Electronic add-on module and assembly of an electronic add-on module and a drug delivery device

Abstract

The present disclosure relates to an electronic add-on module (100) comprising a first portion (101) configured for, e.g. releasable, attachment to a dose dial grip (12) of a drug delivery device (1) such that the first portion follows movement of the dose dial grip and vice versa when attached to the drug delivery device. A second portion (102) is coupled to the first portion (101) allowing relative rotational movement and relative axial movement with respect to the first portion (101). In order to provide an improved electronic add-on module (100), two sensor arrangements (106, 107) are provided and a processor (108) is configured to determine the amount of dose dispensed based on relative rotational movement detected by the first sensor arrangement (106) and on rotation of the second portion (102) relative to earth detected by the second sensor arrangement (107) which comprises an inertial measurement unit.

Description

[0001] Description

[0002] ELECTRONIC ADD-ON MODULE AND ASSEMBLY OF AN ELECTRONIC ADD-ON

[0003] MODULE AND A DRUG DELIVERY DEVICE

[0004] The present disclosure is generally directed to an electronic add-on module and to an assembly of an electronic system, e.g. an electronic add-on module, which is configured to be releasably attached to a drug delivery device.

[0005] 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.

[0006] An electronic module with an electrical power source, a sensor arrangement and a processor is disclosed in WO 2023 / 280419 A1. The module measures a dose of medicament based on a computer-implemented method for measuring comprising: detecting, using a gyroscope, the rotation of a dose dialing component of a drug delivery device; determining, using a mode sensing arrangement, that a dose dialing operation or a dose dispensing operation is being performed on the drug delivery device; and in response determining that the dose dialing operation or the dose dispensing operation is being performed on the drug delivery device, determining a dose based on the rotation of the gyroscope.

[0007] Further, WO 2019 / 185516 A1 and WO 2019 / 185517 A1 each propose a detector integrated into an injection device. For example, the detector may be a magnetic rotation encoder (quadrature), a vibrating structure microelectromechanical systems (MEMS) gyroscope or a combination of a MEMS gyroscope and an accelerometer. A measurement with this detector provides information about the dose size.

[0008] WO 2020 / 217094 A1 discloses an injection monitoring module with a magnetic field producing means and a magnetic field sensor. In addition, the injection monitoring system may comprise a rotational movement measurement means, e.g. a gyroscope, configured to detect and / or measure a user-induced rotational movement of the injection monitoring system.

[0009] 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

[0010] September 22, 2025 S 100 P 554 WO WO 2020 / 217094 A1 , WO 2021 / 140352 A1 and WO 2021 / 214 275 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.

[0011] 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.

[0012] US 2024 / 285867 A1 discloses an electronic add-on module having a first portion rotationally fixed to the dose dial grip of the injector and a second portion defining an auxiliary dose button for the dose button of the injector. The module further comprises a first sensor arrangement measuring relative rotational movement between the first and second portions and a second sensor arrangement measuring rotation between the first portion and the housing. The dose button of the injector is to be axially depressed to trigger the injection.

[0013] WO 2023 / 213756 A1 and US 2020 / 353176 A1 disclose modules with only one sensor.

[0014] Further, in one embodiment the data collection device disclosed in WO 2016 / 198516 A1 is configured to be transferred from a first configuration into a second configuration by axial movement of the second portion with respect to the first portion. Relative rotation between the first portion and the second portion is only allowed in one of these configurations, namely during dose dispensing.

[0015] Considering an injection device, wherein the dose button of the injection device is allowed to rotate relative to the dose dial grip in all states, especially during dose dispensing, as is the case with the device disclosed in WO 2004 / 078239 A1 , rotation of the dose button is typically prevented by the user's thumb or finger applying pressure onto the dose button. For the data collection device disclosed in WO 2016 / 198516 A1 it is typically assumed that the user prevents the rotation of the second portion relative to the first portion during dose dispensing by applying pressure to the second portion.

[0016] September 22, 2025 S 100 P 554 WO However, since rotational movement of the second portion is still possible during dose dispensing measurement inaccuracies may occur if the user cannot completely prevent rotational movement by his or her thumb or finger. Thus, even though, often the dose button or the second portion is essentially prevented from rotating by the user's thumb or finger during dose dispensing, it is impossible to fully rely on the measured data. The measured data thus may form useful information which, for example, provide a physician or user with indications for the use of the injection device. However, it would be deceptive to rely solely on these data if, for example, the dosing regimen needs to be adjusted.

[0017] Based on the aforementioned problem, it is an object of the present disclosure to provide an improved electronic add-on module and an improved assembly comprising a drug delivery device and an electronic add-on module.

