A high-precision deep brain electrical stimulation device and system

Abstract

The application relates to the technical field of medical devices, in particular to a high-precision deep brain electrical stimulation device, which comprises a signal generation module, a low-voltage power supply module, a high-voltage power supply module, a parameter input module, an MCU control module, a parameter display module, a 4x1 voltage division module, a direct current removal module, a constant current source module and an impedance detection module. The application adopts a 4x1 electrode ring configuration, improves the traditional one-pair electrode (positive and negative electrodes) structure into a design of one positive electrode and four negative electrodes, the positive electrode is designed as a miniaturized electrode and is accurately placed in the target stimulation area; the four negative electrodes are uniformly distributed around the positive electrode to form a closed current loop within a limited range. Compared with the traditional bipolar electrical stimulation design, the multi-polar layout effectively limits the diffusion range of the current, so that the output current is more concentrated in the area between the positive electrode and the surrounding four negative electrodes, thereby significantly improving the spatial selectivity and accuracy of the stimulation.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to a high-precision deep brain stimulation device and system. Background Technology

[0002] Temporal Interference Non-Invasive Deep Brain Stimulation (TI-NIDBS) is a neuromodulation technique that generates a low-frequency envelope electric field in the deep brain by applying two pairs of high-frequency sinusoidal currents (with a frequency difference Δf typically between 1 and 100 Hz). Its principle is based on the low-pass filtering characteristics of neurons: when high-frequency currents pass through the scalp and skull, they do not directly activate superficial tissues because their frequency exceeds the neuronal response range; however, in deep brain regions, the interference of two high-frequency currents generates a low-frequency envelope electric field with a frequency of Δf, thereby selectively stimulating target neurons. This technique avoids the trauma risks of invasive electrodes and provides a new approach for the treatment of deep brain diseases such as Parkinson's disease and depression.

[0003] This time-interference-based non-invasive deep brain stimulation technique uses a dual-electrode pair mode, which can achieve selective stimulation of specific brain regions, but it must face the problem of widespread electric field diffusion.

[0004] The low-frequency envelope stimulation electric field in its dual-electrode mode is widely distributed and has low spatial specificity. The peak electric field intensity falls outside the electrode pair, and the actual stimulated deep brain region deviates from the expected region. This defect weakens the reliability of the technology to some extent and also leads to the possibility of inconsistent results in repeated experiments. Utility Model Content

[0005] To address the issue that existing technologies sometimes deviate between the actual deep brain regions stimulated and the desired regions, which weakens the reliability of the technology and can lead to inconsistent results in repeated experiments, this application provides a high-precision deep brain stimulation device and system.

[0006] The embodiments of this application are implemented as follows:

[0007] In a first aspect, this application provides a high-precision time-interventional non-invasive deep brain stimulation device, comprising:

[0008] Signal generation module: includes a dual-channel signal generator with an output frequency range in the high-frequency range and adjustable phase difference adjustment accuracy, including a first signal generator module and a second signal generator module;

[0009] Low-voltage power supply module: Provides low-voltage power support for the MCU control module and signal generator module;

[0010] High-voltage power supply module: Provides high-voltage power support for the constant current source module;

[0011] Parameter input module: used for user input signals, including frequency, amplitude, time interference phase and stimulation mode;

[0012] MCU control module: Receives user parameter input and dynamically adjusts the output of the signal generator and constant current source;

[0013] Parameter display module: Used to display the operating status in real time, and provide fault information and operating status prompts, so that users can intuitively understand the system status;

[0014] 4×1 voltage divider module: The output voltage is adjusted by a digital potentiometer, and the voltage signal is precisely distributed to flexibly adapt to different electrode configurations and stimulation intensity requirements to meet the requirements of various application scenarios;

[0015] DC removal module: Eliminates the DC component in the output signal;

[0016] Constant current source module: contains multiple independent constant current source circuits, which are connected to the four negative electrodes respectively to provide a stable stimulation current, ensure high stability and low noise characteristics of the output current, and improve the overall stimulation effect;

[0017] Impedance detection module: Real-time detection of electrode contact impedance and feedback to the control module.

