User equipment, electronic system, drug delivery device, method, machine-readable code, data storage medium, and set

Abstract

A user equipment is proposed, the user equipment including an electronic control unit (42) and a wireless communication unit (44) operably coupled to the electronic control unit, the electronic control unit (42) operable to determine at least one characteristic associated with at least one component of the drug delivery device (10), the user equipment configured to control the operation of the wireless communication unit (44). Further provided are an electronic system, a drug delivery device, a method, a machine readable code, a data storage medium, and a set.

Description

[Technical field]

[0001] The present disclosure relates to a user equipment, preferably a user equipment for controlling the operation of a drug delivery device or for preparing the drug delivery device for an operation, such as a medication operation. The present disclosure further relates to an electronic system for the drug delivery device, one or more components for the drug delivery device, the drug delivery device, and a method for preparing the drug delivery device for an operation. Additionally, machine readable code, a data storage medium, and a set are provided. [Background technology]

[0002] Various kinds of pen-type and needle-based injection devices are known. Needle-based injection system (NIS) devices are used by patients to conveniently perform frequent (e.g. subcutaneous) injections of drugs, for example insulin for diabetic patients. These NIS devices usually have a mechanism for selecting or setting the dose of the drug to be injected within certain limits, i.e. the injected dose is varied within these limits. In recent years, NIS devices tend to be equipped with more and more electronics to measure and / or detect the selected and / or injected dose and then store it in an internal memory and / or transmit it to an external device for dose logging purposes, etc.

[0003] Different users or patients may need to administer different medications using different devices, which may look similar at first glance, and which are stored in the home where different people could theoretically have access to the devices. Summary of the Invention [Problem to be solved by the invention]

[0004] It is an object of the present disclosure to provide improvements, particularly relating to drug delivery devices or apparatus or systems intended to operate with or be integrated into drug delivery devices.

[0005] This object is achieved by the subject matter of the independent claims. Advantageous embodiments and refinements are the subject matter of the dependent claims. It is to be noted that the present disclosure may provide other advantageous solutions or features besides the solutions claimed in the independent claims. [Means for solving the problem]

[0006] One aspect of the present disclosure relates to user equipment.

[0007] In one embodiment, the user equipment includes an electronic control unit. The user equipment further includes a wireless communication unit operably coupled to the electronic control unit. The electronic control unit is configured to control an operation of the wireless communication unit. The wireless communication unit is operable to determine at least one characteristic associated with at least one component of the drug delivery device. The electronic control unit is preferably configured to evaluate the at least one determined characteristic.

[0008] In one embodiment, based on the results of the evaluation or the determined characteristics, the user equipment is configured to communicate with the drug delivery device, e.g., change the state of the device, or communicate with the user, e.g., indicate whether the device with which the equipment is communicating is the device that the user should use for the next drug administration.

[0009] In one embodiment, based on a result of the evaluation of the at least one determined characteristic, the electronic control unit is configured to issue or determine whether to issue one or more control unit commands. The control unit commands may be commands for affecting a state of a user equipment, e.g. for causing information to be provided by the equipment to a user, or for affecting a state of a drug delivery device, e.g. via a wireless communication unit.

[0010] In one embodiment, the user equipment includes an equipment signalling unit.

[0011] In one embodiment, the one or more control unit commands include a command configured to cause an equipment signaling unit of the user equipment to present information about the drug delivery device to a user, The presented information may be based on at least one determined characteristic or a result of an evaluation of the characteristic.

[0012] In one embodiment, the one or more control unit commands include a command configured to cause the wireless communication unit to transmit a system command to an electronic system of or for the drug delivery device, via which a state of the device is changed.

[0013] In one embodiment, the electronic control unit is configured to determine, for example based on a result of the evaluation, whether the wireless communication unit should send at least one unlock command as a system command to the electronic system, the unlock command being sent to unlock or activate at least one usability function of the drug delivery device.

[0014] In one embodiment, the user equipment is configured to issue or transmit a control unit command (e.g., a system command or a command sent to the equipment signaling unit) and / or an unlocking command or a system command when, and preferably only when, the result of the evaluation is that at least one determined characteristic satisfies at least one predetermined criterion, for example, whether the device is within a predetermined distance from the user equipment and / or whether the components of the device are compatible with each other. The latter is particularly advantageous when components such as a container module for holding a medicament and a mechanism module including a drive mechanism operable to set a dose in a dose setting operation and to deliver a set dose in a dose delivery operation are releasably coupled to each other. In many cases, one mechanism module can be used with multiple container modules having the same medicament, when the medicament provided by one container module is delivered and a new container module is coupled to the mechanism module. Having the devices within a predetermined distance makes it easier for the user to ensure that they are handling the correct device.

[0015] In one embodiment, having the usability functions unlocked (e.g., only unlockable) by the user equipment provides a significant increase in security. For example, without unlocking of the usability functions controlled by the user equipment, the usability functions, e.g., medication administration operations, cannot be performed. The usability functions can preferably be unlocked only when the device is in the user's hand or closer to the wireless communication unit than the user's hand, and / or when an evaluation of the characteristics determined by the user equipment results in the device actually being unlocked, e.g., because its components are compatible or it is the correct device. This can include determining whether the medication the device should administer is the medication currently required by the user or should be administered according to a medication administration scheme.

[0016] In one embodiment, the equipment signaling unit is configured to indicate to the user whether a predefined criterion is met or not. Signaling to the user whether a component is compatible or not and / or whether the device is within a predefined distance from the user equipment is advantageous and enhances user safety.

[0017] In one embodiment, the user equipment includes a memory, e.g., a non-volatile memory. The memory can be configured to store dose history information regarding drug amounts or doses delivered in dose delivery operations performed by a user. The memory can store information regarding drugs that the user needs to administer. The user equipment can include a reminder function, which is operable to remind the user, e.g., visually or audibly, when a drug needs to be administered, e.g., by comparing time information regarding the last administration of a particular drug with a current time or administration schedule. The memory can store pairing information regarding which drug delivery devices are allowed to communicate with the user equipment.

[0018] In one embodiment, the user equipment is preferably an electronic device for personal use. The user equipment can be a separate device from the drug delivery device. The user equipment is expected to have a product life longer than the product life of the drug delivery device. The user equipment may be or include a general purpose computing unit. This unit may function as an electronic control unit.

[0019] In one embodiment, the user equipment is a wearable device. A wearable device is a device worn by a user such that the device is tethered to the user's body during its intended use, and preferably is always in the same position relative to the body or in the same body area during its intended use. The wearable device may be a wrist-worn device or a wrist-wearable device. The wrist is close to the user's hand, and therefore communication with a drug delivery device or elements thereof held by the user in the hand near the wrist, or when the device is brought close to the user equipment, is facilitated, for example, when short-range communication is used as the wireless communication technology. The wearable device may be, for example, a smart watch or a smart bracelet. As an alternative to a wearable device, the user equipment may be a handheld device, for example, a smartphone or a tablet PC. As a further alternative, the user equipment may be a dedicated device, specifically for controlling and / or managing one or more drug delivery devices, such as, for example, a bracelet or an ID badge worn by personnel of a medical facility or a nursing home.

[0020] In one embodiment, the electronic control unit includes a processor unit and / or an ASIC (Application Specific Integrated Circuit). The electronic control unit may include a memory for storing data and / or for storing machine readable code executed by the processor unit. The electronic control unit is conductively connected to the wireless communication unit, for example, via conductors on a circuit board.

