Injection device and add-on device

Abstract

The present disclosure relates to an injection device (1) for injecting a dose of a medicament (24), the injection device (1) comprising:-a housing (10) comprising a body (6) removably connectable to a container portion (7), where the container portion (7) is configured to contain a medicament container (21),-a drive mechanism (20), -a drive mechanism (74) arranged in the body (6) and operable to expel the dose of the medicament (24) from the medicament container (21),-a first antenna (74) on or in a first portion of the body (6), the first antenna being configured for wireless signal transmission with an electronic container marker (89) provided on or in the container portion (7), -a second antenna (76) electrically connected to the first antenna (74) on or in a second portion of the body (6) and configured for wireless signal transmission with a transceiver (38, 39) of an electronic module (34) connectable to an additional device (30) of the injection device (1),-an electronic device marker (29) on or inside the body (6), and is configured for wireless signal transmission with the transceiver (38, 39).

Description

Technical Field

[0001] The present disclosure relates to the field of injection devices, such as handheld pen-type injectors. The present disclosure further relates to an attachment device for such an injection device, in particular to an attachment device that can be attached to a pen-type injector. In another aspect, the present disclosure relates to an injection system, the injection system comprising an injection device and an attachment device. In a further aspect, the present disclosure relates to a method for monitoring the operation or use of an injection device. Background Art

[0002] Drug delivery devices for setting and dispensing single or multiple doses of liquid medicaments are well known in the art per se. Typically, such devices have substantially similar uses to ordinary syringes.

[0003] Drug delivery devices such as pen-type injectors must meet many user-specific requirements. For example, in the case of patients suffering from chronic diseases such as diabetes, the patient may be physically weak and may also be visually impaired. Therefore, suitable drug delivery devices specifically intended for home medication need to be robust and should be easy to use. In addition, the manipulation 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 distribution of doses of equal or variable sizes. In addition, the dose setting and dose distribution procedures must be easy to operate and must be clear and unambiguous.

[0004] Patients with certain diseases may require a certain amount of medication to be injected via a pen-type syringe.

[0005] Some drug delivery devices or injection devices are capable of selecting variable-sized doses of medication and injecting a previously set dose. Other injection devices provide fixed dose setting and dispensing. In this case, the amount of medication that should be injected according to a given prescription schedule is always the same and does not change over time or cannot be changed.

[0006] Some injection devices are implemented as reusable injection devices, allowing users to replace medication containers (such as cartridges). Other injection devices are implemented as disposable injection devices. For disposable injection devices, it is intended that the entire injection device be discarded when the contents (i.e., medication) have been used up.

[0007] In order to control and supervise the administration of medication by the user or the patient himself, it is beneficial to assist the user by utilizing an external electronic device, such as a mobile electronic device, for example implemented as a smartphone, tablet computer or smart watch. A software application provided on such an external electronic device can interact with the user and can provide the user with instructions or suggestions on how to correctly use the injection device.

[0008] In order to control and monitor the administration of medicaments by users or patients themselves, it is desirable to provide automatic detection and recording of repeated and regular use of drug delivery devices. A fairly automated recording of doses injected by a user has significant advantages over manual dose recording in terms of safety and convenience.

[0009] There are many attachments configured for use with injection devices that provide electronic detection and monitoring of repeat dose injection procedures.

[0010] Typically, such an attachment or auxiliary device may be detachably connected to the injection device. The attachment typically includes a detector or detector arrangement that is operable to detect the date and / or time when a user sets or injects a dose of a medicament. Some attachments also provide a quantitative measurement of the size of the dose currently set or dispensed. Some attachments are intended to be used with a range of injection devices. This may be particularly useful for disposable injection devices that are intended to be discarded after use or after the medicament therein has run out.

[0011] For a reusable injection device, e.g. of the pen-type injector type, a container portion containing a medicament container may be detachably connected to a body of the injection device, wherein the body comprises a drive mechanism which is operably engageable with the medicament container for expelling or withdrawing a dose of medicament from the medicament container.

[0012] Some reusable injection devices may be operable to set and dispense different medicaments, such as medicaments provided in different container parts and / or different medicament containers. Here, a specific container part and / or medicament container should only be used with a dedicated drive mechanism and / or body of the injection device. Therefore, the correct pairing of the medicament container with the appropriate drive mechanism must be ensured.

[0013] Moreover, for manually actuated injection devices, such as pen-type injectors, the expelled dose volume per unit settable dose increment is usually determined and fixed by the device mechanism of the drive mechanism. Therefore, reusable injection devices are usually dedicated to a single drug to avoid incorrect administration. However, some drug types, such as insulin, are provided in common unit / volume ratios (e.g. U100, U300), so a reusable pen may support multiple drugs from the same group. Since this increases the risk of potentially dangerous mix-ups, a technical solution should be provided to enhance mix-up prevention.

[0014] Therefore, it is desirable to improve patient safety of reusable injection devices, such as pen-type injector type. Such improvements should help prevent accidental mix-ups of medicament containers and drive mechanisms for 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

[0015] In one aspect, an injection device for injecting a dose of a medicament is provided. The injection device comprises a housing comprising a body that can be detachably connected to a container portion. The container portion is configured to accommodate a medicament container. The injection device further comprises a drive mechanism that is arranged in the body and is operable to discharge and / or extract the dose of medicament from the medicament container.

[0016] The injection device further includes a first antenna on or in the first portion of the body. The antenna is configured to wirelessly transmit signals with an electronic container identifier disposed on or in the container portion. The injection device further includes a second antenna on or in the second portion of the body. The second antenna is electrically connected to the first antenna and is further configured to wirelessly transmit signals with a transceiver of an electronic module of an attachment device that can be connected to the injection device.

[0017] The injection device further includes an electronic device identifier on or inside the body and configured for wireless signal transmission with a transceiver of an electronic module of an additional device.

[0018] For some examples, the first antenna and the second antenna are separated from each other, for example, along the longitudinal direction of the injection device. The injection device can be implemented as a mechanically implemented injection device, in which the user must apply the dispensing force required to expel the medicament from the medicament container. In addition to the first antenna, the second antenna and the electronic device identifier, the injection device may not have any additional electrical or electronic components.

[0019] The second antenna is specifically designed and configured to communicate wirelessly with the additional device when the additional device is attached or connected to the injection device. The electrical connection between the first antenna and the second antenna allows and supports signal transmission between the first antenna and the additional device, even when the wireless transmission range of the additional device is shorter than the distance between the additional device and the first antenna when the additional device is properly fixed to the injection device. Here, the electrical connection between the first antenna and the second antenna provides a relay or spatial range extender function. The additional device is operable to communicate with the first antenna via the second antenna and through the electrical connection between the first antenna and the second antenna and / or is configured for signal transmission with the first antenna.

[0020] The electronic identifier is also configured for wireless signal transmission with the transceiver. The additional device and therefore its transceiver are operable to communicate with both the electronic device identifier and the second antenna disposed on or inside the injection device. In this way, the injection device of the present invention provides dual communication or signal transmission with an external electronic device. When the additional device is assembled or connected to the injection device, the electronic device identifier is operable to communicate with the additional device. In addition, and through the electrical connection between the first and second antennas, separate or additional communication between the identified electronic container and the additional device is also possible. This signal transmission is provided by a communication link formed or established between the electronic container identifier and the first antenna, an electrical connection between the first antenna and the second antenna, and by wireless signal transmission between the second antenna and the additional device.

[0021] By means of the electronic identifier on or within the body of the injection device, the first and second antennas and their mutual electrical interconnection, a dual communication link with the additional device may be provided. The additional device may be made operable to read data or information from the electronic container identifier and to read or obtain information from the electronic device identifier. In this way, the additional device will be able to read or obtain information from both the container portion as well as the body of the injection device, thereby allowing a comparison and checking whether the data indicating the medicament container matches the data indicating the drive mechanism or body of the injection device.

[0022] In this way, a substantially simplified reading or data collection mechanism may be provided for providing relevant information to an additional device when the additional device is attached to, for example, the proximal end of an injection device and when the electronic container identifier is outside the transmission range of the additional device.

[0023] Thus, the electrical connection between the first and second antennas of the injection device enables reading of the electronic container identifier.At the same time, the additional device is operable to wirelessly read or wirelessly obtain information or data from the electronic device identifier.

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

[0025] According to another example, the injection device includes an electrical transmission line interconnecting the first antenna and the second antenna. The transmission line is configured to transmit an electrical signal between the first and second antennas. In this way, even when the first antenna is out of the transmission range of the transceiver of the additional device, indirect signal transmission can be provided between the transceiver of the electronic module of the additional device and the first antenna.

[0026] According to another example, the transmission line also provides power between the first and second antennas. The transmission line can be provided as a power line, which is operable to transfer and / or provide electrical energy or power from the second antenna to the first antenna. When the additional device is attached and / or connected to the injection device, the second antenna can be inductively coupled with the transceiver of the additional device. In this way, the power induced into the second antenna by the additional device can be transmitted to the first antenna via the transmission line, and can be used to wirelessly obtain or wirelessly read corresponding information or data from the electronic container identifier within the transmission range of the first antenna.

