Electronic add-on module with transmission component

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, and a second portion (102) coupled to the first portion, allowing relative axial movement with respect to the first portion, wherein the second portion comprises an abutment surface (106) configured to apply pressure onto a proximal end surface (22) of a dose button (11) of said drug delivery device when axially moved along the first longitudinal axis. The abutment surface (106) comprises at least one distally protruding transmission component (108; 109), wherein each transmission component is configured to be inserted in an aperture (21) of the proximal end surface of said dose button in a predefined number of limited rotational positions of the second portion of the electronic add-on module (100).

Description

[0001] Description

[0002] ELECTRONIC ADD-ON MODULE WITH TRANSMISSION COMPONENT

[0003] 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.

[0004] 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.

[0005] 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 2022 / 265937 A1 , US 2020 / 360614 A1 , US 2023 / 028688 A1 and US 2020 / 405970 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.

[0006] 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.

[0007] 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. Further, a switch comprising an elastically deformable switch arm is used to switch and wake the electronic module. The switch arm as well as light-pipes used with the sensor arrangement are designed to pass through apertures in the dose button.

[0008] The apertures, the light pipes and the switch arm are designed in such a way that the electronic module can be freely positioned in relation to the dose button. This has the advantage that a user can position the electronic module on the dose button without additional constraints. However, due to the sensitivity of electronic components, this also leads to undesirable side effects, as the exact positioning of the electronic components is undefined.

[0009] Based on the aforementioned problem, it is therefore an object of the present disclosure to provide an improved electronic add-on module.

[0010] 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.

[0011] The electronic add-on module for releasable attachment to a drug delivery device comprises a first portion and a second portion. The second portion comprises an abutment surface configured to apply pressure onto a proximal end surface of a dose button of a drug delivery device when the second portion and therefore the abutment surface is axially moved along the first longitudinal axis. The abutment surface further comprises at least one distally protruding transmission component. In other words, the abutment surface comprises a transmission component that protrudes from the abutment surface in a distal direction along the first longitudinal axis. Consequently, the electronic add-on module may comprise one, two or more than two transmission components. Each transmission component is configured to be inserted in an aperture of the proximal end surface of the dose button in a predefined number of limited rotational positions of the second portion of the electronic add-on module.

[0012] In this regard, the at least one distally protruding transmission component may be arranged off-centered with respect to the longitudinal axis. However, the at least one distally protruding transmission component may also be arranged centered and may for example comprise a square cross-section so that the transmission component is configured to be inserted only in a predefined number of limited rotational positions. In more general terms, it is sufficient if the at least one transmission component, if arranged centered, is not rotationally symmetrical about all angles, i.e. from 0° to 360°, with respect to the longitudinal axis.

[0013] The predefined number of limited rotational positions may be predefined by the number of apertures of the proximal end surface of the dose button. The predefined number is limited and therefore not infinite. The predefined number may limit the number of attachment positions, i.e. the number of possible attachment positions of the electronic add-on module to the drug delivery device. Further, the predefined number refers to rotational positions of the second portion of the electronic add-on module. The rotation necessary to reach these positions is a rotation of the electronic add-on module about the first longitudinal axis. To be more precise, when the electronic add-on module is attached to the drug delivery device, a second longitudinal axis of the drug delivery device may be in line with the first longitudinal axis of the electronic add-on module so that the rotation necessary to reach these positions before the electronic add-on module is attached to the drug delivery device may be a rotation of the electronic add-on module about the first longitudinal axis relative to the second longitudinal axis. However, also the drug delivery device may be rotated with respect to the electronic add-on module in order to reach the position.

[0014] 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.

[0015] 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.

[0016] The first portion of the electronic add-on module may define an auxiliary dose dial grip. Further, the first portion is configured to be releasably attached to the dose dial grip of the drug delivery device, such that the first portion follows axial and rotational movement, for example helical movement, of the dose dial grip when attached to the drug delivery device. Hence, when the auxiliary dose dial grip is attached to the dose dial grip and is for example rotated during dose setting, the dose dial grip of the drug delivery device is rotated and may be entrained.

[0017] Furthermore, the electronic add-on module or first portion extends from a proximal region to a distal region along the first longitudinal axis. When the electronic add-on module is attached to the 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 the 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.

[0018] The second portion of the electronic add-on module is coupled to the first portion allowing relative axial movement parallel to the first longitudinal axis with respect to the first portion. An axial movement parallel to the first longitudinal axis may comprise a parallel movement along the first longitudinal axis. Further, allowing relative axial movement between the first portion and the second portion does not exclude any other relative movements between said portions. In one aspect, for example, the second portion may be coupled to the first portion allowing helical movement, for example axial movement along the first longitudinal axis and rotational movement about the first longitudinal axis, with respect to the first portion.

