Injection device with additional 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) and a container portion (7), where the container portion (7) is configured to accommodate a medicament container (21), and where the container portion (7) is removably connectable to the body (6),-a drive mechanism (20), a drive mechanism arranged in the body (6) and operable to expel the dose of the medicament (24) from the medicament container (21),-a machine-readable identification (28; 88) on or inside one of the body (6) and the container portion (7),-a detector arrangement (98) arranged on or inside one of the body (6) and the container portion (7) and operable to detect a mechanical connection between the body (6) and the container portion (7),-wherein the machine readable identification (28; 88) is electrically connected to the detector arrangement (98) and is readable by an electronic module (34) of an additional device (30) connectable to the injection device (1), and wherein the machine-readable identification indicates a mechanical connection between the body (6) and the container portion (7).

Description

Technical Field

[0001] The present disclosure relates to the field of injection devices, and in particular to injection devices, such as pen-type injectors that can be used with dedicated attachments. In another aspect, the present disclosure relates to an injection system, which includes an injection device and an attachment. In another aspect, the present disclosure relates to a method for monitoring the operation 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] Typically, there are a variety of different injection devices that can be equipped with different drugs or medicaments, but are generally operable for use with the same type of attachment device. Although it is common practice to characterize or label different types and / or different concentrations of injection devices and / or medicaments by clear and different labels or logos, detachable connections, detachable connections with attachment devices may bring disadvantages, especially when the label or characteristic part of the injection device is covered by the attachment device when attached to the injection device.

[0012] By providing a reusable injection device that replaces the medicament container, it is desirable to reset the drive mechanism. When such a reusable injection device is used with an additional device, it may also be necessary to perform a reset operation or some initialization process with the additional device. When the additional device is configured to record or track the remaining amount of medicament left in the cartridge, it may also be necessary to reset the data recording program and / or initialize a new tracking program with the additional device when the medicament container of the injection device is replaced.

[0013] In view of this, it is desirable to provide improvements to injection devices and / or additional devices to simplify the device handling process during the replacement of the medicament container. In addition, the recording or monitoring of the reuse of the injection device should be simplified. In addition, patient safety should be enhanced. Summary of the invention

[0014] In one aspect, the present disclosure relates to an injection device for injecting a dose of a medicament. The injection device includes a housing. The housing includes a body and a container portion. The container portion is configured to accommodate a medicament container. The container portion is further detachably connected to the body. The injection device further includes a drive mechanism, which is arranged in the body and is operable to discharge or extract the dose of medicament from the medicament container.

[0015] The injection device further comprises a machine readable identification on or within one of the body and the container part. The injection device further comprises a detector arrangement on or within one of the body and the container part. The detector arrangement is operable to detect a mechanical connection between the body and the container part. The machine readable identification is electrically connected or linked to the detector arrangement. It can be read by an electronic module of an additional device that is connectable, i.e. mechanically connectable to the injection device. The machine readable identification indicates a mechanical connection between the body and the container part.

[0016] Typically, the injection device is implemented as a handheld injection device. It may include a pen-type injector. The injection device may be implemented fully mechanically. It may not have any electrical or electronic components. The only electrical or electronic component may be a machine-readable identification and a detector arrangement of the injection device. The machine-readable identification may be implemented as an electronic identifier. The machine-readable identification may include a passive wireless communication tag or an active wireless communication tag, such as a passive or active RFID tag, an NFC tag or a UWB tag. In this regard, the injection device may not have any active electrical or electronic components.

[0017] The machine-readable identification may include an electronic identifier that can be electronically read by an additional device. The machine-readable identification may include a passive or active type of radio frequency transceiver. For some examples, the machine-readable identification is implemented as one of an RFID tag, an NFC tag, or a UWB tag. For some examples, the machine-readable identification can be electronically read by a transceiver and / or by a corresponding electronic module of the additional device. Therefore, the machine-readable identification is configured to establish a wireless communication link with the additional device, thereby allowing the data or information stored in the machine-readable identification to be read.

[0018] An electrical connection or electronic link between the machine-readable identification and the detector arrangement of the injection device enables the status of the detector arrangement to be electronically read or read out by an additional device.

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

[0020] Typically, the attachment is configured to be fastened to a proximal end of a body or drive mechanism of the injection device. For some examples, the injection device may include a dial extension that undergoes at least one of a rotational displacement and a longitudinal displacement relative to the body of the injection device during or when setting a dose and / or during or when injecting a dose of medicament. Although the attachment is, for example, specifically attachable or fastenable to the proximal end of the injection device and is therefore attachable or fastenable to the corresponding proximal end of the body or drive mechanism of the injection device, the attachment may and may always remain within the transmission range of the machine-readable identification of the injection device when or when attached to the injection device.

[0021] For some examples, the machine-readable identification of the injection device is located at or near the proximal end of the body or drive mechanism of the injection device. The detector arrangement can be located at or near the distal end of the body or drive mechanism of the injection device, which is configured to be fastened or mechanically coupled to the container portion and / or the medicament container positioned therein.

[0022] For some examples, the detector arrangement provides a spatial range extender for a wireless communication link between, for example, an additional device and a machine-readable identification disposed on or within the injection device.

[0023] For some examples, the machine-readable identification is electrically connected to the detector arrangement via at least one or more conductive structures (e.g., via electrical wires). Thus, the electrical connection between the machine-readable identification and the detector arrangement may be implemented as a wire-based electrical connection. The corresponding wires or conductive structures may extend along the sidewalls of the body and may therefore extend along the longitudinal direction of the body, thereby bridging the geometric distance between the detector arrangement at or near the distal end of the body and the machine-readable identification at or near the proximal end of the body.

[0024] In some examples, the container part can be detachably connected to the body so that it can be transformed between the connection configuration and the release configuration. In the connection configuration, the container part is fastened, for example, rigidly fastened to the body. In the release configuration, the container part can be disassembled from the body. Here, the container part can be completely disassembled, i.e. disconnected from the body so that the container part is completely separated from the body. In other examples, and when the container part is in the release configuration, the container part can remain connected to the body, but can be in a configuration that allows to remove the medication container and / or insert a new medication container into the container part. Here, the container part can be permanently connected to the body and can be moved between the connection configuration and the release configuration relative to the body. In some examples, the container part can be pivotally attached to the body. It can pivot about a pivot axis between the connection configuration and the release configuration.

[0025] According to another example, the detector arrangement is configured to enter a first detector state when the body is connected to the container part, and is further configured to enter a second detector state when the body is disconnected from the container part. The first detector state and the second detector state can be read electronically or electrically. Therefore, the condition of the detector arrangement, i.e. the first detector state and the second detector state, is distinguished by an electrically measurable or electrically detectable feature of the detector arrangement.

[0026] For some examples, one of detaching the container portion from the body and attaching the container portion to the body causes or triggers one of the first detector state and the second detector state to switch to the other of the first detector state and the second detector state.

