Auxiliary devices for injection devices

Abstract

This disclosure relates to an auxiliary device (50) for an injection device (1), wherein the auxiliary device (50) is - The main body (51) comprises a fastening structure (60) for detachably fastening to the injection device (1), and a handle portion (70) for the user to grasp, - An electronic circuit (80) comprising a processor (82) and a first transceiver (83), which is switchable between an operating mode and an inactive mode, - A first actuation element (75) is provided on the handle portion (70), is operably connected to the electronic circuit (80), and is operable to activate the electronic circuit (80) when activated by the user. It is equipped with.

Description

Technical Field

[0005]

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

Background Art

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

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

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

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

[0006] Some infusion devices are implemented as reusable infusion devices, such as cartridges, where the user can replace the medication container. Other infusion devices are implemented as disposable infusion devices. In disposable infusion devices, the entire infusion device is intended to be discarded once the contents, i.e., the medication, have been used up.

[0007] To control and manage 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. A fairly automated recording of user-injected doses offers significant advantages over manual dose logging from a safety and convenience standpoint.

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

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

[0010] Situations may arise where a user is unaware of the correct usage of an injection device or auxiliary device. Furthermore, situations may arise where a user unintentionally activates an auxiliary device. Such unintentional activation or use of an auxiliary device may lead to incorrect or inconsistent recording, logging, or monitoring of the injection procedure. [Overview of the project] [Problems that the invention aims to solve]

[0011] Therefore, it is desirable to provide improved auxiliary devices for use with infusion devices, thereby enhancing patient safety and providing improved functionality in their use and handling. A further objective is to provide auxiliary devices that assist the user in performing infusion procedures and / or provide feedback to the user regarding the actual or preceding infusion procedure. Furthermore, auxiliary devices should have enhanced communication capabilities with external electronic devices such as smartwatches, smartphones, and tablet computers. [Means for solving the problem]

[0012] In one embodiment, an auxiliary device for an injection device is provided. The auxiliary device includes a main body. The main body includes a fastening or mounting structure for detachably fastening to the injection device. The main body further includes a handle portion for the user to grasp. The auxiliary device further includes an electronic circuit. The electronic circuit includes a processor and a first transceiver. The electronic circuit is switchable between an operating mode and an inactive mode or sleep mode. The auxiliary device further includes a first actuation element provided on the handle portion. The first actuation element is operably connected to the electronic circuit. The electronic circuit is operable to activate the electronic circuit when activated by the user.

[0013] By positioning the first actuation element on the handle and by the operability of the first actuation element for operating the electronic circuit, the first actuation element can function as a kind of on / off switch for the auxiliary device. By integrating the first actuation element with the handle and / or providing the first actuation element on the handle, a user who intends to use the auxiliary device when it is fixed to the injection device can automatically turn on the auxiliary device's switch when gripping the handle of the auxiliary device.

[0014] In this way, the auxiliary device can be operated fairly intuitively; for example, the user can turn it on and / or off simultaneously with gripping the handle. In some examples, the processor is implemented as a microprocessor or microcontroller, which can be operationally connected to a first actuation element. To that extent, the processor of the electronic circuit can be selectively activated by operation, i.e., by the user acting on the first actuation element. By releasing the first actuation element, the electronic circuit can be automatically deactivated or enter a sleep mode in which the processor or at least a part thereof is inactive. When deactivated or in sleep mode, the energy consumption of the processor is substantially reduced compared to when the processor and / or electronic circuit are in operating mode.

[0015] In some examples, when the electronic circuit is in operating mode, the electronic circuit, for example its processor and / or its first transceiver, may be configured to record, log, or monitor the dose infusion operation of the infusion device. Here, the electronic circuit may be configured to monitor the date and / or time of the infusion procedure. In some examples, the electronic circuit may be configured to measure the size of the dose infusion. In some examples, the electronic circuit may be configured to record the date and / or time of the infusion procedure, along with the size of the dose currently set and / or being infused.

[0016] In some examples, the infusion device is implemented as a syringe, for example, as a pre-filled syringe and / or a safety syringe. A safety syringe typically includes a pre-filled syringe that is housed or assembled within a safety mechanism. The safety mechanism typically provides longitudinal displacement of the syringe's injection needle relative to a housing component or the shield of the infusion device after the completion of the infusion procedure. Thus, the distal injection end of the injection needle can be protected, for example, by a housing component, by a shield, or by a needle guard. In this way, the possibility of puncture injury during use of the infusion device can be substantially reduced.

[0017] In a further example, an electronic circuit is in an inactive mode as long as the first actuation element is released or remains unactuated. Therefore, the electronic circuit can only be activated by activating the actuation element. In this way, by positioning the first actuation element on or inside the handle portion of the auxiliary device's body, the operation of the electronic circuit requires each grip of the handle portion, thereby activating the actuation element. Thus, operation of the auxiliary device always requires the user to use the handle portion correctly, gripping or holding the auxiliary device to which the injection device is attached in the intended manner, thereby automatically activating the actuation element.

[0018] In a further example, the electronic circuitry of the auxiliary device includes a power supply. A first actuation element, when released, is operable to disconnect the processor from the power supply. Here, the first actuation element may be implemented as a switch that can selectively connect or disconnect the processor from the power supply, or it may function as a switch.

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

[0020] In a further example, the auxiliary device includes a second actuation element located on the handle. The second actuation element is operably connected to an electronic circuit and is operable to activate the electronic circuit when actuated by a user. Typically, the electronic circuit is in an inactive mode and remains in an inactive mode as long as the second actuation element is released or not actuated by a user. The second actuation element may also be operable to disconnect the processor from the power supply. To that extent, the first and second actuation elements can rather be implemented identically or at least similarly.

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

[0022] By providing a first and a second actuation element on the handle, the user of the auxiliary device is encouraged to actuate both, i.e., the first and second actuation elements, simultaneously or at least at a time interval that overlaps. Otherwise, the electronic circuit may remain in an inactive mode. In this way, a user of the auxiliary device who intends to actuate the device is encouraged or prompted to actuate it, for example, by pressing the first and second actuation elements substantially simultaneously, or by actinguating the two actuation elements during an overlapping time interval. In this way, inattentive use or accidental operation of the auxiliary device can be effectively suppressed. With only one actuation element, there is still a certain risk that the first or second actuation element may be actuated accidentally when the user does not intend to use the auxiliary device. By requiring simultaneous or time-overlapping operation of the first and second actuation elements, inattentive operation of the auxiliary device can be effectively prevented.

[0023] To that extent, by providing the first and second operating elements, accidental switching of the electronic circuit from inactive mode to operating mode can be effectively suppressed. At the very least, the possibility of accidental activation of the electronic circuit when switching from inactive mode to operating mode can be substantially reduced.

[0024] In a further example, an electronic circuit can switch from an inactive mode to an operating mode or an active mode only by activating a first and a second actuating element. The activation of the first and second actuating elements must occur simultaneously or at least within a predetermined overlapping time interval. Otherwise, for example, the electronic circuit may remain in an inactive mode due to sequential or temporarily non-overlapping activation of the first and second actuating elements.

[0025] According to a further example, the electronic circuit remains in the operating mode as long as both the first operating element and the second operating element are actuated by the user. By releasing only one of the first operating element and the second operating element, the electronic circuit can be switched from the operating mode to the non - active mode.

[0026] Thus, when a user attempts to monitor an injection process by using an auxiliary device connected to an injection device, the user is obliged to keep the first operating element and the second operating element actuated, for example depressed, throughout the dose injection process. Premature release of only one of the first operating element and / or the second operating element may switch the electronic circuit to the non - active mode. Thus, the recording or monitoring of the drug dose injection process may be impaired or may be shown to be inappropriate.

[0027] Generally, switching the electronic circuit to the non - active mode may include at least one of powering off the processor, or switching the processor to the sleep mode or the idle mode, in which modes the processor consumes less energy compared to when it is in the operating mode.

[0028] According to a further example, the electronic circuit can be switched from the operating mode or the active mode to the non - active mode by releasing one or both of the first operating element and the second operating element.

[0029] Typically, the first actuating element and the second actuating element are arranged on the handle part such that the intended use of the auxiliary device or the infusion device and the user are always in contact with the first actuating element and the second actuating element. Typically, after the user has completed the dosage injection procedure, the user releases at least one or both of the first actuating element and the second actuating element. Here, an electronic circuit having a first actuating element and an optional second actuating element can provide an automatic switch-off of the electronic circuit to an automatic inactive mode when at least one or both of the first actuating elements are no longer actuated, and thus can provide a fairly automatic switch-off of the electronic circuit to the inactive mode. In this way, the electrical energy and thus the power provided by the power supply of the auxiliary device can be saved. In this way, the service life of the power supply of the auxiliary device, such as a battery, can be extended.

