WO2025093509A1

WO2025093509A1 - Electronic system for measuring parameters of a drug delivery device and method for localizing the electronic system

Info

Publication number: WO2025093509A1
Application number: PCT/EP2024/080500
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 measuring parameters of a drug delivery device is provided. The electronic system comprises a communication unit configured to try establish at least one first communication channel with at least one external device, e.g. a first external device, and, if the first communication channel is established, the communication unit is configured to communicate with the at least one external device via the first communication channel. The electronic system further comprises a processor unit connected to the communication unit, wherein the processor unit is configured to control the communication unit in response to a signal received from the at least one external device or in response to a signal received from the communication unit.

Description

Title

Electronic system for measuring parameters of a drug delivery device and method for localizing the electronic system

Background

Drug delivery devices provide a convenient option for injecting a drug to a user/patient. For example, drug delivery devices are safer against human error than conventional syringes. Drug delivery devices can be categorized in fixed dose devices and variable dose devices, wherein the latter ones are characterized in that the user can set certain parameters, e.g. the amount of drug, i.e. the dose, to be administered. Especially in these variable dose devices, measuring the parameters of the drug administration process, e.g. the amount of drug that had been administered, is important for ensuring a correct drug level in the patient’s body.

There are electronic systems, so called add-ons or e-buttons, that can be connected to the drug delivery device for measuring and recording the parameters of the drug administration process. Such electronic systems can usually be connected to at least one external device, e.g. a smart device like a smartphone, via which the electronic system can be controlled and measured data can be read-out and processed, facilitating the record keeping of the administered drug for the patient.

These electronic systems are often used in connection with disposable drug delivery devices, e.g. insulin pens. In this use case, the electronic system is usually physically attached to the disposable device, which is why such electronic systems need to be handy and small. This imposes the risk that they are thrown away together with the drug delivery device, when the drug delivery device is disposed. Likewise, there is a risk that the electronic system gets lost quite easily. However, as the electronic system is important for an accurate and complete record keeping of the administered doses, which may play a vital role for the patient, it is important to minimize the risk of not finding the electronic system if it gets lost or accidentally thrown away with the drug delivery device.

Summary As a general note, “distal” is used herein to specify directions, ends or surfaces which are arranged or are to be arranged to face or point towards a dispensing end of the drug delivery device and/or point away from, are to be arranged to face away from or face away from the proximal end. On the other hand, “proximal” is used to specify directions, ends or surfaces which are arranged or are to be arranged to face away from or point away from the dispensing end and/or from the distal end of the drug delivery device or components thereof. The distal end may be the end closest to the dispensing end and/or furthest away from the proximal end and the proximal end may be the end furthest away from the dispensing end. A proximal surface may face away from the distal end and/or towards the proximal end. A distal surface may face towards the distal end and/or away from the proximal end. The dispensing end may be the needle end where a needle is arranged or a needle or needle unit is or is to be mounted to the device, for example. If not explicitly indicated otherwise, the terms "axial" direction and/or "longitudinal” direction refer to an axis extending along the proximal-distal direction.

The disclosure relates to an electronic system for a drug delivery device. Further, the disclosure relates to a drug delivery device comprising the electronic system, a method for localizing an electronic system and a computer program product.

It is an object of the disclosure to provide an electronic system for a drug delivery device, with improved functionality. For example, the electronic system according to the present disclosure might be localized easily, when lost. Further, the electronic system according to the present disclosure might be easily and/or comfortably be used by a user/patient/owner. Further, the electronic system according to the present disclosure shall comprise as few parts as possible. Moreover, it is an object of the present disclosure to provide an improved drug delivery device. Furthermore, a method for localizing an electronic system is provided. The method might simplify the localization of an electronic system, when lost, thereby reducing the risk of not finding the electronic system.

The object is solved by the electronic system according to claim 1 , the drug delivery device according to claim 13, the method according to claim 14 and the computer program product according to claim 15. Further aspects are described in the dependent claims.

According to an aspect of the disclosure, an electronic system for measuring parameters of a drug delivery device is provided. The electronic system may comprise a communication unit. The communication unit may be configured to try to establish at least one first communication channel with at least one external device, e.g. a first external device. The communication unit may be configured to communicate with the at least one external device via the first communication channel, if the first communication channel is established such that data can be exchanged via the first communication channel.

In the following, the term "available" will be used to refer to the "established" state of a communication channel, i.e. the state in which data between two devices connected via the communication channel can be exchanged via the communication channel. In this context, exchanged may mean either in both directions or only in one direction, i.e. from one device to the other device but not vice versa.

The electronic system may further comprise a processor unit. The processor unit may be connected to the communication unit. The processor unit may be configured to control the communication unit in response to a signal received from the at least one external device or in response to a signal received from the communication unit.

In one embodiment, the drug delivery device may be an injection device configured to inject a dose of medicament/drug into a user’s/patient’s body. In one embodiment, the drug delivery device may be a variable dose device configured to administer a dose set by the user. In another embodiment, the drug delivery device may be a fixed dose device, configured to administer a fixed dose, which cannot be set by the user. In one embodiment, the drug delivery device may be an autoinjector. In one embodiment, the drug delivery device may be a peninjector.

In one embodiment, the parameters of the drug delivery device may comprise one or more of: a set dose, an injected dose, an expiry date of the drug, a type of drug, further information regarding the drug, the temperature of the drug etc.

In one embodiment, the first external device may be a first external electronic device. The first external device may be a mobile device, e.g. a smartphone, a tablet or a computer.

Alternatively, the first external device may be a stationary device, e.g. a router or a server. The first external device may be connectable to or connected to the internet. In one embodiment, the first external device may be configured to access a user’s cloud. The first external device may be the device via which the user preferably and predominantly communicates with the electronic system, e.g. for sending requests to the electronic system such as requests for retrieving information from the electronic system, e.g. the measured parameters of the drug delivery device. In one embodiment, the signal received from the first external device may be a request to send information for localizing of the electronic system to the at least one external device via the first communication channel. Upon receipt of the request, the processor unit may be configured to control the communication unit to send the information for localizing the electronic system to the at least one external device via the first communication channel.

In one embodiment, the information for localizing the electronic system may be information relating to the current position of electronic system. This may comprise information regarding the relative position of the electronic system with respect to the drug delivery device.

Alternatively or additionally, information for localizing the electronic system may comprise information regarding the overall position of the electronic system, e.g. satellite based position coordinates of the current location of the electronic system.

In one embodiment, the electronic system may comprise a position determination unit. The position determination unit may be configured to determine the information for localizing the electronic system. The position determination unit may be connectable to or connected to the processor unit.

In one embodiment, the position determination unit may be configured to determine the information for localizing the electronic system via one or more of: satellite based position determination, e.g. Global Positioning System (GPS), Glosnass or Galileo, Bluetooth®, Bluetooth® Low Energy, WiFi™-Positioning-System, Ultra Wide Band (UWB) technologies and other suitable technologies for determining the position of an object.

In one embodiment, the signal received from the communication unit may be a non-availability information indicating that the first communication channel is not available. This may either be the case when the first communication channel cannot be established as well as when the first communication channel is not available, e.g. due to a loss of connection after the first communication channel had been established successfully before. If the first communication channel is not available a communication between the communication unit and the at least one external device is not possible.

In one embodiment, when the non-availability information is received, the processor unit may be configured to control the communication unit to retry to establish the first communication channel. Alternatively or additionally, when the non-availability information is received, the processor unit may be configured to control the communication unit to try to establish at least one second communication channel with at least one auxiliary device. The auxiliary device may be a second external electronic device. The auxiliary device may be a mobile device, e.g. a smartphone, tablet or computer. Alternatively, the auxiliary device may be a stationary device, e.g. a router or a server. The auxiliary device may be connectable to or connected to the internet. In one embodiment, the auxiliary device may be configured to access the user’s cloud.

In one embodiment, the auxiliary device may be a trusted device. A trusted device may be a device different from the first external device which is owned and/or used by the user. The trusted device may further be a device via which the user usually does not communicate with the electronic system. However, in one embodiment, the auxiliary device may be a device capable of providing similar functions than the first external device, at least as regards the communication with the electronic system.

In one embodiment, a trusted auxiliary device may be a device which is not owned by the user but which is nonetheless trusted because it fulfills a predetermined condition. For example, a trusted device may a device not owned or used by the user, but it may be a device with which a communication channel had been established at least once before with the user’s consent. For example, if a communication channel between the electronic system and the trusted device had been established via Bluetooth once before, the trusted device may be a known device from a list of devices with which the electronic system had been paired before. The electronic system may be configured to store and/or access the list of known devices. In one embodiment, at least one, several, or all devices with which the electronic system had been paired before may be trusted devices.

