An adaptive transcutaneous auricular vagus nerve electrical stimulation system based on closed-loop feedback

Abstract

This invention relates to the field of medical device technology, and discloses an adaptive percutaneous vagus nerve electrical stimulation system based on closed-loop feedback. The system includes a sleep monitoring unit with a sleep staging algorithm module, used to receive and process the user's physiological signal data and output real-time sleep depth levels; a wireless stimulation host that communicates with the sleep monitoring unit via Bluetooth, generating stimulation parameter commands based on a preset sleep depth-stimulation intensity mapping rule; several pairs of intraauricular stimulation units that receive stimulation parameter commands and output corresponding electrical stimulation pulses to the ear skin; and a charging and storage case with grooves adapted to the intraauricular stimulation units, which are located within these grooves. This invention solves the problems of inconvenience in wearing and lack of adaptive control based on sleep staging in existing technologies.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an adaptive transcutaneous vagus nerve electrical stimulation system based on closed-loop feedback. Background Technology

[0002] Transauricular vagus nerve stimulation is a non-invasive neuromodulation technique that stimulates the auricular branch of the vagus nerve in the concha, activates the nucleus tractus solitarius and locus coeruleus, and other autonomic regulatory centers, thereby regulating the sympathetic-vagus nerve balance, inducing a physiological relaxation state, and improving insomnia and sleep disorders.

[0003] Currently, most commercially available transauricular vagus nerve stimulation (TANS) devices are wired, with the main unit connected to ear clip electrodes via cables. Patients are restricted by these cables, making it difficult to turn over and significantly impacting their experience during sleep. Furthermore, existing devices generally use fixed parameter output modes, with stimulation frequency and current intensity remaining constant throughout the treatment. This lack of dynamic adjustment based on the user's real-time sleep status can lead to overstimulation or understimulation, affecting treatment effectiveness.

[0004] Furthermore, most existing technologies use wired connections and lack specific mapping rules and closed-loop control methods for automatically adjusting stimulation intensity based on real-time sleep depth levels. Moreover, existing devices generally lack deep integration with smartphone apps, failing to achieve closed-loop feedback between physiological signal acquisition, sleep stage interpretation, and stimulation parameter adjustment. This results in low individualization of treatment and poor patient compliance.

[0005] To address this, an adaptive transcutaneous vagus nerve electrical stimulation system based on closed-loop feedback is proposed. Summary of the Invention

[0006] The purpose of this invention is to provide an adaptive transcutaneous vagus nerve electrical stimulation system based on closed-loop feedback, which aims to solve or improve at least one of the above-mentioned technical problems.

[0007] To achieve the above objectives, the present invention provides the following solution: The present invention provides an adaptive transcutaneous vagus nerve electrical stimulation system based on closed-loop feedback, comprising... A sleep monitoring unit is provided, which is equipped with a sleep staging algorithm module. The sleep monitoring unit is used to receive and process the user's physiological signal data and output the real-time sleep depth level. The wireless stimulation host communicates with the sleep monitoring unit via Bluetooth. The wireless stimulation host is used to receive the real-time sleep depth level output by the sleep monitoring unit and generate stimulation parameter instructions based on the preset sleep depth-stimulation intensity mapping rule. The inner ear stimulation unit is provided in several pairs, with each pair of inner ear stimulation units corresponding to the two ears of the human body. The inner ear stimulation unit is used to receive stimulation parameter instructions and output corresponding electrical stimulation pulses to the skin of the ear. A charging and storage case, wherein a groove adapted to an in-ear stimulation unit is provided inside the charging and storage case, and the in-ear stimulation unit is located in the groove.

[0008] Preferably, the intraocular stimulation unit includes a housing that is adapted to the concha or ear canal of the human ear. The housing is provided with at least one pair of electrode contacts that are in contact with the ear. The housing is equipped with a stimulation receiving circuit and a Bluetooth slave chip for receiving stimulation parameter instructions from a wireless stimulation host or a sleep monitoring unit detached from the wireless stimulation host and applying electrical stimulation pulses to the electrode contacts.

[0009] Preferably, it also includes an impedance adaptive compensation circuit, which is used to monitor the contact impedance between the motor and the skin in real time, and the impedance adaptive compensation circuit is electrically connected to the sleep monitoring unit.

[0010] Preferably, the sleep staging algorithm module has a built-in sleep staging algorithm, which is used to monitor multimodal features and output sleep depth levels.

[0011] Preferably, the sleep depth levels include wakefulness, light sleep, deep sleep, and REM sleep.

