Continuous airflow support for precise detection and treatment of sleep apnea
By combining an open-face mask and a respiratory flow sensor with a positive pressure airflow generation component, the system achieves integrated and accurate detection and treatment of sleep apnea, solving the problems of complexity and misjudgment in traditional equipment, and improving detection accuracy and home use.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- GUANGZHOU RUISHIBO MEDICAL TECH CO LTD
- Filing Date
- 2026-02-12
- Publication Date
- 2026-06-02
AI Technical Summary
Existing technologies cannot achieve accurate integrated detection and treatment of sleep apnea. Traditional equipment is complex, expensive, and cannot be used at home. Sensors are prone to displacement, leading to misjudgments. CPAP is ineffective for central sleep apnea.
Employing an open-face mask covering the mouth and nose, a respiratory flow sensor, a positive pressure airflow generation component, a signal analysis component, and a display, it accurately detects apnea events with continuous airflow support, distinguishes between central and obstructive apnea, and sets appropriate treatment pressure.
It has achieved the integration of accurate detection and treatment of sleep apnea, reduced the cost of diagnosis and treatment, improved detection accuracy and patient compliance, and promoted home-based and intelligent diagnosis and treatment.
Smart Images
Figure CN122123677A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to a device for accurate detection and treatment of sleep apnea under continuous airflow support. Background Technology
[0002] Sleep apnea is a common health hazard, with an incidence rate as high as 20%. It can induce or aggravate cardiovascular and cerebrovascular diseases and impair neurocognitive function. Its characteristics include intermittent cessation of breathing during sleep, each lasting more than ten seconds, accompanied by a decrease in blood oxygen, an increase in carbon dioxide levels, and repeated micro-awakenings. Sleep apnea can be further divided into obstructive and central types. Obstructive sleep apnea (OSA) is characterized by the continued presence of respiratory drive when airflow stops; while central sleep apnea (CSA) is characterized by the disappearance of respiratory drive when airflow stops. Continuous positive airway pressure (CPAP) can treat obstructive sleep apnea, but it is ineffective or poorly effective for central sleep apnea. Currently, there is no instrument worldwide that can accurately detect sleep apnea and treat obstructive sleep apnea syndrome simultaneously.
[0003] Current sleep apnea diagnosis and treatment systems face significant technical bottlenecks: detection relies on polysomnography, which involves complex equipment, requires professional operation, is costly, and cannot achieve precise integrated detection and treatment. Furthermore, it cannot determine the persistence and severity of sleep apnea during home treatment, severely hindering early screening, accurate classification, and personalized treatment. Existing polysomnography for sleep apnea diagnosis often involves simultaneously recording multiple signals, including electroencephalography (EEG), chest and abdominal band monitoring of respiratory movements, blood oxygen saturation, and snoring. Pressure sensors detect nasal airflow, while thermal sensors detect airflow through the mouth and nose, or both pressure and thermal sensors simultaneously record respiratory airflow signals. However, due to changes in body position and sensor displacement, and repeated switching between mouth and nose breathing, respiratory airflow signals are often limited to qualitative analysis, making quantification difficult. Additionally, when pressure sensors detect nasal airflow, nasal congestion may cause patients to switch primarily to mouth breathing, exaggerating the frequency of apnea events. Although ventilation is generally stable during normal sleep, traditional nasal airflow and thermosensitive airflow are only qualitative and cannot be accurately quantified, resulting in dynamic changes in respiratory flow signals during normal sleep, which further affects the identification of sleep apnea events.
[0004] Identifying sleep apnea events is crucial for determining the frequency of apnea-hypopnea. The Apnea-Hypopnea Index (AHI) = (Number of apneas per night + Number of hypopneas per night) / Sleep duration (hours). Accurate identification of apnea-hypopnea events highly depends on the precise quantification of respiratory airflow. Difficulty in quantifying respiratory airflow will inevitably affect the accuracy of apnea-hypopnea event identification and may lead to misdiagnosis.