[0018] This object is essentially solved by an electronic add-on module according to claim 1.

[0019] The electronic add-on module may be, e.g. releasably, attached to the drug delivery device by fastening means, for example, interacting mechanical coupling elements or by frictional or elastic engagement. In more detail, the present disclosure relates to an add-on electronic module that can be embodied as a re-usable clip-on module with a suitably configured pen injector for the purpose of recording doses that are delivered from the pen. This functionality may be of value to a wide variety of device users as a memory aid or to support detailed logging of dose history. It is envisaged that the electronic module could be configured to be connectable to a mobile device, or similar, to enable the dose history to be downloaded from the module on a periodic basis. The module may comprise electronics for detecting and / or calculating the size of a selected and / or dispensed dose. A battery, e.g. a rechargeable battery, may be used to provide the electronics with energy.

[0020] An assembly comprises a drug delivery device and an electronic add-on module configured for, e.g. releasable, attachment to the drug delivery device. 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 and dispensing unit.

[0021] The dose setting and dispensing unit comprises a dose dial grip which is, at least rotationally, e.g. helically, moveable with respect to the housing during dose dispensing 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 in cross-section with a proximal end surface that serves as a pressure surface and a central shaft that extends distally. The dose setting and dispensing unit

[0022] September 22, 2025 S 100 P 554 WO may comprise further components, e.g. a plunger which may be at least axially, e.g. helically, moveable with respect to the housing during dose dispensing.

[0023] The electronic add-on module of the present disclosure is intended to cover a wide variety of different drug delivery devices, preferably pen injectors, that all exhibit a similar behaviour when dispensing a dose, in that: (a) the dial grip rotates relative to the housing during dispense, with a rotation angle related to the amount of dose dispensed, and (b) the dose button is prevented from rotating relative to the housing, or is free to rotate but not driven so that any relative rotation is likely to be small. As the module is intended to be independent of the type of drug delivery device, the present disclosure is not limited to any details of the mechanism of the delivery device.

[0024] Although not required in the context of the present disclosure, the drug delivery device may optionally comprise further components such as a drive sleeve, 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.

[0025] 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 be provided rotationally coupled to the dose dial grip during dose setting and rotationally constrained to the housing during dose dispensing. In other words, the drive sleeve may be guided in the housing to perform a purely axial movement during dose dispensing. The 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 dial grip may perform 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

[0026] September 22, 2025 S 100 P 554 WO 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.

[0027] 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 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.

[0028] The electronic add-on module comprises at least a first portion and a second portion. The first portion defines an auxiliary dose dial grip. Further, the first portion is configured to be permanently or releasably attached to the dose dial grip of the drug delivery device, such that the first portion follows the, e.g. 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 and / or dose dispensing, the dose dial grip of the drug delivery device is also rotated.

[0029] Furthermore, the first portion has a first longitudinal axis. Along the first longitudinal axis, the electronic add-on module or first component extends from a proximal region to a distal region. The module may have a roughly cylindrical shape and the first longitudinal axis may be the center axis of this cylindrical shape. 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 are in line.

[0030] September 22, 2025 S 100 P 554 WO The second portion of the electronic add-on module is coupled to the first portion allowing relative rotational movement about the first longitudinal axis and relative axial movement parallel to the first longitudinal axis with respect to the first portion The second portion may be at least partially arranged inside the first portion and / or may be retained in the first portion. The second portion may be retained in the first portion by clips that engage in a groove. In addition, the second portion defines an auxiliary dose button abutting the dose button of the drug delivery device. Hence, when a user applies pressure onto the auxiliary dose button, the pressure is directly transferred onto the dose button of the drug delivery device. Consequently, the second portion is configured to apply pressure onto the dose button of the drug delivery device, when attached.

[0031] According to the present disclosure, the electronic add-on module further comprises a PCBA (printed circuit board assembly) with processor connected to a first sensor arrangement configured to detect a relative rotational movement between the first portion and the second portion or between the second portion and the dose dial grip. The processor is further connected to at least a second sensor arrangement which is arranged in or on the second portion and which is configured to measure the rotation of the second portion of the electronic add-on module relative to the earth or ground. The processor is configured to determine the amount of dose dispensed based on the relative rotational movement detected by the first sensor arrangement and based on the rotation of the second portion relative to the earth detected by the second sensor arrangement. In more detail, any rotation of the second portion of the module relative to the first portion inadvertently caused by a user during dose dispensing may be detected and adjusted in the determination of the size of the dose delivered. Thus, a detection of the size of the dose delivered by the processor based on the relative rotations detected by both sensors is likely to be identical to the actual relative rotation of the dial grip to the housing with a rotation angle of the dial grip to the housing being related to the amount of dose dispensed.