[0027] The first and second detector states of the detector arrangement can introduce the corresponding first and second identifier states of the machine-readable identification that can be read electrically or electronically. Therefore, when the detector arrangement is in the first detector state, the machine-readable identification can be or switch to the first identifier state. When the detector arrangement is switched to the second detector state, the machine-readable identification can be or switch to the second identifier state.

[0028] Here, the first identifier state can reflect a first machine-readable state of the machine-readable identifier, and the second identifier state can reflect or constitute a second machine-readable state of the machine-readable identifier. The first and second machine-readable states of the machine-readable identifier are distinguished from each other. The additional device is particularly configured to wirelessly communicate with the machine-readable identifier and identify and / or recognize whether the machine-readable identifier is in the first machine-readable state or in the second machine-readable state.

[0029] According to a further example, the machine readable identification and the detector arrangement are electrically connected by an electrical circuit. In this way, the first detector state and / or the second detector state can be tracked or identified quite easily. The electrical or electronic signal and / or the electrically measurable characteristic of the detector arrangement can be transmitted to the machine readable identification via the electrical circuit. In this way, when the additional device is appropriately attached and / or mechanically connected to the injection device, the detector state of the detector arrangement can be easily transmitted to the additional device via the machine readable identification.

[0030] According to another example, the electrical circuit interconnecting the machine-readable identification with the detector arrangement includes a first wire and a second wire. The first wire and the second wire are connected to opposite ends of the detector arrangement. They are further connected to different terminals of the machine-readable identification.

[0031] By connecting first and second wires to, for example, first and second terminals of a machine-readable identifier, a change in the detector state can be detected at the terminals of the machine-readable identifier. The change in the detector state can then be immediately translated into a corresponding change in the input signal at the first and second terminals of the machine-readable identifier, which changes its machine-readable state in response to the corresponding change or modification of the input signal. When the attachment is attached to the injection device, the corresponding change in the machine-readable state can be directly tracked or detected by the attachment.

[0032] According to another example, the detector arrangement includes an electromechanical switch on or in one of the body and the container portion. The other of the body and the container portion includes an actuating element configured to engage the electromechanical switch when the container portion is connected to the body. In addition, the actuating element is configured to disengage the electromechanical switch when the container portion is disconnected from the body.

[0033] For some examples, the electromechanical switch comprises a first switch terminal and a second switch terminal which are electrically insulated from each other and which are electrically disconnected from each other by default. Here, the actuating element may provide a conductive structure which, when the container portion is correctly connected to the body of the injection device, acts as an electrical bridge between the first switch terminal and the second switch terminal. By detaching the container portion from the body, the electrical bridge provided by the actuating element undergoes a movement relative to the switch terminals and thus undergoes a geometric displacement relative to the switch terminals, the movement or movement being accompanied by an electrical disconnection of the actuating element from at least one of the first and second switch terminals.

[0034] For other examples, the actuating element is or includes a mechanical component that interacts with a bridge that is an integral component of the electromechanical switch. For some examples, the electromechanical switch includes a movable portion, such as in the form of a contact spring, that is movable between an open state and a closed state. When in the closed state, the contact spring provides electrical contact between the first and second switch terminals, and thus provides electrical contact between the first and second conductors of the electrical circuit. In the open state or open configuration, the contact spring is disconnected from at least one of the first switch terminal and the second switch terminal, and thus disconnected from at least one of the first and second conductors.

[0035] The movement of the contact spring of the electromechanical switch may be caused or may be capable of being caused or controlled by the actuating element. Thus and after interconnecting the body with the container part, the actuating element may cause the contact spring to move from a closed state to an open state, or vice versa, from an open state to a closed state. When disconnecting the container part from the body, the actuating element moves in the opposite direction, thereby causing the closing or opening of the contact spring.

[0036] By means of an electromechanical switch electrically connected to the machine-readable identification, the mechanical configuration of the injection device, i.e. the mechanical connection between the container portion arranged at the distal end of the body of the injection device and the body, can be electrically detected at the opposite longitudinal end of the body of the injection device, where the machine-readable identification is typically located. This allows for wireless near-field or short-range communication to be implemented between the additional device and the machine-readable identification, wherein the wireless transmission range may be shorter than the longitudinal distance between the machine-readable identification and the detector arrangement, which are typically located at the opposite longitudinal ends of the body of the injector device.

[0037] According to another example, one of the body and the container part includes an insertion section. The other of the body and the container part includes a receiving portion, the size of which is determined to receive the insertion section. The detector is arranged on the outer surface of the insertion section or on the inner surface of the receiving portion. Typically, when the detector is arranged on the inner surface of the receiving portion, the actuating element is arranged on the outer surface of the insertion section. Vice versa, if the detector is arranged on the outer surface of the insertion section, the actuating element is typically arranged on the inner section of the receiving portion.

[0038] For another example, the electromechanical switch is disposed on one of the insertion section and the receiving portion, and the actuating element is disposed on the other of the insertion section and the receiving portion.

[0039] When correctly assembled and connected, the body and the container part are arranged in an at least partially staggered or nested arrangement, wherein the insertion section overlaps the receiving portion. In this way, a mechanically stable mutual interconnection can be provided between the container part and the body.

[0040] For another example, the electromechanical switch is arranged on or in the fastening structure of the body. The actuating element is arranged in or on the mating fastening structure of the container part, wherein the container part and the body can be fastened to each other by mechanical engagement of the fastening structure with the mating fastening structure. In this way, the fastening structure and the mating fastening structure of complementary shape provide dual functions. First, they are configured to provide a mechanical connection between the body and the container part of the injection device. Secondly, they provide operation of the detector arrangement to modify the detector state of the detector arrangement during assembly.

[0041] According to another example, one of the fastening structure and the mating fastening structure includes a groove. The other of the fastening structure and the mating fastening structure includes a protrusion for engaging the groove. For some examples, the groove is implemented as an L-shaped groove or a bayonet groove. It can also be provided in the form of a threaded structure and can therefore be characterized by a spiral shape.

[0042] For some examples, the groove is disposed on the inner surface of the receiving portion, and the protrusion is disposed on the outer surface of the insertion section. For other examples, the groove may be disposed on the outer surface of the insertion section, and the protrusion is disposed on the inner surface of the side wall of the receiving portion.

[0043] For some examples, the groove is configured as a threaded structure. The protrusion is configured as a reverse threaded structure of a complementary shape. In this way, the fastening structure and the matching fastening structure of the complementary shape enable threaded engagement between the body and the container portion.

[0044] According to a further example, the body comprises a distal end and an oppositely positioned proximal end.The machine-readable marking is positioned closer to the proximal end than the detector arrangement, and / or the detector arrangement is positioned closer to the distal end than the machine-readable marking.

[0045] Here, the electrical circuitry between the machine readable marking and the detector arrangement is operable to provide an electrical and hence geometrical bridge between the machine readable marking at or near the proximal end of the body and the detector arrangement at or near the distal end of the body of the injection device.

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

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

[0048] 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.

[0049] 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.

[0050] 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.

