WO2025157887A1

WO2025157887A1 - Electronic add-on module comprising electrically conductive elements providing a switch

Info

Publication number: WO2025157887A1
Application number: PCT/EP2025/051606
Authority: WO
Inventors: Paul Richard Draper; Thomas Alexander EARWAKER; Louis Robert LE MASURIER; David Aubrey Plumptre; Robert Frederick Veasey
Original assignee: Sanofi SA
Current assignee: Sanofi SA
Priority date: 2024-01-24
Filing date: 2025-01-23
Publication date: 2025-07-31
Anticipated expiration: 2026-07-24

Abstract

The present disclosure is generally directed to an electronic system, e.g. an electronic add-on module (100), which is configured to be releasable attached to a drug delivery device (1). The module comprises a first portion (101) configured to be releasably attached to a dose dial grip (12) of the drug delivery device, a second portion (102) coupled to the first portion, allowing relative axial movement with respect to the first portion, wherein the second portion is configured to apply pressure onto a dose button (11) of said drug delivery device when axially moved along the first longitudinal axis, and an electrical power source arranged inside said electronic add-on module and electrically connected to a circuit board assembly. The circuit board assembly is arranged inside said electronic add-on module (100). Further, the electronic add-on module comprises at least two first electrically conductive elements (115), wherein relative axial movement of said second portion relative to said first portion provides an electrical connection between said at least two first electrically conductive elements, and wherein the circuit board assembly or an electronic component (111; 112) connected to said circuit board assembly is actuated due to said electrical connection.

Description

ELECTRONIC ADD-ON MODULE COMPRISING ELECTRICALLY CONDUCTIVE ELEMENTS

PROVIDING A SWITCH

The present disclosure is generally directed to an electronic system, e.g. an electronic add-on module, which is configured to be releasable attached to a drug delivery device.

Electronic add-on modules for releasable attachment to drug delivery devices are generally known and often used to measure relevant data with respect to dose setting and/or dose dispensing.

An exemplary data collection device for attachment to an injection device is shown in WO 2016/198516 A1. Further injection monitoring modules are known from WO 2020/217094 A1 , WO 2021/140352 A1 , WO 2021/214275 A1 , US 2021/008287 A1 and US 2020/061299 A1. The modules typically comprise two portions, wherein one portion is attached and rotationally constrained to a dose dial grip of an injection device to measure for example rotational relative movement between components of the modules and/or the injection devices.

WO 2016/198516 A1 , for example, discloses the use of a sensing arrangement inside the data collection device comprising optical, magnetic, capacitive or mechanical sensors configured to detect rotational movement between a first portion and a second portion of the data collection device. The first portion is configured for attaching to a dosage knob of the injection device and the second portion is coupled to the first portion and axially movable relative thereto. During dose dispensing of a medicament, for example, the first portion rotates with the dosage knob of the injection device, wherein the angle of rotation measured by the sensing arrangement allows to determine the amount of medicament expelled.

An electronic module with an electrical power source, a sensor arrangement and a processor is disclosed in WO 2021/214 275 A1. In order to limit power consumption, the module further may comprise a switch configured to be operated by means of a deflectable switch arm. The switch may activate or deactivate power consuming components, i.e. , the switch may be configured to activate a processor of the module from a no-power sleeping mode. Similarly, WO 2021/140 352 A1 discloses an injection monitoring module with an injection detection switch configured to be activated by a translational movement between a proximal activation button and a hollow main body. When activated, the switch may signal to an integrated data processing and control unit of the injection monitoring module the start of the injection.

However, the known switches for electronic add-on modules have the disadvantage that often, for example, the slightest axial movement may lead to unwanted actuation of the switch and therefore to unwanted powering of the electronic components. In addition, the switches typically include mechanical switch elements that are subject to unpredictable wear during use, thus impairing reliable actuation of the switches.

It is therefore an object of the present disclosure to provide an electronic add-on module allowing improved actuation of a switch configured to power electronic components of the electronic add-on module.

This object is solved by an electronic add-on module according to claim 1. Further, the object is solved by an assembly according to claim 14.

The electronic add-on module for releasable attachment to a drug delivery device comprises a first portion, a second portion, an electrical power source and a circuit board assembly. Further, the electronic add-on module comprises electrically conductive elements configured to activate the circuit board assembly or an electronic component connected to said circuit board assembly upon electrical connection between said electrically conductive elements.

The drug delivery device used for attachment of the electronic add-on module may comprise at least a dose button, a dose dial grip, a drive sleeve and a plunger. Although not required in the context of the present disclosure, the drug delivery device may optionally comprise further components such as a number sleeve, a clutch, a cap, a needle, a spring, a lead screw or the like, interacting with the dose button, the dose dial grip, the drive sleeve, the plunger and/or the housing, for example as disclosed in WO 2004/078239 A1. However, the present disclosure is not limited to the drug delivery device of WO 2004/078239 A1. Other suitable drug delivery devices to be used are described e.g. in EP 1 570 876 B1 , EP 2 814 547 B1 , EP 2 890 434 B1 , WO 2005/018721 A1 , WO 2009/132777 A1 , WO 2014/033195 A1 , US 5,693,027 A, US 6,663,602 B2, US 7,241 ,278 B2 or US 9,937,294 B2.

