• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    The invention relates to an administration device, in particular an auto-injector, for a fluid medicament with electronics. The electronics (26) comprise a controller (18) and a light-emitting diode (19). The light-emitting diode (19) not only emits light, but it can also convert light into an electrical signal. According to the invention, this additional property is used to switch the electronics (26) from an energy-saving mode to an operating mode
    公开号:CH717475A2
    申请号:CH70321/21
    申请日:2021-09-28
    公开日:2021-11-30
    发明作者:Mangold Stefan；Haldi Patrick
    申请人:Ypsomed Ag；
    IPC主号:
    专利说明:

    PRIORITY
    It is hereby claimed the priority of the European patent application EP 21189122.1, which was filed on 08/02/2021 at the European Patent Office (EPA).
    TECHNICAL AREA
    The present invention relates to the field of injection devices, especially modern injection devices which are equipped with communication means.
    BACKGROUND OF THE INVENTION
    Injection devices are known from the prior art, which have an electronic control and wireless communication, for example Bluetooth. In the case of such injection devices, typically designed in pen form or pen form, especially autoinjectors, due to the limited space available, it is important that these devices are surrounded by electrical energy sparingly, since such devices can be stored for months before use and there is often no possibility of removing the devices to be supplied with energy from the outside.
    There is a need for integrated and smart injection devices that meet the above-mentioned challenge.
    The term “product”, “drug” or “medicinal substance” in the present context includes any flowable medical formulation that is suitable for controlled administration by means of a cannula or hollow needle into subcutaneous or intramuscular tissue, for example a liquid, a solution, a gel or a fine suspension containing one or more medicinal active ingredients. Thus, a medicament can be a single agent composition or a premixed or co-formulated multiple agent composition from a single container. The term includes in particular drugs such as peptides (e.g. insulins, drugs containing insulin, GLP 1-containing and derived or analogous preparations), proteins and hormones, biologically obtained or active substances, substances based on hormones or genes, nutritional formulations, enzymes and other substances in solid (suspended) or liquid form. The term also includes polysaccharides, vaccines, DNA or RNA or oligonucleotides, antibodies or parts of antibodies as well as suitable basic, auxiliary and carrier substances.
    The term “distal” denotes a side or direction directed towards the front, single-sided end of the administration device or towards the tip of the injection needle. In contrast, the term “proximal” denotes a side or direction directed towards the rear end of the administration device opposite the penetration-side end.
    The terms “injection system”, “injection device” or “injector” in the present description are understood to mean a device in which the injection needle is removed from the tissue after a controlled amount of the medical substance has been dispensed. Thus, in the case of an injection system or an injector, in contrast to an infusion system, the injection needle does not remain in the tissue for a prolonged period of several hours.
    DISCLOSURE OF THE INVENTION
    It is an object of the invention to provide injection devices, in particular auto-injectors, with smart functionality, which are safe and can be stored well.
    The object is achieved by the independent claim. Further developments according to the invention can be found in the dependent claims as well as the description and the figures (if any).
    One aspect of the invention relates to autoinjectors. Auto-injectors are a type of injection device and are very well known to the public, for example in the form of the applicant's YpsoMate. The Ypso-Mate auto-injector allows the automatic delivery of a single dose of medication by subcutaneous injection. The injection process is started automatically after the injection end of the autoinjector has been attached and the needle protection sleeve has been pushed in. In WO2014146210A1, a conventional autoinjector including its functionality is shown and described in detail. The document WO2014146210A1 is hereby fully incorporated by reference into the present document. Such auto-injectors are typically manufactured by a device manufacturer such as the applicant, but are not yet fully assembled. The final assembly then takes place at the manufacturer of the drug with which the autoinjector is to be used, or a corresponding service provider. During the final assembly, prefabricated assemblies of the autoinjector are married to the medication container.
    In addition to the injection mechanism, modern, so-called smart auto-injectors also include electronics, which can be used to monitor / log the injection process, communicate with other devices or communicate with the person using it. For this purpose, the electronics typically include a controller, memory for data and firmware and an energy source in the form of a battery, which can supply the controller and connected elements with power. Elements such as sensors, communication modules (Bluetooth, WLAN, Zigbee, Enocean, UWB, etc.), light-emitting diodes (in the form of LEDs), displays (LCD or similar), audio modules (buzzer or loudspeaker), and tactile signals (vibrators) can be sent to the controller ), or others can be connected.