[0021] In one embodiment, the wireless communication unit is or includes an electronic circuit configured to transmit and / or receive waves, e.g., radio waves, for establishing a data transfer connection. The unlock command can be transmitted via a communication circuit different from the communication circuit used to determine the characteristic. The wireless communication unit can include at least one wireless communication circuit that transmits and receives (transmits and / or receives) in a specific frequency range and / or follows a specific transmission protocol. The wireless communication unit can include multiple communication circuits, each of which transmits and receives in different frequency ranges and / or according to different wireless transmission protocols. The wireless communication unit can include at least one RFID communication circuit (radio frequency identification). The wireless communication unit can include an NFC circuit (near field communication), e.g., an active NFC circuit (preferably with a power source, e.g., a battery such as a printable battery), or a passive NFC circuit (preferably without a power source powering the circuit). The wireless communication unit can include at least one Bluetooth and / or BLE communication circuit (Bluetooth Low Energy). The wireless communication unit can include at least one WiFi communication circuit (e.g., Wireless Fidelity according to IEEE 802.11 standard / protocol). Alternatively or additionally, the wireless communication unit may include a magnetometer / compass circuit for detecting variations in a magnetic field, for example variations caused by wireless communication circuitry of a component of the drug delivery device.

[0022] In one embodiment, a "wireless communication unit operable to determine" may refer to the receipt and / or evaluation of at least one signal by the wireless communication unit. The signal may be received in response (or as a response) to a request transmitted via the wireless communication unit, for example, to a component of a drug delivery device.

[0023] In one embodiment, the drug delivery device is a device configured to expel a drug from a container and provide the drug to a patient. The drug delivery device includes a needle or is provided to be coupled to a needle for transferring the drug from the container to the patient, for example when the needle is inserted into the patient's body. The drug delivery device can include several components (e.g., modules, such as pre-assembled modules). The components of the drug delivery device can include an electronic system (electronics module), a drive mechanism (mechanism module), a drug container, and / or a container holder for the drug container (container module). The container can be a cartridge. The holder is configured to receive the container. The electronics module and the mechanism module can be integrated into a common module, or the electronics module can be, for example, removably attachable to the mechanism module. The container module and the mechanism module are or can be permanently or removably coupled.

[0024] In one embodiment, the drive mechanism is a mechanism configured to push the medicament out of its container. The drive mechanism may include a conversion unit that converts energy provided by a user and / or an energy storage, such as at least one mechanical spring, an electronic battery (one or more chemical cells) or pressurized air, or other suitable means, into a motion that pushes the medicament out of the container. The drive mechanism may include a piston rod that is axially moved to push the medicament out of the container, for example by displacing a plunger or bung of the container towards the dosing end of the container.

[0025] In one embodiment, the usability features of the drug delivery device are essential features for the proper use of the drug delivery device. Preferably, the device cannot operate unless the usability features are executable. If a usability feature is locked, e.g. before being unlocked, the feature will not be executed or the drug delivery device will not be usable.

[0026] In one embodiment, the at least one characteristic includes a distance or proximity between the component and the user equipment, e.g., its wireless communication unit. Evaluating the at least one determined characteristic may include determining whether the component or the entire drug delivery device is within a predetermined distance of the user equipment. If and only if the result of the evaluation is that the component or the drug delivery device is within the predetermined distance, an unlock command is transmitted or the electronic control unit commands the transmission of an unlock command, e.g., via the wireless communication unit. Thus, the proximity of the user equipment to the component or device may be one of the criteria that must be met for the unlock command to be transmitted. This evaluation may include determining or monitoring the distance, or checking whether a signal is received from the device's short-range communication circuitry, which already suggests proximity due to the short distance of the short-range communication.

[0027] The at least one determined characteristic may include a distance and / or proximity of the components, a distance and / or proximity of at least two of the components, or a distance and / or proximity of all of the components. The electronic control unit may be configured to transmit an unlock command when, e.g., only when, at least one component of the drug delivery device, e.g., at least two of the components, e.g., all of the components, are determined to be within a predetermined distance of the user equipment. The components are evaluated to be in proximity when a response signal is received after a request signal is transmitted (e.g., when a very short range communication module such as NFC is used) and / or when the distance (e.g., determined via signal strength detection / evaluation (RSSI) and / or time of flight measurement) is less than 2 m, e.g., less than 1 m, e.g., less than 0.5 m, less than 20 cm, less than 15 cm, less than 10 cm. This may ensure that the drug delivery device is only used when in proximity with the intended user and not by unauthorized users. Preferably, the predetermined distance is equal to or less than the distance between the wrist and the tips of the outermost fingers when the hand is open, or equal to or less than the distance between the wrist and the end of the fist away from the wrist when the hand adjacent the wrist, preferably the wrist on which the user device is or will be worn, is made into a fist.

[0028] In one embodiment, the predetermined distance is less than or equal to one of the following values: 20cm, 15cm, 10cm, 9cm, 8cm, 7cm, 6cm, 5cm, 4cm, 3cm, 2cm, 1cm, 5mm, 3mm, 2mm, 1.5mm, 1mm.

[0029] In one embodiment, the user equipment is configured to determine whether the drug delivery device or a component thereof is within a predetermined distance from the user equipment, this predetermined distance being typically the distance between the wrist-worn device and the user's hand or the palm of the user's hand, preferably the wrist and the hand involved, e.g. 7-14 cm. Thus, the operation of the drug delivery device is controlled by the user equipment when it is at least highly likely that the user is holding the device in his / her hand. Only when it is confirmed that it is highly likely that the user is holding the device in his / her hand is the unlock command sent. For this purpose, a technology different from NFC may be required for distance measurement and / or monitoring, especially when the hand is adjacent to the wrist of the same arm (see above). Near field wireless communication may also be employed when the other hand is used to bring the device closer to the (wrist-worn) user equipment.

[0030] In one embodiment, to be assessed as being within a predetermined distance, the drug delivery device or a component thereof must be closer to the wrist-worn device than to the hand adjacent the wrist on the same arm, for example when using NFC circuitry, however this requires the user to be closer to the particular device.

[0031] In one embodiment, the at least one determined characteristic includes identifiers of at least two components of the drug delivery device. The respective identifiers are included in or provided by the identifier circuit. Evaluating the at least one determined characteristic may include determining whether the at least two components of the drug delivery device are compatible with each other. The user equipment, e.g. the electronic control unit, is configured to transmit an unlock command when, and preferably only when, the components are compatible with each other, conveniently after evaluation of the characteristics by the electronic control unit. Thus, compatibility between the components of the drug delivery device may be a criterion that must be met for the unlock command to be transmitted. The identifiers may be or may include a component type identifier, a drug type identifier, and / or a device identifier. The identifiers may be or may include a product ID. The electronic control unit is configured to compare the determined identifiers of the components with a look-up table stored in the memory to determine or evaluate compatibility. The drug delivery device, and in particular the drive mechanism, is compatible with or designed only for a specific drug or drug formulation. Thus, the evaluation of whether the components are compatible may include checking whether the drive mechanism is designed for the container module or for delivering the drug contained in the container module. The drive mechanism is configured such that for a given dose setting operation, e.g. a rotation of the dose setting member through a given angle, the axial displacement of the piston rod, which usually correlates with the amount of drug expelled when the same container is used, is always the same regardless of the drug used with the drive mechanism. Therefore, if a drug is administered using a drive mechanism that is not designed for it, there is a serious risk of applying either an incorrect dose, an overdose or an underdose, since for example the concentration of the active ingredient in the drug or the container dimensions may differ for the correct drug and the wrong drug. Also, different drive mechanisms can be designed for different drug volumes, e.g. with regard to a dose setting limiting function that drug delivery devices often have. This function prevents the setting of a dose that exceeds the amount of liquid remaining in the container.Thus, the evaluation can include confirmation that the mechanism and the medication or medication container are suitable for use together. Unlocking the usability features only when the components (modules) match or fit with each other can reduce the risk that the wrong medication and / or the wrong medication amount is applied with a particular drive mechanism, and vice versa.

[0032] In one embodiment, the electronic control unit is configured to send the unlock command only when proximity and compatibility are verified, however, any verification regarding proximity or compatibility to trigger the unlock command is also encompassed by the present disclosure.