[0019] The second portion may be retained in the first portion, for example by clips that engage in a groove. In addition, the second portion may be configured to apply pressure onto the dose button of the drug delivery device when axially moved along the first longitudinal axis. Therefore, the second portion may define an auxiliary dose button configured to abut the dose button of the drug delivery device when attached to the drug delivery device and axially moved. In other words, the auxiliary dose button may not be in abutment with the dose button of the drug delivery device initially but may be moved into abutment when the user applies pressure onto the auxiliary dose button. Hence, when a user applies pressure onto the auxiliary dose button, the pressure is transferred onto the dose button of the drug delivery device. Consequently, the second portion is configured to apply pressure in axial direction onto the dose button of the drug delivery device, when attached.

[0020] The second portion further comprises an abutment surface, wherein the abutment surface is configured to apply pressure onto the dose button. To be more precise, the abutment surface applies pressure onto a proximal end surface of the dose button of the drug delivery device when axially moved along the fist longitudinal axis. Further, the abutment surface comprises at least one distally protruding and proximally transmitting transmission component. "Transmission component" means that the component is transmitting for example radiation from on location to another or movement from one component to another. Further, the transmission component is transmitting proximally. For example, the transmission component may transmit radiation from a reflective surface or movement from a moving surface in a proximal direction. Further, when the second portion is moving distally in order to apply pressure onto the dose button, the transmission component may transmit in an opposite direction, namely proximally.

[0021] Further, the electronic add-on module may comprise an electrical power source, such as a battery, arranged inside the electronic add-on module. In one aspect, the electrical power source may be arranged inside the second portion of the electronic add-on module. The electrical power source may be electrically connected to a circuit board assembly of the electronic add-on module. The circuit board assembly may be arranged inside the second portion of the electronic add-on module and may be supplied with power by the electrical power source. Consequently, the electrical power source may be configured to power electrical components electrically connected to said circuit board assembly. Electronic components may be chips, processors, conductors, wireless modules or the like. The circuit board assembly may comprise a printed circuit board assembly. The circuit board assembly may comprise a substrate equipped with electronic components. The electronic components may be electrically connected to the circuit board assembly and may therefore also be supplied by power of the electrical power source. The electrical component may also be configured to power a sensor arrangement. The sensor arrangement may be connected to the circuit board assembly.

[0022] According to one aspect, the second portion may be at least partially arranged around the first portion. For example, the second portion may also at least partially be arranged inside the first portion. However, the second portion may also be arranged completely in the first portion, for example, when the second portion is moved in its most distal position. The electronic add-on module may also comprise further portions, for example, a third portion coupled to the second portion. The third portion may be free to rotate with respect to the first portion and the second portion about the first longitudinal axis, wherein the second portion may be rotationally constrained to the first portion. Further, the second portion may be retained in the first portion. According to a further additional or alternative aspect, the circuit board assembly may be at least partially arranged perpendicular to the direction of relative axial movement of the first portion and the second portion, i.e. perpendicular to the first longitudinal axis. In one example the entire circuit board assembly may be arranged perpendicular to the first longitudinal axis.

[0023] Unaffected by the arrangement of, for example, the first portion and the second portion, providing said transmission component configured to be inserted in the aperture of the proximal end surface limits and predefines the number of possible attachment positions. Consequently, the position of the electronic components, when the electronic add-on module is attached to the drug delivery device, is no longer undefined. In addition, the configuration of the electronic add-on modules ensures that the electronic add-on module is correctly attached to the drug delivery device before the drug delivery device can be activated and, for example, a transmission by the transmission component takes place. Although transmission is also possible before the attachment of the electronic add-on module to the drug delivery device, for example, a switch arm may be moved proximally before the electronic add-on module is attached to the drug delivery device, the electronic add-on module is then not able to operate the drug delivery device. Therefore, the configuration allows an attachment according to the Poka-Yoke principle.

