Obstructive sleep apnea treatment device

By designing a brace device with built-in microcontroller and electrical stimulation module, using flexible electrodes to transmit electrical stimulation at the bottom or root of the tongue, the problems of trauma, high cost and low stimulation efficiency of existing OSA treatment methods are solved, and a non-invasive, comfortable and efficient OSA treatment effect is achieved.

CN120022124APending Publication Date: 2025-05-23艾力亚尔·艾合麦提
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Patent Information

Application Number
CN202510094953.7
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-01-21
Publication Date
2025-05-23

AI Technical Summary

Technical Problem

Existing obstructive sleep apnea (OSA) treatments are trauma, high cost, poor compliance and low stimulation efficiency, especially implantable sublingual nerve stimulators and mandibular electrical stimulation methods.

Method used

A brace device is designed with a built-in microcontroller module, physiological signal acquisition module and electrical stimulation module. Through flexible adhesive electrodes, the electrical stimulation is transmitted at the bottom or root of the tongue. Combined with open and closed-loop stimulation modes, the electrical stimulation is adjusted in real time according to the wearer's physiological data.

Benefits of technology

It achieves non-invasive, comfortable and efficient geniogloss EMG stimulation, avoids the trauma and postoperative infection risks of implantation surgery, reduces equipment costs, and improves stimulation efficiency and patient experience.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention provides an obstructive sleep apnea treatment device which comprises a tooth socket used for being tightly attached to teeth of a wearer, a main control circuit board is fixed in the tooth socket, and the circuit board comprises a microcontroller module, a physiological signal acquisition module and an electrical stimulation module. The physiological signal acquisition module and the electrical stimulation module are respectively connected with the microcontroller module; the flexible stickable electrode is used for being stuck to the tongue bottom or the tongue root of the wearer, and the electrode is connected with the electrical stimulation module; the physiological signal acquisition module is used for acquiring physiological data of a wearer so as to send the physiological data to the microcontroller module, the microcontroller module is used for matching the physiological data with a preset closed-loop stimulation mode starting condition, if the matching is successful, the electrical stimulation module is controlled to generate electrical stimulation, and if the matching is successful, the electrical stimulation module is controlled to generate electrical stimulation. And the signal is transmitted to an electrode pasting part in the mouth of the wearer. The device can treat OSA in a non-invasive, comfortable and effective mode, and the problem that an existing OSA treatment instrument and product cannot give consideration to comfort and effectiveness at the same time is solved.
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Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a treatment device for obstructive sleep apnea. Background Art

[0002] Obstructive sleep apnea (OSA) is a sleep breathing disorder mainly characterized by snoring accompanied by apnea during sleep and daytime sleepiness. The current first-line therapies for this disease are positive pressure ventilation therapy, oral appliance therapy, and surgical therapy. The first two non-invasive therapies have a strong sense of foreign body, and the patient compliance is poor, while the surgical therapy has a large trauma and is prone to recurrence. The prior art (CN113908438A) uses an implantable hypoglossal nerve stimulator to treat OSA. Such a device can activate the genioglossus muscle through an electrode wound around the hypoglossal nerve, causing the tongue body to protrude forward, so as to widen the respiratory tract and improve the symptoms of OSA. However, this device needs to be surgically implanted, is expensive, and has a risk of wire breakage.

