PULSE ENVELOPE ULTRASONIC AURICULAR VAGUS NERVE STIMULATION SYSTEM

Abstract

The invention relates to a pulse-envelope ultrasonic auricular vagus nerve stimulation system that provides stimulation of the auricular vagus nerve branches located on the auricle with mechanical-acoustic energy without applying an electrical neurostimulation current. The system consists of a power supply (11), control unit (12), ultrasonic carrier signal generator (13), envelope / gating modulator (14), power driver and impedance matching network (15), at least one ultrasonic transducer (16, 30), acoustic coupling element (17), fastening element (18), sensor unit (20), user interface / communication module (21) and memory (22).The control unit (12) manages the ultrasonic carrier signal generator (13) and the envelope / gating modulator (14) with independent time bases, generating the ultrasonic carrier with a frequency of generally 20 kHz to 2 MHz, preferably 200 kHz to 600 kHz and more preferably around 300 kHz, pulsed with a low-frequency on-off envelope with a repetition frequency of generally 1 Hz to 200 Hz, preferably 20 Hz to 30 Hz and more preferably around 25 Hz. The power driver and impedance matching network (15) transmit the generated driving signal to the ultrasonic transducer (16) by ensuring impedance matching, thus achieving high-efficiency mechanical-acoustic energy generation. The ultrasonic transducer (16) transmits controlled ultrasonic energy to the auricular target region (19) via the acoustic coupling element (17), enabling neuromodulation of the auricular vagus nerve using a mechanical-acoustic method.The system performs closed-loop control using feedback data from contact or pressure sensors (23), temperature sensors (24), acoustic / electrical output verification sensors (25) and other optional physiological sensors; it optimizes the carrier frequency, envelope frequency, duty cycle, driving amplitude and macro session cycle in real time. The invention does not include skin electrodes that transmit electrical stimulation current to the auricular target region; neurostimulation is performed solely with ultrasonic mechanical-acoustic energy. This eliminates contact impedance variations, skin irritation and application instabilities caused by the use of electrical electrodes, resulting in an integrated ultrasonic neuromodulation system that provides highly efficient, safe, portable, wearable, customizable and repeatable auricular vagus nerve stimulation.