[0005] Sleep apnea or hypopnea events can be classified as central or obstructive. Traditionally, the differentiation between central and obstructive sleep apnea has relied primarily on chest and abdominal band signals. However, due to the poor sensitivity of chest and abdominal band signals and their susceptibility to loosening, movement, and detachment, a sleep apnea event that is actually obstructive may be misdiagnosed as central due to the loss of the chest and abdominal band signal. Some hypopnea or even apnea events may be caused simply by sensor displacement, changes in head position, or switching between mouth and nose breathing, rather than true hypopnea or apnea. To improve the accuracy of sleep apnea event assessment, clinical practice has had to incorporate auxiliary indicators when identifying hypopnea events, such as whether the hypopnea event is accompanied by microarousing or a decrease in blood oxygen saturation exceeding 3%. A method that combines blood oxygen saturation and microarousing to detect sleep apnea events is complex, time-consuming, laborious, and inaccurate. Because the severity of sleep apnea varies greatly from night to night, and alcohol consumption or fatigue can worsen sleep apnea, a single polysomnography result cannot fully reflect the true extent of sleep apnea. Therefore, polysomnography, especially a single polysomnography session, is not the gold standard for diagnosing sleep apnea. Although a closed-face mask connected to a flow sensor is commonly used to detect respiratory flow and tidal volume during movement (e.g., ... Figure 1 However, the suffocating feeling of a closed mask, the additional breathing resistance, the accompanying dead space ventilation, and the increased CO2 concentration in inhaled air can all seriously affect the detection of sleep and sleep apnea. In addition, the high humidity of exhaled air often leads to water droplets inside the mask when no additional airflow is delivered to the mask connected to the flow sensor, interfering with both wearing comfort and the accuracy of flow measurement. To date, there is no method using a closed mask directly connected to a flow sensor for the assessment of sleep apnea events throughout the night. A comfortable device that can accurately quantify respiratory airflow and tidal volume can more accurately identify apnea and hypopnea events; by analyzing the airflow recovery measured at the end of an apnea, it can determine whether the apnea is central or obstructive, thus eliminating the need to rely on chest and abdominal band signals or respiratory muscle electromyography signals to determine the nature of the event. Furthermore, since hypopnea can be accurately measured, hypopnea events do not need to be inferred from the complex EEG signals of micro-awakening, thus enabling simple and accurate identification of sleep breathing events, including hypopnea events.
[0006] The effectiveness of CPAP in treating obstructive sleep apnea depends on the CPAP pressure output setting and it cannot effectively correct central sleep apnea. For subjects with more than 20 apnea events per hour, an effective CPAP pressure (e.g., CPAP 10 cmH2O) is administered, and sleep breathing events under CPAP are observed. Based on the CPAP intervention effect, the nature of the sleep apnea events can be further determined, distinguishing between central and obstructive sleep apnea. This device, which integrates precise diagnosis and treatment of sleep apnea under continuous airflow support, will make sleep apnea diagnosis and treatment more convenient, community-based, and family-oriented, representing a revolution in the field of sleep apnea diagnosis and treatment.
[0007] Therefore, there is an urgent need for an intelligent medical device that can integrate "detection-classification-treatment" to overcome the limitations of existing technologies, improve the efficiency and accuracy of diagnosis and treatment, and promote the development of sleep apnea diagnosis and treatment towards home-based, intelligent, and precise approaches. Summary of the Invention
[0008] The purpose of this invention is to overcome the shortcomings of the existing technology and provide a device for accurate detection and treatment of sleep apnea under continuous airflow support. This device can accurately detect apnea events without relying on traditional chest and abdominal belts or respiratory muscle electromyography to distinguish between central and obstructive apnea. It can also determine the severity of sleep apnea and select an appropriate treatment pressure.
[0009] The objective of this invention is achieved through the following technical solution: This continuous airflow-supported sleep apnea precision detection and treatment device includes an open-face mask covering the mouth and nose, a respiratory flow sensor, a positive pressure airflow generation component, a signal analysis component, and a display. The open-face mask covering the mouth and nose is divided into a proximal end that contacts the face and a distal end that connects to the respiratory flow sensor. The proximal end of the open-face mask has one or more evenly distributed airflow input connectors to receive airflow from the positive pressure airflow generation component. The positive pressure airflow generation component includes a blower inlet, a blower, a pressure control component, a blower outlet pipe, a noise reduction component, and a pressure flow sensor. The signal analysis component receives and analyzes signals from both the respiratory flow sensor and the pressure flow sensor within the positive pressure airflow generation component. The display is connected to both the signal analysis component and the pressure control component to display apnea events and the airflow pressure input to the mask.
