Ear clip type ultrasonic vagus nerve regulation and control device and use method thereof

Abstract

The invention discloses an ear clip type ultrasonic vagus nerve regulation and control device and a control method thereof, and belongs to the technical field of biomedical engineering and wearable equipment. The device adopts a shell assembly imitating a TWS earphone, and an ultrasonic transducer, a driving circuit module, an optical auxiliary positioning module, a monitoring module, a control module and the like are highly integrated in the shell assembly. The method is characterized in that a system unlocks ultrasonic stimulation only when an optical positioning result is confirmed to be valid by a user, so that the accuracy of a target spot is ensured; in the stimulation process, automatic safety protection is executed by monitoring the temperature and the contact state in real time. According to the control method, subjective feedback and objective monitoring data of a user are fused, and personalized self-adaptive adjustment of stimulation parameters is achieved. The problems that traditional equipment is heavy, inaccurate in positioning and lack of intelligent safety control are solved, and an accurate, safe and comfortable ultrasonic nerve regulation and control solution capable of being worn daily is provided.

Description

An ear clip-on ultrasonic vagus nerve modulation device and its usage method Technical Field

[0001] This invention relates to the fields of biomedical engineering and wearable device technology, and in particular to an ear clip-on ultrasonic vagus nerve modulation device and its usage method. Background Technology

[0002] Neuromodulation techniques, particularly non-invasive peripheral nerve stimulation (TANS), have become an important research direction for treating neurological diseases and regulating autonomic nervous system function. The vagus nerve, the longest cranial nerve in the human body, has auricular branches distributed in specific areas of the auricle (such as the concha and antitragus), making transauricular vagus nerve stimulation (taVNS) a promising approach for intervening in mood disorders and inflammatory responses. Ultrasound, as an emerging neuromodulation modality, has attracted attention due to its non-invasive nature, adjustable penetration depth, and high spatial resolution. Compared to traditional electrical stimulation, it reduces skin discomfort and provides deeper tissue penetration.

[0003] However, applying ultrasound technology to everyday wearable modulation of the vagus nerve in the ear still faces a series of key technical challenges: First, existing ultrasound neuromodulation devices are generally bulky and cumbersome. Traditional ultrasound transducers and their associated drive circuits and power amplifiers are usually desktop or handheld designs, which cannot achieve stable, comfortable, and discreet long-term wear, severely limiting their application in home or everyday scenarios. Although there are some studies attempting miniaturization, how to highly integrate the ultrasound transmitting unit, control circuit, power supply, etc., into a single ear clip device, and solve the resulting problems of heat dissipation, electromagnetic interference, acoustic coupling efficiency, and wearing comfort, remains an unsolved engineering challenge.

[0004] Secondly, precise localization and maintenance of the stimulation target are difficult. The curvature of the auricle surface is complex, with significant individual differences, and the distribution area of ​​the auricular branch of the vagus nerve is relatively small. Current technology lacks a precise localization and guidance mechanism that can be intuitively operated by the user and integrated into a miniature device. It usually relies on the operator's experience and external imaging equipment, making it difficult to ensure that the ultrasound energy can be precisely focused on the target nerve area every time it is worn, resulting in unstable stimulation effects and poor repeatability.

[0005] Furthermore, the existing equipment lacks sufficient intelligence and safety control. Most devices employ an open-loop stimulation mode, with fixed outputs after parameter presets, making real-time adjustments impossible based on wearing status, tissue response, or user subjective experience. There is a lack of effective real-time monitoring and safety protection mechanisms for device operating conditions (such as transducer temperature and probe-skin contact quality), potentially leading to ineffective stimulation or safety risks due to overheating or poor contact. Simultaneously, treatment plans heavily rely on generic parameters, failing to achieve personalized dynamic adjustments based on individual physiological feedback and subjective experience, thus impacting the maximization of therapeutic efficacy and user experience.

[0006] Therefore, there is an urgent need in this field for a control device and method that can miniaturize a complete ultrasound stimulation system and achieve intelligent adaptive optimization of treatment parameters. Summary of the Invention

[0007] In view of this, the purpose of the present invention is to provide an ear clip-on ultrasonic vagus nerve modulation device and its method of use. This device can miniaturize a complete ultrasonic stimulation system and integrate it into a comfortable ear clip form of a TWS (True Wireless Stereo) earphone; integrate intuitive optical-assisted positioning function to ensure that the user can accurately and repeatedly align the stimulation target point; and achieve intelligent adaptive optimization of treatment parameters, thereby providing users with a precise, safe, comfortable and personalized daily wearable ultrasonic neuromodulation device.

[0008] To achieve the above objectives, the present invention provides the following technical solution: The ear clip-type ultrasonic vagus nerve modulation device provided by the present invention includes a shell assembly, and an ultrasonic transducer, a drive circuit module, an optical auxiliary positioning module, a monitoring module, a control module, and a power supply module integrated within the sealed cavity of the shell assembly; the ultrasonic transducer has its radiating surface facing the acoustic coupling surface disposed at the front end of the shell; the drive circuit module is electrically connected to the ultrasonic transducer; the optical auxiliary positioning module is disposed adjacent to the ultrasonic transducer and is used to project a positioning light spot onto the auricular skin; the monitoring module includes a temperature sensor and a contact sensor, respectively used to monitor the ultrasonic... The transducer's operating temperature and the device's contact state with the skin; the control module, electrically connected to the drive circuit module, optical auxiliary positioning module, and monitoring module; the power supply module, supplying power to each module; the control module is configured to: receive positioning status signals from the optical auxiliary positioning module; generate an enable signal to unlock the drive circuit module after obtaining valid positioning confirmation; receive data from the monitoring module in real time during ultrasound stimulation and execute safety protection logic based on a preset safety threshold; wherein, the ultrasound transducer, drive circuit module, control module, and power supply module are interconnected and integrated within the sealed cavity via a flexible circuit board.

[0009] Furthermore, the control module also includes an evaluation logic unit, and the device also includes a wireless communication unit; the evaluation logic unit is configured to: receive subjective feedback information from an external terminal device through the wireless communication unit, and combine it with objective data from the monitoring module to adaptively optimize and adjust the ultrasound stimulation parameters.

[0010] Furthermore, the user's subjective feedback information is a periodic quantitative comfort score; the adaptive optimization adjustment includes: automatically reducing the intensity of ultrasonic stimulation when the comfort score is lower than a first threshold for a predetermined number of consecutive times; and / or slightly increasing the stimulation intensity within a safe range when the score is higher than a second threshold.

[0011] Furthermore, the acoustic coupling surface is made of flexible silicone material, with a coupling pad embedded inside, and is sealed and connected to the radiation surface of the ultrasonic transducer.

[0012] Furthermore, the optical auxiliary positioning module is a miniature laser emitter, whose output light path forms a fixed angle with the acoustic beam axis of the ultrasonic transducer, so that the center of the projected positioning spot coincides with the expected projection position of the acoustic beam focus on the skin surface.

[0013] Furthermore, the effective positioning confirmation includes: the control module determining that the optical signal characteristics of the positioning spot covering the target anatomical area meet preset conditions, and receiving a user confirmation command from an external terminal device.

