Additional device for injection device

Abstract

In one aspect, the present disclosure relates to an add-on device (30) for an injection device (1), where the injection device (1) comprises a barrel (10) filled with a medicament (8) and sealed by a stopper (9), where the stopper (9) is movable relative to the barrel (10) in a distal direction (2) to expel a dose of medicament (8), and where the injection device (1) comprises a machine-readable marker (22), where the machine-readable marker (22) is located in the barrel (10). The invention relates to an add-on device (30) for a machine-readable marker attached or integrated into a barrel (10) or housing (11) of an injection device (1), the add-on device (30) comprising:-a body (60),-a fastening structure (94, 94 ') connected to or integrated into the body (60) and configured to be detachably connected to a stopper (9),-an electronic module (34) inside the body (60), the electronic module (34) comprising a reading unit (39), the body (60) and the fastening structure (94, 94 ') are connected to the barrel (10), and the reading unit is operable to read information stored in or provided by the machine-readable marker (22),-wherein, when connected to the stopper (9), the body (60) and the fastening structure (94, 94') are configured to transmit a driving force imposable by a user onto the stopper (9) to cause movement of the stopper (9) relative to the barrel (10).

Description

Technical Field

[0001] This disclosure relates to auxiliary or additional devices for use with injection devices, such as syringes, safety syringes, or pen syringes. In another aspect, this disclosure relates to an injection system comprising an injection device and additional devices. In yet another aspect, this disclosure relates to a method for monitoring the use of an injection device or injection system for injecting pharmaceutical agents. Background Technology

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

[0003] Medication delivery devices (such as pen injectors) must meet many user-specific requirements. For example, patients with chronic diseases such as diabetes may be frail and visually impaired. Therefore, suitable medication delivery devices specifically designed for home use need to be robust and easy to use. Furthermore, the manipulation and general operation of the device and its components should be clear and easy to understand. Such injection devices should provide the setting and subsequent dispensing of equal or variable doses of medication. Moreover, the dosage setting and dispensing procedures must be easy to operate and unambiguous.

[0004] Patients with certain diseases may need to receive a certain amount of medication via pen syringe.

[0005] Some drug delivery or injection devices allow for the selection of variable-sized drug doses and the injection of pre-set doses. Other injection devices offer fixed-dose settings and dispensing. Here, the dose of drug that should be injected according to a given prescription schedule remains the same and does not change or cannot be changed over time.

[0006] Some injection devices are implemented as reusable injection devices, allowing users to replace the medication container (such as a cartridge). Other injection devices are implemented as single-use injection devices. For single-use injection devices, the design is to discard the entire injection device when the contents (i.e., the medication) have been used up.

[0007] To control and monitor medication administration by the user or patient themselves, it is desirable to provide automated detection and recording of repetitive and regular use of drug delivery devices. Highly automated recording of user-injected doses offers significant advantages in terms of safety and convenience compared to manual dose recording.

[0008] There are many additional or auxiliary devices configured for use with injection devices, which typically provide electronic detection and monitoring of single-dose or repeated-dose injection procedures.

[0009] Additional devices or auxiliary devices can be detachably attached to the injection device. These additional devices typically include sensors, detectors, or detector arrangements operable to detect the date and / or time when a dose of medication is set or injected by the user. Some additional devices also provide a quantitative measurement of the currently set or dispensed dose. Some additional devices are designed for use with a series of injection devices. This can be particularly suitable for disposable injection devices intended to be discarded after use or when the medication within is depleted.

[0010] For certain types of injection devices, such as pre-filled syringes or pre-filled safety syringes, the use and user acceptance of auxiliary or additional devices face considerable challenges because these syringes or safety syringes may be intended for single use. To some extent, the detachable connection or coupling of the additional device to the corresponding injection device should be fairly simple and fail-safe.

[0011] Therefore, it is desirable to provide an add-on device specifically configured for use with pre-filled syringes or safety syringes, which provides enhanced functionality in detecting dose completion and recording drug-related data. Simultaneously, the design and construction of the add-on device should be quite simple and cost-effective to manufacture. It should also generate high user acceptance. Furthermore, the disposal and use of the add-on device should be quite easy, intuitive, and easy to understand. Summary of the Invention

[0012] In one aspect, an additional device for an injection apparatus is provided. The injection apparatus includes a cartridge filled with a pharmaceutical agent and sealed by a stopper. The stopper is movable in a distal direction relative to the cartridge to dispense a dose of the pharmaceutical agent. The injection apparatus includes a machine-readable identifier (e.g., in the form of an electronic identifier) ​​attached to or integrated into one of the cartridge and housing of the injection apparatus. The housing of the injection apparatus may optionally be provided and houses the cartridge filled with the pharmaceutical agent. The machine-readable identifier may be fixedly attached (i.e., non-removably attached) to one of the cartridge and housing.

[0013] The attachment includes a body and a fastening structure connected to or integrated into the body. The fastening structure is configured to be detachably connected to or detachably fastened to a stopper of the injection device. The attachment further includes an electronic module within the body. The electronic module includes a reading unit operable to read information stored in or provided by a machine-readable identifier.

[0014] When connected to the stopper, the body and fastening structure are configured to transmit a user-applied driving force to the stopper to cause movement of the stopper relative to the cylinder.

[0015] In some examples, when the body is attached to the stopper, the body and the stopper are in a thrust-transfer configuration. This means that a user-applicable driving force applied to the body is transmitted to the stopper to cause a corresponding movement of the stopper relative to the cylinder.

[0016] In some examples, the connection between the plug and the body is rigid under compression. Here, the user can apply a distal thrust or pressure to the body of the attachment, which, due to the connection between the body and the plug, is immutably translated into a corresponding movement of the plug relative to the cylinder.

[0017] In some examples, the attachment is configured to attach to a component in a force transmission path or drive system, or to be operable to convert an injection force applied or provided by the user into a corresponding movement of the plug relative to the cylinder to expel a dose of the drug from the cylinder.

[0018] In some examples, the syringe barrel includes an outlet at its distal end. A stopper can be used to close or seal the barrel towards the opposite proximal end. The body, when connected to the stopper, is operable to transmit a distally directed dispensing force to the stopper, causing it to move distally for dose dispensing through the outlet of the barrel.

[0019] The outlet of the barrel is typically in fluid communication with the injection needle. The injection needle may be attached to or integrated into the outlet of the barrel.

[0020] In some examples, the fastening structure provides a direct or indirect connection between the body of the attachment and the stopper of the injection device. In some examples, the stopper of the injection device or the injection device may include an elongated plunger that can be pressed distally by a user to move the stopper distally for dose dispensing.

[0021] In other examples, the stopper may engage with a separate plunger. The plunger may be supplied separately from the injection device, and the user may need to establish a connection between the plunger and the stopper. Here, the fastening structure of the attachment is implemented in or at the separate plunger. The fastening structure and / or the separate plunger may be part of an attachment that includes such a plunger. Therefore, the size of the elongated plunger configured to attach to the stopper or to abut against the stopper of the injection device is set to enter the barrel from the proximal direction toward the distal direction to transmit the corresponding driving or dispensing force to the stopper.

[0022] Accordingly, in some examples, when the fastening structure is integrated into the body, the body itself, or a portion thereof, with the fastening structure can be detachably connected to the plug of the injection device. In other examples, the fastening structure can provide an indirect mechanical connection or link between the attachment and the plug of the injection device.

[0023] In some examples, a separate plunger (e.g., in the form of an elongated rod) can be provided to engage with the proximal thrust receiving surface or proximal end of the plug. Here, the fastening structure of the attachment can be configured to attach to the proximal end of such a separate plunger. The separate plunger can serve as part of the force transmission path or drive system between the body and the plug of the injection device.

[0024] This additional device offers particular advantage because it provides dual functionality. It reads information stored in or provided by a machine-readable identifier on the injection device. Furthermore, the additional device can function as an auxiliary device during the dosing procedure. The additional device itself can be arranged or can be part of a force transmission path or corresponding drive system through which a user-applied driving force can be transmitted to the stopper to dispense a dose of medication. Thus, by arranging the additional device in a transmission path or drive system between the stopper of the injection device and a part of the user's body (e.g., the user's finger, operable to apply the corresponding driving force), the additional device can provide further functionality in recording or detecting drug administration or injection events (such as the start and / or completion of a dosing procedure).

[0025] In a further example, the attachment includes a thrust receiving surface operable to receive a driving force that can be applied by a user. The thrust receiving surface is fastened to the body of the attachment. It can be integrated into the body of the attachment.

[0026] The thrust receiving surface can be located at the proximal end of the add-on device. It can constitute the proximal surface of the add-on device. Typically, the thrust receiving surface of the add-on device can be directly attached and / or pressed by the user to inject a dose or trigger a dose injection procedure. In some examples, the thrust receiving surface can be provided by a cover, button, or cap of the add-on device, which can be displaced relative to the housing or body of the add-on device. Therefore, the thrust receiving surface can be integrated into a dispensing button or operating button of the add-on device, which can be pressed by the user to, for example, activate, actuate, or control the operation of the add-on device.

[0027] In a further example, the electronic module of the add-on device includes a processor. This electronic module and / or processor is operable to detect the completion of an injection performed by the injection device. Various examples may exist regarding how the injection completion function can be implemented in the add-on device. Nevertheless, regardless of the specific dose completion detection provided by one or both of the processor or electronic module, the add-on device can automatically track or detect when the dose injection process has been completed. Through an electronic module operable to read information stored in or provided by a machine-readable identifier, the corresponding information obtainable from the machine-readable identifier can be paired or combined with dosing information (such as the date and / or time when the corresponding dose of medication has been injected).

[0028] According to a further example, the electronic module includes a clock connected to the processor and operable to provide a clock signal. The electronic module is operable to buffer or store the clock signal or a timestamp derived therefrom when injection is detected as complete. In this way, drug-related information (i.e., information indicating the date and / or time when the dose of drug has been injected), which is available as by reading the machine-readable identifier of the injection device and the corresponding dosing information, can be combined and stored, for example, in the memory of an additional device.

[0029] In this way, a dosing history can be provided when the user uses the add-on device for multiple dosing procedures. If the injection device only delivers a single dose, the user will be prompted to disconnect the add-on device from the used injection device and reconnect it to another injection device for use in subsequent dosing procedures.

[0030] According to a further example, the electronic module includes a memory connected to a processor. The processor is configured to perform at least one of the following operations: storing data in the memory and reading data from the memory. The memory can be implemented as a digital memory. It can include volatile or non-volatile memory. Through the memory, data indicating dosing procedures and / or data obtained or acquired from machine-readable identifiers can be stored in the memory individually or in combination. Providing the memory allows for the collection of data indicating multiple dosing procedures and / or multiple drug doses injected by one or more injection devices.

[0031] In some examples, machine-readable identifiers include one of electronic identifiers and visible or optically readable identifiers. When implemented as electronic identifiers, machine-readable identifiers include wireless tags, such as RFID tags, NFC tags, or any other short-range or near-field communication units. Information stored in or provided by machine-readable identifiers may include pharmaceutical-related information, electronic information, or data, such as the name of the pharmaceutical product, the name of the pharmaceutical substance, the concentration of the pharmaceutical product, batch number, LOT number, manufacturing date, manufacturing location, expiration date, and / or the temperature at which the pharmaceutical product should be stored or has been stored.

[0032] In a further example, the processor of the electronic module is connected to the reading unit and is operable to process electronic signals from the reading unit to detect the completion of the injection. Here, the reading unit, which is originally capable of reading information stored in or provided by a machine-readable identifier on the injection device, is further configured to detect the completion of the dosage injection procedure. To some extent, the reading unit and its interaction with the machine-readable identifier provide a dual function. On the one hand, it is used to read information stored in or provided by the machine-readable identifier. On the other hand, the interaction between the machine-readable identifier and the reading unit of the auxiliary device enables the detection of the completion of the dosage injection procedure. To some extent, through the interaction between the reading unit and the machine-readable identifier, all the information required for storing and / or providing the dosing history (indicating a specific drug and the time or date when the specific drug was injected) can be obtained or received solely from the reading unit.

[0033] In a further example, the processor, when connected to the reading unit, can also operate to detect the start of the dose injection procedure. Accordingly, the dose injection process can be monitored fairly precisely through interaction with the reading unit of the machine-readable identifier of the injection device and the electronic module of the auxiliary device.