[0003] The core of the nerve electrical stimulation therapy is to activate the genioglossus muscle. Since the genioglossus muscle is relatively close to the body surface, the muscle can be activated by a lower-cost non-invasive external electrical stimulation device. The non-invasive electrical stimulation method (CN107405486A) mainly includes percutaneous stimulation placed under the mandible and transmucosal stimulation placed in the mouth. By releasing electrical stimulation at the mandibular position, the muscle tension of the genioglossus muscle is increased to a certain extent, thereby improving the patency of the respiratory tract. However, this method usually requires a relatively high-intensity electrical stimulation to cause visible deformation of the tongue body, and the high-intensity electrical stimulation often causes pain. The fat thickness at the mandibular position also affects the intervention range of the electrical stimulation, resulting in it being difficult for male patients with a relatively large neck circumference to obtain good treatment effects. Intraoral electrical stimulation is to stimulate the genioglossus muscle by applying a voltage at both ends in the mouth to cause the tongue body to move forward. However, it is found after actual implementation that the relative position between the electrode and the tongue greatly affects the stimulation effect. When the electrode is close to the root of the tongue, a large forward movement of the tongue body can be caused, but as the tongue body moves away from the electrode, it is difficult for the electrical stimulation to cause the tongue body to move. At the same time, the position of such fixed electrodes is often close to the gums, and the electrical stimulation is likely to accidentally stimulate the dental nerve, resulting in pain. There are also some solutions that use a flexible silicone rubber electrode to press the electrode against the bottom of the tongue, and the tongue protrudes forward when the bottom of the tongue is stimulated. However, it is found after actual implementation of this solution that when the tongue falls back, the electrode may lose contact with the tongue body, resulting in ineffective stimulation. As described above, there is currently a lack of a non-invasive, comfortable, and effective OSA treatment method. Summary of the Invention

[0004] In view of this, the embodiments of the present application provide a treatment device for obstructive sleep apnea, so as to propose a solution that can treat OSA non-invasively, comfortably, and effectively.

[0005] The embodiment of the present application provides the following technical solution: an obstructive sleep apnea treatment device, comprising:

[0006] A dental brace, the dental brace is used to fit closely on the teeth of the wearer, a main control circuit board is fixed in the dental brace, the internal circuit of the main control circuit board includes a microcontroller module, a physiological signal acquisition module and an electrical stimulation module, the physiological signal acquisition module and the electrical stimulation module are respectively connected to the microcontroller module;

[0007] It also includes an electrode, which is connected to the electrical stimulation module and is used to be attached to the tongue base or tongue root of the wearer to transmit the electrical stimulation generated by the electrical stimulation module to the attachment site of the electrode;

[0008] The electrical stimulation module is used to generate electrical stimulation according to the control instructions issued by the microcontroller module when the device is in the open-loop stimulation mode, and transmit the electrical stimulation to the electrode attachment site in the wearer's mouth through the electrode;

[0009] The physiological signal acquisition module is used to collect the wearer's physiological data according to the control instructions issued by the microcontroller module when the device is in the closed-loop stimulation mode, so as to send the collected physiological data to the microcontroller module. The microcontroller module is used to match the obtained physiological data with the preset closed-loop stimulation start conditions. If the match is successful, the closed-loop stimulation is started to control the electrical stimulation module to generate electrical stimulation, and transmit the electrical stimulation to the electrode attachment site in the wearer's mouth through the electrode.

[0010] According to one embodiment of the present application, the electrode includes an adhesive area, an extension wire and a wire port, the adhesive area is provided with a conductive area, one end of the extension wire is connected to the conductive area, and the other end is provided with the wire port, the wire port is connected to the electrical stimulation module, and the adhesive area is used to be adhered to the oral mucosal surface of the wearer.

[0011] According to an embodiment of the present application, the closed-loop stimulation mode includes a closed-loop stimulation mode based on apnea detection, a closed-loop stimulation mode based on snoring detection, and a closed-loop stimulation mode based on inhalation detection;

[0012] The microcontroller module is used to analyze and process the physiological data, obtain the wearer's current breathing data, snoring data and inhalation data, and match the breathing data with the preset breathing mode start condition. If the match is successful, the closed-loop stimulation mode based on apnea detection is started; the snoring data is matched with the preset snoring mode start condition. If the match is successful, the closed-loop stimulation mode based on snoring detection is started; the inhalation data is matched with the preset inhalation mode start condition. If the match is successful, the closed-loop stimulation mode based on inhalation detection is started.

[0013] According to an embodiment of the present application, the internal circuit of the main control circuit board also includes a wireless communication module, and the wireless communication module is connected to the microcontroller module and is used for the microcontroller module to wirelessly communicate with external equipment.