[0014] Furthermore, the safety protection logic includes: when the temperature detected by the temperature sensor exceeds the safe temperature threshold, or when the contact state detected by the contact sensor indicates poor adhesion, the control module immediately controls the drive circuit module to interrupt or reduce the ultrasonic output.

[0015] Furthermore, the power module includes a rechargeable micro lithium battery, a battery management circuit, and supports wireless charging or charging via a dedicated charging case.

[0016] The present invention provides a control method for an ear clip-on ultrasonic vagus nerve modulation device, wherein the device is as described above. The control method includes the following steps: projecting a positioning spot onto the auricular skin through the optical auxiliary positioning module; acquiring and determining the positioning status; after obtaining valid positioning confirmation, the control module generates an enable signal to unlock the drive circuit module; driving the ultrasonic transducer to generate ultrasonic stimulation through the drive circuit module based on user-defined or adaptively generated stimulation parameters; during the stimulation process, collecting operational data in real time through the monitoring module; and the control module performing corresponding safety control operations based on the comparison result of the operational data and a preset safety threshold.

[0017] Furthermore, it also includes a personalized adjustment step: during or between ultrasound stimulation sessions, the user's subjective feedback score is obtained through an external terminal device; the subjective feedback score and the objective data collected by the monitoring module are input into an evaluation algorithm; based on the output of the evaluation algorithm, adjustment suggestions for subsequent stimulation parameters are generated or parameter adjustments are automatically executed to achieve personalized treatment.

[0018] The beneficial effects of this invention are as follows: This invention discloses an ear clip-on ultrasonic vagus nerve modulation device and its control method, belonging to the field of biomedical engineering and wearable medical device technology. The device includes: a shell assembly in the shape of a TWS earphone; an ultrasonic transducer, a drive circuit module, an optical auxiliary positioning module, a monitoring module, a control module, and a power supply module integrated within the sealed cavity of the shell, with each module interconnected via a flexible circuit board. The control module is configured to: unlock ultrasonic stimulation only after obtaining effective positioning based on optical positioning and user confirmation; and to perform real-time safety protection based on multi-dimensional monitoring data such as temperature and contact status during stimulation. The control method includes: optically guided precise positioning, safety interlocking to unlock stimulation, real-time safety monitoring, and parameter adaptive adjustment steps combining user subjective feedback and objective monitoring data. This invention solves the problems of existing ultrasonic neuromodulation devices being bulky and non-wearable, having inaccurate positioning, and low safety and intelligence levels, providing a precise, safe, comfortable, and personalized wearable neuromodulation solution for daily use.

[0019] This device overcomes the shortcomings of existing technologies, such as large transducer size, unstable wearing, difficulty in locating the stimulation area, and outdated control methods. It features a wireless communication unit earphone structure; it can stably fit the vagus nerve area of ​​the auricle; it can be controlled by an external terminal device wireless communication unit; it is portable and wearable; it has a built-in ultrasonic transducer; it supports real-time monitoring; and it supports wireless or charging case charging. This is an ear clip-on ultrasonic vagus nerve modulation device and its control method.

[0020] The above and other objects, advantages, and features of the present invention will be more fully set forth and demonstrated through the following detailed description of specific embodiments in conjunction with the accompanying drawings. Those skilled in the art, upon referring to the following detailed description and the accompanying drawings, will be able to better understand and realize the above advantages of the present invention. Other objects, features, and advantages of the present invention will become clearer after being described in detail in the detailed description section in conjunction with the accompanying drawings. Attached Figure Description

[0021] To make the objectives, technical solutions, and beneficial effects of this invention clearer, the following drawings are provided for illustration.

[0022] Figure 1 is a schematic diagram of the external appearance of the ultrasound vagus nerve modulation device; Figure 2 is a schematic diagram of the installation position of the ultrasound vagus nerve modulation device; Figure 3 is a schematic diagram of the principle of the ultrasound vagus nerve modulation device; Figure 4 is a flowchart of the main working process of the ultrasound vagus nerve modulation device.

[0023] In the diagram, 1 represents the housing assembly, 2 represents the control module, 3 represents the ultrasonic transducer module, 4 represents the power supply, and 5 represents the acoustic coupling surface. Detailed Implementation

[0024] The present invention will be further described below with reference to the accompanying drawings and specific embodiments, so that those skilled in the art can better understand and implement the present invention. However, the embodiments described are not intended to limit the present invention.

[0025] As shown in Figure 1, the ear-clip ultrasonic vagus nerve modulation device provided in this embodiment is characterized by comprising a shell assembly, and an ultrasonic transducer, a drive circuit module, an optical auxiliary positioning module, a monitoring module, a control module, and a power supply module integrated within the sealed cavity of the shell assembly; the shell assembly forms a sealed cavity inside, and its overall shape resembles a TWS earphone; it provides mechanical support and installation space for all internal functional modules; the shell assembly provided in this embodiment is designed for ergonomic wearing: it adopts a flexible ear-clip design similar to Bluetooth earphones, providing a stable clamping force to ensure that the device fits firmly and comfortably against the auricle during use.

[0026] As shown in Figure 2, the shell assembly provided in this embodiment is provided with an acoustic coupling interface: its front end is provided with an acoustic coupling surface (usually flexible silicone with a gel groove) to ensure that the sound waves generated by the ultrasonic transducer can be transmitted to the skin tissue efficiently and with low loss.

[0027] In this embodiment, an elastic ear clip made of flexible polymer material serves as the support body, and an acoustic coupling surface is provided at the front end of the support body. The shape of the ear clip support body matches the contour of the auricle to provide a stable elastic clamping force, so that the acoustic coupling surface can automatically align with the concha cavity or the antitragus area when worn. The shell assembly provided in this embodiment fixes the various components through mechanical connections, and is used to house and fix the control module, drive circuit, transducer, optical module, monitoring sensor and power supply; providing a physical path and exit window for the propagation of optical positioning beam and ultrasonic mechanical wave.

[0028] The ultrasonic transducer has its radiating surface facing the acoustic coupling surface at the front end of the housing. In this embodiment, the ultrasonic transducer, as an energy conversion and execution terminal, converts the electrical energy input from the drive circuit module into mechanical vibration (acoustic energy) of the same frequency, i.e., generates low-intensity pulsed ultrasound (LIPUS) waves. The generated ultrasonic waves are focused or conducted to the vagus nerve target area in the ear through the coupling medium to achieve non-invasive neural modulation. It is directly electrically connected to the output end of the drive circuit module. It is fixed at a predetermined position at the front end of the housing assembly, with its radiating surface aligned with the coupling surface. Its operating temperature, vibration state, etc., are important data acquisition targets of the monitoring module.

