CN106669032B - A fast-chargeable sleep apnea prevention system for snoring - Google Patents

Abstract

The invention discloses a rechargeable snoring sleep apnea prevention system. The system includes: a hypoglossal nerve stimulator and an upper airway muscle stimulator. The hypoglossal nerve stimulator includes a first electrode, a first pulse generator, a pressure Sensors, breathing parameter acquisition equipment, first temperature sensor, first charging coil, first main battery, first backup battery, first processor and first communication module, first electrode located on hypoglossal nerve, pressure sensor located in intercostal Muscle, so that the sublingual stimulation pulse is synchronized with the inhalation action; the upper airway muscle stimulator includes a second pulse generator, a second processor, a wake-up module, a second electrode, a second communication module, a second charging coil, a second The main battery, the second backup battery, the second temperature sensor, and the second electrode are located at the muscle of the upper airway; the charging coil and the backup battery charge the main battery, and monitor the charging temperature through the temperature sensor, which can monitor the epilepsy sleep apnea prevention system Safe and fast charging.

Description

A fast-chargeable sleep apnea prevention system for snoring

technical field

The invention relates to an implantable sleep apnea prevention system for snoring, in particular to a fast-charging implantable sleep apnea prevention system for snoring.

Background technique

The snoring volume of snoring patients increases by more than 60dB after deep sleep, and it hinders the gas exchange during normal breathing. 5% of snoring patients also have different degrees of breath holding during sleep, which is called obstructive sleep apnea syndrome. Consequences of suffocation.

U.S. Patent US8381735B2 discloses an implant under the base of the tongue to improve snoring, but it cannot prevent suffocation.

U.S. Patent No. 8,517,028 B2 discloses placing an implant from the hyoid bone backward toward the rear surface of the tongue along the rear wall toward the free end of the patient's soft palate to improve snoring, but it cannot prevent suffocation.

It can be seen that preventing asphyxia complications while relieving snoring and ensuring fast charging of the epilepsy sleep apnea prevention system are currently technical difficulties.

Contents of the invention

The object of the present invention is to overcome the deficiencies in the above-mentioned technologies, and provide a rechargeable implantable snoring sleep apnea prevention system. The system includes: a hypoglossal nerve stimulator and an upper airway muscle stimulator, the hypoglossal nerve stimulator includes a first electrode, a first pulse generator, a pressure sensor, a breathing parameter acquisition device, a first charging coil, a first The main battery, the first backup battery, the first temperature sensor, the first processor and the first communication module, the first electrode is located on the hypoglossal nerve, and the pressure sensor is located on the intercostal muscle, so that the sublingual stimulation pulse is synchronized with the inhalation action; A processor controls the first charging coil to charge the first main battery and the first backup battery; the first processor controls the first backup battery to charge the first main battery; the first temperature sensor measures the first charge of the hypoglossal nerve stimulator temperature;

The upper airway muscle stimulator includes a second pulse generator, a second processor, a wake-up module, a second electrode, a second communication module, a second charging coil, a second main battery, and a second backup battery; the second electrode is located on the upper At the airway muscle; the second processor controls the second charging coil to charge the second main battery and the second backup battery; the second processor controls the second backup battery to charge the second main battery. A second temperature sensor measures a second charging temperature of the upper airway muscle stimulator. When the first charging temperature exceeds a threshold, the first processor stops charging the first main battery; when the second charging temperature exceeds a threshold, the second processor stops charging the second main battery.

The first processor controls the first pulse generator to send pulses with preset parameters to the first electrode of the hypoglossal nerve for stimulation when the patient is sleeping, and at the same time, the respiratory parameter acquisition device collects respiratory parameters such as blood oxygen saturation to judge the blood oxygen saturation Is it lower than the suffocation threshold? When it is lower than the suffocation threshold, the first communication module communicates with the second communication module, activates the wake-up module, wakes up the upper airway muscle stimulator, and the second processor controls the second pulse generator to preset The parameter sends pulses to the second electrode at the upper airway muscle; the hypoglossal nerve stimulator stimulates the hypoglossal nerve to relieve snoring symptoms, and wakes up the upper airway muscle stimulator when suffocation occurs. The upper airway muscle stimulator stimulates the upper airway muscle, expands the upper airway, and prevents Choking occurs.

