System for monitoring and controlling obstructive sleep apnea by means of an intraoral mechanism, and related intraoral mechanism

Abstract

The sleeping dream system (SDS) disclosed herein comprises an intraoral mechanism (MIB) and a monitoring and control system (SMC) that are associated with a user (U), and an SDS control centre (CSDS) capable of associating two or more users (U). The MIB is a device to be inserted into the oral cavity of the user (U), provided with upper (A) and lower (B) plates that connect to the upper and lower portions of the dental arch of the user (U), in addition to physiological sensors, an inertial movement unit (IMU), and a control logic associated with a wireless transmitter / receiver (1) and a power source (2). Said plates (A) and (B) are articulated by a mandibular movement device (D2M) that is implemented on the lower plate (B) and articulated relative to the upper plate (A).

Description

[0001] SYSTEM FOR MONITORING AND CONTROLLING OBSTRUCTIVE SLEEP APNEA THROUGH AN INTRAORAL MECHANISM AND RELATED INTRAORAL MECHANISM Field of Application of the Invention

[0002]

[0001] The present invention describes a monitoring and control system for obstructive sleep apnea through an Intraoral Mechanism (IOM) and related IOM. More specifically, it comprises a system implemented through an intraoral mechanism that, using Artificial Intelligence (AI), automatically makes small changes to the position of the jaw during sleep. The IOM is equipped with sensors that provide physiological data from the patient to the computer system where the AI ​​is implemented. The AI ​​integrates and analyzes the sensed data, thus concluding physiological information such as breathing quality, patient oxygenation, and the patient's sleeping position. With this data, the AI ​​can trigger the mechanism to change the position of the jaw, improving airflow and preventing the known Obstructive Sleep Apnea (OSA).

[0003] Background of the Invention

[0004]

[0002] Obstructive sleep apnea (OSA) is a condition in which breathing is interrupted or becomes shallow during sleep. This condition can lead to a number of health risks, including increased mortality. Among the main risks are cardiovascular problems, type 2 diabetes, metabolic disorders, cognitive problems, and an increased risk of accidents.

[0005]

[0003] Approximately one billion people worldwide suffer from OSA, with significant variations between regions. Moderate / severe OSA affects approximately four hundred and twenty-five million individuals between thirty and sixty-nine years of age. Prevalence ranges from ten to thirty percent in the adult population, depending on the diagnostic criteria and methodology used.

[0006]

[0004] The options available on the national and international market for treatment are the use of a continuous positive airway pressure (CPAP) device, which provides continuous air pressure, keeping the airways open during sleep. There are portable and automatic models that adjust to the required pressure. It is the most common and effective treatment for moderate to severe cases of OSA.

[0007]

[0005] There is also the possibility of performing the treatment using oral devices, including Mandibular Advancement Devices (MADs) and Lingual Retention Devices (LRDs). Both are fixed and used to reposition the mandible and tongue, helping to keep the airways open. These devices are custom-made and fitted by specialized dentists, and are readjusted periodically. The dentist uses a key to manually increase or decrease the mandibular advancement. These devices are not automated and do not involve electronic circuits.

[0008]

[0006] The CPAP consists of five components: (i) air generator, which creates positive pressure and is the heart of the system. This is connected to a power source and has a motor that pumps air; (ii) mask, which fits the patient's face, and comes in different types: nasal, which covers only the nose; full-face, which covers the nose and mouth; and cushion (or padded), which provides a more comfortable fit compared to the first two; (iii) tubing, which connects the air generator to the mask, allowing pressurized air to flow; (iv) humidifier, which is an optional device used to warm and humidify the air before inhalation, helping to prevent nasal dryness and discomfort; and (v) control system, which allows the user to adjust the pressure, monitor data, and even connect to mobile apps for sleep tracking.

[0009]

[0007] CPAP is used for severe cases where the patient experiences numerous OSA events during the night and would die if not using it. Patients often have great difficulty using it, as the mask causes discomfort and makes it difficult to sleep. Additionally, the equipment is not silent.

[0010]

[0008] Oral devices are an alternative to CPAP, especially for patients who do not tolerate the use of the device or who have mild to moderate sleep apnea. The DAM repositions the jaw forward, increasing the airway opening, while the DRL keeps the tongue in a position that prevents airway blockage, being a less common option. Both are adjustable and customized for each patient.

