Noninvasive treatment system for obstructive sleep apnea syndrome

Abstract

The invention discloses a noninvasive treatment system for obstructive sleep apnea syndrome. The disclosed system comprises a respiration sensing unit, an intraoral stimulation unit and an intelligent controller, the intraoral stimulation unit comprises a carrier capable of being worn in the oral cavity and a stimulation part arranged on the carrier, and after a patient wears the carrier, the stimulation part is located on the surface mucous membrane of the genioglossus part; wherein the respiration sensing unit is used for collecting respiration sleep data of a patient and transmitting the respiration sleep data to the intelligent controller; the intelligent controller recognizes an obstructive breathing sleep pause event according to the breathing sleep data, and if the obstructive breathing sleep pause event is recognized, the stimulation part is controlled to output current to stimulate genioglossus to induce tongue stretching. The mucous membrane at the genioglossus part is stimulated to stimulate the muscle to induce the tongue to stretch forwards, so that the risks of surgical trauma caused by foreign equipment implantation, nerve injury at the implantation part and equipment replacement caused by secondary surgery due to insufficient power supply are avoided.

Description

Technical Field

[0001] The invention relates to an intelligent apnea treatment system, and in particular to a non-invasive treatment system for obstructive sleep apnea syndrome. Background Art

[0002] Obstructive sleep apnea (OSAS) is a sleep-related respiratory disorder characterized by snoring, apnea and daytime sleepiness. It can cause intermittent hypoxia, hypercapnia and sleep structure disorders, and can lead to multiple organ and system damage such as hypertension, coronary heart disease, arrhythmia, cerebrovascular disease, cognitive dysfunction, type 2 diabetes, etc. Studies have shown that the mortality rate of untreated severe OSAS patients is 3.8 times higher than that of the general population.

[0003] Currently, the treatment of OSAS can be roughly divided into three directions: (1) Lifestyle intervention, such as quitting smoking and drinking, and weight loss and exercise. However, most patients often find it difficult to adhere to it, and it is difficult to achieve results in time, and the effect is limited for severe patients; (2) Non-invasive intervention measures, including oral devices pushing the mandible forward and positive airway pressure ventilation, but there is a problem of poor compliance, and patients find it difficult to adhere to it for a long time; (3) Surgical treatment, such as suspension palatopharyngoplasty, orthognathic surgery, etc., but the above methods are often more invasive, expensive, and prone to recurrence.

[0004] In recent years, some studies have shown that electrical stimulation of the hypoglossal nerve can be used to treat OSAS and has good application prospects. Its implementation technology uses surgical implantation to implant a pressure sensor in the chest to detect breathing, and transmit the monitored breathing information to an implantable pulse generator. The device is connected to the stimulation electrode implanted in the hypoglossal nerve. By transmitting a mild current to stimulate the nerve, the tongue root moves forward, opening the upper airway, thereby relieving the symptoms of respiratory obstruction. The device has been verified to have good therapeutic effects through clinical trials and has been approved by the US FDA for marketing. Despite this, the device still has the risks of surgical trauma, high price, nerve damage at the implantation site, and insufficient power supply leading to another surgery to replace the device, making it difficult to promote and apply on a large scale in clinical practice. Summary of the invention

[0005] In view of the defects or shortcomings of the prior art, the present invention provides a non-invasive treatment system for obstructive sleep apnea syndrome.

[0006] To this end, the non-invasive treatment system for obstructive sleep apnea syndrome of the present invention includes a respiratory sensing unit, an intraoral stimulation unit and an intelligent controller; the intraoral stimulation unit includes a carrier that can be worn in the oral cavity and a stimulation part arranged on the carrier, and after the patient wears the carrier, the stimulation part is located at the surface mucosa of the genioglossus muscle; the respiratory sensing unit is used to collect the patient's respiratory sleep data and transmit it to the intelligent controller; the intelligent controller identifies obstructive sleep apnea events based on the respiratory sleep data, and if an obstructive sleep apnea event is identified, the stimulation part is controlled to output current to stimulate the genioglossus muscle to induce tongue extension.

