Electronic module and drug delivery device

Abstract

The present invention relates to an electronic module (11) for releasably attaching to a drug delivery device (1), and to such a drug delivery device. The module (11) may include at least one module lockout molding (323) adapted for mating abutment with a corresponding device lockout molding (21) of a dedicated drug delivery device (1). Furthermore, the module (11) may include at least one attachment element (324) for releasably attaching the module (11) to the drug delivery device (1). Furthermore, the module (11) may include 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 the reflective surface (24) to a light detector sensor (122). Furthermore, the module (11) may include at least one light guide (321) for guiding a light beam from a light source (141) to a user feedback surface (322) of the component adapted to emit light. Additionally, the module 11 may include at least one resiliently deformable switch arm 326. The component 320 may be a unitary component injection molded from a polycarbonate material.

Description

[Technical Field]

[0001] The present invention is directed generally to electronic systems, e.g., modules, for drug delivery devices, and more particularly to components of such modules having multiple functions. The present invention further relates to drug delivery devices, preferably including such electronic modules. [Background technology]

[0002] Pen-type drug delivery devices are used in applications where people without formal medical training administer injections on a regular basis. This may be increasingly common among people with diabetes, and self-treatment allows such patients to effectively manage their disease. In practice, such drug delivery devices allow the user to individually select and administer multiple user-variable doses of medication.

[0003] There are essentially two types of drug delivery devices: resettable (i.e., reusable) and non-resettable (i.e., disposable). For example, disposable pen delivery devices are supplied as self-contained devices. Such self-contained devices do not have a removable pre-filled cartridge. Pre-filled cartridges 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 disposable and reusable devices.

[0004] For such devices, the ability to record the dose dialed and / or delivered from the pen can be beneficial to many device users as a memory aid or to support detailed logging of dose history. Accordingly, drug delivery devices that use electronic devices are becoming increasingly popular not only in the pharmaceutical industry but also with users or patients.

[0005] For example, from US Patent No. 5,949,999 a drug delivery device is known which includes an electronic clip-on module. The clip-on module includes a battery which powers a processor and further components controlled by the processor, such as a light source, a photometer, an acoustic sensor, an acoustic signal generator, a wireless unit, such as a Bluetooth transceiver configured to transmit and / or receive information to and / or from other devices in a wireless manner.

[0006] However, managing the resources of the power supply integrated into the device is particularly important, especially when the device is designed to be self-contained, i.e., there is no connector for connection to the power supply required to provide power for the device's operation.

[0007] Unpublished U.S. Patent Nos. 5,999,949 and 5,999,952 disclose advantageous embodiments of electronic systems for drug delivery devices with improved power management. These electronic systems include a switch assembly for activating / deactivating power-consuming functions of the electronic systems. Reference is made to these two patents for their disclosure of the operating principles of electronic systems associated with drug delivery devices.

[0008] Further examples of electronic modules for use with drug delivery devices are described in U.S. Patent No. 5,929,999. To detect dial settings or dispensed doses, the module includes an encoder system with two optical sensors, each consisting of a transmitting portion, e.g., an LED, and a corresponding receiving portion, e.g., a photodiode. Light emitted by the transmitting portion of the sensor, e.g., IR light, is guided through a light pipe extending from the chassis of the module to near a ring of teeth formed on the proximal end of the rotatable number sleeve of the drug delivery device. The light exits the light pipe at the end opposite the sensor and is reflected back into the light pipe by the teeth of the number sleeve, depending on the rotational position of the teeth relative to the light pipe. The light pipe guides the reflected light beam to the receiving portion of the sensor. The light pipe is made of glass or polycarbonate. Reference is made to this patent document for its disclosure of the operating principles of the encoder system associated with the drug delivery device.

[0009] Unpublished U.S. Patent Nos. 5,629,999 and 5,729,999 disclose similar modules for drug delivery devices having encoder systems including optical sensors with chassis including light pipes. In these patents, the electronic modules are configured to be removably attached to the drug delivery device and include respective fastening elements. By providing dedicated electronic modules for specific drug delivery devices, the risk of incorrect pairing of the electronic modules with the drug delivery device is minimized.

[0010] Such drug delivery devices are typically mass produced and therefore efficient and easy assembly is a key issue in order to keep manufacturing costs reasonably low. [Prior art documents] [Patent documents]

[0011] [Patent Document 1] European Patent Application Publication No. 2814545 [Patent Document 2] European Patent Application No. 20315066.9 [Patent Document 3] European Patent Application No. 20315357.2 [Patent Document 4] International Publication No. 2019 / 101962 [Patent Document 5] International Patent Application No. PCT / EP2020 / 085728 [Patent Document 6] International Patent Application No. PCT / EP2020 / 085729 Summary of the Invention [Problem to be solved by the invention]

[0012] An object of the present disclosure is to provide an improved electronic module for use with a drug delivery device that achieves reasonable manufacturing and assembly effort. [Means for solving the problem]

[0013] This object is solved, for example, by the subject matter defined in the independent claims. Advantageous embodiments and refinements are the subject of the dependent claims. It should be noted, however, that the present disclosure is not limited to the subject matter defined in the appended claims. The present disclosure may also include additional or alternative refinements to the features defined in the independent claims, as will become apparent from the following description.

[0014] One aspect of the present disclosure relates to an electronic module suitable for use in a drug delivery device. Such a drug delivery device may include 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 includes at least one processor, e.g., a microcontroller, a sensor device, a communication unit with a wireless communication interface, at least one electronic user feedback generator, a memory for storing measurement data, and a power source connected to the at least one microcontroller.

[0015] According to one aspect of the present disclosure, an electronic module is suitable for releasable attachment to a drug delivery device. The module includes a component that can be a chassis for the module. The electronic module may further include a cap, a printed circuit board assembly (PCBA), and a power source. For example, the component is a chassis that is securely attached to the cap and supports the PCBA within the cap. This chassis component can have several different functions, thereby reducing the number of components required for the module. This reduces manufacturing and assembly time and costs. In the following, the components will be primarily referred to as chassis components, but the function of the components is not required to be, for example, a chassis for supporting the PCBA. The present disclosure includes all types of components, regardless of whether they can have a chassis function.

[0016] All of the configurations and functions of the chassis components listed below can be integrated into the chassis components, but the present disclosure is not limited to such an embodiment. According to the present disclosure, the chassis components can include only one, and preferably at least two, of the following independent configurations and functions:

[0017] According to a first independent aspect of the present disclosure, a chassis component of a module may include at least one module lockout molding adapted for mating abutment with a corresponding device lockout molding of a dedicated drug delivery device. In other words, the electronic module may include the module lockout molding as a mechanical coding feature that engages with a corresponding device lockout molding as a mechanical counter-coding feature provided on 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 mates or mates with the respective module.