[0027] Thus, at least one or both identifiers (ie, the electronic container identifier and the electrical device identifier) ​​may be implemented as passive radio frequency transmission devices, for example, as passive RFID tags, NFC tags or UWB tags.

[0028] For some examples, an electrical transmission line connected to the first antenna and to the second antenna forms or constitutes 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, which are spaced apart from each other and connected together by an electrical transmission line (e.g., by an electrical conductor).

[0029] Typically, the first antenna is located near the electronic container identifier, which can be implemented as a passive RFID or passive NFC tag. When the additional device is connected to the injection device, the second antenna is located near the transceiver of the electronic module of the additional device. Here, the transceiver forms or constitutes an RFID reader.

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

[0031] In this way, the first antenna and the second antenna interconnected with each other by the transmission line provide wired range extension for wireless signal transmission between the electronic container identifier and the transceiver of the attached device.

[0032] By way of some examples, the first antenna is matched or tuned to a corresponding antenna of the electronic container identifier. Thus, the second antenna can be matched or tuned to a transceiver of the electronic module of the attached 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 and second antennas may be of passive type. A wired connection may be provided between the first and second antennas. 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 vice versa.

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

[0036] The use-related data may indicate the use status of the injection device. The use status may be determined by an additional device. The use status may include information such as: the total number of doses set or injected, the total amount of medicament injected by the injection device, the type, name and / or concentration of the medicament injected by the injection device, the batch number of the medicament container, and other medicament or medicament container related information that may be used for actual or future use of the injection device.

[0037] The container information may indicate at least one of: the type of medicine contained in the medicine container, the concentration of the pharmaceutical substance of the medicine contained in the container, the manufacturing date of the medicine, the expiration date of the medicine, the batch number of the medicine or the medicine container, and / or the environmental parameters to which the medicine container is exposed, such as temperature, humidity or radiation intensity.

[0038] The device information may include information or data about the type of injection device. The device information may be specific about the type of injection mechanism or drive mechanism of the injection device. Thus, the device information may characterize the dose setting and / or dose dispensing operability of the corresponding injection device. The device identification may further include data or information about a suitable medicament or medicament container specific to the corresponding injection device.

[0039] According to another example of the injection device, and for wireless signal transmission between the integrated device circuit and the transceiver, the integrated device circuit is electrically connected to the second antenna, or the integrated device circuit is electrically connected to the identifier antenna of the electronic device identifier. The identifier antenna is configured for wireless signal transmission with the transceiver. In this way, the electronic device identifier is equipped with its own and separate identifier antenna, or the second antenna of the injection device is connected to the integrated device circuit, so as to enable wireless signal transmission between the additional device and the integrated device circuit of the electronic device identifier.

[0040] For some examples, where the electronic device identifier does not have its own identifier antenna, the attachment device is typically provided with a wireless transmission conflict handling function to distinguish between signal transmissions regarding the electronic container identifier by the first and second antennas and signal transmissions with the electronic device identifier occurring via the second antenna.

[0041] In the case where the second antenna is electrically connected to the integrated device circuit, and where the second antenna provides an antenna for the electronic device identifier, the injection device must only be provided with the first antenna and the second antenna. Here, the second antenna provides wireless signal transmission between the additional device and the electronic container identifier via the first antenna. The second antenna further provides signal transmission between the additional device and the electronic device identifier. With this dual transmission function of the second antenna, the construction space of a separate antenna for the electronic device identifier can be saved.

[0042] Furthermore, the costs and expenses for producing the electronic device identifier may be reduced, and the integration or assembly of the second device identifier on or within the injection device may be simplified.

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

[0044] In addition, the transceiver of the electronic module can be operable to communicate with the electronic container identifier via the first and second antennas across the electronic transmission line at a first time or time interval, and can be further operable to communicate with the electronic device identifier at a second time or time interval, wherein the first and second times or the first and second time intervals do not overlap.

[0045] For other examples, where the integrated device circuit of the electronic device identifier is equipped with its own identifier antenna, easier separation of signal transmissions for the electronic container identifier and the electronic device identifier can be provided. Here, the second antenna can be dedicated to communication and signal transmission with the electronic container identifier via the first antenna.

[0046] According to another example, the body of the injection device includes a distal end that can be connected to the container portion. The body further includes a proximal end opposite to the distal end. The first antenna is arranged at or near the distal end. The second antenna is arranged at or near the proximal end of the body. The longitudinal distance between the first and second antennas can be greater than the transmission range of the transceiver of the electronic module of the additional device. The signal transmission between the second antenna and the transceiver of the additional device can be based on a near-field communication protocol. The transmission range can be within the range of only a few centimeters. By a wired connection between the first and second antennas on or inside the body of the injection device, any signal transmitted wirelessly between the second antenna and the additional device can be equally shared and / or transmitted to the first antenna, thereby enabling wireless reading of electronic container identifiers within the transmission range of the first antenna.

[0047] According to another example, the injection device also includes a container portion. The electronic container identifier is arranged on or in one of the container portion and the medicament container accommodated by the container portion. The container portion can be implemented as a cartridge holder, which is configured to be detachably connected to a part of the body. Typically, the proximal end of the container portion can be detachably connected to the distal end of the body. For some examples, the medicament container includes or constitutes a cartridge filled with a liquid medicament. The medicament container is typically arranged inside the container portion. The container portion and the medicament container can be preassembled and can be fixed to each other. The medicament container inside the container portion can constitute or form a container assembly of the injection device.

[0048] The electronic container identifier can be disposed at or near the proximal end of the container portion. For some examples, the container identifier is disposed on or within the medication container. For some examples, the electronic container identifier is disposed on an outer surface or an inner surface of a side wall of the container portion. It can also be disposed on an outer surface of a medication container. It can be disposed on an outer surface of a tubular barrel of a medication container or cartridge. For other examples, the electronic container identifier can be disposed on or inside a stopper of a medication container, which stopper can be longitudinally displaced within the barrel of the medication container to discharge or extract the dose of medication from the medication container.

[0049] For some examples, the electronic container identifier is disposed on or within a label adhered to one of a container portion of the injection device and a medicament container to be disposed within the container portion.

[0050] According to another example, an electronic container identifier includes a container antenna and an integrated container circuit connected to the container antenna. The integrated container circuit includes a container memory configured to store at least one of container information and usage-related data.

[0051] For another example, when the attachment is attached to the injection device, the container storage can be read by the transceiver of the electronic module of the attachment. The reading of the container storage is provided by wireless signal transmission between the first antenna and the container antenna and by wireless signal transmission between the second antenna and the transceiver of the attachment. The signal transmission between the first antenna and the second antenna is provided by an electrical connection therebetween. Typically, the 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 another example, at least one of the electronic container identifier and the electronic device identifier includes a passive RFID, a passive NFC tag, or a passive UWB action.Implementation of a passive RF communication tag for the electronic container identifier helps reduce manufacturing costs and manufacturing expenses.

[0053] For further examples, the drive mechanism includes at least one movable component that moves relative to the housing or relative to the medicament container during at least one of setting the dose and injecting the dose of the medicament. For some examples, the movable component is one of the following: a dose dial that can be rotated relative to the housing to set the dose; a dial sleeve that rotates relative to the housing during setting the dose or dispensing the dose; a drive sleeve or a drive member that rotates and / or moves longitudinally relative to the housing during at least one of setting the dose and dispensing the dose. For some examples, the movable component is a sounder or a sounding element that is operable to generate an audible sound that can be recorded by a sensor of an attached device. For further examples, the movable component is a piston rod that is operably engaged with a piston of a medicament container to displace the piston relative to the medicament container during injection of the dose. For further examples, the movable component is a single dose indicator member, whose movement and / or position relative to the housing or the device body indicates the size of the currently set dose. For a further example, the movable component is a last dose member, whose position relative to the housing of the injection device directly indicates the remaining amount of medicament left in the medicament container or cartridge.

[0054] According to another aspect, the present disclosure further relates to an attachment device for attachment to an injection device. The attachment device includes a device body that can be fastened to a portion of the injection device. The attachment device includes an electronic module, which includes a module processor and a transceiver. The electronic module is operable to read data from an electronic container identifier through a first antenna and through a second antenna, and the electronic module is further operable to read data from the electronic device identifier wirelessly.

[0055] For some examples, the additional device is configured to be attached to and to interact with the injection device as described above. In this regard, all features, effects and benefits described above in conjunction with the injection device also apply to the additional device; and vice versa.

[0056] For some examples, and when appropriately attached to the injection device, the attachment device is operable to obtain data from both the electronic device identifier and the electronic container identifier. In this way, device information indicative of the injection device and container information indicative of the medicament container can be provided. The attachment device can further be operable to process the corresponding data or information to determine whether the medicament container identified by the wireless signal transmission with the electronic container identifier matches the drive mechanism or body of the injection device, wherein the corresponding information or data of the drive mechanism can be obtained by wirelessly reading the electronic device identifier.