[0010] Preferably, the proximal end of the open-face mask fits snugly against the face without leakage; the proximal end of the open-face mask receives positive pressure airflow, while the distal end of the open-face mask has an exhaust port (with an area greater than 700 mm²). 2This ensures that the pressure inside the mask is almost always equal to the atmospheric pressure outside the mask, and that the subject's exhaled air and the positive pressure airflow entering the mask are both discharged from the breathing flow sensor channel at the far end of the mask.
[0011] Preferably, the signal detected by the respiratory flow sensor is transmitted to the signal analysis component for analysis and processing, and the number of times the tidal volume is less than 10% of the baseline tidal volume and lasts for more than 10 seconds is counted as the number of pauses, and the number of times the tidal volume is between 10% and 50% of the baseline tidal volume and lasts for more than 10 seconds is counted as the number of hypoventilations.
[0012] Preferably, the signal detected by the respiratory flow sensor is transmitted to a signal analysis component for analysis. The analysis focuses on the characteristics of airflow recovery after each event in which the tidal volume is less than 10% of the baseline tidal volume and lasts for more than 10 seconds: if it takes only two respiratory cycles to return the tidal volume from less than 10% of the baseline tidal volume to the baseline tidal volume level, it is defined as an obstructive apnea event; if it takes more than three respiratory cycles to return the tidal volume from less than 10% of the baseline tidal volume to the baseline tidal volume level, it is defined as a central apnea event.
[0013] Preferably, in the working state, the positive pressure airflow generating component continuously delivers airflow from the proximal end of the mask to the inside of the mask at a flow rate greater than 30 L / min, which not only provides the subject with sufficient inspiratory airflow, but also accelerates the exhalation of air from the respiratory flow sensor at the distal end of the mask, thereby eliminating functional dead space to the greatest extent.
[0014] Preferably, when a conventional positive pressure nasal mask replaces an open mask covering the mouth and nose and receives continuous positive airway pressure output from the positive pressure airflow generating component, conventional continuous positive airway pressure (CPAP) function can be realized; the pressure change of the airflow output by the positive pressure airflow generating component is detected by a pressure flow sensor to determine the apnea event under CPAP.
[0015] Preferably, when the subject wears a nearly sealed positive pressure nasal mask, if the incidence of apnea detected by the pressure-flow sensor at CPAP 10 cmH2O decreases by more than 50% compared to when CPAP is not used, the apnea event is classified as obstructive; if the incidence of apnea event decreases by less than 50%, it is classified as central.
[0016] Preferably, the positive pressure nasal mask is connected to a positive pressure airflow generating component. When the subject wears the nearly sealed positive pressure nasal mask, if the incidence of apnea detected by the pressure-flow sensor at CPAP 10 cmH2O decreases by more than 50% compared to when no CPAP is used, and the number of respiratory events is less than 10 times / hour, then CPAP 10 cmH2O is taken as the optimal CPAP pressure for treating sleep apnea. If the overnight respiratory event rate is greater than 10 times / hour, then CPAP 12 cmH2O is set as the treatment pressure.
[0017] Preferably, an open-face mask covering the mouth and nose and a positive pressure nasal mask can be used alternately to enable dynamic monitoring of whether sleep apnea still exists and its severity during treatment.
[0018] This sleep apnea detection and treatment device with continuous constant airflow support includes an open-face mask / normal positive pressure nasal mask, a respiratory flow sensor, a mask / nasal mask fastener, a headband, an air delivery tube, a continuous constant airflow input connector for the mask / nasal mask, an adapter and air delivery tube connecting the continuous constant airflow input connector, a positive pressure airflow generation component, a signal analysis component, and a display. The proximal end of the open-face mask can cover the mouth and nose and is provided with one or more constant airflow inlets. The distal end of the open-face mask is connected to the respiratory flow sensor. The positive pressure airflow generation component includes an air inlet, a blower, an outlet airway, a pressure regulation component, a blower adjustment interface, a noise reduction component, and a pressure-flow sensor installed in the outlet airway. This device can realize two functions: apnea detection, including apnea type determination and apnea treatment.
