Electronic Module and Drug Delivery Device

Abstract

An electronic module for releasable attachment to a drug delivery device is disclosed. The module may comprise at least one module lockout form adapted for mating abutment with a corresponding device lockout form of the drug delivery device. The module may comprise at least one attachment element for releasable attachment of the module on the drug delivery device. The module may 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. The module may comprise at least one light guide for guiding a light beam from a light source to a user feedback surface adapted to emit light. The module may comprise at least one elastically deformable switch arm. The component may be a unitary component part injection molded from a polycarbonate material.

Claims

1-15. (canceled)

16. An electronic module for releasable attachment to a drug delivery device, the electronic module comprising a particular component that comprises at least two of the following features: at least one module lockout form adapted for mating abutment with a corresponding device lockout form of the drug delivery device, at least one attachment element for releasable attachment of the electronic module on the drug delivery device, at least one light pipe for guiding a light beam from a first light source to a reflective surface of the drug delivery device and from the reflective surface to a light detector sensor, at least one light guide for guiding a light beam from a second light source to a user feedback surface of the particular component, wherein the user feedback surface is adapted to emit light, at least one elastically deformable switch arm, or the particular component is a unitary component that is injection molded from a polycarbonate material.

17. The electronic module according to claim 16 further comprising: a cap; a printed circuit board assembly; and a power source, wherein the particular component is a chassis rigidly attached to the cap and supports the printed circuit board assembly within the cap.

18. The electronic module according to claim 17, wherein the particular component, with exception of the user feedback surface, is encased by the cap.

19. The electronic module according to claim 18, wherein the printed circuit board assembly and the power source are interposed between the cap and the particular component.

20. The electronic module according to claim 16, wherein the particular component includes the at least one module lockout form, and wherein the at least one module lockout form comprises a profiled protrusion or seat adapted for mating abutment with a corresponding contoured seat or protrusion of the corresponding device lockout form of the drug delivery device.

21. The electronic module according to claim 16, wherein the particular component includes the at least one module lockout form, and wherein the at least one module lockout form prevents attachment of the electronic module on a non-mating drug delivery device.

22. The electronic module according to claim 16, wherein the particular component includes the at least one attachment element, and wherein the at least one attachment element comprises at least one elastically deformable arm with a snap protrusion or a snap recess for releasable engagement with a corresponding snap recess or a snap protrusion of the drug delivery device.

23. The electronic module according to claim 16, wherein the particular component includes the at least one light pipe, and wherein the at least one light pipe is an elongate cuboid shaped protrusion or a protrusion in shape of a conical frustum 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 a surface roughness of the at least one sidewall.

24. The electronic module according to claim 16, comprising at least two light pipes protruding axially in the same direction from an inner portion of the particular component.

25. The electronic module according to claim 16, wherein the particular component comprises the at least one light guide, and wherein the at least one light guide comprises an annular skirt having at least one entry surface and the user feedback surface that is radially facing outwardly from the annular skirt, wherein the at least one entry surface and the user feedback surface have a surface roughness higher than a surface roughness of another surface of the annular skirt.

26. The electronic module according to claim 25, wherein the annular skirt comprises at least two entry surfaces each formed in a respective recess for receiving the first light source.

27. The electronic module according to claim 26, wherein the annular skirt comprises four entry surfaces.

28. The electronic module according to claim 16, wherein the particular component comprises the at least one elastically deformable switch arm, and wherein the at least one elastically deformable switch arm extends in a circumferential direction.

29. The electronic module according to claim 16, wherein the particular component comprises the at least one elastically deformable switch arm, and wherein the at least one elastically deformable switch arm comprises a free end and is deflectable with respect to the particular component in order to actuate an electronic switch.

30. The electronic module according to claim 16, wherein the particular component has a substantially cylindrical outer shape, and wherein the user feedback surface has a radially facing outer portion that forms a distal end of the substantially cylindrical outer shape.

