Add-on devices for injection devices

Abstract

The present disclosure relates to an add-on device (30) for attachment to an injection device (1), the injection device (1) comprising: a device body (60) fastenable to a portion of the injection device (1); a sensor (48) operable to quantitatively determine at least one of the position and movement of movable components (80, 81, 82, 83) of a drive mechanism (20) of the injection device (1), the sensor (48) operable to generate a respective sensor signal; and a machine-readable ID (28; 88) of the injection device (1) that includes at least one of device information and container information. and an electronic module (34) comprising a reader (37) and at least one of a receiver (38, 39) coupled to the sensor (48), the module processor (44) coupled to at least one of the reader (37) and the transceiver (38, 39), the module processor (44) operable to identify or calculate a dose size of the medication (24) to be set or dispensed by the injection device (1) based on the sensor signal and at least one of device information and container information.

Description

[Technical Field]

[0001] The present disclosure relates to the field of add-on devices for injection devices, in particular add-on devices attachable to pen-type injectors. In another aspect, the present disclosure relates to injection devices and injection systems, and methods for monitoring the operation of an injection device or injection system. [Background technology]

[0002] Drug delivery devices for pre-programmed dispensing of 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 many user-specific requirements. For example, in the case of patients with chronic diseases such as diabetes, patients may be physically weak and have impaired eyesight. Therefore, a suitable drug delivery device, particularly for home drug therapy, must 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 equal or variable-sized doses of medication. Furthermore, the dose setting and dose dispensing procedures must be easy to perform and clear.

[0004] Patients suffering from certain illnesses may need to inject a certain amount of medication through a pen injector.

[0005] Some drug delivery or injection devices provide for the selection of variable-sized doses of medication and the injection of preset doses, while other injection devices provide for the setting and dispensing of fixed doses, where the amount of medication to be injected according to a given prescription schedule is always the same and is fixed 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 when the contents, i.e., medication, have been used up.

[0007] To control and manage the administration of medication by the user or patient himself, 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 may interact with the user and provide instructions or recommendations to the user on how to properly use the injection device.

[0008] It is desirable to provide automatic detection and logging of repetitive and regular use of a drug delivery device in order to control and manage the administration of medication by a user or self-patient. A highly automated record of the dose injected by the user offers significant advantages over manual dose logging in terms of safety and convenience.

[0009] There are a number of additional devices configured for use with injection devices that provide electronic detection and monitoring of repeated dose injection procedures.

[0010] Typically, such additional or auxiliary devices can be removably connected to the injection device. The additional device typically comprises a sensor or sensor arrangement operable to detect the date and / or time when the user sets or injects a dose of medication. Some additional devices also provide a quantitative measurement of the size of the currently set or dispensed dose. Some additional devices are intended to be used with a range of injection devices. This may apply in particular to disposable injection devices that are intended to be discarded after use or after the medication in the injection device has been used up.

[0011] Generally, there are a variety of different injection devices, which may be equipped with different drugs or medicaments, but which are generally operable to be used with the same type of add-on device. Although it is common practice to characterize or label injection devices and / or different types and / or strengths of medicaments with a clear and distinct label or ID, detachable connections to add-on devices may impose disadvantages, particularly if the label or distinctive portion of the injection device is covered by the add-on device when attached to the injection device.

[0012] Some add-on devices are generally suitable for use with a variety of injection devices. Such injection devices may be distinguished by different calibrations of the drive mechanism. Such injection devices may also comprise different drugs, drug concentrations, or drug amounts. Therefore, in order to properly monitor the use of the injection device, it is essential that the add-on device is properly positioned and / or properly calibrated during the process of attaching the add-on device to the injection device.

[0013] It is therefore desirable to provide improvements over add-on devices, injection devices, and injection systems that facilitate accurate, easy, and simple calibration of the add-on device and accurate and fail-safe monitoring of repeated use of the injection device. Summary of the Invention [Means for solving the problem]

[0014] In one aspect, the present disclosure relates to an add-on device for attachment to an injection device. The injection device typically comprises a housing and a drive mechanism for injecting a dose of a medicament, the medicament being provided in a medicament container, such as a cartridge. The drive mechanism comprises at least one movable component that moves relative to the housing or relative to the medicament container during at least one of setting and injecting a dose of the medicament.

[0015] The attachment device comprises a device body fastenable to a portion of the injection device, and further comprises sensors operable to quantitatively determine at least one of a position and a movement of the movable component relative to at least one of the housing, the medicament container, and the device body, and the sensors further operable to generate respective sensor signals indicative of the position and / or movement of the movable component relative to at least one of the housing, the medicament container, and the device body.

[0016] The adjunct device further comprises at least one of a reader and a transceiver, the reader or transceiver operable to read or obtain a machine-readable ID of the injection device.

[0017] The add-on device further comprises an electronics module comprising a module processor coupled to the sensor, the module processor coupled to at least one of the reader and the transceiver. The module processor is operable to identify or calculate a dose size of the medication, the dose size being set or dispensed by the injection device. The identification or calculation of the dose size is based on the sensor signal and at least one of device information and container information included in the machine-readable ID.

[0018] Specifically, by reading or obtaining the machine-readable ID of the injection device, the add-on device can be autonomously provided with at least one of the device information and the container information provided by or stored in the machine-readable ID. In this way, the electronic module, and therefore the add-on device, can automatically obtain at least one of the device information and the container information, based on which it must identify or calculate the dose size.

[0019] In some examples, the container information indicates at least one of the type of medication contained in the medication container, the concentration of the pharmaceutical substance in 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.

[0020] The container information may further include information regarding the type of container in which the medicament is currently stored or contained. To that extent, the container information may include container-specific information, such as the type of primary container in which the medicament is filled, or the type of secondary container, e.g. the type of container part of the injection device, such as a cartridge holder configured to receive the primary container and configured for attachment to the body of the housing of the injection device.

[0021] The container information is included in a machine-readable ID. The machine-readable ID may be provided in one of many different forms or formats. In some examples, the machine-readable ID is provided in printed form. The machine-readable ID may include visual or optically readable information, such as characters, symbols, or codes, for example, in the form of a one-dimensional barcode or a two-dimensional data matrix code. Here, the reader or transceiver includes an optical reader, such as an imaging system capable of capturing the visual or optically readable information of the machine-readable ID.

[0022] In other examples, the machine-readable ID is provided in electrical or electronic storage. The machine-readable ID may be provided in digital storage, such as the memory of an integrated circuit. Thus, the reader or transceiver on the electronic module comprises an electronic or digital reader operable to read the digital storage of the machine-readable ID. In some examples, the machine-readable ID comprises one of an active or passive RFID, NFC, or UWB tag readable by the electronic module's respective RFID, NFC, or UWB reader or transceiver.

[0023] In a further example, the machine-readable ID comprises a magnetic code that is readable by a magnetic reading or transmitting / receiving device of each of the electronic modules.

[0024] In some examples, the machine-readable ID is printed on a label that may be adhered to or integrated into one of the medication container and the housing of the injection device.

[0025] The device information may include information or data regarding the type of injection device. The device information may be specific about the type of injection mechanism or drive mechanism of the injection device. Thus, the device information may characterize the dose setting and / or dose dispensing operability of the respective injection device. The device ID may further include data or information regarding the appropriate medication or medication container to be used exclusively with the respective injection device.

[0026] In some instances, the drive mechanism includes a piston rod that must move a predetermined longitudinal displacement relative to the housing of the injection device to expel a predetermined amount of medication. The drive mechanism is characterized by a specific feed rate of the piston rod per unit of medication dose. The feed rate of the drive mechanism must be matched to the medication and / or medication container used with the drive mechanism or injection mechanism.

[0027] The reader or transceiver enables the add-on device to obtain or read device information and / or container information provided on or inside the injection device. Typically, reading of device information and / or container information is enabled and exclusively possible when the add-on device is attached to the injection device. To that extent, upon placing or attaching the add-on device to or onto the injection device, the reader or transceiver of the add-on device is autonomously triggered to read or obtain the machine-readable ID, thereby obtaining at least one of the device information and container information.

[0028] The device information and / or container information can then be used to calibrate dose size determinations or dose size calculations performed by a module processor of an electronic module of an add-on device.

[0029] The sensor of the add-on device is typically capable of providing at least one or a series of sensor signals indicative of the position or movement of a movable component of the drive mechanism relative to at least one of the housing, the medicament container, and the device body. The movable component may allow unique and / or unambiguous identification of the size of the dose currently being set or dispensed or injected by the drive mechanism of the injection device. The movable component may be provided with coding and is movable relative to the sensor such that its movement can be counted or detected in the course of setting and / or injecting or dispensing a dose of medicament.

[0030] Each dose size is unambiguously assigned to a measurable position and / or measurable movement of the movable component of the drive mechanism, and the assignment between the degree or magnitude of movement and the dose size may vary between different drive mechanisms and may vary between different drug containers.

[0031] For example, in a standard size drug container, longitudinal feed movement of the piston rod of the drive mechanism results in dispensing of a standard dose size of drug, whereas in a drug container with a smaller or larger diameter, the same longitudinal feed movement of the piston rod may result in dispensing or injection of a reduced or greater amount of drug from the drug container.

