Electrical stimulation sleep aid device with electrode shift monitoring and control method thereof

Abstract

This invention discloses an electrostimulation sleep aid device with electrode displacement monitoring and its control method. The device mainly includes: a physiological signal acquisition module, a marking module, a transcutaneous electrical stimulation module, a marking detection module, a micro-friction sensing module, an alarm module, and an analysis and control module. The physiological signal acquisition module acquires the user's electroencephalogram (EEG); the transcutaneous EEG module applies electrical stimulation to standard points on the body to aid sleep; the marking module marks the locations near the stimulation points; the marking detection module is attached to the electrodes to detect the markings; the micro-friction sensing module monitors changes in friction between the electrodes and the skin; the analysis and control module determines whether the electrodes have shifted based on changes in friction and the marking detection results, and analyzes the user's sleep state in conjunction with the EEG signals; if electrode shift is detected and the user is awake, an alarm is issued via the alarm module. This invention can monitor electrode shift status in real time and provide corresponding feedback, improving the safety and effectiveness of electrical stimulation.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an electrical stimulation sleep aid device with electrode displacement monitoring and its control method. Background Technology

[0002] Sleep, as a crucial process for the recovery and regulation of the body's physiological functions, directly impacts people's physical and mental health and daily life. With the accelerated pace of modern life, sleep disorders are becoming increasingly prevalent. According to statistics, approximately one-third of the global population suffers from varying degrees of sleep problems. Electrical stimulation sleep aid technology, as an innovative sleep aid method, has gradually become a hot topic in the field of sleep research due to its unique mechanism of action and promising application prospects. This technology involves placing electrodes on specific parts of the body (such as the head, ears, and forehead) and applying weak electrical stimulation to regulate the release of neurotransmitters in the brain, altering the activity patterns of brain waves, thereby helping users relax their mind and body, inducing and maintaining a sleep state.

[0003] However, one of the main technical challenges of implementing electrical sleep stimulation (ESS) is the risk of electrode displacement during the stimulation process. Whether in a home or clinical setting, involuntary body movements during the sleep cycle, changes in head position, variations in skin adhesion, and the aging of the electrode materials themselves can all reduce the adhesion between the electrode and the skin, increasing the risk of electrode displacement. Electrode displacement can alter the current distribution, reduce the stimulation effect, or unintentionally stimulate non-target areas, potentially interfering with sleep or causing adverse effects. Furthermore, signal artifacts or stimulation failures due to poor electrode contact can interfere with data interpretation, reducing the overall quality of treatment or experimental results.

[0004] Currently, existing solutions to the problem of electrode displacement in electrostimulation sleep aids have significant limitations. Some traditional electrostimulation sleep aids rely entirely on the user's own senses to determine whether the electrodes have shifted. However, during sleep, the user's perception decreases, making it difficult to detect electrode displacement in time. This causes the device to continue operating even after electrode displacement, greatly affecting its sleep-aiding effect. While some slightly more advanced devices attempt to reduce displacement by improving electrode fixation methods, these methods only alleviate the problem to a certain extent and do not fundamentally solve it. Furthermore, the market lacks a dedicated real-time monitoring and effective feedback mechanism for electrostimulation sleep aid electrode displacement, making it impossible to promptly control electrical stimulation and remind users to adjust electrode positions to ensure the device remains in optimal working condition. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide an electrical stimulation sleep aid device with electrode shift monitoring and its control method, in order to address the above-mentioned deficiencies of the prior art, and to solve the problem that there is no effective electrode shift monitoring and feedback mechanism in the prior art.

[0006] To solve the above-mentioned technical problems, the technical solution adopted by the present invention is as follows:

[0007] In a first aspect, the present invention provides an electrical stimulation sleep aid device with electrode displacement monitoring, the device comprising: a physiological signal acquisition module, a marking module, a transcutaneous electrical stimulation module, a marking detection module, a micro-friction force sensing module, an alarm module, and an analysis and control module;

[0008] The physiological signal acquisition module is used to acquire human electroencephalogram (EEG) signals.

[0009] The marking module is used to mark the locations near the standard points for human electrical stimulation;

[0010] The transcutaneous electrical stimulation module is used to provide electrical stimulation to standard points on the human body.