[0019] Function 1: Detection of sleep apnea-hypopnea events and differentiation between central and obstructive events.
[0020] The aforementioned open-face mask has a proximal end that conforms to the face and is made of soft material, covering the mouth and nose. The distal end of the open-face mask is connected to a respiratory flow sensor. The proximal end of the open-face mask has one or more airflow input connectors, which are connected to one end of an air delivery tube via an adapter. The other end of the air delivery tube is connected to the output port of a positive pressure airflow generating component, allowing the open-face mask to receive continuous positive pressure airflow. The airflow input connector at the proximal end of the open-face mask is an adapter that can rotate 360 degrees and swing up and down. The inner diameter of the distal end of the open-face mask and the respiratory flow sensor is greater than 15mm. Two fasteners for connecting the headband are located on each side of the open-face mask. The positive pressure airflow generating component consists of an air inlet, a blower, an outlet pipe, a pressure regulating component, a pressure-flow sensor installed in the outlet pipe, and a noise reduction component. The respiratory flow sensor detects the respiratory airflow and transmits it to a signal analysis component, which analyzes the respiratory airflow signal to obtain airflow changes, tidal volume, and respiratory rate signals. It identifies apnea and hypopnea events, and determines whether the event is obstructive or central based on the airflow change at the end of each event. Signals from the pressure-flow sensor are also transmitted to the signal analysis component; the display component shows the pressure set by the pressure regulation component, the pressure and flow detected in the outlet channel of the positive pressure airflow generation component, the airflow detected by the distal respiratory flow sensor of the open mask, tidal volume, and related indicators including apnea, hypopnea frequency, apnea-hypopnea index (AHI), and the nature of each apnea event—whether central or obstructive—achieving accurate identification of sleep apnea-hypopnea events.
[0021] Function 2: Sleep Apnea CPAP Pressure Setting and Treatment
[0022] A positive pressure nasal mask is used instead of an open face mask. The positive pressure nasal mask has a nasal mask airflow input connector, which is connected to one end of the air delivery tube. The other end of the air delivery tube is connected to the air outlet of the positive pressure airflow generating component. The positive pressure airflow generating component, as described above (Function 1), consists of an air inlet, a blower, an air outlet pipe, a pressure regulation component, a pressure-flow sensor installed in the air outlet pipe, and a noise reduction component. The pressure-flow sensor signal is transmitted to a signal analysis component for analysis to obtain residual apnea events and hypopnea events under CPAP intervention. The display component displays the airflow pressure in the air outlet pipe (when airflow stops, the airflow pressure in the air outlet pipe is equal to the airflow pressure in the connected air delivery pipe and the mask cavity), the number of apneas, the number of hypopnea events, and the leakage status. For subjects with significant sleep apnea events (e.g., more than 20 apnea events per hour), the airflow pressure in the delivery channel can be adjusted using the airflow pressure regulation component. By setting a CPAP treatment pressure of 10 cmH2O, the number of apnea events under CPAP 10 cmH2O pressure intervention can be obtained to determine the effect of CPAP on apnea events. If the number of apnea events is less than 10 per hour under CPAP 10 cmH2O pressure intervention, the optimal effective pressure is set to 10 cmH2O. If the number of apnea events is greater than 10 per hour under CPAP 10 cmH2O pressure intervention, and the number of apnea events decreases by more than 50%, then 12 cmH2O is set as the optimal CPAP pressure. If the subject has more than 10 apnea events per hour under CPAP 10 cmH2O pressure intervention, and the number of apnea events decreases by less than 50%, the subject is diagnosed with central sleep apnea.
