WO2025157886A1

WO2025157886A1 - Electronic add-on module comprising a sensor arrangement

Info

Publication number: WO2025157886A1
Application number: PCT/EP2025/051605
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, 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) extending from a proximal side to a distal side. Further, the module comprises a second portion (102) coupled to the first portion, wherein said second portion is axially moveable relative to said first portion and parallel to the first longitudinal axis (X) but rotationally constrained to the first portion, wherein said 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 relative to said first portion. Still further, the module comprises a third portion (103) coupled to said second portion on a proximal side of the second portion, wherein said third portion is free to rotate relative to said second portion about the first longitudinal axis. A sensor arrangement (112) arranged inside said second portion is electrically connected to a circuit board assembly and powered by a electrical power source, wherein the sensor arrangement is configured to detect rotational movement between the second portion of said electronic add-on module (100) and an encoder pattern (24) of the dose button (11) of said drug delivery device (1).

Description

ELECTRONIC ADD-ON MODULE COMPRISING A SENSOR ARRANGEMENT

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 2021/140352 A1 , WO 2020/217094 A1 , WO 2021/214275 A1 , US 2021/113773 A1 , US 2020/188601 A1 , WO 2023/046791 A1 and EP 2 814 547 B1. 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 2021/214275 A1. The sensor arrangement is used to detect rotation of the number sleeve. WO 2020/217094 A1 discloses an injection monitoring module comprising a magnetic field sensor which allows the determination of a translational position of a reference point along a central longitudinal axis in order to determine an administered amount of injectable substance. Although there are different sensor arrangements for electronic modules known in the art, the sensor arrangements have the disadvantage that they either require a lot of space and/or comprise an inconstant sensor output during a measurement process. For example, the sensor output, such as a current, may be inconstant due to a change in distance between the sensor arrangement and an encoder during the measurement process. Further, the sensor arrangements try to detect movement of components that are usually difficult to access or require complicated modifications to the drug delivery device.

Based on the aforementioned problems, it is therefore an object of the present disclosure to provide an electronic add-on module with an improved sensor arrangement.

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 11.

The electronic add-on module for releasable attachment to a drug delivery device comprises a first portion, a second portion, a third portion, a circuit board assembly, an electrical power source and a sensor arrangement. The sensor arrangement of the electronic add-on module is arranged inside the electronic add-on module, e.g. in one of the portions, and is configured to detect rotational movement between a portion of the electronic add-on module and an encoder pattern of a drug delivery device.

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 dose 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. In this regard, the first portion may comprise respective coupling elements, for example fifth coupling elements configured for releasable attachment to the dose dial grip. 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. A distally facing cavity may be provided in the first portion adapted to receive a portion of a drug delivery device. 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. The second portion is axially moveable relative to the first portion and parallel to the first longitudinal axis but rotationally constrained to the first portion. An axial movement parallel to the first longitudinal axis may comprise a parallel movement along the first longitudinal axis. Thus, relative rotational movement between said second portion and said first portion about the first longitudinal axis is prevented, such that the second portion follows rotational movement of said first portion. In other words, the first portion and the second portion are mutually rotated together. Therefore, when the electronic add-on module is for example releasably attached to the dose dial grip of the drug delivery device, rotation of the dose dial grip also rotates the first portion and the second portion together with the dose dial grip. In addition, axial movement of the dose dial grip, axially moves the first portion and the second portion together due to the coupling between the first portion and the second portion. Even further, when the dose dial grip is helically moved, for example axially moved along the first and/or second longitudinal axis and rotationally moved about the first and/or longitudinal axis, the first portion and the second portion may follow the movement of the dose dial grip together. Therefore, rotating the first portion may rotate the dose dial grip and thus may set a dose.

The second portion may be encased and/or retained in the first portion, for example by clips or splines that engage in grooves. In addition, the second portion is configured to apply pressure onto a dose button of the drug delivery device when axially moved along the first longitudinal axis relative to said first portion. Consequently, axial movement of the second portion relative to the first portion may cause dose dispensing.

