CN118001005A - Wearable noninvasive intelligent hypoglossal nerve regulation and control system - Google Patents
Wearable noninvasive intelligent hypoglossal nerve regulation and control system Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/56—Devices for preventing snoring
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
- A61B5/0826—Detecting or evaluating apnoea events
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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- A61B5/48—Other medical applications
- A61B5/4806—Sleep evaluation
- A61B5/4818—Sleep apnoea
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
- A61B5/6802—Sensor mounted on worn items
- A61B5/6803—Head-worn items, e.g. helmets, masks, headphones or goggles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3601—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of respiratory organs
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36014—External stimulators, e.g. with patch electrodes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36014—External stimulators, e.g. with patch electrodes
- A61N1/3603—Control systems
- A61N1/36031—Control systems using physiological parameters for adjustment
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Abstract
The application provides a wearable noninvasive intelligent hypoglossal nerve regulation and control system, which comprises a wearable stimulator module for nerve stimulation at a mandible, a breathing sound collection module for being attached to the mandible angle or nostril position of a collector, a flexible fixing module and a head position side sleeping module, wherein the wearable stimulator module comprises a lightweight wearable structural unit, an intelligent regulation and control anti-wake unit, a breathing phase synchronization unit, a random amplitude modulation unit, a concentric circle electrode unit, an acousto-optic prompting unit and a wireless communication unit, the lightweight wearable structural unit is divided into a head-mounted structure and a mandible pasting structure, and the head-mounted structure and the mandible pasting structure can be used independently or in combination. According to the phase matching relation between the action potential of the hypoglossal nerve and the respiratory circadian rhythm, the application solves the problem of obstructive sleep apnea and can improve the central nerve regulation of central sleep apnea.
Description
Technical Field
The invention relates to the technical field of hypoglossal nerve regulation, in particular to a wearable noninvasive intelligent hypoglossal nerve regulation system.
Background
Sleep apnea syndrome is classified into a central type, an obstructive type, and a mixed type. The central type refers to the simultaneous disappearance of chest and abdomen movements during the apnea, the blocking type refers to the still existence of chest and abdomen movements during the sleep apnea, and the mixed type refers to the sectional representation of the central type characteristic and the blocking type characteristic during the sleep apnea.
Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) is a common and important disease affecting human health, sleep apnea is an ancient disease, but sleep pneumology is a new discipline. The clinical manifestations are complex, wherein snoring, apnea and excessive daytime sleepiness are one of the main manifestations, and ischemic heart disease, pulmonary hypertension, chronic pulmonary heart disease, hypertension, arrhythmia, diabetes, cerebrovascular diseases and the like can also be complicated.
Sleep snoring and breath holding (obstructive sleep apnea) are very common pathological phenomena, and various factors such as obesity, diseases, age and the like can lead to slackening of tongue and pharyngeal cavity tissues, and narrow airway, thus becoming a basic factor of sleep apnea. When a patient suffering from sleep apnea wakes up, the muscle tissues of the pulling tongue body can maintain a certain tension so as to prevent the patient from excessively relaxing and falling down, and the airway can maintain a normal size, so that the patient suffering from sleep apnea does not snore when the patient is awake up; when falling asleep, the muscle tissues relax and fall down, which aggravates the originally narrow airway, and respiratory airflow impacts the soft tissues through the narrow airway to vibrate and generate snoring. If the stenosis is heavier, the negative pressure is formed by the air flow passing through the airway rapidly, so that the airway is further reduced, and the phenomenon of breath holding and apnea occurs due to complete obstruction. Prolonged apneas and hypopneas result in hypoxia, which further leads to degeneration of neuromuscular tissue and more relaxation, forming a vicious circle.