[0057] According to another example, when the device body is fastened to the injection device, the transceiver of the electronic module is configured for wireless signal transmission with the second antenna. The wireless signal transmission with the second antenna can also provide wireless signal transmission between the first antenna and the electronic container identifier, which is within the transmission range of the first antenna. The signal transmission between the first and second antennas can also include power transmission between the first and second antennas, wherein the power for, for example, reading the electronic container identifier can be provided by a reader, which is implemented, for example, in the form of a transceiver of the electronic module of the additional device. Here, both the wireless communication tags of the electronic container identifier and the electronic device identifier can be implemented as passive communication tags.

[0058] According to another example, when the device body is fastened to the injection device, the transceiver of the electronic module is configured to wirelessly transmit signals with the identifier antenna of the electronic device identifier. Here, the transceiver may be operable to communicate with at least two different antennas provided on or inside the injection device. The transceiver of the additional device may be operable to wirelessly communicate with the second antenna and wirelessly communicate 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 transmissions that may be free of any crosstalk due to different antenna transmission characteristics.

[0060] According to another example of an additional device, the electronic module is operable to separate and / or distinguish signals received from the electronic container identifier and the electronic device identifier. To this end, the electronic module can be equipped with a wireless transmission conflict handling function. It can allow for a distinction between signals obtained from the electronic container identifier and signals obtained from the electronic device identifier. In this way, the electronic module can 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 another example, the electronic module is operable to induce power and transmit the power to the first antenna via the second antenna and the transmission line electrically connecting the first antenna and the second antenna. When the electronic container identifier is within the transmission range of the first antenna, the power effectively causes signal transmission between the first antenna and the electronic container identifier. In this way, the electronic container identifier can be implemented as a passive radio frequency communication tag, thereby allowing the structure of the electronic container identifier to be simplified and / or the corresponding manufacturing cost to be reduced.

[0062] For another example, the additional device includes a sensor that is operable to quantitatively determine at least one of the position and movement of the movable component relative to at least one of the housing, the medicament container, and the device body. The sensor is operable to generate a corresponding sensor signal. The module processor of the electronic module of the additional device is further operable to determine or calculate the size of the dose of the medicament currently set or dispensed by the injection device. Determining or calculating the dose size is performed based on the sensor signal and based on data received from one of the electronic container identifier and the electronic device identifier.

[0063] For some examples, the module processor is further operable to determine or calculate the size of the dose based not only on the sensor signal but also based on at least one of the container information and the device information obtained from the machine-readable identification.

[0064] By means of the present attachment and by means of the above-mentioned acquisition of at least one of the device information and the container information, a certain degree of automated calibration of the dose size determination or dose size calculation can be provided. Thus, the attachment itself is capable of deriving and / or processing the medicament container specific information and / or the device specific information, for example during assembly to the injection device. In response to acquiring the container information and / or the device information, the attachment can be configured to perform a calibration routine. In this way, the measurable sensor signal acquired by the sensor of the attachment can be converted or recalculated into the correct dose size information.

[0065] According to another example, the electronic module of the additional device is operable to read at least one of device information and use-related data from an electronic device identifier. The electronic module is further operable to read at least one of container information and use-related data from an electronic container identifier. In this way, the electronic module can obtain both device-related information and container-related information, which is a characteristic of the drive mechanism and a characteristic of a drug container containing a drug therein.

[0066] The electronic module may further be operable to process the respective device information and container information. The electronic module may in particular be operable to compare the device information with the container information in order to reveal whether the device information matches the container information and / or to assert that the container portion and / or the medicament container and thus the medicament contained therein matches the body and / or drive mechanism of the injection device.

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

[0068] According to another example, when the container information does not match the device information, the electronic module is operable to activate a locking mechanism of the drive mechanism. Here, the locking mechanism is operable to prevent at least one of setting a dose and dispensing a dose. To this end, the electronic module may include a locking controller that can be operably engaged with the locking mechanism of the drive mechanism of the injection device when the attachment is properly assembled to the injection device.

[0069] For some examples, the electronics module may be operable to keep the locking mechanism of the drive mechanism locked by default until the electronics module of the attached device obtains a matching combination of container information and device information.

[0070] Here, the locking mechanism of the drive mechanism may also be in a locked configuration by default. It may be unlocked or capable of being unlocked only and exclusively by a locking controller of the attachment. Therefore, unlocking the locking mechanism of the drive mechanism of the injection device may require the attachment to be properly assembled to the injection device, and obtaining and reading matching data about the device information provided by the electronic device identifier and the container information provided by the electronic container identifier. When the attachment is, for example, attached to the proximal end of the injection device, both the information or data (i.e., the device information and the container information) may be obtained by a single transceiver of the attachment.

[0071] For further aspects, the present disclosure also relates to an injection system, which includes the injection device as described above and further includes the additional device as described above. The injection system may optionally include at least one or several external electronic devices, such as a smart phone, a smart watch and a tablet computer or some other electronic device capable of communicating with the additional device.

[0072] In addition and according to another aspect, the present disclosure also relates to a method for monitoring the operation of an injection device. The method includes the step of attaching an additional device as described above to the injection device. Typically, the additional device as described above is connected to the injection device as described above. In a subsequent step, the device information is obtained or read from the electronic body identifier by the electronic module of the additional device. In a further step, the container information is read or obtained from the electronic container identifier by the electronic module of the additional device via the first and second antennas of the injection device.

[0073] Thereafter and in a further step, the device information and the container information obtained by reading the electronic body identifier and by reading the electronic container identifier are evaluated. The corresponding 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 additional device.

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

[0075] Obtaining the device information and the container information may not require any user interaction.By way of some examples, and when the additional device is mounted to a dedicated portion of the injection device, the additional device may be configured to autonomously perform a corresponding reading procedure to wirelessly obtain the device information and the container information.

[0076] The additional device may not be limited to detecting the match between the type of the medication container and the body or drive mechanism of the injection device. Reading and evaluating the device information and the container information may also provide effective prevention of counterfeit drugs. It may be checked whether the medication disposed inside the medication container has not expired. In addition, it may also be checked whether and to what extent the medication container has been stored and / or transported within a predefined temperature range.

[0077] The corresponding device information and / or container information may be stored and updated in a memory of an integrated circuit of at least one or both of the electronic container identifier and the electronic device identifier.

[0078] In this regard and generally, the electronic module and / or module processor may be operable to process any of the device information, usage-related data and container information in order to check whether the respective information matches each other and represents an allowable and intended use or configuration of the injection device.

[0079] According to another aspect, the present disclosure also relates to a computer program, such as a computer program product, comprising computer readable instructions which, when executed by a module processor of an additional device as described above, cause the module processor to perform the steps of the method as described above.

[0080] The computer program and its corresponding computer readable instructions are particularly operable to read device information from an electronic body identifier, read container information from an electronic container identifier, and evaluate the device information and container information, such as comparing or asserting whether the resulting device information matches the container information.

[0081] Typically, the computer program is executable by an attachment as described above. It is further operable to perform a method of monitoring the operation of an injection device using an attachment as described above. In this regard, the computer program and its computer readable instructions are operable to cause a processor of the attachment to perform a method of monitoring or checking an injection device as described above. The computer readable instructions may be executed by a processor of the attachment as described above.

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

[0083] The computer program is to be executed by a processor of the attachment as described above, so as to monitor and / or record the operation of the injection device when the attachment is attached to the injection device. In this regard, all features, effects and benefits as described above in conjunction with the attachment and / or described in conjunction with the method of configuring the attachment, as well as any effects, features and benefits as described above in conjunction with the injection system, also apply to the computer program; and vice versa.

[0084] The present disclosure further discloses and proposes a computer program, which includes computer executable instructions for implementing the method according to the method / device / system disclosed in one or more examples contained herein when the program is executed on a processor, a computer or a computer network. In particular, the computer program can be stored on a computer-readable data carrier. Thus, in particular, one, more than one or even all of the method steps indicated above can 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 with program code means, so that when the program is executed on a computer or a computer network, the method / system disclosed in one or more embodiments contained herein is implemented. Specifically, the program code means can be stored on a computer readable data carrier.

[0086] Furthermore, the present disclosure discloses and proposes a data carrier having a data structure stored thereon, which, after being loaded into a processor, a computer or a computer network, such as loaded into a working memory or a main memory of the processor, the computer or the computer network, can execute a method according to one or more examples disclosed herein.

[0087] The present disclosure further proposes and discloses a computer program product having a program code device stored on a machine-readable carrier, so that when the program is executed on a processor, a computer or a computer network, the method or part thereof according to one or more examples disclosed herein is implemented. As used herein, the computer program product refers to the program as a tradable product. The product can generally exist in any format (such as paper format) or on a computer-readable data carrier. Specifically, the computer program product can be distributed on a data network.

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

[0089] The additional device, in particular the device body thereof, may comprise a receiving portion for mounting on a dose dial and / or a trigger. By implementing or arranging the machine-readable identification in or on the trigger or the dose dial, the geometric distance between the machine-readable identification and a reader or transceiver of the additional device for reading out the machine-readable identification can be reduced to a minimum, thereby allowing the transceiver or reader of the additional device to be implemented as a wireless near-field transceiver operable to read a corresponding near-field communication tag of the machine-readable identification of the device. In this way, the reading out of the machine-readable identification can only occur when the additional device is correctly mounted to the proximal end of the injection device.