[0018] Typically, a kit of multiple electronic modules is provided, and the electronic modules are distinguished by their respective module lockout moldings (mechanical coding). The first mechanical coding of a first electronic module is different from the second mechanical coding of a second electronic module. For example, the first mechanical coding or the first module lockout molding includes at least one of a first protrusion and a first recess. The second mechanical coding feature or the second module lockout molding includes at least one of a second protrusion and a second recess. The geometry of the first protrusion may be different 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 different from the position of the second protrusion in a transverse plane. The same applies to the first and second recesses of the first and second electronic modules. Furthermore, the present disclosure also relates to a set of drug delivery devices having corresponding device lockout moldings or mechanical (counter) codings that differ. At least a first drug delivery device having a first corresponding device lockout molding or first mechanical counter-coding and a second drug delivery device having a second corresponding device lockout molding or second mechanical counter-coding are provided. The first modular lockout molding mates or mates with the first corresponding device lockout molding but not with the second corresponding device lockout molding. Similarly, the second modular lockout molding mates or mates only with the second corresponding device lockout molding but not with the first corresponding device lockout molding. The first and second mechanical counter-codings of the first and second drug delivery devices differ in at least one of the geometry and lateral position of their respective counter-coding features, and thus their shapes and / or the lateral positions of their protrusions or recesses.

[0019] Interengagement of the mechanical coding and the counter mechanical coding is achieved when the respective lockout moldings are mated, i.e., when the mechanical coding matches the counter mechanical coding, and when the electronic module is attached to the proximal end of the drug delivery device in a predetermined fastening configuration.

[0020] In an example of the first aspect of the present disclosure, at least one module lockout molding includes a profiled protrusion or seat adapted for mating abutment with a corresponding contoured seat or protrusion of a device lockout molding of the dedicated drug delivery device. More specifically, in one example of the present disclosure, the drug delivery device includes a button that is rotatable for dose selection and axially displaceable for dose dispensing. Such button is provided with a circular groove on its proximal-facing end face. This groove is adapted to receive at least one, e.g., two, protrusions of the module, e.g., specifically, a chassis component of the module. These protrusions constitute the module lockout molding. The groove is not rotationally symmetric and includes one or more internal blocking features as the corresponding device lockout molding. The design of the module lockout molding and the corresponding device lockout molding is such that if a user attempts to attach the module to an inappropriate device, they will easily come off as soon as pressure is released.

[0021] In other words, at least one module lockout molding prevents attachment of the module to a non-compatible drug delivery device. For example, if the electronic module includes a module lockout molding that does not match a corresponding device lockout molding on the drug delivery device, the lockout moldings (coding features) may be circumferentially misaligned. In a given fastening configuration in which the module is fully attached to the drug delivery device, for example, when fastening elements of the module engage with correspondingly shaped counterfastening elements on the drug delivery device, the respective lockout moldings may not have a suitable mating counter-shape. Thus, they may prevent and hinder proper placement and assembly of the electronic module on the drug delivery device.

[0022] As an alternative to such lockout molding on the chassis component, the keying / blocking features are provided on a separate component, such as the casing or cap of the electronic module and / or an optional adapter for the electronic module. A press fit, form fit, snug fit, pressure fit, or other connecting means is used to connect the keying and / or blocking features to the casing and / or chassis component.

[0023] According to a second independent aspect of the present disclosure, the chassis component of the module may include at least one attachment element for releasably attaching the module to the drug delivery device. For example, the at least one attachment element for releasably attaching the module to the drug delivery device may include 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 is used with several drug delivery devices of similar or identical types. Therefore, assembly or fastening of the electronic module to the drug delivery device is only a temporary assembly. Inter-fastening of the electronic module and the drug delivery device may require distal movement of the electronic module from a pre-assembly configuration to a final assembled configuration, and the final assembled configuration may be a predetermined fastened configuration.

[0024] In other words, the electronic module may include fastening or attachment elements configured to mechanically engage with complementary opposing fastening or attachment elements of the drug delivery device in a predetermined fastening configuration. The fastening or attachment elements and the opposing fastening or attachment elements may define a predetermined fastening configuration in which the electronic module is attachable, coupleable, or connectable to the drug delivery device. The positions and / or geometric shapes of the fastening or attachment elements of the electronic module typically match the geometric shapes and / or positions of the opposing fastening or attachment elements of the drug delivery device. Assembly with each other, and thus placement of the electronic module on the drug delivery device in the predetermined fastening configuration, requires the fastening or attachment elements to mechanically engage with the complementary opposing fastening or attachment elements. When the fastening or attachment elements and the complementary opposing fastening or attachment elements are mechanically engaged, the electronic module is in a predetermined orientation and position relative to the drug delivery device.

[0025] The fastening or attachment element may include a clip feature and may form a clip connection with a corresponding or complementary shaped opposing fastening or attachment element. Thus, the opposing fastening or attachment element of the drug delivery device may also include a clip feature and may contribute to a click connection between the electronic module and the drug delivery device. In other examples, the fastening or attachment element is configured to establish a friction fit or a force fit with a complementary shaped opposing fastening or attachment element of the drug delivery device.

[0026] More specifically, the chassis component may include two flexible clips as attachment elements protruding distally from an inner rim of the chassis component, which axially retain and non-rotationally orient the module relative to the drug delivery device. The drug delivery device may include a button having two apertures into which the two flexible clips snap. For example, the chassis component may have at least one, e.g., two, resiliently deflectable snap hooks suitable for engaging with corresponding snap recesses in the button of the drug delivery device.

[0027] As an alternative to such attachment elements on the chassis components, fastening features are provided on separate components, for example the casing or cap of the electronic module and / or an optional adapter for the electronic module.

[0028] According to a third independent aspect of the present disclosure, the chassis component of the module may include 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 may be a protrusion in the shape of a truncated cone. Alternatively, the at least one light pipe may be a protrusion in the shape of a truncated pyramid. Further alternative forms may include a cylindrical shape or an elongated rectangular parallelepiped shape.

[0029] The at least one light pipe may have two opposing end faces and at least one side wall, and at least one of the two opposing end faces has a surface roughness greater than the surface roughness of the at least one side wall. This facilitates light to pass through the end face and be reflected by the at least one side wall. In other words, the at least one light pipe may include an interface capable of guiding electromagnetic radiation by total internal reflection.

[0030] In an exemplary embodiment, one end face of the light pipe may have the same surface finish as the side face of the light pipe, e.g., polished, so that only one of the end faces has a higher roughness than the side wall. Other combinations of surface finishes may also be suitably used.

[0031] In one example of the present disclosure, the module may include at least two light pipes that protrude axially in the same direction from an inner portion of the chassis component. More specifically, the light pipes are disposed on or in a portion of a circular rim and inserted into apertures in a circular groove of a button of the drug delivery device. The light pipes may be parallel to each other and / or the central axes of each of the light pipes may be parallel to each other.

