Add-on devices for injection devices

Abstract

In one embodiment, the present disclosure relates to an add-on device (30) for an injection device (1), wherein the injection device (1) comprises a barrel (10) filled with a drug (8) and sealed by a stopper (9), the stopper (9) being movable distally (2) relative to the barrel (10) to dispense a dose of the drug (8), the injection device (1) comprises a machine-readable identifier (22) attached to or integrated with the barrel (10) or housing (11) of the injection device (1), and the add-on device (30) - Main unit (60) and, - A fastening structure (94, 94') that is connected to or integrated with the main body (60) and configured to be detachably connected to the stopper (9), - An electronic module (34) inside the main body (60), the electronic module (34) comprises a reading unit (39) that is operable to read information stored in or provided by a machine-readable identifier (22), Equipped with, - When connected to the stopper (9), the main body (60) and fastening structures (94, 94') are configured to transmit a user-applyable driving force to the stopper (9) to cause the stopper (9) to move relative to the barrel (10).

Description

Technical Field

[0001] The present disclosure relates to an auxiliary device or an add-on device for use with an injection device such as a syringe, a safety syringe or a pen-type syringe. In a further aspect, the present disclosure relates to an injection system comprising an injection device and an add-on device. In a further aspect, the present disclosure relates to a method of monitoring the use of an injection device or an injection system for injecting a drug.

Background Art

[0002] Drug delivery devices for setting and administering single or multiple doses of a liquid drug are known in the art. Generally, such devices have substantially the same purpose as a conventional syringe.

[0003] Drug delivery devices such as pen-type syringes must meet many user-specific requirements. For example, in the case of a patient suffering from a chronic disease such as diabetes, the patient may be physically debilitated and may also have reduced vision. Therefore, a suitable drug delivery device, particularly for home healthcare, should be robust in structure and easy to use. Further, the operation and general handling of the device and its components should be clear and easy to understand. Such an injection device should provide for the setting and subsequent administration of equal or variable-sized drug doses. Further, the dose setting and dose administration procedures should be easy to operate and unambiguous.

[0004] A patient suffering from a particular disease may need to inject a certain amount of a drug via a pen-type injection syringe.

[0005] Some drug delivery devices or injection devices perform the selection of variable-sized drug doses and the injection of pre-set doses. Other injection devices perform the setting and administration of fixed doses. In this case, the amount of drug to be injected according to a given prescription schedule is always the same and is invariant or unchangeable over time.

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

[0007] To control and manage drug administration performed by the user or patient themselves, it is desirable to provide automated detection and logging of repetitive and regular use of drug delivery devices. A fairly automated recording of user-injected doses offers significant advantages over manual dose logging from a safety and convenience standpoint.

[0008] There are numerous add-on or auxiliary devices that are generally configured for use with injection devices and provide electronic detection and monitoring of single or repeated dose injection procedures.

[0009] Add-on devices or auxiliary devices can be detachably connected to injection devices. Add-on devices typically include sensors, detectors, or detector configurations that are capable of detecting the date and / or time when the user sets or injects a drug dose. Some add-on devices also provide quantitative measurement of the size of the currently set or administered dose. Some add-on devices are intended for use with a series of injection devices, particularly disposable injection devices intended to be discarded after use or after the drug inside the injection device has been used up.

[0010] With certain types of injection devices, such as pre-filled syringes or pre-filled safety syringes, the use and acceptance by users of auxiliary or add-on devices is extremely difficult because the pre-filled syringes or pre-filled safety syringes are intended for single use. To that extent, the detachable connection or coupling between the add-on device and the respective injection device must be fairly simple and free from the risk of failure.

[0011] Therefore, it would be desirable to provide an add-on device that is configured to be used particularly with pre-filled syringes or safety syringes, and that offers improved functionality in detecting the completion of dose injection and recording drug-related data. At the same time, the design and structure of the add-on device should be fairly simple and cost-effective to produce. It should also evoke acceptance from a high level of users. Furthermore, the handling and use of the add-on device should be fairly easy, intuitive, and simple. [Overview of the Initiative] [Means for solving the problem]

[0012] In one embodiment, an add-on device for an injection device is provided. The injection device comprises a barrel filled with a drug and sealed by a stopper. The stopper is movable distally to the barrel to dispense a dose of the drug. The injection device comprises a machine-readable identifier, for example in the form of an electronic identifier, attached to or integrated with either the barrel or housing of the injection device. The housing of the injection device may optionally be provided and accommodates the barrel filled with the drug. The machine-readable identifier may be fixedly attached to either the barrel or the housing, i.e., immovably attached.

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

[0014] When connected to the stopper, the main body and fastening structure are configured to transmit a user-applyable driving force to the stopper, causing the stopper to move relative to the barrel.

[0015] In some examples, when the body is connected to the stopper, the body and stopper are in a thrust-transmission configuration. This means that a user-operable driving force applied to the body is transmitted to the stopper, causing the stopper to move relative to the barrel.

[0016] In some examples, the connection between the stopper and the body has compressive rigidity. Here, the user may apply distal thrust or pressure to the body of the add-on device, which is invariably transmitted to each movement of the stopper relative to the barrel due to the connection with the stopper.

[0017] In some examples, the add-on device is configured to be mounted on or for an assembly within a force transmission path or drivetrain, which is operable to transmit the injection force acted upon or provided by the user to each movement of a stopper relative to the barrel in order to dispense a dose of medication from the barrel.

[0018] In some examples, the barrel of the injection device has an outlet at its distal end. A stopper may close or seal the barrel toward the proximal end opposite the barrel. The mechanical connection between the body and the stopper allows the body to be operated to transmit a distal dispensing force to the stopper so as to move the stopper distally for the purpose of dispensing a dose through the barrel outlet when connected to the stopper.

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

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

[0021] In other examples, the stopper can engage with a separate plunger. The plunger may be provided 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 add-on device is implemented in or on the separate plunger. The fastening structure and / or the separate plunger may be part of the add-on device comprising such a plunger. Thus, an elongated plunger configured to be attached to a stopper, or configured to abut against the stopper of the injection device, is made to enter the barrel from proximal to distal in order to transmit the respective driving or administering force to the stopper.

[0022] Therefore, in some examples, when the fastening structure is integrated into the main body, the main body itself or the portion of the main body on which the fastening structure is provided can be detachably connected to the stopper of the injection device. In other examples, the fastening structure may provide an indirect mechanical connection or link between the add-on device and the stopper of the injection device.

[0023] In some examples, a separate plunger in the form of an elongated rod may be provided for engaging with the proximal thrust receiving surface or proximal end of the stopper. Here, the fastening structure of the add-on device may be configured to be attached to the proximal end of such a separate plunger. The separate plunger may contribute to a force transmission path or drivetrain between the body and the stopper of the injection device.

[0024] Add-on devices have particular advantages because they provide a dual function. They serve to read information stored in or provided by the machine-readable identifier of the injection device. Furthermore, add-on devices can be used as auxiliary devices during the dose injection process. The add-on device itself may be located in, or be part of, a force transmission path or drivetrain that can transmit a user-applied driving force to a stopper in order to dispense a dose of medication. In this way, by positioning the add-on device in a transmission path or drivetrain between the stopper of the injection device and a user's body part, such as the user's finger, that is operable to apply the respective driving force, the add-on device can provide further functionality with respect to recording or detecting medication or injection events, such as the initiation and / or completion of a dose injection procedure.

[0025] In a further example, the add-on device includes a thrust bearing surface that is operable to receive a driving force that can be applied by the user. The thrust bearing surface is fixed to the body of the add-on device. It may be integrated with the body of the add-on device.

[0026] The thrust receiving surface may be provided at the proximal end of the add-on device. This may constitute the proximal end face of the add-on device. Typically, the thrust receiving surface of the add-on device is directly attachable and / or depressible by the user to inject a dose or trigger a dose injection procedure. In some examples, the thrust receiving surface may be provided by a cover, button or cap of the add-on device, and these buttons, covers or caps may be displaceable relative to the housing of the add-on device or relative to the body of the add-on device. Thus, the thrust receiving surface may be integrated with the dosing button or operating button of the add-on device, which is depressible by the user, for example, to start, activate or control the operation of the add-on device.

[0027] In a further example, the electronic module of the add-on device comprises a processor. The electronic module and / or the processor is operable to detect the completion of an injection performed by the injection device. There may be numerous examples of ways to implement the end of an injection completion function in the add-on device. Nevertheless, regardless of the specific dose completion detection provided by one or both of the processor or the electronic module, the add-on device may automatically track or detect when the dose injection process has completed. Each piece of information obtainable from the machine-readable identifier may be paired or combined with dosing information such as the date and / or time when each dose of the drug was injected, by an electronic module operable to read information stored in or provided by the machine-readable identifier.

[0028] According to a further example, the electronic module comprises a clock operable to be connected to a processor and provide a clock signal. The electronic module is operable to buffer or store the clock signal or a timestamp derived therefrom when detecting the completion of an injection. Thus, it is possible to combine the machine-readable identifier of the injection device and the drug-related information obtainable by reading the corresponding dosing information, i.e., the information indicating the date and / or time when the dose of the drug was injected, and store it, for example, in the memory of the add-on device.

[0029] Thus, when the user uses the add-on device for a multiple-dose injection procedure, a dosing history can be provided. If the injection device provides only a single-dose of the drug, the user is prompted to disconnect the add-on device from the used injection device and reconnect it to another injection device that can be used for subsequent dosing procedures.

[0030] According to a further example, the electronic module comprises a memory connected to a processor. The processor is configured to perform at least one of storing data in the memory and reading data from the memory. The memory can be implemented as a digital memory. It can include a volatile memory or a non-volatile memory. The memory data indicating the dosing procedure and / or the data obtained or derived from the machine-readable identifier can be stored in the memory separately or in combination. By providing the memory, it becomes possible to collect a certain amount of data indicating a number of dosing procedures and / or a number of drug doses injected by a number of injection devices or by many injection devices.

[0031] In some examples, a machine-readable identifier includes both an electronic identifier and a visible or optically readable identifier. When implemented as an electronic identifier, the machine-readable identifier may include a wireless tag such as an RFID, NFC tag, or any other short-range or near-field wireless communication unit. The information stored in or provided by the machine-readable identifier may include drug-related information, electronic information, or data such as the drug name, the name of the drug's medicinal substance, the drug's concentration, batch number, lot number, manufacturing date, manufacturing site or place, expiration date, and / or the temperature at which the drug should or was stored.

[0032] In a further example, the processor of an electronic module is connected to a reading unit and is operable to process electronic signals from the reading unit to detect the completion of an injection. Here, the reading unit, which is originally capable of reading information stored in or provided by the machine-readable identifier of the injection device, is further configured to detect the completion of a dose injection procedure. To that extent, the interaction between the reading unit and the machine-readable identifier provides a dual function. On the one hand, it plays the role of reading information stored in or provided by the machine-readable identifier. On the other hand, the interaction between the machine-readable identifier and the add-on device's reading unit enables the detection of the completion of a dose injection procedure. To that extent, the interaction between the reading unit and the machine-readable identifier allows all the information necessary to store and / or provide the medication history indicating a particular drug and the time or date when a particular drug was injected to be obtained or derived solely from the reading unit.

