Infusion Devices and Add-On Devices

Abstract

The present disclosure provides an injection device (1) for injecting a dose of a medication (24), comprising: a housing (10) including a body (6) detachably connectable to a container portion (7), the container portion (7) being configured to accommodate a medicament container (21); - a drive mechanism (20) disposed within the body (6) and operable to expel a dose of medicament (24) from the medicament container (21); - a first antenna (74) on or within the first portion of the body (6), the first antenna (74) being configured for wireless signal transmission with an electronic container identifier (89) provided on or within the container portion (7); - a second antenna (76) located on or within the second portion of the body (6), electrically connected to the first antenna (74) and configured for wireless signal transmission with the transceivers (38, 39) of the electronic module (34) of the add-on device (30) connectable to the injection device (1); - an electronic device identifier (29) on or within the body (6) and configured for wireless signal transmission with a transceiver (38, 39); The present invention relates to an injection device (1) comprising:

Description

[Technical Field]

[0001] The present disclosure relates to the field of injection devices, such as handheld pen injectors. The present disclosure further relates to add-on devices for such injection devices, and in particular to 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 for monitoring the operation or use of an injection device. [Background technology]

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

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

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

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

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

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

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

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

[0010] Typically, such add-on or auxiliary devices can be removably connected to the infusion device. The add-on device typically includes a sensor, 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] For example, in a pen injector type reusable injection device, the container portion containing the drug container may be removably connected to the main body of the injection device, the main body including a drive mechanism operably engageable with the drug container to expel or extract a dose of drug from the drug container.

[0012] Some infusion devices of the reusable type may function to set and dispense different medicaments, for example, provided in different container portions and / or different medicament containers, where a particular container portion and / or medicament container should only be used with a dedicated drive mechanism and / or body of the infusion device, and therefore, correct pairing of the medicament container with the appropriate drive mechanism must be ensured.

[0013] Additionally, in manually operated injection devices such as pen injectors, the dispensed dose volume per programmable dose increment is typically fixed and determined by the device behavior of the drive mechanism. Therefore, reusable injection devices are generally dedicated to a single drug to avoid incorrect administration. However, because some drug types, such as insulin, are provided in common unit volume ratios (e.g., U100, U300), a reusable pen may support multiple drugs from the same group in some cases. This increases the risk of potentially dangerous mix-ups, and technical solutions should be provided to enhance mix-up prevention.

[0014] It is therefore desirable to improve patient safety for reusable injection devices, for example of the pen injector type. This improvement would help prevent unintentional mix-up of medication containers and drive mechanisms of such injection devices. Furthermore, it is desirable to facilitate and / or simplify the recording and monitoring of doses set and / or injected by such injection devices. Summary of the Invention [Means for solving the problem]

[0015] In one aspect, an injection device for injecting a dose of a medicament is provided. The injection device includes a housing including a body removably connectable to a container portion configured to receive the medicament container. The injection device further includes a drive mechanism disposed within the body and operable to expel and / or remove the medicament dose from the medicament container.

[0016] The infusion device further includes a first antenna on or within the first portion of the body, the antenna configured for wireless signal transmission with an electronic container identifier provided on or within the container portion. The infusion device further includes a second antenna on or within the second portion of the body, the second antenna electrically connected to the first antenna and further configured for wireless signal transmission with a transceiver of an electronic module of an add-on device connectable to the infusion device.

[0017] The infusion device further includes an electronic device identifier on or within the body and configured for wireless signal transmission with the transceiver electronic module of the add-on device.

[0018] In some examples, the first antenna and the second antenna are separated from one another, for example, along the length of the infusion device. The infusion device may be implemented as a mechanically implemented infusion device, where a user must exert a dispensing force necessary to expel the medication from the medication container. Other than the first antenna, the second antenna, and the electronic device identifier, the infusion device may have no other electrical or electronic components.

[0019] The second antenna is specifically designed and configured to wirelessly communicate with the add-on device when the add-on device is attached or connected to the infusion device. The electrical connection between the first antenna and the second antenna enables and supports signal transmission between the first antenna and the add-on device even in situations where the wireless transmission range of the add-on device is shorter than the distance between the add-on device and the first antenna when the add-on device is properly secured to the infusion device. Here, the electrical connection between the first antenna and the second antenna provides a type of relay or spatial range extender function. The add-on device is configured to communicate with and / or transmit signals to the first antenna via the second antenna and the electrical connection between the first antenna and the second antenna.

[0020] The electronic identifier is similarly configured for wireless signal transmission with the transceiver. The add-on device, and therefore its transceiver, functions to communicate with both the electronic device identifier and the second antenna provided on or within the infusion device. In this manner, the infusion device provides dual communication or signal transmission with an external electronic device. When the add-on device is assembled or connected to the infusion device, the electronic device identifier functions to communicate with the add-on device. Furthermore, the electrical connection between the first antenna and the second antenna also enables separate or additional communication between the electronic container identifier and the add-on device. This signal transmission is provided by the communication link formed or established between the electronic container identifier and the first antenna, the electrical connection between the first antenna and the second antenna, and the wireless signal transmission between the second antenna and the add-on device.

[0021] The electronic identifier, first and second antennas, and their mutual electrical interconnections on or within the body of the infusion device may provide a dual communication link with the add-on device. The add-on device may function to read or obtain information from the electronic device identifier as well as read data or information from the electronic container identifier. In this way, the add-on device is able to read or obtain information from both the container portion and the body of the infusion device, thereby enabling comparison and verification of whether data representing the drug container matches data representing the drive mechanism or body of the infusion device.

