Combination of an electronic device and a triggering device configured for releasable attachment to a drug delivery device and method for detecting a dosing event

Abstract

The present disclosure relates to a triggering device (100) configured for releasable attachment to a drug delivery device (1), for example to a dose button (11) of an injection device. The triggering device comprises a housing (101), a switching unit configured to provide a switching signal when actuated by a user, an emitter unit (104) configured to emit a triggering signal (TS), when the switching signal from the switching unit is received, and a power source (107) configured to power the emitter unit for signal emission. In order to provide a less complex and improved triggering device for a drug delivery device which is particularly easy to use for different drug delivery devices, the triggering signal (TS) emitted by the emitter unit (104) is only indicative of a dosing event, and wherein the triggering signal is receivable by an electronic device (1000).

Description

[0001] Description

[0002] COMBINATION OF AN ELECTRONIC DEVICE AND A TRIGGERING DEVICE CONFIGURED FOR RELEASABLE ATTACHMENT TO A DRUG DELIVERY DEVICE AND METHOD FOR DETECTING A DOSING EVENT

[0003] The present disclosure is generally directed to a triggering device configured for releasable attachment to a drug delivery device and for interaction with an electronic device. The present disclosure is further directed to an assembly of a triggering device and a drug delivery device as well as a method for detecting and logging a dosing event by an electronic device.

[0004] Add-on modules such as electronic add-on modules releasably attachable to drug delivery devices are generally known. For example, electronic modules releasably attachable to pentype drug delivery devices are know and often used to provide further functionalities to drug delivery devices. In this regard, electronic modules are regularly used to count and / or record doses, e.g. a number of drug units which are dialed and / or dispensed. To this end, it is further known to integrate a sensor in the electronic module which senses corresponding relative movements to detect the dialed and / or dispensed dose units. In order to process and log the sensor data, it is also known to transmit corresponding sensor data to a processor unit, a storage unit and / or to use means for transmitting sensor data to a mobile device, such as a smartphone.

[0005] An exemplary data collection device for attachment to an injection device is shown in WO 2016 / 198516 A1. Further injection monitoring modules are for example known from EP 3 304 372 B1 , WO 2020 / 217094 A1 , WO 2021 / 140352 A1 and WO 2021 / 214 275 A1.

[0006] Further, WO 2023 / 213756 A1 discloses an add-on module for an injection device with a touch sensor. A control signal is emitted to an external device if the sensor detects a contact with a body part of a user. The external device is configured to prompt the user by a user interface of the external electronic device to operate the injection device.

[0007] In addition, EP 3871 713 A1 discloses a module for fixed or releasable attachment to a medical device comprising a switch configured to detect an actuation action of the medical device and an electric unit connected to said switch and configured to store and / or provide information related to the detected actuation action. However, the electronic modules known in the art are often complex in their design and sometimes require considerable adaptations of the drug delivery devices. For example, movements or noises during a dose delivery, which are normally used to record amounts of dose, are very different between drug delivery devices, so that electronic modules often have to be adapted for a specific drug delivery device. In addition, the known electronic modules are often comparatively heavy and expensive due to the large number of components and functions that are combined and provided by the respective electronic modules. Conversely, not all users derive significant added value from the provided functions.

[0008] In addition, power consumption of the electronic modules is significantly higher due to dose recording and increased data volumes that have to be transmitted. Furthermore, fully automatic dose recording may give users a false sense of security, as incorrect data transmissions are sometimes only recognized too late to correct them, e.g. because the user no longer remembers the amount of dose delivered.

[0009] Based on the aforementioned disadvantages, it is an object of the present disclosure to provide a less complex and improved triggering device for a drug delivery device which is particularly easy to use for different drug delivery devices.

[0010] This object is essentially solved by a triggering device, by a combination of an electronic device and a triggering device according to claim 1 , an assembly according to claim 9 as well as a method according to claim 13.

[0011] An independent aspect of the present disclosure is directed to the triggering device itself as described in the following. A further aspect of the present disclosure is directed to the combination of such a triggering device with an electronic device. The triggering device is configured for releasable attachment to a drug delivery device. For example, the triggering device may be configured for releasably attachment to a dose button of the drug delivery device. The triggering device may for example be configured to be snapped on the drug delivery device.

[0012] The drug delivery may for example be an injection device such as a pen-type injection device configured to inject a dose. However, the drug delivery device may also be an inhalation device, for example a nebulizer, a dry powder inhaler or a pressurized metered-dose inhaler. In other words, the triggering device may also be configured for releasably attachment to a dose button of an inhalation device. The triggering device comprises at least a housing, a switching unit, an emitter unit and a power source. The triggering device may further comprise a circuit board assembly, for example a printed circuit board assembly, providing an electrical circuitry, for example an electric switching circuitry. The emitter unit and the switching unit may both be electrically connected to the circuit board assembly. The printed circuit board assembly or the electrical circuitry may further comprise electronic components such as chips, conductors, a processor unit, a clock unit or the like. Further, the switching unit is configured to provide a switching signal when actuated by a user. In this regard, the user may actuate the switching unit by touching and / or pressing or loading the triggering device, for example by using a thumb or skin of the user. The switching signal may be an electric current which may run in an electric circuitry and may as such be received by the emitter unit.

[0013] In this regard, the emitter unit is configured to emit a triggering signal. The emitter unit may for example be a wireless emitter unit and as such configured to wirelessly emit a triggering signal, e.g. via Bluetooth, NFC or Wi-Fi. The emitter unit may thus comprise a wireless module configure to emit a triggering signal. The emitter unit is configured to emit the triggering signal, when the switching signal from the switching unit is received. In this regard, the emitter unit may be configured to only emit a triggering signal when the emitter unit is actuated, i.e. , when the switching signal is received. Thus, the emitter unit may only emit a triggering signal, when the switching unit is actuated, and the switching signal is received.