[0011] The marker detection module is designed to be bonded to the electrode portion of the transcutaneous electrical stimulation module. It is used to detect markers at locations near the standard electrical stimulation points and to feed back the marker detection mode to the analysis and control template. The bonded design ensures that the marker detection module will shift in the same way as the electrodes. The marker detection mode includes a marker recognition success state and a marker recognition failure state.

[0012] The micro-friction sensing module is embedded in the electrode portion of the transcutaneous electrical stimulation module; wherein, the micro-friction sensing module is used to monitor the friction between the electrode and the surface of human skin;

[0013] The alarm module is used to alert users to alarms.

[0014] The analysis and control module is used to analyze the acquired signals and control the operation of the marker detection module, transcutaneous electrical stimulation module, and alarm module based on the analysis results, including:

[0015] This is used to analyze and determine the electrode friction force mode based on the collected friction force signal, and to control the operation of the marker detection module based on the friction force mode. The electrode friction force mode includes normal state and abnormal state.

[0016] The electrode shifting mode is determined based on the label detection mode fed back by the label detection module, and the operation of the transcutaneous electrical stimulation module is controlled based on the electrode shifting mode. The user's sleep mode is also determined by analyzing the collected human electroencephalogram (EEG) signals. The electrode shifting mode includes a shifted state and a non-shifted state, and the sleep mode includes a sleep state and a wakeful state.

[0017] This is used to control the operation of the alarm module based on the electrode shifting mode and the sleep mode.

[0018] Secondly, the present invention provides a control method for an electrical stimulation sleep aid device equipped with electrode shift monitoring, wherein the control method includes the following steps:

[0019] S1. Correctly wear and operate the electrical stimulation sleep aid device with electrode displacement monitoring, ensure the normal operation of each module, and complete the marking work of the marking module;

[0020] S2. The analysis and control module analyzes and judges the electrode friction force mode by collecting the electrode friction force signal from the micro friction force sensing module. The electrode friction force mode includes a normal state and an abnormal state. If the electrode friction force mode is in a normal state, no operation is performed. If the electrode friction force mode is in an abnormal state, the module controls the marker detection module to detect the markers near the standard points of human electrical stimulation and determine the marker detection mode. The marker detection mode includes a marker recognition success state and a marker recognition failure state.

[0021] S3. The analysis and control module determines the electrode shifting mode based on the marker detection mode. The electrode shifting mode includes a shifted state and a non-shifted state. If the marker detection mode is a marker recognition success state, the electrode shifting mode is determined to be a non-shifted state. If the marker detection mode is a marker recognition failure state, the electrode shifting mode is determined to be a shifted state.

[0022] S4. The analysis and control module controls the operation of the transcutaneous electrical stimulation module based on the electrode shifting mode and analyzes and judges the user's sleep mode by the human brain electrical signals acquired by the physiological signal acquisition module. If the electrode shifting mode is in an unshifted state, no operation is performed; if the electrode shifting mode is in a shifted state, the transcutaneous electrical stimulation module is controlled to stop working, and the human brain electrical signals acquired by the physiological signal acquisition module are analyzed and judged by the user's sleep mode, which includes the sleep state and the awake state.

[0023] S5. The analysis and control module controls the operation of the alarm module based on the sleep mode. If the sleep mode is a sleep state, no operation is performed; if the sleep mode is a wakeful state, the alarm module is controlled to issue an alarm signal.

[0024] Beneficial Effects: Compared with existing technologies, this invention specifically addresses the critical issue of electrode displacement, providing an electrostimulation sleep aid device and its control method with electrode displacement monitoring. The device includes: a physiological signal acquisition module, a marking module, a transcutaneous electrical stimulation module, a marking detection module, a micro-friction sensing module, an alarm module, and an analysis and control module. This invention uses friction signal judgment combined with marking detection to monitor changes in the position of the electrical stimulation electrodes in real time and accurately. It can sensitively capture changes at the first moment of electrode displacement and then take swift action. On the one hand, it promptly shuts down the transcutaneous electrical stimulation module to avoid inappropriate electrical stimulation output due to electrode displacement, effectively reducing the risk of discomfort or even adverse effects on the user. On the other hand, it promptly determines the user's current sleep state. If the user is asleep, it does not interrupt their normal sleep; if the user is awake, it sends an alarm signal to remind them that the electrode has shifted. In this way, it ensures that the device maintains optimal working condition throughout the entire usage process, greatly avoiding adverse consequences such as poor sleep aid effect or unexpected stinging caused by electrode displacement. This is not only crucial for improving the effectiveness and safety of the device, but also brings great convenience to users, allowing them to enjoy a stable and reliable sleep aid experience without worrying about electrode displacement when using the electrical stimulation sleep aid device. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the functional modules of an electrical stimulation sleep aid device with electrode displacement monitoring provided by the present invention.

