Nerve regulation and control instrument

Abstract

The invention relates to the technical field of nerve regulation and control, and provides a nerve regulation and control instrument which comprises a base plate, the bottom of the base plate is fixedly connected with a supporting seat, the top of the base plate is fixedly connected with a cabinet body, the upper portion of the cabinet body is in a four-slope shape, and the slope on one side of the cabinet body is fixedly connected with an input screen used for selecting a stimulation scheme. The outer surface of the base plate is rotatably connected with a rotating shaft, the outer surface of the rotating shaft is fixedly connected with a side cover, the outer surface of the side cover is fixedly connected with a handle, the top of the base plate is provided with a placing unit and a main controller arranged at the top of the base plate, and the outer surface of the main controller is uniformly provided with wiring grooves; the stimulation unit is arranged on the top of the placement unit; when the device works, firstly, the side cover needs to be opened, the placement unit is pulled out of the cabinet body, the stimulation unit is conveniently and directly taken out to be worn on the head of a patient, then a stimulation scheme is selected through the input screen, and the main controller conducts electric shock stimulation on the patient through the stimulation unit.

Description

Technical Field

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

[0002] The regulation of the inflammatory response after stroke is a crucial aspect of clinical stimulation. Vagus nerve electrical stimulation, as an effective intervention, highly depends on the precise alignment of the electrodes with the vagus nerve. Existing neuromodulation devices mostly employ fixed electrode sites, lacking adaptability to individual differences in vagus nerve anatomical location, making it difficult to accurately locate the target nerve, resulting in low stimulation efficiency and increased risk of side effects. Furthermore, stroke patients often require protection of postoperative head wounds, and the structural design of traditional head-mounted electrode devices easily leads to wound compression or infection risks. Summary of the Invention

[0003] The purpose of this invention is to solve the problem of difficulty in accurately locating target nerves, which leads to low stimulation efficiency and increased risk of side effects, and to provide a neuromodulation device.

[0004] The technical solution adopted by this invention to solve its technical problem is: a neuromodulation device, including a base plate, a support base fixedly connected to the bottom of the base plate, a cabinet fixedly connected to the top of the base plate, the upper part of the cabinet being four-sided inclined, an input screen for selecting stimulation programs fixedly connected to one inclined side of the cabinet, a rotating shaft rotatably connected to the outer surface of the base plate, a side cover fixedly connected to the outer surface of the rotating shaft, a handle fixedly connected to the outer surface of the side cover, and a placement unit provided on the top of the base plate, and further comprising: A main controller is disposed on the top of the substrate, and the outer surface of the main controller is uniformly provided with wiring grooves; A stimulation unit positioned at the top of the placement unit; The stimulation unit includes a headband, a control ring fixedly connected to the top of the headband, earmuffs fixedly connected to both sides of the headband, a soft pad fixedly connected to the inner side of the earmuffs, a stimulation module fixedly connected to the outer surface of the earmuffs, a first wire evenly distributed on the outer surface of the stimulation module, a stimulation electrode fixedly connected to the end of the first wire away from the stimulation module, a docking groove fixedly connected to the outer surface of one side of the stimulation module, a positioning stimulation mechanism provided on the inner wall of the earmuffs, and power transmission between the stimulation modules on both sides via a second wire. When the patient wears the headgear, the earcups on both sides come into contact with the patient, while the headgear does not come into contact with the patient's head. VR glasses can be mounted on the outer surface of the headgear.

[0005] Furthermore, the headgear is placed in the placement unit when not in use; By installing a transmission cable between the wiring slot and the docking slot, the main controller can drive and control the overall stimulation unit.

[0006] Furthermore, the positioning stimulation mechanism includes a light emitting device, on the outer surface of which illumination lamps are uniformly arranged. A first micro motor is fixedly connected to the center of the light emitting device. A rotating block is fixedly connected to the output end of the first micro motor. A visual detection device is fixedly connected to the end of the rotating block away from the first micro motor. A first support plate is fixedly connected to the outer surface of the rotating block. A micro electric cylinder is fixedly connected to the outer surface of the first support plate. An internal electrode is fixedly connected to the output end of the micro electric cylinder. A cleaning mechanism is also provided on the outer surface of the first support plate.