Description

1 TARIFF PULSE ENVELOPE ULTRASONIC AURICULAR VAGUS NERVE STIMULATION SYSTEM TECHNICAL FIELD  The invention relates to biomedical engineering, medical electronics, ultrasonic neuromodulation, and It relates to the technical field of nerve stimulation systems. More specifically, the invention concerns the ear. the target where the auricular vagus nerve branches are located on the auricle Neuromodulation by transferring mechanical-acoustic energy to anatomical regions 10 The invention concerns an electrode-free ultrasonic stimulation system that provides this function. ultrasonic signal generation, burst modulation, power electronics, Piezoelectric transducer driving techniques deliver controlled acoustic energy to biological tissues. interdisciplinary encompassing transmission and closed-loop biomedical control systems. It offers a technical solution. 1) The invention also involves timing low-frequency neuromodulation to match high-frequency. with electronic drive architectures created independently of the ultrasonic carrier It is related to this. In this context, the system includes ultrasonic carrier generation, pulse envelope creation, acoustic coupling, transducer resonance control, physiological feedback  by bringing together mechanisms and portable / wearable device architectures Enables safe and repeatable stimulation of the auricular vagus nerve. It is related to a new technical structure. PREVIOUS TECHNIQUE  The auricular vagus nerve can exert a regulatory effect on the autonomic nervous system. TaVNS stimulation (taVNS) has been widely researched in the field of neuromodulation in recent years. It has become one of the methods used in clinical and experimental applications today. The most common approach is to examine the auricle (cymba conchae, cavum conchae, tragus) via conductive electrodes placed on the skin or similar areas It is based on the application of electric current. In electrical stimulation methods  Pulses are generated at a specific frequency, and these pulses are transmitted to the nerves via electrodes. The information is transmitted to the ends. Although these systems can be used in many applications, The transfer of electrical current to biological tissue is entirely dependent on the connection between the skin and the electrode. Since it depends on the quality of electrical contact, application stability is significantly important. It varies depending on user conditions. Contact of electrodes used in electrical auricular vagus nerve stimulation systems impedance; skin moisture level, amount of sweating, drying of the electrode gel, electrode factors such as surface contamination, application pressure, and user anatomical differences It is affected by many parameters. These variables include the applied current. This causes the intensity to be at different levels for each user. Therefore, the targeted neuromodulation effect can differ even with the same parameters. This leads to variations in individual differences. As a result, treatment... Standardizing its effectiveness becomes more difficult, user comfort decreases, and long-term efficiency increases. Application reliability may decrease with prolonged use. 15 Current electrical systems also have various mechanical and biological electrode-related issues. Problems arise when electrodes remain in contact with the skin for extended periods. redness, local irritation, contact dermatitis, burning sensation, pain, and discomfort. This can occur. Especially with long-term or daily use, electrodes can cause  periodic replacement, renewal of conductive gels and contact surfaces It needs to be kept clean. This increases both the operating costs and This makes it difficult to integrate these systems into daily life. In recent years, numerous studies have been conducted on stimulating peripheral nerves with ultrasonic energy. Scientific studies and patent documents have been published. These studies involved ultrasound. nerve energy creates mechanical forces on biological tissues It has been shown that it can affect the activity of cells. However, the current A significant portion of ultrasonic neuromodulation systems are implantable ultrasonic. The components are focused ultrasound systems operating at high megahertz levels. or are based on large-volume medical ultrasound devices. These solutions  direct stimulation of the auricular vagus nerve in a portable and wearable form It does not offer optimized structures for this purpose. In some known ultrasonic ear systems, the transducer can be positioned. For this purpose, mechanical conveyor belts that pass over the head are inserted into the ear canal. Alignment elements or fixed geometric references are used. This These types of mechanical structures make the device difficult to use, and are suitable for different ear anatomies. It reduces compliance and negatively affects positional stability during user movements. It can have an effect. Also, the ultrasound frequencies used in these systems. and timing parameters, in electrical auricular vagus nerve stimulation 10 It differs significantly from the physiological stimulation patterns used. The known technique uses low-frequency ultrasonics operating at approximately 300 kHz. Actual on / off pulse with carrier and approximate repetition frequency of 25 Hz  when the adverb is used together with these two time scales independently of each other produced, transducer residual vibrations are actively suppressed, resonance It is automatically tracked and enables electrodeless mechanical-acoustic energy transfer. An integrated system architecture is not defined. Therefore, the current solutions, Holistic and controlled ultrasonic stimulation of the auricular vagus nerve It is unable to present an optimized technical structure.  The most significant problem with known electrical auricular vagus nerve stimulation systems is, Neurostimulation relies entirely on the transmission of electrical current through the skin. This is because of impedance changes at the skin-electrode interface, affecting the target nerve. The effective energy delivered is constantly changing, even if the same device and the same parameters are used. Even with different applications, different physiological results may occur. This This situation particularly reduces the reproducibility of efficacy in long-term treatments. The use of electrical electrodes can cause skin irritation, burning sensation, and pain. electrode drying, deformation of adhesive surfaces and hygiene problems also  This is often the case. Users placing the electrodes in the correct area is crucial. It becomes difficult, and the shifting of electrodes during application affects the stimulation.  This can cause the transmission to completely different nerve regions. As a result... In current systems, implementation accuracy largely depends on user experience. He / She is becoming addicted. However, known ultrasonic neuromodulation systems have various technical problems. It is located in a small portable environment. The high megahertz frequencies used allow for the creation of portable devices. This makes it difficult to achieve high efficiency in transducers, energy conversion. Efficiency can decrease and electronic drive design becomes more complex. Furthermore, in high-frequency systems, the energy distribution within biological tissue... It can be more difficult to control. 10 A significant portion of current ultrasonic systems utilize carrier frequency. Neuromodulation timing is optimized independently. This is not the case. When the carrier signal is continuously activated, the mechanical impulse transmitted to the target nerve is not detected. The energy cannot adequately mimic physiological stimulation patterns; however, 15 Even when generating actual on / off pulses, the mechanical residue of the transducer... Due to vibrations, the closed state cannot be fully achieved. This is no longer the case. Vibrations lead to unwanted acoustic energy transfer, exceeding impact limits. This causes it to become unclear.  Another significant problem is that different users have different ear anatomies. This refers to fixed headbands, ear canal alignment pieces, or uniform carriers. Structures cannot provide the same contact pressure for every user, this situation affects acoustics. This causes changes in coupling quality. Changes in coupling quality This directly affects the transducer efficiency and the amount of acoustic energy transferred to the tissue. It has an effect. In addition, in existing systems, it is determined whether the contact is sufficient and whether the transducer resonates. whether it is working at that point, whether the targeted acoustic output is actually being achieved. whether it occurred and whether the physiological response was at the desired level.  Advanced closed-loop control mechanisms that monitor simultaneously are mostly There is none. Therefore, the system is not subject to environmental conditions or during operation.  It is unable to adapt to user behavior and experiences significant changes in performance. This can occur. Consequently, due to the aforementioned drawbacks and shortcomings, the relevant The need for an innovation in the technical field has arisen.  THE PURPOSE OF THE INVENTION The overall purpose of the invention is to create a complete system that meets the requirements mentioned above. especially the ear, which eliminates disadvantages and brings some additional advantages. the target where the auricular vagus nerve branches are located on the auricle Neuromodulation by transferring mechanical-acoustic energy to anatomical regions. It relates to an electrode-free ultrasonic stimulation system that provides this service. Due to the drawbacks of the previous technique, the invention, as described above, It aims to resolve the negative aspects. 