[0032] The second sensor arrangement may comprise any type of accelerometer, gyroscope and / or magnetometer, e.g. an inertial measurement unit, allowing measurement of the magnitude and direction of forces and the angular rate. An inertial measurement unit (IMU) is an electronic device that measures and reports specific force, angular rate, and sometimes the orientation of an object, using a combination of accelerometers, gyroscopes, and sometimes magnetometers. Such inertial measurement unit are often used in wearable devices, like smartphones and fitness trackers. For use in the electronic add-on module, the inertial measurement unit of the second sensor arrangement may be a micro-electromechanical

[0033] September 22, 2025 S 100 P 554 WO system having a volume of 1 mm3to 20 mm3, preferably less than 10 mm3, and / or a length not exceeding 7.5 mm, preferably less than 5 mm, in any direction. Such a microelectromechanical system (MEMS) is a microscopic device incorporating both electronic and moving (mechanical) parts. Some known MEMS are made up of components between about 0.001 mm to 0.1 mm, and MEMS units generally range in size from about 0.02 mm to 1.0 mm. For example, a suitable inertial measurement unit is a Bosch BMI270 sensor chip having the dimensions 3.0 mm x 2.5 mm x 0.8 mm.

[0034] In the electronic add-on module, the second sensor arrangement may be provided at different positions. For example, the inertial measurement unit may be arranged directly on the PCBA on the centre of the first longitudinal axis of the module. In this example, the second sensor arrangement may measure rotation, rotational velocity and / or rotational acceleration. From these measurements the estimated user induced rotation can be measured or calculated. Alternatively, the inertial measurement unit may be arranged directly on the PCBA offset from the centre of the first longitudinal axis. Regardless of this off-centre mounting the rotation of second sensor arrangement is equal to the rotation of the PCBA. Therefore, similarly in this example the second sensor arrangement may measure rotation, rotational velocity and / or rotational acceleration directly. From these measurements the estimated user induced rotation can be measured or calculated.

[0035] If the second sensor arrangement is mounted anywhere on the PCB except directly on the axis of rotation, the inertial measurement unit is configured to read linear displacements, speeds and / or accelerations in at least one axis or in up to all three axes. With knowledge of the relative mounting position of the second sensor arrangement and the axis of rotation as well as the alignment vectors of the linear measurement directions it is then possible to calculate the rotation angle of the PCBA relative to central axis of the module. If the inertial measurement unit has its detection axes aligned to a cylindrical coordinate system based on the first longitudinal axis of the module, e.g. one detection axis is aligned with the radial direction and one axis with the tangential direction, this may simplify the calculations required to derive the rotation angle of the module from the linear displacements, speeds and / or accelerations.

[0036] According to a further independent aspect of the present disclosure, the first sensor arrangement comprises at least one light source and at least one optical sensor configured to generate a signal, e.g. voltage signal, based on detection of light, e.g. light reflected or interrupted by an encoder surface of the first portion, the second portion or the dose dial grip. For example, the first sensor arrangement may comprise at least two light sources and at least two optical sensors, each configured to generate a voltage signal based on detection of light

[0037] September 22, 2025 S 100 P 554 WO reflected from an encoder surface, e.g. a ring of encoder flag segments distributed about an inwardly facing cylindrical surface, of the first portion.

[0038] An encoder surface may be any surface or arrangement which has portions of a higher reflectivity and portions of a lower reflectivity, or alternatively which has portions of a higher light transmission and portions of a lower light transmission. For example, one or more reflective type sensor(s) may be used together with regions of reflectivity and absorption present on the target component(s). In more detail, the first portion of the module may comprise regions of reflectivity and regions of absorption as encoder regions wherein the at least one optical sensor is configured and arranged to sense the regions of reflectivity. More specifically, a series of first encoder flag segments may be made from black material and a series of second encoder flag segments may be made from white material. Additionally, or alternatively, the encoder flag segments may comprise different surface finishes to increase or decrease reflectivity. The encoder flag segments may for example be twin-shot molded. The first sensor arrangement may be part of and / or located on the second portion and the first portion may comprise an encoder surface, e.g. an encoder ring facing radially inwards towards the sensor arrangement.

[0039] The use of these specific sensor implementations is not a limitation of the present disclosure. Rather, both sensors could use any previously described arrangement of sensor types. Alternatively, different types of sensor could be used such as: accelerometers, gyroscopes, light sensors, sound sensors, pressure sensors, temperature sensors, proximity sensor, infrared sensor, ultrasonic sensor, colour sensor, humidity sensor, tilt sensor, optical flow sensors, magnetic / Hall effect sensor, radiation sensor, lidar, electrical current sensor, optical sensors, force / torque sensors, strain gauges, mechanical switches.

