WO2025093511A1

WO2025093511A1 - Electronic system for a drug delivery device

Info

Publication number: WO2025093511A1
Application number: PCT/EP2024/080502
Authority: WO
Inventors: Michael Jugl; Axel Teucher
Original assignee: Sanofi SA
Current assignee: Sanofi SA
Priority date: 2023-10-31
Filing date: 2024-10-29
Publication date: 2025-05-08
Anticipated expiration: 2026-04-30

Abstract

An electronic system for a drug delivery device is provided. The electronic system comprises an electronic control unit configured to control operation of the electronic system, the electronic system having a first state and a second state; a final-dose detection unit, the final-dose detection unit being operatively connected to the electronic control unit, the final-dose detection unit being configured to determine at least whether a final dose of a medicament in a medicament container of the drug delivery device has been delivered, wherein the final-dose detection unit is further configured to provide a final-dose signal, wherein the electronic system is configured to be switched from the first state to the second state by the electronic control unit in response to the final-dose signal; a feedback management unit, the feedback management unit being operatively connected to the electronic control unit, the feedback management unit being configured to provide a feedback initiation signal, wherein the feedback management unit is configured to provide the feedback initiation signal to indicate that the electronic system is in its second state and/or in response to the electronic system switching from the first state to the second state.

Description

Title

Electronic system for a drug delivery device

Background

Electronic systems for drug delivery devices, such as injection devices, e.g. pen-type injectors. The known electronic systems however have limited functionality.

Summary

An object of the present disclosure is to provide an improved electronic system for a drug delivery device. A further object of the present disclosure is to provide an improved combination of an electronic system and a drug delivery device. An even further object of the present disclosure is to provide an improved drug delivery device comprising the electronic system. An even further object of the present disclosure is to provide an improved method for providing a feedback to a user of a drug delivery device.

The objects may be achieved by the subject-matter as disclosed herein, e.g. by the elements of the associated independent claims. Preferred and advantageous embodiments are provided in the dependent claims.

According to a first aspect of the present disclosure an electronic system for a drug delivery device is provided. The electronic system may comprise an electronic control unit configured to control operation of the electronic system. The electronic system may have a first state, e.g. an active state or ready-to-use state, and a second state, e.g. an idle or sleep state.

The electronic system may further comprise a final-dose detection unit. The final-dose detection unit may be operatively connected to the electronic control unit. The final-dose detection unit may be configured to determine at least whether a final dose of a medicament in a medicament container of the drug delivery device has been delivered. The final-dose detection unit may be further configured to provide, e.g. generate a final-dose signal. The final-dose signal may for example be indicative that the medicament in the medicament container of the drug delivery device is not enough for delivering a further dose of medicament. The final-dose signal may for example be indicative that the medicament in the medicament container is expired, e.g. that a final dose of a non-expired medicament was delivered. In other words, the term "final-dose" should not be understood in the strict sense that there is not more medicament in the medicament container, but in a broader sense, namely that for any reason the drug delivery device with the medicament container should not be used anymore to deliver a further dose. This may be because there is not enough medicament in the medicament container for delivering a further dose of medicament, e.g. because the medicament container is empty, but could also be because the medicament in the medicament container is expired.

The electronic system may be further configured to be switched from the first state to the second state by the electronic control unit. The switching from the first state to the second state may occur in response to the final-dose signal.

The electronic system may further comprise a feedback management unit. The feedback management unit may be operatively connected to the electronic control unit. The feedback management unit may be configured to provide a feedback initiation signal.

The feedback management unit may be further configured to provide the feedback initiation signal in response to the electronic system switching from the first state to the second state. Additionally, or alternative the feedback initiation signal may be provided to indicate that the electronic system is in its second state.

According to at least one embodiment a feedback providing unit of the electronic system may be configured to provide at least one feedback for a user of the drug delivery device in response to, e.g. in response to receiving, the feedback initiation signal.

According to at least one embodiment the feedback initiation signal is configured to be received by an external device, e.g. a mobile phone, to cause the external device to provide at least one feedback for a user of the external device.

Such an electronic system has the advantage that a user is informed, via the feedback, that the drug delivery device may no longer be used. This might be for example because the drug delivery device has not enough medicament for a further dose, e.g. is empty or because the medicament in the drug delivery device is expired, e.g. the last dose of not expired medicament was delivered. This informs the user that a new or different drug delivery device or a medicament container with medicament or not expired medicament in it should be used for the next dose. According to at least one embodiment the feedback may be a visual and/or an audible and/or a tactile feedback. The feedback may be perceivable for the user of the drug delivery device.

A feedback may comprise several types of feedbacks, e.g. an audible and a visual feedback, and/or several different feedbacks within a type of feedback, e.g. a blinking light and a nonblinking light.

According to at least one embodiment, the electronic system may be configured to be releasably mounted on the drug delivery device, e.g. be configured as an add-on device to be mounted on the drug delivery device.

When the electronic system is releasably mounted on the drug delivery device, the feedback provided by the feedback providing unit and/or external device, in response to the feedback initiation signal provided by the feedback management unit may indicate, e.g. remind, the user of the drug delivery device, not to dispose of the electronic system together with the drug delivery device, when the drug delivery device is disposed.

Electronic systems like the one of the first aspect are expensive and disposing them in vain would result in a high economic burden for the user. A reminder to the user not to dispose of the electronic systems, such as the feedback provided by the feedback providing unit and/or external device, in response to the feedback initiation signal provided by the feedback management unit, is therefore an advantage. Avoiding disposing in-vain an electronic system also minimizes the environmental impact of the electronic systems, e.g. by minimizing the production of trash. As such, the electronic system of the present aspect has also a positive impact on the environment.

According to at least one embodiment, the electronic system may further comprise a mount detection unit. The mount detection unit may be operatively connected to the electronic control unit. The mount detection unit may be configured to detect whether the electronic system is or has been mounted or demounted from a drug delivery device. The mount detection unit may be connected to various sensors allowing such a detection.

According to at least one embodiment, the mount detection unit may be configured to provide, e.g. generate, a de-mount signal. The de-mount signal may be provided, e.g. generated, in response to detecting whether the electronic system is demounted from the drug delivery device, for example from the drug delivery device not having enough medicament in the medicament container for delivering a further dose of medicament. According to at least one embodiment, the mount detection unit may be configured to provide, e.g. generate, a mount signal. The mount signal may be provided, e.g. generated in response to detecting whether the electronic system is mounted to a drug delivery device from an unmounted state, e.g. to a different drug delivery device having at least one dose of medicament to be delivered. The unmounted state being the state in which the electronic system is not mounted to a drug delivery device.

According to at least one embodiment, the electronic system may be configured to remain in the second state after demounting of the electronic system from the drug delivery device, e.g. after generation of a de-mount signal.

According to at least one embodiment, the electronic system may be configured to be switched from the second state, e.g. the idle state, into the first state, e.g. the active state, by the electronic control unit in response to the mount signal.

According to at least one embodiment, the electronic system may be configured to be switched from the second state to a third state, e.g. a waiting-to-be-mounted state, by the electronic control unit in response to a de-mount signal.

According to at least one embodiment the third state may correspond to the second state.

According to at least one embodiment, the electronic system may be configured to be switched from the third state into the first state by the electronic control unit in response to a mount signal.

According to at least one embodiment, the feedback management unit may be configured to provide a feedback termination signal and/or a feedback modification signal in response to the feedback termination signal, the feedback providing unit and/or the external device may be configured to stop providing the or all feedback(s).

