Infusion Devices and Add-On Devices

Abstract

The present disclosure relates to an injection device (1) for injecting a dose of a medication (24), the injection device (1) comprising: - a housing (10) for accommodating a medication container (21) containing the medication (24); - a drive mechanism (20) for injecting the dose of the medication (24) from the medication container (21); and - a machine-readable identification portion (28; 88) including an electronic circuit (90) having a memory (92) configured to store at least one of device information, container information, and usage-related data, the memory (92) being writable by an add-on device (30) configured to be removably connected to a portion of the injection device (1).

Description

[Technical Field]

[0001] The present disclosure relates to the field of injection devices for injecting doses of medication, and to add-on devices for such injection devices, in particular add-on devices attachable to pen injectors. In another aspect, the present disclosure relates to an injection system including an injection device and an add-on device. In a further aspect, the present disclosure relates to a method of monitoring the operation of an injection device by utilizing an add-on device. [Background technology]

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

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

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

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

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

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

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

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

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

[0011] Typically, there are a variety of different infusion devices that may be equipped with different drugs or medications, but that generally function to be used with the same type of add-on device. While it is common practice to characterize or label infusion devices and / or different types and / or concentrations of medication with clear and distinctive labels or identifiers, detachable connections with add-on devices can present certain disadvantages with respect to unintentional attachment mix-ups where an add-on device intended for use with a first infusion device is mistakenly attached to a second infusion device.

[0012] Furthermore, some usage situations may involve alternately removing and reattaching the add-on device to at least two different infusion devices, for example, equipped with different drugs or medications. When the add-on device is removed from the infusion device, digital logging of administration history or dose monitoring may no longer be possible and it may have to be discarded.

[0013] It would therefore be desirable to overcome these drawbacks and provide an improved infusion device and / or an improved add-on device, as well as an improved method for overseeing the monitoring operations of one or more infusion devices. Summary of the Invention [Means for solving the problem]

[0014] In one aspect, an injection device for injecting a dose of a medication is provided. The injection device includes a housing for receiving a medication container. The medication container contains a medication, for example, a liquid injectable medication. The injection device further includes a drive mechanism operative to inject the dose of medication from the medication container. The injection device further includes a machine-readable identification portion including an electronic circuit having a memory. The memory is configured to store at least one of device information, container information, and user-related data. The memory is writable by an add-on device configured to removably connect to a portion of the injection device.

[0015] Typically, the injection device is implemented as a handheld injection device. It may include a pen-type injection device. The injection device may be implemented entirely mechanically. The injection device may be completely devoid of electrical or electronic components. The only electrical or electronic component may be a machine-readable identification of the injection device. The machine-readable identification may be implemented as an electronic identifier. The machine-readable identification may include a passive or active wireless communication tag, such as a passive or active RFID tag, an NFC tag, or an UWB tag. Thus, the injection device may be completely devoid of active electrical or electronic components.

[0016] By providing a machine-readable identification on or within the infusion device, the memory of which can be written or altered by an add-on device configured to removably connect to a portion of the infusion device, specific device information can be provided to the add-on device, for example for correct calibration or initialization of the add-on device. Furthermore, the writable memory allows the add-on device to store usage-related data in the memory of the electronic circuitry of the machine-readable identification. Thus, usage-related data can be stored directly on or within the infusion device.

[0017] In some examples, the usage-related data includes information regarding previous uses of the infusion device. The usage-related data may include a dosing history of the infusion device indicating the time and / or date when a dose of a particular size was set or injected using each infusion device. The dose setting or dose injection process is or can actually be monitored by the add-on device.

[0018] In response to monitoring and / or detecting a dose setting procedure or a dose dispensing procedure, the add-on device may store the respective dose setting or dose injection information in local storage and / or may function to write or store the respective administration-related data in the memory of the electronic circuitry of the machine-readable identification portion. The machine-readable identification portion may be periodically written to or overwritten by the add-on device. Thus, the add-on device may be configured to store any recorded or detected dispense events, dose settings, and / or dose injections, and may immediately record each such dispense event in the memory of the machine-readable identification portion. In this way, the machine-readable identification portion provided on or within the infusion device is always up-to-date with respect to the administration history of the infusion device.

[0019] If an add-on device is to be detached from the infusion device, each information, and therefore usage-related data, can remain on the machine-readable identification and can be read and / or resumed when the infusion device is reconnected or reattached to the same or another add-on device. Each add-on device, when reattached, is then operative to read the usage-related data from the machine-readable identification, thus automatically obtaining the administration history of the infusion device.

[0020] By way of further example, the usage-related data indicates a usage status of the infusion device, which may be determined by an add-on device. The usage status may include information such as the total number of doses set or infused, the total amount of medication infused by the infusion device, the type, name, and / or strength of medication infused by the infusion device, the medication container lot number, and other medication or medication container-related information that may be useful for actual or future use of the infusion device.

[0021] According to a further example, the housing of the injection device comprises a body and a reservoir portion. The reservoir portion is removably connectable to the body. The body houses the drive mechanism. The reservoir portion constitutes or includes a drug container. In particular, the reservoir portion is sized and shaped to house the drug container. At least one of the body and the reservoir portion includes a machine-readable identification portion, which, if provided on or within the body or drive mechanism, includes an electronic body identifier.

[0022] When provided on or within the container portion, the machine-readable identification portion includes an electronic container identifier.

[0023] In fact, it may be sufficient for the infusion device to include only one machine-readable identification, particularly if the infusion device is implemented as a disposable infusion device, i.e., intended to be discarded in its entirety when the drug contained in the drug container is used up. In other examples, particularly if the infusion device is implemented as a reusable infusion device, the container portion is detachably connected or connectable to the main body. It may therefore be particularly advantageous if at least one of the main body and the drive mechanism includes an electronic main body identifier, and if the container portion or the drug container includes an electronic container identifier.

[0024] The container portion may be provided as a pre-assembly or sub-assembly of the infusion device, where the pre-assembly or sub-assembly includes a container portion for accommodating a drug container, where the container portion serves as a secondary container sized and configured to accommodate the drug container implemented as the primary drug container. In some examples, the container portion includes a cartridge holder, and the drug container includes or comprises a cartridge disposed within the container portion or cartridge holder. In some examples, different container portions and / or different drug containers may be provided that are dedicated for use with only one of several available bodies or drive mechanisms.

[0025] It is therefore particularly advantageous if the container portion and the body include at least one machine-readable identification. Thus, the machine-readable identification provided in or on the container portion includes an electronic container identifier, and each machine-readable identification provided on or in the body of the infusion device includes an electronic body identifier. The electronic body identifier and the electronic container identifier can be read separately by an add-on device to electronically identify each container portion or drug container and identify each body or drive mechanism.

[0026] The electronic body identifier and electronic container identifier allow different types of injection devices to be electronically labeled, thus enabling electronic differentiation between different types of container portions or drug containers and between various injection device body portions or drive mechanisms.

[0027] Both the electronic body identifier and the electronic container identifier are connectable to an add-on device configured for mechanical attachment to the infusion device. Thus, the memory, e.g., in the form of digital storage of the electronic circuitry of each of the electronic body identifier and the electronic container identifier, can be read and / or written by the add-on device. In this way, the add-on device can write or store the same or different information in the memory of the electronic body identifier and the electronic container identifier, respectively.

[0028] For example, the add-on device may be operable to store use-related data in at least one or both of the memory of the electronic body identifier and the memory of the electronic container identifier. Furthermore, the add-on device may also be operable to read data from one of the electronic body identifier and the electronic container identifier and write the respective information to the memory of the other of the electronic body identifier and the electronic container identifier. In this manner, existing matches or combinations of a body or drive mechanism with a container portion or a drug container can be stored in the memory of at least one of the electronic body identifier and the electronic container identifier. In this manner, not only the actual combination of one of a container portion or a container with one of a drive mechanism or a body, but also the history of such combinations can be electronically stored in the memory of at least one of the electronic body identifier and the electronic container identifier.

[0029] According to a further example, the electronic body identifier includes device information, and the electronic container identifier includes container information.

[0030] 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 of the medication contained in the container, the date of manufacture of the medication, the expiration date of the medication, or the lot number of the medication or medication container, and / or environmental parameters to which the medication container has been exposed, such as temperature, humidity, or radiation intensity.

[0031] The container information may further include information regarding the type of container the medication is currently stored or contained in. Thus, the container information may include container-specific information, such as the type of primary container into which the medication is filled, or the type of secondary container, e.g., a container portion of an injection device, such as a cartridge holder, configured to receive the primary container and to attach to the body of the housing of the injection device.

[0032] In some examples, the machine-readable identification is provided in electrical or electronic storage. The machine-readable identification may be provided in a digital storage document, such as the memory of an integrated circuit. Thus, the reader or transceiver on the electronic module includes an electronic or digital reader operable to read the digital storage of the machine-readable identification. In some examples, the machine-readable identification includes one of an active or passive RFID tag, an NFC tag, or a UWB tag readable by an RFID, NFC, or UWB reader or transceiver on each of the electronic modules.

[0033] In a further example, the machine-readable identification comprises a magnetic code readable by a magnetic reading or transmitting / receiving device on each of the electronic modules.

[0034] The device information may include information or data regarding the type of infusion device. The device information may also be specific regarding the type of injection mechanism or drive mechanism of the infusion device. Thus, the device information may characterize the dose setting and / or dose dispensing operability of each infusion device. The device identification may further include data or information regarding the appropriate medication or medication container to be used exclusively with each infusion device.

[0035] 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 its 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.

[0036] Via the reader or transceiver, the add-on device can obtain or read device information and / or container information provided on or within the infusion device. Typically, reading of device information and / or container information is enabled and exclusively possible when the add-on device is attached to the infusion device. Thus, installing or attaching the add-on device to or onto the infusion device can autonomously trigger the reader or transceiver of the add-on device to read or obtain the machine-readable identification, thereby obtaining device information and / or container information.