[0018] In one possible implementation, the output of the signal generation module is sequentially connected to a 4×1 voltage divider module, a DC de-energizer module, and a constant current source module. The MCU control module dynamically adjusts the constant current source output based on the feedback from the impedance detection module.

[0019] One possible implementation also includes an anti-phase output circuit: used to generate precise phase-opposite current signals to achieve a time-interference stimulation effect and ensure that the phase difference of the signal meets high-precision requirements.

[0020] In one possible implementation, the constant current source module includes a first constant current source submodule and a second constant current source submodule. Each constant current source submodule includes a positive constant current source circuit and four negative constant current source circuits. The output terminal of each circuit is connected to the impedance detection module.

[0021] The constant current source circuit includes an MD5333 chip, resistors R4 and R5, and capacitor C1. The MD5333 chip's Pin 1 (GND) is grounded and connected to the circuit's common ground. Pin 2 (VIN) is the input voltage terminal, used to provide power to the chip. Pin 3 (VOUT) is the output terminal, from which current or voltage is output to drive the load. Resistor R4 is connected between VCC and the MD5333's input terminal VIN. Resistor R5 is connected between the output terminal VOUT and ground, in parallel with capacitor C1. The capacitor is connected between the output terminal VOUT and ground, in parallel with resistor R5.

[0022] In one possible implementation, the MCU control module receives user input signals from the parameter input module. The received input signals are parsed and stored for configuring the working state of subsequent modules.

[0023] The MCU control module sends control commands to the signal generator module to generate signals with specific frequencies, amplitudes, and waveforms.

[0024] When the system is running in interference mode, the MCU control module adjusts the output phase difference between the first signal generator module and the second signal generator module to accurately generate a time interference signal that meets the requirements.

[0025] The MCU control module obtains real-time feedback data from the impedance detection module, analyzes the changes in brain impedance and the stimulation effect, and dynamically adjusts the output parameters of the constant current source module according to the feedback data to compensate for the deviation of stimulation current caused by impedance changes. If abnormal impedance is detected, the MCU control module will trigger an alarm mechanism and stop the system operation to ensure safety.

[0026] The MCU control module transmits the input parameters and feedback data from the impedance detection module to the parameter display module.

[0027] In one possible implementation, the 4×1 voltage divider module includes a digital potentiometer and a voltage divider ratio input button. The voltage divider ratio input button changes the resistance value of the digital potentiometer by pressing the button. Each time the button is pressed, the resistance value of the digital potentiometer increases or decreases, thereby changing the magnitude of the output voltage.

[0028] Secondly, this application provides a high-precision time-interference non-invasive deep brain stimulation system, characterized in that it includes:

[0029] Forward simulation mode: The electrode position is a known condition, and the distribution of electric field intensity generated by the stimulus is the solution target. The electrode position is selected through the 10-20 EEG system. After selecting a positive electrode, the four nearest electrodes in the surrounding directions are set as its negative electrodes. The current intensity of the positive electrode is the sum of the current intensities of the four negative electrodes. The simulation system solves the problem to obtain the distribution of electric field intensity generated by the stimulus.

[0030] Reverse simulation mode: The stimulus target is known, but the electrode positions are unknown. After selecting the corresponding target point, the simulation system solves the problem and gives the positions of two sets of electrodes, with the positive electrode surrounded by four negative electrodes.

[0031] The technical solution provided in this application can achieve at least the following beneficial effects:

[0032] The high-precision time-interventional non-invasive deep brain stimulation method, device, system, and usage method provided in this application significantly improve the spatial accuracy and targeting capability of electrical stimulation through innovative design and optimization of electrode configuration and stimulation current distribution. Traditional deep brain stimulation devices typically apply current using a pair of electrodes (one positive and one negative), but this method has significant limitations in electric field distribution, easily causing current to diffuse into non-target areas and reducing the stimulation accuracy of specific brain regions.