The third portion, which is coupled to said second portion on a proximal side of the second portion, i.e. substantially opposite to said first portion, such that the second portion is arranged at least partially between said first portion and said third portion, is free to rotate relative to the second portion about the first longitudinal axis. The third portion may protrude from the first portion and may be partially encased in the first portion. Since the second portion is rotationally constrained to the first portion, the third portion is also free to rotate relative to the first portion. However, applying pressure to the third portion, for example to a proximal end surface of the third portion, may axially move the second portion in a distal direction relative to the first portion. The third portion, which is coupled to the second portion, may axially move together with the second portion. 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 third portion. Hence, when a user applies pressure onto the third portion, the pressure is transferred onto the dose button of the drug delivery device by the second portion. 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 the circuit board assembly of the electronic add-on module. The circuit board assembly, which is arranged inside the electronic add-on module, may be arranged inside the second portion of the electronic add-on module. 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 a sensor arrangement arranged inside the second portion of said electronic add-on module. The sensor arrangement is electrically connected to the circuit board assembly. The sensor arrangement is powered by the electrical power source. The sensor arrangement is configured to detect rotational movement between the second portion, rotationally constrained to the first portion, and an encoder pattern of the dose button of the drug delivery device. The encoder pattern may be arranged on a proximal end surface of the dose button. The encoder pattern may be provided by reflective and non- reflective surfaces, by different coloring of surfaces, by different surface finishes or by a combination of the aforementioned aspects. The sensor arrangement is therefore arranged in a portion, namely the second portion, of the electronic add-on module which is not rotated with respect to the first portion responsible for releasably attachment to the dose dial grip of the electronic add-on module of the drug delivery device. Further, the sensor arrangement is arranged in a portion, namely the second portion, of the electronic add-on module which is applying pressure onto the dose button of the drug delivery device. Therefore, when the first portion is releasably attached to the dose dial grip, the sensor arrangement may only be rotating, when the dose dial grip is rotating.

Further, when the second portion is applying pressure onto the dose button in order to axially move the dose button in the distal direction, the sensor arrangement is moved together with the dose button. Therefore, there is no relative axial movement between the dose button of the drug delivery device and the sensor arrangement when the dose button is moved axially in the distal direction, for example for dose delivery.

The rotational movement detectable by the sensor arrangement between the second portion of the electronic add-on module and the encoder pattern may be rotational movement of the dose button relative to the second portion, wherein the dose button is rotating when pressure is applied by the second portion. However, the relative rotational movement may also be caused by rotation of the first portion releasably attached to the dose dial grip and coupled to the second portion, or by a combination of the aforementioned movements.

The electronic add-on module therefore allows the detection of rotational movement without relative axial movement between the sensor arrangement and the encoder pattern. Consequently, there are no negative effects on the sensor output, for example, due to a change in distance between sensor arrangement and the encoder pattern.

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. Further, the second portion may be retained in the first portion. Similarly, to the aforementioned aspect, the relative arrangement of the third portion in relation to the second portion is also possible in different ways.

According to one aspect, the second portion may comprise an abutment surface configured to apply pressure onto said dose button of said drug delivery device. The abutment portion may comprise a protrusion extending at least partially parallel with respect to the first longitudinal axis. Further, said protrusion may form a first thrust bearing when applying pressure onto said dose button. In other words, it is the protrusion of the abutment surface that may be contacting the dose button when pressure is applied. The abutment surface may therefore allow to contact the dose button with a reduced surface area. Therefore, friction caused by relative rotation of the dose button and the abutment surface may be reduced. In addition, the abutment surface still allows to apply pressure onto the dose button. The dose button may comprise, for example a recess, which is particularly suitable for contact with the protrusion due to its design, i.e. the choice of material and/or shape, etc.