In one embodiment, the auxiliary device may be a non-trusted device. A non-trusted device may be a device which is not owned/used by the user or with which no communication channel had been established before. For example, a non-trusted device may be an electronic device of a third party. In one embodiment, the non-trusted device may be connectable to the internet. In one embodiment, the non-trusted device may be configured to access user’s cloud to a certain extent, as will be described below.

In one embodiment, the electronic system may be configured such that the user may manually change the status of an auxiliary device from trusted to non-trusted, or vice versa. For example, the user may change the status via the first external device, when the first communication channel is available.

In one embodiment, the processor unit may be configured to control the communication unit to send the information for localizing the electronic system to the auxiliary device, if the second communication channel is available. In one embodiment, the processor unit may be configured to determine the status of the auxiliary device first before sending the information for localizing the electronic system. Hence, the information for localizing the electronic system may be sent in a different format, e.g. encrypted, depending on the status of the auxiliary device.

In one embodiment, if the second communication channel is available and the auxiliary device is a trusted device, the processor unit may be configured to control the communication unit to send information for localizing the electronic system to the auxiliary device. If the auxiliary device is a non-trusted device, the processor unit may be configured to encrypt the information for localizing the electronic system before controlling the communication unit to send the information for localizing the electronic system to the auxiliary device.

Afterwards, the information for localizing the electronic system may then be sent from the auxiliary device to the first external device. In specific, the information for localizing the electronic system may be sent to the first external device directly, when a direct connection between the auxiliary device and the first external device is or becomes available. For example, the auxiliary device may send the information for localizing the electronic system to the first external device, when both devices are connected to the same WiFi-network or when a Bluetooth connection between both devices is established. In one embodiment, the Bluetooth connection may be established in the background, without active consent of the users. In one embodiment, the information for localizing the electronic system may then be sent from the auxiliary device to the first external device as a background activity of the devices. Alternatively or additionally, the information for localizing the electronic system may be sent from the auxiliary device to the user’s cloud. Hence, the user’s cloud and the auxiliary device may be configured such that the auxiliary device has access to the user’s cloud, at least to the extent that is necessary for sending the information for localizing the electronic system to the user’s cloud. The first external device may be configured to retrieve the information from the user’s cloud. Thus, existing network structures, e.g. mobile devices of third parties which are neither owned nor controlled by the user, may be utilized for localizing the electronic system.

In one embodiment, the electronic system may provide the function of a location tracker, e.g. a Bluetooth tracker.

The first external device may be configured to process the information for localizing the electronic system received from the auxiliary device, e.g. by decrypting the information if encrypted. Further, the first external device may be configured to use the information for localizing the electronic system, e.g. to provide the information to the user. This may include the visual, acoustic and/or haptic provision of the information. In one embodiment, the first external device may be configured to guide/navigate the user to the electronic system.

In one embodiment, if the second communication channel is not available, i.e. it cannot be established or connection is interrupted, the processor unit may be configured to control the communication unit to retry to establish the second communication channel. In one embodiment, the processor unit may be configured to control the communication unit to retry to establish the second communication channel after a predetermined pause interval. The pause interval may have a length between less than 1 second and several hours. For example, the pause interval may be 1/10 of a second, half a second, 1 second, 5 seconds, 10 seconds, 30 seconds, 60 seconds, 120 seconds, 240 seconds, 5 minutes, 10 minutes, 30 minutes, 60 minutes, 2 hours, 5 hours, 10 hours, 24 hours etc.

In one embodiment, if the second communication channel is still not available, e.g. because it cannot be established after a first retry, the processor unit may be configured to control the communication unit to repeatedly retry to establish the second communication channel after the predetermined pause interval. The pause interval may reduce the energy consumption of the electronic system. Hence, the electronic system may perform retries over a longer period of time before running out of power. This may improve the chances of successfully establishing the second communication channel.

In one embodiment, the length of the pause interval may vary according to the number of unsuccessful retries. For example, the pause interval may become longer with every unsuccessful retry. Alternatively or additionally, the processor unit may be configured to control the communication unit to retry to establish the second communication channel only for a predetermined number of times per day. Alternatively or additionally, the processor may be configured to control the communication unit to retry to establish the second communication channel depending on a time of the day. For example, retries to establish the second communication channel may predominantly be performed during the day as the chances that the electronic system and/or auxiliary devices are moved during the night may be lower. In one embodiment, the processor unit may be configured to control the communication unit depending on an energy level of the of an energy source of the electronic device.

In one embodiment, the electronic system may comprise an owner indication unit. The owner indication unit may have stored thereon owner information relating to the owner of the electronic system. The owner of the electronic system may be the user, as described before. Alternatively, the owner of the electronic system may be a medical facility, e.g. a hospital or a doctor’s office. For example, the owner information may comprise one or more of: an owner’s name, an owner’s address, an owner’s telephone number or email address or any other contact details suitable to contact the owner, as well as a personal message of the owner.

In one embodiment, the owner indication unit may comprise one or more of: a Near-Field- Communication (NFC) chip, a Radio-frequency identification (RFID) element, a memory and an information element. The information element may be perceivable and/or readable by a human. The information element may be a display, a speaker, a vibrator, a print and/or an engraving on a surface of the electronic system.

In one embodiment, if the owner indication unit comprises a display, the display may be configured to show the owner information directly or indirectly, e.g. encrypted in a QR-code. The display may be an energy saving display, e.g. an electronic paper (e-ink) display. An energy saving display might provide the advantage of saving energy of the electronic system, while being capable of still displaying the owner information for a very long time.

In one embodiment, the processor unit may be configured to use an output means of the electronic system, e.g. a display thereof, for outputting the owner information of the owner indication unit and make it accessible, e.g. readable, to a third person.

In one embodiment, the owner indication unit may be configured to be activated and deactivated by the processor unit. The owner indication unit may be configured such that, when the owner indication unit is activated, the owner information can be read-out by a third electronic device and/or read by a third person. The read-out may be performed wirelessly, e.g. via NFC or RFID. Alternatively or additionally, the read-out may be performed via a wire, e.g. a communication link connected to an output of the electronic system.

The third electronic device may be an electronic device different from the first external device and the auxiliary device. The third electronic device may be configured to read-out data from the owner indication unit, e.g. the owner information or parts thereof. Apart from reading-out said data from the owner indication unit, the third electronic device and the electronic system may not communicate and/or exchange data. In one embodiment, the third electronic device may be a mobile device, e.g. a smartphone, a tablet or a computer. Alternatively, the third electronic device may be a stationary device, e.g. a router or a server. In one embodiment, the third electronic device may be connectable to or connected to the internet. In one embodiment, the third electronic device cannot communicate with the first external device, when reading-out the data. Further, the third electronic device cannot access the user’s cloud to send the information for localizing the electronic system to the first external device via the user’s cloud. For example, the third electronic device may be a smartphone of a different proprietary information technology (IT-) ecosystem than any device of the user, such that it cannot access communication structures to which a device of the user, e.g. the first external device, is connected. In other words, the third electronic device may be a device which cannot communicate with the user. Alternatively or additionally, the third electronic device may be a device unable to connect to the internet.

In one embodiment, the owner indication unit may be configured such that, when the owner indication unit is not activated the owner information cannot be read-out by the third electronic device and/or read by the third person. This may be advantageous for protecting the owner’s privacy, e.g. the owner information from being illegitimately retrieved or stolen.

In one embodiment, the processor unit may be configured to activate the owner indication unit, when the second communication channel is not available, e.g. because it cannot be established, and a predetermined condition is fulfilled. The predetermined condition may be set by the user. For example, the predetermined condition may be coupled to one or more of the following: a number of unsuccessful retries to establish the second communication channel, movement information of the electronic system, information from the position determination unit and a time of the day.

The movement information of the electronic system may indicate whether the electronic system is moved or in rest. The movement information of the electronic system may comprise information acquired by one or more sensors of the electronic system, e.g. an acceleration sensor and/or position sensor. For example, the movement information may indicate that the electronic system has started moving after it had been stationary for a while. This may be indicative for the event that a third person has been found and/or picked-up the electronic system.