[0032] Therefore, it is important to have accurate knowledge of the type of medication container and the type of drive mechanism when deriving or calculating the medication dose size based on the sensor signal provided by the sensor of the add-on device.

[0033] Using the present add-on device and by obtaining at least one of the device information and container information described above, a degree of automated calibration of the dose size determination or dose size calculation can be provided. 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 the injection device. To obtain the container information and / or device information, the add-on device can be configured to perform a calibration routine. In this way, measurable sensor signals obtained by the sensor of the add-on device can be converted or recalculated into correct dose size information.

[0034] According to further examples, at least one of the reader and transceiver of the additional device includes a short-range wireless transceiver operable to wirelessly communicate with the machine-readable ID of the injection device to obtain at least one of the device information and the container information. Typically, the reader and / or transceiver is operable to obtain the device information and to obtain the container information. The device information and the container information may be included in or provided in one and the same machine-readable ID. In some examples, the device information and the container information are provided in or by separate machine-readable IDs provided on or inside the injection device.

[0035] When the transceiver of the attached device is implemented as a short-range transceiver, the machine-readable ID is typically also provided as a short-range transceiver or a near-field communication tag. The machine-readable ID may include an electronic identifier such as an RFID tag, an NFC tag, or an UWB tag that enables near-field communication with an RFID reader, an NFC reader, and / or an UWB reader. Here, the transceiver of the attached device includes or consists of the respective RFID reader, near-field communication (NFC) reader, or ultra-wideband (UWB) reader.

[0036] The use of a short-range wireless transceiver is beneficial in that the machine-readable ID can only be read when the transceiver, and therefore the attached device, is within a predetermined geometric or spatial range of the machine-readable ID. In this way, configuration or calibration of the attached device can only occur when the distance between the machine-readable ID and the reader or transceiver is less than the short-range wireless communication range of the short-range wireless transceiver.

[0037] According to a further example, at least one of the reader and the transceiver includes a local area wireless transceiver operable to wirelessly communicate with an external electronic device to receive a machine-readable ID of the injection device from or via the external electronic device. The local area transceiver may have a transmission range greater than that of a short-range transceiver. The local area transceiver may include a radio frequency transceiver. The local area transceiver may include a Bluetooth transceiver or a Bluetooth Low Energy (BLE) transceiver. The local area transceiver may also include a Wi-Fi transceiver or similar wireless transceiver that enables local area signal transmission with the external electronic device.

[0038] Typically, the external electronic device comprises one of a smartphone, a smartwatch, and a tablet computer. Using a communication link between the attachment device and the external electronic device, the device information and / or container information provided by the machine-readable ID can also be provided to the electronic module of the attachment device via the external electronic device. Here, the external electronic device may comprise a reader or transceiver operable to read the machine-readable ID of the injection device. In response to such reading of the machine-readable ID 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 ID and transmitting at least one or both of the device information and container information to the attachment device via the local-range transceiver of the attachment device. In this example, the attachment device may not have a short-range transceiver, and the attachment device does not necessarily need to be able to obtain or read the machine-readable ID itself. Here, the external electronic device may act as a relay, further operable to read or obtain device information and / or container information from the machine-readable ID and provide or transmit the collected information to an additional device.

[0039] Naturally, local area transmission between the electronic module of the attached 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.

[0040] According to a further example, the module processor of the add-on device is operable to convert the sensor signal into dose size information by taking into account at least one of device information and container information.

[0041] Typically, at least one of the device information and the container information is used to calibrate the conversion of the sensor signal performed by the module processor.

[0042] Indeed, with the ability to automatically obtain device and / or container information, the add-on device can be used with a variety of different injection devices, generally differentiated by at least one of the drive mechanisms of the injection device and / or by the drug container of the injection device. The conversion of the sensor signal to a dose size then automatically takes into account the device-specific and / or container-specific information. With this in mind, if a user intends to use the add-on device with a particular type of injection device or a particular type of drug, there is no longer any need to manually configure the add-on device or its electronic module.

[0043] According to a further example, the module processor is operable to convert the first sensor signal into first dose size information when provided with at least one of first device information and first container information. The module processor is operable to convert the first sensor signal into second dose size information when provided with at least one of second device information and second container information, where the second device information or second container information is distinct from the first device information and first container information, respectively. Thus, the second dose size information is distinct from the first dose size information. Consequently, using the same sensor signal, different dose size information is derived depending on the device information or container information obtained from the machine-readable ID of the injection device. Thus, the device information and / or container information provided by the machine-readable ID of the injection device can be suitably used to calibrate the dose size calculation or determination derived from the sensor signal of the sensor of the additional device.

[0044] According to a further example, the electronic module further comprises a module memory connected to the module processor, the module memory and / or module processor operable to store at least one of device information and container information as stored information and / or to store a dosing history, the dosing history including a number of dose sizes dispensed or injected by the injection device and identified or calculated by the module processor.

[0045] In some examples, the electronic module is operable to read or acquire at least one of the device information and the container information at least once or only once, i.e., when attaching the add-on device to the injection device. During the process of attaching or attaching the add-on device to the injection device, the electronic module is configured to read or acquire the associated device information and / or container information and / or store the respective information in the module memory of the electronic module. In this manner, the device information and / or container information acquired from the machine-readable ID during the process of assembling the add-on device to the injection device can be at least temporarily stored in the module memory. In this manner, it is not necessary to repeatedly read or acquire the device information and / or container information as long as the add-on device remains stationary or on the injection device.

[0046] The stored information in the module memory can be used to calculate or determine the size of a dose based on sensor signals generated by the sensor and processed by the module processor during the process of setting and / or administering a dose of medication.

[0047] Furthermore, the administration history, and thus for example the series of dose sizes sequentially dispensed or injected by the injection device, can also be stored in the module memory of the electronic module. Typically, via a communication link to an external electronic device, the recorded data, in particular the administration history, and thus the date, time and amount of medication set, dispensed and / or injected by the injection device, can be synchronized with and / or transmitted to the external electronic device.

[0048] In this manner, information collected or derived by the adjunct device that is indicative of repeated use of the injection device can be readily shared with and further processed by a physician and / or healthcare provider.

[0049] According to further examples, the stored information stored in the module memory includes at least one of stored device information and stored container information. In some examples, the module memory can store device information and container information obtained from a machine-readable ID.

[0050] According to a further example, the module processor is operable to determine or calculate the remaining amount of medication contained in the medication container, typically based on administration history and at least one of device information and container information.

[0051] Based on the administration history, the electronic module and / or module processor is operable to determine a total amount of medication dispensed or injected from the medication container during repeated or successive dose injection procedures performed with the injection device. The module processor and / or electronic module also obtains associated information of an initial amount of medication initially provided in the medication container based on at least one of device information and container information obtained from the machine-readable ID of the injection device. By comparing the amount of medication dispensed or injected during the recorded administration history, e.g., subtracting it from the initial amount of medication provided in the medication container, the remaining amount of medication remaining in the container can be electronically derived or calculated.

[0052] According to further examples, the module processor and / or electronic module may be operable to repeatedly read or acquire the machine-readable ID of the injection device. For example, each detection of a dose setting or dose dispensing operation, detectable by a sensor of the add-on device, may trigger a respective readout of the machine-readable ID with the aid of at least one of a reader and transceiver of the add-on device. Thus, the module processor may also be operable to compare at least one of the device information and container information actually or repeatedly acquired from the machine-readable ID with information stored in the module memory, for example, during an initialization procedure of the add-on device performed before, during, or after attachment of the add-on device to the injection device.

[0053] By repeatedly comparing instantaneous container information obtained from the machine-readable ID with previously stored device information and / or previously stored container information, a security check is performed to determine whether the additional device is still attached to the exact same injection device.

[0054] If the comparison of the container or device information actually obtained from the machine-readable ID does not match the previously stored information, the electronic module may take predetermined action to prevent recording of an incorrect dose size.

[0055] According to a further example, the module processor may be operable to activate a signal generator of the attached device and / or generate or trigger an alert signal if at least one of the device information actually obtained from the machine-readable ID does not match the stored device information and / or if the container information actually obtained from the machine-readable ID does not match the stored container information. If this check performed by the module processor fails, the module processor may be operable to activate a signal generator of the attached device and / or trigger the generation of an alert signal.

[0056] Activation of the signal generator may trigger the generation of at least one of an audible signal, a visual signal, and / or a tactile signal. Thus, the signal generator may be configured to generate one of a noise or sound, an optical signal such as a flashing or blinking light, and a vibration signal. In a further example, the warning signal may be triggered or generated by or through signal transmission with an external electronic device. Here, for example, by a local area wireless transceiver, the auxiliary device may trigger the respective warning or signal generation through wireless warning signal transmission with the external electronic device. In this way, the auxiliary device may not have its own signal generator but may effectively use a signal generator of the external electronic device, triggered through wireless warning signal transmission from the auxiliary device to the external electronic device.

[0057] In either case, the attachment device may be configured to alert the user if one of the device information and container information actually obtained or read from the machine-readable ID does not match or no longer matches the respective device information or container information previously stored in the module memory or storage.