Further, the system also includes: an external early warning controller, when the blood oxygen saturation has not risen to a certain threshold after being stimulated by the upper airway muscle stimulator for a period of time, an early warning is sent to the external body for communication.

Further, when the upper airway muscle stimulator stimulates the blood oxygen saturation for a period of time and has not yet risen to a certain threshold, it communicates with the hypoglossal nerve stimulator, and the first processor sets the pulse generator parameters to be able to wake up the patient but not cause damage to the patient Amplitude to wake up the patient.

Further, the extracorporeal warning controller can control the pulse parameters of the pulse generators of the two stimulators.

Further, the first and second main batteries and the first and second backup batteries are lithium-ion rechargeable batteries or other fast-chargeable batteries.

The system guarantees a safe and fast charging of the epilepsy sleep apnea prevention system.

Description of drawings

Fig. 1 is a diagram of the implantable snoring sleep apnea prevention system of the present invention.

101. Hypoglossal nerve stimulator 102. Upper airway muscle stimulator 103. External early warning controller

201. First electrode 202. First pulse generator 203. Pressure sensor 204. Breathing parameter collection device 205. First processor 206. First communication module

301. Second pulse generator 302. Second processor 303. Wake-up module 304. Second electrode 305. Second communication module.

Detailed ways

The present invention will be further described below in conjunction with the accompanying drawings and embodiments.

FIG. 1 shows a sleep apnea prevention system for snoring. The system mainly includes a hypoglossal nerve stimulator 101 and an upper airway muscle stimulator 102 . Among them, the hypoglossal nerve stimulation is mainly used to relieve snoring, and the upper airway muscle stimulator is mainly used to wake up the asphyxia state.

The hypoglossal nerve stimulator includes a first electrode 201 implanted under the tongue, often using a needle-shaped electrode or an electrode array, and the electrodes are implanted into different structures of the nerve in the hypoglossal muscle. When the electrodes are stimulated, the hypoglossal nerve can be stimulated to make the tongue Push forward to relieve snoring action.

The hypoglossal nerve stimulator also includes an IPG pulse generator module generally implanted on the chest, wherein the IPG module includes a pressure sensor 203, a first pulse generator 202, a breathing parameter acquisition device 204, a first charging coil, and a first main battery , a first backup battery, a first temperature sensor, a first processor 205 and a first communication module 206. The IPG module is connected to the first electrode 201 through the wire passing through the neck. The first processor 205 controls the first charging coil to charge the first main battery and the first spare battery; the first processor 205 controls the first spare battery to charge the first main battery; the first temperature sensor measures the hypoglossal nerve stimulator 101 The first charging temperature. When the first charging temperature exceeds a threshold, the first processor 205 stops charging the first main battery.

The pressure sensor 203 is implanted into the intercostal muscle in the right middle subclavian area, detects the pressure of the intercostal muscle and sends a signal to the first processor 205, and the first processor analyzes the above signal to obtain the breathing cycle and the initial suction of the breathing phase. Qi phase, and synchronize the time sequence of its pulse signal to the first pulse generator 202, when the snoring function is turned on, the stimulation of the sublingual electrode is synchronized with the breathing cycle.

The detection of snoring status and apnea status can be realized through breathing parameters, heart rate, and related muscle movements, among which the use of breathing parameters is the most accurate and easy-to-implement monitoring method. The respiratory parameter acquisition device 204 can be realized by using any device integration device capable of monitoring physical signals and converting the signals into electrical signals. The parameters monitored can be airway pressure, muscle activity, airway flow rate, blood oxygen saturation, blood penetration pressure, blood pH, etc.