[0014] The triggering device further comprises the power source, which may for example be a battery configured to power electronic components of the triggering device. As such the power source may be electrically connected to a circuit board assembly. The power source is further configured to power the emitter unit for signal emission. In other words, a power required to emit a triggering signal is provided by the power source. The switching unit, the emitter unit and the power source may all be arranged in the housing of the triggering device. The housing may be a separate housing component or for example at least partially be provided by a snapdome.

[0015] Further, the triggering signal emitted by the emitter unit is only indicative of a dosing event. In other words, the triggering signal may only include information of a dosing event. A dosing event may be a dose delivery or an intended dose delivery. For example, when a user delivers a dose, the corresponding dose event may be a "dose delivery event", wherein when the user intends to deliver a dose, the corresponding event may be an "intended dose delivery event". In other words, the triggering signal emitted by the emitter unit may thus be only indicative of a dose delivery or an intended dose delivery. Therefore, the emitted triggering signal may allow to obtain information that a dose has been delivered or is going to be delivered. However, the triggering signal does not comprise any information about the amount of dose delivered or to be delivered, the type of drug injected, or other information related to the drug. Still, the triggering signal may further comprise information related to the dosing event unrelated to the type of drug or the amount of dose delivered such as for example a date and a time. Further, the triggering signal is receivable by an electronic device.

[0016] The electronic device may be a mobile device such as a smartphone, a tablet, a notebook, a hand-held medical device or the like. The electronic device may be a device which is provided separate to the drug delivery device and the triggering device. The triggering device, the drug delivery device and the electronic device may all function without any of the other. For example, the triggering device may also emit a triggering signal when the emitter unit receives a switching signal, and the triggering device is not attached to the drug delivery device. The drug delivery device may allow for dose setting and / or delivery although the triggering device is not attached to the drug delivery device. The electronic device, for example a smartphone, may be used for calling or sending text messages although the triggering signal is not received. All three devices may thus be separate devices, especially separately functional devices.

[0017] In the combination of the, e.g. mobile, electronic device and the triggering device, the triggering signal is receivable by the electronic device and the electronic device is configured to start a data input process in the electronic device upon receipt of the triggering signal from the emitter unit. A user may be requested to input dose data during the data input process. In other words, when the triggering signal is received by the electronic device, the triggering signal may trigger opening a widget, a pop-up window, an app, a message or the like asking the user to input data. In more general terms, the electric device may request the user to provide a data input when the triggering signal is received. In this regard, the user may for example be asked or requested to input a type of drug, an amount of dose dispensed and / or to confirm that the dosing event was successful, and the intended dose delivery may for example have been actually performed successfully.

[0018] The electronic device may already comprise preset information, for example preset by the user, and may for example already show a type of drug or an amount of drug, when the user is requested to provide further data input. For example, the electronic device may show a standard dose value. In this regard, the user may only need to confirm the displayed information, for example the dose value, or amend the standard information if they are wrong. Still the triggering signal provided by the triggering device does not comprise any information other than that a dose has been delivered or is going to be delivered. The triggering device may thus only inform the electronic device about the dosing event.

[0019] The triggering device may therefore assist the user to record dosing events in a logbook. The triggering device may therefore help to ensure that the user does not forget to log a dosing event in the electronic device. For example, the electronic device may notify the user if there are still unfilled dosing events in the electronic device. For example, the user may administer a dose in the evening, but not enter the dose amount into the electronic device due to time constraints. However, since the electronic device has been informed of the dosing event by the triggering device, the electronic device may also remind the user to administer the dose at a later point in time, so that the user may also add the additional information at a later point in time. To accomplish this, the triggering device essentially only requires a switching unit, an emission unit and a power source. Consequently, the triggering device offers the user an improved triggering device with simple handling and low complexity. In addition, the power source is only slightly loaded due to the low energy requirements for emitting a triggering signal.

[0020] In one aspect, the switching unit may comprise a sensor arrangement and / or an electric switching circuitry. The sensor arrangement may be configured to provide a sensor-based switching signal and may therefore be configured to detect relative movements or sounds. However, the sensor arrangement may not be configured to detect an amount of dose which is set or delivered by the user. The sensor arrangement may for example comprise an acoustic sensor or a microswitch. The acoustic sensor may for example be configured to detect a clicking sound provided during dose setting or dose delivery. The sensor arrangement may for example be configured to detect relative movement between a cap, attached to a drug delivery device, and the drug delivery device. The sensor arrangement may detect detachment of a cap of the drug delivery device. The sensor arrangement may be configured to provide a switching signal, i.e. a sensor signal, to the emitter unit. The emitter unit may then use the switching signal indicative of a dosing event to emit a triggering signal. However, the switching signal may also be provided by influencing of the electric switching circuitry. In this regard, influencing the electric switching circuitry may comprise changing electrically measurable variables in the electric switching circuitry such as for example voltage or ampere. In this respect, the electric switching circuitry may be closed, opened, partially closed, partially opened or simply changed. In one aspect, influencing the electric switching circuitry may thus lead to a current running in the electric switching circuitry or may change the current running in the electric switching circuitry. The emitter unit may form part of the electric switching circuitry or may be electrically connected thereto. The switching signal may thus be an influenced electric current received at the emitter unit, thereby triggering emission of the triggering signal. In summary, the switching signal may thus be provided by detection of a dosing event by the sensor arrangement and / or influencing of the electric switching circuitry. Depending on the drug delivery device the switching unit is used with, the use of a sensor arrangement or influencing the electric switching circuitry may be advantageous. Providing a switching signal through a sensor arrangement and / or an electric switching circuitry allows a triggering device to be provided that has only a low level of complexity.