[0058] According to a further example, the module processor is operable to discard or suspend the determination or calculation of the remaining amount of medication contained in the medication container if at least one of the device information obtained from the machine-readable ID does not match the stored device information and / or if at least one of the container information obtained from the machine-readable ID does not match the stored container information, wherein the discarding or suspension of the calculation of the remaining amount of medication may occur instead of or simultaneously with activating the signal generator or triggering an alert signal if at least one of the actually obtained device information or container information no longer matches the predetermined or previously stored device information or container information.

[0059] According to a further example, the module processor is operable to obtain and / or request at least one of device information and container information before, during, or after processing the sensor signal. By recording or receiving an initial sensor signal after a certain time interval in which the sensor of the attached device is not functioning, repeated readings of the machine-readable ID may be automatically triggered, thereby revealing at least one of device information and container information.

[0060] Obtaining device or container information and / or reading a machine-readable ID may also be triggered during or immediately after processing the sensor signal.

[0061] In some examples, the injection device, in particular the drive mechanism of the injection device, comprises a locking mechanism by which operation of the drive mechanism can be interlocked or blocked. The locking mechanism can be implemented mechanically or electromechanically. The locking mechanism can be operable or controlled by an add-on device. Here, the add-on device can comprise a lock controller that is electrically or mechanically coupled to the locking mechanism of the drive mechanism when the add-on device is properly attached to the injection device. The lock controller can be operated by the electronic module to activate and / or deactivate the locking mechanism.

[0062] In some examples, when the module processor of the electronic module of the add-on device should determine that at least one of the device information and container information provided by the machine-readable ID no longer matches the predetermined and / or previously stored device information or container information, the module processor may be operable to activate a locking mechanism of the drive mechanism, thereby preventing further use of the injection device. In this way, the user is effectively prevented from setting or dispensing an incorrect dose of medication.

[0063] According to further examples, the module processor is operable to generate usage-related data indicative of usage of the injection device. The module processor is further operable to transmit the usage-related data to the machine-readable ID and / or store the usage-related data in a memory of an electronic identifier of the machine-readable ID. In some examples, the machine-readable ID comprises at least one of an RFID tag, an NFC tag, or an UWB tag with a writeable memory. In this manner, usage-related data indicative of usage of the injection device can be stored locally in the memory of the electronic identifier, thereby allowing usage-related data of the injection device and / or medication container to be stored directly on or within the injection device.

[0064] For example, the usage-related data may indicate the total amount of medication extracted or dispensed by the injection device during use with the add-on device attached to the injection device. The usage-related data may further indicate the dosing history of the injection device. The usage-related data may include data such as the time or date a dose dispensing operation occurred. The usage-related data may further include data regarding the amount of medication dispensed in each dispensing or injection operation. Storing the usage-related data directly on the machine-readable ID may allow the add-on device to be removed from the injection device even before all of the medication provided in the medication container has been dispensed or injected from the medication container.

[0065] If the add-on device is to be subsequently reattached to the injection device, the reader or transceiver of the add-on device may be able to read or obtain the device and container information as well as usage-related data from the machine-readable ID. The module processor may then be configured to resume recording the administration history and calculating or determining the remaining amount of medication left in the medication container.

[0066] According to a further aspect, the present disclosure also relates to an injection device for setting a dose of a medication. The injection device includes a housing and a drive mechanism for injecting a dose of a medication provided in a medication container. The drive mechanism includes at least one movable component that moves relative to the housing or relative to the medication container during at least one of setting the dose of the medication and injecting the dose. The injection device further includes a machine-readable ID including an electronic circuit including a writeable memory containing at least one of device information and container information. Typically, the writeable memory is readable and / or writable by at least one of the reader and transceiver of the electronic module of the additional device, as described above. Thus, the writeable memory of the machine-readable ID can be written, read, and / or overwritten by the additional device when the additional device is attached to the injection device. In this way, not only original device or container information but also usage-related data indicating, for example, the usage history of the injection device or medication container, including, for example, administration history, can in principle be stored in the writeable memory. When the injection device is reattached or reconnected to the additional device, the respective information can be read by the device, thereby allowing it to resume recording the administration history and / or calculating the remaining amount of medication left in the medication container.

[0067] According to a further example, the device information stored in the machine-readable ID includes at least one tolerance parameter indicating a device-specific geometric or positional tolerance of at least one moving component measured or determined during manufacture or assembly of the injection device. Such a device-specific geometric or positional tolerance of the at least one moving component may affect the accuracy of measurements made by a sensor of the additional device. Because the geometric and / or positional tolerance of the at least one moving component may vary from injection device to injection device and may distinguish multiple injection devices or drive mechanisms by the geometric and / or positional tolerance, it is particularly advantageous to accurately measure or determine the device-specific geometric and / or positional tolerance of the at least one moving component in each injection device or drive mechanism and store such device-specific geometric and / or positional tolerance in the machine-readable ID.

[0068] In this way, any device-specific geometric position tolerances can be taken into account when calculating or deriving dose size based on sensor signals obtained from sensor signals that measure or determine at least one of the position and movement of the movable component relative to at least one of the housing, the drug container, and the device body.

[0069] 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 dose setting or dose dispensing, a drive sleeve, or a drive member, wherein the movable component undergoes rotational and / or longitudinal movement relative to the housing during at least one of dose setting and dose dispensing. In some examples, the movable component is a clicker or click element operable to generate an audible sound recordable by a sensor of an add-on device. In a further example, the movable component is a piston rod operably engaged with a piston of the medicament container to displace the piston relative to the medicament container during dose injection. In a further example, the movable component is a single-dose indicator, the movement and / or position of which relative to the housing or device body indicates the currently set dose size. In a further example, the movable component is a final-dose component, the position of which relative to the housing of the injection device directly indicates the amount of medicament remaining in the medicament container or cartridge.

[0070] In another example, the present disclosure further relates to an injection system including a first injection device including a housing and a first drive mechanism for injecting a dose of a medicament provided in a first medicament container, the first drive mechanism including at least one movable component that moves relative to the housing or the first medicament container during at least one of setting a dose of the medicament and injecting the dose.

[0071] The first injection device also comprises a machine-readable ID including at least one of first device information and first container information. The injection system further comprises an attachment device, e.g., as described above. The attachment device comprises a device body fastenable to a portion of the injection device. The attachment device further comprises sensors operable to quantitatively determine at least one of a position and a movement of a movable component relative to at least one of the housing, the first medication container, and the device body, typically when the device body is attached and / or secured to the injection device. The sensors are operable to generate respective sensor signals in response to detecting a position and / or a movement or a rate of movement of a movable component of the injection device.

[0072] The add-on device further comprises at least one of a reader and a transceiver operable to read or obtain a machine-readable ID of the injection device, and further comprises an electronic module comprising a module processor coupled to the sensor, the module processor coupled to the at least one of the reader and the transceiver. The module processor is operable to determine or calculate a first dose size of the medication, the first dose size being set or dispensed by the first injection device. The calculation or determination of the first dose size of the medication is performed based on the sensor signal and at least one of first device information and first container information included in the machine-readable ID.

[0073] In practice, the injection system comprises an additional device as described above connected or coupled to an injection device as described above.

[0074] In a further example, the injection system comprises a second injection device, which may have the same or similar operability as the first injection device, which may be distinguished from the first injection device, for example, by the medicament, the medicament container, and / or by the transmission or translation of the drive mechanism, for example, by the transmission between the dose setting or dose dispensing components relative to the feed movement of the piston rod of the drive mechanism.

[0075] The second injection device includes a housing and a second drive mechanism for injecting a dose of medication provided in a second medication container. The second drive mechanism includes at least one movable component that moves relative to the housing or the second medication container during at least one of setting a dose of medication and injecting the dose. The second injection device further includes a second machine-readable ID including at least one of second device information and second container information. Here, the module processor of the additional device is operable to determine or calculate a second dose size of medication to be set or dispensed by the second injection device based on the sensor signal and at least one of the second device information and second container information included in the second machine-readable ID.

[0076] Here, the add-on device can be automatically adapted to the second injection device. The adaptation of the add-on device can be performed autonomously, for example, by reading or otherwise obtaining at least one of the second device information and the second container information. The sensor signal obtained from the sensor of the add-on device is then converted or calibrated based on the second, and therefore corrected, device information or container information.

[0077] According to a further example of the injection device or system, the machine-readable ID includes an electronic identifier. The electronic identifier includes an electronic circuit. The electronic circuit includes an antenna for wireless communication with at least one of a reader and a transceiver of the attached device. The electronic circuit further includes a memory for storing at least one of device information and container information. The machine-readable ID may include at least one of a passive or active RFID tag, an NFC tag, or an UWB tag.

[0078] Typically, by way of further example, the machine readable ID comprises a processor connected to an antenna, the processor connected to a memory for storing information in the memory and / or reading information from the memory.

[0079] According to a further example, the memory of the machine-readable ID is a writeable memory and is further configured to store usage-related data indicative of usage of the injection device, which may include administration history, total amount of medication dispensed from the medication container, and similar data indicative of usage of the injection device.