The traditional method for solving the sleep apnea has the problems of non-invasive positive airway pressure (NPPV), oral appliance treatment and surgical treatment, the NPPV treatment requires that a patient wear a breathing machine to maintain airway opening during sleeping, and the NPPV treatment has the problems of discomfort of wearing a breathing mask, psychological acceptance of the patient, inconvenient operation and the like; surgical treatment requires surgical implantation of a hypoglossal nerve modulator, is costly and has a risk of trauma, and covers a limited patient population. At present, the treatment modes are limited by comfort, effectiveness, safety, convenience and the like, and are difficult to be accepted by most patients suffering from sleep apnea. Therefore, the sleep apnea treatment method with universality, comfort, effectiveness, safety and convenience has great social significance and economic value.
In order for more patients to address sleep apnea problems; therefore, the improvement is made by the method, and a wearable noninvasive intelligent hypoglossal nerve regulation system is provided, and through monitoring the spontaneous breathing rhythm and judging the inspiration phase and the breathing phase, the stimulation output rhythm is intelligently regulated, so that the stimulation rhythm is synchronously matched with the spontaneous breathing rhythm, the stimulation antagonism is avoided, and the noninvasive effective enhancement training of the hypoglossal nerve and the muscle is achieved; meanwhile, according to the phase matching relation between the action potential of the hypoglossal nerve and the respiratory rhythm, the nerve regulation and control which is matched with the biological rhythm can improve the central nerve regulation and control problem of central sleep apnea.
Disclosure of Invention
The invention aims at: for the current method for treating sleep apnea, a respirator is required to be worn to maintain the airway open during the sleeping period of a patient, and the patient is easy to feel uncomfortable, psychological acceptability and inconvenient to operate when wearing a breathing mask, and the problems of high risk and high cost are solved by adopting surgical operation.
In order to achieve the above object, the present invention provides the following technical solutions:
a wearable noninvasive intelligent hypoglossal nerve regulation system is provided to improve the above problems.
The application is specifically as follows:
the wearable noninvasive intelligent hypoglossal nerve regulation and control system comprises a wearable stimulator module for nerve stimulation at the mandible, a breathing sound acquisition module, a flexible fixing module and a head position side sleeping module, wherein the breathing sound acquisition module is used for being attached to the mandible angle or nostril position of a collector, and the wearable stimulator module comprises a lightweight wearable structural unit, an intelligent regulation and control anti-arousal unit, a breathing phase synchronization unit, a random amplitude modulation unit, a concentric circle electrode unit, an acousto-optic prompting unit and a wireless communication unit.
As a preferable technical scheme of the application, the lightweight wearable structural unit is divided into a head-mounted structure and a mandibular part pasting structure, the head-mounted structure and the mandibular part pasting structure can be independently used or combined for use, the intelligent regulation and control anti-wake unit consists of a stimulation decision, a respiratory phase synchronous correction, an information recording and a parameter synchronous part and is used for realizing electric stimulation output of matrix coefficient coupling modulation, and an output signal has a function of penetrating deep tissues and a respiratory rhythm triggering function.
As a preferable technical scheme of the application, the respiratory phase synchronization unit is used for realizing synchronization of the respiratory phase and the expiratory phase with the intelligent regulation and control anti-wake unit, synchronously outputting stimulation in the respiratory phase and the hold phase period, stopping stimulation in the expiratory phase period, and realizing 0% -100% dynamic amplitude modulation depth by matrix coefficient coupling, reducing tolerance of nerves and muscles to stimulation signals, improving sensitivity of the nerves and muscles and reducing stimulation threshold.
As a preferable technical scheme of the application, the concentric circle electrode unit is favorable for transmitting electric stimulation output to deep subcutaneous tissue, realizing synchronous stimulation treatment on bilateral nerves, and avoiding unbalance caused by unilateral stimulation, the acousto-optic prompting unit guides a user to perform operation application and troubleshooting by sending out voice prompting information and display information, comprises electrode position confirmation by voice prompting, and the wireless communication unit is used for transmitting breathing related parameters, treatment logs, equipment application information and the like to the intelligent terminal, so that the subsequent analysis application is facilitated.