[0023] The beneficial effects of this invention are that it accurately detects respiratory airflow, tidal volume, and respiratory rate during sleep under continuous airflow support, achieving precise and dynamic identification of apnea and hypopnea events. Furthermore, by analyzing the airflow recovery pattern at the end of each apnea event, it determines whether the event is obstructive or central. For the first time, it achieves precise identification of apnea-hypopnea events while simultaneously providing CPAP therapy for obstructive sleep apnea, and allows for precise setting of CPAP treatment pressure. Thus, through a sleep apnea detection and treatment device under continuous airflow support, it realizes integrated, intelligent, community-based, and home-based precise diagnosis and treatment of sleep apnea. This invention has significant clinical applicability and social benefits, significantly reducing treatment costs, improving patient compliance, and promoting the upgrading of the sleep health management industry. Attached Figure Description
[0024] Figure 1This is a schematic diagram of respiratory flow, tidal volume, and minute ventilation commonly used in existing technologies to detect respiratory flow during exercise.
[0025] Figure 2 This is a schematic diagram of the monitoring mode in this invention.
[0026] Figure 3 This is a schematic diagram illustrating the use of the monitoring mode in this invention.
[0027] Figure 4A This is a signal diagram used in the monitoring mode of this invention to determine central sleep apnea.
[0028] Figure 4B This is a signal diagram used in the monitoring mode of this invention to determine obstructive sleep apnea.
[0029] Figure 5 This is a schematic diagram illustrating the use of the treatment mode in this invention.
[0030] Figure 6 This is a schematic diagram of the structure of the positive pressure breathing nasal mask of the present invention. Detailed Implementation
[0031] The following is combined with Figure 2 The invention is further described below. To determine whether a subject 20 has nocturnal sleep apnea, the subject 20 wears an open-face mask 2 with a respiratory flow sensor 1 connected to the distal end. The proximal end 3 of the open-face mask 2 is a face connection part, and the proximal end of the open-face mask 2 has an airflow input connector 4 that can rotate 360 degrees and swing upwards and downwards. The airflow input connector 4 is connected to an adapter 5. The positive pressure airflow generated by the positive pressure airflow generating component 6 is connected to the air delivery pipe 8 through the air outlet 7 and then to the adapter 5, thereby providing a continuous positive pressure airflow to the open-face mask 2. The positive pressure airflow generating component 6 supplies air to the blower 10 through the air inlet 9. The positive pressure airflow generated by the blower 10 is delivered to the air delivery pipe 8 through the air outlet 7 of the positive pressure airflow generating component 6 via the air outlet pipe 11. The blower 10 has an interface 12 that accepts the adjustment of the pressure control component 13. The pressure value set by the pressure control component 13 can be transmitted to the display 18 via a wired or wireless connection. A pressure-flow sensor 14 is installed on the outlet duct 11, transmitting the pressure-flow signal to the signal analysis component 16 via a wired or wireless circuit 15, and transmitting the pressure and flow rate and their changes to the display 18 via a wired or wireless circuit 17. To reduce noise during positive pressure airflow generation, noise reduction components 19 are installed in and around the blower 10 and in the duct 11.
[0032] The following is combined with Figure 3The implementation of sleep apnea event recognition (Mode 1) is further described. Subject 20 secures an open-face mask 2 connected to a respiratory flow sensor 1 via a headband 21 and a headband buckle 22 on the mask. The proximal end of the open-face mask has a 360-degree rotatable airflow inlet connector 4, which connects to an adapter 5 and receives a constant pressure airflow (e.g., 40 liters / minute) from an air delivery tube 8. Through the open-face mask 2, subject 20 can inhale air from the inner cavity of the open-face mask 2 into the respiratory tract, and excess air is expelled through the outflow channel 23 of the respiratory flow sensor 1 at the distal end of the mask 2. Suppose that a pressurized airflow with a pressure of 10 cmH2O is to be delivered to the open-face mask 2. The blower 10 is adjusted through the pressure regulating component 13 and then through the wired or wireless channel 24 via the interface 12 to generate a positive pressure airflow with a pressure of 10 cmH2O. The airflow is then delivered to the air supply pipe 8 through the outlet pipe 11 and the outlet 7 of the positive pressure airflow generating component 6. At this time, the pressure-flow sensor 14 installed in the outlet pipe 11 will detect the pressure of 10 cmH2O and the airflow with a flow rate of 40 L / min and display it on the display 18. Because a constant, high-flow-rate airflow is continuously input into the open-face mask for the subject's breathing, excess gas and exhaled air are discharged from the distal end of the open-face mask through the outflow channel 23 of the breathing flow sensor 1. In particular, since the distal end of the open-face mask and the inner diameter of the breathing flow sensor are both greater than 15 mm, according to the principles of fluid dynamics (Batchelor GK. An Introduction to Fluid Dynamics. Cambridge, United Kingdom: Cambridge University Press; 1967.), the internal pressure of the open-face mask is almost equal to the pressure around the open-face mask.