[0034] According to a further example, the additional device includes an elongated plunger extension comprising an elongated rod extending in a longitudinal direction. The plunger extension (and thus the elongated rod) is attached to or integral with the body and projects distally from the bottom or flange portion of the body. The elongated plunger extension further includes a fastening structure at its distal section for engagement or abutment with a plug. The fastening structure may be located at the distal end of the elongated rod of the plunger extension. The fastening structure may form or constitute the distal end or distal section of the elongated rod (and thus the elongated plunger extension).

[0035] The elongated rod and / or the elongated plunger extension is a mechanically rigid component. It is rigid or stiff, at least in the longitudinal direction. The elongated plunger extension or elongated rod is operable to provide force transmission from the bottom or flange portion of the body of the auxiliary device to the plug of the injection device. In some examples, the elongated plunger extension can replace the separate plunger of the injection device, which was originally configured to allow the user to apply distal pressure or driving force to the plug to drive the plug distally relative to the barrel of the injection device.

[0036] In some examples, the elongated plunger extension may be detachably connected to the bottom or flange portion of the body. The body of the add-on may include a cylindrical shape. It may include cylindrical sidewalls that are closed distally by a bottom or flange portion having a relatively flat shape. The sidewalls of the body may be closed proximally by a thrust receiving surface. The thrust receiving surface may be provided on a cap or cover portion that seals or closes the proximal end of the sidewalls of the body proximally. The cap may be movable longitudinally relative to the sidewalls of the body. Here, the cap may replace or mimic the dosage button of an injection device. In some examples, the body of the add-on may include a receiving portion toward its distal end. Here, the bottom or flange portion located at or near the distal end of the sidewalls of the body may be arranged to be slightly recessed relative to the distal end of the sidewalls to form or provide the receiving portion.

[0037] The size of the receiving portion can be set to engage with or receive the plunger flange of the syringe plunger. Here, the fastening structure of the auxiliary device can be provided at the distal end of the side wall of the body (the distal end may be provided with a fastening structure (such as the receiving portion)) to engage with the plunger flange of, for example, a prefilled syringe or a prefilled safety syringe.

[0038] In a further example, the elongated plunger extension may be detachably attached to the bottom or flange portion of the body. When attached to the body, the plunger extension projects distally from the body and provides a plunger to transmit the driving force applied by the user to the stopper of the injection device. The distal end of the plunger extension is then attached to the stopper.

[0039] In a further example, the reading unit is a wireless reading unit, which includes an antenna located on or inside an elongated plunger extension. The antenna can be configured for wireless signal transmission and / or for wireless signal exchange with a machine-readable identifier, which can be implemented as an electronic identifier (such as a wireless tag).

[0040] In a further example, the reading unit is an optical reader or includes an optical reader operable to capture optical signals emitted by or reflected from a machine-readable identifier. Here, the machine-readable identifier may be provided with a machine-readable visual code that can be read by the optical reader or detector.

[0041] In other examples, machine-readable identifiers may include magnetically coded identifiers. Here, the reading unit includes a corresponding magnetic reading device.

[0042] By arranging the antenna on or within the elongated plunger extension, it is possible to make the antenna (and therefore the wireless reading unit) operable to exchange wireless signals with the electronic tag of the machine-readable tag only when the elongated plunger extension has moved the plug in a distal direction and the plug has reached a predefined position relative to the cylinder (and therefore relative to the machine-readable tag).

[0043] In some examples, the transmission range between the machine-readable identifier and the reading unit of the electronic module is less than the longitudinal extension of the barrel of the auxiliary device. This range may be less than 50% of the longitudinal extension of the barrel. In further examples, the transmission range between the machine-readable identifier (e.g., an electronic identifier) ​​and the reading unit or antenna of the auxiliary device is less than 30%, less than 25%, or even less than 20% of the barrel elongation. In some examples, the machine-readable identifier is a passive electronic identifier, and the transmission range of the reading unit is less than 50%, less than 30%, less than 25%, or less than 20% of the barrel elongation.

[0044] In this way, when the injection device is in its initial configuration (in which the stopper is positioned at a clearly defined longitudinal distance from the machine-readable identifier), it is possible to effectively disable the reading unit from reading information stored in or provided by the electronic or machine-readable identifier. To enable reading of information stored in or provided by the machine-readable identifier, the reading unit needs to be brought close to the machine-readable identifier. When the reading unit, its antenna, or some other signal receiving component is positioned on or inside the elongated plunger extension, the longitudinal distance between the machine-readable identifier and the reading unit can be effectively reduced during the dose injection process (i.e., when an auxiliary device with the elongated plunger extension is displaced distally relative to the cylinder, thereby pushing the stopper distally to dispense the dose).

[0045] When the dose end configuration is reached, the machine-readable identifier, which is usually fixed on the cylinder, begins to enter or be within the transmission range of the reading unit, thereby allowing or enabling the reading of the corresponding information stored in or provided by the machine-readable identifier.

[0046] In a further example, the antenna or similar signal receiving unit of the reading unit is located or arranged at or near the distal section of the elongated plunger extension. Accordingly, a machine-readable identifier, for example in the form of a wireless antenna, is arranged in a longitudinal position on the cylinder or housing, which overlaps with the position of the plunger when the plunger has reached the dose-end position or when the injection device is in the dose-end configuration. In this way, it is possible to achieve that the antenna only overlaps longitudinally with the machine-readable identifier after the injection process has begun and when the plunger has moved from the proximal stop position toward the distal position.

[0047] In a further example, at least partial geometric overlap between the antenna and the machine-readable identifier will only occur when the dose-end configuration of the injection device is reached (or about to be reached). In this way, reading of the machine-readable identifier is only enabled at the end of the full dose injection procedure.

[0048] In other examples, machine-readable identifiers are arranged on the cylinder in such a way that once the plug has moved a predefined distance toward the distal direction from a predefined initial position and has reached a predefined intermediate position, access to information stored in or provided by the electronic identifier can be enabled.

[0049] In a further example of the add-on device, the reading unit is inoperable to read information stored in or provided by the electronic tag when and as long as the electronic tag is outside the transmission range of the reading unit. In some examples, the transmission range of the reading unit is relatively small. This transmission range can be less than 5 cm, 3 cm, 2 cm, or even less than 1 cm. In this way, as long as the injection device with the add-on device attached is in its initial configuration (in which the longitudinal distance between the plug and, therefore, the antenna of the wireless reading unit exceeds the transmission range), reading of information stored in or provided by the electronic tag is effectively disabled. This reading is only enabled during or after the dose injection is completed, accompanied by the distalization of the add-on device and the antenna disposed in or on the elongated rod of the plunger extension.

[0050] In a further example, the reading unit is operable to read information stored in or provided by an electronic tag when at least one segment of the antenna overlaps or aligns with an electronic tag and / or a machine-readable tag relative to the longitudinal direction. Reading of information stored in or provided by the electronic tag can be achieved when the corresponding overlap configuration is reached. Enabling the reading of the electronic tag or machine-readable tag can further be used as a trigger for recording a clock signal or a timestamp obtainable from the clock of the electronic module.

[0051] In some examples, transmitting a machine-readable identifier (e.g., an electronic identifier) ​​to the transmission range of the reading unit during or at the end of a dosing procedure can serve as a detector that dosing is in progress or has been completed. In this way, the reading unit provides a dual function. It provides and reads information stored in or provided by a machine-readable or electronic identifier on the injection device, and further provides a trigger for recording a timestamp indicating the date and / or time on which the injection device has administered the corresponding medication or a given dose of the corresponding medication.

[0052] In a further example, the electronic module includes a dose-end sensor disposed on or integrated into the body. The dose-end sensor is configured to detect at least one of a predefined position or movement of the body relative to the barrel or housing of the injection device. The dose-end sensor can operate independently or separately from the readout unit. It can be connected separately to or coupled to the processor of the electronic module. The dose-end sensor is specifically configured to detect a dose-end configuration of the injection device, i.e., a situation where the stopper has reached a defined end position relative to the barrel.

[0053] When the add-on is attached to the plunger flange, or when the add-on forms a plunger flange that can be manually pressed by the user to inject a dose, the dose-end sensor can be operated to detect mechanical contact between the add-on and, for example, the barrel of the injection device. The dose-end sensor can be further configured to measure the distance between the add-on and the barrel of the injection device. In some examples, the dose-end sensor can interact with a radially outwardly projecting flange (e.g., a finger-shaped flange of the injection device) located at or near the proximal end of the barrel or housing of the injection device. In the initial configuration and before injecting a dose of medication, the dose-end sensor is at a well-defined distance from a dedicated portion of the injection device. During dose injection, this distance decreases until a dose-end configuration is reached, in which the distance between the dedicated portion of the barrel or housing of the injection device and the dose sensor is minimized.

[0054] In a further example, the dose end sensor includes one of an electromechanical switch, a capacitive sensor, a magnetic sensor, or an optical sensor. The electromechanical switch allows the dose end sensor to be operated to detect mechanical contact with a dedicated portion, for example, located proximal to the barrel or housing of the injection device. Similarly, a corresponding decrease in contact or longitudinal distance between the dose end sensor and the dedicated portion of the injection device can be detected by at least one of a capacitive sensor and a magnetic sensor, or even by an optical sensor. With capacitive and magnetic sensors, a corresponding electrically or magnetically coded portion will be provided at or near the distal end of the barrel or housing of the injection device. This can also be applied to optical coding or markings when an optical sensor is used as the dose end sensor.

[0055] According to a further example, the electronic module includes a touch sensor connected to the processor. The touch sensor includes a sensing surface. The sensing surface includes a touch-sensitive sensor segment. The touch-sensitive sensor segment is operable to generate or modify an electrical touch signal when touched by a user's body part. By using such a touch-sensitive sensor, for example, on the thrust-receiving surface of an attachment device, when the attachment device is attached to an injection device or injection system, interactions between the user and the user's body part, such as using the thumb or a finger on the user's hand, can be used to detect the completion of dose configuration or dose injection.

[0056] A user holding the attachment or injection system with one hand can easily access the touch-sensitive sensor element to generate or modify control signals. In some examples, the touch sensor is attached to the proximal end of the attachment such that it can be easily accessed, for example, by the user's thumb, when the user holds the attachment to the injection device with their palm and / or other fingers of the same hand.

[0057] According to a further example, the sensing surface of the sensor assembly includes multiple touch-sensitive sensor segments. Each of these sensor segments is operable to generate or modify an electrical touch signal when touched by a user's body part. These sensor segments are spatially separated on the sensing surface in a non-overlapping manner. They can be arranged adjacent to each other in a regular or irregular manner. In some examples, the entire sensing surface is covered and / or occupied by multiple sensor segments. These sensor segments can have equal or unequal sizes.

[0058] The sensor segments can be part of or constitute a touch-sensitive matrix, such as a one-dimensional or two-dimensional array of touch-sensitive segments. Each touch-sensitive segment can include a capacitor or resistor operable to generate or modify an electrical signal in response to, for example, physical contact with a user's body part. To some extent, the plurality of touch-sensitive sensor segments form or constitute a spatially resolved touch-sensitive sensor.

[0059] In a further example, the touch-sensitive surface or touch-sensitive matrix comprises a matrix of resistive elements that change their measurable resistance, for example, when touched by a user. In other examples, the touch-sensitive surface or touch-sensitive matrix comprises a matrix of capacitive elements operable to change their measurable capacitance, for example, when touched by a user.

[0060] In a further example, the touch-sensitive surface or touch-sensitive matrix comprises a combination of resistive sensor segments and capacitive sensor segments. Capacitive sensors can exhibit a considerably low level of power consumption.

[0061] In a further example, the touch-sensitive surface or touch-sensitive matrix is ​​based on surface acoustic wave (SAW) technology, which relies on acoustic waves. Accordingly, the touch-sensitive surface or touch-sensitive matrix includes at least one pair of acoustic transducers and acoustic receivers.

[0062] In another example, the touch-sensitive surface or touch-sensitive matrix includes multiple optical sensors, such as photodetectors or photodiodes.

[0063] In a further example, the touch-sensitive surface or touch-sensitive matrix includes an ultrasonic sensor. The optical sensor and / or ultrasonic sensor may also be implemented as a fingerprint sensor capable of distinguishing the characteristic fingerprint of a first user from that of a second user.