31. The electronic module according to claim 16, wherein the particular component comprises an inner rim comprising the at least one module lockout form, the at least one attachment element, the at least one light pipe, and at least one collar portion, wherein the at least one light pipe extends distally from the inner rim, and the at least one collar portion extending proximally from the inner rim.

32. The electronic module according to claim 16, further comprising: at least one processor; a sensor arrangement connected to the at least one processor and operable to generate measurement data indicative of a dose setting operation and/or a dose delivery operation of the drug delivery device; a communication unit with a wireless communication interface connected to the at least one processor and operable to establish communication with another device and to transfer data to the other device; at least one electronic user feedback generator connected to the at least one processor and operable to generate a feedback signal; and a memory for storing the measurement data.

33. A drug delivery device for delivery of a medicament, the drug delivery device comprising: a dose setting and drive mechanism configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device, and a dose delivery operation for delivering the set dose, wherein the dose setting and drive mechanism comprises a first member; a container receptacle permanently or releasably connected to the dose setting and drive mechanism, and adapted to receive a container containing a medicament; and an electronic module comprising a particular component that comprises at least two of the following features: at least one module lockout form adapted for mating abutment with a corresponding device lockout form of a drug delivery device, at least one attachment element for releasable attachment of the electronic module on the drug delivery device, at least one light pipe for guiding a light beam from a first light source to a reflective surface of the drug delivery device and from the reflective surface to a light detector sensor, at least one light guide for guiding a light beam from a second light source to a user feedback surface of the particular component, wherein the user feedback surface is adapted to emit light, at least one elastically deformable switch arm, or the particular component is a unitary component that is injection molded from a polycarbonate material.

34. The drug delivery device according to claim 33, further comprising the container containing the medicament.

35. The drug delivery device according to claim 33, wherein the electronic module further comprises: a cap; a printed circuit board assembly; and a power source, wherein the particular component is a chassis rigidly attached to the cap and supports the printed circuit board assembly within the cap.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0079] FIG. 1 shows an embodiment of a drug delivery device;

[0080] FIG. 2 schematically illustrates an embodiment of an electronic module for a drug delivery device;

[0081] FIG. 3 schematically illustrates a sectional view of an embodiment of an electronic module for a drug delivery device;

[0082] FIG. 4 schematically illustrates a further sectional view of the electronic module of FIG. 3 attached to a drug delivery device;

[0083] FIG. 5a schematically illustrates a perspective view of the electronic module of FIG. 3;

[0084] FIG. 5b schematically illustrates a perspective view of a further electronic module;

[0085] FIGS. 6a-c schematically illustrate views of embodiments of a button of a drug delivery device for attachment of the electronic module of FIG. 3;

[0086] FIGS. 7a, b schematically illustrate perspective views of a chassis component of the electronic module of FIG. 5b;

[0087] FIG. 8 is a table depicting different lockout forms;

[0088] FIG. 9 schematically illustrates a perspective view of another detail of an electronic module;

[0089] FIGS. 10a-10d schematically illustrate a clip in an unstressed condition, in a deflected (mounted) condition, prior to attachment to the chassis and after attachment to the chassis; and

[0090] FIG. 11 schematically illustrates a sectional view of a further electronic module attached to a drug delivery device.

[0091] In the Figures, identical elements, identically acting elements or elements of the same kind may be provided with the same reference numerals.

DETAILED DESCRIPTION

[0092] In the following, some embodiments will be described with reference to an insulin injection device. The present disclosure is however not limited to such application and may equally well be deployed with injection devices that are configured to eject other medicaments or drug delivery devices in general, preferably pen-type devices and/or injection devices.

[0093] Embodiments are provided in relation to injection devices, in particular to variable dose injection devices, which record and/or track measurement data on doses delivered thereby. These data may include the size of the selected dose and/or the size of the actually delivered dose, the time and date of administration, the duration of the administration and the like. Features described herein include power management techniques (e.g. to facilitate small batteries and/or to enable efficient power usage).