As the preferable technical scheme of the application, the breath sound acquisition module adopts special filtering and gain processing to realize the acquisition and discrimination of the breath phase and the expiration phase, and the breath sound acquisition module can be integrated in a concentric circle electrode unit or can be independently arranged in a wearable structural unit.
As the preferable technical scheme of the application, the flexible fixing module is a head-wearing thin-layer flexible fixing belt and is used for fixing the concentric circle electrode unit or the breathing sound collecting module at the mandible, preventing the electrode from being separated from the breathing sound collecting module, reducing the mechanical stress at the mandible, shortening the distance between the electrode and the neuromuscular, effectively reducing the stimulation dose, avoiding the mouth opening and breathing and reducing the tongue body falling.
As the preferable technical scheme of the application, the head position side sleeping module comprises an anti-vertical mechanism and a slide buckle unit, wherein the anti-vertical mechanism is of a triangle structure or a semi-cylinder structure which can be flexibly assembled, and the slide buckle unit comprises a detachable pasting structure or a slide buckle structure which is arranged behind a pillow of a head wearing structure, so that the head position can be kept in a side deflection state, and the state that the head position is positioned on a supine position tongue body and a soft palate is easy to fall back to block an airway is reduced.
As a preferable technical scheme of the intelligent regulation and control anti-wake unit, an intermediate frequency low frequency modulation carrier technology is adopted to realize the electric stimulation output of matrix coefficient coupling modulation, so that the conditions of sudden discomfort of stimulation, unresponsiveness to neuromuscular fatigue and stimulation tolerance are prevented, the curative effect is weakened, the sleeping quality at night can be promoted by mild and comfortable stimulation, the deep sleeping period of about 5 cycles in the whole night is prolonged, the nerve wake in the rapid eye movement period is reduced, the light sleeping is reduced, and the rest of the organism is ensured; mild stimulation, highly adaptive to the body tolerance threshold, each individual used may produce an optimal stimulation titration dose.
The matrix coefficient coupling modulation algorithm is as follows:
P n is a stimulation related parameter including amplitude, frequency (carrier wave and modulation), pulse width, modulation depth, respiratory phase, intermittent period and the like;
AM-coeff1=ANorm-Matrix×ASparse-Matrix
AM-coeff2=ANorm-Matrix×ADense-Matrix
A Sparse_Matrix,ADense_Matrix is the matrix quantity after A Matrix transformation, A Norm_Matrix is a normalized matrix, A M_coeff* is a coefficient factor, stim is an initial setting quantity, and A Mod_coeff is a parameter after matrix coefficient coupling modulation.
As a preferable technical scheme of the application, the concentric circle electrode unit is designed in a concentric ring shape, the inner diameter ratio of the ring-shaped electrode is R 0, the area ratio of the concentric circle is S 0, the clearance coefficient is L, the electrode contacts tissue characteristic factor epsilon, the electric field characteristic E elec∝(R0,S0,L,ε),Ereal≈K0*Eelec+Ecps,K0 is field intensity coefficient, ecps is a compensation value, the electrode improves the electric field focusing property, increases the penetration depth and strength of the electric field, is beneficial to stimulating the hyoid upper muscle groups with larger area distributed under the mandible, such as the mandibular hyoid muscle, the geniohyoid muscle and the like, and the contraction of the muscles is beneficial to expanding the front and back diameter and the upper and lower diameter of the pharyngeal cavity, increasing the rigidity of the pharyngeal side wall, reducing the collapse of soft tissues, simultaneously exciting bilateral hypoglossal nerves and causing simultaneous symmetrical contraction of geniohyoid muscle under physiological conditions, and preventing imbalance of stimulation.