In one aspect, the abutment surface may be at least partially transparent. In other words, the abutment surface may be at least partially permeable to radiant energy. Thus, in contrast to an impermeable abutment surface, the abutment surface at least partially allows transmittance for radiant energy. However, the abutment surface may also be fully transparent. Using an at least partially transparent abutment surface allows to shield or protect the sensor arrangement inside the second portion. Instead of transparent material portions, the abutment surface may comprise holes allowing transmittance of radiant energy through the abutment surface.

According to one aspect, the electronic add-on module may comprise a light-pipe configured to guide radiation from the sensor arrangement towards the encoder pattern of the dose button of the drug delivery device. The light-pipe may be a portion of the abutment surface or directly attached thereto. When the abutment surface, in order to provide a first thrust bearing, comprises a protrusion as mentioned above, areas of the abutment surface surrounding the protrusion may comprise a distance to the encoder pattern, even when the protrusion is in contact with the dose button. The light-pipe may then partially bridge the distance between the abutment surface and the encoder pattern. In this regard, the radiation may exit the light-pipe at an end of the light-pipe opposite to the sensor arrangement and, depending on the rotational position of the encoder pattern with respect to the light-pipe, may reflect the radiation back into the light-pipe which may then guide the reflected radiation to a receiving portion of the sensor arrangement. This arrangement may improve the detection of the encoder pattern by the sensor arrangement.

In one aspect, the sensor arrangement may be an optical sensor arrangement. Thus, the radiation detectable by the sensor arrangement may be light.

According to one aspect, the first portion may comprise a first coupling element, for example a spline, arranged on an inner lateral surface of said first portion. The first coupling element may comprise a lower part further extending from the inner lateral surface than the rest of the spline. The second portion may comprise a second coupling element, for example a groove, arranged on an outer lateral surface of said second portion. The second coupling element may comprise an axial stop. The axial stop may interact with the lower part of the first coupling element in order to limit axial movement. Thus, when the first coupling element and the second coupling element are engaged, relative axial movement between said second portion and said first portion may be limited. The first and second coupling elements may form counterparts which interact in order to allow relative axial movement but at the same time limit axial translation between the first portion and the second portion. In an unloaded state, in which no pressure is applied to a proximal end surface of the third portion, a spring may push apart the first portion and the second portion, so that both portions may have a maximum axial displacement. When the electronic add-on module is loaded, i.e. when pressure is applied to the proximal end surface, the second portion is axially moved relative to the first portion. When the second portion is distally moved in the axial direction relative to the first portion, a switch may be actuated before the second portion starts to apply a pressure onto the dose button of the drug delivery device. Limiting the relative axial movement between the first portion and the second portion may prevent damaging of components of the electronic add-on module and/or the drug delivery device due to excessive axial movement.

In one aspect, the third portion may be coupled to a spigot of the second portion. The spigot may be a kind of pin which forms a second thrust bearing. The third portion may be free to rotate about the spigot. The spigot may run in line with the first longitudinal axis. The spigot may allow releasable attachment of the third portion to the second portion. When a user applies a pressure onto the third portion in order to axially move the second portion, wherein the axial movement may apply pressure onto the dose button, the dose dial grip may start rotating, wherein the first portion and the second portion may rotate together with the dose dial grip. Thus, for example, the rotation of the dose dial grip, the first portion and the second portion may not be blocked by the thumb of the user resting on the third portion, as the third portion is free to rotate about the spigot.