[0032] The light pipe may extend axially beyond the module lockout molding and / or beyond the attachment element. In other words, the length of the light pipe in the distal direction may be such that the light pipe can enter the button of the drug delivery device when the module is fully attached to the drug delivery device, i.e., with the lockout molding engaged and / or the attachment element fully coupled.

[0033] As an alternative to providing a light pipe, an optical sensor is located within the module, for example an encoder located near the interface of the module with the drug delivery device is detected by the sensor.

[0034] According to a fourth independent aspect of the present disclosure, a chassis component of a module may include at least one light guide for guiding a light beam from a light source to a user feedback surface of said component adapted to emit light. The user feedback surface may be a light-emitting area, i.e., a surface visible from the outside of the module, and may use a light signal to indicate, for example, the status of the module. The user feedback surface may have an annular shape, for example in the form of an outward-facing light ring of the chassis component.

[0035] For example, the at least one light guide may include an annular skirt having at least one entrance surface and a user feedback surface radially outward from the annular skirt. The at least one entrance surface and the user feedback surface may have a surface roughness greater than the surface roughness of the annular skirt. This facilitates light passing through the end surface and the user feedback surface, where the light is reflected by the annular skirt. In other words, the at least one light guide may include the annular skirt as a boundary surface capable of guiding electromagnetic radiation by total internal reflection.

[0036] The surface roughness of the light pipe and / or light guide, such as the two opposing end faces of the light pipe or the entrance and user feedback surfaces of the light guide, can have a textured surface finish, particularly a textured finish according to the SPI D3, D2, or D1 standards. The textured finish can be SPI-D3 or even finer, with a slight roughness or diffuseness, characterized by a feature size of approximately 1 μm, particularly the central wavelength of an infrared (IR)-light-emitting diode (LED) sensor package used as an optical sensor. In light pipes, the sides of the encoder can have a mirrored finish; the sides of the encoder can include an anti-reflective coating. The mirrored finish and anti-reflective coating can reflect interfering light, preventing it from entering the light pipe and reducing the signal-to-noise ratio.

[0037] Furthermore, the surface roughness of the light pipe and / or light guide is selected so that the areas intended to guide light, such as the sidewalls of the light pipe or the skirt of the light guide, have a mirrored finish. This finish can promote total internal reflection (TIR) ​​and the light pipe effect. A mirrored surface can be used in combination with a textured finish on the areas intended for light entry and / or exit, where the roughness of the areas intended for light entry and / or exit reduces the amount of TIR, for example, on the encoder side, compared to a mirrored finish. In further examples of optical guiding means, such as light pipes and / or light guides, the areas intended to guide light can include one or more coatings, where the outermost coating can be opaque to the guided radiation, or all coatings can be transparent to the guided radiation, with the optical refractive index of each transparent coating being lower than the optical refractive index of the chassis component itself. This can, for example, further improve the light guiding by at least one light pipe and can also reduce the influence of interfering light from outside the light pipe. Therefore, the signal-to-noise ratio can be improved.

[0038] In the electronic module, the annular skirt may include at least two, e.g., four, entrance faces each formed within a respective recess for receiving a light source, e.g., a respective LED. In one example of the present disclosure, the light guide may be used to indicate different operational states of the module. Such states may include a state in which the module is attempting to synchronize with another external device via the module's wireless communication interface, e.g., by flashing all LEDs in the light ring, and a state in which the module is attempting to pair with another external device via the module's wireless communication interface.

[0039] As an alternative to providing a light guide in a chassis component, the module may indicate status by one or more light sources visible from the outside directly or through a window. Yet another feedback alternative may include a sound generator and / or a vibration motor. Such other user signals may be provided by the module, for example, to indicate sensor operation, dose dial setting and / or dose dispensing start and / or end, dwell time expiration, etc. However, the module itself need not generate user feedback. Alternatively or additionally, such feedback may be further generated by the drug delivery device.

[0040] According to a fifth independent aspect of the present disclosure, a chassis component of the module may include at least one resiliently deformable switch arm. For example, the at least one resiliently deformable switch arm may extend in a circumferential direction. Alternatively or additionally, the at least one resiliently deformable switch arm may include a free end and may be deflectable relative to the chassis component to activate an electronic switch.

[0041] The present disclosure is further directed to a method of waking an electronic encoding module configured as a reusable clip-on module for a drug delivery device, e.g., an injection device. The method includes waking the electronic module at or just before the start of dose delivery. This limits power consumption by activating the capture system for as short a time as possible. This is particularly useful for systems such as optical encoders, where the power consumption of an IR-LED sensor accounts for a significant portion of the total power consumption of the electronic module. The method may further include waking the module upon initiating dose dispensing by actuating a switch with a switch arm that is deflected when a button on the injection device is moved axially relative to a stationary component of the device, e.g., the housing. There are numerous embodiments of such a wake switch.

[0042] According to a further independent aspect of the present disclosure, a switch, e.g., a low-force microswitch, is mounted on the underside of the electronic module, e.g., on the distal side of the PCBA. The microswitch may have overtravel beyond its switching point. For example, a switch such as the Panasonic ESE 16J001 may be suitable. The switch is actuated by a flexible switch arm formed in a chassis component of the module. The flexible switch arm is configured to fit into an annular groove in the rear of a button component of the injection device, the button intended to form an interface to the electronic module. The flexible switch arm's feature is designed to pass through an aperture in the button and contact a component that does not undergo axial movement during clutch disengagement of the mechanism at the initiation of dose dispensing. For example, the flexible switch arm's feature is designed to bear against a drive sleeve component of the injection pen device.

[0043] In other words, when the top surface of the electronic module is pressed axially to initiate dose dispensing, the injection pen button may move distally, disengaging a clutch function. The resulting relative movement between the electronic module and the drive sleeve may deflect a flexible switch arm of the chassis component and bear against a microswitch mounted on the underside of the PCBA. For example, the microswitch may be configured to switch and wake the electronic module after a short stroke (before the clutch is fully disengaged), but must also allow sufficient overtravel so that the full stroke of the dose button can disengage the clutch after the electronic switch is made.

[0044] To prevent the ingress of water and dirt, the module is configured with an elastomeric sealing 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, preventing the ingress of water and dirt. The elastomeric sealing component is located between the flexible switch arm (formed on the chassis component) and the microswitch (mounted on the PCBA). The flexibility of the sealing component allows it to deflect and transfer axial loads from the switch arm to the microswitch, enabling normal operation of the wake switch as described above.

[0045] As an alternative to providing an elastically deformable switch arm, the switch is located at the proximal end of the PCBA, i.e. facing away from the drug delivery device, and this switch is activated by an elastically deformable portion in the cap when the user presses the cap at the start of dose dispensing. Further alternatives include waking the module using an optical sensor or by a separate switch arm attached to the drug delivery device and / or other components of the module.

