Vagus nerve ultrasonic stimulation device

Abstract

The invention relates to a vagus nerve ultrasonic stimulation device. The vagus nerve ultrasonic stimulation device is used for generating ultrasonic waves to stimulate vagus nerves. The vagus nerve ultrasonic stimulation device comprises an ultrasonic generation unit, and the ultrasonic generation unit is configured to controllably provide ultrasonic waves to a target region of the vagus nerve; wherein the ultrasonic generating unit is configured to provide ultrasonic waves with the frequency ranging from 4.0 MHz to 8.0 MHz, so that the ultrasonic waves are focused on a target area of the vagus nerve through the frequency. According to the vagus nerve ultrasonic stimulation device provided by the invention, ultrasonic energy can be accurately focused on a millimeter-level vagus nerve target area while sufficient penetrating power is ensured, so that safe, efficient and accurate non-invasive nerve regulation and control are realized.

Description

Technical Field

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

[0002] Vagus nerve stimulation (VNS), a promising neuromodulation technique, has demonstrated significant efficacy in treating various neurological disorders, including drug-resistant epilepsy and depression. Traditional invasive VNS requires surgical implantation of electrodes directly wrapped around the vagus nerve in the neck to deliver electrical pulses. While effective, this method has unavoidable limitations: surgical implantation carries risks of infection and nerve damage, the device is irreversible, and patient compliance is low. Furthermore, the spatial resolution of electrical stimulation is limited, easily activating adjacent non-target tissues such as the recurrent laryngeal nerve, leading to side effects such as hoarseness and coughing, severely impacting the treatment experience and accuracy.

[0003] To overcome these drawbacks, non-invasive peripheral nerve stimulation techniques have become a research hotspot. While non-implantable methods such as percutaneous vagus nerve stimulation avoid surgery, most are still based on electrical stimulation principles. The current tends to diffuse on the surface of tissues, making it difficult to precisely penetrate to the deep vagus nerve, and the intensity and accuracy of stimulation remain challenging. Focused ultrasound (FUS), as an emerging non-invasive neuromodulation tool, has attracted widespread attention due to its unique advantages. Ultrasound waves can non-invasively penetrate the skull and soft tissues and can be precisely focused on deep, tiny targets, possessing extremely high spatial resolution, providing a new pathway for precise neuromodulation.

[0004] However, the application of focused ultrasound to vagus nerve stimulation is still in its early stages of exploration, and existing technologies have significant shortcomings in frequency selection and targeting accuracy. Although low-frequency ultrasound has strong penetrating power, its large focal point makes it difficult to selectively stimulate delicate structures like the vagus nerve, and may also cause unnecessary thermal effects on surrounding blood vessels and other tissues.

[0005] Therefore, it is necessary to propose a new technical solution to overcome the shortcomings of existing technologies. Summary of the Invention

[0006] Based on this, this application provides a vagus nerve ultrasound stimulation device that can precisely focus ultrasound energy on the millimeter-level vagus nerve target area while ensuring sufficient penetration, thereby achieving safe, efficient and precise non-invasive neuromodulation.

[0007] Therefore, this application adopts the following technical solution: a vagus nerve ultrasound stimulation device, including an ultrasound generating unit, the ultrasound generating unit being configured to controllably provide ultrasound waves to the target area of ​​the vagus nerve; wherein, the ultrasound generating unit is configured to provide ultrasound waves with a frequency of 4.0MHz to 8.0MHz, so as to focus the ultrasound waves on the target area of ​​the vagus nerve through this frequency.

[0008] In some embodiments, the ultrasound generating unit is configured to provide ultrasound waves with a frequency of 4.0 MHz to 5.0 MHz.

[0009] In some embodiments, the ultrasound generating unit is configured to provide a frequency of 4.5 MHz.

[0010] In some embodiments, the ultrasound generating unit is configured to provide ultrasound waves with a frequency of 5.0 MHz to 6.0 MHz.

[0011] In some embodiments, the ultrasound generating unit is configured to provide ultrasound waves at a frequency of 5.5 MHz.