[0051] According to another example, the integrated circuit comprises a first terminal and a second terminal. The first terminal is connected to one end of the detector arrangement, and the second terminal is connected to the other end of the detector arrangement. In this way, the first and second terminals constitute different terminals of the machine-readable identification as described above.

[0052] The first and second terminals may be provided with a machine-readable and thus electrically detectable signal from the detector arrangement when the body and container part are connected and attached to each other and / or when the body and container part are disconnected.

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

[0054] For another example, the universal input / output terminal and the other of the first terminal and the second terminal are connected via a capacitor, and therefore connected via an input capacitor of the integrated circuit. In the case where the first terminal and the second terminal of the integrated circuit are directly connected to the switch terminals of the electromechanical switch, it may be necessary for the electronic module to periodically make a request for the detector arrangement. Here, the electronic module can cause or trigger a request for the actual status of the detector arrangement through a machine-readable identification. For example, the additional device can be configured to perform or trigger such a check or request at regular time intervals (such as every 1-3 seconds). In this way, the additional device can be configured to periodically check the status of the detector arrangement.

[0055] By means of the GPIO terminal and by means of a resistor connected to one of the first terminal and the second terminal of the integrated circuit, the resistor provides a pull-up resistance for improved or well-defined signal detection. Here, the additional device can also be configured to periodically detect the actual condition of the detector arrangement, for example by periodically transmitting a corresponding request to a machine-readable identification. By means of the pull-up resistor at the terminal of the integrated circuit, a well-defined voltage level can be provided at the corresponding input terminal of the electronic circuit and / or at the GPIO terminal. In this way, a fairly accurate and well-defined voltage measurement result can be provided.

[0056] For another example, where the GPIO terminal of the integrated circuit and the other of the first terminal and the second terminal are connected via a capacitor, an automatic wake-up function may be implemented. Here, the capacitor may be operable to discharge when the electrical circuit interconnecting the detector arrangement with the machine-readable identification is opened (e.g., during the process of disconnecting the body and the container portion). The discharge of the capacitor may cause an electronic wake-up of the integrated circuit, thereby automatically generating a corresponding wireless signal, which may be detected by the additional device when the additional device is attached to the injection device. The generation of the wake-up signal may also result in a corresponding wake-up that acts on the device. In this regard, when the additional device is attached to the injection device, a relatively external digital wake-up function may be provided for the additional device. Here, disconnection of the container portion from the body or connection of the container portion to the body may cause a corresponding wake-up signal to be generated at the machine-readable identification, which in turn may cause a wake-up of the additional device.

[0057] In this way, regular supervision of the actual status of the detector arrangement by additional means may become superfluous and corresponding electrical energy for performing such regular checks or requests may be saved.

[0058] 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.

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

[0060] The module processor is operable to process the read signal to determine whether the container portion of the injection device is connected to the body.For some examples, at least one of the reader and the transceiver is an integral part or component of an electronic module of the attachment device.

[0061] In general, the attachment device is configured to operate 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 attachment device; and vice versa.

[0062] In particular, the additional device is operable to read or read out a machine-readable identification electrically connected to a detector arrangement of the injection device. Via reading out of the machine-readable identification, the additional device is able to obtain or read out a detector state of the detector arrangement and thus is able to distinguish between at least two different states of the detector arrangement indicating that the container part and the body are fastened to each other or that the container part is disconnected from the body.

[0063] For some examples, the device body of the attachment device can be removably fastened or can be connected to the proximal end of the body of the injection device and / or the proximal end of the injection mechanism or drive mechanism of the injection device. For some examples, the device body includes a receiving portion sized to receive a dose dial or dial extension of the injection device.

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

[0065] In the same manner, at least one of the reader and transceiver of the additional device is operable to sample or request a read signal of a connection indication signal from a machine-readable identification and / or from a detector arrangement of an injection device. For some examples, the sampling rate may be in the range of several seconds. Thus, the additional device may be configured to sample or request a read signal from a machine-readable identification and / or from a detector arrangement of an injection device via a machine-readable identification every 1-3 seconds. In this manner, the additional device is operable to constantly or periodically monitor a connection state of the injection device, which indicates mutual fastening between the body and the container portion.

[0066] According to another example, the additional device includes a sensor operable to quantitatively determine at least one of a position and a movement of a movable component of the drive mechanism relative to at least one of a housing, a medicament container, and a device body. The sensor is further operable to generate a corresponding sensor signal. The module processor of the additional device is operable to determine or calculate the size of a dose of the medicament set or dispensed by the injection device based on the sensor.

[0067] According to a further example, at least one of the reader and the transceiver comprises a wireless near-field transceiver operable to wirelessly communicate with the machine-readable identification of the injection device so as to obtain status information of the detector arrangement and / or obtain at least one of device information and container information stored in the machine-readable identification.

[0068] For some examples, at least one of the reader and the transceiver of the attached device is implemented as a radio frequency transceiver, such as an RFID reader, an NFC reader, or a UWB reader.

[0069] Because the machine-readable indicia is electrically connected to the detector arrangement, and because any change in the state of the detector irreversibly reflects a corresponding change in the configuration of the machine-readable indicia, the state or condition of the detector arrangement can be read by an additional device when at least one of the reader and the transceiver is in wireless communication with the machine-readable indicia provided on or within the injection device.

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

[0071] The local range transceiver may include a transmission range greater than the transmission range of the near field transceiver. The local range transceiver may include a radio frequency transceiver. It may include a Bluetooth transceiver or a Bluetooth Low Energy (BLE) transceiver. It may also include a Wi-Fi transceiver or similar wireless transceiver to allow local range signal transmission with external electronic devices.

[0072] Typically, the external electronic device comprises one of a smart phone, a smart watch, and a tablet computer. Through the communication link between the additional device and the external electronic device, the device information and / or container information provided by the machine-readable identification can also be provided to the electronic module of the additional device via the external electronic device. Here, the external electronic device can be equipped with a reader or transceiver, which is operable to read out the machine-readable identification of the injection device. In response to such reading of the machine-readable identification by the external electronic device, the external electronic device can then be able to extract the device information and / or container information from the machine-readable identification, and transmit at least one or both of the device information and the container information to the additional device via the local range transceiver of the additional device. In this way, the additional device is indirectly provided with information or data contained in or provided by the machine-readable identification of the injection device. By way of example, the additional device may not have a near-field transceiver and does not necessarily have to be able to obtain or read the machine-readable identification itself. Here, the external electronic device can operate as a repeater, which reads or obtains the device information and / or container information from the machine-readable identification, and is further operable to provide or transmit the collected information to the additional device.

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

[0074] 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.

[0075] 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.

[0076] According to another example, the electronic module further comprises a module memory connected to the module processor. The module memory and / or the module processor are operable to store at least one of the device information and the container information as stored information and / or store a dosing history, wherein the dosing history comprises a plurality of dose sizes dispensed or injected by the injection device and determined or calculated by the module processor.