[0046] According to a sixth independent aspect of the present disclosure, the chassis component of the module may be a one-piece component injection-molded from a thermoplastic polymer material that has high transparency to light, e.g., visible light and / or IR light, and that is capable of undergoing elastic deformation. For example, the chassis component is made from a polycarbonate material, such as Covestro Makrolon 2458, by an injection molding process.

[0047] According to a seventh independent aspect of the present disclosure, the chassis components may be enclosed by a cap, except for the user feedback surface, and a printed circuit board assembly (PCBA) and power supply are interposed between the cap and the components.

[0048] According to an eighth independent aspect of the present disclosure, the chassis component may have a substantially cylindrical outer shape with a radially facing user feedback surface forming a distal end, the component may include an inner rim having at least one module lockout molding, at least one mounting element and at least one light pipe extending distally from the rim, and at least one collar portion extending proximally from the rim.

[0049] The sensor device is connected to at least one processor and is operable to generate measurement data indicative of dose setting and / or dose delivery operations. The sensor device may include one or more electrical switches and / or may include optical and / or capacitance and / or acoustic sensors for detecting movement of one or more components of the dose setting and drive mechanism of the drug delivery device. In one example, the sensor device includes at least one light source, e.g., an LED, and at least one optical sensor, e.g., a photodetector. The sensor device may be part of an encoding or movement sensing unit designed and functioning as described in unpublished patent documents EP20315066.9 and EP20315357.2, the disclosures of which are incorporated herein by reference.

[0050] A communication unit having a wireless communication interface may be connected to the at least one processor and operable to establish communication with other devices and transfer data to the other devices. Although establishing wireless communication typically involves the transfer of data, for the purposes of this disclosure, establishing communication, which may include, for example, the processes of broadcasting advertising packets, scanning for such advertising packets, and pairing two devices, may be distinguished from the data transfer itself, which is defined as occurring 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.

[0051] The communication unit for communicating with other devices may include a wireless communication interface for communicating with other devices via a wireless network, such as Wi-Fi or Bluetooth®. Furthermore, the communication unit may include 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 includes an RF, Wi-Fi, and / or Bluetooth® unit as the communication unit. The communication unit serves as a communication interface between the module or the drug delivery device and external devices, such as other electronic devices, e.g., mobile phones, personal computers, laptops, etc. For example, measurement data, i.e., dosage data, is transmitted to the external device by the communication unit. The dosage data is used for a dosage log or dosage history established in the external device. Hereinafter, the wireless communication interface will be described with reference to the example of Bluetooth® communication between the module and a smartphone. However, this should not be understood as a limitation that excludes the above-mentioned alternative forms of wireless communication.

[0052] The memory for storing measurement data, e.g., dosage data, may be a separate memory or part of the main memory of the electronic module. These are controlled by a processor, which may be, for example, at least one microcontroller, digital signal processor (DSP), application specific integrated circuit (ASIC), field programmable gate array (FPGA), etc. According to one aspect of the present disclosure, the processor executes program code (e.g., software or firmware) stored in the program memory and uses the main memory to store intermediate results, e.g., dosage data. The main memory may also be used to store a logbook of performed deliveries / injections based on the measurement data. The program memory may be, for example, a read-only memory (ROM), and the main memory may be, for example, a random access memory (RAM).

[0053] A power source is connected to the processor and powers the processor and other components, such as the sensor device, the communication unit, and the at least one electronic user feedback generator. The power source may be a non-rechargeable, non-user replaceable coin cell battery.

[0054] A potting compound or filler layer is applied to the chassis and / or PCBA to prevent dust and water from entering the conductive areas of the PCBA.

[0055] The coin cell battery is secured and connected to the PCBA by a power clip attached to a chassis component. The clip may have a curved shape in an unbiased (unstressed) state and deforms when attached to the chassis component. The chassis component may have corresponding snap features for attaching the clip, particularly the free end of the clip. The clip may be made of an elastically deformable and electrically conductive material, such as a metal.

[0056] An additional or alternative switch may be provided on the PCBA that is actuated when the module is fully and correctly attached to the button, for example, by contact between a distal switch surface and a proximal-facing button surface. Such a switch may be used, for example, to wake the processor or a component thereof from a no-power or sleep mode of the module when the module is not attached to a device.

[0057] The present invention further relates to a drug delivery device including the electronic module described above. According to a further independent aspect of the present disclosure, the drug delivery device may include a button located at its proximal end. The button may be rotatable for a user to dial (select) a dose. Furthermore, the button may be axially displaceable, e.g., distally, to perform a dosing stroke. In one example, the button is adapted to attach the electronic module to the drug delivery device. More specifically, the button may include attachment features, e.g., one or more snap recesses for receiving and engaging attachment features of the module. Furthermore, the button may include a device lockout molding adapted to mate with a lockout molding of the module. This can prevent improper attachment of the module to the device. Furthermore, the button may include one or more apertures that allow a portion of one or more light pipes and / or switch arms to enter the drug delivery device.

[0058] The drug delivery device for delivering a medicament may include 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 a first member. The dose setting and drive mechanism may include a button. The drug delivery device may further include a container receptacle releasably attached to the dose setting and drive mechanism. Alternatively, the container receptacle is permanently attached to the dose setting and drive mechanism. The container receptacle is adapted to receive a container, such as a cartridge, containing the medicament.

[0059] The terms "drug" or "medicament" are used interchangeably herein to describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or medications are used to treat, cure, prevent, or diagnose disease or otherwise improve physical or mental well-being. Drugs or medications can be used for a limited duration or periodically for chronic disorders.

[0060] As described below, drugs or pharmaceutical agents may contain at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs include small molecules with 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, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids, such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0061] The drug or agent can be contained in a primary package or "drug container" adapted for use in 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 chamber suitable for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber can be designed to store the drug for about one month to about two 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 include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components prior to and / or during administration to the human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and to allow mixing of the two components by a user, if desired, prior to administration. Alternatively or additionally, the two chambers can be configured to allow mixing upon administration of the components to the human or animal body.

[0062] The drugs or agents contained in the drug delivery devices described herein can be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, and thromboembolic disorders, such as deep vein thromboembolism or pulmonary embolism. Further examples of disorders include acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those listed in handbooks such as Rote Liste 2014 (e.g., but not limited to, Main Group 12 (antidiabetic agents) or 86 (oncology agents)) and the Merck Index, 15th edition.

[0063] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin, e.g., human insulin, or a human insulin analog or derivative; glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, or an analog 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 "analog" and "derivative" refer to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deletion and / or replacement of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or replaced amino acid residue can be either a codable amino acid residue, another naturally occurring residue, or a purely synthetic amino acid residue. Insulin analogs are also referred to as "insulin receptor ligands." In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, for example, the molecular structure of human insulin in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide are deleted and / or replaced by other amino acids, including non-codable amino acids, or amino acids, including non-codable ones, are added to the naturally occurring peptide.