According to one aspect, the second portion may comprise a backup friction surface arranged around said spigot. In other words, the backup friction surface may surround the spigot and may therefore be arranged on a proximal facing surface of the second portion. The third portion may comprise a support structure directed towards the second portion. For example, towards the proximal facing surface of the second portion. Further, the support structure may be configured to contact the backup friction surface when the third portion is loaded off axis with respect to the first longitudinal axis. The support structure may be a projection or any other structure comprising a flat surface configured to contact the backup friction surface when the third portion is loaded off axis. In this regard, off axis means off axis with respect to the first longitudinal axis, i.e. with respect to the axis of rotation of the third portion. In other words, if the third portion is not loaded centered so that the third portion may tilt slightly, the support structure of the third portion may contact the backup friction surface. The support structure may be ring shaped and arranged around a socket for the spigot. Therefore, the support structure and the backup friction surface may be in abutment in case of excessive off axis load. The abutment between the support structure and the backup friction surface may form an interface. The material of the support structure and the backup friction surface, i.e. the interface, may be selected in order to provide low friction, thus not blocking relative rotation between the second portion and the third portion. In one aspect, the support structure may be arranged close to the socket of the third portion. In other words, the support structure and the backup friction surface may be arranged in an area of the respective portion to minimize the unwanted load caused by off-axis loading.

In one aspect, a material pairing for the interface between the support structure and the backup friction surface may comprise one or more of the following materials: polytetrafluoroethylene, polyoxymethylene, silicone lubricated polyoxymethylene, polytetrafluoroethylene lubricated polyoxymethylene, etc. The materials may be applied as a coating or may form the support structure and/or backup friction surface.

In one aspect, the third portion may be configured to be snapped onto the spigot. Additionally or alternatively, the spigot may comprise a greater diameter in an area closer to the second portion than in an area further away from the second portion. The third portion may be clipped over the area comprising a greater diameter. The structure of the spigot may provide sufficient stability and at the same time reduces possible friction of the second thrust bearing. The snap- on also allows the third portion to be replaced or removed during cleaning.

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 dose button comprises the encoder pattern detectable by the sensor arrangement of the electronic add-on module. The encoder pattern may be arranged on the proximal end surface of the dose button. The sensor arrangement is configured to detect relative rotational movement between the sensor arrangement and the encoder pattern of the dose button. Consequently, when the second portion is axially moved, the second portion may apply a pressure onto the dose button so that relative axial movement between the sensor arrangement and the dose button is prevented during dose dispensing, thereby improving the detection of the sensor arrangement.

In one aspect, the first portion of the electronic add-on module may be rotationally constrained to a component, preferably the dose dial grip, of the drug delivery device that is rotating during dose dispensing. Therefore, the first portion and the second portion may rotate together with this component during dose dispensing. The encoder pattern may be arranged on a proximal end surface of the dose button. In addition, rotation of said encoder pattern may be prevented during dose dispensing. In other words, the encoder pattern may not be rotating during dose dispensing, wherein the second portion may be rotating during dose dispensing. The second portion may thus detect the relative rotational movement between the second portion and the encoder pattern.

In one aspect, however, the first portion of the electronic add-on module may be rotationally constrained to a component, preferably the dose dial grip, of the drug delivery device that is not rotating during dose dispensing. The encoder pattern may be arranged on the proximal end surface of the dose button. Rotation of the encoder pattern may be allowed during dose dispensing. In other words, the encoder pattern may be rotating during dose dispensing, wherein the second portion may not be rotating during dose dispensing. The second portion may thus still detect the relative rotational movement between the second portion and the encoder pattern. However, in this aspect, the second portion may be stationary with respect to the housing of the drug delivery device.

According to one aspect, the dose delivery unit may further comprise a drive sleeve rotationally constrained to the housing during dose dispensing. Hence, the drive sleeve may not be rotating with respect to the housing during dose dispensing. The dose button may be rotationally constrained to the drive sleeve. Therefore, when the drive sleeve is not rotating during dose dis- pensing but is axially moved, the dose button may axially move together with the drive sleeve but may also not be rotating. The electronic add-on module may then be able to detect rotational movement of the second portion relative to the dose button, wherein the dose button may not be rotating during dose dispensing.