[0022] In this way, a significantly simplified reading or data collection mechanism can be provided for providing relevant information to the add-on device when the add-on device is attached to the proximal end of, for example, an infusion device and the electronic container identifier is outside the transmission range of the add-on device.

[0023] Thus, reading of the electronic container identifier is enabled by an electrical connection between the first and second antennas of the infusion device, while the add-on device functions to wirelessly read or wirelessly obtain information or data from the electronic device identifier.

[0024] In this way, all electronically readable information provided in or on the injection device, i.e., information or data provided by the electronic container identifier and information or data provided by or within the electronic device identifier, can be provided wirelessly to the add-on device while the add-on device is attached to a dedicated part of the injection device, for example attached to or near the proximal end of the injection device.

[0025] According to a further example, the injection device includes an electrical transmission line interconnecting the first antenna and the second antenna, the transmission line configured to transmit electrical signals between the first antenna and the second antenna, thereby providing indirect signal transmission between the electronic module of the transceiver of the add-on device and the first antenna even when the first antenna is outside the transmission range of the transceiver of the add-on device.

[0026] According to a further example, the transmission line also provides power between the first antenna and the second antenna. The transmission line may be provided as a power line that functions to transfer and / or provide electrical energy or power from the second antenna to the first antenna. The second antenna may be inductively coupled to a transceiver of the add-on device when the add-on device is attached and / or connected to the infusion device. In this manner, power induced in the second antenna by the add-on device may be transferred to the first antenna via the transmission line and used to wirelessly obtain or wirelessly read respective information or data from electronic container identifiers within the transmission range of the first antenna.

[0027] In this manner, at least one or both of the identifiers, i.e., the electronic container identifier and the electrical device identifier, may be implemented as a passive radio frequency transmitting device, for example as a passive RFID tag, NFC tag, or UWB tag.

[0028] In some examples, an electrical transmission line connected to a first antenna and connected to a second antenna forms or comprises a bridge antenna, such as an NFC bridge antenna or an RFID bridge antenna. Thus, the bridge antenna includes a first antenna and a second antenna spaced apart from each other and coupled together by an electrical transmission line, e.g., by a conductor.

[0029] Typically, the first antenna is located in proximity to an electronic container identifier, which may be implemented as a passive RFID or passive NFC tag, and the second antenna is located in proximity to a transceiver electronic module of the add-on device when the add-on device is connected to the infusion device, where the transceiver forms or comprises an RFID reader.

[0030] The electromagnetic signal transmitted by the transceiver is received by the second antenna and transmitted via an electrical transmission line to the second antenna, which then communicates with an electronic container identifier located on or within the container portion, and a response from the electronic container identifier can then be retransmitted via the first antenna to the second antenna and further to the transceiver electronic module of the add-on device.

[0031] In this manner, the first antenna and the second antenna interconnected by the transmission line provide a wired range extension for wireless signal transmission between the electronic container identifier and the transceiver of the add-on device.

[0032] In some examples, the first antenna is matched or tuned to the antenna of each of the electronic container identifiers, and thus the second antenna can be matched or tuned to the transceiver electronic module of the add-on device.

[0033] The first antenna and the second antenna may be mutually tuned to a common transmission frequency.

[0034] The electrical transmission line interconnecting the first antenna and the second antenna may be passive. The electrical transmission line may provide a wired connection between the first antenna and the second antenna. The transmission range of the first antenna is extended by the longitudinal extension of the transmission line and the position of the second antenna relative to the first antenna and the position of the first antenna relative to the second antenna.

[0035] In a further example, the electronic device identifier includes an integrated device circuit having a device memory configured to store at least one of device information and usage-related data. Similarly or similarly, the electronic container identifier may also include an integrated circuit having a memory configured to store at least one of container information and usage-related data.

[0036] The usage-related data may indicate a usage status of the infusion device. The usage status may be determinable by an add-on device. The usage status may include information such as the total number of doses set or infused, the total amount of medication infused by the infusion device, the type, name, and / or strength of medication infused by the infusion device, the medication container lot number, and other medication or medication container-related information that may be useful for actual or future use of the infusion device.

[0037] The container information may indicate at least one of the type of medication contained in the medication container, the concentration of the pharmaceutical substance of the medication contained in the container, the date of manufacture of the medication, the expiration date of the medication, or the lot number of the medication or medication container, and / or environmental parameters to which the medication container has been exposed, such as temperature, humidity, or radiation intensity.

[0038] 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.

[0039] According to further examples of the injection device, the integrated device circuit is electrically connected to a second antenna or the integrated device circuit is electrically connected to an identifier antenna of the electronic device identifier for wireless signal transmission between the integrated device circuit and the transceiver. The identifier antenna is configured for wireless signal transmission with the transceiver. In this way, the electronic device identifier comprises a unique and separate identifier antenna or the second antenna of the injection device is connected to the integrated device circuit to enable wireless signal transmission between the add-on device and the integrated device circuit of the electronic device identifier.

[0040] In some instances where the electronic device identifier does not have its own identifier antenna, the add-on device typically includes wireless transmission collision handling functionality to distinguish between signal transmissions related to the electronic container identifier via the first antenna and the second antenna and signal transmissions related to the electronic device identifier via the second antenna.

[0041] The second antenna is electrically connected to the integrated device circuit and provides an antenna for the electronic device identifier, so that the injection device only needs to include a first antenna and a second antenna. Here, the second antenna provides wireless signal transmission between the add-on device and the electronic container identifier via the first antenna. The second antenna further provides signal transmission between the add-on device and the electronic device identifier. This dual transmission function of the second antenna can save construction space for a separate antenna for the electronic device identifier.