[0011]

[0009] In a search conducted on the state of the art, we identified several documents claiming anti-AOS monitoring and control systems, among which we can highlight the following documents:

[0012]

[0010] Document KR2096597 “DENTAL APPLIANCE FOR SNORING SLEEP APNEA TREATMENT AT ORAL INSERT MODE, HAS PROTRUSION SELECTIVELY INSERTED INTO MULTIPLE PENETRATION HOLES, AND TOP BODY AND BOTTOM BODY THAT ARE COMBINED WITH EACH OTHER BASED ON REVERSED POSITION OF BODY” discloses an appliance having a lower body formed with multiple penetration holes along a longitudinal direction. A first landing plate or a second landing plate is formed with a soft silicone material at a constant interval. A lower surface of a tooth from the upper portion is fixed as an external lateral protection of the upper portion. A plate-shaped protrusion is connected to a lower part of an upper inner protection. The protrusion is provided with a variable location joint arranged along the longitudinal direction. The protrusion is selectively inserted into multiple penetration holes.An upper body and a lower body are combined with each other based on an inverted position of the lower body. The device is manufactured using a minimal process, so the manufacturing cost of the device can be significantly reduced.

[0013]

[0011] Document US11986312 “SYSTEM FOR USING WIRELESS MOUTHGUARD WITH PRESSURE SENSORS FOR MEASURING BITE COMPRESSION FORCES GENERATED BY BRUXISM PATIENT DURING SLEEP, HAS POWER SUPPLY THAT IS CONNECTED TO SENSOR, MICROCONTROLLER, AND ANTENA” discloses a micro-electro-mechanical system (MEMS) that is coupled to a portion of a mouthguard covering an axial plane of a tooth. The MEMS comprises an antenna. A capacitive sensor is configured to generate sensor signals corresponding to a force generated by a bite from the mouthguard user. A microcontroller is communicatively coupled to the sensor. The microcontroller comprises a processor and memory and is configured to receive signals from the sensor and transmit communication signals that cause the antenna to transmit data representing the sensor signals, where the data describes the user's bite force over a period of time.A power supply is connected to the sensor, microcontroller, and antenna. The mouthguard is equipped with pressure sensors to effectively measure the bite compression forces generated by a patient with bruxism during sleep. The system allows a user to conveniently wear the mouthguard while sleeping.

[0014]

[0012] Finally, noteworthy document US202401 15413 “ORAL APPLIANCE FOR TREATING SNORING AND / OR SLEEP APNEA IN SUBJECT, HAS LEFT SIDE CONNECTOR WHOSE LATERAL ELEMENTS ARE SUFFICIENTLY ELASTICALLY DEFORMABLE TO FIT OVER FLANGES OF LEFT SIDE LATERALLY EXTENDING SUPPORTS OF UPPER DENTAL TRAY AND LOWER DENTAL TRAY” discloses an appliance having an upper dental tray comprising an anterior portion, a posterior portion, a right side, a left side, a buccal side, a lingual side, and an external surface. A right-side connector and a left-side connector comprise a first lateral element and a second lateral element. The lateral elements of the right-side connector are sufficiently elastically deformable to fit over flanges of the right-side lateral extension supports.The lateral elements of the left-side connector are sufficiently elastically deformable to fit over the flanges of the left-side lateral extension supports of the upper and lower dental trays, and to place posts of the right-side lateral extension supports of the dental trays within an internal channel of the left-side connector, where the dental trays are made of a soft plastic material. The device fixes a stop of the connector supports to the dental tray and comprises an engagement surface facing the support that extends laterally but is spaced from it, so that the stop can be fixed and / or integrally formed with the upper or lower dental tray.

[0015]

[0013] None of the technologies mentioned above presents a monitoring and control system for Obstructive Sleep Apnea (OSA) using an Intraoral Mechanism (IOM) and its related components. This specific system uses an IOM and a computer system equipped with Artificial Intelligence (AI) to automatically monitor, through sensors, the patient's physiological data. From the analysis of this data, the AI ​​can infer absolute values ​​and variations in breathing, heart rate, oxygenation, and patient positioning during sleep. Based on this analysis, the system automatically adjusts the position of the jaw, increasing airflow and preventing OSA episodes.