[0033] The core innovation of this application lies in improving the traditional pair of electrodes (positive and negative electrodes) structure into a design with one positive electrode and four negative electrodes. The positive electrode is designed as a miniaturized electrode and is precisely placed in the target stimulation area; the four negative electrodes are evenly distributed around the positive electrode to form a closed current loop within a limited range. Compared with the traditional bipolar electrical stimulation design, this multipolar layout effectively limits the current diffusion range, making the output current more concentrated in the area between the positive electrode and the four surrounding negative electrodes, thereby significantly improving the spatial selectivity and precision of stimulation.

[0034] Furthermore, by employing a smaller electrode design, the effective range of the current is further reduced, avoiding interference from the electric field to non-target areas in traditional methods. The high concentration of the current and the precise positioning of the target area can effectively overcome the shortcomings of the widespread diffusion of the electric field in traditional dual-electrode deep brain interference. Especially when electrical stimulation is involved in deep brain regions, this improved electrode layout and electric field distribution not only improves the targeting ability of the target area, but also reduces unintentional interference to surrounding non-target brain tissue.

[0035] This design significantly improves the spatial precision of electrical stimulation of specific cortical or deep brain regions, and provides a more reliable and efficient tool for the application of non-invasive deep brain stimulation (DBS) technology in basic research, treatment of neurological diseases, and brain function modulation. Furthermore, the system and device design incorporates multiple safety mechanisms (such as impedance detection and feedback) to further ensure reliability and patient safety during use. This approach represents a disruptive advancement over traditional non-invasive brain stimulation techniques, driving further development of brain stimulation technology in clinical and research fields. Attached Figure Description

[0036] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are 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 illustrating the principle of a high-precision deep brain stimulation device according to an exemplary embodiment of this application;

[0038] Figure 2 This is a schematic diagram of the structure of a high-precision deep brain stimulation device shown in an exemplary embodiment of this application;

[0039] Figure 3 This is a schematic diagram illustrating the working logic of an MCU control module according to an exemplary embodiment of this application;

[0040] Figure 4 This is a schematic diagram of the structure of a 4×1 voltage divider module shown in an exemplary embodiment of this application;

[0041] Figure 5 This is a schematic diagram of the structure of a constant current source circuit shown in an exemplary embodiment of this application;

[0042] Figure 6 This is a flowchart illustrating a method of using a high-precision deep brain stimulation system according to an exemplary embodiment of this application;

[0043] Figure 7 This is a comparative diagram of this application and the prior art. Detailed Implementation

[0044] To make the objectives, implementation methods and advantages of this application clearer, the exemplary implementation methods of this application will be clearly and completely described below with reference to the accompanying drawings of the exemplary embodiments of this application. Obviously, the exemplary embodiments described are only some embodiments of this application, and not all embodiments. It should be understood that the specific embodiments described herein are only used to explain this application and are not intended to limit this application.

[0045] It should be noted that the brief descriptions of terms in this application are only for the convenience of understanding the embodiments described below, and are not intended to limit the embodiments of this application. Unless otherwise stated, these terms should be understood in their ordinary and common meaning.

[0046] The terms "first," "second," "third," etc., used in the specification, claims, and accompanying drawings of this application are used to distinguish similar or related objects or entities, and do not necessarily imply a specific order or sequence, unless otherwise specified. It should be understood that such terms are interchangeable where appropriate.

[0047] The terms “comprising” and “having”, and any variations thereof, are intended to cover but not exclude inclusion, for example, a product or device that includes a range of components is not necessarily limited to all of the components that are clearly listed, but may include other components that are not clearly listed or that are inherent to such product or device.

[0048] Before explaining the high-precision time-interference non-invasive deep brain stimulation method provided in the embodiments of this application, the application scenarios and implementation environment of the embodiments of this application will be introduced first.