[0012] In some embodiments, the ultrasound generating unit is configured to provide ultrasound waves with a frequency of 6.0 MHz to 8.0 MHz.

[0013] In some embodiments, the ultrasound generating unit is configured to provide ultrasound waves at a frequency of 6.5 MHz, 7.0 MHz, or 7.5 MHz.

[0014] In some embodiments, the ultrasound generating unit is configured such that the ultrasound waves it generates can be focused within a focal region on the order of millimeters.

[0015] In some embodiments, the ultrasound generating unit is configured such that the ultrasound waves it generates can penetrate biological tissues of 20 mm to 60 mm.

[0016] 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.

[0017] 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.

[0018] In some embodiments, the excitation circuit further includes a boost circuit module and a matching network module, the matching network module being connected between the amplification module and the ultrasonic transducer.

[0019] In some embodiments, the vagus nerve ultrasound stimulation device is adapted to be placed on the neck of a person so that ultrasound waves penetrate the skin of the neck to stimulate the vagus nerve in the neck.

[0020] In some embodiments, the vagus nerve ultrasound stimulation device includes a body adapted to be attached to human skin, and the ultrasound generating unit is disposed on the body.

[0021] In some embodiments, the body is configured as a patch or neckband suitable for attachment to the neck of a person.

[0022] In some embodiments, the body includes a flexible silicone element that can deform to fit the human neck.

[0023] In some embodiments, the vagus nerve ultrasound stimulation device has a hierarchical structure.

[0024] In some embodiments, the hierarchical structure includes a base layer, an ultrasound generating layer, and a coupling layer arranged in sequence.

[0025] In some embodiments, the target area includes the vagus nerve region associated with one or more of the following conditions: epilepsy, depressive disorders, migraine, anxiety disorders, inflammatory diseases, cardiac rehabilitation and arrhythmias, post-stroke rehabilitation, acute and chronic pain management, cognitive impairment, Alzheimer's disease, and obesity and metabolic syndrome.

[0026] In some embodiments, the ultrasound generating unit is configured to transmit ultrasound waves with a pulse repetition frequency of 1 Hz to 100 Hz.

[0027] In some embodiments, the ultrasonic generating unit includes a plurality of ultrasonic transducers arranged in an array.

[0028] In some embodiments, the number of ultrasonic transducers is two or more, arranged in a triangular array, rectangular array, circular array or ring array.

[0029] The vagus nerve ultrasound stimulation device provided in this application uses high-frequency focused ultrasound with a frequency of 4.0MHz to 8.0MHz as the stimulation source, solving the technical bottleneck of traditional nerve stimulation techniques where penetration depth and spatial resolution are difficult to achieve simultaneously. This frequency range has been precisely optimized to ensure that ultrasound waves effectively penetrate the soft tissues of the neck to reach the target depth of the vagus nerve, while highly concentrating the acoustic energy within a millimeter-level microfocal area, achieving precise and selective stimulation of the vagus nerve. Compared with traditional electrical stimulation methods, this technology significantly reduces side effects such as coughing and hoarseness caused by activation of adjacent non-target structures such as the recurrent laryngeal nerve, opening up a completely new technical path for non-invasive neuromodulation. Attached Figure Description

[0030] 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.

[0031] Figure 1 This is a schematic diagram of the action position of an embodiment of the vagus nerve ultrasound stimulation device of this application.

[0032] Figure 2 This is a schematic diagram of an embodiment of the vagus nerve ultrasound stimulation device of this application.

[0033] Figure 3 This is a three-dimensional explosion diagram of an embodiment of the vagus nerve ultrasound stimulation device of this application.

[0034] Figure 4 This is a three-dimensional explosion diagram from another perspective of an embodiment of the vagus nerve ultrasound stimulation device of this application.

[0035] Figure 5 This is a schematic diagram of the circuit module of an embodiment of the vagus nerve ultrasound stimulation device of this application.

[0036] Figure 6 This is a comparison chart of the frequency of epileptic seizures in patients in an epilepsy treatment case, based on an embodiment of the vagus nerve ultrasound stimulation device of this application.

