An obstructive sleep apnea device, method

Abstract

The application discloses an obstructive sleep apnea device and method; the device comprises a mouthpiece carrier, an electrode stimulation module and a control unit, the electrode stimulation module comprises an integrated flexible circuit board transmission link, the transmission link is integrated with a stimulation electrode with a nickel-titanium alloy support strip on the inner side of the mouthpiece carrier, and the stimulation electrode can apply electric stimulation to the genioglossus muscle or hypoglossal nerve; the external control unit is provided with a microcontroller and an acoustic sensor; the method first collects an environmental background signal, processes the signal to generate a signal determination threshold, then collects a human respiratory acoustic vibration signal in real time, processes the signal to generate a respiratory sound energy value, compares the two to determine an abnormal respiratory event; after determining the abnormality, a gradient output electric stimulation is output, and a dynamic feedback mechanism is combined to adjust the stimulation intensity; when the stimulation intensity is zero and there is no abnormal signal, it is determined that the intervention is completed and the standby state is entered; the application can adapt to environmental noise, avoid current mutation discomfort, closed-loop control intervention intensity, and is suitable for sleep apnea auxiliary intervention.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to an obstructive sleep apnea device and method. Background Technology

[0002] Obstructive sleep apnea (OSA) is caused by upper airway obstruction due to pharyngeal collapse and muscle relaxation during sleep. Existing patented technologies mainly maintain airway patency through two methods: mechanical intervention (such as tongue bridge compression and shape memory alloy mandibular adjustment) and electrical stimulation (pulsed stimulation of the genioglossus muscle to promote tongue protrusion). The mainstream approach uses an intraoral brace as a carrier, integrating physiological acoustic sensors and a microcontroller. After monitoring snoring or apnea events, closed-loop electrical stimulation is initiated, with electrical energy mostly transmitted through a built-in battery in conjunction with a wireless charging coil.

[0003] However, existing technologies still have the following shortcomings:

[0004] Poor fit of braces: The secondary coating encapsulation makes it difficult to fit the thickness and edges properly, resulting in a strong foreign body sensation and high cost; Unstable electrode contact: The hydrogel / chitosan has poor adhesion and inaccurate positioning in oral fluid; The titanium wire support has low elastic strain and is prone to contact failure; Weak anti-interference: It lacks fine processing for characteristics such as snoring frequency and RMS, and is easily triggered by teeth grinding and environmental noise; Low charging efficiency: The wireless coil is small, inefficient, and generates significant heat; The wired interface is difficult to reliably waterproof in a moist mouth; High maintenance cost: The integrated encapsulation requires the entire brace to be replaced after aging or circuit damage, making modular low-cost maintenance impossible. Summary of the Invention

[0005] To address the shortcomings of existing technologies, the core technical problem this invention aims to solve is to provide a treatment device and method for obstructive sleep apnea. This solution adopts a physical separation architecture of "intraoral electrode positioning and extraoral module driving". While ensuring wearing comfort, it uses shape memory materials to achieve constant pressure contact between the electrodes and the genioglossus muscle, and combines advanced signal processing algorithms to scientifically characterize and precisely intervene in respiratory obstruction events, thereby effectively maintaining airway patency during the patient's sleep.

[0006] To address the aforementioned technical problems, this application provides an obstructive sleep apnea device, employing the following technical solution:

[0007] It includes a dental brace carrier, an electrode stimulation module, and a control unit; the electrode stimulation module includes a first transmission link placed inside the dental brace carrier and a second transmission link placed outside the dental brace carrier;

[0008] The first transmission link and the second transmission link are integrally formed using a flexible circuit board, which is used for electrical transmission. The first transmission link is composited with a nickel-titanium alloy support strip, which extends along the length direction of the flexible circuit board corresponding to the first transmission link and is located on the back of the flexible circuit board.

[0009] The intraoral end of the first transmission link is integrated with a stimulation electrode, which includes conductive contacts for applying electrical stimulation to the genioglossus muscle or hypoglossal nerve; the control unit is located on the outside of the brace carrier, the second transmission link is electrically connected to the control unit, and the control unit can be fixed to the surface of the mandibular skin;

[0010] The control unit includes a microcontroller and an acoustic sensor. The acoustic sensor is used to collect acoustic vibration signals generated by human respiration. The microcontroller sets a signal judgment threshold and converts the acoustic vibration signals generated by human respiration into respiratory sound energy values.