[0049] Temporal Interference Non-Invasive Deep Brain Stimulation (TI-NIDBS) is a neuromodulation technique that generates a low-frequency envelope electric field in the deep brain by applying two pairs of high-frequency sinusoidal currents (with a frequency difference Δf typically between 1 and 100 Hz). Its principle is based on the low-pass filtering characteristics of neurons: when high-frequency currents pass through the scalp and skull, they do not directly activate superficial tissues because their frequency exceeds the neuronal response range; however, in deep brain regions, the interference of two high-frequency currents generates a low-frequency envelope electric field with a frequency of Δf, thereby selectively stimulating target neurons. This technique avoids the trauma risks of invasive electrodes and provides a new approach for the treatment of deep brain diseases such as Parkinson's disease and depression.

[0050] This time-interference-based non-invasive deep brain stimulation technique uses a dual-electrode pair mode, which can achieve selective stimulation of specific brain regions, but it must face the problem of widespread electric field diffusion.

[0051] The low-frequency envelope stimulation electric field in its dual-electrode mode is widely distributed and has low spatial specificity. The peak electric field intensity falls outside the electrode pair, and the actual stimulated deep brain region deviates from the expected region. This defect weakens the reliability of the technology to some extent and also leads to the possibility of inconsistent results in repeated experiments.

[0052] Based on this, this application provides a high-precision deep brain stimulation device and system, employing a 4×1 electrode ring configuration. This configuration combines one positive electrode with four negative electrodes to form a local current loop, significantly improving the focusing of the current in the target brain region. The device includes a stimulator and a simulation system. The stimulator achieves high-precision current control through an anti-phase output circuit, a voltage divider circuit, a constant current source module, and an impedance detection module. The simulation system supports optimization of both forward and reverse electrode positions, and incorporates a personalized, realistic finite element head model simulation system based on MRI data to guide practical applications. This overcomes the current diffusion defects inherent in traditional dual-electrode modes, improving the accuracy and safety of deep brain stimulation and providing an efficient and reliable technical means for the treatment of neurological diseases and the regulation of brain function.

[0053] Next, the technical solutions of this application and how they solve the aforementioned technical problems will be described in detail through embodiments and in conjunction with the accompanying drawings. The embodiments can be combined with each other, and the same or similar concepts or processes may not be repeated in some embodiments. Obviously, the described embodiments are only some, not all, of the embodiments of this application.

[0054] Figure 2 This is a schematic diagram of the structure of a high-precision deep brain stimulation device shown in an exemplary embodiment of this application. Figure 3 This is a schematic diagram illustrating the working logic of an MCU control module according to an exemplary embodiment of this application. Figure 4 This is a schematic diagram of the structure of a 4×1 voltage divider module shown in an exemplary embodiment of this application. Figure 5 This is a schematic diagram of the structure of a constant current source circuit shown in an exemplary embodiment of this application.

[0055] In one exemplary embodiment, such as Figure 2 As shown, this high-precision deep brain stimulation device includes:

[0056] Signal generation module: includes a dual-channel signal generator with an output frequency range in the high-frequency range and adjustable phase difference adjustment accuracy, including a first signal generator module and a second signal generator module;

[0057] Low-voltage power supply module: Provides low-voltage power support for the MCU control module and signal generator module;

[0058] High-voltage power supply module: Provides high-voltage power support for the constant current source module;

[0059] Parameter input module: used for user input signals, including frequency, amplitude, time interference phase and stimulation mode;

[0060] MCU control module: Receives user parameter input and dynamically adjusts the output of the signal generator and constant current source;

[0061] Parameter display module: Used to display the operating status in real time, and provide fault information and operating status prompts, so that users can intuitively understand the system status;

[0062] 4×1 voltage divider module: The output voltage is adjusted by a digital potentiometer, and the voltage signal is precisely distributed to flexibly adapt to different electrode configurations and stimulation intensity requirements to meet the requirements of various application scenarios;

[0063] DC removal module: Eliminates the DC component in the output signal;

[0064] Constant current source module: contains multiple independent constant current source circuits, which are connected to the four negative electrodes respectively to provide a stable stimulation current, ensure high stability and low noise characteristics of the output current, and improve the overall stimulation effect;

[0065] Impedance detection module: Real-time detection of electrode contact impedance and feedback to the control module.