10 The primary aim of the invention is to target the ear where the auricular vagus nerve branches are located. without requiring the application of electrical neurostimulation current to the region capable of generating neuromodulation only through mechanical-acoustic energy transfer The goal is to develop a new generation ultrasonic stimulation system. Thus, electrical electrode 13 Contact problems, skin irritation, and impedance changes resulting from its use. and eliminating the negative aspects that reduce user comfort is the goal. Another aim of the invention is to combine high-frequency ultrasonic carriers with low-frequency  neuromodulation timing completely independently of each other The goal is to develop an electronic signal architecture capable of generating approximately 300 signals. The ultrasonic carrier at the kHz level has a repetition frequency of approximately 25 Hz. Driven by a true on / off pulse envelope, it is suitable for biological nerve stimulation. Controlled mechanical energy packets can be produced.  The invention also enables active damping of residual vibrations of the transducer in the closed state. by minimizing impact limits through techniques The aim is to launch each pulse packet in a controlled manner. It can be terminated, acoustic energy is only delivered to the target tissue for the desired duration  is being transferred.  One of the key aims of the invention is to address individual differences in ear anatomy. The goal is to develop adaptable modular fastening structures. Ear clip, ear rear carrier, flexible carrier or similar alternative fastening elements using a fixed alignment system that fits inside the headband or ear canal. reliable positioning without the need for personnel that is intended. Another purpose of the invention is to integrate contact sensors, temperature sensors, and acoustic output. using verification sensors and physiological feedback units, the system a closed-loop control that automatically optimizes operating parameters 10 The goal is to create the infrastructure. This way, we can analyze user movements and ear anatomy. caused by changes or shifts in transducer resonance Performance differences are corrected in real time and in every application. A more stable neuromodulation effect is achieved. 1) Finally, the invention is portable, wearable, low power consumption, and suitable for mass production. an auricular device that enhances user comfort during reliable and long-term use. The aim is to develop an ultrasonic neuromodulation platform, and to improve upon existing ones. addressing the technical shortcomings of electrical and ultrasonic systems within the same structure. It offers an integrated solution.  To fulfill all the purposes stated above and those that can be derived from the detailed explanation. Invention to enable the introduction of pulse-enveloped ultrasonic auricular vagus nerve stimulation. It is related to the system. 2  DESCRIPTION OF THE FIGURES Figure 1: The invention's power, control, signal generation, driving, transducer, coupling, and feedback. This is a block diagram showing the notification units.  Figure 2: Ultrasonic carrier (31), low-frequency envelope (32) and macro session It shows the three time scale relationships between the cycle (33). Figure 3: Example of an ultrasonic transducer on an auricular target region. It shows its positioning. 10 Figure 4: Ear clip, ear hook and adhesive / flexible carrier form. This is a schematic view of alternative fastening structures. Figure 5: 1) receiving feedback from contact, temperature, acoustic output and physiological sensors. It shows a closed-loop control structure. Figure 6: Sample between transducer, coherence layer, coupling element and tissue. It shows the layer structure and the optional second transducer.  REFERENCE NUMBERS 11. Power supply 12. Control unit 13. Ultrasonic carrier signal generator  14. Envelope / paving modulator 15. Power driver and impedance matching network 16. First ultrasonic transducer 17. Acoustic coupling element 18. Fastening element  18a. Ear clip 18b. Ear hook  18c. Adhesive or flexible carrier. 19. Auricular target area 20. Sensor unit 21. User interface / communication module 22. Memory  23. Contact or pressure sensor 24. Temperature sensor 25. Acoustic / electrical output verification sensor 27. Auricle 28. Concha / cymba conchae region  29. Tragus or near auricular region 30. Second ultrasonic transducer 31. Ultrasonic carrier 32. Low-frequency on / off casing 33. Macro session cycle 1) 35. Body or rear carrier 36. Acoustic adaptation / rear damping layer 10 DETAILED DESCRIPTION OF THE INVENTION The invention involves electrically activating the branches of the auricular vagus nerve located above the earlobe. Stimulation with mechanical-acoustic energy without the application of neurostimulation current The pulse-enveloped ultrasonic stimulation system that provides this stimulation is related to the auricular vagus nerve stimulation system. The system consists of: power supply (11), control unit (12), ultrasonic carrier signal generator (13), envelope / gating modulator (14), power driver and impedance matching network (15), at least an ultrasonic transducer (16, 30), acoustic coupling element (17), fastening element (18), sensor unit (20), user interface / communication module (21) and memory (22) consists of the control unit (12), the ultrasonic carrier signal generator (13) and 10. envelope / gating modulator (14) with independent time bases by managing generally 20 kHz to 2 MHz, preferably 200 kHz to 600 kHz and more. preferably an ultrasonic transmitter with a frequency of approximately 300 kHz, generally from 1 Hz to 200 Hz, preferably 20 Hz to 30 Hz and even more preferably a repeat frequency of around 25 Hz. It generates pulsed current with a low-frequency switching envelope. Power 1 driver and impedance matching network (15), generated driving signal ultrasonic High efficiency by ensuring impedance matching when transferring to the transducer (16). It produces mechanical-acoustic energy. Ultrasonic transducer (16), Controlled delivery to the auricular target region (19) via acoustic coupling element (17). by transmitting ultrasonic energy, mechanical-acoustic stimulation of the auricular vagus nerve  It provides neuromodulation. The system uses a contact or pressure sensor (23), temperature sensor (24), acoustic / electrical output verification sensor (25) and optionally using feedback data from other connected physiological sensors It performs closed-loop control; carrier frequency, envelope frequency, duty cycle. rate, driving amplitude and macro session cycle in real time  It optimizes the electrical stimulation current to the auricular target region in the invention. There are no skin electrodes transmitting the signal; neurostimulation is only ultrasonic. This is achieved through mechanical-acoustic energy. This allows for the use of electrical electrodes. Contact impedance changes, skin irritation, and application problems resulting from its use. By eliminating uncertainties, it becomes highly efficient, safe, portable, wearable,  Provides customizable and repeatable auricular vagus nerve stimulation. An integrated ultrasonic neuromodulation system is obtained. 11 The overall purpose of the invention is to create a complete system that meets the requirements mentioned above. especially the ear, which eliminates disadvantages and brings some additional advantages. the target where the auricular vagus nerve branches are located on the auricle Neuromodulation by transferring mechanical-acoustic energy to anatomical regions. It relates to an electrode-free ultrasonic stimulation system that provides this. Due to the drawbacks of the previous technique, the invention, as described above, It aims to resolve the negative aspects. The primary aim of the invention is to target the ear where the auricular vagus nerve branches are located. without requiring the application of electrical neurostimulation current to the region capable of generating neuromodulation only through mechanical-acoustic energy transfer The goal is to develop a new generation ultrasonic stimulation system. Thus, an electrical electrode Contact problems, skin irritation, and impedance changes resulting from its use. and eliminating the negative aspects that reduce user comfort 1) is the goal. • Figure 1 shows the invention's power, control, signal generation, driving, transducer, coupling, and This is a block diagram showing the feedback units. • Figure 2 shows the ultrasonic carrier (31), low-frequency envelope (32) and macro session  It shows the three time scale relationships between the cycle (33). • Figure 3 shows an example of an ultrasonic transducer on an auricular target region. It shows its positioning. • Figure 4 shows the ear clip, ear hook, and adhesive / flexible carrier. This is a schematic view of alternative fastening structures in the form of  • Figure 5 shows feedback from contact, temperature, acoustic output, and physiological sensors. The notification area shows a closed-loop control structure. • Figure 6 shows the interaction between the transducer, the coherence layer, the coupling element, and the tissue. It shows a sample layer structure and an optional second transducer. 3 Power supply (11), all electronic and electromechanical components included in the invention. It is the primary power supply unit that provides the electrical energy needed by the components. 12 Power supply (11), control unit (12), ultrasonic carrier signal generator (13), envelope / gating modulator (14), power driver and impedance matching network (15), sensor unit (20), user interface / communication module (21) and other auxiliary circuits It produces the supply voltages necessary for stable operation. Thus, all sub-units within the system operate independently of each other. It is possible for it to operate reliably. Power supply (11) is a rechargeable lithium-ion battery depending on the application requirement, lithium polymer battery, nickel metal hydride battery, disposable battery packs, external direct current adapter, USB power supply, magnetic induction wireless charging receiver 10 This can be achieved using one of these methods or a combination thereof. High energy density batteries are preferred in portable applications. while being used, external adapters that provide continuous power in clinical applications It is available for use. 1) The power supply (11) also contains a battery management circuit, overcurrent protection, short circuit protection, overvoltage protection, undervoltage cutoff circuit, temperature It can include a monitoring circuit and a charge control circuit. Thus, the system can... This increases safety and extends battery life. Power source (11), sudden current changes that may occur during ultrasonic driving  also low internal resistance energy storage elements that can meet the demand It may include. In addition, the power supply (11) meets the needs of different electronic subsystems. Switched regulators are used to create linear supply levels. regulators, boost, buck or buck-boost converters It can also include control electronics circuits. Thus, control electronics can operate at low voltage. During operation, the high voltages required to drive the ultrasonic transducer are the same. It can be produced safely within the system. 