    As mentioned in the background of the invention, injection devices such as the autoinjectors described here are stored before they are actually used. A first time before the final assembly described and then again before use. The so-called “shelf life”, i.e. the possible storage period before use, can typically last years. Smart auto-injectors must also take this fact into account.
    In addition, there is another aspect of smart autoinjectors. As mentioned, the final assembly of the autoinjectors is typically not carried out by the manufacturer of the injection device, but by the drug manufacturer, who also sells the ultimately combined product. With smart auto-injectors, the drug manufacturer may want to store data or software (firmware) on the smart auto-injector during the final assembly. It may also be the case that data or software must be changed, added or deleted after the final assembly (but before use).
    This means that the energy management in the autoinjector plays a central role. Typically, injection devices or more generally administration devices (such as infusion pumps) are put into a deep electrical sleep (energy-saving mode) after assembly, if the energy source for using the device is already being used during assembly, or the power supply is completely interrupted, for example by a switch that can be operated . A mechanical switch would theoretically also be an option for an auto-injector. However, such a switch also has disadvantages, in particular a switch can be actuated (switched on or off) at the wrong moment. A switch also impairs the easy and safe usability of the autoinjector. Auto-injectors should, among other things, be as easy to use as possible so that self-medication is also safely possible for physically handicapped patients. A switch, which is then still very small if possible, has a negative impact on usability.
    In a smart autoinjector according to the invention, it is therefore possible to move the autoinjector electronics from deep sleep to an operating mode without a switch. According to one aspect, the injection device according to the invention is a smart auto-injector in which at least one electronic controller, memory for data and firmware (software) and a battery are arranged. The autoinjector according to the invention further comprises at least one light-emitting diode (hereinafter referred to as LED), for example an RGB LED, which is connected to the controller. An RGB LED is actually the integration of a red, a green and a blue LED in a common LED housing, typically with RGB LEDs the three individual LEDs have a common cathode or anode, whereby an RGB LED can be controlled via four contacts (see https://www.elprocus.com/what-is-three-rgb-led-and-its-working/, or on archive.org: https://web.archive.org/web/ 20210411100309 / https: //www.elprocus.com/what-is-three-rgb-ledand-its-working/; archived on 04/11/2021). The RGB LED is listed here as an example. It can also be advantageous, because it is simpler, to use a simple, for example green, LED in the invention.
    LEDs are normally used to emit light. The applicant's EP3750576A1, in which LEDs on add-ons for administration devices are disclosed, also discloses LEDs which not only serve to convert electrical impulses into light, but also to convert light impulses into electrical impulses. EP3750576A1 is hereby fully incorporated into the present document by reference and the teaching as it is applied to add-ons in EP3750576A1 is hereby applied to an integrated autoinjector in which the add-on described in EP3750576A1 is integrated into the autoinjectors, applied. Light emission and reception can take place staggered in time in a simple LED.
    The inventive LED on the autoinjector is used according to the invention to signal states or events to the person using, on the other hand, the at least one LED is also used for communication via visible light (also called VLC) with other devices. On the one hand, the LED is used to receive data streams encoded as light pulses or light pulse patterns; on the other hand, the at least one LED can also be used to emit light pulses or light pulse patterns which can be received by other devices and converted into data.
    As mentioned, it is advantageous if the at least one LED is implemented by an RGB LED, wherein the RGB LED according to the invention can be easily adapted to standard RGB LED, as shown in FIG.
    In Figure 1, only the green LED G is actually used for light emission and addressed by the voltage source SO, the red LED R and the blue LED B are connected in series, with the anode of the LED B upstream, a resistor R1 is. Not entirely correct, but easier for understanding, are identified in Figure 1 as photodiodes, but they are effectively LEDs and part of the adapted RGB LED. GR1 acts on the one hand as ground and on the other hand as the output of the adapted RGB LED when receiving light signals. GR2 is a ground connection.
    If light is received by the LED according to the invention, for example from a strong white LED of a smart phone, where such LEDs are used as a flash or flashlight, the converted electrical energy (in particular the pulse) can be so large that the Controller can, for example, be woken up from a deep sleep mode via an interrupt contact on the controller (alternatively, a load shedding element can also be present in the electronics of the autoinjector, which is actuated by the pulse and then supplies the controller with energy).