If the drug delivery device has a similar working principle as in the example of WO 2004/078239 A1 , during dose setting components of the drug delivery device may perform the following movements. A housing may be stationary and may be used as a reference system for the further movements of other components. A plunger may be stationary and may be guided in a housing thread. A drive sleeve may perform a helical movement, i.e. a combined axial and rotational movement, and may be in threaded engagement with the plunger. A dose dial grip may perform a rotational movement, e.g. a helical movement. A dose button may be free to rotate but axially constrained to the drive sleeve. For example, the dose button may be axially retained to the drive sleeve by a clutch. An optional clutch may perform a helical movement and may couple a number sleeve to the drive sleeve. An optional clutch spring may perform an axial movement and may be guided in housing splines and may click over clutch teeth. An optional number sleeve may be permanently fixed on the dial grip and may perform a helical movement and may be guided in a housing thread. An optional last dose nut may perform a helical movement on a drive sleeve track of the drive sleeve and may be rotationally constrained to the housing. Hence, the last dose nut may perform axial movement relative to the housing and a helical movement with respect to the drive sleeve.

During dose dispensing components of the drug delivery device may perform the following movements. The housing may remain stationary as a reference system for the further movements of other components. The plunger may perform a helical movement and may be guided in the housing thread. The drive sleeve may perform a pure axial movement and may be in threaded engagement with the plunger. The dose dial grip may perform a rotational movement, e.g. a helical movement and may be permanently fixed on the number sleeve. The dose button may perform an axial movement if coupled to the drive sleeve and/or the clutch. The optional clutch may perform pure axial movement and may de-couple the number sleeve from the drive sleeve. The optional clutch spring may perform pure axial movement and may be rotationally constrained to the clutch due to a pressure applied to the dose button. The optional number sleeve may perform a helical movement and may be guided in the housing thread. The optional last dose nut may maintain its axial position on the drive sleeve track and may be rotationally constrained to the housing.

The first portion of the electronic add-on module may define an auxiliary dose dial grip. Further, the first portion is configured to be releasably attached to the dose dial grip of the drug delivery device, such that the first portion follows axial and rotational movement, for example helical movement, of the dose dial grip when attached to the drug delivery device. Hence, when the auxiliary dose dial grip is attached to the dose dial grip and is for example rotated during dose setting, the dose dial grip of the drug delivery device is rotated and may be entrained. Furthermore, the first portion has a first longitudinal axis. Along the first longitudinal axis, the electronic add-on module or first portion extends from a proximal region to a distal region. When the electronic add-on module is attached to a drug delivery device, the proximal region is generally closer to the second portion and the distal region is closer to the drug delivery device. The drug delivery device may also comprise a second longitudinal axis. The drug delivery device may extend from a distal region, provided for example with a needle, to a proximal region, provided for example with the dose button. If the electronic add-on module is releasably attached to the drug delivery device, the first and second longitudinal axes may be in line.

The second portion of the electronic add-on module is coupled to the first portion allowing relative axial movement parallel to the first longitudinal axis with respect to the first portion. An axial movement parallel to the first longitudinal axis may comprise a parallel movement along the first longitudinal axis. Further, allowing relative axial movement between the first portion and the second portion does not exclude any other relative movements between said portions. In one aspect, for example, the second portion may be coupled to the first portion allowing helical movement, for example axial movement along the first longitudinal axis and rotational movement about the first longitudinal axis and with respect to the first portion.

The second portion may be retained in the first portion, for example by clips that engage in a groove. In addition, the second portion may be configured to apply pressure onto a dose button of the drug delivery device when axially moved along the first longitudinal axis. Therefore, the second portion may define an auxiliary dose button configured to abut the dose button of the drug delivery device when attached to the drug delivery device and axially moved. In other words, the auxiliary dose button may not be in abutment with the dose button of the drug delivery device initially but may be moved into abutment when the user applies pressure onto the auxiliary dose button. Hence, when a user applies pressure onto the auxiliary dose button, the pressure is transferred onto a dose button of the drug delivery device. Consequently, the second portion is configured to apply pressure in axial direction onto the dose button of the drug delivery device, when attached.

Further, the electronic add-on module comprises the electrical power source, such as a battery, arranged inside the electronic add-on module. In one aspect, the electrical power source is arranged inside the second portion of the electronic add-on module. The electrical power source is electrically connected to a circuit board assembly of the electronic add-on module. The circuit board assembly may be arranged inside the second portion of the electronic addon module and may be supplied with power by the electrical power source. Consequently, the electrical power source may be configured to power electrical components electrically connected to said circuit board assembly. Electronic components may be chips, processors, conductors, wireless modules or the like. The circuit board assembly may comprise a printed circuit board assembly. The circuit board assembly may comprise a substrate equipped with electronic components. The electronic components may be electrically connected to the circuit board assembly and may therefore also be supplied by power of the electrical power source.

Further, the electronic add-on module comprises at least two first electrically conductive elements. One of the first electrically conductive elements may for example be electrically connected to the electrical power source, wherein another first electrically conductive element may be electrically connected to the circuit board assembly. The circuit board assembly may also be electrically connected to the electrical power source. According to one aspect, the electrical power source may also be electrically connected to the circuit board assembly, wherein the first electrically conductive elements each form a pole of an electronic component of the circuit board assembly. Other possible arrangements for the electrical supply of the circuit board assembly or an electronic component are possible. Relative axial movement of said second portion relative to said first portion along the first longitudinal axis, as described above, provides an electrical connection between said at least two first electrically conductive elements. In other words, relative axial movement of the second portion relative to the first portion along the first longitudinal axis creates electrical continuity between the at least two first electrically conductive elements. The electrical connection actuates, for example, activates, the circuit board assembly, or an electronic component connected to said circuit board assembly. In other words, upon axial movement of the second portion relative to the first portion, an electrical connection is provided allowing powering the circuit board assembly or an electronic component of the electronic add-on module.