[0037] The device information and / or container information may then be used to calibrate dose sizing or dose size calculations performed by a module processor of an electronic module of an add-on device.

[0038] According to a further example, at least one of the electronic body identifier and the electronic container identifier includes usage-related data, which may be writable by an add-on device directly attachable or connectable to the infusion device.

[0039] In other examples, the usage-related data stored in the electronic body identifier and / or electronic container identifier may also be provided and / or stored by a transceiver of an external electronic device, such as a smartphone, smartwatch, or tablet computer.

[0040] The usage-related data may be stored in one or both of the electronic container identifier and the electronic body identifier, wherein at least one of the electronic body identifier and the electronic container identifier includes a memory having a memory block for the usage-related data.

[0041] The usage-related data may indicate a total amount of medication extracted or dispensed by the infusion device during use with the add-on device attached to the infusion device. The usage-related data may also indicate the dosing history of the infusion device. The usage-related data may include data such as the time or date when a dose dispensing operation occurred. The usage-related data may also include data regarding the amount of medication dispensed in each dosing or infusion operation.

[0042] According to a further example, the electronic circuitry of the machine-readable identification unit includes an antenna for wireless communication with at least one of a transceiver of the add-on device and a device transceiver of the external electronic device, the antenna being connected to a memory of the electronic circuitry of the machine-readable identification unit.

[0043] Typically, in a further example, the electronic circuitry of the machine-readable identification unit also includes a processor connected to the antenna and connected to the memory. The processor may function to manage the reading and / or writing of data from and to the memory. Furthermore, the processor may manage the transmission of radio signals via the antenna of the electronic circuitry. Via the antenna, the memory of the electronic circuitry can be read or written wirelessly. This allows the machine-readable identification unit to be attached or located inside the infusion device. In this way, the machine-readable identification unit can be hidden inside the infusion device, further providing anti-counterfeiting functionality for the infusion device. The machine-readable identification unit may be invisible from the outside of the infusion device and may be readable or writable only or exclusively when a suitable add-on device or external electronic device is in a well-defined position or configuration relative to the antenna of the machine-readable identification unit.

[0044] According to further examples, the machine-readable identification unit comprises a passive RFID transponder. In some examples, the machine-readable identification unit may comprise an active RFID transponder. In some examples, the memory of the machine-readable identification unit is a non-volatile memory. Thus, even in the absence of power or electrical energy, data or information stored in the memory of the electronic circuitry of the machine-readable identification unit remains. In some examples, the machine-readable identification unit comprises an NFC tag or an UWB tag. NFC tag implementations have the advantage that reading or writing information from and / or to the machine-readable identification unit is only possible when a respective reader or writer device, for example in the form of an add-on device or an external electronic device, is in the vicinity and thus within transmission range of the respective NFC transponder or NFC tag.

[0045] According to a further example, the machine-readable identification portion includes a flexible substrate that can be attached to a sidewall of at least one of the body, container portion, and barrel of the medication container. The flexible substrate can include a printed electronic circuit. Thus, the electronic circuit of the machine-readable identification portion can be printed on the flexible substrate. Also, the antenna of the machine-readable identification portion is a printed conductive structure printed on the flexible substrate. The flexible substrate can include a flexible substrate, such as a flexible foil, that can be wrapped around or otherwise attached to the tubular structure of at least one of the body, container portion, and barrel of the medication container.

[0046] The flexible substrate of the machine-readable identification portion may further include printed information indicating the type of medication within the injection device, the container portion, or the medication container. Accordingly, the machine-readable identification portion may be incorporated into a label attached to at least one of the body, container portion, and barrel of the medication container. Furthermore, the machine-readable identification portion may provide or comprise an electronic label attached or attachable to at least one of the body, container portion, and medication container. In some examples, the flexible substrate may include an adhesive layer to provide and enable easy attachment of the machine-readable identification portion to at least one of the body, container portion, and barrel of the medication container via an adhesive connection.

[0047] The drive mechanism includes at least one movable component that undergoes movement relative to the housing or the medication container during at least one of setting a dose and injecting a dose of medication. In some examples, the movable component is one of a dose dial rotatable relative to the housing for setting a dose, a dial sleeve rotatable relative to the housing during setting or dispensing a dose, and a drive sleeve or drive member that undergoes rotational and / or longitudinal movement relative to the housing during at least one of setting a dose and dispensing a dose. In some examples, the movable component is a clicker or click element that functions to generate an audible sound that can be recorded by a sensor in the add-on device. In a further example, the movable component is a piston rod operably engaged with a piston of the medication container to displace the piston relative to the medication container during dose injection. In a further example, the movable component is a single-dose indicating component, the movement and / or position of which relative to the housing or device body indicates the size of the currently set dose. In a further example, the movable component is a last-dose component, the position of which relative to the housing of the injection device directly indicates the amount of medication remaining in the medication container or cartridge.

[0048] In another aspect, the present disclosure also relates to an add-on device for attachment to an infusion device. The infusion device is configured to inject a dose of a medication. The infusion device includes a housing for receiving a medication container, the medication container containing an injectable medication. The infusion device further includes a drive mechanism for injecting the dose of medication from the medication container. The infusion device further includes a machine-readable identification portion including an electronic circuit having a writeable memory configured to store at least one of device information, container information, and usage-related data.

[0049] Typically, the add-on device is configured for use with the infusion device described above. Accordingly, all features, benefits, and advantages described above with respect to the infusion device apply equally to the add-on device, and vice versa. The add-on device further includes a device body removably fastenable to a portion of the infusion device. In some examples, the device body is fastenable to the body of the infusion device. In further examples, the device body is attachable or fastenable to, for example, a dose dial of the infusion device, which is rotatable and / or longitudinally displaceable relative to the body for setting a dose and / or dispensing or injecting a dose of medication. The add-on device further includes an electronic module. The electronic module includes a module processor and a transceiver. The transceiver and / or module processor are operable to read, receive, modify, or generate at least one of device information, container information, and usage-related data. The electronic module is further operable to write and / or store at least one of device information, container information, and usage-related data in a memory of the electronic circuitry of the machine-readable identification portion of the infusion device.

[0050] The add-on device may be configured to monitor recurring use operations of the infusion device. The add-on device may be configured to log or monitor recurring use of the infusion device. In particular, the add-on device, and in particular the electronic module, functions to detect and record the date and / or time when a dose setting or dose dispensing operation is performed by the infusion device. In a further example, the add-on device is further configured to quantitatively measure the size of the dose currently being set, dispensed, or injected by the infusion device when the add-on device is attached to the infusion device.

[0051] The add-on device is therefore configured to record the administration history of the infusion device, the administration history including information regarding the time, date and amount of medication dispensed by the infusion device.

[0052] The add-on device may store at least one of the device information, container information, and usage-related data in a memory of the electronic circuitry of the machine-readable identification portion, so that the infusion device may be directly provided with each usage-related data obtained or generated by the add-on device. Typically, the add-on device, when attached to the infusion device, may also be operable to read at least one of the device information, container information, and usage-related data from the machine-readable identification portion, modify at least one of the device information, container information, and usage-related data, and store the corresponding modified information in the memory of the machine-readable identification portion.

[0053] Thus, for example, if the infusion device comprises first and second machine-readable identification portions, e.g., an electronic body identifier and an electronic container identifier, the add-on device may be configured to read data from the electronic body identifier and store the respective data, or portions thereof, in the memory of the electronic container identifier. Conversely, the add-on device may be operable to read data from the electronic container identifier and store the respective data, or portions thereof, in the electronic body identifier of the infusion device. In this way, the electronic body identifier and the electronic container identifier, which are provided as separate, non-interconnected electronic identifiers on or within the infusion device, may be logically connected.

[0054] Thus, the data or information stored in the electronic body identifier and / or electronic container identifier may not only represent the general data or information of the respective identifier, but may also comprise data or identifying information of the other of the electronic body identifier and / or electronic container identifier. In this way, a kind of pairing history of the mutual pairing or combination of individual components of the infusion device, for example, the body and / or drive mechanism of the infusion device with the container portion or drug container with which the body or drive mechanism is engaged or used, may be stored.

[0055] According to a further example, the add-on device includes sensors operative to quantitatively determine at least one of the position and movement of the movable component relative to at least one of the housing, the first drug container, and the device body, typically when the device body is attached to and / or secured to the infusion device, and the sensors operative to generate respective sensor signals in response to detecting the position and / or movement or rate of movement of the movable component of the infusion device.

[0056] Furthermore, according to another example, the module processor of the add-on device functions to determine or calculate the size of the dose of medication to be set or dispensed by the injection device based on the sensor signal or based on a sequence of sensor signals obtained during operation of the dose setting or dose injection components of the injection device.

[0057] In some examples, the module processor is further operable to determine or calculate a dose size based not only on the sensor signal but also on at least one of container information and device information obtained from the machine-readable identification portion.

[0058] The add-on device, and the above-described acquisition of device and / or container information, can provide somewhat automated calibration of dose sizing or dose size calculations. Thus, the add-on device itself can derive and / or process drug container-specific information and / or device-specific information, for example, during assembly to an infusion device. In response to acquiring the container information and / or device information, the add-on device can be configured to perform a calibration routine. In this manner, measurable sensor signals acquired by sensors in the add-on device can be converted or recalculated into correct dose size information.

[0059] According to a further example, the electronic module further includes a module memory connected to the module processor, the module memory and / or module processor operable to store device information and / or container information as stored information and / or to store administration history, the administration history including the number of dose sizes dispensed or injected by the injection device and determined or calculated by the module processor.