[0007] In some other embodiments, the non-invasive treatment system for obstructive sleep apnea syndrome of the present invention includes the above-mentioned intraoral stimulation unit and intelligent controller.

[0008] An optional solution is that the carrier that can be worn in the oral cavity is a brace covering the lower dentition, and the stimulation part is located on the inner side wall of the brace carrier. Further, a battery is arranged on the carrier. The intelligent controller is arranged on the carrier.

[0009] Another optional solution is that the stimulation part uses a flexible electrode.

[0010] An optional solution is that the output current has a current size of 1-5 mA, and the output duration in the specific solution is determined according to the duration of the patient's apnea. Further, the output current is a pulse current, and the pulse current has a current size of 1-5 mA, a pulse width of 1-3 ms, and a pulse frequency of 20-60 Hz. The output duration in the specific solution is determined according to the duration of the patient's apnea.

[0011] An optional solution is that the sensor used by the respiratory sensing unit is a piezoelectric respiratory sensor, an airflow sensor, a photocapacitance sensor or / and a radar sensor.

[0012] A further solution is that the system of the present invention further includes a patient end, which receives and stores the respiratory sleep data and the control data of the intelligent controller.

[0013] A further solution is that the system of the present invention also includes a doctor side, which receives the respiratory sleep data and the control data of the intelligent controller, optimizes the patient's treatment plan based on the respiratory sleep data and the control data of the intelligent controller, and transmits the optimized treatment plan to the intelligent controller.

[0014] The present invention induces tongue protrusion by stimulating the genioglossus muscle mucosa, thereby avoiding the risks of surgical trauma caused by implanted devices abroad, nerve damage at the implantation site, and reoperation to replace the device due to insufficient power supply, and has broad market application prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 This is a schematic diagram of the anatomy of the tongue muscles innervated by the hypoglossal nerve. The genioglossus and hyoglossus muscles are mainly responsible for tongue protrusion and contraction. In the figure, the genioglossus is responsible for tongue protrusion, while the hyoglossus is responsible for tongue contraction. In the figure: T / V = transverse and longitudinal tongue muscles; IL = inferior longitudinal muscle; SG = styloglossus; HG = hyoglossus; GGo = genioglossus with oblique component; GGh = genioglossus with horizontal component; GH = genioglossus; XII = hypoglossal nerve and its lateral and medial branches.

[0016] Figure 2 Schematic diagram of airway changes before and after electrical stimulation of the genioglossus muscle; (a) without stimulation; (b) after stimulation of the genioglossus muscle at the floor of the mouth.

[0017] Figure 3 A control connection diagram of a non-invasive treatment system for obstructive sleep apnea syndrome provided by an embodiment of the present invention.

[0018] Figure 4 It is a schematic diagram of the structure of the intraoral stimulation unit in an embodiment of the present invention; in the figure: 1-carrier, 2-stimulation part, 3-communication unit, 4-intelligent controller, 5-battery. DETAILED DESCRIPTION

[0019] Unless otherwise specified, the scientific and technical terms used herein are understood according to the knowledge of ordinary technicians in the relevant fields.

[0020] See also Figure 1 As shown, the hypoglossal nerve innervates all tongue muscles except the palatoglossus muscle. Among them, the genioglossus muscle and the hyoglossus muscle play an important role in the movement of the tongue. Activating the genioglossus muscle to contract, the tongue protrudes forward, and the upper airway opens; activating the hyoglossus muscle retracts the tongue and closes the upper airway. In the existing devices for stimulating the hypoglossal nerve to treat OSAS, the part of the hypoglossal nerve that innervates the genioglossus muscle is stimulated as much as possible. The main purpose of stimulating the hypoglossal nerve to treat OSAS is to activate the genioglossus muscle. The inventors noticed that part of the genioglossus muscle is relatively superficial and can be touched inside the oral cavity. The inventors used a current of 2mA and 25HZ to stimulate the floor mucosa of SD rats. MicroCT airway photography confirmed that stimulating the genioglossus muscle in the oral cavity can effectively induce tongue protrusion (results in Participants Figure 2 As shown), the upper airway is opened to relieve respiratory obstruction and achieve the purpose of treatment.