[0016] Summary of the Invention

[0017]

[0014] The system now revealed resembles the traditional Mandibular Advancement Device (MAD), however, it is fully automated, being supported by AI tools that analyze the patient's physiological data.

[0018]

[0015] Physiological measurements, such as heart rate and blood oxygen level, performed by an electronic system embedded in the mandibular plate, are transmitted via wireless communication system (e.g., Bluetooth) to an application positioned near the patient, referred to here as the MIB Monitoring and Control System (MCS).

[0019]

[0016] Based on AI decisions, the SMC commands the MIB to activate micromotors coupled to the mandibular plate, altering the relative position of the jaws. The micromotors are analogous to the switches used by dentists on fixed mandibular advancement plates.

[0017] The system now revealed differs from CPAP mainly because it does not have a mask and equipment necessary to generate forced air intake. Its advantages are greater comfort and adaptability to the use of the device, which are the biggest problems with CPAP, especially for CPAPs with facial masks; some people even report claustrophobia. The system now revealed has a less intrusive design, allowing for greater comfort and facilitating adaptation.

[0020]

[0018] The system that is the focus of this patent application allows for even lower energy consumption, since the CPAP has a motor that generates positive air pressure and consumes orders of magnitude more energy than the micromotors embedded in the MIB. A rechargeable microbattery can store all the energy needed for several nights of sleep, while the CPAP requires a direct connection to the power source. Additionally, the MIB has smaller dimensions, whether considering the complete CPAP assembly, including mask, tubing, air generator, and humidifier device, or even comparing only the CPAP mask with the MIB's intraoral plates, it is noticeable that this system has a smaller volume. Furthermore, the entire device of this system is inserted intraorally, making it not externally visible.

[0021]

[0019] In relation to traditional oral devices, it is noteworthy that this system features dynamic movement of the intraoral plates, whereas current oral devices employ static positioning of the plates, which is performed by dentists. This system has an electronic component embedded in the oral plate, which collects data from sensors related to physiological data and, through the fusion of sensor data, makes decisions that allow for dynamic displacement of the mandibular position, controlling the respiratory tract. Furthermore, it offers greater comfort and adaptability to the use of the device, as some patients report discomfort when using traditional oral devices, especially in the first few days, which may include pain in the jaw, teeth, and temporomandibular joint (TMJ).

[0022]

[0020] Additionally, adaptation can take time, so some patients may give up due to difficulty getting used to using the device during sleep. The mobile mechanism of the system now revealed minimizes these problems, as part of the sleep period can have the plates in a resting position, without straining the patient's joint.

[0023]

[0021] Its greater effectiveness in treating OSA stands out, since traditional oral devices may not completely resolve apnea episodes. In some situations, they only reduce the severity. The system now revealed includes physiological sensing of the patient, such as oximetry and respiratory assessment (snoring), allowing for dynamic treatment that can increase the effectiveness of air intake at critical moments.

[0024]

[0022] Finally, the real-time monitoring of the system now revealed is a highly effective and efficient innovation compared to current oral devices, which do not provide resources to monitor the patient's physiological signals. The system now presented has built-in sensors that allow capturing information such as heart rate, oximetry, and respiratory rate.

[0025]

[0023] Additionally, the SMC captures sound information, such as the patient's snoring. This information can be analyzed locally or remotely in real time, or analyzed in batches at a later time.

[0026]

[0024] Monitoring heart rate and oxygen levels is crucial in the management of OSA, with oxygen level monitoring being able to help identify the severity of apnea.

[0027]

[0025] It is known that frequent and severe desaturation is associated with a higher risk of complications such as hypertension, cardiovascular disease, and sudden death. These metrics not only help in the detection and assessment of the condition, but also allow for more effective monitoring of treatment and reduction of the risk of associated complications.

[0028]

[0026] The patient's historical assessment is also improved, since as a byproduct of monitoring, this system uses the sensor data to generate a history of the patient's evolution in relation to OSA. Additionally, this system does not require readjustment of the plates over time, unlike traditional oral devices that demand periodic adjustments to maximize comfort and function properly. The system shown has a dynamic adaptation during use, not requiring periodic adjustments.