[0021] In one aspect, the switching unit may comprise two electrical contacts and / or a sensitive switch, for example a snap-action switch, and / or a microswitch arranged with respect to an actuation surface of the triggering device. Electrical contacts may for example form part of the electric switching circuitry, wherein a current in the electric switching circuitry may for example change when the electrical contacts are electrically connected, e.g. when the electrical contacts contact each other or when the electrical contacts are being touched. The switching unit may, however, comprise a sensitive switch which, for example, is transferred to an activated state when a load is applied and automatically returns to a deactivated state when the load is released. The snap-action switch may comprise a snap-dome, for example a tactile snap-dome or a metal dome integrated in a membrane switch. As such snap-domes may for example be used in membrane switches, to facilitate closing the electric circuitry. In other words, the snap-action switch may allow the user of the triggering device to initiate a specific electrical function, i.e. to emit a triggering signal when actuated. The snap-action switch may be made of spring steel. Alternatively or additionally, the switching unit may comprise a microswitch that can be moved into two distinct positions, wherein the microswitch is deactivated in a first position and activated in a second position. In contrast to a sensitive switch, the microswitch may remain in its positions until it is actuated again, so that a continuous triggering signal is emitted in an activated state. It may therefore be easier to ensure that this continuous triggering signal is received by the electronic device. In addition, the microswitch may have a lower triggering force than the sensitive switch. In other words, less load may be needed to actuate the microswitch. The actuation surface of the triggering device is a surface typically used to actuate the drug delivery device, when the triggering device is releasably attached to the drug delivery device. Therefore, the user may apply load to the actuation surface of the triggering device in order to dispense a dose by means of the drug delivery device. The electric switching circuitry may thus be configured to be influenced when actuation surface is touched and / or loaded by a user. Although touching the electrical contacts does not necessarily result in the release of a dose, the electrical contacts may be closed by the user's thumb or skin, for example. In other words, simply touching the electrical contacts may cause a change in the current flowing in the electric switching circuitry, which may trigger a corresponding triggering signal. However, the electrical contacts may also be arranged so that the electrical contacts are contacting each other if a load is applied. The switching unit may thus be configured to provide a switching signal when being touched and / or loaded. The user of the triggering device therefore does not have to get used to new actuation patterns but may actuate the drug delivery device with releasably attached triggering device as accustomed, for example by pressing the dose button via the triggering device. The complexity of the triggering device is also kept to a minimum.

[0022] According to one aspect, the switching unit may be configured to influence the electric switching circuitry by partial relative movement of the switching unit relative to the housing of the triggering device. In this regard, simply touching, for example touching the actuation surface, may not be sufficient to influence the electric switching circuitry but a load may need to be applied to the switching unit and more precisely to the actuation surface. This also includes application of a load to the actuation surface by loading an operating element as described below. The switching unit may axially move with respect to the housing of the triggering device. For example, relative movement of the switching unit may influence, for example close, the electric switching circuitry. In one aspect, electrical contacts may be brought into contact by relative movement of the switching unit. Actuation of the triggering device only in the event of relative movement allows to detect not only intended dose delivery, i.e. dosing events in relation to an intended dose delivery, but in particular those events that are more likely to result in a dose delivery, since a load has been applied to the actuation surface. Although a load applied to the actuation surface may not have led to a dose delivery, unintentional actuation of the switching unit by simple contacting or touching may be minimized.

[0023] Further, in one aspect the triggering device may comprise a snap-dome. The snap-dome may for example be made of silicone. In this regard, the actuation surface of the triggering device may be provided by a surface of the snap-dome. The snap-dome may be further configured to be transferred from a relaxed state into a collapsed state by load applied to the actuation surface. The load may for example be applied by the user's thumb. In this regard, the snapdome may be elastically deformable and configured to be returned in the relaxed state when no load is applied to the actuation surface of the triggering device. In other words, the snapdome may only be transferred or brought into the collapsed state, when a load is applied to the actuation surface. In one aspect, the switching signal required for emission of the triggering signal may only be provided in the collapsed state. In addition, a first one of the electrical contacts may be arranged on an opposite side of the actuation surface of the snap-dome and may be configured to be contacted with a second electrical contact when the snap-dome is in the collapsed state. The electrical contacts may thus be spaced apart when the snap-dome is in the relaxed state. Consequently, the electrical contacts may only be brought into contact when load is applied to the snap-dome. Additionally or alternative, the switching unit may be arranged on the actuation surface of the snap-dome. The switching unit may for example be arranged on top of the actuation surface of the snap-dome. For example, a microswitch or a sensitive switch may be arranged on the actuation surface. A different load may be required to transfer the snap-dome into the collapsed state than for actuation of the switching unit. For example, when the load required to bring the snap-dome in the collapsed state is lower than for example the load required to actuate the microswitch, the snap-dome may first be collapsed before the microswitch is actuated. In one aspect, the switching unit may thus be actuated only when the snap-dome is in the collapsed state. Consequently, small relative movements and loads may not unintentionally actuate the switching unit and may therefore not cause emission of a triggering signal.

[0024] Furthermore, a first load of about 2 N, preferably of between 1 N and 2 N, may be required to transfer the snap-dome from the relaxed state into the collapsed state. The first load may be selected upon the user or the setting in which the triggering device is used. For instance, if the product is used with gloves, for example in a hospital, the first load may be selected so that the user has stronger tactile feedback. However, if the product is used by elderly people, it may also be advantageous if less force is required for the transfer, i.e. for bringing the snapdome in the collapsed state. The first load may thus be a snap-dome actuating force. In one aspect, the first load may be less than an unlocking force of the drug delivery device. In other words, the first load may be less than a minimum force required to depress the dose button of the drug delivery device. The force required for dose delivery may be a third load. In one aspect, a load required to actuate a switching unit arranged on the actuation surface of the snap-dome may be greater than the first load, for example equal to a minimum force required to depress the dose button. The switching unit may then only be actuated, when the dose button is actually depressed, i.e. when a dose is actually dispensed. This may allow a triggering signal to be sent only when a dose has actually been delivered. The user may therefore more easily assign an actual relevance to a notification by the electronic device as the notification is not only related to an intended dose delivery.