[0011] The microcontroller determines the energy value of the respiratory sound and the signal determination threshold, and controls the stimulation electrode to start and stop based on the determination result.

[0012] In a preferred embodiment: the brace carrier is thermoformed from EVA shape memory material, the brace carrier has a through hole for the electrode stimulation module to pass through; the brace carrier has an electrode mounting position reserved on the lingual side, and the first transmission link is fixed at the electrode mounting position.

[0013] In a preferred embodiment: the first transmission link is divided into two branches, and the nickel-titanium alloy support strip is composited on the back of each branch; two stimulation electrodes are provided corresponding to the two branches; the conductive contacts of the two stimulation electrodes act on the motor endplates of the bilateral genioglossus muscles.

[0014] In a preferred embodiment: the flexible circuit board is entirely covered with a silicone protective sleeve.

[0015] In a preferred embodiment: the end of the second transmission link is connected to the control unit via a miniature connector structure.

[0016] In a preferred embodiment: the control unit is fixed to the skin below the jaw by a disposable hydrogel patch or a disposable / reusable medical silicone patch.

[0017] In a preferred embodiment: the control unit is equipped with a rechargeable storage box; or the control unit adopts magnetic wireless charging or plug-in wired charging.

[0018] In a preferred embodiment: the acoustic sensor is an electret microphone or a piezoelectric vibratory acoustic sensor or a combination of both.

[0019] In a preferred embodiment: the control unit enters an environmental acquisition mode at the initial stage of device startup, uses the acoustic sensor to acquire ambient background sound signals, and sets a signal judgment threshold based on these signals; the microcontroller sets a preset duration.

[0020] When the device is in use, the control unit collects acoustic vibration signals generated by human respiration in real time through the acoustic sensor and converts them into respiratory sound energy values. When the respiratory sound energy value is greater than the signal judgment threshold and the duration of the respiratory sound energy value meets the preset duration, it is determined that the stimulation electrode is activated.

[0021] To address the aforementioned technical problems, this application also provides a method for treating obstructive sleep apnea, employing the following technical solution:

[0022] The method based on the aforementioned obstructive sleep apnea device includes the following steps:

[0023] Step 1: After the device is started, it enters the environmental acquisition mode. During the preset acquisition time, the acoustic sensor acquires the ambient background sound signal and amplifies and bandpass filters the background sound signal. The microcontroller uses the sliding window root mean square algorithm to construct a dynamic background noise reference value based on the processed background sound signal and generates a signal judgment threshold based on the environmental interference coefficient.

[0024] Step 2: During device use, the acoustic sensor collects the acoustic vibration signals generated by human respiration in real time and converts them into electrical signals; the collected electrical signals are amplified and bandpass filtered to retain the characteristic frequency band signals of human respiration; the microcontroller performs high-speed analog-to-digital conversion on the processed electrical signals to generate discrete digital sequences.

[0025] Step 3: The microcontroller uses the sliding window root mean square algorithm to calculate the discrete digital sequence and outputs the respiratory sound energy value in real time. The respiratory sound energy value is compared with the signal judgment threshold. When the respiratory sound energy value exceeds the signal judgment threshold and the duration meets the preset duration, it is judged as an abnormal breathing event.

[0026] Step 4: Intervene based on the judgment results of Step 3. When an abnormal respiratory event is determined, activate the stimulation electrode and output electrical stimulation. The microcontroller uses a gradient ramp method to control the electrode stimulation module to gradually increase the output current and suppress the discomfort caused by sudden current changes.

[0027] Step 5: During the electrical stimulation output process, the acoustic sensor continuously collects the acoustic vibration signal generated by human respiration to form a dynamic feedback mechanism. If the respiratory sound energy value does not decrease below the signal judgment threshold after the electrical stimulation output, the stimulation intensity is gradually increased within the preset safe current range. If the respiratory sound energy value decreases below the signal judgment threshold, the stimulation intensity is gradually reduced.

[0028] Step 6: Once the stimulation intensity returns to zero and no abnormal signals are detected during the preset silence period, the intervention is considered complete, and the system enters standby data collection mode.