[0090] According to another example, the injection system comprises an external electronic device, for example implemented as a smartphone, a smart watch or a tablet computer. The external electronic device may be operable to perform at least one or several steps of the method of monitoring the operation of the injection device.

[0091] Generally, the scope of the present disclosure is defined by the content of the claims. The present disclosure is not limited to specific embodiments or examples, but includes any combination of elements of different embodiments or examples. In this case, the present disclosure covers any combination of claims and any technically feasible combination of features disclosed in combination with different examples or embodiments.

[0092] In this context, the term "distal" or "distal end" refers to the end of the injection device that faces the injection site of a human or animal. The term "proximal" or "proximal end" refers to the opposite end of the injection device that is farthest from the injection site of a human or animal.

[0093] The terms "drug" or "medicament" are used synonymously herein and describe a pharmaceutical preparation comprising one or more active pharmaceutical ingredients or a pharmaceutically acceptable salt or solvate thereof and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient ("API") is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used to treat, cure, prevent, or diagnose disease or to otherwise enhance physical or mental health. A drug or medicament may be used for a limited duration, or periodically for a chronic disorder.

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

[0095] The drug or medicament can be included in a primary package or "drug container" suitable for use with a drug delivery device. The drug container can be, for example, a cartridge, a syringe, a reservoir or other solid or flexible vessel, which is configured to provide a suitable chamber for storing (for example, short-term or long-term storage) one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (for example, 1 day to at least 30 days). In some cases, the chamber can be designed to store the drug for about 1 month to about 2 years. It can be stored at room temperature (for example, about 20 ° C) or refrigerated temperature (for example, about -4 ° C to about 4 ° C). In some cases, the drug container can be or can include a dual-chamber cartridge, which is configured to store two or more components (for example, API and diluent, or two different drugs) of the pharmaceutical preparation to be applied separately, and one is stored in each chamber. In such a case, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components before and / or during distribution to the human body or animal body. For example, the two chambers may be configured so that they are in fluid communication with each other (e.g., via a conduit between the two chambers) and allow the user to mix the two components if desired prior to dispensing. Alternatively or additionally, the two chambers may be configured to allow mixing when dispensing the components into a human or animal body.

[0096] The drugs or medicaments contained in the 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 or complications associated with diabetes (such as diabetic retinopathy), thromboembolic disorders (such as deep vein or pulmonary thromboembolism). Further examples of disorders are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, tumors, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are examples as described in the following manuals: such as Rote Liste 2014 (for example, but not limited to, main group 12 (antidiabetic drugs) or 86 (oncology drugs)) and Merck Index, 15th edition.

[0097] Examples of APIs for treating and / or preventing type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixtures thereof. As used herein, the terms "analogs" and "derivatives" refer to polypeptides having a molecular structure that can be formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deleting and / or exchanging at least one amino acid residue present in a naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residues can be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands." In particular, the term "derivative" refers to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Alternatively, one or more amino acids present in the naturally occurring peptide may have been deleted and / or replaced by other amino acids (including non-encodable amino acids), or amino acids (including non-encodable amino acids) have been added to the naturally occurring peptide.

[0098] Examples of insulin analogs 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 at position B28 is replaced by Asp, Lys, Leu, Val or Ala and in which the Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[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, ); 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; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (degludec insulin, ); B29-N-(N-lithocholyl-γ-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 are e.g. lixisenatide Exendin-4 A 39-amino acid peptide produced by the salivary glands of the Gila monster), liraglutide Semaglutide, tasmoglutide, albiglutide Dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211, CM-3, GLP-1Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924 , NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA- 3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Telportide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-Xten.

[0101] Examples of oligonucleotides are, for example: Mipomersen sodium A cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport syndrome. Examples of DPP4 inhibitors are linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0102] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory activity peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, chorionic gonadotropin, tocopherol), growth hormone (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin.

[0103] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or ultra low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of a polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20 A sodium hyaluronate.

[0104] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen binding portion thereof. Examples of antigen binding portions of immunoglobulin molecules include F (ab) and F (ab') 2 fragments, which retain the ability to bind antigens. The antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized antibody or a humanized antibody, a fully human antibody, a non-human (e.g., mouse) antibody or a single-chain antibody. In some embodiments, the antibody has effector functions and can fix complement. In some embodiments, the ability of the antibody to bind to Fc receptors is reduced or there is no such ability. For example, the antibody can be an isotype or subtype, an antibody fragment or a mutant, which does not support binding to Fc receptors, for example, its Fc receptor binding region has been mutated or deleted. The term "antibody" also includes antigen binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins with cross-binding region orientation (CODV).

[0105] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule, which does not include a full-length antibody polypeptide, but still includes at least a portion of a full-length antibody polypeptide that can bind to an antigen. Antibody fragments may include cleavage portions of full-length antibody polypeptides, but the term is not limited to such cleavage fragments. Antibody fragments that can be used 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 antibodies, trivalent antibodies, tetravalent antibodies and multivalent antibodies), mini antibodies, chelated recombinant antibodies, triabodies or biabodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies and antibodies containing VHH. Other examples of antigen-binding antibody fragments are known in the art.

[0106] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable region 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 region of both heavy and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the correct positioning of the CDR sequences to allow antigen binding. Although the framework region itself is typically not directly involved in antigen binding as known in the art, certain residues within the framework region of certain antibodies may be directly involved in antigen binding or may affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0107] Examples of antibodies are anti-PCSK-9 mAb (eg, alirocumab), anti-IL-6 mAb (eg, salilumab), and anti-IL-4 mAb (eg, dupilumab).

[0108] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0109] Those skilled in the art will appreciate that modifications (additions and / or removals) may be made to the various components, formulations, apparatuses, methods, systems and embodiments of the API described herein without departing from the overall scope and spirit of the invention, and that the invention encompasses such modifications and any and all equivalents thereof.

[0110] An example drug delivery device may involve 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 can be broadly divided into multi-dose container systems and single-dose (partially or completely emptied) container systems. The container may be a replaceable container or an integral non-replaceable container.

[0111] As further described in ISO 11608-1:2014(E), a multiple-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container contains multiple doses, the sizes of which may be fixed or variable (pre-set by the user). Another multiple-dose container system may involve a needle-based injection device with an integral non-replaceable container. In such a system, each container contains multiple doses, the sizes of which may be fixed or variable (pre-set by the user).

[0112] As further described in ISO 11608-1:2014 (E), a single dose container system can relate to an injection device based on a needle with a replaceable container. In an example of such a system, each container holds a single dose, wherein the entire deliverable volume is discharged (completely emptied). In another example, each container holds a single dose, wherein a portion of the deliverable volume is discharged (partially emptied). Also as described in ISO 11608-1:2014 (E), a single dose container system can relate to an injection device based on a needle with an integral non-replaceable container. In an example of such a system, each container holds a single dose, wherein the entire deliverable volume is discharged (completely emptied). In another example, each container holds a single dose, wherein a portion of the deliverable volume is discharged (partially emptied). BRIEF DESCRIPTION OF THE DRAWINGS

[0113] In the following, several examples of data recording devices for monitoring the use of injection devices and corresponding injection devices will be described in more detail with reference to the accompanying drawings, in which:

[0114] Figure 1 An example of an injection device is schematically shown,

[0115] Figure 2 The process of assembling the additional device to the proximal end of the injection device is shown.

[0116] Figure 3 The injection device is shown in a schematic longitudinal cross section,

[0117] Figure 4 shows a configuration of an injection system comprising an injection device, an additional device and at least one external electronic device,

[0118] Figure 5 shows an example of an additional device before assembly to an injection device,

[0119] Figure 6 Shows Figure 5 The additional device is attached to the injection device,

[0120] Figure 7 A block diagram of one example of an injection device and additional devices is shown.

[0121] Figure 8 shows when the additional device is attached to the injection device Figure 7 For example,

[0122] Fig. 9 Another example of an injection device is shown,

[0123] Fig.10 Shown through Figure 7 or Figure 8 The cross section of the injection device,

[0124] Fig.11 Shows the passage according to Fig. 9 Cross section of the injection device.

[0125] Fig.12 A block diagram of an electronic circuit showing a machine readable identification,

[0126] Fig.13 A block diagram showing an example of an injection device to which an additional device is attached,

[0127] Fig.14 A block diagram showing another example of an injection device to which an additional device is attached,

[0128] Fig.15 A block diagram showing an attachment device, an injection device and external electronic devices,

[0129] Fig.16 An example of an electronic circuit on a substrate is shown,

[0130] Fig.17 A flow chart of a method of configuring an attachment is shown. DETAILED DESCRIPTION

[0131] Figure 1An example of a drug delivery device is shown, which is implemented as a handheld injection device 1. The injection device 1 may include or may be implemented as a pen-type injector. It may be implemented as a disposable injection device or a reusable injection device. In some examples, the injection device 1 is implemented as an autoinjector. The injection device 1 has an elongated shape. It may extend along a longitudinal direction. Towards the longitudinal distal direction 2, the drug delivery device 1 comprises a dispensing end for dispensing or injecting a medicament 24. Towards the proximal direction 3, the injection device 1 comprises at least one of a dose member 8 and a trigger 9, by which doses of equal size or individual or different sizes can be set and dispensed, respectively.