[0024] In one aspect, the transmission component may be a light-pipe configured to transmit radiation to a sensor arrangement of the electronic add-on module, and / or a switch arm configured to transmit a movement to a microswitch. Depending on the number of transmission components, the electronic add-on module may thus for example comprise one or more light-pipes and / or one or more switch arms. Although the light-pipe may also be configured to transmit radiation distally, for example, from a light source to a reflective surface, the light-pipe is also proximally transmitting. The sensor arrangement may thus be an optical sensor arrangement. The microswitch may be operated by the axial movement of the switch arm. The switch arm may be a rod-shaped element that is hinged on one side to the abutment surface. The distal movement of the switch arm with respect to the abutment surface may thus be limited. When the second portion is moved in the distal direction, the switch arm may be proximally moved with respect to the abutment surface in order to operate the microswitch. The microswitch may actuate the sensor arrangement which may, when activated, use the light-pipe to detect rotational movement of a component of the drug delivery device. However, the light-pipe may also be used for example to transmit light to a corresponding optical sensor arrangement in order to switch on the electronic add-on module. In other words, a change in light may switch on the whole electronic add-on module. The light-pipe may thus be used to transmit light which may then be used by a sensor arrangement for different functions. As the transmission component is inserted into the aperture, the transmission component may not be negatively influenced or may only be influenced less easily, for example surrounding light not meant to be detected by the sensor arrangement is better shielded.

[0025] In one aspect, the abutment surface may comprise at least two transmission components, one of which is the light-pipe and the other of which is the switch arm. In other words, the electronic add-on module may at least comprise two different transmission components, namely for example at least one light-pipe and at least one switch arm. The switch arm may then protrude further distally than the light-pipe when the second portion is in an unloaded state. This specific arrangement of the light pipe and the switch arm, in which, when no pressure is applied to the second portion to move the second portion distally in order to apply pressure onto the dose button, the switch arm protrudes further in the distal direction with respect to the abutment surface, may protect the light-pipe from accidental or unintentional contact with other components. This is due to the fact that the switch arm would probably be contacted before the lightpipe because the switch arm protrudes further distally.

[0026] According to one aspect, the switch arm may be axially moveable parallel to the first longitudinal axis and with respect to the abutment surface. The abutment surface may guide the switch arm during axial movement. For example, the abutment surface may guide the switch arm when the second portion is axially moved in order to apply pressure onto the dose button of the drug delivery device, and wherein the switch arm transmits movement proximally. The abutment surface may comprise an opening in which the switch arm is inserted. Guiding the switch arm allows a controlled movement of the switch arm and thus a controlled proximal transmission. In one aspect, the switch arm may be arranged closer to the first longitudinal axis in a radial direction than the light-pipe. In other words, the light-pipe may be less centered than the switch arm. Although the relative arrangement of the light-pipe and the switch arm may be different, arrangement of the light-pipe less centered allows to detect rotational movement at a position of a greater radius. Rotational movement by the same angle may thus cause a greater movement in this position compared to a position comprising a smaller radius and may thus be easier to detect. In addition, the electronic add-on module is usually loaded centered in order to move the second portion axially. In other words, the user usually tries to apply pressure to the second portion centered. Thus, even in the case of an eccentric load, which may tilt the second portion with respect to the first portion, wherein the eccentric load does not cause any movement of the dose button, arrangement of the switch arm more centered may less likely proximally move the switch arm and may less likely actuate the microswitch.

[0027] In one aspect, the sensor arrangement may be kept at a constant distance to an encoder pattern during dose dispensing. In this regard, the sensor arrangement may be arranged inside the second portion of the electronic add-on module. The light-pipe may guide or transmit radiation to the sensor arrangement. In addition, the light-pipe may be configured to guide or transmit radiation to reflective and non-reflective surfaces providing the encoder pattern. As the abutment surface is configured to apply pressure onto a proximal end surface of the dose button of the drug delivery device, there is no relative movement between the abutment surface of the second portion and the proximal end surface of the dose button. Therefore, an inconstant sensor output, such as a current, due to the change in distance between the sensor arrangement and the encoder pattern may be prevented.

[0028] According to one aspect, the encoder pattern may form part of a dose dial grip of the drug delivery device. Further, the sensor arrangement may be configured to detect relative rotational movement between the second portion and the dose dial grip. Thus, the encoder pattern may rotate with respect to the sensor arrangement, wherein the light-pipe may transmit reflected radiation to the sensor arrangement, and wherein the sensor arrangement determines relative rotational movement based on detected reflections. 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 encoder pattern may be arranged on proximally facing surfaces of the dose dial grip, wherein reflections from these surfaces may be transmitted to the sensor arrangement by the light-pipe. The encoder pattern may be at least partially covered by the dose button. In other words, the encoder pattern may be inside the drug delivery device. The dose dial grip may also perform a helical, i.e. a com- bined axial and rotational movement, for example during dose dispensing. Detection of rotational movement of the dose dial grip may be more accurate than, for example, detection of rotational movement of the dose button. In addition, detection of an encoder pattern which is at least partially covered by the dose button, may be improved as interference light may be at least partially blocked by the dose button.