[0037] Figure 7 This is a graph showing the changes in HAMD in a patient during a treatment case of depression, based on an embodiment of the vagus nerve ultrasound stimulation device of this application.

[0038] Figure 8 This is a comparison chart of VAS scores of patients in a chronic pain treatment case using an embodiment of the vagus nerve ultrasound stimulation device of this application.

[0039] The component labels are as follows:

[0040] 1. Neck; 11. Main trunk of vagus nerve; 100. Vagus nerve ultrasound stimulation device; 10. Main body; 101. Basal layer; 102. Coupling layer; 20. Ultrasound generating unit; 21. Ultrasound transducer; 221. High voltage power supply and charging circuit; 222. Signal generating circuit; 223. Pulse control circuit; 224. Drive circuit; 225. Power amplifier circuit; 226. Impedance matching circuit. Detailed Implementation

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] This application relates to the field of neuromodulation technology, specifically a vagus nerve ultrasound stimulation device. It aims to provide a non-invasive technical solution that can precisely focus ultrasound energy on a millimeter-scale target area of ​​the vagus nerve while ensuring sufficient penetration, thereby achieving safe, efficient, and precise non-invasive neuromodulation. This overcomes many problems existing in current technologies, such as the infection, surgical trauma, and high cost of implantable electrode stimulation, and the difficulty in precise targeting and susceptibility to side effects of transcutaneous electrical stimulation. The technical solution is described in detail below with reference to accompanying drawings and specific implementation examples.

[0047] Please see Figures 1 to 5 As shown, this application provides a vagus nerve ultrasound stimulation device 100, which achieves effective, safe, and precise stimulation of the vagus nerve through non-invasive ultrasound stimulation technology. The vagus nerve ultrasound stimulation device 100 is used to generate ultrasound waves to stimulate the vagus nerve, and 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 4.0MHz to 8.0MHz to penetrate the skin and focus on the target area of ​​the vagus nerve.

[0048] The vagus nerve ultrasound stimulation device 100 provided in this application provides ultrasound waves with a frequency of 4.0MHz to 8.0MHz. While ensuring that the ultrasound waves effectively penetrate the soft tissues of the neck to reach the target depth of the vagus nerve, it highly focuses the sound energy within a tiny focal area at the millimeter level, achieving precise and selective stimulation of the vagus nerve. Compared with traditional electrical stimulation methods, this technology significantly reduces side effects such as coughing and hoarseness caused by activation of adjacent non-target structures such as the recurrent laryngeal nerve, opening up a completely new technical path for non-invasive neuromodulation.

[0049] like Figures 2 to 4 As shown, in one embodiment of the vagus nerve ultrasound stimulation device 100 provided in this application, it is configured as a wearable device. 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 be in stable contact with the human body during use, thereby ensuring that the ultrasound waves can accurately act on the target area. The ultrasound generating unit 20 is located 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 the ultrasound waves, and thus achieving the purpose of neuromodulation.

[0050] 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 1, allowing ultrasound waves to penetrate the skin of the neck 1 and stimulate the vagus nerve. In other embodiments, the main body is configured as a neckband suitable for wearing and attaching to the neck 1. The neck 1 is an important distribution area of ​​the vagus nerve. Designing the main body 10 of the vagus nerve ultrasound stimulation device 100 as a patch for the neck 1 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 area of ​​the neck 1 directly opposite the vagus nerve trunk 11 within the carotid sheath, thereby stimulating the vagus nerve more precisely and improving the effect of neuromodulation.

[0051] Furthermore, to better adapt to the shape and physiological characteristics of human skin, and to prevent the vagus nerve ultrasound stimulation 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 has excellent flexibility and deformability, allowing it to deform accordingly according to the undulations and curves of the human skin surface, thus 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 poor contact between the device and the skin.