    Furthermore, the received light can be received in (temporal) patterns (light pulse patterns), which can be converted in the light-emitting diode into a pattern of voltage pulses, which in turn can be converted into data or information and processed by the controller. In one embodiment of the invention, the LED can advantageously also be used to send information or data.
    [0022] An exemplary embodiment is set out below, although it must by no means be interpreted in a restrictive manner.
    In this embodiment, the injection device according to the invention is an auto-injector - as already described above. In addition to the actual elements as are available for the injection process according to WO2014146210A1, the autoinjector also includes electronics including at least one controller, memory for storing data and software (firmware), an RGB LED (according to the above disclosure), a battery for power supply the entire electronics, as well as sensors (connected to the controller) to determine the states of the autoinjector. The controller has interrupt inputs and / or GPIO ports. In production, firmware for the operation of the controller is installed on the controller and / or in the connected memory of the electronics, and functionality (including the correct function of LED, battery and sensors) is checked as part of quality controls. If the test is successful, the electronics are put into a deep sleep by means of a light pulse pattern (visible light) which is radiated onto the RGB LED. Deep sleep means an energy-saving mode in which all of the electronics consume a quiescent current of a few microamperes. This light pulse pattern does not have to have a particularly high light intensity because the electronics are still active when this pattern is received. Once in the energy-saving state, the auto-injector can be delivered to the drug manufacturer in assemblies. In this state it does not matter if the electronics are left lying around for a longer time, as the power consumption is marginal. If the medical manufacturer proceeds to final assembly, he can firstly marry off the drug container with the assemblies of the autoinjector and assemble it. In this embodiment, the drug manufacturer secondly wants to load further data and an adapted firmware into the memory of the electronics, in particular he wants to load data on the drug into the memory (ID, lot, serial number, etc.). He would also like to load at least one cryptographic key into the memory, which, together with the firmware, can then be used to encrypt data exchange between the autoinjector and other devices. It should be mentioned here that the entire communication can basically run via LEDs while the autoinjector is in use, or a Bluetooth unit that uses the key can also be integrated in the electronics.
    In order to get the mentioned data and the firmware in the memory of the electronics, it must first be woken up from the energy-saving state. For this purpose, a strong light source (for example an LED lamp with white light) is aimed at the RGB LED and illuminated with one or more light pulses, advantageously a specific pattern of strong light pulses. The white light contains significant proportions of blue and red light, so that a corresponding electrical signal is generated in the RGB LED, which can trigger the change from energy-saving mode to an operating mode at the interrupt inputs of the controller. In an advantageous variant, the controller can then output a light pulse pattern via the green LED of the RGB LED, which confirms the mode change. Since the electronics of the autoinjector are no longer in energy-saving mode, the desired data and the modified firmware can now be transmitted to the autoinjector by sending additional light pulse patterns (analogous to the digital transmission of bits and bytes) and stored in the memory. The individual light impulses are recorded by the red and blue LEDs and passed on to the controller as electrical impulses.
    During final assembly and the transfer of the additional data, the autoinjector is ideally monitored with a digital camera, which allows light pulse patterns that are output by the autoinjector to be read out and translated into data. For example, after changing the firmware, the controller can output the new firmware identifier via a light pulse pattern on the green LED.
    After everything has been transferred and checked, the electronics of the autoinjector can be put back into energy-saving mode with a corresponding light pulse pattern at the end of the final assembly so that the autoinjector is ready for sale and can be stored. This is followed by a description of a possible application of the auto-injector.
    Typically, people who ultimately want or have to use the autoinjector are instructed for correct use by means of a smart phone app (the smart phone app can be an app from the autoinjector manufacturer or the drug manufacturer). The smart phone app can then also be used to bring the auto-injector back from energy-saving mode to operating mode at the right moment using a light pulse pattern emitted by the smart phone's flash - immediately before the auto-injector is to be used. The app can set up a bi-directional communication link with the auto-injector, whereby the smartphone's flash light can serve as a transmitter and the smartphone's camera as a receiver. On the side of the autoinjector, the modified RGB LED serves as a receiver and transmitter. This communication link can be encrypted using visible light using the key stored on the autoinjector. Ideally, matching key pairs are installed on the auto-injector and the smart phone. After switching from energy-saving mode to operating mode, the auto-injector advantageously sends its identifier to the smart phone one or more times via the RGB LED, so that the app can register which pen is connected to which drug. The app can also use this information to check via the network (cloud) whether the pen and the medication are OK. In one embodiment, the smart phone can also obtain a cryptographic key via the network that specifically matches the autoinjector.