[0025] In one aspect, the actuation surface may be configured to travel about 1 mm between the relaxed state and the collapsed state. The term "travel" may be understood as the distance the snap dome travels from a beginning of the actuation to an end of actuation causing a switching unit to provide a switching signal, for example by closing the electric circuitry. In one aspect, the travel may blend with a distance a dose button may travel in order to dispense a dose. Choosing a small travel may allow to not substantially increase the length of the drug delivery device, when the triggering device is releasably attached. In addition, due to the small travel, the user may hardly notice the actuation of the triggering device. There may thus be no tactile disruption when actuating the triggering device, thereby actuating the drug delivery device. This fact may be supported by small differences in force between, for example, the first load and the third load.

[0026] Further, the microswitch may comprise an elastically deformable operating element configured to be depressed in order to actuate the microswitch. The operating element may be made of rubber and may protect the microswitch against the ingress of dust and / or moisture. A second load required to depress the operating element may be about 2 N, preferably of between 1 N and 2 N, most preferably more than or equal to a first load required to collapse the snap-dome. However, since the microswitch does not necessarily have to be positioned on the actuation surface of the snap dome, a ratio between the first load and the second load is not mandatory. In one aspect, the second load may be less than an unlocking force of the drug delivery device. In other words, the second load may be less than a minimum force required to depress the dose button of the drug delivery device. However, the difference between the second load and a minimum force required to depress the dose button may be low. The microswitch may thus be more likely to be actuated, when the dose button is actually depressed, i.e. when a dose is actually dispensed.

[0027] According to a further aspect of the disclosure, the object may also be solved by an assembly comprising a drug delivery device and a triggering device according to the aforementioned aspects. The triggering device may be releasably attached to the drug delivery device. In other words, the assembly may comprise the triggering device releasably attached to the drug delivery device. The triggering device may be releasably attached to the dose button. Further, when a load may be applied to a switching unit of the triggering device, the load may be transferred onto the dose button of the drug delivery device. For example, when a load may be applied onto an actuation surface of the triggering device, the load may be transferred onto the dose button. If the actuation surface forms part of a snap-dome, the load may first cause the snap-dome to collapse before the load is fully transferred onto the dose button. Further, the drug delivery device may comprise a dose delivery unit configured to deliver a dose upon actuation of the dose button. In other words, a dose delivery unit of the drug delivery device may be actuated via the dose button, and wherein actuation of the dose button and thus actuation of the dose delivery unit may cause dose dispensing. However, as mentioned before, typically a minimum force, for example a third load, is required to depress the dose button, thereby causing the drug delivery device to dispense a dose. This minimum force may thus also be used to actuate the dose delivery unit. Thus, when the load applied to the switching unit of the triggering device exceeds a threshold, the dose button may be configured to be actuated. In other words, application of a load to the switching unit of the triggering device may thus cause the drug delivery device to dispense a dose, at least if the load is sufficiently high. In this regard, actuation of the dose button may comprise, for example, distal movement of the dose button together with a drive sleeve, release of a clutch, activation of an electronic system etc. Using an assembly according to the aforementioned aspects may thus allow the triggering device to actually be used during dose delivery. At the same time, the releasably attachable triggering device may allow more easily, for example, to charge or replace a power source of the triggering device.

[0028] In one aspect the triggering device may be configured to emit a triggering signal before a dose delivery is started. In this regard, a first load or a second load required to actuate the switching unit may be less than or equal to a third load required to allow the drug delivery device to deliver a dose. Actuation of the switching unit may require transferring the snap-dome from the relaxed state into the collapsed state, for example, in order to deliver a dose. If the first load or the second load is less than the third load, the switching unit may be actuated before dose dispensing. In other words, the switching unit may first be actuated before a dose is dispensed by the drug delivery device. Alternatively, the triggering device may be configured to emit a triggering signal at the end of a dose delivery. In this regard, a first load or second load required to actuate the switching unit may be greater than a third load required to allow the drug delivery device to deliver a dose. If the first load or the second load is greater than the third load, a dose may first be dispensed and at the end of a dose dispensing, when for example the dose button may not be depressed any further, the triggering device may be actuated. In other words, the switching unit may be actuated at the end of dose dispensing. Consequently, the corresponding triggering device configurations may be used to either emit a triggering signal at the beginning, e.g., before an intended dose delivery, or at the end of a dose delivery. The advantage of emitting a triggering signal before dose delivery is that the triggering device is always operated before a dose is delivered. This means that false triggering of the triggering device may only occur if no dose has been delivered even though the triggering device has been actuated and a triggering signal has been sent. However, the user would normally notice this false triggering. The advantage of emitting a triggering signal at the end of dose delivery is that the triggering signal may also indicate successful dose delivery, at least if the triggering device is actuated at the end of dose delivery.

[0029] According to a further aspect of the disclosure, when the triggering device may be releasably attached to the drug delivery device, a direction of the first load or the second load required to actuate the switching unit may at least be partially parallel to a direction of the third load required to allow the drug delivery device to deliver a dose. The switching unit may thus be actuated by applying a load onto the switching unit. According to one aspect, the switching unit may partially be moved relative to the housing of the triggering device. The first load or second load required for this movement, may at least be partially parallel to a direction of the third load. Hence, actuation of the triggering device may also actuate the drug delivery device. In other words, actuation of the triggering device may also cause dose dispensing of the drug delivery device.