As a preferred technical scheme of the application, the respiratory phase synchronization unit is used for realizing the discrimination of the respiratory phase and the expiratory phase, and implementing the electric stimulation mode synchronous with the inhalation, wherein the respiratory phase is synchronous with the normal respiratory circadian rhythm and the lingual muscle contraction process, and no stimulation signal is implemented in the expiratory phase, so that the physiological antagonism of muscles, the overstimulation and the muscular fatigue are avoided.
Compared with the prior art, the invention has the beneficial effects that:
in the scheme of the application:
1. The synchronous triggering and fusion of the spontaneous breathing rhythm, particularly the inhalation phase and the exhalation phase and the nerve regulation and control are realized, the synchronous stimulation with the physiological rhythm is realized, the antagonism of the spontaneous breathing rhythm and the electric stimulation is avoided, the effects of immediately eliminating snoring and apnea to treat symptoms and strengthening training to gradually improve the pathological state of muscles to treat root causes are achieved;
2. By fusing human biology, structural mechanics and hypoglossal nerve stimulation strategies, a solution for treating snoring and sleep apnea problems with optimized efficacy, comfort and safety is proposed;
3. The health care product is used for rehabilitation treatment of sleep apnea diseases by a wearable percutaneous noninvasive intelligent hypoglossal nerve regulation technology, and is a treatment means with universality, comfort, effectiveness, safety and convenience.
Drawings
Fig. 1 is a schematic diagram of the overall structure of a wearable noninvasive intelligent hypoglossal nerve regulation system provided by the application;
Fig. 2 is a schematic diagram of a wearable stimulator module system of the wearable noninvasive intelligent hypoglossal nerve regulation system provided by the application;
Fig. 3 is a schematic diagram of a breathing sound collection module system of the wearable noninvasive intelligent hypoglossal nerve regulation system provided by the application;
fig. 4 is a schematic diagram of a head-position side sleep module system of the wearable noninvasive intelligent hypoglossal nerve regulation system provided by the application;
fig. 5 is a schematic diagram of an intelligent regulation and control anti-wake unit and a lightweight wearable structural unit system of the wearable noninvasive intelligent hypoglossal nerve regulation and control system;
Fig. 6 is a schematic diagram of concentric circle electrodes of the wearable noninvasive intelligent hypoglossal nerve regulation system provided by the application;
Fig. 7 is a schematic diagram of a human body application of the wearable noninvasive intelligent hypoglossal nerve regulation system provided by the application;
Fig. 8 is a schematic diagram of the operation of a head-position side sleep module of the wearable noninvasive intelligent hypoglossal nerve control system provided by the application.
The figures indicate:
10. A wearable stimulator module; 101. a lightweight wearable structural unit; 102. an intelligent regulation and control anti-wake unit; 1021. stimulation decision making; 1022. respiratory phase synchronization correction; 1023. recording information; 1024. a parameter synchronization section; 103. a respiratory phase synchronization unit; 104. a random amplitude modulation unit; 105. concentric circle electrode units; 106. an acousto-optic prompting unit; 107. a wireless communication unit; 20. a breath sound collection module; 201. a microphone array unit; 202. a transducer unit; 203. an audio separation unit; 204. a respiratory rhythm marking unit; 30. a flexible fixing module; 40. a head-position side sleep module; 401. an anti-vertical mechanism; 402. and a slider unit.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention more clear, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. It will be apparent that the described embodiments are some, but not all, embodiments of the invention.
Thus, the following detailed description of the embodiments of the invention is not intended to limit the scope of the invention, as claimed, but is merely representative of some embodiments of the invention. All other embodiments obtained by those skilled in the art without creative efforts based on the embodiments of the present invention are within the protection scope of the present invention, and it should be noted that the embodiments of the present invention and the features and technical solutions of the embodiments can be combined with each other without conflict.
It should be noted that: like reference numerals and letters denote like items in the following figures, and thus once an item is defined in one figure, no further definition or explanation thereof is necessary in the following figures.