[0064] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and the Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0065] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin. B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0066] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flathead monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rexendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C (efpegrenatide). , HM-15211, CM-3, GLP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexene, 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.

[0067] Examples of oligonucleotides are, for example, the cholesterol-lowering antisense therapeutic mipomersen sodium (Kynamro®) for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport syndrome.

[0068] Examples of DPP4 inhibitors are linagliptin, vidagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0069] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropine (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0070] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low-molecular-weight heparin or ultra-low-molecular-weight heparin or derivatives thereof, or sulfated polysaccharides, such as the polysulfated forms of the aforementioned polysaccharides, and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low-molecular-weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives include Hylan G-F20 (Synvisc®) and sodium hyaluronate.

[0071] As used herein, the term "antibody" 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 that retain antigen-binding ability. An antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single-chain antibody. In some embodiments, an antibody has effector function and is capable of fixing complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, antibody fragment, or mutant that does not support Fc receptor binding, e.g., has a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable region antibody-like binding proteins (CODVs) with a crossover binding region orientation.

[0072] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to antigen. Antibody fragments can include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, e.g., bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, e.g., bivalent, trivalent, tetravalent, and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0073] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences and that are primarily responsible for maintaining the proper orientation of the CDR sequences to enable 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 a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids within the CDRs to interact with the antigen.

[0074] 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).

[0075] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use as drugs or medicaments in drug delivery devices. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0076] Those skilled in the art will appreciate that modifications (addition and / or removal) of various components of the APIs, formulations, devices, methods, systems, and embodiments described herein may be made without departing from the overall scope and spirit of the invention, and that the invention encompasses all such modifications and any and all equivalents thereof.

[0077] An example of a drug delivery device may include a needle-based injection system, 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 are broadly distinguished between multi-dose container systems and single-dose (with partial or complete ejection) container systems. The container may be an interchangeable container or an integrated, non-interchangeable container.

[0078] As further described in ISO 11608-1:2014(E), a multi-dose container system may include a needle-based injection device with an exchangeable container. In such a system, each container holds multiple doses and may be fixed or variable in size (pre-set by the user). Another multi-dose container system may include a needle-based injection device with an integrated, non-exchangeable container. In such a system, each container holds multiple doses and may be fixed or variable in size (pre-set by the user).

[0079] As further described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based injection device with replaceable containers. In one example of such a system, each container holds a single dose and the entire deliverable volume is expelled (fully expelled). In a further example, each container holds a single dose and a portion of the deliverable volume is expelled (partially expelled). As further described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based injection device with an integrated, non-replaceable container. In one example of such a system, each container holds a single dose and the entire deliverable volume is expelled (fully expelled). In a further example, each container holds a single dose and a portion of the deliverable volume is expelled (partially expelled).

[0080] As used herein, the terms "axial," "radial," or "circumferential" are used with respect to the major longitudinal axis of the device, cartridge, housing, or cartridge holder, e.g., the axis extending through the proximal and distal ends of the cartridge, cartridge holder, or drug delivery device.

[0081] Non-limiting exemplary embodiments of the present invention will now be described with reference to the accompanying drawings. [Brief explanation of the drawings]

[0082] [Figure 1] 1A-1D illustrate embodiments of drug delivery devices. [Figure 2] 1 is a schematic diagram illustrating an embodiment of an electronic module for a drug delivery device. [Figure 3] 1 is a schematic cross-sectional view of an embodiment of an electronic module for a drug delivery device. [Figure 4] 4 is a further schematic cross-sectional view of the electronic module of FIG. 3 mounted on a drug delivery device. [Figure 5a] FIG. 4 is a schematic perspective view of the electronic module of FIG. 3. [Figure 5b] FIG. 10 is a schematic perspective view of a further electronic module; [Figure 6] 4a-c are schematic diagrams of embodiments of a button of a drug delivery device for mounting the electronic module of FIG. 3; [Figure 7] 5a and 5b are schematic perspective views of the chassis components of the electronic module of FIG. 5b; [Figure 8] 1 is a table showing various lockout moldings. [Figure 9] FIG. 2 is a schematic perspective view of another detail of the electronic module. [Figure 10a] 1A-1C are schematic diagrams of the clip in an unstressed state, a deflected (attached) state, before attachment to the chassis, and after attachment to the chassis. [Figure 10b] 1A-1C are schematic diagrams of the clip in an unstressed state, a deflected (attached) state, before attachment to the chassis, and after attachment to the chassis. [Figure 10c] 1A-1C are schematic diagrams of the clip in an unstressed state, a deflected (attached) state, before attachment to the chassis, and after attachment to the chassis. [Figure 10d] 1A-1C are schematic diagrams of the clip in an unstressed state, a deflected (attached) state, before attachment to the chassis, and after attachment to the chassis. [Figure 11] FIG. 10 is a schematic cross-sectional view of a further electronic module attached to the drug delivery device. DETAILED DESCRIPTION OF THE INVENTION

[0083] In the drawings, identical, identically acting or similar elements may be labeled with the same reference numerals.

[0084] Some embodiments will be described below with reference to insulin injection devices, however the present disclosure is not limited to such applications and can equally well be deployed in injection devices configured to eject other medicaments, or in drug delivery devices in general, preferably pen-type devices and / or injection devices.

[0085] Embodiments are provided for injection devices, particularly variable dose injection devices, that record and / or track measurement data related to the dose delivered. These data may include selected and / or actual delivered dose size, date and time of administration, duration of administration, etc. The configurations described herein include power management techniques (e.g., to facilitate small battery sizes and / or enable efficient power usage).

[0086] Some embodiments herein are illustrated with reference to the injection device disclosed in EP 2890435, which combines an injection button and a grip (dose setting member or dose setter). The injection button may provide a user interface member for initiating and / or performing a dose delivery operation of the drug delivery device. The grip or knob may provide a user interface member for initiating and / or performing a dose setting operation. Both devices are of the dial-extension type, i.e., their length increases during dose setting. Other injection devices with the same kinematic behavior of the dial extension and button during dose setting and dose ejection operating modes are known, for example, the Kwikpen® device sold by Eli Lilly and Novopen® 4 device sold by Novo Nordisk. Therefore, application of the general principles to these devices is readily apparent and further description is omitted. However, the general principles of the present disclosure are not limited to the above kinematic behavior. Some other embodiments may be applied to Sanofi's SoloSTAR® injection device, which has separate injection button and grip components / dose setting members. Thus, there may be two separate user interface members, one for the dose setting operation and one for the dose delivery operation.