[0094] Certain embodiments in this document are illustrated with respect to the injection device disclosed in EP 2 890 435 where an injection button and grip (dose setting member or dose setter) are combined. The injection button may provide the user interface member for initiating and/or performing a dose delivery operation of the drug delivery device. The grip or knob may provide the user interface member for initiating and/or performing a dose setting operation. These devices are of the dial extension type, i.e. their length increases during dose setting. Other injection devices with the same kinematical behaviour of the dial extension and button during dose setting and dose expelling operational mode are known as, for example, the Kwikpen® device marketed by Eli Lilly and the Novopen® 4 device marketed by Novo Nordisk. An application of the general principles to these devices therefore appears straightforward and further explanations will be omitted. However, the general principles of the present disclosure are not limited to that kinematical behaviour. Certain other embodiments may be conceived for application to Sanofi's SoloSTAR® injection device where there are 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.

[0095] “Distal” is used herein to specify directions, ends or surfaces which are arranged or are to be arranged to face or point towards a dispensing end of the drug delivery device or components thereof and/or point away from, are to be arranged to face away from or face away from the proximal end. On the other hand, “proximal” is used to specify directions, ends or surfaces which are arranged or are to be arranged to face away from or point away from the dispensing end and/or from the distal end of the drug delivery device or components thereof. The distal end may be the end closest to the dispensing and/or furthest away from the proximal end and the proximal end may be the end furthest away from the dispensing end. A proximal surface may face away from the distal end and/or towards the proximal end. A distal surface may face towards the distal end and/or away from the proximal end. The dispensing end may be the needle end where a needle unit is or is to be mounted to the device, for example.

[0096] FIG. 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 an injection pen disclosed in EP 2 890 435.

[0097] The injection device 1 of FIG. 1 is an injection pen that comprises a housing 10 and contains a container 14, e.g. an insulin container, or a receptacle for such a container. The container may contain a drug. A needle 15 can be affixed 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. An insulin dose to be ejected from injection device 1 can be set, programmed, or ‘dialled in’ by turning a button or dial grip (dosage knob) 12, and a currently programmed or set dose is then displayed via dosage window 13, for instance in multiples of units. The indicia displayed in the window may be provided on a number sleeve 23 or dial sleeve (partially depicted in FIG. 4 with a ring of teeth 24). For example, where the injection device 1 is configured to administer human insulin, the dosage may be displayed in so-called International Units (IU), wherein one IU is the biological equivalent of about 45.5 micrograms of pure crystalline insulin (1/22 mg). Other units may be employed in injection devices for delivering analogue insulin or other medicaments. It should be noted that the selected dose may equally well be displayed differently than as shown in the dosage window 13 in FIG. 1.

[0098] The dosage window 13 may be in the form of an aperture in the housing 10, which permits a user to view a limited portion of a dial sleeve assembly that is configured to move when the button or dial grip 12 is turned, to provide a visual indication of a currently set dose. The button or dial grip 12 is rotated on a helical path with respect to the housing 10 when setting a dose.

[0099] In this example, the button or dial grip 12 includes one or more formations to facilitate attachment of a data collection device. Especially, the button or dial grip 12 may be arranged to attach or integrate an electronic (button) module 11 onto the button or dial grip 12. As an alternative, the dial grip may comprise such a button module of an electronic system.

[0100] The injection device 1 may be configured so that turning the button or dial grip 12 causes a mechanical click sound to provide acoustic feedback to a user. In this embodiment, the button or dial grip 12 also acts as an injection button. When needle 15 is stuck into a skin portion of a patient, and then button or dial grip 12 and/or the attached module 11 is pushed in an axial direction, the insulin dose displayed in display window 13 will be ejected from injection device 1. When the needle 15 of injection device 1 remains for a certain time in the skin portion after the button or dial grip 12 is pushed, the dose is injected into the patient's body. Ejection of the insulin dose may also cause a mechanical click sound, which may be different from the sounds produced when rotating the button or dial grip 12 during dialing of the dose.