In response to the feedback modification signal, the feedback providing unit and/or the external device may be configured to modify the feedback. A modification of the feedback may comprise a modification of the type of feedback e.g. from a visual feedback to an audible feedback. The modification of the feedback may additionally or alternative comprise the modification of the feedback within a type of feedback, e.g. from a blinking light to a non-blinking light. The modification of the feedback may additionally or alternative comprise the addition of a further feedback, e.g. the addition of an audible feedback to an existing visual feedback, and/or the omission of one feedback, when more than one feedback was being provided. The provision of the feedback termination signal and/or the feedback modification signal by the feedback management unit may occur in response to the electronic system switching from the second state to the third state and/or from the third state to the first state.

According to at least one embodiment, the final-dose detection unit is configured to count the doses delivered by the drug delivery device during the period in which the electronic system is in its first state.

According to at least one embodiment, the final-dose detection unit is configured to reset the count of the doses delivered by the drug delivery device when the electronic system switches to the second state.

According to at least one embodiment, the electronic system further comprises a coded information recognition unit. The code information recognition unit may be operable to detect and/or to capture coded information of and/or on the drug delivery device.

According to at least one embodiment, the coded information is indicative of at least one of, more of, or all of:

- a type of the medicament in the drug delivery device,

- a concentration of a pharmaceutically active substance of the medicament,

- the amount of medicament in the medicament container of the drug delivery device,

- a manufacturing date of the medicament,

- an expiry date of the medicament.

According to at least one embodiment, the coded information recognition unit may be an optical sensor. The coded information may be provided at least through one of, more of, or all of: a color scheme, e.g. color ring coding, a QR code, a bar code, a text code.

According to at least one embodiment, the coded information recognition unit may be a magnetic or inductive sensor. The coded information may be provided at least through one of, more of, or all of: a magnetic or plastic magnetized material area, an NFC chip, an RFID chip, an inductive coil or wire.

According to a second aspect of the present disclosure a combination of a drug delivery device and the electronic system of the first aspect is provided. According to at least one embodiment, in the combination at least one of the final-dose detection unit and feedback management unit may be comprised in the drug delivery device.

According to a third aspect of the present disclosure a drug delivery device is provided. The drug delivery device may comprise the electronic system of the first aspect.

According to at least one embodiment the drug delivery device may be a reusable, e.g. a refillable, drug delivery device.

According to at least one embodiment the drug delivery device may comprise a medicament container comprising the medicament.

According to a fourth aspect of the present disclosure, the electronic system of any one of the previous aspects may be used with a drug delivery device, e.g. a drug delivery device of the previous aspects.

According to a fifth aspect of the present disclosure, a method for providing a feedback to a user of a drug delivery device using the electronic system of the previous aspects is provided.

The method may comprise the steps of determining by the final-dose detection unit that a final dose of a medicament in the medicament container of the drug delivery device was delivered.

The method may comprise the further step of generating a final-dose signal by the final-dose detection unit indicative that the medicament in the medicament container is not enough for delivering a further dose.

The method may comprise the further step of switching the electronic system from a first state to a second state in response to the final-dose signal.

The method may comprise the further step of providing a feedback initiation signal by the feedback management unit to indicate that the electronic system is in its second state and/or in response to the electronic system switching from the first to the second state.

According to at least one embodiment the method may comprise sending the feedback initiation signal to a feedback providing unit of the electronic system and/or to an external device. According to at least one embodiment the method may comprise providing a feedback perceivable to a user by the feedback providing unit and/or by the eternal device in response to a feedback initiation signal.

According to a sixth aspect of the present disclosure a computer program is provided. The computer program may comprise instructions to cause the electronic system of the first aspect to execute the steps of the method of the fifth aspect.

According to a seventh aspect of the present disclosure a computer-readable medium having stored thereon the computer program of the seventh aspect is provided.

In the present invention, singular expressions such as "a final-dose detection unit", "a feedback management unit", etc. are used for ease of reading the description and claims. Such a singular expression does not limit the number of components or features concerned. Rather, such a singular expression is intended to be understood as "at least one sensing unit", "at least one localization unit", etc., unless the context indicates otherwise. Same holds for the verbs "comprises" and similar.

It is noted that features, which are disclosed herein in connection with the method, also apply to the electronic system and/or the use and features, which are disclosed herein for the use or the electronic system, also apply for the method. In general, features disclosed in connection with different aspects, examples or embodiments can be combined with one another, even if such a combination is not explicitly described herein. Unless expressly stated otherwise, features disclosed herein above and below apply for all aspects, examples or embodiments of the disclosure, e.g. for the electronic system, the method and the use. For example, if method-like features are described they should be understood so as to also relate to the electronic system being configured for carrying out or performing these features.

The features described above and below in conjunction with different embodiments or aspects can be combined with one another, even if such a combination is not explicitly disclosed herein above or below. Further features, advantages and expediencies of the disclosure and, particularly, of the proposed concepts will become apparent from the following description of the exemplary embodiments in conjunction with the drawings.

Brief description of the drawings

Figure 1 illustrates an embodiment of a drug delivery device or drug delivery device unit. Figure 2 illustrates schematically an electronic system for a drug delivery device, e.g. the one in Figure 1.

Figure 3 illustrates schematically an embodiment of an electronic system for a drug delivery device, e.g. the one in Figure 1.

Figure 4 illustrates schematically a method of using an electronic system, e.g. the one of Figure 2 for generating a feedback to a user.

Figure 5 illustrates a schematic feedback in an external device, e.g. a mobile phone.

Description of exemplary embodiments

In the drawings identical features, features of the same kind or identically or similarly acting features may be provided with the same reference numerals.

In the following, some concepts will be described with reference to an insulin drug delivery device. The systems described herein may be implemented in this device or used as an add-on module to the device. The present disclosure is however not limited to such an application and may equally well be used for or in drug delivery devices that are configured to eject other medicaments or drug delivery devices in general, for example pen-type devices and/or autoinjectors.

In the following, embodiments are provided in relation to drug delivery devices, in particular to variable dose drug delivery devices, which record and/or track data on doses delivered thereby. These data may include the size of the selected dose and/or the size of the actually delivered dose, the time and date of administration, the duration of the administration and the like.

Features described herein may include power management techniques (e.g. to facilitate small batteries and/or to enable efficient power usage).

Certain embodiments in this document are illustrated with respect to a drug delivery device where an injection button and grip (dose setting member or dose setter) are combined e.g. similar to the device disclosed in WO 2014/033195 A1. The injection button may provide the user interface member for initiating and/or performing a dose delivery operation of the drug delivery device. The grip or knob may provide the user interface member for initiating and/or performing a dose setting operation. The devices may be of the dial extension type, i.e. their length increases during dose setting. Other drug delivery devices with the same kinematical behavior of the dial extension and button during dose setting and dose expelling operational mode are known as, for example, the Kwikpen® or Savvio® device marketed by Eli Lilly and the FlexPen®, or Novopen® device marketed by Novo Nordisk. An application of the general principles to these devices therefore appears straightforward and further explanations will be omitted. However, the general principles of the present disclosure are not limited to that kinematical behavior. Certain other embodiments may be conceived for application to drug delivery devices where there are separate injection button and grip components / dose setting members e.g. the drug delivery device disclosed in WO 2004/078239 Thus, the present disclosure also relates to systems with two separate user interface members, one for the dose setting operation and one for the dose delivery operation.