As shown in fig. 1-8, the present embodiment proposes a wearable noninvasive intelligent hypoglossal nerve regulation system, which includes a wearable stimulator module 10 for nerve stimulation at the mandible, a breath sound collection module 20 for attaching to the mandible angle or nostril of a collector, a flexible fixing module 30, and a head position side sleep module 40, wherein the wearable stimulator module 10 includes a lightweight wearable structural unit 101, an intelligent regulation anti-wake unit 102, a breath phase synchronization unit 103, a random amplitude modulation unit 104, a concentric circle electrode unit 105, an acousto-optic prompt unit 106, and a wireless communication unit 107.
The light wearable structural unit 101 is divided into a head-wearing structure and a mandible pasting structure, the head-wearing structure and the mandible pasting structure can be used independently or can be combined, the intelligent regulation and control anti-wake-up unit 102 is composed of a stimulation decision 1021, a respiratory phase synchronous correction 1022, an information record 1023 and a parameter synchronous part 1024 and is used for realizing electric stimulation output of matrix coefficient coupling modulation, and an output signal has a function of penetrating deep tissues and a respiratory rhythm triggering function.
Solves the problems of abnormal arousal and asynchronous stimulation and autonomous rhythm caused by the traditional low-frequency electric stimulation, and can realize the functions of diagnosis and treatment information record 1023 and parameter information synchronization.
The respiratory phase synchronization unit 103 is used for realizing synchronization of the inhalation phase and the exhalation phase with the intelligent regulation and control anti-wake unit 102, synchronously outputting stimulation in the inhalation phase and the retention phase period, stopping stimulation in the exhalation phase period, and realizing 0% -100% of dynamic amplitude modulation depth by matrix coefficient coupling, reducing tolerance of nerves and muscles to stimulation signals, improving sensitivity of the nerves and muscles and reducing stimulation threshold.
The concentric circle electrode unit 105 is favorable for transmitting electric stimulation output to deep subcutaneous tissue and for realizing synchronous stimulation treatment of bilateral nerves, unbalance caused by unilateral stimulation is avoided, the acousto-optic prompting unit 106 guides a user to perform operation application and troubleshooting by sending out voice prompt information and display information, the electrode position confirmation is performed through voice prompt, and the wireless communication unit 107 is used for transmitting breathing related parameters, treatment logs, equipment application information and the like to the intelligent terminal so as to facilitate subsequent analysis application.
The breath sound collection module 20 adopts special filtering and gain processing to realize the collection and discrimination of the breath phase and the breath phase, the breath sound collection module 20 can be integrated in the concentric circle electrode unit 105 or can be independently installed in a wearable structural unit, the breath sound collection module 20 consists of a microphone array unit 201, a transducer unit 202, an audio separation unit 203 and a breath rhythm marking unit 204, breath sound extraction is carried out on the surface of the neck through the microphone array unit 201 and the transducer unit 202, the collection and discrimination of the breath phase and the breath rhythm marking of the breath rhythm marking unit 204 are realized after the special filtering and gain processing of the audio separation unit 203, and the part can be integrated in the concentric circle electrode or can be independently installed in the wearable structural unit, and finally, a breath audio signal is transmitted to the wearable stimulator module 10 at a position close to one side of mandibular angle or nostril during use.
The breath sound collection module 20 is placed at the angle of the mandible or nostril through one or more audio collection sensors to extract breath sound, the collected signals are amplified through an amplifying circuit, and analog and digital filtering processing is adopted to obtain the breath sound of the normal breath sound, such as the inhalation phase, the respiration phase and the snore period, to perform characteristic discrimination and calculate the effective breath volume, so that the prediction of snore diseases and the prediction of curative effects after stimulation can be realized.
The flexible fixing module 30 is a head-wearing thin-layer flexible fixing band, and is used for fixing the concentric circle electrode unit 105 or the breath sound collecting module 20 at the mandible, preventing the electrode from being separated from the breath sound collecting module 20, and relieving the mechanical stress at the mandible.