[0021] See also Figure 3As shown, the non-invasive treatment system for obstructive sleep apnea syndrome of the present invention mainly includes a respiratory sensing unit, an intraoral stimulation unit and an intelligent controller; the oral stimulation unit includes a carrier that can be worn in the oral cavity and a stimulation part arranged on the carrier, and after the patient wears the carrier, the stimulation part is located at the surface mucosa of the genioglossus muscle; the respiratory sensing unit is used to collect the patient's respiratory sleep data and transmit it to the intelligent controller; the intelligent controller identifies obstructive sleep apnea events based on the respiratory sleep data, and if an obstructive sleep apnea event is identified, the stimulation part is controlled to output current to stimulate the genioglossus muscle to induce tongue extension to achieve the purpose of treatment.

[0022] The data transmission involved in the system of the present invention can be carried out wirelessly or wired, preferably using wireless transmission technologies such as Bluetooth and infrared.

[0023] The respiratory sleep data described in the present invention follows clinical knowledge, and generally includes at least the respiratory frequency data, heartbeat and / or pulse of the human body. The commonly used respiratory piezoelectric respiratory sensors, airflow sensors, photoelectric capacitance wave or radar sensors collect the above data. Specifically, the respiratory frequency data can be collected by the piezoelectric respiratory sensor, airflow sensor and radar sensor of the thoracic part, the heartbeat can be collected by the radar sensor, photoelectric capacitance wave sensor, electrocardiogram, etc., and the pulse can be collected by the piezoelectric, piezoresistive or photoelectric sensor. In the specific scheme, the respiratory sensing unit includes the above-mentioned related sensors, and further includes a display screen, etc. The respiratory sensor unit uses wireless or wired technology to transmit data to other working units.

[0024] In the specific solution, the stimulation part can use flexible electrodes, and other devices can be implemented using existing devices.

[0025] When patients use the system of the present invention for the first time, they can further accurately identify the occurrence of respiratory obstruction events through machine learning based on respiratory sleep data information, such as judging whether a respiratory obstruction event occurs based on a respiratory rate of less than 10 times / minute; at the same time, according to the doctor's guidance, the output current size and duration of the stimulation part are debugged and determined to make the tongue root contract rigidly and the upper airway open, and a personalized treatment plan is formulated to achieve a safe and effective treatment purpose. If the output current is a pulse current, the current size of the pulse current is 1-5mA, the pulse width is: 1-3ms, and the pulse frequency is: 20-60Hz. In the specific plan, the output duration is determined according to the patient's respiratory arrest duration (the common clinical pause duration is: more than 10S to several minutes).

[0026] It should be noted that the intraoral stimulation unit and intelligent controller of the present invention can be developed into separate products and used in conjunction with existing respiratory monitoring equipment.

[0027] In a specific embodiment, the carrier that can be worn in the oral cavity of the present invention is based on the principle of comfort and convenience for installing related devices. Figure 4 As shown, the carrier 1 that can be worn in the oral cavity is a compression sleeve structure covering the lower teeth, and the material can be thermoplastic polyurethane, alcohol-modified polyethylene terephthalate PETG, polyethylene terephthalate, polypropylene or polycarbonate, wherein the stimulation part 2 is located inside the compression sleeve at the genioglossus muscle. In a more specific solution, the carrier is also loaded with a communication device 3, a smart controller 4 and a battery 5. Figure 4 The product also includes a communication device 3 (for receiving respiratory and sleep data and transmitting it to the intelligent controller), an intelligent controller 4, and a battery 5 for powering the stimulation part, which is located on the outer wall of the braces to improve wearing comfort, wherein the battery is electrically connected to the stimulation part. Optionally, the battery is a rechargeable battery or a wireless rechargeable battery.

[0028] For further solutions, see Figure 3 As shown, the treatment system of the present invention also includes a patient end, which receives and stores the respiratory sleep data and the control data of the intelligent controller, so that the patient can pay attention to his or her disease status in real time. Further, the patient end is a smart phone, a smart watch, a tablet computer or a laptop computer.

