Infusion device with add-on device

Abstract

The present disclosure provides an injection device (1) for injecting a dose of a medication (24), comprising: a housing (10) including a main body (6) and a container portion (7), the container portion (7) configured to accommodate a medicament container (21), the container portion (7) being removably connectable to the main body (6); - a drive mechanism (20) disposed within the body (6) and operable to expel a dose of medicament (24) from the medicament container (21); - a machine-readable identification (28; 88) on or within one of the body (6) and the container portion (7); a detector arrangement (98) on or within one of the body (6) and the container portion (7), the detector arrangement (98) being operable to detect a mechanical connection between the body (6) and the container portion (7); Including, - the machine-readable identification (28; 88) is electrically connected to the detector arrangement (98) and is readable by an electronic module (34) of an add-on device (30) connectable to the injection device (1), the machine-readable identification indicating a mechanical connection between the body (6) and the container portion (7); It concerns an injection device (1).

Description

[Technical Field]

[0001] The present disclosure relates to the field of injection devices, particularly injection devices such as pen injectors that can be used with dedicated add-on devices. In another aspect, the present disclosure relates to an injection system including an injection device and an add-on device. In a further aspect, the present disclosure relates to a method for monitoring the operation of an injection device. [Background technology]

[0002] Drug delivery devices for setting and dispensing single or multiple doses of liquid medication are known in the art. Generally, such devices serve much the same purpose as a conventional syringe.

[0003] Drug delivery devices, such as pen injectors, must meet several user-specific requirements. For example, patients with chronic diseases such as diabetes may be physically weak and have impaired eyesight. Therefore, drug delivery devices, particularly those suitable for home medical use, should be robust in construction and easy to use. Furthermore, the operation and general handling of the device and its components should be clear and easy to understand. Such injection devices should provide for the setting and subsequent dispensing of doses of the same or different sizes of medication. Furthermore, the dose setting and dose dispensing procedures should be easy to operate and clear.

[0004] Patients suffering from certain illnesses may require specific amounts of medication to be injected via a pen injection syringe.

[0005] Some drug delivery or infusion devices provide for the selection of variable-sized drug doses and the infusion of preset doses, while other infusion devices provide for the setting and dispensing of fixed doses, where the amount of drug to be infused according to a given prescription schedule is always the same and remains constant or unalterable over time.

[0006] Some injection devices are implemented as reusable injection devices, where the user can replace the medication container, such as a cartridge. Other injection devices are implemented as disposable injection devices, where the entire injection device is intended to be discarded once the contents, i.e., medication, have been used up.

[0007] To control and supervise the administration of medications performed by the user or patient themselves, it is beneficial to assist the user by utilizing an external electronic device, such as a portable electronic device implemented as, for example, a smartphone, tablet computer, or smartwatch. A software application provided on such an external electronic device can interact with the user and provide instructions or recommendations to the user on how to properly use the infusion device.

[0008] To control and supervise user or patient self-administration of medication, it is desirable to provide automatic detection and logging of repetitive and periodic use of a drug delivery device. Automating the recording of user-injected doses would offer significant advantages over manual dose logging in terms of safety and convenience.

[0009] There are many add-on devices configured for use with infusion devices that provide electronic detection and monitoring of repeat dose infusion procedures.

[0010] Typically, such add-on or auxiliary devices can be removably connected to an infusion device. The add-on device typically includes a detector or detector arrangement that functions to detect the date and / or time when a user sets or injects a dose of medication. Some add-on devices also provide a quantitative measurement of the size of the currently set or dispensed dose. Some add-on devices are intended for use with a range of infusion devices. This may be particularly true for disposable infusion devices that are intended to be discarded after use or once the medication therein has been depleted.

[0011] There are typically a variety of different infusion devices that may be equipped with different drugs or medications, but that generally function to be used with the same type of add-on device. While it is common practice to characterize or label infusion devices and / or different types and / or concentrations of medication with distinct and distinctive labels or identifiers, detachable connections to add-on devices can present disadvantages, particularly if the label or distinctive portion of the infusion device is covered by the add-on device attached to the infusion device.

[0012] In reusable infusion devices that provide for the exchange of drug containers, it may be desirable to reset the drive mechanism. When such reusable infusion devices are used in conjunction with add-on devices, it may also be necessary to perform a reset operation or some initialization process in the add-on device. If the add-on device is configured to log or track the amount of drug remaining in the cartridge, it may also be necessary to reset data logging procedures and / or initialize new tracking procedures in the add-on device when the drug container of the infusion device is exchanged.

[0013] In this regard, it would be desirable to provide improvements to infusion devices and / or add-on devices to simplify the process of handling the device during the process of changing the drug container. Furthermore, the logging or monitoring of repeated use of the infusion device should be simplified. Furthermore, patient safety should be enhanced. Summary of the Invention [Means for solving the problem]

[0014] In one aspect, the present disclosure relates to an injection device for injecting a dose of a medicament. The injection device includes a housing. The housing includes a body and a reservoir portion. The reservoir portion is configured to receive a medicament container. The reservoir portion is further removably connectable to the body. The injection device further includes a drive mechanism disposed within the body and operable to expel or draw the medicament dose from the medicament container.

[0015] The injection device further includes a machine-readable identification portion on or within one of the body and the container portion. The injection device further includes a detector arrangement on or within one of the body and the container portion. The detector arrangement functions to detect a mechanical connection between the body and the container portion. The machine-readable identification portion is electrically connected or electrically linked to the detector arrangement. The machine-readable identification portion is readable by an electronic module of an add-on device, and the add-on device is connectable, i.e., mechanically connectable, to the injection device. The machine-readable identification portion indicates a mechanical connection between the body and the container portion.

[0016] Typically, the injection device is implemented as a handheld injection device. It may include a pen-type injection device. The injection device may be implemented entirely mechanically. The injection device may be completely devoid of electrical or electronic components. The only electrical or electronic component may be a machine-readable identification of the injection device and detector arrangement. The machine-readable identification may be implemented as an electronic identifier. The machine-readable identification may include a passive or active wireless communication tag, such as a passive or active RFID tag, an NFC tag, or an UWB tag. Thus, the injection device may be completely devoid of active electrical or electronic components.

[0017] The machine-readable identification unit may include an electronic identifier electronically readable by the add-on device. The machine-readable identification unit may include a passive or active radio frequency transceiver. In some examples, the machine-readable identification unit is implemented as one of an RFID tag, an NFC tag, or an UWB tag. In some examples, the machine-readable identification unit is electronically readable by the transceiver and / or by a respective electronic module of the add-on device. Thus, the machine-readable identification unit is configured to establish a wireless communication link with the add-on device, thus enabling data or information stored on the machine-readable identification unit to be read.

[0018] The electrical connection or electronic link between the machine-readable identification of the injection device and the detector arrangement is such that the state of the detector arrangement can be read or retrieved electronically by the add-on device.

[0019] The state or status of the detector arrangement indicates the mechanical connection between the body and the container portion.

[0020] Typically, the add-on device is configured to be fastened to the proximal end of the body or drive mechanism of the injection device. In some examples, the injection device may include a dial extension that undergoes rotational and / or longitudinal displacement relative to the body of the injection device during or during dose setting and / or during injection of a dose of medication. The add-on device may, for example, be attachable or fastenable only to the proximal end of the injection device, and thus only to the proximal end of the body or drive mechanism of the injection device, respectively, but may, when and / or while attached thereto, be within and remain at all times within transmission range of the machine-readable identification of the injection device.

[0021] In some examples, the machine-readable identification portion of the infusion device is located at or near the proximal end of the body or drive mechanism of the infusion device. The detector arrangement may be located at or near the distal end of the body or drive mechanism of the infusion device, the distal end configured to fasten or mechanically couple with the container portion and / or a medication container disposed therein.

[0022] In some examples, the detector configuration provides a spatial range extender for a wireless communication link, for example between an add-on device and a machine-readable identification provided on or within the infusion device.

[0023] In some examples, the machine-readable identification portion is electrically connected to the detector arrangement by at least one or multiple conductive structures, such as conductive wires. Thus, the electrical connection between the machine-readable identification portion and the detector arrangement may be implemented as a wire-based electrical coupling. Each wire or conductive structure may extend along a sidewall of the body and thus along the longitudinal direction of the body, thus spanning the geometric distance between the detector arrangement at or near the distal end of the body and the machine-readable identification portion at or near the proximal end of the body.

[0024] In some examples, the container portion is removably connectable to the body such that it is movable between a connected configuration and a released configuration. In the connected configuration, the container portion is fastened to the body, e.g., rigidly fastened to the body. In the released configuration, the container portion can be removed from the body. In this case, the container portion can be completely removed, i.e., separated, from the body so that the container portion is completely detached from the body. In other examples, when the container portion is in the released configuration, the container portion can remain connected to the body but can be in a configuration that allows for removal of the drug container and / or insertion of a new drug container into the container portion. In this case, the container portion can be permanently connected to the body or can be movable relative to the body between the connected configuration and the released configuration. In some examples, the container portion can be pivotally attached to the body and can be pivoted about a pivot axis between the connected configuration and the released configuration.

[0025] According to a further example, the detector arrangement is configured to assume a first detector state when the body is connected to the container portion and to assume a second detector state when the body is separated from the container portion. The first detector state and the second detector state are electronically or electrically readable. Thus, the status of the detector arrangement, i.e., the first detector state and the second detector state, are distinguished by an electrically measurable or electrically detectable characteristic of the detector arrangement.

[0026] In some examples, one of removing the container portion from the body and attaching the container portion to the body induces or triggers a switch of one of the first detector state and the second detector state to the other of the first detector state and the second detector state.

[0027] The first and second detector states of the detector configuration may introduce respective electrically or electronically readable first and second identifier states of the machine-readable identification portion. Thus, the machine-readable identification portion may be in or switched to the first identifier state when the detector configuration is in the first detector state. The machine-readable identification portion may be in or switched to the second identifier state when the detector configuration switches to the second detector state.

[0028] wherein the first identifier state may reflect a first machine-readable state of the machine-readable identification portion, and the second identifier state may reflect or constitute a second machine-readable state of the machine-readable identifier. The first and second machine-readable states of the machine-readable identification portion are distinct from one another. The add-on device is particularly configured to wirelessly communicate with the machine-readable identification portion and to identify and / or recognize whether the machine-readable identification portion is in the first machine-readable state or the second machine-readable state.

[0029] According to a further example, the machine-readable identification portion and the detector arrangement are electrically connected by an electrical circuit. In this way, the first detector state and / or the second detector state can be tracked or recognized fairly easily. An electrical or electronic signal and / or an electrically measurable characteristic of the detector arrangement can be transmitted to the machine-readable identification portion via the electrical circuit. In this way, the detector state of the detector arrangement can be easily transmitted to the add-on device via the machine-readable identification portion when the add-on device is properly attached and / or mechanically connected to the injection device.

[0030] According to a further example, the electrical circuit interconnecting the machine-readable identification portion and the detector arrangement includes a first conductive wire and a second conductive wire, the first conductive wire and the second conductive wire being connected to opposite ends of the detector arrangement, the first conductive wire and the second conductive wire being further connected to different terminals of the machine-readable identification portion.