[0064] Spatially resolved touch sensing can be provided by providing multiple sensor segments on or across the sensing surface. Therefore, a processor connected to the respective touch-sensitive sensor segments is operable to identify those sensor segments that generate or modify electrical touch signals in response to mechanical contact with a user's body part. In this way, the processor is operable to determine which segment or sub-segment of the sensing surface actually undergoes mechanical contact with the user's body part. This allows for spatially resolved touch sensing of body parts on the sensing surface of the sensor element.

[0065] According to a further example, the processor of the sensor assembly is operable to detect and / or process temporal changes in multiple electrical touch signals generated or modified by multiple touch-sensitive sensor segments. In this way, the sensor is operable to detect and / or provide the spatial distribution and spatial-temporal distribution of the various touch-sensitive sensor segments being touched by a user's body part. Therefore, the processor is operable to identify and / or detect areas on the sensing surface touched by the body part at a given time. The processor is further operable to monitor temporal modifications or movement of such areas over time. Here, the area touched by the body part can also be considered and / or referred to as the sensing area of ​​the sensing surface.

[0066] According to a further example, the touch-sensitive sensor segment and / or some or each of the plurality of touch-sensitive sensor segments are operable to generate different electrical touch signals in response to changes in pressure applied to the touch-sensitive sensor segment. To some extent, the electrical touch signal generated by the touch-sensitive sensor segment varies with the pressure applied, for example, by a part of the user's body that is touching or contacting this particular touch-sensitive sensor segment.

[0067] In response to changes in pressure applied to the touch sensor section, the electrical touch signal can vary in magnitude or amplitude. Furthermore, the electrical touch signal can change its sign or its frequency or periodicity. In response to varying pressure applied to the touch sensor section, the corresponding sensor section can be operated to change the electrical touch signal in a measurable manner, i.e., in a manner detectable or processable by a processor connected to or potentially connected to the touch sensor section.

[0068] In some examples, multiple or all touch-sensitive sensor segments of the sensing surface are operable to generate different electrical touch signals in response to changes in pressure applied thereto.

[0069] In some examples, the touch sensor segment is operable to generate at least two distinct electrical touch signals in response to changes in pressure applied thereto. By default, the touch sensor segment may be operable to generate a first electrical touch signal in response to a first pressure applied to it. Here, the first electrical touch signal can be generated if the first pressure applied to the touch sensor segment is higher than a first predefined threshold.

[0070] The touch sensor section is further operable to generate a second electrical touch signal that differs from the first electrical touch signal in at least one of the following: magnitude, amplitude, sign, or frequency. The second electrical touch signal can be generated when the pressure applied to the touch sensor section is equal to or higher than a second predefined threshold. Typically, the second threshold is higher than the first threshold.

[0071] To some extent, the first and second electrical touch signals can indicate relatively low and relatively high pressures respectively applied to the corresponding touch-sensitive sensor sections.

[0072] In a further example, the touch-sensitive sensor segment or multiple sensor segments are operable to generate various different electrical touch signals. It is conceivable that the touch-sensitive sensor segment is operable to generate at least three, at least four, at least five, at least six, or at least eight different electrical touch signals, wherein each electrical touch signal reflects or indicates a corresponding first, second, third, fourth, fifth, sixth, or eighth pressure applied to the corresponding touch-sensitive sensor segment.

[0073] In a further example, the touch sensor section can be operable to generate an electrical touch signal that varies gradually with changes in pressure applied to the corresponding touch sensor section. Here, the electrical touch signal can directly represent the applied pressure.

[0074] Depending on the number and size of the touch-sensitive sensor segments distributed on the sensing surface, a precise and fairly detailed spatially resolved pressure distribution on or across the sensing surface can be provided by the sensor element. In this way, the sensor assembly can be operated to detect or measure the spatially resolved pressure distribution applied to the sensing surface by parts of the user's body.

[0075] Spatially resolved pressure distribution and / or temporal variations of such spatially resolved pressure distribution can indicate a specific touch procedure or gesture performed by the user of the injection device.

[0076] According to a further example, the processor is operable to recognize or distinguish one of a plurality of predefined user gestures, such as a swipe on a sensing surface, a single tap on a sensing surface, and double or multiple taps on a sensing surface. The processor may be further operable to distinguish between short taps on a sensing surface (e.g., taps lasting less than 1 second) and long taps on a sensing surface (e.g., taps lasting more than 1 second or 2 seconds).

[0077] In addition, the processor can be operated to distinguish between a slight tap and a forceful or hard tap on the sensing surface.

[0078] According to a further example, the processor is operable to recognize at least one of the following: a sweeping motion of a body part on a sensing surface, a short tapping motion of a body part on a sensing surface, multiple short tapping motions of a body part on a sensing surface, a long tapping motion of a body part on a sensing surface, and variable pressure applied by a body part on a sensing surface. These movements may represent a single gesture or multiple gestures made by a user's body part on or toward the sensing surface.

[0079] In the recognition or sensing mode of the sensor assembly, electrical touch signals obtained from (multiple) touch-sensitive sensor segments can be compared with a stored reference distribution. Here, the processor can perform an optimal match comparison to assign one of the stored reference distributions to a distribution generated or obtained based on the actually measured or detected electrical touch signals. The reference distribution assigned to the actually measured electrical touch signal distribution can then indicate the gesture made by a user's body part on the sensing surface. Control signals generated by the processor and transmitted to external electronics can indicate the gesture determined or detected by the processor of the sensor assembly.

[0080] According to a further example, the processor is operable to process electrical touch signals from multiple touch-sensitive sensor segments to identify sensing areas on the sensing surface touched by the body part. Typically, and when a finger is used as a body part to contact the sensing surface of the sensor element, the corresponding touch-sensitive sensor segment will be able to detect the pressure applied by the corresponding body part. In this way, for example during or for the operation of an attachment or injection device, all touch-sensitive sensor segments that come into mechanical contact with the body part can generate corresponding electrical touch signals.

[0081] By simultaneously processing the signals from these touch-sensitive sensor segments, the processor can provide or confirm the sensing areas on the sensing surface that are actually in contact or mechanically in contact with the user's body parts. In this way, the processor can operate to detect whether the central portion or the boundary area of ​​the sensing surface is actually touched by a body part.

[0082] Furthermore, the processor is operable to detect or measure the size of the sensing area. By identifying or determining the sensing area of ​​the sensing surface that is actually touched or in mechanical contact with a user's body part, the sensor assembly provides fairly accurate and spatially resolved monitoring of how a user's body part touches the sensor element.

[0083] According to a further example, the processor of the sensor assembly is operable to detect changes in the size of a sensing area on a sensing surface. The change in the size of the sensing area may be caused by changes in the pressure applied to the sensor element by a body part. Since the body part may include a degree of elasticity and may further include a considerably convex outward-facing structure or surface, by increasing the pressure applied to the sensor element by the body part, the proportion of the body part in direct contact with the sensing surface can be increased, for example, due to elastic deformation of the body part. This may cause an increase in the size of the sensing area on the sensing surface.

[0084] Therefore, detecting changes in the size of the sensing area during operation of the injection device can indicate changes in pressure applied to the sensor element by the user. In some examples, changes in size measurable by the processor and changes in the type, amount, amplitude, sign, or frequency of the electrical touch signal generated by the touch sensor section can be processed in combination. To some extent, changes in pressure applied to the sensor element by a body part can be detected simultaneously by changes in the size of the sensing area and changes in the electrical touch signal generated by the pressure sensor section and the touch sensor section.

[0085] Here, changes in pressure applied by body parts can be monitored or detected in a dual manner. Therefore, changes in pressure applied to the sensor element can be measured or determined in at least two different ways, thereby increasing or providing redundancy to the measurement system provided by the sensor assembly.

[0086] According to a further example, the processor is operable to detect changes in the geometry of a sensing area on a sensing surface and / or changes in the orientation of that sensing area. In this way, additional operating modes can be detected and evaluated during which a user's body part undergoes movement or change relative to the sensor element. Changes in the geometry or orientation of the sensing area on the sensing surface (which are typically detected by corresponding changes in electrical touch signals generated by multiple touch-sensitive sensor segments) can further indicate the specific use case of the injection device.

[0087] In a further example, the sensing surface has a planar shape and is configured to be fastened to the thrust receiving surface. It can be configured to cover at least a portion of the thrust receiving surface. The thrust receiving surface can be provided by a movable or immovable cap forming or constituting a proximal or end segment of the attachment or its body. To some extent, when the attachment is properly attached or fastened to the injection device, the attachment can provide a thrust receiving surface for the user to press, thereby moving the stopper of the injection device to the end-of-content or end-of-dose position. The sensor can operate during the dose infusion process and can record the mechanical interaction between the sensing surface and the user's body part applying an injection force to the thrust receiving surface of the attachment.

[0088] In a further example, the processor is operable to detect the completion of an injection by the injection device by processing multiple electrical touch signals provided by a touch sensor during a predefined time interval. In some examples, the force applied by the user during the injection procedure may gradually increase as the user moves the plunger toward a distal position. Upon reaching the distal position, the user may need to hold the needle within the punctured tissue for a predefined time interval. During this holding time, the user typically applies a constant pressure to the push-receiving surface. This temporary distribution, or pressure distribution, can be monitored and / or analyzed by the processor to determine whether the dosing injection procedure has been completed. The corresponding distribution can record not only the magnitude of the pressure but also the size of the sensing area on the sensing surface. An increase in the sensing area typically indicates a direct increase in pressure applied to the sensing surface by the corresponding body part. As the pressure decreases, the size of the sensing area, and therefore the size of the mutual contact area between the user's body part and the sensing surface, also decreases.

[0089] In a further example, the fastening structure of the auxiliary device is configured to be detachably secured to the plunger flange of the plunger, which is connected to or integrally formed with the stopper of the injection device. Here, the plunger flange may be located at the proximal end of an elongated plunger. The distal end of the plunger may be connected to the stopper or may form a stopper for discharging the medication through the outlet of the barrel. The fastening structure of the auxiliary device may be detachably connected, for example, clamped onto the flange portion.

[0090] In a further example, the fastening structure of the attachment includes a receiving portion configured to receive a plunger flange. The receiving portion may open distally. In a further example, the receiving portion may open laterally. In either case, the size and configuration of the receiving portion can be set for detachable connection and attachment to the plunger flange of the injection device.

[0091] In a further example, the fastening structure includes a snap-fit ​​element configured to detachably engage with a plunger flange in a form-fit manner. The snap-fit ​​element may include a protrusion that projects radially inward from a sidewall of a receiving portion located at or near the bottom or flange portion of the body of the attachment.

[0092] When the fastening structure is configured to be detachably fixed to the plunger flange of the injection device's plunger, the attachment may not have an elongated plunger extension or an elongated rod. Here, the elongated plunger extension can be detachably connected to the body of the attachment. In this way, the attachment can be used in different configurations and can be used with injection devices of different configurations. When the injection device does not have a plunger rod and includes a plug located inside the barrel, the attachment may be equipped with an elongated plunger extension. Here, the fastening structure is typically located at the distal end of the plunger extension to form or establish mechanical contact with the plug of the injection device.

[0093] In other examples, where the injection device includes a plunger with its plunger flange located proximal to the proximal end of the injection device's barrel, the attachment may not have an elongated plunger extension, but may instead include a fastening structure directly located at the bottom of the body or the flange portion. Here, the receiving portion of the body or a similar fastening structure may be directly attached to the plunger flange of the injection device. In both cases, when the attachment is properly attached to the stopper of the injection device, the user can use the attachment to apply distal pressure to the stopper to drive it distally relative to the barrel, thereby dispensing a dose from the barrel.

[0094] In these examples where the add-on does not have an elongated plunger extension, the readout of the electronic marker can be obtained at or shortly before the dose end configuration is reached, at which point the longitudinal distance between the add-on (and therefore the readout unit of the add-on) and the machine-readable marker of the injection device is minimized.

[0095] It is also conceivable that, before the attachment is mounted or attached to the plunger or plunger flange of the injection device, the reading unit is manually triggered to read the machine-readable identifier of the injection device. Here, the user can prompt the attachment to read information stored in or provided by the electronic identifier, for example, by bringing the attachment close to the machine-readable identifier of the injection device. In other words, the user can position the attachment and / or its reading unit at a distance from the machine-readable identifier of the injection device, a distance less than the transmission range of the reading unit. The information stored in or provided by the machine-readable identifier of the injection device can then be read, and the attachment can subsequently be attached or secured to the injection device.