[0014] According to one embodiment of the present application, the microcontroller module is also used to receive and respond to communication instructions sent by the wireless communication module, and the communication instructions include settings of stimulation modes and corresponding stimulation parameters.

[0015] According to an embodiment of the present application, the microcontroller module is also used to transmit the real-time physiological data of the physiological signal acquisition module and the real-time stimulation status of the electrical stimulation module to the outside through the wireless communication module.

[0016] According to an embodiment of the present application, the internal circuit of the main control circuit board also includes a power module, and the power module is used to provide power to the main control circuit board.

[0017] According to an embodiment of the present application, the physiological signal acquisition module includes an acceleration sensor, a gyroscope, a photoplethysmography sensor, an air pressure sensor, and a temperature sensor.

[0018] According to an embodiment of the present application, an embedded slot is provided in the dental brace so as to insert the sealed main control circuit board into the slot.

[0019] According to an embodiment of the present application, the main control circuit board is sealed and then fixed to the inner side of the incisors or the outer side of the back molars in the braces by adhesive.

[0020] Compared with the prior art, the at least one technical solution adopted in the embodiments of this specification can achieve the following beneficial effects:

[0021] (1) The embodiment of the present invention achieves non-invasive electrical stimulation of the genioglossus muscle by placing electrodes on the surface of the genioglossus muscle in the mouth. Compared with the implanted nerve stimulator solution that activates the genioglossus muscle by electrical stimulation of the hypoglossal nerve, it avoids the trauma and postoperative infection risks caused by implantation surgery and greatly reduces the equipment cost. Compared with the mandibular electrical stimulation solution, it can stimulate the genioglossus muscle more directly and accurately, greatly improving the stimulation efficiency.

[0022] (2) The embodiment of the present invention uses a flexible adhesive electrode to ensure long-term effective contact between the electrode and the stimulation target. Compared with the existing solution using fixed electrodes, it overcomes the disadvantage that it cannot transmit stimulation when the tongue falls back.

[0023] (3) The embodiments of the present invention use a variety of means to reduce the foreign body sensation of the device and improve wearing comfort, such as using a flexible substrate for the electrode, using a flexible wire for the extension wire, placing the circuit board in a position with a lower foreign body sensation, and using customized braces to reduce thickness and improve fit. Compared with the ventilator, which is the gold standard treatment (first-line treatment) for obstructive sleep apnea, the patient's experience is greatly improved, which helps to solve the problem of low patient compliance and unwillingness to cooperate with treatment.

[0024] (4) The design of the combination of the dental brace and the main control circuit board in the embodiment of the present invention allows the dental brace to be replaced separately after aging, thus reducing the cost of replacing the dental brace and the entire device. The present invention has extremely high economic and social benefits. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0026] Figure 1 is a system structure diagram of an obstructive sleep apnea treatment device according to an embodiment of the present invention;

[0027] Figure 2 is a schematic structural diagram of a flexible adhesive electrode in an obstructive sleep apnea treatment device according to an embodiment of the present invention;

[0028] Figure 3 is a schematic diagram of an integrated electrical stimulation mouthpiece in an obstructive sleep apnea treatment device according to an embodiment of the present invention;

[0029] Among them, 1 - dental appliance, 2 - physiological signal acquisition module, 3 - microcontroller module, 4 - wireless communication module, 5 - internal circuit of the main control circuit board, 6 - electrical stimulation module, 7 - flexible and adhesive electrode, 8 - conductive area, 9 - adhesive area, 10 - extension wire, 11 - wire port. Detailed implementation manners

[0030] The embodiments of the present application will be described in detail below with reference to the accompanying drawings.

[0031] The following uses specific specific examples to illustrate the implementation manners of the present application. Those skilled in the art can easily understand other advantages and effects of the present application from the content disclosed in this specification. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. The present application can also be implemented or applied through other different specific implementation manners. Various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present application. It should be noted that, without conflict, the following embodiments and the features in the embodiments can be combined with each other. All other embodiments obtained by those of ordinary skill in the art based on the embodiments in the present application without making creative efforts belong to the scope of protection of the present application.