[0007] Furthermore, it also includes a miniature high-resolution near-infrared camera and two miniature synchronous infrared cameras connected to the main controller.

[0008] Furthermore, the light emitting device is connected to the stimulation module, and both are driven by the main controller.

[0009] Furthermore, the cleaning mechanism includes a second micro motor, the output end of which is fixedly connected to a rotating rod, and the end of the rotating rod away from the second micro motor is fixedly connected to a cleaning plate, the outer surface of which is uniformly provided with brushes.

[0010] Furthermore, the base of the second micro motor is fixedly connected to the outer surface of the first support plate.

[0011] Furthermore, when the miniature electric cylinder is in the retracted state, the built-in electrode is flush with the visual inspection device.

[0012] Furthermore, when the miniature electric cylinder is in the retracted state, the rotation of the cleaning plate causes the brush to contact the built-in electrode and the visual inspection device; When the miniature electric cylinder needs to extend, the second miniature motor will drive the rotating rod to rotate, causing the cleaning plate to be in a vertical position.

[0013] Furthermore, the placement unit includes a track plate symmetrically arranged on the top of the substrate. A sliding platform is slidably connected to the outer surface of the track plate. A telescopic rod is fixedly connected to the top of the sliding platform. A second support plate is fixedly connected to the output end of the telescopic rod. A placement platform is fixedly connected to the top of the second support plate. A cable management bracket for storing the transmission cable between the wiring slot and the docking slot is also fixedly connected to the top of the sliding platform.

[0014] Furthermore, the bottom of the track plate is fixedly connected to the top of the base plate, and a headgear can be placed on the top of the placement platform.

[0015] The beneficial effects of the neuromodulation device provided by this invention are as follows: (1) The vagus nerve in the concha can be located and positioned using precise positioning electrodes. The electrical stimulation anchor point is determined according to a specific algorithm, and precise stimulation is performed based on the anchor point. At the same time, a periauricular electrode array is configured to take into account both wide-area and calibrable targeted stimulation.

[0016] (2) Before the vagus nerve is stimulated by an electric motor, the cleaning facility will clean the scalp and other impurities adhering to the visual detection device and the built-in electrodes to avoid affecting the localization of the vagus nerve and the accuracy of the electric shock stimulation.

[0017] (3) By setting up a multi-electrode headband with a specific arc shape, the headband can be fixed by the earmuffs on both sides when the patient wears it. The headband will not come into contact with the top of the patient's head, which has certain practical value for the protection of the wound after surgery.

[0018] (4) The cabinet design combined with the pull-out and lifting placement unit improves the cleanliness and ease of use of the equipment. Attached Figure Description

[0019] Figure 1 This is a three-dimensional structural schematic diagram of the present invention; Figure 2 This is a structural cross-sectional view of the present invention; Figure 3 This is a schematic diagram of the structure of the stimulation unit of the present invention; Figure 4 This is a schematic diagram of the positioning stimulation mechanism of the present invention; Figure 5 This is a schematic diagram of the cleaning mechanism of the present invention; Figure 6 This is a schematic diagram of the placement unit of the present invention.

[0020] Figure 7 This is a schematic diagram of the stimulation algorithm of the present invention.

[0021] In the diagram: 1. Base plate; 2. Support base; 3. Cabinet; 4. Main controller; 5. Rotating shaft; 6. Side cover; 7. Handle; 8. Placement unit; 9. Stimulation unit; 10. Input screen; 11. Wiring channel; 91. Headset; 92. Control wire ring; 93. Earmuff; 94. Soft pad; 95. Stimulation module; 96. Docking groove; 97. Positioning stimulation mechanism; 98. First wire; 99. Stimulation electrode; 910. Second wire; 971. Light emitting device; 9 72. Illumination lamp tube; 973. First micro motor; 974. Rotating block; 975. Visual inspection device; 976. First support plate; 977. Micro electric cylinder; 978. Built-in electrode; 979. Cleaning mechanism; 9791. Second micro motor; 9792. Rotating rod; 9793. Cleaning plate; 9794. Brush; 81. Track plate; 82. Sliding platform; 83. Telescopic rod; 84. Second support plate; 85. Placement table; 86. Cable management bracket. Detailed Implementation

[0022] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the further embodiments described herein are merely illustrative and not intended to limit the invention.