In one embodiment, the movement information may be used as a trigger for retrying to establish the first and/or second communication channel. If unsuccessful, e.g. after one or several failed retries, the electronic system, e.g. the processor thereof, may be configured to activate the owner information unit. The number of retries may be limited. Hence, the electronic system may be configured to activate the owner indication unit, while movement information is still received, in other words, while the electronic system is still in movement. This may ensure that third person who found the electronic system still moves the electronic system, e.g. has it in hand or is nearby. This may increase the chances of a successful read-out of the owner indication unit. In one embodiment, the electronic system may be configured to send a perceivable signal to the third person who found it, e.g. via the information element, based on the movement information. This may help signaling to that person that the electronic system is still active and avoid that the third person leaves the electronic system in the erroneous belief that the electronic system may be inactive or broken. For example, the perceivable signal may include visual, acoustic and/or tactile instructions to read-out the owner indication unit.

Activating the owner information unit based on information from the position determination unit, may allow to selectively active the owner information unit based on target areas/zones. For example, the user me pre-set certain areas in which the owner information unit may or may not be activated. For example, a target area may be a hospital or the vicinity thereof, where it is more likely that the electronic system is found by someone who is familiar with such systems and knows how to read out the owner indication unit. Hence, the electronic system may be configured to activate the owner information unit in such a target area when neither the first nor the second communication channel can be established, or after a certain number of unsuccessful retries. This may help identifying the owner more quickly.

In one embodiment, the target areas/zones may be used to set the frequency of (re-)trying to establish the first and/or second communication channel. For example in crowded areas like hospitals, train stations, airports or major squares, the frequency of trying to establish the communication channels may be set to be higher than in less crowded places. This may improve efficient use of the available power of the electronic system and increase the chances of successfully establishing at least one communication channel.

In one embodiment, the owner indication unit may be configured to be active all the time. This may simplify the structure of the electronic system as the owner indication unit does not need to be controlled. Further, this may reduce the energy consumption of the electronic system.

Further, this may reduce the costs, as the owner indication unit may comprise less expensive components.

In one embodiment, the communication unit may be configured to establish the first communication channel and/or the second communication channel wirelessly. For example, the first and/or second communication channel may be established via one or more of: one or more of WiFi, Bluetooth, Bluetooth Low Energy, Near-field-communication and communication technologies based on radiofrequency. In one embodiment, communication unit may be configured to establish the first communication channel and/or second communication channel wirelessly when the systems/devices to be connected are within a short range, i.e. the distance therebetween is less than 400m, preferably less than 100m, more preferably less than 10m.

In one embodiment, the position determination unit may be configured to determine the information for localizing the electronic system upon receipt of a localization request from the processor unit. Depending on the technology for determining the information for localizing the electronic system, a request triggered determination may be advantageous as it might reduce the energy consumption of the electronic system. Alternatively or additionally, the position determination unit may be configured to determine the information for localizing the electronic system periodically, e.g. every 10 seconds, every minute, every 5 minutes, every 10 minutes, every hour, every two hours etc. In one embodiment, the position determination unit may be configured to determine the information for localizing the electronic system periodically but with a higher frequency, e.g. once per second.

If determined periodically, the electronic system may be configured to store the determined information for localizing the electronic system. In one embodiment, the information is stored permanently. In another embodiment, the information is stored temporarily, e.g. for a predetermined time. Likewise, the electronic system may be configured to overwrite the stored information when new information for localizing the electronic system is determined.

According to an aspect of the disclosure, a drug delivery device is provided. The drug delivery device may be an injection device configured to inject a dose of medicament/drug into a user’s/patient’s body. The drug delivery device may comprise a mechanism for dispensing a drug from a drug container or a reservoir of the drug delivery device.

In one embodiment, the drug delivery device may comprise an electronic system for measuring parameters of the drug delivery device, e.g. an electronic system according to one of the aspects and embodiments described in the foregoing.

In one embodiment, the drug delivery device may further comprise the drug container or the reservoir. The drug container or the reservoir may comprise the drug.

In one embodiment, the drug delivery device may be a variable dose device configured to administer a dose set by the user. In another embodiment, the drug delivery device may be a fixed dose device, configured to administer a fixed dose, which cannot be set by the user. In one embodiment, the drug delivery device may be an autoinjector. In one embodiment, the drug delivery device may be a pen-injector. According to an aspect of the disclosure, a method for localizing an electronic system is provided. The method may comprise the step of trying to establish at least one first communication channel between an electronic system and a first external device. If the first communication channel is established, the method may comprise the step of receiving, via the first communication channel, a signal from the first external device requesting information for localizing the electronic system. If the signal from the first external device is received, the method may comprise the step of sending information for localizing the electronic system to the first external device via the first communication channel. If the first communication channel is not available, e.g. because it cannot be established or connection is lost, the method may comprise the step of trying to establish a second communication channel with an auxiliary device. If the second communication channel is established, the method may comprise the step of sending information for localizing the electronic system to the auxiliary device via the second communication channel.

With respect to some specifics of each method step, reference is made to the explanations given in the foregoing regarding components of the electronic system which may be configured to perform the steps of the method. For the sake of avoiding repetitions, only some exemplary details of the method will be described in detail in the following.

In one embodiment, the first communication channel and/or the second communication channel may be established by a communication unit of an electronic system. The communication unit may be controlled by a processor unit of the electronic system. The information for localizing electronic system may be acquired by a position determination unit of the electronic system. The position determination unit of the electronic system may be connected to the processor unit of the electronic system.

In one embodiment, the information for localizing the electronic system may be sent from the auxiliary device to the first external device directly, when a connection between the auxiliary device and the first external device can be established. Alternatively or additionally, the information for localizing the electronic system may be sent from the auxiliary device to a user’s cloud, from where it may be retrieved by the first external device. Thus, the first external device and the auxiliary device may be configured to have access to the user’s cloud, at least to the extent that is required for sending (auxiliary device) and receiving (first external device) the information for localizing the electronic system. In one embodiment, the information for localizing the electronic system may be sent to the auxiliary device in an encrypted format, if the auxiliary device is a non-trusted device. Consequently, the method may comprise the step of decrypting the information for localizing the electronic system. For example, the information for localizing the electronic system may be decrypted by the first external device or by the user’s cloud, after it is received from the auxiliary device.

In one embodiment, if the first communication channel cannot be established or is not available, the method may comprise the step of retrying to establish the first communication channel. Retrying to establish the first communication channel may be repeated, if the first communication channel cannot be established when retrying. There may be a pause interval between each repetition. Further the number of repetitions may be limited.

In one embodiment, if the second communication channel cannot be established or is not available, the method may comprise the step of retrying to establish the second communication channel. Retrying to establish the second communication channel may be repeated, if the second communication channel cannot be established when retrying. There may be a pause interval between each repetition. Further the number of repetitions may be limited.

In one embodiment, the method may comprise the step of reading-out owner information. The owner information may be stored on an owner indication unit of the electronic system. In one embodiment, the method may comprise the step of reading-out the owner information with a third electronic device and/or reading the owner information by a third person. In one embodiment, the method may comprise the step of reading-out the owner information, if the first and the second communication channel are not available and cannot be re-established.

According to an aspect of the disclosure, a computer program product or a computer readable storage medium is provided. The computer program product or the computer readable storage medium may comprise instructions which, when carried out by a processing unit, cause an electronic system to carry out a method for localizing the electronic system.

In one embodiment, the electronic system may be an electronic system as described in the foregoing. In one embodiment, the method for localizing the electronic system may be a method as described in the foregoing.

In one embodiment, the processing unit may be a processor unit of the electronic system. The making and using of the presently preferred embodiments are discussed in detail above. It should be appreciated, however, that the present disclosure provides many applicable concepts that can be embodied in a wide variety of specific contexts. The specific embodiments discussed are merely illustrative of specific ways to make and use the disclosed concepts, and do not limit the scope of the claims.

As far as "may" is used in this application it means the possibility of doing so as well as the actual technical implementation. The present concepts of the present disclosure are described with respect to preferred embodiments in a more specific context namely drug delivery devices, especially drug delivery devices for humans or animals. The disclosed concepts may also be applied, however, to other situations and/or arrangements as well, e.g. for other injectors, spraying devices or inhalation devices.

The foregoing has outlined rather broadly the features and technical advantages of embodiments of the present disclosure. Additional features and advantages of embodiments of the present disclosure will be described hereinafter. It should be appreciated by those skilled in the art that the conception and specific embodiments disclosed may be readily utilized as a basis for modifying or designing other structures or processes for realizing concepts which have the same or similar purposes as the concepts specifically discussed herein. It should also be recognized by those skilled in the art that equivalent constructions do not depart from the spirit and scope of the disclosure, such as defined in the appended claims.