[0030] In one aspect, the drug delivery device may be an injection device or an inhalation device. The injection device may for example be a pen-type injection device used to deliver a drug or medicament. The drug delivery device may for example be a pen-type injection device similar to the injection device disclosed in WO 2004 / 078239 A1. However, the drug delivery device may also be an inhalation device. Here, actuation of a dose button may cause mechanical, vibrational, electrical, electromechanical or thermal generation of an aerosol cloud. The user may then inhale the aerosol. Regardless of which drug delivery device is eventually used, a device which is used according to the disclosure requires a dose button that must be pressed to effect dose delivery. Consequently, the triggering device, which may be releasably attached to the dose button, may be used to emit a triggering signal. The information about the dosing event may then prompt the user to make a data entry into an electronic device.

[0031] According to a further aspect of the disclosure, the object may also be solved by a method for detecting and logging a dosing event by an electronic device. An electronic device may for example be a mobile phone, a tablet, a personal computer, a laptop and so on. As such, the electronic device may for example be a smartphone or a hand-held medical device. As aforementioned, the electronic device may thus be a separate device, i.e. separate from the triggering device. Further, the dosing event may correspond to a delivered dose or a dose to be delivered by a drug delivery device of an assembly according to the aforementioned aspect. In this regard, the assembly may comprise a triggering device according to the aforementioned aspect, wherein the triggering device may be releasably attached to the drug delivery device. The method may comprise at least the following steps:

[0032] • Providing a switching signal by a switching unit of the triggering device;

[0033] • Emitting a triggering signal indicative of a dosing event by an emitter unit of the triggering device, when the switching signal from the switching unit is received;

[0034] • Receiving the triggering signal by the electronic device;

[0035] • Assigning the dosing event included in the triggering signal to a pre-configured logbook. Providing a switching signal may be caused by actuation of the switching unit of the triggering device. Consequently, the switching signal may for example be provided by detection of a dosing event by the sensor arrangement and / or by influencing of the electric switching circuitry. The switching signal may cause the emitter unit to emit a triggering signal, for example, wirelessly emit a triggering signal. The triggering signal may comprise information about the dosing event but does not comprise a dose value. The triggering signal may thus be emitted, if the triggering device has been actuated, for example if a microswitch of the triggering device has been actuated. However, the triggering signal may purely indicate that a dose has been delivered, for example, if the triggering device is actuated at the end of a dose delivery, or that a dose is to be delivered without comprising any information about the amount of dose that has been delivered. The triggering signal may then be received by the electronic device. The electronic device may assign the dosing event included in the triggering signal to a preconfigured logbook. The logbook may for example be provided by an app or a program running on the electronic device. The fact that the logbook is pre-configured means that the logbook is not set up when the triggering signal is received, for example the app is not installed when the triggering signal is received but may already be installed in advance. Furthermore, a user account may already have been created. The user account may, for example, comprise information about the user's age, gender and username or similar. The dosing event is therefore assigned to the pre-configured logbook and generates a corresponding entry, for example.

[0036] As aforementioned, in one aspect, the triggering signal may for example comprise additional information such as a date or time. The electronic device may thus notice the number of dosing events and may provide related information, alerts or the like to the user. The electronic device may further ask the user to input further data about the dose delivery. The electronic device may request the user to enter a dose value when the triggering signal is received. The user may then for example enter a delivered dose corresponding to the dosing event in the electronic device. In this regard, the user may open the app and complete the requested additional information. The method may thus allow the user to keep track of dosing events using a simple and uncomplex triggering device. In addition, the triggering device may remind the user to dispense a dose and / or fill out a logbook, thus optimizing the user's drug treatment.

[0037] According to one aspect, a data input process may be started in the electronic device by receiving the triggering signal from the emitter unit. The data input process may thus be automatically started when the triggering signal is received. Further, a user may be requested to input dose data during the data input process. The dose data may thus be assigned to the logbook together with the dosing event. The dosing event may for example only be assigned to the logbook if the user enters the additional data. In this regard, the user may for example be prompted by automatic opening or starting of a widget, an app, a pop-up window or a message on the electronic device when the triggering signal is received. The user may for example be requested to enter a dose value or may be requested to record additionally a type of medicament, if for example not pre-configured, for example, pre-configured in the logbook. By automatically starting the data input process, the user may be assisted in logging dose delivery information. Automatically opening a data input process also helps the user to save valuable time searching for the app, for example, or laboriously clicking through to the logbook in the app or program. For drug delivery devices which do not allow for variable dose setting, it may be sufficient to simply register the dosing event without an additional data input process. Alternatively, simply confirming the dosing event may be useful in this case.

[0038] Further, in one aspect, the dose data input during the data input process is conducted orally, visually and / or manually, for example, by pressing a button of the electronic device. The dose data input may thus for example be conducted orally by voice recording, visually by a photo, video or the like and / or manually by typing keys, pressing buttons or the like. The dose data input may for example be conducted orally, wherein the data input may be corrected manually if required. The user pressing on the triggering device may thus for example automatically start the data input process and may already during dose delivery, for example orally, record the dose the user is injecting. The electronic device may also allow to confirm data orally, visually and / or manually. The triggering device may thus allow to provide for an improved user experience during dose delivery and may assist the user to log dosing events and corresponding information.

[0039] 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.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (anti-diabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition. Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.

[0044] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0045] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N- (w-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

[0046] Examples of GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC- 1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211 , CM-3, GLP-1 Eligen, 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 Glucagon-Xten.

[0047] An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.

[0048] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0049] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Fol litropi n, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin. Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

[0050] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

[0051] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0052] 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.