[0052] 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 such as the neck that are frequently in motion. 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 of ultrasound waves during propagation. In some embodiments, the main body 10 is made of medical-grade silicone, which is safe, hygienic, skin-friendly, and lightweight, exhibiting excellent wearable characteristics. Figure 3 and Figure 4As shown, in this embodiment, the vagus nerve ultrasound stimulation device has a layered structure. Specifically, the layered structure includes a base layer 101, an ultrasound generating layer, and a coupling layer 102 arranged in sequence. The base layer 101 and the 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 between the base layer 101 and the 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 vagus nerve ultrasound stimulation device and the human skin, the coupling layer 102 achieves a gradual transition of 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 on the side facing away from the skin.

[0053] The ultrasound generating unit 20 is the core functional part of the vagus nerve ultrasound stimulation 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.

[0054] 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 excitation circuit 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. In some embodiments, the excitation circuit also includes a matching network module connected between the amplification module and the ultrasonic transducer to achieve path matching, so as to provide the amplified excitation wave to the ultrasonic transducer 21, enabling the ultrasonic transducer 21 to generate ultrasonic waves of sufficient intensity and specific characteristics.

[0055] 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 to a high-voltage pulse sufficient to drive the transducer, commonly using a half-bridge or full-bridge topology. VMOS transistors and MOSFET modules are used as switching elements; the drive circuit 224 pre-amplifies the signal before power amplification to ensure rapid turn-on and turn-off of switching devices (such as VMOS transistors), improving pulse steepness and efficiency; the impedance matching circuit 226, composed of a matching transformer and capacitor, is used to match the impedance of the power amplifier circuit and the transducer, maximizing the electro-acoustic conversion efficiency; the high-voltage power supply and charging circuit 221 provides high-voltage DC power for power amplification and charges the energy storage capacitor through a charging resistor, forming a high-voltage pulse discharge circuit when the switch is turned 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) through a host computer or microcontroller to coordinate the operation of each circuit; the frequency selection module, in specific applications such as multi-frequency transducer driving, is used to extract the target frequency from a wideband signal, simplifying multi-frequency drive design.

[0056] The ultrasonic transducer 21 converts electrical energy into ultrasonic energy. In some embodiments, the ultrasonic transducer 21 is configured to generate pulsed ultrasound waves, which can have different duty cycles to meet the treatment needs of different diseases. Pulsed ultrasound waves have unique advantages; by adjusting parameters such as the pulse repetition frequency, pulse width, pulse intensity, and duty cycle, the intensity and frequency of stimulation to the vagus nerve can be more precisely controlled, thereby achieving fine-tuning of nerve modulation. In some embodiments, the ultrasound generating unit 20 is configured to transmit ultrasound waves with a pulse repetition frequency of 1Hz to 100Hz. Lower repetition frequencies are suitable for situations requiring gentler nerve stimulation, while higher repetition frequencies can be used in scenarios requiring stronger stimulation.

[0057] In some embodiments, the ultrasound generating unit 20 can be connected to a handheld terminal, such as a smartphone, via wired or wireless signals such as Bluetooth, infrared, WIFI, or mobile communication networks, so that users can intuitively set stimulation parameters and view treatment progress within the application of the handheld terminal such as the smartphone.

[0058] Please continue reading. Figures 2 to 4 As shown, in some embodiments, there are multiple ultrasonic transducers 21, and these 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 be various forms such as a triangular array, rectangular array, circular array, or ring array, and can be configured according to the shape of the area to be covered. In this embodiment, there are 16 ultrasonic transducers 21 arranged in a rectangular array; in other embodiments, the number of ultrasonic transducers 21 can be two or more. The ultrasonic transducer 21 array can be manufactured using flexible printed circuit technology, which has good surface fit performance. In different application scenarios, different array forms can be used to achieve adjustable focal length. The adjustable focal length increases the flexibility and adaptability of the vagus nerve ultrasound stimulation 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. In this embodiment, the ultrasound generating unit 20 is configured such that the ultrasound waves it generates can be focused within a millimeter-level focal area, i.e., its spatial resolution can reach within 1 mm. In this embodiment, the ultrasound generating unit is configured such that the ultrasound waves it generates can penetrate 20 mm to 60 mm of neck soft tissue, precisely targeting the vagus nerve trunk 11. For patients of different body types, the location and depth of the vagus nerve in the neck may vary; by adjusting the focal length, it can be ensured that the ultrasound waves can always accurately act on the target area.

