Auxiliary device for injection device

Abstract

The present disclosure relates to an auxiliary device (50) for an injection device (1), the auxiliary device (50) comprising:-a body (51) comprising a fastening structure (60) for detachable fastening to the injection device (1) and comprising a handle portion (70) for gripping by a user,-an electronic circuit (80) comprising a processor (82) and a first transceiver (83), the invention relates to an electronic circuit (80) comprising a handle portion (70) and switchable between an operational mode and an inactive mode,-a first actuation element (75) provided on the handle portion (70), operably connected to the electronic circuit (80) and operable to activate the electronic circuit (80) when actuated by the user.

Description

Technical Field

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

[0002] Drug delivery devices for setting and dispensing single or multiple doses of liquid medications are well known in the art. Typically, such devices serve essentially the same purpose as ordinary syringes.

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

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

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

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

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

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

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

[0010] There is a possibility that users may not be aware of the correct use of the injection device or auxiliary device. Furthermore, there is a possibility that users may unintentionally activate the auxiliary device without their consent. Such unintentional activation or use of the auxiliary device may lead to errors or inconsistencies in the recording, documentation, or monitoring of the injection procedure.

[0011] Therefore, it is desirable to provide an improved assistive device for use with an injection device, which enhances patient safety and provides improved functionality for its use and operation. Another objective is to provide an assistive device that assists the user in performing injection procedures and / or provides the user with feedback on the actual injection procedure or previous injection procedures. Furthermore, the assistive device should provide enhanced communication capabilities with external electronic devices such as smartwatches, smartphones, tablets, etc. Summary of the Invention

[0012] In one aspect, an auxiliary device for an injection apparatus is provided. The auxiliary device includes a body. The body includes a fastening structure or attachment structure for detachably securing to the injection apparatus. The body further includes a handle portion for a user to grip. The auxiliary device further includes electronic circuitry. The electronic circuitry includes a processor and a first transceiver. The electronic circuitry is switchable between an operating mode and an inactive mode or a sleep mode. The auxiliary device further includes a first actuation element disposed on the handle portion. The first actuation element is operatively connected to the electronic circuitry. The first actuation element is operable to activate the electronic circuitry when actuated by a user.

[0013] By arranging a first actuating element on the handle portion and activating the operability of the electronic circuitry via the first actuating element, the first actuating element can be used as an on / off switch for the auxiliary device. By integrating the first actuating element into the handle portion and / or by setting the first actuating element on the handle portion, when the auxiliary device is fixed to the injection device, a user intending to use the auxiliary device can automatically open the auxiliary device by grasping the handle portion of the auxiliary device.

[0014] This allows for fairly intuitive operation of the auxiliary device, i.e., opening and / or closing the device, for example, while the user grips the handle portion. In some examples, the processor is implemented as a microprocessor or microcontroller. This processor can be operatively connected to a first actuating element. In this case, the processor's electronic circuitry can be selectively activated by operation, i.e., by the user actuating the first actuating element. By releasing the first actuating element, the electronic circuitry can automatically deactivate or transition to a sleep mode, in which the processor or at least a portion thereof is inactive. When deactivated or in sleep mode, the processor's power consumption is significantly reduced compared to when the processor and / or electronic circuitry are in operating mode.

[0015] In some examples, when the electronic circuitry is in an operating mode, the electronic circuitry (e.g., its processor and / or its first transceiver) is operable for recording, recording, or monitoring the dose injection operation of the injection device. Here, the electronic circuitry may be operable for monitoring the date and / or time of the injection procedure. In some examples, the electronic circuitry may be operable for measuring the dose injection size. In some examples, the electronic circuitry may be operable for recording the date and / or time of the injection procedure and the size of the currently set and / or injected dose.

[0016] In some examples, the injection device is implemented as a syringe, such as a pre-filled syringe and / or a safety syringe. Safety syringes typically comprise a pre-filled syringe arranged or assembled within a safety mechanism. After the injection procedure is completed, the safety mechanism typically provides longitudinal displacement of the syringe needle relative to the housing component or relative to the shield of the injection device. This allows the distal injection tip of the needle to be protected, for example, by the housing component, the shield, or a needle protector. This significantly reduces the likelihood of needle damage during use of the injection device.

[0017] According to another example, the electronic circuitry is in an inactive mode as long as the first actuating element is released or remains inactive. Therefore, the electronic circuitry can be activated simply by actuating the actuating element. In this way, and by arranging the first actuating element on or inside the handle portion of the auxiliary device's body, activation of the electronic circuitry requires correspondingly grasping the handle portion to actuate the actuating element. In this manner, operation of the auxiliary device always requires the user to correctly use the handle portion and grasp or hold the auxiliary device with the attached injection device in the intended manner, thereby automatically actuating the actuating element.

[0018] According to another example, the electronic circuitry of the auxiliary device includes a power supply. When released, the first actuating element is operable to disconnect the processor from the power supply. Here, the first actuating element can be implemented as, or can be used as, a switch by which the processor can selectively connect or disconnect from the power supply.

[0019] When the actuating element is released, the power supply can be disconnected from the processor. Conversely, by actuating the first actuating element, the processor can be connected to the power supply and can operate or be supplied with sufficient electrical energy. Otherwise, the processor can be disconnected from the power supply as long as the first actuating element is released or remains released. The power supply can typically be implemented as a battery, which can be a rechargeable or replaceable battery.

[0020] According to another example, the auxiliary device includes a second actuating element disposed on the handle portion. Furthermore, the second actuating element is operatively connected to electronic circuitry and operable to activate the electronic circuitry when actuated by a user. Typically, the electronic circuitry is in and remains in an inactive mode as long as the second actuating element is released or remains inactive. Additionally, the second actuating element may be operable to disconnect the processor from the power supply. In this case, the first and second actuating elements may be implemented substantially the same or at least in a similar manner.

[0021] By providing a first actuation element and a second actuation element on the handle portion, the user can be prompted to actuate both the first and second actuation elements simultaneously to activate the electronic circuitry. Otherwise, if the user may actuate only one of the first and second actuation elements, the electronic circuitry will remain in an inactive mode. Switching the electronic circuitry from an inactive mode to an active mode or operating mode typically requires actuating both the first and second actuation elements within a time interval that overlaps at least.

[0022] By providing a first and a second actuating element on the handle portion, the user of the assistive device is prompted to actuate both simultaneously or within a time interval that overlaps in time; that is, the first and second actuating elements. Otherwise, the electronic circuitry can remain in an inactive mode. This encourages or prompts the user of the assistive device to activate it (e.g., press down substantially simultaneously) to actuate the first and second actuating elements, or to actuate both actuating elements during the overlapping time interval. This effectively suppresses unintentional use or operation of the assistive device. Even with only one actuating element, there is still a risk that a user unintentionally using the assistive device might accidentally actuate either the first or second actuating element. By requiring simultaneous or overlapping actuation of the first and second actuating elements, unintentional operation of the assistive device can be effectively prevented.

[0023] In this scenario, by providing both a first and a second actuating element, the unintentional switching of the electronic circuit from an inactive mode to an operating mode can be effectively suppressed. At the very least, the likelihood of unintentional activation of the electronic circuit during the switch from an inactive mode to an operating mode can be significantly reduced.

[0024] According to another example, the electronic circuit can only switch from an inactive mode to an operating mode or an active mode by actuating a first actuating element and a second actuating element. Actuation of the first and second actuating elements must occur simultaneously or at least within a predefined overlap time interval. Otherwise, the electronic circuit can remain in an inactive mode, for example, by actuating the first and second actuating elements sequentially or temporarily without overlap.

[0025] According to another example, the electronic circuit remains in operating mode as long as both the first and second actuating elements are actuated by the user. Releasing only one of the first and second actuating elements switches the electronic circuit from operating mode to inactive mode.

[0026] Therefore, if the user intends to monitor the injection process using an auxiliary device connected to the injection apparatus, the user is obligated to keep both the first and second actuating elements actuated, for example, depressed, throughout the entire dosage injection process. Premature release of either the first or second actuating element can switch the electronic circuitry to an inactive mode. Consequently, the recording or monitoring of the drug dosage injection process may be compromised or may be misrepresented.

[0027] Typically, switching electronic circuitry to an inactive mode can include at least one of the following: powering off the processor, or switching the processor to a sleep or idle mode, in which the processor consumes less energy than when it is in an operating mode.

[0028] According to another example, by releasing one or both of the first and second actuating elements, the electronic circuit can switch from an operating mode or an active mode to an inactive mode.

[0029] Typically, the first and second actuating elements are arranged on the handle portion in such a way that, when the auxiliary device or injection device is intended for use, the user maintains constant contact with both the first and second actuating elements. Typically, after completing the dosage injection procedure, the user releases at least one or both of the first and second actuating elements. Here, the electronic circuitry having the first actuating element and the optional second actuating element can provide automatic deactivation, and thus, when at least one or both of the first actuating elements are no longer actuated, the electronic circuitry shuts down considerably automatically into an inactive mode. In this way, electrical energy supplied by the auxiliary device's power source can be saved, and thus power consumption can be conserved. In this way, the lifespan of the auxiliary device's power source (e.g., battery) can be extended.

[0030] According to another example, the first actuating element includes a first switch. Furthermore, the second actuating element may include a second switch. The switch can be manually actuated by the user, for example, while gripping the handle portion of the auxiliary device's body. The implementation of the corresponding switch is quite straightforward and simple. Mechanical or electromechanical switches can also provide tactile feedback to the user upon actuation.