[0053] Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

[0054] 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.

[0055] 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.

[0056] 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), needle-based 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.

[0057] 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).

[0058] 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).

[0059] 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).

[0060] The terms “axial” or “radial" as used herein may be used with respect to a first longitudinal axis of the triggering device or with respect to a second longitudinal axis of the drug delivery device, a cartridge, a housing or a cartridge holder of the drug delivery device or with respect to an assembly of the drug delivery device and the triggering device. In this regard, the first longitudinal axis and the second longitudinal axis may be in line.

[0061] "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 triggering device 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 triggering device 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 triggering device is considered alone, the term "distal" may be used with regard to the more distal end of the triggering device, 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 triggering device, 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 a drug delivery device and a triggering device are described in more detail by making reference to the drawings, in which:

[0062] Figure 1 shows an exemplary drug delivery device configured to be equipped with a triggering device;

[0063] Figure 2 shows an example of a drug delivery device, a triggering device and an electronic device;

[0064] Figure 3A shows an exemplary triggering device with a snap-dome in a relaxed state;

[0065] Figure 3B shows the triggering device shown in Fig. 3A with the snap-dome in a collapsed state;

[0066] Figure 3C shows an exemplary cross-sectional view of the triggering device shown in Fig. 3A;

[0067] Figure 4 shows a further exemplary triggering device comprising two electrical contacts;

[0068] Figure 5A shows a further exemplary triggering device comprising a snap-dome in a relaxed state and a microswitch arranged on an actuation surface of the snap-dome;

[0069] Figure 5B shows the triggering device shown in Fig. 5A in a collapsed state.

[0070] 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.

[0071] 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 or a pen-type injection device 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.

[0072] 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.

[0073] 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 decoupling a number sleeve from the drive sleeve, wherein irrespective of which component of the drug delivery device 1 performs a rotational movement during dose delivery, the dose dial grip 12 is coupled to a respective component in order to perform a rotational movement during dose delivery. During dose delivery the drive mechanism may thus be regarded as a dose delivery unit.

[0074] 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 an outer needle cap 18.

[0075] In order for a triggering device 100 to be functionally and releasably attached to a drug delivery device 1 , i.e. attached and usable, the triggering device 100 may be attached to the dose button 11 of the drug delivery device 1. Although the drug delivery device 1 is shown here as a pen-type injection device, the drug delivery device 1 could also be an inhalation device with a corresponding dose button. Corresponding examples of triggering devices 100 are shown in the following Figures 2 to 5B.

[0076] A first schematic example of a triggering device 100 not attached to a dose button 11 of a drug delivery device 1 is shown in Figure 2. Further, a triggering signal TS is depicted in Figure 2 and is used to indicate that the triggering device 100 is configured to emit a triggering signal TS. Further, an electronic device 1000 is shown in Figure 2. The electronic device 1000 shown in Figure 2 may for example be a mobile phone, a laptop or the like comprising a display 1001 and buttons 1002.

[0077] The electronic device 1000 may receive the triggering signal TS and may assign a dosing event included in the triggering signal TS to a pre-configured logbook. Further, the electronic device 1000 may show a request, for example a widget, on the display 1001 asking the user for a corresponding data input. In this regard, the user may manually enter a dose value using the buttons 1002 of the electronic device 1000. A user may also use the buttons 1002 to confirm a dosing event. Instead of buttons 1002 or in addition to the buttons 1002 the user may also orally or visually conduct a data input.

[0078] A further exemplary triggering device 100 comprising a housing 101 and a snap-dome 102 is shown in Figure 3A. The triggering device 100 extends along a first longitudinal axis X which may be in line with the second longitudinal axis Y, when the triggering device 100 is releasably attached to the drug delivery device 1. Although not shown, the housing 101 may comprise coupling elements for releasable attachment to the drug delivery device 1. Alternatively, the snap-dome 102 may be snapped onto the dose button 11 of the drug delivery device 1.

[0079] In Figure 3A, the snap-dome 102 is shown in a relaxed state. The snap-dome 102 may be made of silicone. When a user applies a load onto an actuation surface 103 of the triggering device 100, the snap-dome 102 may be transferred or brought into a collapsed state shown in Figure 3B. A switching unit, which may for example be arranged inside the triggering device 100, may be actuated in the collapsed state and a corresponding switching signal may be received by an emitter unit 104 (not shown in Figures 3A and 3B but in Figure 3C). In other words, the proximally arranged actuation surface 103 may be depressed and partially moved in the distal direction D in order to actuate the switching unit. The emitter unit 104 may then emit a triggering signal TS which may be received by the electronic device 1000. An exemplary sectional view of the triggering device 100 of Figure 3A is shown in Figure 3C. In Figure 3C, two electrical contacts 105 are arranged with respect to the actuation surface 103, wherein a first one of the electrical contacts 105 is arranged on an opposite side 106 of the actuation surface 103 of the snap-dome 102. The electrical contact 105 arranged on the opposite side 106 of the actuation surface 103 may contact a second one of the electrical contacts 105, which is arranged distal with respect to the first one of the electrical contacts 105, when the snap-dome 102 is transferred in the collapsed state. In the relaxed state as shown in Figure 3C, the electrical contacts 105 are therefore spaced apart. Consequently, the electrical contacts 105 in Figure 3C are only brought into contact when load is applied to the snap-dome 102, more precisely to the actuation surface 103 of the snap-dome 102.