[0029] Specific and reasonable range of ultrasonic working parameters: center frequency 0.5-1 MHz, pulse repetition frequency 10-200 Hz, duty cycle 5%-50%, spatial peak time average acoustic intensity <1 W / cm². 2 These parameters are key to defining the implementation boundaries and protection scope of the technical solution. The drive circuit module is electrically connected to the ultrasonic transducer. In this embodiment, the drive circuit module is used for power amplification and signal modulation. It amplifies and precisely modulates the low-voltage, low-current control signal sent by the control module to generate a high-voltage, high-current AC signal that can efficiently drive the ultrasonic transducer. Through a matching network, the circuit output impedance is matched with the electrical impedance of the transducer to maximize energy transmission efficiency. It is controlled by the control module: it receives precise control signals from the control module; its high-voltage output terminal is directly connected to the electrodes of the ultrasonic transducer to provide energy. The optical auxiliary positioning module is set near the ultrasonic transducer and is used to project a positioning light spot onto the auricular skin. In this embodiment, the optical auxiliary positioning module provides visual guidance. During the wearing or adjustment stage, it projects a visible light pattern (such as a laser dot or spot) onto the surface of the auricular skin to provide the user with an intuitive visual reference and assist in aligning the transducer with the target anatomical areas such as the concha and antitragus. The optical-assisted positioning module, used to generate positioning status signals, may integrate a simple photosensor to determine whether the light spot covers a preset area and generate a positioning success status signal. The module is controlled by a control module, receiving on / off commands from the control module and feeding back positioning status signals (such as digital high / low levels) to the control module; it is powered by a power supply module.

[0030] In this embodiment, the positioning status signal is used to automatically determine the positioning status. The optical auxiliary positioning module can also integrate a photosensitive sensor or a reflection detection unit to collect the reflection signal of the positioning light spot on the skin surface of the auricle.

[0031] In this embodiment, the reflected light intensity, reflection distribution, or stability parameters detected by the photosensitive sensor are compared with preset thresholds. When the detection result meets the preset conditions, a positioning status signal indicating successful positioning is generated.

[0032] The positioning status signal can be output in the form of a digital signal. For example, a high level indicates that the positioning is valid, and a low level indicates that the positioning is not completed. Alternatively, multiple levels of status signals can be used to represent different positioning confidence levels.

[0033] In this embodiment, the light-emitting unit of the optical auxiliary positioning module and the ultrasonic transducer complete the relative position calibration during the structural design stage, so that there is a fixed geometric correspondence between the light spot projection direction and the sound beam output direction of the ultrasonic transducer.

[0034] Therefore, when the light spot is projected onto the predetermined reference area of ​​the auricle, the sound beam of the ultrasonic transducer is also simultaneously pointed to the target anatomical position corresponding to the reference area, thereby achieving indirect alignment of the anticonchal cavity or the antitragus region.

[0035] The predetermined reference area can be set based on the anatomical features of the auricle, allowing ordinary users to complete the alignment operation through visual guidance during the wearing process without the need for additional professional positioning steps.

[0036] The monitoring module includes a temperature sensor and a contact sensor, used to monitor the operating temperature of the ultrasonic transducer and the contact state between the device and the skin, respectively. In this embodiment, the monitoring module collects multi-dimensional physical and status data of the device in real time during operation through a data acquisition front-end. The data includes safety data and process efficacy-related data. The safety data includes the operating temperature of the ultrasonic transducer (temperature sensor), the contact impedance / pressure between the transducer and the skin (contact sensor), and the output voltage / current of the drive circuit (electrical sensor). The process / efficacy-related data acquisition includes indirect signals related to physiological responses (such as local skin temperature, photoplethysmography pulse wave, etc.) to provide data for efficacy evaluation. Data upload: The collected analog or digital sensor signals are transmitted to the control module in real time via wired means (such as I2C, SPI, ADC interface). In this embodiment, the monitoring module is powered by a power supply module, and the sensor probe used for signal acquisition is arranged in key parts (such as the back of the transducer, inside the coupling surface) and integrated with the housing assembly.

[0037] Figure 3 shows the schematic diagram of the ultrasound vagus nerve modulation device, which includes a control module, an ultrasound transducer and drive circuit module, an optical auxiliary positioning module, and a power supply module. The control module, as the core processing unit, works in coordination with the drive circuit and optical positioning module. Temperature and contact sensors are integrated into the system as monitoring modules. All modules are connected by circuitry and ultimately integrated into a sealed cavity.

[0038] The control module is electrically connected to the drive circuit module, optical auxiliary positioning module, and monitoring module; the power supply module supplies power to each module; in this embodiment, the power supply module provides electrical energy to all components of the system; it provides stable, reliable, and compliant voltage and current to all modules requiring power (control, drive, optics, and monitoring). It stores electrical energy through a built-in rechargeable battery and includes charging management, voltage conversion, power monitoring, and overcharge / over-discharge protection circuits. Power is provided to the control module, drive circuit module, optical auxiliary positioning module, and monitoring module through a PCB power network, either in parallel or after voltage regulation. Battery power information is sent to the control module.

[0039] The control module is configured to: receive a positioning status signal from the optical-assisted positioning module; generate an enable signal to unlock the drive circuit module only after obtaining valid positioning confirmation; receive data from the monitoring module in real time during ultrasonic stimulation and execute safety protection logic based on a preset safety threshold; wherein the ultrasonic transducer, drive circuit module, control module and power supply module are interconnected and integrated into the sealed cavity via a flexible circuit board.

[0040] The control module in this embodiment is used for aggregating, processing, logically judging, and issuing commands to all generated data; exchanging data bidirectionally with external terminal devices (receiving parameters, sending status, and logs) through a built-in wireless communication unit (such as Bluetooth); converting user-defined stimulation parameters (frequency, PRF, duty cycle, intensity) into specific waveform control digital signals or PWM parameters; analyzing the safety data uploaded by the monitoring module in real time, and immediately generating commands to interrupt or adjust the output of the drive circuit module once the threshold is exceeded; running the algorithm of the evaluation logic unit to analyze the collected status data, evaluate the stimulation effect, and generate parameter adjustment suggestions or automatic fine-tuning commands accordingly to achieve adaptive stimulation; controlling the start and stop of the optical auxiliary positioning module, managing the charging and discharging status of the power supply module, etc.; sending waveform control signals to the drive circuit module and sending switching commands to the optical auxiliary positioning module; receiving all sensor data from the monitoring module and receiving user commands and parameters from the external terminal device; the control module in this embodiment also includes an evaluation logic unit, and the device also includes a wireless communication unit; the evaluation logic unit is configured to: receive user subjective feedback information from the external terminal device through the wireless communication unit, and combine it with the objective data of the monitoring module to adaptively optimize and adjust the ultrasound stimulation parameters.

[0041] In this embodiment, the evaluation logic unit is configured to evaluate the effect of the ultrasound stimulation process. The evaluation process includes the following steps: (I) Acquisition and preprocessing of evaluation data. The evaluation logic unit first acquires the following two types of input data: Objective monitoring data: uploaded by the monitoring module, including transducer operating temperature, transducer-skin contact state parameters, drive signal characteristic parameters, etc.; Subjective feedback data: received from external terminal devices through the wireless communication unit. The feedback information is used to characterize the user's subjective feelings or state changes during the stimulation process.

[0042] In this embodiment, the evaluation logic unit preprocesses the above data, including denoising, normalization, and statistical analysis based on time windows, in order to eliminate the impact of instantaneous fluctuations on the evaluation results.

[0043] (ii) Stimulus effect evaluation model In this embodiment, the evaluation logic unit performs quantitative evaluation of the current stimulus state based on preset evaluation rules or calculation models.