[0030] According to a further example, the first actuating element includes a first switch. Also, the second actuating element may include a second switch. The switch may be manually actuated by the user, for example, during the process of gripping the handle part of the main body of the auxiliary device. The implementation of each switch is fairly straightforward and simple. A mechanical or electromechanical switch can also provide tactile feedback to the user when actuated.

[0031] According to a further example, at least one of the first and second switches can be electrically connected to a processor and a power supply. One terminal of such a switch may be connected to the processor. Another terminal of each switch may be connected to the power supply. To that extent, power may be supplied to the processor and may be activated to provide the intended operation by closing each switch.

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

[0033] Logic and gates can also be implemented together with electronic circuits. Therefore, an electronic circuit may include AND gates, each operable by a first and second actuation element. Such AND gates may further be integrated into a processor. Each terminal of an AND gate may be selectively operable by a user of an auxiliary or injection device.

[0034] In a further example, the handle portion of the body of the auxiliary device includes a distally facing gripping surface. The first actuation element is positioned on the distally facing gripping surface. In this context, the distal direction extends or is oriented toward the injection end of the infusion device and therefore toward the biological tissue punctured by the injection needle of the infusion device. Thus, the proximal direction faces opposite to the distal direction.

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

[0036] By positioning the first actuation element on the distal gripping surface of the handle, the first actuation element may be automatically actuated by the user when providing or applying a counterforce to the auxiliary device in the process of pushing the stopper of the barrel of the infusion device distally in order to inject a drug. In this way, by providing the first actuation element on the distal gripping surface, the auxiliary device may be automatically actuated by the user when the user intends to use the auxiliary device in conjunction with the infusion device to set and / or inject a drug dose.

[0037] In further examples, the handle portion includes a gripping flange protruding from the fastening structure or body of the auxiliary device. The first and second actuation elements are typically provided on distally facing gripping surfaces extending on both sides of the fastening structure or body of the auxiliary device. Here, the first actuation element may be provided on a first portion of the gripping flange extending outward along a first radial direction from the fastening structure or body. The second actuation element may be provided on a second portion of the gripping flange extending radially opposite to the first portion of the gripping flange. It may extend along a second radial direction opposite to the first radial direction.

[0038] Having first and second actuation elements on a common distal-facing gripping surface, but located on radially outward-extending flange portions opposite the diametrically opposed portion of the gripping flange, the first and second actuation elements can be intuitively actuated by the user when using the gripping flange for and / or to hold an auxiliary device during an injection procedure.

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

[0040] In a further example, the body of the auxiliary device includes a through-hole made to be sized to penetrate and receive at least a portion of the infusion device. The receptacle and / or through-hole of the body of the auxiliary device may include at least one longitudinal contact portion so that the infusion device can be fixed to the body, at least longitudinally, when received into the receptacle and / or through-hole. Here, when the infusion device is implemented, for example, as a syringe or safety syringe, flange portions projecting radially outward from each syringe or syringe body may longitudinally abut or engage with the respective stop surfaces provided on or within the receptacle or through-hole of the body of the auxiliary device.

[0041] In a further example, the fastening structure of the main body includes mechanical coding that mates with a complementary mechanical counter-coding of the injection device. In injection devices with an elongated and rather radially symmetrical shape, such as a syringe or tubular barrel, syringe body, or similar injection device including a housing, a receptacle or through-port provided on or within the body of the auxiliary device may generally be operable to receive the injection device therein in any orientation with respect to the longitudinal axis of the injection device as the axis of rotation. Here, for example, mechanical coding on the edge or inside of the receptacle or through-port for mating with a complementary mechanical counter-coding provided on the outward-facing surface of the injection device can provide a clear, and therefore distinct, mutual fastening or positioning and mounting of the injection device to the fastening structure, and thus to the body of the auxiliary device.

[0042] In this way, the infusion device may be attached to or mounted on the auxiliary device in one or a limited number of clearly defined relative orientations, thereby improving patient safety and proper handling of the infusion device in relation to the auxiliary device.

[0043] In a further example, the auxiliary device includes a first sensor operable to detect at least one of the position and movement of the plunger or stopper of the injection device relative to the barrel, housing, or shield or needle guard 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 first sensor can automatically detect the configuration or operation of the injection device. It can be detected, monitored, or quantitatively measured.

[0044] Typically, the first sensor is part of an electronic circuit. The first sensor may be operably connected to a processor. The sensor signal provided by the sensor is typically processable by the processor to detect the configuration or operating state of an injection device.

[0045] In another example, the auxiliary device also includes a second sensor operable to detect at least one of the position and movement of the plunger or stopper of the injection device relative to one of the barrel, housing, shield, and needle guard of the injection device when the auxiliary device is fastened to the injection device. The second sensor can detect, monitor, or quantitatively measure further configuration or further operating conditions 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 infusion device, for example, before infusing a drug dose. The second sensor may be particularly operable to detect a second configuration or a second operating state of the infusion device, for example, after the completion of a dose infusion procedure.

[0047] To that extent, the first and second sensors can accurately detect at least two different configurations and / or two different operations of the same infusion device. In this way, for example, the first sensor may detect the start of an infusion procedure, and the second sensor may detect the end or completion of a dose infusion procedure.

[0048] Providing a first sensor and a second sensor also provides redundancy in the auxiliary device's functions. If one of the first or second sensor fails, the other sensor can still provide its respective sensor data indicating the configuration or operating status of the injection device.

[0049] However, the first and second sensors can accurately detect or monitor different specific configurations or operating states of the injection device.

[0050] In another example, the first and second sensors are positioned offset with respect to the longitudinal direction of the injection device. Thus, the first sensor may be implemented as a proximal sensor, the second sensor as a distal sensor, or vice versa. The first sensor may indicate the proximal position of the plunger or stopper relative to the barrel, housing, and / or shield of the injection device. Similarly, the second sensor may be operable to generate a sensor signal indicating the distal position of the plunger or stopper of the injection device relative to one of the barrel, housing, and the shield or needle guard of the injection device.

[0051] The first and second sensors, positioned longitudinally offset from each other, are particularly useful in single-use injection devices, such as pre-filled syringes or pre-filled safety syringes. Here, the plunger or stopper of the injection device undergoes a single, typically single, distally directed movement relative to the barrel, housing, and / or shield of the injection device. Thus, after the completion of injection, the configuration of the injection device is distinguished from the configuration of the injection device before dose setting or injection.

[0052] In further examples, the auxiliary device includes a third sensor operable to detect at least one of the presence, position, and movement of the protective cap of the injection device when the auxiliary device is fastened or attached to the injection device. In some examples, the injection device may have a protective cap, for example, a protective cap that covers or encloses an injection needle. Typically, the protective cap needs to be removed before injection to expose the distal end of the injection needle. Typically, the third sensor is operationally connected to a processor and operable to generate and transmit respective sensor signals indicating the presence, and therefore the position and / or movement, of the protective cap to the processor.

[0053] A third sensor can detect whether a protective cap is initially present and / or whether it has been properly removed from the injection device before the injection procedure is performed. Each sensor signal provided by at least one of the first, second, and third sensors is typically processed by a processor in an auxiliary device. Each signal processing can determine whether the user is using the injection device correctly.

[0054] In some examples, the electronic circuit includes a detection unit, which is operablely connected to a processor and further connected to ours, and includes at least one of a first sensor, a second sensor, and a third sensor. The detection unit may provide preprocessing of the signals generated by the individual sensors. The detection unit can further control the operation of the various sensors.

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

[0056] In further examples, the first and second sensors are of the same sensor type. Therefore, the first and second sensors can operate on the same sensor principle. The third sensor can be implemented in many different ways. 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 are of the same sensor type. In some examples, at least one of the sensors is implemented as one of the electrical contact sensors, as a capacitive sensor, as a magnetic sensor, or as 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 beneficial 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. This could include a photosensitive detector such as a photodiode. Such optical sensors can be easily incorporated into electronic circuits in a fairly cost-effective manner. They allow for fairly compact designs of electronic circuits and can operate at relatively low power levels.

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

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

[0060] The optical sensor can be implemented as an optical switch. The optical sensor can be implemented to continuously detect the light intensity reflected from the components of the injection device. As soon as each component of the injection device, such as a plunger, stopper, barrel, housing, or shield, undergoes displacement, the optical sensor can record the respective corrections of transmitted or reflected light from the movable component, and thus detect the positional variation or movement of each component of the device.