In order to switch between a dose setting configuration of the device and a dose delivery configuration, the user interface member for dose delivery may be moved relative to the user interface member for dose setting. If one user interface member is provided, the user interface member may be moved distally relative to a housing. In the course of the respective movement, a clutch between two members of the dose setting and drive mechanism of the device changes its state, e.g. from engaged to released or vice versa.

When the clutch, e.g. formed by sets of meshing teeth on the two members, is engaged, the two members may be rotationally locked to one another and when the clutch is disengaged or released, one of the members may be permitted to rotate relative to the other one of the two members. One of the members may be a drive member or drive sleeve which engages a piston rod of the dose setting and drive mechanism. The drive sleeve may be designed to rotate relative to the housing during dose setting and may be rotationally locked relative to the housing during dose delivery. The engagement between drive sleeve and piston rod may be a threaded engagement. Thus, as the drive sleeve cannot rotate during dose delivery, axial movement of the drive sleeve relative to the housing will cause the piston rod to rotate. This rotation may be converted into axial displacement of the piston rod during the delivery operation by a threaded coupling between piston rod and housing.

The drug delivery device 1 of Figure 1 is an injection pen that comprises a housing 10 and a medicament container 14, e.g. an insulin container, or a receptacle for such a container. The container may contain a medicament, e.g. insulin. The container may be a cartridge or a receptacle for a cartridge which may contain the cartridge or be configured to receive the cartridge. A needle 15 can be affixed to the container or the receptacle. The container may be a cartridge and the receptacle may be a cartridge holder. The needle is protected by an inner needle cap 16 and either an outer needle cap 17 or another cap 18. An insulin dose to be ejected from drug delivery device 1 can be set, programmed, or ‘dialed in’ by turning a dosage knob 12, and a currently programmed or set dose is then displayed via dosage window 13, for instance in multiples of units. The units may be determined by the dose setting mechanism which may permit relative rotation of the knob 12 to the housing 10 only in whole-number multiples of one unit setting increment, which may define one dosage increment. This may be achieved by an appropriate ratchet system, for example. The indicia displayed in the window may be provided on a number sleeve or dial sleeve 70. For example, where the drug delivery device 1 is configured to administer human insulin, the dosage may be displayed in so-called International Units (IU), wherein one IU is the biological equivalent of about 45.5 micrograms of pure crystalline insulin (1/22 mg). Other units may be employed in drug delivery device 1s for delivering analogue insulin or other medicaments. It should be noted that the selected dose may equally well be displayed differently than as shown in the dosage window 13 in Figure 1.

The dosage window 13 may be in the form of an aperture in the housing 10 or a transparent separate component inserted into an aperture of the housing, where the separate component may incorporate a magnifying lens. The dosage window 13 permits a user to view a limited portion of a dial sleeve 70 that is configured to move when the dosage knob 12 is turned, to provide a visual indication of a currently programmed dose. The dosage knob 12 is rotated on a helical path with respect to the housing 10 when turned during programming.

In this example, the dosage knob 12 includes one or more formations 71a, 71b, 71c to facilitate attachment of a data collection device or electronic system. An electronic system 1000 which may be attachable to the user interface member (knob 12 and/or button 11) or, in general, to elements or members of a dose setting and drive mechanism of the drug delivery device 1 or, in even more general, to the drug delivery device will be described in more detail below. The electronic system 1000 may be provided within the user interface member, for example. The electronic system 1000 which will be described in more detail below can also be configured as an add-on for a drug delivery device 1.

The drug delivery device 1 may be configured so that turning the dosage knob 12 causes a mechanical click sound to provide acoustical feedback to a user. In this embodiment, the dosage knob or dose button 12 also acts as an injection button 11. When needle 15 is stuck into a skin portion of a patient, and then dosage knob 12 / injection button 11 is pushed in an axial direction, the insulin dose displayed in display or dosage window 13 will be ejected from drug delivery device 1. When the needle 15 of drug delivery device 1 remains for a certain time in the skin portion after the dosage knob 12 is pushed home, the dose is injected into the patient's body. Ejection of the insulin dose may also cause a mechanical click sound, which is however different from the sounds produced when rotating the dosage knob 12 during dialing of the dose.

In this embodiment, during delivery of the insulin dose, the dosage knob 12 is returned to its initial position in an axial movement, without rotation, while the dial sleeve 70 or number sleeve 70 is rotated to return to its initial position, e.g. to display a dose of zero units. As noted already, the disclosure is not restricted to insulin but should encompass all drugs in the drug container 14, especially liquid drugs or drug formulations.

Drug delivery device 1 may be used for several injection processes until either the insulin container 14 is empty or does not have enough insulin in the medicament container 14 for delivering a further dose of insulin or the expiration date of the medicament in the drug delivery device 1 (e.g. 28 days after the first use) is reached.

Furthermore, before using drug delivery device 1 for the first time, it may be necessary to perform a so-called "prime shot" to ensure fluid is flowing correctly from insulin container 14 and needle 15, for instance by selecting two units of insulin and pressing dosage knob 12 while holding drug delivery device 1 with the needle 15 upwards. For simplicity of presentation, in the following, it will be assumed that the ejected amounts substantially correspond to the injected doses, so that, for instance the amount of medicament ejected from the drug delivery device 1 is equal to the dose received by the user.

As explained above, the dosage knob 12 also functions as an injection button 11 so that the same component is used for dialing/setting the dose and dispensing/delivering the dose. Again, we note that a configuration with two different user interface members which, preferably only in a limited fashion, are movable relative to one another is also possible. The following discussion will, however, focus on a single user interface member which provides dose setting and dose delivery functionality. In other words, a setting surface of the member which is touched by the user for the dose setting operation and a dose delivery surface which is touched by the user for the dose delivery operation are immovably connected. Alternatively, they may be movable relative to one another, in case different user interface members are used. During the respective operation, the user interface member is preferably moved relative to the body or housing of the device. During dose setting the user interface member is moved proximally and/or rotates relative to the housing. During dose delivery, the user interface member moves axially, e.g. distally, preferably without rotating relative to the housing or body.

In the following, a general setup for an electronic system 1000 for a drug delivery device 1 is disclosed. Figure 2 illustrates a general configuration of elements of an electronic system 1000 which can be used in or for a drug delivery device 1, for example the device or device unit discussed further above or in different devices.

The electronic system 1000 may comprise an electronic control unit 1100. The control unit may comprise a processor, e.g. a microcontroller or an ASIC. Also, the control unit 1100 may comprise one, or a plurality of memory units, such as a program memory and/or a main memory. The program memory may be designed to store program code which when carried out by the system controls operation of the system and/or the electronic control unit. The control unit 1100 may be expediently designed to control operation of the electronic system 1000. The control unit 1100 may communicate via wired interfaces or wireless interfaces with further units of the electronic system 1000.

The control unit 1100 may transmit signals containing commands and/or data to the respective unit and/or receive signals and/or data from the respective unit. The connections between the units and the electronic control unit 1100 are symbolized by the lines in Figure 2. However, there also may be connections between the units, which are not illustrated explicitly. The control unit 1100 may be arranged on a conductor carrier, e.g. a (printed) circuit board (see reference 2000 in Figure 3). The other unit(s) of the electronic system 1000 may comprise one or more components which are arranged on the conductor carrier as well.

The electronic system 1000 may have a first state and a second state. The first state of the electronic system 1000 may correspond to an "active state", e.g. a ready-to-use state of the electronic system, e.g. a state in which the electronic system 1000 is capable of performing its functions, e.g. a state in which the electronic system 1000 is applied on a drug delivery device 1 having a medicament container 14 comprising enough medicament to dispense at least one dose.