[0029] In summary, this application has the following beneficial effects:

[0030] 1. This application adopts a split structure with an external control unit, abandoning the traditional fully integrated braces design. The circuit is led out to the outer side of the mandible for application through a transmission link, which greatly reduces the thickness of the braces inside the mouth, effectively reduces the feeling of foreign objects in the mouth, and improves the wearing experience when the mouth is closed. At the same time, it avoids the risk of thermal runaway of the battery inside the mouth and facilitates the maintenance and repair of external components.

[0031] 2. Using nickel-titanium alloy as the support substrate for the flexible circuit board, relying on its superelasticity and shape memory properties to provide constant prestress for the electrodes, ensuring stable contact between the electrodes and the genioglossus muscle, and avoiding electrode detachment due to tongue displacement; it can also be repeatedly shaped by heat to adapt to the oral anatomy of different people and achieve personalized adaptation.

[0032] 3. An adaptive environmental noise compensation mechanism is added. Background noise is collected before the device is started and a dynamic judgment threshold is constructed to suppress environmental noise interference. At the same time, the sliding window root mean square algorithm is used to replace the traditional peak detection method to accurately quantify the respiratory energy intensity, reduce the probability of false triggering, and improve the specificity of abnormal breathing recognition in complex environments.

[0033] 4. Set up gradient current control logic to gradually increase the current when the intervention is started, so as to avoid discomfort caused by sudden current changes; after the intervention eliminates abnormal breathing, the current drops back down in a stepwise manner and a silent monitoring cycle is added to ensure a smooth intervention process and improve patient sleep compliance. Attached Figure Description

[0034] Figure 1 This is a front-view perspective three-dimensional schematic diagram of the overall structure of the obstructive sleep apnea device in this embodiment;

[0035] Figure 2 This is a rear-view three-dimensional schematic diagram of the overall structure of the obstructive sleep apnea device in this embodiment;

[0036] Figure 3 This is a schematic diagram of the overall structure of the electrode stimulation module in this embodiment;

[0037] Figure 4 yes Figure 3Detail A structural diagram;

[0038] Figure 5 yes Figure 3 Detail B of the structure diagram;

[0039] Figure 6 This is a flowchart of the obstructive sleep apnea method in this embodiment.

[0040] Explanation of reference numerals in the attached drawings: 1. Control unit; 2. Electrode stimulation module; 21. First transmission link; 22. Second transmission link; 23. Stimulating electrode; 24. Flexible circuit board; 25. Nickel-titanium alloy support strip; 26. Silicone protective sleeve; 27. Miniature insertion structure; 3. Bracket carrier; 31. Through hole; 32. Electrode mounting position. Detailed Implementation

[0041] 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. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0042] In the description of this invention, it should be noted that the terms "upper," "lower," "inner," "outer," "top / bottom," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0043] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installed", "equipped", "sleeved / connected", "connected", etc., should be interpreted broadly. For example, "connection" can be a wall-mounted connection, a detachable 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. For those skilled in the art, the specific meaning of the above terms in this invention can be understood according to the specific circumstances.

[0044] The following is in conjunction with the appendix Figures 1-6 This application will be described in further detail.

[0045] This embodiment provides a device for obstructive sleep apnea. The device employs a closed-loop electrical stimulation system with a physically separated design of "intraoral electrode positioning and extraoral module driving." Its core principle is to utilize external sensor monitoring and precise intraoral electrical stimulation to synergistically treat OSA. (Refer to...) Figure 1 It consists of the following parts:

[0046] The brace carrier 3 is a personalized intraoral positioning carrier made of EVA shape memory material through thermoplastic molding. Utilizing the thermoplastic properties of EVA shape memory material, it is shaped and fixed to the lower jaw by the user's teeth biting together. This brace carrier 3 serves only as a mechanical support platform for the electrodes and does not contain batteries or main control circuitry, minimizing the feeling of a foreign object in the mouth and ensuring wearing stability, improving the experience of closing the mouth during sleep and overall wearing comfort. The brace carrier 3 has a through-hole 31 for the electrode stimulation module 2 to pass through; the lingual side of the brace carrier 3 has a pre-reserved electrode mounting position 32.

[0047] Electrode stimulation module 2 includes a first transmission link 21 located inside the dental brace carrier 3 and a second transmission link 22 located outside the dental brace carrier 3; Reference Figure 3 The first transmission link 21 and the second transmission link 22 are integrally formed using a flexible circuit board 24, which is used for electrical transmission; Reference Figure 4 The first transmission link 21 is composite with a nickel-titanium alloy support strip 25, which extends along the length direction of the flexible circuit board 24 corresponding to the first transmission link 21 and is located on the back side of the flexible circuit board 24; the intraoral end of the first transmission link 21 is integrated with a stimulation electrode 23, which includes conductive contacts for applying electrical stimulation to the genioglossus muscle or hypoglossal nerve.