[0032] As Figure 1 shown, the embodiment of the present invention provides an obstructive sleep apnea treatment device, specifically relating to a wearable dental appliance that activates the genioglossus muscle through a flexible electrode to treat obstructive sleep apnea. Among them, the microcontroller module 3, the physiological signal acquisition module 2, and the electrical stimulation module 6 are located on the same circuit board, collectively referred to as the main control circuit board, and are pre - placed in the dental appliance 1. The device specifically includes:

[0033] A dental appliance 1, the dental appliance 1 is used to fit closely to the teeth of the wearer. The main control circuit board is fixed in the dental appliance 1. The internal circuit 5 of the main control circuit board includes a microcontroller module 3, a physiological signal acquisition module 2, and an electrical stimulation module 6. The physiological signal acquisition module 2 and the electrical stimulation module 6 are respectively connected to the microcontroller module 3;

[0034] It further includes a flexible and adhesive electrode 7. The flexible and adhesive electrode 7 is connected to the electrical stimulation module 6. The flexible and adhesive electrode 7 is used to be pasted to the bottom or root of the tongue of the wearer to transmit the electrical stimulation generated by the electrical stimulation module 6 to the pasting part of the electrode;

[0035] The electrical stimulation module 6 is used to generate electrical stimulation according to the control instruction issued by the microcontroller module 3 when the device is in the open - loop stimulation mode, and transmit the electrical stimulation to the electrode pasting part in the mouth of the wearer through the flexible and adhesive electrode 7;

[0036] The physiological signal acquisition module 2 is used to collect the wearer's physiological data according to the control instructions issued by the microcontroller module 3 when the device is in the closed-loop stimulation mode, so as to send the collected physiological data to the microcontroller module 3. The microcontroller module 3 is used to match the obtained physiological data with the preset closed-loop stimulation start conditions. If the match is successful, the closed-loop stimulation is started to control the electrical stimulation module 6 to generate electrical stimulation, and transmit the electrical stimulation to the electrode adhesion site in the wearer's mouth through the flexible adhesive electrode 7.

[0037] In specific implementation, the device may include at least two stimulation modes, namely, an open-loop stimulation mode and a closed-loop stimulation mode. The selection of a specific stimulation mode may be actively set by the user, and the microcontroller may issue a corresponding control instruction, or may be actively set in the microcontroller to start the corresponding stimulation mode according to a set cycle or time; the embodiment of the present invention is not limited to the above-mentioned mode selection, and may be adjusted according to actual application.

[0038] In some embodiments of the present invention, the braces 1 can be customized braces or non-customized braces, which can be produced by lamination or 3D printing, can fit tightly to the wearer's teeth, and are used to fix the main control circuit board. Among them, the main control circuit board and the braces 1 can be combined in a variety of ways, so that the main control circuit board and the braces are detachable, so as to facilitate the subsequent replacement and maintenance of the braces or the main control circuit board. Preferably, a modular replaceable design is adopted, and an embedded card slot is provided in the braces 1 to snap the sealed main control circuit board into the card slot. After the main control circuit board is sealed, it is snapped into the card slot reserved in the braces 1, and the braces 1 can be freely replaced later without replacing the main control circuit board. In some other embodiments, the main control circuit board can be embedded in the interlayer of the two layers of braces 1. In some other embodiments, the main control circuit board can be sealed and combined with the braces 1 by bonding with an adhesive. The placement position of the main control circuit board is preferably the inner side of the mouth of the incisors, and can also be selected as the outer side of the posterior molars of the braces 1, such as Figure 3 shown.