[0026] Figure 2 The flowchart illustrates the control method for an electrical stimulation sleep aid device with electrode displacement monitoring provided by the present invention. Detailed Implementation

[0027] To make the objectives, technical solutions, and effects of this invention clearer and more explicit, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention. Furthermore, the technical features involved in the various embodiments of the invention described below can be combined with each other as long as they do not conflict with each other.

[0028] According to a first aspect of the present invention, this embodiment provides an electrical stimulation sleep aid device with electrode shift monitoring, such as... Figure 1 As shown, the device includes: a physiological signal acquisition module 10, a labeling module 20, a transcutaneous electrical stimulation module 30, a label detection module 40, a micro-friction sensing module 50, an alarm module 60, and an analysis and control module 70.

[0029] The physiological signal acquisition module 10 is used to acquire the user's electroencephalogram (EEG) signals in real time to obtain the user's current physiological state. In one specific embodiment, the physiological signal acquisition module 10 is positioned at the FP1 and FP2 electrode positions on the user's forehead, using Ag / AgCl electrodes that contact the skin through conductive gel with a contact impedance of less than 5kΩ. The electrodes are connected to a preamplifier circuit, which includes a 0.1-100 Hz bandpass filter and a 50 Hz power frequency notch filter, resulting in a signal amplification factor greater than 1000 times and a sampling rate greater than 200 Hz. The acquired EEG signals are converted from analog to digital by an ADC and then transmitted as digital signals to the analysis and control module 70 for processing using differential transmission.

[0030] The marking module 20 is used to mark the vicinity of standard points for human electrical stimulation. The markings are biocompatible, have durable adhesion, and reliable identification. In Embodiment 1, the markings can be a fluorescent ink coating applied to the skin surface, which produces visible fluorescence under harmless infrared light excitation, and its adhesion is sufficient to prevent detachment and blurring within an 8-12 hour monitoring period. In Embodiment 2, the markings can be medical-grade adhesive patches printed with machine-readable patterns, ensuring no displacement throughout the sleep monitoring process.

[0031] The transcutaneous electrical stimulation module 30 is used to assist sleep by applying low-intensity transcutaneous electrical stimulation to standard electrical stimulation points on the human body during the user's sleep process, thereby regulating autonomic nerve function. In one specific embodiment, the stimulation electrodes are made of flexible carbon fiber electrodes, coupled to the skin via medical hydrogel. The electrical stimulation parameters are: frequency 1-100 Hz, current intensity 0.1-3 mA, pulse width 100-300 μs, and the module's operating status can be controlled based on the results of electroencephalogram (EEG) analysis.

[0032] The marker detection module 40 is used to identify and detect markers at locations adjacent to the standard points for human electrical stimulation. It is tightly coupled to the electrode portion of the transcutaneous electrical stimulation module 30 via a mechanical bonding structure, enabling synchronized positional movement. In one specific embodiment, this module includes a miniature CMOS image sensor and a set of infrared LED light sources for acquiring images of the marked area during electrode movement. Using an embedded image processing algorithm, including template matching and feature point detection, it determines whether the marker is within a predetermined area centered on the electrode with a radius not exceeding 3-5 mm, and feeds back the marker detection mode to the analysis and control module 70, including a successful marker recognition status and a failed marker recognition status.

[0033] A miniature friction sensing module 50, embedded in the electrode portion of the transdermal electrical stimulation module, is used to monitor changes in friction between the electrodes and the user's skin surface, reflecting the wearing status in real time. When the electrodes shift, the friction signal changes. In one specific embodiment, this module can be a piezoresistive friction sensor based on MEMS technology, with a range of 0.1-5 N and a sensitivity of not less than 0.01 N. This module can be embedded in the electrode backing layer of the transdermal electrical stimulation module 30.