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

[0078] For some examples, as long as the additional device determines or confirms that the container part is connected to and remains connected to the body of the injection device, the dose size or dose information obtained from the sensor of the additional device is only and exclusively considered for calculating the remaining amount of the medicament. Therefore, the additional device, in particular the electronic module and / or its module processor is operable to determine the connection status between the container part and the body of the injection device in the manner as described above, i.e. by reading a machine-readable identification electrically connected to the detector arrangement. If the additional device determines or confirms that the container part and the body of the injection device remain fixed and / or connected to each other, the size of the currently set or dispensed dose is then only used to calculate the remaining amount of the medicament contained in the medicament container.

[0079] To this end, the attachment device may be operable to periodically check the interconnection between the container part and the body, for example by sampling or requesting a read signal from one of a reader and a transceiver, which reader and transceiver may be operable to wirelessly communicate with the machine-readable identification when the attachment device is correctly assembled or attached to the injection device, thereby obtaining corresponding information about the detector status of the detector arrangement of the injection device.

[0080] For some examples, the attachment may be configured to interrupt or discard the calculation of the remaining amount of the medicament contained in the medicament container if a mechanical disconnection of the container portion and the body is detected. Disconnecting the container portion from the body may result in a change in the state of the detector arrangement, which change in state can be read electronically via a machine-readable identification. Detecting a change in state during the ongoing and regular processing of dosing history monitoring and / or remaining amount calculation is a safety feature to avoid calculating an erroneous remaining amount of the medicament remaining in the medicament container in the event that the user prematurely removes the container portion from the body (i.e., before the contents of the medicament container have been completely dispensed or used up).

[0081] By way of further example and when at least one of container information and device information is provided for the machine-readable identifier, detection of the container portion from the body is tolerable, particularly when the medication history obtained, determined or calculated by the attached device is written or stored in the memory of the machine-readable identifier. Reattaching the container portion to the body may then enable reading of the corresponding machine-readable identifier and recovery of the remaining amount calculation of the corresponding container portion or medication container.

[0082] According to another aspect, the present disclosure further relates to an injection system, which includes the injection device as described above and further includes the additional device as described above. In this regard, all features, effects and benefits described above in conjunction with any one of the injection device and the additional device also apply to the injection system.

[0083] The injection system may further include at least one of the external electronic devices operable to communicate with the additional device, such as wirelessly. The external electronic device may be implemented as a smart phone, a smart watch, and a tablet computer or any other digital electronic device capable of communicating with the additional device.

[0084] According to another aspect, the present disclosure relates to a method for monitoring the operation of an injection device configured to inject a dose of a medicament. The method comprises the steps of attaching an attachment to a portion of the injection device, wherein the injection device comprises a machine-readable identification on or within one of a body and a container portion of a housing of the injection device. The machine-readable identification is electrically connected to a detector arrangement. The detector arrangement is disposed on or within one of the body and the container portion. The detector arrangement is operable to detect (e.g., electrically detect) a mechanical connection between the body and the container portion.

[0085] The method further comprises the steps of: reading the machine-readable identification by at least one of the reader and the transceiver of the additional device and generating a read signal indicating the mechanical connection between the body and the container part. The method further comprises the steps of: determining whether the container part is connected to the body by processing the read signal. Typically, the method of monitoring the operation of the injection device will be performed and / or carried out by the injection device as described above and / or by utilizing the additional device as described above. In this regard, all features, effects and benefits described above in conjunction with any one of the injection device and the additional device are also applicable to the method of monitoring the operation of the injection device as described herein.

[0086] According to a further example, the method comprises the following steps: when the attachment is attached to the injection device, quantitatively determining by a sensor of the attachment at least one of a position and a movement of a movable component of a drive mechanism of the injection device. The sensor provides and generates a corresponding sensor signal indicating the extent of movement and / or indicating position information, by which the position of the movable component relative to any one of the housing of the injection device and the device body of the attachment can be detected or determined.

[0087] By quantitatively detecting or measuring the extent of movement of the movable part of the drive mechanism, dose size information indicative of the size of the dose currently set or dispensed by the injection device can be derived. Quantitatively measuring dose size allows monitoring and recording of any dosing events of the injection device and recording the corresponding dosing history.

[0088] Therefore, and for further examples, the method includes the following steps: monitoring a medication administration history with an additional device, wherein the medication administration history includes a plurality of dose sizes that are dispensed (e.g., dispensed or injected sequentially by an injection device and determined or calculated by an additional device). The stored medication administration history may include the time points at which the doses have been set and / or dispensed and the amount of medication that was set or dispensed at each dispensing or injection action. The medication administration history may be stored locally in the additional device. It may be synchronized, for example, by wireless data transmission with an external electronic device, and may be shared with other entities or individuals (such as healthcare providers).

[0089] For some examples, the dosing history may be stored in a memory of a machine-readable identifier of an injection device. In this regard, the recorded dosing history may be stored on-site and directly on the injection device or component thereof that has been used to set and dispense the corresponding dose of the medicament.

[0090] According to a further example, the method comprises the step of determining or calculating a remaining amount of a medicament contained in the medicament container based on a medication history and based on a connection condition between the body and the container portion.

[0091] In this way and in particular by taking into account the connection conditions between the body and the container part, any unintentional use or misuse of the injection device can be retrieved and checked by the detector arrangement and the machine-readable identification of the injection device. In particular, premature removal or replacement of the medicament container can be detected quite autonomously and can be used to discard or interrupt the continuous calculation of the administration history and / or the calculation or determination of the remaining amount of medicament. In this way, incorrect administration information can be prevented from being generated and / or used to calculate the remaining amount of medicament inside the medicament container.

[0092] 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.

[0093] 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.

[0094] 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.

[0095] 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.

[0096] 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).

[0097] 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.

[0098] 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.

[0099] 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.

[0100] 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.

[0101] 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.

[0102] 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.

[0103] 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.

[0104] 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.

[0105] 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.

[0106] 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.

[0107] 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.

[0108] 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.

[0109] 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.

[0110] 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.

[0111] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, ); 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.

[0112] 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.

[0113] 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.

[0114] 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.

[0115] 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.

[0116] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen binding portion thereof. Examples of antigen binding portions of immunoglobulin molecules include F (ab) and F (ab') 2 fragments, 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).

[0117] 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.

[0118] 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.

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

[0120] 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.

[0121] 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.

[0122] 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.

[0123] 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).

[0124] 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

[0125] 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:

[0126] Figure 1 An example of an injection device is schematically shown,

[0127] Figure 2 The process of assembling the additional device to the proximal end of the injection device is shown.

[0128] Figure 3 The injection device is shown in a schematic longitudinal cross section,

[0129] Figure 4 shows a configuration of an injection system comprising an injection device, an additional device and at least one external electronic device,

[0130] Figure 5 shows the pairing between the external electronic device and the additional device,

[0131] Figure 6 shows a visual illustration on a display of an external electronic device to assist a user in setting up an injection device,

[0132] Figure 7 shows the configuration of the external electronic device, which indicates the end of the dose dispensing of the medicament container,

[0133] Figure 8 The display of the external electronic device prompts the user to replace the medicine container.