[0061] In a further example, the first sensor includes a first light source, where the photodetector of the first sensor may be highly sensitive to wavelengths in the spectrum of the first light source. The first light source may be directed towards or onto a detectable component of the injection device, such as a plunger, stopper, barrel, housing, shield, or needle guard of the injection device.

[0062] In a further example, the first light source is aligned with a first dedicated portion of the injection device, i.e., a dedicated portion of a selected or dedicated component of the injection device, if the injection device is correctly or appropriately mounted to the body.

[0063] The first light source is operable to illuminate a dedicated portion of the injection device. For example, if the first light source operates in the visible spectral range, correct alignment or positioning of the injection device and auxiliary devices may result in alignment of the first light source with the dedicated portion or component of the injection device, which can then be illuminated by the radiation produced by the first light source. Such illumination of the dedicated portion or component of the injection device can assist the user when using the injection device. In some examples, the dedicated portion or component of the injection device may be translucent or transparent. Thus, the illumination provided by the first light source can be immediately seen by the users of the auxiliary device and the injection device.

[0064] In a further example of an 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, the second wavelength being distinct from or different from the first wavelength of electromagnetic radiation generated, emitted, or transmitted by the first light source. Typically, the photodetector of the second optical sensor is susceptible to the spectrum or wavelength of radiation generated by the second light source.

[0065] If the wavelengths of the first light source and the wavelength of the second light source are distinguishable, and the sensitivity of the photodetectors of the first and second optical sensors changes accordingly, it is possible to provide 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. The first and second sensors may then be insensitive to radiation provided or emitted by the other light source.

[0066] By making the first and second wavelengths substantially distinct from each other, crosstalk between the first optical sensor and the second optical sensor can be avoided.

[0067] In another example, when the injection device is properly mounted to the body of the auxiliary device, the second light source may be aligned with a second dedicated portion or component of the injection device. The second light source is operable to illuminate the dedicated portion or component of the injection device in the same or similar manner as described above in relation to the first light source. By operating in the visible spectral range, the first and second light sources may provide different colors that can be distinguished by the user of the auxiliary device.

[0068] Therefore, optical sensors having such light sources can be used not only to detect one of the positions and movements of dedicated parts or components of the injection device, but also to illuminate dedicated parts or selected parts or components of the injection device with the same or different colors, thereby to instruct or assist the user when using the auxiliary device and / or the injection device.

[0069] In a further example, at least one of the first and second light sources is operable to produce variable-color visible light. Typically, the optical sensor is operablely connected to a processor in an electronic circuit. Thus, the operation of the optical sensor having each of those light sources can be controlled by the processor. In the case of variable-color light sources, the processor may be further operable to select wavelengths and / or to operate each light source to emit electromagnetic radiation of the selected or selectable color.

[0070] Using different colors, such as red, green, blue, or yellow, can be particularly beneficial to illuminate dedicated parts or components of an injection device, thereby assisting the user in using the auxiliary device. For example, a dedicated part or component of an injection device illuminated in green may indicate to the user that the auxiliary device and / or injection device is ready for use. The illumination of the same or a different dedicated part or component of the injection device may be in a different color, such as blue or red, to indicate to the user that, for example, the auxiliary device or injection device cannot or should not be used again.

[0071] In a further example, a first sensor of an auxiliary device is sensitive to electromagnetic radiation of a first wavelength, and a second sensor is sensitive to electromagnetic radiation of a second wavelength. The first and second wavelengths include different and / or at least non-overlapping spectral ranges. Thus, a first optical sensor having a first light source can operate at the first wavelength, and a second optical sensor having a second light source can operate at a second wavelength that is measurably distinct from the first wavelength.

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

[0073] Typically, the processor can be configured to combine a first sensor signal with a clock signal that is simultaneous with the first sensor signal, and to store the combination of the clock signal and the first sensor signal in memory. In this way, a timestamp can be provided for the first sensor signal, and each piece of data stored in memory indicates the time when the first sensor signal was generated or processed.

[0074] In a further example, the processor can be configured to process a second sensor signal from a second sensor, which indicates a second configuration or operating state of the injection device. Furthermore, the processor can be configured to store the second sensor signal and the clock signal in memory in the form of electronic and / or digital data. To that extent, the processor can be configured to combine the clock signal or timestamp with sensor signals obtainable from the first and second sensors, respectively.

[0075] The first configuration or operating state may indicate the start of an injection procedure. A second configuration or operating state of the injection device, detectable by the second sensor, may indicate the end or completion of each injection procedure.

[0076] In this way, by storing each sensor signal in memory simultaneously with the clock signal, it is possible to provide a medication history indicating the start and end of the injection procedure.

[0077] In further examples, the generation or processing of one of the first and second sensor signals may also trigger the recording or storage of the respective clock signals. This may be particularly true for such auxiliary and injection devices, where the injection device can be used only once and is capable of injecting a fixed-size dose. Here, repeated use of an injection device or several injection devices of the same type may only require recording the point in time when the injection procedure was successfully completed.

[0078] In a further example, the processor can be operated 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. Here, the processor can be operated to generate at least one of a warning signal and an instruction signal if the time interval between the generation of the first clock signal and the generation of the second clock signal is greater than a predetermined time interval. In this way, the electronic circuit, and therefore the processor, can be operated to verify whether the first and second sensor signals are generated within a predetermined time interval. With the intended and correct use of the injection device, the respective first and second sensor signals may be generated or provided, for example, at the start and completion of a dose injection procedure. If the time interval between the generation or recording of the first and second sensor signals, and therefore the generation or recording of the respective first and second clock signals, is greater than a predetermined time interval, this may be an indicator that the injection procedure has not been successfully completed or that the injection procedure has not been performed or carried out correctly.

[0079] Warning signals or instruction signals may be further processed to generate at least one of visual, audible, and / or tactile warnings. Warning generation may be provided by the electronic circuitry of an auxiliary device, which may include respective warning generation hardware such as a visual indicator, a speaker, or a vibration unit.

[0080] In some examples, such warning signals may be transmitted to an external electronic device, such as a smartwatch, smartphone, or tablet computer, via, for example, a first transceiver, and the external electronic device may have its own hardware for generating the respective audible, visual, or tactile warning or instruction signal.

[0081] In a further example, the first transceiver can be operated to transmit or exchange data with an external electronic device. In this way, the auxiliary device may not have any signaling device or hardware, but may simply be operated to communicate with an external electronic device to utilize its respective input and output devices, or with the respective input and output hardware of an external electronic device to communicate with the user of the auxiliary device or injection device.

[0082] The first transceiver may be implemented as a wireless transceiver. The wireless transceiver may be configured to transmit and / or receive radio frequency signals. In particular, the wireless transceiver may be capable of operating to communicate with external electronic devices in accordance with established communication standards such as Bluetooth, Bluetooth Low Energy (BLW), or Wi-Fi standards.

[0083] In a further example, the auxiliary device includes a second transceiver operable to read an electronic identifier provided on or within the injection device. The second transceiver may also belong to the electronic circuitry. The first and second transceivers may be operablely connected to a processor. The first and / or second transceivers may be controllable by the processor of the auxiliary device's electronic circuitry. The second transceiver is particularly operable to read electronic information, and therefore an electronic identifier provided on or within the injection device.

[0084] The second transceiver may be implemented as a wireless transceiver. It may be wirelessly connected to the electronic identifier of the infusion device. The electronic identifier may contain information about the drug. The information stored in the electronic identifier may include at least one of the following: the name of the drug, the name of the medicinal substance of the drug, the concentration of the drug, the batch number, the lot number, the date of manufacture, the manufacturing site or place of manufacture, the expiration date, and / or the temperature at which the drug should or was stored.

[0085] The electronic identifier provided on or within the injection device may include an electronic tag. The electronic identifier may include one of RFID tags and NFC tags. The second transceiver of the auxiliary device may include a reader that is complementary to or implemented in conjunction with the electronic identifier provided on or within the injection device.

[0086] In a further example, the second transceiver comprises a near-field transceiver, while the first transceiver comprises a local-range transceiver. The transmission range of the first transceiver may be greater than that of the second transceiver. Furthermore, correct reading of the electronic identifier of the injection device may require correct mutual assembly, mounting, or fastening of the auxiliary device and the injection device. For this purpose, mechanical coding and complementary shaped mechanical counter coding provided on or within the fastening structure and the injection device may be configured so that good mutual fastening and mounting of the auxiliary device and the injection device is accompanied by the correct intended orientation of the electronic identifier of the injection device with respect to the second transceiver of the auxiliary device.