[0039] In some embodiments of the present invention, Figure 2 As shown, the flexible adhesive electrode 7 includes an adhesive area 9, an extension wire 10 and a wire port 11. The adhesive area 9 is provided with a conductive area 8. One end of the extension wire 10 is connected to the conductive area 8, and the other end is provided with the wire port 11. The wire port 11 is connected to the electrical stimulation module 6. The adhesive area 9 is used to be attached to the wearer's oral mucosal surface. Among them, the flexible electrode is a combination of a flexible oral patch and an electrode. It can be firmly attached to the inside of the mouth, the back of the tongue, and the bottom of the tongue for more than 6 hours while having a conductive effect.

[0040] In the specific implementation of this embodiment, the flexible adhesive electrode 7 mainly functions to transmit electrical stimulation to the adhesive part (the base of the tongue or the root of the tongue). The flexible adhesive electrode 7 is composed of an adhesive area 9 and a conductive area 8, an extension wire 10 and a wire port 11. The adhesive area 9 is responsible for stably sticking the electrode to the surface of the oral mucosa for more than 6 hours. Its material is preferably tissue adhesive hydrogel and chitosan. Carbomer, plant lectin, hydroxypropyl methylcellulose, hydroxyethyl cellulose and other materials can also be used. The conductive area 8 is responsible for transmitting electrical stimulation to the adhesive part. Its electrodes can be one pair or more pairs, and can be combined with the adhesive material in two forms: (1) printing or plating conductive material on the surface of the adhesive material; (2) sticking the conductive film material to the surface of the adhesive material.

[0041] The flexible adhesive electrode 7 is connected to the electrical stimulation module 6 through its electrode extension wire 10 and the wire port 11. In terms of manufacturing process, the electrode and the extension wire 10 can be connected in an integrated manner, or they can be connected in a split manner using a mechanical connection method. The extension wire 10 and the device can be connected in an integrated manner or in a split manner. Preferably, the conductive area 8 and the electrode extension wire 10 are manufactured in an integrated manner to reduce the complexity of the device and improve reliability. The conductive area 8 of the flexible electrode and the conductive part of the electrode extension wire 10 can be printed on the surface of a flexible substrate material such as TPU, EVA, PDMS that meets the biocompatibility requirements, and an insulating material is covered on the upper layer of the electrode extension wire 10 area. Optionally, both ends of the electrode extension wire 10 can also be set to be detachable so that different flexible adhesive electrodes 7 can be replaced, and the other end can replace different electrode extension wire 10 plug-in ports, and the connection methods at both ends are standardized detachable ports.

[0042] The wire port 11 is mainly used to connect the electrode extension wire 10 and the electrical stimulation module 6.

[0043] In some embodiments of the present invention, the closed-loop stimulation mode includes a closed-loop stimulation mode based on apnea detection, a closed-loop stimulation mode based on snoring detection, and a closed-loop stimulation mode based on inhalation detection; the microcontroller module is used to analyze and process the physiological data, obtain the wearer's current breathing data, snoring data, and inhalation data, and match the breathing data with a preset breathing mode start condition. If the match is successful, the closed-loop stimulation mode based on apnea detection is started; the snoring data is matched with a preset snoring mode start condition. If the match is successful, the closed-loop stimulation mode based on snoring detection is started; the inhalation data is matched with a preset inhalation mode start condition. If the match is successful, the closed-loop stimulation mode based on inhalation detection is started.

[0044] In the specific implementation of this embodiment, the physiological signal acquisition module 2 includes but is not limited to an acceleration sensor, a gyroscope, a photoplethysmography (PPG) sensor, an air pressure sensor and a temperature sensor installed on the main control circuit board of the device. This embodiment is based on a sensor in the mouth, such as an acceleration sensor, an air pressure sensor, a gyroscope or a photoplethysmography (PPG) sensor, to detect snoring, apnea events or inhalation events. The main function is to collect the user's physiological data to enable three closed-loop stimulation modes. The three closed-loop stimulation modes include: (1) a closed-loop stimulation mode based on apnea detection, which detects apnea events through the data detected by the above sensors, turns on stimulation when apnea is detected, and turns off stimulation when apnea ends or the stimulation duration reaches an upper limit; (2) a closed-loop stimulation mode based on snoring detection, which detects snoring through the data detected by the above sensors, turns on stimulation when snoring is detected, and turns off stimulation when apnea ends or the stimulation duration reaches an upper limit; (3) a closed-loop stimulation mode based on inhalation detection, which detects inhalation events through the above sensors, turns on stimulation when inhalation starts, and turns off stimulation when inhalation ends. The above three stimulation modes can be turned on independently of each other or used in combination.