A commonly used device is to use a blood oxygen saturation sensor SO2 to monitor blood oxygen saturation, and a transcutaneous blood oxygen detection system can be used. The infrared sensor is used as the blood oxygen detection system as an example, including light generation and receiving modules, emitting infrared light or near-infrared light of more than two wavelengths, and the wavelength range is generally taken as the near-infrared light band where the absorption peaks of oxyhemoglobin and deoxyhemoglobin are located. 500-850nm, the absorbance is monitored by Beer-Lambert Law, and the blood oxygen saturation SO2 is calculated by the different absorbance coefficients of the two hemoglobins. Oxygen sensors and pulse oxygen measurements can also be used to measure blood oxygen levels.

Since the blood sample of the human body changes with the arterial pulse, the blood oxygen saturation R(t) under normal sleep breathing conditions and the blood oxygen saturation Ro(t) under the snoring state can be manually recorded in advance, and recorded by dot method or other methods The value of blood oxygen saturation R(t) time series in normal period and the average interval of the calculator along with the beat, so as to determine the threshold Ro from normal breathing to the snoring state, and the suffocation threshold Rr in the extreme state of snoring through calculation.

The sleep apnea prevention system for snoring has two modes of use, which can be set by the doctor. In one mode, both the apnea prevention mode and the snoring relief mode are turned on at the same time, and in the second mode, only the apnea prevention mode is turned on.

When the snoring function mitigation mode is turned on, the first processor 205 processes the parameters of the blood oxygen saturation sensor to monitor whether the blood oxygen saturation SO2 is continuously lower than the snoring state threshold Ro. If so, the first processor 205 generates a trigger signal to the first pulse generator 202 and synchronizes the time sequence of the respiratory pulse signal from the pressure sensor 203 in the inspiratory phase. The first pulse generator 202 generates a pulse signal synchronized with the inhalation action, and passes through the lead wire upward into the neck of the patient to reach the first sublingual electrode 201 . The first electrode 205 is electrically stimulated at the beginning of the inspiratory phase to make the tongue move forward to alleviate the snoring behavior.

Electrical stimulation at the beginning of the inspiratory phase can avoid the hysteresis effect of the upper airway, so that the motor nerves under the tongue can be stimulated during each voluntary inhalation, so that the muscle fibers of the tongue can move, thereby alleviating snoring behavior. Electrical stimulation can be achieved through a stimulation frequency of 30-50hz, using a voltage of 10-18v, and ensuring a relatively narrow pulse width, which can achieve sufficient stimulation without waking up.

When the suffocation prevention mode is only turned on, the threshold of the snoring state is not judged, that is, the hypoglossal nerve is not subjected to conventional stimulation to delay the snoring action, and only the suffocation state is prevented. This mode is used for low battery states or other conditions that are not suitable for opening In the case of snoring relief mode.

Early warning for asphyxia: the first processor 205 monitors that the blood oxygen saturation SO2 is continuously lower than the asphyxia threshold Rr within 10 seconds, or triggers an early warning when it is lower than the asphyxia threshold Rr for N times within 30 seconds, and N can be set by the physician , such as setting N=5, N=10, etc. At this time, it indicates that there is a further risk of suffocation in the snoring state, and it is necessary to stimulate the muscles of the upper airway and enter the early warning mode.

The upper airway muscle stimulator 102 is implanted near the airway, preferably buried in the airway close to the larynx. It includes a second electrode 304 for stimulating upper airway muscles, a second pulse generator 301, a second processor 302, a wake-up module 303, a second electrode 304, a second communication module 305, a second charging coil, and a second main battery , the second backup battery, the second temperature sensor. The second processor 302 controls the second charging coil to charge the second main battery and the second backup battery; the second processor 302 controls the second backup battery to charge the second main battery. A second temperature sensor measures a second charging temperature of upper airway muscle stimulator 102 . When the second charging temperature exceeds a threshold, the second processor 302 stops charging the second main battery.

The second electrode 304 can also be an implantable needle electrode, which is implanted into the muscles of the upper airway to discharge. Non-invasive flexible electrode patches or other forms of electrodes can also be used to stimulate the muscles. The preset pulse is a group of electrical stimulation pulses lasting 0.1-0.3 seconds, repeated 1-5 times. Specific parameters such as the duration, amplitude, and number of repetitions of the pulse are set by the physician.