[0101] In this embodiment, during delivery of the insulin dose, the button or dial grip 12 is returned to its initial position in an axial movement, without rotation, while the dial sleeve assembly is rotated to return to its initial position, e.g. to display a dose of zero units. FIG. 1 shows the injection device 1 in this 0U dialled condition. As noted already, the disclosure is not restricted to insulin but should encompass all drugs in the drug container 14, especially liquid drugs or drug formulations.

[0102] Injection device 1 may be used for several injection processes until either the insulin container 14 is empty or the expiration date of the medicament in the injection device 1 (e.g. 28 days after the first use) is reached. In the case of a resuable device, it is possible to replace the insulin container.

[0103] Furthermore, before using injection device 1 for the first time, it may be necessary to perform a so-called “prime shot” to remove air from insulin container 14 and needle 15, for instance by selecting two units of insulin and pressing button or dial grip 12 while holding injection device 1 with the needle 15 upwards. For simplicity of presentation, in the following, it will be assumed that the ejected amounts substantially correspond to the injected doses, so that, for instance the amount of medicament ejected from the injection device 1 is equal to the dose received by the user. Nevertheless, differences (e.g. losses) between the ejected amounts and the injected doses may need to be taken into account.

[0104] As explained above, the button or dial grip 12 also functions as an injection button so that the same component is used for dialling/setting the dose and dispensing/delivering the dose. As an alternative (not shown), a separate injection button may be used which is axially displaceable, at least a limited distance, relative to a dial grip 12 to effect or trigger dose dispensing.

[0105] 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 to 6. In FIG. 1, the electronic module 11 is depicted as being integrated in the proximal end of the injection device 1, specifically integrated into the dial grip/dose button 12. As an alternative, the electronic module 11 may be a separate component part which may be permanently or releasably attached to the injection device 1, e.g. to the grip/dose button 12.

[0106] As depicted in FIG. 2, an 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.

[0107] In the example depicted in FIG. 2, the sensor arrangement 120 is connected to the processor 110 and operable to generate measurement data indicative of the dose setting operation and/or the dose delivery operation. For this purpose the sensor arrangement comprises a LED 121 and a photo detector 122 together forming an optical sensor. Alternative sensor types could be implemented in addition to LED 121 and photo detector 122 or as an alternative thereto. Such alternative sensor types may include but are not limited to optical sensors, acoustic sensors, capacitive sensors, electrical switches.

[0108] The communication unit 130 comprises with a wireless Bluetooth® 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 transfer data, e.g. measurement data, to said other device 200.

[0109] The electronic user feedback generator 140 connected to the processor 110 and operable to generate a feedback signal to a user. In the exemplary arrangement of FIG. 2, the electronic user feedback generator 140 comprises a LED 141 for generating optical feedback signals. In addition to the LED 141 or as an alternative to the LED 141, the electronic user feedback generator 140 may comprise a sounder and/or a vibration motor.

[0110] The memory 150 is adapted for storing measurement data and is connected to the processor 110 or is 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.

[0111] Turning now to FIGS. 3 to 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 the power source 160 in the form of a coin cell.

[0112] The cap 310 may be a cup-shaped component with a cosed proximal end (upper end in FIGS. 3 and 4), a closed skirt which may have a serration or the like surface structure, and an open distel end facing towards 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 component 320.

[0113] The component 320 which is depicted in FIGS. 7a and 7b from different sides is made from a transparent material, e.g. injection moulded from a polycarbonate material. The component 320 has an outer skirt 321 which is substantially cylindrical and fits into the space defined by cap 310. The skirt 321 may 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 suitable to emit light which enters the component 320 e.g. from an LED 141 provided e.g. 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 may be adapted to enhance or permit the light guiding function. The user feedback surface 322 extends axially beyond the distal end of the cap 310 and may have an outer diameter similar to that 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 may be provided with information relating to the module 11 itself and/or to the device 1 to be used with the module 11.

[0114] FIGS. 3 and 4 show that the component 320 is provided with a rim 328 facing inwardly from the skirt 321. This rim 328 supports the PCBA 330 and the coin cell 160. For this purpose, at least one collar portion 329 may extend proximally from the rim 328. Further, this rim 328 may comprise one or more recess(es) for receiving an LED 141 mounted on the PCBA 330.