3 The control unit (12) is the central processing unit that manages all the operating functions of the invention. It is the control unit (12) of all electronic components in the system. 13 coordinating the working timing, ultrasonic carrier signal generator (13), the envelope / gating modulator (14), the power driver (15) and the sensor unit (20) It manages the system in a timely manner. Thus, the system's predetermined operation... It is ensured that it operates reliably in accordance with its algorithm.  Control unit (12), microcontroller, microprocessor, FPGA, DSP, ASIC, programmable logic circuits or hybrid control using a combination of these. This can be achieved using various architectures. Processor selection depends on the application's processing capabilities. based on capacity, power consumption and real-time control requirements It can be determined. 10 The control unit (12) sets the ultrasonic carrier frequency, pulse envelope, duty cycle, active continuously monitor durations, rest periods, driving amplitude, and macro session cycles. It calculates these values ​​and sends control signals to the relevant electronic units. At the same time, the system evaluates the feedback data from the sensors. It can change its parameters in real time. Control unit (12), temperature increase, insufficient contact, excessive power for safety purposes consumption, transducer malfunction, or exceeding user-defined limits By detecting situations like these, it can reduce or completely eliminate the ultrasonic output. It can stop it. This ensures both user safety and device reliability. is being increased. The control unit (12) also communicates with mobile devices via the communication module (21), It can exchange data with computers or clinical control systems. It can save user-defined work schedules to memory and It can analyze past usage data. Ultrasonic carrier signal generator (13), operation of ultrasonic transducer generating the high-frequency electrical carrier signal required for the purpose It is an electronic oscillator unit. This unit is the basic energy production mechanism of the system. It generates and the electrical signal it creates is then used by the power driver. It is amplified by (15) and transferred to the ultrasonic transducer (16). 14 Ultrasonic carrier signal generator (13), preferably in the range of 200 kHz to 600 kHz. It is currently in operation and in more preferred applications, it is centered at approximately 300 kHz. It generates a signal at a specific frequency. However, this depends on the application requirements. as 250-350 kHz, 280-320 kHz or other suitable for transducer resonance It can also operate in other frequency ranges. Carrier signal generator (13), sinusoidal, square wave, multi-level square wave, resonant coherent signals or waveforms with limited harmonic components. It can be implemented in a way that can generate a high signal. frequency stable crystal oscillators, phase-locked loops (PLL), 10 directly with the help of digital synthesizers (DDS) or digital timers It can be produced. The ultrasonic carrier signal generator (13) is continuously controlled by the control unit (12). It can be monitored and its frequency changes depending on the changes in the transducer impedance. It can change automatically. Thus, the ultrasonic transducer (16) can change every The operating point is kept close to resonance over time, and maximum acoustics are achieved. Energy production is provided. The envelope / gating modulator (14) is powered by the ultrasonic carrier signal generator (13)  low-frequency pulse packets of the generated high-frequency carrier signal It is a timing control unit that enables its implementation in this manner. This modulator thanks to the continuously produced ultrasonic transmitter, which is necessary for neuromodulation. They are converted into actual on / off pulses at specific repetition frequencies. 2 Envelope / gating modulator (14), preferably operating in the range of 20 Hz to 30 Hz and In more preferred applications, a low repeat frequency of approximately 25 Hz. It generates a frequency envelope signal. When operated at approximately 50% duty cycle. Each pulse cycle consists of approximately 20 ms on and approximately 20 ms off periods. This is why ultrasonic energy is not applied continuously, but in specific packets. It is transferred to the target tissue in this form. 1) The envelope / gating modulator (14) starts the open state at zero of the carrier signal. It can synchronize with the transition points, and during closing, the transducer no longer... active damping processes to reduce mechanical vibrations It can initiate impacts. Thus, unwanted acoustic conditions may occur at the impact edges. Transitional regimes are being significantly reduced. The modulator (14) adjusts the duty cycle, on time, off time and pulse repetition frequency. physiological feedback can be dynamically modified via software. According to the data, it is able to perform adaptive work. 10 Power driver and impedance matching network (15): Ultrasonic carrier signal generator (13) the low-power electrical carrier signal generated by ultrasonic power that enables the transducer (16) to be raised to a level that can effectively drive it. It is the electronics unit. Power driver and impedance matching network (15), transducer By providing the voltage and current that match the electrical impedance, electrical energy is converted into 1. This enables the conversion of mechanical-acoustic energy into high-efficiency energy. Thus, the targeted acoustics are achieved without unnecessary power losses on the transducer. output is obtained. Power driver and impedance matching network (15), half bridge, full bridge, class-D, class- E, resonant power amplifiers, MOSFET or GaN-based switching circuits This can be achieved using. The impedance matching section is performed in series or... Parallel resonant circuits, inductance, capacitance, transformer or multiple It can consist of hierarchical mesh structures. Thanks to this structure, ultrasonic Maximum energy transfer is achieved at the transducer's resonance frequency while the driver  The efficiency of the circuit is also significantly increased. power in accordance with the control signals sent by the control unit (12) driver and impedance matching network (15), initiation of ultrasonic pulses, It enables stopping and adjusting the amplitudes. Off state  Active damping is used to reduce residual vibrations of the transducer at the beginning. Short-circuiting or high-impedance mode switching operations are also performed by this unit.  It can be applied by [the relevant authority]. Thus, pulse transitions are sharpened and Unwanted acoustic energy transfer to the target tissue is prevented. First ultrasonic transducer (16): Power driver and impedance matching network (15) the electrical ultrasonic driving signal generated by mechanical-acoustic  It is an energy converter element that converts energy into a medium. The first ultrasonic transducer. (16), the basic stimulation element of the system that interacts directly with biological tissue It is formed by the ultrasonic vibrations produced into the acoustic coupling element (17) mechanical transmission of vagus nerve branches to the auricular target region (19) via This ensures that a warning is given. 10 First ultrasonic transducer (16), PZT, lead-free piezoceramic, PVDF, PMUT, CMUT is one of the transducers with a piezocomposite or magnetostrictive structure. This can be achieved using single-element or multi-element transducers. It can be produced in various structures; in flat, curved, focused or unfocused geometries. It can be designed. The type of transducer to be used will be determined based on the anatomical features of the application area. according to its characteristics, operating frequency and targeted acoustic intensity It is determined. The transducer (16) will provide high efficiency at a center frequency of approximately 300 kHz. It can be designed to have resonance characteristics in this way. The control unit (12) continuously monitors the transducer impedance and adjusts the operating frequency. It can bring it closer to the resonance point, thus adapting to different user anatomies. Even stable acoustic energy transfer can be achieved. Acoustic coupling element (17): Between ultrasonic transducer (16) and ear tissue  By creating acoustic impedance matching, the ultrasound energy reaches the biological tissue at a high level. It is the intermediate transmission layer that enables efficient transmission. Acoustic coupling element (17), By preventing the formation of an air gap between the transducer and the skin, it provides acoustic protection. It reduces reflection losses and increases transmission efficiency. 