[0048] Specifically, the shape memory properties of the nickel-titanium alloy support strip 25 are used as the "endoskeleton" of the stimulation electrode 23. The elasticity of the metal ensures that the electrode maintains constant pressure contact with the mucosa when the tongue moves, improving stimulation efficiency. At the same time, in order to minimize the foreign body sensation between the lips and cope with stretching fatigue during sleep, the second transmission link 22 does not contain the nickel-titanium alloy support strip 25.

[0049] Utilizing the shape memory properties and superelasticity of nickel-titanium alloy, this structure can be manually fine-tuned and maintain its shape according to the user's tongue anatomy. Its core principle is to achieve constant pressure contact using the continuous pre-stress of the metal, ensuring that the stimulation contact points remain firmly against the mucosa even when the tongue falls back or moves during sleep. Simultaneously, the plasticity of the nickel-titanium alloy support strip 25 allows for adjustment of the electrical stimulation position, ensuring accuracy and preventing ineffective treatment. The nickel-titanium alloy support strip 25 also possesses shape recovery capabilities; when the temperature exceeds its phase transition temperature, it can return to its original shape, enabling reuse and repeated position adjustments.

[0050] refer to Figure 2 The first transmission link 21 is divided into two branches, each with the nickel-titanium alloy support strip 25 attached to its back. Two stimulation electrodes 23 are disposed corresponding to the two branches. The conductive contacts of the two stimulation electrodes 23 act on the motor endplates of the bilateral genioglossus muscles. The two branches of the first transmission link 21 pass through the electrode mounting position 32 and are fixed to the first transmission link 21 by food-grade adhesive or clips. The contacts of the two stimulation electrodes 23 are precisely pointed to the motor endplates of the bilateral genioglossus muscles, ensuring efficient activation under low current.

[0051] refer to Figure 5 The flexible circuit board 24 is covered with a silicone protective sleeve 26. It is encapsulated with medical-grade silicone using ultra-thin flexible circuit board 24 (FPC). This not only ensures the biocompatibility and waterproofness of the cable, but also ensures natural closure of the mouth due to its softness and eliminates the discomfort caused by friction between the wire and the skin of the mouth and lips due to its flexible touch.

[0052] The control unit 1 is located on the outside of the brace carrier 3. The end of the second transmission link 22 is electrically connected to the control unit 1 through a miniature plug structure 27. When the user wears the brace, the plug is inserted to connect the circuit. When not in use, the plug is removed to achieve modular decoupling, which facilitates independent cleaning, maintenance and component replacement.

[0053] Specifically, the control unit 1 includes a microcontroller and an acoustic sensor. The acoustic sensor is used to collect acoustic vibration signals generated by human respiration. The microcontroller sets a signal judgment threshold and converts the acoustic vibration signals generated by human respiration into respiratory sound energy values. The microcontroller judges the respiratory sound energy values ​​against the signal judgment threshold and controls the stimulation electrode 23 to start and stop based on the judgment result.

[0054] The control unit 1 enters the environmental acquisition mode at the initial stage of device startup, and uses the acoustic sensor to collect ambient background sound signals and sets a signal judgment threshold based on this; the microcontroller sets a preset duration; when the device is in use, the control unit 1 collects the acoustic vibration signals generated by human breathing in real time through the acoustic sensor and converts them into respiratory sound energy values; when the respiratory sound energy value is greater than the signal judgment threshold and the duration of the respiratory sound energy value meets the preset duration, it is determined that the stimulation electrode 23 is activated.

[0055] The control unit 1 is fixed to the skin below the jaw with a disposable hydrogel patch or a disposable / reusable medical silicone patch, ensuring that the acoustic sensor can efficiently capture tracheal vibration signals while avoiding lateral displacement; at the same time, this suspension patch design avoids the risk of thermal runaway of lithium batteries in the mouth and is convenient for charging and operation.