[0096] In another aspect, this disclosure relates to an injection system. The injection system includes an injection device and additional devices as described above. The injection device includes a pharmaceutical container. The pharmaceutical container includes a cylinder filled with a pharmaceutical agent (e.g., a liquid and therefore injectable agent). The cylinder is sealed by a stopper. The stopper is movable in a distal direction relative to the cylinder to dispensing a dose of the pharmaceutical agent from the cylinder. The injection device further includes a machine-readable identifier attached to or integrated into the cylinder or housing of the injection device.

[0097] Machine-readable identifiers may include or constitute electronic identifiers. Electronic identifiers can be implemented as wireless tags, such as RFID tags or NFC tags. Electronic identifiers can be passive electronic tags operable to communicate with a corresponding wireless reader (and therefore an electronic reader) of an attached device. In some examples, machine-readable identifiers are one of magnetically coded identifiers and optical or visual identifiers, which can be read by an optical reader or a corresponding magnetic reading device.

[0098] In some examples, the injection system includes the injection device as described above. To some extent, all the features, effects, and benefits described above in combination with the additional device and the injection device also apply to the injection system.

[0099] In a further example, the electronic tag is positioned at or near the distal section of the barrel. The reading unit is a wireless reading unit and includes an antenna located on or inside an elongated plunger extension that protrudes distally from the bottom or flange portion of the body, and thus from the distal portion of the body. Here, the antenna may be located at a longitudinal distance from the electronic module of the device. It may include a limited transmission range such that reading of the machine-readable tag (and therefore the electronic tag) can only be enabled by moving the plunger extension from its proximal starting position toward its distal position, thereby pushing or actuating the stopper of the injection device toward the distal position.

[0100] The distal movement of the stopper (e.g., from the proximal position to the distal position) can be caused and / or controlled by an additional device in mechanical pressure or thrust transmission contact or engagement with the stopper.

[0101] When the antenna is located on or inside an elongated plunger extension, and the antenna is, for example, located at or near the distal or end section of the plunger extension, the longitudinal overlap arrangement or configuration of the antenna with the machine-readable identifier can be achieved or occur simultaneously when the plug reaches or approaches the distal position relative to the cylinder. Only then can the information stored in or provided by the machine-readable identifier be read by the wireless reading unit. Typically, as described above, the attachment is equipped with a clock operable to provide a clock signal, based on which a timestamp can be generated. The generation of the timestamp and / or the use of the corresponding time or date indication provided by the clock can be triggered by enabling the reading of information stored in or provided by the machine-readable identifier, i.e., triggered when the plug driven by the attachment reaches or approaches the distal position (and thus the dose-end configuration).

[0102] In a further example, the injection system can transition from an initial configuration to a dose-end configuration by pushing and inserting the stopper from a proximal position toward a distal position via an attachment device. Here, the attachment device is attached to the stopper via a longitudinal or elongated plunger extension and its elongated rod, or via the plunger of the injection device. The plunger of the injection device can be attached to or integrally formed with the stopper, which is configured to seal the volume of the drug substance inside the cartridge. The body of the attachment device can then be attached to and / or secured to the proximal end of the plunger or plunger rod of the injection device. It can be secured to the plunger flange located proximally.

[0103] In a further example, when the injection system is in pre-use configuration, the electronic tag is outside the transmission range of the reading unit or antenna.

[0104] In a further example, when the injection system is in a dose-end configuration, the electronic tag is within the transmission range of the reading unit or antenna. In this way, reading information stored in or provided by the electronic tag requires the reading unit or antenna to move distally relative to the machine-readable tag during the dose injection process.

[0105] Information reading will be enabled when the dose end configuration is reached or nearing its end. Reading the information can then trigger the generation or provision of a timestamp, which can then be combined with information collected or obtained from machine-readable identifiers. The information, along with the timestamp, can be stored in the memory of an add-on device and can be transferred to external electronic devices such as smartphones, smartwatches, or tablets for further data analysis or precise monitoring.

[0106] On the other hand, this disclosure also relates to a method for monitoring the use of an injection device. The method includes the step of providing the injection device as described above. Accordingly, the injection device includes a cylinder filled with a pharmaceutical agent and typically sealed in the proximal direction by a stopper. The stopper is movable relative to the cylinder in the distal direction to dispense a dose of the pharmaceutical agent.

[0107] The injection device further includes a machine-readable identifier attached to or integrated into the barrel or housing of the injection device.

[0108] The method includes providing an additional device as described above and reading information stored in or provided by a machine-readable identifier through a reading unit of the additional device.

[0109] As described above, reading information stored in or provided by a machine-readable identifier can be implemented in various different ways. In one example, the machine-readable identifier includes, for example, an electronic identifier (such as a wireless transceiver) in the form of a passive or active RFID tag or NFC tag, which can be read by a wireless reading unit. Here, the reading unit of the auxiliary device includes a corresponding transceiver operable to interact with the electronic identifier.

[0110] In a further example, the machine-readable identifier includes a magnetic code that can be read by a reading unit implemented as a magnetic reading device. In another example, the machine-readable identifier includes an optical or visual code that can be read by a reading unit including a corresponding optical reader.

[0111] In some examples, reading of information stored in or provided by a machine-readable identifier is performed before or after attaching the attachment device to the injection device (i.e., before or after attaching or connecting the body of the attachment device directly or indirectly to the plug of the injection device). In some examples, reading of information stored in or provided by a machine-readable identifier occurs after or during the dosing procedure (i.e., when the plug of the injection device moves distally relative to the barrel, or when the plug reaches or approaches the distal position and thus the dosing is completed).

[0112] In a further example, the attachment is connected to the stopper via pressure transmission. Here, the fastening structure of the attachment is directly connected to a mating fastening structure of complementary shape to the stopper. In some examples, the fastening structure of the attachment is operable to connect to the plunger of the injection device, wherein the plunger is connected to the stopper, integral with the stopper, or longitudinally abuts against the stopper.

[0113] In another example, a driving force is applied to the attachment and transmitted to the stopper, causing the stopper to move distally relative to the barrel. Here, the attachment can be used in a dual manner. First, it provides force transmission between the stopper and the body part of the user who applies pressure to the stopper to perform or control the injection procedure. Second, the attachment provides readability of information or data stored in or provided by a machine-readable identifier.

[0114] In a further example, the method includes detecting the completion of the injection by an electronic module of the additional device. The detection of the completion of the injection procedure can be performed in different ways. In one example, the completion of the dose injection can be detected by a reading unit, wherein reading of a machine-readable identifier is initially disabled and will be enabled during or at the end of the dose injection procedure (e.g., when the stopper reaches or approaches the dose-end position or dose-end configuration).

[0115] In another example, the completion of the injection can be detected, for example, by a touch sensor provided or integrated into the attachment. In yet another example, the completion of the dosage injection procedure can be detected by a separate dose-end sensor, which, for example, is operable to detect a specific (and therefore well-defined) position of the attachment relative to the barrel or housing.

[0116] In a further example, the method includes recording at least one of the date or time of dose injection completion in the memory of the auxiliary device. Recording the corresponding timestamp may be performed simultaneously with recording information stored in or provided by a machine-readable identifier. This information typically indicates the medication stored or administered in the barrel of the injection device.

[0117] Generally, the scope of this disclosure is defined by the content of the claims. The injection systems, auxiliary devices, and / or injection apparatuses and corresponding methods described herein are not limited to specific embodiments or examples, but include any combination of elements from different embodiments or examples. To a certain extent, this disclosure covers any combination of claims and any technically feasible combination of features disclosed in different examples or embodiments.

[0118] In this context, the term 'distal' or 'far end' refers to the end of the injection device facing the injection site in a human or animal. The term 'proximal' or 'proximal end' refers to the opposite end of the injection device, which is furthest from the injection site in a human or animal.

[0119] The terms “drug” or “pharmaceutical preparation” are used synonymously herein and describe pharmaceutical preparations comprising one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally pharmaceutically acceptable carriers. 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 pharmaceutical preparation is used to treat, cure, prevent, or diagnose a disease or to otherwise enhance physical or mental health. A drug or pharmaceutical preparation may be used for a limited duration or periodically for chronic disorders.

[0120] As described below, a drug or pharmaceutical agent may include at least one API or combination thereof in different types of formulations for the treatment of 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 considered.

[0121] Drugs or pharmaceutical preparations may be contained in primary packaging or "drug containers" suitable for use with drug delivery devices. Drug containers may be, for example, cartridges, syringes, reservoirs, or other robust or flexible vessels configured to provide suitable chambers for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chambers may be designed to store the drug for at least one day (e.g., from 1 day to at least 30 days). In some cases, the chambers may be designed to store the drug for about one month to about two years. Storage may be carried out at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, drug containers may be or may include dual-chamber cartridges configured to separately store two or more components of the pharmaceutical preparation to be administered (e.g., an API and a diluent, or two different drugs), one component in each chamber. In such cases, the two chambers of a dual-chamber cartridge may be configured to allow mixing between the two or more components before and / or during administration to a human or animal. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., through a conduit between the two chambers), allowing the user to mix the two components as needed before dispensing. Alternatively or additionally, the two chambers can be configured to allow mixing during dispensing of the components into a human or animal body.

[0122] Drugs or agents contained in drug delivery devices as described herein can be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes or diabetes-related complications (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 those described in the following manuals: such as Rote Liste 2014 (e.g., but not limited to, main group 12 (antidiabetic drugs) or 86 (oncology drugs)), and Merck Index (15th edition).

[0123] Examples of APIs used to treat and / or prevent 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-1 (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 mixture of the above. As used herein, the terms “analyte” and “derivative” refer 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) by deletion and / or exchange of at least one amino acid residue present in a naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues may be encoding amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. Specifically, 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., human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in a naturally occurring peptide may have been missing and / or substituted with other amino acids (including non-coding amino acids), or amino acids (including non-coding amino acids) may have been added to a naturally occurring peptide.

[0124] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (glargine insulin); Lys(B3), Glu(B29) human insulin (glutamate insulin); Lys(B28), Pro(B29) human insulin (lispro insulin); Asp(B28) human insulin (aspart insulin); human insulin wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala and wherein Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0125] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (detemir insulin, B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 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 (degludecinin, ); B29-N-(N-lithochyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0126] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixilatin. Exenatide (Exendin-4, Liraglutide, a 39-amino acid peptide produced by the salivary glands of the Gila monster. Semaglutide, Tasglutide, Albiglutide Duraglutide 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, Tepirotide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-Xten.

[0127] Examples of oligonucleotides include, for instance, sodium mipronil. Cholesterol-reducing antisense agents used to treat familial hypercholesterolemia or RG012 used to treat Alport syndrome. Examples of DPP4 inhibitors are liraliptin, vedagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0128] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, fertility-stimulating hormone), growth hormone (growth hormone), desmopressin, terlipressin, gosorelin, triptorelin, leuprorelin, buserorelin, nafarelin, and goserelin.

[0129] Examples of polysaccharides include glucosamine, 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-mentioned polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20. A type of sodium hyaluronate.

[0130] As used herein, the term "antibody" refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigens. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized antibodies or humanized antibodies, fully human antibodies, non-human (e.g., mouse) antibodies, or single-chain antibodies. In some embodiments, antibodies have effector functions and can fix complement. In some embodiments, the ability of an antibody to bind to an Fc receptor is reduced or absent. For example, an antibody can be an isotype or subtype, an antibody fragment or a mutant that does not support binding to an Fc receptor, for example, its Fc receptor-binding region has been mutagenized or deleted. The term "antibody" also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or antibody-like binding proteins with dual variable regions having cross-binding region orientation (CODV).

[0131] 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 that does not contain the full-length antibody polypeptide but still contains at least a portion of the full-length antibody polypeptide capable of binding to an antigen. Antibody fragments may contain cleaved portions of the full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments that can be used in this invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (e.g., bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., double-chain, triple-chain, and quadruple-chain antibodies)), monovalent or multivalent antibody fragments (e.g., bivalent, trivalent, quadruvalent, and multivalent antibodies), microantibodies, chelated recombinant antibodies, tri- or bivalent antibodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camel-derived antibodies, and antibodies containing VHH. Further examples of antigen-binding antibody fragments are known in the art.