[0029] In one aspect, the abutment surface additionally may comprise a distally protruding clutch element. The distally protruding clutch element may be configured to engage with a corresponding engagement portion of the dose button of the drug delivery device in the predefined number of limited rotational positions of the second portion of the electronic add-on module. The clutch element may rotationally constrain the abutment surface and therefore the second portion of the electronic add-on module to the dose button. The clutch element may protrude further distally than the at least one transmission component at all times. The clutch element may be axially stationary or fixed with respect to the abutment surface. The clutch element may have a blade-shape. Since the clutch element may be brought into engagement with the engagement portion in the predefined number of limited rotational positions, in which the transmission components may be inserted into the apertures, the clutch element may also favor the alignment of the electronic add-on module with respect to the drug delivery device. The clutch element may be configured to be engaged with the engagement portion in two predefined rotational positions, for example, at 0° (360°) and at 180°. The rotational positions may define rotational positions of the electronic add-on module with respect to the first longitudinal axis. The engagement portion may be shaped so that if the clutch element is not perfectly aligned, it still comes into engagement with the engagement portion. For example, if the clutch element is rotated to 2° and tried to be engaged with the engagement portion of the dose button, the clutch element may still engage with the engagement portion as the engagement portion ensures that the clutch element rotates to the 0° (360°) position and may therefore be aligned. Hence, the engagement portion may, for example, have chamfered positioning surfaces, for example, helical ramps, in order to compensate for a certain degree of misalignment, for example, 5°. Further, the engagement portion may compensate for any degree of misalignment. As such, the engagement portion may always ensure that the clutch element is rotated out of misalignment. For example, the engagement portion may always ensure that the clutch element is rotated in the 0° (360°) or 180° position independent of the rotational position at the beginning of the engagement. In addition, the clutch element may be used as an alignment element so that when the clutch element is engaged in the engagement portion, the transmission components may also be aligned, i.e. the transmission components can be inserted into the apertures. In one aspect, the predefined number of limited rotational positions may be an even number, for example, two. For example, if the electronic add-on module comprises a transmission component, such as a light-pipe, the proximal end surface of the dose button may have two apertures so that the light pipe may be inserted into one of the apertures in two different rotational positions. Consequently, a clutch element may also have two engagement positions corresponding to these positions. An even number of predefined rotational positions may have the advantage of a symmetrical arrangement of apertures, for example. If the predefined number of limited rotational positions is two, attachment of electronic add-on module and dose button at 0° (360°) and at 180° rotation around the first longitudinal axis may be possible. If the predefined number of limited rotational positions is four, attachment of electronic add-on module and dose button at 0° (360°), 90°, 180° and at 270° rotation around the first longitudinal axis may be possible. As mentioned above, the engagement portion may ensure that the electronic add-on module is rotated in these positions, e.g. 0° (360°), 90°, 180° and at 270°, during engagement of the clutch element, independent of the relative rotational position of the electronic add-on module with respect to the drug delivery device.

[0030] According to one aspect, the transmission component may be configured to be inserted in the aperture of the proximal end surface of the dose button when the electronic add-on module is attached to the drug delivery device. Consequently, the transmission component may already pass through the proximal end surface into the drug delivery device before, for example, an axial movement of the second portion of the electronic add-on module relative to the first portion may move the transmission component axially relative to the dose button.

[0031] 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. Furthermore, the drug delivery device comprises a dose setting unit and a dose delivery unit.

[0032] 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 which is 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 and a central shaft that extends distally. Further, the dose button comprises the proximal end surface that serves as a pressure surface and as such is configured and to be pressurized by an abutment surface of the electronic addon module. The proximal end surface comprises at least two apertures. Each aperture is con- figured to receive a proximally transmitting transmission component of the electronic add-on module. The transmission component is distally protruding from the abutment surface of the second portion of the electronic add-on module. The dose delivery unit comprises a plunger at least axially, e.g. helically, moveable with respect to the housing during dose dispensing.

[0033] Further, the electronic add-on module is configured to be releasably attached to the drug delivery device in a predefined number of limited rotational positions of the second portion of the electronic add-on module with respect to the dose button. The predefined number of limited rotational positions is determined by the number of apertures and corresponding transmission components configured to be inserted in said apertures. Therefore, when the dose button comprises two apertures configured to receive a transmission component and the electronic addon module comprises one corresponding transmission component, there may be two possible rotational positions, for example 0° (360°) and 180°. However, when the dose button comprises four apertures and the electronic add-on module comprises two corresponding transmission components, there may be four possible rotational positions in which the electronic add-on module may be attached to the drug delivery device, for example 0° (360°), 90°, 180° and 270°.

[0034] In one aspect, the proximal end surface may comprise at least twice as many apertures as the number of corresponding transmission components configured to be inserted in the apertures. Therefore, attachment of the electronic add-on module and the transmission component at 0° (360°) and 180° may be assured. For example, the dose button may comprise four apertures and the abutment surface may comprise two corresponding transmission components as aforementioned.