[0033] In a further example, the processor may also be capable of detecting the start of a dose injection procedure when connected to a reading unit. Thus, the interaction between the machine-readable identifier of the injection device and the reading unit of the electronic module of the add-on device allows for fairly accurate monitoring of the dose injection process.

[0034] In a further example, the add-on device comprises an elongated plunger extension including an elongated rod extending longitudinally. The plunger extension, and therefore the elongated rod, is attached to or integral with the main body and protrudes distally from the bottom or flange portion of the main body. The elongated plunger extension further comprises a fastening structure at its distal end section that connects to or abuts against a stopper. The fastening structure may be provided at the distal end of the elongated rod of the plunger extension. The fastening structure may form or constitute the distal end or distal end section of the elongated rod, and therefore the elongated plunger extension.

[0035] Elongated rods and / or elongated plunger extensions are mechanically rigid components. They are stiff or rigid, 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 add-on device body to the stopper of the injection device. In some examples, the elongated plunger extension may replace a separate plunger of the injection device, which is originally provided to allow the user to apply distal pressure or driving force to the stopper in order to drive the stopper distally relative to the barrel of the injection device.

[0036] In some examples, an elongated plunger extension may be detachably connected to the bottom or flange portion of the main body. The main body of the add-on device may include a cylindrical shape. It may include a cylindrical side wall closed distally by a fairly planar bottom or flange portion. The side wall of the main body may be closed proximal to the thrust bearing surface. The thrust bearing surface may be provided on a cover or cover portion that seals or closes proximal to the proximal end of the side wall of the main body. The cover may be movable longitudinally with respect to the side wall of the main body. Here, the cover may replace or mimic the dispensing button of an injection device. In some examples, the main body of the add-on device may have a receptacle toward its distal end. Here, a bottom or flange portion provided at or near the distal end of the side wall of the main body may be positioned slightly recessed relative to the distal end of the side wall to form or provide a receptacle.

[0037] The receptacle may be sized to engage with or accept the plunger flange of a syringe plunger. Here, the fastening structure of the add-on device may be provided at the distal end of the side wall of the main body, where a fastening structure such as a receptacle for engaging with the plunger flange of a prefilled syringe or prefilled safety syringe plunger may be provided.

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

[0039] In a further example, the reading unit is a wireless reading unit having an antenna on or inside an elongated plunger extension. The antenna may be configured for transmitting a wireless signal and / or exchanging wireless signals with a machine-readable identifier, which may then be implemented as an electronic identifier such as a wireless tag.

[0040] In a further example, the reading unit is or includes an optical reader capable of capturing light signals emitted by or reflected from a machine-readable identifier, where the machine-readable identifier may be provided with a machine-readable visual code that is readable by the optical reader or detector.

[0041] In other examples, a machine-readable identifier may include a magnetically encoded identifier, where the reading unit includes a corresponding magnetic reading device.

[0042] By positioning the antenna on or within the elongated plunger extension, the antenna, and therefore the radio reading unit, can be operated to exchange radio signals with the electronic identifier of the machine-readable identifier only when the stopper is moved distally by the elongated plunger extension and reaches a predetermined position relative to the barrel, and therefore relative to the machine-readable identifier, or exclusively.

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

[0044] Thus, when the injection device is in its initial configuration, with the stopper positioned at a clearly defined longitudinal distance from the machine-readable identifier, the reading of information stored in or provided by the electronic or machine-readable identifier by the reading unit can be effectively disabled. To enable the reading of information stored in or provided by the machine-readable identifier, it is necessary to position the reading unit close to the machine-readable identifier. If the reading unit, antenna, or any other signal-receiving component of the reading unit is positioned above 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., while the add-on device with the elongated plunger extension is subjected to distal displacement relative to the barrel, thereby biasing the stopper distally to administer the dose.

[0045] When the end-of-dose configuration is reached, a machine-readable identifier, typically fixed on the barrel, enters or enters the transmission range of the reading unit, thereby enabling or activating the retrieval of the respective information stored in or provided by the machine-readable identifier.

[0046] In a further example, a signal receiving unit, such as the antenna of a reading unit, is located or positioned in or near the distal end section of an elongated plunger extension. Thus, a machine-readable identifier, for example, in the form of a wireless antenna, is positioned longitudinally on the barrel or housing, and this coincides with the position of the stopper when the stopper reaches the end-of-dose position or when the injection device is in the end-of-dose configuration. In this way, the antenna can be positioned longitudinally with the machine-readable identifier only after the injection process has started and when the stopper has moved from the proximal stop position toward the distal end position.

[0047] In a further example, at least partial geometric overlap between the antenna and the machine-readable identifier occurs only before or immediately before reaching the dose-end configuration of the injection device. Thus, the reading of the machine-readable identifier is only valid at the end of the complete dose-injection procedure.

[0048] In another example, a machine-readable identifier is positioned on a barrel such that reading the information stored in or provided by the electronic identifier becomes effective as soon as the stopper moves a predetermined distance distally from a clearly defined initial position and reaches a clearly defined intermediate position.

[0049] In a further example of an add-on device, the reading unit is unable to operate to read information stored in or provided by the electronic identifier when the electronic identifier is outside the reading unit's transmission range, and as long as the electronic identifier is outside the reading unit's transmission range. In some examples, the reading unit's transmission range is relatively small. It may be less than 5 cm, 3 cm, 2 cm, or even less than 1 cm. Thus, as long as the injection device to which the add-on device is attached is in its initial configuration in which the stopper and therefore the antenna of the wireless reading unit are located at a longitudinal distance beyond the transmission range from each other, the reading of information stored in or provided by the electronic identifier is effectively disabled. Such reading becomes effective only during or after the completion of dose injection, which involves distal movement of the antenna located in or on the elongated rod of the add-on device and plunger extension.

[0050] In a further example, the reading unit may be operable to read information stored in or provided by an electronic identifier when at least a section of the antenna overlaps with or aligns with the electronic identifier and / or machine-readable identifier in the longitudinal direction. Upon reaching each overlapping configuration, it may be possible to provide a read of the information stored in or provided by the electronic identifier. Enabling the reading of an electronic identifier or machine-readable identifier may further be used as a trigger to record a clock signal or timestamp that can be derived from the clock of the electronic module.

[0051] In some cases, the transmission of a machine-readable identifier, such as an electronic identifier, to the transmission range of a reading unit during or after a dose injection procedure can be used as a detector to detect that a dose injection is in progress or has been completed. Thus, the reading unit provides a dual function: it provides and reads information stored in or provided by the machine-readable identifier or electronic identifier of the injection device, and further provides a trigger to record a timestamp indicating the date and / or time that each drug or each dose of drug was injected by the injection device.

[0052] In a further example, the electronic module includes a dose end sensor located on or integrated into the main body. The dose end sensor is configured to detect at least one of a predetermined position or movement of the main body relative to the barrel or housing of the injection device. The dose end sensor may operate individually or independently of the reading unit. The dose end sensor may be connected or coupled separately to the processor of the electronic module. In particular, the dose end sensor is configured to detect when the dose end configuration of the injection device, i.e., when the stopper has reached a clearly defined end position relative to the barrel.

[0053] When an add-on device is attached to a plunger flange, or when the add-on device forms a type of plunger flange that can be manually pressed by the user to inject a dose, the dose end sensor may be operable to detect mechanical contact between the add-on device and, for example, the barrel of the injection device. It may be further configured to measure the distance between the add-on device and the barrel of the injection device. In some examples, the dose end sensor may interact with a radially outward projecting flange, such as a finger flange of the injection device, which may be located at or near the proximal end of the barrel or housing of the injection device. In the initial configuration, before injecting a dose of the drug, the dose end sensor is at a clearly defined distance from the dedicated portion of the injection device. During dose injection, this distance will decrease 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 further examples, the dose end sensor includes one of an electromechanical switch, a capacitive sensor, a magnetic sensor, or an optical sensor. An electromechanical switch allows the dose end sensor to be operated to detect mechanical contact with a dedicated portion, for example, at the proximal end of the barrel or housing of the injection device. Similarly, the respective contact or decrease in longitudinal distance between the dose end sensor and the dedicated portion of the injection device can be detected by at least one of the capacitive sensor and magnetic sensor, or even by an optical sensor. The capacitive sensor and magnetic sensor ensure that their respective electrically or magnetically encoded portions are located at or near the distal end of the barrel or housing of the injection device. When an optical sensor is used as the dose end sensor, the same may apply to optical encoding or identifiers.

[0055] In a further example, the electronic module includes a touch sensor connected to a processor. The touch sensor includes a sensing surface. The sensing surface includes a touch-sensing sensor segment. The touch-sensing sensor segment is operable to generate or modify an electrical touch signal when touched by a user's body part. For example, by utilizing such a touch-sensing sensor on the thrust-receiving surface of an add-on device, it is possible to detect the completion of a dose completion configuration or dose injection using user interaction (e.g., by the user's thumb or fingers) between the add-on device, when attached to an injection device or injection system, and a user's body part.

[0056] A user holding an add-on device or injection system in one hand can easily access a touch-sensitive sensor element to generate or modify control signals. In some examples, the touch sensor is mounted on the proximal end of the add-on device, so that the user's thumb, for example, can easily reach the touch sensor while holding the add-on device attached to the injection device with the palm and / or other fingers of the same hand.

[0057] In a further example, the sensing surface of a sensor assembly contains many touch-sensitive sensor segments. Each sensor segment is operable to generate or modify an electrical touch signal when touched by a user's body part. The sensor segments are spatially separated on the sensing surface so as not to overlap. The sensor segments may be arranged adjacent to one another regularly or irregularly. In some examples, the entire sensing surface is covered and / or occupied by a number of sensor segments. The sensor segments may be of equal or unequal size.

[0058] A sensor segment may belong to a touch-sensing matrix or constitute a touch-sensing matrix, such as a one-dimensional or two-dimensional array of touch-sensing segments. Each touch-sensing segment may include a capacitor or resistor that is operable to generate or modify an electrical signal in response to physical contact with, for example, a part of the user's body. To that extent, multiple touch-sensing sensor segments form or constitute a touch-sensing sensor with spatial resolution.

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

[0060] In further examples, a touch-sensitive surface or touch-sensitive matrix may include a combination of electrical resistance sensor segments and capacitive sensor segments. Capacitive sensors can exhibit relatively low power consumption.

[0061] In a further example, the touch-sensitive surface or touch-sensitive matrix is ​​based on surface acoustic wave technology that relies on sound waves. Thus, the touch-sensitive surface or touch-sensitive matrix comprises at least one pair of acoustic wave transducers and acoustic wave receivers.

[0062] In another example, a touch-sensitive surface or touch-sensitive matrix may include many optical sensors, such as photodetectors or photodiodes.

[0063] In further examples, 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 between the characteristic fingerprints of a first user and the characteristic fingerprints of a second user.