[0132] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term "frame region" refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides; it is not a CDR sequence and is primarily responsible for maintaining the correct positioning of the CDR sequence to allow antigen binding. Although frame regions, as is known in the art, typically do not directly participate in antigen binding, certain residues within the frame region of some antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0133] Examples of antibodies are anti-PCSK-9 mAb (e.g., aliximumab), anti-IL-6 mAb (e.g., thalidomumab), and anti-IL-4 mAb (e.g., dupilumab).

[0134] It is also taken into consideration that pharmaceutically acceptable salts of any API described herein may be used in pharmaceuticals or preparations in drug delivery devices. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0135] Those skilled in the art will understand that modifications (additions and / or removals) can be made to the different components, formulations, devices, methods, systems, and embodiments of the API described herein without departing from the full scope and spirit of the invention, which covers such modifications and any and all equivalents thereof.

[0136] Example drug delivery devices may relate to needle-based injection systems 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 categorized 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.

[0137] As further described in ISO 11608-1:2014(E), a multi-dose container system can relate to a needle-based injection device with replaceable containers. In such a system, each container holds multiple doses, the sizes of which can be fixed or variable (preset by the user). Another multi-dose container system can relate to a needle-based injection device with an integrated, non-replaceable container. In such a system, each container holds multiple doses, the sizes of which can be fixed or variable (preset by the user).

[0138] As further described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device having a replaceable container. In one example of such a system, each container contains a single dose, in which the entire deliverable volume is discharged (completely emptied). In a further example, each container contains a single dose, in which 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 a needle-based injection device having an integral, non-replaceable container. In one example of such a system, each container contains a single dose, in which the entire deliverable volume is discharged (completely emptied). In a further example, each container contains a single dose, in which a portion of the deliverable volume is discharged (partially emptied). Attached Figure Description

[0139] In the following, an example of an injection system including an injection device and an auxiliary device for monitoring the use of the injection device will be described in more detail with reference to the accompanying drawings, in which:

[0140] Figure 1 An example of an injection system is illustrated, which includes an attachment device and an injection device in a configuration prior to the attachment device being connected to or attached to the injection device.

[0141] Figure 2 It shows Figure 1 The injection system in which the additional device is attached to the injection device before injection is performed.

[0142] Figure 3 The following was shown after the injection was completed. Figure 1 and Figure 2 The injection system

[0143] Figure 4 A further example of the injection system is shown.

[0144] Figure 5 It was shown at the end of the injection Figure 4 Example,

[0145] Figure 6 Further details are shown of machine-readable markings that are attached to or attached to the barrel or housing of the injection device.

[0146] Figure 7 The diagram shows a longitudinal section of an injection device that is implemented as a safety injection cartridge before or during the attachment of the additional device to the injection device.

[0147] Figure 8 It shows the end of the dose injection Figure 7 Examples, and

[0148] Figure 9 This shows what happens after the injection needle retracts into the housing of the injection device. Figure 7 and Figure 8 The device,

[0149] Figure 10 The diagram schematically illustrates several components of the attachment and their assembly within the attachment's main body.

[0150] Figure 11 Another example of an attached device is shown during the reading of information stored in or provided by a machine-readable identifier.

[0151] Figure 12 The assembly of the additional device and the plunger of the injection device is shown.

[0152] Figure 13 The injection system communicates with external electronic devices.

[0153] Figure 14 A further example of the touch sensor in the first configuration is shown.

[0154] Figure 15 Shown in the second configuration Figure 14 Touch sensor,

[0155] Figure 16 A further example of the touch sensor in the first configuration is shown.

[0156] Figure 17 Shown in the second configuration Figure 16 Touch sensor,

[0157] Figure 18 The demonstration shows that it can be shown according to Figures 14 to 17 A simplified diagram of the pressure distribution measured by the touch sensor.

[0158] Figure 19 A block diagram of the electronic components of the additional device is shown.

[0159] Figure 20 A flowchart illustrating a method for monitoring the use of an injection device by utilizing an additional device is shown, and

[0160] Figure 21 Another flowchart illustrating a different method for monitoring the use of an injection device is shown. Detailed Implementation

[0161] exist Figures 1 to 9 The sequence schematically illustrates a scenario using injection device 1 with attachment 30. In the illustrated example, injection device 1 includes a syringe, for example, implemented as a safety syringe. Injection device 1 includes a body 10 filled with a liquid injectable agent 8. The body 10 is sealed in the proximal longitudinal direction 3 by a stopper 9, which is movable relative to the body 10 in the distal direction 2. The body 10 may have a tubular shape. It may include an outlet 14 at its distal end. The outlet 14 may be provided with an injection needle 15 fastened to the outlet 14 of the body 10. The body 10 terminates in the proximal or proximal direction 3 with a radially outwardly extending or protruding flange portion 17, which can serve as a gripping part for the user's index finger 6 and middle finger 7 to properly hold the syringe, while the user can use the thumb 5 of the same hand 4 to press the plunger 20 protruding proximally from the body 10.

[0162] In some examples, such as Figures 7 to 9As shown, the stopper 9 can be integrally formed with or detachably connected to the longitudinally extending plunger 20. The plunger 20 may include an elongated rod extending in the longitudinal direction (z). In some examples, the stopper 9 and the plunger 20 may be provided as separate components. Here, the plunger 20 may be used to apply distal pressure to the stopper 9 to move the stopper 9 relative to the barrel 10 in the distal direction 2, thereby discharging a defined amount of liquid medication 8 through the outlet 14 and into the biological tissue when the injection needle 15 has penetrated or punctured the tissue. The stopper 9 may include an elastomeric material to hermetically seal the interior of the barrel 10.

[0163] The proximal end of the plunger 20 may be provided with a radially widened plunger flange 21. The plunger flange 21 is typically configured to be pressed by a user's thumb 5, such as, for example... Figure 10 As shown. In Figures 1 to 9 In the example, the injection device 1 is implemented as a safety syringe. It is provided with a housing 11, which has a generally elongated or tubular shape. The size of the housing 11 is set to accommodate the syringe body 10 and the spring element 27. The spring element 27 is operatively engaged with the housing 11 and the syringe body 10. It can be configured to induce relative longitudinal movement between the syringe body 10 and the housing 11, particularly when the dosing injection procedure is completed.

[0164] The cylinder 10 can be locked by the interlocking member 24 to prevent longitudinal movement relative to the shell 11. In such cases... Figures 7 to 9 In the example shown, the interlock 24 is located at or near the proximal end of the cylinder 10 or housing 11. The housing 11 (which may also have a sleeve-like shape) includes mating latching elements 26 for releasably engaging with latching elements 25 disposed on the cylinder 10. The latching elements 25 and the mating latching elements 26 are initially in an engaged configuration that prevents or locks longitudinal displacement of the cylinder 10 relative to the housing 11.

[0165] Only when the plunger 10 reaches the distal configuration does the plunger flange 21 engage with the mating latch element 26 by deforming or pivoting the mating latch element 26 to make room for the latch element 25. Once the latch element 25 is released from the mating latch element 26, the mechanical energy stored in the spring element 27 can be released, resulting in longitudinal movement or displacement of the cylinder 10 relative to the housing 11.

[0166] Initially protruding from the distal end of the housing 11 and passing through the outlet 14 or needle 15 of the through opening 28 provided on the distal end face of the housing 11, it retracts back into the interior of the housing 11, as... Figure 9As shown. Here, the injection needle 15 is in a shielded or protected configuration in which the injection device 1 is no longer usable, and in this shielded or protected configuration, the distally protruding end of the injection needle 15 is protected by the housing 11. The flange portion 18 may be complementary in shape to the flange portion 17. The proximal end of the flange portion 18 and / or the proximal end of the housing 11 may be further provided with a chamfered edge, which is configured to be such that when the plunger 20 reaches... Figure 6 The distal position shown engages with the distal side or edge of the plunger flange 21. When the plunger flange 21 abuts against the chamfered edge, the chamfered edge (and thus the mating latch element 26) is pushed radially outward, thereby disengaging from the latch element 25, which can be easily achieved by the radially outwardly extending flange portion 17 of the barrel 10.

[0167] like Figure 1 , Figure 2 and Figure 4 As further shown, in the initial configuration, outlet 14 and / or injection needle 15 can be protected or covered by a separate protective cap 16. The protective cap 16 should be removed from outlet 14 or needle 15 before the injection procedure. In the example currently shown, the mating latching element 26 may be located at or near the radially outwardly extending flange portion 18 of the housing 11.

[0168] Alternatively, such as from Figures 1 to 3 As is evident, the syringe body 10 can be encapsulated or mounted in a syringe holder 13, which is operatively engaged with a spring element 27. The syringe holder 13 can provide a dedicated sliding function within the housing 11 and can accommodate the syringe body 10 therein.

[0169] The injection device 1 is further provided with a machine-readable identifier 22. The machine-readable identifier 22 is attached to or integrated into a barrel 10 and housing 11 of the injection device 1 or therein. The machine-readable identifier 22 can be implemented as an electronic identifier 33. It can include a wireless communication tag, such as a passive RFID tag or an NFC tag. The machine-readable identifier 22 can also be implemented in the form of a magnetic coating or optical encoding, which can be read by a corresponding reading device (e.g., a magnetic reader or optical reader of the attachment 30). The machine-readable identifier 22 stores and / or provides electronic information or data, such as the name of the drug, the name of the pharmaceutical substance in the drug, the concentration of the drug, batch number, LOT number, manufacturing date, manufacturing location or place, expiration date, and / or the temperature at which the drug should be stored or has been stored.

[0170] Electronic information or data can be read or captured by the reading unit 39 of the auxiliary device 30, as will be explained below. In some examples, such as... Figure 1, Figure 4 and Figure 5 The machine-readable identifier 22 shown is located at or near the distal end of the cylinder 10 or housing 11. It is positioned near the outlet 14 of the injection device 1.

[0171] like Figure 6 As specifically shown, the machine-readable identifier 22 may include an antenna 23 for wireless signal transmission with the reading unit 39 of the auxiliary device 30. The antenna 23 may be disposed on a flexible substrate or layer 121. Layer 121 may include plastic foil or any other flexible or bendable layer or sheet to wrap around one of the barrel 10 and the housing 11 of the injection device 1.

[0172] Layer 121 may be provided with printed electronic circuitry constituting or including a wireless communication tag. A printed label layer 122 may be provided on the underside of layer 121. Label layer 122 may contain printed information that is visible to the user when wrapped around the tube 10 or housing 11. Here, in the wrapped configuration, layer 121 is located inside label layer 122, which includes a printed visible surface on its opposite outward-facing side.

[0173] A shielding or isolation layer 120 may be provided inside layer 121 and around antenna 23, which is operable to shield electromagnetic radiation. The shielding or isolation layer 120 may include a metal foil that is insulated relative to the electronic circuitry of the machine-readable identifier 22. This shielding or isolation layer may be a cutout around antenna 23, or it may be omitted. The shielding or isolation layer and the cutout help prevent unauthorized or premature reading of data in the machine-readable identifier 22. For data to be read from the machine-readable identifier 22, the corresponding antenna 43 of a suitable reading unit 39 needs to at least partially overlap with antenna 23 in the longitudinal direction (z).

[0174] like Figure 10 The attachment 30, shown in detail, can be detachably connected to the plug 9 via fastening structures 94, 94'. The attachment 30 includes a body 60, the sidewalls 61 of which are tubular.

[0175] To the distal end, sidewall 61 defines a receiving portion 63, the size of which is configured to receive the plunger flange 21. For this purpose, the inner side of sidewall 61 may include one or more fasteners (e.g., resilient fastening ribs) configured to provide a non-slip fastening of the attachment 30 to the plunger flange 21 of the syringe plunger 20, such as, for example… Figure 7 What is shown.

[0176] The receiving portion 63 is defined by a radially inwardly extending bottom or flange portion 62. The flange portion 62 divides the interior of the device body 60 into a distal receiving portion 63 and a proximal receiving portion 64. The proximal receiving portion 64 is sized to accommodate a support member 70 and a cover 75 to accommodate an electronic module 34. The support member 70 includes a longitudinally extending main rod 71 that extends through the flange portion 62 in the distal direction. The support member 70 is displaceably mounted within the receiving portion 64. It is movable in the distal direction 2 against the action of one or more return elements 65. The support member 70 is connected to a cup-shaped cover 75 that protrudes from the side wall 61 of the device body 60 in the proximal direction.