[0066] These circuit modules ensure that each pair of stimulation currents is distributed only within the corresponding 4×1 electrode position range, improving the focusing of the current flow path of each pair, thereby improving the focusing of the interference electric field generated by the two pairs of currents, and further enhancing the overall reliability and stimulation effect of the system. To verify the effectiveness of this method...

[0067] In one possible implementation, the stimulation device also includes an anti-phase output circuit for generating precise phase-opposite current signals to achieve a time-interference stimulation effect and ensure that the phase difference of the signal meets high-precision requirements.

[0068] In one possible implementation, the constant current source module is equipped with four independent small constant current sources to provide a stable stimulation current, ensuring high stability and low noise characteristics of the output current and improving the overall stimulation effect.

[0069] Through the efficient collaboration of its various modules, this device provides technical support for achieving high-precision, non-invasive deep brain stimulation.

[0070] In one possible implementation, the output of the signal generation module is connected in sequence to a 4×1 voltage divider module, a DC-DC converter module, and a constant current source module. The MCU control module dynamically adjusts the constant current source output based on the feedback from the impedance detection module.

[0071] In one possible implementation, such as Figure 5 As shown, the constant current source module includes a first constant current source submodule and a second constant current source submodule. Each constant current source submodule includes a positive constant current source circuit and four negative constant current source circuits. The output terminal of each circuit is connected to the impedance detection module.

[0072] The constant current source circuit includes an MD5333 chip, resistors R4 and R5, and capacitor C1. The MD5333 chip's Pin 1 (GND) is grounded and connected to the circuit's common ground. Pin 2 (VIN) is the input voltage terminal, used to provide power to the chip. Pin 3 (VOUT) is the output terminal, from which current or voltage is output to drive the load. Resistor R4 is connected between VCC and the MD5333's input terminal VIN. Resistor R5 is connected between the output terminal VOUT and ground, in parallel with capacitor C1. The capacitor is connected between the output terminal VOUT and ground, in parallel with resistor R5.

[0073] In one possible implementation, such as Figure 3 As shown, the MCU control module receives user input signals from the parameter input module. The received input signals are parsed and stored for configuring the working status of subsequent modules.

[0074] The MCU control module sends control commands to the signal generator module to generate signals with specific frequencies, amplitudes, and waveforms.

[0075] When the system is running in interference mode, the MCU control module adjusts the output phase difference between the first signal generator module and the second signal generator module to accurately generate a time interference signal that meets the requirements.

[0076] The MCU control module obtains real-time feedback data from the impedance detection module, analyzes the changes in brain impedance and the stimulation effect, and dynamically adjusts the output parameters of the constant current source module according to the feedback data to compensate for the deviation of stimulation current caused by impedance changes. If abnormal impedance is detected, the MCU control module will trigger an alarm mechanism and stop the system operation to ensure safety.

[0077] The MCU control module transmits the input parameters and feedback data from the impedance detection module to the parameter display module.

[0078] In one possible implementation, such as Figure 4 As shown, the 4×1 voltage divider module includes a digital potentiometer and a voltage divider ratio input button. The voltage divider ratio input button changes the resistance value of the digital potentiometer by pressing the button. Each time the button is pressed, the resistance value of the digital potentiometer increases or decreases, thereby changing the magnitude of the output voltage.

[0079] Specific limitations regarding high-precision deep brain stimulation (DBS) devices can be found in the above section on the limitations of high-precision time-interventional non-invasive DBS methods, and will not be repeated here. The various modules in the aforementioned high-precision DBS devices can be implemented entirely or partially through software, hardware, or a combination thereof. These modules can be embedded in or independent of the processor in a computer device, or stored in the computer device's memory as software, allowing the processor to call and execute the corresponding operations of each module.

[0080] Corresponding to the aforementioned embodiments of the high-precision deep brain stimulation method and device, and employing the same technical concept, this application also provides embodiments of a high-precision deep brain stimulation system.

[0081] In one exemplary embodiment, the high-precision deep brain stimulation system includes:

[0082] Forward simulation mode: The electrode position is a known condition, and the distribution of electric field intensity generated by the stimulus is the solution target. The electrode position is selected through the 10-20 EEG system. After selecting a positive electrode, the four nearest electrodes in the surrounding directions are set as its negative electrodes. The current intensity of the positive electrode is the sum of the current intensities of the four negative electrodes. The simulation system solves the problem to obtain the distribution of electric field intensity generated by the stimulus.