[0087] "Distal" is used herein to designate a direction, end, or surface that is or will be positioned to face or orient toward the dosing end of a drug delivery device or a component thereof, and / or that faces away from or is opposite to the proximal end. "Proximal," on the other hand, is used to designate a direction, end, or surface that is or will be positioned to face away from or is opposite to the dosing end and / or distal end of a drug delivery device or a component thereof. The distal end may be the end closest to the dosing end and / or farthest from the proximal end, and the proximal end may be the end farthest from the dosing end. The proximal face may face away from the distal end and / or face toward the proximal end. The distal face may face the distal end and / or face away from the proximal end. The dosing end may, for example, be the needle end where the needle unit is or will be attached to the device.

[0088] 1 is an exploded view of a medication or drug delivery device, in this example the medication delivery device is an injection device 1, for example a pen-type injector such as the injection pen disclosed in EP 2 890 435.

[0089] The injection device 1 of FIG. 1 is an injection pen that includes a housing 10 and a container 14, e.g., an insulin container, or a receptacle for such a container. The container may contain a medication. A needle 15 may be attached to the container or the receptacle. The container may be a cartridge, and the receptacle may be a cartridge holder. The needle is protected by an inner needle cap 16 and either an outer needle cap 17 or another cap 18. The insulin dose to be delivered from the injection device 1 can be set, programmed, or "dialled in" by turning a button or dial grip (dose knob) 12, and the currently programmed or set dose is displayed, e.g., in whole multiples of one unit, through a dose window 13. The markings displayed in the window are provided on a number sleeve 23 or dial sleeve (partially shown in FIG. 4 by a ring of teeth 24). For example, if injection device 1 is configured to administer human insulin, the dosage may be displayed in so-called international units (IU), where 1 IU is the bioequivalent of approximately 45.5 micrograms of pure crystalline insulin (1 / 22 mg). In injection devices for delivering insulin analogs or other medications, other units may also be employed. Note that the selected dose may similarly be displayed in a different form than that shown in dosage window 13 in FIG. 1.

[0090] The dose window 13 may be in the form of an aperture in the housing 10 that allows the user to view a limited portion of the dial sleeve assembly that is configured to move when the button or dial grip 12 is turned, providing 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.

[0091] In this example, the button or dial grip 12 includes one or more moldings to facilitate attachment of a data collection device. In particular, the button or dial grip 12 is arranged to attach or integrate an electronic (button) module 11 to the button or dial grip 12. Alternatively, the dial grip may include such a button module of the electronic system.

[0092] The injection device 1 is configured so that turning the button or dial grip 12 produces a mechanical clicking sound to provide acoustic feedback to the user. In this embodiment, the button or dial grip 12 also functions as an injection button. When the needle 15 is inserted into a patient's skin area and the button or dial grip 12 and / or attached module 11 are then pressed axially, the insulin dose displayed in the display window 13 is expelled from the injection device 1. If the needle 15 of the injection device 1 remains in the skin area for a certain period of time after the button or dial grip 12 is pressed, the dose is injected into the patient's body. The expulsion of the insulin dose may also produce a mechanical clicking sound, which may be different from the sound produced when turning the button or dial grip 12 during dose dialing.

[0093] In this embodiment, during delivery of an insulin dose, the button or dial grip 12 is returned to its initial position in an axial motion without rotation, while the dial sleeve assembly is rotated back to its initial position, e.g., to indicate a dose of zero units. Figure 1 shows the injection device 1 in this 0U dial setting state. As already mentioned, the present disclosure is not limited to insulin, but should encompass all drugs in the drug container 14, particularly liquid drugs or drug formulations.

[0094] The injection device 1 can be used for multiple injection processes until the insulin container 14 is empty or the expiration date of the medication in the injection device 1 is reached (e.g., 28 days after first use). In the case of a reusable device, the insulin container can be replaced.

[0095] Furthermore, before using the injection device 1 for the first time, it may be necessary to perform a so-called "prime shot" in order to remove air from the insulin container 14 and the needle 15, for example by selecting two units of insulin and pressing the button or dial grip 12 while holding the injection device 1 with the needle 15 pointing upwards. For ease of presentation, it will be assumed below that the ejected amount substantially corresponds to the injected dose, e.g. the amount of drug ejected from the injection device 1 is equal to the dose received by the user. Nevertheless, it may also be necessary to take into account differences between the ejected amount and the injected dose (e.g. losses).

[0096] As explained above, the button or dial grip 12 also functions as an injection button, and thus the same component is used for dialing / setting the dose and dispensing / delivering the dose. Alternatively (not shown), a separate injection button that is axially displaceable at least a limited distance relative to the dial grip 12 can be used to effect or trigger dose dispensing.

[0097] In the following, an electronic module 11 according to the present disclosure will be described with respect to an exemplary embodiment and with reference to Figures 1 to 6. In Figure 1, the electronic module 11 is shown integrated into the proximal end of the injection device 1, and in particular integrated into the dial grip / dose button 12. Alternatively, the electronic module 11 may be a separate component that is permanently or releasably attached to the injection device 1, for example to the grip / dose button 12.

[0098] As shown in FIG. 2, the exemplary electronic module includes a processor 110 , a sensor device 120 , a communication unit 130 , an electronic user feedback generator 140 , a memory 150 , and a power supply 160 .

[0099] 2, the sensor device 120 is connected to the processor 110 and is operable to generate measurement data indicative of dose setting and / or dose delivery operations. To this end, the sensor device includes an LED 121 and a photodetector 122 that together form an optical sensor. Alternative sensor types may be implemented in addition to or as an alternative to the LED 121 and the photodetector 122. Such alternative sensor types may include, but are not limited to, optical sensors, acoustic sensors, capacitance sensors, and electrical switches.

[0100] The communication unit 130 is connected to the processor 110 and includes a wireless Bluetooth® communication interface operable to establish communication with other (external) devices, for example, a smartphone 200. Furthermore, the communication unit 130 is operable to transfer data, for example measurement data, to said other device 200.

[0101] The electronic user feedback generator 140 is connected to the processor 110 and is operable to generate a feedback signal to the user. In the exemplary arrangement of Figure 2, the electronic user feedback generator 140 includes an LED 141 for generating an optical feedback signal. In addition to, or as an alternative to, the LED 141, the electronic user feedback generator 140 may include a sounder and / or a vibration motor.

[0102] The memory 150 is adapted to store the 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 coin cell battery.

[0103] 3-7b, the electronic module 11 includes a cap 310, internal components 320, such as chassis components, a printed circuit board assembly (PCBA) 330, and a power source 160 in the form of a coin cell battery.

[0104] The cap 310 may be a cup-shaped component having a closed proximal end (top end in Figures 3 and 4), a closure skirt that may have a sawtooth or similar surface structure, and an open distal end that faces the drug delivery device 1. The cap forms an outer shell for the module 11 and houses the PCBA 330, the coin cell 160, and at least a portion of the component 320.