According to one aspect, the second portion may be at least partially arranged around the first portion. For example, the second portion may also at least partially be arranged inside the first portion. However, the second portion may also be arranged completely in the first portion, for example, when the second portion is moved in its most distal position. The electronic add-on module may also comprise further portions, for example, a third portion coupled to the second portion. The third portion may be free to rotate with respect to the first portion and the second portion about the first longitudinal axis, wherein the second portion may be rotationally constrained to the first portion. Further, the second portion may be retained in the first portion. According to a further additional or alternative aspect, the circuit board assembly may be at least partially arranged perpendicular to the direction of relative axial movement of the first portion and the second portion, i.e. perpendicular to the first longitudinal axis. In one example the entire circuit board assembly may be arranged perpendicular to the first longitudinal axis. Unaffected by the arrangement of, for example, the first portion and the second portion, providing said electrical connection and thereby activating the circuit board assembly or an electronic component thereof, may therefore be regarded as a type of switch that may be actuated without mechanical actuation of a switch element.

According to one aspect, the electronic add-on module may comprise a second electrically conductive element. The second electrically conductive element may be at least partially axially constrained to the first portion. In other words, at least a part of the second electrically conductive element may be axially stationary with respect to first portion. However, some regions of said second electrically conductive element may be flexible and therefore axially moveable with respect to the first portion. Further, the second electrically conductive element may allow the at least two first electrically conductive elements to be electrically connected. In other words, an electrical connection between said at least two first electrically conductive elements may comprise contacting said second electrically conductive element with the first electrically conductive elements. Therefore, instead of directly contacting each other, the at least two first electrically conductive elements may both contact another element such as the second electrically conductive element in order to provide an electrical connection between said at least two first electrically conductive elements. Providing another element which is partially stationary in order to electrically connect first electrically conductive elements ensures a more reliable electrical connection between the electrically conductive elements.

According to one aspect, the first electrically conductive elements may at least partially be axially constrained to the second portion. In other words, the first electrically conductive elements may at least partially be axially stationary with respect to the second portion. For example, the electrically conductive elements may be fixed to said second portion and may be elastically deformable. Therefore, the first electrically conductive elements may axially move mutually with the second portion. Axially constraining the first electrically conductive elements to the second portion further ensures a more reliable electrical connection between the electrically conductive elements.

In one aspect, when said second portion is in an unloaded state in which no pressure is applied onto the second portion in order to axially move the second portion relative to the first portion, a gap may be provided between the at least two first electrically conductive elements and the second electrically conductive element. The gap may be an axial gap which may be closed due to the relative axial movement between the second portion and the first portion. Therefore, none of the at least two first electrically conductive elements may be in contact, for example, in contact with the second electrically conductive element before the second portion is axially moved. The gap thus may prevent that a small unintentional load on the second portion leads to an unwanted electrical connection.

In one aspect, the first electrically conductive elements and/or the second electrically conductive element may be elastically deformable. In other words, when a load is applied onto the second portion in order to provide the electrical connection, at least one of the first electrically conductive elements or the second electrically conductive element may deform elastically. Consequently, when the second portion is unloaded, the first electrically conductive elements and/or the second electrically conductive element may deform back into initial state, i.e. the state before being loaded. This may allow that an electrical connection between the at least two electrically conductive elements may be provided, for example, after the gap is closed due to the axial movement of the second portion with respect to the first portion, wherein further travel may still be possible and may simply deform the electrically conductive elements without interrupting the electrical connection. In addition, once an electrical connection is established between the electrically conductive elements, deformation of the electrically conductive elements may contribute to maintaining the electrical connection.

In one aspect, the second electrically conductive element may push the first portion and the second portion apart in an axial direction along the first longitudinal axis. The second electrically conductive element may provide a spring force, wherein the spring force may push the first portion and the second portion apart. Therefore, the second electrically conductive element may hold the first portion and the second portion spaced apart at a constant axial gap as long as the second portion is unloaded. Loading the second portion and thereby axially moving the second portion with respect to the first portion may therefore elastically deform the second electrically conductive element, wherein the first electrically conductive elements may approach the second electrically conductive element upon deformation of the second electrically conductive element.

According to one aspect, the first electrically conductive elements may be provided by pins, by spring-loaded pins, for example pogo pins, or by spring elements. The pins may comprise a round contact surface. The pins may be rigid or may have a spring element, for example an inner spring element, and may therefore be spring-loaded. The elastic deformation of the first electrically conductive elements described above may be achieved the inner spring elements. For example, the pins may be pogo pins. The spring-loaded pins may allow controlled, purely axial deformation under load and, at the same time, may have an unchanged contact surface due to the deformation, which ensures that the electrical connection is reliably achieved. However, the first electrically conductive elements may also be formed by spring elements. For example, the first electrically conductive elements may be formed by spring clips. The spring elements may, for example, have two spring legs spaced from one another, wherein when the spring legs are moved towards each other under load, the spring legs may contact each other.

In one aspect, the second electrically conductive element may be provided by a spring washer or by a rigid element, for example a rigid ring element. The spring washer may elastically deform when being loaded by the axial movement of the second portion relative to the first portion. The spring washer may elastically deform due to load applied by the first electrically conductive elements. The spring washer may provide for the axial gap between the at least two first electrically conductive elements and the second electrically conductive element. The spring washer may have a wave-shape, for example a wave-shape similar with DIN 137 Form B. In other words, the wave shape may be close to that shape but still different. For example, the spring washer may comprise at least three peaks in the wave-shape, i.e. at least three points of contact, when being loaded by the axial movement of the second portion. This may improve stability of the spring washer and may prevent the second portion from being tilted. Further, the spring washer may have two free ends. In other words, the spring washer may be split. Thus, the spring washer may for example not form a full ring. However, the free ends may also abut. Providing a spring washer with two free ends allows to easily form a spring washer with regard to spring force and flexibility. The spring washer may also have a flat shape, the spring washer takes on a wave shape when the spring washer is inserted into the electronic add-on module.. The spring washer may be a disc spring. The rigid element may be a platelike element. The rigid element may have a ring shape. The rigid element may also be a ring segment. The first electrically conductive elements and the second electrically conductive element may comprise the same or different materials.