[0034] An alarm module 60 is used to issue a prompt when the electrode shifts and the user is awake, ensuring the correct use of the device. In one specific embodiment, the module includes a miniature buzzer (sound pressure level 60-70 dB) and a vibration motor (amplitude 0.8 G). It can issue one or more alarm signals, including sound and vibration, according to the instructions of the analysis and control module 70.

[0035] The analysis and control module 70 receives signal inputs from various modules, performs logical analysis and judgment, and controls the overall operation of the device. Its main functions include: analyzing and judging the electrode friction mode based on the friction signals collected by the micro-friction sensing module 50, which includes normal and abnormal states; triggering the marker detection module 40 to perform marker recognition analysis and judge the marker detection mode, which includes successful marker recognition and failed marker recognition; judging whether the electrode has shifted based on the marker detection mode, which includes shifted and unshifted states; analyzing the electroencephalogram (EEG) signals collected by the physiological signal sensing module 10 to judge the user's sleep mode, which includes falling asleep and awake states; and controlling the alarm module to issue an alarm prompt based on the electrode shift mode and sleep mode. In one specific implementation, the module is based on an STM32 series microcontroller. The specific functions include: based on the real-time friction force signal collected by the micro-friction force sensing module 50, when the electrode shifts during wear, the electrode changes from a static friction state to a dynamic friction state. The friction force signal exhibits a pulse characteristic of first increasing and then decreasing. If the ratio of the decreased steady-state value to the peak value before the decrease is lower than a preset threshold coefficient (0.6-0.8), it is judged as an abnormal state; otherwise, it is a normal state. When the friction force mode is in an abnormal state, the marker detection module 40 is triggered to perform marker recognition and analysis; if the marker detection... If the measurement module 40 returns a mark recognition failure status, it is determined that the electrode shifting mode is in the shifted state. Real-time frequency domain analysis is performed on the EEG signal input by the physiological signal acquisition module 10. When the δ wave power ratio exceeds 30% and the α wave power ratio is less than 10%, it is determined that the user is in a sleep state; otherwise, the user is awake. When the electrode shifting mode is in the shifted state and the user is awake, the alarm module 60 is controlled to issue a first-level alarm prompt (vibration) and a second-level alarm prompt (vibration and sound synchronization) in stages, with a time interval of 3 seconds between different levels. If the user is in a sleep state, no alarm prompt is triggered.

[0036] According to a second aspect of the present invention, this embodiment also provides a control method for an electrical stimulation sleep aid device equipped with electrode shift monitoring, such as... Figure 2 As shown, the control method includes the following steps:

[0037] S1. The user correctly wears and sets up the electrical stimulation sleep aid device with electrode displacement monitoring to ensure the normal operation of each module, and the marking module completes the skin marking of the position near the standard electrical stimulation point;

[0038] S2. During device operation, the micro friction force sensing module collects real-time data on the friction force changes between the electrode and the skin, and transmits it to the analysis and control module for analysis. The analysis and control module can determine whether there is an abnormal friction force of the current electrode by setting a coefficient threshold. The electrode friction force mode includes normal state and abnormal state.

[0039] S3. If the ratio of the friction force signal after the change to that before the change is greater than the threshold, it is determined that the electrode friction force mode is in a normal state, and the device continues to operate normally without performing any other operations.

[0040] S4. If the ratio of the friction force signal after the change to that before the change is less than a threshold, the electrode friction force mode is determined to be in an abnormal state, and the mark detection module is triggered to perform mark recognition and determine the mark detection mode. The mark detection mode includes a mark recognition success state and a mark recognition failure state. Based on the mark detection mode, the electrode displacement mode is determined. The electrode displacement mode includes a displacement state and a non-displacement state.

[0041] S5. If the marker detection mode is in the marker recognition success state, it means that the electrode is still in the original position, and the electrode shift mode is determined to be in the no-shift state;

[0042] S6. If the marker detection mode is in the marker recognition failure state, it means that the electrode has shifted and driven the marker detection module to shift synchronously. The electrode shift mode is determined to be in the shifted state.