[0040] In the electronic add-on module the processor may be configured to determine the amount of dose dispensed based on subtracting or adding the rotational movement detected by the second sensor arrangement from the relative rotational movement detected by the first sensor arrangement. This eliminates potential misreadings inadvertently caused by some rotation of the second portion by a user before, during or after dose dispensing.

[0041] During dose dispensing, the first portion may rotate with the pen dial grip along a helical path. The second portion may be free to rotate, although any rotation is likely to be inadvertently applied by the user and would typically only result in a small rotation relative to the pen housing. In some drug delivery devices, the dose button is also free to rotate, but if no torque is applied it will remain rotationally aligned with the pen housing, due to friction within the mechanism.

[0042] September 22, 2025 S 100 P 554 WO Any torque applied within the pen is likely to be small. If the second portion rotates relative to the first portion, torque might be applied via a contact feature on the second portion that contacts dose button in order to initiate dose dispensing. This torque can be minimized in several ways, for example by ensuring that the contact feature has a small diameter. In other words, the second portion may be provided with a thrust bearing with a tip facing towards the dose button, wherein the tip of the thrust bearing has a diameter being less than about 5%, preferably less than 2%, for example between 0.1 % and 1%, of the diameter of the dose button. In addition or as an alternative, at least the tip of the thrust bearing may be made from a low friction material, may be coated with a low friction material, and / or may be provided with a lubricant. Further, a clearance between the second portion and the dose button may be small at the tip of the thrust bearing and larger in a region radially spaced from the tip so that contact can only occur at the intended contact feature, i.e. the tip of the thrust bearing. Still further, the second portion may be constrained so that its axis cannot tilt enough to allow contact with the first portion away from the intended contact feature. For example, the second portion may be guided within the first portion such that a center axis of the second portion cannot tilt with respect to first longitudinal axis by more than about 5°, preferably by less than 2°, e.g. about 1°.

[0043] The electronic add-on module may be 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 actuating the microswitch. 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.

[0044] According to one aspect, the electronic add-on module may comprise a microswitch configured to be operated by axial movement of the second portion relative to the housing of the drug delivery device. Further, the operation of the microswitch may wake up electronic components of the electronic add-on module and / or the drug delivery device. In other words, axial movement of the second portion in the distal direction may operate the microswitch. The microswitch may be electrically connected to electronic components arranged in the drug delivery device and / or the electronic add-on module such as a display, a sensor arrangement, a wireless module configured to transmit and receive data or the like. Non-continuous activation of these electronic components may protect an electrical power source, such as a battery, so that the battery lasts longer.

[0045] September 22, 2025 S 100 P 554 WO If the electronic add-on module comprises a switch, the module and its processor may be configured so that data from the sensors starts being logged when the second portion is pressed at the start of dose dispensing and stops being logged when the second portion is released at the end. In an example of the present disclosure, the switch may be operated by the contact feature, i.e. the tip of the thrust bearing, or the tip may be a switch plunger for operating the switch.

[0046] The electronic add-on module may be or may comprise 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.

[0047] 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. Generally, data from the sensors may be processed either in electronics or software of the module itself, so that dose information can be presented to the user or HCP, such as whether a dose event has occurred, the time when it occurred, and the dose size. This information may be presented on an external device such as a mobile device or computer, or might be presented on the module itself.

[0048] In a further aspect, the object may be solved by an assembly comprising a drug delivery device and an electronic add-on module according to the aforementioned aspects. In such an assembly the drug delivery device may comprise a housing with a container configured to receive a drug or a cartridge filled with a drug, dose setting and dispensing unit comprising a dose dial grip at least rotationally moveable with respect to the housing during dose dispensing, a dose button at least axially moveable with respect to the housing for causing dose

[0049] September 22, 2025 S 100 P 554 WO dispensing, and a plunger at least axially moveable with respect to the housing during dose dispensing. The first portion of the electronic add-on module may be adapted to be rotationally constrained to the dose dial grip and the second portion of the electronic add-on module may be adapted to be rotatable relative to the dose button of the drug-delivery device when attached to the drug delivery device. In an example of the present disclosure, the drug delivery device of the assembly contains a drug or a medicament.

[0050] 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.

[0051] 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.

[0052] 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 dualchamber 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

[0053] September 22, 2025 S 100 P 554 WO 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.

[0054] 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 (anti-diabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0055] 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 peptidase-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.