The second state of the electronic system 1000 may correspond to an "idle state" of the electronic system, e.g. a no-more-dose state of the drug delivery device 1 , e.g. a state in which the medicament container 14 of the drug delivery device 1 does not have enough medicament for a further dose. In the second state of the electronic device, the medicament container 14 of the drug delivery device 1, may therefore be empty or comprise a quantity of medicament which is not enough for delivering a further dose of medicament.

The electronic system 1000 may be configured to consume more power in its first state, e.g. its active state, rather than its second state, e.g. its idle state. In particular the electronic system 1000 may be configured to bring itself into a sleep mode in its second state, e.g. by turning off some or many of its functions.

The electronic system 1000 may further comprise a final-dose detection unit 1200. The finaldose detection unit 1200 may be connected, e.g. operatively connected to the electronic control unit 1100. The final-dose detection unit 1200 may be configured to detect at least whether a final dose of medicament has been delivered. The final dose of medicament, may be the last dose that can be delivered from the drug delivery device 1 , e.g. before the medicament container 14 does not contain a quantity of medicament enough for a further dose or e.g. before the medicament in the medicament container surpasses its expiration date.

In particular, this may mean, that after the last dose of medicament has been delivered, the medicament container 14 and/or the drug delivery device 1 comprising the medicament container 14 may need to be replaced by a user.

The final-dose detection unit 1200 may be configured to provide, e.g. generate, a final-dose signal. The final-dose signal may be indicative that the medicament in the medicament container 14 of the drug delivery device 1 is not enough for delivering a further dose, e.g. indicative that the medicament container 14 and/or the drug delivery device 1 needs to be replaced.

The electronic system 1000 may be configured to be switched from its first state, e.g. the active state, to its second state, e.g. its idle state by the electronic control unit 1100. The electronic control unit 1100 may switch the electronic system 1000 from its first state, e.g. active state to its second state, e.g. idle state, after receipt of the final-dose signal, e.g. provided by the finaldose detection unit 1200.

The electronic system 1000 may further comprise a feedback management unit 1300. The feedback management unit 1300 may be connected, e.g. operatively connected, to the electronic control unit 1100. The feedback management unit 1300 may be configured to provide, e.g. generate, a feedback initiation signal.

The feedback management unit 1300, may be further configured to provide the feedback in response to the electronic system 1000 switching from the first state, e.g. an active state, to the second state, e.g. the idle state. Additionally, or alternatively the feedback management unit 1300, may be further configured to provide the feedback to indicate that the electronic system 1000 switched from the first state, e.g. an active state, to the second state, e.g. the idle state. The electronic system may further comprise a feedback providing unit (not shown). The feedback providing unit may be configured to provide a feedback in response to the feedback initiation signal. In other words, the feedback initiation signal provided by the feedback management unit may prompt the feedback providing unit to generate a feedback.

Additionally, or alternatively to the feedback providing unit, the feedback initiation signal may be configured to be received by an external device, e.g. a mobile phone (as shown in Figure 5). In response to receiving the feedback initiation signal the external device may provide a feedback.

In other words, the feedback initiation signal received by the external device may prompt the external device to provide a feedback, e.g. to indicate on the external device that the medicament in the medicament container 14 of the drug delivery device 1 is not enough for a further dose.

The feedback of the feedback providing unit and/or of the external device may be visual feedback, e.g. through light emitted by a light source comprised in the electronic system and/or in the external device, and/or audible feedback, e.g. a sound notification being emitted by a sound source comprised in the electronic system and/or in the external device and/or in the drug delivery device; and/or a tactile feedback, e.g. a vibration of the electronic system and/or of the drug delivery device and/or of the external device. At least one, some or all of the feedbacks are configured to be perceivable by a user, e.g. the patient, of the drug delivery device 1.

The feedback may comprise several types and/or combinations of feedback, e.g. an audible and a tactile feedback, e.g. a beep and vibration. The feedback may comprise a continuous feedback, e.g. a continues red light, and/or alternating feedbacks, e.g. blinking (red) light. The feedback types may also alternate, e.g. the electronic system 1000 may blink for a predetermined period and afterward vibrate for a predetermined period.

Providing an external device with the feedback initiation signal creates a further alert to the user of the external device and of the drug delivery device 1 , e.g. that the medicament container 14 does not comprise enough medicament for a further dose or that the medicament in the medicament container is expired. External devices like mobile phone, tablets and personal computer are usually within reach of the user, so that such an indication is easily perceivable by the user.

The electronic system 1000 may be configured to be releasably mounted on a drug delivery device 1, e.g. on the drug delivery device 1 of Figure 1. In particular the drug delivery device 1 may be a refillable, e.g. reusable drug delivery device 1. The electronic system 1000 may be configured as an add-on device for a drug delivery device 1.

The electronic system 1000 may further comprise a mount detection unit 1500, shown in dashed lines in Figure 2. The mount detection unit may be connected, e.g. operatively connected to the electronic control unit 1100. The mount detection unit 1500 may be configured to provide, e.g. to generate, signals, which may be send to the electronic control unit. The signal may be indicative, e.g. comprise information, regarding the mounting status of the electronic system 1000 on the drug delivery device 1.

The mount detection unit may be configured to detect whether the electronic system 1000 is mounted and/or demounted from a drug delivery device 1. The mount detection unit 1500 may for example be configured to provide, e.g. generate, a de-mount signal in response to detecting whether the electronic system 1000, e.g. in its second state, e.g. in its idle state, is or is being demounted from the drug delivery device.

In other words, the mount detection unit may be configured to detect that the electronic system 1000 was demounted, e.g. from a drug delivery device not having enough medicament in the medicament container 14 for delivering a further dose of medicament, e.g. an empty drug delivery device. It may further be configured to provide, e.g. generate, a de-mounting signal indicating that the electronic system 1000 was demounted from the drug delivery device 1 .

Additionally, or alternatively, the mount detection unit 1500 may for example be configured to provide, e.g. generate, a mount signal in response to the electronic system 1000, e.g. in its second state, e.g. in its idle state, being mounted to a (different) drug delivery device 1 , e.g. a drug delivery device 1 having enough medicament in the medicament container 14 for delivering at least one further dose and/or having a medicament in the medicament container which is not expired.

In other words, the mount detection unit may be configured to detect that the electronic system 1000 was mounted on a drug delivery device 1 , e.g. a full drug delivery device. It may further be configured to provide a mounting signal indicating that the electronic system 1000 was mounted from the drug delivery device 1.

The electronic system 1000 may further be configured to remain in the second state, e.g. in the idle state, after demounting of the electronic system 1000 from the drug delivery device 1, e.g. after receiving a demount signal from the mount detection unit. At this stage, the electronic system 1000 is demounted from the drug delivery device 1 having no more medicament in the medicament container 14 for a further dose, but is still not arranged, e.g. mounted, on a new or different drug delivery device 1. The electronic system 1000 may be configured to remain in the second state, e.g. its idle state, thereby consuming less power.

The feedback management unit 1300 may be configured to provide a feedback modification signal. The feedback modification signal may be provided in response to the electronic system 1000 being in its second state and the mount detection unit providing a demount signal. In response to the feedback modification signal the feedback providing unit and/or the external device may be configured to modify the feedback they are providing.