[0132] The injection device 1 comprises a housing 10. The housing 10 may comprise a plurality of housing components, such as a body 6 and a container portion 7 (e.g. implemented as a cartridge holder 7). The size and configuration of the body 6 may be configured to accommodate a drive mechanism 20. The size and configuration of the container portion 7 is configured to accommodate a medicament container 21, which is, for example, implemented as a cartridge containing a liquid medicament 24. The medicament container 21 comprises a tubular barrel 22, which is sealed towards the distal end by a seal 23. The seal 23 may comprise a pierceable septum fixed to an outlet 25 of the medicament container 21. The interior of the barrel 22 is sealed towards the proximal end by a piston 18 or a stopper, which is slidably disposed in the barrel 22.

[0133] By advancing the piston 18 toward the distal direction 2, a dose of medicament 24 can be discharged from the medicament container 21. In use, the medicament container 21 is arranged inside the container part 7. The drive mechanism 20 of the injection device 1 includes a piston rod 19, which can be displaced in the distal direction 2 to advance the piston 18 toward the outlet 25 of the medicament container 21. The details of the drive mechanism are not further shown and described here. In some examples, the drive mechanism 20 can be implemented as a full mechanical drive mechanism, wherein the user must provide the entire dispensing force required to move the piston rod 19 and therefore the piston 18 in the distal direction 2. For other examples, the drive mechanism includes a mechanical energy storage device, which is configured to provide at least a portion of the dispensing force. Examples of drive mechanisms can be found in, for example, WO 2004 / 078241A1, WO 2014 / 033197 A1 or WO 2014 / 033195 A1, and the entire contents of these documents are incorporated herein by reference.

[0134] For some examples, such as in Figure 2As described or shown in , the injection device 1 and therefore the drive mechanism 20 may include a dial extension 27 that projects and moves from the proximal end of the body 6 in the proximal direction 3 when or during setting a dose, and returns to its initial distal position during a dose injection procedure. To this end, the user can use the thumb 114 of his hand 110 to exert distally directed pressure on the trigger 9, thereby pushing the dial extension 27 in the distal direction 2 during and / or for a dose injection procedure.

[0135] In order to set or dial a dose, the user may, for example, twist or rotate the dose dial 8 in a dose incrementing direction 4, thus in a clockwise direction when viewed from the proximal end. In order to correct a previously set dose, the user may also rotate the dose dial 8 in an opposite dose decrementing direction 5. The size of the dose is typically displayed in a window 26 provided in or on the body 6 of the injection device 1. Before a dose of medicament 24 is injected, the distal end of the container part 7 or cartridge holder must be connected to the needle assembly 12. To this end, the distal end of the cartridge holder 7 comprises a connector 11, for example in the form of a threaded interface, to engage with a complementary shaped threaded mating interface of the needle assembly 12.

[0136] The needle assembly 12 is detachably or releasably fixed to the container part 7. It includes a double-pointed injection needle 13. The proximal end of the injection needle (not shown) is configured to enter the through opening at the distal end face of the connector 11 or the container part 7 so as to pierce or penetrate the seal 23 of the medicament container 21. The distal end of the injection needle 13 is usually covered by a removable inner needle cap 14. The entire needle assembly 12 can be covered by a removable outer needle cap 15.

[0137] The container part 7 and thus a part of the housing 10 will be received in a protective cap 16 which can be detachably connected to the cartridge holder 7 or the body 6 .

[0138] exist Figure 2 and Figure 4 , an example of an attachment 30 configured to be fastened to the proximal end of the injection device 1 is shown. The attachment 30 includes a sensor 48 or a sensor assembly that is operable to detect, identify, characterize and / or measure the operation of the injection device 1. Typically, the sensor 48 of the attachment 30 and the like are Fig.15 As indicated in the block diagram of , the device 1 is capable of or operable to quantitatively determine or measure at least one of the position and movement of a movable part 80, 81, 82, 83 of the drive mechanism 20 of the injection device 1. The movable part 80, 81, 82, 83 is movable relative to at least one of the body 6 and the medicament container 21 during or for setting and / or injecting a dose of medicament 24.

[0139] This movement or position can be quantitatively measured by the sensor 48. Typically, the sensor 48 is implemented as an electronic sensor. When the attachment 30 is attached to the injection device 1, the sensor is able to detect or measure the extent of the 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. Figure 3 An example of a movable part 80 is schematically shown in a cross section of the injection device 1 of

[0140] The sensor 48 of the attachment device 30 is capable or operable to generate a sensor signal or a sequence of sensor signals which, due to the coupling or connection to the module processor 44, can be processed by the module processor 44 in order to derive or calculate the size of the currently set or dispensed dose.

[0141] For some examples, the movable component 80 is a dose setting member or a dose setting sleeve. For other examples, the movable component 81 is implemented as a drive member or a drive sleeve 81 of the drive mechanism 20. For other examples, the movable component is implemented as a volume indicator 82 (e.g., a single dose indication member), whose position or configuration relative to the body 6 directly indicates the size of the currently set dose. For other examples, the movable component 82, and therefore the volume indicator, is a last dose indication member, whose position or configuration relative to the body 6 indicates the remaining amount of medicine left in the cartridge or medicament container 21.

[0142] For some examples, the movable part 83 is or includes a code (such as a digital code), which is movable relative to the sensor 48 so that the sensor can count the number of discrete code parts of the code to collect corresponding quantitative movement information of the movable part 80. In general, different types of spatial coding, such as optical or visual coding, electrical or electrostatic coding, magnetic coding or mechanical coding, can be provided. Depending on the type of coding provided on or inside the movable part 80, 81, 82, 83, the sensor 48 is configured accordingly. Therefore, the sensor 48 can 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 is operable to quantitatively measure the relative position or relative movement of the movable parts 80, 81, 82, 83.

[0143] For some examples, during at least one of setting a dose and dispensing a dose, the movable part 80, 81, 82, 83 undergoes a longitudinal and / or rotational movement relative to the body 6, relative to the medicament container 21 and / or relative to the device body 60. Typically, a code provided on or together with the movable part 80, 81, 82, 83 is encoded along the direction of movement of the movable part relative to the sensor 48 so as to enable a corresponding quantitative measurement of the corresponding dose setting or dose dispensing movement.

[0144] like Figure 3 As further indicated in the figure, the drive mechanism 20 may optionally be equipped with a locking mechanism 85, which can be operated by a locking control of the attachment 30 when the attachment 30 is properly assembled to the injection device 1. The locking mechanism 85 is operable to block or lock the drive mechanism 20, thereby preventing unauthorized or accidental setting of a dose and / or dispensing or injection of a dose. The locking mechanism 85 can be controlled by a locking control 86 of the attachment 30. The locking mechanism 85 can be electromechanically implemented and can be electrically or electronically controlled by the locking control 86 of the attachment 30. In this way, the attachment 30 can prevent unauthorized or accidental use of the injection device 1.

[0145] like Figures 2 to 15 The additional device 30 shown in the figures in the figures can be detachably connected to the dose dial 8. It comprises a device body 60 having a tubular side wall 61. Towards the distal end, the side wall 61 defines a receiving portion 63, which is dimensioned to receive the dose dial 8 and the trigger 9 of the injection device 1. To this end, the inner side of the side wall 60 may include one or more fastening ribs 64, which are configured to provide a non-slip fastening of the additional device 30 to the dose dial 8.

[0146] The device body 60 comprises a receiving portion 63 at a distal section of the attachment 30. The receiving portion 63 is open towards the distal direction 2. It is sized and configured to be mounted on the proximal end of the injection device 1. The inner surface of the side wall 61 defining the receiving portion 63 comprises a plurality of fastening ribs 64, for example made of an elastic or elastically deformable material, such as an elastomeric material.

[0147] When the device body 60 is assembled onto the dose dial 8 of the injection device 1, the fastening rib 64 provides a friction fit with the dose dial 8. The receiving portion 63 may be defined in the longitudinal direction by a flange portion 62 protruding radially inwardly from the tubular sidewall 61 of the receiving portion 63. The flange portion 62 is located at a position proximally offset from the insertion opening of the receiving portion 63. The flange portion 62 may be annular in shape and may be configured to axially abut on a stepped section at the proximal end of the dose dial 8. Thus, when the attachment 30 is properly fastened to the dose dial 8, the trigger 9 comprising a reduced diameter compared to the dose dial 8 may protrude through the flange portion 62 in the proximal direction 3, while the flange portion 62 may rest or abut against the proximal end face of the dose dial 8.

[0148] The attachment 30 further comprises a movable portion 70 protruding in a proximal direction from the device body 60. The movable portion 70 comprises or forms an auxiliary trigger or a trigger button configured to mechanically engage with the trigger 9 of the injection device 1 when the attachment 30 is correctly assembled to the injection device 1.