[0056] 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

[0057] September 22, 2025 S 100 P 554 WO be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0058] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-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-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N- (w-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

[0059] Examples of GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, 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.

[0060] An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.

[0061] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0062] 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.

[0063] 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

[0064] September 22, 2025 S 100 P 554 WO enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

[0065] 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).

[0066] 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, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0067] 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.

[0068] September 22, 2025 S 100 P 554 WO Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

[0069] 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.

[0070] 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 and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

[0071] 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.

[0072] 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).

[0073] 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).

[0074] The terms “axial”, “radial”, or “circumferential” as used herein may be used with respect to a 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.

[0075] September 22, 2025 S 100 P 554 WO "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 drug delivery device if connected with the electronic add-on module and / or point away from, are to be arranged to face away from or face 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. 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. 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.

[0076] 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:

[0077] Figure 1 shows a drug delivery device;

[0078] Figure 2 shows a partial cross section of an electronic add-on module according to the present disclosure during dispensing;

[0079] Figure 3 shows a further partial cross section of an electronic add-on module according to the present disclosure during dispensing;

[0080] Figure 4 the PCBA of the electronic add-on module of Figure 3;

[0081] Figure 5 the PCBA an electronic add-on module according to an alternative example of the present disclosure;

[0082] Figure 6 the PCBA an electronic add-on module according to a further alternative example of the present disclosure; and

[0083] Figure 7 the PCBA an electronic add-on module according to a still further alternative example of the present disclosure.

[0084] September 22, 2025 S 100 P 554 WO 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.

[0085] 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 D to a proximal point P to a distal direction D along a 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 proximal 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.

[0086] The drive mechanism of the drug delivery device 1 may comprise e.g. a plunger, a drive sleeve, a clutch, a clutch spring, a number sleeve and / or a last dose nut which may move during dose setting and / or dose dispensing. Although these components are not 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.

[0087] 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 in order to dispense the dose. When pressing the dose button 11 , the user applies a force moving the dose button 11 in the distal direction of the pen and parallel to the longitudinal axis Y. This axial movement of the dose button 11 releases the drive mechanism for example by decoupling 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.

[0088] This rotational movement of the dose dial grip 12 during dose dispensing may be used to determine, for example, the actual dose delivered by means of an electronic add-on module 100 as shown in Figures 2 and 3 and described here below.

[0089] September 22, 2025 S 100 P 554 WO 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 13, a container 14, and a needle 15. The set dose may be displayed via the dosage window 13. The container 14 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 15 may be affixed to the container or the receptacle. During dose dispensing the drug is dispensed through the needle 15. The needle 15 may be protected by an inner needle cap 16. In addition, the needle 15 may be protected by either an outer needle cap 17 or another cap 18.

[0090] 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 and the dose dial grip 12.

[0091] Figures 2 and 3 only show the electronic add-on module 100 in sectional views from two sides and, partially, the dose button 11 of a pen type drug delivery device 1 . The electronic add-on module 100 is designed to be releasably attached to the drug delivery device 1 by the user pushing first portion 101 onto the dial grip 12 (not shown in Figures 2 and 3). The first portion

[0092] 101 is depicted as an essentially cylindrical component comprising several pre-assembled component parts. The first portion 101 has a first longitudinal axis X which is aligned with the longitudinal axis Y of the drug delivery device 1 when the module 100 is attached to the device 1. The radially outer surface of the first portion 101 may have a profile allowing gripping and rotating the first portion 101 such that the first portion has the function of an auxiliary dose dial grip which at least partially surrounds the dial grip 12 and transmits to the dial grip 12 any rotational movements applied by a user. Further, an encoder surface 110 is provided on the first portion 101 . In the depicted example, the encoder surface 110 comprises a ring of encoder flag segments distributed about an inwardly facing cylindrical surface of the first portion.

[0093] The first portion 101 receives and guides a second portion 102 which has the function of an auxiliary dose button configured to apply pressure onto the dose button 11 . The second portion

[0094] 102 is guided within the first portion 101 such that a center axis of the second portion 102 cannot tilt with respect to first longitudinal axis X by more than about 1°, for example less than 0,5°. The second portion 102 comprises several pre-assembled component parts including a proximally facing button surface and a rigidly fixed chassis 103 to form a button assembly,

[0095] September 22, 2025 S 100 P 554 WO which contains the electronics, e.g. a battery 104, a switch with a plunger forming a tip 105, a first sensor arrangement 106 with an optical sensor, a second sensor arrangement 107, and a printed circuit board assembly (PCBA) 108 which comprises or is a processor.