[0031] According to another example, at least one of the first and second switches can be electrically connected to the processor and the power supply. One terminal of such a switch can be connected to the processor. The other terminal of the corresponding switch can be connected to the power supply. In this case, by closing the corresponding switch, power can be supplied to the processor and the processor can be woken up to provide the expected operation.

[0032] In another example, the first and second switches are connected in series. This series arrangement of the first and second switches provides a logic AND gate. Here, a conductive connection between the power supply and the processor can only be provided by closing the first and second switches. Opening or releasing at least one of the first and second switches effectively disconnects the processor from the power supply. The electronic circuit then switches to an inactive mode.

[0033] Logic AND gates can also be implemented using electronic circuits. Therefore, electronic circuits can include corresponding AND gates operable by a first actuating element and a second actuating element. Such AND gates can even be integrated into a processor. The corresponding terminals of the AND gate can be selectively actuated by a user of an auxiliary device or injection device.

[0034] According to another example, the handle portion of the auxiliary device's body includes a distally facing gripping surface. The first actuating element is disposed on this distally facing gripping surface. In this context, the distal direction extends toward or points towards the injection end of the injection device, and therefore toward or points towards the biological tissue to be pierced by the injection needle of the injection device. Correspondingly, the proximal direction faces the opposite direction to the distal direction.

[0035] In some examples, the handle portion provides a distally facing gripping surface that can mechanically contact, for example, the middle and index fingers of a user's hand intending to inject a dose of medication using an injection device attached to an auxiliary device. Typically, when properly attached or fastened together, the injection device is fixed to the auxiliary device at least in the longitudinal direction, for example, along the distance between the distal and proximal ends of the injection device.

[0036] By arranging a first actuating element on the distal gripping surface of the handle portion, this first actuating element can be automatically actuated by the user when the user provides or applies a reaction force to the auxiliary device during the process of pushing the stop of the injection device's barrel distally to inject the medication. In this way, by providing the first actuating element on the distal gripping surface, the first actuating element can be automatically actuated by the user when the user intends to use the auxiliary device connected to the injection device to set and / or inject a certain dose of medication.

[0037] In another example, the handle portion includes a gripping flange projecting from the fastening structure or body of the auxiliary device. A first actuating element and a second actuating element are typically disposed on a distally facing gripping surface that extends on the opposite side of the fastening structure or body of the auxiliary device. Here, the first actuating element may be disposed on a first portion of the gripping flange extending outward along a first radial direction from the fastening structure or body. The second actuating element may be disposed on a second portion of the gripping flange extending diametrically opposite to the first portion of the gripping flange. The second actuating element may extend along a second radial direction opposite to the first radial direction.

[0038] By giving the first and second actuating elements a common distal gripping surface, but on radially opposite, outwardly extending flange portions of the gripping flange, the user can intuitively actuate the first and second actuating elements when using the gripping flange to hold the auxiliary device for an injection procedure and / or during an injection procedure.

[0039] In another example of the auxiliary device, the body of the auxiliary device includes a receiving portion for receiving at least a portion of the injection device. The receiving portion of the body provides a fairly easy and intuitive mutual fastening of the auxiliary device and the injection device. The receiving portion may be part of or constitute part of a fastening structure.

[0040] In another example, the body of the auxiliary device includes a through opening, the size of which is determined to receive at least a portion of the injection device passing through it. The receiving portion and / or through opening of the auxiliary device body may include at least one longitudinally abutting portion through which the injection device, when received in the receiving portion and / or through opening, can be fixed relative to the body at least in the longitudinal direction. Here, when the injection device is implemented, for example, as a syringe or safety syringe, a flange portion projecting radially outward from the corresponding syringe or syringe body may longitudinally abut or engage with a corresponding stop surface disposed on or within the receiving portion or through opening of the auxiliary device body.

[0041] According to another example, the fastening structure of the body includes a mechanical coding section to mate with a mechanically mating coding section of the injection device having a complementary shape. For injection devices with an elongated and relatively radially symmetrical shape (such as injection devices including tubular bodies, syringe bodies, or shells), a receiving portion or through opening provided on or within the body of the auxiliary device is generally operable to receive the injection device in any orientation relative to the longitudinal axis of the injection device as the axis of rotation. Now, by cooperating the mechanical coding section (e.g., at the edge or inside of the receiving portion or through opening) with a mechanically mating coding section of a complementary shape (e.g., provided on the outward-facing surface of the injection device), a clear and therefore well-defined mutual fastening or arrangement and attachment of the injection device to the fastening structure and thus to the body of the auxiliary device can be provided.

[0042] In this way, the injection device can be mounted or attached to the auxiliary device in only one or a limited number of clearly defined mutual orientations, thereby improving patient safety and proper control of the injection device connected to the auxiliary device.

[0043] According to another example, the auxiliary device includes a first sensor operable to detect at least one of the positioning and movement of the plunger or stop of the injection device relative to one of the barrel, housing, and shield or needle protection device of the injection device when the auxiliary device is fastened to the injection device, or when the injection device is fastened to the auxiliary device. The configuration or operation of the injection device can be automatically detected by the first sensor. This configuration or operation can be detected, monitored, or quantitatively measured.

[0044] Typically, the first sensor is part of an electronic circuit. The first sensor can be operatively connected to a processor. The sensor signal provided by the sensor can usually be processed by the processor to detect the configuration or operating status of the injection device.

[0045] In another example, the auxiliary device further includes a second sensor operable to detect, when the auxiliary device is secured to the injection device, the positioning and movement of at least one of the plunger or stop of the injection device relative to one of the barrel, housing, shield, and needle protection device of the injection device. The second sensor can also detect, monitor, or quantitatively measure another configuration or another operating state of the injection device.

[0046] In some examples, the first sensor may be operable to detect and / or quantitatively measure a first configuration or first operating state of the injection device, for example, before injecting a dose of medication. In particular, the second sensor may be operable to detect a second configuration or a second operating state of the injection device, for example, after the dosage injection procedure has been completed.

[0047] In this configuration, using both the first and second sensors, at least two different configurations and / or two different operations of the same injection device can be accurately detected. Thus, for example, the start of an injection procedure can be detected using the first sensor, and the termination or completion of a dosage injection procedure can be detected using the second sensor.

[0048] Providing both the first and second sensors also provides redundancy in the functionality of the auxiliary device. Even if one of the first and second sensors fails, the other sensor can still provide corresponding sensor data indicating the configuration or operating status of the injection device.

[0049] However, by using the first and second sensors, different specialized configurations or operating states of the injection device can be accurately detected or monitored.

[0050] In another example, the first and second sensors are offset relative to the longitudinal direction of the injection device. Therefore, the first sensor can be implemented as a proximal sensor, and the second sensor can be implemented as a distal sensor, and vice versa. The first sensor can indicate the proximal positioning of the plunger or stop relative to the barrel, housing, and / or the shroud of the injection device. Similarly, the second sensor can be operable to generate a sensor signal indicating the distal positioning of the plunger or stop of the injection device relative to one of the barrel, housing, shroud, or needle protection device of the injection device.

[0051] The first and second sensors, positioned longitudinally offset from each other, are specifically designed for single-use injection devices, such as pre-filled syringes or pre-filled safety syringes. Here, the plunger or stop of the injection device makes a single, typically distal, movement relative to the syringe body, housing, and / or shield. Therefore, after injection, the configuration of the injection device is distinct from that before the dose was set or injected.

[0052] In another example, the auxiliary device includes a third sensor operable to detect at least one of the presence, positioning, and movement of a protective cap of the injection device when the auxiliary device is secured or attached to the injection device. In some examples, the injection device may be equipped with a protective cap, for example, covering or enclosing the injection needle. Before injection, the protective cap typically needs to be removed to expose the distal end of the injection needle. Typically, the third sensor is operatively connected to a processor and operable to generate and transmit corresponding sensor signals to the processor, indicating the presence of the protective cap, and thus indicating its positioning and / or movement.

[0053] The third sensor can detect the initial presence of a protective cap and / or whether it has been properly removed from the injection device before the injection procedure. The corresponding sensor signals provided by at least one of the first, second, and third sensors are typically processed by the processor of the auxiliary device. Through this signal processing, it can be determined whether the user is using the injection device correctly.

[0054] In some examples, the electronic circuitry includes a detection unit operatively connected to a processor and further connected to or including at least one of a first sensor, a second sensor, and a third sensor. The detection unit can provide preprocessing of the signals generated by the respective sensors. The detector unit can further control the operation of the various sensors.

[0055] In some examples, the electronic circuitry further includes an actuation unit operatively connected to a first actuating element and a second actuating element. The actuation unit may include both a first actuating element and a second actuating element. The actuation unit may be provided in the form of an integrated circuit and / or in the form of an electromechanically implemented switching device.

[0056] According to another example, the first and second sensors have the same sensor type. Therefore, the first and second sensors can operate based on the same sensor principle. The third sensor can be implemented in a different manner. Therefore, the type of the third sensor can be distinguished from the types of the first and second sensors. In some examples, the first, second, and third sensors have the same sensor type. In some examples, at least one of these sensors is implemented as an electrical contact sensor, a capacitive sensor, a magnetic sensor, or an optical sensor. In some examples, at least one of the first, second, and third sensors is a non-contact sensor type. Non-contact sensors can be particularly advantageous because they do not interfere with the mechanical operation of the injection device or auxiliary device.

[0057] In some examples, the first sensor includes an optical sensor. The first sensor may include a photosensor, such as a photodiode. Such optical sensors can be easily integrated into electronic circuits in a fairly cost-effective manner. These optical sensors allow for fairly compact electronic circuit designs and can operate at relatively low power levels.

[0058] In another example, the second sensor also includes an optical sensor. The second sensor can be implemented in the same way as the first optical sensor.