[0064] By providing numerous sensor segments on or across a sensing surface, spatially isolated touch sensing can be provided. Thus, a processor connected to each touch-sensing sensor segment can be configured to identify which sensor segment generates or modifies an electrical touch signal in response to mechanical contact with a user's body part. In this way, the processor can be configured to determine which section or subsection of the sensing surface is actually receiving mechanical contact with the user's body part. This makes it possible to provide spatially isolated touch sensing of body parts on the sensing surface of the sensor element.

[0065] In a further example, the processor of a sensor assembly can be operated to detect and / or process the temporal changes of multiple electrical touch signals generated or modified by a number of touch-sensing sensor segments. In this way, the sensor can be operated to detect and / or provide the spatial and spatial-temporal profiles of the individual touch-sensing sensor segments touched by the user's body parts. Thus, the processor may be operated to confirm and / or detect the area on the sensing surface that is touched by a body part at a given time. The processor may further be operated to monitor the temporal changes or movement of such an area over time. Here, the area touched by the body part may also be considered and / or indicated as the sensing area of ​​the sensing surface.

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

[0067] In response to changes in pressure applied to a touch-sensitive sensor segment, the electrical touch signal may have different magnitudes or amplitudes. Furthermore, the electrical touch signal may change its sign or its frequency or periodicity. In response to the changing pressure applied to a touch-sensitive sensor segment, each sensor segment is operable to change the electrical touch signal in a measurable manner, i.e., in a manner detectable or processable by a processor connected to or connectable to the touch-sensitive sensor segment.

[0068] In some examples, multiple or all touch-sensitive sensor segments on a sensing surface can be configured to generate different electrical touch signals in response to changes in pressure applied thereto.

[0069] In some examples, a touch-sensitive sensor segment can be configured to generate at least two distinct electrical touch signals in response to a change in pressure applied to it. Initially, the touch-sensitive sensor segment may be configured to generate a first electrical touch signal in response to a first pressure applied to it. Here, the first electrical touch signal may be generated if the first pressure applied to the touch-sensitive sensor segment exceeds a first predetermined threshold.

[0070] The touch-sensitive sensor segment may further be operable to generate a second electrical touch signal from a first electrical touch signal, wherein at least one of the magnitude, amplitude, sign, or frequency is different. The second electrical touch signal may be generated when the pressure applied to the touch-sensitive sensor segment is greater than or equal to a second predetermined threshold. Typically, the second threshold is greater than the first threshold.

[0071] To that extent, the first electrical touch signal and the second electrical touch signal may indicate a fairly low pressure and a fairly high pressure applied to their respective touch-sensing sensor segments, respectively.

[0072] In a further example, a touch-sensitive sensor segment or multiple sensor segments may be operable to generate a variety of different electrical touch signals. A touch-sensitive sensor segment may be operable to generate at least three, at least four, at least five, at least six, or at least eight different electrical touch signals, each of which may reflect or indicate the respective first, second, third, fourth, fifth, sixth, or eighth pressure applied to the respective touch-sensitive sensor segment.

[0073] In a further example, touch-sensitive sensor segments may be capable of generating an electrical touch signal that gradually changes in response to changes in the pressure applied to each touch-sensitive sensor segment. Here, the electrical touch signal may directly represent the applied pressure.

[0074] Depending on the number and size of touch-sensitive sensor segments distributed across the entire sensing surface, the sensor element can provide an accurate and fairly detailed spatially resolved pressure profile of the sensing surface or the entire sensing surface. In this way, the sensor assembly can operate to detect or measure the spatially resolved pressure profile applied across the entire sensing surface by a user's body part.

[0075] Spatially resolved pressure profiles and / or temporal variations of such spatially resolved pressure profiles may indicate specific touch procedures or gestures performed by the user of the injection device.

[0076] In a further example, the processor may be capable of recognizing or distinguishing one of several predetermined user gestures, such as a swipe across the sensing surface, a single tap on the sensing surface, and two or more taps on the sensing surface. The processor may also be capable of distinguishing between short taps on the sensing surface, such as a tap lasting less than one second, and long taps on the sensing surface, such as a tap lasting longer than one or two seconds.

[0077] Furthermore, the processor may be capable of operating to distinguish between light taps on the sensing surface and firm or strong taps.

[0078] In a further example, the processor may be operable to recognize at least one of the following: a swipe motion of a body part across the sensing surface; a short tap motion of a body part on the sensing surface; multiple short tap motions of a body part on the sensing surface; a long tap motion of a body part on the sensing surface; and variable pressure applied to the sensing surface by a body part. These actions may represent a single or multiple gestures performed by a user's body part on or using the sensing surface.

[0079] In the recognition or sensing mode of the sensor assembly, the electrical touch signal acquired from the touch-sensing sensor segment may be compared to a stored reference profile. Here, the processor may perform an optimal matching comparison to assign one of the stored reference profiles to a profile generated or derived based on the actually measured or detected electrical touch signal. The reference profile assigned to the profile of the actually measured electrical touch signal may represent a gesture performed by a user's body part on the sensing surface. The control signal generated by the processor and transmitted to an external electronic device may represent a gesture determined or detected by the processor of the sensor assembly.

[0080] In a further example, a processor can be configured to process electrical touch signals from multiple touch-sensitive sensor segments to determine the sensing area of ​​a sensing surface being touched by a body part. Typically, when a finger is used as the body part to contact the sensing surface of a sensor element, each touch-sensitive sensor segment can detect the pressure applied by its respective body part. Thus, all touch-sensitive sensor segments that mechanically contact a body part during or for the operation of, for example, an add-on device or injection device, can generate their respective electrical touch signals.

[0081] By simultaneously processing signals from touch-sensitive sensor segments, the processor can provide or confirm a sensing area on the sensing surface that is actually touching or mechanically contacting a user's body part. In this way, the processor can operate to detect whether a body part is actually touching the central or boundary area of ​​the sensing surface.

[0082] Furthermore, the processor may be capable of detecting or measuring the size of the sensing area. By confirming or determining that the sensing area of ​​the sensing surface is actually touching or mechanically contacting a part of the user's body, the sensor assembly provides a fairly accurate and spatially resolved monitoring of how the user's body is touching the sensor element.

[0083] In a further example, the processor of a sensor assembly can be operated to detect changes in the size of the sensing area on the sensing surface. Changes in the size of the sensing area may result from changes in the pressure applied to the sensor element by a body part. Since a body part may have a certain elasticity and may also have a considerably convex outward-facing structure or surface, increasing the pressure applied to the sensor element by the body part may increase the proportion of the body part in direct contact with the sensing surface, for example due to the elastic deformation of the body part. This may increase the size of the sensing area on the sensing surface.

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

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

[0086] In a further example, the processor may be operable to detect changes in the geometric shape of a sensing area on a sensing surface and / or changes in the orientation of a sensing area on a sensing surface. In this way, further operating modes in which a user's body part is moved or changed relative to the sensor element can be detected and evaluated. Typically, changes in the geometric shape or orientation of a sensing area on a sensing surface, detected by changes in the electrical touch signals generated by multiple touch-sensing sensor segments, may further illustrate specific scenarios of use for injection devices.

[0087] In a further example, the sensing surface is planar in shape and configured to engage with a thrust receiving surface. It may be configured to cover at least a portion of the thrust receiving surface. The thrust receiving surface may be provided by a removable or immovable cover that forms or constitutes the proximal end or proximal end section of the add-on device or its body. To that extent, it may provide a thrust receiving surface that can be pressed by the user to move the stopper of the injection device to the end of the contents or the end of the dose when the add-on device is properly attached to or engaged with the injection device. The sensor may be operable during the dose injection process and may record the mechanical interaction between the sensing surface and the part of the user's body that applies the injection force to the thrust receiving surface of the add-on device.

[0088] In further examples, the processor may be configured to detect the completion of an injection performed by the injection device by processing a number of electrical touch signals provided by a touch sensor over a predetermined time interval. In some examples, the force applied by the user during the injection procedure may gradually increase as the stopper moves toward the distal end position caused by the user. Upon reaching the end position, the user may be obligated to hold the needle inside the punctured tissue for a predetermined time interval. During this holding time, the user typically applies constant pressure to the thrust receiving surface. Such transient or pressure profiles may be monitored and / or analyzed by the processor to determine whether the dose injection procedure is complete. Each profile may be recorded not only in terms of the magnitude of the pressure but also in terms of the size of the sensing area of ​​the sensing surface. An increase in the sensing area is typically a direct indicator of the increase in pressure applied to the sensing surface by each body part. As the pressure decreases, the size of the sensing area also decreases, 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 add-on device is configured to be detachably secured to the plunger flange of a plunger connected to or integrated 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 a stopper or form a stopper for dispensing the drug through the barrel outlet. The fastening structure of the add-on device may be detachably connected, for example, by clipping onto the flange portion.

[0090] In a further example, the fastening structure of the add-on device comprises a receptacle configured to receive a plunger flange. The receptacle may open distally. In a further example, the receptacle may open laterally. In any case, the receptacle may be made and configured to be sized and configured to detachably connect to and secure the plunger flange of the injection device.

[0091] In a further example, the fastening structure includes a snap element configured to removably engage with a plunger flange by shape fitting. The snap element may include a projection that radially projects inward from the side wall of a receptacle located at or near the bottom or flange portion of the add-on device body.

[0092] The add-on device may not have an elongated plunger extension or rod, provided that the fastening structure is configured to be detachably fixed to the plunger flange of the injection device's plunger. Here, the elongated plunger extension may be detachably connected to the body of the add-on device. Thus, the add-on device can be used with different configurations for different injection devices. The add-on device may be equipped with an elongated plunger extension, while the injection device lacks a plunger rod and includes a stopper located within the barrel. Here, the fastening structure is typically provided at the distal end of the plunger extension to make or establish mechanical contact with the stopper of the injection device.

[0093] In another example, if the injection device has a plunger with a plunger flange located proximal to the proximal end of the injection device barrel, the add-on device may not have an elongated plunger extension and may have a fastening structure directly on the bottom or flange portion of the main body. Here, the fastening structure, such as a receptacle of the main body, can be directly attached to the plunger flange of the injection device. In both scenarios, if the add-on device is properly attached to the stopper of the injection device, it can be used by the user to apply distal pressure to the stopper in order to drive the stopper distally relative to the barrel for the purpose of dispensing a dose from the barrel.

[0094] In these examples of add-on devices without elongated plunger extensions, the reading of the electronic identifier may be obtained at or immediately before reaching the end-of-dose configuration, in which case the longitudinal distance between the add-on device, and therefore the reading unit of the add-on device, and the machine-readable identifier of the injection device is minimized.

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

[0096] In another embodiment, the disclosure relates to an injection system. The injection system comprises the injection device described above and further comprises the add-on device described above. The injection device comprises a drug container. The drug container includes a barrel filled with a drug, for example, a liquid, and therefore an injectable drug. The barrel is sealed by a stopper. The stopper is movable distally to the barrel to dispense a dose of the drug from the barrel. The injection device further comprises a machine-readable identifier attached to or integrated with the barrel or housing of the injection device.