[0033] In one embodiment, the user equipment is configured to determine, at one relative position relative to the drug delivery device, for example simultaneously, a first identifier of a first component and a second identifier of a second component of the device. Thus, the first identifier is located on the first component and the second identifier is located on the second component. Both identifiers may be within communication range of a wireless communication unit, for example, some communication circuitry of the unit, for example, an NFC circuitry. The first and / or second identifier may be or include a passive or active NFC circuitry. The relative position may be near the wireless communication unit, for example, within 2 cm or less, or 1 cm or less, or 0.5 cm or less of the unit, for example, within 1 mm of the unit.

[0034] In one embodiment, the user equipment includes an equipment signaling unit, which is preferably operably coupled to the electronic control unit. The signaling unit is formed by or includes a display. The signaling unit is configured to show an audible and / or visual indication, for example via a speaker or a multi-pixel display. The signaling unit, preferably when commanded by the electronic control unit, is configured to: - an alarm for a scheduled delivery operation or drug administration, e.g. an audible and / or visual alarm signal (the determination of whether an administration is scheduled or not is made by the electronic control unit based on dose history or administration history values ​​retrieved from the drug delivery device or from the internal memory of the user equipment); and / or - device identification information to indicate which drug delivery device the user should use for the next drug administration in a dose delivery operation (the indication of the device identification information can be made before the user selects the device for the delivery operation. The indication of the device identification information in the signaling unit can be correlated with an indication given on the device, for example a mark of the same color, the same symbol or the same text. The indication shown on the device can be a permanent one, for example a color mark, or is given by the device signaling unit, for example upon receiving a request by the user equipment. The indication of the device identification information can be a signal indicating which drug delivery device should be used. The device identification information may be a feature that distinguishes the device from other, e.g. visually similar, devices. The electronic control unit is configured to determine the device identification information after a pairing process with the drug delivery device, e.g. by device ID or user entry. Alternatively or additionally, the device identification information may be a characteristic, e.g. a visible and / or audible signal, e.g. activated by the drug delivery device only temporarily during an alarm condition of a scheduled drug administration, a flashing light (LED) of a particular color or symbol, e.g. only visible when backlit. This may prevent mix-up of similar devices used in the same household; and / or - a ready state of the drug delivery device, e.g. after sending an unlock command; the device can have a locked state, e.g. a state in which a dosing operation, e.g. a dose setting operation and / or a dose delivery operation, is not possible, and a ready state, e.g. a state in which a dosing operation is possible. For example, the ready state is indicated or the drug delivery device can be in the ready state, e.g. only when the device is unlocked and a dosing operation is possible; and / or - information regarding whether a criterion for evaluating at least one determined characteristic is met (in other words, the signaling unit may indicate whether the components of the device are compatible or not and / or whether the distance between the user equipment and the device is sufficiently small or not. Thus, the signaling unit may indicate information regarding the compatibility of the components of the drug delivery device, e.g. components that are removably connectable to one another, e.g. a mechanism module and a reservoir module. If the components are found to be incompatible, the user is prompted by the information indicated by the signaling unit to replace one of the components with another. If compatibility is confirmed, the indicated information may assure the user that the device is properly set up. If the device is found not to meet the distance or proximity criterion, the user is prompted via the signaling unit to use a different device); and / or - a dose to be set in the drug delivery device for a dose delivery operation, preferably after indicating a ready state and / or after compatibility and / or proximity of the device's components have been confirmed (the dose can be calculated by the user equipment or retrieved from the electronic system of the drug delivery device. The calculation of the dose may include consideration of the time elapsed since the last drug administration, i.e. the last drug delivery operation, the dose delivered in that administration, and / or the time until the next planned / scheduled administration. The electronic control unit is configured to adapt the dose to be set according to the component type identifiers of the drug container, the cartridge holder and / or the drive mechanism. The dose to be set may depend on the combination of components used, to compensate for different parameters such as e.g. container diameter or drug. However, it is also possible that the drive mechanism is applicable only for one type of drug formulation in a specific container with a specific volume of liquid drug therein) may be configured to present at least one, an arbitrarily selected plurality, or all of the above to, for example, a user.

[0035] Another aspect of the present disclosure relates to an electronic system for a drug delivery device.

[0036] In one embodiment, the electronic system includes a system wireless communication unit. The system wireless communication unit is configured to communicate with the user equipment, preferably with the wireless communication unit of the user equipment, for example via a circuit different from that used for the proximity check. The system wireless communication unit is preferably configured to wirelessly communicate with the user equipment, for example the user equipment further described above, to receive an unlock command from the user equipment. The electronic system further includes a system electronic control unit. The system electronic control unit is operably coupled to the system wireless communication unit. The system electronic control unit is configured to issue an activation command for activating at least one usability function of the drug delivery device in response to the unlock command. The electronic system is integrated into the mechanism module or, for example, releasably coupleable or coupled to the module. The communication unit and the control unit are generally configured as further described above with respect to the control unit of the user equipment. However, for the electronic system, an ASIC is particularly suitable.

[0037] In one embodiment, activating or unlocking at least one usability feature includes: - switching or revealing a dose display or indication member of the drug delivery device (the dose display is configured to show the currently set dose to the user, e.g., preferably through a window in the housing of the device or drive mechanism. During a dose setting operation, the dose can be increased or decreased. The set dose is delivered in a dose delivery operation. The dose display may be an electronically or mechanically operated display. A mechanically operated display may include an indication member that is visible through the window and / or that is movable relative to the window to change the indicated dose in the window. For example, in a locked state of the device before an unlock command is sent, the indication member or indicia thereon is not visible through the window. In a ready state, the indication member is visible through the window. In the locked state of the locking device, a shutter member is disposed between the indication member and the window. Thus, the user cannot see the indication member in the locked state. The shutter member can be removed, for example in response to an unlock command, to reveal the indication member and thus the dose display. The indication member can be a sleeve, for example a number sleeve. The indication member is configured to move, for example spirally, for example rotate, such that a number proportional to the set dose is visible / readable in the window during dose setting. Instead of having a shutter member, the number sequence can be offset relative to the window such that the numbers are not visible or readable through the window before the unlock command is received. The dose display can be revealed by offsetting the number sleeve and / or the window to a position such that the number sequence is aligned with the window) - enabling a dosing operation of the drug delivery device, e.g. unlocking a dose member of the drug delivery device for manipulating the dose member to perform a dose setting operation or a dose delivery operation (the enabled dosing operation may be a dose setting operation or a dose delivery operation. In the locked state, e.g. before an unlock command is sent, the dosing operation is prevented. In the ready state after receiving the unlock command, the dosing operation is possible. For example, the dose member arranged to be touched by the user for dose setting may not be movable, e.g. axially and / or non-rotatably locked relative to the housing and / or the dose member is decoupled from e.g. a drive mechanism of the mechanism module such that in the locked state a dose setting operation cannot be performed. In the ready state, the dose setting operation is expediently possible. Preferably, the dose setting operation is prevented in the locked state); Includes.

[0038] In one embodiment, the user equipment and the electronic system are paired. As a result, the electronic system can receive unlock commands only from the paired user equipment and not from any other user equipment. For pairing, a device ID code must be entered and stored in the user equipment, for example in a non-volatile memory. Of course, other pairing procedures are possible.

[0039] In one embodiment, activating or unlocking the at least one usability feature comprises unlocking a dose member of the drug delivery device. When the dose member is locked, it cannot move, for example in a dose setting direction relative to the housing. When the dose member is unlocked, this movement is permitted. The dose member may be a dose setting member and / or a dose delivery actuation member.

[0040] In one embodiment, in response to an activation command, the drug delivery device or drive mechanism is configured such that the dose member is moved from a locked or non-operating position to an operating position, for example relative to the housing of the mechanism module. The operating position can be displaced proximally from the locked or non-operating position. In the locked or non-operating position, the dose member is non-rotatably and / or axially locked relative to the housing. Thus, rotation of the dose member, which may be necessary to set a dose, can be prevented. Alternatively or additionally, the dose member is decoupled from the dose setting mechanism (e.g. from the drive mechanism) in the locked or non-operating position and coupled to the dose setting mechanism in the operating position. The movement to the operating position may be spring-driven. In the locked position, the spring is biased and tends to move the dose member towards the operating position. The electronic control unit is configured to unlock the mechanical lock to allow movement to the (spring-driven) operating position.