[0044] In this embodiment, the evaluation logic unit constructs a comprehensive evaluation index E to characterize the current ultrasound stimulation state. The calculation method includes, but is not limited to: E=α*O+β*S; where: O represents the objective evaluation parameter calculated from objective monitoring data; S represents the subjective evaluation parameter calculated from user subjective feedback information; α and β are preset or adjustable weight coefficients.

[0045] In this embodiment, the objective evaluation parameter O can be calculated in the following form: O = ω1*T + ω2*C + ω3*D; where: T represents the transducer operating temperature related parameter; C represents the transducer contact state related parameter; D represents the drive signal characteristic parameter; ω1, ω2, and ω3 are preset weighting coefficients.

[0046] The subjective evaluation parameter S can be calculated based on the feedback information input by the user in an external terminal device. In this embodiment, it is quantified by a rating, trend of change, or discrete state mapping.

[0047] In this embodiment, each component of the objective evaluation parameter O can be normalized to limit its value range to between 0 and 1.

[0048] For example, the transducer operating temperature parameter T can be linearly mapped from the real-time measured transducer temperature to a preset safe temperature range. When the temperature is at the lower limit of the safe range, T takes a smaller value; when the temperature is close to the upper limit of the safe threshold, T takes a larger value.

[0049] The transducer-skin contact state parameter C can be quantified based on the transducer impedance change, reflected signal amplitude, or contact pressure sensing signal. When the contact state is good, C takes a better value, and when the contact is poor, C takes a worse value.

[0050] The characteristic parameter D of the driving signal can be calculated based on the stability of the driving signal, the degree of waveform distortion, or the consistency of energy output, and is used to reflect the current working status of the ultrasonic output.

[0051] After the above parameters are normalized, the evaluation logic unit calculates the objective evaluation parameter O according to the preset weight coefficients ω1, ω2, and ω3.

[0052] The above-mentioned comprehensive evaluation index is based on the general method of multidimensional evaluation of stimulation state in the fields of closed-loop neuromodulation and brain-computer interface. By integrating and analyzing objective physiological or engineering monitoring data with subjective user feedback, dynamic evaluation and adaptive adjustment of stimulation effect can be achieved.

[0053] The evaluation model can be implemented using linear weighting, piecewise rules, or other equivalent calculation methods. This invention does not limit the specific mathematical form, and its purpose is to guide the adjustment or safe control of ultrasound stimulation parameters through comprehensive evaluation results.

[0054] (III) Evaluation Result Judgment and Decision Logic The evaluation logic unit compares the comprehensive evaluation index E with the preset target range to determine whether the current stimulus state meets the expected regulatory effect.

[0055] When E falls within the preset target range, the current stimulation parameters are maintained; when E deviates from the preset target range but does not exceed the preset safety threshold, parameter adjustment suggestions or automatic fine-tuning instructions are generated; when E exceeds the safety-related threshold, a protection mechanism is triggered to limit or interrupt ultrasound output.

[0056] In this embodiment, the evaluation logic unit pre-sets a target interval Emin, Emax to represent the expected range of stimulation effect.

[0057] During device operation, the control module periodically or in real time calculates the current comprehensive evaluation index E and compares it with the target range. The determination process is as follows: when the calculated E satisfies Emin ≤ E ≤ Emax, the current ultrasound stimulation state is determined to be within the expected control range, and the control module maintains the current stimulation parameters unchanged; when the calculated E is less than Emin or greater than Emax, but still within the preset safety threshold range, the current stimulation effect is determined to have a deviation trend, and the control module generates parameter adjustment suggestions or automatic fine-tuning instructions to gradually adjust the stimulation parameters; when the calculated E exceeds the safety-related threshold range, the current stimulation state is determined to have potential risks, and the control module triggers a protection mechanism to limit or interrupt the output of the drive circuit module.

[0058] Through the above comparison process, it is possible to classify and control the stimulus state.

[0059] In this embodiment, the safety-related threshold is not a single value, but is determined based on a comprehensive set of multi-dimensional monitoring parameters.

[0060] Specifically, the process of setting the safety threshold includes, but is not limited to, the following aspects: determining the safety threshold range related to the transducer's operating temperature based on the temperature rise tolerance range of biological tissues and medical ultrasound safety standards; determining the threshold conditions corresponding to abnormal contact conditions based on the engineering characteristics of the contact state between the transducer and the skin, such as abnormal changes in contact impedance or significant deviations of the feedback signal from the normal range; and determining the judgment threshold for abnormal drive signals based on the stability and output consistency of the drive signal.

[0061] In one embodiment, when any of the above-mentioned safety-related parameters exceeds its corresponding preset safety threshold, the evaluation logic unit determines that the comprehensive evaluation index E has exceeded the safety allowable range and outputs a protection trigger signal to the control module.

[0062] The safety threshold can be preset at the factory based on engineering test results, or it can be adjusted according to different users or different usage scenarios, provided that safety requirements are met.

[0063] (iv) Adaptive parameter adjustment mechanism In this embodiment, the adaptive adjustment is not based on a fixed threshold judgment method, but on the changing trend, relative relationship or historical comparison results of the evaluation results to gradually adjust the stimulation parameters.

[0064] The adaptive adjustment includes, but is not limited to, one or more of the following methods: adjusting based on the direction of change between the current evaluation result and the historical evaluation result; adjusting based on the relative performance of the evaluation result under different combinations of stimulus parameters; and adjusting based on the convergence trend of the evaluation result during multiple rounds of stimulation.

[0065] In this embodiment, the stimulation parameters include at least one of frequency, pulse repetition frequency, duty cycle, output intensity, and stimulation duration.

[0066] The control module adjusts the above-mentioned stimulation parameters in a single or multiple manner based on the evaluation results output by the evaluation logic unit. The adjustment methods include, but are not limited to: slightly increasing or decreasing a single stimulation parameter; adjusting other parameters while keeping some parameters unchanged; and reconfiguring the parameter combination between consecutive stimulation cycles.

[0067] The adjustment process aims for gradual optimization, avoiding abrupt changes in the stimulus parameters.

[0068] In this embodiment, the acoustic coupling surface is made of flexible silicone material, and a storage tank for accommodating the acoustic coupling medium is formed on its inner side. The opening of the storage tank is sealed and connected to the radiation surface of the ultrasonic transducer.

[0069] In this embodiment, a glue storage tank is provided inside the acoustic coupling surface. The volume of the glue storage tank is designed according to the transducer size and coupling requirements, and its volume range can be from 0.01 mL to 0.5 mL.

[0070] The adhesive reservoir and the ultrasonic transducer are sealed using at least one of the following methods: elastic sealing ring (such as an O-ring); ultrasonic welding to form an integrated structure; or sealing with medical-grade adhesive material. These sealing methods are used to prevent leakage of the coupling medium and maintain stable acoustic performance at the transducer's front end.

[0071] The coupling medium is an aqueous acoustic coupling material with an acoustic impedance close to that of human soft tissue, in order to reduce acoustic interface reflection loss.

[0072] In this embodiment, the optical auxiliary positioning module is a miniature laser emitter. Its output light path forms a fixed angle with the acoustic beam axis of the ultrasonic transducer, so that the center of the projected positioning spot coincides with the expected projection position of the acoustic beam focus on the skin surface.