[0033] The following is combined with Figure 3 , Figure 4A and Figure 4BFurther explanation regarding sleep apnea events and their nature. Assume subject 20 has a tidal volume of 500 ml. Subject 20 secures the open-face mask 2 with headband buckle 22 and headband 21, ensuring the padding 3 seals tightly against the face. When subject 20 inhales, they inhale positive pressure airflow generated by the positive pressure airflow generator 6, which provides breathing airflow to the open-face mask 2 via the outlet 7 and delivery tube 8 of the positive pressure airflow generator 6. The continuous positive pressure airflow from the delivery tube 8 enters the open-face mask via the adapter 5 and airflow input connector 4. A portion of this airflow is supplied to the user 20's inhalation tract, while excess air is expelled from the outlet 23 of the respiratory flow sensor 1 at the distal end of the open-face mask 2. During inhalation, because subject 20 inhales airflow generated by the positive pressure airflow generator 6, delivered through the delivery tube 8, and then through the adapter 5 and airflow input connector 4 into the open-face mask 26, the amount of air expelled from the outlet 23 will be less than the amount of air entering the mask from the delivery tube 8. When the subject exhales, the exhaled air will be superimposed on the continuous positive pressure airflow from the air delivery tube 8 and discharged together from the outflow channel 23. At this time, the airflow flowing out of the outflow channel 23 of the respiratory flow sensor 1 will be greater than the continuous positive pressure airflow from the air delivery tube 8. Therefore, if the airflow entering the mask is 60 L / min, the respiratory airflow will fluctuate with the breathing based on 60 L / min, such as... Figure 4A and Figure 4B The recorded signals. The signals detected by the respiratory flow sensor 1 are transmitted via the respiratory flow sensor connector 30 and then through the airway or circuit 25 to the signal analysis component 16 for analysis and processing. The results, including respiratory flow, tidal volume, respiratory rate, number of apneas, and number of hypopneas, are transmitted to the display 18 through the pathway 17 to show the respiratory status throughout the night, including recording time, average tidal volume, average ventilation, number of apneas, number of hypopneas, and number of sleep apnea events per hour. Because central sleep apnea (CSA), especially heart failure complicated by CSA, is characterized by alternating strong and weak Chernobyl breathing, such as... Figure 4A In particular, ventilation gradually increases in the later stages of an apnea event, while after an obstructive sleep apnea event ends, ventilation suddenly increases, lacking the gradual fluctuations in the breathing pattern. Figure 4BBy analyzing the changes in tidal volume at the end of each event, it can be determined whether the apnea event is central or obstructive. The criteria for judging apnea-hypopnea events are: if the tidal volume is less than 10% of the tidal volume in the quiet, awake state and lasts for more than 10 seconds, it is judged as an apnea event; if the tidal volume is between 10% and 50% of the normal baseline tidal volume and ventilation volume and lasts for 10 seconds or more, it is judged as hypopnea. The average tidal volume in the quiet, awake state before falling asleep is used as the baseline tidal volume. Because respiratory airflow, including tidal volume, can be accurately measured, apnea and hypopnea can be accurately judged, making hourly sleep breathing event detection more accurate. Therefore, when judging hypopnea events, it is not necessary to identify and correct for hypopnea events based on micro-arousals obtained from EEG, nor is it necessary to include indicators such as changes in blood oxygen saturation exceeding 3% in judging hypopnea events, thus making the detection of sleep apnea simpler and more accurate.