[0149] Typically, the attachment 30, in particular the device body 60, frictionally engages 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 can simply rotate the device body 60 relative to the body 6 of the injection device 1. In this way, the dial extension 27 can undergo a dose increment dial or rotational movement. The corresponding size of the currently set dose will then be displayed in the window 26 of the body 6 of the injection device 1, as shown in FIG. Figure 2 shown.

[0150] To dispense a dose, the user has to depress the movable part 70, which can then move in the distal direction relative to the device body 60. The movable part 70, which can be directly or indirectly mechanically engaged with the trigger 9, can then exert a corresponding dispensing force on the trigger 9, thereby initiating a dose dispensing action of the injection device 1.

[0151] like Fig.15 The additional device 30 schematically shown in FIG. 1 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 (thus digital) module memory 40, and a clock 42. In addition, 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 to the power supply 46. The electronic module 34 further includes a reader 37 and at least one of the wireless transceivers 38, 39. The additional device 30 may also include a device identification 50 that is perceptible to a user.

[0152] For some examples, the device identifier 50 includes or comprises a signal generator 52 coupled to the module processor 44 and operable or reconfigurable by the module processor 44. For some examples, the device identifier 50 may indicate the injection device 1 to which the attachment 30 is actually connected or coupled.

[0153] For some examples, the signal generator 52 is operable to generate at least one of a visual signal, an acoustic signal, and a tactile signal or a device identifier, and is therefore operable to produce or generate a visual identifier, an acoustic identifier, or a tactile identifier or a corresponding alarm signal. For some examples, the additional device 30 includes multiple signal generators 52 of the same or different types (e.g., optical, acoustic, or tactile types).

[0154] for Figure 2 As an example, the signal generator 52 may comprise a speaker operable to generate an acoustic signal, wherein the acoustic signal may represent or constitute an alarm signal, for example in the form of an acoustic code or sequence characteristic of a particular configuration or setting of the injection device 1 or the additional device 30.

[0155] Figure 4 An injection system 120 is shown that includes at least an additional device 30 and an injection device 1. Optionally, the injection system 120 includes one or several external electronic devices 100, 101'. The external electronic device 100 is implemented as a smart phone, which includes a housing 101 and is equipped with a device display 151 to visually display various types of information to the user, such as various illustrations 153 or notifications 154. The display 151 can be implemented as a touch-sensitive display. The device display 151 can be operated to provide or simulate a device signal generator 152. The device display 151 is operable to provide at least one of the illustrations 153 and the notifications 154 to the user.

[0156] The further optional external electronic device 100' is implemented as a smart watch, which includes a corresponding housing and a display 151' and further includes a wristband 103 for fixing the external electronic device 100' to the user's hand 110 or wrist 111. Similar to the external electronic device 100, the external electronic device 100' is also operable to provide at least one of a graphic representation 153 and a notification 154 to the user. Generally, the external electronic device 100, 100' can be equipped with a separate device signal generator 152, such as a speaker or a vibration module, through which a user-perceivable signal can be generated to provide an alarm signal to the user of the corresponding device.

[0157] The electronic device 100 is typically implemented as a handheld electronic device. It can be held in the user's hand 110 or can be worn on the user's wrist 111. Figure 4In the example shown, the electronic device 100 is held in the palm 112 of a user. The device display 151 is implemented as a touch-sensitive display and can be operated by the thumb 114 and / or individual fingers 116 of the hand 110 of the user.

[0158] like Fig.15 The electronic module 34 of the additional device 30 schematically shown in the figure includes a reader 37 and at least one of a transceiver 38, 39, which is operable to wirelessly communicate with at least one of the machine-readable identification 28, 88 of the injection device 1 or with a device reader 137 and / or a device transceiver 138, 139 of a complementary or corresponding implementation of the external electronic device 100, 100'.

[0159] For a typical example, transceivers 38, 138 are implemented as near-field type radio frequency transceivers. Transceivers 38, 138 can be implemented as wireless short-range transceivers or near-field transceivers. They can be implemented as so-called NFC transceivers that allow wireless communication within a limited spatial range of a few centimeters or decimeters. Transceivers 38, 138 can be implemented as active and / or passive NFC tags or readers. Typically, transceiver 38 is implemented as a passive NFC tag, and transceiver 138 is implemented as an active NFC tag or NFC reader.

[0160] The transceiver 39, 139 may be implemented as a wireless local range transceiver, such as an RFID, Bluetooth, Bluetooth Low Energy (BLE), or UWB transceiver. Here again, the transceiver 39 may be implemented as a passive communication tag, while the transceiver 139 may be implemented as an active transceiver, and thus implemented as a reader. Typically, the transmission range of the transceiver 39, 139 is greater than the transmission range of the transceiver 38, 138. The transmission range of the transceiver 39, 139 may be in the range of a few meters or tens of meters.

[0161] The optional reader 37 , 137 may be implemented as an optical reader or optical information collecting unit, for example comprising an imaging system, in order to capture or record a visual or optical machine-readable identification 28 , 88 provided on or inside the injection device 1 .

[0162] 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. Moreover, the electronic device 100 includes a device display 151, typically implemented as a touch-sensitive display. The device display 151 can be operated to provide at least one of an illustration 153 and a notification 154 to the user.

[0163] The device transceiver 138 is operable to communicate with the transceiver 38 of the additional device. The transceiver 139 is configured to communicate with the transceiver 39 of the additional device 30. The reader 137 is operable to read a visual identifier provided on the injection device 1. For some examples, the device reader 137 includes an imaging system. It may include a camera objective and a spatially resolved detector to read or capture a visual code, which is provided, for example, on the outer surface of the injection device 1 or on the outer surface of the medication container 21.

[0164] The external device 100 is configured to establish a communication link, such as a wireless communication link with the additional device 30. To this end, the local range transceiver 39 of the additional device 30 can wirelessly communicate with the local range device transceiver 139 of the additional device 100. Once the communication link has been established between the electronic device 100 and the additional device 30, the electronic device 100 can be operated to visually display information or data of the injection device or medication container 21 on the device display 151.

[0165] The injection device 1 is provided with a machine-readable mark 28, 88, such as Fig.15 The machine-readable identification 28 includes an electronic identification object 29. The machine-readable identification 88 includes an electronic identification object 89. The electronic identification object 28 may include a passive wireless communication tag, such as Fig.12 or Fig.16 Schematically shown in .

[0166] like Fig.12 and Fig.16 As shown, the electronic identifier 29 may include an electronic circuit 90 having 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 to the processor 94. The electronic circuit 90 may be disposed on a planar substrate 95. The substrate 95 may be flexible or foldable. It may include a flexible structure or foil that allows the substrate 94 and therefore the entire electronic identifier 29 to be easily mounted, fastened, such as adhesively fastened, to at least one of the tubular body 6, the container portion 7, or the medication container 21.

[0167] The electronic circuit 90 may be a printed electronic circuit printed on a substrate 95. Here, the substrate 95 may include or constitute, for example, a flexible printed circuit board. The substrate 95 may also be provided with an adhesive layer 97 that allows the machine-readable mark 28, 88 to be easily and directly adhesively attached to a predetermined portion on or inside the injection device 1. The electronic identifier 89 may include a Fig.12 and Fig.16The electronic marker 29 shown has the same or similar structure.

[0168] For some examples, the machine-readable identification 28, 88 is implemented in a label 17 located on one of the body 6, the container portion 7, or the medication container 21. The label 17 includes or contains the machine-readable identification 28, 88. For some examples, the label 17 includes a passive radio frequency tag. For other examples, the label 17 includes machine-readable identification 28, 88, which is implemented as a visual or optical code that can be captured by a reader 37 or a device reader 137 that is implemented as an imaging system or includes an imaging system.

[0169] The reader 37 , at least one of the device readers 137 or the transceivers 38 , 39 or at least one of the device transceivers 138 , 139 are operable to read the machine-readable identification 28 , 88 to obtain at least one of the device information and the container information stored in the memory 92 of the electronic circuit 90 , for example.

[0170] Typically, the machine-readable mark 28 is disposed or positioned on or within the body 6 of the housing 10 of the injection device 1. Another machine-readable mark 88 is disposed on or within the container portion 7. It may be disposed on or within the medicament container 21. For some examples, the machine-readable mark 28 may be disposed in or on the piston 18 of the medicament container 21.

[0171] The machine-readable identification 28, 88 can be implemented as a passive RF communication tag, such as an NFC tag. The information stored in at least one of the machine-readable identification 28, 88 (e.g., device information and / or container information) can be read by the electronic module 34, and thus can be read by any one of the transceivers 38, 39 of the additional device 30 and / or by any one of the transceivers 138, 139 of the external electronic device 100, 100'.

[0172] For some examples and in particular when the injection device 1 is implemented as a disposable injection device that does not support replacement of the medicament container 21, it is sufficient for the injection device 1 to include only one machine-readable mark 28. It may be particularly advantageous when the machine-readable mark 28 is disposed at or near the proximal end 68 of the body 6. It may be disposed on or within the dose dial 8 or the trigger 9 so as to be within the transmission range of the transceiver 38, 39 when the attachment 30 is attached to the proximal end of the injection device 1.