In one aspect, the electronic add-on module may comprise more than two first electrically conductive elements. For example, the electronic add-on module may comprise four first electrically conductive elements which are each offset by 90°. Providing more than two first electrically conductive elements may allow an electrical connection to be reliably provided during off- axis loading of the second portion. In other words, if the second portion is not loaded centered so that the second portion may tilt slightly, the multiple first electrically conductive elements still ensure the electrical connection of at least two of the electrically conductive elements.

According to one aspect, when the second portion is in the unloaded state and the second electrically conductive element is provided by the spring washer, the spring washer may partially abut against the first portion and the second portion without providing the electrical connection between the first electrically conductive elements and the second electrically conductive element. The spring washer may be provided inside the first portion. The spring washer may be fixed to the second portion by clamping elements. Consequently, the spring washer may have two functions: firstly, the spring washer may allow to form the electrical connection between the first electrically conductive elements and secondly, the spring washer may push the first portion and the second portion apart, when said second portion is in an unloaded state. The spring washer may therefore ensure that the electronic add-on module is returned to its unloaded initial state after loading ends, i.e. for example when the user does not apply any further pressure to the second portion. The spring washer may thus reduce the number of components required by taking over two functions.

In one aspect, the first portion may comprise a projection provided on an inner lateral surface of the first portion. The projection may be circumferential. The second electrically conductive element may abut on the projection. For example, when the second electrically conductive element may be a rigid ring, the rigid ring may rest on this projection. The second electrically conductive element in form of a spring washer may abut on the projection in order to space the first portion and the second portion apart. In contrast to a plate inside the first portion, the projection may allow components of the second portion not to be separated from a dose button of the drug delivery device.

According to one aspect, the electronic component connected to the circuit board assembly being actuated upon electrical connection may be a sensor arrangement. This may ensure that detection, for example, detection of an encoder pattern, by the sensor is activated when the second portion is moved axially, in particular when the axial movement of the second portion causes dose dispensing. However, other components, such as a display etc., may also be actuated. Several electronic components may also be actuated. The sensor arrangement may be an optical sensor arrangement. However, the sensor arrangement may also be a magnetic, capacitive or mechanical sensor arrangement.

In one aspect, the second portion may be axially moveable relative to the first portion over a distance greater than the gap. Axial movement of a distance greater than the gap may be referred to as overtravel. In other words, the relative axial movement of the second portion relative to the first portion may be greater than the axial gap in the unloaded state. Consequently, there may be overtravel after the gap is closed. Hence, the second portion may move axially further relative to the first portion after electrical connection between the at least two first electrically conductive elements is provided. Hence, the second portion may move further axially after actuation of the circuit board assembly or after actuation of an electronic component connected to the circuit board assembly. This further axial movement of the second portion may cause dose dispensing. Consequently, the overtravel may ensure that the actuation or activation of the circuit board assembly or the electronic component takes place before the dose dispensing may start.

According to one aspect, the object may also be solved by an assembly comprising a drug delivery device and an electronic add-on module according to the aforementioned aspects. The electronic add-on module is configured for releasable attachment to the drug delivery device. Further, the drug delivery device comprises at least a housing with a container configured to receive a drug or a cartridge filled with a drug. Further, the drug delivery device comprises a dose setting unit and a dose delivery unit.

The dose setting unit comprises a dose dial grip which is, at least rotationally, e.g. helically, moveable with respect to the housing during dose setting and a dose button at least axially moveable with respect to the housing for causing dose dispensing. The dose button may have a T-shape with a proximal end surface that serves as a pressure surface and a central shaft that extends distally. The dose delivery unit comprises a plunger at least axially, e.g. helically, moveable with respect to the housing during dose dispensing.

Further, the electrical connection between said at least two first electrically conductive elements is provided prior to the start of dose dispensing. Consequently, and as already aforementioned with respect to the electronic add-on module, for example, a sensor arrangement may be actuated before the dose dispensing starts.

In one aspect, when the second portion applies pressure in axial direction onto the dose button of the drug delivery device in order to move the dose button axially with respect to the housing, neither the first electrically conductive elements nor the second electrically conductive element may be in contact with the dose button. Therefore, in other words, it is not the electrically conductive elements that apply the pressure onto the dose button. However, and as described above, the second portion may overtravel and therefore apply pressure onto the dose button after the electrical connection is provided.

Therefore, the electronic add-on module as well as the assembly of the electronic add-on module and the drug delivery allow for an improved switch causing actuation of the circuit board assembly or an electronic component electrically connected thereto. The electronic add-on module may be an electronic dose recording system for determining, storing and/or transmitting data indicative of at least a condition of the drug delivery device or its use. For example, the system may detect if the drug delivery device is switched between a dose setting mode and a dose dispensing mode and vice versa. In addition or as an alternative, the system may detect if a dose is set and/or if a dose is dispensed. Still further, the system may detect the amount of dose selected and/or the amount of dose dispensed. Preferably, the electronic add-on module is configured such that it may be switched from a first state having lower energy consumption into a second state having higher energy consumption. This may be achieved by operation of the electronic add-on module, especially by providing the electrical connection between the electrically conductive elements. The first state may be a sleeping mode and the second mode may be a detection and/or communication mode. As an alternative, an electronic control unit may issue a command, e.g. a signal, to another unit of the electronic dose recording system such that this unit is switched on or rendered operational.

The electronic add-on module may further comprise a communication unit for communicating with another device, e.g. a wireless communications interface for communicating with another device via a wireless network such as Wi-Fi or Bluetooth, or even an interface for a wired communications link, such as a socket for receiving a Universal Series Bus (USB), mini-USB or micro-USB connector. Preferably, the electronic add-on module comprises an RF, Wi-Fi and/or Bluetooth unit as the communication unit. The communication unit may be provided as a communication interface between the electronic add-on module and the exterior, such as other electronic devices, e.g. mobile phones, personal computers, laptops and so on. For example, dose data may be transmitted by the communication unit to the external device. The dose data may be used for a dose log or dose history established in the external device.