In one aspect, the dose button may comprise a third coupling element, for example a second spline. Further, the drive sleeve may comprise a fourth coupling element, for example a slot. The third coupling element of the dose button and the fourth coupling element of the drive sleeve may be engaged at least during dose dispensing in order to rotationally constrain the drive sleeve and the dose button. The third and fourth coupling element may also be designed the other way round, wherein the third coupling element may be provided by a slot and the fourth coupling element may be provided by a spline. Any other coupling may be suitable. The coupling between the third and fourth coupling element may allow relative axial movement along the second longitudinal axis and may only prevent relative rotational movement.

In summary, the electronic add-on module as well as the assembly according to the aforementioned aspects allow for an improved detection mechanism to detect relative rotational movement between the electronic add-on module and a component of the drug delivery device.

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 glar- gine); 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- 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, Tres- iba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(w-carboxy- heptadecanoyl)-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, Lixisen- atide (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, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1 , CVX-096, ZYOG-1 , ZYD-1 , GSK-2374697, DA-3091 , MAR-701 , MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651 , ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN and Gluca- gon-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, Chorion- gonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gon- adorelin, 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 anti- gen-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., Sarilu- mab), 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 and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

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 an exploded view of an electronic add-on module according to a first example;

Figure 3 shows an exploded view of a dose button and a drive sleeve of a drug delivery device;

Figure 4 shows a perspective view of a dose button with an encoder pattern;

Figure 5 shows a sectional view of an electronic add-on module according to the first example, which is attached to a drug delivery device, wherein the abutment surface comprises a transparent area;

Figure 6 shows a sectional view according to Figure 5, wherein the abutment surface additionally comprises a light-pipe;

Figure 7 shows a sectional view of an electronic add-on module according to a second example, which is attached to a drug delivery device, in an unloaded state;

Figure 8 shows a sectional view of the electronic add-on module attached to a drug delivery device according to Figure 7 at a switch point;

Figure 9 shows a sectional view of the electronic add-on module attached to a drug delivery device according to Figure 7 and 8 during dose dispensing;

Figure 10 shows a perspective view of a first portion of an electronic add-on module;

Figure 11 shows a top view of the first portion of Figure 10; and

Figure 12 shows a sectional view of the first portion of Figure 10 and 11.

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 , for example shown in more detail in Figures 10 to 12, a second portion 102 and a third portion 103 arranged along a first longitudinal axis X. The second portion 102 comprises a proximal facing surface 104 facing the third portion 103. The third portion 103 comprises a proximal end surface 105 onto which a pressure may be applied, for example, by a user's thumb during dose dispensing.

The first portion 101 further comprises fifth coupling elements 122 for releasable attachment to a drug delivery device. 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.

When the electronic add-on module 100 is attached to a 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 the 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 third portion 103 of the electronic add-on module 100 is coupled by a spigot 106 to the second portion 102. The third portion 103 is free to rotate about said spigot 106.

If the proximal end surface 105 is not loaded centered, i.e., when the user presses eccentrically onto the proximal end surface 105, the third portion 103 may tilt relative to the first longitudinal axis X, so that a support structure 107 of the third portion 103 comes into contact with a backup friction surface 108 on the proximal facing surface 104 of the second portion 102. The material pairing of the support structure 107 and the backup friction surface 108 may be selected in such a way that only low friction occurs between the two components. In other words, the friction of the interface between the support structure 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 as shown in Figures 5 to 9, here a battery 109, may be 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 may be electrically connected to said circuit board assembly. Various electronic components 111 are arranged on the substrate 110. In addition, a sensor arrangement 112, for example an optical sensor arrangement, 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 arranged to apply pressure to a dose button 11 of a 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 , especially with a recess 20 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 11 of the drug delivery device 1. A transparent area 115 of the abutment surface 113 is exemplarily indicated by reference sign 115.

Additionally or alternatively to the transparent area 115, a light-pipe 116 as shown in Figure 6 may be used to guide radiation towards the dose button 11.