    The use of the autoinjector can, for example, be guided step by step and illustrated in the smart phone app. Effective use steps can be detected by the sensors in the autoinjector and then confirmed by communications from the autoinjector to the smart phone, with the successful delivery of medication and any error messages being transmitted in particular. After the injection has been completed, the electronics can, for example, automatically return to deep sleep mode.
    The autoinjector used is advantageously then recycled by the manufacturer of the autoinjector, so that in particular the electronics of the autoinjector can be used again.
    During the final assembly, not only the information and data already mentioned can be transmitted to the autoinjector, but everything that makes sense for a person skilled in the art.
    If, for example, a temperature sensor is installed in the autoinjector, which is connected to the controller, a drug-specific, ideal administration temperature can also be stored in the memory during final assembly and the autoinjector can report to the smart phone app when using the autoinjector the corresponding temperature has been reached.
    In a further embodiment of the invention, the autoinjector has an electric motor for the drive to dispense medicament. The electric motor is connected to the controller, is controlled by it and supplied with energy by the battery. Now, during final assembly, the drug manufacturer can store a specific dispensing speed that is adapted to the drug viscosity in the memory, so that the electric motor can be optimally controlled for the drug.
    In a further embodiment of the invention, the electronics of the autoinjector have an additional radio unit, specifically a Bluetooth receiver and transmitter. During final assembly, a secret key for the autoinjector and the public key for the smart phone app can be transferred to the autoinjector via light communication and stored in the autoinjector's memory. When used, the smart phone app can download the appropriate public key for the autoinjector via a secure internet connection, for example, based on the transferred identifier of the autoinjector. As a result, the key pairs can be used for secure Bluetooth communication at the application level. To do this, an encrypted Just Works Bluetooth connection (details: https://www.bluetooth.com/) is first established between the autoinjector and smart phone, and then the smart phone app and autoinjector can also exchange data again via encrypt the keys previously acquired out-of-band.
    The examples listed can be combined with one another as desired without deviating from the inventive idea.
    CHARACTERS
    In connection with the attached figures, preferred embodiments of the invention are described below. These are intended to show the basic possibilities of the invention and are in no way intended to be interpreted as restrictive. 1 shows the scheme for a modified RGB LED 19 as it could be used according to the invention. FIGS. 2a / b show an injection device according to the invention, the autoinjector 1 proximal area of the autoinjector from FIG. 2 without the housing. FIG. 5 shows a system according to the invention comprising an injection device and a smart phone
    FIGURE DESCRIPTION
    FIG. 1 shows a circuit diagram according to the invention for a modified RGB LED 19. The details of this have already been discussed above.
    Figures 2a to 4 show an inventive embodiment of an injection device in the form of the autoinjector 1. The basic mechanical structure and the mechanical functionality of the autoinjector 1 is not described in detail at this point, reference is again made to WO2014146210A1. FIGS. 2a and 2b show the autoinjector 1 with the housing 2, the proximal closing housing 3 and the needle protection pull-off cap 7. The viewing window 5 through which the reservoir or medicament container 6 is visible is arranged on the housing 2. In the perspective view of FIG. 2b, the light guide 4 for the RGB LED 19 (see FIG. 4) can be seen in the region of the proximal closing housing 3. The light guide 4 guides light which is emitted by the RGB LED 19 through the housing wall to the outside and vice versa to the outside into the interior of the housing when the area of the housing is irradiated with light. The structure of the RGB LED 19 is according to the scheme shown in FIG. The red LED R and the blue LED B are used to receive light signals, while the green LED G is used to emit (green) light.