Brief description of the drawings

Figure 1 illustrates an exploded view of a drug delivery device for use with an electronic system according to an embodiment of the invention;

Figure 2 illustrates the electronic system attached to the drug delivery device of Figure 1;

Figure 3A illustrates a block diagram of the electronic system shown in Figure 2;

Figure 3B illustrates a block diagram of the electronic system shown in Figures 2 and 3A as well as its connections to other devices/systems;

Figure 4 illustrates a perspective view of a portion of the drug delivery device of Figure 1 ; Figure 5 illustrates a perspective view of a movable dosage programming component of the drug delivery device of Figure 1 ;

Figure 6 illustrates a cross-sectional view of portions of the electronic system of Figures 2 and 3 and the drug delivery device of Figure 1 when attached together;

Figure 7 illustrates a graph showing an intensity of light received by a sensor arrangement in the electronic system of Figures 2 and 3;

Figure 8 illustrates a graph showing an output of the sensor arrangement based on the received light intensities shown in Figure 7;

Figure 9 illustrates a system in which data from the electronic system of Figures 2 and 3 is transmitted to another device; and

Figure 10 schematically illustrates the steps of a method for localizing an electronic system.

Description of exemplary embodiments

In the following, embodiments of the present invention will be described with reference to an insulin drug delivery device. The present invention is however not limited to such application and may equally well be deployed with drug delivery devices that eject other medicaments.

Identical elements, elements of the same kind and identically or similarly acting elements may be provided with the same reference numerals in the figures, if not stated otherwise. The invention is not restricted to the illustrated or described embodiments.

Figure 1 is an exploded view of a medicament delivery device. In this example, the medicament delivery device is a drug delivery device 1 , such as described in WO 2004/078239 A1 and WO 2016/131713 A1 , the entire disclosure content of each of which is included by reference for all purposes into the present disclosure.

In one embodiment, the drug delivery device 1 may be an injection device configured to inject a dose of medicament/drug into a user’s/patient’s/owner’s body. In one embodiment, the drug delivery device 1 may be a variable dose device configured to administer a dose set by the user. In another embodiment, the drug delivery device 1 may be a fixed dose device, configured to administer a fixed dose, which cannot be set by the user. In one embodiment, the drug delivery device 1 may be an autoinjector. In one embodiment, the drug delivery device 1 may be a pen-injector.

The drug delivery device 1 of Figure 1 is a pre-filled, disposable injection pen that comprises a housing 10 and contains an insulin container 14, to which a needle 15 may be affixed. The needle is protected by an inner needle cap 16 and an outer needle cap 17 and/or another cap 18.

An insulin dose to be ejected from drug delivery device 1 may be programmed, or 'dialled in' by turning a dosage knob 12, and a currently programmed dose is then displayed via dosage window 13, for instance in multiples of units. 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 devices 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, which permits a user to view a limited portion of a number 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, e.g. 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 an electronic system to be described herein below.

The drug delivery device 1 may be configured so that turning the dosage knob 12 generates a haptic and/or acoustic feedback, e.g. mechanical click sound, perceivable by a user/patient. The number sleeve 70 mechanically interacts with a piston in insulin container 14. When needle 15 is stuck into a skin portion of the patient, and then injection button 11 is pushed, the insulin dose displayed in display 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 injection button 11 is pushed, a high percentage of the dose is actually injected into the patient's body. The drug delivery device may be configured such that several events of the injection process, e.g. the completion, may generate a haptic and/or acoustic feedback for the user. For example, the acoustic feedback may be a mechanical click sound, which, however, may be different from the sound produced when using dosage knob 12. In one embodiment, during delivery of the insulin dose, the dosage knob 12 is moved to its initial position in an axial movement, that is to say without rotation, while the number sleeve 70 is rotated to return to its initial position, e.g. to display a dose of zero units.

Drug delivery device 1 may be used for several injection processes until either the insulin container 14 is empty 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 remove air from insulin container 14 and needle 15, for instance by selecting two units of insulin and pressing injection button 11 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. Nevertheless, differences (e.g. losses) between the ejected amounts and the injected doses may need to be taken into account.

Figure 2 is a perspective view of the proximal end of the drug delivery device 1 when an electronic system 20 according to an embodiment of the disclosure is attached. The electronic system 20 may comprise an electronic system housing 21 and a dose information unit. For the sake of facilitating the understanding, the dose information unit will be exemplarily described as being a display 22. The display may be configured to present dosage information 22a. However, other types of visual dose information units, e.g. analogue indicators such as markings etc., may be used. Alternatively or additionally, the dose information unit may comprise means for providing the dosage information non-visually, e.g. acoustically or haptically.

The electronic system 20 may be configured for measuring injected doses and/or other parameters of the drug delivery device 1. Other parameters may include, for example, the expiry date of the medication, the set dose for a scheduled injection, the type of medication, the temperature of the medication, etc. The electronic system 20 may be a reusable add-on device that may be repeatedly releasably attached to the drug delivery device 1. It should be noted that the electronic system 20 may also be used in reusable assemblies of drug delivery devices. For example, reference in this context is made to reusable drive units that may be equipped with different containers or syringes. As illustrated in Figure 2, the electronic system 20 may be attached to the injection button 11 of the drug delivery device 1. Alternatively, the electronic system 20 may be configured to be attached to the housing 10 of the drug delivery device 1 , e.g. such that the electronic system housing 21 covers the window 13.

Figure 3A illustrates components of the electronic system 20. As shown, the electronic system 20 may comprise a sensing unit 25.1 configured to provide information about, or monitor, a change in the spatial position of the electronic system 20, in relation to the drug delivery device and/or as a whole. The sensing unit 25.1 may comprise an inertial sensor such as an accelerometer and/or a gyroscope.

The electronic system may further include a localization unit 25.2 configured to assist the localization of the electronic system 20. In addition, the electronic system 20 may include a processor unit 24. The processor unit 24 may be operatively connected, inter alia, to the sensing unit 25.1 and localization unit 25.2.

The localization unit 25.2 may be configured to emit a signal in response to receiving a respective signal from the processor unit 24. The processor unit24 may be configured to send the signal when a signal received by the processor unit 24 from the sensing unit 25 fulfills a certain criterion. The localization unit 25.2 may comprise a physically perceptible component 25.3 and a non-physically perceptible component 25.4. The physically perceptible component may be an output device that is capable of converting types of signals into physical phenomena or perceptions. Such an output device may be, for example, a light, a loudspeaker and/or a vibration element. A non-physically perceptible component may be an output device that is not capable of converting types of signals into physical phenomena or perceptions. Such an output device may be, a transmitter, receiver or transceiver.

The processor unit 24 may comprise one or more processors, such as a microprocessor, a Digital Signal Processor (DSP), an Application Specific Integrated Circuit (ASIC), a Field Programmable Gate Array (FPGA) or the like. The electronic system 20 may further comprise memory units 24.1 , 24.2, including a program memory 24.1 and a main memory 24.2, which may store software for execution by the processor unit 24.

The electronic system may comprise an interface 26 to the drug delivery device 1, such as a sensor arrangement, comprising one or more sensors. In the illustrated embodiment, the interface 26 is an optical encoder, including a light source 26a, such as a light emitting diode (LED) and a light detector 26b, such as an optical transducer. The interface 26 may be configured to detect the presence of the drug delivery device 1 if the electronic system 20 is attached to the drug delivery device 1.

The electronic system 20 may comprise an output 27. The output 27 may be a wireless communications interface for communicating with another device, via a wireless network such as WiFi or Bluetooth®, or an interface for a wired communications link 41 , such as a socket for receiving a connector for at least one of Universal Series Bus (USB), mini-USB, micro-USB, USB-C and other data transmission technologies, e.g. Thunderbolt, HDMI, and DisplayPort. The output 27 may be comprised in a communication unit 23 of the electronic system 20.

The electronic system 20 may comprise a power source 29.2 for providing electrical energy to the electronic system 20. The power source 29.2 may be, for example, an accumulator or a battery. The electronic system 20 may further comprise a power switch 29.1. The power switch 29.1 may be configured to respond to pressure, e.g. applied via the display 22. The power switch 29.1. may turn the electronic system 20 on or off in response to pressure applied to the power switch 29.1.

In the following, the function of the electronic device 20 of Figures 2, 3A and 3B will be described with additional reference to the steps of the method for localizing an electronic system, which are exemplarily illustrated in Figure 10.