[0177] The cover 75 includes a planar end face 76 facing proximal direction 3. In some examples, the end face 76 is provided with a touch sensor 80. Even the entire end face 76 may be covered by the touch sensor 80. In this way, the end face 76 serves as an actuating surface to be pressed by a user (e.g., by the user's thumb 5). The user can apply a distal force on the end face 76, thereby pushing the cover 75 and the support 70 against the action of the return element 65 in the distal direction 2.

[0178] Upon release of end face 76, return element 75 (e.g., implemented as a return spring) is used to move support 70 and cover 75 toward the proximal starting position, such as Figure 10 As shown. At least one of the cover 75 and the support 70 includes a radially outwardly extending protrusion 74, which is guided in a longitudinally extending recess 66 on the inner side of the sidewall 61 of the device body 60. Viewed in the longitudinal direction, the recess 66 is defined by a proximal stop surface 69 and a distal stop surface 67. As shown... Figure 10 In the initial configuration shown, the protrusion 74 abuts longitudinally against the proximal stop surface 69 of the recess 66.

[0179] When the cover 75 is pressed distally in the direction 2 against the action of the return element 65, the distal position is reached when the protrusion 74 engages with the distal stop surface 67. The longitudinal movement of the support 70 and the cover 75 can be defined within predetermined limits relative to the device body 60 by the protrusion 74 guided in the groove 66. Here, the support 70 and / or the cover 75 can form or constitute an auxiliary trigger for an additional device. When the cover 75 abuts distally against the stop surface 67 of the sidewall 61, any additional distally directed pressure present on the cover 75 is irrevocably transmitted to the sidewall and then to the body 60, which, when the body is attached to the plug 9, translates into a corresponding distally directed movement of the plug 9 relative to the cylinder 10.

[0180] When pressed in the distal direction 2, the support 70 and its main rod 71 begin to protrude from the flange portion 62. In either case, when the user presses the cap 75 in the distal direction 2, the corresponding driving force can be transmitted to the plug 9 via the main rod or via the side wall 61.

[0181] exist Figure 10 In the example, the main rod 71, extending distally from the flange portion 62, is extended and lengthened by a plunger extension 91 including an elongated rod 92. The elongated rod 92 includes a fastening structure 94 at its distal end, such as... Figure 1 and Figure 10 As shown, the fastening structure 94 is configured to connect, attach, and / or fasten to a mating fastening structure 29 of complementary shape disposed on the proximal end face of the plug 9. In some examples, the fastening structure 94 includes a threaded portion 95, such as an external threaded portion, to engage with the threaded portion of the mating fastening structure 29 of the plug 9 of complementary shape.

[0182] In other examples, the plunger extension 91 may be connected (e.g., non-movably connected) to the body 60. It may also protrude from the tubular sidewall 21 and / or from the receiving portion 63 in a distal direction.

[0183] The inner sidewall of the cover 75 may include at least one of a radial protrusion and a recess 68 to engage with a radially recessed or protruding portion 72 of a complementary shape to the support 70. The cup-shaped cover 75, connected or fastened to the support 70, provides a receiving portion for the electronic module 34, which is arranged within the hollow space formed by the support 70 and the cover 75.

[0184] The electronic module 34 may include, for example, electronic circuitry 35 located on a printed circuit board 36. The electronic module may further include a transceiver 38 and a readout unit 39, a memory 40, a clock 42, a processor 44, a power supply 46, a switch 48, a sensor unit 50, and a signal generator 52 (e.g., including light sources 53, 54).

[0185] The sidewall 77 of the cover 75 may include a window 55 aligned with a corresponding window 56 in the sidewall 61 of the device body 60. In this way, visual signals generated by different light sources 53, 54 located in the hollow space of the cover 75 can be perceived and visually detected from outside the auxiliary device 30.

[0186] The two light sources 53 and 54 may belong to a visual signal generator 52, which is operable to generate or produce visual signals of different colors and / or variable durations. Windows 55 and 56 may be provided with light tubes or light guide structures. In this way, the device body 60 can be protected from dust or moisture ingress.

[0187] In another example, signal generator 52 may be implemented as a tactile signal generator, for example, configured to generate perceptible vibrations of electronic module 34. In a further example, signal generator 52 may include an audible signal generator configured to generate audible sounds.

[0188] exist Figure 19 The diagram shows an example block diagram of electronic module 34 and / or touch sensor 80. Also, Figure 10 As shown, the processor 44 is mounted on a printed circuit board 36, which is connected to the sensor element 81 of the touch sensor 80, which substantially covers the end face 76 of the cover 75.

[0189] Typically, the electronic module 34 can be mounted on the printed circuit board 36. The electronic module 34 can be configured to communicate with external electronic devices 100, such as… Figure 13 As shown in the diagram, the external electronic device 100 can be implemented as a mobile electronic device. It may include a smartwatch, a smartphone, or a tablet computer. The electronic module 34 includes a transceiver 38 configured to establish or build a communication link between the external electronic device 100 and the electronic module 34. The communication link can be implemented wirelessly or via a wired connection.

[0190] External electronic device 100 can be implemented as a smartphone. External electronic device 100 includes a housing 101 and can be implemented as a portable electronic device. External electronic device 100 further includes a device processor 102 and a display 104. Optionally, external electronic device 100 includes a speaker and / or a haptic user interface. Additionally, external electronic device 100 includes a communication unit 106 operable to communicate with a transceiver 38 of the auxiliary device 30. In some examples, the first transceiver 38 includes a local range transceiver with a transmission range of several meters or tens of meters.

[0191] Electronic module 34 can be configured to exchange data with external electronic device 100. Data indicating the operation of the injection device and collected or acquired by electronic module 34 can be transmitted to the external electronic device via transceiver 38. Transceiver 38 can be implemented as a wireless RF transceiver, for example, as a Bluetooth transceiver, Bluetooth Low Energy (BLE) transceiver, or a WIFI transceiver. Reading unit 39 can also be implemented as a wireless RF transceiver, for example, as an NFC transceiver. The two transceivers can be distinguished in terms of their communication protocol and / or their transmission range.

[0192] The transmission range of transceiver 38 can be greater than that of reading unit 39. The transmission range of transceiver 38 can be within a range of several meters or tens of meters. Transceiver 38 can be implemented as a local range or short-range wireless transceiver. Reading unit 39 can be implemented as a near-field transceiver. It can include ranges of less than 10cm, less than 5cm, etc.

[0193] Transmission range of 3cm, less than 2cm, or even less than 1cm.

[0194] In some examples, the machine-readable identifier 22 may include or provide electronic information or data, such as the name of the drug, the name of the pharmaceutical substance in the drug, the concentration of the drug, batch number, LOT number, manufacturing date, manufacturing location, expiration date, and / or the temperature at which the drug should be stored or has been stored. The corresponding information or data can be read by the reading unit 39, for example, when in proximity to the machine-readable identifier 22. Once the data of the machine-readable identifier 22 has been read by the reading unit 39, the corresponding data can be further processed by the processor 44 and can be transmitted to the external electronic device 100 via a local range or short-range transceiver 38 2. In this way, the auxiliary device 30 can act as a range extender for reading the electronic identifier 33 of the injection device 1.

[0195] The electronic identifier 33, which can be implemented as a near-field communication tag (NFC tag), can be read by the near-field reading unit 39 of the auxiliary device 30. The information or data obtained therefrom can be further processed by the processor 44 and can be transmitted to the external electronic device 100 via another transceiver 38.

[0196] The electronic module 34 includes a memory 40 configured to store multiple measurement results from the touch sensor 80. The electronic module 34 further includes a clock 42 configured to provide a time index or timestamp to each of the multiple measurement data from the sensor assembly 80, indicating the detection time point and / or detection date of the corresponding operation of the injection device 1.

[0197] Processor 44 is configured to process signals generated by the operation of sensor element 81 obtained from touch sensor 80. Electronic module 34 (and therefore electronic circuitry 35) is further equipped with power supply 46 configured to power processor 44, touch sensor 80, and clock 42. Power supply 46 may be implemented as a battery. Sensor assembly 80 may further include switch 48 configured to turn electronic circuitry 35 on and off, or to toggle electronic module 34 between active and inactive modes (e.g., sleep mode). Switch 48 may be implemented as an electromechanical switch. The switch may be operable to toggle when a user causes the cover 75 or support 70 to move relative to body 60. The location of switch 48 between support 70 and cover 75 is merely exemplary. The switch may also be located between support 70 and, for example, the bottom or flange portion 62 of body 60.

[0198] The electronic module 34 may further include a sensor unit 50, such as including or comprising at least one of a touch sensor 80 and a dose-end sensor 90. Figure 19 In the block diagram, sensor unit 50 may represent at least one of touch sensor 80 and dose end sensor 90.

[0199] The dose end sensor 90 is operatively connected to the processor 44. The dose end sensor is operable to detect a specific configuration of the injection device 1, for example, upon reaching a dose end configuration. The dose end sensor 90 may be disposed on the body 60. The dose end sensor may be positioned in the receiving portion 63 and may face distal direction 2. The dose end sensor 90 may be implemented as an electromechanical switch, thereby making direct mechanical contact with the barrel 10 or housing 11 of the injection device 1 upon reaching a dose end or injection end configuration, such as, for example... Figure 8 As shown. In some examples, the dose end sensor 90 may be in mechanical contact with one of the flanges 17 or 18.

[0200] In other examples, the dose end sensor 90 may be implemented as a magnetic or capacitive sensor operable to qualitatively or quantitatively detect or measure the distance between the body 60 of the auxiliary device 30 and the barrel 10 or housing 110 of the injection device 1. In a further example, the dose end sensor 90 may be implemented as an optical sensor architecture operable to qualitatively or quantitatively detect or measure the distance between the body 60 and one of the barrel 10 or housing 11.

[0201] exist Figures 14 to 17The image schematically illustrates an example of a touch sensor 80. The touch sensor 80 includes a sensor element 81 having multiple touch-sensitive or pressure-sensitive sensor segments 84, 85, and 86 on sensing surfaces 82 and 83. The touch sensor 80 may include a regular arrangement of the touch-sensitive sensor segments 84, 85, and 86. Each sensor segment 84, 85, and 86 may correspond to a pixel of a touch-sensitive display. Each sensor segment 84, 85, and 86 may each include a volume measuring device, through which mechanical contact with a user's body part can be accurately detected.

[0202] In some examples, sensor segments 84, 85, and 86 are pressure-sensitive. Therefore, they are operable to generate or modify electrical touch signals when touched by a user's body part. Sensor segments 84, 85, and 86 may be spatially distributed across the sensing surfaces 82 and 83 of sensor element 81. Sensor element 81 can provide spatially resolved detection of sensing areas 88 and 89 that are actually touched or mechanically contacted by the user's skin or body part.

[0203] In some examples, the individual sensor sections 84, 85, and 86 are not only touch-sensitive but also operable to generate electrical touch signals indicating the pressure or intensity of mechanical contact with a user's body part. Therefore, the touch-sensitive sensor sections 84, 85, and 86 are operable to generate different electrical touch signals indicating the magnitude of pressure or force applied to the respective sensor sections 84, 85, and 86.

[0204] To some extent, the touch-sensitive sensor sections 84, 85, and 86 are operable to generate electrical touch signals that differ in at least one aspect of magnitude, amplitude, sign, or frequency. These differences in the electrical touch signals can be detected by the processor 44 and can be evaluated to detect, identify, characterize, and / or measure at least one of user-induced operations of the attachment 30 and thus user-induced operations of the injection device 1 when the attachment is in a pressure-transmitting connection or linkage with the injection device 1.

[0205] Sensor element 81 may include a planar sensing surface 82 of circular shape and a tubular sensing surface 83, the tubular sensing surface being longitudinally positioned adjacent to the outer circumference of sensing surface 82. To some extent, in some examples, sensor element 81 may include a cup-shaped receiving portion, the size of which is set to, for example, receive or surround at least a portion of the cover 75 of attachment 30.

[0206] Touch sensor sections 84, 85, and 86 are operable to generate different electrical touch signals based on the force or pressure level applied to the respective sensor section 84, 85, and 86. Figure 14In the scenario shown, the user applies moderate or relatively weak pressure to the touch sensor 80. Therefore, only the sensor segments 85 and 86 located within the sensing area 88 can generate electrical touch signals indicating relatively weak pressure. Sensor segments covered by the boundary area, and further covered by the boundary sensing area 89 surrounding or at least partially enclosing the sensing area 88, can also detect pressure significantly weaker than that detected in the central sensing area 88. These sensor segments can generate electrical touch signals indicating even weaker pressure.