[0073] The effective positioning confirmation in this embodiment includes: the control module determining that the optical signal characteristics of the positioning spot covering the target anatomical area meet preset conditions, and receiving a user confirmation command from an external terminal device.

[0074] In this embodiment, the optical signal characteristics of the positioning spot covering the target anatomical area meet the preset conditions, specifically including at least one of the following judgment methods: (1) The positioning spot projected by the optical auxiliary positioning module is set as a visible light pattern with a preset geometric shape and size, and the control module collects the reflected light signal through a photosensitive sensor arranged adjacent to the positioning spot; (2) When the intensity distribution, spot outline integrity or center position stability of the reflected light signal matches the pre-stored target area reference features, it is determined that the positioning spot has covered the target anatomical area; for example, in this embodiment, when the intensity of the reflected light is detected to be within a preset range, and the offset of the spot center position in multiple consecutive sampling periods is less than the preset allowable deviation, the control module determines that the positioning state is valid; (3) After the positioning state is determined to be valid, the control module waits for or receives a user confirmation instruction from an external terminal device to complete the final valid positioning confirmation.

[0075] The safety protection logic in this embodiment includes: when the temperature detected by the temperature sensor exceeds the safe temperature threshold, or when the contact state detected by the contact sensor indicates poor adhesion, the control module immediately controls the drive circuit module to interrupt or reduce the ultrasonic output.

[0076] In this embodiment, the judgment process of the safety protection logic includes: the control module acquires data from the temperature sensor and the contact state-related sensor at a preset sampling period; when it is detected that the transducer operating temperature shows an abnormal upward trend in multiple consecutive sampling periods, or when it is detected that the signal characteristics related to the skin contact state have changed significantly, the control module determines that there is a potential safety risk and immediately controls the drive circuit module to reduce or interrupt the ultrasound output.

[0077] The safe temperature threshold described in this embodiment is determined by one of the following methods: based on the temperature resistance characteristics of the transducer material; based on empirical parameters of skin contact comfort; or obtained through experimental calibration.

[0078] When the transducer temperature exceeds the safe temperature threshold, the control module limits or interrupts the ultrasonic output.

[0079] In this embodiment, the safe temperature threshold can be determined in at least one of the following ways: based on the temperature resistance characteristics of the ultrasonic transducer material; based on engineering experience parameters related to skin contact comfort; or obtained through experimental calibration.

[0080] For example, in one embodiment, the safe temperature threshold may be set in the range of approximately 38 °C to 42 °C; when the transducer surface temperature is detected to exceed the range, or when an abnormal heating rate occurs within a short period of time, the control module limits or interrupts the ultrasonic output.

[0081] The contact state between the transducer and the skin is determined by at least one of the following methods: based on changes in the driving signal impedance; based on changes in the amplitude of the reflected signal; based on abnormal changes in the rate of temperature rise.

[0082] When the above parameters are detected to deviate from the preset range, the control module determines that the contact state is abnormal.

[0083] In this embodiment, the contact state between the transducer and the skin can be determined by at least one of the following methods: (1) Based on the change of driving signal impedance: the control module monitors the equivalent impedance of the transducer driving circuit. When the impedance is detected to be significantly deviated from the normal fit state, the contact state is determined to be abnormal. For example, in one embodiment, when the change of equivalent impedance exceeds about 20% to 40% of the normal working state, it is determined to be poor fit; (2) Based on the change of reflected signal amplitude: the control module collects the echo or reflected signal amplitude of the transducer. When the reflected signal amplitude is significantly higher than the reference value in the normal fit state, it is determined that there is an air gap or poor coupling; (3) Based on the abnormal change of temperature rise rate: when the temperature rise rate of the transducer under the same driving conditions is detected to be significantly higher than the normal range of the historical record, the coupling state between the transducer and the skin is determined to be abnormal.

[0084] When any of the above parameters is detected to deviate from the preset normal operating range, the control module determines that the contact state is abnormal and takes protective measures such as reducing output or interrupting output.

[0085] The power module in this embodiment includes a rechargeable micro lithium battery, a battery management circuit, and supports wireless charging or charging via a dedicated charging case.

[0086] This embodiment provides a control method for an ear clip-on ultrasonic vagus nerve modulation device, wherein the device is the aforementioned ultrasonic nerve modulation device. The control method includes the following steps: projecting a positioning spot onto the auricular skin through the optical auxiliary positioning module; acquiring and determining the positioning status; and, after obtaining valid positioning confirmation, generating an enable signal to unlock the drive circuit module. In this embodiment, the process of acquiring and determining the positioning status includes the following steps: while controlling the optical auxiliary positioning module to project the positioning spot onto the auricular skin, the control module acquires the reflected light signal of the positioning spot on the auricular skin surface through an optical acquisition unit adjacent to the positioning spot; the control module performs feature analysis on the acquired reflected light signal to determine whether the positioning spot covers the target anatomy. In one specific embodiment, the feature analysis includes at least one of the following: determining whether the intensity of the reflected light signal is within a preset effective range; determining whether the spatial distribution or stability of the reflected light signal matches a pre-stored reference feature; determining whether the offset of the center position of the positioning spot within multiple consecutive sampling periods is less than a preset allowable deviation; when the reflected light signal meets at least one of the above preset conditions, the control module determines that the positioning spot covers the target anatomical area and generates a positioning status signal indicating successful positioning; after generating the positioning status signal, the control module further receives a user confirmation command from an external terminal device, and when the positioning status signal and the user confirmation command are simultaneously satisfied, determines that a valid positioning confirmation has been obtained, and generates an enable signal to unlock the drive circuit module.

[0087] Based on user-defined or adaptively generated stimulation parameters, the ultrasonic transducer is driven by the driving circuit module to generate ultrasonic stimulation; during the stimulation process, the monitoring module collects operating data in real time; the control module performs corresponding safety control operations based on the comparison results of the operating data and the preset safety threshold.

[0088] In this embodiment, to achieve automatic determination of the positioning status, the optical auxiliary positioning module may also integrate a photosensitive sensor or a reflection detection unit to collect the reflection signal of the positioning light spot on the surface of the auricle skin. The reflected light intensity, reflection distribution, or stability parameters detected by the photosensitive sensor are compared with preset thresholds. When the detection result meets the preset conditions, a positioning status signal indicating successful positioning is generated.

[0089] The positioning status signal can be output in the form of a digital signal. For example, a high level indicates that the positioning is valid, and a low level indicates that the positioning is not completed. Alternatively, multiple levels of status signals can be used to represent different positioning confidence levels.

[0090] The control module is configured to determine whether the current device is in a valid positioning state based on the positioning status signal.

[0091] In this embodiment, the positioning status can be determined based on at least one of the following conditions: the intensity of the positioning spot reflection signal is within a preset range; the positioning status signal remains stable for more than a preset time threshold; and the positioning status signal does not exhibit significant fluctuations or interruptions. When the above conditions are met, the control module determines that the ultrasound transducer has been aligned with the target anatomical region and allows the device to enter the ultrasound stimulation working state; when the conditions are not met, the control module restricts or prohibits ultrasound output.