[0042] Additionally, the cost and expense of producing an electronic device identifier may be reduced, and the integration or assembly of a second device identifier onto or within an infusion device may be simplified.

[0043] Here, when a second antenna is electrically connected to the integrated device circuitry and / or when the second antenna provides an antenna for the electronic device identifier, the transceiver of the electronic module typically includes or is provided with a collision management function, which may function to implement or control time multiplexing to avoid crosstalk between signals received from the electronic device identifier and the electronic container identifier.

[0044] Further, the transceiver of the electronic module may be operable to communicate with the electronic container identifier via the first antenna and the second antenna over the electronic transmission line at a first time or time interval, and may be operable to communicate with the electronic device identifier at a second time or time interval, wherein the first time and the second time or the first time interval and the second time interval do not overlap.

[0045] In other examples where the integrated device circuitry of the electronic device identifier includes its own identifier antenna, easier separation of signal transmissions related to the electronic container identifier and the electronic device identifier may be provided, where the second antenna may be used exclusively for communication and signal transmission with the electronic container identifier via the first antenna.

[0046] According to a further example, the body of the infusion device includes a distal end connectable to the container portion. The body further includes a proximal end opposite the distal end. The first antenna is located at or near the distal end. The second antenna is located at or near the proximal end of the body. The longitudinal distance between the first and second antennas may be greater than the transmission range of the transceiver of the electronic module of the add-on device. Signal transmission between the second antenna and the transceiver of the add-on device may be based on a near-field communication protocol. The transmission range may be in the range of only a few centimeters. A wired connection between the first and second antennas on or within the body of the infusion device allows any signals wirelessly transmitted between the second antenna and the add-on device to be equally shared and / or transmitted to the first antenna, thus enabling wireless reading of electronic container identifiers within the transmission range of the first antenna.

[0047] According to a further example, the infusion device also includes a container portion. The electronic container identifier is disposed on or within one of the container portion and the medicament container housed by the container portion. The container portion may be implemented as a cartridge holder configured to detachably connect with a portion of the main body. Typically, a proximal end of the container portion is detachably connectable with a distal end of the main body. In some examples, the medicament container includes or constitutes a cartridge filled with a liquid medicament. The medicament container is typically disposed within the container portion. The container portion and the medicament container may be pre-assembled or fixed to each other. The medicament container within the container portion may constitute or form a container assembly of the infusion device.

[0048] The electronic container identifier may be provided at or near the proximal end of the container portion. In some examples, the container identifier is provided on or within the medication container. In some examples, the electronic container identifier is provided on an exterior or interior surface of a sidewall of the container portion. The electronic container identifier may also be provided on an exterior surface of the medication container. The electronic container identifier may be provided on an exterior surface of a tubular barrel of a medication container or cartridge. In a further example, the electronic container identifier may be provided on or within a stopper of the medication container, the stopper being longitudinally displaceable within the barrel of the medication container to expel or remove a dose of medication from the medication container.

[0049] In some instances, the electronic container identifier is provided on or within a label that adheres to one of the container portion of the infusion device and the medication container that is disposed within the container portion.

[0050] According to a further example, the electronic container identifier includes a container antenna and integrated container circuitry coupled to the container antenna, the integrated container circuitry including a container memory configured to store at least one of container information and usage-related data.

[0051] In a further example, the container memory is readable by an electronic module of a transceiver of the add-on device when attached to the infusion device. Reading of the container memory is performed via wireless signal transmission between the first antenna and the container antenna and via wireless signal transmission between the second antenna and the transceiver of the add-on device. Signal transmission between the first antenna and the second antenna is provided by an electrical connection therebetween. Typically, signal transmission between the first antenna and the second antenna is provided by an electrical transmission line interconnecting the first antenna and the second antenna.

[0052] According to further examples, the electronic container identifier and / or the electronic device identifier include a passive RFID, a passive NFC tag, or a passive UWB tag. Implementing a passive RF communication tag in the electronic container identifier helps reduce manufacturing costs and expenses.

[0053] In further examples, the drive mechanism includes at least one movable component that undergoes movement relative to the housing or the medication container during at least one of setting a dose and injecting a dose of medication. In some examples, the movable component is one of a dose dial rotatable relative to the housing for setting a dose, a dial sleeve rotatable relative to the housing during setting a dose or dispensing a dose, and a drive sleeve or drive member that undergoes rotational and / or longitudinal movement relative to the housing during at least one of setting a dose and dispensing a dose. In some examples, the movable component is a clicker or click element that functions to generate an audible sound that can be recorded by a sensor in the add-on device. In a further example, the movable component is a piston rod operably engaged with a piston of the medication container to displace the piston relative to the medication container during dose injection. In a further example, the movable component is a single-dose indicating component, the movement and / or position of which relative to the housing or device body indicates the size of the currently set dose. In a further example, the movable component is a last-dose component, the position of which relative to the housing of the injection device directly indicates the amount of medication remaining in the medication container or cartridge.

[0054] According to another aspect, the present disclosure further relates to an add-on device for attachment to an infusion device. The add-on device includes a device body fastenable to a portion of the infusion device. The add-on device includes an electronic module including a module processor and a transceiver. The electronic module is operative to read data from an electronic container identifier via a first antenna and a second antenna, and the electronic module is further operative to wirelessly read data from the electronic device identifier.