    FIG. 3 shows a longitudinal section through the autoinjector 1, in which more details about the autoinjector 1 become visible. The autoinjector 1 is a spring-driven autoinjector with which the medicament 8 can be administered from a pre-filled syringe 6. The pre-filled syringe 6 comprises a syringe body 9 in which the medicament 8 can be stored. The open proximal end of the syringe body 9 is closed by the movable stopper 10. The injection cannula 11, which is protected by the needle guard 12 before use, is arranged at the distal end of the syringe body 9. The needle guard 12 is removed with the aid of the needle guard pull-off cap 7 immediately before the auto-injector 1 is used. For the person using it, there is still at least a visual protection in front of the injection cannula through the needle protection sleeve 15, which is movably supported on the housing 2 and is pressed in the distal direction by the spring 24. As mentioned, the auto-injector 1 is spring-driven. For this purpose, the drive spring 14 is arranged in the sleeve-shaped piston rod 13. In the stored state, the spring 14 is pretensioned and is held in the piston rod 13 in a compressed state. The piston rod 13 is in turn held axially in position by the holding elements 25 in the storage state. When released, the holding elements 25 move slightly outward perpendicular to the axis of the autoinjector and release an axial movement of the piston rod 13 in the distal direction, the piston rod 13 being driven by the drive spring 14. As a result of the movement of the piston rod 13, the stopper 10 is also moved in the distal direction and medicament 8 is poured out through the injection cannula 11. For details, in particular also on the release mechanism, reference is made once again to WO2014146210A1.
    FIG. 4 shows, in particular, the proximal area “detail B” of the autoinjector 1 without the proximal closing housing 3, whereby the view of the electronics 26 of the autoinjector 1 becomes clear. The electronics include at least the battery 16, the battery contact 20, sensors (not shown) and the electronics board 17. The controller 18 is arranged on the electronics board 17. The RGB-LED 19 (as already described above for FIG. 1) and the Bluetooth module 21 are connected to the controller 18 and also arranged on the electronics board 17. The controller 18 is also connected to various sensors (not shown) , which can pick up various measurement signals on and in the auto-injector, which can be processed in the controller 18. The controller 18 has (at least) one interrupt input (not shown) which is connected to the output GR1 of the RGG-LED. Furthermore, memory (not shown), which is used to store information, data and firmware, is also integrated in the controller 18. As described above, data, in particular cryptographic keys, can be loaded into the memory during final assembly.
    Figure 5 shows the application of the inventive autoinjector 1 in a system with a smart phone 100, the smart phone in particular an Apple iPhone (for example an iPhone 12) or an Android smart phone (for example a Samsung Galaxy S21) can be. The person skilled in the art is familiar with the typical examples and their equipment, so that a detailed description is dispensed with at this point. In any case, the smart phone 100 has at least one current smart phone camera (at the time of the registration date of the present document, not shown), a Bluetooth module and a flashlight / lamp (not shown), all of which are controlled by a smart phone app ( not shown) can be driven and controlled. The aforementioned smart phone app is an app which is provided either by the manufacturer of the autoinjector 1 or the manufacturer of the drug 8 and is tailored to the use of the autoinjector 1. Alternatively, it can also be provided by a third party. The smart phone 100 also has a touch-sensitive screen 101 and optionally at least one further operating element 102 (which can also be arranged on the side of the smart phone 100).
    A use according to the invention of the described autoinjector 1 in interaction with the smart phone 100 and the smart phone app is discussed again below.
    The person using installs the smart phone app (hereinafter simply called the app) on the smart phone 100 via an app store (how this is done is known to a person skilled in the art). When the app is started for the first time, the person using the app typically has to give the app authorization to use the camera, lamp and / or Bluetooth functionality. It may also be necessary for the person using the app to log in or register so that the app can obtain information, data or firmware etc. from a remote server (not shown) or send it to a remote server. Once all of this has happened, the person using can, for example, start instructions for using the autoinjector 1 in the app, the instructions being able to guide the person using it step-by-step through the use, including the injection of drug 8.