[0035] In one aspect, each transmission component may be only slightly smaller than the aperture into which the transmission component is configured to be inserted. In other words, the aperture may not be unnecessarily oversized with respect to the transmission component. Although this may require more precise alignment of the transmission components with the apertures to be inserted, it may reduce the amount of dirt or moisture that may enter into the drug delivery device through the apertures, when the electronic add-on module is attached to the drug delivery device.

[0036] According to one aspect, the apertures of the proximal end surface of the dose button may be configured to guide the transmission components. Although this may not necessarily mean that there is contact between the apertures and the transmission components, this may mean that as soon as the transmission components have been partially inserted into the apertures, rota- tional movement between the second portion and the dose button is limited. The apertures thus may determine and limit a possible axial insertion movement of the transmission components into the apertures and may therefore guide the transmission components accordingly.

[0037] In one aspect, the proximal end surface of the dose button of the drug delivery device may comprise an engagement portion. The abutment surface of the electronic add-on module may comprise a distally protruding clutch element. The distally protruding clutch element may be configured to engage with the corresponding engagement portion of the dose button in order to align the at least one transmission component with a corresponding aperture of the dose button as aforementioned. Further, the engagement portion and the clutch element may be configured to correct for a certain degree of misalignment. In other words, and as described above, if the clutch element is not perfectly aligned with the engagement portion, the clutch element may still come into engagement with the engagement portion and may be aligned as the clutch element may be urged by the engagement portion in the rotational position for alignment. This may facilitate the attachment of the electronic add-on module and drug delivery device and may align the transmission components with the apertures without the risk of damaging them during attachment of the electronic add-on module.

[0038] In one aspect, when the proximal end surface of the dose button is pressurized by the abutment surface of the electronic add-on module, for example to start dose dispensing, the switch arm of the electronic add-on module transmits movement, preferably proximally, to the microswitch. The switch arm transmits movement due to abutment against a drive sleeve of the drug delivery device. In other words, when pressure is applied, for example to the second portion of the electronic add-on module, wherein the second portion is axially moved, contact between the switch arm and the drive sleeve moves the switch arm. In this regard, the drug delivery device is purely axially moved during dose dispensing. Consequently, the switch arm contacts or abuts on a component of the drug delivery device which is not rotating during dose dispensing. Therefore, there may be not relative rotational movement between the drive sleeve and the switch arm during dose dispensing. Thus, there is no friction loss due to the contact between the switch arm and the drive sleeve during dose dispensing. It may therefore be advantageous to contact the drive sleeve, which does not rotate during dose delivery, instead of contacting the dose dial grip of the drug delivery device, for example, which may be rotating.

[0039] 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.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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-(co-carboxy- heptadecanoyl)-des(B30) human insulin and B29-N-(co-carboxyheptadecanoyl) human insulin.

[0048] 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.

[0049] 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.

[0050] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0051] 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, Gon- adorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] 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.

[0056] “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).

[0057] 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).

[0058] 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.

[0059] 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).

[0060] 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.

[0061] 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.

[0062] 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.

[0063] 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).

[0064] 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).

[0065] 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.

[0066] "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.

[0067] 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:

[0068] Figure 1 shows a drug delivery device;

[0069] Figure 2 shows an electronic add-on module;

[0070] Figure 3 shows an exploded view of the electronic add-on module of Figure 2;

[0071] Figure 4 shows a second portion of the electronic add-on module;

[0072] Figure 5 shows a sectional the second portion of Figure 4;

[0073] Figure 6 shows a proximal end of a drug delivery device;

[0074] Figure 7 shows a top view of a drug delivery device;

[0075] Figure 8 shows a top view of a dose dial grip with an encoder pattern;

[0076] Figure 9 shows a sectional view of an assembly of an electronic add-on module and a proximal end of a drug delivery device in a non-activated state; and

[0077] Figure 10 shows a sectional view of the assembly of Figure 9 in an activated state.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] 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.

[0082] 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.

[0083] 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.

[0084] 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.

[0085] 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 and a second portion 102 coupled to the first portion 101 and arranged along a first longitudinal axis X. The electronic add-on module may further comprise a third portion which may be arranged proximally with respect to the second portion 102, and which may be free to rotate relative to the first portion 101 and the second portion 102. The first portion 101 comprises a surface structure 103 providing an auxiliary dose dial grip when the electronic add-on module 100 is attached to the drug delivery device 1. The second portion 102 comprises a proximal end surface 104 onto which a pressure may be applied. The proximal end surface 104 is facing in a proximal direction P and may be operated by a thumb of a user.