In the early warning mode, the first processor 205 transmits the above-mentioned early warning signal to the first communication module 206 , and the first communication module sends the signal to the second communication module 305 . The communication between the second communication module and the first communication module preferably has a wireless communication unit, and wireless communication protocols such as Bluetooth and Zigbee can be used for signal transmission.

The second communication module 305 inputs the early warning signal to the wake-up module 303, thereby starting the second processor 302 to control the second pulse generator 301 to send pulses to the second electrode 304 at the upper airway muscle, and directly discharge to stimulate the upper airway muscle, thereby Stimulate the uvula to dilate the upper airway and prevent choking.

In another aspect, for the triggering of the suffocation prevention mode, the breathing frequency collected by the respiratory parameter collection device and the pressure sensor can be used to jointly judge. For example, the parameter R(t) collected by the blood oxygen saturation sensor and the average breathing cycle T calculated by the first processor 205 through the respiratory pulse collected by the pressure sensor.

At this time, if one of the following conditions is met: R(t) is continuously lower than the asphyxia threshold Rr within 10 seconds, and is lower than the asphyxia threshold Rr N times within 30 seconds, and the breath has not been measured for a time greater than M1*T0 Behavior, or the measured average cycle is greater than M2*T0; T0 is the measured breathing cycle in good condition;

Or when condition 1 and condition 2 are met at the same time, the suffocation warning mode will be triggered.

Condition 1: continuously lower than the asphyxia threshold Rr within X1 seconds or lower than one of the asphyxia thresholds n times within X2 seconds,

Condition 2: Respiratory behavior has not been measured within a period greater than m1*T0, or the measured average period is greater than one of m2*T0

Where X1<10, 10<X2<30, M1>m1>M2>m2,

In another aspect, the respiratory parameter collection device 205 can be set to collect various respiratory parameters, such as the combination of a blood oxygen sensor and an airway pressure sensor, and the processor combines the above parameters to determine whether the user is snoring or whether the user has suffocation risk.

Preferably, after the first processor 205 triggers the warning, it monitors whether the blood oxygen saturation rises to the threshold R1 or effectively remains above the threshold R2 15 seconds after the warning is triggered. The threshold can be set by the physician, and the preferred range is R1>Ro, R2>Rr. If the above indicators are not met, it means that there is no effective contact respiratory obstruction risk for upper airway muscle stimulation. At this time, the first processor 205 sends a signal to the external early warning controller 103 through the first communication module 206 to start the wake-up mode. Both the first communication module 206 and the body have a wireless communication unit, and signal transmission is performed through Zigbee or Bluetooth.

The external early warning controller 103 includes a communication module, a control interface, a processor, a switch, a power supply, and the like. The communication module has a wireless communication unit, which receives the wake-up request transmitted from the first communication module 206 and can send control signals to the first communication module 206 and the second communication module 305 . The control interface can include buttons, knobs, touch screens, etc., and the waveform, amplitude, and duration of the signal can be set; preferably, the hypoglossal nerve stimulator 101 and the upper airway can also be set through the external early warning controller. The muscle stimulator 201 is not limited to setting the stimulation waveform, amplitude, stimulation duration, repetition times, etc. for the relevant stimulation signals of the sublingual muscles and airway muscles. The processor processes the wake-up request and the information of the control interface, and sends a corresponding signal through the communication module.

The external early warning controller mainly adopts two working modes:

Setting mode: the physician sets the parameters of the hypoglossal nerve stimulator 101 and the upper airway muscle stimulator 201 for the hypoglossal muscle and airway muscle related stimulation signals through the control interface, not limited to waveform, amplitude, and duration , frequency, pulse width, etc. The processor sends the control signal to the first processor and the second processor through the first communication module 206 and the second communication module 305 . Other control functions such as reset, mode selection (such as whether to enable the function of relieving snoring symptoms), switch, etc. can also be performed through the external early warning controller.