[0134] Fig. 9 The display of the external electronic device provides statistics of the most recent dose setting and injection procedures.

[0135] Fig.10 shows the display configuration of the external electronic device after replacing the medicine container,

[0136] Fig.11 Shows the configuration of the attachment device before attempting to inject the proximal end of the device

[0137] Fig.12 showing visual feedback provided on an external electronic device in response to reading information from an electronic container identifier,

[0138] Fig.13 An example of a container portion being detached from the body of the injection device is shown,

[0139] Fig.14 The distal end of the body is shown separately, and is configured to be connected to the proximal end of the container portion,

[0140] Fig.15shows an example of an injection device and an additional device before assembling the additional device to the injection device,

[0141] Fig.16 shows the assembly of the attachment device to the injection device,

[0142] Fig.17 An example of an electromechanical switch showing a detector arrangement,

[0143] Fig.18 Another example of an electromechanical switch showing a detector arrangement,

[0144] Fig.19 A further example of an electromechanical switch showing a detector arrangement,

[0145] Fig. 20 A block diagram showing an attachment device, an injection device and external electronic devices,

[0146] Fig.21 A block diagram of an electronic circuit showing a machine readable identification,

[0147] Fig. 22 An example of an electronic circuit on a substrate is shown,

[0148] Fig.23 A flow chart of a method of configuring an attachment is shown. DETAILED DESCRIPTION

[0149] Figure 1 An 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.

[0150] 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.

[0151] 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.

[0152] For some examples, such as in Figure 2 As 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.

[0153] 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.

[0154] 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.

[0155] 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 .

[0156] 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. 20 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.

[0157] 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

[0158] 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.

[0159] 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.

[0160] 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.

[0161] 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.

[0162] like Figure 3As 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.

[0163] like Figures 2 to 14 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.

[0164] 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.

[0165] 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.

[0166] 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.

[0167] 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.

[0168] 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.

[0169] like Fig. 20 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.

[0170] 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.

[0171] 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).

[0172] 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.

[0173] 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.

[0174] 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.

[0175] 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 4 In 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.

[0176] like Fig. 20 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'.

[0177] 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.

[0178] 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.

[0179] 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 .

[0180] 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.

[0181] 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.

[0182] 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.

[0183] The injection device 1 is provided with a machine-readable mark 28, 88, such as Fig. 20 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 Schematically shown in .

[0184] like Fig.21 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.

[0185] 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.13 The electronic marker 29 shown has the same or similar structure.

[0186] 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.

[0187] 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.

[0188] 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.

[0189] 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'.

[0190] 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.

[0191] 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. 20 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 .

[0192] 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.

[0193] As in Fig.15 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.

[0194] like Fig.16 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.

[0195] 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.

[0196] Figures 5 to 12 The sequence of FIG. 1 shows one of several examples of how to use the attachment device 30 in conjunction with the injection device. Figure 5In the configuration of the external electronic device, the user of the external electronic device is informed of the pairing between the external electronic device 100 and the additional device 30. Such pairing may be achieved by establishing a wireless communication link between the transceiver 39 and the device transceiver 139. Once the external electronic device 100 detects the presence of the additional device and / or is properly paired with the additional device, it may be operable to provide a corresponding visual representation 1053 on the device display 1051.

[0197] In a subsequent step, the external electronic device 100 can be operated to assist or guide the user to bring the medicine container 21 near the additional device 30 so as to be able to read the machine-readable mark 88 provided on the medicine container 21. In this way, when the medicine container 21 provided with the machine-readable mark 88 is inserted into the receiving portion 63 of the additional device 30, for example, the additional device 30 can be operated to read the corresponding container information. Figure 6 As shown on the right-hand side of FIG. 1 , it is also conceivable that the container part 7 of the injection device is provided with a corresponding machine-readable identification.

[0198] The machine-readable identification can be read out in Figure 7 The illustrated configuration reveals that a relatively large number of medicament units have been injected and thus dispensed from the medicament container 21. The empty medicament container can be provided on the device display 1050 in the form of a visual illustration 1053. Here, the nearly empty configuration of the medicament container 21 can be accompanied by a virtual indicator 156 provided simultaneously on the device display 1051, and an illustration of the medicament container 20 or the container portion 7.

[0199] Afterwards, if Figure 8 As shown, the attachment 100 can prompt the user to replace the medicament container 21 with respect to the container part 7. Therefore, the empty medicament container 21 should be taken out from the container part 7, and the new medicament container 21 should be inserted into the container part 7.

[0200] Optionally and as Fig. 9 As shown, the external electronic device can provide, for example, statistics or statistical diagrams of the recent use of the injection device 10053. After a new medicament container 21 has been inserted into the interior of the container portion 7 and after, for example, the above combination has been performed Figure 6 After the described repeated reading procedure, the external electronic device 100 may provide a visual representation 1054 of a new and therefore sealed medication container 20 or container portion 7 and a corresponding indicator 156. In addition, a notification 1054 may be provided on the device display 1051 indicating to the user the number of available medication units provided in the medication container 21 and / or provided in the container portion 7.

[0201] Fig.11The scene before the attachment device 30 is attached to the proximal end of the injection device 1 is shown. Here, the transceiver 38 of the attachment device 30 is located inside the receiving portion 63. After the attachment device 30 is mounted to the proximal end of the injection device 1, and thus to the dose dial 8, the spatial distance between the transceiver 38 and the electronic device identifier 29 can be reduced to a minimum, thereby allowing the configuration of the electronic device identifier 29 to be read and / or the information stored in the electronic device identifier 29 to be read out.

[0202] In the event that the container information obtained from the electronic container identifier 89 matches the device information obtained from the electronic device identifier 29, the external electronic device 100 may be configured to indicate to the user the correct pairing of the body 6 and the container portion 7, such as Fig.12 Both the body 6 and the container part 7 can be individually identified by their respective electronic body identifiers 29 and electronic container identifiers 89. The matching of the medicament container 21 and / or the container part 7 with the body 6 can be visually demonstrated on the display 151 of the external electronic device 100, for example in the form of a graphic representation 153 of the identified or marked components and / or by a corresponding notification 154 indicating to the user that the individually identified or marked components of the injection device 1 match each other.

[0203] Typically, the external electronic device 100 can be permanently or periodically synchronized with the attached device, such as through a local range communication interface provided by the transceiver 39, 139. In this regard, any information collected or read by the attached device 30 can be immediately transmitted to the external electronic device 100, 100' and further processed, such as visualized, by the external electronic device.

[0204] for Fig.13 and Fig.14 In the example of the injection device 1, the injection device 1 comprises a detector arrangement 98 on or inside the body 6, which is operable to detect the mechanical connection between the body 6 and the container part 7. The machine-readable mark 28 is electrically connected to the detector arrangement 98. Due to the electrical connection between the detector arrangement 98 and the machine-readable mark 28, the machine-readable mark becomes indicative of the mechanical connection between the body 6 and the container part 7. In this way and by reading the machine-readable mark 28, for example by the additional device 38, the condition of the detector arrangement 98 can be detected and therefore determined.