[0023] This invention uses near-infrared spectroscopy (NIRS) to identify densely vascularized areas by detecting differences in tissue absorption of near-infrared light. Since the vagus nerve accompanies the internal jugular vein and common carotid artery, densely vascularized areas serve as nerve localization reference areas.

[0024] The headband of this invention adopts an engineering-mechanically curved design with a radius of curvature R=150-180mm, combined with an inward tilt angle of 15-20° for the earcups, achieving three-point mechanical balance (two earcups + occipital bone fulcrum). Traditional headband devices rely on the top of the head for stability. like Figures 1-6 As shown: A neuromodulation device includes a base plate 1, a support base 2 fixedly connected to the bottom of the base plate 1, and a cabinet 3 fixedly connected to the top of the base plate 1. The upper part of the cabinet 3 is four-sided inclined, and an input screen 10 for selecting stimulation programs is fixedly connected to one inclined side of the cabinet 3. A rotating shaft 5 is rotatably connected to the outer surface of the base plate 1, a side cover 6 is fixedly connected to the outer surface of the rotating shaft 5, and a handle 7 is fixedly connected to the outer surface of the side cover 6. A placement unit 8 is provided on the top of the base plate 1. The device also includes: The main controller 4 is disposed on the top of the substrate 1, and the outer surface of the main controller 4 is uniformly provided with wiring grooves 11; Stimulation unit 9 is positioned on top of placement unit 8; When this invention is in operation, the side cover 6 needs to be opened first, and the placement unit 8 needs to be pulled out of the cabinet 3 to make it easy to take out the stimulation unit 9 and put it on the patient's head. Then, the stimulation program is selected through the input screen 10, and the main controller 4 uses the stimulation unit 9 to perform electric shock stimulation on the patient.

[0025] The stimulation unit 9 includes a headband 91, a control wire ring 92 fixedly connected to the top of the headband 91, earmuffs 93 fixedly connected to both sides of the headband 91, a soft pad 94 fixedly connected to the inner side of the earmuffs 93, a stimulation module 95 fixedly connected to the outer surface of the earmuffs 93, a first wire 98 evenly arranged on the outer surface of the stimulation module 95, a stimulation electrode 99 fixedly connected to the end of the first wire 98 away from the stimulation module 95, a docking groove 96 fixedly connected to the outer surface of one side of the stimulation module 95, a positioning stimulation mechanism 97 provided on the inner wall of the earmuffs 93, and power transmission between the stimulation modules 95 on both sides through a second wire 910. After the patient puts on the headgear 91, the stimulation electrodes 99 need to be attached to the side of the patient around the earmuffs 93. Then, the stimulation module 95 will transmit electrical energy to the stimulation electrodes 99 through the first wire 98 to provide electrical stimulation to the patient's blood vessels.

[0026] When the patient wears the headgear 91, the earcups 93 on both sides come into contact with the patient, while the headgear 91 does not come into contact with the patient's head. VR glasses can be mounted on the outer surface of the headgear 91.

[0027] When not in use, the headgear 91 is placed in the storage unit 8; By installing a transmission cable between the wiring slot 11 and the docking slot 96, the main controller 4 can drive and control the overall stimulation unit 9.

[0028] The positioning stimulation mechanism 97 includes a light emitting device 971. Illumination lamps 972 are evenly arranged on the outer surface of the light emitting device 971. A first micro motor 973 is fixedly connected to the center of the light emitting device 971. A rotating block 974 is fixedly connected to the output end of the first micro motor 973. A visual detection device 975 is fixedly connected to the end of the rotating block 974 away from the first micro motor 973. A first support plate 976 is fixedly connected to the outer surface of the rotating block 974. A micro electric cylinder 977 is fixedly connected to the outer surface of the first support plate 976. An internal electrode 978 is fixedly connected to the output end of the micro electric cylinder 977. A cleaning mechanism 979 is also provided on the outer surface of the first support plate 976.

[0029] Simultaneously, the internal light emitting device 971 illuminates the blood vessels around the patient's ear through the illumination lamp 972, thereby detecting areas with dense blood vessels. Since areas with dense blood vessels and the vagus nerve are associated, detecting areas with dense blood vessels can detect the vagus nerve. After the visual detection device 975 detects the vagus nerve, the first micro motor 973 drives the first support plate 976 to rotate to the vagus nerve, and the micro electric cylinder 977 extends to drive the built-in motor to move to the vagus nerve to perform electric shock stimulation.