In other words, the feedback provided by the feedback providing unit and/or by the external device may change when the electronic system in its second state, e.g. its idle state, is demounted from the drug delivery device. The change of feedback and/or the different feedback may indicate that the electronic system 1000 is demounted from the drug delivery device and should be mounted on a different drug delivery device 1.

The changes in feedback may be in the same type of feedback but in a different form, e.g. a change in color for a visual feedback, and/or a different type of feedback, e.g. a visual feedback instead of an audible feedback. This informs and reminds the user of the drug delivery device not to dispose the electronic system 1000. The change of feedback may also comprise the addition of a feedback or the omission of a feedback when more than one feedback is being provided.

The electronic system 1000 may be configured to be switched from the second state, e.g. from an idle state, into the first state, e.g. an active state, by the electronic control unit 1100 in response to a mount signal. In this case mounting the electronic system 1000 onto a drug delivery device 1 having enough medicament in the medicament container 14 for delivering a further dose of medicament, switches the electronic system 1000 from an idle state to the active state.

In other words, once the mount detection unit detects that the electronic system 1000 may have been mounted from a drug delivery device 1 , the electronic control unit might switch the electronic system 1000 from the second state, e.g. an idle state, to the first state, e.g. the active state.

The feedback management unit 1300 may be configured to provide a feedback termination signal in response to the electronic system 1000 switching from the second state to the first state. The feedback providing unit and/or the external device may be configured to stop providing the feedback in response, e.g. upon receipt, of the feedback termination signal.

The stop in feedback may indicate the user of the drug delivery device 1 that the electronic system 1000 is mounted and ready to use on a drug delivery device 1, e.g. a drug delivery device comprising a medicament container 14 having enough medicament for delivering at least one more dose.

The electronic system 1000 may be configured to be switched from the second state, e.g. an idle state, to a third state, e.g. a ready-to-mount state. This may occur in response to a demount signal provided by the mount detection unit 1500, for example to the electronic control unit 1100.

The electronic device may consume more power in its third state than in the second state. The third state may however consume less power than the first state. During the third state the mount detection unit 1500 may be configured to operate to detect if the electronic system 1000 is mounted or not, thereby consuming more power than in the second state, e.g. the idle state.

The feedback management unit 1300 may be configured to provide a feedback modification signal in response to the switch of the electronic system 1000 from the second state to the third state and/or to indicate that the electronic system 1000 is in its third state. In response to the feedback modification signal the feedback providing unit and/or the external device may be configured to modify the feedback they are providing.

In other words. Once the electronic system is demounted from the drug delivery device 1 , the feedback provided by the feedback providing unit and/or the external device may change, for example into a visible feedback, such as a blinking light. In this way the user of the electronic system 1000 is provided with feedback that the electronic system 1000 should be mounted on a drug delivery device 1 e.g. on a drug delivery device 1 having a medicament container 14 comprising enough medicament for delivering at least one more dose. In this way the user is also reminded not to dispose in vain the electronic system, e.g. is reminded to mount the electronic system 1000 on a different drug delivery device 1.

Alternatively, the feedback management unit 1300 may be configured to provide a feedback termination signal in response to the switch of the electronic system 1000 from the second state to the third state. The feedback providing unit and/or the external device may be configured to stop providing feedback in response to the feedback termination signal.

The electronic system 1000 may be configured to be switched from the third state, e.g. a ready- to-mount state, to the first state, e.g. active state. This may occur in response to a mount signal provided by the mount detection unit 1500, for example to the electronic control unit 1100, e.g. in response to detecting that the electronic system 1000 may have been mounted on a drug delivery device 1 , e.g. a new drug delivery device.

The feedback management unit 1300 may be configure to send a feedback termination signal to the switch of the electronic system 1000 from the third state to the first state. The feedback providing unit and/or the external device may be configured to stop providing feedback in response to the feedback termination signal...

The final-dose detection unit 1200 may be further configured to count the doses delivered by the drug delivery device 1 during the period in which the electronic system 1000 is in its first state. This may be advantageous in order for the electronic system 1000 to identify how many doses were dispensed and if the drug delivery device 1 has enough medicament in the medicament container 14 for delivering a further dose.

The final-dose detection unit may be further configured to reset the count of the dose delivered by the drug delivery device 1 when the electronic system 1000 switches to the second state, e.g. to the idle state. In this case, the drug delivery device 1 has not enough medicament in the medicament container 14 to be dispensed as a dose and the final-dose detection unit may therefore reset the count as it is no longer required. Additionally, or alternatively the final-dose detection unit may perform two dose counts: a count of all doses delivered by drug delivery devices 1 to which the electronic system 1000 was mounted and a respective count of the doses delivered for each drug delivery device 1 , singularly.

The electronic system 1000 may further comprise a coded information recognition unit 1600. The coded information recognition unit 1600 may be operable to detect and/or to capture coded information (not shown) on or of the drug delivery device 1.

The coded information may be indicative of at least one of, more of, or all of:

- a type of the medicament in the drug delivery device 1,

- a concentration of a pharmaceutically active substance of the medicament,

- the amount of medicament in the medicament container 14 of the drug delivery device 1 ,

- a manufacturing date of the medicament, - an expiry date of the medicament.

The coded information recognition unit 1600 may be an optical sensor. The coded information may be provided in the form of: a color scheme, e.g. color ring coding, a QR code, a bar code, a text code.

Additionally, or alternatively the code information recognition unit 1600 may be a magnetic or inductive sensor. The coded information may be provided in the form of: a magnetic or plastic magnetized material area, an NFC chip, an RFID chip, an inductive coil or wire.

The electronic system 1000 may further comprise a communication unit 1700, e.g. an RF, Wi-Fi and/or Bluetooth unit. The communication unit may be provided as a communication interface between the system or the drug delivery device 1 and an external device, 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 and/or synchronized with the device. The dose data may be used for a dose log or dose history established in the external device. The communication unit may be provided for wireless communication. The communication unit 1700 may for example be configured to send the signals of the feedback management unit, e.g. the feedback initiation signal, the -feedback termination signal and/or the feedback modification signal, to the external device.

The electronic system 1000 further comprises an electrical power supply 1400, such as a rechargeable or non-rechargeable battery. The power supply 1400 may provide electrical power to the respective units of the electronic system 1000.

In one embodiment, the power consumption, in particular the maximum power consumption, of the electronic system 1000 in the second state, e.g. in the idle state, may be less than or equal to one of the following values: 300 nA, 250 nA, 200 nA (nA: nanoampere). Alternatively, or additionally, in the first state of the electronic system, the power consumption, in particular the minimum power consumption, may be greater than or equal to one of the following values: 0.5 mA, 0.6 mA, 0.8 mA (mA: milliampere). The difference can result from the power consumption of the final-dose detection unit 1200 and/or feedback management unit 1300 and/or mount detection unit 1500 and/or coded information recognition unit 1600 and/or of the communication unit 1700 which may be active or operable in the first state and switched off or in a sleep state in the second state of the electronic system 1000.

In one embodiment, the power consumption P1, e.g. the minimum or maximum power consumption, in the first state may be greater than or equal to at least one of the following values: 2*P2, 3*P2, 4*P2, 5*P2, 10*P2, 20*P2, 30*P2, 40*P2, 50*P2, 100*P2, 500*P2, 1000*P2, 2000*P2, 5000*P2, 10000*P2 where P2 is the power consumption in the second state. In the first state, the final-dose detection unit 1200 and/or feedback management unit 1300 and/or mount detection unit 1500 and/or coded information recognition unit and/or of the communication unit 1700 may be active, e.g. for wireless communication.