[0059] The vagus nerve ultrasound stimulation device 100 provided in this application has an ultrasound generating unit 20 configured to provide ultrasound waves with a frequency of 4.0MHz to 8.0MHz to act on a small focal area of ​​the vagus nerve, achieving precise and selective stimulation of the vagus nerve. It is particularly suitable for various diseases requiring powerful and precise neuromodulation, including but not limited to epilepsy, depressive disorders, migraines, anxiety disorders, inflammatory diseases (such as rheumatoid arthritis), cardiac rehabilitation and arrhythmia, post-stroke rehabilitation, acute and chronic pain management, cognitive function improvement and Alzheimer's disease, as well as obesity and metabolic syndrome. By generating ultrasound waves to stimulate target areas of the vagus nerve associated with one or more of the above-mentioned conditions, it modulates neural activity to treat or alleviate symptoms. This device provides a revolutionary solution for the long-term management of chronic neurological diseases.

[0060] In some specific application embodiments, the ultrasonic generating unit 20 may be configured to provide ultrasonic waves with a frequency of 4.0MHz to 5.0MHz, 5.0MHz to 6.0MHz, or 6.0MHz to 8.0MHz. It has even been configured to provide ultrasound waves at specific frequencies, such as 4.0MHz, 4.1MHz, 4.2MHz, 4.3MHz, 4.4MHz, 4.5MHz, 4.6MHz, 4.7MHz, 4.8MHz, 4.9MHz, 5.0MHz, 5.1MHz, 5.2MHz, 5.3MHz, 5.4MHz, 5.5MHz, 5.6MHz, 5.7MHz, 5.8MHz, 5.9MHz, 6.0MHz, 6.1MHz, 6.2MHz, 6.3MHz, 6.4MHz, 6.5MHz, 6.6MHz, 6.7MHz, 6.8MHz, 6.9MHz, 7.0MHz, 7.1MHz, 7.2MHz, 7.3MHz, 7.4MHz, 7.5MHz, 7.6MHz, 7.7MHz, 7.8MHz, 7.9MHz, and 8.0MHz. Ultrasound waves of different frequencies have different penetration depths and tissue interaction characteristics. Generally speaking, relatively low-frequency ultrasound waves penetrate deeper but have relatively lower spatial resolution; relatively high-frequency ultrasound waves have higher spatial resolution but shallower penetration. By selecting an appropriate ultrasound frequency, precise stimulation of the vagus nerve can be achieved based on the depth and accuracy requirements of the target area. For example, for vagus nerve target areas located in deeper regions, lower-frequency ultrasound waves can be selected within the aforementioned range; while for target areas requiring higher precision stimulation, higher-frequency ultrasound waves can be selected within the aforementioned range.

[0061] In the vagus nerve ultrasound stimulation device 100 of this application, the target areas include target areas of the vagus nerve associated with one or more of the following conditions: epilepsy, depressive disorders, migraines, anxiety disorders, inflammatory diseases, cardiac rehabilitation and arrhythmia, post-stroke rehabilitation, acute and chronic pain management, cognitive impairment, Alzheimer's disease, and obesity and metabolic syndrome. 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 the aforementioned one or more conditions. Ultrasound stimulation of these target areas can effectively alleviate or treat the corresponding conditions. By stimulating target areas of 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.

[0062] When using the vagus nerve ultrasound stimulation device 100 provided in this application, the main body 10 is first attached to a suitable location on the skin, ensuring a tight fit between the device and the skin. The suitable location refers to a position where the vagus nerve can be effectively stimulated; this location can be determined in advance using anatomical techniques and human endoscopic techniques. Then, by controlling the excitation circuit, the ultrasound generating unit 20 generates ultrasound waves with a set frequency, phase, duty cycle, repetition frequency, and intensity, and focuses the ultrasound waves onto the target area of ​​the vagus nerve to achieve stimulation modulation.

[0063] The following are some specific clinical trials illustrating the application of the vagus nerve ultrasound stimulation device 100 provided in this application in terms of neuromodulation.