[0056] The acoustic sensor employs an electret microphone, a piezoelectric vibratory acoustic sensor, or a combination of both. The control unit 1 is equipped with a rechargeable storage case and a dedicated charging case. After the control unit 1 is placed in a specific slot within the case, it contacts the electrodes inside the case via integrated pogo pins for power replenishment. Alternatively, the control unit 1 can employ magnetic wireless charging. A magnetic adsorption component and induction coil are built into the back or side of the control unit 1. When the charging head approaches, it automatically aligns and attracts the charging head using magnetic force, initiating electromagnetic induction charging and achieving a seamless, physically sealed interface. Alternatively, the control unit 1 can employ plug-in wired charging. The control unit 1 has a pre-installed miniature charging interface (such as a waterproof USB or other plug-in interface), allowing users to directly use a standard power cord for fast charging.

[0057] Based on the aforementioned obstructive sleep apnea device, this embodiment provides an obstructive sleep apnea method, as described above. Figure 6 The method includes the following steps:

[0058] Step 1: After the device is started, it enters the environmental acquisition mode. Within the preset acquisition time (e.g., the preset duration is 30 seconds), it samples the environmental noise. The acoustic sensor collects the environmental background sound signal, and the background sound signal is amplified and bandpass filtered. The microcontroller constructs a dynamic background noise reference value based on the processed background sound signal, and generates a signal judgment threshold according to the environmental interference coefficient.

[0059] In step 1, signal conditioning: filtering and amplification. The background sound signal needs to be processed synchronously through bandpass filtering and multi-stage amplification circuits in the subsequent step 2 to ensure that background feature extraction and human breathing feature detection are under the same technical standard.

[0060] Feature calculation: The microcontroller (MCU) calculates the conditioned background signal to establish a dynamic background noise reference value. , The calculation uses the sliding window root mean square algorithm, and its calculation formula is the same as the formula for calculating the respiratory sound energy value in step 3; and the dynamic threshold for triggering is set based on this. ,in This is the environmental gain coefficient. For redundant bias, dynamic threshold This serves as the threshold for signal determination. It should be noted that the signal processing and calculation methods for ambient background sound and the collected real-time breathing sound are consistent.

[0061] Step 2: Raw signal acquisition. During device use, the acoustic sensor acquires the acoustic vibration signal generated by human respiration in real time and converts it into a weak analog millivolt (mV) electrical signal. The acquired electrical signal is amplified and bandpass filtered to retain the characteristic frequency band signal of human respiration. The microcontroller performs high-speed analog-to-digital conversion on the processed electrical signal to generate a discrete digital sequence.

[0062] In step 2, the electrical signal needs to be conditioned. Because the original signal is extremely weak and contains a lot of interference, it must be processed by precise physical circuitry.

[0063] Multi-stage gain amplification: The acquired electrical signal is gain compensated (usually 40dB-60dB) through a pre-amplifier low-noise operational amplifier (Op-Amp) to match the signal amplitude with the range of the ADC.

[0064] Band-pass filtering:

[0065] High-pass filtering: Removes extremely low frequency signals below a certain value (e.g., 60Hz) to eliminate baseline drift caused by human turning over or clothing friction;

[0066] Low-pass filtering: cuts off high-frequency noise above a certain value (e.g., 2000Hz) to prevent signal aliasing during digitization;

[0067] Result: Only core human respiratory characteristic frequency band signals within a certain range (e.g., 100Hz-1500Hz) are retained, thus improving the signal-to-noise ratio.

[0068] In step 2, the conditioned electrical signal needs to be digitized and sampled:

[0069] The conditioned electrical signal is input to the ADC port of the microcontroller (MCU) and digitally converted at a sampling frequency of not less than a certain value (e.g., 4kHz) to form a high-resolution discrete digital sequence.

[0070] Step 3: The microcontroller uses the sliding window root mean square algorithm to calculate the discrete digital sequence and outputs the respiratory sound energy value in real time. The respiratory sound energy value is compared with the signal judgment threshold. When the respiratory sound energy value exceeds the signal judgment threshold and the duration meets the preset duration, it is judged as an abnormal breathing event.

[0071] In step 3, the core operation of the sliding window root mean square algorithm generates the effective energy assessment of the sliding window. The microcontroller (MCU) executes the sliding window root mean square algorithm on the digital sequence to evaluate the sound energy in real time; the calculation formula is as follows: Parameter description: Among them The value is the energy density of the respiratory sound signal over a period of time, which is used as the respiratory sound energy value. The sampled voltage value within the window; The formula represents the window length and effectively smooths signal fluctuations, reflecting the true sound energy intensity.