Wake-up mode: the external early warning controller receives a wake-up request from the first communication module 206, and the external early warning controller sends control signals to the first communication module 206 and the second communication module 305 simultaneously, through the first processor and the second processor Set the parameters of the first pulse generator and the second pulse generator respectively, and generate a pulse with a larger amplitude through the sublingual electrode and the electrode of the upper airway muscle, so as to wake up the patient and avoid the risk of suffocation.

Both the hypoglossal nerve stimulator 101 and the upper airway muscle stimulator 201 have a power module, the power module can use a lithium battery or a rechargeable battery, and has a wireless charging unit, which can wirelessly charge the stimulator through an external charging module .

The first and second main batteries and the first and second backup batteries are lithium-ion rechargeable batteries or other fast-chargeable batteries.

Claims (5)

1. A rechargeable sleep apnea preventing system comprising a hypoglossal nerve stimulator (101) and an upper airway muscle stimulator (102), characterized by: the hypoglossal nerve stimulator (101) comprises a first electrode (201), a first pulse generator (202), a pressure sensor (203), a respiratory parameter acquisition device (204), a first charging coil, a first main battery, a first standby battery and a first temperature sensor; a first processor (205) and a first communication module (206), the first electrode (201) being located on the hypoglossal nerve, the pressure sensor (203) being located on the intercostal muscle to synchronize the sublingual stimulation pulses with the inspiratory action; the first processor (205) controls the first charging coil to charge the first main battery and the first standby battery; the first processor (205) controls the first backup battery to charge the first main battery; the first temperature sensor measures a first charging temperature of the hypoglossal nerve stimulator (101); the upper airway muscle stimulator (102) comprises a second pulse generator (301), a second processor (302), a wake-up module (303), a second charging coil, a second main battery, a second standby battery, a second temperature sensor, a second electrode (304) and a second communication module (305); the second electrode (304) is located at an upper airway muscle; -the second processor (302) controls the second charging coil to charge the second main battery and the second backup battery; -the second processor (302) controls the second backup battery to charge the second main battery; the second temperature sensor measures a second charging temperature of the upper airway muscle stimulator (102);

the first processor (205) controls the first pulse generator (202) to send pulses to the first electrode (201) of the hypoglossal nerve for stimulation according to preset parameters when the patient sleeps, the respiratory parameter acquisition device (204) acquires respiratory parameter blood oxygen saturation, judges whether the blood oxygen saturation is lower than a suffocation threshold, the first communication module (206) is communicated with the second communication module (305) when the blood oxygen saturation is lower than the suffocation threshold, the wake-up module (303) is activated, the upper airway muscle stimulator (102) is woken up, and the second processor (302) controls the second pulse generator (301) to send pulses to the second electrode (304) at the upper airway muscle according to preset parameters; the hypoglossal nerve stimulator (101) stimulates the hypoglossal nerve to relieve snoring symptoms, and when suffocation is about to occur, the upper airway muscle stimulator (102) is aroused to stimulate upper airway muscles, expand the upper airway and prevent the suffocation from occurring;

when the upper airway muscle stimulator (102) stimulates that blood oxygen saturation has not risen to a certain threshold for a period of time, in communication with the hypoglossal nerve stimulator (101), the first processor (205) sets pulser parameters to an amplitude that can wake up the patient but is not damaging to the patient, thereby waking up the patient.

2. The rechargeable snoring sleep apnea prevention system of claim 1, wherein: stopping charging the first main battery by the first processor (205) when the first charging temperature exceeds a threshold; when the second charging temperature exceeds a threshold, charging of the second main battery is stopped by the second processor (302).

3. The rechargeable snoring sleep apnea prevention system of claim 1, wherein: the prevention system is provided with an in-vitro early warning controller (103), and when the upper airway muscle stimulator (102) stimulates that the blood oxygen saturation does not rise to a certain threshold value for a period of time, early warning is carried out through the in-vitro early warning controller (103).

4. A rechargeable snoring sleep apnea prevention system according to claim 3, wherein: the external early warning controller (103) can control pulse parameters of the first pulse generator (202) and the second pulse generator (301).

5. The rechargeable snoring sleep apnea prevention system of claim 1, wherein: the first and second primary batteries and the first and second backup batteries are lithium ion rechargeable batteries.

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