[0060] According to a further example, the module processor is operative to store at least one of the size of those injected, the number of doses injected, and the time or date of dose injection in the memory of the machine-readable identification as usage-related data. In this way, the machine-readable identification of the infusion device may be directly provided with usage-related data indicative of the administration history of previous uses of the infusion device. If the infusion device is to be attached or re-attached to another add-on device, each add-on device may read its respective usage-related data and may resume or continue recording the administration history of each infusion device.

[0061] According to another example of an add-on device, the module processor is operative to read usage-related data from the memory of the machine-readable identification, and the module processor is further operative to determine or calculate a remaining amount of medication contained in the medication container based on the usage-related data.

[0062] Typically, for example, an electronic container identifier provided on the medication container and / or provided on or within a container portion of an infusion device may comprise stored information indicative of the remaining amount of medication left in the medication container. Thus, information regarding the effective remaining amount of medication in the medication container or remaining amount information can be stored directly in the electronic, and therefore digital, memory of the respective container portion or machine-readable identification portion of the medication container. In this way, the medication container itself, or the container portion that receives or houses the medication container, directly comprises relevant information regarding the actual condition or status of the medication container.

[0063] Storing use-related data directly in the electronic container identifier allows for arbitrary combinations of the medication container or container portion with other drive mechanisms or bodies of other infusion devices, and / or logically connecting or pairing each medication container with different add-on devices, thus providing a fairly flexible and universal way of using and / or combining the medication container with, for example, a variety of suitable drive mechanisms or infusion devices, as well as a variety of different add-on devices.

[0064] According to another aspect, the present disclosure further relates to an infusion system, comprising the infusion device described above, and further comprising an add-on device described above.

[0065] Specifically, the injection device of the infusion system includes a housing for containing a medication container with a medication. The injection device further includes a drive mechanism for injecting a dose of the medication from the medication container. The injection device further includes a machine-readable identification portion including an electronic circuit having a writeable memory configured to store at least one of device information, container information, and usage-related data. The add-on device includes a device body removably fastenable to a portion of the injection device. The add-on device further includes an electronic module including a module processor and a transceiver operative to read, receive, modify, or generate at least one of device information, container information, and usage-related data.

[0066] The electronic module functions to store at least one of device information, container information, and usage-related data in the module memory. Because the infusion system includes the infusion device and add-on devices described above, all features, effects, and advantages described above with respect to either the infusion device or the add-on device apply equally to the infusion system, and vice versa.

[0067] According to a further aspect, the present disclosure also relates to a method for monitoring operation of an infusion device configured to inject a dose of a medication. The method includes attaching an add-on device to a portion of the infusion device. The infusion device includes a machine-readable identification portion including an electronic circuit having a writeable memory. The writeable memory is configured to store at least one of device information, container information, and usage-related data. The method further includes reading, receiving, converting, or generating at least one of the device information, container information, and usage-related data by an electronic module of the add-on device. Finally, at least one of the device information, container information, and usage-related data is stored in memory by the electronic module.

[0068] In some examples, it may be only the electronic module of the add-on device that is configured to store at least one of the device information, container information, and usage-related data in memory. In further examples, it may be a transceiver of an external electronic device, such as a smartphone, smartwatch, or tablet computer, that stores at least one of the device information, container information, and usage-related data in memory of the machine-readable identification portion of the infusion device.

[0069] The method of monitoring the operation of an infusion device may be performed by utilizing the infusion system described above, and thus by utilizing at least one of the infusion devices described above, and by utilizing at least one of the add-on devices described above. Accordingly, all features, effects, and advantages described above with respect to any one of the infusion devices, add-on devices, and infusion systems apply equally to the method of monitoring the operation of an infusion device, and vice versa.

[0070] According to a further example, the step of storing at least one of the device information, the container information, and the usage-related data includes establishing a wireless communication link between a transceiver of the electronic module and an antenna of the electronic circuit of the machine-readable identification unit. Wireless information or data exchange can be provided between the machine-readable identification unit of the infusion device and the add-on device or the external electronic device via the wireless communication link between the transceiver of the add-on device or the transceiver of the external electronic device and the antenna of the electronic circuit of the machine-readable identification unit. In this way, the machine-readable identification unit can be located not only on the outside but also inside the infusion device. The machine-readable identification unit can be concealed by the housing or by any functional component of the infusion device, thus providing an anti-counterfeiting function.

[0071] According to another aspect, the present disclosure relates to an add-on device for attachment to an injection device. The injection device includes a housing, a medication container, and a drive mechanism. The drive mechanism is configured to inject a dose of medication from the medication container. The housing includes a body and a container portion removably connectable to the body. The body includes an electronic body identifier containing device information, and the container portion includes an electronic container identifier containing the container information. The add-on device includes a device body removably fastenable to a portion of the injection device and further includes an electronic module including a module processor and a transceiver. The processor and / or transceiver are operative to read the device information from the electronic body identifier and the container information from the electronic container identifier.

[0072] The electronic module may be operable to read the device information and the container information separately and / or sequentially. The electronic module may be operable to store the device information or the container information in module memory. Thus, the add-on device may be capable of or operable to separately identify the container portion or drug container and the body portion or drive mechanism of the infusion device. Thus, the add-on device may track or identify individual components of the infusion device, which may be removable or replaceable, for example, to reset or reconfigure the infusion device.

[0073] According to a further example, the electronic module is operative to compare the device information with the container information. The electronic module is further operative to determine whether the device information matches the container information. Thus, the add-on device is operative and capable of individually identifying the drive mechanism or body, as well as individually identifying the container portion and / or medicament container. In response to each identification, the electronic module is operative to compare the container information with predefined device information, and vice versa. Thus, the electronic module may comprise a reference data set or a matching data set that indicates which type of medicament container or container portion can or should be used with which type of drive mechanism or body portion of the infusion device.

[0074] In this manner, the add-on device functions or is configured to assert or determine proper match between the drive mechanism and the drug container, and thus proper or intended match between the body and container portion of the reusable injection device.

[0075] According to a further example, the electronic module is operable to activate a locking mechanism of the drive mechanism if the container information does not match the device information. The locking mechanism is operable to block at least one of setting and dispensing of the dose. To this end, the add-on device and / or its electronic module may include a lock controller electrically connected or electromechanically connectable or engagable with the locking mechanism of the drive mechanism. The locking mechanism may be activated if it is determined that the electronic container identifier indicates a particular container portion or drug container that does not match the drive mechanism or body of the infusion device obtained from the electronic body identifier.

[0076] Conversely, it is conceivable or possible that the locking mechanism of the drive mechanism of the add-on device is in a locked mode by default, and that it is necessary to connect the add-on device to the infusion device in order to unlock the locking mechanism of the drive mechanism. Thus, the lock controller of the add-on device can unlock the locking mechanism of the drive mechanism of the infusion device only or exclusively when the device information obtained from the main body identifier and the container information obtained from the electronic container identifier match. In this way, setting and / or dispensing a dose of medication is only possible when a) the add-on device is connected to the infusion device and b) the first drive mechanism matches the medication container or medication in the medication container. In this way, misuse of the infusion device can be effectively prevented, thereby improving patient safety, particularly in the field of home medication or self-treatment using an infusion device.

[0077] According to a further example, the electronic module is operable to generate a user-perceivable warning signal if the container information does not match the device information, the container information being obtained or retrieved from the container identifier and the device information being obtained or retrieved from the electronic body identifier. The generation of the user-perceivable warning signal may be generated by the add-on device itself, where a signal generator of the add-on device may be activated.

[0078] The user-perceivable alert may also be triggered by the add-on device, for example by signal transmission between the add-on device and at least one external electronic device, where an alert signal may be transmitted wirelessly from a transceiver of the electronic module to a transceiver of each of the external electronic devices, each of the transceivers of the external electronic devices being operable to generate a respective user-perceivable alert upon receiving the respective alert signal, the user-perceivable alert being of the audible, visual or tactile type.

[0079] According to a further aspect, the present disclosure also relates to a method for testing an injection device. The injection device includes a housing, a medication container, and a drive mechanism. The drive mechanism is configured to inject a dose of medication from the medication container. The injection device housing includes a body and a container portion, the container portion being detachably connectable to the body. The body includes an electronic body identifier including device information, and the container portion includes an electronic container identifier including the container information. The method includes reading the device information from the electronic body identifier by an electronic module of an add-on device configured to attach to the injection device, and reading the container information from the electronic container identifier by the electronic module. Then, in a further step, the device information is compared with the container information to determine a degree of match between the device information and the container information. The determination of the degree of match between the device information and the container information may be based on a predefined or predetermined matching schedule that defines allowable pairings between different medication containers and different drive mechanisms.

[0080] According to a further aspect, the present disclosure also relates to a computer program, e.g. a computer program product, comprising computer readable instructions which, when executed by a module processor of the above-mentioned add-on device, cause the module processor to perform the steps of the above-mentioned method.

[0081] Typically, the computer program is executable by the add-on device as described above and is further operable to implement the method of monitoring the operation of an infusion device in the add-on device as described above. Thus, the computer program and its computer readable instructions are operable to cause a processor of the add-on device to implement the method of monitoring or checking the infusion device as described above. The computer readable instructions may be executable by the processor of the add-on device as described above.

[0082] Additionally or alternatively, if the external electronic device of the above-described injection system is configured to read the machine-readable identification portion of the injection device, the computer program and its computer-readable instructions may be at least partially executable by a processor of the external electronic device.

[0083] The computer program is executed by a processor of the add-on device to monitor and / or record the operation of the infusion device when the add-on device is attached to the infusion device. Accordingly, all features, effects, and advantages described above with respect to the add-on device and / or with respect to the method of configuring the add-on device, as well as with respect to any infusion system, apply equally to the computer program, and vice versa.

