Nerve regulation and control device

Abstract

The invention relates to a nerve regulation device. The nerve regulation and control device is used for generating ultrasonic waves to stimulate vagus nerves. The nerve regulation device comprises an ultrasound generating unit, and the ultrasound generating unit is configured to controllably provide ultrasound waves to a target region of the vagus nerve. The ultrasonic generation unit is configured to provide ultrasonic waves with the frequency ranging from 0.2 MHz to 4 MHz to act on a target area of vagus nerves. According to the nerve regulation and control device, accurate, effective and safe stimulation on vagus nerves can be achieved, and a new solution is provided for neuroscience research and clinical treatment.

Description

Technical Field

[0001] This application relates to the field of neuromodulation technology, and in particular to a neuromodulation device. Background Technology

[0002] Among numerous neuromodulation targets, the vagus nerve has attracted much attention due to its extensive physiological regulatory functions. In traditional treatments, stimulation is mainly achieved by surgically implanting electrodes. While this method is effective, it carries inherent risks such as infection, surgical trauma, and high costs, which greatly limit its clinical application.

[0003] With the rapid development of neuroscience and biomedical engineering, non-invasive neuromodulation techniques have become important tools for treating neurological diseases and studying brain function due to their safety and accessibility. To overcome the limitations of implantable devices, non-invasive percutaneous vagus nerve stimulation (VAS) has emerged. Current techniques mainly rely on percutaneous electrical stimulation (EDS) or magnetic stimulation. However, EDS struggles to effectively penetrate superficial tissues for precise targeting of the deep vagus nerve, easily leading to stimulation diffusion and side effects such as peripheral muscle spasms. While magnetic stimulation can achieve deeper stimulation, its spatial resolution is low, and the equipment is often bulky and expensive, failing to meet the needs of patients for long-term daily use. Therefore, there is an urgent clinical need for a new non-invasive neuromodulation method that can achieve deep, precise, safe, and convenient daily use.

[0004] Therefore, it is necessary to propose a new technical solution to overcome the shortcomings of existing technologies. Summary of the Invention

[0005] Based on this, this application provides a neuromodulation device that can achieve precise, effective, and safe stimulation of the vagus nerve, providing a new solution for neuroscience research and clinical treatment.

[0006] Therefore, this application adopts the following technical solution: a neuromodulation device for generating ultrasound waves to stimulate the vagus nerve, the neuromodulation device comprising:

[0007] An ultrasound generating unit configured to controllably deliver ultrasound waves to a target area of ​​the vagus nerve;

[0008] The ultrasound generating unit is configured to provide ultrasound waves with a frequency of 0.2MHz to 4MHz to act on the target area of ​​the vagus nerve.

[0009] In some embodiments, the ultrasound generating unit is configured to provide ultrasound waves with a frequency of 0.2 MHz to 0.7 MHz.

[0010] In some embodiments, the ultrasound generating unit is configured to provide ultrasound waves at frequencies of 0.2 MHz, 0.25 MHz, 0.3 MHz, 0.35 MHz, 0.4 MHz, 0.45 MHz, 0.5 MHz, 0.55 MHz, or 0.6 MHz.

[0011] In some embodiments, the ultrasound generating unit is configured to provide ultrasound waves with a frequency of 0.7 MHz to 1 MHz.

[0012] In some embodiments, the ultrasound generating unit is configured to provide ultrasound waves at a frequency of 0.7 MHz, 0.8 MHz, 0.9 MHz, or 1 MHz.

[0013] In some embodiments, the ultrasound generating unit is configured to provide ultrasound waves with a frequency of 1 MHz to 2 MHz.

[0014] In some embodiments, the ultrasound generating unit is configured to provide ultrasound waves at a frequency of 1.5 MHz or 2 MHz.

[0015] In some embodiments, the ultrasound generating unit is configured to provide ultrasound waves with a frequency of 2 MHz to 3 MHz.

[0016] In some embodiments, the ultrasound generating unit is configured to provide ultrasound waves at a frequency of 2.5 MHz or 3 MHz.

[0017] In some embodiments, the ultrasound generating unit is configured to provide ultrasound waves with a frequency of 3 MHz to 4 MHz.

[0018] In some embodiments, the ultrasound generating unit is configured to provide ultrasound waves at a frequency of 3.5 MHz, 3.7 MHz, or 4 MHz.

[0019] In some embodiments, the ultrasonic generating unit includes an ultrasonic transducer and an excitation circuit, the excitation circuit being electrically connected to the ultrasonic transducer to excite the ultrasonic transducer to generate ultrasonic waves.