[0092] In this embodiment, a personalized adjustment step is also included: during or between ultrasound stimulation sessions, the user's subjective feedback score is obtained through an external terminal device; the subjective feedback score and the objective data collected by the monitoring module are input into an evaluation algorithm; based on the output of the evaluation algorithm, adjustment suggestions for subsequent stimulation parameters are generated or parameter adjustments are automatically executed to achieve personalized adaptation of the treatment.

[0093] In this embodiment, the external terminal device can be a mobile APP to achieve the following functions: human-computer interaction interface: users can use it to set stimulation parameters, start / stop treatment, view real-time status and feedback prompts.

[0094] Data display and recording: Receives and displays treatment logs, historical data, and assessment reports uploaded by the device.

[0095] Adjustment command initiator: Converts the user-confirmed "adjustment suggestion" into a new parameter command and sends it back to the device.

[0096] Wireless two-way communication: Data exchange is conducted with the wireless communication unit within the device's control module via wireless methods such as Bluetooth. Example 2: This example details the specific operation and control process of the ear-clip type ultrasonic vagus nerve modulation device, using an actual working process as an example to illustrate the control method: The device provided in this example is fixed to the user's auricle via an ear clip, and uses low-intensity pulsed ultrasound (LIPUS) signal waves to non-invasively modulate the vagus nerve branches in target areas of the ear (such as the concha and antitragus). The device integrates precise positioning, intelligent control, wireless communication, and safety monitoring functions, aiming to achieve safe, effective, and user-friendly neuromodulation therapy.

[0097] The outer shell of the device is the ear clip support body, made of a flexible polymer material with elastic resilience. Its structure is specially designed to have a limited clamping force range, ensuring that the device can be continuously and stably fixed in the predetermined area of ​​the auricle, while avoiding causing obvious pressure discomfort.

[0098] Geometric constraint positioning design: The bending radius, thickness distribution, and transducer installation position of the support are all designed to match the anatomical structure of the auricle. When worn properly, this design enables the ultrasonic transducer to automatically form a predetermined spatial correspondence with the target area (such as the concha or antitragus), achieving preliminary physical positioning.

[0099] Transducer mounting section: used to fix the ultrasonic transducer.

[0100] Optical positioning module: Integrated near the transducer mounting section, it includes a low-power optical emission unit. During the wearing process, this module projects a visual positioning mark (such as a light spot) onto the surface of the auricle, intuitively indicating the relative position of the current transducer beam axis and the target irradiation area, assisting the user in making fine adjustments to achieve the optimal wearing condition.

[0101] Ultrasonic transducer: It is fixed in a dedicated support structure inside the housing assembly, which strictly defines the spatial position of the transducer relative to the housing assembly and the direction of sound beam emission.

[0102] Sound beam localization: Through the design of the transducer support structure, it is ensured that the ultrasound beam is directed vertically or at a specific tilt angle toward the target nerve region (such as the concha or antitragus) to improve the consistency of ultrasound energy irradiation on the target during each treatment.

[0103] Coupling interface optimization: A flexible acoustic coupling surface is incorporated at the front end of the ultrasonic transducer. This structure is made of a material with an acoustic impedance close to that of human tissue to minimize the reflection loss of ultrasonic energy at the skin contact interface. Microcavities can be designed within the acoustic coupling surface to accommodate acoustic gels or other coupling media, further ensuring efficient transmission of ultrasonic energy.

[0104] The drive circuit module includes a power amplifier circuit, a pulse modulation circuit, and an impedance matching network. Its function is to convert the modulation signal generated by the control module into a low-intensity pulsed ultrasound (LIPUS) signal with specific parameters that can drive the transducer to emit such a signal.

[0105] The control module includes a central control unit and a wireless communication unit. The central control unit processes stimulation parameters and generates corresponding modulation signals to be sent to the drive circuit module. The wireless communication unit establishes a wireless connection with an application (APP) on external terminal devices such as smartphones. It receives ultrasound stimulation parameter commands from the APP and feeds back the device's real-time operating status to the APP.

[0106] Positioning and Treatment Interlock Control: This module is configured to monitor the status of the optical positioning module. The restriction on ultrasound output is only lifted, allowing the device to enter treatment mode, when the system detects a preset correspondence between the optical positioning marker and the target area on the ear (i.e., the positioning conditions are met). This mechanism ensures that treatment is only initiated when the device is worn correctly.

[0107] Parameter Management and Safety Limitations: This function is responsible for generating and controlling key parameters of the low-intensity pulsed ultrasound (LIPUS) signal, including frequency, pulse repetition rate, duty cycle, and output intensity. All adjustable parameters are limited to preset safe operating ranges and can be adjusted according to preset treatment plans.

[0108] Monitoring module: Integrates at least one type of sensor for real-time acquisition of operational monitoring information such as transducer operating temperature, transducer-skin contact status (e.g., contact pressure or impedance), and drive signal characteristics.

[0109] Feedback Assessment and Adjustment Unit (Optional Advanced Function): Based on data collected by the monitoring module, this unit assesses the current ultrasound stimulation status. The assessment may include determining whether the stimulation is in an effective working state or whether it deviates from a preset safe and effective range. Based on the assessment results, this unit can automatically and dynamically adjust the ultrasound output parameters to maintain the stimulation effect.

[0110] Safety protection mechanism: When the operating status deviates from the preset conditions (such as poor contact or increased temperature), the control module can automatically adjust or limit the stimulation parameters. When the operating status exceeds the safety threshold (such as overheating or overload), the control module will immediately interrupt or stop the ultrasonic output to ensure user safety.

[0111] Power module: Provides the necessary operating power for all electronic modules within the device.

[0112] The external terminal device in this embodiment is typically a smartphone or tablet with a dedicated application (APP) installed. Function: It connects to the device via a wireless communication unit. User interaction: Users set and adjust ultrasound stimulation parameters through the APP interface. Status monitoring: It receives and displays real-time operational status information from the device (such as battery level, connection status, treatment progress, safety alarms, etc.).

[0113] Treatment management: Record detailed parameters, timestamps, and key events for each ultrasound stimulation process to form a treatment log for users or medical professionals to conduct subsequent analysis and efficacy evaluation.

[0114] Example 3 is shown in Figure 4. Figure 4 is the main flowchart of the operation of the ultrasound vagus nerve modulation device. When in use, the device is first worn on the ear and the optical auxiliary positioning module is activated to project the light spot. Then, the core working cycle is entered. The system monitors the contact status between the device and the skin and the working temperature. If the status is normal, the ultrasound with the set parameters is output for stimulation. The process ends when the treatment time is up or the user interrupts.

[0115] This embodiment details the implementation process of the control method of the ear clip ultrasonic vagus nerve modulation device. The ear clip ultrasonic vagus nerve modulation device provided in this embodiment has the following structure: (1) Shell assembly: The shell assembly adopts the shape structure design of a wireless communication unit earphone. The overall size is suitable for wearing on the auricle. An electronic module cavity is formed inside to accommodate functional units such as the control module, optical auxiliary positioning module, ultrasonic transducer and power module.

[0116] The outer shell assembly includes an ear clip support body and an acoustic coupling surface. The ear clip support body is made of a flexible material, including TPU, silicone, or other polymer materials with elastic recovery properties, allowing the device to conform to the ear and provide a stable clamping force when worn, thus ensuring the device is stably fixed to the ear during use and does not easily fall off.