The flexible fixing module 30 covers the concentric circle electrode or the breath sound collecting module 20 at the mandible by adopting a thin layer of flexible material, and simultaneously extends upwards to form a fixing band based on a head wearing structure, and the flexible fixing module 30 has elastic pressure on the electrode.
The flexible fixing module 30 can avoid the movement of the adhesive electrode, and can effectively reduce the irritation of the electric stimulation to the skin;
Secondly, the device has a certain lifting force, and can efficiently reduce the distance from the mandibular skin to the hypoglossal nerve and muscle, so that the stimulation threshold can be reduced, and the device is power-saving and more comfortable;
furthermore, the mouth opening sleeping can be prevented, and the degree of the tongue body falling back can be greatly increased during the mouth opening sleeping period.
The head position side sleeping module 40 comprises an anti-standing mechanism 401 and a slide fastener unit 402, the anti-standing mechanism 401 is a triangle structure or a semi-cylinder structure which can be flexibly assembled, the slide fastener unit 402 comprises a detachable pasting structure or a slide fastener structure which is arranged behind a pillow of a head-wearing structure, so that the head position can be kept in a sideways state, the state that the head position is positioned on a supine position tongue body and the soft palate is easy to fall back to block an air passage is reduced, and the head position side sleeping module 40 can be selectively arranged for use.
The intelligent regulation and control anti-wake unit 102 adopts a medium-frequency and low-frequency modulation carrier technology to realize the electric stimulation output of matrix coefficient coupling modulation, prevents the conditions of sudden discomfort, unresponsiveness of neuromuscular fatigue and stimulus tolerance, and has weak curative effect, and mild and comfortable stimulus can promote the night sleep quality, so that the deep sleep period of about 5 cycles of one night is prolonged, the nerve wake in the rapid eye movement period is reduced, the light sleep is reduced, and the rest of the organism is ensured; mild stimulation, highly adaptive to the body tolerance threshold, each individual used may produce an optimal stimulation titration dose.
The matrix coefficient coupling modulation algorithm is as follows:
P n is a stimulation related parameter including amplitude, frequency (carrier wave and modulation), pulse width, modulation depth, respiratory phase, intermittent period and the like;
AM-coeff1=ANorm-Matrix×ASparse-Matrix
AM-coeff2=ANorm-Matrix×ADense-Matrix
A Sparse_Matrix,ADense_Matrix is the matrix quantity after A Matrix transformation, A Norm_Matrix is a normalized matrix, A M_coeff* is a coefficient factor, stim is an initial setting quantity, and A Mod_coeff is a parameter after matrix coefficient coupling modulation.
The concentric circle electrode unit 105 is designed in a concentric ring shape, the inner diameter ratio of the ring-shaped electrode is R 0, the area ratio of the concentric circle is S 0, the clearance coefficient is L, the electrode contact tissue characteristic factor epsilon, the electric field characteristic E elec∝(R0,S0,L,ε),Ereal≈K0*Eelec + Ecps, K0 is the field intensity coefficient, ecps is a compensation value, the electrode improves the electric field focusing property, increases the penetration depth and strength of the electric field, is beneficial to stimulating the hyoid upper muscle groups with larger area distributed under the mandible, such as the mandibular hyoid muscle, the geniohyoid muscle and the like, the contraction of the muscles is beneficial to expanding the front-back diameter and the upper-lower diameter of the pharyngeal cavity, increasing the pharyngeal sidewall rigidity, reducing the soft tissue collapse, simultaneously exciting bilateral hypoglossal nerves and causing simultaneous symmetrical contraction of bilateral geniohyoid muscles under physiological conditions, and preventing unbalanced stimulation.
The respiratory phase synchronization unit 103 is configured to determine an inhalation phase and an exhalation phase, and perform an electrical stimulation mode synchronized with inhalation, wherein the inhalation phase is synchronized with a normal respiratory circadian rhythm and a lingual muscle contraction process, and no stimulation signal is performed during exhalation, thereby avoiding physiological antagonism of muscles, excessive stimulation, and muscular fatigue.