[0080] According to a further example, 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 reading or obtaining at least one of device information and container information from a machine-readable ID of the injection device by at least one of a reader and a transceiver of an add-on device configured to attach to the injection device. The method further includes quantitatively determining at least one of a position and a movement of a movable component of a drive mechanism of the injection device, the drive mechanism being operable to inject a dose of the medication provided in the medication container. Determining the position and / or the movement of the movable component is typically performed by a sensor of the add-on device.

[0081] In response to quantitatively detecting, measuring, or determining the position and / or movement of the movable component, the sensor generates a respective sensor signal indicative of the position and / or movement of the movable component. The method further includes determining or calculating a dose size of the medication, the dose size of which is set or dispensed by the injection device. The calculation or determination of the size is based on the sensor signal and at least one of device information and container information obtained from the machine-readable ID.

[0082] Typically, the method of monitoring the operation of an injection device is performed by the injection device, by an add-on device, and / or by an injection system, as described above, and insofar as all features, effects, and advantages described above in relation to any one of the add-on device, the injection device, and the injection system apply equally to the method of monitoring the operation of an injection device, and vice versa.

[0083] According to a further aspect, the present disclosure also relates to a computer program, e.g., a computer program product, comprising computer-readable instructions that, when executed by a module processor of an adjunct device as described above, cause the module processor to perform the steps of the method as described above.

[0084] Typically, the computer program is executable by the attachment device described above. The computer program is further operable to perform the method for configuring the attachment device described above. To that extent, the computer program and its computer readable instructions are operable to cause a processor of the attachment device to perform the method for configuring the attachment device described above. The computer readable instructions may be executable by a processor of the attachment device described above.

[0085] Additionally or alternatively, if the external electronic device of the injection system described above is configured to read the machine-readable ID 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.

[0086] The computer program is executed by a processor of the add-on device described above to perform the method of configuring the add-on device described above and / or to monitor and / or record the operation of the injection device when the add-on device is attached to the injection device. To that extent, all features, effects, and advantages described above in relation to the add-on device and / or in relation to the method of configuring the add-on device, as well as any effects, features, and advantages described above in relation to the injection system, apply equally to the computer program, and vice versa.

[0087] The present disclosure further discloses and proposes a computer program comprising computer-executable instructions for performing the method according to the method / device / system disclosed in one or more 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.

[0088] The present disclosure further discloses and proposes a computer program product having program code means for performing the methods according to the disclosed methods / systems in one or more of the embodiments contained herein when the program is executed on a computer or computer network. In particular, the program code means may be stored on a computer readable data carrier.

[0089] Furthermore, the present disclosure discloses and proposes a data carrier having stored thereon a data structure which, after loading into a processor, computer or computer network, for example into a working memory or main memory of the processor, computer or computer network, can perform a method according to one or more of the examples disclosed herein.

[0090] The present disclosure further proposes and discloses a computer program product having program code means stored on a machine-readable carrier for performing a 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 be present in any form, such as in paper form, or on a computer-readable data carrier. In particular, the computer program product may be distributed over a data network.

[0091] In a further example, the injection device comprises 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-type injector. The dose dial and / or trigger may be provided at the proximal longitudinal end of the pen-type injector. Here, the machine-readable ID may be provided in or on the dose dial and / or trigger. The attachment device may be configured for detachable or removable fastening to the proximal end of the injection device.

[0092] The add-on device, particularly its device body, may comprise a receptacle that fits over the dose dial and / or trigger. By mounting or locating the machine-readable ID in or on the trigger or dose dial, the geometric distance between the reader or transceiver of the add-on device for reading the machine-readable ID and the machine-readable ID can be minimized, thereby enabling the transceiver or reader of the add-on device to be implemented as a short-range wireless transceiver operable to read the respective near-field wireless communication tag of the device's machine-readable ID. In this way, reading of the machine-readable ID can only be performed when the add-on device is properly attached to the proximal end of the injection device.

[0093] According to a further example, the injection system includes an external electronic device, for example implemented as a smartphone, a smartwatch, or a tablet computer, operable to read a machine-readable ID of the injection device, and further operable to transmit the ID of the injection device to the additional device.

[0094] In this manner, the attachment device may not have its own reader or transceiver operable to read the machine-readable ID of the injection device. Rather, it may be sufficient if the attachment device includes only one transceiver, such as a local area wireless transceiver operable to wirelessly communicate with an external electronic device. Readout of the machine-readable ID of the injection device may then be provided or performed through the external electronic device, which, when properly paired with the attachment device, is operable to provide identifying information of the injection device to the attachment device, and the attachment device may configure or reconfigure a user-perceptible device ID.

[0095] In this example, the machine-readable ID of the injection device can be implemented in a variety of different ways, where the machine-readable ID can be implemented as a physical code, a mechanical code, or an optical code that is readable by the respective sensing arrangement and / or imaging system of the external electronic device.

[0096] Generally, the scope of the present disclosure is defined by the content of the claims. The present disclosure is not limited to specific embodiments or examples, but includes any combination of elements from different embodiments or examples. To that extent, the present disclosure covers any combination of claims and any technically feasible combination of features disclosed in relation to different examples or embodiments.

[0097] In the present context, the term "distal" or "distal end" relates to the end of the injection device that points towards the injection site of a person 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 person or animal.

[0098] The terms "drug" or "medicament" are used synonymously herein to refer to a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and, optionally, a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in the broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or agents are used to treat, cure, prevent, or diagnose disease, or otherwise improve physical or mental well-being. Drugs or agents may be used for a limited duration or periodically for chronic conditions.

[0099] 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 having a molecular weight of 500 Da or less, polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, 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.

[0100] 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 sturdy or flexible container 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 some cases, the two chambers of the dual-chamber cartridge may be configured to allow mixing between 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.

[0101] The drugs or agents contained in the drug delivery devices 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 include those listed in handbooks such as the Rote Liste 2014, e.g., but not limited to, Main Group 12 (antidiabetic drugs) or 86 (oncology drugs), and the Merck Index, 15th edition.

[0102] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes mellitus or complications associated with 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 can be formally derived from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deleting and / or substituting at least one amino acid residue present 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 another 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 formally derivable from that 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 by other amino acids, including non-codable amino acids, or amino acids, including non-codable amino acids, may be added to the naturally occurring peptide.

[0103] 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 can be replaced by Asp, Lys, Leu, Val or Ala and in position B29 Lys can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0104] 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. These include 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.

[0105] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flathead sea urchin), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rexendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C (efpegrenatide), HM-15211, CM-3, GLP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexene, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (pegapamodtide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, tirzepatide (LY3298176), bamadutide (SAR425899), exenatide-XTEN, and glucagon-Xten.

[0106] An example of an oligonucleotide is, 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 are linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0107] Examples of hormones include pituitary 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.

[0108] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or ultra-low molecular weight heparin, or derivatives thereof, or sulfated polysaccharides, such as polysulfated forms of the above polysaccharides, 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 G-F20 (Synvisc®), sodium hyaluronate.

[0109] 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 can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single-chain antibody. In some embodiments, an antibody has effector function and can fix 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).

[0110] 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 can include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful in the present invention include 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, and 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.

[0111] 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.

[0112] 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).

[0113] Pharmaceutically acceptable salts of any of the APIs described herein are also contemplated for use as drugs or medicaments in drug delivery devices. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0114] It will be understood by those skilled in the art that modifications (addition and / or deletion) of the various components of the APIs, formulations, devices, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the invention, which includes such modifications and any and all equivalents thereof.

[0115] An exemplary drug delivery device may include a needle-based injection system as described in Table 1 of Section 5.2 of ISO11608-1:2014(E). As described in ISO11608-1:2014(E), needle-based injection systems 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.

[0116] 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 a system, each container holds multiple doses and may be fixed or variable in size (pre-set by the user). Another multi-dose container system may include a needle-based injection device integrated with non-replaceable containers. In such a system, each container holds multiple doses and may be fixed or variable in size (pre-set by the user).

[0117] 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 discharging the entire deliverable amount (full discharge). In a further example, each container holds a single dose, thereby discharging 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, non-replaceable container. In one example of such a system, each container holds a single dose, thereby discharging the entire deliverable amount (full discharge). In a further example, each container holds a single dose, thereby discharging a portion of the deliverable amount (partial discharge).

[0118] A number of examples of injection devices and data logging devices for monitoring the use of the respective injection devices are described in more detail below with reference to the drawings. [Brief explanation of the drawings]

[0119] [Figure 1] 1 shows 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 the injection device. [Figure 3] 1A and 1B show schematic cross-sectional views of an example of an injection device. [Figure 4] 1 illustrates a configuration of an injection system including an injection device, an additional device, and at least one external electronic device. [Figure 5] 1 illustrates pairing of an external electronic device with an additional device. [Figure 6] 10 illustrates the process of attaching an add-on device to an injection device. [Figure 7] 10 shows the configuration of the external electronic device upon successful reading of the machine-readable ID of the injection device. [Figure 8] 1 shows the configuration of an injection system. [Figure 9] 1 illustrates another injection system configuration. [Figure 10a] 10 shows further examples of additional devices. [Figure 10b] 10 shows further examples of additional devices. [Figure 11] 1 shows a block diagram of an additional device, an injection device, and an external electronic device. [Figure 12] 1 shows a block diagram of the electronic circuitry of a machine-readable ID. [Figure 13] 1 shows an example of an electronic circuit on a substrate. [Figure 14] 1 shows a flowchart of a method for configuring an adjunct device. DETAILED DESCRIPTION OF THE INVENTION

[0120] 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-type injection device. 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 autoinjector. The injection device 1 has an elongated shape. The injection device 1 may extend along a longitudinal direction. The drug delivery device 1 comprises, at a longitudinal distal direction 2, a dosing end for dosing or injecting a medication 24. At a proximal direction 3, the injection device 1 comprises at least one of a dose member 8 and a trigger 9, by which doses of equal, individual, or different sizes can be set and dispensed, respectively.