[0084] The present disclosure further discloses and proposes a computer program comprising computer-executable instructions for performing a method according to one or more of the disclosed methods / devices / systems of the examples contained herein when the program is executed on a processor, a computer, or a computer network. Specifically, the computer program may be stored on a computer-readable data carrier. Thus, specifically, one, two or more, or even all of the method steps as described above may be performed by using a computer or a computer network, typically by using a computer program.

[0085] The present disclosure further discloses and proposes a computer program product having program code means for performing the methods according to one or more of the disclosed methods / systems of the embodiments contained herein when the program is run on a computer or computer network. In particular, the program code means may be stored on a computer readable data carrier.

[0086] Furthermore, the present disclosure discloses and proposes a data carrier having stored thereon a data structure that, after being loaded into a processor, a computer, or a computer network, e.g., into the working memory or main memory of a processor, computer, or computer network, is capable of executing a method according to one or more of the examples disclosed herein.

[0087] The present disclosure further proposes and discloses a computer program product having program code means stored on a machine-readable carrier for performing the method or part thereof according to one or more of the examples disclosed herein when the program is executed on a processor, a computer, or a computer network. As used herein, a computer program product refers to a program as a tradeable product. The product may generally exist in any form, for example in paper form or on a computer-readable data carrier. In particular, the computer program product may be distributed over a data network.

[0088] In a further example, the injection device includes a dose dial and a trigger, for example, provided at the proximal longitudinal end of the injection device. The injection device may be implemented as a pen injector. The dose dial and / or trigger may be provided at the proximal longitudinal end of the pen injector. Here, the machine-readable identification may be provided in or on the dose dial and / or trigger. The add-on device may be configured to be releasably or detachably fastened to the proximal end of the injection device.

[0089] The add-on device, particularly its device body, may include a receptacle that fits over the dose dial and / or trigger. By mounting or locating the machine-readable identification within or on the trigger or dose dial, the geometric distance between the machine-readable identification and a reader or transceiver of the add-on device for reading the machine-readable identification can be reduced to a minimum, thus allowing the transceiver or reader of the add-on device to be implemented as a wireless near-field transceiver that functions to read the near-field communication tag of each of the device's machine-readable identification. In this way, reading of the machine-readable identifier can only occur when the add-on device is properly attached to the proximal end of the injection device.

[0090] According to a further example, the infusion system includes an external electronic device, for example implemented as a smartphone, a smartwatch, or a tablet computer, which may be operable to perform at least one or several steps of the method for monitoring the operation of the infusion device.

[0091] Generally, the scope of the present disclosure is defined by the content of the claims. The present disclosure is not limited to a particular embodiment or example, but includes any combination of elements from different embodiments or examples. Thus, the present disclosure covers any combination of the claims and any technically feasible combination of the disclosed features in relation to different examples or embodiments.

[0092] In the present context, the term "distal" or "distal end" relates to the end of the injection device facing the injection site of a human or animal, and the term "proximal" or "proximal end" relates to the opposite end of the injection device that is furthest from the injection site of a human or animal.

[0093] The terms "drug" or "medicament" are used synonymously herein to refer to a formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in the broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or medications are used to treat, cure, prevent, or diagnose disease or otherwise improve physical or mental well-being. Drugs or medications may be used for a limited period of time or periodically for chronic conditions.

[0094] As described below, drugs or pharmaceutical agents can include at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs include small molecules, i.e., polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes) with a molecular weight of 500 Da or less, carbohydrates and polysaccharides, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0095] The drug or agent may be contained within a primary package or "drug container" adapted for use with a drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber may be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber may be designed to store the drug for about one month to about two years. Storage may occur at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, the drug container may be or include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during administration to a 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 prior to administration. Alternatively, or additionally, the two chambers may be configured to allow mixing upon administration of the components into the human or animal body.

[0096] Drugs or agents contained in drug delivery devices as described herein can be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes mellitus or complications associated with diabetes mellitus, such as diabetic retinopathy, and thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders include acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those listed in handbooks such as the Rote Liste 2014, for example, but not limited to, Main Group 12 (antidiabetic drugs) or 86 (oncology drugs), and the Merck Index, 15th edition.

[0097] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes mellitus or complications of type 1 or type 2 diabetes mellitus include insulin, e.g., human insulin, or an insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, or an analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deleting and / or replacing at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or substituted amino acid residue can be either a codable amino acid residue or other naturally occurring residue, or a purely synthetic amino acid residue. Insulin analogs are also referred to as "insulin receptor ligands." In particular, the term "derivative" refers to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide may be deleted and / or substituted with other amino acids, including non-codable amino acids, or amino acids, including non-codable amino acids, may be added to the naturally occurring peptide.

[0098] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine), Lys(B3), Glu(B29) human insulin (insulin glulisine), Lys(B28), Pro(B29) human insulin (insulin lispro), Asp(B28) human insulin (insulin aspart), human insulin in which the proline in position B28 may be substituted with Asp, Lys, Leu, Val or Ala and the Lys in position B29 may be substituted with Pro, Ala(B26) human insulin, Des(B28-B30) human insulin, Des(B27) human insulin and Des(B30) human insulin.

[0099] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin. B29-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin, and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0100] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flathead sea urchin), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rexendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C, HM-15211, CM-3, G LP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexene, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3 022, ZP-DI-70, TT-401 (pegapamodtide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, tirzepatide (LY3298176), bamadutide (SAR425899), exenatide-XTEN, and glucagon-Xten.

[0101] Examples of oligonucleotides include, for example, mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic agent for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport syndrome. Examples of DPP4 inhibitors include linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0102] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin, and their antagonists.

[0103] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or ultra-low molecular weight heparin, or derivatives thereof, or sulfated forms of the above polysaccharides, such as polysulfated forms, and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F20 (Synvisc®), sodium hyaluronate.

[0104] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain antigen-binding ability. An antibody may be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single-chain antibody. In some embodiments, an antibody has effector function and is capable of fixing complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, antibody fragment, or mutant that does not support Fc receptor binding, e.g., with a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable region antibody-like binding proteins with a crossover binding region orientation (CODV).

[0105] The term "fragment" or "antibody fragment" refers to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to antigen. Antibody fragments may include truncations of a full-length antibody polypeptide, although the term is not limited to such truncated fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, such as bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, such as bivalent, trivalent, tetravalent, and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0106] 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.

[0107] 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).

[0108] Pharmaceutically acceptable salts of any of the APIs described herein are also contemplated for use with the drugs or medicaments in the drug delivery devices. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0109] It will be understood by those skilled in the art that modifications (addition and / or deletion) of various components of the APIs, formulations, devices, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the invention, and that the invention encompasses such modifications and any and all equivalents thereof.

[0110] An exemplary drug delivery device may include a needle-based injection system as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems may be broadly divided into multi-dose container systems and single-dose (partial or full discharge) container systems. The container may be a replaceable container or an integrated, non-replaceable container.

[0111] As further described in ISO 11608-1:2014(E), a multi-dose container system may include a needle-based injection device with replaceable containers. In such systems, each container holds multiple doses and may be fixed or variable in size (pre-set by the user). Other multi-dose container systems may include needle-based injection devices integrated with non-replaceable containers. In such systems, each container holds multiple doses and may be fixed or variable in size (pre-set by the user).

[0112] As further described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based injection device with replaceable containers. In one example of such a system, each container holds a single dose, thereby dispensing the entire deliverable amount (full discharge). In a further example, each container holds a single dose, thereby dispensing a portion of the deliverable amount (partial discharge). Also as described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based injection device with an integrated replaceable container. In one example of such a system, each container holds a single dose, thereby dispensing the entire deliverable amount (full discharge). In a further example, each container holds a single dose, thereby dispensing a portion of the deliverable amount (partial discharge).

[0113] A number of examples of data logging devices for monitoring infusion device usage and corresponding infusion devices are described in more detail below with reference to the drawings. [Brief explanation of the drawings]

[0114] [Figure 1] 1 illustrates a schematic diagram of an example of an injection device. [Figure 2] 10 illustrates the process of assembling an add-on device to the proximal end of an infusion device. [Figure 3] 1 shows an injection device in a schematic longitudinal cross-section. [Figure 4] 1 illustrates a configuration of an infusion system including an infusion device, an add-on device, and at least one external electronic device. [Figure 5] 1 illustrates pairing between an external electronic device and an add-on device. [Figure 6] 10 shows a visual illustration on the display of an external electronic device to assist a user in setting up an infusion device. [Figure 7] 10 illustrates the further step of reading an electronic container identifier provided on the container portion of the injection device. [Figure 8]10 illustrates visual feedback provided on an external electronic device in response to reading information from an electronic container identifier. [Figure 9] 1 shows the injection device and the add-on device prior to final assembly of the add-on device to the injection device. [Figure 10] 10 illustrates the visual feedback provided on the display of an external electronic device after detecting the correct pairing of components of an infusion device. [Figure 11] 10 shows a further example of an add-on device when attached to an infusion device. [Figure 12] 12 shows the example of FIG. 11 before the add-on device is attached to the infusion device. [Figure 13] 1 illustrates the variable connection of an add-on device to one of two available infusion devices. [Figure 14] 1 shows block diagrams of an add-on device, an injection device, and an external electronic device. [Figure 15] 1 shows a block diagram of the electronic circuitry of the machine-readable identification unit. [Figure 16] 1 shows an example of an electronic circuit on a substrate. [Figure 17] 1 shows a flowchart of a method for configuring an add-on device. DETAILED DESCRIPTION OF THE INVENTION

[0115] FIG. 1 shows an example of a drug delivery device implemented as a handheld injection device 1. The injection device 1 may include or be implemented as a pen injector. The injection device 1 may be implemented as a disposable injection device or a reusable injection device. In some examples, the injection device 1 is implemented as an automatic injector. The injection device 1 is elongated in shape. The injection device 1 may extend along a longitudinal direction. The drug delivery device 1 includes, toward a longitudinal distal direction 2, a dispensing end for dispensing or injecting a medicament 24. Toward a proximal direction 3, the injection device 1 includes at least one of a dose member 8 and a trigger 9, which can set and dispense doses of equal, individual, or different sizes, respectively.