[0083] Reverse simulation mode: The stimulus target is known, but the electrode positions are unknown. After selecting the corresponding target point, the simulation system solves the problem and gives the positions of two sets of electrodes, with the positive electrode surrounded by four negative electrodes.

[0084] Figure 6 This is a flowchart illustrating a method of using a high-precision deep brain stimulation system according to an exemplary embodiment of this application.

[0085] In one exemplary embodiment, such as Figure 6 As shown, this application also provides a method for using a high-precision deep brain stimulation system, which may include the following steps:

[0086] Brain imaging data of users is collected by MRI equipment, and brain tissue is modeled using finite element simulation technology to simulate electric field distribution and stimulation effects, and to determine key parameters of stimulation.

[0087] Based on the simulation results, combined with the patient's treatment goals and specific needs, the brain target points that need to be stimulated are accurately located.

[0088] Based on the target location and simulation results, an electrode placement scheme was designed, with one positive electrode placed in the target area and four negative electrodes symmetrically arranged around it to ensure the uniformity of electrical stimulation and the accuracy of the target.

[0089] Turn on the stimulator device to prepare for operation, attach the designed electrodes to the designated positions, and ensure that the electrodes are securely connected to the system and have good conductivity.

[0090] Based on experimental or therapeutic requirements, parameters such as current intensity, frequency, and stimulation time are set to ensure the precision and personalization of electrical stimulation.

[0091] The set stimulation parameters are input into the MCU control module, which generates an electrical stimulation signal through the signal generation module. The signal is then output after being adjusted by the DC de-current circuit and the constant current source circuit.

[0092] The impedance detection circuit monitors the impedance between the electrode and the skin in real time and feeds the detection results back to the MCU control module. If the impedance value is within the safe range, the MCU maintains the output of the stimulation signal. If the impedance value is abnormal, the MCU control module will issue a warning, pause the output of the stimulation signal, or prompt the operator to adjust the electrode position and contact quality.

[0093] The display screen shows key parameters such as current, resistance, and frequency in real time, allowing operators to monitor them dynamically and ensure the transparency and controllability of the stimulation process.

[0094] The system automatically monitors the stimulation process. When the stimulation time reaches the set value, the stimulator automatically stops working and prompts that the operation is complete.

[0095] Corresponding to the aforementioned embodiments of high-precision deep brain stimulation devices, and employing the same technical concept, this application also provides embodiments of high-precision deep brain stimulation methods.

[0096] Figure 1 This is a schematic diagram illustrating the principle of a high-precision deep brain stimulation device according to an exemplary embodiment of this application.

[0097] In one exemplary embodiment, a high-precision deep brain stimulation method is provided, which may include the following steps:

[0098] Step 100: Using a 4×1 electrode ring configuration, a single positive electrode is precisely positioned at the center of the target brain region, and four negative electrodes are symmetrically arranged around the positive electrode to form a closed ring current path.

[0099] Step 200: Generate two high-frequency sinusoidal current signals using a signal generator. The frequency of the first signal is f1, and the frequency of the second signal is f2, where |f1-f2| is 1-100Hz, and the phase difference between the two signals is adjustable.

[0100] Step 300: Input the two signals into two independent 4×1 electrode groups, each containing one positive electrode and four negative electrodes, and generate a low-frequency envelope electric field in the target area through current interference.

[0101] Step 400: Monitor the electrode-skin contact impedance in real time and dynamically adjust the output current intensity according to the impedance changes.

[0102] In one possible implementation, such as Figure 1 As shown, a smaller electrode design is employed, with the positive electrode precisely placed in the target area, while four negative electrodes are evenly distributed around the positive electrode. By limiting the output current and precisely controlling the current's effective range between the four negative electrodes, the drawbacks of traditional dual-electrode deep brain interference electric fields—wide diffusion and difficulty in focusing—are effectively overcome, thereby significantly improving the spatial resolution and stimulation accuracy of current targeting specific cortical regions.