[0097] A machine-readable identifier may include or constitute an electronic identifier. An electronic identifier may be implemented as a wireless tag, such as an RFID tag or an NFC tag. An electronic identifier may also be a passive electronic tag capable of communicating with the corresponding wireless, and therefore electronic reader, of an add-on device. In some examples, a machine-readable identifier is one of a magnetically encoded identifier and an optical or visual identifier, which are readable by an optical reader or their respective magnetic reading device.

[0098] In some cases, the injection system includes the injection device described above. To that extent, all the features, effects, and advantages described above for the add-on device and injection device also apply equally to the injection system.

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

[0100] For example, distal movement of a stopper from a proximal end position to a distal end position can be induced and / or controlled by an add-on device being in contact with or engaged with the stopper, thereby transmitting mechanical pressure or thrust.

[0101] An arrangement or configuration may be obtained in which the antenna and the machine-readable identifier overlap longitudinally, with the antenna located on or inside an elongated plunger extension, and the antenna positioned, for example, at or near the distal end or end section of the plunger extension, or this may coincide with the stopper reaching or approaching the distal end position relative to the barrel. It may be up to that point that the information stored in or provided by the machine-readable identifier becomes readable by the wireless reading unit. Typically, as described above, the add-on device is provided with a clock which is operable to provide a clock signal and can generate a timestamp based on this clock signal. The generation of a timestamp as provided by the clock and / or the use of the respective time or date display may be triggered by enabling the reading of the information stored in or provided by the machine-readable identifier, i.e., when the stopper driven by the add-on device reaches or approaches the distal end position, and thus the dose end configuration.

[0102] In a further example, the injection system can transition from an initial configuration to a dose-ending configuration by pushing a stopper from a proximal end position toward a distal end position via an add-on device. Here, the add-on device is attached to the stopper by a longitudinal or elongated plunger extension and its elongated rod, or by the plunger of the injection device. Here, the plunger of the injection device may be attached to a stopper configured to seal the internal volume of the barrel occupied by the drug, or may be integrally molded with the stopper. The body of the add-on device is then attachable and / or fixable to the proximal end of the plunger or plunger rod of the injection device. It may be fixed to the proximal plunger flange.

[0103] In a further example, when the injection system is in its pre-use configuration, the electronic identifier 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 identifier is within the transmission range of the reading unit or antenna. Thus, reading the information stored in or provided by the electronic identifier requires distal movement of the reading unit or antenna relative to the machine-readable identifier during the dose injection process.

[0105] When the end-of-dose configuration is reached or approaching, information reading is enabled. Information reading may then trigger the generation or provision of a timestamp, which may then be combined with information collected or obtained from a machine-readable identifier. The information, along with the timestamp, may be stored in the memory of the add-on device and may be transmitted to an external electronic device such as a smartphone, smartwatch, or tablet computer for further data analysis or accuracy monitoring.

[0106] In another embodiment, the disclosure also relates to a method for monitoring the use of an injection device. The method includes the step of providing an injection device as described above. Thus, the injection device comprises a barrel filled with a drug and sealed typically proximal by a stopper. The stopper is movable distally to the barrel to dispense a dose of the drug.

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

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

[0109] As described above, reading information stored in or provided by a machine-readable identifier can be implemented in a variety of 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 that can be read by a wireless reading unit. Here, the reading unit of the add-on device comprises a transceiver capable of operating to interact with the electronic identifier.

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

[0111] In some cases, the reading of information stored in or provided by a machine-readable identifier is performed before or after attaching the add-on device to the injection device, i.e., before or after directly or indirectly attaching or connecting the body of the add-on device to the stopper of the injection device. In some cases, the reading of information stored in or provided by a machine-readable identifier is performed after or during the dose injection process, i.e., when the stopper of the injection device undergoes distal movement relative to the barrel, or when the stopper reaches or approaches the distal end position, and thus when the dose end configuration is established.

[0112] In further examples, the add-on device is connected to the stopper by a pressure transmission mechanism, where the fastening structure of the add-on device is directly connected to a complementary, opposing fastening structure of the stopper. In some examples, the fastening structure of the add-on device is operable to connect to the plunger of an injection device, which is connected to the stopper, integrated with the stopper, or longitudinally abuts against the stopper.

[0113] In another example, a driving force acts on an add-on device and is transmitted onto a stopper, causing the stopper to move distally relative to the barrel. Here, the add-on device can be used in a dual manner: it provides pressure to the stopper to perform or control an injection procedure, and provides force transmission between the user's body part that applies pressure to the stopper. Secondly, the add-on device provides the retrieval of information or data stored in or provided by a machine-readable identifier.

[0114] In a further example, the method includes detection of injection completion by an electronic module of an add-on device. Detection of the completion of the injection procedure can be performed in various ways. In one example, the completion of the dose injection may be detected by a reading unit, the reading of a machine-readable identifier being initially deactivated and then activated during or at the end of the dose injection procedure, for example, when a stopper reaches or approaches the dose end position or dose end configuration.

[0115] In another example, completion of an injection may be detected, for example, by a touch sensor provided on or integrated into the add-on device. In yet another example, completion of a dose injection procedure may be detected, for example, by a separate dose completion sensor operable to detect a dedicated position of the add-on device relative to the barrel or housing, and thus a clearly defined position.

[0116] In a further example, the method includes recording at least one of the date or time of completion of the dose injection in the memory of the add-on device. The recording of each timestamp may be performed simultaneously with the recording of information stored in or provided by a machine-readable identifier. Such information typically indicates the drug stored or provided in the barrel of the injection device.

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

[0118] In this context, the term "distal" or "distal 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 end of the injection device furthest from the injection site in a human or animal, opposite to the injection site.

[0119] The terms “drug” or “pharmaceutical” are used herein as synonyms and refer to a pharmaceutical preparation containing one or more pharmacokinetic active ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. A pharmacokinetic active ingredient ("API") is, in its broadest sense, a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or pharmaceuticals are used to treat, cure, prevent or diagnose diseases, or otherwise to improve physical or mental health. Drugs or pharmaceuticals may be used over a limited period or, in the case of chronic diseases, regularly.

[0120] As described below, drugs or pharmaceuticals may contain at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs include small molecules with molecular weights of 500 Da or less, polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids or liposomes. Mixtures of one or more drugs are also possible.

[0121] Drugs or pharmaceuticals may be contained within a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other robust or flexible vessel configured to provide a chamber suitable for the storage of one or more drugs (e.g., short-term or long-term storage). For example, in some cases, the chamber may be designed to store drugs for at least one day (e.g., one day to at least 30 days). In some cases, the chamber may be designed to store drugs for about one month to about two years. Storage may be carried out at room temperature (e.g., about 20°C) or refrigerated temperature (e.g., about -4°C to about 4°C). In some cases, the drug container may be, or include, a dual-chamber cartridge configured to store two or more components of a pharmaceutical preparation to be administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such cases, the two chambers of the dual-chamber cartridge may be configured to allow mixing of the two or more components before and / or during administration to the body of a human or animal. For example, the two chambers may be configured to be fluidly connected to each other (e.g., by a conduit between the two chambers), allowing the two components to be mixed before administration as desired by the user. Alternatively or additionally, the two chambers may be configured to allow mixing when the components are administered into the body of a human or animal.

[0122] Drugs or agents contained in the drug delivery devices described herein can be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes mellitus or complications associated with diabetes mellitus, such as diabetic retinopathy, and thromboembolic disorders such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders include acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are listed in the Rote Liste 2014, for example, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and handbooks such as the Merck Index, 15th edition.

[0123] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes mellitus or complications thereof include insulin, e.g., human insulin, or insulin analogs or derivatives; glucagon-like peptides (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or their analogs or derivatives; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof, or any mixture thereof. As used herein, the terms “analog” and “derivative” refer to polypeptides having a molecular structure that can be formally derived from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deleting and / or replacing at least one amino acid residue in the naturally occurring peptide, and / or adding at least one amino acid residue. The amino acid residue added and / or replaced may be an encoding amino acid residue, another naturally occurring residue, or a purely synthetic amino acid residue. Insulin analogs are also referred to as “insulin receptor ligands.” In particular, the term "derivative" refers to a polypeptide having a molecular structure that can be formally derived from the structure of a naturally occurring peptide, such as the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are bonded to one or more amino acids. Optionally, one or more amino acids present in the naturally occurring peptide may be substituted with other amino acids, including deletions and / or non-coding amino acids, or amino acids, including non-coding amino acids, may be added to the naturally occurring peptide.

[0124] Examples of insulin analogs include Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glardine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which proline at position B28 may be replaced with Asp, Lys, Leu, Val or Ala, and Lys at position B29 may be replaced with Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0125] Examples of insulin derivatives include, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin These are B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-litocoryl-gamma-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, lixisenatide (Lyxumia®), exenatide (Exendin-4, Byetta®, Bydureon®), and Hiramonster (Gila Monster's salivary glands produce a 39-amino acid peptide, liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), r-exendin-4, CJC-1134-PC, PB-1023, TTP-054, langlenatide / HM-11260C (efpeglenatide), HM-15211, CM-3, GLP-1 eligene, ORMD-0901, NN-9423, NN-9709, NN-9924, NN These include -9926, NN-9927, Nodexene, Biador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodotide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Chilzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-XTEN.

[0127] Examples of oligonucleotides include mipomersen sodium (Kynamro®), a cholesterol-lowering antisense drug for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport syndrome. Examples of DPP4 inhibitors include linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0128] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides such as gonadotropins (follitropin, lutropin, choriongonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadrelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin, as well as their antagonists.

[0129] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or very low molecular weight heparin, or derivatives thereof, or sulfated polysaccharides, such as polysulfated forms of the above 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 G-F20 (Synvisc®), 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 antigen-binding ability. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, immunized or humanized antibodies, fully human antibodies, non-human (e.g., mouse) antibodies, or single-chain antibodies. In some embodiments, antibodies have effector function and can immobilize complement. In some embodiments, antibodies have reduced or no ability to bind to Fc receptors. For example, an antibody may be an isotype or subtype, antibody fragment, or mutant having mutations or deletions in the Fc receptor-binding region, for example, which do not support binding to the Fc receptor. The term “antibody” also includes antigen-binding molecules based on bivalent bispecific tandem immunoglobulin (TBTI) and / or bivariable region antibody-like binding proteins having crossover binding region orientation (CODV).

[0131] The terms “fragment” or “antibody fragment” refer to polypeptides derived from antibody polypeptide molecules (e.g., antibody heavy and / or light chain polypeptides) that do not contain a full-length antibody polypeptide but still contain at least a portion of a full-length antibody polypeptide capable of binding to an antigen. Antibody fragments may include cleavage portions of a full-length antibody polypeptide, but the term is not limited to such cleavage fragments. Examples of antibody fragments useful in the present invention include Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, e.g., bispecific, trispecific, quadrispecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, e.g., bivalent, trivalent, quadrivalent and multivalent antibodies, minibodies, chelated recombinant antibodies, tribodies or vibodies, intrabodies, nanobodies, small module immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[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 "framework region," rather than the CDR sequence itself, refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for maintaining the proper arrangement of the CDR sequence to enable antigen binding. While the framework region itself typically does not directly participate in antigen binding, as is well known in the industry, certain residues within the framework region of a particular antibody can directly participate in antigen binding or influence the interaction ability of one or more amino acids in the CDR with the antigen.