[0012] Preferably, the stimulation parameter instructions include a pulse width of 100μs-500μs, a frequency of 1Hz-100Hz, and a current intensity of 0.1mA-5mA.

[0013] Preferably, the electrode contacts are made of conductive silicone, conductive fabric, or a flexible substrate material coated with a conductive polymer, and the electrode contacts protrude 0.5mm-2mm above the surface of the housing.

[0014] Preferably, the sleep monitoring unit is a smartphone.

[0015] Preferably, the charging storage box is equipped with a lithium battery of not less than 2000mAh, the housing is equipped with a lithium battery of not less than 40mAh, and the housing is equipped with a wear detection sensor, a nine-axis inertial measurement unit, and a photoplethysmography sensor.

[0016] The present invention discloses the following technical effects: Adopting a true wireless stereo design, it completely eliminates the constraints of physical cables. The left and right earbuds work independently, significantly improving wearing comfort. It meets the ergonomic requirements for side-lying sleep, allowing patients to wear it throughout their natural sleep, greatly improving user compliance.

[0017] By directly mapping real-time sleep staging results to stimulation intensity control words, a closed-loop feedback system of "physiological state perception - stimulation parameter decision-making - real-time output adjustment" is constructed to achieve physiological following automatic adjustment of "the deeper the sleep, the weaker the stimulation", avoiding excessive stimulation at night that leads to awakening, and improving the accuracy and comfort of treatment.

[0018] Integrating a nine-axis inertial measurement unit and a PPG sensor, it combines multi-dimensional features such as body movement and heart rate variability to achieve high-precision sleep staging without the need for additional EEG electrodes, thus lowering the barrier to entry for users.

[0019] The system incorporates an impedance adaptive compensation circuit and a detachment detection mechanism to monitor the electrode contact status in real time. In case of abnormality, it automatically cuts off the output and issues an alarm, eliminating the risk of skin burns and complying with medical device safety standards.

[0020] By using smartphones to record full-cycle sleep data and stimulation parameters, a visual report is generated, and stimulation strategies are dynamically optimized through algorithmic models, achieving an upgrade from "one policy for a thousand people" to "a thousand policies for a thousand people" for personalized treatment. Attached Figure Description

[0021] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0022] Figure 1 This is a schematic diagram of the electrical stimulation system of the present invention; Figure 2 This is a schematic diagram of the in-ear stimulation unit of the present invention in conjunction with the ear; The components include: 1. Charging and storage box; 2. Shell; 3. Sleep monitoring unit; 4. Wireless stimulation host. Detailed Implementation

[0023] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0024] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0025] Reference Figures 1-2This invention provides an adaptive transcutaneous vagus nerve electrical stimulation system based on closed-loop feedback, comprising: Sleep monitoring unit 3 is equipped with a sleep staging algorithm module. Sleep monitoring unit 3 receives the user's physiological signal data through wireless communication, performs preprocessing, feature extraction and pattern recognition on the signal, and outputs the real-time sleep depth level. The wireless stimulation host 4 communicates with the sleep monitoring unit 3 via Bluetooth. The wireless stimulation host 4 is used to receive the real-time sleep depth level output by the sleep monitoring unit 3 and generate stimulation parameter instructions based on the preset sleep depth-stimulation intensity mapping rules. The main control chip of the wireless stimulation host 4 adopts the QCC5171 Bluetooth audio SoC, which integrates the Cortex-M4F core and has a main frequency of 120MHz, and is used to run real-time control logic. The inner ear stimulation unit consists of several pairs, with each pair corresponding to both ears of the human body. The inner ear stimulation unit is used to receive stimulation parameter instructions and output corresponding electrical stimulation pulses to the skin of the ear. The charging case 1 has a recess inside that is adapted to the in-ear stimulation unit, which is located within the recess. The charging case 1 adopts a flip-top design.

[0026] Further optimization of the design includes an in-ear stimulation unit comprising a housing 2, which is adapted to fit the concha or ear canal of the human ear. The housing 2 has at least one pair of electrode contacts that are in contact with the ear. The housing 2 houses a stimulation receiving circuit and a Bluetooth slave chip, used to receive stimulation parameter commands from the wireless stimulation host 4 or, detached from the wireless stimulation host 4, from the sleep monitoring unit 3, and to apply electrical stimulation pulses to the electrode contacts. The stimulation circuit employs a dual-channel precision current source DAC with an output accuracy of ±2%, a current range of 0.1mA-5mA, and a step size of 0.05mA.