[0055] In some examples, the add-on device is configured for attachment to and interaction with the infusion device as described above, and therefore all features, benefits, and advantages described above with respect to the infusion device apply equally to the add-on device, and vice versa.

[0056] In some examples, when properly attached to the infusion device, the add-on device is operable to obtain data from both the electronic device identifier and the electronic container identifier. In this manner, device information indicative of the infusion device and container information indicative of the medication container may be provided. The add-on device may further be operable to process each of the data or information to determine whether a medication container identified by wireless signal transmission with the electronic container identifier matches a drive mechanism or body of the infusion device, the drive mechanism information or data being obtainable by wirelessly reading the electronic device identifier.

[0057] According to a further example, the transceiver of the electronic module is configured for wireless signal transmission with a second antenna when the device body is attached to the infusion device. The wireless signal transmission with the second antenna may also provide wireless signal transmission between the first antenna and an electronic container identifier within the transmission range of the first antenna. The signal transmission between the first antenna and the second antenna may also include power transmission between the first antenna and the second antenna, e.g., power for reading the electronic container identifier may be provided by a reader implemented, for example, in the form of a transceiver electronic module of the add-on device. Here, both the wireless communication tag of the electronic container identifier and the wireless communication tag of the electronic device identifier may be implemented as passive communication tags.

[0058] According to a further example, the transceiver of the electronic module is configured for wireless signal transmission with an identifier antenna of the electronic device identifier when the device body is fastened to the infusion device, wherein the transceiver may be operative to communicate with at least two different antennas provided on or within the infusion device, and the transceiver of the add-on device may be operative to wirelessly communicate with a second antenna and with a separate identifier antenna of the electronic device identifier.

[0059] Having two separate antennas for wireless signal transmission with the electronic container identifier and the electronic device identifier respectively may be beneficial for separate signal transmission, and there may be no crosstalk due to different antenna transmission characteristics.

[0060] According to a further example of an add-on device, the electronic module functions to separate and / or distinguish between signals received from the electronic container identifier and the electronic device identifier. To this end, the electronic module may include a wireless transmission collision handling function, which may provide for distinguishing between signals obtained from the electronic container identifier and signals obtained from the electronic device identifier. In this way, the electronic module may distinguish between signals provided by and received from the electronic container identifier and signals provided by and received from the electronic device identifier.

[0061] According to a further example, the electronic module is operable to induce and transmit power to the first antenna via the second antenna and a transmission line electrically connecting the first and second antennas. The power is effective to induce signal transmission between the first antenna and the electronic container identifier when the electronic container identifier is within the transmission range of the first antenna. In this manner, the electronic container identifier can be implemented as a passive radio frequency communication tag, thus simplifying the structure of the electronic container identifier and / or reducing the respective manufacturing costs.

[0062] In 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 medication container, and the device body. The sensors operative to generate respective sensor signals. The module processor of the electronic module of the add-on device is further operative to determine or calculate the size of the medication dose currently being set or dispensed by the infusion device. The dose size determination or calculation is performed based on the sensor signals and on data received from one of the electronic container identifier and the electronic device identifier.

[0063] 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.

[0064] 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.

[0065] According to a further example, the electronic module of the add-on device is operative to read at least one of device information and usage-related data from the electronic device identifier. The electronic module is further operative to read at least one of container information and usage-related data from the electronic container identifier. In this way, the electronic module may obtain both device-related information indicative of characteristics of the drive mechanism and container-related information indicative of characteristics of the medication container in which the medication is contained.

[0066] The electronic module may further be operable to process each of the device information and the container information, and may be operable, inter alia, to compare the device information with the container information to determine whether the device information matches the container information and / or to determine that the container portion and / or medicament container, and thus the medicament contained therein, matches the body and / or drive mechanism of the infusion device.

[0067] According to a further example, the electronic module is operable to compare the device information and the container information, and further operable to determine whether the device information matches the container information.

[0068] According to a further example, the electronic module is operative to activate a locking mechanism of the drive mechanism if the container information does not match the device information, wherein the locking mechanism is operative to block at least one of setting and dispensing of the dose. To this end, the electronic module may include a lock controller operably engageable with the locking mechanism of the drive mechanism of the injection device when the add-on device is correctly assembled to the injection device.

[0069] In some examples, the electronic module may function to keep the locking mechanism of the drive mechanism locked by default until a matching combination of container information and device information is obtained by the electronic module of the add-on device.

[0070] Here, the locking mechanism of the drive mechanism may also be in a locked configuration by default. The locking mechanism of the drive mechanism may be exclusively unlocked or unlockable only by the lock controller of the add-on device. Thus, unlocking the locking mechanism of the drive mechanism of the injection device may require correct assembly of the add-on device to the injection device and obtaining and reading matching data regarding the device information provided by the electronic device identifier and the container information provided by the electronic container identifier. Both information or data, i.e., device information and container information, can be obtained by a single transceiver of the add-on device when the add-on device is attached, for example, to the proximal end of the injection device.

[0071] In a further aspect, the present disclosure also relates to an infusion system including the infusion device described above and further including the add-on device described above. The infusion system may optionally include at least one or several external electronic devices, such as a smartphone, a smartwatch, and a tablet computer, or any other electronic device capable of communicating with the add-on device.

[0072] Furthermore, according to another aspect, the present disclosure also relates to a method for monitoring the operation of an infusion device, the method comprising the steps of attaching the add-on device to the infusion device. Typically, the add-on device is connected to the infusion device. In a subsequent step, device information is obtained or read from the electronic body identifier by an electronic module of the add-on device. In a further step, container information is read or obtained from the electronic container identifier by the electronic module of the add-on device via a first antenna and a second antenna of the infusion device.