[0115] FIGS. 5a, 5b, 7a and 7b show a module lockout form 323 of the component 320 which comprises a profiled protrusion adapted for mating abutment with a corresponding contoured seat of a device lockout form 21 of a dedicated a drug delivery device 1, specifically of a button 12 of a drug delivery device 1. The function of the module lockout form 323 becomes apparent from the table of FIG. 8 which depicts three different types of module lockout forms 323 in combination with three different types of corresponding device lockout forms 21 of button 12. The respective lockout frms 323 and 21 are designed such that only one specific module lockout form 323 mates with a specific corresponding device lockout form 21, thereby permitting attachment of the module 11 on the button 12 of the respective dedicated drug delivery device 1. However, if a user attempts to attach a module 11 to an incorrect drug delivery device 1, full attachment is prevented by non-mating module lockout form 323 and corresponding device lockout form 21. While FIG. 8 shows three types of modules 11 and three types of drug delivery devices 1, different numbers of mating pairs of a module 11 and a dedicated drug delivery device 1 may be chosen.

[0116] The module 11 may be releasably fixed on the drug delivery device 1 by means of attachment elements 324 formed on component 320. FIGS. 5a, 5b, 7a and 7b show a pair of these attachment elements 324 in the form of elastically deformable snap hooks which may engage with corresponding recesses 22 formed in a disally facing groove 25 of the button/dial grip 12.

[0117] The attachment elements 324 extend distally from the rim 328 of the component 320 The module 11 is attached rigidly to the button 12, meaning that it moves rotationally and axially with the button 12 at all times. Thus, during dialling, as the button 12 moves outwards on a helical path, along with the drive sleeve and the number sleeve 23, during this phase the module moves helically with the button 12, drive sleeve and number sleeve 23 on the same path.

[0118] The component 320 further comprises two light pipes 325 which are elongate cuboid shape protrusions extending from rim 328 distally. The light pipes 325 have two opposite end faces adapted to permit light entry and light exit. The sidewalls of the light pipes 325 form a border surface that guides an 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 apertures 19 (see FIGS. 6a, 6b) in the groove 25 in the distal end face of button 12 as shown in FIG. 4.

[0119] The sensor arrangement 120 with LED 121 and photo detector 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 LED 121 may enter the light pipe 325, is guided distally, exits the light pipe 325 at its distal end, is reflected by a tooth 24 of number sleeve 23 (depending on the rotational position of the number sleeve 23) enters back into light pipe 325 and exits the light pipe at its proximal end to be detected by photo detector 122. On the other hand, if the number sleeve 23 is in a rotational position such that none of the reflective teeth 24 is located beneath the distal end of a respective light pipe 325, a light beam exiting the light pipe 325 is not reflected and, hence, is not detected by photo detector 122. Time shifted emission of light signals from the LEDs 121 may be used to detect rotation of the number sleeve 23 which is indicative of an amount of the dose dispensed from the drug delivery device 1. Thus, teeth 24 of number sleeve 23 act as an encoder reflecting or not reflecting light depending on the relative rotational position of the teeth.

[0120] Still further, component 320 comprises an elastically 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 a diameter on which the light pipes 325 are arranged. As depicted in FIGS. 5a and 5b, the switch arm 326 may have the form of an open ring hinged with its two ends to the rim 328. The free end 327 may be located in the middle of the open ring at a position substantially opposite of the light pipes 325.

[0121] This arrangement permits that the switch arm 326 may be received in the groove 25 when the switch arm 326 is deflected in a state in which the module 11 is mounted onto the button 12 of the drug delivery device 1. In this state, the free end 327 extends through a further aperture 20 in the button 12 into the drug delivery device 1. Thus, the free end 327 and the switch arm 326 may be deflected if components within the drug delivery device 1 move relative to the button 12. More specifically, at the beginning of dose dispensing, a user presses on the proximal end of the module 11, thereby displacing the module 11 with the button 12 relative to e.g. the number sleeve 23, or alternatively relative to the drive sleeve. This results in the free end 327 contacting e.g. the number sleeve 23 and deflecting the switch arm 326 which in turn actuates switch 331 on the distal side of the PCBA 330 which may trigger waking up of the module 11.