[0096] During dose dispensing, the first portion 101 rotates with the dial grip 12 along a helical path. The second portion 102 is free to rotate, although any rotation is likely to be inadvertently applied by the user and would typically only result in a small rotation relative to the housing 10. The dose button 11 is also free to rotate, but if no torque is applied it will remain rotationally aligned with the housing 10, due to friction within the mechanism. Any torque applied within the drug delivery device 1 is likely to be small. If the second portion 102 rotates relative to dose button 11 , torque might be applied via the contact feature on the button assembly that contacts dose button 11. In the depicted example the contact feature is the tip 105 of a thrust bearing which is part of the switch. This torque is reduced in the depicted example by reducing the diameter of the contact feature, here to less than 5% of the diameter of the dose button 11. In addition, the tip 105 may consist of a low friction material and / or may be provided with a low friction coating or lubricant.

[0097] The tip 105 protrudes distally such that a clearance between the button assembly and the dose button 11 is small near the contact feature, i.e. near the tip 105, and larger radially away from the tip 105, so that contact can only occur at the tip 105 which is the intended contact feature. In addition, the button assembly is guided and constrained within the first portion 101 so that its axis cannot tilt enough to allow contact with the dose button 11 away from the tip 105 as the intended contact feature. In the depicted example, the tip 105 is the distal end of a switch plunger, but alternatively it may be on other parts within button assembly, for example on the second portion 102 or on the chassis 103.

[0098] When the user pushes second portion 102 at the start of dispense, movement is detected by the switch and the electronics start to monitor signals from both sensor assemblies 106, 107, which are then used to calculate the size of the dose dispensed. Figures 2 and 3 both depict the module 100 in a state in which the second portion 102 has been pushed distally such that the tip 105 contacts the dose button 11. In the not depicted state during dose setting, the second portion 102 is in a more proximal position with respect to the first portion 101 and there is a small clearance between the tip 105 and the dose button 11.

[0099] The first sensor arrangement 106 measures the rotation of chassis 103 relative to the first portion 101. In the depicted example, the first sensor arrangement 106 comprises two light sources, a light pipe 109 and two optical sensors, each configured to generate a voltage signal

[0100] September 22, 2025 S 100 P 554 WO based on detection of light reflected from the encoder surface of the first portion 101. In more detail, the first sensor arrangement 106 is located on the distally facing side of the PCBA 108 which comprises the processor. As the PCBA 108 is retained in the second portion 102 or its chassis 103 the first sensor arrangement 106 is rotationally constrained to the second portion 102. The light pipe 109 has a curved configuration in order to guide light from a light source towards the encoder surface 110 of the first portion 101 and to guide light reflected from encoder surface 110 towards an optical sensor. The encoder surface 110 may be a ring of encoder flag segments of different reflectivity, e.g. white and black flag segments, distributed about the inwardly facing cylindrical surface of the first portion 101.

[0101] As second portion 102 and its chassis 103 are fixed to the first sensor arrangement 106 and the first portion 101 with its encoder surface 110 is fixed to the pen dial grip 12, any rotation of the first sensor arrangement 106 with respect to the encoder surface 110 is the same as the rotation of second portion 102 relative to the pen dial grip 12.

[0102] The second sensor arrangement 107 measures rotation of the second portion 102 relative to the earth, in order to use this as an estimate of an inadvertently induced rotation caused by the user rotating their thumb or finger during dispensing. If the user rotates their dispensing thumb / finger then this causes a rotation of second portion 102 relative to earth or ground. The second sensor arrangement 107 is or comprises an inertial measurement unit with at least one accelerometer, gyroscope and / or magnetometer. In order to be sufficiently small to fit inside the module 100 the second sensor arrangement 107 may incorporate MEMS technology. An example of such a sensor chip is a Bosch BMI270 however this disclosure is not limited to a specific sensor chip.

[0103] With reference to Figures 3 and 4, the inertial measurement unit of the second sensor arrangement 107 may be mounted directly on the PCBA 108 not on the longitudinal axis X which is the centre axis of rotation of the module 100. Regardless of this off-centre mounting the rotation of the second sensor arrangement 107 is equal to the rotation of the PCBA 108. Therefore, in this example the second sensor arrangement 107 may measure rotation, rotational velocity and / or rotational acceleration directly. From these measurements the estimated user induced rotation can be measured or calculated.

[0104] With reference to Figure 5, the inertial measurement unit of the second sensor arrangement 107 may be mounted directly on the PCBA 108 on the centre axis of rotation, i.e. on longitudinal axis X. In this example the second sensor arrangement 107 may measure rotation, rotational

[0105] September 22, 2025 S 100 P 554 WO velocity and / or rotational acceleration. From these measurements the estimated user induced rotation can be measured or calculated.