[0030] The following technical solutions are used for blood vessel detection: 1. Hardware System Composition Imaging module: Miniature high-resolution near-infrared camera (resolution ≥ 5MP, frame rate ≥ 30fps), equipped with laser speckle illumination (e.g.); Binocular vision module: two miniature synchronized infrared cameras with a baseline distance of 60–100 mm, or a structured light projector (wavelength 850 nm) with a depth error ≤0.3 mm.

[0031] Processing unit: GPU-accelerated real-time computing platform, supporting 3D Fourier transform (e.g.) and matrix reconstruction (e.g.).

[0032] 2. Software and Algorithm Flow Deep information extraction: Three-dimensional point clouds of tissue surfaces are generated by structured light coding or binocular parallax calculation (method reference). Registering vascular imaging data: Mapping two-dimensional vascular images onto three-dimensional point clouds to form a three-dimensional vascular model.

[0033] Neural localization algorithm: Input: blood vessel density, direction, depth; Output: Heatmap of possible nerve locations (confidence rings shown, for reference); Training data: The neural network was trained based on historical surgical data (MRI / CT and intraoperative images aligned).

[0034] 3. Real-time navigation interface Predicted vascular and neural pathways are overlaid on the surgical field in AR format (as shown in the multi-image switching display in the image). Provide a confidence score (e.g.), and prompt the doctor to manually verify if the score is below a threshold.

[0035] The light emitting device 971 is connected to the stimulation module 95, and both are driven by the main controller 4.

[0036] The cleaning mechanism 979 includes a second micro motor 9791, a rotating rod 9792 is fixedly connected to the output end of the second micro motor 9791, a cleaning plate 9793 is fixedly connected to the end of the rotating rod 9792 away from the second micro motor 9791, and brushes 9794 are evenly arranged on the outer surface of the cleaning plate 9793.

[0037] Before stimulation treatment, the second micro motor 9791 drives the cleaning plate 9793 to rotate, thereby driving the brush 9794 to brush away impurities such as scalp adhering to the visual detection device and the built-in electrode 978, so as to avoid affecting the detection of the vagus nerve position and the electric shock stimulation.

[0038] The base of the second micro motor 9791 is fixedly connected to the outer surface of the first support plate 976.

[0039] When the miniature electric cylinder 977 is in the retracted state, the built-in electrode 978 is flush with the vision inspection device 975.

[0040] When the miniature electric cylinder 977 is in the retracted state, the rotation of the cleaning plate 9793 causes the brush 9794 to come into contact with the built-in electrode 978 and the vision inspection device 975. When the miniature electric cylinder 977 needs to extend, the second miniature motor 9791 will drive the rotating rod 9792 to rotate, causing the cleaning plate 9793 to be in a vertical position.

[0041] The placement unit 8 includes a track plate 81 symmetrically arranged on the top of the base plate 1. A sliding platform 82 is slidably connected to the outer surface of the track plate 81. A telescopic rod 83 is fixedly connected to the top of the sliding platform 82. A second support plate 84 is fixedly connected to the output end of the telescopic rod 83. A placement table 85 is fixedly connected to the top of the second support plate 84. A cable management bracket 86 for storing the transmission cable between the wiring slot 11 and the docking slot 96 is also fixedly connected to the top of the sliding platform 82.

[0042] When the stimulation unit 9 is needed, the mobile platform needs to be pulled to move the mobile platform out of the cabinet 3. The telescopic rod 83 will extend upward, thereby moving the stimulation unit 9 upward, making it convenient for medical staff and patients to take it.

[0043] The bottom of the track plate 81 is fixedly connected to the top of the base plate 1, and the top of the placement platform 85 can hold the headgear 91.

[0044] It should be noted that the stimulation electrodes and built-in electrodes use a constant current device to control the stimulation current. The current is controlled by a constant current source connected to a microcontroller. The microcontroller is wirelessly connected to the user's wristband, which collects the user's blood pressure and pulse.

[0045] The microcontroller controls the release current and stimulation time of the constant current source based on the following algorithm.