[0064] Example 1: High-frequency focused ultrasound for the treatment of epilepsy

[0065] This example provides a high-frequency focused ultrasound therapy device specifically designed for patients with drug-resistant epilepsy targeting the vagus nerve. It employs an ultrasound operating frequency of 6MHz to 8MHz, preferably a focused ultrasound frequency of 6.5MHz. This frequency is specially optimized to penetrate 20mm to 60mm of neck soft tissue depth, precisely targeting the main trunk of the vagus nerve. The device is equipped with a 32-element phased-array ultrasound transducer, each element with a diameter of 3mm, achieving precise stimulation with a focal spot size of less than 2mm × 2mm × 3mm. During treatment, the target point is first determined through cervical anatomical landmark localization and impedance detection. Then, pulsed ultrasound stimulation is applied with the following parameters: pulse repetition frequency 30Hz, duty cycle 50%, sound intensity 0.8W / cm², and each treatment session lasting 30 minutes.

[0066] This device features a flexible wearable design, using a medical-grade silicone substrate. It is only 1.5mm thick and weighs less than 80g, with a built-in flexible lithium battery supporting up to 8 hours of continuous operation. Connecting to a smartphone app via Bluetooth, patients can view treatment data at any time, and doctors can remotely adjust treatment plans, making it suitable for long-term home use. Figure 6 As shown, the Control group represents the number of seizures in the 14 days prior to treatment with the device of this embodiment; the Treatment group represents the number of seizures in the 14 days following 21 days of treatment with the device of this embodiment. Clinical studies have shown that this approach reduces the seizure frequency in patients with refractory epilepsy by an average of 65%, while avoiding common side effects of traditional VNS such as hoarseness.

[0067] Example 2: Wearable neuromodulation devices for the treatment of depression

[0068] This example demonstrates the design of a wearable vagus nerve ultrasound stimulation device for patients with severe depression. The system operates at a frequency of 5MHz to 6MHz, preferably 5.5MHz, for deep stimulation. The core of the device is a 128-element curved transducer made of flexible piezoelectric composite material, with a radius of curvature matched to the anatomical structure of the adult neck to ensure stable acoustic coupling in different body positions. Stimulation parameters are set as follows: pulse width 500μs, repetition rate 20Hz, peak sound pressure level 0.6MPa, with treatment twice daily for 20 minutes each time.

[0069] The device features a modular design, including replaceable ultrasound emission and control modules. The flexible circuit board is directly printed on a polyimide substrate, with an overall thickness of only 2mm and a weight under 100g. It boasts an IP67 waterproof rating, allowing for wear during daily activities other than showering. A cloud-based management platform allows doctors to monitor patient adherence and treatment efficacy in real time and adjust treatment plans accordingly. The device also integrates multimodal biosignal monitoring and artificial intelligence optimization algorithms. It uses a heart rate variability (HRV) sensor to assess autonomic nervous system function in real time, and Galvanic Skin Reaction (GSR) to monitor emotional stress levels, combining this with activity data to construct an individualized model of depressive states. Machine learning algorithms dynamically adjust stimulation parameters based on these physiological indicators, automatically increasing stimulation intensity during periods of emotional distress and maintaining basic treatment during stable periods. Figure 7 As shown, the Control group represents the control group data, and the Treatment group represents the experimental group data. Clinical trials have shown that after 8 weeks of treatment with this device, the Hamilton Depression Rating Scale (HAMD-17) score decreased by an average of 15 points, with a significantly higher efficacy rate than traditional drug treatment.