[0041] In one embodiment, the electronic system is integrated into the dose member, in other words the housing of the electronic system may form the user interface surface of the device for the dosage operation.

[0042] In one embodiment, the system includes a system signaling unit, such as an electronic display (e.g., liquid crystal or e-ink display) and / or an LED or non-pixelated display. The system signaling unit may preferably be configured to indicate alarms related to user-initiated drug delivery operations upon command by the system electronic control unit.

[0043] In one embodiment, the system electronic control unit is configured to issue a ready command. In response to the ready command, the electronic control unit is configured to cause the system signaling unit to indicate to the user that the drug delivery device is ready, for example, to start a dispensing operation. Thus, the system signaling unit can indicate the ready state to the user. The system signaling unit may be the device signaling unit further described above. The ready command can be issued only after the dispensing operation has been enabled. Alternatively or additionally, the ready state can be indicated by the signaling unit of the user equipment. When the signaling units of the system and the equipment indicate the ready state, the indications of the different units are conveniently correlated using the same indication method, for example, the same color, LED or blinking pattern of the display. The ready command is generated after an activation or unlock command, for example, after a time delay, and / or in response to the enablement of the dispensing operation being completed.

[0044] Another aspect relates to a drug delivery device.

[0045] The device may be a needle-based and / or pen-type device. The device may be a variable dose device, where the size of the drug dose delivered by the device is set by the user. The device may be of the dial-extension type, i.e. the length of the device may increase during the dose setting operation by an amount proportional to the size of the currently set dose. The device may be partially or fully user-driven, i.e. during the dose delivery operation the user may have to apply some (e.g. in addition to the spring force) or all of the force required for the dose delivery operation. Alternatively, the device is driven by an energy source, e.g. a spring. The energy source is loaded by the user during the dose setting operation.

[0046] In one embodiment, the drug delivery device comprises: - a reservoir module as a component of a drug delivery device, the reservoir module being configured to contain or hold a reservoir having a medicament; - a mechanism module as a component of the drug delivery device, the mechanism module including, for example, a drive mechanism for setting a drug dose to be delivered from a container and for delivering the set dose (hence, a "drive mechanism" can encompass a "dose setting mechanism" and a "dose delivery mechanism"); - preferably in a mechanical module, as an interface for mechanical coupling with components of the drug delivery device or with such electronic systems, e.g. with the electronic systems further described above; includes one, any selected number, or all of the following:

[0047] The receptacle module and the mechanism module are releasably connectable or connected to one another, for example, a proximal end of the receptacle module is connected to a distal end of the mechanism module, for example, by a thread or bayonet connection.

[0048] Each component of the delivery device may further comprise a (component) identifier for being (wirelessly) communicated to and / or determined by the above-mentioned user equipment, preferably a wireless communication unit thereof, each identifier comprising or provided by active or passive NFC circuitry.

[0049] In one embodiment, the identifier of the mechanism module and the identifier of the receptacle module are in close proximity to each other, especially when the modules are coupled. The identifiers are located within 3 cm, 2 cm, or 1.5 cm of each other. The identifier of the mechanism module is located at a distal end region of the mechanism module. The identifier of the receptacle module is located at a proximal end region of the receptacle module. The identifier of the receptacle module is located distal to the identifier of the mechanism module. Each identifier may include wireless communication circuitry, for example active or passive NFC circuitry.

[0050] In one embodiment, the device has a locked state in which medication operations are not possible, and a ready state in which medication operations are possible, as further described above. Switching between states can be managed by the user equipment, conveniently with the unlock command being sent and received by the electronic system.

[0051] In one embodiment, the device is configured to return to a locked state after or when a dose delivery operation is completed. For example, the dose member is relocked relative to the housing when an end position is reached at the end of the dose delivery operation. The member is moved distally relative to the housing from the dose setting position to the end position. The lock can be mechanically or electronically operated or controlled.

[0052] Another aspect relates to a method for preparing a drug delivery device for a medication operation or for controlling the operation of a drug delivery device, such as a drug delivery device as described above, using a user equipment, such as a user equipment as described above, comprising: - wirelessly determining, by a user equipment, at least one characteristic of at least one component of the drug delivery device; - unlocking at least one usability feature of the drug delivery device, for example, when, and preferably only when, at least one determined characteristic meets a predetermined criterion. Includes.

[0053] The user equipment is configured to operate in accordance with the method.

[0054] Another aspect relates to machine-readable code which, when loaded into and / or executed by an electronic control unit of a user equipment, causes the user equipment to further function as the user equipment described above or to control the methods described above.

[0055] Another aspect relates to a data storage medium, such as a physical data storage or a data stream, that includes the machine-readable code.

[0056] Another aspect relates to a set or article, comprising: - the user equipment as mentioned above, - an electronic system as described above, - one or more components of the drug delivery device as described above, - a drug delivery device as described above, - the machine-readable code described above, and / or - the above mentioned data carrier includes one, any selected number, or all of the following:

[0057] It should be noted that the configurations described in relation to different embodiments or aspects can be combined with each other. It should be noted that the configurations described in relation to the entities, user equipment, electronic system, drug delivery device, method, set, data storage medium, code above and below also apply to other entities, and not only to the entities in the context in which they are disclosed. For example, the configurations of the device also relate to the method, electronic system or user equipment.

[0058] A component "configured" to perform a particular task or function can refer to a component that performs that task or function during at least one state of operation of the device, the component being specially formed, programmed, and / or arranged to enable the performance of the task.

[0059] As used herein, "distal" is used to identify a direction, end, or surface that is or becomes arranged to face or point toward the dosing end of the drug delivery device or a component thereof, and / or that points away from the proximal end, is configured to face away from the proximal end, or faces away from the proximal end. On the other hand, "proximal" is used to identify a direction, end, or surface that is or becomes arranged to face or point away from the dosing end and / or the distal end of the drug delivery device or a component thereof. The distal end may be the end closest to the dosing end and / or the end furthest from the proximal end, and the proximal end may be the end furthest from the dosing end. The proximal face may face away from the distal end and / or towards the proximal end. The distal face may face towards the distal end and / or away from the proximal end. The dosing end may be, for example, the needle end at which the needle unit is or will be attached to the device.

[0060] Further features, advantages, and utilities of the present disclosure will become apparent from the following description of exemplary embodiments taken in conjunction with the drawings. [Brief description of the drawings]

[0061] [Figure 1] 1A-1C are schematic diagrams illustrating an embodiment of a drug delivery device and a user equipment in a locked state. [Diagram 2] FIG. 2 is a partial view of a drug delivery device in an unlocked or ready state. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0062] In the drawings, identical elements, identically acting elements or elements of the same type are given the same reference signs.

[0063] FIG. 1 shows a drug delivery device 10. The drug delivery device 10 is a needle-based drug delivery device. The drug delivery device 10 is a variable dose device. The drug delivery device 10 is an injection device. The drug delivery device 10 is a pen-type device whose shape resembles a pen.