[0031] A change in detector state can be detected at the terminals of the machine-readable identification portion, for example, via first and second conductive wires connected to the first and second terminals of the machine-readable identification portion. The change in detector state can then be immediately communicated to a change in each of the input signals at the first and second terminals of the machine-readable identification portion, with its machine-readable state changing in response to each change or modification in the input signal. When attached to an infusion device, each change in the machine-readable state can be directly tracked or detected by the add-on device.

[0032] According to a further example, the detector arrangement includes an electromechanical switch on or within one of the body and the container portion, and the other of the body and the container portion includes an actuating element configured to engage the electromechanical switch when the container portion is connected to the body, and further configured to disengage the electromechanical switch when the container portion is separated from the body.

[0033] In some examples, the electromechanical switch includes first and second switch terminals that are electrically isolated from each other and electrically disconnected from each other by default. Here, the actuation element may provide a conductive structure that serves as an electrical bridge between the first and second switch terminals when the container portion is properly connected to the body of the injection device. By removing the container portion from the body, the electrical bridge provided by the actuation element undergoes a movement, and thus a geometric displacement, relative to the switch terminals, and this movement or displacement is accompanied by an electrical disconnection of the actuation element from at least one of the first and second switch terminals.

[0034] In other examples, the actuating element is or includes a mechanical component that interacts with an electrical bridge that is an integral component of the electromechanical switch. In some examples, the electromechanical switch includes a moving part, for example, in the form of a contact spring, that is movable between an open state and a closed state. When in the closed state, the contact spring provides electrical contact between the first and second switch terminals and, therefore, the first and second conductive wires of the electrical circuit. In the open state or configuration, the contact spring is disconnected from at least one of the first and second switch terminals and, therefore, from at least one of the first and second conductive wires.

[0035] The movement of the contact spring of the electromechanical switch may be induced or may be inducible or controllable by an actuating element. In this way, when the body and the container portion are interconnected, the actuating element may induce movement of the contact spring from a closed state to an open state or vice versa, from an open state to a closed state. When the container portion and the body are separated, the actuating element moves in the opposite direction, thus inducing the closing or opening of the contact spring.

[0036] An electromechanical switch electrically connected to the machine-readable identification portion allows for electrically detecting the mechanical configuration of the injection device, i.e., the mechanical connection between the container portion and the body, located at the distal end of the body of the injection device, at the opposite longitudinal end of the body of the injection device from where the machine-readable identification portion is typically located, thereby enabling the implementation of wireless near-field or short-range communication between the add-on device and the machine-readable identification portion, with a wireless transmission range that can be shorter than the longitudinal distance between the machine-readable identification portion and the detector configuration, typically located at the opposite longitudinal end of the body of the injector device.

[0037] According to a further example, one of the body and the container portion includes an insertion section. The other of the body and the container portion includes a receptacle sized to receive the insertion section. The detector arrangement is provided on an outer surface of the insertion section or on an inner surface of the receptacle. Typically, when the detector arrangement is provided on the inner surface of the receptacle, the actuating element is provided on an outer surface of the insertion action. Conversely, when the detector arrangement is provided on the outer surface of the insertion section, the actuating element is typically provided on an inner section of the receptacle.

[0038] In a further example, the electromechanical switch is provided on one of the insert section and the receptacle, and the actuation element is provided on the other of the insert section and the receptacle.

[0039] When properly assembled and connected, the body and container portion are disposed in an at least partially interleaved or nested arrangement in which the insert section overlaps the receptacle, thus providing a mechanically stable interconnection between the container portion and the body.

[0040] In a further example, the electromechanical switch is provided on or within the fastening structure of the main body. The actuating element is provided on or within the counter-fastening structure of the container portion, such that the container portion and the main body can be interlocked with each other via mechanical engagement of the fastening structure with the counter-fastening structure. In this way, the counter-fastening structures, which are complementary in shape to the fastening structure, provide two functions. First, they are configured to provide a mechanical connection between the main body and the container portion of the injection device. Second, they provide for the operation of the detector arrangement to change the detector state of the detector arrangement during assembly.

[0041] According to a further example, one of the fastening structure and the counter-fastening structure includes a groove. The other of the fastening structure and the counter-fastening structure includes a protrusion for engaging the groove. In some examples, the groove is implemented as an L-shaped groove or a bayonet groove. The groove may also be provided in the form of a threaded structure and thus may feature a helical shape.

[0042] In some examples, the groove is provided on the inner surface of the receptacle, and the protrusion is provided on the outer surface of the insert section. In other examples, the groove may be provided on the outer surface of the insert section, while the protrusion is provided on the inner surface of the sidewall of the receptacle.

[0043] In some examples, the groove is provided as a threaded structure and the protrusion is provided as a complementary counter-threaded structure, thereby enabling threaded engagement between the body and the container portion via a complementary counter-fastening structure.

[0044] According to a further example, the body includes a distal end and an opposing proximal end, the machine-readable identification portion being closer to the proximal end than the detector arrangement and / or the detector arrangement being closer to the distal end than the machine-readable identification portion.

[0045] Here, the electrical circuit between the machine-readable identification portion and the detector arrangement functions to provide electrical, and therefore geometric, bridging between the machine-readable identification portion at or near the proximal end of the body and the detector arrangement at or near the distal end of the body of the injection device.

[0046] According to further examples, the machine-readable identification unit includes an electronic circuit. The electronic circuit includes an antenna and an integrated circuit and is operable to wirelessly communicate with the electronic module of the add-on device. In some examples, the machine-readable identification unit includes one of an RFID tag, an NFC tag, or an UWB tag. The machine-readable identification unit may be implemented as a passive tag or an active tag, the latter including its own energy source.

[0047] According to a further example, the machine-readable identification portion includes a memory configured to store at least one of device information, container information, and usage-related data.

[0048] The usage-related data may indicate a usage status of the infusion device. The usage status may be determinable by an add-on device. The usage status may include information such as the total number of doses set or infused, the total amount of medication infused by the infusion device, the type, name, and / or strength of medication infused by the infusion device, the medication container lot number, and other medication or medication container-related information that may be useful for actual or future use of the infusion device.

[0049] The container information may indicate at least one of the type of medication contained in the medication container, the concentration of the pharmaceutical substance of the medication contained in the container, the date of manufacture of the medication, the expiration date of the medication, or the lot number of the medication or medication container, and / or environmental parameters to which the medication container has been exposed, such as temperature, humidity, or radiation intensity.

[0050] The device information may include information or data regarding the type of infusion device. The device information may also be specific regarding the type of injection mechanism or drive mechanism of the infusion device. Thus, the device information may characterize the dose setting and / or dose dispensing operability of each infusion device. The device identification may further include data or information regarding the appropriate medication or medication container to be used exclusively with each infusion device.

[0051] According to a further example, the integrated circuit includes a first terminal and a second terminal, the first terminal being connected to one end of the detector arrangement and the second terminal being connected to the other end of the detector arrangement, such that the first terminal and the second terminal constitute different terminals of the machine-readable identification unit as referred to above.

[0052] The first terminal and the second terminal may provide a machine-readable, and therefore electrically detectable, signal from the detector arrangement when the body and container portion are interconnected and attached and / or when the body and container portion are separated.

[0053] According to a further example, the integrated circuit includes a general purpose input / output (GPIO) terminal connected by or through a resistor to one of the first and second terminals. In this way, changes in detector state can be easily detected electronically at the GPIO terminal, which may be at a low voltage or a high voltage depending on the configuration of the detector arrangement, for example depending on the configuration of the electromechanical switch.

[0054] In a further example, the general-purpose input / output terminal and the other of the first and second terminals are connected via a capacitor, and thus an input capacitor of the integrated circuit. Directly connecting the first and second terminals of the integrated circuit to the switch terminals of the electromechanical switch may require the electronic module to periodically request the detector configuration. Here, the electronic module may trigger or provoke a request for the actual status of the detector configuration via the machine-readable identification. For example, the add-on device may be configured to perform or trigger such a check or request at regular time intervals, such as every 1 to 3 seconds. In this way, the add-on device may be configured to periodically check the status of the detector configuration.

[0055] By connecting a resistor to the GPIO terminal and one of the first and second terminals of the integrated circuit, the resistor provides a pull-up resistor for improved or well-defined signal detection. Here, the add-on device may also be configured to periodically detect the actual status of the detector configuration, for example, by periodically sending a respective request to the machine-readable identification unit. By using the pull-up resistor of the terminal of the integrated circuit, a well-defined voltage level may be provided to each input terminal and / or GPIO terminal of the electronic circuit. In this way, a fairly accurate and well-defined voltage measurement may be provided.

[0056] In a further example where the GPIO terminal and the other of the first and second terminals of the integrated circuit are connected by a capacitor, a type of automatic wake-up function can be implemented. Here, the capacitor can function to discharge when an electrical circuit interconnecting the detector arrangement and the machine-readable identification is opened, for example, during the process of separating the container portion from the main body. Discharging the capacitor can trigger an electronic wake-up of the integrated circuit, thereby automatically generating a respective wireless signal that can be detected by the add-on device when attached to the injection device. The generation of the wake-up signal can also lead to the respective wake-up of the device's operation. This can therefore provide a rather external wake-up function of the add-on device when attached to the injection device. Here, separation of the container portion from the main body or connection of the container portion to the main body can trigger the generation of a respective wake-up signal in the machine-readable identification, which can then trigger the wake-up of the add-on device.

[0057] In this way, regular supervision of the actual state of the detector configuration by the add-on device may become unnecessary, saving electrical energy for each such periodic check or request.

[0058] In further examples, the drive mechanism includes at least one movable component that undergoes movement relative to the housing or the medication container during at least one of setting a dose and injecting a dose of medication. In some examples, the movable component is one of a dose dial rotatable relative to the housing for setting a dose, a dial sleeve rotatable relative to the housing during setting a dose or dispensing a dose, and a drive sleeve or drive member that undergoes rotational and / or longitudinal movement relative to the housing during at least one of setting a dose and dispensing a dose. In some examples, the movable component is a clicker or click element that functions to generate an audible sound that can be recorded by a sensor in the add-on device. In a further example, the movable component is a piston rod operably engaged with a piston of the medication container to displace the piston relative to the medication container during dose injection. In a further example, the movable component is a single-dose indicating component, the movement and / or position of which relative to the housing or device body indicates the size of the currently set dose. In a further example, the movable component is a last-dose component, the position of which relative to the housing of the injection device directly indicates the amount of medication remaining in the medication container or cartridge.

[0059] According to another aspect, the present disclosure relates to an add-on device for attachment to the injection device described above. The add-on device includes a device body fastenable to a portion of the injection device. The add-on device further includes at least one of a reader and a transceiver operable to read a machine-readable identification portion of the injection device and generate a read signal. The add-on device further includes an electronics module including a module processor coupled to at least one of the reader and / or transceiver.

[0060] The module processor functions to process the read signal to determine whether the container portion of the infusion device is connected to the main body. In some examples, at least one of the reader and transceiver is an integral part or component of the electronics module of the add-on device.

[0061] Generally, the add-on devices are configured to operate in conjunction with the infusion devices described above, and therefore all features, benefits, and advantages described above with respect to the infusion devices apply equally to the add-on devices, and vice versa.

[0062] In particular, the add-on device functions to read or read a machine-readable identification electrically connected to the detector arrangement of the injection device. By reading the machine-readable identification, the add-on device can obtain or read the detector state of the detector arrangement and thus be able to distinguish between at least two different states of the detector arrangement indicative of the interlocking of the container portion and the main body or the separation of the container portion from the main body.