[0020] In some embodiments, the excitation circuit includes a power supply module, a signal generation module, and an amplification module. The signal generation module generates an excitation wave of a set waveform, and the amplification module amplifies the excitation wave and provides it to the ultrasonic transducer to excite the ultrasonic transducer to generate ultrasonic waves.

[0021] In some embodiments, the ultrasonic transducer is configured to generate pulsed ultrasound waves with a repetition frequency of 1 Hz to 100 Hz to meet the treatment needs of different diseases.

[0022] In some embodiments, the duty cycle of the pulsed ultrasound is adjustable.

[0023] In some embodiments, the ultrasonic generating unit includes multiple ultrasonic transducers arranged in an array.

[0024] In some embodiments, the plurality of ultrasonic transducers are arranged in a circular array.

[0025] In some embodiments, the focal length of the ultrasound transducer is adjustable within the range of 15mm to 35mm to cover the depth variations of the vagus nerve in patients of different body types.

[0026] In some embodiments, the diameter of the annular array is 2cm to 3cm.

[0027] In some embodiments, the neuromodulation device is adapted to be placed in the neck so that ultrasound waves penetrate the neck skin and act on the vagus nerve in the neck.

[0028] In some embodiments, the neuromodulation device includes a body adapted to adhere to human skin, and the ultrasound generating unit is disposed on the body.

[0029] In some embodiments, the body is configured as a patch or neckband suitable for attachment to human skin, and the patch or neckband is designed to be easily removed from human skin.

[0030] In some embodiments, the body includes a flexible silicone element that can deform to fit human skin.

[0031] In some embodiments, the body is configured to attach to the anterior border of the sternocleidomastoid muscle on the left side of the neck, so that the ultrasound generating unit is aligned with the vagus nerve trunk in the neck.

[0032] In some embodiments, the neuromodulation device is a hierarchical structure.

[0033] In some embodiments, the hierarchical structure includes a base layer, an ultrasound generating layer, and a coupling layer arranged in sequence.

[0034] In some embodiments, the target area includes the vagus nerve region associated with one or more conditions such as epilepsy, depressive disorders, migraines, inflammatory diseases, chronic pain, cardiac rehabilitation, and cognitive impairment.

[0035] The neuromodulation device provided in this application delivers ultrasound waves at frequencies of 0.2MHz to 4MHz to the target area of ​​the vagus nerve. It combines deep penetration with focusing capabilities, effectively penetrating skin, fat, and muscle tissues in areas such as the neck to ensure sufficient sound energy reaches the vagus nerve trunk located deep within the carotid sheath. Simultaneously, it maintains excellent beam focusing ability, precisely concentrating ultrasound energy on the target nerve region to minimize non-specific stimulation of adjacent blood vessels, trachea, and recurrent laryngeal nerve, thus improving the safety and targeting of the treatment process. This device can be widely applied in various clinical scenarios, including epilepsy, depressive disorders, migraines, inflammatory diseases, chronic pain, cardiac rehabilitation, and cognitive impairment, providing a new technological solution for neuroscience research and clinical treatment. Attached Figure Description

[0036] To more clearly illustrate the technical solutions in the embodiments of this application or the conventional technology, the drawings used in the description of the embodiments or the conventional technology will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0037] Figure 1 This is a schematic diagram of the action position of an embodiment of the neural modulation device of this application.

[0038] Figure 2 This is a schematic diagram of the structure of an embodiment of the neural modulation device of this application.

[0039] Figure 3 This is a three-dimensional explosion diagram of an embodiment of the neural modulation device of this application.

[0040] Figure 4 This is a three-dimensional exploded view of another embodiment of the neuromodulation device of this application.

[0041] Figure 5 This is a schematic diagram of a circuit module of an embodiment of the neural modulation device of this application.

[0042] Figure 6 This is a schematic diagram of another embodiment of the neural modulation device of this application.

[0043] The component labels are as follows:

[0044] 1. Neck; 11. Vagus nerve trunk; 100. Neuromodulation device; 10. Main body; 101. Basal layer; 102. Coupled layer; 20. Ultrasound generation unit; 21. Ultrasound transducer; 221. High voltage power supply and charging circuit; 222. Signal generation circuit; 223. Pulse control circuit; 224. Drive circuit; 225. Power amplifier circuit; 226. Impedance matching circuit; 30. Miniature EEG electrode. Detailed Implementation

[0045] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0046] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on the other component or there may be an intermediate component. When a component is considered to be "connected to" another component, it can be directly connected to the other component or there may be an intermediate component present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application's specification are for illustrative purposes only and do not represent the only possible implementation.

