presses the proximal end of the module 11, thereby displacing the module 11 together with the button 12 relative to, for example, the digital sleeve 23, or, alternatively, relative to the drive sleeve. This causes the free end 327 to contact, for example, the digital sleeve 23 and deflect the switch arm 326, which in turn actuates the switch 331 on the distal side of the PCBA 330, which can trigger the wake-up of the module 11.

[0123] The PCBA 330 can comprise or form the processor 110, the sensor arrangement 120, the communication unit 130, the electronic user feedback generator 140, and the memory 150. The PCBA 330 is supported on a component 320 which serves as a chassis in the module 11. In addition to the LEDs 121 and the photodetector 122, one or more LEDs 141 can be provided on the PCBA 330. Further, a switch 331 can be provided on the PCBA 330, e.g. on the distal side facing the drug delivery device 1.

[0124] Figures 6a, 6b and 6c show three similar embodiments of the design of the button 12 of the drug delivery device 1. In Figure 6a, the button 12 comprises a recess 25 with apertures 19, 20 for the free ends 327 of the light pipe 325 and the switch arm 326, respectively. Further, a recess 22 is provided for snap-in engagement with an attachment element 324 of the module 11. In Figures 6b and 6c, an additional inner recess is provided in which a module locking formation 323 is arranged. The apertures 19 and 20 are formed as one common slot-like opening in Figure 6c, instead of separate openings as in Figure 6a.

[0125] As depicted in Figure 9, a potting compound 340 or a filling layer can be applied to prevent dust and water from entering the electrically conductive regions of the PCBA 330. In addition or as an alternative, only one or both sides of the PCBA 330 can be at least partially covered by a potting material or by a potting compound or by a conformal coating at all locations not covered by electronic parts. For example, the chassis component 320 is configured to separate the potting compound from the electrical sensor and / or from the radiation source of the detector unit.

[0126] Figures 10a to 10d show an exemplary use of a power clip 350 which can be attached to the chassis component 320 in order to hold the coin cell battery 160 on the chassis component 320 and to connect the coin cell battery 160 with the PCBA 330. As depicted in Figures 10a and 10c, the clip 350 has a curved form in its unbiased state. In contrast thereto, the clip 350 has a more flat curvature in the configuration mounted on the chassis component 320 (see Figures 10b and 10d). The chassis component 320 can have corresponding snap features for attaching the clip 350, in particular the free end of the clip 350.

[0127] The clip 350 is composed of an elastically deformable and electrically conductive material, e.g. metal. If the clip 350 is attached to the chassis component 320 (Fig. 10d), a central portion of the clip 350 is adapted to contact one terminal of the coin cell battery 160 (upper terminal in Figs. 10c and 10d), while at least one of the free ends of the clip 350 is adapted to contact a corresponding terminal on the PCBA 330. For this purpose, at least a portion of the clip 350, e.g. its free end as shown in Fig. 10d, can extend through a corresponding aperture in the chassis component 320.

[0128] Still further, Fig. 11 depicts an alternative embodiment, in which an additional switch 332 is provided on the PCBA 330. This switch 332 can be actuated if the module 11 is fully and correctly assembled onto the button 12 by contact between the distal switch surface and the proximally facing button surface. Such a switch can be used to activate the processor 110 or components thereof, e.g. from a no-power or sleep mode, when the module is not attached to the device 1.

[0129] While mainly described with respect to a drug delivery device 1 having a similar working principle as the device disclosed in EP 2 890 435, the electronic module 11 is applicable to any other type of drug delivery device having component parts that perform relative axial and / or rotational movements under defined conditions or states.

[0130] Reference signs

[0131]

Claims

1. An electronic module (11) for releasably attaching to a drug delivery device (1), the electronic module (11) comprising a printed circuit board assembly (330), a power supply (160), and a component (320) forming the base of the electronic module (11), comprising the following features: - At least one light tube (325) is used to guide a light beam from the light source (121) to the reflective surface (24) of the drug delivery device (1) and from the reflective surface (24) to the photodetector sensor (122). - At least one light guide (321) for guiding a light beam from another light source (141) to a user feedback surface (322) of the component (320) suitable for emitting light. - The power source (160) is a button cell battery, which is secured and connected to the printed circuit board assembly (330) by means of a power clip (350) attached to the base component. The power clip (350) is made of an elastically deformable and conductive material and includes a free end and a central portion. The central portion of the power clip (350) is adapted to contact the upper terminal of the button cell battery, and the free end of the power clip (350) is adapted to contact a corresponding terminal on the printed circuit board assembly (330). The free end of the power clip (350) extends through a corresponding opening in the base component.

2. The electronic module according to claim 1, wherein the component (320) further comprises at least one of the following features: - At least one module locking configuration (323), said at least one module locking configuration being adapted to match and be adjacent to a corresponding device locking configuration (21) of the drug delivery device (1), - At least one attachment element (324) for releasably attaching the electronic module (11) to the drug delivery device (1), - At least one elastically deformable switch arm (326, 327). - The component (320) is an integral component part injection molded from polycarbonate material.