[0105] Component 320, shown from different sides in FIGS. 7a and 7b, is formed from a transparent material, e.g., injection molded from a polycarbonate material. Component 320 has an outer skirt 321, which is substantially cylindrical and fits into the space defined by cap 310. Skirt 321 is provided with a circumferential outer bead and / or groove for secure attachment with a corresponding bead and / or groove structure in cap 310. The annular distal end surface of skirt 321 forms user feedback surface 322 suitable for emitting light entering component 320, e.g., from LED 141 provided on PCBA 330. Thus, skirt 321 functions as a light guide. As described above, the surface roughness of skirt 321 and user feedback surface 322 may be adapted to enhance or enable the light-guiding function. User feedback surface 322 extends axially beyond the distal end of cap 310 and may have an outer diameter similar to that of cap 310. Thus, the user feedback surface 322 is visible from the exterior of the module 11. The interior surface of the skirt 321 provides information about the module 11 itself and / or the device 1 with which the module 11 is intended to be used.

[0106] 3 and 4 show that component 320 includes a rim 328 facing inwardly from skirt 321. This rim 328 supports PCBA 330 and coin cell 160. To this end, at least one collar portion 329 may extend proximally from rim 328. Additionally, rim 328 may include one or more recesses for receiving LEDs 141 mounted on PCBA 330.

[0107] 5a, 5b, 7a, and 7b show the module lockout molding 323 of the component 320, which includes a profiled protrusion adapted for mating abutment with a corresponding contoured seat of a dedicated drug delivery device 1, specifically a device lockout molding 21 of the button 12 of the drug delivery device 1. The function of the module lockout molding 323 becomes apparent from the table in FIG. 8, which shows three different types of module lockout moldings 323 in combination with three different types of corresponding device lockout moldings 21 of the button 12. Each lockout molding 323 and 21 is designed such that only one specific module lockout molding 323 mates with a specific corresponding device lockout molding 21, thereby enabling attachment of the module 11 to the button 12 of the respective dedicated drug delivery device 1. However, if a user attempts to attach the module 11 to an inappropriate drug delivery device 1, the mismatch between the module lockout molding 323 and the corresponding device lockout molding 21 will prevent complete attachment. Although FIG. 8 shows three types of modules 11 and three types of drug delivery devices 1, different numbers of mating pairs of modules 11 and dedicated drug delivery devices 1 can be selected.

[0108] The module 11 is releasably secured to the drug delivery device 1 by attachment elements 324 formed on the component 320. Figures 5a, 5b, 7a, and 7b show a pair of these attachment elements 324 in the form of resiliently deformable snap hooks that can engage with corresponding recesses 22 formed in the distally facing groove 25 of the button / dial grip 12. The attachment elements 324 extend distally from a rim 328 of the component 320. The module 11 is rigidly attached to the button 12, which means that the module always rotatably and axially moves with the button 12. Thus, during dial setting, when the button 12 moves outward in a helical path together with the drive sleeve and number sleeves 23, the module moves helically in the same path together with the button 12, drive sleeve, and number sleeves 23 during this phase.

[0109] The component 320 further includes two light pipes 325, which are elongated, rectangular-shaped protrusions extending distally from the rim 328. The light pipes 325 have two opposing end faces adapted to allow light entry and light exit. The side walls of the light pipes 325 form interfaces that guide electromagnetic radiation by total internal reflection. When the module 11 is attached to the button 12 of the drug delivery device 1, the light pipes 325 extend through apertures 19 (see FIGS. 6a and 6b) in the grooves 25 on the distal end face of the button 12, as shown in FIG. 4.

[0110] A sensor device 120 having an LED 121 and a photodetector 122 is located on the PCBA 330 at or near the proximal end face of each light pipe 325. 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 the teeth 24 of the number sleeve 23 (depending on the rotational position of the number sleeve 23), return to the light pipe 325, exit the light pipe 325 at its proximal end, and be detected by the photodetector 122. On the other hand, if the number sleeve 23 is in a rotational position such that the reflecting teeth 24 are not located under the distal end of the respective light pipe 325, the light beam exiting the light pipe 325 is not reflected and therefore not detected by the photodetector 122. The time-shifted emission of the light signal from the LED 121 is used to detect the rotation of the number sleeve 23, which indicates the amount of dose dispensed from the drug delivery device 1. Thus, the teeth 24 of the number sleeve 23 function as an encoder, reflecting or not reflecting light depending on the relative rotational position of the teeth.

[0111] Additionally, component 320 includes a resiliently deformable switch arm 326 having an elongated, distally extending free end 327. Two different designs of free end 327 are shown in Figures 5a and 5b. Switch arm 326 extends substantially circumferentially on a diameter about which light pipe 325 is disposed. As shown in Figures 5a and 5b, switch arm 326 may have the shape of an open ring hinged to rims 328 at its two ends. Free end 327 is located in the center of the open ring at a position substantially opposite light pipe 325.

[0112] This configuration allows the switch arm 326 to be received in the groove 25 when the switch arm 326 is deflected while the module 11 is attached to the button 12 of the drug delivery device 1. In this state, the free end 327 extends through the further aperture 20 of the button 12 into the drug delivery device 1. Therefore, when a component within the drug delivery device 1 moves relative to the button 12, the free end 327 and the switch arm 326 are deflected. More specifically, at the start of dose dispensing, the user presses the proximal end of the module 11, thereby displacing the module 11 with the button 12 relative to, for example, the digit sleeve 23, or alternatively, the drive sleeve. This causes the free end 327 to contact, for example, the digit sleeve 23, deflecting the switch arm 326, which in turn activates the switch 331 on the distal side of the PCBA 330, triggering the wake-up of the module 11.

[0113] The PCBA 330 may include or form the processor 110, the sensor device 120, the communication unit 130, the electronic user feedback generator 140, and the memory 150. The PCBA 330 is supported on a component 320 that serves as a chassis for the module 11. In addition to the LED 121 and the photodetector 122, one or more LEDs 141 are provided on the PCBA 330. Furthermore, a switch 331 is provided on the PCBA 330, for example on the distal side facing the drug delivery device 1.

[0114] 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 includes a groove 25 with apertures 19, 20 for the light pipe 325 and the free end 327 of the switch arm 326, respectively. In addition, a recess 22 is provided for snap engagement with the mounting element 324 of the module 11. In Figures 6b and 6c, an additional inner groove is provided, in which a module lockout molding 323 is located. In Figure 6c, the apertures 19 and 20 are formed as one common slot-like opening, rather than as separate openings as in Figure 6a.

[0115] 9, a potting compound 340 or filler layer is applied to prevent dust and water ingress to the conductive areas of the PCBA 330. Additionally or alternatively, only one side or both sides of the PCBA 330 are covered, at least partially, or in all locations not covered by electronic components, with a potting material, potting compound, or conformal coating layer. For example, the chassis component 320 is configured to separate the potting compound from the electrical sensors and / or from the radiation source of the detector unit.