    In a first step, the app instructs the user to take the auto-injector 1 out of its packaging (not shown). In this state, the auto-injector 1 is in the described energy-saving mode. In a further step, the app then instructs the user to align the smart phone 100 geometrically with the auto-injector 1 so that the lamp of the smart phone 100 can illuminate the light guide 4 for the RGB LED 19. If the user confirms the alignment in the app, the app sends a strong light pulse or a strong light pulse pattern 22a via the lamp, which is received in the RGB LED 19 and via the output GR1 to the interrupt input of the controller 18 is directed. The interrupt signal at the controller 18 switches the electronics 26 from the energy-saving mode to the operating mode and the auto-injector 1 is ready for operation; the Bluetooth module 21 is also now activated and signals readiness for pairing via wireless radio signals 23. The app has meanwhile activated the camera and the controller 18 sends out a light pulse pattern 22b via the RGB LED 19, which is detected by the camera and which is then evaluated by the app. The light pulse pattern can be evaluated by the app as confirmation that the autoinjector is now ready for operation. With the confirmation, the controller also sends identification data for the autoinjector 1 to the smart phone 100, wherein the identification data can contain the serial number of the autoinjector 1, a drug identifier and / or other data. Alternatively, the pattern can also contain error messages. The app now reports the status on the screen 101 of the smartphone to the person using it and asks the person using it to allow the Bluetooth connection, since the smartphone app has recognized that the autoinjector is ready for pairing. After allowing, smart phone 100 and autoinjector 1 establish an encrypted Just Works Bluetooth connection 23 (see above). Now the Bluetooth connection is still missing the encryption at the application level (between the app and the autoinjector). For this purpose, in the final assembly of the autoinjector 100 in the memory of the controller 18, on the one hand, the private or secret cryptographic key of the autoinjector was stored; on the other hand, a unique identifier of the autoinjector 1 was stored, which is already available on the smart phone 100 with the confirmation light pulse pattern. The smart phone can now call up the public key for the autoinjector 1 from a remote server via a secure internet connection. After receiving the public key of the autoinjector 1, the smart phone 100 sends the public key of the app to the autoinjector 1 via Bluetooth connection 23, the public key of the smartphone being encrypted using the public key of the autoinjector 1. As a result, it is only possible for the auto-injector 1 to decrypt the public key of the smart phone again, namely with the stored private key. If that worked, the controller 18 sends a confirmation to the smart phone 100 via the Bluetooth module 21, which in turn is now encrypted with the public key of the app, which also results in end-to-end encryption of the Bluetooth connection Application level is established. Both devices are now ready for secure data exchange 23 via Bluetooth and the app can now guide the person using the injection process.
    For example, the app can now ask the person using it to remove the needle guard 12 with the aid of the needle guard pull-off cap 7. The removal can be detected by means of a sensor mentioned on the autoinjector and the controller 18 can send a confirmation via Bluetooth connection. As soon as the confirmation reaches the app, it can indicate the next step to the users. The app can now instruct the person using the autoinjector to place the autoinjector on the skin (which can also be detected and confirmed in a variant) and then to press in the needle protection sleeve 15 and thus to insert the injection cannula 11 into the tissue. Pressing in the needle protection sleeve 15 has the consequence that the release elements 25 now release the piston rod 13 and medicament 8 is injected. In a variant, the beginning of the movement of the piston rod 13 is also detected, the controller 18 sends a corresponding message to the app via Bluetooth 23 and the controller 18 emits a light pulse pattern via the green LED G, which is visible to the person using it and signals that the injection is in progress. If the stopper 10 reaches the distal end of the syringe body 9, it is stopped and the plunger rod 9 is also stopped, which is detected by a further sensor and registered by the controller 18. Typically, the controller waits a few seconds and then sends a final signal to the app via Bluetooth 23 and another light pulse pattern that differs from the previous light pulse pattern via the green LED G. On the one hand, the app can indicate to the user that the injection has been completed, on the other hand the autoinjector 1 can also signal the same via LED, so that the person using does not necessarily have to look at the screen 101 of the smart phone 100 at this moment.
    The app can now instruct the user further about disposal or recycling of the autoinjector and, in particular, log the entire administration process in the background and, if necessary, transmit data to a remote server which stores the transmitted data.
    Further variations of the examples described are obvious to the person skilled in the art and do not deviate from the claimed invention.