[0045] In some embodiments of the present invention, the electrical stimulation module 6 is located on the main control circuit board, and its main function is to output voltages or currents of different amplitudes and frequency ranges. The output waveform can be conventional fixed-frequency electrical stimulation or burst stimulation. Burst stimulation refers to a stimulation method in which a low-frequency signal modulates a high-frequency signal. It can also be variable-frequency stimulation. The pulse output is mainly composed of a voltage generating circuit, a voltage regulating circuit, a storage capacitor, a voltage release circuit, and a constant current source circuit. The voltage generating circuit can be a boost circuit, a buck circuit, a boost-buck circuit, a charge pump circuit, and other circuits with voltage conversion functions. The constant voltage source circuit is a circuit or device with feedback function such as an operational amplifier / transistor / MOS tube added to the voltage source circuit.

[0046] In some embodiments of the present invention, the main control circuit board internal circuit 5 further includes a wireless communication module 4, which is connected to the microcontroller module 3 and is used for the microcontroller module 3 to wirelessly communicate with external devices. The communication method is mainly Bluetooth.

[0047] In some embodiments of the present invention, the internal circuit 5 of the main control circuit board also includes a power module, and the power module is used to provide power for the main control circuit board.

[0048] In the specific implementation of this embodiment, the power module is mainly composed of a battery and a wireless charging circuit, a voltage stabilizing circuit, and a protection circuit. The battery is used to store energy. The wireless charging circuit is composed of a coil and a rectifier and a voltage stabilizing circuit. The voltage of electromagnetic induction is converted into a battery charging adaptation voltage and determines whether it is full. The voltage stabilizing circuit mainly converts the battery voltage into a stable voltage required for the normal operation of the control circuit board. The protection circuit mainly performs overvoltage, overcurrent and other protections on the battery charging and discharging process.

[0049] In some embodiments of the present invention, the microcontroller module 3 has the following main functions: (1) receiving communication instructions from the wireless communication module 4 and making corresponding responses, such as setting stimulation parameters, setting stimulation modes, and setting parameters of different stimulation modes, including stimulation duration, etc.; (2) controlling the stimulation parameters and switch status of the electrical stimulation module 6; (3) receiving and processing data from the physiological signal acquisition module 2 to determine whether the electrical stimulation module 6 needs to be turned on or off; (4) when the acquisition conditions are not sufficient to carry out the closed-loop stimulation mode, the open-loop stimulation mode of the periodically switching electrical stimulation module 6 can be enabled, and the switching frequency and duty cycle are adjustable; (5) transmitting the real-time physiological data of the physiological signal acquisition module 2 and the real-time stimulation status of the electrical stimulation module 6 through the wireless communication module 4 for doctors to debug or conduct further scientific research.

[0050] The embodiment of the present invention adheres the flexible electrode to the tongue root or tongue base area of ​​the wearer and transmits electrical stimulation to activate the genioglossus muscle. In addition, the intraoral electrical stimulation for closed-loop stimulation based on snoring, apnea events or inhalation events avoids the trauma and postoperative infection risks caused by implant surgery, while greatly reducing the equipment cost. Compared with the mandibular electrical stimulation solution, it can stimulate the genioglossus muscle more directly and accurately, greatly improving the stimulation efficiency.

[0051] The above is only a specific implementation of the present application, but the protection scope of the present application is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed in the present application should be included in the protection scope of the present application. Therefore, the protection scope of the present application shall be based on the protection scope of the claims.