[0047] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0048] In this application, unless otherwise expressly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature and the second feature are in indirect contact through an intermediate medium. Furthermore, "above," "over," and "on top" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0049] Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and / or" as used in this application includes any and all combinations of one or more of the associated listed items.

[0050] This application relates to the field of neuromodulation technology, specifically a neuromodulation device. It aims to provide a non-invasive, precise, and safe technical solution for stimulating the vagus nerve, overcoming many problems existing in current technologies, such as infection, surgical trauma, and high cost associated with implanted electrode stimulation; difficulty in precise targeting and susceptibility to side effects with transcutaneous electrical stimulation; and low spatial resolution, large size, and high cost of magnetic stimulation. Please refer to [link to relevant documentation]. Figures 1 to 6 As shown, this application provides a neuromodulation device 100, which achieves precise and effective stimulation of the vagus nerve through non-invasive ultrasound stimulation technology, maintaining sufficient penetration depth while ensuring both treatment accuracy and biosafety. The technical solution will be described in detail below with reference to the accompanying drawings and specific implementation examples.

[0051] The neuromodulation device 100 is used to generate ultrasound waves to stimulate the vagus nerve. The neuromodulation device 100 includes a main body 10 and an ultrasound generating unit 20. The main body 10 is configured to adhere to the skin of a human body. The ultrasound generating unit 20 is disposed on the main body 10 and is configured to controllably provide ultrasound waves to the target area of ​​the vagus nerve. Specifically, the ultrasound generating unit 20 is configured to provide ultrasound waves with a frequency of 0.2 MHz to 4 MHz to the target area of ​​the vagus nerve.

[0052] The neuromodulation device 100 provided in this application delivers ultrasound waves at frequencies of 0.2MHz to 4MHz to the target area of ​​the vagus nerve, combining both penetration depth and focusing performance. It can effectively penetrate skin, fat, and muscle tissues in areas such as the neck, ensuring sufficient sound wave energy to reach the vagus nerve trunk 11 located deep within the carotid sheath. Simultaneously, it maintains good beam focusing capability, precisely concentrating ultrasound energy on the target nerve region to minimize non-specific stimulation of adjacent blood vessels, trachea, and recurrent laryngeal nerve, thus improving the safety and targeting of the treatment process. This device can be widely applied in various clinical scenarios such as epilepsy, depressive disorders, migraines, inflammatory diseases, chronic pain, cardiac rehabilitation, and cognitive impairment, providing a new technological solution for neuroscience research and clinical treatment.

[0053] like Figures 2 to 4As shown, in one embodiment of the neuromodulation device 100 provided in this application, the main body 10 is configured to adhere to the skin of the human body, providing a stable attachment base for the entire device and ensuring that the device can maintain stable contact with the human body during use, thereby ensuring that ultrasound waves can accurately act on the target area. The ultrasound generating unit 20 is disposed within the main body 10, and its core function is to controllably provide ultrasound waves to the target area of ​​the vagus nerve, thereby stimulating the vagus nerve through the specific action of ultrasound waves, and thus achieving the purpose of neuromodulation.

[0054] In this embodiment, the design of the main body 10 fully considers its conformity to human skin and ease of use. In some embodiments, the main body 10 is configured as a patch suitable for attachment to the neck, allowing ultrasound waves to penetrate the skin of the neck 1 and stimulate the vagus nerve. The neck 1 is an important distribution area of ​​the vagus nerve; designing the main body 10 of the neuromodulation device 100 as a neck patch allows ultrasound waves to penetrate the skin of the neck 1 more effectively and directly stimulate the vagus nerve. Furthermore, the main body 10 is configured to be attached to the anterior border of the sternocleidomastoid muscle on the left side of the neck 1, because this location corresponds to the main trunk 11 of the vagus nerve, thereby stimulating the vagus nerve more precisely and improving the effect of neuromodulation.

[0055] Furthermore, to better adapt to the shape and physiological characteristics of human skin, and to prevent the neuromodulation device 100 from failing to maintain constant contact with the skin during human activity, in this embodiment, the main body 10 includes a flexible silicone component. Flexible silicone possesses excellent flexibility and deformability, enabling it to deform accordingly according to the undulations and curves of the human skin surface, thereby closely conforming to the skin. This close fit not only helps improve the transmission efficiency of ultrasound waves and reduce energy loss, but also enhances patient comfort during use, avoiding discomfort or device displacement caused by insufficient contact between the device and the skin.