[0116] The injection device 1 includes a housing 10. The housing 10 may include a number of housing components, such as a body 6 and a reservoir portion 7, for example implemented as a cartridge holder 7. The body 6 may be sized and configured to accommodate a drive mechanism 20. The cartridge holder 7 is sized and configured to accommodate a medicament container 21, for example implemented as a cartridge containing a liquid medicament 24. The medicament container 21 includes a tubular barrel 22 sealed towards its distal end by a seal 23. The seal 23 may include a pierceable septum secured to an outlet 25 of the medicament container 21. The interior of the barrel 22 is sealed towards its proximal end by a piston 18 or stopper slidably disposed within the barrel 22.

[0117] By advancing the piston 18 in the distal direction 2, a dose of the medicament 24 can be expelled from the medicament container 21. In use, the medicament container 21 is disposed within the container portion 7. The drive mechanism 20 of the injection device 1 includes a piston rod 19 that is displaceable in the distal direction 2 to advance the piston 18 toward the outlet 25 of the medicament container 21. Details of the drive mechanism will not be further shown or described herein. In some examples, the drive mechanism 20 may be implemented as an all-mechanical drive mechanism in which the user must provide all of the dispensing force required to move the piston rod 19, and therefore the piston 18, in the distal direction 2. In other examples, the drive mechanism includes a mechanical energy store configured to provide at least a portion of the dispensing force. Examples of drive mechanisms can be found, for example, in WO 2004 / 078241 A1, WO 2014 / 033197 A1 or WO 2014 / 033195 A1, the entire contents of which are incorporated herein by reference.

[0118] 2, the injection device 1, and thus the drive mechanism 20, may include a dial extension 27 that projects and moves in the proximal direction 3 from the proximal end of the body 6 at or during dose setting and returns to its initial distal position during the dose injection procedure. To this end, the user may use the thumb 114 of their hand 110 to apply distal pressure to the trigger 9, thereby pushing the dial extension 27 in the distal direction 2 during and / or throughout the dose injection procedure.

[0119] To set or dial a dose, the user can twist or rotate the dose dial 8, for example, in the dose-increase direction 4, thus clockwise when viewed from the proximal end. To modify a previously set dose, the user can also rotate the dose dial 8 in the opposite dose-decrease direction 5. The dose size is typically indicated in a window 26 provided in or on the body 6 of the injection device 1. Before injecting a dose of medicament 24, the distal end of the container portion 7 or cartridge holder must be connected with the needle assembly 12. For this purpose, the distal end of the cartridge holder 7 includes a connector 11, for example in the form of a threaded interface, for engaging a complementary-shaped threaded counter-interface of the needle assembly 12.

[0120] The needle assembly 12 is detachably or removably securable to the container portion 7. The needle assembly 12 includes a double-ended infusion needle 13. The proximal end (not shown) of the infusion needle is configured to enter a through-opening in the distal end face of the connector 11 or the container portion 7 so as to pierce or penetrate the seal 23 of the medication container 21. The distal end of the infusion needle 13 is typically covered by a removable inner needle cap 14. The entire needle assembly 12 may be covered by a removable outer needle cap 15.

[0121] The container portion 7 , and therefore part of the housing 10 , will be housed within a protective cap 16 which is removably connectable to the cartridge holder 7 or the body 6 .

[0122] 2 and 4 show an example of an add-on device 30 configured to be fastened to the proximal end of the injection device 1. The add-on device 30 includes a sensor 48 or sensor assembly operable to detect, recognize, characterize, and / or measure the operation of the injection device 1. Typically, the sensor 48 of the add-on device 30 is capable of or operable to quantitatively determine or measure the position and / or movement of movable components 80, 81, 82, 83 of the drive mechanism 20 of the injection device 1, as shown in the block diagram of FIG. 14. The movable components 80, 81, 82, 83 are movable relative to the main body 6 and / or the medicament container 21 during or during setting and / or injecting a dose of the medicament 24.

[0123] This movement or position can be quantitatively measured by a sensor 48. Typically, the sensor 48 is implemented as an electronic sensor. When the add-on device 30 is attached to the injection device 1, the sensor 48 can detect or measure the degree of longitudinal translation and / or rotation of at least one movable component 80, 81, 82, 83 relative to the housing 10 or relative to the device body 60. An example of a movable component 80 is shown schematically in the cross-sectional view of the injection device 1 according to FIG. 3.

[0124] The sensor 48 of the add-on device 30 is capable of or functions to generate a sensor signal or sequence of sensor signals, which, upon coupling or connection to the module processor 44, can be processed by the module processor 44 to derive or calculate the size of the dose currently being set or dispensed.

[0125] In some examples, the movable component 80 is a dose setting member or a dose setting sleeve. In further examples, the movable component 81 is implemented as a drive member or drive sleeve 81 of the drive mechanism 20. In a further example, the movable component is implemented as a volume indicator 82, for example as a single dose indicating member, the position or configuration of which relative to the body 6 directly indicates the size of the currently set dose. In a further example, the movable component 82, and thus the volume indicator, is a final dose indicating member, the position or configuration of which relative to the body 6 indicates the remaining amount of medicament left in the cartridge or medicament container 21.

[0126] In some examples, the movable components 83 are or include an encoding, such as a digital encoding, movable relative to the sensor 48 so that the sensor can count the number of discrete code portions of the encoding to gather quantitative movement information about each of the movable components 80. Generally, different types of spatial encoding may be provided, such as optical or visual encoding, electrical or electrostatic encoding, magnetic encoding, or mechanical encoding. The sensor 48 is configured to respond depending on the type of encoding provided on or within the movable components 80, 81, 82, 83. Thus, the sensor 48 may include at least one of an optical sensor, an electrical or electrostatic sensor, and a magnetic sensor or a mechanical sensor such as a micromechanical switch, each of which functions to quantitatively measure the relative position or movement of the movable components 80, 81, 82, 83.

[0127] In some examples, the movable components 80, 81, 82, 83 undergo longitudinal and / or rotational movement relative to the body 6, relative to the drug container 21, and / or relative to the device body 60 during dose setting and / or dose dispensing. Typically, the encoding provided on or with the movable components 80, 81, 82, 83 is encoded along the direction of movement of the movable component relative to the sensor 48 to enable quantitative measurement of each dose setting or dose dispensing movement.

[0128] As further shown in Figure 3, the drive mechanism 20 may optionally be provided with a locking mechanism 85 operable by a lock controller of the add-on device 30 when the add-on device 30 is properly assembled to the injection device 1. The locking mechanism 85 functions to block or lock the drive mechanism 20 to prevent unauthorized or unintended setting and / or dispensing or injection of a dose. The locking mechanism 85 is controllable by a lock controller 86 of the add-on device 30. The locking mechanism 85 may be implemented electromechanically and may be electrically or electronically controlled by the lock controller 86 of the add-on device 30. In this way, the add-on device 30 may prevent unauthorized or unintended use of the injection device 1.

[0129] The add-on device 30 shown in various Figures 2-14 is removably connectable to a dose dial 8. The add-on device 30 includes a device body 60 having a tubular side wall 61. Towards its distal end, the side wall 61 encloses a receptacle 63 sized to receive the dose dial 8 and trigger 9 of the injection device 1. To this end, the inside of the side wall 60 may include one or multiple fastening ribs 64 configured to provide a non-slip fastening to the dose dial 8 of the add-on device 30.

[0130] The device body 60 includes a receptacle 63 at the distal end section of the add-on device 30. The receptacle 63 is open in the distal direction 2. The receptacle 63 is sized and configured to fit onto the proximal end of the injection device 1. The inner surface of the side wall 61 enclosing the receptacle 63 includes a number of fastening ribs 64 of a resilient or resiliently deformable material, such as an elastomeric material.

[0131] The fastening ribs 64 provide a friction fit with the dose dial 8 when the device body 60 is assembled to the dose dial 8 of the injection device 1. The receptacle 63 may be longitudinally confined by a flange portion 62 protruding radially inward from the tubular side wall 61 of the receptacle 63. The flange portion 62 is positioned proximally offset from the insertion opening of the receptacle 63. The flange portion 62 may be annular and configured to axially abut a stepped section at the proximal end of the dose dial 8. Thus, the trigger 9, which includes a reduced diameter compared to the dose dial 8, may protrude in the proximal direction 3 through the flange portion 62, and the flange portion 62 may rest or abut against the proximal end face of the dose dial 8 when the add-on device 30 is properly fastened to the dose dial 8.

[0132] The add-on device 30 further includes a movable part 70 protruding proximally from the device body 60. The movable part 70 includes or forms an auxiliary trigger or trigger button configured to mechanically engage the trigger 9 of the injection device 1 when the add-on device 30 is properly assembled to the injection device 1.

[0133] Typically, the add-on device 30, and in particular the device body 60, is frictionally engageable with the dose dial 8. In this way, the user can apply a dose setting torque to the dose dial via the device body 60. Instead of rotating the dose dial 8 to set a dose, the user may simply rotate the device body 60 relative to the body 6 of the injection device 1. In this way, the dial extension 27 may undergo a dose increment dial or rotational movement. Thereafter, the size of each currently set dose is displayed in the window 26 of the body 6 of the injection device 1, as shown in FIG. 2 .

[0134] To dispense a dose, the user needs to press down on the movable part 70, which may then undergo a distally directed movement relative to the device body 60. The movable part 70, which may be in direct or indirect mechanical engagement with the trigger 9, may then apply a respective dispensing force to the trigger 9, thereby initiating the dose-dispensing operation of the injection device 1.