[0207] like Figure 15 As shown, when the user increases the pressure applied to the touch sensor 80, the sensor section located in the sensing area 89 may experience a corresponding increase in pressure. Therefore, the pressure previously applied to the sensing area 89 will increase by at least [amount missing]. Figure 14 The pressure level present in the sensing area 88. In other words, the increase in the size or shape of the sensing area 88, which indicates the first level of pressure, occurs simultaneously with the change in the size or shape of the sensing area 89, and the same applies to the corresponding decrease.

[0208] In the same or similar manner, the spatially resolved touch sensor 80 is operable to detect spatial and / or temporal changes in pressure applied to the sensing surface 82. Figure 16 In the example, the user can initially apply relatively weak pressure to the sensing surface 82. Accordingly, the central sensing area 88 can reflect a first level of pressure, while the surrounding sensing area 89 can reflect a second level of pressure, which is lower than the first pressure level. When the user presses their thumb 5 firmly onto the sensing surface 82 (e.g., ...), the pressure increases. Figure 17 When the force or pressure effect on the sensing surface is increased (as shown), due to the elasticity of the corresponding body part (e.g., thumb 5), the area of ​​the first pressure level (i.e., the central sensing area 88) extends to the surrounding sensing area 89. Therefore, the sensing areas 88, 89 that the touch sensor 80 can detect change their shape and / or position, on which the pressure distribution indicating typical operation of the auxiliary device 30 or the injection device 1 can be obtained or measured.

[0209] In practice, the touch sensor 80 can monitor pressure, spatial pressure distribution, and temporal changes in pressure applied to the sensing surfaces 82 and 83. Typical actions (rolling or grinding) performed by the user, for example, with the thumb 5 or fingers 6 and 7 on the sensing surface 82 during the dosing procedure can be detected. Based on qualitative and / or quantitative measurements of pressure distribution in the spatial and / or temporal domains, the processor 44 can be operable to determine the start and / or end of the dosing procedure based on the electrical touch signals generated by the touch sensor 80.

[0210] In addition, not only can spatially resolved contact distribution be provided on one-dimensional or two-dimensional sensing surfaces 82, 83 of sensor element 81, but pressure distribution can also indicate different pressure levels applied to (multiple) sensing surfaces 82, 83.

[0211] For pressure distribution, and therefore the pressure or force measured over time during the user's injection procedure. Figure 18 The simplified diagram 200 is exemplary. During the first time interval 202, the user applies a distal pressure to the thrust receiving surface 76 of the attachment 30 when it is properly attached to the stopper 9 of the injection device 1. During the first time interval 202, the pressure continues to increase until, at time T1, the applied pressure is equal to or greater than the frictional force between the stopper 9 and the sidewall of the cylinder 10.

[0212] Accordingly, during the subsequent time interval 204, i.e., between time T1 and time T2, the stopper 9 undergoes a constant movement in the distal direction 2, thereby discharging a certain dose or all of the agent 8 located inside the cylinder 10. At time T2, the stopper 9 reaches the distal position. At this point, the user can automatically apply increased pressure because the stopper 9 can no longer move in the distal direction 2. The stopper may engage with a radially inwardly extending shoulder portion of the cylinder 10, or it may engage with some other longitudinally acting stop.

[0213] Therefore, within time interval 206, i.e., between time T2 and time T3, the measurable pressure applied to the attachment 30 increases to another level. At time T3 and throughout the final time interval 208 continuing to time T4, the user can apply a constant but increasing pressure level to the attachment 30 and thus the plunger 20 or plunger extension 91 for a predefined time period 208. This time interval 208 represents or reflects the hold time during which the needle 15 should remain within the tissue actually punctured. At time T4 and after time interval 208 has elapsed, the user typically releases the attachment 30, and thus the thrust receiving surface 76. This allows the touch sensor 80 to detect a measurable pressure drop or force drop. Therefore, at time T4, the processor 44 can detect the termination or completion of the dosage injection procedure.

[0214] For example Figure 1 In the example of the injection system 110 shown, the auxiliary device 30 is equipped with a longitudinally extending plunger extension 91. The plunger extension 91 includes an elongated rod 92. The diameter of the elongated rod 91 is smaller than the inner diameter of the barrel 10. Figure 7As specifically shown, the distal end of the plunger extension 91 includes a fastening structure 94 that is complementary in shape or configuration to a mating fastening structure 29 located at the proximal end or side of the plug 9. This allows the plunger extension 91 or rod 92 to be detachably connected to the plug 9. In some examples, the fastening structure 94 includes a threaded portion 95 that is complementary in shape to a corresponding or complementary mating threaded portion located on the proximal side of the plug 9.

[0215] As from Figure 4 , Figure 5 and Figure 10 As further clarified in the illustration, the antenna 43 of the read unit 39 (or the antenna connected to the read unit 39) can be located on or inside the plunger extension 91. The antenna can also be located on the outer surface 93 of the plunger extension 91. The antenna 43 can be disposed at or near the distal segment 98 of the plunger extension 91. Figure 4 and Figure 5 As shown, the machine-readable identifier 22 of the injection device 1 may be located at or near the distal end of the housing 11 or the barrel 10. The antenna 43 is connected via a conductor 41 to the remaining components of the reading unit 39, which are typically located inside the receiving portion 64 and thus inside the body 60 of the auxiliary device 30.

[0216] In such Figure 4 In the initial configuration shown, and prior to the injection dose, the antenna 43, located at or near the distal end 98 of the plunger extension 91, is situated at a relatively large longitudinal distance from the machine-readable identifier 22. Here, when the machine-readable identifier 22 is implemented as an NFC tag or similar near-field communication tag or identifier, it may be outside the transmission range of the antenna 43, and therefore outside the transmission range of the reading unit 39. Thus, in situations such as Figure 4 In the initial configuration shown and prior to the dose injection procedure, antenna 43 is not and therefore inoperable to read information stored in or provided by machine-readable identifier 22.

[0217] Only during the injection procedure or when the following conditions are met. Figure 5When the dose configuration shown is complete, antenna 43 only longitudinally overlaps with machine-readable identifier 22, or the machine-readable identifier enters the transmission range of antenna 43. To some extent, when antenna 43 approaches or reaches electronic identifier 33 or machine-readable identifier 22 in the longitudinal direction (z), machine-readable identifier 22 becomes readable by reading unit 39. The ability to read information stored in or provided by machine-readable identifier 22 can then autonomously trigger a corresponding readout of the information and transmit said information to processor 44. Simultaneously with reading machine-readable identifier 22, processor 44 can be operable to prompt or request a timestamp from clock 42 and combine the corresponding timestamp with the information retrieved or obtained from machine-readable identifier 22.

[0218] In this way, a pairing can be provided between information obtained from machine-readable identifier 22 and a timestamp indicating the time and / or date when or during which the corresponding injection has been completed or performed.

[0219] In further examples, such as Figure 11 and Figure 12 As shown, the elongated plunger extension 91 may be provided only as an optional component of the add-on device 30. In some examples, the elongated plunger extension 91 may be detachably connected to at least one of the body 20, the flange portion 62, the bottom of the body 60, or the support member 70. The elongated plunger extension may be detachably connected to the body 60 or the add-on device. Here, when the antenna 43 is disposed in or on the elongated plunger extension 91, a detachable connection of the conductor 41 may also be provided, which extends longitudinally along or through the elongated rod 92 and connects to the reading unit 91.

[0220] The main body 60 of the auxiliary device 30 can be provided with, via the detachable longitudinal plunger extension 91, as shown in the example. Figure 1 and Figure 12 The additional fastening structure 94' is shown. Here, the receiving portion 63, defined by the inner side of the sidewall 61 and the bottom or flange portion 62, can be configured to detachably fix or detachably attach the body 60 of the auxiliary device 30 to the plunger flange 21 of the plunger 20 of the injection device 1. The fastening structure 94' can be complementary in shape to the corresponding mating fastening structure 29' provided on or at the plunger flange 21 of the plunger 20 of the injection device 1.

[0221] In some examples, the fastening structure 94' and the corresponding mating fastening structure 29' are configured to form a friction fit. Here, the inner side of the sidewall 61 of the receiving portion 63 can be securely fitted onto the outer circumference of the plunger flange 21. In another example, the fastening structure 94' and / or the mating fastening structure 29' may include a snap-fit ​​element 97 to establish or provide a form-fit engagement between the body 60 of the attachment 30 and the plunger flange 21.

[0222] In such Figure 11 and Figure 12 In the example shown, plunger 20 can be implemented as a component of injection device 1. Plunger 20 can be attached to or integrally formed with stopper 9. Plunger 20 can be provided as a separate piece, which can be connected to attachment 30 via one longitudinal end and to stopper 9 via the opposite longitudinal end. In either case, plunger 20 provides an indirect mechanical connection between attachment 30 and stopper 9 of injection device 1. Plunger 20 is rigid in compression, at least with respect to the longitudinal direction (z). To some extent, when attachment 30 is attached to the proximal end of plunger 20, attachment is in a force transmission path or drive system for transmitting user-applyable force or pressure to stopper 9.

[0223] The auxiliary device 30 of the injection system 110 provides multiple functions. On one hand, the auxiliary device 30 provides automatic reading of information stored in or provided by the machine-readable identifier 22 of the injection device 1. On the other hand, the auxiliary device 30 provides automatic injection program detection when attached to the stopper 9 of the injection device 1. The auxiliary device 30 can be operable to detect at least one of the start and end of the dosage injection program. In such cases… Figures 1 to 6 In the example shown, the additional device is specifically operable to at least detect the completion of the dose injection procedure.

[0224] exist Figure 11 and Figure 12 In this example, information stored in or provided by the machine-readable identifier 22 can be read in advance (i.e., before the attachment 30 is installed or attached to the injection device 1). Successful reading of the information can be visually indicated by the signal generator 52. Furthermore, the signal generator 52 can assist the user in operating or manipulating the attachment 30 or the injection device 1. Variations in the duration of signal generation, variations in the intensity of the generated signal, and / or variations in the type of signal (e.g., the signal frequency or color of the signal sound) can further indicate to the user whether the information reading procedure was successful or unsuccessful and / or whether the attachment 30 is ready to transmit a user-applicable force to the stopper 9 of the injection device 1.

[0225] Detection of the dose end configuration can be achieved by enabling readout of the machine-readable identifier 22 (i.e., when the antenna 43 approaches or overlaps with the machine-readable identifier 22). In a further example, signal processing of a signal obtainable from the touch sensor 80 and according to, for example... Figure 18 The pressure or force distribution shown is used to detect the end of the dose. In a further example, the end of the dose configuration can be detected by a separate end-of-dose sensor 90 and / or via switch 48.

[0226] Various methods or procedures for detecting the end of a dose can be used or implemented simultaneously. This provides redundancy when configuring the injection device 1 to detect the end of a dose. Therefore, information obtained from the touch sensor 80 can be processed simultaneously with signals obtainable from the dose end sensor 90. Similarly, reading the machine-readable identifier 22 via, for example, antenna 43 and reading unit 39 can be processed simultaneously with processing or obtaining signals from at least one of the touch sensor 80 and the dose end sensor 90.

[0227] Figure 20 The flowchart schematically illustrates an example of a method for using the attachment 30 with the injection device 1. In a first step 300, the user attaches the attachment 30 to the injection device 1, thereby establishing a force transmission connection between the attachment 30 and the plug 9 of the injection device 1. In a subsequent step 302, the user simply begins injection, for example by applying a driving force to the body 30 and / or the support 70 to simultaneously push the attachment 30 and the plunger 20 or plunger extension 91 in the distal direction 2, thereby transmitting the corresponding driving force to the plug 9.

[0228] With the cap 75 movable, the user-actuable switch 48 can be pressed or actuated, and this pressure application is detected in step 304. In the subsequent step 306, in response to the user applying pressure to the cap 75 and moving the cap 75 in a distal direction relative to the body 60, the auxiliary device 30 can begin to provide visual indications via the signal generator 52, thereby indicating that injection has begun and / or the auxiliary device 30 is ready for use.