[0029] For some other solutions, see Figure 3 As shown, the treatment system of the present invention also includes a doctor-side APP, which receives the respiratory sleep data and the control data of the intelligent controller, optimizes the patient's treatment plan according to the patient's recent respiratory sleep data and the control data of the intelligent controller while monitoring the patient's condition (i.e., readjusting the output current parameters according to the patient's recent condition, such as the recent respiratory sleep data performance, the number of onsets, the duration, etc.), and transmits the optimized treatment plan to the intelligent controller. Further, the doctor's side is a smart phone, a smart watch, a tablet computer or a laptop computer. In a specific scheme, the doctor's side can be a special software used by doctors for diagnosis and treatment and academic research, used to analyze patient data and condition, and propose treatment plans for a single patient or multiple patients in a targeted manner, which can automatically track the patient's recovery, provide patient data analysis reports, and communicate with the patient side in real time. Furthermore, the doctor's side can store various data on doctors, patients, diagnosis and treatment plans, and the development of the disease, and realize automatic diagnosis and treatment based on artificial intelligence through functions such as data adapters, intelligent inspections, big data analysis, treatment rule bases, expert knowledge bases, and treatment data cloud computing and push.

Claims

1. A non-invasive treatment system for obstructive sleep apnea syndrome, characterized in that: It includes a respiratory sensor unit, an intraoral stimulation unit and an intelligent controller; the intraoral stimulation unit includes a carrier that can be worn in the oral cavity and a stimulation part arranged on the carrier, and after the patient wears the carrier, the stimulation part is located at the surface mucosa of the genioglossus muscle; The respiratory sensor unit is used to collect the patient's respiratory and sleep data and transmit it to the intelligent controller; The intelligent controller identifies obstructive sleep apnea events based on the respiratory sleep data. If an obstructive sleep apnea event is identified, the stimulation unit is controlled to output current to stimulate the genioglossus muscle to induce tongue extension.

2. A non-invasive treatment system for obstructive sleep apnea syndrome, characterized in that: It comprises the intraoral stimulation unit and intelligent controller as claimed in claim 1.

3. The non-invasive treatment system for obstructive sleep apnea syndrome according to claim 1, characterized in that: The carrier that can be worn in the oral cavity is a brace that covers the lower dentition, and the stimulation part is located on the inner wall of the brace carrier.

4. The non-invasive treatment system for obstructive sleep apnea syndrome according to claim 1, characterized in that: A battery is arranged on the carrier.

5. The non-invasive treatment system for obstructive sleep apnea syndrome according to claim 1, characterized in that: The intelligent controller is arranged on a carrier.

6. The non-invasive treatment system for obstructive sleep apnea syndrome according to claim 1, characterized in that: The stimulation part uses a flexible electrode.

7. The non-invasive treatment system for obstructive sleep apnea syndrome according to claim 1, characterized in that: The output current has a current magnitude of 1-5 mA.

8. The non-invasive treatment system for obstructive sleep apnea syndrome according to claim 1, characterized in that: The output current is a pulse current, the current size of the pulse current is 1-5mA, the pulse width is: 1-3ms, and the pulse frequency is: 20-60Hz.

9. The non-invasive treatment system for obstructive sleep apnea syndrome according to claim 1, characterized in that: The sensor used by the respiratory sensing unit is a piezoelectric respiratory sensor, an airflow sensor, a photoelectric capacitance wave sensor or / and a radar sensor.

10. The non-invasive treatment system for obstructive sleep apnea syndrome according to claim 1, characterized in that: It also includes a patient end, which receives and stores the respiratory sleep data and the control data of the intelligent controller.

11. The non-invasive treatment system for obstructive sleep apnea syndrome according to claim 1, characterized in that: It also includes a doctor's end, which receives the respiratory sleep data and the control data of the intelligent controller, optimizes the patient's treatment plan according to the respiratory sleep data and the control data of the intelligent controller, and transmits the optimized treatment plan to the intelligent controller.

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