[0056] In some embodiments, the main body 10 is a deformable component, such as a flexible circuit board, or a component with a flexible substrate such as rubber, silicone, woven fabric, or hydrogel that can be combined with flexible circuitry. Preferably, the main body 10 is a flexible sheet to adapt to skin folds and areas that frequently move, such as the neck. The flexible main body 10 allows for a stable acoustic coupling interface between the ultrasound generating unit 20 and the skin, effectively reducing energy loss during ultrasound propagation. In some embodiments, the main body 10 is made of medical-grade silicone, with an overall thickness of only 4mm and a weight of no more than 20g, exhibiting excellent wearable characteristics. Figure 3 and Figure 4As shown, in this embodiment, the neuromodulation device has a hierarchical structure. Specifically, the hierarchical structure includes a base layer 101, an ultrasound generating layer, and a coupling layer 102 arranged in sequence. The base layer 101 and coupling layer 102 constitute the main body 10, and the ultrasound generating layer is the layer containing the ultrasound generating unit 20, sandwiched between or encased within the base layer 101 and coupling layer 102. The base layer 101 is a deformable layer, for example, made of silicone. The coupling layer 102 is made of, for example, hydrogel, which improves sound wave transmission. By filling the gap between the neuromodulation device and human skin, the coupling layer 102 achieves a gradual transition in acoustic impedance, effectively reducing interface reflection and allowing more ultrasound energy to penetrate human biological tissue. In use, the coupling layer 102 is attached to the human skin, with the base layer 101 facing away from the skin.

[0057] The ultrasound generating unit 20 is the core functional part of this neuromodulation device 100, and its performance directly affects the stimulation effect on the vagus nerve. In this embodiment, the ultrasound generating unit 20 includes an ultrasound transducer 21 and an excitation circuit. The excitation circuit is electrically connected to the ultrasound transducer 21 to excite the ultrasound transducer 21 to generate ultrasound waves.

[0058] Furthermore, the excitation circuit includes a power supply module, a signal generation module, and an amplification module. The power supply module provides stable power to the entire excitation circuit, ensuring that each module can operate normally; in some embodiments, the power supply module may include a boost circuit module to generate sufficient supply voltage. The signal generation module generates an excitation wave of a set waveform, such as a square wave or a sine wave. The amplification module amplifies the excitation wave and provides the amplified excitation wave to the ultrasonic transducer 21, enabling the ultrasonic transducer 21 to generate ultrasonic waves of sufficient intensity and specific characteristics.

[0059] Specifically, such as Figure 5As shown, in one embodiment, the excitation circuit of the ultrasonic transducer 21 mainly consists of the following key circuits, designed to drive the transducer efficiently and accurately, achieving efficient conversion between electrical and acoustic signals. Signal generation circuit 222: Typically employs Direct Digital Synthesis (DDS) technology, such as using a DDS chip like the AD9850, to generate frequency- and phase-adjustable sine or square wave signals to meet the resonant frequency requirements of different transducers; Pulse control circuit 223: Controls the number, phase, and timing of pulse trains using a microcontroller or programmable logic device (such as a CPLD) to ensure the accuracy of the excitation signal; Power amplifier circuit 225: Amplifies the low-power signal generated by the signal generation circuit 222 to a high-voltage pulse sufficient to drive the transducer, commonly using a half-bridge or full-bridge topology. The system utilizes VMOS transistors and MOSFET modules as switching elements. The drive circuit 224 pre-amplifies the signal before power amplification to ensure rapid turn-on and turn-off of the switching devices (such as VMOS transistors), improving pulse steepness and efficiency. The impedance matching circuit 226, composed of a matching transformer and capacitor, matches the impedance of the power amplifier circuit and the transducer, maximizing electro-acoustic conversion efficiency. The high-voltage power supply and charging circuit 221 provides high-voltage DC power for the power amplification and charges the energy storage capacitor through a charging resistor, forming a high-voltage pulse discharge circuit when the switch is on. Additionally, auxiliary functional modules such as a control module and a frequency selection module may be included. The control module sets parameters (such as frequency and pulse count) via a host computer or microcontroller to coordinate the operation of each circuit. In specific applications, such as multi-frequency transducer driving, the frequency selection module extracts the target frequency from a wideband signal, simplifying multi-frequency drive design.

[0060] The ultrasonic transducer 21 converts electrical energy into ultrasonic energy. In some embodiments, the ultrasonic transducer 21 is configured to generate pulsed ultrasound waves with a repetition frequency of 1Hz to 100Hz to meet the treatment needs of different diseases. In some embodiments, parameters such as the repetition frequency, pulse width, pulse intensity, and duty cycle of the pulsed ultrasound waves are adjustable. By adjusting these parameters, the intensity and frequency of stimulation to the vagus nerve can be more precisely controlled, thereby achieving fine-tuning of nerve modulation. For example, a lower repetition frequency is suitable for situations requiring gentler nerve stimulation, while a higher repetition frequency can be used in scenarios requiring stronger stimulation.