When the system is in the second state, e.g. with none or not all of the units being active, the current consumption may be 200 nA. When e.g. (only) the final-dose detection unit 1200 is active, the power consumption may be 0.85 mA. When the communication unit is active, e.g. in addition to the final-dose detection unit 1200 or only the communication unit, the power consumption may be 1.85 mA.

Although not explicitly depicted, the electronic system 1000 preferably comprises a, e.g. permanent and/or non-volatile, storage or memory unit, which may store data related to the operation of the drug delivery device 1 such as dose (history) data, for example.

The units of the electronic system may be connected to respective sensors.

The respective unit which has been described above may be integrated into the user interface member of the electronic system 1000 which is discussed in further detail below in conjunction with various embodiments.

It goes without saying that the electronic system 1000 may comprise further electronic units other than the ones shown such as other sensing units, which sense or detect different quantities or events.

In the following some more detailed embodiments of the electronic system 1000 are described. It should be noted that features which have been discussed above do also apply for these embodiments.

Figure 3 schematically illustrates an embodiment of an electronic system 1000. The system 1000 comprises a user interface member 1800. The user interface member may be designed to be operated during a dose setting operation and/or a dose delivery operation by the user. The user interface member 1800 has different exterior operation surfaces. The operation surfaces may be defined by exterior surfaces which are accessible from the exterior of a user interface member housing or body 1805, preferably when the user interface member is connected to a drug delivery device 1 unit or integrated into a device such as the unit or the device discussed in conjunction with figure 1. The user interface member 1800 has a setting surface 1810 which is arranged to be gripped by the user for dose setting, e.g. with two fingers such as the index finger and the thumb. The setting surface is a radially facing surface, which, preferably circumferentially, delimits the user interface member 1800 with respect to the exterior. The user interface member 1800 also has a delivery surface 1820. The delivery surface is arranged to be contacted, e.g. pressed and/or moved distally, by the user for dose delivery. The delivery surface 1820 is an axially oriented surface, e.g. a proximally facing surface. As noted above, embodiments of the disclosure can employ different user interface members for setting and delivery.

Within the user interface member 1800, e.g. within an interior hollow defined by the user interface member body 1805, some additional elements or units of the electronic system 1000 are housed. Specifically, the electronic system 1000 comprises the electronic control unit 1100. The system also comprises a conductor carrier 2000, e.g. a circuit board such as a printed circuit board. Conductors on the conductor carrier may conductively connect the electronic control unit to further electrical or electronic units or members of the system. The electronic control unit is arranged on the conductor carrier, e.g. mounted to the carrier.

The electronic system 1000 comprises the final-dose detection unit 1200. In the depicted embodiment, the final-dose detection unit 1200 has at least one sensor or switch or a plurality of sensors or switches 1210. In the depicted embodiment, at least one switch 1210 is associated with the setting surface 1810. Alternatively, or additionally, at least one switch 1210 is associated with the delivery surface 1820. The respective switch is expediently configured to generate an electrical signal or switch signal when the user interface member or a portion thereof is moved for performing the dose setting operation (the sensor or switch is expediently associated with the setting surface) or the dose delivery operation (the sensor or switch is expediently associated with the delivery surface). For example, for the dose setting operation, the user interface member 1800 may be rotated relative to the housing 10. A plurality of switches may be provided, e.g. to enable the control unit to distinguish between rotations in different directions. For the dose delivery operation, the user interface member can be moved axially towards the housing, e.g. to switch the clutch such as from the state where the dial sleeve and the drive member are rotationally locked for dose setting to a state where relative rotation is allowed for dose delivery. The user interface member is preferably biased, e.g. by a clutch spring (not shown), to the position it has for dose setting which may be proximally offset to the one for dose delivery by the clutch switching distance. The clutch switching distance (the distance the user interface member has to be moved in order to switch the clutch) is for example greater than or equal to 1.5 mm. The electrical signal generated by the final-dose detection unit, e.g. the final-dose signal - may directly trigger the electronic control unit 1100 to switch the system from the first state to the second state. The movement for the manipulation which triggers generation of the signal is expediently unidirectional, i.e. only movement in one direction is required. In this way complicated manipulations of the user interface member 1800 for switching the system to the second state can be avoided.

The system furthermore comprises the feedback management unit 1300 which is only schematically represented. The feedback management unit 1300 may be bidirectionally conductively connected to the electronic control unit 1100 as hinted by the double arrow. One direction may be the one where a switch signal indicating the change of state of the electronic system 1000 is transmitted from the electronic control unit to the feedback management unit 1300. In the other direction, signals, e.g. the feedback initiation signal, the feedback modification signal and/or the feedback termination signal, may be sent from the feedback management unit 1300 to the electronic control unit, which may process the signals further, e.g. by sending it to an external device or to the feedback providing unit. The feedback management unit 1300 may be arranged on that side of the conductor carrier 2000 which faces away from the control unit 1100.

Further, the system 1000 comprises the power supply 1400, e.g. a battery, such as a coin cell. The power supply may be configured to provide a total charge of approx. 25 - 500 mAh at a voltage of approx. 1.4 - 3V. This may be achieved or assisted by stacking multiple coin cells, for example. The power supply 1400 is conductively connected or connectable to the other components of the electronic system, which require electrical power for operating. The conductive connection is not explicitly illustrated in Figure 3. A metal pressing may be provided for connecting the power supply 1400 to the conductor carrier 2000 which may distribute the power to further elements via conductors on the carrier. The power supply may, however, be arranged so as to extend along one main surface of the conductor carrier 2000 as depicted. The power supply, in the depicted embodiment, is arranged between the conductor carrier 2000 and the delivery surface 1820. This facilitates a compact formation of the user interface member 1800.

A radial width or diameter of the user interface member 1800 as seen from the exterior of the member, e.g. in top view onto the delivery surface, may be less than or equal to one of the following values: 2 cm, 1 .5 cm. Alternatively or additionally, the radial width or diameter of the user interface member may be greater than or equal to one of the following values: 0.5 cm, 0.7 cm. The radial extension may be determined relative to the rotation axis of the user interface member during dose setting or relative to the main longitudinal axis of the user interface member, which axes may coincide. The length or axial extension of the user interface member 1800 may be less than or equal to one of the following values: 2.5 cm, 2 cm, 1.5 cm. Alternatively or additionally, the length or axial extension of the user interface member 1800 may be greater than or equal to one of the following values: 0.5 cm, 0.7 cm.

Electronic system 1000 is configured to be connected, e.g. mounted, preferably releasably, e.g. releasably mounted, to a drug delivery device 1 unit as an add-on unit or module. The drug delivery device 1 unit may be electronic free. Accordingly, all electronics may be provided in the electronic system. The drug delivery device 1 unit may be disposable. That is to say, the unit can be disposed of after a reservoir of the unit has been emptied using the drug delivery device 1 comprising the unit and the system 1000. The electronic system 1000 could be reused for another drug delivery device 1 unit. The drug delivery device 1 unit is preferably configured as fully functional on its own, i.e. it could be operated for setting a dose to be delivered and deliver the set dose. One exemplary unit is the one depicted in Figure 1 . The electronic system 1000 may be a pure add-on to an, otherwise, fully functional unit, which is expediently free of electronical or electrically operated parts. Alternatively, a drug delivery device 1 may comprise the electronic system, e.g. as an integral part, i.e. a part which is necessary such that the device can be operated for setting and delivering a dose of drug, e.g. because without the electronic system 1000 the drug delivery device 1 unit would lack a surface accessible for the user for conducting a dose setting operation or a dose delivery operation. Alternatively, a drug delivery device 1 may comprise some elements of the electronic system, such as the final-dose detection unit and/or the feedback management unit. For a connection to the drug delivery device 1 unit, the electronic system 1000 may comprise one or more connection features 1815, e.g. snap features. The respective connection feature is arranged in a distal portion of the user interface member 1800, e.g. in the interior of the member.