The application is used when in use: through monitoring the spontaneous breathing rhythm and judging the inspiration phase and the breathing phase, the stimulation output rhythm is intelligently regulated and controlled, so that the stimulation rhythm is synchronous to the spontaneous breathing rhythm, stimulation antagonism is avoided, and noninvasive effective enhancement training of hypoglossal nerves and muscles is achieved; meanwhile, according to the phase matching relation between action potential of hypoglossal nerve and respiratory rhythm, the nerve regulation and control which is matched with biological rhythm solves the problem of obstructive sleep apnea, and can improve the central nerve regulation and control problem of central sleep apnea.
The above embodiments are only for illustrating the present invention and not for limiting the technical solutions described in the present invention, and although the present invention has been described in detail in the present specification with reference to the above embodiments, the present invention is not limited to the above specific embodiments, and thus any modifications or equivalent substitutions are made to the present invention; all technical solutions and modifications thereof that do not depart from the spirit and scope of the invention are intended to be included in the scope of the appended claims.
Claims (10)
1. The wearable noninvasive intelligent hypoglossal nerve regulation and control system comprises a wearable stimulator module (10) for nerve stimulation at the mandible, a breathing sound collection module (20) for being attached to the mandible angle or nostril position of a collector, a flexible fixing module (30) and a head position side sleeping module (40), and is characterized in that the wearable stimulator module (10) comprises a lightweight wearable structural unit (101), an intelligent regulation and control anti-arousal unit (102), a breathing phase synchronization unit (103), a random amplitude modulation unit (104), a concentric circle electrode unit (105), an acousto-optic prompt unit (106) and a wireless communication unit (107).
2. The wearable noninvasive intelligent hypoglossal nerve regulation and control system according to claim 1, wherein the lightweight wearable structural unit (101) is divided into a head-wearing structure and a mandibular pasting structure, the head-wearing structure and the mandibular pasting structure can be used independently or can be used in combination, the intelligent regulation and control anti-arousal unit (102) is composed of a stimulation decision (1021), a respiratory phase synchronous correction (1022), an information record (1023) and a parameter synchronous part (1024) and is used for realizing electric stimulation output of matrix coefficient coupling modulation, and an output signal has a function of penetrating deep tissues and a respiratory rhythm triggering function.
3. The wearable noninvasive intelligent hypoglossal nerve control system according to claim 2, wherein the respiratory phase synchronization unit (103) is configured to synchronize an inhalation phase and an exhalation phase with the intelligent control anti-arousal unit (102), output stimulation synchronously during the inhalation phase and the maintenance phase, stop stimulation during the exhalation phase, and achieve a dynamic amplitude modulation depth of 0% -100% by matrix coefficient coupling, reduce tolerance of nerves and muscles to stimulation signals, improve sensitivity of nerves and muscles, and reduce stimulation threshold.
4. The wearable noninvasive intelligent hypoglossal nerve regulation and control system according to claim 3, wherein the concentric circle electrode unit (105) is beneficial to transmitting electrical stimulation output to deep subcutaneous tissue and to realizing synchronous stimulation treatment on bilateral nerves, imbalance caused by unilateral stimulation is avoided, the acousto-optic prompting unit (106) guides a user to perform operation application and troubleshooting by sending voice prompt information and display information, the electrode position confirmation is performed through voice prompt, and the wireless communication unit (107) is used for transmitting respiration related parameters, treatment logs, equipment application information and the like to the intelligent terminal, so that subsequent analysis application is facilitated.