[0046] Step 1: Input the patient's individualized baseline parameter set into the controller via the touch screen, including the duration of stroke (θ1), stroke severity (θ2), MRS score (θ3), ASPECTS score (θ4), NIHSS score (θ5), and weight (θ6), and record them as the parameter set. Θ=(θ1, θ2, θ3, θ4, θ5, θ6).(1) Step 2: Construct a stimulus-inflammatory response kinetic model, denoting the degree of inflammatory factor inhibition as y, the stimulus duration as T, and the stimulus intensity as S. Based on the mechanism of inflammatory factor inhibition by stimulus duration and intensity, a kinetic model reflecting the rate of change of inflammatory factors is constructed using partial differential equation modeling techniques: Each parameter is related to the basic parameter set Θ, meaning that each parameter may change as Θ changes. Their physiological significance and units are shown in Table 1.

[0047] Table 1. Parameter descriptions in models (1) and (2) Step 3: Solve for the individualized response surface. Use partial differential equation solving techniques to find the analytical solution that satisfies model (2). y(T, S)= C(Θ)+a1 (Θ)× T+b1 (Θ)× S ×T× S.(3) Where C(Θ) represents the daily level of inflammatory factors in a normal human body, and is also related to the baseline parameter set Θ. Formula (3) is the nonlinear estimation formula that uses both stimulation duration and stimulation intensity to predict the level of inflammatory factors.

[0048] Step 4: The patient receives n consecutive stimuli. For each stimulus, m stimulus durations and r stimulus intensities are recorded, resulting in a total of n × m × r data points, denoted as [missing information]. (yi,j,k,Ti,j,k,Si,j,k, Θi,j,k),i=1,2,…,n;j=1,2,…,m; k=1,2,…,r.(4) Step 5: Based on the analytical solution expression (3) obtained in Step 3, the experimental data obtained in Step 4 are coupled with statistical analysis techniques (such as surface fitting) and machine learning techniques (such as neural networks) to obtain the estimated expressions for all parameters C(Θ), ai(Θ), bi(Θ), i=1,2,3. Therefore, a nonlinear estimation formula for predicting inflammatory factor levels using both stimulation duration and intensity can be obtained. T×S.(5) Step 6: Clinical Dynamic Decision Making and Continuous Optimization. Given the expected set of basic parameters Θ, within the allowable range of stimulation duration and intensity, numerical simulation techniques are used. First, the nonlinear estimation formula (5) obtained above is used to numerically simulate the surface of the inflammatory factor level changing with stimulation duration and intensity, as shown in Figure 7A. Then, given the expected inflammatory factor level, the expected inflammatory factor level plane is drawn in the obtained surface graph (as shown in Figure 7B). The projection of the curve obtained by the intersection of this plane and the surface onto the TS plane (the blue dotted line in Figure 7C) is the corresponding feasible stimulation duration.

[0049] The following describes some of the parameters that users input via touchscreen in this invention.

[0050] 1. MRS score (θ3) - Modified Rankin Scale Modified Rankin Scale (Post-Cerebrovascular Event Functional Disability Assessment) Purpose: To assess the degree of long-term functional disability and prognosis and quality of life of stroke patients, and to reflect the patient's ability to perform daily activities independently.

[0051] Scoring criteria: 0-6 points (7 levels in total) - 0 points: Completely asymptomatic - 1 point: Symptoms present but no significant disability, able to perform all daily activities. - 2 points: Mild disability, able to live independently, but unable to complete all activities previously performed. - 3 points: Moderate disability, requiring some assistance (such as walking and dressing), but able to walk independently. - 4 points: Moderate to severe disability, unable to walk independently, requires assistance with daily living activities. - 5 points: Severe disability, bedridden, incontinent, completely dependent on others for care. - 6 points: Death Function in the patent: To quantify the patient's baseline functional status as a weighted parameter for selecting the intensity of stimulation therapy (a higher θ3 value usually indicates the need for a more conservative stimulation strategy).

[0052] 2. ASPECTs score (θ4) - Alberta Stroke Program Early CT Score Alberta Stroke Program Early CT Score (Acute Ischemic Lesion Extent Score) Purpose: To assess the extent of ischemic changes in the middle cerebral artery supply area on early CT scans of acute ischemic stroke and to predict the prognosis of thrombolytic / thrombectomy treatment.