As shown in Figure 3A, the electronic system 20 may comprise a communication unit 23 and the processor unit 24. The processor unit 24 may be connected to the communication unit 23 and configured to control the communication unit 23. For example, the processor unit 24 may be configured to control the communication unit 23 to try, S101, to establish at least a first communication channel 61 with at least one external device 50, e.g. a first external device 50. The first external device 50 may be a mobile device, e.g. a smartphone, a tablet or a computer or a stationary device, e.g. a router or a server. The first external device 50 may be connected to the internet. The first external device 50 may be configured to access a user’s cloud 53 (see Figure 3B).

The communication unit 23 may be configured to communicate with the at least one external device 50 via the first communication channel 61 , if the first communication channel 61 is established and available. In one embodiment, the processor unit 24 may be configured to control the communication unit 23 in response to a signal received from the first external device 50 or in response to a signal received from the communication unit 23.

The signal received, S110, from the first external device 50 may be a request to send information for localizing of the electronic system 20 to the first external device 50 via the established first communication channel 61. Upon receipt of the request, the processor unit 24 may be configured to control the communication unit to send, S111, the information for localizing the electronic system 20 to the first external device 50 via the first communication channel 61. With the information for localizing the electronic system 20 being available, the first external device 50, may be configured to provide, S124, the information for localizing the electronic system 20 to the user, e.g. for navigating the user to the electronic system 20.

In one embodiment, the information for localizing the electronic system 20 may be information relating to the current position of electronic system 20. This may comprise information regarding the relative position of the electronic system 20 with respect to the drug delivery device 1. Alternatively or additionally, information for localizing the electronic system 20 may comprise information regarding the overall position of the electronic system 20, e.g. satellite based position coordinates of the current position of the electronic system 20.

In one embodiment, the electronic system 20 may comprise a position determination unit 25. The position determination unit 25 may be configured to determine the information for localizing the electronic system 20. The position determination unit 25 may be connectable to or connected to the processor unit 24. The position determination unit 25 may be configured to determine the information for localizing the electronic system 20 via one or more of: satellite based position determination, e.g. Global Positioning System (GPS), Glosnass or Galileo, Bluetooth®, Bluetooth® Low Energy, WiFi™-Positioning-System, Ultra Wide Band technologies and other suitable technologies for determining the position of an object.

In one embodiment, the processor unit 24 may be configured to control the communication unit 23 based on a signal received from the communication unit 23. The signal may be a nonavailability information indicating that the first communication channel 61 is not available or cannot be established such that communication between the communication unit 23 and the at least one external device 50 is not possible. When the non-availability information is received, S101.1 , the processor unit 24 may be is configured to control the communication unit 23 to retry, S101.2, to establish the first communication channel 61. Alternatively or additionally, when the non-availability information is received, S101.1, the processor unit 24 may further be configured to control the communication unit 23 to try, S102, to establish at least one second communication channel 62 with at least one auxiliary device 51. The auxiliary device 51 may be a second external electronic device. Like the first external device 50, the auxiliary device 51 may be a mobile device, e.g. a smartphone, tablet or computer. Alternatively, the auxiliary device 51 may be a stationary device, e.g. a router or a server. The auxiliary device 51 may be connectable to or connected to the internet. The auxiliary device 51 may further be configured to access the user’s cloud 53.

In one embodiment, the auxiliary device 51 may be a trusted device. A trusted auxiliary device 51 may be a device different from the first external device 50 which is owned and/or used by the user. The trusted device may further be a device via which the user usually does not communicate with the electronic system 20. Alternatively, a trusted auxiliary device 51 may be a device which is not owned by the user but which is nonetheless trusted because it fulfills a predetermined condition. The predetermined condition may, for example, be that the electronic system had been paired with the auxiliary device 51 in the past with the user’s consent, as described above.

In one embodiment, the auxiliary device 51 may be a non-trusted device. A non-trusted device may be any device with which no communication channel had been established before. For example, a non-trusted device may be a mobile device of a third party.

The processor unit 24 may be configured to control the communication unit 23 to send, S121.1 or S121.2, the information for localizing the electronic system 20 to the auxiliary device 51, if the second communication channel 62 is available and the status of the auxiliary device 51 has been determined, S121.

In one embodiment, if the second communication channel 62 is available and the auxiliary device 51 is a trusted device, the processor unit 24 may be configured to control the communication unit 23 to send, S121.1 , information for localizing the electronic system 20 to the auxiliary device 51. If the auxiliary device 51 is a non-trusted device, the processor unit 24 may be configured to encrypt the information for localizing the electronic system before controlling the communication unit to send, S121.2, the encrypted information to the auxiliary device 51.

Afterwards, the auxiliary device 51 may be configured to send, S122.1 , the information for localizing the electronic system 20 to the first external device 50 when a direct connection between the auxiliary device 51 and the first external device 50 is or becomes available. For example, the auxiliary device 51 may send the information for localizing the electronic system to the first external device 50, when both devices are connected to the same WiFi-network or when a Bluetooth connection between both devices is established. Alternatively or additionally, the auxiliary device 51 may be configured to send, S122.2, the information for localizing the electronic system 20 to the user’s cloud 53. The user’s cloud 53 may be configured to send the information for localizing the electronic system 20 to the first external device 50. Alternatively or additionally, the user’s cloud 53 may be configured to store the information for localizing the electronic system 20 for a later access by the user.

The first external device 50 may be configured to retrieve, S123, the information for localizing the electronic system 20 from the user’s cloud 53. If encrypted, the first external device 50 may be configured to decrypt, S124.1 , the information for localizing the electronic system 20, after retrieving it from the user’s cloud 53. Alternatively or additionally, the user’s cloud 53 may be configured to decrypt, S124.1 , the encrypted information for localizing the electronic system 20 before sending the information to the first external device 50.

With the decrypted information for localizing the electronic system 20 being available, the first external device 50, may be configured to provide, S124, the information for localizing the electronic system 20 to the user. For example, the user may be visually, acoustically and/or haptically guided to the electronic system 20.

In one embodiment not shown in Figure 10, the processor unit 24 may be configured to control the communication unit 23 to retry to establish the second communication channel 62 after a predetermined pause interval, if the second communication channel 62 cannot be established or is not available, e.g. because connection is lost. The pause interval may have a length between less than 1 second and several hours. For example, the pause interval may be 1/10 of a second, half a second, 1 second, 5 seconds, 10 seconds, 30 seconds, 60 seconds, 120 seconds, 240 seconds, 5 minutes, 10 minutes, 30 minutes, 60 minutes, 2 hours, 5 hours, 10 hours, 24 hours etc.

In one embodiment, the processor unit 24 may be configured to control the communication unit 23 to repeatedly retry to establish the second communication channel 62, if it cannot be established. There may be the pause interval, optionally with varying length, between unsuccessful retries, as described above.

As further shown in Figure 3A, the electronic system 23 may comprise an owner indication unit 28. The owner indication unit 28 may have stored thereon owner information relating to the owner of the electronic system 20, e.g. contact details etc., as described above. In one embodiment, the owner indication unit 28 may comprise one or more of: a Near-Field- Communication (NFC) chip, a Radio-frequency identification (RFID) element and an information element (not shown), as described above. The owner indication unit 28 may be configured to be read-out, S131 , by a third electronic device 52 (see Figure 3B and Figure 10).

The third electronic device 52 may be a smartphone, a tablet, a computer, a router, a server etc. The third electronic device 52 may be connectable to or connected to the internet, but cannot communicate with the first external device 50, when reading-out the data. Further, the third electronic device 52 cannot access the user’s cloud 53 to send the information for localizing the electronic system 20 to the first external device 50 via the user’s cloud 53. For example, the third electronic device 52 may be a smartphone of a different proprietary IT-ecosystem than any device of the user, such that it cannot access communication structures to which a device of the user, e.g. the first external device 50, is connected. In other words, the third electronic device 52 may be a device which cannot communicate with the user. Alternatively or additionally, the third electronic device 52 may be a device unable to connect to the internet.

In the illustrated embodiment, the owner indication unit 28 may be an NFC-chip and the third electronic device 52 may be a smartphone of a different IT-ecosystem than the first electronic device 50. The NFC chip may be read-out wirelessly by the smartphone so that a third person owning the smartphone may retrieve contact details of the owner of the electronic system 20. Alternatively or additionally, the smartphone may be connected to the electronic device 20 via the output 27 so that the information may be read-out in a wired manner, e.g. via the communication link 41 (see Figure 9). The owner information may be read-out and made accessible to the third person without internet and/or cloud access.