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

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

The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., short- or long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dual-chamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and/or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and/or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

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

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

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-pal- mitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carbox- ypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(w-carboxyheptadeca- noyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

Examples of GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lix- isenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semag- lutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC-1134- PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211 , CM-3, GLP-1 Eligen, GRMD-0901 , NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador- GLP-1 , CVX-096, ZYOG-1 , ZYD-1 , GSK-2374697, DA-3091 , MAR-701 , MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651 , ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN and Glucagon-Xten.

An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a choles- terol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.

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

Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and/or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

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

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

The term “immunoglobulin single variable domain” (ISV), interchangeably used with “single variable domain”, defines immunoglobulin molecules wherein the antigen binding site is present on, and formed by, a single immunoglobulin domain. As such, immunoglobulin single variable domains are capable of specifically binding to an epitope of the antigen without pairing with an additional immunoglobulin variable domain. The binding site of an immunoglobulin single variable domain is formed by a single heavy chain variable domain (VH domain or VHH domain) or a single light chain variable domain (VL domain). Hence, the antigen binding site of an immunoglobulin single variable domain is formed by no more than three CDRs.

An immunoglobulin single variable domain (ISV) can be a heavy chain ISV, such as a VH (derived from a conventional four-chain antibody), or VHH (derived from a heavy-chain antibody), including a camelized VH or humanized VHH. For example, the immunoglobulin single variable domain may be a (single) domain antibody, a "dAb" or dAb or a Nanobody® ISV (such as a VHH, including a humanized VHH or camelized VH) or a suitable fragment thereof. [Note: Nanobody® is a registered trademark of Ablynx N.V.]; other single variable domains, or any suitable fragment of any one thereof. “VHH domains”, also known as VHHs, VHH antibody fragments, and VHH antibodies, have originally been described as the antigen binding immunoglobulin variable domain of “heavy chain antibodies” (i.e., of “antibodies devoid of light chains”; Hamers-Casterman et al. 1993 (Nature 363: 446-448). The term “VHH domain” has been chosen in order to distinguish these variable domains from the heavy chain variable domains that are present in conventional 4- chain antibodies (which are referred to herein as “VH domains”) and from the light chain variable domains that are present in conventional 4-chain antibodies (which are referred to herein as “VL domains”). For a further description of VHH’s, reference is made to the review article by Muyldermans 2001 (Reviews in Molecular Biotechnology 74: 277-302).

For the term “dAb’s” and “domain antibody”, reference is for example made to Ward et al. 1989 (Nature 341 : 544), to Holt et al. 2003 (Trends Biotechnol. 21 : 484); as well as to WO 2004/068820, WO 2006/030220, WO 2006/003388. It should also be noted that, although less preferred in the context of the present invention because they are not of mammalian origin, single variable domains can be derived from certain species of shark (for example, the so- called “IgNAR domains”, see for example WO 2005/18629).

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

Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sari- lumab), and anti IL-4 mAb (e.g., Dupilumab).

Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

Those of skill in the art will understand that modifications (additions and/or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope of the present invention, which encompass such modifications and any.

An example drug delivery device may involve 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), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

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

As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608- 1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

The terms “axial”, “radial”, or “circumferential” as used herein may be used with respect to a first longitudinal axis of the electronic add-on module, the first portion, the second portion, the drug delivery device, the cartridge, the housing, the cartridge holder or the assembly of the drug delivery device and the electronic add-on module, e.g. the axis which extends through the proximal and distal ends of the cartridge.

"Distal" is used herein to specify directions, ends or surfaces which are arranged or are to be arranged to face or point towards dispensing end of the electronic add-on module or 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 electronic add-on module or 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. Similarly, a distal element compared to a proximal element is located closer to the dispensing end than to the proximal end. Furthermore, when the electronic add-on module is considered alone, the term "distal" may be used with regard to the more distal end of the electronic add-on module, which is located closer to the dispensing end of the drug delivery device when attached to the drug delivery device, and the term "proximal" may be used with regard to the proximal end of the electronic add-on module, which is located further away from the dispensing end of the drug delivery device when attached to the drug delivery device.

In the following, non-limiting, examples of the electronic add-on module, the drug delivery device and the assembly of the drug delivery device and the electronic add-on module are described in more detail by making reference to the drawings, in which:

Figure 1 shows a drug delivery device;

Figure 2 shows a sectional view of a first example of an electronic add-on module in an unloaded state;

Figure 3 shows a sectional view of the electronic add-on module according to the first example in a state in which first electrically conductive elements provide an electrical connection;

Figure 4 shows a sectional view of the electronic add-on module according to the first example in a state of overtravel;

Figure 5 shows a perspective bottom view of the electronic add-on module according to the first example;

Figure 6 shows an exploded view of the electronic add-on module according to the first example; Figure 7 shows an exploded view of an electronic add-on module according to a second example;

Figure 8 shows a sectional view of the electronic add-on module according to the second example in a state in which first electrically conductive elements provide an electrical connection; and

Figure 9 shows a sectional view of the electronic add-on module according to the second example in a state of overtravel.

In the Figures, identical elements and components as well as identical elements and components in different examples or embodiments, i.e. elements and components acting identical or provided for the same purposes but belong to different examples, are provided with the same reference signs.