[0059] In some examples, the third sensor can also be implemented as an optical sensor.

[0060] Optical sensors can be implemented as optical switches. They can also be implemented to continuously detect the intensity of light reflected from components of an injection device. Once a corresponding component of the injection device (such as a plunger, stop, barrel, housing, or shield) shifts, the optical sensor can record the corresponding change in transmitted or reflected light from the moving component, and thus detect the corresponding positional change or movement of the device component.

[0061] According to another example, the first sensor includes a first light source. Here, the photodetector of the first sensor can be sensitive to the spectral wavelength of the first light source. The first light source can be directed toward or directed onto a detectable component of the injection device, such as the plunger, stop, barrel, housing, shield, or needle protector of the injection device.

[0062] In another example, when the injection device is correctly or properly attached to the body, the first light source is aligned with a first dedicated portion of the injection device, that is, aligned with a dedicated portion of a selected or dedicated component of the injection device.

[0063] The first light source is operable to illuminate a dedicated portion of the injection device. For example, when the first light source operates within the visible spectrum, proper alignment or arrangement of the injection device and auxiliary devices can cause corresponding alignment of the first light source with the dedicated portion or component of the injection device, which can then be illuminated by radiation generated by the first light source. This illumination of the dedicated portion or component of the injection device can assist the user in using the injection device. In some examples, the dedicated portion or component of the injection device can be translucent or transparent. The illumination provided by the first light source can then be immediately seen by the auxiliary devices and the user of the injection device.

[0064] According to another example of the auxiliary device, the second sensor includes a second light source. The second light source may be operable to transmit or emit electromagnetic radiation of a second wavelength, wherein the second wavelength is distinct from or different from the electromagnetic radiation of a first wavelength generated, emitted, or transmitted by the first light source. Typically, the photodetector of the second optical sensor is susceptible to the influence of the spectrum or wavelength of the radiation generated by the second light source.

[0065] When the wavelengths of the first and second light sources are differentiated, and when the sensitivities of the photodetectors of the first and second optical sensors change accordingly, it can be specified that the first optical sensor operates at a first wavelength or a first spectrum, and the second optical sensor operates at a second wavelength or a second spectrum of electromagnetic radiation. Then, the first and second sensors can be insensitive to radiation provided or emitted by the light source of the other optical sensor.

[0066] By ensuring that the first and second wavelengths are substantially distinct from each other, any crosstalk between the first and second optical sensors can be avoided.

[0067] In another example, when the injection device is properly attached to the body of the auxiliary device, the second light source can be aligned with a second dedicated part or component of the injection device. The second light source is operable to illuminate the dedicated part or component of the injection device in the same or similar manner as described above in conjunction with the first light source. When both the first and second light sources operate within the visible spectrum, they can provide different colors that can be distinguished by the user of the auxiliary device.

[0068] Therefore, optical sensors and their light sources can be used not only to detect the positioning and movement of a specific part or component of the injection device, but also to illuminate a specific or selected part or component of the injection device with the same or different colors, thereby guiding or assisting the user in using the auxiliary device and / or the injection device.

[0069] According to another example, at least one of the first and second light sources is operable to generate visible light of a variable color. Typically, the optical sensor is operatively connected to a processor of electronic circuitry. Thus, the processor can control the operation of the optical sensor and its corresponding light source. Using a variable-color light source, the processor can be further operable to select a wavelength and / or activate the corresponding light source to emit electromagnetic radiation with a selected or selectable color.

[0070] Using different colors (e.g., red, green, blue, or yellow) can be particularly beneficial for illuminating specific parts or components of an injection device to assist the user in using the device. For example, illuminating a specific part or component of the injection device in green can indicate to the user that the auxiliary device and / or the injection device is immediately available. Illuminating the same specific part or component of the injection device, or another specific part or component, in a different color (e.g., blue or red) can indicate to the user, for example, that the auxiliary device or injection device cannot be reused or should not be reused.

[0071] In another example, the auxiliary device's first sensor is sensitive to electromagnetic radiation of a first wavelength, and the second sensor is sensitive to electromagnetic radiation of a second wavelength. The first and second wavelengths are different and / or at least encompass non-overlapping spectral ranges. In this way, a first optical sensor using a first light source can operate at the first wavelength, and a second optical sensor using a second light source can operate at the second wavelength, which is measurably different from the first wavelength.

[0072] According to another example, the electronic circuitry includes a clock operable to provide a clock signal indicating a date and / or time. The electronic circuitry further includes a memory operable to store electronic data. The memory and the clock are operatively connected to a processor. The processor is further operable to process a first sensor signal from the first sensor, the first sensor signal indicating a first configuration or operating state of the injection device. Furthermore, the processor is operable to store the first sensor signal and the clock signal in the memory as electronic data.

[0073] Typically, the processor is operable to combine a first sensor signal with a clock signal occurring simultaneously with the first sensor signal, and to store the combination of the clock signal and the first sensor signal in memory. In this way, the first sensor signal can be timestamped, and the corresponding data stored in memory indicates the time point at which the first sensor signal was generated or processed.

[0074] In another example, the processor is operable to process a second sensor signal from a second sensor. This second sensor signal indicates a second configuration or operating state of the injection device. Furthermore, the processor is operable to store the second sensor signal and a clock signal in a memory as electronic and / or digital data. In this case, the processor is operable to combine the clock signal or timestamp with the sensor signals obtainable from the first and second sensors, respectively.

[0075] The first configuration or operating state can indicate the start of the injection procedure. The second configuration or operating state of the injection device, detectable by the second sensor, can indicate the termination or completion of the corresponding injection procedure.

[0076] In this way, by storing the corresponding sensor signals and clock signals simultaneously in the memory, a dose administration history indicating the start and end of the injection procedure can be provided.

[0077] In another example, it is conceivable that generating or processing one of the first and second sensor signals triggers the recording or storage of the corresponding clock signal. This is particularly applicable to auxiliary devices and injection devices that can only be used once and are operable for injecting a fixed dose. Here, reusing the injection device or multiple injection devices of the same type only requires recording the time point at which the injection procedure is successfully completed.

[0078] In another example, the processor is operable to compare a first clock signal with a second clock signal. The first clock signal indicates the generation of a first sensor signal. The second clock signal indicates the generation of a second sensor signal. Here, if the time interval between the generation of the first clock signal and the generation of the second clock signal is greater than a predefined time interval, the processor is operable to generate at least one of an alarm signal and an indication signal. In this way, the electronic circuitry, and therefore the processor, is operable to verify whether the first and second sensor signals will be generated within the predefined time interval. When the injection device is used as intended and correctly, the corresponding first and second sensor signals can be generated or provided, for example, at the start and end of the dosage injection procedure. If the time interval between the generation or recording of the first sensor signal and the generation or recording of the second sensor signal, and therefore the time interval between the generation or recording of the corresponding first clock signal and the generation or recording of the second clock signal, is greater than a predefined time interval, this can indicate that the injection procedure has not been successfully terminated or that the injection procedure has not been correctly executed or performed.

[0079] The alarm signal or indication signal can be further processed to generate at least one of a visual alarm, an auditory alarm, and / or a tactile alarm. The alarm generation can be provided by the electronic circuitry of an auxiliary device, which may be an electronic circuitry equipped with corresponding alarm generation hardware, such as a visual indicator, a speaker, or a vibration unit.

[0080] In some examples, such alarm signals may be transmitted, for instance, via a first transceiver to an external electronic device, such as a smartwatch, smartphone, or tablet computer, which is equipped with corresponding hardware for generating corresponding auditory, visual, or tactile alarms or corresponding indication signals.

[0081] In another example, the first transceiver is operable to transmit or exchange data with an external electronic device. Thus, the auxiliary device may not have any signal transmitting means or hardware, but can be simply operable to communicate with an external electronic device using appropriate input and output means, or with appropriate input and output hardware of the external electronic device, in order to communicate with the user of the auxiliary device or injection device.

[0082] The first transceiver can be implemented as a wireless transceiver. The first transceiver can be configured to transmit and / or receive radio frequency signals. Specifically, the first transceiver can be operable to communicate with external electronic devices according to established communication standards (such as Bluetooth, Bluetooth Low Energy (BLW), or Wi-Fi standards).

[0083] According to another example, the auxiliary device includes a second transceiver operable to read an electronic tag disposed on or inside the injection device. The second transceiver may also be part of the electronic circuitry. Both the first and second transceivers may be operatively connected to a processor. The first and / or second transceivers may be controllable by a processor of the auxiliary device's electronic circuitry. Specifically, the second transceiver is operable to read electronic information, and thus read an electronic tag disposed on or inside the injection device.

[0084] The second transceiver can be implemented as a wireless transceiver. The second transceiver can wirelessly connect to an electronic identifier of the injection device. The electronic identifier can include information about the drug. The information stored in the electronic identifier can include at least one of the following: the name of the drug, the name of the pharmaceutical substance in the drug, the concentration of the drug, batch number, LOT number, manufacturing date, manufacturing location, shelf life, and / or the temperature at which the drug should be stored or is stored.

[0085] The electronic identifier disposed on or inside the injection device may include an electronic tag. The electronic identifier may include one of an RFID tag and an NFC tag. The second transceiver of the auxiliary device may include a corresponding reader that is complementary to or corresponds to the electronic identifier disposed on or inside the injection device.