3 Acoustic coupling element (17), silicone, polyurethane, thermoplastic elastomer, hydrogel, acoustic gel, water-based gel, liquid-filled membrane, multilayer impedance matching pad  or similar elastic materials. Adapts to ear anatomy. in order to provide this, in flat, concave, convex or custom geometries It can be accomplished. The coupling element (17) not only increases energy transfer but also  It enhances user comfort by distributing contact pressure evenly. This can prevent mechanical damage to the ear during prolonged use. Discomfort is reduced. Anchoring element (18): Ultrasonic transducer (16) auricular target area (19) 10 It is the mechanical support structure that ensures its stable positioning. The fastening element (18) secures the transducer to the target area throughout the application. It helps maintain acoustic coupling quality by preventing separation. Fastening element (18), ear clip (18a), ear hook (18b), adhesive 1 or flexible carrier (18c), spring holder, ear mold, magnetic connection system, The eyeglass frame can be constructed from a connection or a combination of these. This allows it to easily adapt to different ear anatomies. Thanks to this design, the system can be attached to fixed headbands that go over the head or to the ears. without the need for alignment elements that fit inside the ear canal It can be transported safely on its bucket. This feature of the device It significantly increases portability and convenience for daily use. Ear clip (18a): Used within the scope of fastening element (18) and the transducer  A mechanical device that secures the earlobe with a controlled clamping force. It is a fastening element. Ear clip (18a), spring force or elastic deformation It works on the principle of keeping the transducer in the same position throughout the application. It provides. 3 Ear clip (18a) made of metal, polymer composite or elastomer materials. It can be manufactured to be flexible enough to accommodate different ear thicknesses. 1 It can be designed with soft silicone supports on the contact surfaces. User comfort can be increased by using these methods. Behind-the-ear hook (18b): Supports the transducer behind the ear. It is an ergonomic carrier element that enables carrying. Ear hook (18b),  By distributing the device's weight over a wide surface, it sits comfortably on the ear. It reduces the local pressure that may occur. The ear hook (18b) will accommodate different user anatomies. It can be manufactured with flexibility and prevents the device from slipping during long-term use. This prevents acoustic contact between the transducer and the target area. Its determination is maintained. Adhesive or flexible carrier (18c): Ultrasonic transducer to the ear surface It is an alternative carrier structure that allows for direct fixation. Adhesive or flexible 1) carrier (18c), medical grade biocompatible adhesives, silicone-based elastic films or they can be produced from thin polymer layers. This supporting structure is particularly important for long-term wearable applications of the device. It reduces the visibility of the transducer during the user's daily activities. It helps him maintain his position. Auricular target region (19): Created by ultrasonic transducer (16) auricular vagus nerve branches are stimulated by applying mechanical-acoustic energy It refers to the anatomical region. The auricular target region (19) is the region of the vagus nerve. They are selected from the regions where the cutaneous branches are closest to the surface, controlled transfer of generated ultrasonic energy to nerve fibers This allows the system to operate without the use of an electrical stimulation electrode. It can achieve neuromodulation through mechanical vibrations. 3 Auricular target area (19), cymba conchae, cavum conchae, concha base, tragus, antitragus, antihelix, circumference of the crus helix, circumference of the external auditory canal entrance, or ear 1 to include one or more of the appropriate anatomical regions behind it This can be determined. The area to be selected depends on the user's anatomical structure and the targeted goals. depending on the neuromodulation effect and transducer geometry It can be changed.  The control unit (12) provides contact and physiological feedback via the sensor unit (20). By evaluating the notification data, the most suitable target area on the auricular target region (19) It can create energy transfer conditions. Thus, different users even in their anatomy, repeatable and stable ultrasonic stimulation can be obtained. It is being done. 10 Sensor unit (20): System operational safety, application accuracy and closed It is the sensing subsystem that provides cycle control. The sensor unit (20) is the system. data obtained from various sensors located inside it is sent to the control unit (12) by transmitting and monitoring ultrasonic stimulation parameters in real time 1 It provides. Sensor unit (20), contact or pressure sensor (23), temperature sensor (24), acoustic / electrical output verification sensor (25), accelerometer, optical sensor, photoplethysmography sensor, electrocardiography sensor, electroencephalography  sensor, skin conductivity sensor, breath sensor, motion sensor or similar It may include one or more biophysiological sensors. The control unit (12) continuously analyzes the data transmitted by the sensor unit (20). insufficient contact pressure, temperature exceeding the safety limit,  Failure to achieve the targeted acoustic output or unexpected physiological response It can reduce the ultrasonic output if changes occur, It can change the parameters or stop the system completely. Thus The system significantly improves both user security and application accuracy. It increases.   User interface / communication module (21): User's system operation to define its parameters and for the system to exchange data with external electronic devices. It is an electronic communication unit that enables the user to perform this function. The interface / communication module (21) facilitates the portable use of the system. It also enables clinical monitoring and data recording processes. User interface / communication module (21), Bluetooth®, Wi-Fi, NFC, USB, serial communication, wired data transfer or one of the other wireless communication protocols This can be achieved using LED indicators. touch screens, mechanical keys, mobile applications or computer software 10 Interaction with the user can be established through this medium. This module allows the user to set the ultrasonic carrier frequency, envelope frequency, and task frequency. rate, execution time, macro session cycle and other operational parameters can change its parameters, and also view past application records. They can view the data and create new treatment programs. Memory (22): The operating parameters generated by the control unit (12), storing sensor data, user settings, and application history. Memory (22) is the data storage unit that provides important work even when the system is shut down. It allows for the protection of information. Memory (22), EEPROM, Flash memory, FRAM, SD card, eMMC or similar permanent memory. This can be achieved using data storage technologies. 2 Application dates, ultrasonic parameters, sensor records are stored in memory (22), Error logs, user profiles, and device performance statistics can be stored. This information is used in clinical evaluations and system performance analyses. It is available for use. 3 Contact or pressure sensor (23): Ultrasonic transducer (16) with ear surface It is the sensing element that determines whether sufficient contact has been made. Contact 21 or pressure sensor (23) to ensure that acoustic coupling is at a sufficient level It continuously monitors the mechanical contact force. If the contact pressure falls below the specified limit, the control unit (12), It either fails to start the ultrasonic output or stops the current application. Thus  Energy losses that may occur due to inadequate coupling and incorrect applications. is being prevented. Contact or pressure sensor (23), piezoresistive sensor, capacitive sensor, force one of the following: sensor resistor (FSR), strain gauge or microelectromechanical sensor 10 This can be achieved using [method / technique]. Temperature sensor (24): Ultrasonic transducer (16), power driver (15) or ear It is a safety sensor that monitors temperature increases that may occur on its surface. Temperature sensor (24) may occur during long-term ultrasound applications. It ensures user safety by detecting overheating at an early stage. Temperature sensor (24), NTC, PTC, digital temperature sensor, thermocouple or infrared This can be accomplished using one of the temperature sensors.  If the specified safety temperature is exceeded, the control unit (12) outputs reducing its power, temporarily suspending the application, or banning the user It can provide a warning. Acoustic / electrical output verification sensor (25): Ultrasonic transducer (16)  a check to verify whether it actually produces the intended acoustic output It is a sensor. Thanks to this sensor, the system only detects when a driving signal is generated. not only the actual acoustic energy transferred to the biological tissue It ensures verification. 3 22 Acoustic / electrical output verification sensor (25), second piezoelectric element, back EMF measurement, impedance analysis, microphone, near-field acoustic sensor, or This can be done using one of the echo measurement systems. The closed-loop control algorithm evaluates the data from this sensor. automatic adjustment of carrier frequency, output amplitude, or active damping parameters. It can be changed accordingly. Auricle (27): Where the ultrasonic transducer (16) is mechanically positioned. It is the anatomical structure in which the auricular vagus nerve branches are located. The auricle (27), 10 while performing the function of mechanical support that enables the device to be moved, It also creates a surface through which ultrasound energy will be transferred to biological tissue. Different anatomical regions of the auricle have different nerve densities. Therefore, the system selects the appropriate target area according to the user's anatomy. It allows for selection. Conchae / cymba conchae region (28): Densely populated with auricular vagus nerve branches and is the most preferred target in neuromodulation applications It is an anatomical region. The concha / cymba conchae region (28), ultrasonic energy to the nerve  its superficial anatomical structure that allows efficient transfer to the fibers It is preferred for this reason. Ultrasonic transducer (16) through acoustic coupling element (17) this region controlled low-power mechanical-acoustic energy packets are placed on it. It ensures that it is implemented in this way. Tragus or near auricular region (29): Branches of the auricular vagus nerve This is an alternative target application site that can be reached. Tragus or near auricular region. (29), alternative to the concha region depending on the user's anatomy or It can be used as a complementary application point. 