[0029] Description of the Drawings

[0030]

[0027] Figure 1 presents a block diagram of the system now revealed, with the main systems that make up the Sleeping Dream System (SDS).

[0031]

[0028] Figure 2 shows the intraoral mechanism in normal (a) and open (b) states, with a top and bottom view of the MIB, highlighting the plates (A) and (B) that are in contact with the jaws.

[0032]

[0029] Figure 3 shows the intraoral mechanism with the micromotors installed, with a side view of the MIB with the D2M control board and motor images enlarged and illustrated externally to allow understanding of the system.

[0033]

[0030] Figure 4 shows the electronic circuit of the microcontroller that reads the vital sensors and communicates wirelessly using a Bluetooth Low Energy (BLE) transmitter / receiver.

[0034]

[0031] Figure 5 shows the electronic circuit responsible for inductive charging of the battery embedded in the MIB.

[0035]

[0032] Figure 6 shows the electronic circuit responsible for making physiological measurements using the photoplethysmography (PPG) sensor.

[0036]

[0033] Figure 7 shows the electronic circuit responsible for the battery level.

[0037]

[0034] Figure 8 shows the electronic circuit of the Inertial Measurement Unit (IMU), which combines an accelerometer, magnetometer, and gyroscope.

[0038]

[0035] Figure 9 shows the electronic circuit responsible for generating voltage levels for the circuits that make up the D2M.

[0039]

[0036] Detailed Description of the Invention

[0040]

[0037] The complete solution, now revealed, called the Sleeping Dream System (SDS), includes an Intra-Oral Mechanism (MIB) and a Monitoring and Control System (SMC) that are associated with a User (U), and a Central SDSs (CSDS), capable of associating two or more users.

[0041]

[0038] The MIB is an electromechanical device that must be inserted into the user's oral cavity (U), having a pair of upper (A) and lower (B) plates that connect to the upper and lower parts of the user's dental arch (U), similar to two adaptable dental plates (traditional removable orthodontic appliances).

[0039] The plates (A) and (B) are articulated by a Mandibular Movement Device (D2M) that is implemented inside the MIB. The MIB is equipped with physiological sensors and a control logic associated with a wireless transmitter / receiver (1) and a power source (2); the D2M is positioned on the lower plate (B) and articulated in relation to the upper plate (A).

[0042]

[0040] The D2M includes two micromotors (3) which are enlarged in Figure 3 to allow their recognition. The micromotors, located one to the right and the other to the left of the lower plate (B), are embedded in the plate, being completely covered by resin so as to make access impossible. They are coupled, for example, to two threaded elements (3.1), similar to screws, which allow a displacement (D) of the upper plate (A) relative to the lower plate (B).

[0043]

[0041] These micromotors (3) are controlled by embedded control logic and are housed in the lower board (B). The movement adjustments are made, for example, by clockwise or counterclockwise rotation of the micromotors (3) in relation to the threaded elements (3.1).

[0044]

[0042] The MIB's embedded electronic system comprises physiological sensors, control logic and wireless transmitter / receiver (1). This system is based on a microcontroller (4) with very low power consumption, sensors responsible for acquiring physiological signals from the user (U), such as heart rate and blood oxygen saturation level (SpO2), and an inertial measurement unit (IMU), which combines an accelerometer, magnetometer and gyroscope.

[0043] The physiological sensors are in contact with the inner side of the user's cheek (U), performing measurements in real time.

[0045]

[0044] The IMU also allows you to determine the position in which the user (U) is lying, as well as movements made during sleep.

[0046]

[0045] The MIB has an electronic circuit that controls the micromotors (3), causing them to rotate in one direction or the other, to tighten or loosen the threaded elements (3.1) that allow the movement of the plates (A) and (B).

[0047]

[0046] The MIB acquires physiological signals and data from the IMU and transmits them via radio frequency to the Monitoring and Control System (MCS).

[0048]

[0047] An AI system implemented in the SMC can return control information to the MIB, controlling, for example, the micromotors (3), and consequently, the user's breathing channel (U).