[0063] In some examples, the device body of the add-on device is removably fastenable or connectable to the proximal end of the body of the injection device and / or the proximal end of the injection mechanism or drive mechanism of the injection device. In some examples, the device body includes a receptacle sized to receive a dose dial or dial extension of the injection device.

[0064] According to a further example, the module processor is configured to sample or request a read signal from one of the reader and transceiver according to a predefined time interval.

[0065] Similarly, at least one of the reader and transceiver of the add-on device is operable to sample or request a signal indicative of connection from the machine-readable identification and / or detector arrangement of the infusion device. In some examples, the sample rate may be on the order of a few seconds. Thus, the add-on device may be configured to sample or request a read signal from the machine-readable identification and / or detector arrangement of the infusion device via the machine-readable identification every 1 to 3 seconds. In this manner, the add-on device is operable to constantly or periodically monitor the connection status of the infusion device, the connection status being indicative of the interlocking of the main body and the container portion.

[0066] According to a further example, the add-on device includes sensors operative to quantitatively determine at least one of the position and movement of the movable components of the drive mechanism relative to at least one of the housing, the drug container, and the device body. The sensors are further operative to generate respective sensor signals. The module processor of the add-on device is operative to determine or calculate the size of the drug dose to be set or dispensed by the infusion device based on the sensors.

[0067] According to a further example, at least one of the reader and transceiver includes a wireless near-field transceiver that functions to wirelessly communicate with a machine-readable identification portion of the injection device to obtain status information of the detector configuration and / or to obtain at least one of device information and container information stored in the machine-readable identification portion.

[0068] In some examples, the reader and / or transceiver of the add-on device is implemented as a radio frequency transceiver, for example, an RFID reader, an NFC reader, or an UWB reader.

[0069] Because the machine-readable identification portion is electrically connected to the detector configuration and because any change in the detector state invariably reflects each change in the configuration of the machine-readable identification portion, the state or status of the detector configuration can be read by the add-on device when at least one of the reader and transceiver communicates wirelessly with the machine-readable identification portion provided on or within the injection device.

[0070] According to a further example, at least one of the reader and the transceiver includes a wireless local range transceiver operable to wirelessly communicate with an external electronic device to receive status information of the detector arrangement and / or device information and / or container information stored in the machine-readable identification from or via the external electronic device.

[0071] The local range transceiver may include a transmission range greater than the transmission range of the near-field transceiver. The local range transceiver may include a radio frequency transceiver. The local range transceiver may include a Bluetooth transceiver or a Bluetooth low energy (BLE) transceiver. The local range transceiver may also include a wireless transceiver, such as a Wi-Fi transceiver, that enables local range signal transmission with an external electronic device.

[0072] Typically, the external electronic device includes one of a smartphone, a smartwatch, and a tablet computer. A communication link between the add-on device and the external electronic device may also allow device information and / or container information provided by the machine-readable identification portion to be provided to the electronic module of the add-on device via the external electronic device. Here, the external electronic device may include a reader or transceiver operable to read the machine-readable identification portion of the infusion device. In response to such reading of the machine-readable identification portion by the external electronic device, the external electronic device may then be capable of extracting the device information and / or container information from the machine-readable identification portion and transmitting at least one or both of the device information and container information to the add-on device via the local range transceiver of the add-on device. In this manner, the add-on device is indirectly provided with information or data contained in or provided by the machine-readable identification portion of the infusion device. In this example, the add-on device may not have a near-field transceiver and is not necessarily capable of acquiring or reading the machine-readable identification portion itself. Here, the external electronic device may act as a relay that functions to read or obtain device and / or container information from the machine-readable identification portion and further provide or transmit the collected information to the add-on device.

[0073] Of course, local range transmission between the electronic module of the add-on device and the external electronic device requires some kind of authentication procedure or pairing so that unauthorized reading or transmission of device information and / or container information can be effectively controlled and / or prevented.

[0074] In some examples, the module processor is further operable to determine or calculate a dose size based not only on the sensor signal but also on at least one of container information and device information obtained from the machine-readable identification portion.

[0075] The add-on device, and the above-described acquisition of device and / or container information, can provide somewhat automated calibration of dose sizing or dose size calculations. Thus, the add-on device itself can derive and / or process drug container-specific information and / or device-specific information, for example, during assembly to an infusion device. In response to acquiring the container information and / or device information, the add-on device can be configured to perform a calibration routine. In this manner, measurable sensor signals acquired by sensors in the add-on device can be converted or recalculated into correct dose size information.

[0076] According to a further example, the electronic module further includes a module memory connected to the module processor, the module memory and / or module processor operable to store device information and / or container information as stored information and / or to store administration history, the administration history including the number of dose sizes dispensed or injected by the injection device and determined or calculated by the module processor.

[0077] According to a further example, the module processor is operable to determine or calculate the remaining amount of medication contained in the medication container based on administration history and on the connection status between the main body and the container portion.

[0078] In some examples, the dose size or dose information obtained from the sensor of the add-on device is taken into account only and exclusively for calculating the remaining amount of medication as long as the add-on device determines or confirms that the container portion is connected to the main body of the injection device and remains connected. Thus, the add-on device, in particular the electronic module and / or its module processor, functions to determine the connection status between the container portion and the main body of the injection device as described above, i.e., by reading the machine-readable identification electrically connected to the detector arrangement. Thus, when the add-on device determines or confirms that the container portion and the main body of the injection device remain secured and / or connected to each other, the size of the currently set or dispensed dose is only used for calculating the remaining amount of medication contained in the medication container.

[0079] Thus, the add-on device may function, for example, to wirelessly communicate with the machine-readable identification portion when the add-on device is properly assembled or attached to the injection device, and to periodically check the interconnection between the container portion and the main body by sampling or requesting a read signal from one of the reader and transceiver, each of which obtains information regarding the detector status of the detector configuration of the injection device.

[0080] In some examples, the add-on device may be configured to suspend or discard the calculation of the remaining amount of medication contained in the medication container if a mechanical separation of the container portion and the main body is detected. Separation of the container portion from the main body may result in a change in the state of the detector arrangement, which may be electronically readable via the machine-readable identification. Detection of the status change during ongoing and periodic processing of administration history monitoring and / or remaining amount calculation is a safety feature to avoid erroneous calculation of the remaining amount of medication in the medication container if the user should remove the container portion from the main body prematurely, i.e., before the contents of the medication container have been completely dispensed or used up.

[0081] In a further example, when the machine-readable identification unit comprises container information and / or device information, detection of the container portion from the main body may be permitted, particularly when the administration history obtained, determined, or calculated by the add-on device is written or stored in the memory of the machine-readable identification unit. Reattaching the container portion to the main body may allow reading of each machine-readable identification unit and resuming calculation of the remaining amount of each container portion or drug container.

[0082] According to another aspect, the present disclosure further relates to an infusion system including the infusion device described above and further including the add-on device described above. Accordingly, all of the features, effects, and advantages described above with respect to either the infusion device or the add-on device apply equally to the infusion system.

[0083] The infusion system may further include at least one external electronic device operable to communicate, e.g., wirelessly, with the add-on device. The external electronic device may be implemented as a smartphone, a smartwatch, a tablet computer, or any other digital electronic device capable of communicating with the add-on device.

[0084] According to another aspect, the present disclosure relates to a method for monitoring operation of an injection device configured to inject a dose of a medication. The method includes attaching an add-on device to a portion of the injection device, the injection device including a machine-readable identification portion on or within one of a body and a container portion of a housing of the injection device. The machine-readable identification portion is electrically connected to a detector arrangement. The detector arrangement is provided on or within one of the body and the container portion. The detector arrangement functions to detect, e.g., electrically detect, a mechanical connection between the body and the container portion.

[0085] The method further comprises reading the machine-readable identification with at least one of a reader and a transceiver of the add-on device to generate a read signal indicative of a mechanical connection between the main body and the container portion. The method further comprises processing the read signal to determine whether the container portion is connected to the main body. Typically, the method of monitoring operation of an infusion device is performed and / or carried out by the infusion device and / or by using the add-on device as described above. Accordingly, all features, effects, and advantages described above with respect to either the infusion device or the add-on device apply equally to the method of monitoring operation of an infusion device described herein.

[0086] According to a further example, the method includes quantitatively determining the position and / or movement of a movable component of a drive mechanism of the injection device by sensors of the add-on device when the add-on device is attached to the injection device, the sensors providing and generating respective sensor signals indicative of the degree of movement and / or indicative of position information that can detect or determine the position of the movable component relative to either the housing of the injection device or the device body of the add-on device.

[0087] By quantitatively detecting or measuring the extent of movement of the movable component of the drive mechanism, dose size information can be derived that indicates the size of the dose currently being set or dispensed by the injection device. Quantitative measurement of dose size allows every dispensing event of the injection device to be monitored and logged, recording the administration history of each.

[0088] Thus, in a further example, the method includes monitoring a dosing history with the add-on device, the dosing history including the number of doses dispensed by the infusion device, e.g., sequentially dispensed or injected, and the dose size determined or calculated by the add-on device. The stored dosing history may include the time when the doses were set and / or dispensed and the amount of medication set or dispensed with each dispense or injection operation. The dosing history may be stored locally on the add-on device. The dosing history may be synchronized, e.g., via wireless data transmission with an external electronic device, and may be shared with other entities or persons, such as healthcare providers.

[0089] In some examples, the administration history may be stored in memory in a machine-readable identification portion of the infusion device, and thus the recorded administration history may be stored on-site directly on the infusion device or components thereof used to set and dispense each dose of medication.

[0090] According to a further example, the method includes determining or calculating the remaining amount of medication contained in the medication container based on the administration history and based on the connection status between the main body and the container portion.

[0091] In this way, any unintended or misused use of the infusion device can be captured and checked by the detector arrangement and the machine-readable identification of the infusion device, in particular by taking into account the connection status between the main body and the container part. In particular, premature removal or replacement of the medication container can be detected fairly autonomously and used to discard or interrupt ongoing administration history calculations and / or remaining medication quantity calculations or determinations. In this way, erroneous administration information can be prevented from being generated and / or used to calculate the remaining amount of medication in the medication container.

[0092] According to a further aspect, the present disclosure also relates to a computer program, e.g. a computer program product, comprising computer readable instructions which, when executed by a module processor of the above-mentioned add-on device, cause the module processor to perform the steps of the above-mentioned method.

[0093] Typically, the computer program is executable by the add-on device as described above and is further operable to implement the method of monitoring the operation of an infusion device in the add-on device as described above. Thus, the computer program and its computer readable instructions are operable to cause a processor of the add-on device to implement the method of monitoring or checking the infusion device as described above. The computer readable instructions may be executable by the processor of the add-on device as described above.

[0094] Additionally or alternatively, if the external electronic device of the above-described injection system is configured to read the machine-readable identification portion of the injection device, the computer program and its computer-readable instructions may be at least partially executable by a processor of the external electronic device.

[0095] The computer program is executed by a processor of the add-on device to monitor and / or record the operation of the infusion device when the add-on device is attached to the infusion device. Accordingly, all features, effects, and advantages described above with respect to the add-on device and / or with respect to the method of configuring the add-on device, as well as with respect to any infusion system, apply equally to the computer program, and vice versa.