[0086] In another example, the second transceiver includes a near-field transceiver, while the first transceiver includes a local range transceiver. The transmission range of the first transceiver may be greater than that of the second transceiver. Furthermore, correctly reading the electronic tag of the injection device may require proper assembly, mounting, or fastening of the auxiliary device and the injection device. For this purpose, mechanical coding portions disposed on or within the fastening structure and mechanically mating coding portions of complementary shapes disposed on or within the injection device can be configured such that the auxiliary device and the injection device are successfully fastened and attached to each other, and the electronic tag of the injection device and the second transceiver of the auxiliary device are correctly and as intended oriented.

[0087] An auxiliary device including a first transceiver and a second transceiver can operate or provide a relay station for wireless transmission between an electronic tag of the injection device and an external electronic device of a user intending to utilize the auxiliary device and the injection device. Electronic circuitry having the first and second transceivers can be operated to read at least a portion of the information stored in the electronic tag of the injection device and transmit the corresponding information to the external electronic device via the first transceiver. Since the transmission range of the first transceiver exceeds that of the second transceiver, the auxiliary device can operate to provide a range extender for wireless data transmission between the electronic tag and the external electronic device.

[0088] Therefore, in another example, the electronic circuitry is operable to read the identification data of the electronic tag of the injection device via a second transceiver and transmit the identification data to an external electronic device via a first transceiver.

[0089] According to another example, the auxiliary device includes an indicator for aligning with a visual marker disposed on or inside the injection device when the injection device is properly secured or assembled to the body of the auxiliary device. The indicator corresponds to or interacts with the visual marker and allows information to be visually indicated to the user via the visual marker.

[0090] In some examples, the visual marker disposed on or inside the injection device is or includes a light guide or light guide structure that can be activated or illuminated by an indicator of the auxiliary device. Here, the indicator may include a light source operatively connected to and operable by a processor. When the injection device and the auxiliary device are properly assembled and / or attached to each other, the light source of the indicator may at least partially overlap with and illuminate the visual marker, and this illumination may be directly visible on the portion of the injection device not obstructed by the auxiliary device.

[0091] In some examples, the visual identifier of the injection device may include at least one longitudinal strip extending in the longitudinal direction. One end of the longitudinal strip may overlap with an indicator or light source of a light source or auxiliary device, which, when activated, can trigger a visible light signal to propagate through the injection device and eliminate the visual identifier of the injection device. The light source of the indicator may be a monochromatic or multicolor light source, such as a light-emitting diode (LED).

[0092] In another aspect, this disclosure also relates to an injection system. The injection system includes an injection device. The injection device includes a barrel filled with a pharmaceutical agent and sealed proximally by a stop. The stop is movable distally relative to the barrel to allow the pharmaceutical agent to exit through an outlet of the barrel. Typically, the outlet of the barrel is in fluid communication with an injection needle. In some examples, the injection needle is connected to, or constitutes or forms part of, the outlet of the barrel. The outlet is typically located at the distal end of the barrel.

[0093] The injection system further includes the auxiliary device as described above. In some examples, the injection device and the auxiliary device are fixed and assembled together. In other examples, the injection system is provided as a kit, wherein the injection device and the auxiliary device are provided separately in an unconnected or detached state. Here, the user or healthcare professional can assemble or attach the auxiliary device to the injection device; or vice versa.

[0094] Since the injection system includes the auxiliary devices described above, all the features, effects, and benefits described above in conjunction with the auxiliary devices also apply to the injection system; and vice versa.

[0095] According to another example of the injection system, the injection device is one of a pre-filled syringe or a pre-filled safety syringe. In another example, the injection device is a pre-filled injection pen. In another example, the injection device is a reusable device. In another example, the injection device is a disposable device that is to be discarded entirely after use.

[0096] On the other hand, this disclosure relates to a method for monitoring the use of an injection device or injection system for injecting a drug. The method includes the steps of providing an injection device operable for injecting a drug and an auxiliary device as described above. Furthermore, the method includes the step of activating the electronic circuitry of the auxiliary device by actuating a first actuating element. For some examples, the method is applicable to an auxiliary device as described above, characterized by or including a second actuating element operatively connected to and operable to activate the electronic circuitry. Activating the electronic circuitry may then include actuating the first actuating element during a first time interval and actuating the second actuating element during a second time interval. Here, the first and second time intervals at least partially overlap in the time domain.

[0097] In other words, activating the electronic circuit includes activating the first actuating element and the second actuating element relatively simultaneously, or at least actuating the first actuating element and the second actuating element during an overlapping time interval.

[0098] In another example, the method further includes deactivating the electronic circuitry, thus switching it to an inactive mode. Here, at least one of the first and second actuating elements is released, and therefore the electronic circuitry is switched to an inactive mode in which the auxiliary device consumes no electrical power or consumes less electrical power compared to its operating mode.

[0099] In another independent aspect, such as according to a second embodiment, this disclosure relates to an auxiliary device for an injection apparatus. The auxiliary device includes a body. The body includes a fastening structure for removably fastening to the injection apparatus. The auxiliary device includes electronic circuitry, which includes a processor. The electronic circuitry further includes a first sensor and a second sensor. The first sensor and the second sensor are operatively connected to the processor of the electronic circuitry. The first sensor is operable to detect, when the auxiliary device is fastened to the injection apparatus, at least one of the positioning and movement of a plunger or stop of the injection apparatus relative to one of the barrel, housing, and shield or needle protection device of the injection apparatus.

[0100] In another example, the second sensor is operable to detect, when the auxiliary device is fastened to the injection device, the positioning and movement of at least one of the plunger or stop of the injection device relative to one of the barrel, housing, and shield or needle protection device of the injection device.

[0101] Typically, a first sensor is operable to detect a first configuration or first operating state of the injection device when it is secured to an auxiliary device. Correspondingly, a second sensor is operable to detect a second configuration or second operating state of the injection device when it is properly secured to the auxiliary device.

[0102] In addition, the first and second sensors can be implemented in the manner described above regarding the auxiliary device and the injection system. The first and second sensors may include optical sensors, or, for example, be equipped with dedicated first or second light sources.

[0103] Furthermore, these optical sensors can be aligned with a first or second dedicated part or component of the injection device. A corresponding light source for at least one of the first and second sensors can be operable to illuminate the corresponding dedicated part or component of the injection device. The first and second sensors of the auxiliary device can be implemented in the manner described in more detail above. Here, in contrast to the auxiliary device described above, the second embodiment of this auxiliary device may lack a first actuating element and / or an optional second actuating element. In other words, for the second embodiment of the auxiliary device, the first and second actuating elements described above may be optional only.

[0104] Generally, the scope of this disclosure is defined by the content of the claims. The injection systems, auxiliary devices, and / or injection apparatuses and corresponding methods described herein are not limited to specific embodiments or examples, but include any combination of elements from different embodiments or examples. To a certain extent, this disclosure covers any combination of claims and any technically feasible combination of features disclosed in different examples or embodiments.

[0105] In this context, the term 'distal' or 'far end' refers to the end of the injection device facing the injection site in a human or animal. The term 'proximal' or 'proximal end' refers to the opposite end of the injection device, which is furthest from the injection site in a human or animal.

[0106] The terms “drug” or “pharmaceutical preparation” are used synonymously herein and describe pharmaceutical preparations comprising one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally pharmaceutically acceptable carriers. In the broadest sense, an active pharmaceutical ingredient (“API”) is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or pharmaceutical preparation is used to treat, cure, prevent, or diagnose a disease or to otherwise enhance physical or mental health. A drug or pharmaceutical preparation may be used for a limited duration or periodically for chronic disorders.

[0107] As described below, a drug or pharmaceutical agent may include at least one API or combination thereof in different types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules (having a molecular weight of 500 Da or less); polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids (such as antisense DNA and RNA), small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems (such as vectors, plasmids, or liposomes). Mixtures of one or more drugs are also considered.

[0108] Drugs or pharmaceutical preparations may be contained in primary packaging or "drug containers" suitable for use with drug delivery devices. Drug containers may be, for example, cartridges, syringes, reservoirs, or other robust or flexible vessels configured to provide suitable chambers for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chamber may be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chamber may be designed to store the drug for about one month to about two years. Storage may be carried out at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., about -4°C to about 4°C). In some cases, drug containers may be or may include dual-chamber cartridges configured to separately store two or more components of a pharmaceutical preparation to be administered (e.g., an API and a diluent, or two different drugs), with one component stored in each chamber. In such cases, the two chambers of a dual-chamber cartridge may be configured to allow mixing between the two or more components before and / or during administration to a human or animal. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., through a conduit between the two chambers), allowing the user to mix the two components as needed before dispensing. Alternatively or additionally, the two chambers can be configured to allow mixing during the dispensing of the components into a human or animal body.

[0109] Drugs or agents contained in drug delivery devices as described herein can be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes or diabetes-related complications (such as diabetic retinopathy), thromboembolic disorders (such as deep vein or pulmonary thromboembolism). Other examples of disorders are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, tumors, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those described in the following manuals: such as Rote Liste 2014 (e.g., but not limited to, main group 12 (antidiabetic drugs) or 86 (oncology drugs)), and the Merck Index (15th edition).

[0110] Examples of APIs used to treat and / or prevent type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide-1 (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture of the above. As used herein, the terms “analyte” and “derivative” refer to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deletion and / or exchange of at least one amino acid residue present in a naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues may be encoding amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. Specifically, the term "derivative" refers to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in a naturally occurring peptide may have been missing and / or substituted with other amino acids (including non-coding amino acids), or amino acids (including non-coding amino acids) may have been added to a naturally occurring peptide.