In one embodiment not shown, the owner indication unit 28 may be configured to be activated and deactivated, e.g. by the processor unit 24. Accordingly, the owner information might be read-out only, if the owner indication unit 28 is activated, for example by the processor unit 24. In one embodiment, the processor unit 24 may be configured to read-out the owner information and to use the display 22 of the electronic system 20 for outputting the owner information, thereby making it accessible to a third person.

In one embodiment, the communication unit 23 may be configured to establish the first communication channel 61 and/or second communication channel 62 wirelessly, e.g. via one or more of WiFi, Bluetooth, Bluetooth Low Energy, Near-field-communication and communication technologies based on radiofrequency. As regards further technical details of the electronic system 20 and components thereof, e.g. the communication unit 23, the position determination unit 25 and/or the owner indication unit 28, reference is made to the foregoing, for the sake of avoiding repetitions.

According to an aspect of the disclosure, a drug delivery device 1 is provided. The drug delivery device 1 may be a variable dose injection device configured to inject a dose of drug set by the user into the user’s body, e.g. subcutaneously. As shown, the drug delivery device may be a pen-injector. The drug delivery device 1 may comprise a mechanism for dispensing the drug from a drug container 14 (see Figure 1). In one embodiment not shown, the drug delivery device 1 may comprise the electronic system 20 for measuring parameters of the drug delivery device 1, e.g. the electronic system shown in Figures 2, 3A and 3B and described in the foregoing. In one embodiment, the drug delivery device 1 may further comprise the drug container 14. The drug container 14 may comprise the drug.

In one embodiment, the drug delivery device 1 may be an autoinjector.

Referring to Figure 10, the steps of the method for localizing an electronic system 20 according to the present disclosure have been explained above. For the sake of avoiding repetitions, not all details will be set forth again. Instead, reference is made to the explanations given in the foregoing regarding components of the electronic system 20 which may be configured to perform the steps of the method.

The illustrated method comprises the step of trying, S101 , to establish a first communication channel 61 between a communication unit 23 of the electronic system 20 and a first external device 50. If the first communication channel 61 is available, the method comprises the step of receiving, S110, a request for information for localizing the electronic system 20 from the first external device 50. The method further comprises the step of sending, S111 , information for localizing electronic system 20 to first external device 50, which may provide, S124, the information to the user.

If the first communication channel 61 is not available, the method comprises the step of making the processor unit 24 receive, S101.1 , a non-availability information that the first communication channel 61 is not available, so the communication unit 23 cannot communicate with the first external device 50. In other words, communication unit 23 informs a processor unit 24 of the electronic system 20 about the non-availability of the first communication channel 61. When the information is received, S101.1 , it may be retried, S101.2, to establish the first communication channel 61. Alternatively or additionally, the illustrated method comprises the step of trying, S102, to establish a second communication channel 62 with an auxiliary device 51. If successful, the method comprises the step of determining, S121 , the status of auxiliary device 51 and send information, S121.1 , or send encrypted information, S121.2, for localizing electronic system 20 to the auxiliary device 51 , depending on the status of the auxiliary device 51, i.e. whether it is trusted or non-trusted. From the auxiliary device 51 , the information for localizing electronic system 20 may be sent, S122.1 , to the first electronic device 50. Alternatively or additionally, the information for localizing electronic system 20 may be sent, S122.2, to a user’s cloud 53, from where it may be retrieved, S123, by the first external device 50. If encrypted information for localizing electronic system 20 was sent, the information may be decrypted, S124.1, by the first external device 50 before it is provided, S124, to the user, e.g. to guide the user to the electronic system 20.

The method may further comprise the step of reading-out, S131 , owner information from an owner indication unit 28 of the electronic system 20. For example, the owner information may be read-out by a third electronic device 52 and/or a third person. In one embodiment, the owner information may be read out, if the first communication channel 61 and/or the second communication channel 62 are not available and cannot be established.

The method may further comprise the step of retrying, S101.2, to establish the first communication channel 61 , and/or the second communication channel 62, when the first communication channel 61 and/or the second communication channel 62 is not available or cannot be established. Retrying to establish the first and/or second communication channel 61, 62 may be repeated, if unsuccessful. There may be a pause interval between each repetition. The length of the pause interval may vary, e.g. depending on the number of failed retries. The number of retries may be limited, e.g. by a user input.

For the sake of facilitating the understanding of the electronic system 20 and the method of the present disclosure, three exemplary scenarios will be described in the following.

According to the first scenario, the user realizes a loss of the electronic system 20, i.e. the user cannot find the electronic system 20. Via the first external device 50, e.g. the user’s smartphone, the user may send a signal to the electronic system 20, requesting information for localizing the electronic system 20. If the first communication channel 61 between the electronic system 20 and the first external device 50 is available, the electronic system 20 can receive, S110, the request from the first external device 50. Subsequently, the processor unit 24 controls the communication unit 23 of the electronic system 20 to send, S111 , the information for localizing the electronic system 20, which is determined by the position determination unit 25 of the electronic system 20, to the first external device 50. Afterwards, the first external device 50 may provide, S124, information for guiding/navigating the user to the electronic system 20.

In the second scenario, the electronic system 20 determines that the first communication channel 61 is not available, e.g. because the connection between the electronic system 20 and the first external device 50, i.e. the user’s smartphone, has been lost, e.g. because the user moved too far away from the electronic system 20 with the smartphone. The processor unit 24 may determine the non-availability of the first communication channel 61 based on an information received from the communication unit 23. The electronic system 20 may then try, S102, to establish the second communication channel 62 between the electronic system 20 and the auxiliary device 51. If successful, the information for localizing the electronic system 20 may be sent from the electronic system 20 to the auxiliary device 51 , from where it may be sent, S122.2, to the user’s cloud 53. As soon as a connection between the user’s cloud 53 and the smartphone is available, the information may be received, S123, by the smartphone. The user may then get notified about the loss of the electronic system 20, e.g. via a push notification and/or when the user realizes the loss of the electronic system 20 and tries to use the smartphone to send the request for information for localizing the electronic system 20.

In one embodiment, the user may additionally be notified about the unavailability of the first communication channel 61 , e.g. via a push-notification on the smartphone, as soon as the connection between the smartphone and the electronic system 20 is lost. This may prevent the user from moving away from the electronic system 20 and may remind the user to go back to take the electronic system 20 before moving further.

In the third scenario, the electronic system 20 determines that neither the first communication channel 61 nor the second communication channel 62 is available. If not already active, the processor unit 24 may activate the owner indication unit 28, having stored thereon the owner information. For example, the display 22 of the electronic system may be activated to display the owner information. Alternatively or additionally, the owner indication unit 28 may comprise an NFC-chip, which may be always active. From the active or activated owner indication unit 28, the owner information may be read-out by the third electronic device 52 of any third person who has found the electronic system 20. With the owner information, the third person may then contact the user, e.g. by sending a message or calling.

According to an aspect of the disclosure, a computer program product or a computer readable storage medium is provided. The computer program product or the computer readable storage medium may comprise instructions which, when carried out by a processing unit, cause an electronic system to carry out a method for localizing an electronic system.

In one embodiment, the electronic system may be an electronic system 20 as described with reference to Figures 2, 3A and 3B above. In one embodiment, the method for localizing the electronic system may be a method as described with reference to Figure 10.

In one embodiment, the processing unit may be a processor unit 24 of the electronic system 20.

Figure 4 shows the injection button 11 and dosage knob 12 of the drug delivery device 1 in more detail. In the illustrated embodiment, the injection button 11 includes a cavity 30 on its upper surface, configured to receive at least a portion of the electronic system 20. In this embodiment, a sidewall of the cavity 30 includes an aperture 31 , through which a portion of the number sleeve 70 may be visible.

Figure 5 depicts the number sleeve 70. In the illustrated embodiment, castellations 72 are formed, e.g. moulded, on one end of the number sleeve 70. One end of the number sleeve 70 is provided with castellations 72 that may act as light barriers for light emitted by the light source 26a.

In the embodiment shown in Figure 5, twelve castellations 72 are provided. The twelve castellations and the gaps between them have widths selected to provide 24 "edges". Each edge may correspond to one dose increment, such that up to a maximum dose of 24 units may be shown on the number sleeve 70. The castellations 72 are formed using a material that has a reflectivity that differs from the reflectivity of an inner surface of the injection button 11.

The number sleeve 70 is arranged to rotate helically along one direction as a dose is programmed into the drug delivery device 1 using the dosage knob 12. The number sleeve 70 is arranged to rotate helically in an opposite direction during delivery of a medicament dose by the drug delivery device 1.