[0116] 10a-10d illustrate an exemplary use of a power clip 350 attached to a chassis component 320 to retain a coin battery 160 thereon and connect the coin battery 160 to a PCBA 330. The clip 350 has a curved shape in an unenergized state, as shown in FIGS. 10a and 10c. In contrast, the clip 350 has a flatter curvature in a configuration attached to the chassis component 320 (see FIGS. 10b and 10d). The chassis component 320 may have corresponding snap features for attaching the clip 350, particularly the free end of the clip 350.

[0117] The clip 350 is made of an elastically deformable conductive material, for example, metal. When 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 battery 160, the upper terminal in FIGS. 10c and 10d, and at least one of the free ends of the clip 350 is adapted to contact a respective terminal on the PCBA 330. For this purpose, at least a portion of the clip 350, for example, its free end as shown in FIG. 10d, can extend through a respective aperture of the chassis component 320.

[0118] 11 illustrates an alternative embodiment having an additional switch 332 provided on PCBA 330 that is actuated when module 11 is fully and correctly attached to button 12 by contact between a distal switch face and a proximal-facing button face. Such a switch may be used to wake processor 110 or components thereof from a no-power or sleep mode of module 11 when the module is not attached to device 1, for example.

[0119] Although described primarily with respect to a drug delivery device 1 having a similar operating principle to the device disclosed in EP 2890435, the electronic module 11 is applicable to any other type of drug delivery device having components that undergo relative axial and / or rotational movement under predetermined conditions or conditions. [Explanation of symbols]

[0120] 1 device 10. Housing 11 Button Module 12 Dial Grip / Button 13 Dosage window 14 Container / Container Receptacle 15 needles 16 Inner needle cap 17 Outer needle cap 18 Cap 19 aperture 20 aperture 21 Device Lockout Molding 22 recess 23 Number Sleeve 24 teeth 25 groove 110 processors 120 Sensor Device 121 LED 122 Photodetector 130 Communication Unit 140 Electronic User Feedback Generator 141 LED 150 memory 160 Power supply (coin battery) 200 Smartphones (other devices) 310 Cap 320 (chassis) components 321 Skirt 322 User Feedback Surface 323 Module Lockout Molding 324 Mounting Elements 325 Light Pipe 326 Switch Arm 327 Free end 328 Rim 329 Color part 330 PCBA 331 Switch 332 Switch 340 Potting Compound 350 Power Clip

Claims

1. An electronic module (11) for releasably attaching to a drug delivery device (1), comprising a printed circuit board assembly (330), a power supply (160) and components (320), the components being the chassis of the module, in the following configuration: at least one light pipe (325) for guiding a light beam from the light source (121) to the reflective surface (24) of the drug delivery device (1) and from said reflective surface (24) to the light detector sensor (122); 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 (320) adapted to emit light; the power source (160) is a coin cell battery secured and connected to the printed circuit board assembly (330) by a power clip (350) attached to the chassis component; The electronic module.

2. The component further comprises: at least one module lockout molding (323) adapted for mating abutment with a corresponding device lockout molding (21) of the dedicated drug delivery device (1); at least one attachment element (324) for releasably attaching the module (11) to the drug delivery device (1); At least one elastically deformable switch arm (326, 327); The component (320) is a one-piece component injection molded from a polycarbonate material.

2. The electronic module (11) of claim 1, comprising at least one of:

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

4. At least one modular lockout molding (323) is provided to lock out said dedicated drug delivery device.

3. The electronic module of claim 2, including a profiled protrusion or seat adapted for mating abutment with a corresponding contoured seat or protrusion of the device lockout molding (21) of the vice (1).

5. The electronic module of any one of claims 2 to 4, wherein at least one module lockout molding (323) prevents attachment of the module (11) to a non-mating drug delivery device (1).

6. An electronic module according to any one of claims 2 to 5, wherein at least one attachment element (324) for releasably attaching the module (11) to the drug delivery device (1) comprises at least one elastically deformable arm having a snap protrusion or snap recess for releasably engaging with a corresponding snap recess (22) or snap protrusion of the drug delivery device (1).

7. 7. The electronic module of claim 1, wherein at least one light pipe (325) is an elongated rectangular parallelepiped-shaped protrusion or a truncated cone-shaped protrusion having two opposing end faces and at least one side wall, and at least one of the two opposing end faces has a surface roughness higher than the surface roughness of the at least one side wall.

8. An electronic module according to any one of the preceding claims, comprising at least two light pipes (325) projecting in the same axial direction from an inner portion (328) of the component (320).

9. 9. The electronic module of claim 1, wherein the at least one light guide comprises an annular skirt (321) having at least one entrance surface (328) and a user feedback surface (322) facing radially outward from the annular skirt (321), and the at least one entrance surface (328) and the user feedback surface (322) have a surface roughness that is higher than the surface roughness of the annular skirt (321).

10. 10. The electronic module of claim 9, wherein the annular skirt (321) comprises at least two, for example four, inlet faces each formed in a respective recess for receiving a light source (141).

11. The electronic module of any one of claims 2 to 10, wherein the at least one resiliently deformable switch arm (326) extends circumferentially.

12. 12. The electronic module of claim 2, wherein at least one resiliently deformable switch arm (326) includes a free end (327) and is deflectable relative to the component (320) to activate the electronic switch (331).

13. 13. The electronic module of claim 3, wherein the component (320) is surrounded by a cap (310) except for a user feedback surface (322), and the printed circuit board assembly (330) and the power supply (160) are interposed between the cap (310) and the component (320).

14. The component (320) has a substantially cylindrical outer shape with a radially facing user feedback surface (322) forming a distal end, the component (320) includes an inner rim (328) having at least one module lockout molding (323), at least one attachment element (324) and at least one light pipe (325) extending distally from the rim (328), and at least one collar portion (329) extending proximally from the rim (328). The electronic module according to any one of claims 2 to 13, extending in a lateral direction.

15. at least one processor (110); a sensor device (120) connected to said at least one processor (110) and operable to generate measurement data indicative of dose setting and / or dose delivery operations of the dedicated drug delivery device (1); a communication unit (130) connected to the at least one processor (110) and having a wireless communication interface operable to establish communication with another device (200) and transfer data to said other device (200); at least one electronic user feedback generator (140) connected to the at least one processor (110) and operable to generate a feedback signal; a memory (150) for storing measurement data; The electronic module of any one of claims 1 to 14, further comprising:

16. A drug delivery device (1) for delivering a medicament, the drug delivery device (1) being 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, the drug delivery device (1) comprising: a dose setting and drive mechanism (23) including a first member (20); and a container receptacle (14) permanently or releasably coupled to the dose setting and drive mechanism and adapted to receive a container containing the medicament; Comprising an electronic module (11) according to any one of claims 1 to 15, The drug delivery device.

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