[0106] Further, with reference to Figure 6, the inertial measurement unit of the second sensor arrangement 107 may be mounted anywhere on the PCBA 108 except directly on the axis of rotation i.e. on longitudinal axis X. In this example the second sensor arrangement 107 may read linear displacements, speeds and / or accelerations in one, two or three axes. With knowledge of the relative mounting position of the second sensor arrangement 107 and the axis of rotation X as well as the alignment vectors of the linear measurement directions it is then possible to calculate the rotation angle of the PCBA relative to central axis of the module 100.

[0107] Still further, with reference to Figure 7, the inertial measurement unit of the second sensor arrangement 107 may be mounted anywhere on the PCBA 108 except directly on the axis of rotation X and it may have its detection axes aligned to a cylindrical coordinate system based on the longitudinal axis X of the module, i.e. the rotation axis. In this example it can be seen that one detection axis is aligned with the radial direction and one axis with the tangential direction. In this way it may simplify the calculations required to derive the rotation angle of the module 100 from the linear displacements, speeds and / or accelerations.

[0108] The processor (PCBA 108) is configured to receive the signals from the first sensor arrangement 106 and from the second sensor arrangement 107 and to subtract or add the rotation detected by the first sensor arrangement 106 from the rotation detected by the second sensor arrangement 107 in order to adjust or correct the measured dose value according to an estimate of the inadvertent user induced rotation which then allows calculating the rotation of the pen dial grip 12 relative to the pen housing 10 which is proportional to the dose size and hence can be used to accurately calculate the size of the dose dispensed.

[0109] It will be understood from the above example that this working principle of detecting two different relative rotations by two sensors in order to determine the size of the dose dispensed is not limited to the example of an optical sensor and an inertial measurement unit. Rather, any type of sensor suitable to detect relative rotation could be used for the first sensor arrangement. In addition, it will be understood that the first sensor arrangement 106 could be fixed in the first portion 101 and the encoder surface 110 could be provided on the second portion 102 or its chassis 103. Still further, the light source of the first sensor arrangement 106 could be located on one of the first portion 101 and the second portion 102 while the optical sensor is located on the other of the first portion 101 and the second portion 102. In this case,

[0110] September 22, 2025 S 100 P 554 WO the encoder surface 110 may be a ring of teeth arranged between the light source and the optical sensor such that light is either blocked by a tooth or can pass through the free space between two teeth. The module 100, more specifically the processor (PCBA 108) may further be configured to be in a sleeping mode with low power consumption and to be activated into a detecting mode with higher power consumption by means of the switch, e.g. a microswitch operable by a plunger with the tip 105. This, the module 100 is configured to be operated by axial movement of the second portion 102 relative to the housing 10 or relative to the dose button 11 of the drug delivery device 1 , when the electronic add-on module 100 is attached to the drug delivery device 1. This operation of the microswitch wakes up electronic components of the electronic add-on module 100.

[0111] In addition to the sensor arrangements 106, 107, the processor (PCBA 108) may further comprise 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. Still further, a communication unit for communicating with another device may be provided in the module 100, e.g. as part of the PCBA 108.

[0112] September 22, 2025 S 100 P 554 WO Reference Numerals

[0113] I drug delivery device

[0114] 10 housing

[0115] I I dose button

[0116] 11a proximal surface of dose button 11

[0117] 12 dose dial grip

[0118] 13 display window

[0119] 14 container

[0120] 15 needle

[0121] 16 inner needle cap

[0122] 17 outer needle cap

[0123] 18 cap

[0124] 100 electronic add-on module

[0125] 101 first portion

[0126] 102 second portion

[0127] 103 chassis

[0128] 104 battery

[0129] 105 tip

[0130] 106 first sensor arrangement (optical sensor)

[0131] 107 second sensor arrangement (inertial measurement unit)

[0132] 108 PCBA (printed circuit board assembly I processor)

[0133] 109 light pipe

[0134] 110 encoder portion

[0135] D distal end

[0136] P proximal end

[0137] X first longitudinal axis (of the first portion)

[0138] Y longitudinal axis (of the drug delivery device)