30 3 The control unit (12) receives sensor data in different target regions. By evaluating the situation, we can determine the most suitable application area and, if necessary... It can automatically optimize application parameters. This structure allows for different It contributes to maintaining effectiveness in user anatomies.  Second ultrasonic transducer (30): Together with the first ultrasonic transducer (16) or functioning independently and the different anatomical structures of auricular vagus nerve stimulation auxiliary acoustic energy that enables implementation in regions It is a transducer. The second ultrasonic transducer (30) is placed on a different ear in the same ear. It can be placed on the target point as well as on the opposite ear. It can be positioned. Thus, the system can be unilateral, bilateral, simultaneous or It is capable of performing alternating ultrasonic neuromodulation applications. The second ultrasonic transducer (30) has the same structure as the first ultrasonic transducer (16). or piezoelectric elements with different resonance characteristics 1) It can be created. The control unit (12) controls both transducers independently. It can be managed as follows: different carrier frequencies, different envelope parameters, or different It can apply output levels. Thus, user-specific neuromodulation is possible. protocols can be implemented.  In one application, a second ultrasonic transducer (30) was used for verification purposes only. can be operated and the acoustic field created by the first transducer It can enable measurement. In another application, two transducers are used simultaneously. By running the device for a longer period, a wider area of ​​auricular stimulation can be created. Additionally, by applying phase-controlled driving, constructive or destructive transmission occurs between the two transducers. It is possible to create interference and control the acoustic energy distribution. is happening. Ultrasonic carrier (31): Created by the ultrasonic carrier signal generator (13) and high  which enables the ultrasonic transducer (16) to produce mechanical vibration. Ultrasonic carrier (31) is the basic electrical signal with frequency. It forms the basis of the mechanical-acoustic energy it transfers to the tissue. 4 Ultrasonic carrier (31), preferably in the range of 200 kHz to 600 kHz, more preferred In applications, it is generated at a center frequency of approximately 300 kHz. However, transducer resonance, biological tissue loading, and application It can also be produced in different frequency ranges depending on its purpose.  The control unit (12) measures the frequency of the ultrasonic carrier, the transducer impedance, and the phase. information is continuously available based on current, voltage, or acoustic feedback data. It can be adjusted. Thus, the resonance point is maintained and energy conversion is achieved. Efficiency is being increased. 10 Ultrasonic carrier (31), instead of being applied continuously alone, low frequency By operating it together with the opening-closing envelope (32), biological nerve stimulation is further enhanced. It generates suitable pulse packages. Low frequency opening and closing envelope (32): Ultrasonic carrier (31) at a specific time  low-level settings that allow it to be enabled and disabled within certain intervals. It is a low-frequency timing signal. Low-frequency switching envelope (32), continuous By creating pulsed ultrasound packets instead of applying ultrasound directly, mechanically- It enables the controlled transfer of acoustic energy to the target tissue.  Low frequency switching envelope (32), preferably in the range of 20 Hz to 30 Hz It is currently operating at a repeat frequency of approximately 25 Hz in the most preferred applications. It has approximately 20 ms per cycle when run at approximately 50% duty cycle. It consists of open and closed periods of approximately 20 ms. 2 During the off period, the power driver and impedance matching network (15) activate the transducer. By switching to damping mode, it now suppresses vibrations. Thus, it is open and Clear transitions are created between closed states, and only the target nerve is accessed. Ultrasonic energy is applied for the desired duration. 3 Macro session cycle (33): Stimulation consisting of low-frequency pulse packets the application of blocks at specific intervals and rest periods between these blocks 2 It is the overarching scheduling mechanism that enables the creation of intervals. Macro session cycle (33), biological adaptation in long-term neuromodulation applications in order to keep it under control and optimize energy consumption It is used.  Macro session cycle (33), e.g. 30 seconds active stimulation and 60 seconds rest It can consist of periods. However, this depends on the purpose of the application. Active and passive times can be changed via the software. The control unit (12) receives physiological feedback from the sensor unit (20) 10 By evaluating it, we can dynamically change the macro session cycle and each It can create personalized treatment protocols for the user. Body or rear carrier (35): The electronic circuits located within the system, Main unit where ultrasonic transducers and mechanical coupling elements are transported together. It forms the structural body. The body or rear carrier (35) forms the mechanical body of the device. It increases durability while also ensuring user ergonomics. Body or rear carrier (35), biocompatible polymers, engineering plastics, It can be produced from composite materials or lightweight metal alloys. Its structure is  curved or flexible to conform to ear anatomy It can be designed. Inside the fuselage are the battery, control electronics, communication module, and other components. While electronic components are protected, they are also resistant to external environmental influences such as water. It is also possible to create a structure that is resistant to dust and impact. Acoustic adaptation / back damping layer (36): Back of ultrasonic transducer located on its surface and enabling the suppression of unwanted mechanical vibrations. It is the acoustic regulation layer. Acoustic harmony / back damping layer (36),  By reducing the spread of energy generated by the transducer in the background, the energy is distributed. It ensures that the tissue is directed to the target biological tissue.  This layer consists of epoxy-based composites, tungsten-reinforced polymers, and elastomeric materials. damping materials, acoustic foams or high internal damping composites It can be produced. Acoustic matching / back damping layer (36) determines the transducer resonance characteristic. improving, optimizing bandwidth and addressing post-impact situations Mechanical residual vibrations are reduced. Thus, pulse-enveloped ultrasound In their applications, open and closed states are becoming more distinct, and Neuromodulation efficacy is increased. 10 How the Invention Works The invention relates to the anatomical branches of the auricular vagus nerve located on the auricle. mechanical-acoustic energy without the use of electrical neurostimulation electrodes a pulse-enveloped ultrasonic neuromodulation system that enables its application It is related to. Unlike existing systems, the invention uses high-frequency ultrasonic technology. The carrier signal and the low-frequency physiological stimulation envelope are independent of each other. It uses a multi-layered scheduling architecture that creates this. Thus Ultrasonic energy is delivered to the target tissue only at specified time intervals. and controlled, repeatable and safe transmission of the auricular vagus nerve. This ensures that the animal is stimulated in this way.  The operation of the system requires electrical energy from the power supply (11). It starts with providing power. The power supply is used for charging in portable applications. This can be done using rechargeable batteries or disposable batteries, as well as in clinical settings. external DC sources or wireless power transfer in applications  It can also be powered by control systems. The energy obtained from the power source is used to control the system. unit (12), ultrasonic carrier signal generator (13), envelope / gating modulator (14), power driver and impedance matching network (15), sensor unit (20) and communication It is distributed in a controlled manner to all electronic subsystems such as module (21). Thanks to power management circuits, sudden current changes are balanced, and the battery  The lifespan is increased, ensuring the system operates stably for a long time.  Control unit (12), central control that manages all functions of the system. It is a component. Microcontroller, microprocessor, FPGA, DSP or application-specific This unit, which can be implemented using integrated circuit architectures, is ultrasonic. separate the carrier signal generator (13) from the envelope / gating modulator (14) It controls through independent time bases. Thanks to this architecture  The frequency of the ultrasonic transmitter and the physiological stimulation rhythm are independent of each other. It is adjustable and has optimum parameters for different application scenarios. Combinations can be created. At the same time, data obtained from the sensors... Feedback data is evaluated in real time and the system The parameters are updated dynamically. 10 Ultrasonic carrier signal generator (13) for driving ultrasonic transducer It produces a high-frequency electrical signal. The generated signal is sinusoidal, square. wave, multi-level square wave, resonant coherence, or harmonic content It can be one of the confined waveforms. In the invention, the carrier frequency is 1. Generally selectable between 20 kHz and 2 MHz, the auricular vagus wave... The most suitable working range for nerve stimulation is between 200 kHz and 600 kHz. It has been determined as follows: Specifically, a nominal carrier frequency of approximately 300 kHz. preferred in terms of transducer efficiency, tissue penetration, and acoustic energy transfer. This is the operating point. In addition, the control unit determines the transducer impedance,  by monitoring phase information, current and voltage values, or acoustic feedback It automatically tracks the resonance frequency and changes the operating frequency. It continuously optimizes itself according to load conditions. Thus, it optimizes the ear anatomy. Differences or changes in contact conditions negatively affect energy transfer. It does not affect.  