[0070] Example 3: Comprehensive Management of Chronic Pain

[0071] This example provides a vagus nerve ultrasound stimulation device for treating chronic pain, particularly for patients with fibromyalgia syndrome and neuropathic pain. The device operates at an ultrasound frequency of 4MHz to 6MHz, preferably with a center frequency of 4.5MHz, balancing penetration depth and resolution requirements, with the focal spot size controlled within the range of 3mm × 3mm × 4mm. The device employs a dual-mode stimulation strategy, featuring at least two pulse repetition frequencies: a low-frequency mode, for example, a pulse repetition frequency of 10Hz, used during acute pain attacks; and a high-frequency mode, for example, a pulse repetition frequency of 25Hz, used for maintenance therapy. The low-frequency mode directly activates inhibitory neurons in the dorsal horn of the spinal cord, promoting the release of endogenous opioid peptides (such as β-endorphin and enkephalin), exerting a rapid analgesic effect through μ receptors. This mechanism is similar to the body's natural pain inhibition pathways, suitable for immediate control of acute pain. The high-frequency mode continuously inhibits excessive firing of dorsal horn neurons, reducing the plasticity of the pain pathway and thus decreasing sensitivity to long-term pain. Long-term use of low-frequency stimulation may lead to desensitization of the endorphin system and the development of tolerance, making it unsuitable for long-term use; while high-frequency stimulation works through a non-opioid mechanism, making it suitable for long-term maintenance therapy. Furthermore, the sound intensity range is controlled within 0.3~1.2 W / cm² and is adjustable to automatically adjust according to the degree of pain.

[0072] In this example, the device features an ergonomic design, using a composite material of memory foam and medical-grade silicone to fit patients with different neck circumferences. It is equipped with an intelligent temperature control system to maintain the surface temperature below 41°C, preventing discomfort from prolonged wear. A built-in nine-axis motion sensor identifies effective wearing status, ensuring standardized treatment. Furthermore, the device innovatively combines vagus nerve stimulation with pain biomarker monitoring and, through data interaction with the hospital's pain management platform, enables standardized management and remote guidance of outpatient pain treatment. Figure 8 As shown, the Control group represents the control group data, and the Treatment group represents the experimental group data. Clinical trials have shown that this device reduces the average Visual Analog Scale (VAS) score of patients with chronic pain by 6 points and reduces the amount of analgesic medication used by 42%.

[0073] As can be seen from the above description of specific embodiments, the vagus nerve ultrasound stimulation device of this application has significant advantages compared with the prior art. First, it is a non-invasive neuromodulation method, avoiding the problems of infection, surgical trauma, and high costs associated with implanted electrode stimulation, greatly improving patient acceptance and safety. Second, through the action of ultrasound, precise targeted stimulation of the vagus nerve can be achieved, overcoming the problems of percutaneous electrical stimulation's difficulty in penetrating superficial tissues and its tendency to cause stimulation diffusion and side effects. Furthermore, the main design of the device facilitates daily use by patients, improving the convenience and compliance of treatment.

[0074] The vagus nerve ultrasound stimulation device 100 provided in this application uses high-frequency focused ultrasound with a frequency of 4.0MHz to 8.0MHz as the stimulation source, successfully overcoming the technical bottleneck of traditional nerve stimulation techniques where penetration depth and spatial resolution are difficult to achieve simultaneously. This frequency range has been precisely optimized to ensure that ultrasound waves effectively penetrate the soft tissues of the neck to reach the target depth of the vagus nerve, while highly concentrating the acoustic energy within a millimeter-level microfocal area, achieving precise and selective stimulation of the vagus nerve. Compared with traditional electrical stimulation methods, this technology significantly reduces side effects such as coughing and hoarseness caused by activation of adjacent non-target structures such as the recurrent laryngeal nerve, opening up a new technical path for non-invasive neuromodulation. Furthermore, the vagus nerve ultrasound stimulation device 100 provided in this application uses a flexible main body 10 combined with an array of ultrasound transducers 21, making it comfortable to wear and conforming to the neck and other positions, maintaining excellent acoustic coupling performance, and suitable for home use.

[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 vagus nerve ultrasound stimulation device, characterized in that, The device includes an ultrasound generating unit configured to provide ultrasound waves to a target area of ​​the vagus nerve in a controlled manner; wherein the ultrasound generating unit is configured to provide ultrasound waves at a frequency of 4.0 MHz to 8.0 MHz to focus on the target area of ​​the vagus nerve at that frequency.

2. The vagus nerve ultrasound stimulation device according to claim 1, characterized in that, The ultrasonic generating unit is configured to provide ultrasonic waves with a frequency of 4.0MHz to 5.0MHz.