[0061] In some embodiments, the ultrasound generating unit 20 employs a miniaturized design, with its excitation circuitry housed on a circuit board measuring only 2cm × 2cm. Furthermore, the ultrasound generating unit 20 can connect to a handheld terminal, such as a smartphone, via wired or wireless signals such as Bluetooth, infrared, Wi-Fi, or mobile communication networks, allowing users to intuitively set stimulation parameters and view treatment progress within an application on their smartphone or other handheld terminal.

[0062] Please continue reading. Figure 2 As shown, in some embodiments, there are multiple ultrasound transducers 21, and these multiple ultrasound transducers 21 are arranged in an array. This array arrangement can further improve the accuracy and effectiveness of vagus nerve stimulation. The array arrangement can specifically be various forms such as a rectangular array, a circular array, or a ring array, and can be configured according to the shape of the area to be covered. In this embodiment, the multiple ultrasound transducers 21 are arranged in a ring array. Furthermore, the focal length of the ultrasound transducers 21 in the ring array is adjustable within the range of 15mm to 35mm. The design of the ring array allows ultrasound waves to be focused on the target area from multiple directions, forming a concentrated energy area, thereby increasing the stimulation intensity on specific parts of the vagus nerve. The adjustable focal length increases the flexibility and adaptability of the neuromodulation device 100, allowing the focal length to be adjusted according to different patients and the location of the vagus nerve target area, so that the ultrasound waves are more accurately focused on the target area, further improving the accuracy of stimulation. For example, the location and depth of the vagus nerve in the neck may vary for patients of different body types. By adjusting the focal length, it can be ensured that the ultrasound waves can always accurately target the intended area. The array of ultrasound transducers 21 can be manufactured using flexible printed circuit technology, which has good surface fit performance. Further, the diameter of the annular array is 2cm to 3cm, preferably 2.5cm. Here, the diameter of the annular array refers to the diameter of the virtual circle passing through the center of the outermost ring of ultrasound transducers 21 in the annular array, such as... Figure 2 As shown by the dashed line. This size range of the annular array ensures sufficient coverage of the vagus nerve target area without being too large to affect the portability and ease of use of the device. In this embodiment, the ultrasonic transducer 21 array includes 8 ultrasonic transducers 21. In other embodiments, the number can be increased or decreased and is not limited to 8.

[0063] The neuromodulation device 100 provided in this application has an ultrasound generating unit 20 configured to provide ultrasound waves with a frequency of 0.2MHz to 4MHz to act on the target area of ​​the vagus nerve. This frequency range combines penetration depth and focusing performance. On the one hand, this frequency range can effectively penetrate the skin, fat, and muscle tissues of areas such as the neck 1, ensuring sufficient sound wave energy to reach the vagus nerve trunk 11 located deep within the carotid sheath; on the other hand, this frequency range simultaneously maintains good beam focusing capability, precisely concentrating the ultrasound energy on the target nerve area to minimize non-specific stimulation of adjacent blood vessels, trachea, recurrent laryngeal nerve, and other important structures, thereby improving the safety and targeting of the treatment process. In particular, the focusing performance can be further improved through a specific array structure such as a ring as described above.

[0064] In some specific application embodiments, the ultrasonic generating unit 20 may be configured to provide ultrasonic waves with frequencies of 0.2MHz~0.7MHz, 0.7MHz~1MHz, 1MHz~2MHz, 2MHz~3MHz, or 3MHz~4MHz, or even configured to provide ultrasonic waves with frequencies of 0.2MHz, 0.25MHz, 0.3MHz, 0.35MHz, 0.4MHz, 0.45MHz, 0.5MHz, 0.55MHz, 0.6MHz, 0.7MHz, 0.8MHz, 0.9MHz, 1.0MHz, and 1.1MHz. Ultrasound waves can be emitted at specific frequencies, including 1.2MHz, 1.3MHz, 1.4MHz, 1.5MHz, 1.6MHz, 1.7MHz, 1.8MHz, 1.9MHz, 2MHz, 2.1MHz, 2.2MHz, 2.3MHz, 2.4MHz, 2.5MHz, 2.6MHz, 2.7MHz, 2.8MHz, 2.9MHz, 3MHz, 3.1MHz, 3.2MHz, 3.3MHz, 3.4MHz, 3.5MHz, 3.6MHz, 3.7MHz, 3.8MHz, 3.9MHz, and 4MHz. Different frequencies of ultrasound waves have different penetration depths and tissue interaction characteristics. Generally, lower frequency ultrasound waves have deeper penetration depths but relatively lower spatial resolution; higher frequency ultrasound waves have higher spatial resolution but shallower penetration depths. By selecting an appropriate ultrasound frequency, precise stimulation of the vagus nerve can be achieved according to the depth and accuracy requirements of the target area. For example, for the vagus nerve target area located in a deeper part, a lower frequency ultrasound can be selected; while for the target area that requires higher precision stimulation, a higher frequency ultrasound can be selected.