The generated high-frequency carrier signal is modulated by the envelope / gating modulator (14). It is converted into low-frequency pulse packets. The envelope signal is generally 1 It can be produced between 20 Hz and 200 Hz, especially in the 20 Hz to 30 Hz range. It preferably operates at a repeat frequency of approximately 25 Hz. Thus, the carrier signal is  It is not applied continuously; it is approximately 20 ms on and approximately 20 ms off. controlled pulse packets consisting of intervals are delivered to the target area. 2 is transmitted. In the closed state, only the driving signal is interrupted. not only is active damping required by the power driver, but it is also necessary. By applying this method, residual mechanical vibrations that may occur in the transducer are suppressed. In this way, sharp boundaries are created between open and closed states, and Unwanted acoustic energy transfer is significantly reduced. Power driver and impedance matching network (15), low power carrier signal ultrasonic It upgrades the transducer to a level where it can operate. This unit is a half-bridge, full-bridge. bridge, using class D, class E or resonant power amplifiers This can be achieved with transformers using series or parallel LC circuits. In this way, the transducer impedance is matched to the driver circuit. This reduces electrical power losses and maximizes acoustic energy production. is provided. Ultrasonic transducer (16), piezoelectric or similar transducer technologies 1 It converts electrical energy into mechanical vibrations using a transducer. They can be generated as single-element or multi-element arrays; in straight, curved, and focused forms. or can be realized in phase-controlled geometries. The produced ultrasonic energy directly to the auricular target via an acoustic coupling element (17) It is transferred to the region (19). The acoustic coupling element eliminates air gaps. by removing and creating acoustic impedance matching, and the biological use of ultrasound energy It ensures that the tissue is delivered with high efficiency. The fastening element (18) used in the invention is an ear clip (18a), an ear hook. (18b), adhesive or flexible carrier (18c), ear mold, magnetic holder or  It can be constructed from similar mechanical fasteners. Thus, the system, By adapting to different ear anatomies, the transducer remains stable in the target area. This makes it possible to position the system in this way. In particular, the system can only Thanks to its design that provides support to the earlobe and surrounding area, the head bulky carrier bands passing over it or fixed devices placed inside the ear canal  Alignment elements are not required.  The auricular target region (19) is densely populated with cutaneous branches of the vagus nerve. cymba conchae, cavum conchae, concha base, tragus, antitragus, It is selected from the antihelix or similar anatomical regions. Second ultrasonic In applications where a transducer (30) is used, the system detects two different points in the same ear, It can stimulate both ears simultaneously or alternately, or with two transducers. by performing phase-controlled operation between them, acoustic energy distribution It can direct. The system operates as a completely closed loop thanks to the sensor unit (20). The contact or pressure sensor (23) measures the contact between the transducer and the ear surface. monitoring whether it is sufficient; temperature sensor (24), in long-term applications monitoring potential temperature increases; acoustic or electrical output The verification sensor (25) confirms that the targeted acoustic vibration actually occurs. This is confirmed by accelerometers, optical sensors, and photoplethysmography. Data from ECG, EEG, skin conductivity and other physiological sensors are also included. This information can be passed on to the control algorithm. Based on this information, the control unit, carrier frequency, envelope frequency, duty cycle, output amplitude, macro session It can automatically adjust the cycle and application time. One of the key features of the invention is that three different time scales can be used together. It is usable. It operates at approximately 300 kHz on the first time scale. When an ultrasonic carrier is generated, it repeats at approximately 25 Hz on the second timescale. Pulse packets are generated by a frequency-controlled on-off envelope. Third In terms of time scale, the macro session cycle (33) comes into play and for example 30 Long-term stimulation is achieved by creating 60-second active stimulation followed by 60-second rest periods. Neuromodulation applications are being carried out. Thus, biological adaptation is achieved. Energy consumption is being reduced, optimized, and user safety is being improved. is being increased. One of the most important technical features is the direct electrical impulse delivery to the auricular target region. The absence of electrode pairs delivering neurostimulation current. Electrical energy It is used solely for the purpose of driving an ultrasonic transducer, not for nerve stimulation. 3 This is achieved entirely through mechanical-acoustic energy. Thus Contact impedance changes resulting from the use of electrical electrodes, gel Dryness, skin irritation, and electrode placement problems are eliminated. Benefits of the Invention The most important technical benefit provided by the invention is the electrical activity of the auricular vagus nerve. the ability to be stimulated solely by mechanical-acoustic energy without the use of electrodes This structure provides a solution for classical electrical auricular vagus stimulation. Skin-electrode impedance variations encountered in these systems, electrode gel Application issues such as drying, changes in contact resistance, and skin irritation. Problems that negatively affect its stability are eliminated. As a result... a more stable and repeatable neuromodulation effect is obtained in each application. is being done. Another important advantage of the invention is the combination of ultrasonic carrier frequency and low frequency 1. The ability to create independent neuromodulation timing. In this way, high-frequency mechanical vibrations at approximately 300 kHz, applied in conjunction with a physiological stimulation rhythm at a repetition frequency of approximately 25 Hz Controlled energy packets are delivered to the nerve tissue. This is a multi-layered process. The timing architecture is more efficient compared to simply applying continuous ultrasound. It provides a controlled energy distribution and higher temporal accuracy. The use of an active damping mechanism ensures a reduction in shock packets. It largely eliminates residual mechanical vibrations remaining on the transducer. It eliminates unwanted acoustic energy transfer in enclosed spaces. This is prevented, impact edges are sharpened, and the targeted stimulation profile is more precise. It is being formed correctly. This is especially true for low-frequency pulsed devices. It provides a significant technical advantage in ultrasound applications. Thanks to the resonance tracking mechanism working together with the impedance matching network,  The transducer is always kept close to the optimum operating point. Ear differences in anatomy, changes in contact pressure, or temperature-related factors. 31 Resonance shifts are automatically compensated, thus improving acoustic energy production. Efficiency is consistently maintained at a high level. This feature reduces both energy consumption. This reduces and also improves the long-term performance of the device. Closed-loop control architecture allows the system to operate in real time. This enables the assessment of conditions such as contact quality, temperature, and acoustics. Output and physiological feedback are continuously analyzed; carriers are monitored when necessary. frequency, envelope frequency, duty cycle, driving amplitude, or macro session The parameters are automatically readjusted. Thus, the user Safe and optimized operation without the need for intervention 10 is provided. Thanks to its modular attachment system, the device can be easily adapted to different ear anatomies. It is adaptable. Such as ear clip, ear hook or flexible carrier. Thanks to different mounting options, the transducer remains stable in the target area. while being held, bulky support systems are needed that pass over the head. It is not audible. This improves the ergonomics of the device and its daily use. It simplifies things and increases user comfort during long-term use. Active stimulation in long-term applications thanks to the macro session loop structure  and rest periods are managed in a controlled manner. Thus, biological reducing adaptation, preventing unnecessary energy consumption and battery It is possible to extend the usage period. At the same time, different clinical settings... Personalized treatment protocols can be created to suit specific applications. 2 The invention features control algorithms that can be updated via software, and allows for the integration of different sensors into the system. easy integration, support for single or multiple transducer architectures and thanks to its modular design and adaptability to different ultrasonic working scenarios. It offers a scalable platform. These features mean the system is not only for auricular Not for vagus nerve stimulation, but for different peripheral nerves that may be developed in the future. to create a suitable technological infrastructure for neuromodulation applications It provides. 32 To fulfill all the purposes stated above and those that can be derived from the detailed explanation. Invention to enable the introduction of pulse-enveloped ultrasonic auricular vagus nerve stimulation. It is related to the system. 