[0173] For some examples, the distal end 67 of the body 6 is detachably connected to the proximal end of the container part 7. Then, the injection device 1 is implemented as a reusable device, which allows the container part 7 and / or the medicament container 21 in the container part 7 to be replaced. For a reusable injection device 1, it may be particularly beneficial when both the body 6 and the container part 7 are provided with separate machine-readable markings 28, 88. Fig.15 As shown, the container portion 7 is provided with a machine-readable marking 88 , while the body 6 is provided with a machine-readable marking 28 .

[0174] For some examples, the transceiver 38 can be located inside the receiving portion 63 of the device body 60 so as to minimize the spatial distance from the machine-readable identification 28 disposed at or near the proximal end 68 of the body 6. By using near-field communication technology for the machine-readable notification 28, 88 and the corresponding transceiver 38, 138, it can be ensured that the machine-readable identification and the device information and / or container information stored therein can only be acquired or obtained when the additional device 30 and / or the external electronic device 100, 100' is within the near-field transmission range.

[0175] As in Fig.12 As further shown in FIG. 1 , the receiving portion 63 of the device body comprises an alignment feature 65 in the form of a longitudinal recess or groove on the inner side of the side wall of the receiving portion 63. Correspondingly, the proximal end of the dose dial 8 comprises a mating alignment feature 66 of complementary shape, for example in the form of a protrusion, which is sized to fit into the recess or groove of the alignment feature 65. In this way, when the additional device 30 is attached to the housing 10 or the dose dial 8 of the injection device 1, a rotationally-inhibiting fastening of the additional device can be provided.

[0176] like Figure 5 As shown, when the alignment feature 65 is mechanically engaged with the mating alignment feature 66, an anti-rotation lock for mutually securing the attachment 30 and the injection device 1 is provided. In this way, it can be ensured that the identification 28 and therefore the electronic identification 29 are always correctly aligned with the associated wireless transceiver 38 of the attachment 30. Thus, a unique and well-defined mounting position for mounting the attachment 30 on the injection device 1 is provided. When the mounting position or mounting configuration predefined by the alignment feature 65 engaging the mating alignment feature 66 is reached, it is also ensured that the machine-readable identification 28 and the transceiver 38 are at a minimum distance from each other. This allows a signal transmission between the identification 28 or electronic identification 29 and the transceiver 38 to be carried out to a certain extent without interference.

[0177] Typically, the external electronic device 100 may be permanently or periodically synchronized with the attachment device, such as via a local range communication interface provided by the transceiver 39, 139. In this regard, any information collected or read by the attachment device 30 may be immediately transmitted to the external electronic device 100, 100' and further processed, such as visualized, thereby.

[0178] exist Figures 7 to 14 , many examples of injection devices 1 are shown, which are 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 separated in the longitudinal direction. The first antenna 74 is arranged at or near the distal end 67 of the body 6. The second antenna 76 is arranged at or near the proximal end 68 of the body 6 or the drive mechanism 20.

[0179] For some examples, the second antenna 76 may be disposed on or within the trigger 9 or the 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. In the case where the second antenna 76 should 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. For some examples, the first antenna 74 interconnected to the second antenna 76 via the transmission line 75 may constitute a bridge circuit 172, which effectively provides a range extender for wireless transmission of the second antenna 76.

[0180] The first antenna 74 is operable to wirelessly communicate with the electronic container identifier 89, and thus wirelessly communicate with the machine-readable identifier 88 disposed on one of the container portion 7 and the medication container 21. The electronic container identifier 89 may be disposed 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 with the first antenna 74. The electronic container identifier 89 and the first antenna 74 may be concentrically arranged.

[0181] 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 additional device 30. When the additional device 30 is attached to the body 6 or the proximal end 68 of the injection device 1, signal transmission between the transceivers 38, 39 and the second antenna 76 can be achieved, such as Figure 8 Then, the distance between the device transceiver 38 and the second antenna 76 may be less than the transmission range of the device transceiver 38 .

[0182] For some examples, the device transceiver 38 is implemented as a near field communication interface operable to communicate wirelessly with a complementary near field communication antenna 76 .

[0183] 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, and in order to provide signal transmission 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 and second antennas 74, 76.

[0184] For Figure 7 and Figure 8 In the example shown, the injection device 1 is further equipped with 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 antenna 91 of the machine-readable identifier 28 and thus the electronic device identifier 29 of the injection device 1.

[0185] The electronic module 34 is operable to read or obtain container information of the electronic container identifier 89 provided by the memory 92'. Likewise, the electronic module 34 is operable to read and / or obtain device-related information from the memory 92 of the electronic device identifier 29. The electronic module 34 is operable to evaluate the device information and the container information and compare the corresponding information to check or assert whether the medicament container 21 or the container portion 7 matches the drive mechanism 20 and / or the body 6.

[0186] In the event 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 is operable to activate at least one of an alarm and a locking mechanism 85 of the drive mechanism 20 .

[0187] For Figure 7 and Figure 8 In the example shown, the second antenna 76 is exclusively connected to the first antenna 74 via the transmission line 75. Thus, when the attachment 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 body 6, the second antenna 76 is exclusively used to provide reading of the electronic container identifier 89.

[0188] The transmission line 75 and / or the antennas 74, 76 are further operable to transmit power from the transceiver 38 to the first antenna 74, which power is sufficient and operable to cause a wireless response from the electronic container identifier 89. Here, the electronic container identifier can be implemented as a passive wireless communication tag. In this way, the electronic device identifier 89 does not require its own power source.

[0189] exist Fig.13An example of wireless electronic communication between an external electronic device 30, an electronic device identifier 29, and an electronic container identifier 89 is further shown. Both the electronic device identifier 29 and the electronic container identifier 89 include an electronic circuit 90. The electronic circuit 90 of the electronic container 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 can be similar to the corresponding structure or hardware implementation of the integrated circuit 93'; and vice versa. In this regard, the integrated circuit 93 also includes a processor 94 and a memory 92, as described with respect to Fig.12 Examples of electronic device identifiers 29 are described in more detail.

[0190] 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. It may be outside the transmission range of the second antenna 76. It may also be outside the transmission range of the antenna 91 ' of the transceiver 38 of the additional device 30 when the additional device 30 is attached to the injection device 1.

[0191] The antenna 91 of the electronic device identifier 29 is within the transmission range of the second antenna 76. It may be outside the wireless transmission range of the antenna 91' of the electronic container identifier 89. The antenna 91 may be operable to communicate wirelessly directly with the antenna 91" of the transceiver 38 of the additional device 30. For some examples, the antenna 91 may be operable to communicate wirelessly with the second antenna 76. Here, the transceiver 38 is provided with a wireless signal anti-collision mechanism to distinguish between signals received from the antenna 91' and signals received from the antenna 91. In this regard, the transceiver 38 and / or the module processor 44 may be operable to provide demultiplexing of wireless data transmissions with the antennas 91, 91'. For other examples, the antennas 91, 91' may be operated with different communication protocols that inherently provide corresponding signal separation.

[0192] For Fig.14 It is also reflected in Fig. 9 In another example of the example, the second antenna 76 can be integrated into the electronic circuit 90 of the electronic device identifier 29. Here, the electronic device identifier 29 may not have its own antenna, but can be operated to communicate with the transceiver 38 exclusively using the second antenna 76. Here, the transceiver 38 also has an anti-collision and / or corresponding multiplexing mechanism to distinguish between the signal obtained from the electronic container identifier 89 and the signal obtained from the electronic device identifier 29.

[0193] The transceiver 38 of the electronic module 34 of the additional device 30 can be implemented as an RFID reader, an NFC reader and / or a UWB reader. It includes an antenna 91", an integrated circuit 93" and optionally also a known power supply 96". Typically, the integrated circuit 93" can include a module processor 44, and the power supply 96" can be provided by the power supply 46 of the electronic module 34.

[0194] For some examples, the injection device 1 is equipped with a dose detection arrangement 84. The dose detection arrangement 84 may include a movable component 80, 81, 82, 83, the position or movement of which relative to at least one of the housing 10, the medicament container 21 and / or the device body 60 may be detected and / or quantitatively measured, for example, by the sensor 48 of the electronic module 34 of the additional device 30.

[0195] exist Fig.10 , 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 is shown. Here, 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 efficient signal transmission.

[0196] exist Fig.11 In the Fig. 9 and Fig.14 There, the second antenna 76 is connected to the first antenna 74 via a transmission line 75, and the second antenna 76 is further directly connected to the integrated circuit 93 of the electronic device identifier 29. It should be noted that Fig.11 The integrated circuit 93 may be located within the circumference of the antenna 76, which may be implemented as a loop antenna 76. Thus, the integrated circuit 93 may be located coaxially within the circumferential antenna 76.