[0049]

[0048] The SMC is the computer system that stays close to the user (U) while they sleep, performing monitoring and MIB. The SMC comprises:

[0050] (i) wireless communication with the MIB;

[0051] (ii) a sound sensor (X) to recognize the user's breathing (U);

[0052] (iii) an Internet communication channel for accessing remote systems; and

[0053] (iv) an AI-powered management software that collects, analyzes and controls the MIB, and can also communicate with the CSDS.

[0049] The SMC’s computing requirements are met by most modern smartphones.

[0054]

[0050] In this way, this system is limited to the implementation of the management software, which adds AI functions to correlate the user's breathing information (U), collected with the sound sensor (X), with data provided by the physiological sensor and the IMU.

[0055]

[0051] It is important to emphasize that in order to provide a long duration to the MIB's power source, data collection from the sensors and IMU occurs in an optimized way and only at times defined by the SMC, due to a sudden change in breathing or on a programmable time basis.

[0056]

[0052] Additionally, the MIB transmits sensed data, requiring a data analysis step to extract useful information for the SMC.

[0057]

[0053] Once the raw data is processed, the management software becomes aware of the user's vital conditions (U), correlating them with their breathing and thus controlling the MIB to trigger the D2M.

[0058]

[0054] The functionality of the SMC can be understood in three stages:

[0059] a) Recognize and interpret the user's breathing (U):

[0060] For this purpose, the SMC, which is placed near the user while they sleep, is equipped with a sound sensor (X). Using AI techniques, the SMC removes ambient noise and recognizes the “quality” of the user’s breathing (U);

[0061] b) Interpret the raw data received from the physiological and IMU sensors into vital data and user positioning information (U): The vital data of interest to this project are blood oxygenation, heart rate, respiration, and blood pressure. All of this data is extracted using AI techniques that allow for the evaluation of sensory data variation over time;

[0062] c) Correlate the user's (U) breathing information with information from physiological sensors, IMU, and the user's (U) history, in order to generate efficient and effective MIB control, which allows for the elimination of OSA, generating comfort for the user (U).

[0063] d) Acting on plates (A) and (B): If it is necessary to widen the airway, the micromotors (3) are activated, displacing the threaded elements (3.1) and moving the upper plate (A) relative to the lower plate (B), promoting a displacement (D), thus opening the user's airway. If biological levels are within normal limits, the micromotors (3) are not activated, keeping plates (A) and (B) in their original positions. Additionally, according to the analyzed data, the micromotors (3) can be activated to return plates (A) and (B) to their original positions (see Figure 2).

[0064]

[0055] Given that each SDS is associated with a user (U). The complete system includes a CSDS which is the data center responsible for analyzing information collected by one or more SDSs. The collection of information from various SDSs allows for improved effectiveness and efficiency of the operation of existing SDSs and future versions.

[0056] The CSDS uses publicly available worldwide data on patients with OSA, the history of these patients, as well as the histories of other SDS users, all data stored in a database (5).

[0065]

[0057] By cross-referencing this data, the CSDS can change parameters programmed in the SDS, such as changing the reading frequency of physiological and IMU sensors or the movement limits defined for D2M.

[0066]

[0058] CSDS performs a long-term temporal analysis, considering the evolution of the user's sleep quality; in order to maintain or readjust the movement of the MIB plates.

[0067]

[0059] The CSDS can also access the history of several patients using the SDS and, in this way, evaluate and optimize the operation of each local SDS.

[0068]

[0060] Note that Figure 1 presents the complete SDS sketch, considering only one MIB / SMC pair connected via the Internet to the CSDS.

[0069]

[0061] The MIB exemplifies physiological sensors through the photoplethysmography (PPG) sensor, which allows for the optical detection of changes in blood volume in the mandibular tissue, enabling the collection of oximetry, blood pressure, heart rate, and respiration data.

[0070]

[0062] Additionally, the micromotors (3) are represented, in enlarged size, in Figure 3, highlighting the presence of the threaded elements (3.1) that implement the relative movement between the intraoral plates.

[0071]

[0063] Figure 4 details the electronic circuit of the microcontroller that reads the vital sensors and communicates wirelessly using a Bluetooth Low Energy (BLE) transmitter / receiver.

[0064] Figure 5 details the electronic circuit responsible for inductive charging of the battery embedded in the MIB, and Figure 6 details the electronic circuit responsible for making physiological measurements through the photoplethysmography (PPG) sensor. The circuit optically detects changes in blood volume in the mandibular tissue, enabling the collection of oximetry, blood pressure, heart rate, and respiration data.