[0111] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (glargine insulin); Lys(B3), Glu(B29) human insulin (glutamate insulin); Lys(B28), Pro(B29) human insulin (lispro insulin); Asp(B28) human insulin (aspart insulin); human insulin wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala and wherein Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0112] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (detemir insulin, B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (degludecinin, ); B29-N-(N-lithochyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0113] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixilatin. Exenatide (Exendin-4, Liraglutide, a 39-amino acid peptide produced by the salivary glands of the Gila monster. Semaglutide, Tasglutide, Albiglutide Duraglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efp eglenatide)), HM-15211, CM-3, GLP-1Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN- 9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, M AR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Tepirotide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-Xten.

[0114] Examples of oligonucleotides include, for instance, sodium mipronil. Cholesterol-reducing antisense agents used to treat familial hypercholesterolemia or RG012 used to treat Alport syndrome. Examples of DPP4 inhibitors are liraliptin, vedagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0115] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, fertility-stimulating hormone), growth hormone (growth hormone), desmopressin, terlipressin, gosorelin, triptorelin, leuprorelin, buserorelin, nafarelin, and goserelin.

[0116] Examples of polysaccharides include glucosamine, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above-mentioned polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20. A type of sodium hyaluronate.

[0117] As used herein, the term "antibody" refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigens. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized antibodies or humanized antibodies, fully human antibodies, non-human (e.g., mouse) antibodies, or single-chain antibodies. In some embodiments, antibodies have effector functions and can fix complement. In some embodiments, the ability of an antibody to bind to an Fc receptor is reduced or absent. For example, an antibody can be an isotype or subtype, an antibody fragment or a mutant that does not support binding to an Fc receptor, for example, its Fc receptor-binding region has been mutagenized or deleted. The term "antibody" also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or antibody-like binding proteins with dual variable regions having cross-binding region orientation (CODV).

[0118] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not contain the full-length antibody polypeptide but still contains at least a portion of the full-length antibody polypeptide capable of binding to an antigen. Antibody fragments may contain cleaved portions of the full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments that can be used in this invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (e.g., bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., double-chain, triple-chain, and quadruple-chain antibodies)), monovalent or multivalent antibody fragments (e.g., bivalent, trivalent, quadruvalent, and multivalent antibodies), microantibodies, chelated recombinant antibodies, tri- or bivalent antibodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camel-derived antibodies, and antibodies containing VHH. Further examples of antigen-binding antibody fragments are known in the art.

[0119] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term "frame region" refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides; it is not a CDR sequence and is primarily responsible for maintaining the correct positioning of the CDR sequence to allow antigen binding. Although frame regions, as is known in the art, typically do not directly participate in antigen binding, certain residues within the frame region of some antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0120] Examples of antibodies are anti-PCSK-9 mAb (e.g., aliximumab), anti-IL-6 mAb (e.g., thalidomumab), and anti-IL-4 mAb (e.g., dupilumab).

[0121] It is also taken into consideration that pharmaceutically acceptable salts of any API described herein may be used in pharmaceuticals or preparations in drug delivery devices. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0122] Those skilled in the art will understand that modifications (additions and / or removals) can be made to the different components, formulations, devices, methods, systems, and embodiments of the API described herein without departing from the full scope and spirit of the invention, which covers such modifications and any and all equivalents thereof.

[0123] Example drug delivery devices may relate to needle-based injection systems as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems can be broadly classified into multiple-dose container systems and single-dose (partially or completely emptied) container systems. The container may be a replaceable container or an integral, non-replaceable container.

[0124] As further described in ISO 11608-1:2014(E), a multiple-dose container system can relate to a needle-based injection device with replaceable containers. In such a system, each container holds multiple doses, the size of which can be fixed or variable (preset by the user). Another multiple-dose container system can relate to a needle-based injection device with an integral, non-replaceable container. In such a system, each container holds multiple doses, the size of which can be fixed or variable (preset by the user).

[0125] As further described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device having a replaceable container. In one example of such a system, each container contains a single dose, in which the entire deliverable volume is discharged (completely emptied). In another example, each container contains a single dose, in which a portion of the deliverable volume is discharged (partially emptied). Also as described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device having an integral, non-replaceable container. In one example of such a system, each container contains a single dose, in which the entire deliverable volume is discharged (completely emptied). In another example, each container contains a single dose, in which a portion of the deliverable volume is discharged (partially emptied). Attached Figure Description

[0126] In the following, an example of an injection system including an injection device and an auxiliary device for monitoring the use of the injection device will be described in more detail with reference to the accompanying drawings, in which:

[0127] Figure 1 An example of an injection system including auxiliary devices and an injection device is shown.

[0128] Figure 2 The diagram shows the auxiliary device attached to the injection device and prior to the injection procedure. Figure 1 Example,

[0129] Figure 3 This demonstrates what happens after the dosage injection procedure is completed. Figure 2 The injection system

[0130] Figure 4 The following is shown after the needle is retracted into the housing of the injection device. Figure 3 The configuration of the injection system.

[0131] Figure 5 It schematically shows the passage according to Figure 2 The longitudinal section of the injection device with the configuration of [missing information] Figure 6 Is with Figure 3 Corresponding situation Figure 5 The longitudinal section of the device, and

[0132] Figure 7 Another longitudinal section through the injection system is shown after the needle has retracted into the housing of the injection device.

[0133] Figure 8 A perspective view of the fastening structure of the auxiliary device is shown.

[0134] Figure 9 According to the view from below. Figure 8 Perspective view of the auxiliary device,

[0135] Figure 10 This schematically illustrates the configuration of the injection system when operated by a user.

[0136] Figure 11 This schematically illustrates the data exchange between external electronic devices and auxiliary devices.

[0137] Figure 12 Another example of an auxiliary device suitable for use with an injection device is illustrated schematically.

[0138] Figure 13 It is a block diagram of an example electronic circuit, and

[0139] Figure 14This is a flowchart of a method for monitoring the readiness of an injection device using an auxiliary device. Detailed Implementation

[0140] exist Figures 1 to 7 The sequence schematically illustrates a scenario where the injection device 1 is used in conjunction with the auxiliary device 50. For the example shown, the injection device 1 includes a syringe, such as one implemented as a safety syringe. The injection device 1 includes a body 10 filled with a liquid injectable agent 8. The body 10 is sealed by a stop 9 in the proximal longitudinal direction 3, which is movable relative to the body 10 in the distal direction 2. The body 10 may have a tubular shape. The body may include an outlet 14 at its distal end. An injection needle 15 may be provided at the outlet 14, which is secured to the outlet 14 of the body 10. The body 10 terminates in the proximal or proximal direction 3 with a radially outwardly extending or protruding flange portion 17, which, when the injection device is conventional, can serve as a finger grip for the user's index and middle fingers to properly hold the syringe, while the user can use the thumb 5 of the same hand 4 to press a plunger 20 protruding proximally from the body 10.

[0141] The stop 9 may be integrally formed with the longitudinally extending plunger 20. The plunger 20 may include an elongated rod extending in the longitudinal direction (z). In some examples, the stop 9 and the plunger 20 may be provided as separate components. Here, the plunger 20 may be used to apply distal pressure to the stop 9 to move the stop relative to the barrel 10 in the distal direction 2, thereby expelling a defined amount of liquid agent 8 through the outlet 14 and into the tissue once the injection needle 15 has penetrated or punctured the biological tissue. The stop 9 may include an elastic material to hermetically seal the interior of the barrel 10.

[0142] The proximal end of the plunger 20 is typically provided with a radially widened plunger flange 21. The plunger flange 21 is typically configured to be pressed down by the user's thumb 5, for example... Figure 10 As shown. For Figures 1 to 7 For example, the injection device 1 is implemented as a safety syringe. The injection device is provided with a housing 11, which has a generally elongated or tubular shape. The size of the housing 11 is determined to accommodate a syringe body 10 and a spring element 27. The spring element 27 is operatively engaged with the housing 11 and the syringe body 10. The spring element can be configured to cause relative longitudinal movement between the syringe body 10 and the housing 11, particularly when performing a dosage injection procedure.

[0143] The cylinder 10 can be fixed by the interlocking device 24 to prevent longitudinal movement relative to the housing 11. In such cases... Figure 6In the example shown, the interlocking device 24 is located at or near the proximal end of the cylinder 10 or housing 11. The housing 11 may also have a sleeve-like shape, including a mating latching element 26 for releasably engaging with a latching element 25 disposed on the cylinder 10. The latching element 25 and the mating latching element 26 are initially in an engaged configuration that prevents or locks longitudinal displacement of the cylinder 10 relative to the housing 11.

[0144] The mating latch element 26 is deformed or pivoted only when the plunger 10 reaches the distal configuration where the plunger flange 21 engages with the mating latch element 26, in order to make way for the latch element 25. Once the latch element 25 is released from the mating latch element 26, the mechanical energy stored in the spring element 27 can be released, thereby causing longitudinal movement or displacement of the cylinder 10 relative to the housing 11.

[0145] Initially protruding from the distal end of the housing 11 and passing through the outlet 14 or needle 15 of the through opening 28 provided on the distal end face of the housing 11, it retracts into the interior of the housing 11, as... Figure 7 As shown. Here, the injection device 1' is in a protective or safeguarding configuration in which the injection device 1 can no longer be used, and in which the distal tip of the injection needle 15 is protected by the housing 11.