Figure 6 is a cross-sectional view of part of the electronic system 20 and the drug delivery device 1.

As shown in Figure 6, the dosage knob 12 and the housing 21 of the electronic system 20 include co-operating formations 71a, 73a. In this particular embodiment, these formations are in the form of a projection 73a provided in the housing 21 of the electronic system 20 and a detent 71a provided in the dosage knob 12. As shown in Figure 1 , the formations 71a, 71b, 71c have only a limited extent, so that the electronic system 20 cannot rotate relative to the dosage knob 12 when attached.

Since the electronic system 20 and dosage knob 12 cannot rotate relative to one another, they move correspondingly as a dosage is programmed into the drug delivery device 1. This may allow provision of a more ergonomic arrangement, since the electronic system 20 may provide a larger surface that may be gripped and rotated by the user during dosage programming. Alternatively or additionally, the electronic system 20 may be provided with formations on its outer surface to facilitate rotation of the electronic system 20 and, therefore, the dosage knob 12.

In arrangements where the electronic system 20 is to be releasably attachable to the drug delivery device 1 , the co-operating formations 71a, 73a may provide a form fit engagement, e.g. a clip-type engagement, that allows for easy removal of the electronic system 20. Such an arrangement may be useful where the electronic system 20 is to be used with disposable drug delivery devices 1 , since it allows the electronic system 20 to be removed from a drug delivery device 1 easily. This facilitates re-use and allows the user greater flexibility in attaching and removing the electronic system 20 at will.

Alternatively, the co-operating formations 71a, 73a may be configured to attach the electronic system 20 to the drug delivery device 1 permanently, for example, using a "snap-fit". In other embodiments, the electronic system 20 maybe permanently attached in other ways, for example, through bonding. Such permanent attachments may be useful where the injection device 1 is reusable.

In one embodiment, the number and/or positions of the co-operating formations 71a, 73a may be configured so that the electronic system 20 may only be attached to the drug delivery device 1 in one particular position. In this particular example, the housing 21 of the electronic system 20 may include an aperture 74 through which light emitted by the light source 26a may pass and may be detected by the light detector 26b when the electronic system 20 is in position. The co-operating formations 71a, 73a may be arranged so that, when the electronic system 20 is attached to the drug delivery device 1, the aperture 74 in the housing 21 of the electronic system 20 is aligned with the aperture 31 in the sidewall of the cavity 30 in the injection button 11 , as shown in Figure 6. As shown by the arrow in Figure 6, light emitted by the light source 26a thus may pass through the apertures 74, 31 and into the injection button 11. If a castellation 72 of the number sleeve 70 is viewable through the aperture 31 , then the light will be reflected from the castellation 72, and back through the apertures 31 , 74, where it may be detected by the light detector 26b. Since the reflectivity of the castellations 72 differs from that of the inner surface of the injection button 11 , the amount of light detected by the light detector 26b will depend on how much of a castellation 72 may be viewed through the aperture 31.

In certain embodiments, the interface 26 may be arranged to emit and/or detect only light with particular polarization characteristics, in order to mitigate effects of stray light entering the aperture 74.

Figure 7 is a graph showing changes in the intensity of light received by the light detector 26b during programming and delivery of a medicament dose, while Figure 8 is a graph showing an output that may be generated by the interface 26 of this embodiment.

As noted above, while a dose is being programmed into the drug delivery device 1 , during a time period t1 in Figures 7 and 8, the dosage knob 12 and the number sleeve 70 rotate helically. As the electronic system 20 moves in concert with the dosage knob 12, the amount of light reflected back towards the light detector 26b should remain substantially constant, since there is little or no relative rotational movement between the number sleeve 70 and the electronic system 20. The amount of reflected light should also remain substantially constant between the completion of dosage programming and the start of the injection, shown as a time period t2 in Figure 7, since the number sleeve 70, the dosage knob 12 and the electronic system 20 are not moved by the user.

The output of the interface 26, which may be a sensor arrangement shown in Figure 8, is therefore substantially constant during time periods t1 and t2. The actual level of the output during time periods t1 and t2 will depend on whether a castellation 72 is visible through the aperture 31 and, if so, how much of the aperture is covered by the castellation 72.

During the delivery of the medicament, shown as time period t3 in Figures 7 and 8, the number sleeve 70 rotates helically but the dosage knob 12 moves only axially, without rotating. Hence, the number sleeve 70 is rotating relative to the electronic system 20.

During time period t3, the castellations 72 of the number sleeve 70 will move across the aperture 31 as the number sleeve 70 rotates relative to the dosage knob 12 and the electronic system device 20, and the intensity of light received by the light detector 26b will vary accordingly, as shown in Figure 7. The number sleeve 70 may be more reflective than the inner surface of the injection button 11 , and so the highest intensity levels shown in Figure 7 may correspond to positions where the amount by which the castellation 72 covers the aperture 31 is at its greatest.

The output of the light detector 26b during time period t3 will switch between a high and a low level, based on the received light intensity, as shown in Figure 8. Since the edges of the castellations 72 correspond to increments in the medicament dosage, the processor unit 24 may determine an amount of medication delivered by the drug delivery device 1 based on the number of transitions between the high level and the low level in the output of the sensor arrangement 26.

The length of time period t3 will depend on the administered dosage. Further, the length of time period t3 may depend on a time at which the medicament delivery is completed. When the medicament delivery is completed, the number sleeve 70 will cease to rotate relative to the dosage knob 12 and the electronic system 20, and the signal from the sensor arrangement 26 will stay at a substantially constant level.

In some embodiments, the processor unit 24 is arranged to monitor the time period that has elapsed from the last transition or the last pulse in the output of the interface 26. When the elapsed time period reaches a predefined threshold t4, the medicament delivery is considered to have been completed and the processor unit 24 proceeds with determining the medicament dose delivered to the user, based on the number of detected transitions in the output of the sensor arrangement 26 during time period t3. In the particular example shown in Figures 7 and 8, there are eight transitions. Since the transitions correspond to the edges of the castellations which, in turn, correspond to the dosage increments in this particular embodiment, the determined medicament dose is 8 units.

The processor unit 24 then stores the determined medicament dose in main memory 24.2. The processor unit 24 may also store time stamp information, to provide a log recording delivery of medicament to the user.

The processor unit 24 may then power down the electronic system 20, in order to save energy.

When the electronic system 20 is powered on again, e.g. when the user activates the power switch 29.1 , the processor unit 24 may control the display to show the determined medicament dose information 22a, to aid the memory of the user. Optionally, the processor unit 24 may monitor an elapsed time since the determined medicament dose was delivered and control the display to show that elapsed time information too. For example, the processor unit 24 may cause the display 22 to switch periodically between displaying the determined medicament dosage information 22a and the elapsed time.

In one embodiment, the processor unit 24 may be configured to control the communication unit 27 to transmit one or more of the determined medicament dosage and, where determined, the time stamp information to the first external device 50, e.g. via the first communication channel 61. Alternatively or additionally, the electronic system 20 may be connected to the first external device 50 using the wired communication link 41. The processor unit 24 may be configured to transmit the information to the external device 50 periodically and/or upon a user interaction.

In one embodiment, the processor unit 24 may also transmit the determined medicament dosage and, where determined, the time stamp information to another device, such as a computer 40, as shown in Figure 9. As noted above, the output 27 may be configured to transmit the information using a wireless communications link. Alternatively, the data collection device 20 may be 30 connected to the computer 40 using a wired connection 41 to allow the information to be uploaded to the computer 40. The processor unit 24 may be configured to transmit the information to the computer 40 periodically.

The specific embodiments described in detail above are intended merely as examples of how the present invention may be implemented. Many variations in the configuration of the electronic system 20 and/or the drug delivery device 1 may be conceived.

For example, it is not necessary that the formations 71a, 71b, 71c are provided on the number sleeve 70. Neither is it necessary that the formations are in the form of castellations 72, nor is it necessary that the widths of the castellations and the gaps between them correspond precisely to individual dosage increments, as exemplarily described above.

While it is exemplarily described herein that the interface 26 may be an optical sensing arrangement 26, other types of sensors may be used as well as, or instead of, optical sensors. For example, the interface may include a magnetic sensor, such as a Hall effect sensor. In such an example, one or more magnets may be mounted on the number sleeve, so that rotation of the number sleeve relative to the electronic system results in a varying magnetic field. In another example, a capacitive sensor may be used, where elements provided on the number sleeve may affect the capacitance between two plates provided in the electronic system. In other examples, mechanical sensors, with mechanical switches and/or tracks, may be used to detect the relative movement.