[0096] The present disclosure further discloses and proposes a computer program comprising computer-executable instructions for performing a method according to one or more of the disclosed methods / devices / systems of the examples contained herein when the program is executed on a processor, a computer, or a computer network. Specifically, the computer program may be stored on a computer-readable data carrier. Thus, specifically, one, two or more, or even all of the method steps as described above may be performed by using a computer or a computer network, typically by using a computer program.

[0097] The present disclosure further discloses and proposes a computer program product having program code means for performing the methods according to one or more of the disclosed methods / systems of the embodiments contained herein when the program is run on a computer or computer network. In particular, the program code means may be stored on a computer readable data carrier.

[0098] Furthermore, the present disclosure discloses and proposes a data carrier having stored thereon a data structure that, after being loaded into a processor, a computer, or a computer network, e.g., into the working memory or main memory of a processor, computer, or computer network, is capable of executing a method according to one or more of the examples disclosed herein.

[0099] The present disclosure further proposes and discloses a computer program product having program code means stored on a machine-readable carrier for performing the method or part thereof according to one or more of the examples disclosed herein when the program is executed on a processor, a computer, or a computer network. As used herein, a computer program product refers to a program as a tradeable product. The product may generally exist in any form, for example in paper form or on a computer-readable data carrier. In particular, the computer program product may be distributed over a data network.

[0100] In a further example, the injection device includes a dose dial and a trigger, for example, provided at the proximal longitudinal end of the injection device. The injection device may be implemented as a pen injector. The dose dial and / or trigger may be provided at the proximal longitudinal end of the pen injector. Here, the machine-readable identification may be provided in or on the dose dial and / or trigger. The add-on device may be configured to be releasably or detachably fastened to the proximal end of the injection device.

[0101] The add-on device, particularly its device body, may include a receptacle that fits over the dose dial and / or trigger. By mounting or locating the machine-readable identification within or on the trigger or dose dial, the geometric distance between the machine-readable identification and a reader or transceiver of the add-on device for reading the machine-readable identification can be reduced to a minimum, thus allowing the transceiver or reader of the add-on device to be implemented as a wireless near-field transceiver that functions to read the near-field communication tag of each of the device's machine-readable identification. In this way, reading of the machine-readable identifier can only occur when the add-on device is properly attached to the proximal end of the injection device.

[0102] According to a further example, the infusion system includes an external electronic device, for example implemented as a smartphone, a smartwatch, or a tablet computer, which may be operable to perform at least one or several steps of the method for monitoring the operation of the infusion device.

[0103] Generally, the scope of the present disclosure is defined by the content of the claims. The present disclosure is not limited to a particular embodiment or example, but includes any combination of elements from different embodiments or examples. Thus, the present disclosure covers any combination of the claims and any technically feasible combination of the disclosed features in relation to different examples or embodiments.

[0104] In the present context, the term "distal" or "distal end" relates to the end of the injection device facing the injection site of a human or animal, and the term "proximal" or "proximal end" relates to the opposite end of the injection device that is furthest from the injection site of a human or animal.

[0105] The terms "drug" or "medicament" are used synonymously herein to refer to a formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in the broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or medications are used to treat, cure, prevent, or diagnose disease or otherwise improve physical or mental well-being. Drugs or medications may be used for a limited period of time or periodically for chronic conditions.

[0106] As described below, drugs or pharmaceutical agents can 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 include small molecules, i.e., polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes) with a molecular weight of 500 Da or less, 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 can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0107] The drug or agent may be contained within a primary package or "drug container" adapted for use with the drug delivery device. The drug container may 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 may 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 may be designed to store the drug for about one month to about two years. Storage may occur 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 may 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 may be configured to allow mixing between the two or more components before and / or during administration into the human or animal body. For example, the two chambers may be configured so that they are in fluid communication with each other (e.g., by a conduit between the two chambers), allowing the user to mix the two components if desired before administration. Alternatively, or additionally, the two chambers may be configured to allow mixing upon administration of the components into the human or animal body.

[0108] Drugs or agents contained in drug delivery devices as described herein can be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes mellitus or complications associated with diabetes mellitus, such as diabetic retinopathy, and thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders include acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those listed in handbooks such as the Rote Liste 2014, for example, but not limited to, Main Group 12 (antidiabetic drugs) or 86 (oncology drugs), and the Merck Index, 15th edition.

[0109] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes mellitus or complications of type 1 or type 2 diabetes mellitus include insulin, e.g., human insulin, or an insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, or an analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "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 deleting and / or replacing at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or substituted amino acid residue can be either a codable amino acid residue or other naturally occurring residue, or a purely synthetic amino acid residue. Insulin analogs are also referred to as "insulin receptor ligands." In particular, the term "derivative" refers 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, 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 may be deleted and / or substituted with other amino acids, including non-codable amino acids, or amino acids, including non-codable amino acids, may be added to the naturally occurring peptide.

[0110] 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 substituted with Asp, Lys, Leu, Val or Ala and the Lys in position B29 may be substituted with Pro, Ala(B26) human insulin, Des(B28-B30) human insulin, Des(B27) human insulin and Des(B30) human insulin.

[0111] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin. B29-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.

[0112] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flathead sea urchin), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rexendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C, HM-15211, CM-3, G LP-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-3 022, 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.

[0113] Examples of oligonucleotides include, for example, mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic agent for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport syndrome. Examples of DPP4 inhibitors include linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0114] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin, and their antagonists.

[0115] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or ultra-low molecular weight heparin, or derivatives thereof, or sulfated forms of the above polysaccharides, such as polysulfated forms, and / or pharmaceutically acceptable salts thereof. 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 GF 20 (Synvisc®), sodium hyaluronate.

[0116] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain antigen-binding ability. An antibody may 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, antibody fragment, or mutant that does not support Fc receptor binding, 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 with a crossover binding region orientation (CODV).

[0117] The term "fragment" or "antibody fragment" refers to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to antigen. Antibody fragments may include truncations of a full-length antibody polypeptide, although 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.

[0118] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within 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 within the variable regions of both heavy and light chain polypeptides that are not CDR sequences but are primarily responsible for maintaining the proper orientation of the CDR sequences to enable antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of a particular antibody can be directly involved in antigen binding or can affect the ability of one or more amino acids in the CDRs to interact with the antigen.

[0119] Examples of antibodies are anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0120] Pharmaceutically acceptable salts of any of the APIs described herein are also contemplated for use with the drug or medicament in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0121] It will be understood by those skilled in the art that modifications (addition and / or deletion) of 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, and that the invention encompasses such modifications and any and all equivalents thereof.

[0122] An exemplary drug delivery device may include a needle-based injection system as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems may be broadly divided into multi-dose container systems and single-dose (partial or full discharge) container systems. The container may be a replaceable container or an integrated, non-replaceable container.

[0123] As further described in ISO 11608-1:2014(E), a multi-dose container system may include a needle-based injection device with replaceable containers. In such systems, each container holds multiple doses and may be fixed or variable in size (pre-set by the user). Other multi-dose container systems may include needle-based injection devices integrated with non-replaceable containers. In such systems, each container holds multiple doses and may be fixed or variable in size (pre-set by the user).

[0124] As further described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based injection device with replaceable containers. In one example of such a system, each container holds a single dose, thereby dispensing the entire deliverable amount (full discharge). In a further example, each container holds a single dose, thereby dispensing a portion of the deliverable amount (partial discharge). Also as described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based injection device with an integrated replaceable container. In one example of such a system, each container holds a single dose, thereby dispensing the entire deliverable amount (full discharge). In a further example, each container holds a single dose, thereby dispensing a portion of the deliverable amount (partial discharge).

[0125] A number of examples of data logging devices for monitoring infusion device usage and corresponding infusion devices are described in more detail below with reference to the drawings. [Brief explanation of the drawings]

[0126] [Figure 1] 1 illustrates a schematic diagram of an example of an injection device. [Figure 2] 10 illustrates the process of assembling an add-on device to the proximal end of an infusion device. [Figure 3] 1 shows an injection device in a schematic longitudinal cross-section. [Figure 4] 1 illustrates a configuration of an infusion system including an infusion device, an add-on device, and at least one external electronic device. [Figure 5] 1 illustrates pairing between an external electronic device and an add-on device. [Figure 6] 10 shows a visual illustration on the display of an external electronic device to assist a user in setting up an infusion device. [Figure 7] 10 illustrates a configuration of an external electronic device that indicates an end-of-dose configuration of a medication container. [Figure 8]10 shows a display on an external electronic device prompting a user to replace a medication container. [Figure 9] 1 shows a display of an external electronic device that provides statistical data of recent dose setting and injection procedures. [Figure 10] 10 shows the display configuration of the external electronic device after the medicine container has been replaced. [Figure 11] 10 shows the configuration of the add-on device before attempting to the proximal end of the injection device. [Figure 12] 10 illustrates visual feedback provided on an external electronic device in response to reading information from an electronic container identifier. [Figure 13] 1 shows an example of a container portion detached from the body of an injection device. [Figure 14] The distal end of the body is shown separately, configured to connect with the proximal end of the reservoir portion. [Figure 15] 1 shows an example of an injection device and an add-on device before the add-on device is assembled to the injection device. [Figure 16] 1 shows an add-on device assembled to an injection device. [Figure 17] 1 illustrates an example of an electromechanical switch in a detector configuration. [Figure 18] 1 illustrates another example of an electromechanical switch in a detector configuration. [Figure 19] 10 shows a further example of an electromechanical switch in a detector configuration. [Figure 20] 1 shows block diagrams of an add-on device, an injection device, and an external electronic device. [Figure 21] 1 shows a block diagram of the electronic circuitry of the machine-readable identification unit. [Figure 22] 1 shows an example of an electronic circuit on a substrate. [Figure 23] 1 shows a flowchart of a method for configuring an add-on device. DETAILED DESCRIPTION OF THE INVENTION

[0127] FIG. 1 shows an example of a drug delivery device implemented as a handheld injection device 1. The injection device 1 may include or be implemented as a pen injector. The injection device 1 may be implemented as a disposable injection device or a reusable injection device. In some examples, the injection device 1 is implemented as an automatic injector. The injection device 1 is elongated in shape. The injection device 1 may extend along a longitudinal direction. The drug delivery device 1 includes, toward a longitudinal distal direction 2, a dispensing end for dispensing or injecting a medicament 24. Toward a proximal direction 3, the injection device 1 includes at least one of a dose member 8 and a trigger 9, which can set and dispense doses of equal, individual, or different sizes, respectively.

[0128] The injection device 1 includes a housing 10. The housing 10 may include a number of housing components, such as a body 6 and a reservoir portion 7, for example implemented as a cartridge holder 7. The body 6 may be sized and configured to accommodate a drive mechanism 20. The cartridge holder 7 is sized and configured to accommodate a medicament container 21, for example implemented as a cartridge containing a liquid medicament 24. The medicament container 21 includes a tubular barrel 22 sealed towards its distal end by a seal 23. The seal 23 may include a pierceable septum secured to an outlet 25 of the medicament container 21. The interior of the barrel 22 is sealed towards its proximal end by a piston 18 or stopper slidably disposed within the barrel 22.