The dose button 11 may comprise third coupling elements 21 configured to be engaged with fourth coupling elements 22 of the drive sleeve 13. At least when pressure is applied to a proximal end surface 23 of the dose button 11 as shown in Figure 3, the third and fourth coupling elements 21 and 22 engage in order to rotationally constrain the dose button 11 to the drive sleeve 13.

When the electronic add-on module 100 is attached to the drug delivery device 1 and the second portion 102 is sufficiently axially moved with respect to the first portion 101 , the abutment surface 113 applies pressure onto the dose button 11 , more precisely onto the proximal end surface 23 of the dose button 11. The proximal end surface 23 of the dose button 11 is provided with an encoder pattern 24 as shown in Figure 4. The encoder pattern 24 is detectable by the sensor arrangement 112 in order to detect relative rotational movement between the second portion 102 of the electronic add-on module 100 and the encoder pattern 24 of the dose button 11. The encoder pattern 24 may comprise reflective surface portions 25 and non- reflective surface portions 26 which are arranged in a circumferential ring as shown in Figure 4. However, other arrangements of the encoder pattern 24 may be possible.

When the encoder add-on module 100 is attached to the drug delivery device 1 , the abutment surface 113 may permanently be in contact with the dose button 11 , more precisely with the proximal end surface 23 of the dose button 11 as shown in Figure 5, wherein the proximal end surface 23 comprises the encoder pattern 24 as shown in Figure 4 detectable by the sensor arrangement 112. When a user applies presses onto the proximal end surface 105 of the third portion 103 of the electronic add-on module 100, the second portion 102 is axially moved in the distal direction D with respect to the first portion 101 along the first longitudinal axis X.

The second portion 102 may be coupled to the first portion 101 , wherein the first portion 101 comprises first coupling elements 117 arranged to an inner lateral surface 118, for example shown in Figures 10 to 12, which engage with second coupling elements 119 arranged on an outer lateral surface 120 of the second portion 102 as shown in Figure 2. The first coupling elements 117 may be splines and may comprise a lower part 117A that may slide into splines as second coupling elements 119. The further part of the first coupling elements may create a running surface running on the outer lateral surface 120 of the second portion 102. In Figure 11 , there are shown four first coupling elements 117 comprising the same shape. The second coupling element 119 may comprise an axial stop 119A which may limit the relative axial movement between the second portion 102 and the first portion 101 , when the lower part 117A abuts against the axial stop 119A of the second coupling element 119.

When a pressure is applied onto the proximal end surface 23 of the dose button 11 , which may be splined to the drive sleeve 13, this pressure may release a clutch mechanism of the drug delivery device 1. Releasing the clutch mechanism may cause rotational movement of the dose dial grip 12. Thus, the electronic add-on module 100, more precisely the first portion 101 , rotates together with the dose dial grip 12. The second portion 102, which is rotationally constrained to the first portion 101 , rotates together with the first portion 101. Consequently, the sensor arrangement 112 is rotated relative to the dose button 11 and thus to the encoder pattern 24 of the dose button 11. The protrusion 114 and the recess 20 may provide for a first thrust bearing, allowing relative rotation of the second portion 102 and the dose button 11. The encoder pattern 24 may then be detected and a dispensed dose may be determined. However, the electronic add-on module 100 may also allow to detect and register a set dose by measuring rotational movement during dose setting, i.e. when the first portion 101 is rotated about the first longitudinal axis X in order to rotate the dose dial grip 12 of the drug delivery device 1 .

An (optical) sensor arrangement 112 may be used to detect the encoder pattern 24 of the proximal end surface 23 of the dose button 11. As previously mentioned, the abutment surface 113, which abuts the proximal end surface 23 of the dose button 11 , may comprise a transparent area 115 (see Figure 5) and/or a light-pipe 116 (see Figure 6) to guide radiation to the encoder pattern 24 and from the encoder pattern 24 to a receiver of the sensor arrangement 112.