In the above , the injection button 11 is exemplarily described as including a central cavity 30 for receiving at least part of the electronic system 20. However, the central cavity 30 may be omitted if not required by the structure of the electronic system 20.

While the arrangement shown in Figure 6 includes co-operating formations in the form of a detent 71 a in the dosage knob 12 and a projection 73a in the housing 21 of the electronic system 20, other types of co-operating formations or attachment methods may be used.

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., short- or long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a 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-(w-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 antigenbinding 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.

Although embodiments of the present disclosure and their advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made therein without departing from the spirit and scope of the disclosure as defined by the appended claims. For example, it will be readily understood by those skilled in the art that many of the features, functions, processes and methods described herein may be varied while remaining within the scope of the present disclosure. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the system, process, manufacture, method or steps described in the present disclosure. As one of ordinary skill in the art will readily appreciate from the disclosure of the present disclosure, systems, processes, manufacture, methods or steps presently existing or to be developed later that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present disclosure. Accordingly, the appended claims are intended to include within their scope such systems, processes, methods or steps. The embodiments mentioned in the first part of the description may be combined with each other. The embodiments of the description of figures may also be combined with each other. Further, it is possible to combine embodiments mentioned in the first part of the description with examples of the second part of the description which relates to Figures 1 to 10.

List of reference numbers

I drug delivery device

10 housing

I I injection button

12 dosage knob

13 window

14 insulin container

15 needle

16 inner needle cap

17 outer needle cap

18 cap

20 electronic system

21 electronic system housing

22 display

22a dosage information

23 communication unit

24 processor unit

24.1 program memory

24.2 main memory

25 position determination unit

25.1 sensing unit

25.2 localization unit

25.3 physically perceptible component

25.4 non-physically perceptible component

26 Interface

26a light source

26b light detector

27 output

28 owner indication unit

29.1 power switch

29.2 battery

30 cavity

31 aperture 40 computer

41 communication link

50 external device

51 auxiliary device

52 third electronic device

53 cloud

61 first communication channel

62 second communication channel

70 number sleeve

71a formation

71b formation

71c formation

72 castellation

73a projection

74 aperture

5101 try to establish first communication channel with first external device

5101.1 receive non-availability information from communication unit

5101.2 retry to establish first communication channel

5102 try to establish second communication channel with auxiliary device

5110 receive request for information for localizing from first external device

5111 send information for localizing electronic system to first external device

S121 determine status of auxiliary device

5121.1 send information for localizing electronic system to trusted auxiliary device

5121.2 send encrypted information for localizing electronic system to non-trusted auxiliary device

5122.1 send information for localizing electronic system to first external device

5122.2 send information for localizing electronic system to cloud

5123 retrieve information for localizing electronic system from cloud

5124 provide information for localizing electronic system

S124.1 decrypt encrypted information for localizing electronic system

S131 read-out owner indication unit

Claims

1. An electronic system (20) for measuring parameters of a drug delivery device (1), comprising: a communication unit (23) configured to try to establish at least one first communication channel (61) with at least one external device (50), e.g. a first external device, and, if the first communication channel (61) is established, the communication unit (23) is configured to communicate with the at least one external device (50) via the first communication channel (61); and a processor unit (24) connected to the communication unit (23), wherein the processor unit (24) is configured to control the communication unit (23) in response to a signal received from the at least one external device (50) or in response to a signal received from the communication unit (23).

2. The electronic system (20) of claim 1 , wherein the signal received from the first external device (50) is a request to send information for localizing of the electronic system (20) to the at least one external device (50) via the first communication channel (61).

3. The electronic system (20) of claim 2, further comprising a position determination unit (25) configured to determine the information for localizing the electronic system (20).

4. The electronic system (20) of any one of the preceding claims, wherein the signal received from the communication unit (23) is a non-availability information indicating that the first communication channel (61) is not available such that communication between the communication unit (23) and the at least one external device (50) is not possible.

5. The electronic system (20) of claim 4, wherein, when the non-availability information is received, the processor unit (24) is configured to control the communication unit (23) to try to establish at least one second communication channel (62) with at least one auxiliary device (51).

6. The electronic system (20) of claim 5, wherein, when the second communication channel (62) is available, the processor unit (24) is configured to control the communication unit (23) to send the information for localizing the electronic system (20) to the auxiliary device (51).

7. The electronic system (20) of claim 5, wherein, when the second communication channel (62) is not available, the processor unit (24) is configured to control the communication unit (23) to retry to establish the second communication channel (62) after a predetermined pause interval, and wherein, optionally, the processor unit (24) is configured to control the communication unit (23) to repeatedly retry to establish the second communication channel (62), e.g. after the predetermined pause interval.

8. The electronic system (20) of any of the preceding claims, further comprising an owner indication unit (28) having stored thereon owner information relating to the owner of the electronic system (20).

9. The electronic system (20) of claim 8, wherein the owner indication unit (28) is configured to be activated and deactivated by the processor unit (24), and wherein, when activated, the owner information can be read-out by a third electronic device (52) and/or read by a third person.

10. The electronic system (20) of claim 9, wherein, when the second communication channel (62) is not available and a predetermined condition is fulfilled, the processor unit (24) is configured to activate the owner indication unit (28).

11. The electronic system (20) of any one of the preceding claims, wherein the communication unit (23) is configured to establish the first communication channel (61) and/or the second communication channel (62) wirelessly, e.g. via one or more of WiFi, Bluetooth, Near-field-communication and communication technologies based on radiofrequency, and/or wherein the position determination unit (25) is configured to determine the information for localizing the electronic system via one or more of: satellite based position determination, Bluetooth, Bluetooth Low Energy, WiFi-Positioning-System and Ultra Wide Band technologies.

12. The electronic system (20) of any one of claims 3 to 11 , wherein the position determination unit (25) is configured to determine the information for localizing the electronic system (20) upon receipt of a localization request from the processor unit (24).

13. The electronic system (20) of any one of claims 6 to 12, wherein the processor unit is configured to determine the status of the auxiliary device before sending the information for localizing the electronic system.

14. The electronic system (20) of claim 13, wherein the processor unit is configured to adapt the format of the information for localizing the electronic system depending on the status of the auxiliary device.

15. Drug delivery device (1), comprising: the electronic system (20) according to one of the preceding claims, and a mechanism for dispensing a drug from a drug container (14) or a reservoir of the drug delivery device (1), wherein, optionally, the drug delivery device comprises the drug container (14) or the reservoir containing the drug.

16. Method for localizing an electronic system, the method comprising the following steps: a) trying to establish (S101) at least one first communication channel (61) between an electronic system (20) and a first external device (50); b) if the first communication channel (61) is established, i) receiving (S110), via the first communication channel (61), a signal from the first external device (50) requesting information for localizing the electronic system (20); and ii) sending (S111) information for localizing the electronic system (20) to the first external device (50) via the first communication channel (61); or c) if the first communication channel (61) is not available, trying (S102) to establish a second communication channel (62) with an auxiliary device (51), and iii) if the second communication channel (62) is established, sending

(S121.1 , S121.2) information for localizing the electronic system to the auxiliary device via the second communication channel (62).

17. A computer program product, e.g. a computer program or a computer readable storage medium, comprising instructions which, when carried out by a processing unit, cause the electronic system (20) according to any one of claims 1 to 14 to perform the method according to claim 16.

18. An electronic system (20) for measuring parameters of a drug delivery device (1), comprising: a communication unit (23) configured to try to establish at least one first communication channel (61) with at least one external device (50), e.g. a first external device, and, if the first communication channel (61) is established, the communication unit (23) is configured to communicate with the at least one external device (50) via the first communication channel (61); and a processor unit (24) connected to the communication unit (23), wherein the processor unit (24) is configured to control the communication unit (23) in response to a signal received from the at least one external device (50) or in response to a signal received from the communication unit (23), wherein the signal received from the communication unit (23) is a non-availability information indicating that the first communication channel (61) is not available such that communication between the communication unit (23) and the at least one external device (50) is not possible, wherein, when the non-availability information is received, the processor unit (24) is configured to control the communication unit (23) to try to establish at least one second communication channel (62) with at least one auxiliary device (51), and wherein, when the second communication channel (62) is not available, the processor unit (24) is configured to control the communication unit (23) to repeatedly retry to establish the second communication channel (62) after a predetermined pause interval.