[0086] Although not shown, the first portion 101 may comprise coupling elements for releasable attachment to the drug delivery device 1. The first portion 101 may for example comprise clips for releasable attachment to the dose dial grip 12 of the drug delivery device 1. When the electronic add-on module 100 is coupled to the drug delivery device 1 , the first longitudinal axis X and the second longitudinal axis Y may be in line.

[0087] When the electronic add-on module 100 is attached to the drug delivery device 1 , the user may rotate the first portion 101 in order to set a dose for delivery. The first portion 101 may provide the auxiliary dose dial grip, i.e. the surface structure 103, allowing for a controlled rotational movement of the first portion 101. Further, a pressure which may be applied to the proximal end surface 104, for example by the thumb of the user, may axially move the second portion 102 relative to the first portion 101 along the first longitudinal axis X.

[0088] As shown in Figure 3, the second portion 102 may be clutched to the first portion 101 by splines 105, which may disengage with corresponding grooves (not shown) of the second portion 102 when the second portion 102 is axially moved. Axial movement of the second portion 102 with respect to the first portion 101 may further cause an abutment surface 106 of the second portion 102 to apply pressure onto the dose button 11 of the drug delivery device 1.

[0089] The second portion 102, or to be more precise, the abutment surface 106 of the second portion 102 comprises a clutch element 107 distally protruding from the abutment surface 106, i.e. in a distal direction D. Here, the clutch element 107 comprises a blade-shape. A corresponding engagement portion 20 of the dose button 11 is for example shown in Figure 7.

[0090] The abutment surface 106 comprises at least one distally protruding and proximally transmitting transmission component such as a light-pipe 108 as shown in Figure 4 or 5. The lightpipes 108 in Figure 4 are shorter than the clutch element 107. In other words, the light-pipes 108 a smaller distance in the distal direction D from the abutment surface 106 than the cutch element 107. The light-pipes 108 are configured to be inserted in respective apertures 21 of the dose button 11 as shown in in Figures 6 and 7.

[0091] Additionally, the second portion 102 may comprise a further distally protruding and proximally transmitting transmission component, for example a switch arm 109, as shown in Figure 5. The switch arm 109 is hinged to the abutment surface 106. The movement of the switch arm 109 in the distal direction D with respect to the abutment surface 106 is therefore limited. When the switch arm 109 is proximally moved, i.e. in the proximal direction P, the switch arm 109 may actuate a microswitch 110, i.e. the switch arm 109 may transmit a movement proximally.

[0092] In the present example, the switch arm 109 is guided by the abutment surface 106. Therefore, lateral tilting of the switch arm 109 is prevented. When the second portion 102 is distally moved with respect to the first portion 101 in order to apply pressure onto a proximal end surface 22 of the dose button 11 , the switch arm 109 is proximally moved, actuates the microswitch 110 and thereby electronic components 111 such as a sensor arrangement 112 as part of a circuit board assembly. In other words, proximal transmission of movement actuating the microswitch 110 may power the electronic components 111 on a substrate 113 of the circuit board assembly. A corresponding electrical power source as a battery 114 is arranged inside the second portion 102 as shown in Figure 5. However, other switches may also be used with the electronic add-on module 100 in order to acuate the electronic components.

[0093] When the electronic add-on module 100 is attached to a drug delivery device 1 , for example, to the dose dial grip 12 as shown in Figure 6, the first longitudinal axis X and the second longitudinal axis Y are brought into line. The first portion 101 may be coupled to the dose dial grip 12. The clutch element 107 may be aligned by chamfered positioning surfaces 23 of the engagement portion 20 and the transmission components, i.e. the light-pipes 108 and the switch arm 109, may be inserted into the apertures 21 of the proximal end surface 22 of the dose button 11.

[0094] The engagement portion 20 and the six apertures 21 may be better seen in Figure 7. Here the chamfered positioning surfaces 23 are helical ramps. Consequently, although the bladeshaped clutch element 107 may not be perfectly aligned in one of the two possible engagement positions, the helical ramps may urge the clutch element and thereby the electronic add-on module 100 in the correct position. As can be seen in Figure 8, the transmission components are then inserted into the apertures 21.

[0095] When the electronic add-on module 100 is attached to the drug delivery device 1 , the sensor arrangement 112 may be able to detect reflective surfaces 24 of the dose dial grip 12 as shown in Figure 8. Empty spaces are arranged between the reflective surfaces 24 of the dose dial grip 12. Together, the reflective surfaces 24 and the empty spaces may provide an encoder pattern. Thus, radiation may be reflected by the reflective surfaces 24 and may be transmitted by the light-pipe 108 in order to be detected by the sensor arrangement 112 and in order to determine relative rotational movement of the dose dial grip 12 with respect to the second portion 102 of the electronic add-on module 100.