The electronic add-on module 100 may further comprise a switch 121 as shown in Figures 7 to 9. The switch 121 shown here is a mechanical switch comprising a lever which is deflected due to relative axial movement between the second portion 102 and the first portion 101 of the electronic add-on module 100. The switch 121 may be used to ensure that electronic components 111 of the electronic add-on module 100 are only activated or actuated or only wake-up when they are needed in order to save energy of the electrical power source. For example, the sensor arrangement 112 may only be actuated if sufficient load is exerted on the proximal end surface 105 of the third portion 103 to move the second portion 102 axially relative to the first portion 101 in order to dispense a dose. This axial movement may then deflect the lever of the switch 121 which may then activate the sensor arrangement 112.

Figure 7 may show an unloaded state in which no pressure is applied to the proximal end surface 105 of the third portion 103. Figure 8 may show a switch point, i.e. a state in which the electronic components are actuated. Figure 9 may show the state in which dose dispensing begins. In this state the lever of the switch 121 is deflected the most.

However, other switches allowing similar purposes may be used. For example, switches may be used that actuate components, such as a sensor arrangement, by creating an electrical connection due to the axial relative movement of the first portion 101 and the second portion 102.

Regardless of this and regardless of whether a switch is used to actuate components, it can be recognized that the abutment surface 113 is in contact with the dose button 11 and remains in contact with the dose button 11 during axial movement of the dose button 11 , wherein the contact is caused by pressure applied to the second portion 102. Thus, the distance between the sensor arrangement 112 and the encoder pattern 24, which is arranged on the proximal end surface 23 of the dose button 11 , remains unchanged during dose dispensing. Depending on the configuration of the drug delivery device and/or the electronic add-on module, the distance may also be unchanged during dose setting.

In summary, the electronic add-on modules 100 therefore allows an improved detection of the encoder pattern 24 and thus of the relative rotational movement of a component of the drug delivery device.

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

20 recess

21 third coupling element

22 fourth coupling element

23 proximal end surface (dose button)

24 encoder pattern

25 reflective surface portion

26 non-reflective surface portion

100 electronic add-on module

101 first portion

102 second portion

103 third portion

104 proximal facing surface

105 proximal end surface (third portion)

106 spigot

107 support structure (third portion)

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 transparent area (of the abutment surface) 116 light-pipe

117 first coupling element

117A lower part (of the first coupling element)

118 inner lateral surface (first portion)

119 second coupling element

119A axial stop (second coupling element)

120 outer lateral surface (second portion)

121 switch

122 fifth coupling element

D distal direction

P proximal direction

X first longitudinal axis (of the first portion) second longitudinal axis (of the drug delivery device)

Claims

1. An electronic add-on module (100) for releasable attachment to a drug delivery device (D, the electronic add-on module (100) 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) extending from a proximal side to a distal side,

• a second portion (102) coupled to the first portion, wherein the second portion is rotationally constrained to the first portion,

• a third portion (103) coupled to said second portion on a proximal side of the second portion,

• a circuit board assembly and an electrical power source arranged inside the electronic add-on module, and

• a sensor arrangement (112) arranged inside said second portion, wherein the sensor arrangement is electrically connected to the circuit board assembly and powered by the electrical power source, characterized in that:

• said second portion is axially moveable relative to said first portion and parallel to the first longitudinal axis (X), wherein said 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 relative to said first portion,

• said third portion is free to rotate relative to said second portion about the first longitudinal axis, and

• the sensor arrangement is configured to detect rotational movement between the second portion of said electronic add-on module (100) and an encoder pattern (24) of the dose button (11) of said drug delivery device (1).