[0133] Examples of antibodies include anti-PCSK-9 mAbs (e.g., alirocumab), anti-IL-6 mAbs (e.g., sarilumab), and anti-IL-4 mAbs (e.g., dupilumab).

[0134] Any pharmaceutically acceptable salt of any API described herein is intended for use with drugs or pharmaceuticals in drug delivery devices. Examples of pharmaceutically acceptable salts include acid addition salts and basic salts.

[0135] Without departing from the full scope and spirit of the present invention, various components of the APIs, formulations, apparatus, methods, systems, and embodiments described herein may be modified (added and / or deleted), and it will be understood by those skilled in the art that the present invention encompasses such modifications and all equivalents thereof.

[0136] Exemplary drug delivery devices may include needle-based injection systems, such as those 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 classified into multi-dose container systems and single-dose (with partial or full discharge) container systems. Containers may be replaceable or integrated non-replaceable containers.

[0137] As further described in ISO 11608-1:2014(E), a multi-dose container system may include a needle-based injection device with replaceable containers. In such a system, each container holds multiple doses, and its size may be fixed or variable (pre-set by the user). Another multi-dose container system may include a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, and its size may be fixed or variable (pre-set by the user).

[0138] As further described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based injection device with replaceable containers. In one example of such a system, each container holds a single dose, thereby dispensing the entire deliverable amount (total dispensing). In a further example, each container holds a single dose, thereby dispensing a portion of the deliverable amount (partial dispensing). As also described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based injection device with an integrated, non-replaceable container. In one example of such a system, each container holds a single dose, thereby dispensing the entire deliverable amount (total dispensing). In a further example, each container holds a single dose, thereby dispensing a portion of the deliverable amount (partial dispensing).

[0139] Below, an example of an injection system comprising an injection device and an add-on device for monitoring the use of the injection device will be described in more detail with reference to the drawings. [Brief explanation of the drawing]

[0140] [Figure 1] A schematic diagram illustrates an example of an injection system comprising an injection device with an add-on device, configured before the add-on device is connected to or attached to the injection device. [Figure 2] Figure 1 shows the injection system with the add-on device attached to the injection device before the injection is administered. [Figure 3] Figures 1 and 2 show the injection system after the injection is completed. [Figure 4] Further examples of injection systems are shown. [Figure 5] Figure 4 shows an example of the state after the injection is completed. [Figure 6] Further details of the machine-readable identifier connected to or attached to the barrel or housing of the injection device are shown. [Figure 7]This shows a longitudinal section of an injection device implemented as a safety syringe, before or during the process of attaching an add-on device to the injection device. [Figure 8] Figure 7 shows an example of the end of dose injection. [Figure 9] Figures 7 and 8 show the device after the injection needle has been retracted into the housing of the injection device. [Figure 10] This diagram schematically illustrates the numerous components of the add-on device and their assembly within the add-on device's main body. [Figure 11] Another example of an add-on device retrieving information stored in or provided by a machine-readable identifier is shown. [Figure 12] This demonstrates the assembly of an add-on device to the plunger of an injection device. [Figure 13] This shows an injection system for communicating with an external electronic device. [Figure 14] Further examples of touch sensors in the first configuration are shown. [Figure 15] Figure 14 shows the touch sensor in the second configuration. [Figure 16] Further examples of touch sensors in the first configuration are shown. [Figure 17] Figure 16 shows the touch sensor in the second configuration. [Figure 18] Figures 14 to 17 show diagrams illustrating the pressure profiles that can be measured by the touch sensor. [Figure 19] This shows a block diagram of the electronic components of the add-on device. [Figure 20] This flowchart shows how to monitor the use of an injection device by utilizing an add-on device. [Figure 21] Another flowchart illustrating a different method for monitoring the use of injection devices is shown. [Modes for carrying out the invention]

[0141] The sequences in Figures 1 to 9 schematically illustrate a scenario using injection device 1 with add-on 30. In the illustrated example, injection device 1 comprises a type of syringe, which is implemented, for example, as a safety syringe. Injection device 1 comprises a barrel 10 filled with liquid injectable drug 8. The barrel 10 is sealed by a stopper 9 that is movable distally 2 relative to the barrel 10 in the proximal longitudinal direction 3. The barrel 10 may be tubular. It may have 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 barrel 10. Towards the proximal end or proximal direction 3, the barrel 10 terminates with a radially outward-extending or protruding flange portion 17, which can be used as a finger grip for the user's index finger 6 and middle finger 7 to properly hold the syringe, while the user can press a plunger 20 protruding proximally from the barrel 10 with the thumb 5 of the same hand 4.

[0142] For example, as shown in Figures 7 to 9, in some examples the stopper 9 may be integrally formed with a longitudinally extending plunger 20 or may be detachably connected. 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 move the stopper 9 distally 2 relative to the barrel 10, thereby acting distal pressure on the stopper 9 to discharge a well-defined amount of liquid drug 8 into the biological tissue through the outlet 14 when the injection needle 15 penetrates or punctures the tissue. The stopper 9 may include an elastomer material for hermetically sealing the inside of the barrel 10.

[0143] The proximal end of the plunger 20 may be provided with a radially flared plunger flange 21. The plunger flange 21 is typically configured to be pressed by the user's thumb 5, for example, as shown in Figure 10. In the examples of Figures 1 to 9, the injection device 1 is implemented as a safety syringe. The injection device 1 is provided with a substantially elongated or tubular housing 11. The housing 11 is made to accommodate the barrel 10 and a spring element 27. The spring element 27 is operably engaged with the housing 11 and the barrel 10. It may be configured to cause relative longitudinal movement between the barrel 10 and the housing 11, particularly upon completion of a dose injection procedure.

[0144] The barrel 10 can be fixed against longitudinal movement relative to the housing 11 by an interlock 24. In the examples shown in Figures 7 to 9, the interlock 24 is located at or near the proximal end of the barrel 10 or the housing 11. The housing 11 may also be sleeve-shaped and includes a counter-latch element 26 that releasably engages with a latch element 25 provided on the barrel 10. The latch element 25 and the counter-latch element 26 are initially engaged, thereby preventing or locking longitudinal displacement of the barrel 10 relative to the housing 11.

[0145] Only when the plunger 10 reaches the distal end configuration does the plunger flange 21 engage with the counter latch element 26, thereby causing the counter latch element 26 to deform or pivot to give way to the latch element 25. When the latch element 25 is released from the counter latch element 26, the mechanical energy stored in the spring element 27 may be released, thus leading to longitudinal movement or displacement of the barrel 10 relative to the housing 11.

[0146] As shown in Figure 9, the exit 14 or needle 15, which initially protrudes from the distal end of the housing 11 and reaches through a through-opening 28 provided on the distal end face of the housing 11, is retracted into the housing 11. Here, the injection needle 15 is in a shielded or protected configuration, the injection device 1 can no longer be used, and the distally protruding tip of the injection needle 15 is protected by the housing 11. The flange portion 18 may have a shape complementary to the flange portion 17. The proximal end of the flange portion 18 and / or the proximal end of the housing 11 may further be provided with an inclined edge, which is configured to engage with the distally facing surface or edge of the plunger flange 21 when the plunger 20 reaches the distal end position, as shown in Figure 6. When the plunger flange 21 contacts the inclined edge, the inclined edge, and therefore the counter latch element 26, is biased radially outward, thereby disengaging from the latch element 25. This latch element 25 can be easily provided by a flange portion 17 extending radially outward from the barrel 10.

[0147] As further illustrated in Figures 1, 2, and 4, in the initial configuration, the outlet 14 and / or the injection needle 15 may be protected or covered by a separate protective cap 16. Before performing the injection procedure, the protective cap 16 must be removed and detached from the outlet 14 or needle 15. In the illustrated example, the counter latch element 26 may be located in or near the radially outward-extending flange portion 18 of the housing 11.

[0148] Optionally, and as is evident from, for example, Figures 1 to 3, the syringe barrel 10 may be enclosed or mounted within the syringe carrier 13, which is operably engaged with a spring element 27. The syringe carrier 13 may have a dedicated sliding mechanism inside the housing 11, and may house the barrel 10 inside.

[0149] The injection device 1 is further provided with a machine-readable identifier 22. The machine-readable identifier 22 is attached to or integrated with one of the barrels 10 and housing 11 of the injection device 1. The machine-readable identifier 22 may be implemented as an electronic identifier 33. It may include a wireless communication tag such as a passive RFID tag or an NFC tag. The machine-readable identifier 22 may also be implemented in the form of a magnetic coating or optical coating that is readable by a reading device, for example, a magnetic reader or optical reader of an add-on device 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 medicinal substance of the drug, the concentration of the drug, batch number, lot number, manufacturing date, manufacturing site or place, expiration date, and / or the temperature at which the drug should or has been stored.

[0150] Electronic information or data can be read or captured by the reading unit 39 of the add-on device 30, as described below. In some examples, as illustrated in Figures 1, 4, and 5, the machine-readable identifier 22 is located at or near the distal end of the barrel 10 or housing 11. It is located near the outlet 14 of the injection device 1.

[0151] In particular, as shown in Figure 6, the machine-readable identifier 22 may include an antenna 23 for wireless signal transmission with the reading unit 39 of the add-on device 30. The antenna 23 may be provided on a flexible substrate or layer 121. The layer 121 may include a plastic foil or any other flexible or bendable layer or sheet material that is wrapped around one of the barrel 10 and housing 11 of the injection device 1.

[0152] Layer 121 may be provided with printed electronic circuits that constitute or include a wireless communication tag. Below layer 121, a printed label layer 122 may be provided. The label layer 122 may be provided with printed information that is visible to the user when wrapped around the barrel 10 or housing 11. In the wrapped configuration, layer 121 is inside the label layer 122, which includes a visible surface printed on its opposite, outward-facing side.

[0153] A shielding or insulating layer 120 may be provided inside layer 121 and around antenna 23, which is capable of shielding electromagnetic radiation. The shielding or insulating layer 120 may include a metal foil that is insulated with respect to the electronic circuitry of the machine-readable identifier 22. It may be cut out or excluded around antenna 23. The shielding or insulating layer and the cutout help prevent unauthorized or premature reading of data from machine-readable identifier 22. In order to read data from machine-readable identifier 22, each antenna 43 of the appropriate reading unit 39 must at least partially overlap with antenna 23 in the longitudinal direction (z).

[0154] As illustrated in detail in Figure 10, the add-on device 30 is detachably connected to the stopper 9 via fastening structures 94, 94'. The add-on device 30 comprises a main body 60 having tubular side walls 61.

[0155] Towards the distal end, the side wall 61 defines a receptacle 63 sized to receive the plunger flange 21. For this purpose, the inside of the side wall 61 may be provided with one or more fasteners, such as elastic fastening ribs configured to provide a non-slip fastening of the add-on device 30 to the plunger flange 21 of the syringe plunger 20, as illustrated in Figure 7.