[0129] By advancing the piston 18 in the distal direction 2, a dose of the medicament 24 can be expelled from the medicament container 21. In use, the medicament container 21 is disposed within the container portion 7. The drive mechanism 20 of the injection device 1 includes a piston rod 19 that is displaceable in the distal direction 2 to advance the piston 18 toward the outlet 25 of the medicament container 21. Details of the drive mechanism will not be further shown or described herein. In some examples, the drive mechanism 20 may be implemented as an all-mechanical drive mechanism in which the user must provide all of the dispensing force required to move the piston rod 19, and therefore the piston 18, in the distal direction 2. In other examples, the drive mechanism includes a mechanical energy store configured to provide at least a portion of the dispensing force. Examples of drive mechanisms can be found, for example, in WO 2004 / 078241 A1, WO 2014 / 033197 A1 or WO 2014 / 033195 A1, the entire contents of which are incorporated herein by reference.

[0130] 2, the injection device 1, and thus the drive mechanism 20, may include a dial extension 27 that projects and moves in the proximal direction 3 from the proximal end of the body 6 at or during dose setting and returns to its initial distal position during the dose injection procedure. To this end, the user may use the thumb 114 of their hand 110 to apply distal pressure to the trigger 9, thereby pushing the dial extension 27 in the distal direction 2 during and / or throughout the dose injection procedure.

[0131] To set or dial a dose, the user can twist or rotate the dose dial 8, for example, in the dose-increase direction 4, thus clockwise when viewed from the proximal end. To modify a previously set dose, the user can also rotate the dose dial 8 in the opposite dose-decrease direction 5. The dose size is typically indicated in a window 26 provided in or on the body 6 of the injection device 1. Before injecting a dose of medicament 24, the distal end of the container portion 7 or cartridge holder must be connected with the needle assembly 12. For this purpose, the distal end of the cartridge holder 7 includes a connector 11, for example in the form of a threaded interface, for engaging a complementary-shaped threaded counter-interface of the needle assembly 12.

[0132] The needle assembly 12 is detachably or removably securable to the container portion 7. The needle assembly 12 includes a double-ended infusion needle 13. The proximal end (not shown) of the infusion needle is configured to enter a through-opening in the distal end face of the connector 11 or the container portion 7 so as to pierce or penetrate the seal 23 of the medication container 21. The distal end of the infusion needle 13 is typically covered by a removable inner needle cap 14. The entire needle assembly 12 may be covered by a removable outer needle cap 15.

[0133] The container portion 7 , and therefore part of the housing 10 , will be housed within a protective cap 16 which is removably connectable to the cartridge holder 7 or the body 6 .

[0134] 2 and 4 show an example of an add-on device 30 configured to be fastened to the proximal end of the injection device 1. The add-on device 30 includes a sensor 48 or sensor assembly operable to detect, recognize, characterize, and / or measure the operation of the injection device 1. Typically, the sensor 48 of the add-on device 30 is capable of or operable to quantitatively determine or measure the position and / or movement of movable components 80, 81, 82, 83 of the drive mechanism 20 of the injection device 1, as shown in the block diagram of FIG. 20. The movable components 80, 81, 82, 83 are movable relative to the main body 6 and / or the medicament container 21 during or during setting and / or injecting a dose of the medicament 24.

[0135] This movement or position can be quantitatively measured by a sensor 48. Typically, the sensor 48 is implemented as an electronic sensor. When the add-on device 30 is attached to the injection device 1, the sensor 48 can detect or measure the degree of longitudinal translation and / or rotation of at least one movable component 80, 81, 82, 83 relative to the housing 10 or relative to the device body 60. An example of a movable component 80 is shown schematically in the cross-sectional view of the injection device 1 according to FIG. 3.

[0136] The sensor 48 of the add-on device 30 is capable of or functions to generate a sensor signal or sequence of sensor signals, which, upon coupling or connection to the module processor 44, can be processed by the module processor 44 to derive or calculate the size of the dose currently being set or dispensed.

[0137] In some examples, the movable component 80 is a dose setting member or a dose setting sleeve. In further examples, the movable component 81 is implemented as a drive member or drive sleeve 81 of the drive mechanism 20. In a further example, the movable component is implemented as a volume indicator 82, for example as a single dose indicating member, the position or configuration of which relative to the body 6 directly indicates the size of the currently set dose. In a further example, the movable component 82, and thus the volume indicator, is a final dose indicating member, the position or configuration of which relative to the body 6 indicates the remaining amount of medicament left in the cartridge or medicament container 21.

[0138] In some examples, the movable components 83 are or include an encoding, such as a digital encoding, movable relative to the sensor 48 so that the sensor can count the number of discrete code portions of the encoding to gather quantitative movement information about each of the movable components 80. Generally, different types of spatial encoding may be provided, such as optical or visual encoding, electrical or electrostatic encoding, magnetic encoding, or mechanical encoding. The sensor 48 is configured to respond depending on the type of encoding provided on or within the movable components 80, 81, 82, 83. Thus, the sensor 48 may include at least one of an optical sensor, an electrical or electrostatic sensor, and a magnetic sensor or a mechanical sensor, such as a micromechanical switch, each of which functions to quantitatively measure the relative position or movement of the movable components 80, 81, 82, 83.

[0139] In some examples, the movable components 80, 81, 82, 83 undergo longitudinal and / or rotational movement relative to the body 6, relative to the drug container 21, and / or relative to the device body 60 during dose setting and / or dose dispensing. Typically, the encoding provided on or with the movable components 80, 81, 82, 83 is encoded along the direction of movement of the movable component relative to the sensor 48 to enable quantitative measurement of each dose setting or dose dispensing movement.

[0140] As further shown in Figure 3, the drive mechanism 20 may optionally be provided with a locking mechanism 85 operable by a lock controller of the add-on device 30 when the add-on device 30 is properly assembled to the injection device 1. The locking mechanism 85 functions to block or lock the drive mechanism 20 to prevent unauthorized or unintended setting and / or dispensing or injection of a dose. The locking mechanism 85 is controllable by a lock controller 86 of the add-on device 30. The locking mechanism 85 may be implemented electromechanically and may be electrically or electronically controlled by the lock controller 86 of the add-on device 30. In this way, the add-on device 30 may prevent unauthorized or unintended use of the injection device 1.

[0141] The add-on device 30 shown in various Figures 2-14 is removably connectable to a dose dial 8. The add-on device 30 includes a device body 60 having a tubular side wall 61. Towards its distal end, the side wall 61 encloses a receptacle 63 sized to receive the dose dial 8 and trigger 9 of the injection device 1. To this end, the inside of the side wall 60 may include one or multiple fastening ribs 64 configured to provide a non-slip fastening to the dose dial 8 of the add-on device.

[0142] The device body 60 includes a receptacle 63 at the distal end section of the add-on device 30. The receptacle 63 is open in the distal direction 2. The receptacle 63 is sized and configured to fit onto the proximal end of the injection device 1. The inner surface of the side wall 61 enclosing the receptacle 63 includes a number of fastening ribs 64 of a resilient or resiliently deformable material, such as an elastomeric material.

[0143] The fastening ribs 64 provide a friction fit with the dose dial 8 when the device body 60 is assembled to the dose dial 8 of the injection device 1. The receptacle 63 may be longitudinally confined by a flange portion 62 protruding radially inward from the tubular side wall 61 of the receptacle 63. The flange portion 62 is positioned proximally offset from the insertion opening of the receptacle 63. The flange portion 62 may be annular and configured to axially abut a stepped section at the proximal end of the dose dial 8. Thus, the trigger 9, which includes a reduced diameter compared to the dose dial 8, may protrude in the proximal direction 3 through the flange portion 62, and the flange portion 62 may rest or abut against the proximal end face of the dose dial 8 when the add-on device 30 is properly fastened to the dose dial 8.

[0144] The add-on device 30 further includes a movable part 70 protruding proximally from the device body 60. The movable part 70 includes or forms an auxiliary trigger or trigger button configured to mechanically engage the trigger 9 of the injection device 1 when the add-on device 30 is properly assembled to the injection device 1.

[0145] Typically, the add-on device 30, and in particular the device body 60, is frictionally engageable with the dose dial 8. In this way, the user can apply a dose setting torque to the dose dial via the device body 60. Instead of rotating the dose dial 8 to set a dose, the user may simply rotate the device body 60 relative to the body 6 of the injection device 1. In this way, the dial extension 27 may undergo a dose increment dial or rotational movement. Thereafter, the size of each currently set dose is displayed in the window 26 of the body 6 of the injection device 1, as shown in FIG. 2 .

[0146] To dispense a dose, the user needs to press down on the movable part 70, which may then undergo a distally directed movement relative to the device body 60. The movable part 70, which may be in direct or indirect mechanical engagement with the trigger 9, may then apply a respective dispensing force to the trigger 9, thereby initiating the dose-dispensing operation of the injection device 1.

[0147] The add-on device 30, shown schematically in Figure 20, includes an electronic module 34. The electronic module 34 includes a printed circuit board 36. The electronic module 34 includes a module processor 44, an electronic, and therefore digital, module memory 40, and a clock 42. Furthermore, the electronic module 34 includes a power supply 46 and a sensor 48. The electronic module 34 also includes a signal generator 52 coupled to the processor 44 and / or coupled to the power supply 46. The electronic module 34 further includes a reader 37 and / or a wireless transceiver 38, 39. The add-on device 30 may also include a user-perceivable device identifier 50.

[0148] In some examples, the device identifier 50 comprises or includes a signal generator 52 coupled to the module processor 44 and operable or reconfigurable by the module processor 44. In some examples, the device identifier 50 may indicate the infusion device 1 to which the add-on device 30 is actually connected or coupled.

[0149] In some examples, the signal generator 52 functions to generate at least one of a visual, an acoustic, and a tactile signal, or the device identifier thus functions to generate or generate a visual, an acoustic, or a tactile identifier, or a respective warning signal. In some examples, the add-on device 30 includes multiple signal generators 52 of the same or different types, e.g., visual, acoustic, or tactile.

[0150] In the example of FIG. 2, the signal generator 52 may include a speaker that functions to generate an acoustic signal, which may represent or constitute, for example, a warning signal in the form of an acoustic code or sequence characteristic of a particular configuration or setting of the injection device 1 or add-on device 30.

[0151] 4 illustrates an infusion system 120 including at least an add-on device 30 and an infusion device 1. Optionally, the infusion system 120 includes one or several external electronic devices 100, 101′. The external electronic device 100 is implemented as a smartphone including a housing 101 and is equipped with a device display 151 for visually presenting various types of information to a user, such as various illustrations 153 or notifications 154. The display 151 may be implemented as a touch-sensitive display. The device display 151 may function to provide or emulate a device signal generator 152. The device display 151 functions to provide at least one of the illustrations 153 and notifications 154 to the user.

[0152] Further optional external electronic devices 100' are implemented as smart watches, each including a housing and a display 151', and further including a wristband 103 for securing the external electronic device 100' to a user's hand 110 or wrist 111. Similar to the external electronic device 100, the external electronic device 100' also functions to provide at least one of an illustration 153 and a notification 154 to the user. Generally, the external electronic devices 100, 100' may each include a separate device signal generator 152, such as a speaker or vibration module, capable of generating a user-perceivable signal to provide a warning signal to the user of the device.