    FURTHER LITERATURE
    A Survey on Visible Light Communication Standards. https://dl.acm.org/doi/10.1145/3471440.3471444 [02] Stefan Schmid, Giorgio Corbellini, Stefan Mangold, and Thomas R. Gross. 2013. LED-to-LED visible light communication networks. In Proceedings of the fourteenth ACM international symposium on Mobile ad hoc networking and computing (MobiHoc '13). Association for Computing Machinery, New York, NY, USA, 1-10. DOI: https: //doi.org/10.1145/2491288.2491293 [03] IEEE, IEEE standard for local and metropolitan area networks - Part 15.7: Short-range optical wireless communications. April 2019. IEEE Std 802.15.7-2018 (Revision of IEEE Std 802.15.7-2011), 1-407. doi: https://doi.org/10.1109/IEEESTD.2019.8697198 [04] disneyresearch.com/2012/12/03/an-led-to-led-visible-light-communication-system-withsoftware-based-synchronization
    REFERENCE LIST
    G green LED (part of the RGB LED) B blue LED (part of the RGB LED) R red LED (part of the RGB LED) R1 resistance (typ. 10 MΩ) SO voltage source GR1 ground / output GR2 ground 1 autoinjector 2 housing 3 proximal end housing 4 light guide for LED 5 viewing window 6 reservoir / pre-filled syringe 7 needle protection cap 8 medicament 9 syringe body 10 stopper 11 injection cannula 12 needle protection 13 plunger rod 14 drive spring 15 needle protection sleeve 16 battery 17 electronics board 18 controller 19 RGB LED 20 battery contact 21 bluetooth module 22a visible Light λ (symbolic) 22b Visible light λ (symbolic) 23 Bluetooth connection 24 Spring 25 Retaining elements 26 Electronics 100 Smart phone (symbolic) 101 Screen (touch screen) 102 Control element
    权利要求:
    Claims (8)
    [1]
    1. Administration device (1) for administering a fluid medicament (8) at least comprising• a one-part or multi-part housing (2,3) with a translucent zone (4),• an administration mechanism (13,14,25) which is at least partially arranged in the housing (2,3),• electronics (26) which are arranged in the housing (2, 3) and includeo a controller (18) with which data and information can be processed,o Memory for storing data, information and / or software, connected to the controller (18),o a light-emitting diode (19), in particular an RGB light-emitting diode, which is connected to the controller (18) and is arranged in the area of the transparent zone (4) of the housing (2, 3),• an energy supply (16), in particular a battery (16), with which at least the electronics (26) can be supplied with energy,wherein the light-emitting diode (19) not only converts electrical signals into light, but also conversely also converts light into electrical signals,wherein the electronics (26) can adopt an energy-saving mode in which the electronics (26) consume very little energy, in particular in the range of a few microamps, and in which the controller (18) does not process any data,wherein the electronics (26) can also adopt an operating mode in which the energy consumption is higher and in which the controller (18) can process data from various sources,characterized in thatthe electronics (26) can be switched from the energy-saving mode to the operating mode by a first light pulse or a first light pulse pattern (22a) which is received at the light-emitting diode.
    [2]
    2. Administration device according to the preceding claim, wherein the electronics can be switched from the operating mode to the energy-saving mode by a second light pulse or a second light pulse pattern.
    [3]
    3. Administration device according to claim 2, wherein the first and second light pulse and the first and second light pulse pattern are different or the same.
    [4]
    4. Administration device according to one of the preceding claims, wherein the administration device is an auto-injector (1).
    [5]
    5. Administration device according to one of the preceding claims, wherein the light-emitting diode (19) is a red / green / blue light-emitting diode - RGB light-emitting diode - which comprises three partial light-emitting diodes (R, G, B), one of which (G) for light emission is used and the other two (R, B) are used to receive light.
    [6]
    6. Administration device according to one of the preceding claims, characterized in that in the operating mode via the light emitting diode (19) data can be emitted as a light pulse pattern, which the controller (18) controls and which can be recorded and processed as data by means of a camera of a separate data processing device (100) .
    [7]
    7. Administration device according to one of the preceding claims, characterized in that in the operating mode via the light-emitting diode (19) data can be received as a light-pulse pattern, the electrical signals, which are converted from light into electrical signals by the light-emitting diode (19), into data by the controller are convertible.
    [8]
    8. A method for the final assembly of an administration device (1) according to claim 2 in a final assembly plant, at least comprising the following steps:• Switching the electronics (26) from energy-saving mode to operating mode with the aid of the first light pulse pattern from a light source of the final assembly system, which is received by the light-emitting diode (19),• Reading out a device identifier from the memory by the controller (18),• Coding of the device identification in the controller (18) in a pattern of electrical impulses,• Sending the pattern of electrical pulses from the controller (18) to the light-emitting diode (19), which converts the pattern and emits it as a further light pulse pattern,• Reception of the further light pulse pattern by a camera in the final assembly system,• Sending a drug identification and / or a cryptographic key to the electronics (26), with the drug identification and / or cryptographic key also being sent as a light pulse pattern from the light source to the light emitting diode,• Storage of the drug identification and / or the cryptographic key in the memory of the electronics (26),• Switching the electronics (26) from the operating mode to the energy-saving mode by means of the second light pulse pattern, which is sent from the light source to the light-emitting diode (19).
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    EP21189122|2021-08-02|
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