[0156] The receptacle 63 is defined by a bottom or flange portion 62 that extends radially inward. The flange portion 62 separates the inside of the device body 60 into a distal receptacle 63 and a proximal receptacle 64. The proximal receptacle 64 is sized to accommodate a support 70 and cover 75 for housing the electronic module 34. The support 70 includes a longitudinally extending stem portion 71 that extends distally through the flange portion 62. The support 70 is displaceably mounted inside the receptacle 64. The support 70 is movable distally against the action of a return element or several return elements 65. The support 70 is connected to a cup-shaped cover 75 that protrudes proximal from the side wall 61 of the device body 60.

[0157] The cover 75 includes a planar end face 76 facing the proximal direction 3. In some examples, a touch sensor 80 is provided on the end face 76. In some cases, the entire end face 76 may be covered by the touch sensor 80. Thus, the end face 76 serves as an actuation surface that can be pressed by the user, for example, by the user's thumb 5. The user can apply a distal force to the end face 76, thereby biasing the cover 75 and support 70 distally 2 against the action of the return element 65.

[0158] When the end face 76 is released, a return element 75, which is implemented as, for example, a return spring, moves the support 70 and cover 75 toward the proximal starting position, as shown in Figure 10. At least one of the cover 75 and the support 70 includes a radially outward-extending projection 74 that is guided into a longitudinally extending recess 66 on the inside of the side wall 61 of the device body 60. Viewed longitudinally, the recess 66 is defined by a proximal stop surface 69 and a distal stop surface 67. In the initial configuration shown in Figure 10, the projection 74 is in longitudinal contact with the proximal stop surface 69 of the recess 66.

[0159] When the cover 75 is pushed distally 2 against the action of the return element 65, the projection 74 reaches the distal end position when it engages with the distal stop surface 67. The projection 74, guided within the groove 66, allows for the setting of limits to the longitudinal movement of the support 70 and cover 75 within a predetermined margin relative to the device body 60. Here, the support 70 and / or cover 75 may form or constitute an auxiliary trigger for the add-on device. When the cover 75 distally contacts the stop surface 67 of the side wall 61, any further distal pressure present on the cover 75 is invariably transmitted to the side wall and therefore to the body 60, which, when attached to the stopper 9, is transmitted to the respective distal movement of the stopper 9 relative to the barrel 10.

[0160] When pressed distally 2, the support 70 and its stem portion 71 begin to protrude from the flange portion 62. In any case, when the user presses the cover 75 distally 2, the respective driving forces can be transmitted to the stopper 9 via the stem portion or via the side wall 61.

[0161] In the example shown in Figure 10, the stem portion 71 extending distally from the flange portion 62 is extended by a plunger extension portion 91 which includes an elongated rod 92. The elongated rod 92 is provided with a fastening structure 94 at its distal end, as shown in Figures 1 and 10. The fastening structure 94 is configured to connect, attach, and / or fasten to a complementary shaped opposing fastening structure 29 provided on the proximal surface of the stopper 9. In some examples, the fastening structure 94 includes a threaded portion 95, for example, an external threaded portion for engaging with the complementary shaped threaded portion of the opposing fastening structure 29 of the stopper 9.

[0162] In other examples, the plunger extension 91 may be connected to the main body 60, for example, in a way that prevents it from moving. It may also project distally from the tubular side wall 21 and / or receptacle 63.

[0163] The inner side of the side wall of the cover 75 may include at least one of radial protrusions and recesses 68 for engaging with a complementary radial recess or protrusion 72 of the support 70. The cup-shaped cover 75 connected to or fastened to the support 70 provides a receptacle for an electronic module 34 to be placed in the hollow space formed by the support 70 and the cover 75.

[0164] The electronic module 34 may include an electronic circuit 35 on, for example, a printed circuit board 36. The electronic module 34 may further include a transceiver 38 and a reading 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 including, for example, light sources 53, 54.

[0165] The side walls 77 of the cover 75 may have windows 55 aligned with the respective windows 56 of the side walls 61 of the device body 60. In this way, visual signals that can be generated by different light sources 53, 54 located within the hollow space of the cover 75 can be perceived and visually detected from outside the add-on device 30.

[0166] The two light sources 53, 54 may belong to a visual signal generator 52 that is operable to produce or generate visual signals of different colors and / or variable durations. Light pipes or light guide structures may be provided in the windows 55, 56. In this way, the device body 60 can be protected from the ingress of dust or humidity.

[0167] In another example, the signal generator 52 may be implemented as a tactile signal generator configured to generate perceptible vibrations of, for example, an electronic module 34. In yet another example, the signal generator 52 may include an audible signal generator configured to generate an audible sound.

[0168] Figure 19 shows a block diagram of an example of an electronic module 34 and / or touch sensor 80. As also shown in Figure 10, the processor 44 is mounted on a printed circuit board 36, which is connected to the sensor element 81 of the touch sensor 80, substantially covering the end face 76 of the cover 75.

[0169] Generally, the electronic module 34 can be mounted on a printed circuit board 36. The electronic module 34 may be configured to communicate with an external electronic device 100, for example, as shown in Figure 13. The external electronic device 100 may be implemented as a mobile electronic device. The external electronic device 100 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. Each communication link can be implemented wirelessly or wired.

[0170] The external electronic device 100 may be implemented as a smartphone. The external electronic device 100 may be implemented as a portable electronic device comprising a housing 101. The external electronic device 100 further comprises a device processor 102 and a display 104. Optionally, the external electronic device 100 may include a speaker and / or a haptic user interface. Additionally, the external electronic device 100 may include a communication unit 106 capable of communicating with the transceiver 38 of the add-on device 30. In some examples, the first transceiver 38 comprises a local range transceiver having a transmission range of several meters or tens of meters.

[0171] The electronic module 34 may be configured to exchange data with an external electronic device 100. Data collected or retrieved by the electronic module 34, indicating the operation of the injection device, may be transmitted to the external electronic device via the transceiver 38. The transceiver 38 may be implemented as a wireless RF transceiver, for example, as a Bluetooth transceiver, a Bluetooth Low Energy (BLE) transceiver, or a Wi-Fi transceiver. The reading unit 39 may also be implemented as a wireless RF transceiver, for example, an NFC transceiver. The two transceivers may be distinguished with respect to their communication protocols and / or their transmission range.

[0172] The transmission range of the transceiver 38 may be greater than the transmission range of the reading unit 39. The transmission range of the transceiver 38 may be in the range of several meters or tens of meters. The transceiver 38 may be implemented as a local range or short-range transceiver. The reading unit 39 may be implemented as a short-range wireless transceiver. It may include a transmission range of less than 10 cm, less than 5 cm, 3 cm, less than 2 cm, or even less than 1 cm.

[0173] 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 drug's medicinal substance, the drug's concentration, batch number, lot number, manufacturing date, manufacturing site or location, expiration date, and / or the temperature at which the drug should or was stored. Each piece of information or data is readable by the reading unit 39, for example, when it is close to the machine-readable identifier 22. Once the data of the machine-readable identifier 22 is read by the reading unit 39, each piece of data may be further processed by the processor 44 and transmitted to an external electronic device 100 via a local range or short-range transceiver 38 2. Thus, the add-on device 30 may function as a range extender for reading the electronic identifier 33 of the injection device 1.

[0174] The reading of the electronic identifier 33, which can be implemented as a near-field communication tag (NFC tag), can be provided by the near-field communication reading unit 39 of the auxiliary device 30. The information or data thus obtained can be further processed by the processor 44 and transmitted to an external electronic device 100 via a further transceiver 38.

[0175] The electronic module 34 includes a memory 40 configured to store multiple measurement results of the touch sensor 80. The electronic module 34 further includes a clock 42 configured to provide each of the multiple measurement data of the sensor assembly 80 with a time index or timestamp indicating the detection time and / or detection date of each operation of the injection device 1.

[0176] The processor 44 is configured to process signals acquired from the touch sensor 80, resulting from the operation of the sensor element 81. The electronic module 34, and therefore the electronic circuit 35, is further equipped with a power supply 46 configured to power the processor 44, the touch sensor 80, and the clock 42. The power supply 46 may be implemented as a battery. The sensor assembly 80 may further include a switch 48 configured to switch the electronic circuit 35 on and off, or to switch the electronic module 34 between an active mode and an inactive mode, such as a sleep mode. The switch 48 may be implemented as an electromechanical switch. It may be operable to perform a switching operation when the user causes the cover 75 or support 70 to move relative to the body 60. The location of the switch 48 between the support 70 and the cover 75 is merely illustrative. It may similarly be located between the support 70 and, for example, the bottom or flange portion 62 of the body 60.

[0177] The electronic module 34 may further include a sensor unit 50 which comprises or includes at least one of a touch sensor 80 and a dose completion sensor 90. In the block diagram of Figure 19, the sensor unit 50 may represent at least one of the touch sensor 80 and the dose completion sensor 90.

[0178] The dose end sensor 90 is operably connected to the processor 44. It is operable to detect a specific configuration of the injection device 1, for example, when a dose end configuration is reached. The dose end sensor 90 may be located on the body 60. It may be located inside the receptacle 63 and may face distal 2. The dose end sensor 90 may be implemented as an electromechanical switch that makes direct mechanical contact with the barrel 10 or housing 11 of the injection device 1 when a dose end or injection end configuration is reached, as shown in Figure 8, for example. In some examples, the dose end sensor 90 may make mechanical contact with either the flange 17 or the flange 18.

[0179] In other examples, the dose end sensor 90 may be implemented as a magnetic or capacitive sensor capable of qualitatively or quantitatively detecting or measuring the distance between the body 60 of the add-on device 30 and the barrel 10 of the housing 110 of the injection device 1. In further examples, the dose end sensor 90 may be implemented as an optical sensor architect capable of qualitatively or quantitatively detecting or measuring the distance between the body 60 and either the barrel 10 or the housing 11.

[0180] Figures 14 to 17 schematically illustrate an example of a touch sensor 80. The touch sensor 80 comprises a sensor element 81 having a number of touch-sensing or pressure-sensing sensor segments 84, 85, and 86 on sensing surfaces 82 and 83. The touch sensor 80 may include a regular arrangement of touch-sensing sensor segments 84, 85, and 86. Each sensor segment 84, 85, and 86 may correspond to a pixel of a touch-sensing display. Each sensor segment 84, 85, and 86 may be equipped with a capacity measuring device capable of accurately detecting mechanical contact with a part of the user's body.

[0181] In some examples, sensor segments 84, 85, and 86 are pressure-sensitive. Thus, sensor segments 84, 85, and 86 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 may provide spatially resolved detection of sensing areas 88 and 89 where the user's skin or body part is actually touching or mechanically in contact with the user's skin or body part.

[0182] In some examples, individual sensor segments 84, 85, and 86 are not only touch-sensitive but also operable to generate electrical touch signals indicating the pressure or strength of mechanical contact with a user's body part. Thus, touch-sensitive sensor segments 84, 85, and 86 are operable to generate different electrical touch signals indicating the magnitude of the pressure or force applied to each sensor segment 84, 85, and 86.