[0087] An auxiliary device including a first transceiver and a second transceiver may operate or provide a relay station for wireless transmission between an external electronic device of a user intended to utilize the auxiliary device and the injection device and the electronic identifier of the injection device. An electronic circuit comprising the first transceiver and the second transceiver may be operated to read at least a portion of the information stored in the electronic identifier of the injection device and transmit the respective information to the external electronic device via the first transceiver. Since the first transceiver includes a transmission range that exceeds the transmission range of the second transceiver, the auxiliary device may be operated to provide a kind of range extender for wireless data transmission between the electronic identifier and the external electronic device.

[0088] Therefore, in a further example, the electronic circuit can be configured to read identification data of the electronic identifier of the injection device via a second transceiver and transmit the identification data to an external electronic device via a first transceiver.

[0089] In a further example, the auxiliary device includes an indicator for aligning with a visual identifier provided on or within the injection device when the injection device is properly fastened or assembled to the body of the auxiliary device. The indicator corresponds to or interacts with the visual identifier, enabling the user to visually see information through the visual identifier.

[0090] In some examples, a visual identifier provided on or within an injection device is or includes a light guide or light guide structure that can be operated or illuminated by an indicator of an auxiliary device. Here, the indicator may include a light source that is operably connected to and operable by a processor. If the injection device and the auxiliary device are properly assembled and / or mounted to each other, the light source of the indicator may at least partially overlap with the visual identifier and illuminate the visual identifier, and this illumination may be directly visible in the portion of the injection device not obstructed by the auxiliary device.

[0091] In some examples, the visual identifier of an injection device may include at least one longitudinal stripe extending in the longitudinal direction. One end of the longitudinal stride may overlap with a light source or indicator or light source of an auxiliary device, which, when activated, may induce a visible light signal propagating through the injection device and obscure the visual identifier of the injection device. The light source of the indicator may be a single-color or multi-color light source such as a light-emitting diode (LED).

[0092] In another embodiment, the disclosure also relates to an infusion system. The infusion system includes an infusion device. The infusion device includes a barrel filled with a drug and sealed proximal to a stopper. The stopper is movable distal to the barrel to discharge the drug through the barrel outlet. Typically, the barrel outlet is in fluid communication with an infusion needle. In some examples, the infusion needle is connected to the barrel outlet or constitutes or contributes to the barrel outlet. Typically, the outlet is located at the distal end of the barrel.

[0093] The infusion system further includes auxiliary devices as described above. In some examples, the infusion device and auxiliary devices are fixed and assembled together. In other examples, the infusion system is provided as a kit, and the infusion device and auxiliary devices are provided separately, either unconnected or disassembled. Here, the user or healthcare professional may assemble or attach the auxiliary devices to the infusion device, and vice versa.

[0094] Since the injection device includes the auxiliary devices described above, all the features, effects, and advantages described above in relation to the auxiliary devices apply equally to the injection system, and vice versa.

[0095] In further examples of infusion systems, the infusion device is a pre-filled syringe or a pre-filled safety syringe. In even further examples, the infusion device is a pre-filled infusion pen. In even further examples, the infusion device is a reusable device. In even further examples, the infusion device is a disposable device, which is discarded entirely after use.

[0096] In another aspect, the disclosure relates to a method for monitoring the use of an infusion device or an infusion system preparation for infusing a drug. The method includes the steps of providing an infusion device and an auxiliary device, which are operable to infuse a drug, as described above. The method further includes the step of activating an electronic circuit of the auxiliary device by activating a first actuation element. In some examples, the method is applicable to an auxiliary device as described above, which features or includes a second actuation element that is operably connected to the electronic circuit and operable to activate the electronic circuit. Activating the electronic circuit may then include activating the first actuation element during a first time interval and activating the second actuation element during a second time interval, where the first and second time intervals overlap at least partially in the time domain.

[0097] In other words, activating an electronic circuit involves activating the first and second actuation elements substantially simultaneously, or activating at least the first and second actuation elements over or during overlapping time intervals.

[0098] In another example, the method further includes deactivating an electronic circuit, and thus switching the electronic circuit to an inactive mode. Here, at least one of the first and second operating elements is released, and as a result, the electronic circuit is switched to an inactive mode, in which the auxiliary device consumes no power or a reduced amount of power compared to its operating mode.

[0099] In another independent embodiment, for example according to a second embodiment, the disclosure relates to an auxiliary device for an injection device. The auxiliary device includes a body, which includes a fastening structure for detachably fastening to the injection device.

[0100] The auxiliary device includes an electronic circuit including a processor. The electronic circuit further comprises a first sensor and a second sensor. The first sensor and the second sensor are operably connected to the processor of the electronic circuit. The first sensor is operable to detect at least one of the position and movement of the plunger or stopper of the injection device relative to one of the barrel, housing, and shield or needle guard of the injection device when the auxiliary device is fastened to the injection device.

[0101] In a further example, a second sensor may be operable to detect at least one of the position and movement of the plunger or stopper of the injection device relative to one of the barrel, housing, and shield or needle guard of the injection device when the auxiliary device is fastened to the injection device.

[0102] Typically, the first sensor is operable to detect a first configuration or first operating state of the injection device when fastened to an auxiliary device. Correspondingly, the second sensor is operable to detect a second configuration or second operating state of the injection device when properly fastened to an auxiliary device.

[0103] Separately, the first and second sensors may be implemented in the manner described above, together with auxiliary devices and injection systems. The first and second sensors may include optical sensors or, for example, a dedicated first or second light source.

[0104] Furthermore, the optical sensor may be aligned with a first or second dedicated portion or component of the injection device. At least one light source of each of the first and second sensors may be operable to illuminate the respective dedicated portion or component of the injection device. The first and second sensors of the auxiliary device may be implemented in the manner described in more detail above. Here, in contrast to the auxiliary device described above, the second embodiment of the auxiliary device may lack the first actuation element and / or an optional second actuation element. In other words, in the second embodiment of the auxiliary device, the first and second actuation elements described above may be simply optional.

[0105] Generally, the scope of this disclosure is defined by the claims. The injection systems, auxiliary devices and / or injection devices, and their respective methods described herein are not limited to specific embodiments or examples, but include any combination of elements of different embodiments or examples. To that extent, this disclosure covers any combination of claims and any technically feasible combination of features disclosed in relation to different examples or embodiments.

[0106] In this context, the terms “distal” or “distal end” refer to the end of the injection device facing the injection site in a human or animal. The terms “proximal” or “proximal end” refer to the end of the injection device opposite to the injection site in a human or animal.

[0107] The terms “drug” or “pharmaceutical” are used herein as synonyms and refer to a formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. A pharmacopoeial active ingredient ("API") is, in its broadest sense, a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or pharmaceuticals are used to treat, cure, prevent or diagnose diseases, or otherwise to improve physical or mental health. Drugs or pharmaceuticals may be used over a limited period or, in the case of chronic diseases, regularly.

[0108] As described below, drugs or pharmaceuticals may contain at least one API or combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs include small molecules with molecular weights of 500 Da or less, polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids or liposomes. Mixtures of one or more drugs are also possible.

[0109] Drugs or pharmaceuticals may be contained within a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other robust or flexible vessel configured to provide a chamber suitable for storing one or more drugs (e.g., short-term or long-term storage). For example, in some cases, the chamber may be designed to store drugs for at least one day (e.g., one day to at least 30 days). In some cases, the chamber may be designed to store drugs for about one month to about two years. Storage may be carried out at room temperature (e.g., about 20°C) or refrigerated temperature (e.g., about -4°C to about 4°C). In some cases, the drug container may be or include a dual-chamber cartridge configured to store two or more components of a pharmaceutical preparation to be administered (e.g., an API and a diluent, or two different drugs) separately in each chamber. In such cases, the two chambers of the dual-chamber cartridge may be configured to allow mixing of two or more components before and / or during administration to the body of a human or animal. For example, the two chambers may be configured to be in fluid communication with each other (e.g., by a conduit between the two chambers), allowing the two components to be mixed if desired by the user before administration. Alternatively or additionally, the two chambers may be configured to allow mixing when the components are administered into the body of a human or animal.

[0110] Drugs or agents contained in drug delivery devices as described herein may be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes mellitus or complications associated with diabetes mellitus, such as diabetic retinopathy, and thromboembolic disorders such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders include acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are listed in the Rote Liste 2014, for example, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and handbooks such as the Merck Index, 15th edition.