3. The vagus nerve ultrasound stimulation device according to claim 2, characterized in that, The ultrasonic generating unit is configured to provide ultrasonic waves at a frequency of 4.0 MHz or 4.5 MHz.

4. The vagus nerve ultrasound stimulation device according to claim 1, characterized in that, The ultrasonic generating unit is configured to provide ultrasonic waves with a frequency of 5.0MHz to 6.0MHz.

5. The vagus nerve ultrasound stimulation device according to claim 4, characterized in that, The ultrasonic generating unit is configured to provide ultrasonic waves at a frequency of 5.0 MHz or 5.5 MHz.

6. The vagus nerve ultrasound stimulation device according to claim 1, characterized in that, The ultrasonic generating unit is configured to provide ultrasonic waves with a frequency of 6.0MHz to 8.0MHz.

7. The vagus nerve ultrasound stimulation device according to claim 6, characterized in that, The ultrasonic generating unit is configured to provide ultrasonic waves at frequencies of 6.0 MHz, 6.5 MHz, 7.0 MHz, 7.5 MHz, or 8 MHz.

8. The vagus nerve ultrasound stimulation device according to claim 1, characterized in that, The ultrasonic generating unit is configured such that the ultrasonic waves it generates can be focused within a focal region at the millimeter level.

9. The vagus nerve ultrasound stimulation device according to claim 1, characterized in that, The ultrasound generating unit is configured such that the ultrasound waves it generates can penetrate biological tissues of 20mm to 60mm.

10. The vagus nerve ultrasound stimulation 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.

11. The vagus nerve ultrasound stimulation device according to claim 10, 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.

12. The vagus nerve ultrasound stimulation device according to claim 11, characterized in that, The excitation circuit also includes a boost circuit module and a matching network module, wherein the matching network module is connected between the amplification module and the ultrasonic transducer.

13. The vagus nerve ultrasound stimulation device according to any one of claims 1 to 12, characterized in that, The vagus nerve ultrasound stimulation device is adapted to be placed on the neck so that ultrasound waves can penetrate the skin of the neck and stimulate the vagus nerve.

14. The vagus nerve ultrasound stimulation device according to any one of claims 1 to 12, characterized in that, The vagus nerve ultrasound stimulation device includes a main body adapted to be attached to human skin, and the ultrasound generating unit is disposed on the main body.

15. The vagus nerve ultrasound stimulation device according to claim 14, characterized in that, The main body is configured as a patch or neckband suitable for attachment to the human neck.

16. The vagus nerve ultrasound stimulation device according to claim 15, characterized in that, The main body includes a flexible silicone component that can deform to fit the human neck.

17. The vagus nerve ultrasound stimulation device according to any one of claims 1 to 12, characterized in that, The vagus nerve ultrasound stimulation device has a hierarchical structure.

18. The vagus nerve ultrasound stimulation device according to claim 17, characterized in that, The hierarchical structure includes a base layer, an ultrasound generating layer, and a coupling layer arranged in sequence.

19. The vagus nerve ultrasound stimulation device according to any one of claims 1 to 12, characterized in that, The target area includes the vagus nerve region associated with one or more of the following conditions: epilepsy, depressive disorders, migraine, anxiety disorders, inflammatory diseases, cardiac rehabilitation and arrhythmia, post-stroke rehabilitation, acute and chronic pain management, cognitive impairment, Alzheimer's disease, and obesity and metabolic syndrome.

20. The vagus nerve ultrasound stimulation device according to any one of claims 1 to 12, characterized in that, The ultrasonic generating unit is configured to transmit ultrasonic waves with a pulse repetition frequency of 1Hz to 100Hz.

21. The vagus nerve ultrasound stimulation device according to any one of claims 1 to 12, characterized in that, The ultrasonic generating unit includes multiple ultrasonic transducers arranged in an array.

22. The vagus nerve ultrasound stimulation device according to claim 21, characterized in that, The number of ultrasonic transducers is two or more, arranged in a triangular array, rectangular array, circular array or ring array.

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