[0146] like Figure 5 and Figure 1 As further shown, in the initial configuration, outlet 14 and / or injection needle 15 can be protected or covered by a separate protective cap 16. The protective cap 16 should be removed from outlet 14 or needle 15 before the injection procedure. In the example currently shown, the mating latching element 26 can be located at or near the radially outwardly extending flange portion 18 of housing 11. The shape of flange portion 18 can be complementary to flange portion 17. The proximal end of flange portion 18 and / or the proximal end of housing 11 can be further provided with a chamfered edge 23, which is configured such that when plunger 20 reaches... Figure 6 When in the distal position, it engages with the distal side or edge of the plunger flange 21. When the plunger flange 21 abuts the chamfered edge 23, the chamfered edge 23 and thus the mating latching element 26 are pushed radially outward, thereby disengaging from the latching element 25, which can be simply provided by the radially outward extending flange portion 17 of the barrel 10.

[0147] Alternatively, for example, as from such Figure 4 As is evident in the illustrated protective configuration, the syringe barrel 10 can be encapsulated or mounted within a syringe barrel carrier 13, which is operatively engaged with a spring element 27. The syringe barrel carrier 13 can provide a dedicated sliding function within the housing 11 and can accommodate the syringe barrel 10 within it.

[0148] exist Figure 1 as well as Figure 8 , Figure 9 , Figure 11 and Figure 12 The auxiliary device 50 is shown schematically separately. The auxiliary device 50 includes a body 51 and a fastening structure 60, through which the body 51 can be detachably connected to the injection device 1. Conversely, the injection device 1 can be fastened or fixed to the body 51 of the auxiliary device 50 via the fastening structure 60. Figure 8 As shown, the fastening structure 60 includes a receiving portion 61 having a lateral abutment portion 62 or an abutment structure. The receiving portion 61 and the abutment portion 62 are shaped and configured to receive a flange portion 18 of the injection device 1 having a distally facing abutment surface 19, as shown. Figure 1 As shown.

[0149] The receiving portion 61 may include a through opening 63 for receiving a portion (e.g., the distal portion) of the injection device 1 passing through it, such as from... Figures 2 to 4 or Figure 10 As is evident, a mechanical coding section 59 may be provided inside the receiving section 63, which mates with a mechanical mating coding section 29 provided at or near the flange portion 18 of the housing 11 of the injection device 1. Here, the mechanical mating coding section 29 may include radially outwardly projecting flange portions 18', 18'', which may be of different sizes or shapes so that they can be fitted into the receiving section 61 in only one or a limited number of selected predefined orientations. For this purpose, the abutment portion 62 or corresponding abutment shoulder inside the receiving section 61 may be a shape complementary to the distally facing abutment surface 19 of the flange portion 18. In this way, a clear mounting or fastening configuration for securing or attaching the injection device 1 to the auxiliary device 50 can be provided.

[0150] The body 51 of the auxiliary device 50 further includes a handle portion 70. The handle portion 70 includes a distally facing gripping surface 71. The gripping surface 71 is disposed on a gripping flange 72, which, when attached to the elongated injection device 1, projects radially outward from the elongated structure of the body 51 or the barrel 10. Alternatively, as for example... Figure 8 As shown, the main body 51 includes an elongated appendage 64, which, when attached to the injection device 1, is aligned with the elongated housing 11 or cylinder 10 of the injection device 1.

[0151] like Figure 2 and Figure 3 As shown, the appendage 64 extends along the side wall of the housing 11. For example, as... Figure 9As shown, the appendage 64 may have a plate-like profile and extend longitudinally from the sidewall 78 of the receiving portion 61. When the injection device 1 is assembled inside the receiving portion 61 or the through opening 63, at least a portion of the sidewall of the housing 11 of the injection device 1 extends along the inner side 78 of the appendage 64, which faces the interior of the receiving portion 61 or the through opening 63. When properly attached or installed in the receiving portion 61, the distally facing abutment surface 19 of the flange portion 18 of the injection device 1 longitudinally abuts against the proximal facing abutment portions 62, 62', as shown. Figure 8 As shown. In this way, the injection device 1 is fixed to the auxiliary device 50 at least with respect to the longitudinal direction (z) and therefore with respect to the distal direction 2.

[0152] In order to inject a certain dose of drug 8, the user must apply distal pressure to the plunger flange 21, such as... Figure 10 As shown. Here, the user typically uses two fingers (e.g., the index finger 6 and middle finger 7 of the same hand 4) to provide a reaction force relative to the pressure applied by the thumb 5.

[0153] The handle portion 70 of the auxiliary device 50 mimics or replicates the typical flange portions 17, 18 of the injection device 1. For ease of use, the size of the handle portion 70, and therefore the size of the gripping flange 72, can be significantly larger than the corresponding sizes of the flange portions 17, 18. A first actuating element 75 and a second actuating element 76 are provided on the distal gripping surface 71 of the handle portion 70, and therefore the gripping flange 72. The actuating elements 75, 76 can be implemented as electrical switches 77, 77'. The electrical switches 77, 77' can be operatively connected to the actuation unit 88 of the electronic circuitry 80 of the auxiliary device 50.

[0154] A first sensor 65 and a second sensor 66 are provided on the inner sidewall 78 of the main body 51. A transceiver 84 may be further provided, which may be implemented as, for example, the second transceiver as described above. An additional sensor, namely a third sensor 37, may also be provided.

[0155] When the injection device 1 and the auxiliary device 50 are properly installed or interconnected, the first sensor 65 and the second sensor 66 can be aligned with a dedicated part or component of the injection device 1. For example, such as... Figure 5 As shown, the first sensor 65 can be longitudinally aligned with the mark 22 provided on the plunger 20. The second sensor 66 can be aligned with the flange portion 17 and / or with the corresponding syringe carrier 13 of the safety syringe. The first sensor 65 and the second sensor 66 can be implemented as optical sensors.

[0156] In an exemplary use case, the first sensor 65 may be operable to detect movement of the plunger 20 relative to the cylinder 10 or relative to the housing 11. The first sensor 65 may also be operable to generate a corresponding first sensor signal indicating that the indicator 22 has left its initial position. Therefore, the first sensor 65 generates a corresponding first sensor signal indicating the start of the injection procedure.

[0157] The second sensor 66 is operable to detect the positioning, presence, or movement of the cylinder 10 or the corresponding injection cartridge carrier 13 as the cylinder 10 moves relative to the housing 11. Throughout the lifespan of the injection device 1, the housing 11 is fixed and held to the body 51 of the auxiliary device. When the desired effect is achieved... Figure 7 In the configuration shown, the second sensor 66 can detect the corresponding movement of the characteristic or dedicated parts of the barrel 10 and / or the injection cartridge carrier 13. Therefore, the electronic circuit 80 equipped with the first sensor 65 and the second sensor 66 can be operated to detect at least two different configurations or operating states of the injection device.

[0158] In some examples, the second sensor 66 can also be implemented to detect the end position reached by the barrel 10 or the injection cartridge carrier 13 when the injection procedure is completed, for example, as shown in the example. Figure 7 As shown.

[0159] In some examples, at least one of the first sensor 65 and the second sensor 66 is implemented as an optical sensor. The corresponding sensors 65 and 66 may each include optical detectors 69 and 69', such as... Figure 9 The magnified cross-section is shown. Alongside the corresponding optical detector, the corresponding sensors 65, 66 can be equipped with their own light source or separate light sources 68, 68'. Typically, the light sources 68, 68' are implemented as light-emitting diodes (LEDs).

[0160] The first optical sensor 65 may be equipped with a first light source 68, and the second optical sensor 66 may be equipped with a second light source 68'. The operating wavelengths of the light sources 69 and 69', or the wavelengths or spectra of the light generated by the light sources 68 and 68', can be significantly distinguished. This also applies to the sensitivity of the optical detectors 69 and 69' of the corresponding optical sensors 65 and 66. As an example, the light source 68 and optical detector 69 of the first optical sensor 65 operate with electromagnetic radiation of a first wavelength or a first spectral range that does not overlap with the second wavelength or second spectral range of the light source 68' and corresponding optical detector 69' of the second optical sensor 66. In this way, crosstalk between the light source 68 of the first optical sensor 68 and the detector 69' of the second optical sensor 66 can be effectively avoided; and vice versa.

[0161] In some examples, when the injection device 1 is attached to or assembled to the auxiliary device 50, the light sources 68, 68' of the respective sensors 65, 66 are aligned with dedicated parts or components of the injection device 1. These dedicated parts or components (e.g., the barrel 10, housing 11, the shield 12 of the syringe carrier 13) may be provided or manufactured from at least partially translucent or at least partially transparent materials. Proper alignment of the light sources 68, 68' with any of these components can provide an illumination effect on the corresponding device component. Furthermore, when the first optical sensor 65 and the second optical sensor 66 operate in different non-overlapping spectral ranges, various illumination effects can be provided that can assist the user in operating the auxiliary device and / or the injection device.

[0162] In some examples, when the injection device 1 is in the first configuration or operating state, the first sensor 65 is longitudinally aligned with the plunger 20 or with a mark 22 disposed on the plunger 20, for example, Figure 5 As shown. Here, the injection device 1 is in a configuration or condition prior to dose injection. In this configuration, the light source 68 of the first sensor 65 can be aligned with the plunger 20 so as to illuminate the plunger 20. For other examples and / or for other configurations, the light source 68 of the first sensor 65 can be aligned with the cylinder 10 or the housing 11, wherein the cylinder 10 and / or the housing 11 can be at least partially transparent so that the light source 68 can illuminate these components.

[0163] Simultaneously, light generated by light source 68 and propagating, for example, toward plunger 20 and / or toward cylinder 10 or housing 11, can be reflected at any of these components and can be captured by optical detector 69. In this case, sensor 65, having light source 68 and optical detector 69, can provide dual functionality. On one hand, the combination of light source 68 and optical detector 69 allows the detection of the presence or location of appropriate light-reflecting components of injection device 1 (such as plunger 20, cylinder 10, or any other movable component (such as stop 9)). On the other hand, light source 68 can also be used to irradiate dedicated parts or components of injection device 1. The light sources 68, 68' of the first sensor 65 and the second sensor 66 can be operable to emit electromagnetic radiation with different wavelengths or distinguishable electromagnetic spectra.