[0103] As can be seen, in some embodiments of this application, each stimulation current in the target brain region consists of one output electrode (positive electrode) and four input electrodes (negative electrodes). This configuration not only optimizes the spatial arrangement of the electrodes but also significantly improves the focusing of stimulation on the target brain region. Specifically, in this method, the 4×1 electrode ring structure ensures that the stimulation current can act more concentratedly on the target brain region, and each positive electrode and its four corresponding negative electrodes form a local current loop, thereby generating a higher electric field focusing degree in the target region.

[0104] In addition, to support this stimulation method, some embodiments of this application have designed a dedicated stimulation circuit to support signal generation and transmission for a 2-pair 4×1 electrode configuration.

[0105] It should be understood that although the steps in the flowcharts of the above embodiments are shown sequentially as indicated, these steps are not necessarily executed in the indicated order. Unless explicitly stated herein, there is no strict order restriction on the execution of these steps, and they can be executed in other orders. Moreover, at least some steps in the flowcharts of the above embodiments may include multiple steps or multiple stages. These steps or stages are not necessarily completed at the same time, but can be executed at different times. The execution order of these steps or stages is not necessarily sequential, but can be performed alternately or in turn with other steps or at least some of the steps or stages in other steps.

[0106] This application provides a high-precision time-interventional non-invasive deep brain stimulation system and device. Through innovative design, the electrode configuration and stimulation current distribution are optimized, significantly improving the spatial accuracy and targeting capability of the electrical stimulation. Traditional deep brain stimulation devices typically apply current using a pair of electrodes (one positive and one negative). However, this method has significant limitations in electric field distribution, easily causing the current to diffuse into non-target areas, reducing the stimulation accuracy of specific brain regions.

[0107] The core innovation of this application lies in improving the traditional pair-electrode (positive and negative) structure into a design with one positive electrode and four negative electrodes. The positive electrode is designed as a miniaturized electrode and precisely placed in the target stimulation region; the four negative electrodes are evenly distributed around the positive electrode to form a closed current loop within a confined area. Compared to traditional bipolar electrical stimulation designs, this multipolar layout effectively limits the current diffusion range, making the output current more concentrated in the area between the positive electrode and the four surrounding negative electrodes, thereby significantly improving the spatial selectivity and precision of stimulation.

[0108] Furthermore, by employing a smaller electrode design, the effective range of the current is further reduced, avoiding interference from the electric field to non-target areas as seen in traditional methods. The high concentration of the current and precise targeting effectively overcome the drawback of widespread electric field diffusion in traditional dual-electrode deep brain interference. Especially when electrical stimulation involves deep brain regions, this improved electrode layout and electric field distribution not only enhances the targeting ability of the target area but also reduces unintentional interference to surrounding non-target brain tissue.

[0109] This design significantly improves the spatial precision of electrical stimulation of specific cortical or deep brain regions, providing a more reliable and efficient tool for the application of non-invasive deep brain stimulation (DBS) technology in basic research, treatment of neurological diseases, and brain function modulation. Furthermore, the system and device design incorporates multiple safety mechanisms (such as impedance detection and feedback) to further ensure reliability and patient safety during use. This approach represents a disruptive advancement over traditional non-invasive brain stimulation techniques, driving further development of brain stimulation technology in clinical and research fields.