[0065] In the neuromodulation device 100 of this application, the target area includes a target area in the vagus nerve associated with one or more of the following conditions: epilepsy, depressive disorders, migraines, inflammatory diseases, chronic pain, cardiac rehabilitation, and cognitive impairment. The vagus nerve plays a crucial role in human physiological regulation and is closely related to the occurrence and development of various diseases. The term "associated" refers to the important role these target areas play in the pathological mechanisms of one or more of these conditions. Ultrasonic stimulation of these target areas can effectively alleviate or treat the corresponding conditions. By precisely stimulating the target areas in the vagus nerve associated with specific conditions, the function of the nervous system can be modulated, thereby achieving the purpose of treating or alleviating these conditions.

[0066] For example, in epilepsy treatment, stimulating specific target areas of the vagus nerve can regulate brain electrical activity, reducing the frequency and intensity of seizures; for patients with depressive disorders, stimulating relevant target areas can regulate neurotransmitter release and improve their mood; in migraine treatment, stimulating vagus nerve target areas can relieve vasospasm and alleviate headache symptoms; for inflammatory diseases, stimulating the vagus nerve can regulate the function of the immune system and reduce inflammatory responses; in chronic pain treatment, stimulating vagus nerve target areas can block the transmission of pain signals and relieve pain; in cardiac rehabilitation, stimulating the vagus nerve can regulate the autonomic nervous function of the heart and improve cardiac function; and for patients with cognitive impairment, stimulating relevant target areas can promote the growth and connection of nerve cells and improve cognitive abilities.

[0067] The neuromodulation device 100 provided in this application can be made into a basic patch device with a simple structure, or it can be configured into a multi-element adaptive focusing system with better focusing performance, or it can be further integrated with other functions to become a multifunctional integrated treatment platform.

[0068] For example, in one embodiment, the neuromodulation device 100 is configured as a basic patch-type device, employing a single-chip transducer design with its operating frequency precisely set at 0.8MHz. This specific frequency value achieves an optimal balance between penetration depth and focusing accuracy. The transducer is embedded in a flexible substrate made of medical-grade silicone (such as Ecoflex silicone), resulting in an overall thickness of only 4mm and a weight of no more than 20g, exhibiting excellent wearability characteristics. The device integrates an intelligent control module, employing a miniaturized design to integrate the drive circuit, waveform generator, and impedance matching network onto a circuit board measuring only 2cm × 2cm. This module can generate pulsed ultrasound with an adjustable duty cycle to meet the treatment needs of different diseases. The intelligent control module is a chip integrating Bluetooth radio frequency and a microprocessor core, such as the nRF52832 chip or CC2640R2F chip. The device connects to a smartphone application via a low-power Bluetooth module, allowing users to intuitively set stimulation parameters and view treatment progress. In practical applications, patients only need to attach the device to a specific location on the anterior border of the sternocleidomastoid muscle on the left side of the neck, and use anatomical landmarks to ensure that the transducer is aligned with the main trunk of the vagus nerve 11.

[0069] For example, in another embodiment, the neuromodulation device 100 is configured as a multi-element adaptive focusing system. Specifically, it employs an 8-element ring phased array transducer. The system's operating center frequency is 1MHz~4MHz, preferably 1.5MHz, 2MHz, 3MHz, or 3.7MHz. Through electronic focusing technology, the focal length can be continuously adjusted within the range of 15mm~35mm, precisely covering the depth variations of the vagus nerve in patients of different body types. The array diameter is only 2.5cm, manufactured using flexible printed circuit technology, providing excellent curved surface fit and allowing for continuous wear for 12 hours with high comfort. This system is particularly suitable for clinical environments requiring precise dose control, such as the treatment of treatment-resistant depression, where doctors can finely adjust stimulation parameters based on patient responses.