Figure 1 shows an exploded view of an exemplary medicament or drug delivery device 1. The drug delivery device 1 is a pen-type injector comprising a housing 10 in which a drive mechanism for dose setting and dose dispensing is arranged. The drug delivery device 1 extends from a distal point to a proximal direction P or from a proximal point to a distal direction D along a second longitudinal axis Y of the drug delivery device 1. In order to set a dose for delivery a user may rotate or dial a dose dial grip 12 with respect to the housing 10, wherein the dose dial grip 12 is arranged at a distal end of the housing 10. During dose setting the dose dial grip 12 may perform a helical movement, i.e. a combined axial and rotational movement, or may perform pure rotational movement.

The drive mechanism of the drug delivery device 1 may comprise a plunger, a drive sleeve 13, a clutch, a clutch spring, a number sleeve, a last dose nut and so on, which may move during dose setting and/or dose dispensing. Although not all of these components are shown in detail, for example, the drive mechanisms disclosed in EP 1 570 876, EP 2 814 547, US 9,937,294 B2 or WO 2004/078239 A1 represent suitable drive mechanisms for the present disclosure.

Once the dose is set by means of the dose dial grip 12, the user may press a dose button 11 arranged at the proximal end of the drug delivery device 1 in the distal direction D in order to dispense the dose. When pressing the dose button 11 , the user applies a force directed towards the proximal end of the drug delivery device 1 , wherein the force moves the dose button 11 in the distal direction of the pen and parallel to the second longitudinal axis Y. This axial movement of the dose button 11 releases the drive mechanism for example by de-coupling a number sleeve from the drive sleeve, wherein irrespective of which component of the drug delivery device 1 performs a rotational movement during dose delivery, the dose dial grip 12 is coupled to a respective component in order to perform a rotational movement during dose delivery.

This rotational movement of the dose dial grip 12 during dose delivery may be used to determine, for example, the actual dose delivered by means of an electronic add-on module 100 as shown in various examples in the Figures and described here below.

The exemplary drug delivery device 1 shown in Figure 1 comprises in addition to the dose dial grip 12 and the dose button 11 an optional dosage window 14, a container 15, and a needle 16. The set dose may be displayed via the dosage window 14. The container 15 may be filled directly with a drug, for example, insulin or may be configured to receive a cartridge and thus act as a cartridge holder. The needle 16 may be affixed to the container or the receptacle. During dose dispensing the drug is dispensed through the needle 16. The needle 16 may be protected by an inner needle cap 17. In addition, the needle 16 may be protected by either an outer needle cap 18 or another cap 19.

In order for an electronic add-on module 100 to be functionally attached to a drug delivery device 1 , i.e. attached and usable, either the drug delivery device 1 can be adapted to the electronic add-on module 100 or, conversely, the electronic add-on module 100 can be adapted to the drug delivery device 1. Regardless of this, the drug delivery device 1 as well as the electronic add-on module 100 may have different examples, wherein the further description with respect to the drug delivery device 1 essentially deals with the dose button 11 , the dose dial grip 12 and the drive sleeve 13.

A corresponding first example of an electronic add-on module 100 is shown in Figure 2. The electronic add-on module 100 comprises a first portion 101 , a second portion 102 and a third portion 103 arranged along a first longitudinal axis X. The electronic add-on module 100 comprises coupling elements 104 for releasable attachment to a drug delivery device 1. When the electronic add-on module 100 is coupled to the drug delivery device 1 , the first longitudinal axis X and the second longitudinal axis Y may be in line. The coupling elements 104 of the electronic add-on module 100 may be adapted to a component of the drug delivery device for attachment, for example to the dose dial grip 12 of the drug delivery device 1. Conversely, the drug delivery device 1 may also be adapted to the electronic add-on module 100 so that releasable attachment of the electronic add-on module 100 is permitted. When the electronic add-on module 100 is attached to the drug delivery device 1 , a user may rotate the first portion 101 in order to set a dose for delivery. The first portion 101 may provide an auxiliary dose dial grip allowing for a controlled rotational movement of the first portion 101. Further, pressure may be applied to a proximal end surface 105, for example by a thumb of a user, in order to axially move the second portion 102 with respect to the first portion 101 along the first longitudinal axis X. Here, the proximal end surface 105 is part of the third portion 103 of the electronic add-on module 100, wherein the third portion 103 is coupled by a spigot 106 to the second portion 102, and wherein the third portion 103 is free to rotate about the spigot 106. However, the proximal end surface 105 may also be part of the second portion 102, for example, if the electronic add-on module 100 only comprises two portions.

If the proximal end surface 105 is not loaded centered, the third portion 103 may tilt relative to the first longitudinal axis X, so that third portion projections 107 come into contact with a backup friction surface 108. Preferably, the material pairing of the third portion projections 107 and the backup friction surface 108 is selected in such a way that only low friction occurs between the two components. In other words, the friction between the third portion projections 107 and the backup friction surface 108 may still allow relative rotation between the third portion 103 and the second portion 102 while the second portion 102 is axially moved due to a load applied to the proximal end surface 105.

An electrical power source, here a battery 109, is arranged in the second portion 102. In addition, the second portion 102 comprises a circuit board assembly with a substrate 110. The electrical power source is electrically connected to the circuit board assembly. Various electronic components 111 such as a sensor arrangement 112 are arranged on the substrate 110. The sensor arrangement 112 may, for example be an optical sensor arrangement, which is electrically connected to the circuit board assembly.

The components of the second portion 102 are arranged inside a housing of the second portion 102, wherein the housing is formed, inter alia, by an abutment surface 113 which is configured to apply pressure onto a dose button 11 of the drug delivery device 1 in order to move the dose button 11 axially to cause dose dispensing. The abutment surface 113 comprises a protrusion 114 which provides a thrust bearing when the protrusion 114 comes into contact with the dose button 11 , for example, a recess of the dose button 11 . The abutment surface 113 may be at least partially transparent so that the sensor arrangement 112 may, for example, detect a movement of the dose button of the drug delivery device. The sensor arrangement 112 may detect relative rotational movement of the second portion 102 and an encoder pattern, for example, arranged on the dose button 11 of the drug delivery device 1.