[0153] The electronic device 100 is typically implemented as a handheld electronic device. The electronic device 100 can be held in a user's hand 110 or may be worn on the user's wrist 111. In the example shown in Figure 4, the electronic device 100 is held in the user's palm 112. The device display 151 is implemented as a touch-sensitive display and can be operated by the thumb 114 and / or various fingers 116 of the user's hand 110.

[0154] The electronic module 34 of the add-on device 30, shown schematically in Figure 20, includes a reader 37 and / or transceiver 38, 39 that function to wirelessly communicate with at least one of the machine-readable identification units 28, 88 of the injection device 1, or with a complementary or correspondingly implemented device reader 137 and / or device transceiver 138, 139 of the external electronic device 100, 100'.

[0155] In a typical example, the transceivers 38, 138 are implemented as near-field radio frequency transceivers. The transceivers 38, 138 may be implemented as wireless short-range transceivers or near-field transceivers. They may be implemented as so-called NFC transceivers that enable wireless communication within a limited spatial range of a few centimeters or decimeters. The transceivers 38, 138 may be implemented as active and / or passive NFC tags or readers. Typically, the transceiver 38 is implemented as a passive NFC tag, and the transceiver 138 is implemented as an active NFC tag or NFC reader.

[0156] The transceivers 39, 139 may be implemented as wireless local range transceivers, such as RFID, Bluetooth, Bluetooth low energy (BLE), or UWB transceivers. Also here, the transceivers 39, 139 may be implemented as passive communication tags, while the transceivers 139 may be implemented as active transceivers and thus as readers. Typically, the transmission range of the transceivers 39, 139 is greater than the transmission range of the transceivers 38, 138. The transmission range of the transceivers 39, 139 may be in the range of several meters or decameters.

[0157] The optional reader 37, 137 may be implemented as an optical reader or optical information collection unit, for example including an imaging system for capturing or recording visual or optical machine-readable identification 28, 88 provided on or within the injection device 1.

[0158] The external electronic device 100, 100′ typically includes a device processor 144 coupled to an electronic device memory 140. The electronic device 100 further includes a device power supply 146. The electronic device 100 also includes a device display 151, which is typically implemented as a touch-sensitive display. The device display 151 may function to provide at least one of illustrations 153 and notifications 154 to a user.

[0159] The device transceiver 138 functions to communicate with the transceiver 38 of the add-on device. The transceiver 139 is configured to communicate with the transceiver 39 of the add-on device 30. The reader 137 may function to read a visual identifier provided on the infusion device 1. In some examples, the device reader 137 includes an imaging system, which may include, for example, a camera objective and a spatial resolution detector for reading or capturing a visual code provided on the exterior surface of the infusion device 1 or provided on the exterior surface of the medication container 21.

[0160] The external device 100 is configured to set up a communication link, for example a wireless communication link, with the add-on device 30. To this end, the local range transceiver 39 of the add-on device 30 may communicate wirelessly with the local range device transceiver 139 of the add-on device 100. Once a communication link is established between the electronic device 100 and the add-on device 30, the electronic device 100 may function to visually show information or data of the infusion device or medication container 21 on the device display 151.

[0161] The infusion device 1 comprises a machine-readable identification portion 28, 88, as shown schematically in Figure 20. The machine-readable identification portion 28 comprises an electronic identifier 29. The machine-readable identification portion 88 comprises an electronic identifier 89. The electronic identifier 28 may comprise a passive wireless communication tag, as shown schematically in Figure 12.

[0162] 21 , the electronic identifier 29 may include an electronic circuit 90 comprising a wireless communication antenna 91 and an integrated circuit 93. The integrated circuit 93 includes an electronic, and therefore digital, memory 92 and a processor 94 connected to the memory 92. Naturally, the integrated circuit 93, and therefore the processor 94, are connected to the antenna 91. The electronic identifier 29 may optionally include a power supply 96 to provide power or energy for the processor 94. The electronic circuit 90 may be provided on a planar substrate 95. The substrate 95 may be flexible or foldable. The substrate 95 may include a flexible structure or foil that allows the substrate 94, and therefore the entire electronic identifier 29, to be easily attached, secured, for example, adhesively secured, to at least one of the tubular body 6, the container portion 7, or the drug container 21.

[0163] The electronic circuitry 90 may be a printed electronic circuit printed on a substrate 95, where the substrate 95 may comprise or consist of, for example, a flexible printed circuit board. The substrate 95 may further comprise an adhesive layer 97 that allows for straightforward adhesive attachment of the machine-readable identification portion 28, 88 to a predetermined portion on or within the infusion device 1. The electronic identifier 89 may comprise the same or similar structure as the electronic identifier 29 shown in Figures 12 and 13.

[0164] In some examples, the machine-readable identification 28, 88 is implemented on a label 17 disposed on one of the body 6, container portion 7, or medication container 21. The label 17 includes or houses the machine-readable identification 28, 88. In some examples, the label 17 includes a passive radio frequency tag. In further examples, the label 17 includes the machine-readable identification 28, 88 implemented as a visual or optical code that can be captured by a reader 37 or device reader 137 implemented as or including an imaging system.

[0165] At least one of the reader 37, device reader 137, or at least one of the transceivers 38, 39 or device transceivers 138, 139 functions to read the machine-readable identification portion 28, 88, thereby obtaining at least one of the device information and container information stored, for example, in the memory 92 of the electronic circuit 90.

[0166] Typically, the machine-readable identification 28 is provided or located on or within the body 6 of the housing 10 of the injection device 1. The further machine-readable identification 88 is provided on or within the container portion 7. The further machine-readable identification 88 may also be provided on or within the medicament container 21. In some examples, the machine-readable identification 28 may be provided in or on the piston 18 of the medicament container 21.

[0167] The machine-readable identification units 28, 88 may be implemented as passive RF communication tags, such as NFC tags, etc. Information, e.g., device information and / or container information, stored in at least one of the machine-readable identification units 28, 88 is readable by the electronic module 34 and thus by one of the transceivers 38, 39 of the add-on device 30 and / or by one of the transceivers 138, 139 of the external electronic device 100, 100′.

[0168] In some instances, particularly when the injection device 1 is implemented as a disposable injection device that does not support replacement of the medication container 21, it may be sufficient for the injection device 1 to include only one machine-readable identification 28. It may be particularly advantageous if the machine-readable identification 28 is provided at or near the proximal end 68 of the body 6. The machine-readable identification 28 may be provided on or within the dose dial 8 or trigger 9 such that it is within transmission range of the transceivers 38, 39 when the add-on device 30 is attached to the proximal end of the injection device 1.

[0169] In some examples, the distal end 67 of the body 6 is detachably connectable to the proximal end of the container portion 7. The injection device 1 is then implemented as a reusable device, allowing for replacement of the container portion 7 and / or replacement of the drug container 21 within the container portion 7. In a reusable injection device 1, it may be particularly advantageous if both the body 6 and the container portion 7 are provided with separate machine-readable identification portions 28, 88. As shown in Figure 20, the container portion 7 is provided with a machine-readable identification portion 88, whereas the body 6 is provided with a machine-readable identification portion 28.

[0170] In some examples, the transceiver 38 may be located within the receptacle 63 of the device body 60 to minimize the spatial distance to the machine-readable identification 28 provided at or near the proximal end 68 of the body 6. The use of near-field communication technology for the machine-readable notification 28, 88 and the respective transceiver 38, 138 may ensure that the machine-readable identification and the device and / or container information stored thereon can only be obtained or retrieved when the add-on device 30 and / or external electronic device 100, 100′ are within near-field transmission range.

[0171] 15, the receptacle 63 of the device body includes an alignment feature 65 in the form of a longitudinal recess or groove on the inside of the side wall of the receptacle 63. Correspondingly, the proximal end of the dose dial 8 includes a complementary shaped counter alignment feature 66, for example in the form of a protrusion, sized to fit into the recess or groove of the alignment feature 65. In this way, a fastening can be provided which inhibits rotation of the add-on device 30 when attached to the housing 10 or dose dial 8 of the injection device 1.

[0172] When the alignment feature 65 is mechanically engaged with the counter-alignment feature 66, as shown in Figure 16, an anti-rotation lock is provided for interfastening the add-on device 30 to the injection device 1. In this way, it can be ensured that the identification portion 28, and therefore the electronic identifier 29, is always correctly aligned with the associated wireless transceiver 38 of the add-on device 30. A unique, well-defined mounting position is therefore provided for attaching the add-on device 30 to the injection device 1. Reaching the pre-defined mounting position or configuration with the alignment feature 65 engaging the counter-alignment feature 66 also ensures that the machine-readable identification portion 28 and the transceiver 38 are at a minimum distance from each other. This allows for a somewhat smoother signal transmission between the identification portion 28 or electronic identifier 29 and the transceiver 38.

[0173] Generally, the external electronic device 100 may be permanently or periodically synchronized with the add-on device by means of a local range communication interface provided, for example, by a transceiver 39, 139. Thus, any information collected or read by the add-on device 30 can be immediately transmitted to the external electronic device 100, 100′ and further processed, for example visualized, by the external electronic device 100, 100′.

[0174] The sequence of Figures 5-12 illustrates one of several examples of how to use the add-on device 30 in conjunction with the infusion device 1. In the configuration of Figure 5, a user of the external electronic device is notified of pairing between the external electronic device 100 and the add-on device 30. Such pairing may be achieved by the establishment of a wireless communication link between the transceiver 39 and the device transceiver 139. When the external electronic device 100 detects the presence and / or correct pairing of the add-on devices, it functions to provide a visual illustration 153 of each on the device display 151.

[0175] In a sub-sequence step, the external electronic device 100 may function to assist or guide the user in bringing the enclosed medication container 21 into the vicinity of the add-on device 30 to enable reading of the machine-readable identification 88 provided on the medication container 21. In this way, when the medication container 21 provided with the machine-readable identification 88 is inserted, for example, into the receptacle 63 of the add-on device 30, the add-on device 30 functions to read out the respective container information. Alternatively, it is also conceivable that the container portion 7 of the injection device 1 is provided with the respective machine-readable identification, as shown on the right side of Figure 6.

[0176] 7, a readout of the machine-readable identification may reveal that a relatively large number of medication units have already been injected and thus dispensed from medication container 21. An empty medication container may be provided in the form of a visual illustration 153 on device display 151. Here, the nearly empty configuration of medication container 21 may be accompanied by a virtual indicator 156 that is simultaneously provided on device display 151 along with the illustration of medication container 21 or container portion 7.

[0177] 8, the add-on device 100 may then prompt the user to exchange the medication container 21 with respect to the container portion 7. Thus, the empty medication container 21 should be removed from the container portions 7 and 8, and a new medication container 21 should be inserted into the container portion 7.

[0178] Optionally, as shown in Figure 9, the external electronic device may provide statistical data or a statistical illustration 153, for example, regarding recent usage of the infusion device 1. After inserting a new medication container 21 into the container portion 7 and after performing the repetitive reading procedure described above, for example, in connection with Figure 6, the external electronic device 100 may provide a visual illustration 154 of the new, and therefore sealed, medication container 21 or container portion 7 together with respective indicators 156. Additionally, a notification 154 may be provided on the device display 151 indicating to the user the number of medication units provided in the medication container 21 and / or provided in the container portion 7 that are available.