[0064] The drug delivery device 10 includes two modules, e.g., a mechanism module and a container module. The drug delivery device 10 comprises a drive mechanism 12 and an electronic system 14. The drive mechanism 12 (or dose setting and drive mechanism) and the electronic system 14 are combined in the illustrated embodiment into a first module, e.g., the mechanism module. That is, the electronic system 14 is integrated into the mechanism module. However, it is also conceivable to have another module including the electronic system that can be (e.g., releasably) coupled to the mechanism module, e.g., as a button or a user interface member that can provide electronic control functions to the device. The drug delivery device 10 further includes a container holder 16 (a member of a second module). The holder 16 includes a receptacle 18 for a drug container 19. The holder 16 includes the drug container 19 (the holder 16 and the container 19 together can form a second module). The drug container 19 includes a liquid drug. The amount of drug in the container is advantageously sufficient to deliver multiple user-settable doses, even if the maximum dose deliverable with the device is set by the user. The drug container 19 is preferably permanently held in the holder 16. The drug container may be a cartridge. The dispensing end of the cartridge body of the cartridge is covered by a pierceable septum (not explicitly shown). The proximal opening of the cartridge body is closed by a movable stopper or bung (not explicitly shown). Fluid communication between the interior and the exterior of the cartridge body is established, for example by a needle piercing the septum, and the drug is delivered from the cartridge when the stopper is moved distally towards the dispensing end of the cartridge (towards the septum). The holder 16 includes an interface for coupling the cartridge holder with the first module. The housing 15 of the drive mechanism 12 (of the first module) includes an interface for coupling to the holder 16. The interface of the cartridge holder 16 and the drive mechanism include configurations for, for example, a threaded interface or a bayonet-type interface for attachment to one another. The housing 15 has a cylindrical shape.

[0065] The terms "drug" or "medicament" are used interchangeably herein to describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or their pharma- ceutically acceptable salts or solvates, and optionally a pharma- ceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or medicines are used to treat, cure, prevent, or diagnose diseases or otherwise improve physical or mental well-being. Drugs or medicines can be used for a limited duration or periodically for chronic disorders.

[0066] As described below, a drug or agent may include at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules with molecular weights of 500 Da or less, polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, double-stranded 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.

[0067] The drug or agent can be contained in a primary package or "drug container" adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber can be designed to store the drug for about one month to about two years. Storage can be at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, the drug container can be or include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between the two or more components before and / or during administration to the human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and to optionally allow mixing of the two components by a user prior to administration. Alternatively or additionally, the two chambers can be configured to allow mixing upon administration of the components to the human or animal body.

[0068] The drugs or agents contained in the drug delivery devices described herein can be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders are acute coronary syndromes (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those found in handbooks such as Rote Liste 2014 (e.g., but not limited to, Main Groups 12 (antidiabetic agents) or 86 (oncology agents)) and the Merck Index, 15th edition.

[0069] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin, e.g., human insulin, or a human insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharma-ceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deletion and / or replacement of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or replaced amino acid residues can be either codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, for example the molecular structure of human insulin in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide are deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable ones, are added to the naturally occurring peptide.

[0070] 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 in which the proline in position B28 may be replaced by Asp, Lys, Leu, Val or Ala and in which the Lys in position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0071] Examples of insulin derivatives are e.g. 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-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0072] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flathead monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C (efpegrenatide). , HM-15211, CM-3, GLP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexene, 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.

[0073] Examples of oligonucleotides are, for example, the cholesterol-lowering antisense therapeutic mipomersen sodium (Kynamro®) for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport Syndrome.

[0074] Examples of DPP4 inhibitors are linagliptin, vidagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0075] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropine (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0076] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or very low molecular weight heparin or their derivatives, or sulfated polysaccharides, such as the above-mentioned polysaccharides in polysulfated form, and / or their pharmaceutically acceptable salts.An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium.An example of a hyaluronic acid derivative is Hylan G-F20 (Synvisc®), sodium hyaluronate.

[0077] The term "antibody" as used herein refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of an immunoglobulin molecule include F(ab) and F(ab')2 fragments that retain the ability to bind to an antigen. An antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single chain antibody. In some embodiments, an antibody has effector function and is capable of fixing complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to Fc receptors, e.g., with a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable region antibody-like binding proteins (CODVs) with crossover binding region orientation.

[0078] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but includes at least a portion of the full-length antibody polypeptide that is still capable of binding to an antigen. An antibody fragment can include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0079] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences in the variable regions 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 in the variable regions of both heavy and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the proper arrangement of CDR sequences to allow antigen binding. Although framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues in the framework regions of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids in the CDR to interact with an antigen.

[0080] Exemplary antibodies are anti-PCSK-9 mAbs (e.g., alirocumab), anti-IL-6 mAbs (e.g., sarilumab), and anti-IL-4 mAbs (e.g., dupilumab).

[0081] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use in the drug or medicament in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0082] Those of skill in the art will understand that modifications (addition and / or removal) of the various components of the APIs, formulations, devices, methods, systems, and embodiments described herein may be made without departing from the full scope and spirit of the invention, which encompasses such modifications and all equivalents thereof.

[0083] Exemplary drug delivery devices can include needle-based injection systems as described in Table 1 of Section 5.2 of ISO11608-1:2014(E). As described in ISO11608-1:2014(E), needle-based injection systems can be broadly distinguished into multi-dose container systems and single-dose (with partial or complete ejection) container systems. The container may be an exchangeable container or an integrated non-exchangeable container.

[0084] As further described in ISO11608-1:2014(E), a multi-dose container system can include a needle-based injection device with an exchangeable container. In such a system, each container holds multiple doses and the size may be fixed or variable (pre-set by the user). Another multi-dose container system can include a needle-based injection device with an integrated non-exchangeable container. In such a system, each container holds multiple doses and the size may be fixed or variable (pre-set by the user).

[0085] The drive mechanism 12 includes a first wireless communication circuit 20. The first wireless communication circuit 20 may be a passive NFC circuit (without a power source) or an active NFC circuit with a power source, such as a printable battery, where the passive NFC circuit may be more suitable since it is more cost-effective. The holder 16 includes a second wireless communication circuit 22. The second wireless communication circuit 22 may be a passive NFC circuit or an active NFC circuit, such as a printable battery, where the passive NFC circuit may be more suitable here as well. The first wireless communication circuit 20 is disposed near the interface of the first module, for example near its distal end, such as near the distal end of the housing 15. The second wireless communication circuit 22 is disposed near the interface of the second module, for example near its proximal end. When the holder 16 is coupled to the first module (drive mechanism 12), the first and second wireless communication circuits 20, 22 are in close proximity to each other. In this way, it is more likely that the user equipment 40 is within communication range of both wireless communication circuits 20, 22 at the same time. The circuits 20 and 22 are separated by less than 3 cm, for example 2 cm or less or 1.5 cm or less. According to an alternative embodiment, instead of or in addition to the wireless communication circuit 22 in the holder 16, the wireless communication circuit is arranged in the medication container 19. This is particularly suitable in cases where the container is removed from the holder and replaced with a new container. The assembly of the container and the container holder, which are otherwise non-releasably fixed to each other, may form one disposable article. In this case, the container or the holder comprises the circuit.

[0086] FIG. 1 further illustrates a user equipment 40. The user equipment 40 is a smart watch in the illustrated embodiment. A smart bracelet is a possible alternative embodiment, or a handheld device such as a smartphone. Wearable devices are particularly suitable as user equipment in the context of the present disclosure. The user equipment 40 includes an electronic control unit 42 and a wireless communication unit 44. The electronic control unit 42 is configured to determine at least one characteristic of at least one component of the drug delivery device via the wireless communication unit 44. The wireless communication unit 44 includes an NFC circuit, for example an active NFC. The electronic control unit 42 includes a processor unit configured to execute machine-readable code (e.g., an app) stored in a memory of the electronic control unit 42.

[0087] The electronic control unit 42 is configured to determine the proximity of the holder 16 or the second module to the user equipment 40. The electronic control unit 42 is configured to determine the proximity of the drive mechanism 12 or the first module to the equipment. The electronic control unit 42 is configured to determine the proximity of the respective components (holder 16, drive mechanism 12) by sending a request to the wireless communication circuits 20, 22 of the drug delivery device 10 via the wireless communication unit 44 (e.g., the NFC circuit of the wireless communication unit 44). Each component is considered to be in proximity or evaluated to be in proximity to the user equipment 40 when a response is received from the wireless communication circuits 20, 22 of that component. NFC is a short-range communication and may require the communication partners to be very close, for example, less than 2 cm, less than 1 cm, for example, less than 0.5 cm. NFC functionality is integrated into standard smart watches, for example, for payment functions, and is therefore easily available for proximity detection.