Further, the electronic add-on module 100 comprises first electrically conductive elements 115. Here the first electrically conductive elements 115 are spring-loaded pins which are elastically deformable as can be seen in Figure 4, wherein in Figure 4 the pins are compressed and a spring element (not shown) inside the pins is elastically deformed. In addition, the electronic add-on module 100 comprises a second electrically conductive element 116. Here the second electrically conductive element 116 is a spring washer having a wave-shape.

The second electrically conductive element 116 abuts in the distal direction D against projections 117 arranged on an inner lateral surface 118 of the first portion 101 and against the abutment surface 113 in the proximal direction P, thereby pushing the first portion 101 and the second portion 102 apart in an axial direction along the first longitudinal axis X. An axial gap 119 is formed by the axial separation of the first portion 101 and the second portion 102. Here, the gap 119 is formed between the most distal end of the first electrically conductive element 115 and the corresponding section of the second electrically conductive element 116 to be contacted by the first electrically conductive element 115 when axially moved in the distal direction D.

When the second portion 102 is axially moved in the distal direction D with respect to the first portion 101 , a spline 120 of the second portion 102 may slide inside a groove 121 arranged on the inner lateral surface 118 of the first portion 101. In the example shown in Figures 2 to 6, the coupling of the splines 120 and grooves 121 between the second portion 102 and the first portion 101 only allow limited relative axial movement. However, other couplings between the first portion 101 and the second portion 102 may be possible.

Further, as shown in Figures 2 to 6, the spline 120 and groove 121 coupling limit the maximum axial movement between the first portion 101 and the second portion. However, a maximum axial travel may also be limited by other means.

Figures 3 and 4 show two different states in which the second portion 102 has been moved axially relative to the first portion 101 along the first longitudinal axis X compared to an initial state shown in Figure 2. Figure 3 shows a state of the electronic add-on module 100 in which the first electrically conductive element 115 is contacting the second electrically conductive element 116. Thus, compared to Figure 2, the second portion 102 in Figure 3 was moved axially by a distance corresponding to the gap 119 relative to the first portion 101. Further and compared to Figure 3, Figure 4 shows a state in which the second portion 102 was moved further axially relative to the first portion 101. In other words, the relative axial movement between the second portion 102 and the first portion 101 was greater than the axial gap 119. Hence, Figure 4 shows an overtravel after the gap 119 is closed. Consequently, the first electrically conductive element 115 is compressed and therefore shorter compared to the states shown in Figures 2 and 3. In comparison between Figures 3 and 4, the abutment surface 113 is moved further in the distal direction D, so that after the electrical connection between the first electrically conductive elements 115 is provided, the second portion 102 is moved further distally and may therefore apply pressure to a dose button of a drug delivery device after the circuit board assembly or the electronic components 111 or the sensor arrangement 112 electrically connected to the circuit board assembly is actuated.

In Figure 5, the electronic add-on module 100 is shown from below, wherein two first electrically conductive elements 115, which may contact the second electrically conductive element 116 upon axial movement of the second portion 102 with respect to the first portion 101 , are visible as part of the electronic add-on module 100. The spring washer in Figure 5 is fixed to the second portion 102 by clamping elements 122. The clamping elements 122 are provided by bars under which the spring washer is pushed in order to fix the second electrically conductive element 116 to the second portion 102.

An exploded view of the electronic add-on module 100 as shown in Figures 2 to 5 is shown in Figure 6. The spring washer is shown here with two free ends 123, which may be deformed with respect to each other and may allow the spring washer to be fixed to the clamping element 122. As aforementioned, however, it is not necessary for the spring washer to have two free ends 123.

Figures 7 to 9 show a further example of an additional electronic module 100, which differs from the example shown in Figures 2 to 6 in that other electrically conductive elements 115 and 116 are used.

Figure 7 depicts an exploded view of the electronic add-on module 100 comprising a respective first, second and third portion 101 , 102 and 103. As basically only the electrically conductive elements 115 and 116 differ from the previous example shown in Figures 2 to 6, only these electrically conductive elements 115 and 116 will be discussed below.

The electronic add-on module 100 comprises three first electrically conductive elements 115 which are each offset by 120°. The first electrically conductive elements 115 are provided by spring clips. When these spring clips are deformed upon axial movement of the second portion 102 relative to the first portion 101 , a first spring leg 124 and a second spring leg 125 of the spring clips are brought into contact.

Thus, when the second spring leg 125, for example, is brought into contact with the second electrically conductive element 116 shown here as a rigid ring, the second spring leg 125 may start to deform towards the first spring leg 124. The point of contact between the first electrically conductive elements 115 and the second electrically conductive element 116 providing an electrical connection between the first electrically conductive elements 115 is shown in Figure 8.

Further axial movement of the second portion 102 with respect to the first portion 101 , as shown in Figure 9, causes the second spring leg 125 to abut against the first spring leg 124. This abutment may prevent further deformation of the spring clips, therefore, preventing that the first electrically conductive elements 115 are deformed beyond the elastic limit. In addition, this abutment may limit the amount of overtravel.

Further, the ring element as the second electrically conductive element 116 is arranged on the projection 117 of the first portion 101 as shown in Figures 8 and 9. The ring element is therefore not moved or deformed relative to the first portion 101. However, when the second portion 102 is moved axially in the distal direction D relative to the first portion 101 , the first electrically conductive elements 115 are contacting the second elastically conductive element 116.