The system 1000 is expediently configured to be mechanically connected, either permanently or removably/releasably, to a member of the drug delivery device 1 unit such as a member of the dose setting and drive mechanism, e.g. to the drive sleeve or the dose knob and/or the injection button of the unit discussed in conjunction with Figure 1. The system, e.g. via the user interface member body 1805, may be rotationally and axially locked to the member of the drug delivery device 1 unit. The member to which the system is connected may be movable relative to the housing 10 during dose setting and/or dose delivery, e.g. rotationally and/or axially during setting and, e.g. only, axially during delivery. The member can engage the piston rod, e.g. threadedly. The dose knob and the drive sleeve of the unit in Figure 1 may be formed integral or act as a single member during dose setting and dose delivery. During dose setting, the drive sleeve may be selectively rotationally locked to a dial sleeve of the dose setting and drive mechanism such that the dial sleeve and the drive sleeve co-rotate during dose setting, e.g. by a clutch, and the dial sleeve rotates relative to the drive sleeve during dose delivery. The dial sleeve may be the number sleeve. The relative rotation between dial sleeve and drive sleeve during dose delivery may be measured by the final-dose detection unit. However, it will be readily apparent to those skilled in the art that the disclosed concepts will also work with dose setting and drive mechanisms having different ways of operation and/or different configurations.

The following embodiments illustrate implementations of the final-dose detection unit 1200. In each case, the final-dose detection unit 1200 may be configured to provide or to generate the signal, e.g. the final-dose signal, in response to a movement of a first portion of the user interface member 1800 relative to a second portion of the user interface member. The first portion and the second portion are expediently connected or fixed to one another to operate as one member aside from the movement required to generate the signal and, preferably, the movement to re-establish the original relative position between the two portions. For the signal generation a limited relative mobility between the portions of the user interface member is utilized.

Figure 4 shows a flow diagram of an exemplary schematic method for providing a user of a drug delivery device 1 , e.g. a drug delivery device 1 according to Figure 1, with a feedback, e.g. a feedback informing the user of the electronic system 1000 not to dispose the electronic system 1000.

The electronic system 1000 may be the electronic system 1000 described schematically in Figure 2. The electronic system 1000 may for example be an add-on device which is mounted on a drug delivery device 1, for example the drug delivery device 1 of Figure 1.

In step 2100 the final-dose detection unit 1200 determines that a final dose of a medicament in the medicament container 14 of a drug delivery device 1 was delivered. The determination may occur for example through the detection of the quantity of medicament left in the medicament container 14 of the drug delivery device 1 and/or for example through a comparison of the information of how many doses have been delivered with the specific drug delivery device 1 , the quantity of medicament per dose and the total quantity of medicament in the medicament container 14 when the electronic system 1000 was mounted on the drug delivery device 1 or when a new medicament container 14 is provided to the drug delivery device 1. This information might have been gathered by the electronic system 1000 through the coded information recognition unit 1600 having recognized a respective code on the drug delivery device 1.

After having determined that the final dose of medicament was delivered, the final-dose detection unit may provide, e.g. generate in step 2200 a final-dose signal. The final-dose signal may for example be indicative that the medicament in the medicament container 14 is not enough for delivering a further dose of medicament, or for example that the medicament in the medicament container has expired. The final-dose signal may be sent to the electronic control unit 1100.

In step 2300, the electronic control unit switches the electronic system 1000 from the first state, e.g. a ready to use state, to a second state, e.g. an idle state.

In step 2400 the feedback management unit 1300 may provide a feedback initiation signal to indicate that the electronic system 1000 is in its second state, e.g. the idle state. Additionally, or alternatively, the feedback initiation signal may be provided as a response to the electronic system 1000 switching from the first to the second state. The switching from the first to the second state may for example generate a signal which is sent by the electronic control unit to the feedback management unit 1300. In response the feedback management unit 1300 may provide the feedback initiation signal.

Step 2400 may occur in several ways. For example, as shown in step 2500, the feedback management unit may provide a feedback initiation signal to a feedback providing unit of the electronic system 1000. The feedback providing unit may provide a feedback in response to the feedback initiation signal. The feedback may be perceivable to a user of the drug delivery device 1. The feedback may be for example a visual feedback, an audible feedback and/or a tactile feedback. The feedback provided by the feedback providing unit may also comprise a combination of the mentioned feedbacks, e.g. both a visual and an audio feedback. The user may therefore be informed by the feedback that medicament in a medicament container 14 of the drug delivery device 1 is not enough for delivering a further dose and/or that the medicament in the medicament container is expired.

The user of the drug delivery device 1 may be furthermore informed by the feedback, or reminded, that the electronic system, e.g. as addon device, has to be removed from the drug delivery device 1 and/or mounted on a new drug delivery device 1 . In particular the feedback may remind the user not to dispose of the electronic system. This minimizes the risk of user disposing of the electronic system 1000 with the drug delivery device 1. In case in which the electronic system 1000 is integral with the drug delivery device 1 the feature serves to remind the user of the drug delivery device 1 to replace the medicament container 14.

Additionally, or alternatively, as shown in step 2600, the feedback management unit may provide the feedback initiation signal to an external device, a feedback information signal. The feedback initiation signal may for example be send to at least one external device, e.g. a mobile phone or a smartwatch. The external device 3000 (see e.g. Figure 5) may be configured to generate a feedback in response to receiving the feedback initiation signal.

Figure 5 shows a schematic representation of an external device 3000 shown as a mobile phone. The external device 3000 received a feedback information signal and started providing the user of the drug delivery device 1 with two different types of feedback, namely an audible feedback 3100 and a visual feedback 3200 on the screen of the eternal device. The visual feedback 3200 may for example be a push notification on the mobile phone informing the user that the drug delivery device 1 is empty, e.g. that it does not have enough medicament in the medicament container 14 for delivery of another dose of medicament. The visual feedback 3200 may further comprise an information to for the user on the next steps, e.g. reminding the user to demount the electronic system 1000 from the drug delivery device 1 .

Furthermore, a computer program is provided (not shown) the computer program may comprise instructions to cause the electronic system 1000, e.g. the electronic system 1000 of Figure 2 to execute the steps of the method of Figure 4. A computer-readable medium having stored thereon the computer program may also be provided.

While the embodiments above have been described in relation to collecting data from an insulin injector pen, it is noted that embodiments of the invention may be used for other purposes, such as monitoring of injections of other medicaments.

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

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

The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., shorter 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 dualchamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and/or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

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

Examples of APIs for the treatment and/or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl 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.

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

Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N- 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-(co-carboxyheptadecanoyl) human insulin.

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. 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.

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

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

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

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

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

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

An immunoglobulin single variable domain (ISV) can be a heavy chain ISV, such as a VH (derived from a conventional four-chain antibody), or VHH (derived from a heavy-chain antibody), including a camelized VH or humanized VHH. For example, the immunoglobulin single variable domain may be a (single) domain antibody, a "dAb" or dAb or a Nanobody® ISV (such as a VHH, including a humanized VHH or camelized VH) or a suitable fragment thereof. [Note: Nanobody® is a registered trademark of Ablynx N.V.]; other single variable domains, or any suitable fragment of any one thereof.