[0139] September 22, 2025 S 100 P 554 WO

Claims

Claims1. An electronic add-on module (100) configured for attachment to a drug delivery device (1), which drug delivery device comprises a housing (10) and a dose setting and dispensing unit with a dose button (11) at least axially moveable with respect to the housing (10) for causing dose dispensing and a dose dial grip (12) at least rotationally moveable with respect to the housing (10) during dose dispensing with a rotation angle related to the amount of dose dispensed, wherein the electronic add-on module comprises: a first portion (101) defining an auxiliary dose dial grip and configured to be attached to the dose dial grip (12) of the drug delivery device, such that the first portion follows the movement of the dose dial grip (12) and vice versa 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 rotational movement about the first longitudinal axis (X) and relative axial movement parallel to the first longitudinal axis (X) with respect to the first portion, wherein the second portion (102) defines an auxiliary dose button configured to apply pressure onto the dose button (11) of the drug delivery device, and a PCBA (108) with a processor connected to a first sensor arrangement (106) configured to detect a relative rotational movement between the first portion (101) and the second portion (102), characterized in that the processor is connected to at least a second sensor arrangement (107), wherein the second sensor arrangement (107) comprises at last one of an accelerometer, a gyroscope and / or a magnetometer arranged in or on the second portion (102) and configured to measure the rotation of the second portion (102) relative to the earth, wherein the processor is configured to determine the amount of dose dispensed based on the relative rotational movement detected by the first sensor arrangement (106) and on the rotation of the second portion (102) relative to the earth detected by the second sensor arrangement (107).

2. The electronic add-on module (100) according to claim 1 , wherein the second sensor arrangement (107) comprises an inertial measurement unit with at least an accelerometer, a gyroscope and / or a magnetometer.

3. The electronic add-on module (100) according to claim 1 or 2, wherein the second sensor arrangement (107) is a micro-electromechanical system having a volume of 1 mm3to 20 mm3and / or a length not exceeding 7.5 mm in any direction.September 22, 2025 S 100 P 554 WO4. The electronic add-on module (100) according to any one of the preceding claims, wherein the processor is configured to determine the amount of dose dispensed based on subtracting or adding the rotational movement relative to earth detected by the second sensor arrangement (107) from the relative rotational movement detected by the first sensor arrangement (106).

5. The electronic add-on module (100) according to any one of the preceding claims, wherein second sensor arrangement (107) is arranged directly on the PCBA (108) on the centre of the first longitudinal axis (X).

6. The electronic add-on module (100) according to any one of the preceding claims, wherein the second sensor arrangement (107) is arranged directly on the PCBA (108) offset from the centre of the first longitudinal axis (X).

7. The electronic add-on module (100) according to claim 6, wherein the second sensor arrangement (107) is configured to read linear displacements, speeds and / or accelerations in at least one axis.

8. The electronic add-on module (100) according to claim 6 or 7, wherein the second sensor arrangement (107) has its detection axes aligned to a cylindrical coordinate system based on the first longitudinal axis (X).

9. The electronic add-on module (100) according to any one of the preceding claims, wherein the first sensor arrangement (106) comprises at least one light source and at least one optical sensor configured to generate a signal based on detection of light reflected or interrupted by an encoded surface (110) of the first portion (101), the second portion (102) or the dose dial grip (12).

10. The electronic add-on module (100) according to claim 9, wherein the first sensor arrangement (106) comprises at least two light sources and at least two optical sensors, each configured to generate a voltage signal based on detection of light reflected from an encoder surface (110) of the first portion (101).

11. The electronic add-on module (100) according to any one of the preceding claims, wherein the first sensor arrangement (106) is part of and / or located on the second portion (102) and that the first portion (101) comprises the encoder surface (110) which comprises a ring ofSeptember 22, 2025 S 100 P 554 WOencoder flag segments distributed about an inwardly facing cylindrical surface of the first portion (101).

12. The electronic add-on module (100) according to any one of the preceding claims, further comprising a microswitch (123) configured to be operated by axial movement of the second portion (102) relative to the housing (10) of the drug delivery device (1), when the electronic add-on module (100) is attached to the drug delivery device (1), and wherein operation of the microswitch wakes up electronic components of the drug delivery device and / or the electronic add-on module.

13. The electronic add-on module (100) according to any one of the preceding claims, further comprising 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.

14. The electronic add-on module (100) according to any one of the preceding claims, further comprising a communication unit for communicating with another device.

15. 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 (14) configured to receive a drug or a cartridge filled with a drug,• a dose setting and dispensing unit comprising a dose dial grip (12) at least rotationally moveable with respect to the housing during dose dispensing, a dose button (11) at least axially moveable with respect to the housing for causing dose dispensing, and a plunger at least axially moveable with respect to the housing during dose dispensing, characterized in that the first portion (101) of the electronic add-on module (100) is adapted to be rotationally constrained to the dose dial grip (12) and that the second portion (102) of the electronic add-on module (100) comprises at least one optical sensor and an inertial measurement unit.September 22, 2025 S 100 P 554 WO

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