[0111] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes mellitus or complications thereof include insulin, e.g., human insulin, or insulin analogs or derivatives; glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or their analogs or derivatives; dipeptidyl peptidase-4 (DPP4) inhibitors; or pharmaceutically acceptable salts or solvated compounds thereof; or any mixture thereof. As used herein, the terms “analog” and “derivative” refer to polypeptides having a molecular structure that can be formally derived from the structure of a spontaneously occurring peptide, e.g., the structure of human insulin, by deleting and / or replacing at least one amino acid residue occurring in the spontaneously occurring peptide, and / or by adding at least one amino acid residue. The amino acid residue added and / or replaced may be a coding amino acid residue, another spontaneously occurring residue, or a purely synthetic amino acid residue. Insulin analogs are also referred to as “insulin receptor ligands.” In particular, the term "derivative" refers to a polypeptide having a molecular structure that can be formally derived from the structure of a naturally occurring peptide, such as the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are bonded to one or more amino acids. Optionally, one or more amino acids present in the naturally occurring peptide may be substituted with other amino acids, including deletions and / or non-coding amino acids, or amino acids, including non-coding amino acids, may be added to the naturally occurring peptide.

[0112] Examples of insulin analogs include Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glardine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which proline at position B28 may be replaced with Asp, Lys, Leu, Val or Ala, and Lys at position B29 may be replaced with Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0113] Examples of insulin derivatives include, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin These are B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-litocoryl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0114] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (Exendin-4, Byetta®, Bydureon®), and Hiramonster (Gila Monster's salivary glands produce a 39-amino acid peptide, liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), r-exendin-4, CJC-1134-PC, PB-1023, TTP-054, langlenatide / HM-11260C (efpeglenatide), HM-15211, CM-3, GLP-1 eligene, ORMD-0901, NN-9423, NN-9709, NN-9924, NN These include -9926, NN-9927, Nodexene, Biador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodotide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Chilzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-XTEN.

[0115] Examples of oligonucleotides include mipomersen sodium (Kynamro®), a cholesterol-lowering antisense drug for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport syndrome. Examples of DPP4 inhibitors include linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0116] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides such as gonadotropins (follitropin, lutropin, choriongonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadrelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin, and their antagonists.

[0117] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or very low molecular weight heparin, or their derivatives, or polysulfated forms, such as sulfated forms of the above polysaccharides and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives are Hylan GF 20 (Synvisc®) and sodium hyaluronate.

[0118] As used herein, the term “antibody” refers to an immunoglobulin molecule or its antigen-binding region. Examples of antigen-binding regions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain antigen-binding ability. Antibodies may be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, immunized or humanized antibodies, fully human antibodies, non-human (e.g., mouse) antibodies, or single-chain antibodies. In some embodiments, antibodies may have effector function and be capable of immobilizing complement. In some embodiments, antibodies may have reduced or no ability to bind to Fc receptors. For example, an antibody may be an isotype or subtype, antibody fragment, or mutant having mutations or deletions in the Fc receptor-binding region that do not support binding to the Fc receptor, for example. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulin (TBTI) and / or bivariable region antibody-like binding proteins having crossover binding region orientation (CODV).

[0119] The terms “fragment” or “antibody fragment” refer to polypeptides derived from antibody polypeptide molecules (e.g., antibody heavy and / or light chain polypeptides) that do not contain the full-length antibody polypeptide but still contain at least a portion of a full-length antibody polypeptide capable of binding to an antigen. Antibody fragments may include cleavage portions of full-length antibody polypeptides, but the term is not limited to such cleavage fragments. Examples of antibody fragments useful in the present invention include Fab fragments, F(ab')2 fragments, scFv (single-stranded Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, e.g., bispecific, trispecific, quadrispecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, e.g., bivalent, trivalent, quadrivalent and multivalent antibodies, minibodies, chelated recombinant antibodies, tribodies or vibodies, intrabodies, nanobodies, small module immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0120] The term "complementarity-determining region," or "CDR," refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term "framework region," rather than the CDR sequence itself, refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for maintaining the proper arrangement of the CDR sequence to enable antigen binding. While the framework region itself typically does not directly participate in antigen binding, as is well known in the industry, specific residues within the framework region of a particular antibody can directly participate in antigen binding or influence the interaction ability of one or more amino acids in the CDR with the antigen.

[0121] Examples of antibodies include anti-PCSK-9 mAbs (e.g., alirocumab), anti-IL-6 mAbs (e.g., sarilumab), and anti-IL-4 mAbs (e.g., dupilumab).

[0122] Any pharmaceutically acceptable salt of any API described herein is intended for use with drugs or pharmaceuticals in drug delivery devices. Examples of pharmaceutically acceptable salts include acid addition salts and basic salts.

[0123] Those skilled in the art will understand that modifications (additions and / or deletions) of various components of the APIs, formulations, apparatus, methods, systems, and embodiments described herein may be made without departing from the full scope and spirit of the invention, including such modifications and all their equivalents.

[0124] Exemplary drug delivery devices may include needle-based infusion systems, such as those described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based infusion systems can be broadly classified into multi-dose container systems and single-dose (with partial or full discharge) container systems. Containers may be replaceable or integrated non-replaceable containers.

[0125] As further described in ISO 11608-1:2014(E), a multi-dose container system may include a needle-based infusion device with replaceable containers. In such a system, each container holds multiple doses, and its size may be fixed or variable (pre-configured by the user). Another multi-dose container system may involve a needle-based infusion device with an integrated non-replaceable container. In such a system, each container holds multiple doses, and its size may be fixed or variable (pre-configured by the user).

[0126] As further described in ISO 11608-1:2014(E), a single-dose container system may involve a needle-based infusion device with replaceable containers. In one example of such a system, each container holds a single dose, and the entire deliverable volume is dispensed (total discharge). In a further example, each container holds a single dose, and a portion of the deliverable volume is dispensed (partial discharge). As also described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based infusion device with an integrated, non-replaceable container. In one example of such a system, each container holds a single dose, and the entire deliverable volume is dispensed (total discharge). In a further example, each container holds a single dose, and a portion of the deliverable volume is dispensed (partial discharge).

[0127] Below, 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 drawings. [Brief explanation of the drawing]

[0128] [Figure 1] An example of an injection system including auxiliary devices and injection devices is shown. [Figure 2] Figure 1 shows an example of the auxiliary device attached to the injection device before the injection procedure is performed. [Figure 3] Figure 2 describes the infusion system after the completion of the dose infusion procedure. [Figure 4] Figure 3 shows the configuration of the injection system after the needle has retracted into the housing of the injection device. [Figure 5] Figure 2 schematically shows a longitudinal cross-section passing through the injection device with the configuration shown. [Figure 6] Figure 5 shows a longitudinal cross-section of the device corresponding to the situation in Figure 3. [Figure 7] This shows a further longitudinal cross-section through the injection system after the needle has retracted into the housing of the injection device. [Figure 8]A perspective view of the fastening structure of the auxiliary device is shown. [Figure 9] Figure 8 shows a perspective view of the auxiliary device from below. [Figure 10] This provides a schematic representation of the injection system's configuration when operated by the user. [Figure 11] This diagram schematically illustrates data exchange between external electronic devices and auxiliary devices. [Figure 12] Another example of an auxiliary device suitable for use with an injection device is schematically shown below. [Figure 13] A block diagram of an example of an external electronic device is shown. [Figure 14] This is a flowchart showing how to monitor the use of an injection device by utilizing an auxiliary device. [Modes for carrying out the invention]

[0129] Figures 1-7, shown sequentially, schematically illustrate a scenario in which an infusion device 1 with an auxiliary device 50 is used. In the illustrated example, the infusion device 1 includes a type of syringe, for example, implemented as a safety syringe. The infusion device 1 includes a barrel 10 filled with a liquid injectable agent 8. The barrel 10 is sealed by a stopper 9 that is movable distally 2 relative to the barrel 10 in the proximal longitudinal direction 3. The barrel 10 may be cylindrical. It may have an outlet 14 at its distal end, and the outlet 14 may be provided with an infusion needle 15 fixed to the outlet 14 of the barrel 10. Towards the proximal end or proximal direction 3, the barrel 10 terminates with a radially outward-extending or projecting flange portion 17, which, if the infusion device is conventional, can be used as a finger grip for the user's index and middle fingers to properly hold the syringe, and the user can press a plunger 20 projecting proximally from the barrel 10 with the thumb 5 of the same hand 4.

[0130] The stopper 9 may be integrally formed with a longitudinally extending plunger 20. The plunger 20 may include an elongated rod extending in the longitudinal direction (z). In some examples, the stopper 9 and the plunger 20 may be provided as separate parts. Here, the plunger 20 may be used to act distally on the stopper 9 to move the stopper distally 2 relative to the barrel 10, thereby releasing a well-defined amount of liquid drug 8 into the living tissue through the outlet 14 when the injection needle 15 penetrates or punctures the tissue. The stopper 9 may include an elastomer material for hermetically sealing the inside of the barrel 10.