[0117] The acoustic coupling surface is located at the front end of the ultrasonic transducer and makes direct contact with the skin of the auricle. The acoustic coupling surface is made of flexible silicone material and can be internally configured with micro-gel grooves to accommodate the acoustic coupling medium, thereby improving the acoustic coupling efficiency between the ultrasonic transducer and the skin of the auricle.

[0118] The optical auxiliary positioning module is located near the transducer mounting part and is used to project a positioning indicator cursor onto the surface of the auricle during the wearing or adjustment phase to indicate the relative positional relationship between the transducer and the concha or antitragus region.

[0119] (2) Control Module: Located on the main board inside the outer casing assembly, it includes a central control unit, an evaluation logic unit, and a wireless communication unit. A microcontroller (MCU or BLE SoC) is used for: generating ultrasound driving parameters; starting and stopping the optical auxiliary positioning module and making judgments; executing the wireless communication unit to achieve bidirectional communication; adjusting stimulation parameters (frequency, PRF, duty cycle, sound intensity); managing power; receiving and processing real-time monitoring data and feedback information; and uploading treatment records. The evaluation logic unit includes an evaluation logic unit. The monitoring module is used to collect multi-dimensional state information related to the treatment process during ultrasound modulation, and to evaluate and adjust the ultrasound stimulation parameters based on the state information, thereby achieving feedback control of the modulation process. In some embodiments, the monitoring information may further include behavioral or subjective feedback information reflecting the subject's immediate response to the modulation stimulus. This feedback information can be input through an external terminal device wirelessly connected to the device.

[0120] (3) Ultrasonic transducer and drive circuit module: The ultrasonic transducer is arranged at one end of the ear clip shell assembly near the inner side of the auricle. Its structure is similar to the installation method of the functional unit in the ear clip headphones and is consistent with the wearing direction of the auricle.

[0121] The transducer and drive circuit module includes a power amplifier circuit, a PWM / Low Intensity Pulse Ultrasonic (LIPUS) signal modulation circuit, and an LC matching network, which are used to convert the output of the control module into a stable ultrasonic drive signal.

[0122] This ultrasonic transducer is fixed inside the outer shell assembly by a support structure, allowing it to stably fit the concha or antitragus region when worn. When the device is in operation, the ultrasonic transducer generates low-intensity pulsed ultrasound (LIPUS) signals in conjunction with the drive circuit module, and applies them to the target area of ​​the ear via a coupling interface to achieve non-invasive ultrasonic modulation of vagus nerve-related branches.

[0123] (4) Power module: including micro lithium battery + matching battery management and protection circuit, and monitoring module electrically connected to the control module, which can support: wireless charging; charging case charging; magnetic charging.

[0124] The monitoring module is used to collect status information related to operational safety. The status information includes, but is not limited to, transducer operating temperature, drive signal characteristics, transducer contact status with skin, or wearing stability.

[0125] The control module judges the ultrasonic output status based on the monitoring information, and limits or interrupts the ultrasonic output when an abnormality is detected, so as to improve the safety of the device.

[0126] This embodiment provides an ear clip-on ultrasonic vagus nerve modulation device that uses a wireless communication unit for ultrasonic stimulation control. Parameters are set via an external terminal device, transmitted by the wireless communication unit, received and parsed by the control module, and the drive circuit module outputs a drive waveform. Optical-assisted positioning is used, and the ultrasonic transducer generates a low-intensity pulsed ultrasound (LIPUS) signal. The real-time monitoring module provides feedback on the contact status / temperature. The APP updates the interface and allows adjustment of stimulation parameters. After stimulation is completed, the device automatically powers off or returns to standby mode and uploads treatment log records.

[0127] Example 4 This example further illustrates the method with specific illustrations and implementation details. Specifically: In this example, the outer shell assembly is integrally injection molded from ABS+TPU, and the internal mainboard uses flexible PCB wiring to adapt to bending structures. The ultrasonic transducer uses a 6mm diameter piezoelectric ceramic sheet, installed at the front end of the earphone, and contacts the skin via a silicone coupling end. An internal gel groove is provided to enhance acoustic coupling.

[0128] Control process: The external terminal device sets the following via the wireless communication unit: ultrasonic frequency: 0.8MHz; duty cycle: 20%; pulse repetition frequency: 100Hz; sound intensity: 0.5W / cm² 2 The control module generates a PWM signal, which is modulated and amplified by the drive circuit module to enable the transducer to output a low-intensity pulsed ultrasound (LIPUS) signal.

[0129] (1) Housing Assembly The housing assembly adopts an ear clip structure, and its overall shape is designed to resemble an ear clip wearable device. The interior forms an electronic module cavity for accommodating the control module, transducer, and power module. The housing assembly includes an ear clip support body, a transducer mounting part, and an acoustic coupling surface.

[0130] The ear clip support body is made of flexible elastic material and its shape matches the contour of the auricle. When worn, it generates a stable clamping force on the auricle, so that the device can be repeatedly and stably fixed in a predetermined position on the ear.

[0131] To achieve accurate positioning of the ultrasonic transducer on the target area of ​​the ear, the housing assembly also includes an optical auxiliary positioning module. The optical auxiliary positioning module is located near the transducer mounting part and is used to project a positioning indicator cursor onto the surface of the auricle during the wearing or adjustment phase to indicate the relative positional relationship between the transducer and the concha or antitragus area.

[0132] In this embodiment, when the control module determines that the positioning indication meets the preset conditions, it allows the device to enter the treatment working state, thereby avoiding the accidental triggering of ultrasound output when the transducer is not properly attached to the target area.

[0133] The acoustic coupling surface is located at the front end of the transducer, is made of flexible silicone material, and can be equipped with a micro gel-containing structure to improve the coupling efficiency of ultrasonic energy to the skin of the auricle.

[0134] (2) Control Module (including feedback logic) The control module is located on the main board inside the housing assembly and includes a central control unit and a wireless communication unit. The central control unit uses a microcontroller or a system-on-a-chip with integrated wireless communication unit functionality to control the overall operation of the device.

[0135] The control module is used to perform the following functions: generate the driving parameters required for ultrasound stimulation; control the start and stop of the optical auxiliary positioning module and its status judgment; execute the wireless communication unit to realize bidirectional communication with external terminal devices; manage the power supply status of the power module; and receive and process the operation feedback information during the treatment process.

[0136] The control module also includes an evaluation logic unit, used to evaluate the ultrasound stimulation process based on the operating parameters collected by the monitoring module, and to determine whether the current stimulation is within a preset effective working range. The monitoring module receives and implements feedback closed-loop control information. The monitoring module incorporates a therapeutic effect perception and evaluation mechanism, comprehensively analyzing the collected monitoring information and determining the current ultrasound stimulation state.

[0137] In some embodiments, the monitoring module and the control module together constitute a closed-loop control system, enabling the device to adaptively adjust the ultrasound stimulation parameters based on the monitored operating status and subject feedback, thereby improving the stability and consistency of the control process. This feedback closed-loop control method differs from a simple passive output mode; instead, through continuous monitoring and feedback control, it maintains the ultrasound stimulation process within a more suitable control state within a safe range and reflects the user's subjective feedback information regarding the stimulation process in real time. This subjective feedback information can be input through an external terminal device wirelessly connected to the device.