[0080] When the triggering device 100 is releasably attached to a dose button 11 of a drug delivery device 1 , loading the actuation surface 103, for example by a first load of below 2 N, may transfer the actuation surface 103 from the relaxed state into the fully depressed, collapsed state. In this relaxed state, the electrical contacts 105 may be contacting each other and may therefore influence an electric switching circuitry. The user may then further load the actuation surface 103, wherein, when the load exceeds an unlocking force of the drug delivery device 1 or when the load applied exceeds a third load required to allow the drug delivery device to deliver a dose, which may for example be 2 N, the drug delivery device 1 may dispense a preset dose. In this regard, the first load may be applied along the first longitudinal axis X. If the triggering device 100 is not attached to the drug delivery device 1 , the third load may be applied along the second longitudinal axis Y of the drug delivery device in order to dispense a dose. If the triggering device 100 is releasably attached to the drug delivery device 1 , the first load and the third load may be at least partially parallel, depending on the drug delivery device 1 the triggering device 100 is attached to. Here, a distal end of the triggering device 100 may be attached to a proximal end of the drug delivery device 1.

[0081] The mutual contacting of the electrical contacts 105 shown in Figure 3C influences the electric switching circuitry, which may include a power source 107, for example a battery, and a circuit board assembly 108, for example a printed circuit board assembly. A current running inside the electric switching circuitry may for example be influenced when the electrical contacts 105 are brought into contact. The influenced current may thus be regarded as a switching signal. The emitter unit 104 electrically connected to the circuit board assembly 108 may emit a triggering signal TS, when the switching signal is received.

[0082] A further example of a triggering device 100 comprising two electrical contacts 105 arranged with respect to the actuation surface 103 is depicted in Figure 4. Also here, the two electrical contacts 105 may for example form part of an electric switching circuitry. The electric switching circuitry may for example be provided by an electric circuit comprising electric connections 109 electrically connecting the electrical contacts 105 to the circuit board assembly 108 and the power source 107. When the user may for example touch the actuation surface 103 of the triggering device 100, the user's skin may close the electrical contacts 105, i.e., provide an electrical connection between the two electrical contacts 105, and may therefore influence the electric switching circuitry.

[0083] A current which may run inside the electric switching circuitry due to the closure of the electrical contacts 105 by the skin may thus be regarded as a switching signal. When the switching signal is received by the emitter unit 104, the emitter unit may emit a triggering signal TS. When touching the electrical contacts 105, the user may also apply a load onto the actuation surface 103 so that the load may be transferred onto a dose button 11 of a drug delivery device 1 for dose dispensing. However, if the user does not directly apply a load for dose dispensing, the dosing event included in the triggering signal TS may just indicate a dose to be delivered, i.e. an intended dose delivery. The electronic device 1000 may then ask the user for a data input, wherein the user may, for example orally, provide a dose value, the user is about to deliver. The user may then set the dose and deliver the dose. Alternatively, the user may delete the dose event if the user decides not to deliver a dose.

[0084] An exemplary triggering device 100 comprising a snap-dome 102, wherein the switching unit is arranged on the actuation surface 103 of the snap dome 102, is shown in Figures 5A and 5B. The switching unit in this example is provided by a microswitch 110 arranged inside a switching unit housing 111. The switching unit is arranged on top of the actuation surface 103. Inside the switching unit housing 111 a power source 107 and circuit board assembly 108 are provided. The microswitch 110 comprises an elastically deformable operating element 112. The operating element 112 may be depressed in order to actuate the microswitch 110. The operating element 112 may be made of rubber and may protect the microswitch against the ingress of dust and / or moisture. A second load may be required to depress the operating element 112 of the microswitch 110. The second load may be more than or equal to a first load required to depress the snap-dome 102, i.e. to transfer the snap-dome 102 into the collapsed state.

[0085] When a user applies a load onto the switching unit, i.e. on the operating element 112, the snapdome 102 may therefore start to collapse until a fully collapsed state is reached. In this state, shown in Figure 5B, the microswitch 110 is actuated and a switching signal may be received by the emitter unit. A corresponding triggering signal TS may thus be emitted. Considering the triggering device 100 attached to a dose button 11 of a drug delivery device 1 , the dose button 11 may be about to actuate injection. In this regard, a first load required to collapse the snapdome 102 may be greater than a second load required to operate the microswitch 110. Further, the first load and the second load may be smaller than a third load required to dispense a dose.

[0086] A corresponding emitter unit 104 (not shown) may be arranged as part of the circuit board assembly 108. The emitter unit 104 may emit the triggering signal TS in the state shown in Figure 5B, i.e. when the microswitch 110 has been actuated and a switching signal has been received at the emitter unit 104. The triggering signal TS may then be received by an electronic device 1000 and a dosing event included in the triggering signal TS may be assigned to a preconfigured logbook. The user may further be asked to complete or add to the data in the logbook.

[0087] In summary, the triggering device 100 may thus provide an indicator for a dosing event and may thus allow to inform another device, i.e. an electronic device 1000, about the dosing event, i.e. also an intended dose delivery, by using a triggering signal TS. However, the triggering device 100 is not capable of detecting a dose amount or recording a set or delivered dose amount. Compared to known electronic modules, the triggering device 100 therefore has a significantly less complex structure, which in particular enables reliable dosing event detection without the need for complex, error-prone dose recording mechanisms. The user may therefore decide which data the user wants to store in his logbook and is simultaneously prompted and / or reminded by the triggering device 100 to add data, when the electronic device 1000 is informed about the dosing event.

[0088] The triggering device 100 thus provides a device that is simple and uncomplicated to use, and which allows a drug delivery device 1 to be supplemented.