3. The electronic module according to claim 1 or 2, further comprising a cap (310), wherein the component (320) is rigidly attached to the cap (310) and supports the printed circuit board assembly (330) within the cap (310).

4. The electronic module according to claim 2, wherein the at least one module locking structure (323) includes a protrusion or seat adapted to mate adjacent to a seat or protrusion of a corresponding profile of the device locking structure (21) of the drug delivery device (1).

5. The electronic module according to claim 2 or 4, wherein the at least one module locking configuration (323) prevents the electronic module (11) from being attached to a mismatched drug delivery device (1).

6. The electronic module according to claim 2 or 4, wherein the at least one attachment element (324) for releasably attaching the electronic module (11) to the drug delivery device (1) comprises at least one resiliently deformable arm having a snap-fit ​​protrusion or snap-fit ​​recess for releasably engaging with a corresponding snap-fit ​​recess (22) or snap-fit ​​protrusion of the drug delivery device (1).

7. The electronic module according to any one of claims 1-2 and 4, wherein the at least one light tube (325) is an elongated cuboid protrusion or a truncated cone protrusion having two opposite end faces and at least one sidewall, wherein at least one of the two opposite end faces has a surface roughness higher than the surface roughness of the at least one sidewall.

8. The electronic module according to any one of claims 1-2 and 4, comprising at least two light tubes (325) projecting axially in the same direction from the internal portion (328) of the component (320).

9. The electronic module according to any one of claims 1-2 and 4, wherein the at least one light guide includes an annular skirt (321), the annular skirt having at least one entry surface (328) and a user feedback surface (322) radially outward from the annular skirt (321), wherein the at least one entry surface (328) and the user feedback surface (322) have a surface roughness higher than that of the annular skirt (321).

10. The electronic module of claim 9, wherein the annular skirt (321) includes at least two access surfaces, each of which is formed in a corresponding recess for receiving the other light source (141).

11. The electronic module of claim 9, wherein the annular skirt (321) includes four access surfaces, each of which is formed in a corresponding recess for receiving the other light source (141).

12. The electronic module according to claim 2 or 4, wherein the at least one elastically deformable switch arm (326) extends in the circumferential direction.

13. The electronic module according to claim 2 or 4, wherein the at least one elastically deformable switch arm (326) includes a free end (327) and is deflectable relative to the component (320) to actuate the electronic switch (331).

14. The electronic module of claim 3, wherein, apart from the user feedback surface (322), the component (320) is covered by the cap (310), and wherein the printed circuit board assembly (330) and the power supply (160) are located between the cap (310) and the component (320).

15. The electronic module according to claim 2 or 4, wherein the component (320) has a substantially cylindrical external shape, wherein the radially facing user feedback surface (322) forms a distal end, and wherein the component (320) includes an inner edge (328) having the at least one module locking configuration (323), the at least one attachment element (324) extending distally from the inner edge (328) and the at least one light tube (325), and at least one collar portion (329) extending proximally from the inner edge.

16. The electronic module according to claim 2 or 4, wherein the at least one attachment element (324) includes a clamping feature for forming a clamp connection with a drug delivery device (1) including an opposing fastening element of complementary shape.

17. The electronic module of claim 15, wherein the electronic module includes two clamping features as attachment elements (324) projecting distally from the inner edge (328), wherein the clamping features axially hold the electronic module and orient it toward the drug delivery device (1).

18. The electronic module according to any one of claims 1-2 and 4, wherein the at least one light tube (325) is a protrusion in the form of a truncated pyramid or a cylinder.

19. The electronic module according to any one of claims 1-2 and 4, wherein the at least one optical tube (325) extends axially over the at least one module locking structure (323).

20. The electronic module according to any one of claims 1-2 and 4, wherein the at least one optical tube (325) extends axially over the at least one attachment element (324).

21. The electronic module according to any one of claims 1-2 and 4, wherein the component (320) is an integral component part injection molded from a thermoplastic polymer material that is highly transparent to light.

22. The electronic module according to any one of claims 1-2 and 4, further comprising: - At least one processor (110). - Sensor arrangement (120), the sensor arrangement being connected to the at least one processor (110) and operable to generate measurement data indicative of dose setting operations and / or dose delivery operations of the drug delivery device (1), - Communication unit (130), the communication unit having a wireless communication interface connected to the at least one processor (110) and operable to establish communication with another device (200) and transmit data to the other device (200). - At least one electronic user feedback generator (140), said at least one electronic user feedback generator being connected to said at least one processor (110) and operable to generate feedback signals, and - Memory (150), the memory is used to store measurement data.

23. A drug delivery device (1) for delivering a drug, the drug delivery device (1) comprising a dose setting and drive mechanism (23) configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device (1) and a dose delivery operation for delivering the set dose, and the dose setting and drive mechanism comprising a first member (20) and a container receiving seat (14) permanently or releasably connected to the dose setting and drive mechanism and adapted to receive a container containing a drug. Its features are, The drug delivery device (1) includes an electronic module (11) according to any one of claims 1-22.

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