[0096] Looking at the dose button 11 of Figure 7 and attempting to attach the electronic add-on module 100 to the second portion 102 of Figure 5 to the dose button 11 of Figure 7, it can be seen that there are a total of two predefined number of limited rotational positions of the second portion 102 in which attachment of the electronic add-on module 100 to the dose button 11 is possible. Both positions are offset by 180° so that, for example, insertion of the transmission components into the apertures 21 of the proximal end surface 22 of the dose button 11 is possible, for example, at 0° (360°) (light pipes 108 engage in the upper apertures 21 shown at the top of Figure 7) and at 180° (light pipes 108 engage in the lower apertures 21 shown at the bottom of Figure 7). In Figures 9 and 10, attachment of the electronic add-on module 100 to the drug delivery device is shown.

[0097] Both states, i.e. the non-activated state in Figure 9 and the activated state in Figure 10, show transmission components (the light pipe 108 and the switch arm 109) to be inserted into the apertures 21 of the dose button 11. The transmission components are thus passing into the drug delivery device 1 or through the proximal end surface 22 of the dose button 11. The sensor arrangement 112 may thus be able to detect relative rotation of the drive sleeve 13 and the second portion 102 by detection of the encoder pattern of the dose dial grip 12.

[0098] Further, the clutch element 107 is inserted into the engagement portion 20. In Figure 9 the abutment surface 106 abuts against the proximal end surface 22 of the dose button 11. However, the switch arm 109 has not yet actuated the microswitch 110. Hence, in this state the electronic components 111 are not yet activated.

[0099] In Figure 10, the second portion 102 is axially moved in the distal direction D with respect to the first portion 101 and the switch arm 109 is proximally moved with respect to the abutment surface 106. In this regard, the switch arm 109 is moved due to contact with the drive sleeve 13. This may be especially helpful as the drive sleeve 13 is not rotating during dose dispensing. Consequently, there is no friction loss due to the contact between the switch arm 109 and the drive sleeve 13. When the switch arm 109 is moved proximally the microswitch 110 is actuated and pressure is applied to the proximal end surface 22 of the dose button 11 by the abutment surface 106 of the second portion 102.

[0100] In summary, the electronic add-on modules 100 therefore allows for an improved assembly with a drug delivery device 1 as well as an improved detection of relative rotational movements between the second portion 102 and a component of the drug delivery device.

[0101] Reference Numerals

[0102] 1 drug delivery device

[0103] 10 housing

[0104] 11 dose button

[0105] 12 dose dial grip

[0106] 13 drive sleeve

[0107] 14 display window

[0108] 15 container

[0109] 16 needle

[0110] 17 inner needle cap

[0111] 18 outer needle cap

[0112] 19 cap

[0113] 20 engagement portion

[0114] 21 aperture

[0115] 22 proximal end surface (dose button)

[0116] 23 chamfered positioning surfaces

[0117] 24 reflective surface portion

[0118] 100 electronic add-on module

[0119] 101 first portion

[0120] 102 second portion

[0121] 103 surface structure

[0122] 104 proximal end surface (second portion)

[0123] 105 spline

[0124] 106 abutment surface

[0125] 107 clutch element

[0126] 108 light-pipe

[0127] 109 switch arm

[0128] 110 microswitch

[0129] 111 electronic components

[0130] 112 sensor arrangement

[0131] 113 substrate (of the circuit board assembly)

[0132] 114 battery

[0133] D distal direction

[0134] P proximal direction X first longitudinal axis (of the first portion)

[0135] Y second longitudinal axis (of the drug delivery device)

Claims

Claims1. An electronic add-on module (100) for releasable attachment to a drug delivery device (D, the electronic add-on module comprising:• a first portion (101) configured to be releasably attached to a dose dial grip (12) of the drug delivery device, such that the first portion follows axial and rotational movements of the dose dial grip when attached to the drug delivery device, wherein the first portion has a first longitudinal axis (X),• a second portion (102) coupled to the first portion, allowing relative axial movement parallel to the first longitudinal axis (X) with respect to the first portion, wherein the second portion comprises an abutment surface (106) configured to apply pressure onto a proximal end surface (22) of a dose button (11) of said drug delivery device when axially moved along the first longitudinal axis, characterized in that the abutment surface (106) comprises at least one distally protruding transmission component (108; 109), wherein each transmission component is configured to be inserted in an aperture (21) of the proximal end surface of said dose button in a predefined number of limited rotational positions of the second portion of the electronic add-on module.