[0135] The add-on device 30, shown schematically in Figure 14, includes an electronic module 34. The electronic module 34 includes a printed circuit board 36. The electronic module 34 includes a module processor 44, an electronic, and therefore digital, module memory 40, and a clock 42. Furthermore, the electronic module 34 includes a power supply 46 and a sensor 48. The electronic module 34 also includes a signal generator 52 coupled to the processor 44 and / or coupled to the power supply 46. The electronic module 34 further includes a reader 37 and / or a wireless transceiver 38, 39. The add-on device 30 may also include a user-perceivable device identifier 50.

[0136] In some examples, the device identifier 50 comprises or includes a signal generator 52 coupled to the module processor 44 and operable or reconfigurable by the module processor 44. In some examples, the device identifier 50 may indicate the infusion device 1 to which the add-on device 30 is actually connected or coupled.

[0137] In some examples, the signal generator 52 functions to generate at least one of a visual, an acoustic, and a tactile signal, or the device identifier thus functions to generate or generate a visual, an acoustic, or a tactile identifier, or a respective warning signal. In some examples, the add-on device 30 includes multiple signal generators 52 of the same or different types, e.g., visual, acoustic, or tactile.

[0138] In the example of FIG. 2, the signal generator 52 may include a speaker that functions to generate an acoustic signal, which may represent or constitute, for example, a warning signal in the form of an acoustic code or sequence characteristic of a particular configuration or setting of the injection device 1 or add-on device 30.

[0139] 4 illustrates an infusion system 120 including at least an add-on device 30 and an infusion device 1. Optionally, the infusion system 120 includes one or several external electronic devices 100, 101′. The external electronic device 100 is implemented as a smartphone including a housing 101 and is equipped with a device display 151 for visually presenting various types of information to a user, such as various illustrations 153 or notifications 154. The display 151 may be implemented as a touch-sensitive display. The device display 151 may function to provide or emulate a device signal generator 152. The device display 151 functions to provide at least one of the illustrations 153 and notifications 154 to the user.

[0140] A further optional external electronic device 100' is implemented as a smart watch, including a respective housing and display 151', and further including a wristband 103 for securing the external electronic device 100' to a user's hand 110 or wrist 111. Similar to the external electronic device 100, the external electronic device 100' also functions to provide at least one of an illustration 153 and a notification 154 to the user. Generally, the external electronic devices 100, 100' may each include a separate device signal generator 152, such as a speaker or vibration module, capable of generating a user-perceivable signal to provide a warning signal to the user of the device.

[0141] The electronic device 100 is typically implemented as a handheld electronic device. The electronic device 100 can be held in a user's hand 110 or may be worn on the user's wrist 111. In the example shown in Figure 4, the electronic device 100 is held in the user's palm 112. The device display 151 is implemented as a touch-sensitive display and can be operated by the thumb 114 and / or various fingers 116 of the user's hand 110.

[0142] The electronic module 34 of the add-on device 30, shown schematically in Figure 14, includes a reader 37 and / or transceiver 38, 39 that function to wirelessly communicate with at least one of the machine-readable identification units 28, 88 of the injection device 1, or with a complementary or correspondingly implemented device reader 137 and / or device transceiver 138, 139 of the external electronic device 100, 100'.

[0143] In a typical example, the transceivers 38, 138 are implemented as near-field radio frequency transceivers. The transceivers 38, 138 may be implemented as wireless short-range transceivers or near-field transceivers. They may be implemented as so-called NFC transceivers that enable wireless communication within a limited spatial range of a few centimeters or decimeters. The transceivers 38, 138 may be implemented as active and / or passive NFC tags or readers. Typically, the transceiver 38 is implemented as a passive NFC tag, and the transceiver 138 is implemented as an active NFC tag or NFC reader.

[0144] The transceivers 39, 139 may be implemented as wireless local range transceivers, such as RFID, Bluetooth, Bluetooth low energy (BLE), or UWB transceivers. Also here, the transceivers 39, 139 may be implemented as passive communication tags, while the transceivers 139 may be implemented as active transceivers and thus as readers. Typically, the transmission range of the transceivers 39, 139 is greater than the transmission range of the transceivers 38, 138. The transmission range of the transceivers 39, 139 may be in the range of several meters or decameters.

[0145] The optional reader 37, 137 may be implemented as an optical reader or optical information collection unit, for example including an imaging system for capturing or recording visual or optical machine-readable identification 28, 88 provided on or within the injection device 1.

[0146] The external electronic device 100, 100′ typically includes a device processor 144 coupled to an electronic device memory 140. The electronic device 100 further includes a device power supply 146. The electronic device 100 also includes a device display 151, which is typically implemented as a touch-sensitive display. The device display 151 may function to provide at least one of illustrations 153 and notifications 154 to a user.

[0147] The device transceiver 138 functions to communicate with the transceiver 38 of the add-on device. The transceiver 139 is configured to communicate with the transceiver 39 of the add-on device 30. The reader 137 may function to read a visual identifier provided on the infusion device 1. In some examples, the device reader 137 includes an imaging system, which may include, for example, a camera objective and a spatial resolution detector for reading or capturing a visual code provided on the exterior surface of the infusion device 1 or provided on the exterior surface of the medication container 21.

[0148] The external device 100 is configured to set up a communication link, for example a wireless communication link, with the add-on device 30. To this end, the local range transceiver 39 of the add-on device 30 may communicate wirelessly with the local range device transceiver 139 of the add-on device 100. Once a communication link is established between the electronic device 100 and the add-on device 30, the electronic device 100 may function to visually show information or data of the infusion device or medication container 21 on the device display 151.

[0149] The infusion device 1 comprises a machine-readable identification portion 28, 88, as shown schematically in Figure 14. The machine-readable identification portion 28 comprises an electronic identifier 29. The machine-readable identification portion 88 comprises an electronic identifier 89. The electronic identifier 28 may comprise a passive wireless communication tag, as shown schematically in Figure 12.

[0150] 15 , the electronic identifier 29 may include an electronic circuit 90 comprising a wireless communication antenna 91 and an integrated circuit 93. The integrated circuit 93 includes an electronic, and therefore digital, memory 92 and a processor 94 connected to the memory 92. Naturally, the integrated circuit 93, and therefore the processor 94, are connected to the antenna 91. The electronic identifier 29 may optionally include a power supply 96 to provide power or energy for the processor 94. The electronic circuit 90 may be provided on a planar substrate 95. The substrate 95 may be flexible or foldable. The substrate 95 may include a flexible structure or foil that allows the substrate 94, and therefore the entire electronic identifier 29, to be easily attached, secured, for example, adhesively secured, to at least one of the tubular body 6, the container portion 7, or the drug container 21.

[0151] 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 comprise an adhesive layer 97 that allows for straightforward adhesive attachment of the machine-readable identification portion 28, 88 to a predetermined portion on or within the infusion device 1. The electronic identifier 89 may comprise the same or similar structure as the electronic identifier 29 shown in Figures 12 and 13.

[0152] In some examples, the machine-readable identification 28, 88 is implemented on a label 17 disposed on one of the body 6, container portion 7, or medication container 21. The label 17 includes or houses the machine-readable identification 28, 88. In some examples, the label 17 includes a passive radio frequency tag. In further examples, the label 17 includes the machine-readable identification 28, 88 implemented as a visual or optical code that can be captured by a reader 37 or device reader 137 implemented as or including an imaging system.

[0153] At least one of the reader 37, device reader 137, or at least one of the transceivers 38, 39 or device transceivers 138, 139 functions to read the machine-readable identification portion 28, 88, thereby obtaining at least one of the device information and container information stored, for example, in the memory 92 of the electronic circuit 90.

[0154] Typically, the machine-readable identification 28 is provided or located on or within the body 6 of the housing 10 of the injection device 1. The further machine-readable identification 88 is provided on or within the container portion 7. The further machine-readable identification 88 may also be provided on or within the medicament container 21. In some examples, the machine-readable identification 28 may be provided in or on the piston 18 of the medicament container 21.

[0155] The machine-readable identification units 28, 88 may be implemented as passive RF communication tags, such as NFC tags, etc. Information, e.g., device information and / or container information, stored in at least one of the machine-readable identification units 28, 88 is readable by the electronic module 34 and thus by one of the transceivers 38, 39 of the add-on device 30 and / or by one of the transceivers 138, 139 of the external electronic device 100, 100′.

[0156] In some instances, particularly when the injection device 1 is implemented as a disposable injection device that does not support replacement of the medication container 21, it may be sufficient for the injection device 1 to include only one machine-readable identification 28. It may be particularly advantageous if the machine-readable identification 28 is provided at or near the proximal end 68 of the body 6. The machine-readable identification 28 may be provided on or within the dose dial 8 or trigger 9 such that it is within transmission range of the transceivers 38, 39 when the add-on device 30 is attached to the proximal end of the injection device 1.

[0157] In some examples, the distal end 67 of the body 6 is detachably connectable to the proximal end of the container portion 7. The injection device 1 is then implemented as a reusable device, allowing for replacement of the container portion 7 and / or replacement of the drug container 21 within the container portion 7. In a reusable injection device 1, it may be particularly advantageous if both the body 6 and the container portion 7 comprise separate machine-readable identification portions 28, 88. As shown in Figure 14, the container portion 7 comprises the machine-readable identification portion 88, whereas the body 6 comprises the machine-readable identification portion 28.

[0158] 9, the transceiver 38 may be located within the receptacle 63 of the device body 60 to minimize the spatial distance to the machine-readable identification 28 provided at or near the proximal end 68 of the body 6. The use of near-field communication technology for the machine-readable notification 28, 88 and the respective transceiver 38, 138 may ensure that the machine-readable identification and the device and / or container information stored therein can only be obtained or retrieved when the add-on device 30 and / or external electronic device 100, 100′ are within near-field transmission range.