[0088] The first and second wireless communication circuits 20, 22 can each be configured to respond to a request (from a user equipment) by transmitting a response that includes a device type identifier. The responses from the wireless communication circuits 20, 22 of the drug delivery device 10 can each include a component type identifier, for example, one for the first module and one for the second module.

[0089] The electronic control unit 42 is configured to determine from the received type identifiers whether the components are compatible. This is performed via a look-up table stored in the user equipment 40, which links compatible component type identifiers together. If an incompatibility is detected, this is communicated to the user via the user equipment.

[0090] The electronic control unit 42 is configured to send an unlock command to the electronic system 14 of the drug delivery device 10 via the communication unit 44 to unlock at least one usability function of the drug delivery device 10. The electronic control unit 42 is configured to send the unlock command when the components (the holder 16 or the second module and the drive mechanism 12 or the first module) are determined to be compatible with each other and / or when they are determined to be in proximity with the user equipment 40. The unlock command is preferably sent via a Bluetooth communication circuit, e.g., a Bluetooth Low Energy circuit, included in the wireless communication unit 44, for example.

[0091] The electronic system 14 of or for the drug delivery device includes a system wireless communication unit or further wireless communication unit 30 configured to wirelessly receive an unlock command from a user equipment 40. The further wireless communication unit 30 includes a Bluetooth Low Energy communication circuit for receiving the unlock command and / or communicating with the user equipment. The electronic system 14 includes a system electronic control unit or further electronic control unit 32 configured to activate one or more usability functions, e.g. two usability functions, of the drug delivery device when the unlock command is received. For each activation, an activation command is issued by the control unit 32. The first and second wireless communication circuits 20, 22 are expediently electronically independent from the electronic system 14. The electronic system 14 further includes a power source, e.g. one or more batteries, such as coin cells, for powering the respective elements of the electronic system (not explicitly shown). The electronic system 14 may be or include an ASIC, or a microcontroller, or another, e.g. programmable, processor. The elements of the electronic system, for example a communications unit 30 and a control unit 32, are disposed on a common conductor carrier, for example a circuit board such as a flexible circuit board.

[0092] The drive mechanism 12 includes a dose setting member 34. The dose (setting) member 34 is a rotary dial or knob. The dose setting member 34 forms the proximal end of the drug delivery device 10. The drive mechanism 12 includes a locking mechanism (not explicitly shown) for maintaining the dose setting member 34 in a locked state at a predetermined position relative to the housing 15. The locking mechanism may include a locking feature, e.g., a pin or a bar, for maintaining the dose setting member 34 in the locked state. The further electronic control unit 32 is configured to power the activation circuit and release the dose setting member 34 from the locked state, e.g., by issuing an activation command, expediently only after an unlock command is received. Releasing the dose setting member 34 from the locked state causes the dose setting member 34 to perform an emergence or proximal operation. The member 34 can "pop" out or move proximally relative to the housing 15 from a locked position (see FIG. 1) to an operating position (see FIG. 2). In the locked position, the dose setting member 34 is decoupled from the drive mechanism and / or a dose setting operation is prevented. Alternatively or additionally, in the locked position, the dose setting member is non-rotatably and / or axially locked relative to the housing 15. In the operating position, movement of the dose setting member for a dose setting operation is expediently enabled, e.g. involving rotational and proximal movement relative to the housing 15. The axial distance between the operating position and the non-operating or locked position may be less than 1 cm, e.g. less than 0.5 cm. The electronic system 14 is expediently integrated in the dose setting member 34. The electronic system moves proximally together with the dose setting member during a dose setting operation.

[0093] The activation circuit is configured, for example, to generate a magnetic field to release a magnetic locking mechanism. The drive mechanism 12 can, for example, comprise a spring to trigger an emergence movement of the dose setting member 34 as soon as the lock is released, for example, by moving a locking feature. Other locking (unlocking) mechanisms are also possible, for example heat-based or electric field-based, or unlocking via a relative movement induced by an electronic control unit or a motor.

[0094] The drive mechanism 12 further comprises a dose delivery actuation member 36. The dose delivery actuation member 36 is arranged at a proximal end of the dose setting member 34. The dose setting member and the dose delivery actuation member may be integrated into a common dose member. The dose delivery actuation member 36 or dose member is a button. Alternatively, if two separate members are provided, the dose delivery actuation member 36 may move relative to the dose setting member 34 when pressed to actuate or initiate a dose delivery operation.

[0095] When the dose setting member 34 is unlocked, it can move proximally relative to the housing 15, i.e. rotating (e.g. helically) from an operating position (the position after the member 34 is unlocked) to a dose setting position. The movement distance of the dose setting member 34 is proportional, e.g. directly proportional, to the set dose. When the dose delivery actuation member 36 is pressed, the dose setting member 34 is expediently mechanically coupled to a transmission unit of the drive mechanism 12, and the pressure exerted by the user on the dose delivery actuation member 36, and preferably therewith on the dose setting member 34, is converted into a movement of a piston rod (not explicitly shown) of the drive mechanism. The piston rod acts on a bung of a medicament container 19, e.g. a cartridge, causing the medicament to be expelled from the drug delivery device 10. The force acting on the dose setting member 34 moves it back to its original position. When the dose setting member 34 reaches a distal end position, e.g. the position (closest) to the housing 15, the dose setting member 34 is locked again. The end position may therefore correspond to a locked position relative to the housing 15. The lock can be released for a next dose setting operation, preferably via a user device. Instead of or in addition to the dose setting member 34, the dose delivery actuation member 36 can be held in a locked state until power is supplied to the actuation circuit or a further actuation circuit, for example if the member is not integrated in one dose member.

[0096] The drug delivery device 10 further comprises a dose display 38. When the drug delivery device 10 is in the locked state, the dose display 38 is blank. The dose display 38 is arranged on one side of the housing 15. When an unlock command is received, the further electronic control unit 32 is configured to unblank the dose display 38, for example by supplying power to the (other) activation circuit. The dose display 38 can be unblanked by removing an obstruction, for example a shutter element, from a viewing window in the area of ​​the dose display. This movement can be spring-driven or motor-driven. When unblanked, a number sleeve with a dose indicia indicating the size of the currently set dose can be visible or appear in the window. Alternatively, the electronic dose display is turned on by the activation circuit or the number sleeve is displaced relative to the window, for example together with the dose (setting) member.

[0097] The user equipment 40 further includes a signaling unit 46, and the electronic control unit 42 is configured to signal the ready state to the user via the signaling unit 46 after sending the unlock command. The signaling unit 46 includes a display, for example a dot matrix display (for example a liquid crystal display or an organic light emitting diode display). The electronic system 14 includes a system signaling unit or a further signaling unit 39, and the further electronic control unit 32 is configured to signal the ready state to the user via the further signaling unit 39 when a usability function is active or activated. The further signaling unit 39 includes a plurality, for example three, light emitting diodes of different colors (for example red, green and blue) and can display a range of different colors, for example at least yellow and green. The further signaling unit 39 is integrated into the dose member 34 / 36, for example at the proximal end face of the dose delivery activation member 36. The dose delivery actuation member 36 has an at least partially transparent, or at least translucent, surface through which light from a signal transmission unit 39 arranged behind the dose delivery actuation member 36 can shine when actuated.

[0098] The method for controlling the drug delivery device 10 or preparing the device for a dispensing operation, for example by the user equipment 40, may include a set-up portion or step.

[0099] During the setup portion, the user equipment 40 and the electronic system 14 of the drug delivery device 10 are paired. This can be done in a variety of ways. For example, the user equipment can request a device ID from the drug delivery device and store the device ID in memory. During the setup portion, a drug administration schedule is set and / or timers or clocks of the user equipment 40 and the electronic system 14 are synchronized. An alarm for the next injection (drug administration) can be set.