[0043] S7. If the electrode shifting mode is in the unshifted state, the device continues to operate normally without performing any other operations; S8. If the electrode shifting mode is in the shifted state, the analysis and control module immediately controls the transcutaneous electrical stimulation module to stop electrical stimulation to avoid ineffective or unsafe stimulation due to deviation from the standard electrical stimulation points; at the same time, the analysis and control module determines the user's sleep state based on the EEG signals acquired by the current physiological signal acquisition module.

[0044] S9. If the user's sleep state is determined to be "asleep state", the device will maintain the status quo and will not take any other actions to avoid affecting the user's normal sleep.

[0045] S10. If the user's sleep state is determined to be "awake", the analysis and control module controls the alarm module to send an alarm signal to remind the user to readjust the electrode wearing position to ensure the normal operation of the device.

[0046] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. An electrical stimulation sleep aid device with electrode shift monitoring and its control method, characterized in that, The device includes: a physiological signal acquisition module for acquiring human electroencephalogram (EEG) signals; a marking module for marking locations near standard points of human electrical stimulation; a transcutaneous electrical stimulation (TES) module for applying electrical stimulation to the standard points of human electrical stimulation; a marking detection module, bound to the electrode portion of the TES module, for detecting the markings provided by the marking module and feeding back the marking detection mode to the analysis and control module, the marking detection mode including a successful marking recognition state and a failed marking recognition state; a micro-friction sensing module, embedded in the electrode portion of the TES module, for monitoring the friction between the electrodes and the surface of human skin; an alarm module for alerting the user according to instructions from the analysis and control module; and an analysis and control module for receiving signals from the physiological signal acquisition module, ... The signals from the micro-friction sensing module and the marker detection module are used to control the operation of the device based on the following logic: The electrode friction mode is determined based on the signal changes of the micro-friction sensing module, including normal and abnormal states; when the electrode friction mode is abnormal, the marker detection module is controlled to perform marker recognition and determine whether the electrode has shifted based on the marker detection mode, including non-shifted and shifted states; the transcutaneous electrical stimulation module is controlled to continue working, and if the electrode shift mode is shifted, the transcutaneous electrical stimulation module is controlled to stop working; the EEG signals are analyzed to determine the user's sleep mode, including falling asleep and awake states; when the electrode has shifted and the user is awake, the alarm module is controlled to issue an alarm signal.

2. The control method is as follows: S1. The user wears and activates the device, and the marking module marks the standard points of electrical stimulation. S2. The micro friction force sensing module collects the friction force signal between the electrode and the skin and transmits it to the analysis and control module for analysis and judgment to determine whether the electrode friction force mode is abnormal. If the electrode friction force mode is normal, the device is maintained; if the electrode friction force mode is abnormal, the subsequent steps are executed. S3. Control the marker detection module to identify the marker and determine the marker detection mode, determine the electrode shifting mode. If the marker detection mode is a marker recognition success state, determine the electrode shifting mode as an unshifted state and maintain device operation. If the marker detection mode is a marker recognition failure state, determine the electrode shifting mode as a shifted state and continue to execute subsequent steps. S4. Control the transcutaneous electrical stimulation module to stop working, and analyze and judge the user's sleep mode based on the human brain electrical signals collected by the physiological signal acquisition module. If the sleep mode is a sleep state, maintain the current state of the device; if the sleep mode is a wakeful state, continue to execute the subsequent steps. S5. Control the alarm module to send an alarm signal.

3. An electrical stimulation sleep aid device with electrode shift monitoring and its control method, characterized in that... The marking module generates either fluorescent markings or medical patches with specific patterns.

4. An electrical stimulation sleep aid device with electrode shift monitoring and its control method, characterized in that... The marker detection module uses an image sensor to identify the marker and uses an image processing algorithm to determine whether the marker deviates from a preset position.

5. An electrical stimulation sleep aid device with electrode shift monitoring and its control method, characterized in that... The micro friction sensing module determines whether the electrode friction is in a normal state by setting a threshold for the friction change coefficient.

6. An electrical stimulation sleep aid device with electrode shift monitoring and its control method, characterized in that... The alarm module includes one or more of sound signals and vibration signals.

7. An electrical stimulation sleep aid device with electrode shift monitoring and its control method, characterized in that... When the analysis and control module determines that the electrode has shifted, it controls the transcutaneous electrical stimulation module to adjust its working state, and controls the alarm module to issue a prompt based on whether the user is asleep or awake.

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