[0073] Then, in a further step, the device information and the container information obtained by reading the electronic body identifier and reading the electronic container identifier are evaluated, and the respective information can be compared with each other and / or with predefined data stored, for example, in a module memory of an electronic module of the add-on device.

[0074] By comparing or evaluating the device information and the container information, it can be checked whether the drug container identified or characterized by the electronic container identifier matches the body or drive mechanism of the infusion device identified or characterized by the electronic device identifier.

[0075] Acquisition of device and container information may not require user interaction. In some examples, when an add-on device is attached to a dedicated portion of an infusion device, the add-on device may be configured to autonomously perform the respective reading procedures to wirelessly acquire device and container information.

[0076] The add-on device may not be limited to detecting a match between the type of medication container and the body or drive mechanism of the injection device. Reading and measuring device and container information may also provide effective drug counterfeit prevention. It may be checked whether the medication provided in the medication container has expired. Furthermore, it may be checked whether and for how long the medication container has been stored and / or transported within a predetermined temperature range.

[0077] Each device information and / or container information can be stored and updated in memory of the integrated circuit of the electronic container identifier and / or the electronic device identifier.

[0078] Thus, generally, the electronic module and / or module processor may function to process any of the device information, use-related data, and container information to check whether each piece of information matches each other and represents the acceptable and intended use or configuration of the infusion device.

[0079] 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.

[0080] The computer program and its respective computer readable instructions function, among other things, to read device information from the electronic body identifier, read container information from the electronic container identifier, and evaluate the device information and container information, e.g., perform a comparison or assertion as to whether the device information matches the container information.

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

[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. 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.

[0102] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or ultra-low molecular weight heparin, or derivatives thereof, or sulfated forms of the above polysaccharides, such as polysulfated forms, and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20 (Synvisc®), sodium hyaluronate.

[0103] 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).

[0104] 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.

[0105] 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. Examples of antibodies are anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab). Pharmaceutically acceptable salts of any of the APIs described herein are also contemplated for use with the drug or medicament in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0106] 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.

[0107] 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.

[0108] 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).

[0109] 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).

[0110] 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]

[0111] [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 shows an example of an add-on device before assembly to an injection device. [Figure 6] 6 shows the add-on device of FIG. 5 when attached to an injection device. [Figure 7] 1 shows a block diagram of an example of an infusion device and an add-on device. [Figure 8] 8 shows the example of FIG. 7 when the add-on device is attached to the infusion device. [Figure 9] 1 shows another example of an injection device. [Figure 10] 9 shows a cross-section through the injection device of FIG. 7 or FIG. 8. [Figure 11] 10 shows a cross section through the injection device according to FIG. 9. [Figure 12] 1 shows a block diagram of the electronic circuitry of the machine-readable identification unit. [Figure 13] FIG. 1 shows a block diagram of an example of an infusion device with an add-on device attached. [Figure 14] 10 shows a block diagram of another example of an infusion device with an add-on device attached. [Figure 15] 1 shows block diagrams of an add-on device, an injection device, and an external electronic device. [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

[0112] 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.

[0113] 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.

[0114] 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.

[0115] 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.

[0116] 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.

[0117] 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.

[0118] 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 .

[0119] 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. 15. 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.

[0120] 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.

[0121] 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.

[0122] 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.

[0123] 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.

[0124] 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.

[0125] 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.

[0126] The add-on device 30 shown in various Figures 2-15 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.

[0127] 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.

[0128] 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.

[0129] 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.

[0130] 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 .

[0131] 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.

[0132] The add-on device 30, shown schematically in Figure 15, 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.

[0133] 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.

[0134] 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.

[0135] 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.

[0136] 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.

[0137] Further optional external electronic devices 100' are implemented as smart watches, each including a housing and a display 151', and further including a wristband 103 for securing the external electronic device 100' to a user's hand 110 or wrist 111. Similar to the external electronic device 100, the external electronic device 100' also functions to provide at least one of an illustration 153 and a notification 154 to the user. Generally, the external electronic devices 100, 100' may each include a separate device signal generator 152, such as a speaker or vibration module, capable of generating a user-perceivable signal to provide a warning signal to the user of the device.

[0138] 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.

[0139] The electronic module 34 of the add-on device 30, shown schematically in Figure 15, 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'.

[0140] 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.

[0141] 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.

[0142] 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.

[0143] 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.

[0144] 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.

[0145] 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.

[0146] The infusion device 1 comprises a machine-readable identification portion 28, 88, as shown schematically in Figure 15. 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 or Figure 16.

[0147] 12 and 16, 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. Of course, 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.

[0148] 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 16.

[0149] 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.

[0150] 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.

[0151] 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.

[0152] 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′.

[0153] 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.

[0154] In some examples, the distal end 67 of the body 6 is detachably connectable to the proximal end of the container portion 7. The injection device 1 is then implemented as a reusable device, allowing for replacement of the container portion 7 and / or replacement of the drug container 21 within the container portion 7. In a reusable injection device 1, it may be particularly advantageous if both the body 6 and the container portion 7 are provided with separate machine-readable identification portions 28, 88. As shown in Figure 15, the container portion 7 is provided with the machine-readable identification portion 88, whereas the body 6 is provided with the machine-readable identification portion 28.