[0229] In step 310, clock 42 provides a clock signal, which is used in step 308 to start or control the timer. The start of the timer in step 308 triggers the activation of the reading unit 39 in step 312. In step 324, the injection device 1 has reached the dose-end configuration. Here, therefore, the reading unit 39 detects the presence of the machine-readable identifier 22 in step 312 and begins reading the data from the machine-readable identifier 22. Therefore, in step 314, the timer that was started in step 308 is stopped. In step 316, the processor 44 performs a rationality check, that is, checks whether the time interval determined by the timer matches a typical predefined time interval required for the injection dose.

[0230] In step 320, information from the machine-readable identifier is read. In step 322, the corresponding information is stored in memory 40. Simultaneously with reaching the dose end configuration in step 324, in step 326, the user needs to hold the injection device in the patient's punctured tissue for a predefined time interval (e.g., 5 seconds). At the start of the holding time, processor 44 may control signal generator 52 in step 328 to generate a distinguishable signal or characteristic signal during the holding time.

[0231] Here, in step 328, signal generator 52 may generate a flash or blink of a specific color (e.g., green) to instruct the user to hold the injection device until a predefined holding time has elapsed. After the holding time has elapsed in step 330, in step 332, the flash or blink of the light as described with respect to step 328 becomes a constant signal generated by the signal generator in step 332.

[0232] In step 334, the user releases the button or cover 75, which then returns to its initial configuration under the action of the return element 65. Therefore, switch 48 will open and can indicate to processor 44 that the injection procedure has successfully terminated. The opening of the switch 336 can ultimately trigger the storage of data in step 322. After releasing the button in step 334, the electronic module 34 can wait for a predefined time interval (e.g., a few seconds or minutes) before switching to sleep mode in step 338.

[0233] In another example, such as Figure 21 As shown in the flowchart, the dose end sensor 90 detects the dose end configuration. Here, the additional device 30 can be used for, for example... Figure 11 and Figure 12The configuration is shown. Information stored in or provided by the machine-readable identifier 22 can be read before the attachment device 30 is attached to the injection device 1. In the first step 400, the attachment device switches from sleep mode to active mode. Here, the reading unit 39 can be arranged near the machine-readable identifier 22, and the corresponding drug-related information is transmitted from the machine-readable identifier 22 to the reading unit 39. Therefore, data reading or data retrieval is performed in step 400.

[0234] Then, in step 402, the corresponding information obtained by the reading unit 39 is stored in the memory 40. In step 404, user feedback is provided to the user, for example, by generating a flashing or blinking visual signal via the signal generator 52. Thereafter, the attachment 30 is attached to the plunger flange 21 of the plunger 20 of the injection device 1, and in step 406, the patient begins the injection. Subsequently, once the button or cap 75 of the attachment 30 is pressed and thus moves relative to the body 60, the switch 48 closes, and the timer controlled by the clock 42 begins timing in step 408.

[0235] In step 410, the information obtained from the machine-readable identifier 22 is optionally stored locally or temporarily in memory 40. At the end of the dosage injection procedure, switch 48 may be turned off in step 412, and the timer may be stopped in step 414. In step 416, an assessment is made as to whether the injection has actually been successfully performed. Here, signals from at least two of the reading unit 39, switch 48, dosage end sensor 90, and touch sensor 80 may be compared and evaluated to determine whether the dosage has been successfully injected and / or whether the dosage injection procedure has been completed.

[0236] If the evaluation fails, the method is interrupted in step 418. However, if the injection is successfully completed as should be evaluated in step 416, the corresponding information (i.e., drug-related information obtained from machine-readable identifier 22) and a corresponding timestamp indicating the injection time or date are simultaneously stored in memory 40 in step 420.

[0237] Upon successful completion and storage of the data in memory 40, in step 422, signal generator 52 changes its appearance and / or signal generation. For example, light sources 53 and 54 of signal generator 52 switch to a constant green, thereby indicating to the user that the injection procedure has been successfully recorded. In step 424, electronic module 34 counts or waits for a predefined time interval, and then returns to sleep mode in step 426.

[0238] Figure Labels

[0239] 1. Injection device

[0240] 2. Distal direction

[0241] 3. Proximal direction

[0242] 4. Hands

[0243] 5. Thumb

[0244] 6 fingers

[0245] 7 fingers

[0246] 8. Pharmacology

[0247] 9. Stoppers

[0248] 10. Cylinder

[0249] 11. Shell

[0250] 12 shields

[0251] 13. Injector holder

[0252] 14 Exports

[0253] 15 needles

[0254] 16 Protective Helmet

[0255] 17. Flange portion

[0256] 18. Flange portion

[0257] 20 plungers

[0258] 21. Plunger flange

[0259] 22 Electronic Identifiers

[0260] 23 antennas

[0261] 24 Interlocking devices

[0262] 25. Latch element

[0263] 26 Paired latching elements

[0264] 27 Spring elements

[0265] 28 Through opening

[0266] 29. Paired fastening structure

[0267] 30 Additional devices

[0268] 34 Electronic Modules

[0269] 35 Electronic Circuits

[0270] 36 Printed Circuit Boards

[0271] 38 transceivers

[0272] 39 Reading Unit

[0273] 40 Memory

[0274] 41 Conductors

[0275] 42 clocks

[0276] 43 antennas

[0277] 44 processors

[0278] 46 Power Supply

[0279] 48 Switches

[0280] 50 sensor units

[0281] 52 Signal Generator

[0282] 53 Light Source

[0283] 54 Light Sources

[0284] 55 windows

[0285] 56 windows

[0286] 60 Device body

[0287] 61 Sidewall

[0288] 62 Flange portion

[0289] 63 Reception Department

[0290] 64 Reception Department

[0291] 65 Return element

[0292] 66 recess

[0293] 67 Stop surface

[0294] 68 recess

[0295] 69 Stop surface

[0296] 70 Support components

[0297] 71 Main rod

[0298] 72. Protrusion

[0299] 74 Protrusion

[0300] 75 lids

[0301] 76 Thrust Receiving Surface

[0302] 77 Sidewall

[0303] 79 sheets

[0304] 80 touch sensors

[0305] 81 Sensor Components

[0306] 82 Sensing Surface

[0307] 83 Sensing Surface

[0308] 84 Sensor Section

[0309] 85 Sensor Section

[0310] 86 Sensor Section

[0311] 88 Sensing Area

[0312] 89 Sensing Area

[0313] 90 Dosage End Sensor

[0314] 91 Plunger Extension

[0315] 92 strokes

[0316] 93 Surface

[0317] 94 Fastening Structure

[0318] 95 Threaded section

[0319] 97. Clip-on components

[0320] 98 Remote Section

[0321] 100 External electronic devices

[0322] 101 Casing

[0323] 102 Device Processor

[0324] 104 monitor

[0325] 106 Communication Units

[0326] 110 Injection System

[0327] 120 floors

[0328] 121st floor

[0329] 122nd floor

Claims

1. An auxiliary device (30) for an injection device (1), wherein, The injection device (1) includes a barrel (10) filled with a drug (8) and sealed by a stopper (9), wherein the stopper (9) is movable in a distal direction (2) relative to the barrel (10) to dispense a dose of the drug (8), and wherein the injection device (1) includes a machine-readable identifier (22) attached to or integrated into the barrel (10) or housing (11) of the injection device (1), and the additional device (30) includes: -Ontology(60), - A fastening structure (94, 94') that is connected to or integrated into the body (60) and is configured to be detachably connected to the plug (9). - The electronic module (34) inside the body (60) includes a reading unit (39) operable to read information stored in or provided by the machine-readable identifier (22). - Wherein, when connected to the plug (9), the body (60) and the fastening structure (94, 94') are configured to transmit a user-applicable driving force to the plug (9) to cause the plug (9) to move relative to the cylinder (10).

2. The additional device (30) according to claim 1, wherein, The electronic module (34) includes a processor (44) and is operable to detect the completion of an injection performed by the injection device (1).

3. The additional device (30) according to claim 2, wherein, The electronic module (34) includes a clock (42) connected to the processor (44) and operable to provide a clock signal, wherein the electronic module (34) is operable to buffer or store the clock signal or a timestamp derived therefrom when the injection is detected to be complete.

4. The additional device (30) according to any one of claims 2 or 3, wherein, The processor (44) is connected to the reading unit (39) and is operable to process electronic signals from the reading unit (39) to detect the completion of the injection.

5. The additional device (30) according to claim 4, further comprising: - An elongated plunger extension (91) comprising an elongated rod (92) extending in the longitudinal direction (z), attached to or integral with the body (60), and protruding in the distal direction (2) from the bottom or flange portion (62) of the body (60). -The elongated plunger extension (91) includes a fastening structure (94) at the distal section (98) for connection or contact with the plug (9).

6. The additional device (30) according to claim 5, wherein, The reading unit (39) is a wireless reading unit, which includes an antenna (43) located on or inside the elongated plunger extension (91).

7. The additional device (30) according to claim 6, wherein, The reading unit (39) is operable to read information stored in or provided by the machine-readable identifier (22) when at least one segment of the antenna (43) overlaps or aligns with the machine-readable identifier (22) relative to the longitudinal direction (z).

8. The additional device (30) according to any one of claims 6 or 7, wherein, The reading unit (39) is inoperable to read information stored in or provided by the machine-readable identifier (22) when and whenever the machine-readable identifier (22) is outside the transmission range of the reading unit (39).

9. The additional device (30) according to any one of claims 6 to 8, wherein, The transmission range of the reading unit (39) is less than 5cm, 3cm, 2cm or even less than 1cm.

10. The additional device (30) according to any one of claims 2 to 9, wherein, The electronic module (34) includes a dose end sensor (90) disposed on or integrated into the body (60) and configured to detect at least one of a predefined position or movement of the body (60) relative to the barrel (10) of the injection device.

11. The additional device (30) according to any one of claims 2 to 10, wherein, The electronic module (34) includes a touch sensor (80) connected to the processor (44), wherein the touch sensor (80) includes a sensing surface (82, 83), the sensing surface (82, 83) includes touch-sensitive sensor segments (84, 85, 86), the touch-sensitive sensor segments (84, 85, 86) being operable to generate or modify an electrical touch signal when touched by a user's body parts (5, 6, 7).

12. The additional device (30) according to claim 11, wherein, The processor (44) is operable to detect the completion of an injection performed by the injection device (1) by processing a plurality of electrical touch signals provided by the touch sensor (80) during a predefined time interval.

13. The additional device (30) according to any one of the preceding claims, wherein, The fastening structure (94') is configured to be detachably fixed to the plunger flange (21) of the plunger (20) which is connected to or integral with the plug (9).

14. An injection system (110), comprising: - An injection device (1), comprising: - A cylinder (10) filled with a drug (8) and sealed by a stopper (9), wherein the stopper (9) is movable relative to the cylinder (10) in a distal direction (2) to discharge a dose of the drug (8). - A machine-readable identifier (22) attached to or integrated into the barrel (10) or housing (11) of the injection device (1), and - An additional device (30) according to any one of the preceding claims.

15. The injection system (110) according to claim 14, wherein, The machine-readable identifier (22) is arranged at or near the far end of the cylinder (10), and wherein the reading unit (39) is a wireless reading unit and includes an antenna (43) located on or inside an elongated plunger extension (91) that protrudes from the bottom or end portion (62) of the body (60) in the distal direction (2).

16. The injection system (110) according to any one of claims 14 or 15, wherein, The injection system (110) can be converted from a pre-use configuration to a dose-end configuration by pushing the stopper (9) from the proximal position toward the distal position and pushing it into the distal position via the additional device (30).

17. The injection system (10) according to claim 16, wherein, When the injection system (10) is in the pre-use configuration, the machine-readable identifier (22) is outside the transmission range of the reading unit (39) or the antenna (43).

18. The injection system (10) according to any one of claims 15 to 17, wherein, The machine-readable identifier includes an electronic identifier (22) that is within the transmission range of the reading unit (39) or antenna (43) when the injection system (10) is in the dose-end configuration.

19. A method for monitoring the use of an injection device (1), the method comprising the following steps: - The injection device (1) is provided, wherein the injection device (1) includes a barrel (10) filled with a drug (8) and sealed by a stopper (9), wherein the stopper (9) is movable relative to the barrel (10) in a distal direction (2) to dispense at least a dose of the drug (8), and wherein the injection device (1) includes a machine-readable identifier (22) attached to or integrated into the barrel (10) or housing (11) of the injection device (1). - Provide an additional device (30) according to any one of claims 1 to 13. - Information stored in or provided by the machine-readable identifier (22) can be read through the reading unit (39).

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