[0034] The following is combined with Figure 5 , Figure 6 Further description is provided regarding the determination of the nature of sleep apnea events and the setting of CPAP treatment pressure (Mode 2). If a patient is found to have significant apnea events during sleep apnea testing, such as more than 20 apnea-hypopnea events per hour, then Mode 2 (Mode 2) should be selected. Figure 5 , Figure 6 This mode is characterized by the use of a positive pressure nasal mask instead of an open face mask, allowing the positive pressure nasal mask to receive the positive pressure airflow generated by the positive pressure airflow generation component 6, thus enabling the subject to receive CPAP mode.
[0035] When a subject 20 is preliminarily diagnosed with sleep apnea, they wear a positive pressure nasal mask 26, which is secured by headband buckles 22 and headband 21 to prevent air leakage between the face and the mask. A pressure regulation component 13 adjusts a blower 10 via an interface 12 to generate the required pressurized airflow (e.g., CPAP 10 cmH2O), which is delivered to an outlet pipe 11 equipped with a pressure-flow sensor 14. The signal from the pressure-flow sensor 14 is transmitted to a signal analysis component 16 via a signal path 15. The outlet pipe 11 is connected to the outlet 7 of the positive pressure airflow generating component 6 and further connected to an air delivery pipe 8. The positive pressure nasal mask 26 is connected to the air delivery pipe 8 via an airflow input connector 27 and an adapter 5, thereby continuously supplying the nasal mask 26 with the positive pressure airflow generated by the positive pressure airflow generating component 6. The nasal mask airflow input connector 27 is a connector that can rotate 360 degrees and change its upward or downward direction. For ease of testing, the data set by the pressure regulation component 13 can be transmitted to the display 18 via a wired or wireless channel 28.
[0036] like Figure 6The nasal mask airflow inlet connector 27 is designed with multiple small through holes 29 for expelling exhaled air and helping to maintain the pressure inside the positive pressure nasal mask 26. When the user wears the positive pressure nasal mask 26, the pressure regulation component 13 adjusts the blower 10 through the blower interface 12, causing the positive pressure airflow generating component 6 to generate the required positive pressure airflow. The setting data of the pressure regulation component 13 can be transmitted to the display 18 via a wired or wireless path 28. The positive pressure airflow outputs a pressure (e.g., 10 cmH2O of airflow) to the positive pressure nasal mask 26 through the air delivery tube 8. When the subject 20 breathes through the positive pressure nasal mask 26, the pressure-flow sensor 14 installed on the outlet tube 11 detects the pressure airflow signal that changes with breathing and transmits it to the signal analysis component 16 through the path 15 to determine the number of apnea-hypopnea episodes under continuous positive airway pressure, and displays the number of apnea-hypopnea episodes on the display 18. Apnea assessment under CPAP primarily relies on pressure changes detected by a pressure-flow sensor installed on the outlet airway 11. The criteria for assessing respiratory events are similar to those in Mode 1. An apnea event is defined as a pressure change of less than 10% of the baseline normal value lasting for more than 10 seconds. A hypoventilation event is defined as a pressure change between 10% and 50% of the baseline normal pressure lasting for 10 seconds or more. The baseline normal respiratory pressure is defined as the average respiratory pressure change under a positive airflow of 10 cmH2O through a nasal mask in a supine, quiet, and awake state before falling asleep. If the number of apnea events decreases by less than 50% under CPAP at 10 cmH2O, the sleep apnea is classified as central. If the number of sleep apnea events is <10 times / hour under CPAP at 10 cmH2O and the subject can tolerate it, then 10 cmH2O is considered the optimal CPAP pressure. If a subject experiences a decrease in respiratory events by more than half while receiving CPAP at 10 cmH2O, but has an AHI > 10 breaths / hour, the CPAP pressure is adjusted to 12 cmH2O, and 12 cmH2O is taken as the optimal CPAP pressure.
[0037] Those skilled in the art will readily understand that the above description is merely an embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.