[0053] Scoring criteria: 0-10 points (reverse scoring, with a maximum score of 10 indicating no early signs of infarction) - Anatomical Divisions: Assessment of 10 Subcortical Regions of the Middle Cerebral Artery - Caudate nucleus head (C), lentiform nucleus (L), posterior limb of internal capsule (IC), insular band (I) - M1-M6 areas (6 cortical areas of the middle cerebral artery) - Scoring rules: 1 point will be deducted for each region showing early signs of ischemia (blurred gray-white matter boundary / disappearance of sulci). - Clinical threshold: - ≥7 points: Suitable for thrombolytic therapy, with a better prognosis. - <7 points: Large infarction at its core, increased treatment risk Function in the patent: Reflects the anatomical extent of brain tissue damage and serves as a key limiting parameter for stimulation tolerance (the lower the θ4 value, the narrower the safe window for stimulation parameters).

[0054] 3. NIHSS score (θ5) - National Institutes of Health Stroke Scale The National Institutes of Health Stroke Scale (Acute Phase Neurological Deficit Assessment) Purpose: To quantitatively assess the severity of neurological deficits in patients with acute stroke and to guide emergency triage and treatment decisions.

[0055] Scoring criteria: 0-42 points (11 items, the higher the score, the more severe the defect) Key projects: - Consciousness level (0-3 points): Questioning and instruction execution. - Gaze function (0-2 points): Eye movement disorder - Visual field defects (0-3 points) - Facial paralysis (0-3 points) - Upper limb movement (0-4 points × 2 sides): Muscle strength assessment - Lower limb movement (0-4 points × 2 sides): Muscle strength assessment - Ataxia (0-2 points) - Sensory impairment (0-2 points) - Language impairment (0-3 points): Aphasia assessment - Articulation disorder (0-2 points) - Neglect (0-2 points) Clinical significance: - 0 points: Normal - 1-4 points: Mild stroke - 5-15 points: moderate stroke - 16-20 points: moderate to severe stroke - 21-42 points: severe stroke Function in the patent: Real-time reflection of dynamic changes in neurological deficits, serving as a core regulatory parameter for the sensitivity of immediate response to stimulation therapy (the trend of θ5 value changes is used in the feedback control algorithm).

[0056] This algorithm is essentially a stimulation and treatment parameter optimization method driven by physiological parameters. Its technical chain is as follows: individualized data acquisition → mechanism modeling (PDE) → analytical solution → data fitting → dynamic decision-making.

[0057] The algorithm described above can produce the following technical effects in this invention: 1. Personalized precision medicine achieves patient stratification through a 6-dimensional parameter set Θ, overcoming the "one-size-fits-all" drawbacks of traditional stimulation protocols. Dynamic parameter adjustment mechanism: a i (Θ), b i (Θ) It has adaptive learning characteristics as the patient's condition evolves.

[0058] 2. Multi-dimensional synergistic optimization simultaneously couples the synergistic effect of stimulation duration T and stimulation intensity S (interaction term T×S), which has the advantage of nonlinear prediction compared with single-parameter optimization. The concept of "biochemical limit of the body" is introduced to reflect physiological constraints at the model level and improve safety.

[0059] 3. Hybrid modeling techniques combine mechanistic modeling (PDE), statistical analysis (surface fitting), and machine learning (neural networks), achieving both interpretability and predictive accuracy. Figure 7 The A-7C's visual decision-making interface transforms complex calculations into clinically actionable parameter selection curves. 4. Continuous Iterative Optimization: Through the n×m×r clinical data feedback loop, the model can be continuously optimized to provide the most effective stimulation for a specific user.

[0060] This invention addresses the issues of "blind stimulation" and individual differences in its positioning stimulation mechanism (light emission + visual detection + rotation + extension). Traditional vagus nerve stimulation typically relies on average anatomical location or physician experience. Because the vagus nerve accompanies blood vessels and individual anatomical location varies significantly, it is prone to off-target effects. This application identifies densely vascularized areas using near-infrared spectroscopy (NIRS), effectively establishing a "physiological feature navigation" mechanism. The technical solution employs a dynamic fit mechanism: the rotating block, combined with a miniature electric cylinder, achieves not just movement, but precise addressing in polar coordinates (angle + radial distance). Compared to traditional XY-axis movement, the rotating structure better conforms to the curved physiological structure of the concha, covering the largest detection range with minimal mechanical volume. The technical solution employs constant contact pressure: the extension and retraction of the miniature electric cylinder not only facilitates contact but also controls the contact pressure through current feedback, ensuring consistent contact impedance between the electrode and the skin, thereby ensuring stable transdermal transmission efficiency of the electrical stimulation signal.