[0179] 11 shows the situation before the add-on device 30 is attached to the proximal end of the injection device 1. Here, the transceiver 38 of the add-on device 30 is located in the receptacle 63. Attaching the add-on device 30 to the proximal end of the injection device 1, and thus to the dose dial 8, allows the spatial distance between the transceiver 38 and the electronic device identification 29 to be reduced to a minimum, thus making it possible to read the configuration of the electronic device identification 29 and / or to read information stored in the electronic device identification 29.

[0180] If the container information obtained from the electronic container identifier 89 matches the device information obtained from the electronic device identifier 29, the external electronic device 100 may be configured to indicate to the user the correct pairing of the main body 6 and the container portion 7, as shown in Figure 12. Both the main body 6 and the container portion 7 may be individually identified via their respective electronic main body identifier 29 and electronic container identifier 89. The matching of the medication container 21 and / or container portion 7 with the main body 6 may be visually indicated on the display 151 of the external electronic device 100, for example, in the form of an illustration 153 of the recognized or identified components and / or by a respective notification 154 indicating to the user that the individually recognized or identified components of the infusion device 1 match each other.

[0181] Generally, the external electronic device 100 may be permanently or periodically synchronized with the add-on device by means of a local range communication interface provided, for example, by a transceiver 39, 139. Thus, any information collected or read by the add-on device 30 can be immediately transmitted to the external electronic device 100, 100′ and further processed, for example visualized, by the external electronic device 100, 100′.

[0182] 13 and 14, the injection device 1 includes a detector arrangement 98 on or within the body 6, which is operable to detect a mechanical connection between the body 6 and the container portion 7. The machine-readable identification portion 28 is electrically connected to the detector arrangement 98. Due to the electrical connection between the detector arrangement 98 and the machine-readable identification portion 28, the machine-readable identification portion indicates a mechanical connection between the body 6 and the container portion 7. Thereby, by reading the machine-readable identification portion 28, for example by an add-on device 38, the status of the detector arrangement 98 can be detected and thus determined.

[0183] Thus, the status of the mechanical connection between the container portion 7 and the body 6 is electronically readable by the machine-readable identification portion 28. Typically, as shown in Figure 13, the machine-readable identification portion 28 may be implemented as an RFID tag 99, as an NFC tag or as an UWB tag.

[0184] Depending on the mechanical connection between the container portion 7 and the body 6, the detector arrangement 98 is switchable between one of a first detector state and a second detector state. When the body 6 is connected to the container portion 7, the detector arrangement 98 is in the first detector state. When the body 6 is separated from the container 7, the detector arrangement 98 is in the second detector state. Both the first detector state and the second detector state are electronically readable via the machine-readable identification portion 28.

[0185] 13 and 14 , the machine-readable identification portion 28 and the detector arrangement 98 are electrically connected by an electrical circuit 190. The electrical circuit 190 includes a first conductive wire 191 and a second conductive wire 192. The detector arrangement 98 further includes an electromechanical switch 180. For example, when the switch 180 is closed, the detector arrangement 98 is in a first detector state. When the switch 180 is open, the detector arrangement 98 is in a second detector state.

[0186] In another example, when the detector arrangement 98 is in the second detector state, the electromechanical switch 180 is closed. When the detector arrangement 98 is in the second detector state, the electromechanical switch 180 is open.

[0187] 13, electromechanical switch 180 functions to interrupt electrical circuit 190. Thus, when switch 180 is open, the electrical connection between detector arrangement 98 and machine-readable identification portion 28 is interrupted. Closing electromechanical switch 180 establishes the electrical connection between detector arrangement 98 and machine-readable identification portion 28.

[0188] The electrical circuitry 190 may be electrically connected to or directly incorporated into the electronic circuitry 90 of the machine-readable identification portion 28 and / or its electronic identifier 29. In some examples, opening the switch 180 may interrupt the connection between, for example, the antenna 91 and the integrated circuit 93 of the electronic circuitry 90, preventing the machine-readable identification portion 28 from communicating wirelessly with the add-on device 30.

[0189] The electronic circuit 90 is closed and the electronic identifier 29, and therefore the machine-readable identification portion 28, can only and exclusively communicate with the add-on device 30 when the switch 180 is closed.

[0190] 13 and 14, the distal end 67 of the body 6 is provided with a receptacle 165 for receiving a complementary shaped insert section 170 provided on the proximal end of the container portion 7. The body 6 includes a side wall 161 that encloses the receptacle 160. The side wall 161 has a distal end face 163 facing in the distal direction 2. The end face 163 is configured to engage, i.e., longitudinally abut, with a stepped portion 173 provided on the outer surface of the side wall 171 of the container portion 7.

[0191] Here, insert section 170 projects in proximal direction 3 from step-down portion 173. Insert section 170 includes a smaller diameter compared to the tubular portion of sidewall 171 extending distally from step-down portion 173.

[0192] On the inner surface 162 of the receptacle 160 is provided a fastening structure 164 of a shape complementary to a counter-fastening structure 174 on the outer surface 172 of the side wall 171 of the container portion 7, and thus on the insert section 170. The fastening structure 164 includes a groove 165 configured to engage with a complementary shaped protrusion 175 of the counter-fastening structure 174.

[0193] The groove 165 may comprise one of an L-shaped groove and a bayonet groove, as shown in more detail in Figure 14. The groove 165 may be defined tangentially or circumferentially by detents 166 that provide clearly defined end detents for the interconnection between the fastening structure 164 and the counter-fastening structure 174. Alternatively to the illustrated example, it is also contemplated that the inner surface 162 may be internally threaded and the outer surface 1172 may be externally threaded.

[0194] The electromechanical switch 180 may include a movable contact spring 181 that extends at least partially into the groove 164 in an open configuration as shown in FIG. 14 . The contact spring 181 is permanently connected to a second conductive wire 192. Due to an inherent spring force, the contact spring 181 tends to disengage from the first conductive wire 191. It is only and exclusively when a mechanical connection is established between the container portion 7 and the body 6 that an actuating element 182 provided on the outer surface 172 of the insertion section 170 engages the contact spring 181, thus electrically connecting the contact spring 181 with the first conductive wire 191, thereby closing the electrical circuit 190.

[0195] Actuation element 182 may mate with protrusion 175 provided on outer surface 172 of insert section 170. By attaching, and thus fastening, insert section 172 to receptacle 160, protrusion 175 slides along groove 165 until it reaches detent 166. When in this particular detent position, protrusion 175 engages contact spring 181, establishing an electrical connection between first conductive wire 191 and second conductive wire 192, respectively.

[0196] Thus, when the interlocking configuration between the main body 6 and the container portion 7 is reached, the electrical circuit 190 is closed.

[0197] An example of an implementation of electrical circuit 190 is shown in Figure 17. Here, switch 180 may be directly connected to first and second input terminals 194, 195 of integrated circuit 93 of machine-readable identification unit 28. In the example of Figure 17, opening switch 180 may disconnect terminals 194, 195, and thus disable the wireless communication functionality of integrated circuit 93. Here, opening switch 180 may disconnect integrated circuit 93 from antenna 91. Only when switch 180 is closed may an electrical connection be established between antenna 91 and integrated circuit 93, enabling wireless communication functionality of machine-readable identification unit 28.

[0198] In this example, when the add-on device 30 is attached to the injection device 1, it is desired or intended to periodically send or request status information from the machine-readable identification 28. Here, the add-on device 30 may be configured to send or route each request to the machine-readable identification 28. As long as the container portion 7 is not connected to the body portion 6 and as long as the switch 180 is open, the machine-readable identification 28 cannot respond to the requests of the add-on device 30.

[0199] In the further example of FIG. 18 , integrated circuit 93 includes first and second input terminals 194, 195 as well as a GPIO terminal 196. Here, first terminal 194 and GPIO terminal 196 are interconnected by a resistor 197. Switch 180 is provided between the other input terminal 195 and the GPIO terminal. In this way, a pull-up resistor is provided to improve signal detection. Therefore, when switch 180 is closed, a well-defined voltage is supplied to GPIO terminal 196, which can be easily detected by integrated circuit 93.

[0200] In the example of Figure 18, when the add-on device 30 is attached to the injection device 1, it is also desired or intended to periodically transmit or request status information from the machine-readable identification unit 28 indicating the configuration or state of the detector configuration 98.

[0201] In a further example according to Fig. 19, the configuration of Fig. 18 is slightly modified. Here, the GPIO terminal 196 and the second input terminal 195 are connected to each other via a capacitor 198. When the switch 188 is closed, the capacitor 198 is charged.

[0202] By opening switch 180, for example, in the course of separating container portion 7 from main body 6, the discharge of capacitor 198 may be detected by integrated circuit 93, and / or the discharging capacitor may temporarily supply power to the integrated circuit, for example, for transmitting status information to add-on device 30. Thus, capacitor 198 may be configured to at least temporarily supply electrical energy to integrated circuit 93 when switch 180 is open.

[0203] 19 may also provide a type of auto-wake-up function for integrated circuit 93, specifically when closing or opening switch 180. In the example of FIG. 19, it may be particularly beneficial to keep switch 180 closed when enclosure portion 7 is separated from body 6, and to keep switch 180 open when enclosure portion 7 is attached to body 6.

[0204] It is also contemplated that the switch 180 may remain open when the container portion 7 is separated from the body 6, and that the switch 180 may close when the container portion 7 is attached and connected to the body 6. In either approach, via the capacitor 198 the integrated circuit 93 may function to obtain power to wirelessly indicate a change in state of the switch arrangement 98 that is readable and / or detectable by the add-on device 30 when attached to the infusion device 1.

[0205] Advantageously, the detector arrangement 98 is implemented on or within the body of the injection device 1 to allow electronic reading or detection when the container portion 7 is correctly assembled or attached to the body 6. Here, it is sufficient for the injection device to have no active electrical or electronic components. The detector arrangement 98 may be implemented solely by an electromechanical switch 180 connected to the integrated circuit 93 of the electronic device identifier 28, which may be implemented as a passive radio frequency tag.

[0206] An electrical connection between the detector arrangement 98 and the machine-readable identification portion 28 allows for detecting and / or recording a mechanical connection between the body 6 and the container portion 7, the proximal end of which is connectable or connected to the distal end 67 of the body 6. The machine-readable identification portion 28 may be provided at or near the proximal end 68 of the body 6 and may provide near-field communication with the add-on device 30 within a transmission range that is shorter than the longitudinal distance between the detector arrangement 98 and the machine-readable identification portion 28.

[0207] In order to record the administration history and / or calculate the remaining amount of drug left in the drug container 21, the add-on device 30 functions to constantly and / or periodically check the status of the detector arrangement 98 to determine that the connection between the container portion 7 and the main body 6 is maintained while recording the administration history and / or calculating the remaining amount of drug left in the drug container 21.

[0208] The flow chart of Figure 23 shows a schematic representation of a typical use of the infusion system 120. In a first step 200, the add-on device 30 is assembled to the infusion device 1. During the initial assembly, the add-on device 30 may be properly calibrated. In step 201, recording of dose history is initiated.

[0209] In optional step 202, status information indicating the configuration of the infusion device 1 and / or indicating the configuration or particular characteristics of the medication container 21 may be written or stored in either the memory 92 of the electronic device identifier 28 and / or the electronic container identifier 89.