Claims

1. An obstructive sleep apnea treatment device, characterized in that: include: A dental brace, the dental brace is used to fit closely on the teeth of the wearer, a main control circuit board is fixed in the dental brace, the internal circuit of the main control circuit board includes a microcontroller module, a physiological signal acquisition module and an electrical stimulation module, the physiological signal acquisition module and the electrical stimulation module are respectively connected to the microcontroller module; It also includes an electrode, which is connected to the electrical stimulation module and is used to be attached to the tongue base or tongue root of the wearer to transmit the electrical stimulation generated by the electrical stimulation module to the attachment site of the electrode; The electrical stimulation module is used to generate electrical stimulation according to the control instructions issued by the microcontroller module when the device is in the open-loop stimulation mode, and transmit the electrical stimulation to the electrode attachment site in the wearer's mouth through the electrode; The physiological signal acquisition module is used to collect the wearer's physiological data according to the control instructions issued by the microcontroller module when the device is in the closed-loop stimulation mode, so as to send the collected physiological data to the microcontroller module. The microcontroller module is used to match the obtained physiological data with the preset closed-loop stimulation start conditions. If the match is successful, the closed-loop stimulation is started to control the electrical stimulation module to generate electrical stimulation, and transmit the electrical stimulation to the electrode attachment site in the wearer's mouth through the electrode.

2. The obstructive sleep apnea treatment device according to claim 1, characterized in that: The electrode includes an adhesive area, an extension wire and a wire port. The adhesive area is provided with a conductive area. One end of the extension wire is connected to the conductive area, and the other end is provided with the wire port. The wire port is connected to the electrical stimulation module. The adhesive area is used to be adhered to the oral mucosal surface of the wearer.

3. The obstructive sleep apnea treatment device according to claim 1, characterized in that: The closed-loop stimulation mode includes a closed-loop stimulation mode based on apnea detection, a closed-loop stimulation mode based on snoring detection, and a closed-loop stimulation mode based on inhalation detection; The microcontroller module is used to analyze and process the physiological data, obtain the wearer's current breathing data, snoring data and inhalation data, and match the breathing data with the preset breathing mode start condition. If the match is successful, the closed-loop stimulation mode based on apnea detection is started; the snoring data is matched with the preset snoring mode start condition. If the match is successful, the closed-loop stimulation mode based on snoring detection is started; the inhalation data is matched with the preset inhalation mode start condition. If the match is successful, the closed-loop stimulation mode based on inhalation detection is started.

4. The obstructive sleep apnea treatment device according to claim 1, characterized in that: The internal circuit of the main control circuit board also includes a wireless communication module, which is connected to the microcontroller module and is used for the microcontroller module to wirelessly communicate with external equipment.

5. The obstructive sleep apnea treatment device according to claim 4, characterized in that: The microcontroller module is also used to receive and respond to communication instructions sent by the wireless communication module, and the communication instructions include settings of stimulation modes and corresponding stimulation parameters.

6. The obstructive sleep apnea treatment device according to claim 4, characterized in that: The microcontroller module is also used to transmit the real-time physiological data of the physiological signal acquisition module and the real-time stimulation status of the electrical stimulation module to the outside through the wireless communication module.

7. The obstructive sleep apnea treatment device according to claim 1, characterized in that: The internal circuit of the main control circuit board also includes a power module, and the power module is used to provide power to the main control circuit board.

8. The obstructive sleep apnea treatment device according to claim 1, characterized in that: The physiological signal acquisition module includes an acceleration sensor, a gyroscope, a photoplethysmography sensor, an air pressure sensor, and a temperature sensor.

9. The obstructive sleep apnea treatment device according to claim 1, characterized in that: An embedded slot is provided in the dental brace so that the sealed main control circuit board can be inserted into the slot.

10. The obstructive sleep apnea treatment device according to claim 1, characterized in that: After being sealed, the main control circuit board is fixed to the inner side of the front teeth or the outer side of the back molars in the braces by adhesive.

Citation Information

Patent Citations

  • Apparatus for treatment of snoring and sleep apnoea

    CN107405486A

  • Stimulation for treating sleep disordered breathing

    CN113908438A