[0205] Thus, the mechanical connection between the container portion 7 and the body 6 can be electronically read by the machine-readable mark 28. Fig.13 As shown, the machine-readable identification 28 may be implemented as an RFID tag 99 , an NFC tag, or a UWB tag.

[0206] Depending on the mechanical connection between the container part 7 and the body 6, the detector arrangement 98 can be switched into one of a first detector state and a second detector state. If the body 6 is connected to the container part 7, the detector arrangement 98 is in the first detector state. When the body 6 is disconnected from the container 7, the detector arrangement 98 is in the second detector state. Both the first and second detector states can be read electronically by the machine-readable identification 28.

[0207] As in Fig.13 and Fig.14 , the machine-readable identification 28 and the detector arrangement 98 are electrically connected by an electrical circuit 190. The electrical circuit 190 includes a first conductor 191 and a second conductor 192. In addition, the detector arrangement 98 includes an electromechanical switch 180. For example, and when the switch 180 is closed, the detector arrangement 98 is in a first detector state. When the switch 180 is open, the detector arrangement 98 is in a second detector state.

[0208] For other examples, when the detector arrangement is in the second detector state, the electromechanical switch 180 is closed. When the detector arrangement 98 is in the second detector state, the electromechanical switch 180 is open.

[0209] For Fig.13 In the example shown, the electromechanical switch 180 is operable to interrupt the electrical circuit 190. Thus, when the switch 180 is open, the electrical connection between the detector arrangement 98 and the machine-readable identification 28 is interrupted. By closing the electromechanical switch 180, an electrical connection between the detector arrangement 98 and the machine-readable identification 28 is established.

[0210] The electrical circuit 190 can be directly electrically connected to or integrated with or located in the electronic circuit 90 of the machine-readable identification 28 and / or its electronic identification 29. For some examples and by opening the switch 180, for example, the connection between the antenna 91 and the integrated circuit 93 of the electronic circuit 90 can be interrupted, and the machine-readable identification 28 can be disabled from wirelessly communicating with the attached device 30.

[0211] Only and exclusively after the switch 180 is closed, the electronic circuit 90 is closed and the electronic identifier 29 and therefore the machine-readable identifier 28 are able to communicate with the additional device 30 .

[0212] for Fig.13 and Fig.14, the distal end 67 of the body 6 is provided with a receiving portion 165 for receiving a complementary shaped insertion section 170 provided at the proximal end of the container part 7. The body 6 includes a side wall 161 limiting the receiving portion 160. The side wall 161 is provided with a distal end face 163 facing the distal direction 2. The end face 163 is configured to engage with a stepped portion 173 provided on the outer surface of the side wall 171 of the container part 7, i.e., longitudinally abut.

[0213] Here, the insertion section 170 protrudes from the stepped descending portion 173 in the proximal direction 3. Compared to the tubular portion of the side wall 171 extending distally from the stepped descending portion 173, the insertion section 170 comprises a smaller diameter.

[0214] On the inner surface 162 of the receiving portion 160, a fastening structure 164 is provided which is complementary in shape to a mating fastening structure 174 on the outer surface 172 of the side wall 171 of the container part 7 and thus on the insertion section 170. The fastening structure 164 comprises a groove 165 which is configured to engage with a complementary shaped protrusion 175 of the mating fastening structure 174.

[0215] The groove 165 may include one of an L-shaped groove and a bayonet groove, such as Fig.14 The groove 165 may be delimited in tangential or circumferential direction by a stop 166 which provides a well-defined end stop for the interconnection between the fastening structure 164 and the mating fastening structure 174. As an alternative to the illustrated example, it is also conceivable to provide an internal thread on the inner surface 162 and an external thread on the outer surface 172.

[0216] The electromechanical switch 180 may include a movable contact spring 181 that is movable in a manner such as Fig.14 In the open configuration shown, the contact spring 181 at least partially extends into the groove 164. The contact spring 181 is permanently connected to the second wire 192. Due to the inherent spring force, the contact spring 181 tends to disengage from the first wire 191. Only and exclusively after the mechanical connection between the container part 7 and the body 6 is established, the actuating element 182 arranged on the outer surface 172 of the insertion section 170 engages the contact spring 181, thereby electrically connecting the contact spring 181 with the first wire 191, thereby closing the electrical circuit 190.

[0217] The actuating element 182 may coincide with a protrusion 175 provided on the outer surface 172 of the insertion section 170. By attaching and thus fastening the insertion section 172 to the receiving portion 160, the protrusion 175 slides along the groove 165 until it reaches the stop 166. When in this particular stop position, the protrusion 175 engages with the contact spring 181 and establishes a corresponding electrical connection between the first wire 191 and the second wire 192.

[0218] Thus, when the mutual fastening configuration is reached between the body 6 and the container portion 7, the electrical circuit 190 is closed.

[0219] exist Fig.17 In FIG. 1 , an example of an implementation of an electrical circuit 190 is shown. Here, the switch 180 may be directly connected to the first and second input terminals 194, 195 of the integrated circuit 93 of the machine-readable identification 28. Fig.17 In the example of FIG. 1 , opening the switch 180 may disconnect the terminals 194, 195, thereby disabling the wireless communication function of the integrated circuit 93. Here, and by opening the switch 180, the integrated circuit 93 may be disconnected from the antenna 91. Only after the switch 180 is closed, an electrical connection may be provided between the antenna 91 and the integrated circuit 93, thereby enabling the wireless communication function of the machine-readable identification 28.

[0220] For this example, it is required or expected that the additional device 30, when attached to the injection device 1, periodically submits or requests status information from the machine-readable identification 28. Here, the additional device 30 can be configured to transmit or send a corresponding request to the machine-readable identification. As long as the container portion 7 is not connected to the body portion 6, and as long as the switch 180 is turned on, the machine-readable identification 28 cannot respond to the request of the additional device 30.

[0221] for Fig.18 In another example, in addition to the first and second input terminals 194, 195, the integrated circuit 93 is also provided with a GPIO terminal 196. Here, the first terminal 194 and the GPIO terminal 196 are connected to each other through a resistor 197. The switch 180 is arranged between the other input terminal 195 and the GPIO terminal. In this way, a pull-up resistor for improved signal detection is provided. Therefore, when the switch 180 is closed, a well-defined voltage is provided at the GPIO terminal 196, which can be easily detected by the integrated circuit 93.

[0222] for Fig.18 For example, it is also required or expected that the attachment device 30, when attached to the injection device 1, periodically transmits or requests status information from the machine-readable identification 28 indicating the configuration or status of the detector arrangement 98.

[0223] For according to Fig.19 Another example of Fig.18 Here, the GPIO terminal 196 and the second input terminal 195 are connected to each other via a capacitor 198. When the switch 188 is closed, the capacitor 198 will be charged.