[0164] In this way, when the first optical sensor 65 and the second optical sensor 66 operate simultaneously, crosstalk can be minimized. Therefore, the optical detector 69 of the first optical sensor 65 can be substantially insensitive to the radiation generated by the light source 68' of the second optical sensor 66. Conversely, the optical detector 69 of the first optical sensor 65 can be substantially insensitive to the radiation generated by the light source 68' of the second sensor 66.

[0165] In some examples, light sources 68, 68' may be monochromatic. In other examples, light sources 68, 68' may be implemented as fairly broadband light sources. These light sources may include polychromatic light sources, which may be selectively operable to emit electromagnetic radiation in different and non-overlapping spectral ranges. In some examples, light sources 68, 68' may be operable to generate electromagnetic radiation in the visible light range, such as any one or more of the following colors: blue, green, yellow, orange, and / or red.

[0166] Furthermore, since the optical sensors 65, 66 and their light sources 68, 68' can be controlled by the processor 82 of the electronic circuit 80, it is conceivable that one of the first light sources 68, 68' can be operated to irradiate a component or portion of the injection device 1 with a first color at a first time point, and to eliminate the same component or portion or another component or portion of the injection device 1 with a different color at a second time point. For some examples, when the injection device 1 is in, for example Figure 2 or Figure 5 In the pre-use condition or configuration shown, at least one of the light sources 68, 68' is operable to illuminate, for example, a portion or component of the injection device 1 with a first color. For example, as... Figure 7 In the different configurations shown, and when, for example, the second sensor 66 detects the corresponding second configuration or operating state of the injection device, the corresponding light sources 68, 68' may be operable to eliminate the same part or component or any part or component of the injection device 1 in a different color (e.g., red).

[0167] In this way, when a selected or dedicated part or component of the injection device 1 is irradiated, the user can be intuitively assisted in using the auxiliary device 50, the injection device 1 and / or the injection system 30.

[0168] exist Figure 10 The image illustrates a typical scenario using the injection system 30. Figure 10 In the middle, the injection device, such as according to Figure 7 As shown in the configuration, that is, after using the injection device 1 and after the injection needle 15 is retracted into the housing 11 of the injection device 1.

[0169] Here, before reaching the configuration shown, the user holds the injection system 30 with one hand, whereby the index finger 6 and middle finger 7 of the user's hand 4 are diametrically positioned adjacent to the gripping flange 72 of the body 51 of the auxiliary device 50. As shown... Figure 10 As shown, the tips of fingers 6 and 7 are directly adjacent to the first actuating element 75 and the second actuating element 76, as... Figure 9 As shown. The gripping surface 71 faces the distal side, that is, toward the distal end of the housing 11. The user can apply distal pressure to the plunger flange 21 of the plunger 20 with his thumb 5.

[0170] After completing such Figure 10 Following the injection procedure shown, the barrel 10 or injection barrel carrier 13 protrudes proximally from the proximal end of the body 51 because the spring 27 located between the barrel 10 and the housing 11 pushes the barrel 10 in the proximal direction 3. Both the first actuating element 75 and the second actuating element 76 can be implemented as mechanical or electromechanical switches 77. Both switches 77, 77' can belong to the actuation unit 88, such as... Figure 8 The block diagram of the electronic circuit 80 is shown schematically.

[0171] The two switches 77 and 77', and therefore the first actuating element 75 and the second actuating element 76, can form or constitute a logic AND gate. Accordingly, the electronic circuit 80 can switch from an inactive mode to an operating mode via the first actuating element 75 and the second actuating element 76. For this to be done, the actuating elements 75 and 76 must be manually activated simultaneously. Actuation of only one of the actuating elements 75 and 76 will not be sufficient to switch the electronic circuit 80 from an inactive mode to an operating mode.

[0172] When implemented as switches 77, 77', these switches can be arranged in series in the actuation unit 88. The actuation unit can be directly or indirectly connected to the processor 82 of the electronic circuit 80 and connected to a power source 81, for example, in the form of a battery, which can be rechargeable. The actuation unit and / or the two actuating elements 75, 76 can be connected to the processor 82 solely or exclusively via the actuation unit 88. This means that once the user releases one of the actuating elements 75, 76, the processor 82 or the processing unit of the electronic circuit 80 can be turned off, decoupled from power, or disconnected.

[0173] In this way, the possibility of accidental and unintentional activation of the electronic circuit 80 can be significantly reduced (i.e., when the user only unintentionally touches or presses one of the actuating elements 75, 76).

[0174] like Figure 8 The illustrated electronic circuit 80 further includes a detection unit 87. The detection unit 87 includes at least one of sensors 65 and 66. Optionally, the detection unit 87 also includes a third sensor 67 operable to detect the presence or positioning of the protective cap 16. The detection unit 87 is operatively connected to the processor 82.

[0175] The processor 82 is further connected to the memory 85. This memory is a digital memory. It can be implemented as volatile or non-volatile memory. The electronic circuitry 80 further includes a clock 86. The clock 86 is operable to generate a clock signal indicating the date and / or time. In typical use cases, when the electronic circuitry is in operating mode, and when the detection unit 87 detects at least one of the positioning or movement of a dedicated device component indicating, for example, the start or completion of a dose dispensing procedure, the clock signal indicating a point in time can be used as a timestamp and a corresponding indication that a specific dose has been administered. This dose administration information (typically along with the timestamp) can be stored in the memory 85.

[0176] Processor 82 may be further configured to process different signals, such as those provided by detection unit 87. For some examples, first detector 65 may be operable to provide a first sensor signal, while second sensor 66 may be operable to provide a second sensor signal. The first and second sensor signals may be processed by processor 82. Furthermore, processor 82 may be operable to determine whether the determined sensor signals are consistent with each other and belong to the same dose-injection event. Only when an assertion of the corresponding consistency check is made can the corresponding dose-injection data be generated and / or stored in memory 85.

[0177] The electronic circuit 80 further includes a first transceiver 83 and a second transceiver 84. Transceivers 83 and 84 can be connected to the processor 82 and can provide communication with other electronic devices external to the electronic circuit 80. For some examples, the first transceiver 83 is operable for transmitting or exchanging data with external electronic devices, such as… Figure 11 As shown. The external electronic device 100 can be implemented as a smartphone. The external electronic device 100 includes a housing 101 and can be implemented as a portable electronic device. The external electronic device 100 further includes a device processor 102 and a display 104. Optionally, the external electronic device 100 includes a speaker and / or a haptic user interface. Additionally, the external electronic device 100 includes a communication unit 106 operable to communicate with a first transceiver 83. For some examples, the first transceiver 83 includes a local range transceiver with a transmission range of several meters or tens of meters.

[0178] The additional transceiver 84 is a near-field transceiver and is operable to exchange data with a complementary near-field electronic tag 33 disposed on the injection device 1. Typically, when the injection device 1 is properly arranged or fixed to the auxiliary device 50, the electronic tag 33 can be near the second transceiver 84, at least within the transmission range of the second transceiver 84.

[0179] The electronic identifier 33 may include electronic information or data, such as the name of the drug, the name of the pharmaceutical substance, the concentration of the drug, batch number, LOT number, manufacturing date, manufacturing location, shelf life, and / or the temperature at which the drug should be stored or is stored. The corresponding information or data can be read by the second transceiver 84. The corresponding data can be further processed by the processor 82 and can be transmitted to the external electronic device 100 via the first transceiver 83. In this way, the auxiliary device 50 can be used as a range extender for reading the electronic identifier 33 of the injection device 1. The reading of the electronic identifier 33 (which may be implemented as a near-field communication tag (NFC tag)) can be provided by the second transceiver 84 of the auxiliary device 50. The information or data obtained thereby can be further processed by the processor 82 and can be transmitted to the external electronic device 100 via the first transceiver 83.

[0180] For example Figure 12 In another example shown, the injection device 1 is equipped with a visual identifier 34, which may be disposed on the outer surface of the housing. When the injection device 1 is correctly assembled with the auxiliary device 50, at least a portion of the visual identifier 34 may coincide with or overlap with an indicator 54 disposed on the body 51 of the auxiliary device 50. When the injection device 1 is correctly assembled or attached to the auxiliary device 50, the indicator 54 may be disposed on the inner side 78 of the body 51 facing outwards from the injection device 1.

[0181] like Figure 12 As shown, the indicator 54 can be configured to operate for illuminating a light source 55 of the visual sign 34. The visual sign 34 may include a longitudinally extending light guide 35 or a light guide structure 35 having any other shape or geometry. The visual sign 34 may include a frosted surface with a frosted structure and may be operable to reflect light emitted by the indicator 54 or the light source 55 in a diffuse manner.

[0182] The indicator 54 or the light source 55 can be connected to and operated by the processor 82. Here, depending on the configuration of the detected operating state of the injection device 1, the processor 82 can be configured to generate visible light signals (e.g., light signals with different durations, frequencies, or colors) to provide a corresponding visual effect along the visual marker 34 or the light guide 35.

[0183] Irradiation that varies over time, in terms of irradiation time or duration and in terms of intensity or color change, can further assist the user in using the injection device 1, the auxiliary device 50, and / or the injection system 30 that includes the injection device 1 and the auxiliary device 50.

[0184] Figure 14The flowchart illustrates a possible scenario using the injection system 30, which includes an injection device 1 assembled or attached to the auxiliary device 50 as described above. Here, in the first step 200, the injection device 1 is attached and / or secured to the auxiliary device 50.