[0122] The PCBA 330 may 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 the component 320 which acts as a chassis in the module 11. In addition to the LEDs 121 and photo detectors 122, one or more LED(s) 141 may be provided on the PCBA 330. In addition, a switch 331 may be provided on the PCBA 330, e.g. on a distal side facing towards the drug delivery device 1.

[0123] FIGS. 6a, 6b and 6c show three similar embodiments of the design of the button 12 of the drug delivery device 1. In FIG. 6a, the button 12 comprises the groove 25 with apertures 19, 20 for the light pipes 325 and the free end 327 of the switch arm 326, respectively. Further, recesses 22 are provided for snap engagement with the attachment elements 324 of the module 11. In FIGS. 6b and 6c, an additional inner grove is provided in which the module lockout forms 323 are arranged. Apertures 19 and 20 are formed as one common, slot-like opening in FIG. 6c instead of separate openings as in FIG. 6a.

[0124] As depicted in FIG. 9, a potting compound 340 or filling layer may be applied preventing ingress of dust and water to the conductive areas of the PCBA 330. In addition or as an alternative, only one side or both sides of the PCBA 330 may be covered at least partially or at all locations that are not covered by electronic parts by a potting material or by a potting compound or by a conformal coating layer. For example, the chassis component 320 is configured to separate the potting compound from an electrical sensor and/or from a radiation source of the detector unit.

[0125] FIGS. 10a to 10d show an exemplary use of a power source clip 350 which may be attached to the chassis component 320 in order to retain the coin cell 160 on the cassis component 320 and to connect the coin cell 160 with the PCBA 330. The clip 350 has a curved form in its unbiased state as depicted in FIGS. 10a and 10c. In contrast to that, the clip 350 has a flatter curvature in a configuration mounted on the chassis component 320 (see FIGS. 10b and 10d). The chassis component 320 may have corresponding snap features for attachment of clip 350, in particular of the free ends of clip 350.

[0126] The clip 350 consists of an elastiacally deformable and electrically conductive material, e.g. a metal. A central portion of the clip 350 is adapted to contact one terminal of coin cell 160, the upper terminal in FIGS. 10c and 10d, whereas at least one of the free ends of the clip 350 is adapted to contact a respective terminal on the PCBA 330 if the clip 350 is attached to the chassis component 320 (FIG. 10d). For this purpose, at least a portion of the clip 350, e.g. its free ends as shown in FIG. 10d, may extend through a respective aperture in the chassis component 320.

[0127] Still further, FIG. 11 depicts an alternative embodiment with an additional switch 332 provided on the PCBA 330. This switch 332 is actuated if the module 11 is fully and correctly fitted onto the button 12 by contact between the distal switch surface and a proximally facing button surface. Such a switch may be used to activate the processor 110 or components thereof, e.g. from a no-power or sleeping mode of the module 11 when the module is not attached to the device 1.

[0128] Although described mainly 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 performing a relative axial and/or rotational movement in defined conditions or states.

TABLE-US-00001 REFERENCE NUMERALS 1 device 10 housing 11 button module 12 dial grip/button 13 dosage window 14 container/container receptacle 15 needle 16 inner needle cap 17 outer needle cap 18 cap 19 aperture 20 aperture 21 device lockout form 22 recess 23 nuber sleeve 24 teeth 25 groove 110 processor 120 sensor arrangement 121 LED 122 photo detector 130 communication unit 140 electronic user feedback generator 141 LED 150 memory 160 power source (coin cell) 200 smartphone (other device) 310 cap 320 (chassis) component 321 skirt 322 user feedback surface 323 module lockout form 324 attachment element 325 light pipe 326 switch arm 327 free end 328 rim 329 collar portion 330 PCBA 331 switch 332 switch 340 potting compound 350 power source clip