“VHH domains”, also known as VHHs, VHH antibody fragments, and VHH antibodies, have originally been described as the antigen binding immunoglobulin variable domain of “heavy chain antibodies” (i.e. , of “antibodies devoid of light chains”; Hamers-Casterman et al. 1993 (Nature 363: 446-448). The term “VHH domain” has been chosen in order to distinguish these variable domains from the heavy chain variable domains that are present in conventional 4- chain antibodies (which are referred to herein as “VH domains”) and from the light chain variable domains that are present in conventional 4-chain antibodies (which are referred to herein as “VL domains”). For a further description of VHH’s, reference is made to the review article by Muyldermans 2001 (Reviews in Molecular Biotechnology 74: 277-302).

For the term “dAb’s” and “domain antibody”, reference is for example made to Ward et al. 1989 (Nature 341: 544), to Holt et al. 2003 (Trends Biotechnol. 21 : 484); as well as to WO 2004/068820, WO 2006/030220, WO 2006/003388. It should also be noted that, although less preferred in the context of the present invention because they are not of mammalian origin, single variable domains can be derived from certain species of shark (for example, the so-called “IgNAR domains”, see for example WO 2005/18629). The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

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

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

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

An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

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

As further described in ISO 11608-1:2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). Any invention described herein is not limited by the description in conjunction with the exemplary embodiments. Rather, the invention and the associated disclosure comprise any new feature as well as any combination of features, particularly including any combination of features in the patent claims, even if said feature or said combination per se is not explicitly stated in the patent claims or exemplary embodiments.

Reference signs:

1 drug delivery device

10 housing

12 dosage knob

13 dosage window

14 medicament container

15 needle

16 inner needle cap

17 outer needle cap

18 other cap

70 dial sleeve

71a, 71b, 71c formations

1000 electronic system

1100 electronic control unit

1200 final-dose detection unit

1210 switch

1300 feedback management unit

1400 power supply

1500 mount detection unit

1600 coded information recognition unit

1700 communication unit

1800 user interface member

1805 body

1810 setting surface

1815 connection features

1820 delivery surface

2000 conductor carrier

3000 external device

3100 audible feedback

3200 visual feedback

2100...2600 method steps

Claims

1. An electronic system (1000) for a drug delivery device (1), the electronic system (1000) comprising:

- an electronic control unit (1100) configured to control operation of the electronic system (1000), the electronic system (1000) having a first state and a second state,

- a final-dose detection unit (1200), the final-dose detection unit (1200) being operatively connected to the electronic control unit (1100), the final-dose detection unit (1200) being configured to determine at least whether a final dose of a medicament in a medicament container (14) of the drug delivery device (1) has been delivered, wherein the final-dose detection unit is further configured to provide a final-dose signal, wherein the electronic system (1000) is configured to be switched from the first state to the second state by the electronic control unit (1100) in response to the final-dose signal, a feedback management unit (1300), the feedback management unit (1300) being operatively connected to the electronic control unit (1100), the feedback management unit (1300) being configured to provide a feedback initiation signal, wherein the feedback management unit (1300) is configured to provide the feedback initiation signal to indicate that the electronic system (1000) is in its second state and/or in response to the electronic system (1000) switching from the first state to the second state.

2. The electronic system (1000) according to claim 1 , wherein a feedback providing unit of the electronic system is configured to provide a feedback in response to the feedback initiation signal, and/or wherein the feedback initiation signal is configured to be received by an external device (3000) to cause the external device (3000) to provide a feedback.

3. The electronic system (1000) according to claim 2, wherein the feedback is a visual and/or an audible and/or a tactile feedback, the feedback being perceivable by the user of the drug delivery device (1).

4. The electronic system (1000) according to any one of the preceding claims, the electronic system (1000) being configured to be releasably mounted on the drug delivery device (1).

5. The electronic system (1000) according to claim 4, further comprising a mount detection unit (1500), the mount detection unit (1500) being operatively connected to the electronic control unit (1100).

6. The electronic system (1000) according to claim 5, wherein the mount detection unit (1500) is configured to provide a de-mount signal in response to detecting whether the electronic system (1000) is demounted from the drug delivery device (1) and/or wherein the mount detection unit (1500) is configured to provide a mount signal in response to the electronic system (1000) being mounted to the drug delivery device (1).

7. The electronic system (1000) according to claim 6, wherein the electronic system (1000) is configured to be switched from the second state to a third state by the electronic control unit (1100) in response to a de-mount signal, which is indicative for the electronic system being demounted from the drug delivery device.

8. The electronic system (1000) according claims 7, wherein the electronic system (1000) is configured to be switched from the third state into the first state by the electronic control unit (1100) in response to the mount signal.

9. The electronic system (1000) according to any one of claims 7 to 8, wherein the feedback management unit (1300) is configured to provide a feedback termination signal or a feedback modification signal in response to the electronic system (1000) switching from the second state to the third state and/or from the third state to the first state.

10. A combination of a drug delivery device (1) and the electronic system (1000) of any of the preceding claims.

11. A drug delivery device (1), the drug delivery device (1) comprising the electronic system (1000) of any one of claims 1 to 9.

12. The drug delivery device (1) according to claim 11, further comprising a medicament container (14) comprising the medicament.

13. Use of the electronic system (1000) of any one of claims 1 to 9 with a drug delivery device (1) according to claim 11 or 12.

14. Method of providing a feedback to a user of a drug delivery device (1), using the electronic system (1000) of any of the previous claims, the method comprising the steps of: determining by the final-dose detection unit (1200) that a final dose of a medicament in the medicament container (14) of the drug delivery device (1) was delivered;

- generating a final-dose signal by the final-dose detection unit (1200),

- switching, by the electronic control unit (1100), the electronic system (1000) from a first state to a second state in response to the final-dose signal;

- providing a feedback initiation signal by the feedback management unit (1300) to indicate that the electronic system (1000) is in its second state and/or in response to the electronic system (1000) switching from the first to the second state.

15. Computer program, the computer program comprising instructions to cause the electronic system of any of the claims 1 to 9 to execute the method of claim 14.

16. An electronic system (1000) for a drug delivery device (1), the electronic system (1000) comprising:

- an electronic control unit (1100) configured to control operation of the electronic system (1000), the electronic system (1000) having a first state, in which the electronic system (1000) is capable of performing its functions, and a second state, in which a medicament container (14) of the drug delivery device (1) does not have enough medicament for a further dose,

- a final-dose detection unit (1200), the final-dose detection unit (1200) being operatively connected to the electronic control unit (1100), the final-dose detection unit (1200) being configured to determine at least whether a final dose of a medicament in the medicament container (14) of the drug delivery device (1) has been delivered, wherein the final-dose detection unit is further configured to provide a final-dose signal, wherein the electronic system (1000) is configured to be switched from the first state to the second state by the electronic control unit (1100) in response to the final-dose signal, a feedback management unit (1300), the feedback management unit (1300) being operatively connected to the electronic control unit (1100), the feedback management unit (1300) being configured to provide a feedback initiation signal, wherein the feedback management unit (1300) is configured to provide the feedback initiation signal to indicate that the electronic system (1000) is in its second state and/or in response to the electronic system (1000) switching from the first state to the second state.