[0027] Furthermore, the in-ear stimulation unit adopts an in-ear TWS earphone design, with the shell 2 made of medical-grade PC+ABS material and a skin-friendly coating. The electrode contacts are made of conductive silicone, with a diameter of 3mm and protruding 1.2mm from the surface of the shell 2, corresponding to the cymba concha and the concha cavity areas respectively. The Bluetooth slave chip is TLSR8250, supporting the BLE5.2 protocol.

[0028] Further optimizations include an impedance adaptive compensation circuit, which monitors the contact impedance between the motor and the skin in real time. This circuit is electrically connected to the sleep monitoring unit 3. The impedance adaptive compensation circuit uses an AC small-signal injection method, measuring the electrode-skin impedance every 10 seconds. A threshold of 5kΩ is set; if this threshold is exceeded, the output is automatically cut off and reported to the app.

[0029] The scheme has been further optimized by incorporating a sleep staging algorithm module. This algorithm is used to monitor multimodal features and output sleep depth levels.

[0030] The scheme has been further optimized, with sleep depth levels including wakefulness, light sleep, deep sleep, and REM sleep. Random forest, support vector machine, or lightweight neural network models are employed, integrating multimodal physiological features, including: body energy values, heart rate, time / frequency domain indicators of heart rate variability, and ambient light noise, to achieve sleep staging output every 30 seconds to 1 minute, with a staging accuracy of no less than 90%.

[0031] Furthermore, the sleep depth-stimulus intensity mapping rule: Awake period: Output preset basic stimulation intensity, current intensity 0.5mA-1.0mA, pulse frequency 1Hz-100Hz, pulse width 100μs-500μs, to assist in physical and mental relaxation; Light sleep stage: Linearly reduce the stimulation intensity to 50%-70% of the baseline value, or correspondingly reduce the pulse frequency; Deep sleep: Maintain minimum maintenance intensity (e.g., 0.1mA-0.2mA) or suspend stimulus output; REM sleep: Based on the trend characteristics of heart rate variability, choose whether to maintain microstimulation or enter an inhibitory state to avoid interfering with sleep structure.

[0032] The APP outputs a sleep stage label every 30 seconds, and the wireless stimulation host 4 adjusts the stimulation parameters accordingly and broadcasts them to the in-ear stimulation unit via Bluetooth to achieve closed-loop adaptive control.

[0033] The scheme is further optimized, and the stimulation parameter instructions include a pulse width of 100μs-500μs, a frequency of 1Hz-100Hz, and a current intensity of 0.1mA-5mA. The wireless stimulation host 4 performs continuous incremental adjustments within the parameter range according to the received sleep depth level. The adjustment step size can be preset (e.g., a current step size of 0.1mA and a frequency step size of 1Hz), and the adjustment cycle is synchronized with the sleep stage output cycle.

[0034] Further optimization of the design involves using conductive silicone, conductive fabric, or a flexible substrate material coated with a conductive polymer for the electrode contacts, with the electrode contacts protruding 0.5mm-2mm above the surface of the housing 2.

[0035] To further optimize the solution, sleep monitoring unit 3 is now a smartphone. An app is installed on the smartphone, containing a built-in random forest-based sleep staging model. This model is pre-trained on publicly available sleep datasets (such as SHHS and MESA), with input features including: root mean square body energy, mean heart rate, low-frequency / high-frequency power ratio (LF / HF), ambient light intensity, etc., and outputs sleep stage labels (awake, light sleep, deep sleep, REM) every 30 seconds.

[0036] The design has been further optimized. The charging case 1 contains a lithium battery with a capacity of at least 2000mAh, and the housing 2 contains a lithium battery with a capacity of at least 40mAh, providing 6 hours of continuous stimulation time. Combined with the charging case 1, this allows for overnight use. It also functions as a wireless relay device. The housing 2 houses a wear detection sensor, a nine-axis inertial measurement unit, and a photoplethysmography (PPG) sensor. The wear detection sensor detects whether the in-ear stimulation unit is being worn; the nine-axis inertial measurement unit includes an accelerometer, gyroscope, and magnetometer to collect head movement and body turning motion signals; and the PPG sensor collects heart rate and heart rate variability data.

[0037] Furthermore, the nine-axis inertial measurement unit uses an ICM-20948 with a sampling rate of 50Hz; the PPG sensor uses a MAX30102 with a sampling rate of 100Hz, used to extract heart rate and HRV features.