In summary, the electronic add-on modules 100 therefore allow the actuation and thus the switching of electronic components based on relative axial movement of the first portion 101 and the second portion 102 simply by providing an electrical connection between electrically conductive elements. Once the electronic add-on module is attached to a drug delivery device, a user may apply a force onto the proximal end surface 105, thereby axially moving the second portion 102 relative to the first portion 101 and actuating, for example a sensor arrangement. The actuation the sensor arrangement, may then allow to detect an amount of drug which is dispensed, when the dose button is for example axially moved due to the pressure applied to the proximal end surface of the electronic add-on module. Reference Numerals

1 drug delivery device

10 housing

11 dose button

12 dose dial grip

13 drive sleeve

14 display window

15 container

16 needle

17 inner needle cap

18 outer needle cap

19 cap

100 electronic add-on module

101 first portion

102 second portion

103 third portion

104 coupling elements

105 proximal end surface

106 spigot

107 third portion projection

108 backup friction surface

109 battery

110 substrate(of the circuit board assembly)

111 electronic components

112 sensor arrangement

113 abutment surface

114 protrusion

115 first electrically conductive element (spring-loaded pin)

116 second electrically conductive element (spring washer)

117 projection

118 inner lateral surface

119 gap

120 spline

121 groove

122 clamping elements 123 free ends (spring washer)

124 first spring leg

125 second spring leg

D distal direction

P proximal direction

X first longitudinal axis (of the first portion)

Y second longitudinal axis (of the drug delivery device)

Claims

1. An electronic add-on module (100) for releasable attachment to a drug delivery device (1), the electronic add-on module comprising:

• a first portion (101) configured to be releasably attached to a dose dial grip (12) of the drug delivery device, such that the first portion follows axial and rotational movements of the dose dial grip when attached to the drug delivery device, wherein the first portion has a first longitudinal axis (X),

• a second portion (102) coupled to the first portion, allowing relative axial movement parallel to the first longitudinal axis with respect to the first portion, wherein the second portion is configured to apply pressure onto a dose button (11) of said drug delivery device when axially moved along the first longitudinal axis,

• an electrical power source arranged inside said electronic add-on module and electrically connected to a circuit board assembly,

• the circuit board assembly being arranged inside said electronic add-on module, characterized in that the electronic add-on module additionally comprises at least two first electrically conductive elements (115), wherein relative axial movement of said second portion relative to said first portion along the first longitudinal axis provides an electrical connection between said at least two first electrically conductive elements, and wherein the circuit board assembly or an electronic component (111 ; 112) connected to said circuit board assembly is actuated due to said electrical connection.

2. Electronic add-on module (100) according to claim 1 , wherein the electronic add-on module comprises a second electrically conductive element (116) which is at least partially axially constrained to said first portion (101), and wherein said second electrically conductive element allows electrical connection between said at least two first electrically conductive elements (115).

3. Electronic add-on module (100) according to claim 1 or 2, wherein the first electrically conductive elements (115) are at least partially axially constrained to said second portion (102).

4. Electronic add-on module (100) according to claim 2 or 3, wherein, when said second portion (102) is in an unloaded state in which no pressure is applied onto said second portion in order to axially move said second portion relative to said first portion, a gap (119) is provided between said at least two first electrically conductive elements (115) and said second electrically conductive element (116).

5. Electronic add-on module (100) according to any one of claims 1 to 4, wherein the first electrically conductive elements (115) and/or the second electrically conductive element (116) are elastically deformable.

6. Electronic add-on module (100) according to any one of claim 5, wherein the second electrically conductive element (116) pushes the first portion (101) and the second portion (102) apart in an axial direction along the first longitudinal axis (X).

7. Electronic add-on module (100) according to any one of claims 1 to 6, wherein the first electrically conductive elements (115) are provided by pins, by spring-loaded pins, for example pogo pins, or by spring elements.

8. Electronic add-on module (100) according to any one of claims 2 to 7, wherein the second electrically conductive element (116) is provided by a spring washer or by a rigid element, for example a rigid ring element.

9. Electronic add-on module (100) according to any one of claims 1 to 8, wherein the electronic add-on module comprises more than two first electrically conductive elements (115).

10. Electronic add-on module (100) according to any one of claims 8 or 9, wherein, when said second portion is in the unloaded state and the second electrically conductive element (116) is provided by the spring washer, the spring washer partially abuts against said first portion (101) and said second portion (102) without providing the electrical connection between the first electrically conductive elements (115) and the second electrically conductive element.

11 . Electronic add-on module (100) according to any one of claims 2 to 10, wherein the first portion (101) comprises a projection (117) provided on an inner lateral surface (118) of said first portion, and wherein the second electrically conductive element (116) abuts on said projection.

12. Electronic add-on module (100) according to any one of claims 1 to 11 , wherein the electronic component connected to said circuit board assembly being actuated upon electrical connection is a sensor arrangement (112).

13. Electronic add-on module (100) according to any one of claims 4 to 12, wherein the second portion (102) is axially moveable relative to said first portion (101) over a distance greater than the gap (119).

14. An assembly comprising a drug delivery device (1) and an electronic add-on module (100) according to any one of the preceding claims configured for releasable attachment to the drug delivery device, wherein the drug delivery device comprises:

• a housing (10) with a container configured to receive a drug or a cartridge filled with a drug,

• a dose setting unit comprising a dose dial grip (12) at least rotationally moveable with respect to the housing during dose setting and a dose button (11) at least axially moveable with respect to the housing for causing dose dispensing, and

• a dose delivery unit comprising a plunger at least axially moveable with respect to the housing during dose dispensing, characterized in that said electrical connection between said at least two first electrically conductive elements (115) is provided prior to the start of dose dispensing.

15. The assembly according to claim 14, wherein when said second portion (102) applies pressure in axial direction onto said dose button (12) in order to move said dose button axially with respect to the housing, neither the first electrically conductive elements (115) nor the second electrically conductive element (116) are in contact with said dose button.