[0155] In some examples, the transceiver 38 may be located within the receptacle 63 of the device body 60 to minimize the spatial distance to the machine-readable identification 28 provided at or near the proximal end 68 of the body 6. The use of near-field communication technology for the machine-readable notification 28, 88 and the respective transceiver 38, 138 may ensure that the machine-readable identification and the device and / or container information stored thereon can only be obtained or retrieved when the add-on device 30 and / or external electronic device 100, 100′ are within near-field transmission range.

[0156] 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.

[0157] When the alignment feature 65 is mechanically engaged with the counter-alignment feature 66, as shown in Figure 5, 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.

[0158] 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′.

[0159] 7-14 show a number of examples of injection devices 1 equipped with a first antenna 74 and a second antenna 76. The first antenna 74 is electrically connected to the second antenna 76. The first antenna 74 and the second antenna 76 are longitudinally separated. The first antenna 74 is located at or near the distal end 67 of the body 6. The second antenna 76 is located at or near the proximal end 68 of the body 6 or the drive mechanism 20.

[0160] In some examples, the second antenna 76 may be provided on or within the trigger 9 or dose dial 8 of the drive mechanism 20. The first antenna 74 and the second antenna 76 are connected by an electrical transmission line 75. If the second antenna 76 is to be movable relative to the first antenna 74, the transmission line 75 may include at least one or several sliding contacts for maintaining an electrical connection between the first antenna 74 and the second antenna 76. In some examples, the first antenna 74 interconnected to the second antenna 76 via the transmission line 75 may form a bridge circuit 172 that effectively provides a kind of range extender for the wireless transmission of the second antenna 76.

[0161] The first antenna 74 functions to wirelessly communicate with an electronic container identifier 89, and thus a machine-readable identification 88, provided on one of the container portion 7 and the medication container 21. The electronic container identifier 89 may be provided at or near the proximal end of the container portion 7 or at or near the proximal end of the medication container 21. When the container portion 7 is properly attached and connected to the body 6, the electronic container identifier 89 may radially overlap the first antenna 74. The electronic container identifier 89 and the first antenna 74 may be concentrically arranged.

[0162] The second antenna 76 is configured to wirelessly communicate with at least one of the transceivers 38, 39 of the electronic module 34 of the add-on device 30. Signal transmission between the transceivers 38, 39 and the second antenna 76 may be possible when the add-on device 30 is attached to the proximal end 68 of the body 6 or to the infusion device 1, as shown in FIG. 8 . Thus, the distance between the device transceiver 38 and the second antenna 76 may be less than the transmission range of the device transceiver 38.

[0163] In some examples, the device transceiver 38 is implemented as a near-field communication interface that functions to wirelessly communicate with a complementary near-field communication antenna 76 .

[0164] When assembled or attached to the injection device 1, the distance between the first antenna 74 and the transceiver 38 may be greater than the transmission range of the transceiver 38. Here, to transmit signals between the first antenna 74 and the transceiver 38, the first antenna 74 is connected to the second antenna 76 via a transmission line 74 extending between the first antenna 74 and the second antenna 76.

[0165] 7 and 8, the infusion device 1 further comprises an electronic device identifier 28. The electronic device identifier 28 includes an electronic circuit 90 having an antenna 91 and an integrated circuit 93. Here, the antenna 91 is or represents the identifier antenna of the electronic device identifier 29. The transceiver 38 may be operable to communicate with both the second antenna 76 and the machine-readable identification portion 28 of the infusion device 1, and thus the antenna 91 of the electronic device identifier 29.

[0166] The electronic module 34 is operative to read or retrieve container information provided by the memory 92′ of the electronic container identifier 89. Similarly, the electronic module 34 is operative to read and / or retrieve device-related information from the memory 92 of the electronic device identifier 29. The electronic module 34 is operative to evaluate the device information and the container information and compare the respective information to check or determine whether the medication container 21 or container portion 7 matches the drive mechanism 20 and / or body 6.

[0167] If an incorrect match is detected by comparing the device information obtained from the electronic device identifier 29 with the container information obtained from the electronic container identifier 89, the electronic module 34 functions to activate at least one of an alarm and a locking mechanism 85 of the drive mechanism 20.

[0168] 7 and 8, the second antenna 76 is exclusively connected to the first antenna 74 via the transmission line 75. The second antenna 76 is therefore exclusively used to read the electronic container identifier 89 when the add-on device 1 is attached to the proximal end of the injection device 1 and when the container portion 7 is attached to the distal end of the main body 6.

[0169] The transmission line 75 and / or antennas 74, 76 further function to transmit power from the transceiver 38 to the first antenna 74, which power is sufficient and functions to induce a wireless response from the electronic container identifier 89. Here, the electronic container identifier may be implemented as a passive wireless communication tag. In this way, the electronic device identifier 89 does not require its own power source.

[0170] An example of wireless electronic communication between the external electronic device 30 and the electronic device identifier 29 and electronic receptacle identifier 89 is further illustrated in FIG. 13 . Both the electronic device identifier 29 and the electronic receptacle identifier 89 include electronic circuitry 90. The electronic circuitry 90 of the electronic receptacle identifier 89 includes an integrated circuit 93′ and an antenna 91′. The integrated circuit 93′ includes a memory 92′ and a processor 94′. Similarly, the electronic device identifier 29 includes an electronic circuit 90 having an antenna 91 and an integrated circuit 93. The integrated circuit 93 itself and / or its hardware implementation may be similar in structure or hardware implementation to the respective integrated circuit 93′, or vice versa. Accordingly, the integrated circuit 93 also includes a processor 94 and a memory 92, as described in more detail with respect to FIG. 12 along with the example electronic device identifier 29.