[0197] About Fig. 9 In the further example shown, the body 6 of the injection device 1 is provided with a longitudinal body extension 6' protruding distally from the distal end 67 of the tubular portion of the body 6. The longitudinal body extension 6' is provided with a first antenna 74, which is connected to a second antenna 76 via a transmission line 75. Arranging the first antenna 74 distal to the tubular portion of the body 6 can provide the benefit of reducing the geometric distance between the first antenna 74 and the electronic container identifier 89.

[0198] Here, the electronic container identifier 89 may be provided on the side wall of the container portion 7 and / or on the side wall of the barrel 22 of the medication container 21. The electronic container identifier 89 may be provided by a label 17 or provided on a label, which is, for example, adhered to the inner or outer surface of the container portion 7 or to the outer surface of the barrel 22. Arranging the electronic container identifier 89 on the side wall of at least one of the medication container 21 and the container portion 7 allows the use of a relatively large antenna 91 ', for example in the form of a rectangular tag antenna, which improves and facilitates the corresponding reading of the electronic container identifier 89.

[0199] Fig.17 A flow chart of a method of monitoring the operation of an injection device 1 is shown. Here, in a first step 200, an additional device 30 is attached to the injection device 1. Thereafter and in a second step 202, container information provided by an electronic container identifier is read or obtained by the electronic module 34 of the additional device 30.

[0200] The reading of the container information is provided by wireless signal transmission between the transceiver 38 and the second antenna 77, which is connected to the first antenna 74 via a transmission line 75 of the injection device 1. The first antenna 74 communicates wirelessly with an electronic container identifier 89, which is disposed on or within one of the medicament container 21 and the container portion 7 of the injection device 1.

[0201] In a further step 204, device information from the electronic body identifier 29 is obtained or read by the electronic module 34. Here too, the transceiver 38 is operable to read the corresponding device information from the memory 92 of the electronic body identifier 29.

[0202] After the device information has been obtained from the electronic body identifier 29, and after the container information has been obtained from the electronic container identifier 89, the corresponding device information and container information are evaluated in step 206. Here, information or data about the medication container 21 or medication 24 can be compared with corresponding information about the body 6 and / or the drive mechanism 20.

[0203] As a result of the comparison or evaluation of the device information and the container information, the electronic module 34 may approve or disapprove the use of the injection device 1, for example by unlocking the locking mechanism 85 through the lock controller 86. For further examples and in response to the evaluation of the device information and the container information, the electronic module 34 may be operable to generate an alert or any other indication to the user, thereby notifying the user of the condition of the injection device 1 and / or the additional device 30. In addition, data obtained from any of the electronic container identifier 89 and the electronic device identifier 28 may be synchronized with the external electronic device 100, 100' to provide corresponding information to the user.

[0204] Reference numerals

[0205] 1 Injection device

[0206] 2 Distal direction

[0207] 3 Proximal direction

[0208] 4 Dose escalation direction

[0209] 5 Dose reduction direction

[0210] 6 body

[0211] 6' Body extension

[0212] 7 Container part

[0213] 8-dose dial option

[0214] 9 Triggers

[0215] 10 Housing

[0216] 11 Connectors

[0217] 12-pin assembly

[0218] 13. Injection needle

[0219] 14 Inner needle cap

[0220] 15 Outer needle cap

[0221] 16 Protective cap

[0222] 17 Tags

[0223] 18 Piston

[0224] 19 Piston rod

[0225] 20 Driving mechanism

[0226] 21 Medicine Container

[0227] 22 Cylinder

[0228] 23 Seals

[0229] 24 Pharmacy

[0230] 25 Exit

[0231] 26 Window

[0232] 27 Dial extension

[0233] 28 Logo

[0234] 29 Electronic device identifiers

[0235] 30 Additional devices

[0236] 34 Electronic modules

[0237] 36 Integrated Circuits

[0238] 37 Reader

[0239] 38 Transceiver

[0240] 39 Transceiver

[0241] 40 Module Memory

[0242] 42 clock

[0243] 44 Module Processor

[0244] 46 Power Supply

[0245] 48 Sensors

[0246] 50 Indicator

[0247] 51 Display

[0248] 52 Signal Generator

[0249] 53 Display Segment

[0250] 54 Display Segments

[0251] 60 Device body

[0252] 61 Sidewall

[0253] 62 flange part

[0254] 63 Reception Department

[0255] 64 Fastening rib

[0256] 65 Alignment Features

[0257] 66 Mating Alignment Features

[0258] 67 Far End

[0259] 68 Proximal

[0260] 69 extension

[0261] 70 Movable part

[0262] 72 Bridge Circuit

[0263] 74 Antenna

[0264] 75 Transmission Line

[0265] 76 Antenna

[0266] 80 Dose setting element

[0267] 81 driving components

[0268] 82 Volume indicator

[0269] 83 Encoding

[0270] 84 Dose detection arrangement

[0271] 85 Locking mechanism

[0272] 88 Logo

[0273] 89 Electronic container markers

[0274] 90 Electronic Circuits

[0275] 91 Marker Antenna

[0276] 92 Memory

[0277] 93 Integrated Circuits

[0278] 94 processors

[0279] 95 substrate

[0280] 96 Power Supply

[0281] 97 Adhesive layer

[0282] 100 Electronic devices

[0283] 101 Housing

[0284] 103 Wristband

[0285] 110 hands

[0286] 111 Wrist

[0287] 112 Palm

[0288] 114 Thumb

[0289] 116 fingers

[0290] 120 Injection System

[0291] 137 Device Reader

[0292] 138 Device transceiver

[0293] 139 Device transceiver

[0294] 140 Device Memory

[0295] 144 Device Processor

[0296] 146 Device power supply

[0297] 151 Device Display

[0298] 152 Device Signal Generator

[0299] 153 Graphics

[0300] 154 Notice

Claims

1. An injection device (1) for injecting a dose of a medicament (24), the injection device (1) comprising: a housing (10) comprising a body (6) detachably connectable to a container part (7), wherein the container part (7) is configured to accommodate a medicament container (21), a drive mechanism (20) arranged in the body (6) and operable to expel the dose of the medicament (24) from the medicament container (21), a first antenna (74) on or in the first portion of the body (6), the first antenna being configured for wireless signal transmission with an electronic container identifier (89) disposed on or in the container portion (7), a second antenna (76) on or in the second part of the body (6), electrically connected to the first antenna (74) and configured for wireless signal transmission with a transceiver (38, 39) of an electronic module (34) of an additional device (30) connectable to the injection device (1), - an electronic device identifier (29), which is on or inside the body (6) and is configured to perform wireless signal transmission with the transceiver (38, 39).

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

3. The injection device (1) according to claim 2, wherein: To perform 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 a tag antenna (91') of the electronic device tag (29), wherein the tag antenna (91) is configured to perform wireless signal transmission with the transceiver (38, 39).

4. Injection device (1) according to any one of the preceding claims, wherein: The body (6) includes a distal end (67) capable of being connected to the container portion (7), and wherein the body (6) includes a proximal end (68) opposite to the distal end (67), wherein the first antenna (74) is arranged at or near the distal end (67), and wherein the second antenna is arranged at or near the proximal end (68).

5. The injection device (1) according to any one of the preceding claims, further comprising the container part (7), and wherein, The electronic container identifier (89) is arranged on or in one of the container portion (7) and the medicament container (21) accommodated by the container portion (7).

6. The injection device (1) according to 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'), wherein the integrated container circuit (93') includes a container memory (92') configured to store at least one of container information and usage-related data.

7. The injection device (1) according to claim 6, wherein: When the attachment is attached to the injection device (1), the container memory (92) can be read by the transceiver (38, 39) of the electronic module (34) of the attachment (30) through wireless signal transmission between the first antenna (74) and the container antenna (91') and through wireless signal transmission between the second antenna (76) and the transceiver (38, 39).

8. 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 attachment device (30) for attachment to an injection device (1) according to any one of the preceding claims, the attachment device (30) comprising: - a device body (60) which can be fastened to a part of the injection device (1), - an electronic module (34) comprising a module processor (44) and a transceiver (38, 39), wherein the electronic module (34) is operable to: - reading data from the electronic container identifier (89) via the first antenna (74) and the second antenna (76), and - Wirelessly reading data from the electronic device identifier (29).

10. The attachment (30) according to claim 9, wherein: When the device body (60) is fastened to the injection device (1), the transceiver (38, 39) is configured to perform wireless signal transmission with the second antenna (76).

11. The attachment (30) according to claim 9 or 10, wherein: When the device body (60) is fastened to the injection device (1), the transceiver (38, 39) is configured to perform wireless signal transmission with the identifier antenna (91) of the electronic device identifier (29).

12. An attachment device (30) according to any one of the preceding claims 9 to 11, wherein: The electronic module (34) is operable to separate and / or differentiate signals received from the electronic container identifier (89) and the electronic device identifier (29).

13. An attachment device (30) according to any one of the preceding claims 9 to 12, wherein: The electronic module (34) is operable to induce power 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), wherein the power is effective to cause signal transmission between the first antenna (74) and the electronic container identifier (89).

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

15. An injection system (120) comprising an injection device (1) according to any one of the preceding claims 1 to 8 and comprising an additional device (30) according to any one of the preceding claims 9 or 14.

Images