[0121] The injection device 1 comprises a housing 10. The housing 10 may comprise a number of housing components, such as a body 6 and a reservoir portion 7, e.g., implemented as a cartridge holder 7. The body 6 may be sized and configured to accommodate a drive mechanism 20. The reservoir portion 7 is sized and configured to accommodate a medicament container 21, e.g., implemented as a cartridge containing a liquid medicament 24. The medicament container 21 comprises 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.

[0122] 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 inside the container portion 7. The drive mechanism 20 of the injection device 1 comprises a piston rod 19 that is displaceable in the distal direction 2 to advance the piston 18 towards the outlet 25 of the medicament container 21. Details of the drive mechanism will not be further shown or described here. 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 dosing force required to move the piston rod 19, and therefore the piston 18, in the distal direction 2. In other examples, the drive mechanism comprises a mechanical energy store configured to provide at least a portion of the dosing force. Examples of drive mechanisms can be found, for example, in WO 2004 / 078241 A1, WO 2014 / 033197 A1, or WO 2014 / 033195 A1, which are incorporated herein by reference in their entirety.

[0123] 2, the injection device 1, and thus the drive mechanism 20, may comprise a dial extension 27 that moves proximally in the proximal direction 3 from the proximal end of the body 6 at or during dose setting and returns to an initial distal position during the dose injection procedure. To this end, a user may use the thumb 114 of their hand 110 to exert distal pressure on the trigger 9, thereby urging the dial extension 27 in the distal direction 2 during and / or for the dose injection procedure.

[0124] To set or dial a dose, the user may twist or rotate the dose dial 8, for example, in the dose increment direction 4, thus clockwise as viewed from the proximal end. To modify a previously set dose, the user may rotate the dose dial 8 in the opposite dose decrement 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 a dose of medicament 24 can be injected, the distal end of the container part 7 or cartridge holder must be connected to the needle assembly 12. For this purpose, the distal end of the cartridge holder 7 is provided with a connector 11, for example in the form of a threaded interface for engaging a complementary threaded mating interface on the needle assembly 12.

[0125] The needle assembly 12 is detachably or removably securable to the container portion 7. The needle assembly 12 includes a double-ended injection needle 13. The proximal end (not shown) of the 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 puncture or penetrate the seal 23 of the drug container 21. The distal end of the injection 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.

[0126] The container part 7 , and thus part of the housing 10 , is received in a protective cap 16 , which is removably connectable to the cartridge holder 7 or the body 6 .

[0127] 2 and 4 show an example of an add-on device 30 configured to fasten to the proximal end of the injection device 1. The add-on device 30 comprises a sensor 48 or sensor assembly operable to detect, recognize, characterize and / or measure the movement of the injection device 1. Typically, the sensor 48 of the add-on device 30, shown in block diagram form in FIG. 11, is capable of quantitatively identifying or measuring at least one of the positions and movements of the movable components 80, 81, 82, 83 of the drive mechanism 20 of the injection device 1. The movable components 80, 81, 82, 83 are movable relative to at least one of the body 6 and the medicament container 21 during or for setting and / or injecting a dose of the medicament 24.

[0128] This movement or position can be quantitatively measured by a sensor 48. Typically, the sensor 48 is implemented as an electronic sensor. When the additional device 30 is attached to the injection device 1, it is possible to 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.

[0129] The sensor 48 of the additional device 30 is capable of or operable to generate a sensor signal or series of sensor signals and is coupled or connected to the module processor 44 so that the sensor signal or series of sensor signals can be processed by the module processor 44 to derive or calculate the size of the dose currently set or dispensed.

[0130] In some examples, the movable component 80 is a dose setting member or a dose setting sleeve. In a further example, 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, whose position or configuration 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 member, whose position or configuration relative to the body 6 indicates the remaining amount of medicament left in the cartridge or medicament container 21.

[0131] In some examples, the movable components 83 are or include a coding, such as a digital coding, that is movable relative to the sensor 48 such that the sensor 48 can count multiple discrete code portions of the coding to gather quantitative movement information for each of the movable components 80. Generally, different types of spatial coding may be provided, such as optical or visual coding, electrical or electrostatic coding, magnetic or mechanical coding, etc. Depending on the type of coding provided on or within the movable components 80, 81, 82, 83, the sensor 48 is configured accordingly. Thus, the sensor 48 may comprise at least one of an optical sensor, an electric or electrostatic sensor, and a magnetic or mechanical sensor, such as a micromechanical switch, each of which is operable to quantitatively measure the relative position or movement of the movable components 80, 81, 82, 83.

[0132] In some examples, the movable components 80, 81, 82, 83 move longitudinally and / or rotationally 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 coding provided on or with the movable components 80, 81, 82, 83 is coded along the direction of movement of the movable components relative to the sensor 48 to enable quantitative measurement of each respective dose setting or dose dispensing movement.

[0133] 3 , the drive mechanism 20 may optionally include 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 is operable to block or lock the drive mechanism 20 to prevent unauthorized or unintended setting and / or dispensing or injecting a dose. The locking mechanism 85 is controllable by the lock controller of the add-on device. The locking mechanism 85 may be implemented electromechanically and may be electrically or electronically controlled by a 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.

[0134] The attachment device 30 shown in various Figures 2 to 10 is removably connectable to the dose dial 8. The attachment device 30 comprises a device body 60 with a tubular side wall 61. At its distal end, the side wall 61 defines 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 be provided with one or multiple fastening ribs 64 configured to provide a non-slip fastening of the attachment device 30 to the dose dial 8.

[0135] The device body 60 comprises a receptacle 63 at the distal end of the addition device 30. The receptacle 63 is open in the distal direction 2. The receptacle 63 is sized and configured to fit over the proximal end of the injection device 1. The inner surface of the side wall 61 enclosing the receptacle 63 comprises a number of fastening ribs 64 of a resilient or elastically deformable material, for example an elastomeric material.

[0136] 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 located proximally offset from the insertion opening of the receptacle 63. The flange portion 62 may have an annular shape and may be configured to axially abut a stepped section at the proximal end of the dose dial 8. Thus, the trigger 9, which has a reduced diameter compared to the dose dial 8, may protrude in the proximal direction 3 through the flange portion 62, while 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.

[0137] The add-on device 30 further comprises a movable part 70 protruding proximally from the device body 60. The movable part 70 comprises or forms an auxiliary trigger or trigger button that is configured to mechanically engage the trigger 9 of the injection device 1 when the add-on device 30 is correctly assembled to the injection device 1.

[0138] Typically, the add-on device 30, and in particular the device body 60, is frictionally engageable with the dose dial 8. In this way, a 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, a user can simply rotate the device body 60 relative to the body 6 of the injection device 1. In this way, the dial extension 27 can perform a dial setting or rotational movement that increments the dose. The respective size of the currently set dose is then displayed in the window 26 of the body 6 of the injection device 1, as shown in FIG. 2 .

[0139] To dispense a dose, the user must press the movable part 70, which may then make a distal 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 dosing force to the trigger 9, thereby initiating the dose dispensing operation of the injection device 1.

[0140] The attachment device 30, shown schematically in Figure 11, comprises an electronic module 34. The electronic module 34 comprises a printed circuit board 36. The electronic module 34 comprises a module processor 44, an electronic, and therefore digital, module memory 40, and a clock 42. Furthermore, the electronic module 34 comprises a power supply 46 and a sensor 48. The electronic module 34 also comprises a signal generator 52 coupled to the processor 44 and / or coupled to the power supply 46. The electronic module 34 further comprises a reader 37 and at least one of wireless transceivers 38, 39. The attachment device 30 may also comprise a user-perceivable device ID 50.

[0141] In some examples, the device ID 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 ID 50 may indicate the injection device 1 to which the additional device 30 is actually connected or coupled.

[0142] In some examples, the signal generator 52 is operable to generate at least one of a visual signal, an acoustic signal, and a tactile signal, or a device ID, and is therefore operable to produce or generate a visual, acoustic, or tactile identifier or a respective warning signal. In some examples, the attachment device 30 comprises multiple signal generators 52 of the same or different types, for example, optical, acoustic, or tactile.

[0143] In the example of Figure 2, the signal generator 52 may comprise a speaker operable to generate an acoustic signal, which may represent or constitute a warning signal, for example in the form of an acoustic code or sequence that is characteristic of a particular configuration or setting of the injection device 1 or the additional device 30.