[0070] For example, in another embodiment, the neuromodulation device 100 is configured as a multifunctional integrated treatment platform. This multifunctional integrated treatment platform innovatively combines ultrasound neurostimulation with physiological parameter monitoring. Through physiological parameter monitoring, it provides real-time feedback for ultrasound stimulation, enabling the stimulation parameters to be dynamically adjusted according to the patient's immediate state, achieving truly personalized and adaptive treatment. For example, as... Figure 6 As shown, this multifunctional integrated treatment platform further integrates a miniature electroencephalogram (EEG) electrode 30, which can be used to continuously monitor cortical EEG activity to identify abnormal EEG signals specific to epileptic seizures in real time. When an abnormal EEG signal is detected, indicating that an epileptic seizure is imminent, the platform immediately sends a command to the ultrasound generator unit 20, causing the ultrasound generator unit 20 to emit ultrasound waves with specific parameters towards the epileptic lesion area. This neuromodulation aims to inhibit abnormal synchronous discharge of neurons, thereby interrupting or weakening the impending epileptic seizure. By innovatively combining ultrasound neurostimulation with physiological parameter monitoring, traditional passive treatment is transformed into active prevention, greatly improving quality of life and reducing patient suffering. In one embodiment, the platform uses ultrasound waves with a frequency of 0.25MHz to 0.7MHz, preferably 0.5MHz for deep stimulation. This design enables simultaneous treatment and monitoring, providing a technical basis for personalized treatment plans. Furthermore, the device adopts a modular design, with the main body containing a core processing unit and a power supply. The ultrasound patches can be configured into multiple groups of different shapes, allowing for the replacement of different ultrasound patch groups according to different application scenarios. For example, one set of ultrasound patches can be designed in the shape of a strip or band to cover a section of the vagus nerve trunk along its course, for scenarios requiring stimulation of a longer section of the vagus nerve trunk. As another example, one set of ultrasound patches can cover a circular or square area to cover areas such as the stellate ganglion, for scenarios requiring stimulation of nerve endings distributed in a sheet-like pattern, such as ganglia.

[0071] When using the neuromodulation device 100 provided in this application, the main body 10 is first attached to a suitable location on the skin, ensuring a tight fit. The suitable location refers to a position that effectively stimulates the vagus nerve; this location can be determined beforehand using anatomical techniques and endoscopic techniques. Then, by controlling the excitation circuit, the ultrasound generating unit 20 generates ultrasound waves with preset parameters such as frequency, phase, duty cycle, repetition rate, and intensity, and focuses the ultrasound waves onto the target area of ​​the vagus nerve to achieve stimulation modulation.

[0072] Compared with existing technologies, the neuromodulation device of this application has significant advantages. First, it is a non-invasive neuromodulation method, avoiding the problems of infection, surgical trauma, and high cost associated with implanted electrode stimulation, greatly improving patient acceptance and safety. Second, through the action of ultrasound, it can achieve precise targeted stimulation of deep tissues, overcoming the problems of percutaneous electrical stimulation's difficulty in penetrating surface tissues, its tendency to cause stimulation diffusion and side effects, and the shortcomings of magnetic stimulation such as low spatial resolution and large, expensive equipment. In addition, the main design of the device is convenient for patients to use daily, improving the convenience and compliance of treatment.

[0073] The neuromodulation device 100 provided in this application employs non-invasive percutaneous transmission of ultrasound waves ranging from 0.2MHz to 4MHz, enabling it to penetrate biological tissues such as skin and muscle to reach the target area of ​​the vagus nerve. By selecting an appropriate frequency band within this frequency range in conjunction with practical applications, a balance can be achieved between penetration depth, spatial resolution, and treatment safety. Furthermore, the neuromodulation device 100 provided in this application combines a flexible main body 10 with an array of ultrasound transducers 21, making it comfortable to wear and conforming to positions such as the neck, maintaining excellent acoustic coupling performance, and suitable for home use.

[0074] As can be seen from the above description of the specific embodiments, the neuromodulation device of this application, through its unique structural design and technical means, achieves precise, safe, and effective stimulation of the vagus nerve, providing a new and promising technical solution for the treatment and research of nervous system diseases. With the continuous development and improvement of the technology, it is believed that this device will play a greater role in clinical applications, bringing better treatment outcomes and quality of life to patients.

[0075] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the scope of protection of this application. Therefore, the patent protection scope of this application should be determined by the appended claims.

Claims

1. A neural modulation device, characterized in that, The neuromodulation device, used to generate ultrasound waves to stimulate the vagus nerve, includes: An ultrasound generating unit configured to controllably deliver ultrasound waves to a target area of ​​the vagus nerve; The ultrasound generating unit is configured to provide ultrasound waves with a frequency of 0.2MHz to 4MHz to act on the target area of ​​the vagus nerve.

2. The neural modulation device according to claim 1, characterized in that, The ultrasonic generating unit is configured to provide ultrasonic waves with a frequency of 0.2MHz to 0.7MHz.