[0159] 12, the receptacle 63 of the device body includes an alignment feature 65 in the form of a longitudinal recess or groove on the inside of the side wall of the receptacle 63. Correspondingly, the proximal end of the dose dial 8 includes a complementary shaped counter alignment feature 66, for example in the form of a protrusion, sized to fit into the recess or groove of the alignment feature 65. In this way, a fastening can be provided which inhibits rotation of the add-on device 30 when attached to the housing 10 or dose dial 8 of the injection device 1.

[0160] When the alignment feature 65 is mechanically engaged with the counter-alignment feature 66, as shown in Figure 11, an anti-rotation lock is provided for interfastening the add-on device 30 to the injection device 1. In this way, it can be ensured that the identification portion 28, and therefore the electronic identifier 29, is always correctly aligned with the associated wireless transceiver 38 of the add-on device 30. A unique, well-defined mounting position is therefore provided for attaching the add-on device 30 to the injection device 1. Reaching the pre-defined mounting position or configuration with the alignment feature 65 engaging the counter-alignment feature 66 also ensures that the machine-readable identification portion 28 and the transceiver 38 are at a minimum distance from each other. This allows for a somewhat smoother signal transmission between the identification portion 28 or electronic identifier 29 and the transceiver 38.

[0161] Generally, the external electronic device 100 may be permanently or periodically synchronized with the add-on device by means of a local range communication interface provided, for example, by a transceiver 39, 139. Thus, any information collected or read by the add-on device 30 can be immediately transmitted to the external electronic device 100, 100′ and further processed, for example visualized, by the external electronic device 100, 100′.

[0162] The infusion device 1 comprises at least one machine-readable identification portion 28, 88, as shown in Figure 14. The machine-readable identification portion 28 includes an electronic identifier 29, referred to as an electronic body identifier. The machine-readable identification portion 88 includes a respective electronic container identifier 89. Each electronic identifier includes an antenna 91 and an integrated circuit 93, respectively, as described above with respect to Figure 15.

[0163] In some examples, the machine-readable identification 28, 88 is implemented as a passive or active RFID and functions to store device information and / or container information.

[0164] In the illustrated example of Figures 5 to 13, it is particularly advantageous if the individual components 1 of the injection device are each provided with a separate machine-readable identification 28, 88. Here, the injection device 1 is implemented as a reusable injection device. The container portion 7 is removably connectable to the body portion 6. The container portion 7 houses the drug container 21, while the body 6 includes or houses the drive mechanism 20. The container portion 7 and the body 6 each have their own machine-readable identification 28, 88.

[0165] For example, the container portion 7, which may be implemented as, for example, a cartridge holder, includes an electronic container identifier 89. The body 6 includes an electronic body identifier 29. As specifically shown in FIG. 7 , the container identifier 89 may be provided either on or within the container portion 7 of the injection device 1. In some examples, the electronic container identifier 89 may be provided on or within the barrel 22 of the medication container 21. In some examples, the electronic container identifier 89 is provided on or within the stopper or piston 18 of the medication container 21.

[0166] The electronic container identifier 89 may include a memory 92 that stores container- or medication-specific information. The electronic main body identifier 29, and in particular its memory 92, stores information or data specific to the main body 6 and / or the drive mechanism 20. A user intending to use the infusion device 1 in combination with an add-on device 30 may optionally pair or synchronize the add-on device 30 with an external electronic device 100, as shown in FIG. 5 . Here, a communication link may be established between the device transceiver 139 of the external electronic device 100 and the transceiver 39 of the add-on device 30, respectively. The add-on device 30 may include a unique identifier that may be transmitted to the external electronic device 100. Upon receiving the respective identifications via the wireless communication link between the external electronic device 100 and the add-on device 30, the external electronic device may indicate successful pairing with the add-on device 30 or otherwise provide an audible or tactile indication. Thus, once a communication link between the add-on device 30 and the external electronic device 100 is established, the visual illustration 153 and / or the respective notification 154 may be displayed on the display 151 of the external electronic device 100 .

[0167] Thereafter, and as shown in Figure 6, the external electronic device 100, and in particular an infusion device specific app installed on the external electronic device 100, may prompt the user to use the add-on device 30 to read the machine-readable identification 88 provided on one of the medication container 21 and the container portion 7. To this end, the display 151 of the external electronic device 100 may provide a notification 154 and / or a respective illustration 153, which may thus serve to assist or guide the device user in bringing the medication container 21 and / or the container portion 7 comprising such medication container 21 into the vicinity of the transceiver 38 of the add-on device and thus into the transmission range of the transceiver 38 of the add-on device, as shown in Figure 6 or Figure 7.

[0168] By bringing the electronic container identifier 89 into proximity with the transceiver 38 of the add-on device 30, the add-on device 30 can read the stored container information stored in the memory 92 of the electronic container identifier 89. The respective information can then be shown on the display 151 as a notification 154 or graphic 153 indicating at least one of the drug type, expiration date, batch number, or lot number for drug production.

[0169] Further notifications 154' may be provided on the display 151 prompting the user to perform further steps to set up the infusion device or infusion system 120. Here, the user may be prompted to insert a cartridge or medication container 21 into the container portion 7.

[0170] In other cases where the drug container 21 is pre-assembled, for example in the container portion 70, it may be sufficient to bring the container portion provided with the drug container 21 close enough to be able to read the add-on device 30 or within the transmission range of the add-on device 30 in order to enable reading of each of the container information.

[0171] The user may then be prompted by the add-on device 100 to connect the add-on device 30 to the injection device 1. Here, the user may be prompted to connect the add-on device 30 with its receptacle 63 to the dose dial 8 provided at or near the proximal end of the injection device 1. Thus, as shown in FIG. 9 , the electronic body identifier 29 is provided at or near the proximal end 68 of the body 6. Alternatively, the electronic body identifier 29 may be provided on or within the dose dial 8 to minimize the reading or transmission distance between the transceiver 38 of the add-on device 30 and each antenna 91 of the electronic circuit 90 of the electronic body identifier 29. When the add-on device 30 is properly attached to the injection device 1, the electronic body identifier 29 is within the transmission range of the transceiver 38, which functions to read device information from the electronic body identifier 29.

[0172] 10 , the respective container information and device information are compared with each other by at least one of the add-on device 30 and the external electronic device 100 to determine whether the medication container 21 matches the drive mechanism 20 of the infusion device 1 and / or to determine whether the container portion 7 matches the main body 6 or the drive mechanism 20. The comparison of the container information and the device information may be performed or executed by at least one of the module processor 44 and the device processor 144.

[0173] To this end, the electronic module 34 may be operable to read the container information, the device information and / or the usage-related data, and further to transfer and / or transmit the respective information to the external electronic device 100, for example via a wireless local range communication link, which may be established, for example, between the transceiver 39 and the device transceiver 139. In this way, the computing power or digital data processing resources required for the comparison of the acquired data may be provided exclusively by the external electronic device 100, thus simplifying the computing demands of the add-on device 30 and making it possible to reduce the manufacturing costs of the add-on device 30.

[0174] In a further example, the comparison may be provided by a third party provider, for example a healthcare provider database, which receives the respective container information and device information via communication with the external electronic device 100, and the external electronic device 100 receives confirmation or disapproval regarding a match between the infusion device components each comprising an electronic container identifier 89 and the electronic device identifier 29.

[0175] If the container information matches the device information, the external electronic device 100 may be configured to indicate to the user the correct pairing of the main body 6 and container portion 7, as shown in Figure 10. Both the main body 6 and container portion 7 may be individually identified via their respective electronic main body identifier 29 and electronic container identifier 89. The matching of the medication container 21 and / or container portion 7 with the main body 6 may be indicated visually on the display 151 of the external electronic device 100, for example, in the form of an illustration 153 of the recognized or identified components and / or by a respective notification 154 indicating to the user that the individually recognized or identified components of the infusion device 1 match each other.

[0176] If the match is successful, the respective match information may also be stored in memory 92 of the electronic container identifier 89 and / or the electronic body identifier 29. In this way, each component of the infusion device 1 may be electronically marked or electronically linked to one another. Each individual component of the infusion device 1 equipped with a machine-readable identification 28, 88 may be equipped with a usage history written to memory 92 by the add-on device 30 and / or by the external electronic device 100.

[0177] If the injection device 1 is to be disassembled, for example to replace an empty medication container 21, each user-related data, e.g., data recorded, generated, or changed during use of the injection device 1 and stored in the memory 92 of the electronic container identifier 89 and / or electronic body identifier 29, can be read by the add-on device 30 and / or by the external electronic device 100 to determine whether a particular body 6 has been correctly reattached to the same, another, or a different container part 7. In the situation where a container part 7 comprising an electronic container identifier 89 is mixed with another container part during replacement of a medication container, such mixing can be detected electronically by collecting, reading, and comparing the user-related data previously stored in the memory 92 of each electronic container identifier 89.

[0178] The add-on device 30 may further comprise a lock controller 86 operably engageable with the lock mechanism 85 of the drive mechanism 20. If the add-on device 30 and / or the electronic module 34 should detect a mismatched configuration between the body 6 and the container portion 7 or the medicament container 21, the electronic module 34, and thus the module processor 44, may be operable to activate the lock mechanism 85 via the lock controller 86. In other circumstances, the lock mechanism 85 is activated by default, and unlocking the lock mechanism 85 via the lock controller 86 may a) when the add-on device 30 is properly attached to the injection device 1, and / or b) when the add-on device 30 detects the correct and proper pairing of the main body 6 or drive mechanism 20 with the intended medication container 21 and / or container portion 7; may be considered to be offered exclusively.