[0171] The first antenna 74 is connected to the second antenna 76 via a transmission line 75. The antenna 91′ of the container identifier 89 is within the transmission range of the first antenna 74. The antenna 91′ of the container identifier 89 may be outside the transmission range of the second antenna 76. The antenna 91′ of the container identifier 89 may also be outside the transmission range of the antenna 91″ of the transceiver 38 of the add-on device 30 when the add-on device 30 is attached to the infusion device 1.

[0172] The antenna 91 of the electronic device identifier 29 is within the transmission range of the second antenna 76. The antenna 91 of the electronic device identifier 29 may be outside the wireless transmission range of the antenna 91' of the electronic container identifier 89. The antenna 91 may function to wirelessly communicate directly with the antenna 91'' of the transceiver 38 of the add-on device 30. In some examples, the antenna 91 may function to wirelessly communicate with the second antenna 76. Here, the transceiver 38 includes a wireless signal collision prevention mechanism to distinguish between signals received from the antenna 91' and signals received from the antenna 91. Thus, the transceiver 38 and / or the module processor 44 function to provide demultiplexing of wireless data transmissions by the antennas 91, 91'. In other examples, the antennas 91, 91' may operate with different communication protocols that inherently provide signal isolation from each other.

[0173] 14, which is also reflected in the example of FIG. 9, the second antenna 76 may be incorporated into the electronic circuitry 90 of the electronic device identifier 29. Here, the electronic device identifier 29 may not have its own antenna, but functions to exclusively use the second antenna 76 to communicate with the transceiver 38. Here, the transceiver 38 also has anti-collision and / or respective multiplexing mechanisms to distinguish between signals obtained from the electronic container identifier 89 and signals obtained from the electronic device identifier 29.

[0174] The transceiver 38 of the electronic module 34 of the add-on device 30 may be implemented as an RFID reader, an NFC reader, and / or a UWB reader. The transceiver 38 includes an antenna 91'', an integrated circuit 93'', and optionally also a known power source 96''. Generally, the integrated circuit 93'' may include the module processor 44, and the power source 96'' may be provided by the power source 46 of the electronic module 34.

[0175] In some examples, the injection device 1 comprises a dose detection arrangement 84. The dose detection arrangement 84 may include movable components 80, 81, 82, 83 whose position or movement relative to at least one of the housing 10, the medication container 21 and / or the device body 60 can be detected and / or quantitatively measured, for example, by a sensor 48 of the electronic module 34 of the add-on device 30.

[0176] 10 illustrates a concentric arrangement between the antenna 91 of the electronic device identifier 29 and the second antenna 76 at or near the proximal end of the body 6, where the second antenna 76 is connected or connectable to the first antenna 74 via a longitudinally extending transmission line 75. The concentric arrangement of the antennas 91, 76 is particularly beneficial for effective signal transmission.

[0177] 11 provides a schematic cross-sectional view through the device configuration according to FIGS. 9 and 14. Here, a second antenna 76 is connected to the first antenna 74 by a transmission line 75, which is further connected directly to an integrated circuit 93 of the electronic device identifier 29. It should be noted that the view of FIG. 11 is merely schematic in nature. The integrated circuit 93 may be located inside the periphery of the antenna 76, which may be implemented as a loop antenna 76. Thus, the integrated circuit 93 may be located coaxially inside the surrounding antenna 76.

[0178] 9, the body 6 of the injection device 1 comprises a longitudinal body extension 6′ projecting distally from the distal end 67 of the tubular portion of the body 6. The longitudinal body extension 6′ comprises a first antenna 74 connected to a second antenna 76 via a transmission line 75. Locating the first antenna 74 distally from the tubular portion of the body 6 may provide the advantage of reducing the geometric distance between the first antenna 74 and the electronic container identifier 89.

[0179] Here, the electronic container identifier 89 may be provided on a sidewall of the container portion 7 and / or on a sidewall of the barrel 22 of the medication container 21. The electronic container identifier 89 may be provided by or on a label 17, for example, adhered to the inner or outer surface of the container portion 7 or adhered to the outer surface of the barrel 22. Locating the electronic container identifier 89 on the sidewall of at least one of the medication container 21 and the container portion 7 allows for the use of a relatively large antenna 91′, for example in the form of a rectangular label antenna, improving and facilitating readout of each of the electronic container identifiers 89.

[0180] 17 shows a flowchart of a method for monitoring the operation of an infusion device 1, where in a first step 200 an add-on device 30 is attached to the infusion device 1. Then, in a second step 202, container information provided by an electronic container identifier is read or obtained by the electronic module 34 of the add-on device 30.

[0181] Reading of the container information is provided via wireless signal transmission between the transceiver 38 and a second antenna 77 connected to a first antenna 74 via a transmission line 75 of the infusion device 1. The first antenna 74 wirelessly communicates with an electronic container identifier 89 provided on or within one of the medication container 21 and container portion 7 of the infusion device 1.

[0182] In a further step 204, device information from the electronic body identifier 29 is obtained or read by the electronic module 34. Also here, the transceiver 38 serves to read the respective device information from the memory 92 of the electronic body identifier 29.

[0183] After obtaining the device information from the electronic body identifier 29 and the container information from the electronic container identifier 89, the respective device information and container information is evaluated in step 206. Here, information or data relating to the drug container 21 or drug 24 may be compared with the respective information relating to the body 6 and / or drive mechanism 20.