[0183] To that extent, the touch-sensing sensor segments 84, 85, and 86 are operable to generate electrical touch signals that differ in at least one of magnitude, amplitude, sign, or frequency. These differences in the electrical touch signals are detectable by the processor 44 and can be evaluated to detect, recognize, characterize, and / or measure at least one of the actions of the add-on device 30, and therefore the injection device 1, caused by the user when the add-on device is pressure-transmitted coupled or connected to the injection device 1.

[0184] The sensor element 81 may include a circular planar sensing surface 82 and a tubular sensing surface 83 located longitudinally adjacent to the outer circumference of the sensing surface 82. To that extent, in some examples, the sensor element 81 may include a cup-shaped receptacle, which is sized to accept or surround, for example, at least a portion of the cover 75 of the add-on device 30.

[0185] The touch-sensing sensor segments 84, 85, and 86 are operable to generate different electrical touch signals depending on the force or pressure level applied to each sensor segment 84, 85, and 86. In the scenario illustrated in Figure 14, the user applies moderate to fairly weak pressure to the touch sensor 80. Therefore, only the sensor segments 85 and 86 located in the sensing area 88 can generate electrical touch signals indicating relatively weak pressure. Sensor segments covered by a boundary area, and therefore covered by a boundary sensing area 89 that surrounds or at least partially surrounds the sensing area 88, can also detect pressure substantially weaker than the pressure detected in the centrally located sensing area 88. These sensor segments can generate electrical touch signals indicating even weaker pressure.

[0186] As shown in Figure 15, when the user increases the pressure applied to the touch sensor 80, the sensor segments located in the sensing area 89 may experience a corresponding increase in pressure. Therefore, the pressure previously applied to the sensing area 89 may rise to at least the pressure level present in the sensing area 88 in Figure 14. In other words, the size of the sensing area 88, which indicates a first level of pressure, decreases accordingly, and the shape of the sensing area 89 changes or increases simultaneously with the change in size or shape of the sensing area 89.

[0187] Similarly, a touch-sensing sensor 80 with spatial resolution can be operated to detect spatial and / or temporal changes in pressure applied to the sensing surface 82. In the example of Figure 16, the user may initially apply a relatively weak pressure to the sensing surface 82. Thus, the central sensing area 88 may reflect a first level of pressure, and the surrounding sensing area 89 may reflect a second level of pressure lower than the first level. As the user increases the force or pressure effect on the sensing surface by firmly pressing their thumb 5 against the sensing surface 82, as shown in Figure 17, the area of ​​the first pressure level, and therefore the central sensing area 88, extends over the surrounding sensing area 89, due to the elasticity of each body part, e.g., the thumb 5. Thus, the sensing areas 88, 89, as detectable by the touch sensor 80, change their shape and / or position, and based on this, a pressure profile representing the typical operation of the add-on device 30 or the injected device 1 can be derived or measured.

[0188] In practice, the touch sensor 80 can monitor pressure, spatial pressure profile, and temporal changes in pressure applied to the sensing surfaces 82 and 83. Typical actions applied by the user, for example, with the thumb 5 or fingers 6 and 7, such as rolling or milling across the sensing surface 82 during the dose injection procedure, can be detected. Based on qualitative and / or quantitative measurements of the pressure profile in the spatial and / or temporal domains, the processor 44 may be able to operate to determine the start and / or end of the dose injection procedure based on the electrical touch signals generated by the touch sensor 80.

[0189] Furthermore, not only can a spatially resolved contact profile be provided across the entire one-dimensional or two-dimensional sensing surfaces 82, 83 of the sensor element 81, but the pressure profile may also indicate different pressure levels applied across the entire sensing surfaces 82, 83.

[0190] Figure 18, Table 200, is an example of a pressure profile, and therefore, the pressure or force measured over time while the user performs the injection procedure. During a first time interval 202, the user applies distal pressure to the thrust receiving surface 76 of the add-on device 30 when it is properly mounted on the stopper 9 of the injection device 1. The pressure increases during the first time interval 202, and at time T1, the applied pressure becomes greater than or equal to the frictional force between the stopper 9 and the side wall of the barrel 10.

[0191] Therefore, in the subsequent time interval 204, and thus between time T1 and time T2, the stopper 9 undergoes a constant movement distally 2, thereby dispensing a dose or the entirety of the drug 8 located in the barrel 10. At time T2, the stopper 9 reaches its distal end position. Thereafter, since the stopper 9 does not move any further distally 2, the user can automatically apply increased pressure. It may engage with a shoulder portion of the barrel 10 extending radially inward, or it may engage with some other longitudinally acting stopper.

[0192] Therefore, during the time interval 206, i.e., between time T2 and time T3, the measurable pressure applied to the add-on device 30 increases to a further level. During time T3 and the final time interval 208, which continues to time T4, the user may apply a constant but increased pressure level to the add-on device 30, and therefore to the plunger 20 or plunger extension 91, for a predetermined period 208. This time interval 208 represents or reflects the retention time that the needle 15 should remain in the actually punctured tissue. At time T4, after the time interval 208 has elapsed, the user typically releases the add-on device 30, and therefore to the thrust receiving surface 76. This results in a measurable pressure drop or force drop detectable by the touch sensor 80. Therefore, at time T4, the processor 44 may detect the end or completion of the dose injection procedure.

[0193] In the example of the injection system 110 shown in Figure 1, the add-on 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. Particularly as shown in Figure 7, the distal end of the plunger extension 91 includes a fastening structure 94 having a shape or configuration complementary to an opposing fastening structure 29 provided on the proximal end or proximal side of the stopper 9. In this way, the plunger extension 91 or the rod 92 is detachably connected to the stopper 9. In some examples, the fastening structure 94 includes a threaded portion 95 having a shape complementary to a corresponding or complementary reverse threaded portion provided on the proximal side of the stopper 9.

[0194] As is further evident from the illustrations in Figures 4, 5 and 10, the antenna 43 of the reading unit 39 or connected to the reading unit 39 may be located on or inside the plunger extension 91. It may also be located on the outer surface 93 of the plunger extension 91. The antenna 43 may be provided on or near the distal end section 98 of the plunger extension 91. As illustrated in Figures 4 and 5, the machine-readable identifier 22 of the injection device 1 may be provided on or near the distal end of the housing 11 or 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 receptacle 64 and therefore inside the body 60 of the add-on device 30.

[0195] As shown in Figure 4, in the initial configuration, before dose injection, the antenna 43 located at or near the distal end 98 of the plunger extension 91 is at a relatively large longitudinal distance from the machine-readable identifier 22. Here, if the machine-readable identifier 22 is implemented as a near-field wireless communication tag or identifier such as an NFC tag, it may be outside the transmission range of the antenna 43 and therefore outside the transmission range of the reading unit 39. Therefore, in the initial configuration shown in Figure 4, before the dose injection procedure, the antenna 43 cannot read the information stored in or provided by the machine-readable identifier 22 and is therefore unable to operate.

[0196] Antenna 43 overlaps longitudinally with the machine-readable identifier 22, or the machine-readable identifier enters the transmission range of antenna 43, only during the injection procedure or when a dose-end configuration, as shown in Figure 5, is reached. To that extent, as antenna 43 approaches or reaches the electronic identifier 33 or machine-readable identifier 22 in the longitudinal direction (z), the machine-readable identifier 22 becomes readable by the reading unit 39. The ability to read information stored in or provided by the machine-readable identifier 22 can then autonomously trigger the reading of each piece of information and its transfer to the processor 44. Simultaneously with the ability to read the machine-readable identifier 22, the processor 44 may be able to prompt or request a timestamp from the clock 42 and operate to combine each timestamp with the information retrieved or obtained from the machine-readable identifier 22.

[0197] In this way, it is possible to provide a pair between information obtained from the machine-readable identifier 22 and a timestamp indicating the time and / or date when each injection was completed or performed.

[0198] In further examples, as shown in Figures 11 and 12, the elongated plunger extension 91 may be provided only optionally with the add-on device 30. In some examples, the elongated plunger extension 91 may be detachably connected to at least one of the main body 20, the flange portion 62, the bottom of the main body 60, or the support 70. It may be detachably connected to the main body 60 or the add-on device. Where the antenna 43 is provided in or on the elongated plunger extension 91, a detachable connection of a conductor 41 extending longitudinally along or through the elongated rod 92 and connected to the reading unit 91 may also be provided.

[0199] A detachable longitudinal plunger extension 91 may provide the main body 60 of the add-on device 30 with a further fastening structure 94', as shown in Figures 1 and 12. Here, the receptacle 63, defined by the inside of the side wall 61 and the bottom or flange portion 62, may be configured to detachably fix or attach the main body 60 of the add-on device 30 to the plunger flange 21 of the plunger 20 of the injection device 1. The fastening structure 94' may have a shape complementary to the respective opposing fastening structures 29' provided on or on the plunger flange 21 of the plunger 20 of the injection device 1.

[0200] In some examples, the fastening structure 94' and each of the opposing fastening structures 29' are configured to form a friction fit, where the inside of the side wall 61 of the receptacle 63 can be firmly on the outer circumference of the plunger flange 21. In another example, the fastening structure 94' and / or the opposing fastening structure 29' may include a snap element 97 to establish or provide a shape-fit engagement between the body 60 of the add-on device 30 and the plunger flange 21.

[0201] In examples as shown in Figures 11 and 12, the plunger 20 may be implemented as a component of the injection device 1. The plunger 20 may be connected to the stopper 9 or may be integrally formed with the stopper 9. The plunger 20 may be provided as a separate component, connectable to the add-on device 30 at one longitudinal end and connectable to the stopper 9 at the opposite longitudinal end. In any case, the plunger 20 provides an indirect mechanical connection between the add-on device 30 and the stopper 9 of the injection device 1. The plunger 20 has compressive stiffness at least in the longitudinal direction (z). To that extent, when the add-on device 30 is attached to the proximal end of the plunger 20, the add-on device 30 is located in a force transmission path or drivetrain for transmitting a user-applyable force or pressure to the stopper 9.

[0202] The add-on device 30 of the injection system 110 provides multiple functions. On the one hand, the add-on 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 add-on device 30 provides automatic injection procedure detection when attached to the stopper 9 of the injection device 1. The add-on device 30 may be operable to detect at least one of the start and end of a dose injection procedure. In the examples illustrated in Figures 1 to 6, the add-on device is operable, in particular, to detect at least the completion of a dose injection procedure.

[0203] In the examples of Figures 11 and 12, the reading of information stored in or provided by the machine-readable identifier 22 may be performed early, i.e., before the add-on device 30 is installed or attached to the injection device 1. Success in reading the information may be visually indicated by the signal generator 52. Furthermore, the signal generator 52 may assist the user when operating or handling the add-on device 30 or the injection device 1. Changes in the duration of signal generation, changes in the intensity of the generated signal, and / or changes in the type of signal, such as the signal frequency or signal color of a signal tone, may further indicate to the user that the information reading procedure was successful or unsuccessful, and / or that the add-on device 30 is ready to be used to transmit force that the user can apply onto the stopper 9 of the injection device 1.