[0224] By opening the switch 180, for example, during the process of disconnecting the container portion 7 from the body 6, the capacitor 198 can detect the discharge of the capacitor by the integrated circuit 93, and / or the discharged capacitor temporarily provides power to the integrated circuit to, for example, submit status information to the additional device 30. Therefore, the capacitor 198 can be configured to at least temporarily provide power to the integrated circuit 93 when the switch 180 is opened.

[0225] Fig.19 The example can also provide an automatic wake-up function for the integrated circuit 93, that is, when the switch 180 is closed or opened. Fig.19 In the example of FIG. 6 , it may be particularly beneficial to keep the switch 180 closed when the container part 7 is disconnected from the body 6 , and to open the switch 180 when the container part 7 is attached to the body 6 .

[0226] It is also conceivable that the switch 180 remains open when the container portion is disconnected from the body 6, and that the switch 180 is closed when the container portion 7 is attached and connected to the body 6. In either way and through the capacitor 198, the integrated circuit 93 may be operable to obtain power to wirelessly indicate a change in state of the switch arrangement 98, which can be read and / or detected by the attachment 30 when the attachment is attached to the injection device 1.

[0227] The embodiment of the detector arrangement 98 on or inside the body of the injection device 1 is beneficial so as to be able to electronically read or electronically detect when the container part 7 is correctly assembled or attached to the body 6. Here, it is sufficient when the injection device does not have any active electrical or electronic components. The detector arrangement 98 can be implemented exclusively by an electromechanical switch 180 connected to an integrated circuit 93 of an electronic device identifier 28, which can be implemented as a passive radio frequency tag.

[0228] The electrical connection between the detector arrangement 98 and the machine-readable mark 28 allows for detection and / or recording of the mechanical connection of the body 6 to the container portion 7, wherein the proximal end of the container portion 7 is capable of being connected to or is actually connected to the distal end 67 of the body 6. The machine-readable mark 28 can be disposed at or near the proximal end 68 of the body 6 and can provide near field communication with the attachment 30 within a transmission range that is shorter than the longitudinal distance between the detector arrangement 98 and the machine-readable mark 28.

[0229] In order to record the dosing history and / or calculate the remaining amount of medicine remaining in the medicine container 21, the additional device 30 is operable to constantly and / or periodically check the condition of the detector arrangement 98 so as to assert that the connection between the container portion 7 and the main body 6 is maintained during the recording of the dosing history and / or during the calculation of the remaining amount of medicine remaining in the medicine container 21.

[0230] exist Fig.23 In the flowchart of FIG. 1 , a typical scenario of using the injection system 120 is schematically shown. In an initial step 200, the attachment 30 is assembled to the injection device 1. During the initial assembly process, the attachment 30 may be properly calibrated. In step 201, dose history recording is started.

[0231] In optional step 202 , status information indicative of the configuration of the injection device 1 and / or indicative of the configuration or specific features of the medicament container 21 may be written or stored in any of the memories 92 of the electronic device identifier 28 and / or the electronic container identifier 89 .

[0232] In steps 202 and / or 203, the presence of the electronic device identifier 28 and thus the presence of the machine-readable identifier 28 is repeatedly and thus permanently monitored to a certain extent by requesting a corresponding response from the machine-readable identifier 28. In step 203, the additional device 30 can be and remain in a corresponding standby mode, during which corresponding presence requests for the electronic device identifier 29 and thus for the machine-readable identifier 28 are regularly performed.

[0233] In step 204, it is checked whether the communication link between the attachment 30 and the machine-readable identifier 28 has been lost. If the communication between the machine-readable identifier 28 and the attachment 30 is to be interrupted, the method proceeds to step 212. Then, and in a subsequent step 213, the electronic module 34 generates an alarm, which can be indicated to the user via the signal generator 52. For example, a flashing light implemented by the identifier 55 (e.g. integrated into the movable part 70 of the attachment 30) can provide a visual alarm signal, for example in the form of a flashing light.

[0234] In subsequent step 214, the additional device 30 can communicate with the external electronic device 100 to stop calculating the remaining amount of the medicine of the corresponding medicine container. Here, the recorded administration history and / or remaining amount calculation can be discarded to prevent the patient or healthcare provider from using such information that may have become invalid due to the premature replacement of the medicine container 21.

[0235] As long as the presence of the machine-readable mark 28 and / or the indication container part 7 is connected to and remains connected to the body 6 is confirmed in step 204, the program continues to step 205. Here, the user can set the dose to be injected by the injection device. In step 206, the sensor 48 of the electronic module 34 can be awakened by performing the dose setting.

[0236] In the following step 207, and after or during the dispensing of a dose of medicament, the corresponding dose dispensing event is recorded. The dose injection recorded in step 207 is then subjected to a plausibility check in step 210. Here, the recorded or detected dose dispensing information is compared or confirmed with status parameters of the injection device 1 and / or with status parameters of the medicament container 21.

[0237] In step 208, it is detected whether the user disconnects the container part 7 from the body 6. A reconnection of the container part 7 to the body 6 may also be recorded and / or detected in step 208. In a subsequent step 209, a correspondingly modified condition of the injection device 1 may be recorded and / or stored in the memory 92 of the electronic device identifier 29 and thus in the machine-readable identifier 28.

[0238] The status information provided by the machine-readable identification 28 can always be compared with the recorded administration event of step 207. This comparison is performed in step 210. Typically, this rationality check should be performed before, during or after each dose injection record. This enables the attachment 30 to check the connection status between the container part 7 and the body 6 at the latest, and simplifies, for example reduces, the power consumption of the attachment 30. Here, each injection may only require one wireless read request between the machine-readable identification 28 and the attachment 30.

[0239] If the plausibility check 210 is successful, the procedure continues to step 211. Here, recording of the dose history and / or calculation of the remaining amount of medicament left in the medicament container 21 continues.

[0240] In case the detector arrangement 98 is electrically connected to the machine-readable identification 28, the correct installation and / or configuration of the injection device 1 can be permanently monitored by the additional device 30. In this way, patient safety can be enhanced and unintentional or unauthorized use of the injection device 1 can be at least hindered or even prevented.