Claims

 REQUESTS 1. The invention relates to a target area of ​​the ear where a branch of the auricular vagus nerve is located. (19) an ultrasonic transducer suitable for mechanical-acoustic energy transfer (16), an acoustically connecting the transducer (16) to the target region  coupling element (17), a fastening element (18), a control unit (12), a carrier signal generator (13), an envelope / gating modulator (14) and a power It is a transcutaneous auricular stimulation system containing a driver (15), and its feature is; an ultrasonic carrier signal generator (13) in the range of 200 kHz to 600 kHz producing carrier (31), envelope / capping modulator (14) ultrasonic 10 the carrier according to an envelope (32) with a repeat frequency of 20 Hz to 30 Hz. acoustic output condition with a maximum of 20% of the acoustic output in the first condition. periodically between the corresponding second acoustic output state switching and electrical neurostimulation to the ear target region (19) It contains a stimulation electrode that comes into contact with the skin to transmit the current. It is characterized by...

2. The invention describes the transducer driving signal of an auricular ultrasonic stimulation device. It is an in-device generation method, characterized by its frequency range of 200 kHz to 600 kHz. Generating an electrical ultrasonic carrier signal within the range of  the first drive of the signal according to an envelope with a repetition frequency of 20 Hz to 30 Hz with its condition having a maximum amplitude of 20% of the first driving condition. switching between the second driving state and the switched signal Transfer of impedance to ultrasonic transducer (16) via impedance matching network (15) It is characterized by including its steps.  3. It is a system according to claim 1, and its characteristic is; — the ultrasonic carrier (31) should be in the range of 250 kHz to 350 kHz It is characterized by   4. It is a system according to claim 1, and its characteristic is; — with the envelope repeat frequency being between 23 Hz and 27 Hz It is characterized by...  5. It is a system according to claim 1, and its characteristic is; — the acoustic pressure amplitude in the second acoustic output state is the same as the first Acoustic pressure amplitude in acoustic exit case is no more than 10%. It is characterized by being. 10 6. It is a system according to claim 1, and its characteristic is; — with the duty rate of the envelope (32) being between 20% and 80% It is characterized. 1) 7. It is a system according to claim 1, and its characteristic is; — the nominal 300 kHz, envelope repeat frequency of the ultrasonic carrier (31) nominal 25 Hz, envelope duty cycle of 40% to 60%, and second acoustic  acoustic pressure amplitude in the outlet state compared to the first state Characterized by having an acoustic pressure amplitude of no more than 10%. is being done.

8. It is a system according to claim 1, and its characteristic is;  — at the beginning of the closed gap, the transducer (16) has high impedance damping by taking in, short-circuiting or active counter-phase driving a damping circuit that performs at least one of these operations It is characterized by its inclusion.   9. It is a system according to claim 8, and its characteristic is; — the beginning of the open gap is the zero-pass of the ultrasonic carrier or Phase-controlled synchronization with a predetermined phase angle It is characterized by the inclusion of gating.

10. It is a system according to claim 1, and its characteristic is; — Active blocks lasting from 1 second to 120 seconds, and from 1 second to 600 seconds. Macro session consisting of rest blocks lasting 10 seconds It is characterized by the application of the cycle (33).

11. It is a system according to claim 1, and its characteristic is; — auricular target area (19) cymba conchae, cavum conchae,  concha base, tragus, antitragus, circumference of the crus helix, antihelix, outer at least one of the following areas: the area around the entrance of the ear canal or the area behind the ear. It is characterized by its being.

12. It is a system according to claim 1, and its characteristic is;  — fastening element (18), ear clip (18a), ear hook (18b), ear mold, adhesive or flexible carrier (18c), spring-loaded at least from the clamp, magnetic holder or spectacle frame attachment one of them and the system passing through the parietal region of the head  a band that fits securely at the entrance of the ear canal, fixed in relation to the transducer. the need for the combined use of a positioned alignment protrusion It is characterized by deafness.

13. It is a system according to claim 1, and its characteristic is;   — ultrasonic transducer (16) PZT, lead-free piezoceramic, PVDF, PMUT, CMUT, piezocomposite or magnetostrictive elements It is characterized by containing at least one of them.  14. It is a system according to claim 1, and its characteristic is; — acoustic coupling element (17) silicone, polyurethane, thermoplastic elastomer, hydrogel, acoustic gel, liquid-filled membrane or multi 10 by including at least one of the layered impedance matching pads It is characterized by...

15. It is a system according to claim 1, and its characteristic is; — a transducer working in one ear, 15 transducers working simultaneously in both ears Transducers, or first and second transducers that work alternately in both ears. It is characterized by containing transducers (16, 30).

16. It is a system according to claim 1, and its characteristic is;  — contact or pressure sensor (23), temperature sensor (24) and acoustic or at least one of the electrical output verification sensors (25) including and control unit (12) sensor measurement within the defined limit When outside, it does not initiate, reduce, or stop the output. It is characterized by its stopping power.  17. It is a system according to claim 1, and its characteristic is; — transducer (16) impedance, phase, current, voltage or acoustic feedback According to the return measurement, the carrier frequency is between 280 kHz and 320 kHz. scanning within the range and selecting resonance or yield study  by including a frequency tracking scheme that locks onto that point It is characterized by...

18. It is a system according to claim 1, and its characteristic is;  — heart rate, heart rate variability, respiration, photoplethysmography, electrocardiography, electroencephalography, skin conductivity, pupil a physiological person who takes at least one of the diameter or movement measurements It is characterized by containing a sensor unit (20). 10 19. It is a system according to claim 1, and its characteristic is; — applied carrier and envelope parameters and sensor data a memory (22) that records and transfers the recordings to an external device  by including a wired or wireless communication module (21) It is characterized by...

20. It is a method according to Claim 2, and its characteristic is; — carrier nominal 300 kHz, envelope nominal 25 Hz and duty cycle  characterized by establishing a ratio of 40 to 60 percent. is being done.

21. It is a method according to Claim 2, and its characteristic is; 2 — initiation at the carrier zero crossing of each open interval and each closed interval characterized by active attenuation of the transducer in the interval. is being done.

22. It is a method according to claim 2, and its characteristic is;   — an output of the transducer in both the open and closed states. Measurement via the verification sensor (25) and in the closed state When the output exceeds 20% of the first state, the driving signal is activated. It is characterized by its reduction or cessation.

23. It is a system according to claim 3, and its characteristic is; — the ultrasonic carrier (31) should be in the range of 280 kHz to 320 kHz It is characterized by 10.

24. It is a system according to claim 4, and its characteristic is; — with the envelope repeat frequency being in the range of 24.5 Hz to 25.5 Hz It is characterized. 1) 25. It is a system according to claim 5, and its characteristic is; — the acoustic pressure amplitude in the second acoustic output state is the same as the first Acoustic pressure amplitude in acoustic exit case is at most 5%  It is characterized by its being.

26. It is a system according to claim 6, and its characteristic is; — with the duty rate of the envelope (32) being between 40% and 60%  It is characterized by...

27. It is a system according to claim 8, and its characteristic is;  — after the end of the open range, the transducer (16) acoustic its output in less than 2 ms to below 10% of the first state It is characterized by its lowering effect.

28. It is a system according to claim 10, and its characteristic is;  — macro session cycle (33), 30 seconds active and 60 seconds It is characterized by being composed of resting blocks.

29. It is a system according to claim 16, and its characteristic is; 10 — acoustic output verification sensor (25) target in open range that vibration occurs and in the closed space the first vibration is no longer present. characterized by confirming that the situation remains below 10%. It is being done. 1) 30. It is a system according to claim 18, and its characteristic is; — carrier according to the physiological sensor measurement of the control unit (12) frequency, envelope frequency, duty cycle, open time, closed time, driving  amplitude, macro session cycle, or ear selection by setting at least one of its parameters to closed loop It is characterized by...

31. It is a system according to claim 23, and its characteristic is;  — the ultrasonic carrier (31) should be in the range of 295 kHz to 305 kHz It is characterized by... 3 32. It is a system according to claim 24, and its characteristic is;  — characterized by a nominal envelope repetition frequency of 25 Hz. is being done.

33. It is a system according to claim 26, and its characteristic is;  — It will provide a 50% duty cycle at a 25 Hz envelope repeat frequency. by creating 20 ms open and 20 ms closed intervals It is characterized by... 10 34. It is a system according to claim 31, and its characteristic is; — the ultrasonic carrier (31) nominal 300 kHz and operation characterized by keeping the frequency within ±2% of the nominal value. It is being done. 1)

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