[0100] When the next injection is scheduled, the method enters an alarm portion or step. During the alarm portion, the user equipment 40 alerts the user. The electronic control unit 42 is configured to issue an alarm using the signaling unit 46. Alternatively or additionally, during the alarm portion, the drug delivery device 10 issues an alarm. The further electronic control unit 32 is configured to issue an alarm, for example, via the further signaling unit 39, for example, an LED. The further electronic control unit 32 is configured to issue an alarm, for example, by causing the signaling unit to emit a constant or flashing signal of a specific alarm color (for example, yellow). The alarm color is set by the user and / or the user equipment 40 during the setup portion. The alarms in the device and the equipment can be correlated, for example, with the same color, the same symbol, etc. In this way, the alarms can distinguish a particular device, for example, from other devices used in the same environment, for example, in the same household. Depending on the capabilities of the signaling unit, other types of alarms other than alarm colors can be applied, for example, audible alarms, alarm symbols or alarm texts, or combinations of different alarms. Instead of and / or in addition to the LED, the further signalling unit may comprise a dot matrix display and / or a display foil. The (dot matrix) display may be used to display a symbol as an identification mark, for example instead of an alarm colour. The electronic control unit 42 of the user equipment is configured to display the symbol via the signalling unit 46. During the alarm part, the electronic control unit 42 is configured to display an alarm colour as an identification mark of the drug delivery device 10 used for injection via the signalling unit 46, for example together with an audible alarm (e.g. emitted through a speaker).

[0101] During or after the alarm portion, the proximity of the user equipment 40 to the components of the drug delivery device may be checked from time to time (e.g., periodically and / or periodically). The electronic control unit 42 is configured to send periodic requests via the wireless communication unit 44 (e.g., via an NFC communication circuit).

[0102] During or after the alarm portion, the method includes wirelessly determining, by the user equipment, at least one characteristic of at least one component of the drug delivery device 10.

[0103] Upon completion of the alarm portion, or in the absence of a preceding alarm portion, the method may involve determining at least one characteristic of a component of the device in a preparation portion or step of the method, in which the device is ready for a medication administration operation.

[0104] When the drug delivery device 10 is in close proximity (e.g., within a few centimeters or less than 0.5 cm, see above) to the user equipment 40, the wireless communication circuits 20, 22 of the components of the drug delivery device 10 receive the request and transmit a signal in response. Thus, the proximity of the user equipment 40 to the components is determined wirelessly when the wireless communication unit 44 receives a response from the wireless communication circuits 20, 22 of the components of the drug delivery device 10. Before the user equipment and the components are in close proximity, the equipment can also transmit a request, but there is no corresponding response, e.g. due to the limited range of the communication circuits 20, 22. Checking the proximity between the components of the device and the user equipment may require that the distance between the components and the wireless communication unit 44 is smaller than the distance between the device when held in the user's hand and the user equipment worn on the user's wrist adjacent to the hand. This means that the device may have to be very close to the user equipment to check the proximity. Note that it is also possible to check the proximity when the user is holding the device or when the components are in the user's hand.

[0105] Instead of a passive circuit, the respective wireless communication circuit 20 or 22 may be an active circuit, e.g., an NFC circuit, and / or is preferably powered by a printable battery. The circuit 20, 22 is configured to transmit a signal during the alarm portion without receiving a previous request. In this case, the electronic control unit 42 is configured not to transmit a request via the wireless communication unit 44 (at least not via the NFC communication circuit, or not at all). Rather, it may wait for a signal to be received from the circuit to confirm the proximity between the device or its components and the user equipment.

[0106] The signal received from the wireless communication circuit 20, 22 in the wireless communication unit 44 includes a component type identifier. The electronic control unit 42 checks the received component type identifier for an identifier identifying a (dedicated) receptacle module. The electronic control unit 42 checks the received component type identifier for an identifier identifying a (dedicated) drive mechanism suitable for the (dedicated) receptacle module. The electronic control unit 42 checks whether the received component type identifier belongs to a compatible component, e.g. a receptacle module that was dedicated to a drive mechanism. It is noted that the compatibility check may be independent of the proximity check. Thus, the present disclosure may relate to any one of these checks being performed or a combination of these checks being performed.

[0107] Information regarding the compatibility of the modules, e.g., textual and / or color-based information, is conveniently shown to the user via the signaling unit 46. For example, if the components are found to be incompatible, a red symbol is displayed by the signaling unit 46 of the user equipment. This may prompt the user to replace at least one of the components, e.g., to use a different receptacle module with the mechanism module. If the components are found to be compatible, the shown information may assure the user that the device is properly configured. Alternatively or additionally, it is indicated whether the device under investigation is in close proximity to the user equipment.

[0108] The electronic control unit 42 may further, for example, instead of or in addition to the above-mentioned confirmation, communicate with the further electronic control unit 32 via the wireless communication unit 44 and the further wireless communication unit 30 to request information from the device regarding the scheduled time of injection and / or a device identifier, for example to verify that the drug delivery device 10 in proximity is the correct drug delivery device.

[0109] When the components of the drug delivery device 10 are determined to be in close proximity and matched (correct pairing) and / or the drug delivery device is determined to be the correct one, the electronic control unit 42 sends an unlock command to the drug delivery device 10 to unlock the usability functions of the drug delivery device. As a result, the dose setting member 34 is released from its locked state and the dose display 38 is unblanked or becomes visible, for example by moving the shutter member away from the window to reveal the number sleeve. It should be noted that opening the dose setting member without revealing the dose display or number sleeve or the other is also encompassed by the present disclosure.

[0110] After the unlock command is sent, the method enters into a dose setting part or step, where the ready state is signaled or indicated to the user. The further signaling unit 39 can change colour and / or signalling mode. For example, the dose delivery actuation member can illuminate green and may also flash. Other indications are of course possible.

[0111] After an unlock command is sent, for example in response to the dose setting member reaching its operating position (in this case the further electronic control unit of the electronic system 14 can command a corresponding signal to be sent from the electronic system to the user equipment 40) or after a predefined time, for example less than 1 or 2 seconds, has elapsed after the unlock command has been sent, the user equipment 40 preferably indicates the dose to be set in the drug delivery device 10 to the user, for example by a signaling unit of the user equipment. The user can then set the indicated dose, for example by rotating the dose setting member until the corresponding dose appears on the dose display 38. During dose setting, the dose displayed on the dose display changes to always reflect the currently set dose. The length of the device increases proportionally to the dose. The more the dose, the longer the device. The dose setting member is moved proximally relative to the housing 15 in the course of dose setting. The set dose can then be delivered, for example by the user moving the dose delivery actuation member 36 distally towards the housing 15, for example until the member is again axially locked relative to the housing in its end position. The size of the delivered dose is determined in the electronic system 14 and stored in the electronic system 14 and / or transmitted to the user device, for example together with a timestamp.

[0112] It will be understood that the present disclosure also encompasses alternatives to the implementation in the above-mentioned exemplary embodiment. For example: According to alternatives, the drive mechanism and the holder include different types of communication circuits. In the proximity detection in the above-mentioned example, short-range or short-range communication is used. In particular, the presence of the circuitry within this communication range is used to confirm the proximity. It is also possible to use non-short-range or longer-range wireless communication for distance determination, for example Bluetooth, such as Bluetooth low energy (BLE). In contrast to NFC, non-short-range communication may be more suitable for detecting whether the device is in the user's hand or not, since the distance between the wrist and the hand may be outside the communication range of the NFC circuitry. Proximity or distance detection or measurement for this purpose may be performed, for example: - BLE with signal strength detection (RSSI), - BLE with time-of-flight measurements, - Ultra-wideband (UWB) distance measurement, - A modulated magnetic field (e.g. detectable by a magnetometer or compass in a user device or smartwatch) is applied and used.