[0138] Based on the efficacy evaluation results, the control module is configured to adjust the ultrasound stimulation parameters, including but not limited to: adjusting the frequency of the ultrasound signal; adjusting the pulse repetition frequency; adjusting the duty cycle; and adjusting the output intensity or stimulation duration. Through these methods, the subsequent stimulation process is made closer to the preset control target, thereby improving the stability and consistency of the control process.

[0139] (3) Ultrasonic transducer and drive circuit module The ultrasonic transducer is arranged at one end of the outer shell assembly near the inner side of the auricle. Its installation position is consistent with the wearing direction of the auricle, so that it can fit the concha cavity or antitragus area when worn.

[0140] The ultrasonic transducer is fixed in the transducer mounting structure inside the housing assembly.

[0141] The drive circuit module is used to convert the control signal output by the control module into a low-intensity pulsed ultrasound (LIPUS) signal drive signal. The parameters of the drive signal include frequency, pulse repetition frequency, duty cycle and output intensity.

[0142] During device operation, the ultrasonic transducer outputs low-intensity pulsed ultrasound (LIPUS) signals to the target area of ​​the ear under the control of the control module, which is used to achieve non-invasive modulation of the vagus nerve-related branches.

[0143] (4) Power module: The power module includes a micro lithium battery and its matching battery management and protection circuit, which is used to provide working power for each functional module of the device.

[0144] The device also includes a monitoring module electrically connected to the control module, used to collect status information related to operational safety. The status information includes, but is not limited to, transducer operating temperature, drive signal characteristics, transducer-skin contact status, and abnormal status information during wear or use.

[0145] The control module judges the ultrasonic output status based on the monitoring information, and limits or interrupts the ultrasonic output when an abnormality is detected, so as to improve the safety of the device.

[0146] When the control module detects an abnormal situation, including but not limited to: the transducer temperature exceeding a preset safety threshold, abnormal contact between the transducer and the skin, or abnormal characteristics of the drive signal, the control module will limit, reduce, or interrupt the ultrasound output, and can send status prompt information to external terminal devices through the communication module to improve the safety of the device during use.

[0147] The above-described embodiments are merely preferred embodiments provided to fully illustrate the present invention, and the scope of protection of the present invention is not limited thereto. Equivalent substitutions or modifications made by those skilled in the art based on the present invention are all within the scope of protection of the present invention. The scope of protection of the present invention is defined by the claims.

Claims

1. An ear clip-on ultrasonic vagus nerve modulation device, characterized in that, The device includes a housing assembly, and an ultrasonic transducer, a drive circuit module, an optical auxiliary positioning module, a monitoring module, a control module, and a power supply module integrated within the sealed cavity of the housing assembly. The ultrasonic transducer has its radiating surface facing the acoustic coupling surface located at the front end of the housing. The drive circuit module is electrically connected to the ultrasonic transducer. The optical auxiliary positioning module is located adjacent to the ultrasonic transducer and is used to project a positioning light spot onto the skin of the auricle. The monitoring module includes a temperature sensor and a contact sensor, used to monitor the operating temperature of the ultrasonic transducer and the contact state between the device and the skin, respectively. The control module is electrically connected to the drive circuit module, the optical auxiliary positioning module, and the monitoring module. The power supply module supplies power to each module. The control module is configured to: receive a positioning status signal from the optical auxiliary positioning module; and, upon obtaining valid positioning confirmation, generate an enable signal to unlock the drive circuit module. During ultrasound stimulation, data from the monitoring module is received in real time, and safety protection logic is executed based on a preset safety threshold. The ultrasound transducer, drive circuit module, control module, and power supply module are interconnected and integrated into the sealed cavity via a flexible circuit board.

2. The ear clip-type ultrasonic vagus nerve modulation device as described in claim 1, characterized in that, The control module further includes an evaluation logic unit and a wireless communication unit connected to the control module; the evaluation logic unit is configured to receive subjective feedback information from an external terminal device through the wireless communication unit, and combine it with the objective data from the monitoring module to adaptively optimize and adjust the ultrasound stimulation parameters.

3. The ear clip-type ultrasonic vagus nerve modulation device as described in claim 2, characterized in that, The user's subjective feedback information is a periodic quantitative comfort score; the adaptive optimization adjustment includes: automatically reducing the intensity of ultrasonic stimulation when the comfort score is lower than a first threshold for a predetermined number of consecutive times; and / or slightly increasing the stimulation intensity within a safe range when the score is higher than a second threshold.

4. The ear clip-type ultrasonic vagus nerve modulation device as described in claim 1, characterized in that, The acoustic coupling surface is made of flexible silicone material, and a coupling pad can be placed inside it.

5. The ear clip-type ultrasonic vagus nerve modulation device as described in claim 1, characterized in that, The optical auxiliary positioning module is a miniature laser emitter, whose output light path forms a fixed angle with the acoustic beam axis of the ultrasonic transducer, so that the center of the projected positioning spot coincides with the expected projection position of the acoustic beam focus on the skin surface.

6. The ear clip-type ultrasonic vagus nerve modulation device as described in claim 1, characterized in that, The effective positioning confirmation includes: the control module determining that the optical signal characteristics of the positioning spot covering the target anatomical area meet preset conditions, and receiving a user confirmation command from an external terminal device.

7. The ear clip-type ultrasonic vagus nerve modulation device as described in claim 1, characterized in that, The safety protection logic includes: when the temperature detected by the temperature sensor exceeds the safe temperature threshold, or when the contact state detected by the contact sensor indicates poor adhesion, the control module immediately controls the drive circuit module to interrupt or reduce the ultrasonic output.

8. The ear clip-type ultrasonic vagus nerve modulation device as described in claim 1, characterized in that, The power module includes a rechargeable micro lithium battery, a battery management circuit, and supports wireless charging or charging via a dedicated charging case.

9. A method of using an ear clip-on ultrasonic vagus nerve modulation device, characterized in that, The device is the device according to any one of claims 1 to 8, and the method of use includes the following steps: projecting a positioning light spot onto the skin of the auricle through the optical auxiliary positioning module; acquiring and judging the positioning status, and after obtaining valid positioning confirmation, the control module generates an enable signal to unlock the drive circuit module; driving the ultrasonic transducer to generate ultrasonic stimulation through the drive circuit module based on user-set or adaptively generated stimulation parameters; during the stimulation process, collecting operating data in real time through the monitoring module; and the control module performing corresponding safety control operations based on the comparison result of the operating data and the preset safety threshold.

10. The method of using the ear clip-type ultrasonic vagus nerve modulation device as described in claim 9, characterized in that, It also includes personalized adjustment steps: during or between ultrasound stimulation sessions, the user's subjective feedback score is obtained through an external terminal device; the subjective feedback score and the objective data collected by the monitoring module are input into an evaluation algorithm; based on the output of the evaluation algorithm, adjustment suggestions for subsequent stimulation parameters are generated or parameter adjustments are automatically executed to achieve personalized treatment.

Images