5. The wearable noninvasive intelligent hypoglossal nerve regulation system according to claim 4, wherein the breath sound collection module (20) is placed at a mandibular angle or nostril through one or more audio collection sensors to extract breath sounds, amplifies the collected signals through an amplifying circuit, performs analog and digital filtering processing to obtain the inhalation phase, the respiration phase of normal breath sounds, and the breath sounds of snore periods to perform feature discrimination and calculate the effective breath volume, and the breath sound collection module (20) is integrated in a concentric circular electrode unit (105) or independently installed in a wearable structural unit, and is positioned near the mandibular angle or nostril during application.
6. The wearable noninvasive intelligent hypoglossal nerve control system of claim 5, wherein the flexible fixing module (30) is a head-mounted thin flexible fixing band, and is used for fixing the concentric circle electrode unit (105) or the respiratory sound collecting module (20) at the mandible, preventing the electrode from being separated from the respiratory sound collecting module (20), relieving mechanical stress at the mandible, and shortening the distance between the electrode and neuromuscular.
7. The wearable noninvasive intelligent hypoglossal nerve control system of claim 6, wherein the head position side sleep module (40) comprises an anti-vertical mechanism (401) and a slide fastener unit (402), the anti-vertical mechanism (401) is a triangle structure or a semi-cylinder structure which can be flexibly assembled, and the slide fastener unit (402) comprises a detachable pasting structure or a slide fastener structure which is arranged behind a pillow of the head-mounted structure, so that the head position can be kept in a sideways state to reduce the state that the head position is in a supine position and the tongue and the soft palate are easy to fall back to block an airway.
8. The wearable noninvasive intelligent hypoglossal nerve regulation and control system according to claim 7, wherein the intelligent regulation and control anti-arousal unit (102) adopts a medium-frequency low-frequency modulation carrier technology to realize matrix coefficient coupling modulation electric stimulation output, so as to prevent stimulation burst discomfort, neuromuscular fatigue unresponsiveness and stimulation tolerance, reduce curative effect, and promote night sleep quality, so that the deep sleep period of about 5 cycles is prolonged, nerve arousal in the rapid eye movement period is reduced, shallow sleep is reduced, body rest is ensured, mild stimulation is highly adaptive to a body tolerance threshold, and each individual can generate optimal stimulation titration dose.
The matrix coefficient coupling modulation algorithm is as follows:
For the non-normalized multi-parameter coefficient matrix, pn is a stimulation related parameter including amplitude, frequency (carrier wave and modulation), pulse width, modulation depth, respiratory phase, intermittent period and the like;
AM-coeff1=ANorm-Matrix×ASparse-Matrix
AM-coeff2=ANorm-Matrix×ADense-Matrix
A Sparse_Matrix,ADense_Matrix is the matrix quantity after A Matrix transformation, A Norm_Matrix is a normalized matrix, A M_coeff* is a coefficient factor, stim is an initial setting quantity, and A Mod_coeff is a parameter after matrix coefficient coupling modulation.
9. The wearable noninvasive intelligent hypoglossal nerve control system of claim 8, wherein the concentric electrode unit (105) is designed in concentric ring shape, the inner diameter ratio of the ring electrode is R 0, the area ratio of the concentric ring is S 0, the gap coefficient is L, the electrode contact tissue characteristic factor epsilon, the electric field characteristic E elec∝(R0,S0,L,ε),Ereal≈K0*Eelec+Ecps,K0 is the field strength coefficient, ecps is the compensation value, the electrode improves the electric field focusing, increases the electric field penetration depth and strength, and causes simultaneous symmetric contraction of bilateral genioglossus muscles.
10. The wearable noninvasive intelligent hypoglossal nerve control system according to claim 9, wherein the respiratory phase synchronization unit (103) is configured to determine an inhalation phase and an exhalation phase, and perform an electrical stimulation mode synchronized with inhalation, the inhalation phase is synchronized with a normal respiratory circadian rhythm and a lingual muscle contraction process, and no stimulation signal is performed during exhalation phase, so as to avoid muscle physiological antagonism, and overstimulation and muscle fatigue.
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