[0184] As a result of comparing or evaluating the device information and the container information, the electronic module 34 may approve or disapprove use of the infusion device 1, for example, by unlocking the locking mechanism 85 via the lock controller 86. In a further example, in response to evaluating the device information and the container information, the electronic module 34 may function to generate an alert or any other indication to the user, thus informing the user about the status of the infusion device 1 and / or the add-on device 30. Furthermore, data obtained from either the electronic container identifier 89 and the electronic device identifier 28 may be synchronized with the external electronic device 100, 100' to provide the respective information to the user. [Explanation of symbols]

[0185] 1. Injection Device 2 Distal direction 3 Proximal direction 4. Dose escalation 5 Direction of dose reduction 6 Main unit 6' body extension 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 Integrated Circuits 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 67 Distal end 68 Proximal end 69 Extension 70 Moving parts 72 Bridge Circuit 74 Antenna 75 Transmission Line 76 Antenna 80 Dose-Finding Elements 81 Driving member 82 Capacity indicator 83 Encoding 84 Dose detection configuration 85 Locking mechanism 88 Identification unit 89 Electronic Container Identifier 90 Electronic circuits 91 Identifier 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) comprising a body (6) detachably connectable to a container part (7), said container part (7) being adapted to accommodate a medicament container (21); a drive mechanism (20) arranged in said body (6) and operative to expel said dose of said medicament (24) from said medicament container (21); a first antenna (74) on or in a first portion of said body (6), said first antenna (74) being configured for radio signal transmission with an electronic container identifier (89) provided on or in said container portion (7); a second antenna (76) on or in a second part of said body (6), electrically connected to said first antenna (74) and configured for wireless signal transmission with a transceiver (38, 39) of an electronic module (34) of an add-on device (30) connectable to said injection device (1); an electronic device identifier (29) on or in said body (6) and configured for wireless signal transmission with said transceivers (38, 39); An injection device (1) comprising:

2. 2. The injection device (1) of claim 1, wherein the electronic device identifier (29) comprises an integrated device circuit (93) having a device memory (92) configured to store at least one of device information and usage-related data.

3. For wireless signal transmission between the integrated device circuit (93) and the transceiver (38, 39), i) the integrated device circuit (93) is electrically connected to the second antenna (76); or ii) the integrated device circuit (93) is electrically connected to an identifier antenna (91′) of the electronic device identifier (29), the identifier antenna (91) being configured for wireless signal transmission with the transceiver (38, 39); An injection device (1) according to claim 2.

4. An injection device (1) according to any one of claims 1 to 3, wherein the main body (6) includes a distal end (67) connectable to the container portion (7), the main body (6) includes a proximal end (68) opposite the distal end (67), the first antenna (74) being positioned at or near the distal end (67), and the second antenna being positioned at or near the proximal end (68).

5. An injection device (1) as described in any one of claims 1 to 4, further comprising a container portion (7), the electronic container identifier (89) being located on or within one of the container portions (7), and the drug container (21) being contained by the container portion (7).

6. The injection device (1) of claim 5, wherein the electronic container identifier (89) includes a container antenna (91') and an integrated container circuit (93') connected to the container antenna (91'), the integrated container circuit (93') including a container memory (92') configured to store at least one of container information and usage-related data.

7. 7. The injection device (1) of claim 6, wherein when attached to the injection device (1), the container memory (92) is readable by the transceiver (38, 39) of the electronic module (34) of the add-on device (30) via wireless signal transmission between the first antenna (74) and the container antenna (91′) and via wireless signal transmission between the second antenna (76) and the transceiver (38, 39).

8. An injection device (1) according to any one of the preceding claims, wherein at least one of the electronic container identifier (89) and the electronic device identifier (29) comprises a passive RFID tag.

9. An add-on device (30) for attachment to an injection device (1) according to any one of claims 1 to 8, comprising: a device body (60) that can be fastened to a part of said injection device (1); an electronic module (34) including a module processor (44) and a transceiver (38, 39), said electronic module (34) comprising: - reading data from said electronic container identifier (89) via said first antenna (74) and said second antenna (76); - wirelessly reading data from said electronic device identifier (29) an electronic module (34) that functions as An add-on device (30) comprising:

10. The add-on device (30) of claim 9, wherein the transceiver (38, 39) is configured for wireless signal transmission with the second antenna (76) when the device body (60) is fastened to the injection device (1).

11. The add-on device (30) of claim 9 or 10, wherein the transceiver (38, 39) is configured for wireless signal transmission with an identifier antenna (91) of the electronic device identifier (29) when the device body (60) is fastened to the injection device (1).

12. The add-on device (30) of any one of claims 9 to 11, wherein the electronic module (34) functions to separate and / or distinguish between signals received from the electronic container identifier (89) and the electronic device identifier (29).

13. The add-on device (30) of any one of claims 9 to 12, wherein the electronic module (34) is operative to induce and transmit power to the first antenna (74) via the second antenna (76) and a transmission line (75) connecting the first antenna (74) and the second antenna (76), the power being effective to induce signal transmission between the first antenna (74) and the electronic container identifier (89).

14. The add-on device (30) of any one of claims 9 to 13, further comprising sensors (48) operative to quantitatively determine at least one of the position and movement of movable components (80, 81, 82, 83) relative to at least one of the housing (10), the medicament container (21) and the device body (60) and operative to generate respective sensor signals, wherein the module processor (44) operative to determine or calculate the size of the dose of the medicament (24) to be set or dispensed by the injection device (1) based on the sensor signals and based on data received from one of the electronic container identifier (89) and the electronic device identifier (29).

15. An infusion system (120) comprising an infusion device (1) according to any one of claims 1 to 8 and comprising an add-on device (30) according to any one of claims 9 to 14.

Images