[0144] 4 illustrates an injection system 120 comprising at least an additional device 30 and an injection device 1. Optionally, the injection system 120 comprises one or more external electronic devices 100, 101′. The external electronic device 100 is implemented as a smartphone comprising a housing 101 and includes 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 be operable to provide or emulate a device signal generator 152. The device display 151 is operable to provide at least one of the illustrations 153 and notifications 154 to the user.

[0145] A further optional external electronic device 100' is implemented as a smart watch comprising a respective housing and display 151', and further comprising 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' is also operable to provide at least one of an illustration 153 and a notification 154 to the user. Generally, the external electronic devices 100, 100' may comprise a separate device signal generator 152, such as a speaker or vibration module, capable of generating a user-perceptible signal to provide an alert signal to the user of the respective device.

[0146] The electronic device 100 may typically be implemented as a handheld electronic device. The electronic device 100 may be held in a user's hand 110 or 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 may be operated by the thumb 114 and / or various fingers 116 of the user's hand 110.

[0147] The electronic module 34 of the additional device 30, shown schematically in Figure 11, comprises at least one reader 37 and transceiver 38, 39 operable to communicate wirelessly with at least one machine-readable ID 28, 88 of the injection device 1 or to communicate wirelessly with a complementary or correspondingly implemented device reader 137 and / or device transceiver 138, 139 of the external electronic device 100, 100'.

[0148] In a typical example, the transceivers 38, 138 are implemented as short-range radio frequency transceivers. The transceivers 38, 138 may be implemented as short-range radio transceivers or short-range transceivers. The transceivers 38, 138 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.

[0149] The transceivers 39, 139 may be implemented as local area radio transceivers, such as RFID, Bluetooth, Bluetooth Low Energy (BLE), or UWB transceivers. Also here, the transceivers 39 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.

[0150] The optional reader 37, 137 may be implemented, for example, as an optical reader or optical information collection unit comprising an imaging system for capturing or recording a visual or optical machine-readable ID 28, 88 provided on or inside the injection device 1.

[0151] 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, typically implemented as a touch-sensitive display. The device display 151 may be operable to provide at least one of an illustration 153 and a notification 154 to the user.

[0152] The device transceiver 138 is operable to communicate with the transceiver 38 of the additional device. The transceiver 139 is configured to communicate with the transceiver 39 of the additional device 30. The reader 137 may be operable to read a visual identifier provided on the injection device 1. In some examples, the device reader 137 comprises an imaging system. The device reader 137 may comprise a camera objective and a spatial resolution detector for reading or capturing a visual code, for example, provided on the exterior of the injection device 1 or on the exterior of the medication container 21.

[0153] The external device 100 is configured to establish a communication link, for example a wireless communication link, with the attachment device 30. To this end, the local area transceiver 39 of the attachment device 30 may communicate wirelessly with the local area device transceiver 139 of the attachment device 100. Once a communication link is established between the electronic device 100 and the attachment device 30, the electronic device 100 may be operable to visually present information or data about the injection device or medication container 21 on the device display 151.

[0154] The injection device 1 is provided with a machine-readable ID 28, 88, as shown schematically in Figure 11. The machine-readable ID 28 includes an electronic identifier 29. The machine-readable ID 88 includes an electronic identifier 89. The electronic identifier 28 may include a passive wireless communication tag, as shown schematically in Figure 12.

[0155] 13 , the electronic identifier 29 may comprise an electronic circuit 90 featuring a wireless communication antenna 91 and an integrated circuit 93. The integrated circuit 93 comprises an electronic memory, and thus a digital memory 92, and a processor 94 connected to the memory 92. Naturally, the integrated circuit 93, and thus the processor 94, is connected to the antenna 91. The electronic identifier 29 may optionally comprise a power source 96 to provide power or energy to 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 comprise a flexible structure or foil that allows for easy attachment, fastening, e.g., clamping, of the substrate 94, and thus the entire electronic identifier 29, to at least one of the tubular body 6, the container portion 7, or the medicament container 21.

[0156] The electronic circuit 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 be provided with an adhesive layer 97 that allows for easy and simple adhesive attachment of the machine-readable ID 28, 88 to a predetermined part on or inside the injection device 1. The electronic identifier 89 may have the same or similar structure as the electronic identifier 29 shown in Figures 12 and 13.

[0157] In some examples, the machine-readable ID 28, 88 is implemented on a label 17 located on one of the body 6, the container portion 7, or the medication container 21. The label 17 comprises or includes the machine-readable ID 28, 88. In some examples, the label 17 comprises a passive RF tag. In further examples, the label 17 comprises the machine-readable ID 28, 88 implemented as a visual or optical code that can be captured by a reader 37 or a device reader 137 that is implemented as or comprises an imaging system.

[0158] At least one of the reader 37, device reader 137, or at least one of the transceivers 38, 39 or device transceivers 138, 139 is operable to read the machine-readable ID 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.

[0159] Typically, the machine-readable ID 28 is provided on or located inside the body 6 of the housing 10 of the injection device 1. A further machine-readable ID 88 is provided on or inside the container portion 7. The machine-readable ID 88 is provided on or inside the medicament container 21. In some examples, the machine-readable ID 28 may be provided in or on the piston 18 of the medicament container 21.

[0160] The machine-readable IDs 28, 88 may be implemented as passive RF communication tags, such as NFC tags. Information, e.g., device information and / or container information, stored in at least one of the machine-readable IDs 28, 88 is readable by the electronic module 34 and thus by any one of the transceivers 38, 39 of the attachment device 30 and / or by any of the transceivers 138, 139 of the external electronic device 100, 100′.

[0161] In some examples, when the injection device 1 is implemented as a disposable injection device that does not support replacement of the medication container 21, it is sufficient for the injection device 1 to include only one machine-readable ID 28. The injection device 1 may be particularly advantageous if the machine-readable ID 28 is provided at or near the proximal end 68 of the body 6. The machine-readable ID 28 may be provided on or within the dose dial 8 or trigger 9 such that it is located within the transmission range of the transceivers 38, 39 when the add-on device 30 is attached to the proximal end of the injection device 1.

[0162] 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 medicament container 21 within the container portion 7. In a reusable injection device 1, it may be particularly beneficial if both the body 6 and the container portion 7 are provided with separate machine-readable IDs 28, 88. As shown in Figure 11, the container portion 7 is provided with a machine-readable ID 88, while the body 6 is provided with a machine-readable ID 28.

[0163] 6, the transceiver 38 may be located inside the receptacle 63 of the device body 60 to minimize the spatial distance to the machine-readable ID 28 located at or near the proximal end 68 of the body 6. By utilizing near-field wireless communication technology for the machine-readable notification 28, 88 and the respective transceiver 38, 138, it may be ensured that the machine-readable ID and the device and / or container information stored therein can only be obtained or acquired when the attached device 30 and / or external electronic device 100, 100′ is within near-field transmission range.

[0164] Generally, when properly assembled or attached to the injection device 1, the add-on device 30, and in particular the electronic module 34, is able to read at least one of device and container information from a machine-readable ID 28, 88 provided on or inside the injection device 1. The module processor 44 is also operable to receive and / or process signals from the sensors 48 that are indicative of the amount of movement of the movable components 80, 81, 82, 83 relative to at least one of the housing 10, the medication container 21 and the device body 60 during operation of the injection device 1.

[0165] The electronic module 34 is operable to perform or execute an automated calibration procedure that takes into account, respectively, one or more sensor signals obtained from the sensor 48 as well as device and / or container information provided by the machine-readable ID 28, 88 to calculate or identify the dose size of the medication currently being set or dispensed by the injection device.

[0166] Typically, the container information indicates at least one of the type of medicament contained in the medicament container, the concentration of the pharmaceutical substance of the medicament contained in the container, the manufacturing date of the medicament, the expiration date of the medicament, or the lot number of the medicament or medicament container, and / or environmental parameters such as temperature, humidity, or radiation intensity to which the medicament container has been exposed. The container information may further include information regarding the type of container in which the medicament is currently stored or contained. To that extent, the container information may include container-specific information, such as the type of primary container in which the medicament is filled, or the type of secondary container, e.g., the type of container part of an injection device, such as a cartridge holder configured to receive the primary container and for attachment to the body of the housing of the injection device.

[0167] Typically, the device information indicates at least one type of injection mechanism or drive mechanism of the injection device. Thus, the device information may characterize the dose setting and / or dose dispensing operability of the respective injection device. The device ID may further include data or information regarding the appropriate medication or medication container to be used exclusively with the respective injection device.

[0168] In this way, the sensor signal can be processed simultaneously with at least one of the container information and the device information to correctly calculate or identify the size of the dose currently being set or dispensed by the injection device.

[0169] The container or device information may be necessary to properly convert the sensor signal obtained from the sensor 48 into a dose size.