[0131] The proximal end of the plunger 20 is typically provided with a radially flared plunger flange 21. The plunger flange 21 is typically configured to be pressed down by the user's thumb 5, for example, as shown in Figure 10. In the examples of Figures 1-7, the injection device 1 is implemented as a safety syringe. The injection device 1 is provided with a housing 11 having a substantially elongated or tubular shape. The housing 11 is made to accommodate the barrel 10 and a spring element 27. The spring element 27 is operably engaged with the housing 11 and the barrel 10. The spring element 27 may be configured to induce relative longitudinal motion between the barrel 10 and the housing 11, in particular upon completion of the dose injection procedure.

[0132] The barrel 10 may be fixed against longitudinal movement relative to the housing 11 by an interlock 24. In the example shown in Figure 6, the interlock 24 is located at or near the proximal end of the barrel 10 or the housing 11. The housing 11 may also be sleeve-shaped and includes a counter-latch element 26 that releasably engages with a latch element 25 provided on the barrel 10. The latch element 25 and the counter-latch element 26 are initially engaged, thereby preventing or locking longitudinal displacement of the barrel 10 relative to the housing 11.

[0133] Only when the plunger 10 reaches the distal end configuration does the plunger flange 21 engage with the counter latch element 26, causing the counter latch element 26 to pivot and deform, allowing the latch element 25 to pass. When the latch element 25 is released from the counter latch element 26, the mechanical energy stored in the spring element 27 may be released, thus resulting in longitudinal movement or displacement of the barrel 10 relative to the housing 11.

[0134] As shown in Figure 7, the outlet 14 or needle 15, which initially protrudes from the distal end of the housing 11 and extends through a through-hole 28 provided on the distal end face of the housing 11, is retracted into the interior of the housing 11. Here, the injection device 1' is in a shielded or protected configuration, the injection device 1 is no longer usable, and the distally protruding tip of the injection needle 15 is protected by the housing 11.

[0135] As further shown in Figures 5 and 1 in the initial configuration, the outlet 14 and / or injection needle 15 may be protected or covered by a separate protective cap 16. Before performing the injection procedure, the protective cap 16 must be removed from the outlet 14 or needle 15. In the example shown herein, the counter latch element 26 may be located in or near the flange portion 18 extending radially outward from the housing 11. The flange portion 18 may have a shape complementary to the flange portion 17. The proximal end of the flange portion 18 and / or the proximal end of the housing 11 may further be provided with an inclined edge 23 configured to engage with the distally facing side or edge of the plunger flange 21 when the plunger 20 reaches the distal end position, as shown in Figure 6. When the plunger flange 21 contacts the inclined edge 23, the inclined edge 23, and therefore the counter latch element 26, is biased radially outward, thereby disengaging from the latch element 25, which may simply be provided by the flange portion 17 extending radially outward from the barrel 10.

[0136] Optionally, as is evident from the shielded configuration shown in Figure 4, for example, the syringe barrel 10 may be enclosed or mounted within the syringe carrier 13, which operably engages with the spring element 27. The syringe carrier 13 may provide a dedicated sliding function within the housing 11 and may house the barrel 10 inside.

[0137] The auxiliary device 50 is schematically shown separately in Figure 1 and Figures 8, 9, 11, and 12. The auxiliary device 50 includes a body 51 and a fastening structure 60, by which the body 51 can be removably 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 by the fastening structure 60. As shown in Figure 8, the fastening structure 60 includes a lateral contact portion 62 or a receptacle 61 having a contact structure. The receptacle 61 and the contact portion 62 are shaped and configured to receive a flange portion 18 having a distal contact surface 19 of the injection device 1, as shown in Figure 1.

[0138] The receptacle 61 may include a through-hole 63 for receiving a portion of the injection device 1, such as the distal portion, as is evident from Figures 2-4 or 10. Inside the receptacle 63, there may be a mechanical coding 59 that matches a mechanical counter coding 29 provided in or near the flange portion 18 of the housing 11 of the injection device 1. Here, the mechanical counter coding 29 may include flange portions 18', 18'' projecting radially outward, and the flange portions 18', 18'' may differ in size or shape to fit into the receptacle 61 in one or a limited number of selected predetermined orientations. For this purpose, the inner contact portion 62 of the receptacle 61 or each contact portion shoulder may have a shape complementary to the distal contact surface 19 of the flange portion 18. In this way, a clear mounting or fastening configuration can be provided for fastening or attaching the injection device 1 to the auxiliary device 50.

[0139] The main 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 provided on a gripping flange 72 that projects radially outward from the elongated structure of the main body 51 or barrel 10 when attached to the elongated injection device 1. Optionally, and as shown, for example in Figure 8, the main body 51 includes an elongated attachment 64 that aligns with the elongated housing 11 or barrel 10 of the injection device 1 when attached to the injection device 1.

[0140] As shown in Figures 2 and 3, the attachment 64 extends along the side wall of the housing 11. For example, as shown in Figure 9, the attachment 64 may be a slat-like profile and extend longitudinally from the side wall 78 of the receptacle 61. When the injection device 1 is assembled inside the receptacle 61 or through-hole 63, at least a portion of the side wall of the housing 11 of the injection device 1 extends along the inner side 78 of the attachment 64, the inner side facing the interior of the receptacle 61 or through-hole 63. When properly attached or fitted to the receptacle 61, the distal contact surface 19 of the flange portion 18 of the injection device 1 longitudinally contacts the proximal contact portions 62, 62', as shown in Figure 8. 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.

[0141] To inject a dose of drug 8, the user needs to apply distal pressure to the plunger flange 21, as shown in Figure 10. Here, the user typically uses two fingers, for example, the index finger 6 and middle finger 7 of the same hand 4, to provide a reaction force against the pressure applied by the thumb 5.

[0142] 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, may be substantially larger than the respective sizes of the flange portions 17, 18. The gripping surface 71 facing distal to the handle portion 70, and therefore the gripping flange 72, is provided with a first actuation element 75 and a second actuation element 70. The actuation elements 75, 76 may be implemented as electrical switches 77, 77'. The electrical switches 77, 77' may be operably connected to an actuation unit 88 of the electronic circuit 80 of the auxiliary device 50.

[0143] First and second sensors 65 and 66 are provided on the inner side wall 78 of the main body 51. For example, a transceiver 84 implemented as a second transceiver as described above may be further provided. Further sensors, namely a third sensor 37, may also be provided.

[0144] When the injection device 1 and the auxiliary device 50 are properly mounted or connected to each other, the first and second sensors 65 and 66 may be aligned with dedicated portions or components of the injection device 1. For example, and as shown in Figure 5, the first sensor 65 may be longitudinally aligned with a marking 22 provided on the plunger 20. The second sensor 66 may be aligned with the flange portion 17 and / or the respective syringe carriers 13 of the safety syringe. The first sensor 65 and the second sensor 66 may be implemented as optical sensors.

[0145] In an exemplary usage scenario, the first sensor 65 may be operable to detect the movement of the plunger 20 relative to the barrel 10 or housing 11. The first sensor 65 may be operable to generate a first sensor signal indicating that the marking 22 has left its initial position. Thus, the generation of each first sensor signal by the first sensor 65 indicates the start of the injection procedure.

[0146] The second sensor 66 may be operable to detect the position, presence, or movement of the barrel 10 or the respective syringe carrier 13 when the barrel 10 undergoes movement relative to the housing 11. The housing 11 remains fixed to the body 51 of the auxiliary device for the entire lifespan of the infusion device 1. Upon reaching the configuration shown in Figure 7, the movement of each characteristic or dedicated part of the barrel 10 and / or syringe carrier 13 can be detected by the second sensor 66. Thus, the electronic circuit 80 with the first and second sensors 65, 66 is operable to detect at least two different configurations or operating states of the infusion device.

[0147] In some examples, the second sensor 66 may also be implemented to detect the end position of the barrel 10 or syringe carrier 13 that is reached when the injection procedure is completed, for example, as shown in Figure 7.

[0148] In some examples, at least one of the first sensor 65 and the second sensor 66 is implemented as an optical sensor. Each sensor 65, 66 may include an optical detector 69, 69', as shown in the enlarged cross section of Figure 9. Along with each optical detector, each sensor 65, 66 may have its own or separate light source 68, 68'. Typically, the light sources 68, 68' are implemented as light-emitting diodes (LEDs).

[0149] 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, 69' or the wavelengths or spectra of the light produced by the light sources 68, 68' may be distinctly different. The same may be true for the sensitivity or responsiveness of the optical detectors 69, 69' of the respective optical sensors 65, 66. In one 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 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.