[0113] The range of NFC may be too small to detect whether the device is in the user's hand or not, and therefore preparing the device for a dispensing operation may require the device to be moved closer to the user equipment to perform one or more of the required checks before the respective usability functions are unlocked. For example, UWB, which complies with the standard IEEE 802.15.4-2011, is particularly suitable for distance measurements at distances beyond the range of NFC and / or at the typical distance between the wrist and the device held in the hand adjacent to the wrist. The drive mechanism may not include an independent communication circuit, but may include a communication circuit included in the electronic system, especially if the system is integrated in the mechanism module. The user equipment is then configured to determine the characteristics of the mechanism module by sending a request to and / or receiving a signal from the further wireless communication unit. It should also be noted that the Summary of the Invention section may describe configurations that are not explicitly described in the description of the exemplary embodiments, but that apply to the embodiments described in the Summary of the Invention section. The Summary of the Invention section is therefore incorporated by reference to the description of the embodiments.

[0114] The scope of protection is not limited to the examples described herein above. Any invention disclosed herein is embodied in each and every novel feature and each combination of features, and specifically includes any combination of any of the features described in the claims, even if this feature or this combination of features is not explicitly recited in the claims or examples. [Explanation of symbols]

[0115] 10 Drug Delivery Devices 12 Drive mechanism 14 Electronic Systems 16 Cartridge holder 18 Receptacle 19 Drug containers 20 Wireless communication circuit 22 Wireless communication circuits 30 Further wireless communication units 32 Further Electronic Control Units 34 Dose setting components 36 Dose delivery actuator 38 Dose Display 39 Further signalling units 40 User Equipment 42 Electronic Control Unit 44 Wireless communication unit 46 Signal transmission unit

Claims

1. A user device, such as a smart watch, comprising: an electronic control unit (42); a wireless communication unit (44) operably coupled to the electronic control unit; and the electronic control unit (42) comprises: controlling operation of a wireless communication unit (44) operable to determine at least one characteristic associated with at least one component of the drug delivery device (10); Evaluating the at least one determined characteristic; and configured to issue or determine whether to issue one or more control unit commands based on the result of the evaluation, the one or more control unit commands comprising: a) causing a device signaling unit of the user device to present information to a user about the drug delivery device based on the at least one determined characteristic; and / or b) causing the wireless communication unit to transmit system commands to an electronic system of or for the drug delivery device; The user equipment includes a command configured to:

2. The user equipment of claim 1, wherein the electronic control unit is configured to determine, based on the result of the evaluation, whether the wireless communication unit (44) should send at least one unlock command as a system command to the electronic system (14) to unlock at least one usability feature of the drug delivery device (10), and the user equipment is configured to send the unlock command only when the result of the evaluation is such that at least one determined characteristic satisfies at least one predetermined criterion.

3. 3. The user equipment (40) according to claim 1 or 2, wherein the user equipment (40) is a wearable device, for example a smart watch.

4. The at least one determined characteristic includes a distance or proximity between a component of the drug delivery device (10) and the user equipment, and evaluating the at least one determined characteristic determines whether the component or the entire drug delivery device is within a predetermined distance of the user equipment. determining that the unlock command is sent as a system command only when the component or the drug delivery device is within a predetermined distance; 3. The user equipment of claim 1 or 2, optionally configured to use UWB (ultra-wideband) distance measurements to determine the distance or proximity between the drug delivery device and the user equipment.

5. 3. The user equipment of claim 1 or 2, wherein the at least one determined characteristic includes identifiers, such as component type identifiers, of at least two components of the drug delivery device (10), and evaluating the at least one determined characteristic includes determining whether the at least two components of the drug delivery device are compatible with each other, and the user equipment is configured to send an unlock command only when the components are compatible with each other.

6. The user equipment of claim 5 , wherein the user equipment is configured to determine, at one relative position with respect to the drug delivery device, for example simultaneously, a first identifier of a first component and a second identifier of a second component of the device.

7. The user equipment (40) includes an equipment signaling unit (46) operatively coupled to the electronic control unit (42) and configured to, when commanded by the electronic control unit (42), device identification information to indicate which drug delivery device (10) the user should use for the next medication dose; Information regarding the compatibility of components of the drug delivery device; the ready state of the drug delivery device, especially after sending an unlock command; and / or A dose set in the drug delivery device (10) for a dose delivery operation.

3. The user equipment of claim 1, configured to indicate at least one of:

8. An electronic system (14) for a drug delivery device (10), comprising: a system wireless communication unit (30) configured to wirelessly receive unlock commands from a user equipment (40), such as a user equipment according to claim 1 or 2; and a system electronic control unit (32) operably coupled to the system wireless communication unit and configured to issue an activation command to activate at least one usability function of the drug delivery device (10) in response to an unlock command.

9. activating the at least one usability feature includes switching on or revealing a dose display (38) of the drug delivery device; and / or The electronic system of claim 8, wherein activating at least one usability function includes unlocking a dose member (34, 36) of the drug delivery device (10), and the drug delivery device is configured such that the dose member is moved, for example axially, from a locked or non-operating position to an operating position relative to a housing of the drug delivery device in response to an activation command.

10. 8. The electronic system of claim 7, wherein the system electronic control unit (32) is configured to issue a ready command and, in response to the ready command, cause the system signaling unit (39) to indicate to the user that the drug delivery device is ready to begin a medication operation.

11. 1. A drug delivery device comprising: a reservoir module (16) as a component of the drug delivery device, the reservoir module being configured to contain or hold a reservoir having a medicament; a mechanism module (12) as a component of the drug delivery device, the mechanism module including a drive mechanism for setting a drug dose to be delivered from the container and for delivering the set dose; wherein the container module and the mechanism module are releasably coupleable to one another, and the container module includes an identifier that is communicated to the wireless communication unit of the user equipment of claim 1; The drug delivery device, wherein the mechanism module includes an identifier that is communicated to a wireless communication unit of a user equipment of claim 1 .

12. 12. A drug delivery device according to claim 11, further comprising an electronic system (14) according to claim 8 or 9 as a component of the drug delivery device.

13. 1. A method for preparing a drug delivery device (10), e.g. a drug delivery device according to claim 11, for a medication operation using a user equipment (40), e.g. a user equipment according to claim 1 or 2, comprising: wirelessly determining, by a user equipment (40), at least one characteristic of at least one component of the drug delivery device (10); unlocking at least one usability feature of the drug delivery device (10) when at least one determined characteristic meets a predetermined criterion; The method comprising:

14. 14. Machine-readable code which, when loaded into and / or executed by an electronic control unit of a user equipment (40), causes the user equipment to function as a user equipment according to claim 1 or to control the method according to claim 13.

15. 15. A data storage medium containing the machine-readable code of claim 14.

16. A user equipment (40) according to claim 1 or 2, An electronic system (14) according to claim 8, One or more components of the drug delivery device (10) according to claim 11; A drug delivery device (10) according to claim 11, 15. The machine readable code of claim 14, and 16. A data storage medium according to claim 15. A set including one, an arbitrarily selected number, or all of:

17. A user device, such as a smart watch, comprising: an electronic control unit (42); a wireless communication unit (44) operably coupled to the electronic control unit; and the electronic control unit (42) comprises: controlling the operation of a wireless communication unit (44) operable to determine at least one characteristic associated with at least one component of the drug delivery device (10), the at least one characteristic including a distance or proximity between the component and a user equipment, e.g., the wireless communication unit; Evaluating the at least one determined characteristic; and configured to issue or determine whether to issue one or more control unit commands based on the result of the evaluation, the one or more control unit commands comprising: a) providing a device signaling unit of said user device with at least one signal relating to a drug delivery device; presenting information to the user based on another determined characteristic; and / or b) causing the wireless communication unit to transmit system commands to an electronic system of or for the drug delivery device; The user equipment includes a command configured to:

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