[0061] The self-cleaning mechanism (micro-motor + rotating rod + cleaning plate + brush) of this invention ensures a high signal-to-noise ratio for optical / electrical signals, which is a key feature of this patent. Earwax, oil, or dander often accumulates in the concha. For visual detection devices / light emitting devices, oil can cause light scattering, affecting the accuracy of blood vessel recognition. The cleaning mechanism ensures a clear field of view for the "navigation system." For internal electrodes, dander can significantly increase contact impedance, leading to stimulation voltage drift or skin burns. This invention employs closed-loop calibration preparation: automatic cleaning before each treatment provides a standardized physical interface for subsequent high-precision algorithms, eliminating uncontrollable variables caused by a dirty wearing environment.

[0062] This invention, a suspended headband (with fixed earcups and a suspended top of the head), increases postoperative compatibility: specifically designed for stroke patients. Stroke patients often undergo craniotomy, and the top of the head may have surgical incisions, drainage tubes, or titanium mesh repair areas. Traditional headphones that span the top of the head can compress the wound. The lateral clamping structure of this design (three-point mechanical balance: two earcups + occipital bone fulcrum) cleverly avoids the "postoperative sensitive area," expanding the device's applicable population (i.e., patients in the acute / subacute phase).

[0063] This invention's stimulus-inflammatory response dynamics model algorithm overcomes physiological tolerance: simple constant-current stimulation easily leads to adaptation in the human nervous system, causing therapeutic effects to decay over time. This algorithm introduces parameters and explicitly considers both the "biochemical limits of the body" and the "inhibitory effect." Nonlinear dose-response relationship control: a coupled model (cross-term) of stimulation duration (T) and intensity (S) is established. This overcomes the limitations of single-parameter adjustment, avoiding problems such as "excessive intensity causing side effects" or "excessive duration leading to inflammatory rebound," and achieving dynamic locking of the treatment window.

[0064] This invention combines a cleaning mechanism, a positioning mechanism, and algorithm control, resulting in a synergistic technological effect: constructing a highly robust neural modulation closed loop. Without the cleaning mechanism, the oil in the ear canal would interfere with near-infrared light, causing the positioning mechanism to locate blood vessels incorrectly. Once the location is incorrect, the precise parameters (T and S) calculated by the subsequent algorithm will not only be ineffective but may even stimulate incorrect nerve branches (such as the pain fibers of the auricular-temporal nerve), triggering pain. Therefore, the cleaning mechanism is not merely a simple hygiene device but a prerequisite physical condition for the high-precision neural navigation algorithm to function effectively.

[0065] The cabinet-style storage + placement unit + stimulation unit of this invention has a synergistic technical effect: maintaining the long-term accuracy of precision instruments.

[0066] Unlike ordinary home physiotherapy devices, this invention integrates micron-level motion control and optical detection. The cabinet design, combined with a sliding platform, not only provides storage but also offers a protective environment against dust and mechanical shock. The cable management bracket prevents changes in cable impedance caused by frequent plugging and unplugging (which can affect the accuracy of microampere-level stimulation current). This ensures the repeatability and consistency of the device during long-term clinical use.

[0067] This invention's headgear structure combined with a VR visual glasses interface offers synergistic technological benefits: a multimodal rehabilitation interface. Stroke rehabilitation not only requires vagus nerve stimulation (physiological regulation) but also often combines mirror therapy or virtual reality training (cognitive regulation). The suspended structure of this design reserves space in the forehead, allowing patients to simultaneously wear VR devices for audiovisual feedback training, achieving a dual closed-loop rehabilitation of "central (VR) + peripheral (vagus nerve)"—something traditional overhead headgear devices cannot achieve.