[0150] In some examples, the light sources 68, 68' of individual sensors 65, 66 are aligned with dedicated parts or components of the injection device 1 when the injection device 1 is attached to or assembled with the auxiliary device 50. Dedicated parts or components of the injection device 1, such as the barrel 10, housing 11, and shield 12 for the syringe carrier 13, may be at least partially provided or manufactured from a translucent or at least partially transparent material. By appropriately aligning the light sources 68, 68' with any of these components, illumination effects for each device component can be provided. Furthermore, if the first optical sensor 65 and the second optical sensor 66 operate in different non-overlapping spectral ranges, a variety of illumination effects can be provided to assist the user when operating the auxiliary device and / or the injection device.

[0151] In some examples, the first sensor 65 is longitudinally aligned with the plunger 20, or a marking 22 on the plunger 20, when the injection device 1 is in a first configuration or operating state, for example, as shown in Figure 5. Here, the injection device 1 is in a configuration or state prior to dose injection. In this configuration, the light source 68 of the first sensor 65 may be aligned with the plunger 20 to illuminate the plunger 20. In other examples and / or other configurations, the light source 68 of the first sensor 65 may be aligned with the barrel 10 or the housing 11, and the barrel 10 and / or the housing 11 may be at least partially transparent so that these components can be illuminated by the light source 68.

[0152] Simultaneously, light generated by the light source 68 and propagating toward, for example, the plunger 20 and / or the barrel 10 or housing 11 may be reflected by any of these components and captured by the optical detector 69. To that extent, the sensor 65, equipped with the light source 68 and the optical detector 69, can provide two functions. On the one hand, the combination of the light source 68 and the optical detector 69 may enable the detection of the presence or location of suitable light-reflecting components of the injection device 1, such as the plunger 20, the barrel 10, or any other movable component such as the stopper 9. On the other hand, the light source 68 may also be used to illuminate dedicated parts or components of the injection device 1. The light sources 68, 68' of the first sensor 65 and the second sensor 66 may be operable to emit electromagnetic radiation of different wavelengths or distinct electromagnetic spectra.

[0153] In this way, when the first and second optical sensors 65 and 66 need to be operated simultaneously, the degree of crosstalk can be minimized. Therefore, the optical detector 69 of the first optical sensor 65 may 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 may be substantially unresponsive to the radiation generated by the light source 68' of the second sensor 66.

[0154] 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. They may include polychromatic light sources that can be selectively operated to emit electromagnetic radiation in different and non-overlapping spectral ranges. In some examples, light sources 68, 68' may be operated to produce electromagnetic radiation in the visible range, e.g., blue, green, yellow, orange, and / or red, one or more of them.

[0155] Furthermore, since the optical sensors 65, 66 having these 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 illuminate a component or part of the injection device 1 with a first color at a first time point, and to remove the same or another component or part of the injection device 1 with a different color at a second time point. In some examples, when the injection device 1 is in a pre-use state or configuration as shown, for example, in Figure 2 or 5, at least one of the light sources 68, 68' can be operated to illuminate a part or component of the injection device 1 with, for example, a first color. In a different configuration, for example, as shown in Figure 7, when, for example, the second sensor 66 detects each of the second configurations or operating states of the injection device, each light source 68, 68' may be operated to remove the same or any other part or component of the injection device 1 with a different color, for example, red.

[0156] In this way, by illuminating selected or dedicated parts or components of the injection device 1, the user can be intuitively assisted when using the auxiliary device 50, the injection device 1, and / or the injection system 30.

[0157] Figure 10 schematically shows a typical usage scenario of the injection system 30. Figure 10 shows the injection device as shown in Figure 7, i.e., after use of the injection device 1 and after the injection needle 15 has retracted into the housing 11 of the injection device 1.

[0158] Before reaching the illustrated configuration, the user holds the injection system 30 with one hand, so that the index finger 6 and middle finger 7 of the user's hand 4 are in contact with the diametrically opposite portion of the gripping flange 72 of the body 51 of the auxiliary device 50. As shown in Figure 10, the tips of the fingers 6 and 7 are in direct contact with the first actuation element 75 and the second actuation element 76 shown in Figure 9. The gripping surface 71 faces distally, i.e., toward the distal end of the housing 11. Using the thumb 5, the user can apply distally directed pressure onto the plunger flange 21 of the plunger 20.

[0159] After the injection procedure as shown in Figure 10 is completed, the barrel 10 or syringe carrier 13 protrudes proximally from the proximal end of the body 51 because a spring 27 positioned between the barrel 10 and the housing 11 biases the barrel 10 in the proximal direction 3. Both the first actuation element 75 and the second actuation element 76 can be implemented as mechanical or electromechanical switches 77. Both switches 77, 77' may belong to an actuation unit 88 as schematically shown in the block diagram of the electronic circuit 80 in Figure 8.

[0160] The two switches 77, 77', and thus the first and second actuation elements 75, 76, may or may constitute a kind of logic AND gate. Thus, the first actuation element 75 and the second actuation element 76 can switch the electronic circuit 80 from inactive mode to operating mode. For this purpose, the actuation elements 75, 76 must be actuated simultaneously by manual operation. Actuation of only one of the actuation elements 75, 76 is insufficient to switch the electronic circuit 80 from inactive mode to operating mode.

[0161] When implemented as switches 77, 77', the switches may be arranged in series within the actuator unit 88. The actuator unit may be directly or indirectly connected to the processor 82 of the electronic circuit 80 and to a power supply 81 in the form of a battery, for example, which may be rechargeable. The actuator unit and / or two actuator elements 75, 76 may be connected to the processor 82 only or exclusively via the actuator unit 88. This means that as soon as one of the actuator elements 75, 76 is released by the user, the processor 82 or the processing unit of the electronic circuit 80 can be powered off, disconnected, or cut off from power.

[0162] In this way, the possibility of the electronic circuit 80 operating unintentionally and therefore carelessly, that is, the possibility of the user carelessly touching or pressing down only one of the operating elements 75 or 76, can be substantially reduced.

[0163] The electronic circuit 80 shown in Figure 8 further comprises a detection unit 87. The detection unit 87 includes at least one of sensors 65, 66. Optionally, the detection unit 87 also includes a third sensor 67 operable to detect the presence or location of the protective cap 16. The detection unit 87 is operablely connected to a processor 82.

[0164] The processor 82 is further connected to memory 85. The memory is digital memory. It may be implemented as volatile or non-volatile memory. The electronic circuit 80 further includes a clock 86. The clock 86 is operable to generate a clock signal indicating the date and / or time. In a typical use scenario, when the electronic circuit is in operating mode and the detection unit 87 detects at least one of the positions or movements of a dedicated device component indicating, for example, the start or completion of a dose-dosing procedure, the clock signal indicating a point in time may be used as a timestamp, along with each indication that a dose of a particular size has been administered. This dosing information may typically be stored in memory 85 along with the timestamp.

[0165] The processor 82 may be further configured to process different signals provided by the detection unit 87. In some examples, the first detector 65 may be operable to provide a first sensor signal, while the second sensor 66 may be operable to provide a second sensor signal. The first and second sensor signals may be processed by the processor 82. As a result, the processor 82 may be operable to determine whether the identified sensor signals match each other and belong to the same dose infusion event. Each dose infusion data may be generated and / or stored in memory 85 only when each consistency check is performed.

[0166] The electronic circuit 80 further includes a first transceiver 83 and a second transceiver 84. The transceivers 83 and 84 may be connected to a processor 82 and may provide communication with other electronic devices outside the electronic circuit 80. In some examples, the first transceiver 83 may be operable to transmit or exchange data with an external electronic device, as shown in Figure 11. The external electronic device 100 may be implemented as a smartphone. The external electronic device 100 may include a housing 101 and 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 may include a speaker and / or a haptic user interface. In addition, the external electronic device 100 may include a communication unit 106 operable to communicate with the first transceiver 83. In some examples, the first transceiver 83 may include a local range transceiver having a transmission range of several meters or tens of meters.

[0167] A further transceiver 84 is a short-range transceiver and is operable to exchange data with a complementary short-range electronic identifier 33 provided on the injection device 1. Typically, if the injection device 1 is properly positioned or fixed to the auxiliary device 50, the electronic identifier 33 may be in the vicinity of the second transceiver 84 and at least within the transmission range of the second transceiver 84.

[0168] The electronic identifier 33 may include electronic information or data such as the name of the drug, the name of the drug's medicinal substance, the drug's concentration, batch number, lot number, manufacturing date, manufacturing site or location, expiration date, and / or the temperature at which the drug should or was stored. Each piece of information or data is readable by the second transceiver 84. Each piece of data may be further processed by the processor 82 and transmitted to an external electronic device 100 via the first transceiver 83. In this way, the auxiliary device 50 can function as a range extender for reading the electronic identifier 33 of the injection device 1. Reading of the electronic identifier 33, which may be implemented as a near-field communication tag (NFC tag), may be provided by the second transceiver 84 of the auxiliary device 50. The information or data thus obtained can be further processed by the processor 82 and transmitted to an external electronic device 100 via the first transceiver 83.