[0210] In step 202 and / or step 203, the presence of the electronic device identifier 28, and therefore the machine-readable identification portion 28, is repeatedly, and therefore somewhat permanently, monitored by requesting a respective response from the machine-readable identification portion 28. In step 203, the add-on device 30 may be in, and remain in, a respective standby mode during which a request for the presence of the electronic device identifier 29, and therefore each machine-readable identification portion 28, is periodically performed.

[0211] In step 204, it is checked whether the communication link between the add-on device 30 and the machine-readable identifier 28 has been lost. If the communication between the machine-readable identification 28 and the add-on device 30 should be interrupted, the method proceeds to step 212. Then, in a subsequent step 213, the electronic module 34 generates a warning that can be shown to a user via the signal generator 52. For example, a flashing light implemented by, for example, the identifier 55 integrated in the moving part 70 of the add-on device 30 may provide a visual warning signal, for example in the form of a flashing light.

[0212] In a subsequent step 214, the add-on device 30 may communicate with the external electronic device 100 to stop calculating the remaining amount of medication in each medication container, where the recorded dosing history and / or remaining amount calculations may be discarded to prevent the patient or healthcare provider from using such information that may have been invalidated by premature replacement of the medication container 21.

[0213] As long as the machine-readable identification 28 is confirmed to be present in step 204 and / or indicates that the container portion 7 has been connected to the body 6 and will remain connected, the procedure proceeds to step 205. The user may now set the dose to be injected by the injection device. Setting the dose setting may wake up the sensor 48 of the electronic module 34 in step 206.

[0214] In a next step 207, after or during the dispensing of a dose of medication, each dose dispensing event is recorded. The dose injection recorded in step 207 is then subjected to a plausibility check in step 210, where the recorded or detected dose dispensing information is compared or verified with status parameters of the injection device 1 and / or status parameters of the medication container 21.

[0215] In step 208 it is detected whether the user has separated the container part 7 from the main body 6. In step 208, a reconnection of the container part 7 to the main body 6 may also be recorded and / or detected. In a subsequent step 209, each changed status of the injection device 1 may be recorded and / or stored in the memory 92 of the electronic device identifier 29 and thus in the machine-readable identification portion 28.

[0216] The status information provided by the machine-readable identification 28 may be constantly compared with the recorded dispensing events of step 207. This comparison occurs in step 210. Typically, such a validity check should occur before, during, or after each recorded dose injection. This allows the add-on device 30 to check the status of the most recent connection between the container portion 7 and the body 6, simplifying, e.g., reducing, the power consumption of the add-on device 30. Here, a wireless read request between the machine-readable identification 28 and the add-on device 30 may only be required once per injection.

[0217] If the validity check 210 is successful, the procedure proceeds to step 211, where recording of dose history and / or calculation of the remaining amount of medication left in the medication container 21 continues.

[0218] The detector arrangement 98 is electrically connected to the machine-readable identification 28, allowing the add-on device 30 to permanently monitor the correct installation and / or configuration of the injection device 1. In this way, patient safety can be increased and unintended or fraudulent use of the injection device 1 can at least be hindered or even prevented. [Explanation of symbols]

[0219] 1. Injection Device 2 Distal direction 3 Proximal direction 4. Dose escalation 5 Direction of dose reduction 6 Main unit 7 Container part 8 Dose Dial 9 Triggers 10. Housing 11 Connector 12 Needle Assembly 13 Injection needle 14 Inner needle cap 15 Outer needle cap 16 Protective cap 17 Label 18 Piston 19 Piston rod 20 Drive mechanism 21 Medicine container 22 barrels 23 Seal 24 Drugs 25 Exit 26 Windows 27 Dial extension 28 Identification unit 29 Electronic Device Identifiers 30 Add-on Devices 34 Electronic Module 36 Printed Circuit Board 37 Leader 38 Transceiver 39 Transceiver 40 module memory 42 Clock 44 Module Processor 46 Power supply 48 sensors 50 indicators 51 Display 52 Signal Generator 53 Display Section 54 Display Section 60 Device body 61 Side wall 62 Flange 63 Receptacle 64 Fastening rib 65 Alignment Features 66 Counter Alignment Features 66 Neck 67 Distal end 68 Proximal end 69 Extension 70 Moving parts 80 Dose-Finding Elements 81 Driving member 82 Capacity indicator 83 Encoding 85 Locking mechanism 86 Lock Controller 88 Identification unit 89 Electronic Container Identifier 90 Electronic circuits 91 Antenna 92 memory 93 Integrated Circuits 94 processors 95 PCB 96 Power supply 97 Adhesive layer 98 Detector Configuration 99 RFID tags 100 Electronic Devices 101 Housing 103 Wristband 110 moves 111 Wrist 112 Palm 114 Thumb 116 fingers 120 Injection System 137 Device Reader 138 Device Transceiver 139 Device Transceiver 140 device memory 144 Device Processors 146 Device Power Supply 151 Device Display 152 Device Signal Generator 153 Illustrated 154 Notification 156 Indicators 160 receptacle 161 Side wall 162 Inside 163 End face 164 Fastening structure 165 Groove 166 Stopper 170 Insert Section 171 Side wall 172 Exterior 173 Stepped section 174 Counter fastening structure 175 Protrusion 180 Switch 181 Contact spring 182 Actuating Elements 190 Electrical Circuits 191 Conductive Wire 192 Conductive Wire 194 terminals 195 terminals 196 General-purpose input / output terminals 197 Resistance 198 Capacitors

Claims

1. An injection device (1) for injecting a dose of a drug (24), comprising: a housing (10) comprising a main body (6) and a container part (7), said container part (7) being adapted to accommodate a medicament container (21), said container part (7) being removably connectable to said main body (6); a drive mechanism (20) arranged in said body (6) and operative to expel said dose of said medicament (24) from said medicament container (21); - a machine-readable identification (28; 88) on or in one of said body (6) and said container part (7); a detector arrangement (98) on or inside one of said body (6) and said container part (7), and operable to detect a mechanical connection between said body (6) and said container part (7); Including, - said machine-readable identification (28; 88) is electrically connected to said detector arrangement (98) and is readable by an electronic module (34) of an add-on device (30) connectable to said injection device (1), said machine-readable identification indicating said mechanical connection between said body (6) and said container part (7); Injection device (1).

2. 2. The injection device (1) of claim 1, wherein the machine-readable identification (28; 88) and the detector arrangement (98) are electrically connected by an electrical circuit (190).

3. 3. The injection device (1) of claim 1 or 2, wherein the detector arrangement (98) includes an electromechanical switch (180) on or inside one of the main body (6) and the container portion (7), and the other of the main body (6) and the container portion (7) includes an actuating element (182) configured to engage with the electromechanical switch (180) when the container portion (7) is connected to the main body (6) and to disengage from the electromechanical switch (180) when the container portion (7) is separated from the main body (6).

4. An injection device (1) according to any one of claims 1 to 3, wherein one of the body (6) and the container portion (7) includes an insertion section (170), and the other of the body (6) and the container portion (7) includes a receptacle (160) sized to receive the insertion section (170), and the detector arrangement (98) is provided on an outer surface (172) of the insertion section (170) or on an inner surface (162) of the receptacle (160).

5. 5. An injection device (1) as described in claim 3 or 4, wherein the electromechanical switch (180) is provided within or on a fastening structure (164) of the main body (6), the actuation element (182) is provided within or on a counter-fastening structure (174) of the container portion (7), and the container portion (7) and the main body (6) can be inter-fastened to each other via mechanical engagement between the fastening structure (164) and the counter-fastening structure (174).

6. An injection device (1) as described in any one of claims 1 to 5, wherein the body (6) includes a distal end (67) and an opposite proximal end (68), and the machine-readable identification portion (28) is located closer to the proximal end (68) than the detector arrangement (98) and / or the detector arrangement (98) is located closer to the distal end (67) than the machine-readable identification portion (28).

7. An injection device (1) according to any one of claims 1 to 6, wherein the machine-readable identification portion (28; 88) comprises an electronic circuit (90) including an antenna (91) and an integrated circuit (93) that functions to wirelessly communicate with the electronic module (34) of the add-on device (30).

8. An infusion device (1) according to any one of the preceding claims, wherein the machine-readable identification (28; 88) comprises an RFID tag (99), an NFC tag or an UWB tag.

9. An injection device (1) according to any one of claims 1 to 8, wherein the machine-readable identification (28; 88) comprises a memory (92) configured to store at least one of device information, container information and usage-related data.

10. An injection device (1) according to any one of claims 1 to 9, wherein the detector arrangement (98) is configured to be in a first detector state when the body (6) is connected to the container portion (7), and further configured to be in a second detector state when the body (6) is separated from the container portion (7).

11. 11. The injection device of claim 10, wherein when the detector arrangement (98) is in the first detector state, the machine-readable identification portion (28; 88) is in a first machine-readable state, and when the detector arrangement (98) is in the second detector state, the machine-readable identification portion (28; 88) is in a second machine-readable state.

12. An add-on device (30) for attachment to an injection device (1) according to any one of claims 1 to 11, comprising: a device body (60) that can be fastened to a part of said injection device (1); a reader (37) and / or a transceiver (38, 39) operable to read the machine-readable identification (28; 88) of the injection device (1) and to generate a read signal; an electronic module (34) including a module processor (44) coupled to at least one of said reader (37) and said transceiver (38, 39), said module processor (44) being operable to process said read signal in order to determine whether said container portion (7) is connected to said body (6); An add-on device (30) comprising:

13. 13. The add-on device (30) of claim 12, wherein the module processor (44) is configured to sample or request the read signal from one of the reader (37) and the transceiver (38, 39) according to a predefined time interval.

14. The add-on device (30) of claim 12 or 13, further comprising sensors (48) that function to quantitatively determine at least one of the position and movement of movable components (80, 81, 82, 83) of the drive mechanism (20) relative to at least one of the housing (10), the drug container (21), and the device body (60) and that function to generate respective sensor signals, and the module processor (44) functions to determine or calculate the size of the dose of the drug (24) to be set or dispensed by the injection device (1) based on the sensor signals.

15. The add-on device (30) of claim 14, wherein the electronic module (34) further comprises a module memory (40) connected to the module processor (44) and operative to store administration history, the administration history including the number of dose sizes dispensed or injected by the injection device (1) and determined or calculated by the module processor (44).

16. The add-on device (30) of claim 15, wherein the module processor (44) is operative to determine or calculate the remaining amount of the drug (24) contained in the drug container (21) based on the administration history and based on the connection status between the main body (6) and the container portion (7).

17. An infusion system (120) comprising an infusion device (1) according to any one of claims 1 to 11 and comprising an add-on device (30) according to any one of claims 12 to 16.

18. 1. A method for monitoring the operation of an infusion device (1) configured to inject a dose of a medication (24), comprising: - attaching an add-on device (30) to a portion of the injection device (1), the injection device (1) comprising a machine-readable identification (28; 88) on or in one of the body (6) and the container portion (7) of the housing (10) of the injection device (1), the machine-readable identification (28; 88) being electrically connected to a detector arrangement (98) on or in one of the body (6) and the container portion (7), the detector arrangement (98) being operable to detect a mechanical connection between the body (6) and the container portion (7); - reading said machine-readable identification (28; 88) by at least one of a reader (37) and a transceiver (38, 39) of said add-on device (30) and generating a reading signal indicative of a mechanical connection between said body (6) and said container portion (7); - processing the read signal to determine whether the container part (7) is connected to the body (6); A method comprising:

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