[0170] Typically, reading of the machine-readable ID 28, 88 may be triggered automatically upon mounting the addition device 30, for example, on the proximal end 68 of the body 6 of the injection device 1 or when attaching the addition device 30 to the dose dial 8. For this purpose, the addition device 30 may be provided with a contact sensor, for example a mechanical or electrical contact, operable to detect the presence of the dose dial 8 in the receptacle 63 of the device body 60. Furthermore, reading of at least one of the device information and container information from the machine-readable ID 28 may also be triggered, for example, when the transceiver 38 is brought into proximity of the machine-readable ID 28, i.e., within transmission range for the machine-readable ID 28.

[0171] The device or container information obtained by the transceiver 38 may be processed by the module processor 44 and stored in the module memory 40. In this manner, the electronic module 34 may be calibrated to the device-specific device and / or container information.

[0172] 5, the attachment device 30 may optionally communicate with the external electronic device 100. The attachment device 30 may establish a communication link, e.g., a wireless communication link, when the external electronic device 100 and the attachment device 30 are within a predetermined transmission range. Here, the attachment device 30 and the external electronic device 100 may communicate by means of local area transceivers 39, 139.

[0173] 6 , when device information and / or container information is successfully acquired or read by the attachment device 30 during the process of attaching or mounting the attachment device 30 to the injection device 1 or after the attachment device 30 has been attached or mounted to the injection device 1, communication between the attachment device 30 and the external electronic device 100 may be able to illustrate or indicate the successful detection of the injection device 1 and / or the successful reading of the respective device or container information. The external electronic device 100 may then provide the user with either an illustration 153 and / or a notification 154 that a particular type of injection device 1 has been registered or detected by the attachment device 30.

[0174] In some examples, as shown in FIGS. 8 and 9 , after the attachment device 30 is attached to the injection device 1, the attachment device 30 is operable to quantitatively measure the size of the currently set or dispensed dose and calculate the size of each dose based on the sensor signal and device-specific or container-specific information. Optionally, the movable part 70 or some other part of the attachment device 30, e.g., part of the device body 60, may be provided with a separate indicator 50 operable to provide a user-perceptible indication, e.g., optical, audible, or tactile. In this way, the user may be notified, for example, that a dose setting procedure or a dose dispensing or dose injection procedure is currently scheduled, currently in progress, or has just been completed. Wireless communication between the attachment device 30 and the external electronic device 100 may provide respective user assistance information in the form of a notification 154 and / or an illustration 153 on the device display 151. In the example of FIG. 8 , a notification may provide information about the dose size, e.g., 20 units, when the dose dial is set to a well-defined extent.

[0175] Generally, the external electronic device 100 may be permanently or periodically synchronized with the additional device, for example by means of a local area communication interface provided by the transceiver 39, 139. To that extent, any information collected or read by the additional device 30 may be immediately transmitted to the external electronic device 100, 100′ and further processed, for example visualized, by the external electronic device 100, 100′.

[0176] In a further example shown in Figure 9, the add-on device 30 is assembled or attached to a different type of injection device 1'. The injection device 1' also comprises a machine-readable ID 28' containing different type of device or container information. The injection device 1' is distinguished from the injection device 1 shown in Figure 8 by the transmission ratio of the drive mechanism 20' of the injection device 1' compared to the transmission ratio of the drive mechanism 20. For example, the drive mechanism 20' is dedicated or designed for a different type of medication. The transmission ratio may be characteristic of the degree of movement of the dose dial 8 relative to the degree of movement of the piston rod 19.

[0177] The electronic module 34 of the add-on device 30 is likewise configured to read the machine-readable ID 28 when the add-on device 30 is assembled to the injection device 1', thereby obtaining the respective device and / or container information. The injection system 120' as shown in Figure 9 can be used in the same way as the injection device 1 or injection system 120 as shown in Figure 8. Again, to set the dose, the dose dial 8 can be rotated the same amount or to the same extent as compared to the situation as described above in connection with Figure 8.

[0178] Because drive mechanism 20' includes a different mechanical transmission or transmission ratio compared to drive mechanism 20, an equivalent movement of dose dial 8 corresponds to a different dose size, for example 30 units, shown on device display 151. Here, the sensor signal obtained from sensor 48 may be equal in both situations shown in Figures 8 and 9.

[0179] However, since the additional device 30 is attached to a different injection device 1, 1' having a drive mechanism 20, 20' that includes a different transmission ratio between the dose setting movement of the dose dial 8 and the resulting feed or forward movement of the piston rod 19, the dose size calculation or determination must be recalibrated according to at least one of device-specific information and container-specific information.

[0180] 10a and 10b show a further embodiment of an add-on device 30 for attachment to the proximal end of the body 6 of the injection device 1. Here, the device body 60 comprises a distally projecting extension 69 that overlaps, for example, a machine-readable ID 28 provided at or near the proximal end 68 of the body 6. The device body 60 comprises a somewhat tubular or sleeve-like structure sized and shaped to receive a dose dial 8 at the proximal end of the injection device 1. The extension 69 projects distally from the distal end face of the tubular portion of the device body 60. The device body 60, and thus its tubular portion, is secured to and remains secured to the dose dial 8, which is located proximally offset from the body 6 of the injection device 1, and the extension 69 has a longitudinal dimension or extent that extends into the device body 6, at least to the proximal end of the device body 6. To that extent, the distal end of the extension 69 may overlap the body 6. In this manner, due to the laterally overlapping configuration of the extension 69 with the main body 6 of the housing 10, a short-range transceiver, i.e., electronic identifier 28 and / or short-range transceiver 38, can be provided in the near-to-near overlapping portion of the main body 6 and the extension 69.

[0181] Thus, the transceiver 38 of the electronic module 34 is located on or inside the longitudinal extension 69 so as to axially and / or radially overlap the machine-readable ID 28, while the main or base portion of the device body 60 is attached to and remains attached to the dose dial 8 at least in such a configuration that the injection device 1 is in at least the zero dose configuration, for example when the dial extension 27 is in the distal end position.

[0182] Here, the machine-readable ID 28 may be provided on the inner or outer surface of the main body 6. The machine-readable ID 28 may be provided in or on a label 17 adhered to the main body 6.

[0183] 10a, the receptacle 63 of the device body is provided with an alignment feature 65 in the form of a longitudinal recess or groove on the inside of a side wall of the receptacle 63. Correspondingly, the proximal end of the dose dial 8 is provided with an opposing alignment feature 66 of complementary shape, for example in the form of a protrusion sized to fit within the recess or groove of the alignment feature 65. In this way, an anti-rotational fastening of the add-on device 30 can be provided when attached to the housing 10 or dose dial 8 of the injection device 1.

[0184] When the alignment feature 65 mechanically engages with the opposing alignment feature 66, an anti-rotation lock is provided for the interlocking of the add-on device 30 to the injection device 1. In this way, it can be ensured that the ID 28, and therefore the electronic identifier 29, is always correctly aligned with the associated wireless transceiver 38 of the add-on device 30. A well-defined and unique mounting position is therefore provided for mounting the add-on device 30 to the injection device 1. Reaching the predetermined mounting position or configuration with the alignment feature 65 engaging with the opposing alignment feature 66 also ensures that the machine-readable ID 28 and the transceiver 38 are located at a minimum distance from each other. This allows for somewhat unimpeded signal transmission between the ID 28 or electronic identifier 29 and the transceiver 38.

[0185] Generally, the external electronic device 100 may be permanently or periodically synchronized with the additional device, for example by means of a local area communication interface provided by the transceiver 39, 139. To that extent, any information collected or read by the additional device 30 may be immediately transmitted to the external electronic device 100, 100′ and further processed, for example visualized, by the external electronic device 100, 100′.

[0186] In some examples, the electronic module 34 may periodically check or read the machine-readable ID 28, 88. Reading of the device information and / or container information may occur based on a predetermined time schedule, such as once per day or once per hour. In some examples, reading of the machine-readable ID by the electronic module 34 may be triggered each time the electronic module 34 is activated or when the electronic components of the electronic module 34 switch from an idle mode to an active mode, for example, when the electronic module 34 is subjected to a wake-up procedure.

[0187] The device information and / or container information may be at least temporarily stored in the module memory 40 of the electronic module 34 during the process of mounting or attaching the addition device 30 to the injection device 1. During repeated uses of the addition device 30, the respective device information and / or container information may be repeatedly obtained from the machine-readable ID 28, 88. The actually obtained device information and / or container information may then be compared with the previously stored device information or container information. If the actually obtained device information or container information does not match the previously stored respective device information or container information, the addition device 30 may no longer be properly assembled to the injection device 1 or may have been reassembled to another injection device 1′.

[0188] If a discrepancy is detected between the initially stored container information or the initially stored device information and the actually acquired device information or container information, the electronic module 34 may activate a lock controller 86 of the electronic module 34 to induce or activate a lock mechanism 85 of the drive mechanism 20, thereby locking the operation of the drive mechanism 20.

[0189] In some examples, it may be implemented that the locking mechanism 85 of the drive mechanism 20 is in the locked configuration by default and that the additional device 30 must be present at or on the injection device 1 in order to unlock the locking mechanism 85. In this way, user or patient safety can be increased and misuse of the injection device 1 can be effectively prevented.

[0190] 14 shows, in a schematic manner, a method for monitoring the operation of an injection device 1 as described herein. In a first step 200, an add-on device 30 is attached to the injection device 1. In a second step 202, at least one of device information and container information is read or obtained from the machine-readable ID 28, 88 of the add-on device by at least one of the reader 37 and transceivers 38, 39 of the add-on device 30.