[0241] Reference numerals

[0242] 1 Injection device

[0243] 2 Distal direction

[0244] 3 Proximal direction

[0245] 4 Dose escalation direction

[0246] 5 Dose reduction direction

[0247] 6 body

[0248] 7 Container part

[0249] 8-dose dial option

[0250] 9 Triggers

[0251] 10 Housing

[0252] 11 Connectors

[0253] 12-pin assembly

[0254] 13. Injection needle

[0255] 14 Inner needle cap

[0256] 15 Outer needle cap

[0257] 16 Protective cap

[0258] 17 Tags

[0259] 18 Piston

[0260] 19 Piston rod

[0261] 20 Driving mechanism

[0262] 21 Medicine Container

[0263] 22 Cylinder

[0264] 23 Seals

[0265] 24 Pharmacy

[0266] 25 Exit

[0267] 26 Window

[0268] 27 Dial extension

[0269] 28 Logo

[0270] 29 Electronic device identifiers

[0271] 30 Additional devices

[0272] 34 Electronic modules

[0273] 36 Printed Circuit Board

[0274] 37 Reader

[0275] 38 Transceiver

[0276] 39 Transceiver

[0277] 40 Module Memory

[0278] 42 clock

[0279] 44 Module Processor

[0280] 46 Power Supply

[0281] 48 Sensors

[0282] 50 Indicator

[0283] 51 Display

[0284] 52 Signal Generator

[0285] 53 Display Segment

[0286] 54 Display Segments

[0287] 60 Device body

[0288] 61 Sidewall

[0289] 62 flange part

[0290] 63 Reception Department

[0291] 64 Fastening rib

[0292] 65 Alignment Features

[0293] 66 Mating Alignment Features

[0294] 66 Neck

[0295] 67 Far End

[0296] 68 Proximal

[0297] 69 extension

[0298] 70 Movable part

[0299] 80 Dose setting element

[0300] 81 driving components

[0301] 82 Volume indicator

[0302] 83 Encoding

[0303] 85 Locking mechanism

[0304] 86 Lock Controller

[0305] 88 Logo

[0306] 89 Electronic container markers

[0307] 90 Electronic Circuits

[0308] 91 Antenna

[0309] 92 Memory

[0310] 93 Integrated Circuits

[0311] 94 processors

[0312] 95 substrate

[0313] 96 Power Supply

[0314] 97 Adhesive layer

[0315] 98 Detector Arrangement

[0316] 99 RFID tags

[0317] 100 Electronic devices

[0318] 101 Housing

[0319] 103 Wristband

[0320] 110 hands

[0321] 111 Wrist

[0322] 112 Palm

[0323] 114 Thumb

[0324] 116 fingers

[0325] 120 Injection System

[0326] 137 Device Reader

[0327] 138 Device transceiver

[0328] 139 Device transceiver

[0329] 140 Device Memory

[0330] 144 Device Processor

[0331] 146 Device power supply

[0332] 151 Device Display

[0333] 152 Device Signal Generator

[0334] 153 Graphics

[0335] 154 Notice

[0336] 156 Indicator

[0337] 160 Reception Department

[0338] 161 Sidewall

[0339] 162 Inner surface

[0340] 163 End face

[0341] 164 Fastening structure

[0342] 165 Grooves

[0343] 166 Stopper

[0344] 170 Insert section

[0345] 171 Sidewall

[0346] 172 External surface

[0347] 173 Stepped section

[0348] 174 Paired fastening structure

[0349] 175 Protrusion

[0350] 180 Switch

[0351] 181 Contact spring

[0352] 182 Actuating element

[0353] 190 Electrical Circuits

[0354] 191 Wire

[0355] 192 Wire

[0356] 194 terminal

[0357] 195 terminal

[0358] 196 general input / output terminals

[0359] 197 Resistors

[0360] 198 Capacitor

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) and a container part (7), wherein the container part (7) is configured to accommodate a medicament container (21) and wherein the container part (7) is detachably connectable to the body (6), 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 machine-readable marking (28; 88) on or in one of the body (6) and the container part (7), a detector arrangement (98) arranged on or in one of the body (6) and the container part (7) and operable to detect a mechanical connection between the body (6) and the container part (7), - wherein the machine-readable marking (28; 88) is electrically connected to the detector arrangement (98) and can be read by an electronic module (34) of an additional device (30) that can be connected to the injection device (1), and wherein the machine-readable marking indicates a mechanical connection between the body (6) and the container part (7).

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

3. Injection device (1) according to any one of the preceding claims, wherein: The detector arrangement (98) includes an electromechanical switch (180) on or in one of the body (6) and the container portion (7), and wherein the other of the body (6) and the container portion (7) includes an actuating element (182) configured to engage the electromechanical switch (180) when the container portion (7) is connected to the body (6) and configured to disengage the electromechanical switch (180) when the container portion (7) is disconnected from the body (6).

4. Injection device (1) according to any one of the preceding claims, wherein: One of the body (6) and the container portion (7) includes an insertion section (170), and wherein the other of the body (6) and the container portion (7) includes a receiving portion (160) sized to receive the insertion section (170), and wherein the detector arrangement (98) is disposed on an outer surface (172) of the insertion section (170) or on an inner surface (162) of the receiving portion (160).

5. The injection device (1) according to claim 3 or 4, wherein: The electromechanical switch (180) is arranged in or on the fastening structure (164) of the main body (6), and the actuating element (182) is arranged in or on the matching fastening structure (174) of the container part (7), wherein the container part (7) and the main body (6) can be fastened to each other by mechanical engagement of the fastening structure (164) with the matching fastening structure (174).

6. Injection device (1) according to any one of the preceding claims, wherein The body (6) includes a distal end (67) and an oppositely positioned proximal end (68), wherein the machine-readable marker (28) is positioned closer to the proximal end (68) than the detector arrangement (98), and / or wherein the detector arrangement (98) is positioned closer to the distal end (67) than the machine-readable marker (28).

7. Injection device (1) according to any one of the preceding claims, wherein The machine-readable identification (28; 88) includes an electronic circuit (90), wherein the electronic circuit (90) includes an antenna (91) and an integrated circuit (93) operable to wirelessly communicate with an electronic module (34) of the attachment (30).

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

9. Injection device (1) according to any one of the preceding claims, wherein: The machine-readable identification (28; 88) includes a memory (92) configured to store at least one of device information, container information, and usage-related data.

10. Injection device (1) according to any one of the preceding claims, wherein The detector arrangement (98) is configured to enter a first detector state when the body (6) is connected to the container part (7), and is further configured to enter a second detector state when the body (6) is disconnected from the container part (7).

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

12. 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), - at least one of a reader (37) and a transceiver (38, 39) operable to read a machine-readable identification (28; 88) of the injection device (1) and to generate a read signal, - an electronic module (34) comprising a module processor (44) coupled to the reader (37) and at least one of the transceivers (38, 39), wherein the module processor (44) is operable to process the read signal to determine whether the container portion (7) is connected to the body (6).

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

14. The attachment (30) according to claim 12 or 13, further comprising a sensor (48) operable to quantitatively determine at least one of a position and a movement of a movable component (80, 81, 82, 83) of the drive mechanism (20) 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, and 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.

15. The attachment (30) according to claim 14, wherein: The electronic module (34) further comprises a module memory (40) connected to the module processor (44) and operable to store a dosing history comprising a plurality of dose sizes dispensed or injected by the injection device (1) and determined or calculated by the module processor (44).

16. The attachment (30) according to claim 15, wherein: The module processor (44) is operable to determine or calculate the remaining amount of the medicine (24) contained in the medicine container (21) based on the administration history and based on the connection status between the body (6) and the container part (7).

17. An injection system (120) comprising an injection device (1) according to any one of the preceding claims 1 to 11 and comprising an additional device (30) according to any one of the preceding claims 12 or 16.

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

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