[0179] In the further illustration of Figure 13, it is shown that the add-on device 30 can be used with a variety of different injection devices 1, 1'. Each injection device 1, 1' is equipped with an electronic body identifier 29, 29'. In the illustration of Figure 13, the add-on device 30 is attached to a first injection device 1. In particular, the add-on device 30 is attached to the dose dial 8 of the first injection device 1. The add-on device 30 can likewise be attached to a different, and therefore second, injection device 1', equipped with a different or identical body 6'.

[0180] The first infusion device 1 is provided with a first electronic body identifier 29. The second infusion device is provided with a second electronic body identifier 29'. Any operation of the infusion device 1 can be suitably monitored and / or quantitatively measured by the add-on device 30, and each operation or procedure can be stored in the memory 92 of each electronic body identifier 29, 29'.

[0181] This allows the add-on device 30 to be detached from the first injection device 1 and assembled or re-attached to the second injection device 1′. Now, when the add-on device 30 is attached to the second injection device 1′, the information contained in the memory 92 of the second electronic body identifier 29 can be read and the dose recording or recording of the dose history can be resumed.

[0182] 17 is a schematic flow chart illustrating a method for monitoring the operation of an infusion device 1. In a first step 200, an add-on device 30 is attached to a portion of the infusion device 1. The add-on device 30 may be attached and / or fixed to the proximal end of the infusion device 1. In a subsequent step 202, device and / or container information is read by wireless communication between the add-on device 30 and the electronic body identifier 29 and / or electronic container identifier 89. Then, in optional step 204, the setting of a dose and / or the injection of a dose of medication is detected or measured by the add-on device's sensor 48. The add-on device 30 may then record the dispensing event in the module memory 40.

[0183] In a further step 206, the add-on device 30 stores or modifies data in the memory 92 of the machine-readable identification portion 28, 88 of the infusion device. Here, usage-related data, such as data indicative of administration history, or other device-related or container-related data, may be stored in either the memory of the electronic body identifier 29 and / or the electronic container identifier 89. Similarly, data previously obtained from the electronic body identifier may be stored in the memory of the electronic container identifier, and vice versa. In this way, individual components of the infusion device, i.e., the body 6 or the drive mechanism 20, may be linked to a particular medication container 21 or container portion 7. [Explanation of symbols]

[0184] 1. Injection Device 2 Distal direction 3 Proximal direction 4. Dose escalation 5 Direction of dose reduction 6 Main unit 7 Container part 8 Dose Dial 9 Triggers 10. Housing 11 Connector 12 Needle Assembly 13 Injection needle 14 Inner needle cap 15 Outer needle cap 16 Protective cap 17 Label 18 Piston 19 Piston rod 20 Drive mechanism 21 Medicine container 22 barrels 23 Seal 24 Drugs 25 Exit 26 Windows 27 Dial extension 28 Identification unit 29 Electronic Device Identifiers 30 Add-on Devices 34 Electronic Module 36 Printed Circuit Board 37 Leader 38 Transceiver 39 Transceiver 40 module memory 42 Clock 44 Module Processor 46 Power supply 48 sensors 50 indicators 51 Display 52 Signal Generator 53 Display Section 54 Display Section 60 Device body 61 Side wall 62 Flange 63 Receptacle 64 Fastening rib 65 Alignment Features 66 Counter Alignment Features 70 Moving parts 67 Distal end 68 Proximal end 69 Extension 80 Dose-Finding Elements 81 Driving member 82 Capacity indicator 83 Encoding 85 Locking mechanism 86 Lock Controller 88 Identification unit 89 Electronic Container Identifier 90 Electronic circuits 91 Antenna 92 memory 93 Integrated Circuits 94 processors 95 PCB 96 Power supply 97 Adhesive layer 100 Electronic Devices 101 Housing 103 Wristband 110 moves 111 Wrist 112 Palm 114 Thumb 116 fingers 120 Injection System 137 Device Reader 138 Device Transceiver 139 Device Transceiver 140 device memory 144 Device Processors 146 Device Power Supply 151 Device Display 152 Device Signal Generator 153 Illustrated 154 Notification

Claims

1. An injection device (1) for injecting a dose of a drug (24), comprising: a housing (10) for containing a drug container (21) containing said drug (24); a drive mechanism (20) for injecting said dose of said medicament (24) from said medicament container (21); a machine-readable identification (28; 88) comprising an electronic circuit (90) having a memory (92) configured to store at least one of device information, container information and usage-related data, said memory (92) being writable by an add-on device (30) configured to be detachably connected to a portion of said injection device (1); An injection device (1) comprising:

2. 2. The injection device (1) of claim 1, wherein the usage-related data indicates a usage status of the injection device (1), the usage status being determinable by the add-on device (30).

3. 3. The injection device (1) of claim 1 or 2, wherein the housing (10) comprises a main body (6) and a container portion (7) detachably connectable to the main body (6), the main body (6) accommodating the drive mechanism (20), the container portion (7) constituting or including the drug container (21), and at least one of the main body (6) and the container portion (7) comprising the machine-readable identification portion (28; 88), the machine-readable identification portion (28; 88) comprising an electronic main body identifier (29) if provided on or within the main body (6) or the drive mechanism (20), and comprising an electronic container identifier (89) if provided on or within the container portion (7).

4. An injection device (1) according to claim 3, wherein the electronic body identifier (29) comprises the device information and the electronic container identifier (89) comprises the container information.

5. An injection device (1) according to claim 3 or 4, wherein at least one of the electronic body identifier (29) and the electronic container identifier (89) comprises the usage-related data.

6. An injection device (1) as claimed in any one of claims 1 to 5, wherein the electronic circuit (90) of the machine-readable identification portion (28; 88) includes an antenna (91) for wireless communication with at least one of a transceiver (38, 39) of the add-on device (30) and a device transceiver (138, 139) of an external electronic device (100).

7. An infusion device (1) according to any one of the preceding claims, wherein the machine-readable identification (28; 88) comprises a passive RFID transponder.

8. An injection device (1) as described in any one of claims 1 to 7, wherein the drive mechanism (20) includes at least one movable component (80, 81, 82, 83), which is subjected to movement relative to the housing (10) or relative to the drug container (21) during at least one of setting the dose and injecting the dose of the drug (24), and at least one of the position and movement of the movable component (80, 81, 82, 83) relative to at least one of the housing (10) and the drug container (21) is measurable by a sensor (48) of the add-on device (30) when attached to the injection device (1).

9. An add-on device (30) for attachment to an injection device (1), the injection device (1) being configured to inject a dose of a medication (24), the injection device (1) comprising: a housing (10) for containing a drug container (21) containing said drug (24); a drive mechanism (20) for injecting said dose of said medicament (24) from said medicament container (21); a machine-readable identification (28, 88) comprising an electronic circuit (90) having a writeable memory (92) configured to store at least one of device information, container information and usage-related data; Including, The add-on device (30) a device body (60) that can be removably fastened to a part of said injection device (1); an electronic module (34) including a module processor (44) and a transceiver (38, 39) operable to read, receive, modify or generate at least one of the device information, the container information and the usage-related data, the electronic module (34) operable to store at least one of the device information, the container information and the usage-related data in the memory (92); An add-on device (30) comprising:

10. The add-on device (30) of claim 9 further comprises a sensor (48) that functions to quantitatively determine at least one of the position and movement of movable components (80, 81, 82, 83) of the drive mechanism (20) relative to at least one of the housing (10), the drug container (21), and the device body (60) when the add-on device (30) is attached to the injection device (1), and the sensor (48) functions to generate a sensor signal indicative of at least one of the position and movement of the movable components (80, 81, 82, 83).

11. The add-on device (30) of claim 9 or 10, wherein the module processor (44) functions to determine 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.

12. The add-on device (30) of claim 11, wherein the module processor (44) is operative to store in the memory (92) as the usage-related data at least one of the size of the injected dose, the number of injected doses, and the time or date of dose injection.

13. The add-on device (30) of any one of claims 9 to 12, wherein the electronic module (34) further comprises a module memory (40) connected to the module processor (44) and operative to store an administration history, the administration history comprising the number of dose sizes sequentially dispensed or injected by the injection device (1) and determined or calculated by the processor (44).

14. The add-on device (30) of any one of claims 9 to 13, wherein the module processor (44) is operative to read usage-related data from the memory (92) of the machine-readable identification (28; 88) and further operative to determine or calculate the remaining amount of the medication (24) contained in the medication container (21) based on the usage-related data.

15. a housing (10) for containing a medicament container (21) containing a medicament (24); a drive mechanism (20) for injecting said dose of said medicament (24) from said medicament container (21); a machine-readable identification part (28; 88) comprising an electronic circuit (90) having a writeable memory (92) adapted to store at least one of device information, container information and usage-related data; an injection device (1) comprising: a device body (60) that can be removably fastened to a part of said injection device (1); an electronic module (34) including a module processor (44) and a transceiver (38, 39) operable to read, receive, modify or generate at least one of the device information, the container information and the usage-related data, the electronic module (34) operable to store at least one of the device information, the container information and the usage-related data in the memory (92); an add-on device (30) including: An injection system (120) comprising:

16. 1. A method for monitoring the operation of an infusion device (1) configured to inject a dose of a medication (24), comprising: - attaching an add-on device (30) to a portion of the injection device (1), the injection device (1) including a machine-readable identification portion (28; 88) including an electronic circuit (90) having a writeable memory (92) configured to store at least one of device information, container information, and usage-related data; - reading, receiving, converting or generating at least one of said device information, said container information and said usage-related data by an electronic module (34) of said add-on device (30); - storing, by said electronic module (34), at least one of said device information, said container information and said usage-related data in said memory (92); A method comprising:

17. 17. The method of claim 16, wherein storing at least one of the device information, the container information, and the usage-related data comprises establishing a wireless communication link between a transceiver (38, 39) of the electronic module (34) and an antenna (91) of the electronic circuit (90) of the machine-readable identification (28; 88).

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