[0191] Thereafter, in step 204, at least one of the positions and movements of the movable components 80, 81, 82, 83 of the drive mechanism 20 is quantitatively determined by sensors, thereby generating a respective sensor signal or series of sensor signals.

[0192] In the following step 206, the sensor signal obtained from the sensor 40 of the additional device 30 is processed simultaneously with the device information and / or container information to correctly calculate or obtain the dose size of the medication currently being set or injected. [Explanation of symbols]

[0193] 1. Injection device 2 Distal direction 3 Proximal direction 4 Dose Increment Direction 5 Dose decrement direction 6 Main unit 7 Container section 8 Dose Dial 9 Triggers 10. Housing 11 Connector 12 Needle Assembly 13 Syringe 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 ID 29 Electronic Identifiers 30 Additional 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 part 63 Receptacle 64 Fastening rib 65 Alignment Features 66 Opposing Alignment Features 70 Moving parts 80 Dose setting member 81 Driving member 82 Volume Indicator 83 Encoding 85 Locking mechanism 86 Lock Controller 88 ID 89 Electronic Identifiers 90 Electronic circuits 91 Antenna 92 memory 93 Integrated Circuits 94 processors 95 PCB 96 Power supply 97 Adhesive layer 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 Signal Generator 153 Illustrations 154 Notification

Claims

1. An attachment device (30) for attachment to an injection device (1), said injection device (1) comprising: a housing (10); a drive mechanism (20) for injecting a dose of a medicament (24) provided in a medicament container (21), the drive mechanism (20) comprising at least one movable component (80, 81, 82, 83) that moves relative to the housing (10) or relative to the medicament container (21) during at least one of setting the dose of the medicament (24) and injecting the dose; a machine-readable ID (28; 88) containing at least one of device information and container information; Equipped with The additional device (30) a device body (60) that can be fastened to a portion of the injection device (1); a sensor (48) operable to quantitatively determine at least one of a position and a movement of the movable component (80, 81, 82, 83) relative to at least one of the housing (10), the medicament container (21), and the device body (60), the sensor (48) operable to generate a respective sensor signal; at least one of a reader (37) and a transceiver (38, 39) operable to read or obtain the machine-readable ID (28; 88) of the injection device (1); an electronic module (34) comprising a module processor (44) coupled to the sensor (48), the module processor (44) coupled to at least one of the reader (37) and transceiver (38, 39), the module processor (44) operable to identify or calculate the size of the dose of the medication (24) to be set or dispensed by the injection device (1) based on the sensor signal and at least one of the device information and the container information contained in the machine-readable ID (28; 88); An attachment device (30) comprising:

2. The accessory device (30) of claim 1, wherein at least one of the reader (37) and the transceiver (38, 39) includes a short-range wireless transceiver (38) operable to wirelessly communicate with the machine-readable ID (28; 88) of the injection device (1) to obtain at least one of the device information and the container information.

3. 3. The accessory device of claim 1 or 2, wherein at least one of the reader (37) and the transceivers (38, 39) comprises a local area wireless transceiver (39), the local area wireless transceiver (39) operable to wirelessly communicate with an external electronic device (100) to receive the machine-readable ID (28; 88) of the injection device (1) from or via the external electronic device (100).

4. The attachment device (30) of any one of claims 1 to 3, wherein the module processor (44) is operable to convert the sensor signal into dose size information by taking into account at least one of the device information and the container information.

5. The attachment device (30) of any one of claims 1 to 4, wherein the module processor (44) is operable to convert a first sensor signal into first dose size information when provided with at least one of first device information and first container information, and the module processor (44) is operable to convert the first sensor signal into second dose size information when provided with at least one of second device information and second container information.

6. The electronic module (34) comprises a module memory (40) connected to the module processor (44), i) at least one of the device information and the container information as stored information; and / or ii) a dose history including a number of dose sizes administered or injected by the injection device (1) and identified or calculated by the module processor (44); The attachment device (30) of any one of claims 1 to 5, further comprising a module memory (40) operable to store:

7. The auxiliary device (30) of claim 6, wherein the module processor (44) is operable to identify or calculate the remaining amount of the medication (24) contained in the medication container (21) based on the administration history and at least one of the device information and the container information.

8. 8. The attachment device (30) of claim 6 or 7, wherein the module processor (44) is operable to compare at least one of the device information and the container information obtained from the machine-readable ID (28; 88) with the stored information.

9. The module processor (44) if the device information obtained from the machine-readable ID (28; 88) does not match the stored device information; and If the container information obtained from the machine-readable ID (28; 88) does not match the stored container information.

9. The attachment device (30) of claim 8, wherein at least one of the following is operable to activate a signal generator (52) of the attachment device (30) and / or generate or trigger a warning signal.

10. The module processor (44) if the device information obtained from the machine-readable ID (28; 88) does not match the stored device information; and If the container information obtained from the machine-readable ID (28; 88) does not match the stored container information.

10. The additional device (30) of claim 7, 8 or 9, operable to abort or interrupt the determination or calculation of the remaining amount of the drug (24) contained in the drug container (21) if at least one of the following conditions is met.

11. The attachment device (30) of any one of claims 1 to 10, wherein the module processor (44) is operable to obtain and / or request at least one of the device information and the container information before, during or after processing the sensor signal.

12. An additional device (30) according to any one of claims 1 to 11, wherein the module processor (44) is operable to generate usage-related data indicative of the usage status of the injection device (1), and the module processor (44) is operable to transmit the usage-related data to the machine-readable ID (28; 88) and / or store the usage-related data in a memory (92) of an electronic identifier (29; 89) of the machine-readable ID (28; 88).

13. An injection system (120) comprising: A first injection device (1), comprising: a housing (10); a first drive mechanism (20) for injecting a dose of a medicament (24) provided in a first medicament container (21), the first drive mechanism (20) comprising at least one movable component (80, 81, 82, 83) that moves relative to the housing (10) or relative to the first medicament container (21) during at least one of setting the dose of the medicament (24) and injecting the dose; a machine-readable ID (28; 88) including at least one of first device information and first container information; a first injection device comprising: An attachment device (30), a device body (60) that can be fastened to a portion of the injection device (1); a sensor (48) operable to quantitatively determine at least one of a position and a movement of the movable component (80, 81, 82, 83) relative to at least one of the housing (10), the drug container (21), and the device body (60) and to generate a respective sensor signal; at least one of a reader (37) and a transceiver (38, 39) operable to read or obtain the machine-readable ID (28; 88) of the injection device (1); an electronic module (34) comprising a module processor (44) coupled to the sensor (48), the module processor (44) coupled to at least one of the reader (37) and transceiver (38, 39), the module processor (44) operable to identify or calculate a first size of the dose of the medication (24) to be set or dispensed by the first injection device (1) based on the sensor signal and at least one of the first device information and the first container information contained in the machine-readable ID (28; 88); an attachment device (30) comprising: An injection system (120) comprising:

14. a housing (10); a second drive mechanism (20') for injecting a dose of a medicament (24) provided in a second medicament container (21), the second drive mechanism (20') comprising at least one movable component (80, 81, 82, 83) that moves relative to the housing (10) or relative to the second medicament container (21) during at least one of setting the dose of the medicament (24) and injecting the dose; a second machine-readable ID (28') including at least one of second device information and second container information; and a second injection device (1′) comprising:

13. The injection system (120) of claim 12, wherein the module processor (44) of the additional device (30) is operable to identify or calculate a second size of the dose of the medication (24) to be set or dispensed by the second injection device (1) based on the sensor signal and at least one of the second device information and the second container information included in the second machine-readable ID (28').

15. The injection system (120) of claim 13 or 14, wherein the machine-readable ID (28; 88) comprises an electronic identifier (29, 89) comprising an electronic circuit (90) having an antenna (91) for wireless communication with at least one of the reader (37) and the transceiver (38, 39) of the auxiliary device (30), the electronic circuit (90) having a memory (92) for storing at least one of the device information and the container information.

16. An injection system (120) according to any one of claims 13 to 15, wherein the memory (92) is a writable memory and is further configured to store usage-related data indicative of the usage status of the injection device (1).

17. 1. A method for monitoring the operation of an injection device (1) configured to inject a dose of a medication (24), comprising: reading or obtaining at least one of device information and container information from a machine-readable ID (28; 88) of the injection device (1) by at least one of a reader (37) and a transceiver (38, 39) of an additional device (30) configured to be attached to the injection device (1); quantitatively determining at least one of the positions and movements of movable components (80, 81, 82, 83) of a drive mechanism (20) of said injection device (1) operable to inject a dose of said medicament (24) provided in a medicament container (21) and generating respective sensor signals; determining or calculating the size of the dose of the medication to be set or dispensed by the injection device (1) based on the sensor signal and at least one of the device information and the container information; A method comprising:

18. 18. A computer program comprising computer readable instructions that, when executed by a module processor (44) of an attachment device (30) according to any one of claims 1 to 12, causes said processor (44) to perform the steps of the method according to claim 17.

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