[0204] Detection of a dose end configuration may be provided by enabling the reading 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, dose end may be detected based on signal processing of a signal obtainable from the touch sensor 80 and according to a pressure or force profile as shown in Figure 18. In a further example, dose end configuration may be detected by a separate dose end sensor 90 and / or by a switch 48.

[0205] Various methods or procedures for detecting the end of a dose can be used or implemented simultaneously. In this way, redundancy can be provided for detecting the end of a dose configuration of the injection device 1. Thus, information obtained from the touch sensor 80 may be processed simultaneously with signals obtainable from the end of a dose sensor 90. Similarly, for example, the reading of the machine-readable identifier 22 by the antenna 43 and the reading unit 39 may be processed simultaneously with the processing or acquisition of signals from at least one of the touch sensor 80 and the end of a dose sensor 90.

[0206] An example of how to use the add-on device 30 with the injection device 1 is schematically illustrated in the flowchart of Figure 20. In the first step 300, the user attaches the add-on device 30 to the injection device 1, thereby establishing a force transmission connection between the add-on device 30 and the stopper 9 of the injection device 1. In the subsequent step 302, the user simply starts the injection by applying a driving force to, for example, the main body 30 and / or support 70 in order to bias the add-on device 30 distally 2 simultaneously with the plunger 20 or plunger extension 91, thereby transmitting the respective driving forces to the stopper 9.

[0207] The movable cover 75 can press or activate a user-operable switch 48, and such pressure application is detected in step 304. In the subsequent step 306, in response to the user applying pressure to the cover 75 and moving the cover 75 distally relative to the main body 60, the add-on device 30 can initiate a visual indication via the signal generator 52, thereby indicating that injection has been initiated and / or that the add-on device 30 is ready for use.

[0208] In step 310, the clock 42 provides a clock signal, and in step 308, the clock signal is used to start or control the timer. The start of the timer in step 308 triggers the start of the reading unit 39 in step 312. In step 324, the injection device 1 has reached the dose completion configuration. Here, as a result, the reading unit 39 in step 312 detects the presence of the machine-readable identifier 22 and begins reading data from the machine-readable identifier 22. As a result, in step 314, the timer started in step 308 is stopped. In step 316, the processor 44 performs a validation check, i.e., a check to see if the time interval determined by the timer matches a typical predetermined time interval required to inject a dose.

[0209] The machine-readable internal identifier information is read in step 320. Each piece of information is stored in memory 40 in step 322. Simultaneously with reaching the end-of-dose configuration in step 324, the user is obligated in step 326 to hold the injection device in the patient's punctured tissue for a predetermined time interval, for example, 5 seconds. At the start of the holding time, the processor 44 may control the signal generator 52 in step 328 so that the holding time is accompanied by the generation of a distinguishable or characteristic signal.

[0210] Here, in step 328, the signal generator 52 may produce a flash or blink of a specific color, such as green, to indicate to the user that the injection device should be held for a predetermined holding time. After the holding time has elapsed in step 330, in step 332, the flash or blink of a light as described in relation to step 328 is converted into a constant signal generated by the signal generator in step 332.

[0211] In step 334, the user releases the button or cover 75, which then returns to its initial configuration under the influence of the return element 65. Thus, the switch 48 opens, indicating to the processor 44 that the injection procedure has been successfully completed. Releasing the switch 336 may trigger the storage of data in step 322. After releasing the button in step 334, the electronic module 34 may wait for a predetermined time interval, for example, several seconds or several minutes, and then switch to sleep mode in step 338.

[0212] In another example, as illustrated in the flowchart of Figure 21, detection of the end-of-dose configuration is provided by the end-of-dose sensor 90. Here, the add-on device 30 may be used in a configuration as shown in Figures 11 and 12. Information stored in or provided by the machine-readable identifier 22 may be read before the add-on device 30 is attached to the injection device 1. In the first step 400, the add-on device is switched from sleep mode to active mode. Here, the reading unit 39 may be positioned close to the machine-readable identifier 22, and each drug-related piece of information is transferred from the machine-readable identifier 22 to the reading unit 39. Thus, in step 400, data reading or data retrieval is performed.

[0213] Next, each piece of information acquired by the reading unit 39 is stored in the memory 40 in step 402. In step 404, user feedback is provided to the user, for example, by the signal generator 52, which produces a visual signal that flashes or blinks. Subsequently, the add-on device 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. Then, as soon as the button or cover 75 of the add-on device 30 is pressed and thus moved relative to the main body 60, the switch 48 is closed and a timer controlled by the clock 42 starts in step 408.

[0214] Information obtained from the machine-readable identifier 22 is optionally stored locally or temporarily in memory 40 in step 410. At the end of the dose injection procedure, the switch 48 may be released in step 412, and the timer may be stopped in step 414. In step 416, an evaluation is performed to determine whether the injection was actually successfully administered. Here, at least two signals from the reading unit 39, the switch 48, the dose completion sensor 90, and the touch sensor 80 may be compared and evaluated to determine whether the dose was successfully injected and / or whether the dose injection procedure was completed.

[0215] If the evaluation is unsuccessful, the procedure will be terminated in step 418. However, if the injection should be evaluated as successfully completed in step 416, the respective pieces of information, namely the drug-related information obtained from the machine-readable identifier 22 and the respective timestamps indicating the time or date of the injection, will be simultaneously stored in memory 40 in step 420.

[0216] In step 422, upon successful completion and storage of the data in memory 40, the signal generator 52 changes its appearance and / or signal generation. For example, the light sources 53 and 54 of the signal generator 52 switch to a constant green color, thus indicating to the user that the injection procedure has been successfully recorded. In step 424, the electronic module 34 counts or waits for a predetermined time interval before returning to sleep mode in step 426. [Explanation of Symbols]

[0217] 1. Injection device 2. Distal direction 3. Proximal direction 4 moves 5 Thumb 6 fingers 7 fingers 8. Medications 9 Stopper 10 barrels 11 Housing 12 Shields 13 Syringe carrier 14 Exit 15 needles 16 protective caps 17 Flange section 18 Flange section 20 plungers 21 Plunger flange 22 Electronic Identifiers 23 Antennas 24 Interlock 25 Latch elements 26 Counter latch element 27 Spring elements 28 Through-opening 29 Opposing fastening structure 30 Add-on Devices 34 Electronic Modules 35 Electronic circuit 36 Printed circuit boards 38 transceivers 39 Reading Unit 40 memory 41 Conductor 42 clocks 43 Antenna 44 processors 46 Power supply 48 switches 50 Sensor Units 52 Signal Generator 53 Light source 54 Light source 55 windows 56 windows 60 Device Body 61 Side wall 62 Flange section 63 Receptacles 64 Receptacles 65 Return elements 66 recesses 67 Stop surface 68 recess 69 Stopping surface 70 Support 71 Stem section 72 Convex part 74 Protrusion 75 Cover 76 Thrust bearing surface 77 Side wall 79 seats 80 touch sensors 81 Sensor Elements 82 Sensing surface 83 Sensing surface 84 sensor segments 85 sensor segments 86 Sensor Segments 88 Sensing area 89 Sensing area 90 Dosage end sensor 91 Plunger extension 92 rods 93 Surface 94 Fastening structure 95 Screw part 97 snap elements 98 Distal section 100 External electronic devices 101 Housing 102 Device Processors 104 displays 106 Communication Unit 110 Injection System 120 layers 121 layers 122 layers

Claims

1. An add-on device (30) for an injection device (1), wherein the injection device (1) comprises a barrel (10) filled with a drug (8) and sealed by a stopper (9), the stopper (9) being movable distally (2) relative to the barrel (10) to dispense a dose of the drug (8), the injection device (1) comprises a machine-readable identifier (22) attached to or integrated with the barrel (10) or housing (11) of the injection device (1), and the add-on device (30) is - The main unit (60) and, - A fastening structure (94, 94') connected to or integrated with the main body (60) and configured to be detachably connected to the stopper (9), - An electronic module (34) inside the main body (60), wherein the electronic module (34) comprises a reading unit (39) that is operable to read information stored in or provided by the machine-readable identifier (22), Equipped with, - When connected to the stopper (9), the main body (60) and the fastening structure (94, 94') are configured to transmit a user-applyable driving force to the stopper (9) to cause the stopper (9) to move relative to the barrel (10). Add-on device (30).

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

3. The add-on device (30) according to claim 2, wherein the electronic module (34) is connected to the processor (44) and comprises a clock (42) operable to provide a clock signal, and the electronic module (34) is operable to buffer or store the clock signal or a timestamp derived from the clock signal when the completion of the injection is detected.

4. The add-on device (30) according to claim 2 or 3, wherein the processor (44) is connected to the reading unit (39) and is operable to process an electronic signal from the reading unit (39) to detect the completion of the injection.

5. The add-on device (30) according to claim 4, - An elongated plunger extension (91) that extends in the longitudinal direction (z), is attached to or integral with the main body (60), and includes an elongated rod (92) that protrudes distally (2) from the bottom or flange portion (62) of the main body (60). Furthermore, - The elongated plunger extension (91) is provided with the fastening structure (94) at its distal end section (98) so as to connect to or abut against the stopper (9). Add-on device (30).

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

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

8. The add-on device (30) according to claim 6 or 7, wherein the reading unit (39) is unable to operate to read the information stored in or provided by the machine-readable identifier (22) when the machine-readable identifier (22) is outside the transmission range of the reading unit (39), and as long as it is outside the transmission range of the reading unit (39).

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

10. The add-on device (30) according to any one of claims 2 to 9, wherein the electronic module (34) is disposed on or integrated with the main body (60) and comprises a dose completion sensor (90) configured to detect at least one of a predetermined position or movement of the main body (60) relative to the barrel (10) of the injection device.

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

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

13. The fastening structure (94') is configured to be detachably fixed to the plunger flange (21) of a plunger (20) connected to or integrated with the stopper (9), the add-on device (30) according to any one of claims 1 to 12.

14. An injection system (110), - An injection device (1), wherein the injection device (1) is - A barrel (10) filled with a drug (8) and sealed by a stopper (9), wherein the stopper (9) is movable distally (2) relative to the barrel (10) to dispense a dose of the drug (8), - A machine-readable identifier (22) attached to or integrated with the barrel (10) or housing (11) of the injection device (1), - An add-on device (30) according to any one of claims 1 to 13, An injection device (1) comprising An injection system (110) equipped with the following:

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

16. The injection system (110) according to claim 14 or 15, wherein the injection system (110) is transitionable from a pre-use configuration to a dose-end configuration by pushing the stopper (9) from a proximal end position toward a distal end position via the add-on device (30).

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

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 a dose-end configuration.

19. A method for monitoring the use of an injection device (1), - A step of providing the injection device (1), wherein the injection device (1) comprises a barrel (10) filled with a drug (8) and sealed by a stopper (9), the stopper (9) being movable distally (2) relative to the barrel (10) to dispense at least one dose of the drug (8), and the injection device (1) comprises a machine-readable identifier (22) attached to or integrated with the barrel (10) or housing (11) of the injection device (1), - A step of providing an add-on device (30) according to any one of claims 1 to 13, - A step of reading information stored in the machine-readable identifier (22) or provided by the machine-readable identifier (22) through the reading unit (39), Methods that include...

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