[0089] Reference Numerals

[0090] 1 drug delivery device

[0091] 10 housing

[0092] 11 dose button

[0093] 12 dose dial grip

[0094] 13 drive sleeve

[0095] 14 display window

[0096] 15 container

[0097] 16 needle

[0098] 17 inner needle cap

[0099] 18 outer needle cap

[0100] 100 triggering device

[0101] 101 housing

[0102] 102 snap-dome

[0103] 103 actuation surface

[0104] 104 emitter unit

[0105] 105 electrical contact

[0106] 106 opposite side

[0107] 107 power source

[0108] 108 circuit board assembly

[0109] 109 electric connection

[0110] 110 microswitch

[0111] 111 switching unit housing

[0112] 112 operating element

[0113] 1000 electronic device

[0114] 1001 display

[0115] 1002 button

[0116] TS triggering signal

[0117] X first longitudinal axis

[0118] Y second longitudinal axis

Claims

Claims1. A combination of an electronic device (1000) and a triggering device (100) configured for releasable attachment to a drug delivery device (1), for example to a dose button (11) of an injection device, wherein the triggering device comprises• a housing (101),• a switching unit configured to provide a switching signal when actuated by a user,• an emitter unit (104) configured to emit a triggering signal (TS) only indicative of a dosing event, when the switching signal from the switching unit is received, and• a power source (107) configured to power the emitter unit for signal emission, characterized in that the triggering signal (TS) is receivable by the electronic device (1000) and in that the electronic device (1000) is configured to start a data input process in the electronic device (1000) upon receipt of the triggering signal (TS) from the emitter unit (104), and wherein a user is requested to input dose data during the data input process.

2. The combination according to claim 1 , wherein the switching unit comprises a sensor arrangement and / or an electric switching circuitry, and wherein the switching signal is provided by detection of a dosing event by the sensor arrangement and / or influencing of the electric switching circuitry.

3. The combination according to any one of the preceding claims, wherein the switching unit comprises two electrical contacts (105) and / or a sensitive switch, for example a snapaction switch, and / or a microswitch (110) arranged with respect to an actuation surface (103) of the triggering device (100), and wherein the electric switching circuitry is configured to be influenced when actuation surface is touched and / or loaded by a user.

4. The combination according to claim 3, wherein the switching unit is configured to influence the electric switching circuitry by partial relative movement of the switching unit relative to the housing (101) of the triggering device (100).

5. The combination according to any one of claims 3 or 4, wherein the triggering device comprises a snap-dome (102), wherein the actuation surface (103) is provided by a surface of the snap-dome, wherein the snap-dome is configured to be transferred from a relaxed state into a collapsed state by load applied to the actuation surface, wherein the snap-dome iselastically deformable and configured to be returned in the relaxed state when no load is applied to the actuation surface, and• wherein first one of the two electrical contacts (105) is arranged on an opposite side (106) of the actuation surface (103) of the snap-dome (102) and configured to be contacted with a second electrical contact (105) when the snap-dome is in the collapsed state, and / or• wherein the switching unit is arranged on the actuation surface (103) of the snap dome (102).

6. The combination according to claim 5, wherein a first load of about 2 N, preferably of between 1 N and 2 N, is required to transfer the snap-dome (102) from the relaxed state into the collapsed state.

7. The combination according to any one of claims 5 or 6, wherein the actuation surface (103) is configured to travel about 1 mm between the relaxed state and the collapsed state.

8. The combination according to any one of the claims 3 to 7, wherein the microswitch (110) comprises an elastically deformable operating element (112) configured to be depressed in order to actuate the microswitch, and wherein a second load required to depress the operating element is about 2 N, preferably of between 1 N and 2 N, most preferably more than or equal to a first load required to collapse the snap-dome.

9. An assembly comprising a drug delivery device (1) and a combination according to any one of the claims 1 to 8 wherein the triggering device (100) is releasably attached to the drug delivery device, wherein a load applied to a switching unit of the triggering device is transferred onto a dose button (11) of the drug delivery device (1), wherein the drug delivery device comprises a dose delivery unit configured to deliver a dose upon actuation of the dose button, and wherein, when the load applied to the switching unit of the triggering device (100) exceeds a threshold, the dose button is configured to be actuated.

10. The assembly according to claim 9,• wherein the triggering device (100) is configured to emit a triggering signal (TS) before a dose delivery is started, and wherein a first load or a second load required to actuate the switching unit is less than or equal to a third load required to allow the drug delivery device (1) to deliver a dose, or• wherein the triggering device (100) is configured to emit a triggering signal (TS) at the end of a dose delivery, and wherein a first load or a second load required to actuate the switching unit is greater than a third load required to allow the drug delivery device (1) to deliver a dose.

11. The assembly according to claim 9 or 10, wherein, when the triggering device (100) is releasably attached to the drug delivery device (1), a direction of the first load or the second load required to actuate the switching unit is at least partially parallel to a direction of the third load required to allow the drug delivery device to deliver a dose.

12. The assembly according to any one of claims 9 to 11 , wherein the drug delivery device (1) is an injection device or an inhalation device.

13. A method for detecting and logging a dosing event by an electronic device (1000), wherein the dosing event corresponds to a delivered dose or a dose to be delivered by a drug delivery device (1) of an assembly according to any one of the claims 9 to 12 comprising a combination according to any of the claims 1 to 8 with the triggering device (100) releasably attached to the drug delivery device (1), and wherein the method comprises at least the following steps:• Providing a switching signal by a switching unit of the triggering device (100);• Emitting a triggering signal (TS) indicative of a dosing event by an emitter unit (104) of the triggering device (100), when the switching signal from the switching unit is received;• Receiving the triggering signal (TS) by the electronic device (1000);• Assigning the dosing event included in the triggering signal to a pre-configured logbook.

14. The method according to claim 13, wherein a data input process is started in the electronic device (1000) by receiving the triggering signal (TS) from the emitter unit (104), and wherein a user is requested to input dose data during the data input process.

15. The method according to claim 14, wherein the dose data input during the data input process is conducted orally, visually and / or manually, for example, by pressing a button (1002) of the electronic device (1000).

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