[0169] In a further example as shown in Figure 12, the injection device 1 includes a visual identifier 34 which may be provided on the outer surface of the housing. When the injection device 1 is properly assembled with the auxiliary device 50, at least a portion of the visual identifier 34 may coincide with or overlap with an indicator 54 provided on the body 51 of the auxiliary device 50. The indicator 54 may be provided on the inside 78 of the body 51 facing outwards when the injection device 1 is properly assembled or attached to the auxiliary device 50.

[0170] As shown in Figure 12, the indicator 54 may be provided as a light source 55 capable of illuminating the visual identifier 34. The visual identifier 34 may include a longitudinally extending light guide 35 or a light guide structure 35 of any other shape or geometric shape. The visual identifier 34 may include a frosted surface of a frosted structure and may be capable of diffusely reflecting light emitted by the indicator 54 or the light source 55.

[0171] The indicator 54 or light source 55 may be connected to the processor 82 and may be operable through the processor 82. Here, depending on the detected configuration of the operating state of the injection device 1, the processor 82 may be configured to generate light signals of various durations, frequencies, or colors to provide the respective visual effects along the visible light signals, for example, the visual identifier 34 or the light guide 35.

[0172] Lighting that changes over time with respect to illumination time or duration and changes in intensity or color may further assist the user when using the injection system 30, which includes the injection device 1, the auxiliary device 50, and / or the injection device 1 and the auxiliary device 50.

[0173] The flowchart in Figure 14 illustrates possible scenarios for using the injection system 30, which includes the 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 fixed to the auxiliary device 50.

[0174] In step 202, the operation of the first actuation element 75 is monitored or detected. In step 204, the operation of the second actuation element 76 is monitored or detected. Only when both actuation elements 75, 76 are actuated by the user, for example, when the respective switches 77, 77' are pressed by the respective fingers 6, 7 of the user's hand 4, the electronic circuit 80 of the auxiliary device 50 is switched from non-actuated mode to actuated mode in step 206.

[0175] Once the electronic circuit 80 is switched to operating mode, the method may proceed to step 208. Here, the electronic identifier 33 provided on or inside the body 51 of the auxiliary device 50 can be read by the electronic circuit 80. Specifically, as described above, the second transceiver 84 can read the electronic data provided by the electronic identifier 33 of the injection device 1, which may be implemented as an electronic tag such as a short-range tag.

[0176] In step 210, the first sensor 65 is activated and configured to detect movement or position 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 determine whether the first component of the injection device 1 has moved or is currently undergoing expected movement. Unless movement is detectable in step 212, the method returns to step 210. The loop of steps 210, 212 continues as long as the first sensor 65 detects expected movement or position of the first component of the injection device 1.

[0177] In the subsequent step 214, each timestamp or clock signal is generated by the clock 86, and each clock signal or timestamp can be stored in the memory 85 of the electronic circuit 80.

[0178] The method may then proceed to step 216, in which the second sensor 66 is activated or the first sensor 65 is activated again, enabling it to operate to detect the movement or position of the first or second component of the injection device 1. Again, step 216 is repeated multiple times in step 216, as long as the expected movement or position of the first or second component of the injection device 1 is detected in step 216, unless the expected position or movement is detected by the respective sensors 65, 66. If the expected movement or position of the first or second component of the injection device 1 is detected by either the first or second sensors 65, 66, the method proceeds to step 218. Again, as in step 214, each timestamp is generated by the clock 86 and the timestamp or clock signal is stored in memory 85.

[0179] For example, a timestamp or clock signal indicating the start and completion of a dose infusion procedure may be combined with the drug-related infusion device-related information obtained in step 208. In step 220, the data obtained from the electronic identifier 33 may be compared with or combined with the timestamps provided in steps 214 and 218. In step 222, the combination of obtained data may then be stored in the local memory 85 of the electronic circuit 80. In a further subsequent, and therefore optional, step 224, the data stored in memory 85 may finally be transmitted to an external electronic device 100, for example, further data processing. [Explanation of Symbols]

[0180] 1. Injection device 2. Distal direction 3. Proximal direction 4 moves 5 Thumb 6 fingers 7 fingers 8. Medications 9 Stopper 10 barrels 11 Housing 12 Shields 13 Syringe carrier 14 Exit 15 needles 16 protective caps 17 Flange section 18 Flange section 19 Contact surface 20 plungers 21 Plunger Shaft 22 Markings 23. Inclined edge 24 Interlock 25 Latch elements 26 Counter latch element 27 Spring elements 28 Through-hole 29 Mechanical Counter Coding 30 Injection Systems 33. Electronic Identifier 34 Visual Identifiers 35 Light source 50 Auxiliary Devices 51 Main unit 54 Indicators 55 Light source 59 Mechanical Coding 60 Fastening structure 61 Receptacle 62 Contact part 63 Through-hole 64 Accessories 65 Sensors 66 sensors 67 Sensors 68 Light source 69 Optical detectors 70 Handle section 71 Gripping surface 72 Gripping flange 75 Operating elements 76 Operating elements 77 Switches 78 Side wall 80 Electronic circuits 81 Power supply 82 processors 83 Transceivers 84 transceivers 85 memory 86 clocks 87 Detection Unit 88 Operating Unit 100 External electronic devices 101 Housing 102 Device Processors 104 displays 106 Communication Unit

Claims

1. An auxiliary device (50) for an injection device (1), - The main body (51) comprises a fastening structure (60) for detachably fastening to the injection device (1), and a handle portion (70) for the user to grasp, - An electronic circuit (80) comprising a processor (82) and a first transceiver (83), which is switchable between an operating 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 activated by the user. Equipped with, Auxiliary device (50).

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

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

4. The electronic circuit (80) remains in the inactive mode when only one of the first operating element (75) and the second operating element (76) is operated by the user. The auxiliary device (50) according to claim 2 or 3.

5. Switching the electronic circuit (80) from the inactive mode to the operating mode requires the operation of both the first operating element (75) and the second operating element (76) at least for time intervals that overlap. An auxiliary device (50) according to any one of claims 2 to 4.

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

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

8. The handle portion (70) is provided with a gripping surface (71) facing distally, The first operating element (75) is positioned on the distal gripping surface (71), An auxiliary device (50) according to any one of claims 1 to 7.

9. The auxiliary device (50) further comprises a first sensor (65) operable to detect at least one of the position and movement of the plunger (20) or stopper (9) of the injection device (1) relative to one of the barrel (10), housing (11), and shield (12) of the injection device (1) when the auxiliary device (50) is fastened to the injection device (1). An auxiliary device (50) according to any one of claims 1 to 8.

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

11. The first sensor (65) includes an optical sensor. The auxiliary device (50) according to claim 9 or 10.

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

13. The first light source (68) is aligned with the first dedicated portion of the injection device (1) when the injection device (1) is correctly attached to the main body (51), The first light source (68) is operable to illuminate the dedicated portion of the injection device (1). The auxiliary device (50) according to claim 12.

14. The auxiliary device (50) further comprises a third sensor (76) that is operable to detect at least one of the presence, position, and movement of the protective cap (16) of the injection device (1) when the auxiliary device (50) is fastened to the injection device (1). An auxiliary device (50) according to any one of claims 1 to 13.

15. The system further comprises a second transceiver (84) capable of reading an electronic identifier (33) provided on or inside the injection device (1), An auxiliary device (50) according to any one of claims 1 to 14.

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

17. The inactive mode of the electronic circuit (80) is a sleep mode in which the energy consumption of the processor (82) is reduced compared to the state in which the processor (82) and / or the electronic circuit (80) are in the operating mode. The device (50) according to any one of claims 1 to 16.

18. An injection system (30), - An infusion device (1) having a barrel (10), wherein the barrel (10) is filled with a drug (8) and is sealed proximal (3) to the barrel (10) by a stopper (9) that is movable distally (2) relative to the barrel (10) in order to discharge the drug (8) through an outlet (14) of the barrel (10), - An auxiliary device (50) according to any one of claims 1 to 17 and Equipped with, Injection system (30).

19. A method for monitoring the use or preparation of an infusion device or infusion system for injecting a drug, - To provide an injection device (1) capable of injecting the aforementioned drug, and an auxiliary device (50) according to any one of claims 1 to 17, - By activating the first operating element (75), the electronic circuit (80) of the auxiliary device (50) is activated. A method that includes this.

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