[0072]

[0065] Figure 7 details the electronic circuit responsible for the battery level: this circuit monitors the battery charge and reports the battery status via Bluetooth Low Energy (BLE).

[0073]

[0066] Figure 8 details the electronic circuit of the Inertial Measurement Unit (IMU), which combines an accelerometer, magnetometer, and gyroscope. The IMU also allows determining the position in which the user (U) is lying, as well as movements made during sleep, and Figure 9 details the electronic circuit responsible for generating voltage levels for the circuits that make up the D2M.

[0074]

[0067] Wireless communication is exemplified with a Bluetooth Low Energy (BLE) transmitter / receiver, but note that BLE is only one possible wireless communication technology to be employed in the solution shown.

[0075]

[0068] The electronic components mentioned are not limiting to the subject matter claimed, and other technologies may be employed to achieve the same objective.

Claims

CLAIMS:

1. Obstructive Sleep Apnea Monitoring and Control System characterized by being composed of the following stages: a) Recognize and interpret the user's breathing (U); b) Interpret the data; c) Correlate the user's breathing information (U) with other information from inertial and physiological sensors; and d) Act on plates (A) and (B).

2. ANTI-OBSTRUCTIVE SLEEP APNEA MONITORING AND CONTROL SYSTEM, according to claim 1, characterized by the recognition step (a) occurring through the Monitoring and Control System (MCS) near the user while he or she sleeps, being equipped with a sound sensor (X).

3. ANTI-OBSTRUCTIVE SLEEP APNEA MONITORING AND CONTROL SYSTEM, according to claims 1 and 2, characterized by using Artificial Intelligence (AI) techniques in the SMC to remove ambient noise and recognize the user's breathing parameters (U).

4. ANTI-OBSTRUCTIVE SLEEP APNEA MONITORING AND CONTROL SYSTEM, according to claim 1, characterized in that the interpretation step (b) is performed using raw data received from physiological sensors and Inertial Measurement Unit (IMU) into vital data and user positioning information (U) by the central unit (CSDS) equipped with a database (5).

5. ANTI-OBSTRUCTIVE SLEEP APNEA MONITORING AND CONTROL SYSTEM, according to claims 1 and 4, characterized in that the data analyzed are the user's blood oxygenation (U), the user's heart rate (U), the user's respiration (U), the user's blood pressure (U), and the user's movement (U) throughout sleep, extracted through AI and evaluated over time.

6. ANTI-OBSTRUCTIVE SLEEP APNEA MONITORING AND CONTROL SYSTEM, according to claim 1, characterized in that the correlation step (c) is performed in such a way as to promote MIB control in step (d).

7. MONITORING AND CONTROL SYSTEM FOR OBSTRUCTIVE SLEEP APNEA, according to claims 1 and 6, characterized in that the actuation step (d) is performed to, if necessary, increase the respiratory channel, activating the micromotors (3), displacing the threaded elements (3.1) and moving the upper plate (A) in relation to the lower plate (B), promoting a displacement (D).

8. ANTI-OBSTRUCTIVE SLEEP APNEA MONITORING AND CONTROL SYSTEM, according to claims 1, 6 and 7, characterized in that, if biological levels are within normal parameters, the micromotors (3) are not activated.

9. ANTI-OBSTRUCTIVE SLEEP APNEA MONITORING AND CONTROL SYSTEM, according to claims 1, 6, 7 and 8, characterized in that the micromotors (3) can be activated to return the plates (A) and (B) to their original positions.

10. INTRA-ORAL MECHANISM characterized by comprising an upper plate (A), a lower plate (B) and a Mandibular Movement Device (D2M) installed on the lower plate (B) and articulated in relation to the upper plate (A).

11. INTRA-ORAL MECHANISM, according to claim 10, characterized in that the mechanism includes two micromotors (3), one located to the right and the other to the left of the lower plate (B), coupled to threaded elements (3.1) that allow the upper plate (A) to move relative to the lower plate (B), and in that the MIB is equipped with physiological sensors and a control logic associated with a wireless transmitter / receiver (1) and a power source (2).

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