[0185] In step 202, the actuation of the first actuating element 75 is monitored or detected. In step 204, the actuation of the second actuating element 76 is monitored or detected. Only when the user activates both actuating elements 75 and 76, for example when the user's corresponding fingers 6 and 7 press the corresponding switches 77 and 77', does the electronic circuit 80 of the auxiliary device 50 switch from the inactive mode to the operating mode in step 206.

[0186] Once the electronic circuit 80 switches to the operating mode, the method can proceed to step 208. Here, the electronic circuit 80 can read the electronic identifier 33 disposed on or within the body 51 of the auxiliary device 50. Specifically, and as described above, the second transceiver 84 can read the electronic data provided by the electronic identifier 33 of the injection device 1, which can be implemented as an electronic tag, such as a near-field tag.

[0187] In step 210, the first sensor 65 is activated and configured to detect movement or positioning of the first component of the injection device 1. In the subsequent step 212, the first sensor 65 and / or the processor 82 connected to the first sensor 65 check or assert whether the first component of the injection device 1 has moved or is currently undergoing a planned movement. If and as long as no movement is detected in step 212, the method returns to step 210. The cycle of steps 210 and 212 continues as long as the first sensor 65 detects a planned movement or planned positioning of the first component of the injection device 1.

[0188] In the subsequent step 214, the clock 86 generates a corresponding timestamp or clock signal, and the corresponding clock signal or timestamp can be stored in the memory 85 of the electronic circuit 80.

[0189] The method can then proceed to step 216, in which the second sensor 66 is active, or in which the first sensor 65 is reactivated and becomes operable to detect movement or positioning of the first or second component of the injection device 1. Again, step 216 is repeated multiple times as long as the corresponding sensors 65, 66 do not detect the expected positioning or movement, or as long as the expected movement or positioning of the first or second component of the injection device 1 is detected in step 216. If either the first sensor 65 or the second sensor 66 detects the expected movement or positioning of the first or second component of the injection device 1, the method proceeds to step 218. Again, similar to step 214, the clock 86 generates a corresponding timestamp, and the timestamp or clock signal is stored in the memory 85.

[0190] Timestamps or clock signals indicating the start and completion of, for example, a dosage injection procedure can be combined with drug-related injection device information obtained in step 208. In step 220, data obtained from electronic identifier 33 can be matched or combined with the timestamps provided in steps 214 and 218. Then, in step 222, the combination of the obtained data can be stored in the local memory 85 of electronic circuitry 80. In a further subsequent and therefore optional step 224, the data stored in memory 85 can ultimately be transferred to external electronic device 100, for example, for further data processing.

[0191] Figure Labels

[0192] 1. Injection device

[0193] 2. Distal direction

[0194] 3. Proximal direction

[0195] 4 hands

[0196] 5. Thumb

[0197] 6 fingers

[0198] 7 fingers

[0199] 8. Pharmacology

[0200] 9. Stop components

[0201] 10. Cylinder

[0202] 11. Shell

[0203] 12 shields

[0204] 13 Injection cylinder carrier

[0205] 14 Exports

[0206] 15 stitches

[0207] 16 Protective Helmet

[0208] 17. Flange portion

[0209] 18. Flange portion

[0210] 19 Adjacent surfaces

[0211] 20 plungers

[0212] 21. Plunger flange

[0213] 22 marks

[0214] 23. Beveled edge

[0215] 24 Interlocking devices

[0216] 25. Latch element

[0217] 26 Paired latching elements

[0218] 27 Spring elements

[0219] 28 Through opening

[0220] 29 Mechanical pairing coding unit

[0221] 30 Injection System

[0222] 33 Electronic Identifiers

[0223] 34 Visual identifiers

[0224] 35 Optical Guide

[0225] 50 Auxiliary devices

[0226] 51 body

[0227] 54 Indicators

[0228] 55 Light Source

[0229] 59 Mechanical Coding Department

[0230] 60 Fastening Structure

[0231] 61 Reception Department

[0232] 62 Adjacent parts

[0233] 63 Through opening

[0234] 64. Appendages

[0235] 65 Sensors

[0236] 66 sensors

[0237] 67 Sensors

[0238] 68 Light Sources

[0239] 69 Optical detectors

[0240] 70 Handle section

[0241] 71 Grip Surface

[0242] 72. Grasp the flange

[0243] 75 Actuating elements

[0244] 76 Actuating elements

[0245] 77 Switch

[0246] 78 Sidewalls

[0247] 80 Electronic Circuits

[0248] 81 Power Supply

[0249] 82 processor

[0250] 83 Transceiver

[0251] 84 transceiver

[0252] 85 Memory

[0253] 86 clocks

[0254] 87 detection units

[0255] 88 Actuation Units

[0256] 100 External electronic devices

[0257] 101 Casing

[0258] 102 Device Processor

[0259] 104 monitor

[0260] 106 Communication Units

Claims

1. An auxiliary device (50) for an injection apparatus (1), the auxiliary device (50) comprising: - Body (51), which includes a fastening structure (60) for detachably fastening to the injection device (1), and includes a handle portion (70) for the user to grip. - An electronic circuit (80) comprising a processor (82) and a first transceiver (83), capable of switching between an operating mode and an inactive mode. - A first actuating element (75) is disposed on the handle portion (70), operably connected to the electronic circuit (80), and operable to activate the electronic circuit (80) when actuated by the user.

2. The auxiliary device (50) according to claim 1 further includes a second actuation element (76) disposed on the handle portion (70), operatively connected to the electronic circuit (80), and operable to activate the electronic circuit (80) when actuated by the user.

3. The auxiliary device (50) according to claim 2, wherein, The electronic circuit (80) can only switch from the inactive mode to the operating mode by actuating the first actuating element (75) and the second actuating element (76).

4. The auxiliary device (50) according to claim 2 or 3, wherein, If the user actuates only one of the first actuation element (75) and the second actuation element (76), the electronic circuit (80) remains in the inactive mode.

5. The auxiliary device (50) according to any one of claims 2 to 4, wherein, Switching the electronic circuit (80) from the inactive mode to the operating mode requires actuating both the first actuating element (75) and the second actuating element (76) within a time interval that overlaps at least.

6. The auxiliary device (50) according to any one of claims 2 to 5, wherein, By releasing one or both of the first actuating element (75) and the second actuating element (76), the electronic circuit (80) can switch from the operating mode to the inactive mode.

7. The auxiliary device (50) according to any one of claims 2 to 6, wherein, The first actuating element (75) includes a first switch (77), wherein the second actuating element (76) includes a second switch (77'), and wherein the first switch (77) and the second switch (77') are connected in series.

8. The auxiliary device (50) according to any one of the preceding claims, wherein, The handle portion (70) includes a distal gripping surface (71), wherein the first actuating element (75) is disposed on the distal gripping surface (71).

9. The auxiliary device (50) according to any one of the preceding claims further includes a first sensor (65) operable to detect, when the auxiliary device (50) is fastened to the injection device (1), at least one of the positioning and movement of the plunger (20) or stop (9) of the injection device (1) relative to one of the cylinder (10), housing (11) and shield (12) of the injection device (1).

10. The auxiliary device (50) according to any one of the preceding claims further includes a second sensor (66) operable to detect, when the auxiliary device (50) is fastened to the injection device (1), at least one of the positioning and movement of the plunger (20) or stop (9) of the injection device (1) relative to one of the cylinder (10), housing (11) and shield (12) of the injection device (1).

11. The auxiliary device (50) according to any one of claims 9 or 10, wherein, The first sensor (65) includes an optical sensor.

12. The auxiliary device (50) according to claim 11, wherein, The first sensor (65) includes a first light source (68), or wherein the first sensor (65) is coupled to the first light source (68).

13. The auxiliary device (50) according to claim 12, wherein, When the injection device (1) is properly attached to the body (51), the first light source (68) is aligned with the first dedicated portion of the injection device (1), and wherein the first light source (68) is operable to irradiate the dedicated portion of the injection device (1).

14. The auxiliary device (50) according to any one of the preceding claims further includes a third sensor (76) operable to detect at least one of the presence, positioning and movement of the protective cap (16) of the injection device (1) when the auxiliary device (50) is fastened to the injection device (1).

15. The auxiliary device (50) according to any one of the preceding claims further includes a second transceiver (84) operable to read an electronic tag (33) disposed on or inside the injection device (1).

16. The auxiliary device (50) according to claim 15, wherein, The second transceiver (84) includes a near-field transceiver, and wherein the first transceiver (83) includes a local range transceiver, and wherein the transmission range of the first transceiver (83) is greater than the transmission range of the second transceiver (84).

17. The apparatus (50) according to any one of the preceding claims, wherein, The inactive mode of the electronic circuit (80) is a sleep mode, in which the power consumption of the processor (82) is reduced compared to when the processor (82) and / or the electronic circuit (80) are in the operating mode.

18. An injection system (30), comprising: - An injection device (1) having a cylinder (10) filled with a drug (8) and sealed by a stop (9) in a proximal direction (3), the stop being movable relative to the cylinder (10) in a distal direction (2) to discharge the drug (8) through an outlet (14) of the cylinder (10). - The auxiliary device (50) according to any one of the preceding claims.

19. A method for monitoring the use or preparation of an injection device or injection system for injecting a drug, the method comprising: - Provides an injection device (1) capable of operating for injecting the drug and an auxiliary device (50) according to any one of the preceding claims, - The electronic circuit (80) of the auxiliary device (50) is activated by actuating the first actuating element (75).

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