2. Electronic add-on module (100) according to claim 1 , wherein the transmission component is:• a light-pipe (108) configured to transmit radiation, preferably proximally, to a sensor arrangement (112) of the electronic add-on module, and / or• a switch arm (109) configured to transmit a movement, preferably proximally, to a microswitch (110).

3. Electronic add-on module (100) according to claim 2, wherein the abutment surface (106) comprises at least two transmission components, one of which is the light-pipe (108) and the other of which is the switch arm (109), and wherein the switch arm (109) protrudes further distally than the light-pipe (108) when the second portion (102) is in an unloaded state.

4. Electronic add-on module (100) according to claim 2 or 3,• wherein the switch arm (109) is axially moveable parallel to the first longitudinal axis (X) and with respect to the abutment surface (106), and wherein said abutment surface guides said switch arm during axial movement, and / orwherein the switch arm (109) is arranged closer to the first longitudinal axis (X) in a radial direction than the light-pipe (108).

5. Electronic add-on module (100) according to any one of claims 2 to 4, wherein the sensor arrangement (112) is kept at a constant distance to an encoder pattern during dose dispensing.

6. Electronic add-on module (100) according to any one of claim 5, wherein the encoder pattern forms part of a dose dial grip (12) of the drug delivery device (1), and wherein the sensor arrangement (112) is configured to detect relative rotational movement between the second portion (102) and the dose dial grip (12).

7. Electronic add-on module (100) according to any one of the preceding claims, wherein the abutment surface (106) additionally comprises a distally protruding clutch element (107), and wherein the distally protruding clutch element is configured to engage with a corresponding engagement portion (20) of the dose button (11) of the drug delivery device (1) in said predefined number of limited rotational positions of the second portion of the electronic add-on module.

8. Electronic add-on module (100) according to any one of the preceding claims, wherein the predefined number of limited rotational positions is an even number, for example, two.

9. Electronic add-on module (100) according to any one of the preceding claims, wherein the transmission component is configured to be inserted in the aperture (21) of the proximal end surface (22) of said dose button (11) when the electronic add-on module (100) is attached to the drug delivery device (1).

10. An assembly comprising a drug delivery device (1) and an electronic add-on module (100) according to any one of the preceding claims configured for releasable attachment to the drug delivery device, wherein the drug delivery device comprises:• a housing (10) with a container configured to receive a drug or a cartridge filled with a drug,• a dose setting unit comprising a dose dial grip (12) at least rotationally moveable with respect to the housing during dose setting and a dose button (11) at least axially moveable with respect to the housing for causing dose dispensing, wherein the dose button (11) comprises a proximal end surface (22) configured to be pressurized by an abutment surface (106) of the electronic add-on module (100), wherein the proximal endsurface comprises at least two apertures (21), wherein each aperture is configured to receive a proximally transmitting transmission component of the electronic add-on module distally protruding from the abutment surface, and• a dose delivery unit comprising a plunger at least axially moveable with respect to the housing during dose dispensing, characterized in that the electronic add-on module (100) is configured to be releasably attached to the drug delivery device in a predefined number of limited rotational positions of the second portion of the electronic add-on module with respect to the dose button, and wherein the predefined number of limited rotational positions is determined by the number of apertures and corresponding transmission components (108; 109) configured to be inserted in said apertures.

11. The assembly according to claim 10, wherein the proximal end surface (22) comprises at least twice as many apertures (21) as the number of corresponding transmission components configured to be inserted in said apertures.

12. The assembly according to claim 10 or 11 , wherein each transmission component is only slightly smaller than the aperture (21) into which the transmission component is configured to be inserted.

13. The assembly according to any one of claims 10 to 12, wherein the apertures (21) of the proximal end surface (22) of the dose button (11) are configured to guide the transmission components.

14. The assembly according to any one of claims 10 to 13, wherein the proximal end surface (22) of the dose button (11) of the drug delivery device (1) comprises an engagement portion (20), wherein the abutment surface (106) of the electronic add-on module (100) comprises a distally protruding clutch element (107) wherein the distally protruding clutch element is configured to engage with the corresponding engagement portion of the dose button in order to align the at least one transmission component with a corresponding aperture (21) of the dose button, and wherein the engagement portion and the clutch element are configured to correct for a certain degree of misalignment.

15. The assembly according to any one of claims 10 to 14, wherein, when the proximal end surface (22) of the dose button (11) is pressurized by the abutment surface (106) of the electronic add-on module (100), a switch arm (109) of the electronic add-on module (100) transmits movement, preferably proximally, to a microswitch (110) due to abutment against a drivesleeve (13) of the drug delivery device (1), and wherein the drug delivery device (13) is purely axially moved during dose dispensing.

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