[0068] In the description of this disclosure, it should be noted that, unless otherwise expressly specified and limited, the term "fixed connection" should be interpreted broadly. For example, it can refer to a bolted connection, a welded connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be a connection within two components. Those skilled in the art can understand the specific meaning of the above terms in this disclosure according to the specific circumstances. The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A neuromodulation device, comprising a base, a support fixedly connected to the bottom of the base, a cabinet fixedly connected to the top of the base, the upper part of the cabinet being four-sided beveled, an input screen for selecting stimulation programs fixedly connected to one beveled side of the cabinet, a rotating shaft rotatably connected to the outer surface of the base, a side cover fixedly connected to the outer surface of the rotating shaft, a handle fixedly connected to the outer surface of the side cover, and a placement unit provided on the top of the base, characterized in that... Also includes: A main controller is disposed on the top of the substrate, and the outer surface of the main controller is uniformly provided with wiring grooves; A stimulation unit positioned at the top of the placement unit; The stimulation unit includes a headband, a control ring fixedly connected to the top of the headband, earmuffs fixedly connected to both sides of the headband, a soft pad fixedly connected to the inner side of the earmuffs, a stimulation module fixedly connected to the outer surface of the earmuffs, a first wire evenly distributed on the outer surface of the stimulation module, a stimulation electrode fixedly connected to the end of the first wire away from the stimulation module, a docking groove fixedly connected to the outer surface of one side of the stimulation module, a positioning stimulation mechanism provided on the inner wall of the earmuffs, and power transmission between the stimulation modules on both sides via a second wire. When the patient wears the headgear, the earcups on both sides come into contact with the patient, while the headgear does not come into contact with the patient's head. VR glasses can be mounted on the outer surface of the headgear.

2. The neuromodulation device according to claim 1, characterized in that: The headgear is placed in the placement unit when not in use; By installing a transmission cable between the wiring slot and the docking slot, the main controller can drive and control the overall stimulation unit.

3. A neural modulation device according to claim 1, characterized in that: The positioning stimulation mechanism includes a light emitting device, on the outer surface of which illumination lamps are uniformly arranged. A first micro motor is fixedly connected to the center of the light emitting device. A rotating block is fixedly connected to the output end of the first micro motor. A visual detection device is fixedly connected to the end of the rotating block away from the first micro motor. A first support plate is fixedly connected to the outer surface of the rotating block. A micro electric cylinder is fixedly connected to the outer surface of the first support plate. An internal electrode is fixedly connected to the output end of the micro electric cylinder. A cleaning mechanism is also provided on the outer surface of the first support plate.

4. A neural modulation device according to claim 3, characterized in that: The light emitting device is connected to the stimulation module, and both are driven by the main controller.

5. A neuromodulation device according to claim 3, characterized in that: The cleaning mechanism includes a second micro motor, a rotating rod is fixedly connected to the output end of the second micro motor, a cleaning plate is fixedly connected to the end of the rotating rod away from the second micro motor, and brushes are evenly arranged on the outer surface of the cleaning plate.

6. A neuromodulation device according to claim 5, characterized in that: The base of the second micro motor is fixedly connected to the outer surface of the first support plate.

7. A neural modulation device according to claim 6, characterized in that: When the miniature electric cylinder is in the retracted state, the built-in electrode is flush with the visual inspection device.

8. A neural modulation device according to claim 7, characterized in that: When the miniature electric cylinder is in the retracted state, the rotation of the cleaning plate causes the brush to contact the built-in electrode and the vision detection device; When the miniature electric cylinder needs to extend, the second miniature motor will drive the rotating rod to rotate, causing the cleaning plate to be in a vertical position.

9. A neuromodulation device according to claim 1, characterized in that: The placement unit includes a track plate symmetrically arranged on the top of the substrate. A sliding platform is slidably connected to the outer surface of the track plate. A telescopic rod is fixedly connected to the top of the sliding platform. A second support plate is fixedly connected to the output end of the telescopic rod. A placement platform is fixedly connected to the top of the second support plate. A cable management bracket for storing the transmission cable between the wiring slot and the docking slot is also fixedly connected to the top of the sliding platform.

10. A neural modulation device according to claim 9, characterized in that: The bottom of the track plate is fixedly connected to the top of the base plate, and a headgear can be placed on the top of the placement platform.

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