3. The neural modulation device according to claim 2, characterized in that, The ultrasonic generating unit is configured to provide ultrasonic waves at frequencies of 0.2 MHz, 0.25 MHz, 0.3 MHz, 0.35 MHz, 0.4 MHz, 0.45 MHz, 0.5 MHz, 0.55 MHz, or 0.6 MHz.

4. The neural modulation device according to claim 1, characterized in that, The ultrasonic generating unit is configured to provide ultrasonic waves with a frequency of 0.7MHz to 1MHz.

5. The neural modulation device according to claim 4, characterized in that, The ultrasonic generating unit is configured to provide ultrasonic waves with a frequency of 0.7 MHz, 0.8 MHz, 0.9 MHz, or 1 MHz.

6. The neural modulation device according to claim 1, characterized in that, The ultrasonic generating unit is configured to provide ultrasonic waves with a frequency of 1MHz to 2MHz.

7. The neural modulation device according to claim 6, characterized in that, The ultrasonic generating unit is configured to provide ultrasonic waves with a frequency of 1.5 MHz or 2 MHz.

8. The neural modulation device according to claim 1, characterized in that, The ultrasonic generating unit is configured to provide ultrasonic waves with a frequency of 2MHz to 3MHz.

9. The neural modulation device according to claim 8, characterized in that, The ultrasonic generating unit is configured to provide ultrasonic waves with a frequency of 2.5 MHz or 3 MHz.

10. The neural modulation device according to claim 1, characterized in that, The ultrasonic generating unit is configured to provide ultrasonic waves with a frequency of 3MHz to 4MHz.

11. The neural modulation device according to claim 10, characterized in that, The ultrasonic generating unit is configured to provide ultrasonic waves with a frequency of 3.5 MHz, 3.7 MHz, or 4 MHz.

12. The neural modulation device according to claim 1, characterized in that, The ultrasonic generating unit includes an ultrasonic transducer and an excitation circuit. The excitation circuit is electrically connected to the ultrasonic transducer to excite the ultrasonic transducer to generate ultrasonic waves.

13. The neural modulation device according to claim 12, characterized in that, The excitation circuit includes a power supply module, a signal generation module, and an amplification module. The signal generation module generates an excitation wave with a set waveform, and the amplification module amplifies the excitation wave and provides it to the ultrasonic transducer to excite the ultrasonic transducer to generate ultrasonic waves.

14. The neuromodulation device according to claim 12, characterized in that, The ultrasonic transducer is configured to generate pulsed ultrasound waves with a repetition frequency of 1 Hz to 100 Hz to meet the treatment needs of different diseases.

15. The neuromodulation device according to claim 14, characterized in that, The duty cycle of the pulsed ultrasound is adjustable.

16. The neuromodulation device according to any one of claims 1 to 15, characterized in that, The ultrasonic generating unit includes multiple ultrasonic transducers arranged in an array.

17. The neuromodulation device according to claim 16, characterized in that, The multiple ultrasonic transducers are arranged in a circular array.

18. The neuromodulation device according to claim 16, characterized in that, The focal length of the ultrasound transducer can be adjusted within the range of 15mm to 35mm to cover the depth variations of the vagus nerve in patients of different body types.

19. The neuromodulation device according to claim 17, characterized in that, The diameter of the circular array is 2cm to 3cm.

20. The neuromodulation device according to any one of claims 1 to 15, characterized in that, The neuromodulation device is adapted to be placed in the neck so that ultrasound waves can penetrate the skin of the neck and act on the vagus nerve.

21. The neuromodulation device according to any one of claims 1 to 15, characterized in that, The neuromodulation device includes a main body adapted to be attached to human skin, and the ultrasound generating unit is disposed on the main body.

22. The neuromodulation device according to claim 21, characterized in that, The main body is configured as a patch or neckband suitable for attachment to human skin, and the patch or neckband is designed to be easily removed from human skin.

23. The neural modulation device according to claim 21, characterized in that, The main body includes a flexible silicone component that can deform to fit human skin.

24. The neuromodulation device according to claim 21, characterized in that, The main body is configured to attach to the anterior border of the sternocleidomastoid muscle on the left side of the neck, so that the ultrasound generating unit is directly facing the vagus nerve trunk in the neck.

25. The neuromodulation device according to any one of claims 1 to 15, characterized in that, The neuromodulation device has a hierarchical structure.

26. The neuromodulation device according to claim 25, characterized in that, The hierarchical structure includes a base layer, an ultrasound generating layer, and a coupling layer arranged in sequence.

27. The neuromodulation device according to any one of claims 1 to 15, characterized in that, The target area includes the vagus nerve region associated with one or more conditions such as epilepsy, depressive disorders, migraine, inflammatory diseases, chronic pain, cardiac rehabilitation, and cognitive impairment.

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