[0072] Step 4: Intervene based on the judgment result of Step 3. When it is determined to be an abnormal respiratory event, activate the stimulation electrode 23 and output electrical stimulation. The microcontroller uses a gradient ramp method to control the electrode stimulation module 2 to gradually increase the output current and suppress the discomfort caused by the sudden change in current.

[0073] In step 4, a logical decision is made, and the controller (MCU) calculates the obtained respiratory sound energy value in real time. Compared with the signal determination threshold in step 1 To make a comparison, if If the duration reaches the preset duration (e.g., ≥500ms), it is confirmed as an abnormal breathing event, the closed-loop control logic enters the execution stage, and the stimulation electrode 23 is activated.

[0074] In step 4, to prevent sudden current changes from waking the patient, the controller employs a smooth start logic: a preset initial current (e.g., set to 0.1mA) is gradually increased to the preset initial treatment intensity in very short time steps (e.g., increasing by 0.1mA every 10ms).

[0075] Step 5: During the electrical stimulation output process, the acoustic sensor continuously collects the acoustic vibration signals generated by human respiration to form a dynamic feedback mechanism. After the electrical stimulation output, if the respiratory sound energy value does not decrease below the signal judgment threshold, the stimulation intensity is gradually increased within the preset safe current range (e.g., 0.1mA-50mA), and the minimum effective intensity that can make the abnormal respiratory event disappear is recorded in real time. If the respiratory sound energy value decreases below the signal judgment threshold, the stimulation intensity is gradually reduced.

[0076] Step 6: Once the stimulation intensity returns to zero and no abnormal signals are detected during the preset silence period, the intervention is considered complete, and the system enters standby data collection mode.

[0077] In step 6, when the detected respiratory sound energy value drops below the signal determination threshold, the controller enters the gradient attenuation monitoring period:

[0078] Stepwise attenuation: The stimulus intensity is gradually reduced in small steps (e.g., decreasing by 0.2 mA or 10% of the intensity per second), rather than being abruptly cut off. If no abnormal respiratory event occurs, the intensity is reduced to 0.

[0079] Synchronous feedback: If the respiratory sound energy value triggers the signal judgment threshold again during the attenuation process, the system immediately stops attenuation and readjusts the intensity. If the abnormal respiratory event recurs, the intensity and frequency are readjusted according to the gradient.

[0080] Pause determination: The intervention is considered successful only when the stimulus intensity decreases to 0 and the respiratory sound energy value / electrical signal 22 remains stable during the subsequent preset duration (e.g., 3-5 seconds) of "silent period". The next round of standby is then initiated, which is to return to the original signal acquisition in step 2.

[0081] It should be noted that the device is equipped with safety redundancy and anomaly handling throughout the entire process. By designing an independent current limiting circuit at the hardware end, the upper limit of the current (e.g., 50mA) is forcibly locked to achieve hardware current limiting protection. Through anomaly monitoring and real-time impedance monitoring, if electrode detachment, impedance change, or software calculation abnormality is detected, the system immediately performs physical power cut-off to ensure the patient's electrical safety.

[0082] The above description is merely a preferred embodiment of the present invention, but the design concept of the present invention is not limited thereto. Any non-substantial modifications made to the present invention by those skilled in the art within the scope of the technology disclosed in the present invention using this concept shall be deemed as an infringement of the protection scope of the present invention.

Claims

1. An obstructive sleep apnea device, characterized in that: It includes a dental brace carrier, an electrode stimulation module, and a control unit; the electrode stimulation module includes a first transmission link placed inside the dental brace carrier and a second transmission link placed outside the dental brace carrier; The first transmission link and the second transmission link are integrally formed using a flexible circuit board, which is used for electrical transmission. The first transmission link is composited with a nickel-titanium alloy support strip, which extends along the length direction of the flexible circuit board corresponding to the first transmission link and is located on the back of the flexible circuit board. The intraoral end of the first transmission link is integrated with a stimulation electrode, which includes conductive contacts for applying electrical stimulation to the genioglossus muscle or hypoglossal nerve; the control unit is located on the outside of the brace carrier, the second transmission link is electrically connected to the control unit, and the control unit can be fixed to the surface of the mandibular skin; The control unit includes a microcontroller and an acoustic sensor. The acoustic sensor is used to collect acoustic vibration signals generated by human respiration. The microcontroller sets a signal judgment threshold and converts the acoustic vibration signals generated by human respiration into respiratory sound energy values. The microcontroller determines the energy value of the respiratory sound and the signal determination threshold, and controls the stimulation electrode to start and stop based on the determination result.