[0038] Further optimizing the solution, the sleep monitoring unit 3 is also used to generate sleep efficiency reports, cumulative stimulation dose reports, statistics on the number of nighttime awakenings, and analysis of sleep latency, and presents them through a graphical interface; based on historical sleep data and stimulation response data, it generates stimulation parameter suggestions for the next day through machine learning algorithms to achieve dynamic individualized treatment.

[0039] A closed-loop control method for a sleep aid includes the following steps: Step 1: Collect real-time data on the user's exercise and heart rate variability. Step 2: Input the feature data into the sleep staging model and output the current sleep staging label; Step 3: Query the preset "stage-dosage" mapping table to generate the target stimulation current intensity and frequency; Step 4: Send stimulation parameter commands to the in-ear stimulation unit via wireless communication; Step 5: The intraocular stimulation unit updates the output waveform based on the received parameters, achieving adaptive iteration of stimulation intensity every 30 seconds to 1 minute.

[0040] In the description of this invention, it should be understood that the terms "longitudinal", "lateral", "up", "down", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this invention, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention.

[0041] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation of the present invention. For those skilled in the art, other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the claims of the present invention.

Claims

1. An adaptive transcutaneous vagus nerve electrical stimulation system based on closed-loop feedback, characterized in that: include The sleep monitoring unit (3) is equipped with a sleep staging algorithm module. The sleep monitoring unit (3) is used to receive and process the user's physiological signal data and output the real-time sleep depth level. The wireless stimulation host (4) communicates with the sleep monitoring unit (3) via Bluetooth. The wireless stimulation host (4) is used to receive the real-time sleep depth level output by the sleep monitoring unit (3) and generate stimulation parameter instructions based on the preset sleep depth-stimulation intensity mapping rule. The inner ear stimulation unit is provided in several pairs, with each pair of inner ear stimulation units corresponding to the two ears of the human body. The inner ear stimulation unit is used to receive stimulation parameter instructions and output corresponding electrical stimulation pulses to the skin of the ear. A charging storage box (1) is provided with a groove inside the charging storage box (1) that is compatible with the in-ear stimulation unit, and the in-ear stimulation unit is located in the groove.

2. The adaptive transcutaneous vagus nerve electrical stimulation system based on closed-loop feedback according to claim 1, characterized in that: The in-ear stimulation unit includes a housing (2) that is adapted to the concha or ear canal of the human ear. The housing (2) is provided with at least one pair of electrode contacts that are in contact with the ear. The housing (2) is equipped with a stimulation receiving circuit and a Bluetooth slave chip, which are used to receive stimulation parameter instructions from the wireless stimulation host (4) or to receive the sleep monitoring unit (3) without the wireless stimulation host (4) and to apply electrical stimulation pulses to the electrode contacts.

3. The adaptive transcutaneous vagus nerve electrical stimulation system based on closed-loop feedback according to claim 1, characterized in that: It also includes an impedance adaptive compensation circuit, which is used to monitor the contact impedance between the motor and the skin in real time, and is electrically connected to the sleep monitoring unit (3).

4. The adaptive transcutaneous vagus nerve electrical stimulation system based on closed-loop feedback according to claim 1, characterized in that: The sleep staging algorithm module has a built-in sleep staging algorithm, which is used to monitor multimodal features and output sleep depth levels.

5. The adaptive transcutaneous vagus nerve electrical stimulation system based on closed-loop feedback according to claim 1, characterized in that: The sleep depth levels include wakefulness, light sleep, deep sleep, and REM sleep.

6. The adaptive transcutaneous vagus nerve electrical stimulation system based on closed-loop feedback according to claim 1, characterized in that: The stimulation parameter instructions include a pulse width of 100μs-500μs, a frequency of 1Hz-100Hz, and a current intensity of 0.1mA-5mA.

7. The adaptive transcutaneous vagus nerve electrical stimulation system based on closed-loop feedback according to claim 2, characterized in that: The electrode contacts are made of conductive silicone, conductive fabric or a flexible substrate material coated with conductive polymer, and the electrode contacts are 0.5mm-2mm higher than the surface of the housing (2).

8. The adaptive transcutaneous vagus nerve electrical stimulation system based on closed-loop feedback according to claim 1, characterized in that: The sleep monitoring unit (3) is a smartphone.

9. The adaptive transcutaneous vagus nerve electrical stimulation system based on closed-loop feedback according to claim 2, characterized in that: The charging storage box (1) is equipped with a lithium battery of not less than 2000mAh, the housing (2) is equipped with a lithium battery of not less than 40mAh, and the housing (2) is equipped with a wear detection sensor, a nine-axis inertial measurement unit and a photoplethysmography sensor.

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