[0110] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0111] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of the utility model patent. 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 protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A high-precision deep brain stimulation device, characterized in that, include: Signal generation module: includes a dual-channel signal generator with an output frequency range in the high-frequency range and adjustable phase difference adjustment accuracy, including a first signal generator module and a second signal generator module; Low-voltage power supply module: Provides low-voltage power support for the MCU control module and signal generator module; High-voltage power supply module: Provides high-voltage power support for the constant current source module; Parameter input module: used for user input signals, including frequency, amplitude, time interference phase and stimulation mode; MCU control module: Receives user parameter input and dynamically adjusts the output of the signal generator and constant current source; Parameter display module: Used to display the operating status in real time, and provide fault information and operating status prompts, so that users can intuitively understand the system status; 4×1 voltage divider module: The output voltage is adjusted by a digital potentiometer, and the voltage signal is precisely distributed to flexibly adapt to different electrode configurations and stimulation intensity requirements to meet the requirements of various application scenarios; DC removal module: Eliminates the DC component in the output signal; Constant current source module: contains multiple independent constant current source circuits, which are connected to the four negative electrodes respectively to provide a stable stimulation current, ensure high stability and low noise characteristics of the output current, and improve the overall stimulation effect; Impedance detection module: Real-time detection of electrode contact impedance and feedback to the control module.

2. The stimulation device as described in claim 1, characterized in that, The output of the signal generation module is connected in sequence to a 4×1 voltage divider module, a DC de-DC module, and a constant current source module. The MCU control module dynamically adjusts the constant current source output based on the feedback from the impedance detection module.

3. The stimulation device as described in claim 1, characterized in that, It also includes an anti-phase output circuit: used to generate precise phase-opposite current signals, thereby achieving a time-interference stimulation effect and ensuring that the phase difference of the signal meets high-precision requirements.

4. The stimulation device as described in claim 1, characterized in that, The constant current source module includes a first constant current source submodule and a second constant current source submodule. Each constant current source submodule includes a positive constant current source circuit and four negative constant current source circuits. The output terminal of each circuit is connected to the impedance detection module. The constant current source circuit includes an MD5333 chip, resistors R4 and R5, and capacitor C1. The MD5333 chip's Pin 1 (GND) is grounded and connected to the circuit's common ground. Pin 2 (VIN) is the input voltage terminal, used to provide power to the chip. Pin 3 (VOUT) is the output terminal, from which current or voltage is output to drive the load. Resistor R4 is connected between VCC and the MD5333's input terminal VIN. Resistor R5 is connected between the output terminal VOUT and ground, in parallel with capacitor C1. The capacitor is connected between the output terminal VOUT and ground, in parallel with resistor R5.

5. The stimulation device as described in claim 1, characterized in that, The MCU control module receives user input signals from the parameter input module. The received input signals are parsed and stored for configuring the working status of subsequent modules. The MCU control module sends control commands to the signal generator module to generate signals with specific frequencies, amplitudes, and waveforms. When the system is running in interference mode, the MCU control module adjusts the output phase difference between the first signal generator module and the second signal generator module to accurately generate a time interference signal that meets the requirements. The MCU control module obtains real-time feedback data from the impedance detection module, analyzes the changes in brain impedance and the stimulation effect, and dynamically adjusts the output parameters of the constant current source module according to the feedback data to compensate for the deviation of stimulation current caused by impedance changes. If abnormal impedance is detected, the MCU control module will trigger an alarm mechanism and stop the system operation to ensure safety. The MCU control module transmits the input parameters and feedback data from the impedance detection module to the parameter display module.

6. The stimulation device as described in claim 1, characterized in that, The 4×1 voltage divider module includes a digital potentiometer and a voltage divider ratio input button. The voltage divider ratio input button changes the resistance value of the digital potentiometer by pressing the button. Each time the button is pressed, the resistance value of the digital potentiometer increases or decreases, thereby changing the magnitude of the output voltage.

7. A system using the high-precision deep brain stimulation device according to any one of claims 1-6, characterized in that, include: Forward simulation mode: The electrode position is a known condition, and the distribution of electric field intensity generated by the stimulus is the solution target. The electrode position is selected through the 10-20 EEG system. After selecting a positive electrode, the four nearest electrodes in the surrounding directions are set as its negative electrodes. The current intensity of the positive electrode is the sum of the current intensities of the four negative electrodes. The simulation system solves the problem to obtain the distribution of electric field intensity generated by the stimulus. Reverse simulation mode: The stimulus target is known, but the electrode positions are unknown. After selecting the corresponding target point, the simulation system solves the problem and gives the positions of two sets of electrodes, with the positive electrode surrounded by four negative electrodes.

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