2. The obstructive sleep apnea device according to claim 1, characterized in that: The brace carrier is thermoformed from EVA shape memory material. The brace carrier has a through hole for the electrode stimulation module to pass through. The lingual side of the brace carrier has a reserved electrode mounting position, and the first transmission link is fixed at the electrode mounting position.

3. The obstructive sleep apnea device according to claim 2, characterized in that: The first transmission link is divided into two branches, and the nickel-titanium alloy support strip is composited on the back of each branch; two stimulation electrodes are provided corresponding to the two branches; the conductive contacts of the two stimulation electrodes act on the motor endplates of the bilateral genioglossus muscles.

4. The obstructive sleep apnea device according to claim 1, characterized in that: The flexible circuit board is entirely covered with a silicone protective sleeve.

5. The obstructive sleep apnea device according to claim 1, characterized in that: The end of the second transmission link is connected to the control unit via a miniature connector structure.

6. The obstructive sleep apnea device according to claim 1, characterized in that: The control unit is fixed to the skin below the jaw using a disposable hydrogel patch or a disposable / reusable medical silicone patch.

7. The obstructive sleep apnea device according to claim 1, characterized in that: The control unit is equipped with a rechargeable storage box; or the control unit adopts magnetic wireless charging or plug-in wired charging.

8. The obstructive sleep apnea device according to claim 1, characterized in that: The acoustic sensor is an electret microphone or a piezoelectric vibratory acoustic sensor or a combination of both.

9. The obstructive sleep apnea device according to claim 1, characterized in that: The control unit enters the environmental acquisition mode at the initial stage of device startup, uses the acoustic sensor to collect ambient background sound signals, and sets a signal judgment threshold based on this; the microcontroller sets a preset duration. When the device is in use, the control unit collects acoustic vibration signals generated by human respiration in real time through the acoustic sensor and converts them into respiratory sound energy values. When the respiratory sound energy value is greater than the signal judgment threshold and the duration of the respiratory sound energy value meets the preset duration, it is determined that the stimulation electrode is activated.

10. A method for treating obstructive sleep apnea, characterized in that: According to any one of claims 1-9, the method of the obstructive sleep apnea device comprises the following steps: Step 1: After the device is started, it enters the environmental acquisition mode. During the preset acquisition time, the acoustic sensor acquires the ambient background sound signal and amplifies and bandpass filters the background sound signal. The microcontroller uses the sliding window root mean square algorithm to construct a dynamic background noise reference value based on the processed background sound signal and generates a signal judgment threshold based on the environmental interference coefficient. Step 2: During device use, the acoustic sensor collects the acoustic vibration signals generated by human respiration in real time and converts them into electrical signals; the collected electrical signals are amplified and bandpass filtered to retain the characteristic frequency band signals of human respiration; the microcontroller performs high-speed analog-to-digital conversion on the processed electrical signals to generate discrete digital sequences. Step 3: The microcontroller uses the sliding window root mean square algorithm to calculate the discrete digital sequence and outputs the respiratory sound energy value in real time. The respiratory sound energy value is compared with the signal judgment threshold. When the respiratory sound energy value exceeds the signal judgment threshold and the duration meets the preset duration, it is judged as an abnormal breathing event. Step 4: Intervene based on the judgment results of Step 3. When an abnormal respiratory event is determined, activate the stimulation electrode and output electrical stimulation. The microcontroller uses a gradient ramp method to control the electrode stimulation module to gradually increase the output current and suppress the discomfort caused by sudden current changes. Step 5: During the electrical stimulation output process, the acoustic sensor continuously collects the acoustic vibration signal generated by human respiration to form a dynamic feedback mechanism. If the respiratory sound energy value does not decrease below the signal judgment threshold after the electrical stimulation output, the stimulation intensity is gradually increased within the preset safe current range. If the respiratory sound energy value decreases below the signal judgment threshold, the stimulation intensity is gradually reduced. Step 6: Once the stimulation intensity returns to zero and no abnormal signals are detected during the preset silence period, the intervention is considered complete, and the system enters standby data collection mode.

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