2. The electronic add-on module (100) according to claim 1 , wherein the second portion (102) comprises an abutment surface (113) configured to apply pressure onto said dose button (11) of said drug delivery device (1), wherein said abutment surface comprises a protrusion (114) extending at least partially parallel with respect to the first longitudinal axis (X), and wherein said protrusion forms a first thrust bearing when applying pressure onto said dose button.

3. The electronic add-on module (100) according to claim 2, wherein the abutment surface (113) is at least partially transparent.

4. The electronic add-on module (100) according to any one of claims 1 to 3, wherein the electronic add-on module comprises a light-pipe (116) configured to guide radiation from the sensor arrangement (112) towards the encoder pattern (24) of said dose button (11) of said drug delivery device (1).

5. The electronic add-on module (100) according to any one of claims 1 to 4, wherein said sensor arrangement (112) is an optical sensor arrangement.

6. The electronic add-on module (100) according to any one of claims 1 to 5, wherein the first portion (101) comprises a first coupling element (117), for example a first spline, arranged on an inner lateral surface (118) of said first portion, wherein the second portion (102) comprises a second coupling element (119), for example a groove, arranged on an outer lateral surface (120) of said second portion, and wherein when said first coupling element and said second coupling element are engaged, relative axial movement between said second portion and said first portion is limited.

7. The electronic add-on module (100) according to any one of claims 1 to 6, wherein said third portion (103) is coupled to a spigot (106) of said second portion (102), wherein said spigot forms a second thrust bearing, and wherein said third portion is free to rotate about said spigot.

8. The electronic add-on module (100) according to claim 7, wherein the second portion (102) comprises a backup friction surface (108) arranged around said spigot (106), wherein the third portion (103) comprises a support structure (107) directed towards said second portion, and wherein said support structure is configured to contact said backup friction surface when said third portion is loaded off axis with respect to said first longitudinal axis (X), thereby forming an interface.

9. The electronic add-on module (100) according to claim 8, wherein a material pairing for said interface between said support structure (107) and said backup friction surface (108) comprises one or more of the following materials: polytetrafluoroethylene, polyoxymethylene, a lubricated material, for example, silicone lubricated polyoxymethylene or polytetrafluoroethylene lubricated polyoxymethylene.

10. The electronic add-on module (100) according to any one of claims 7 to 9, wherein the third portion (103) is configured to be snapped onto the spigot (106), and/or wherein the spigot comprises a greater diameter in an area closer to the second portion (102) than in an area further away from said second portion.

11. 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 (15) 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 dose button (11) comprises an encoder pattern (24) detectable by the sensor arrangement (112) of said electronic add-on module, wherein said sensor arrangement is configured to detect relative rotational movement between said sensor arrangement and said encoder pattern of said dose button.

12. The assembly according to claim 11 , wherein the first portion (101) of said electronic add-on module (100) is rotationally constrained to a component, preferably the dose dial grip (12), of the drug delivery device (1) that is rotating during dose dispensing, wherein the encoder pattern (24) is arranged on a proximal end surface (23) of said dose button (11), and wherein rotation of said encoder pattern is prevented during dose dispensing.

13. The assembly according to claim 11 , wherein the first portion (101) of said electronic add-on module (100) is rotationally constrained to a component, preferably the dose dial grip (12), of the drug delivery device (1) that is not rotating during dose dispensing, wherein the encoder pattern (24) is arranged on the proximal end surface (23) of said dose button (11), and wherein rotation of said encoder pattern is allowed during dose dispensing.

14. The assembly according to claim 12, wherein the dose delivery unit further comprises a drive sleeve (13) rotationally constrained to the housing (10) during dose dispensing, and wherein the dose button (11) is rotationally constrained to said drive sleeve.

15. The assembly according to claim 14, wherein the dose button (11) comprises a third coupling element (21), for example a second spline, and the drive sleeve (13) comprises a fourth coupling element (22), for example a slot, and wherein the third coupling element and the fourth coupling element are engaged at least during dose dispensing in order to rotationally constrain the drive sleeve and the dose button.