Claims
1. A device for precise detection and treatment of sleep apnea under continuous airflow support, characterized in that: The device includes an open-face mask covering the mouth and nose, a respiratory flow sensor, a positive pressure airflow generation component, a signal analysis component, and a display. The open-face mask is divided into a proximal end that contacts the face and a distal end that connects to the respiratory flow sensor. The proximal end of the open-face mask has one or more evenly distributed airflow inlet connectors to receive airflow from the positive pressure airflow generation component. The positive pressure airflow generation component includes a blower inlet, a blower, a pressure control component, a blower outlet duct, a noise reduction component, and a pressure flow sensor. The signal analysis component receives and analyzes signals from both the respiratory flow sensor and the pressure flow sensor within the positive pressure airflow generation component. The display is connected to both the signal analysis component and the pressure control component to display apnea events and the airflow pressure input to the open-face mask.
2. The device for precise detection and treatment of sleep apnea under continuous airflow support according to claim 1, characterized in that: The proximal end of the open-face mask fits snugly against the face to prevent air leakage; the proximal end of the open-face mask receives positive pressure airflow, while the distal end of the open-face mask is connected to a respiratory flow sensor; the inner diameter of both the distal end of the mask and the respiratory flow sensor is greater than 15 mm to ensure that the internal pressure of the open-face mask is almost always equal to the atmospheric pressure outside the open-face mask, and to ensure that the subject's exhaled air and the positive pressure airflow entering the open-face mask are discharged from the respiratory flow sensor channel connected to the distal end of the open-face mask.
3. The device for precise detection and treatment of sleep apnea under continuous airflow support according to claim 2, characterized in that: The signals detected by the respiratory flow sensor are transmitted to the signal analysis component for analysis. The number of times the tidal volume is less than 10% of the baseline tidal volume and lasts for more than 10 seconds is counted as the number of pauses, and the number of times the tidal volume is between 10% and 50% of the baseline tidal volume and lasts for more than 10 seconds is counted as the number of hypoventilations.
4. The device for precise detection and treatment of sleep apnea under continuous airflow support according to claim 2, characterized in that: The signal detected by the respiratory flow sensor is transmitted to the signal analysis component for processing. The characteristics of airflow recovery after each event in which the tidal volume is less than 10% of the baseline tidal volume and lasts for more than 10 seconds are analyzed: if it only takes two respiratory cycles to go from the tidal volume less than 10% of the baseline tidal volume to the baseline tidal volume level, it is defined as an obstructive sleep apnea event. If it takes more than three respiratory cycles to return to the baseline tidal volume level from less than 10% of the baseline tidal volume, it is defined as a central sleep apnea event.
5. The device for precise detection and treatment of sleep apnea under continuous airflow support according to claim 1, characterized in that: In operation, the positive pressure airflow generating component continuously delivers airflow from the proximal end of the open mask to the inside of the open mask at a flow rate greater than 30 L / min, providing the subject with sufficient inspiratory airflow and accelerating the exhalation of air from the respiratory flow sensor at the distal end of the open mask, thereby minimizing functional dead space.
6. The device for precise detection and treatment of sleep apnea under continuous airflow support according to claim 1, characterized in that: When a positive pressure nasal mask replaces an open-face mask covering the mouth and nose and receives continuous positive airway pressure from the positive pressure airflow generation component, it can realize the conventional continuous positive airway pressure (CPAP) function; by detecting the pressure change of the airflow output by the positive pressure airflow generation component through a pressure flow sensor, apnea events under CPAP can be determined.
7. The device for precise detection and treatment of sleep apnea under continuous airflow support according to claim 1 or 4, characterized in that: When subjects wear a nearly sealed positive pressure nasal mask, if the incidence of apnea events detected by the pressure-flow sensor at CPAP 10 cmH2O decreases by more than 50% compared to CPAP 0 cmH2O, the apnea event is further classified as obstructive; if the decrease is less than 50%, it is classified as central.
8. The device for precise detection and treatment of sleep apnea under continuous airflow support according to claim 7, characterized in that: The positive pressure nasal mask is connected to a positive pressure airflow generating component. When the subject wears the nearly sealed positive pressure nasal mask, if the incidence of apnea events detected by the pressure-flow sensor is less than 10 times / hour at CPAP 10 cmH2O, then CPAP 10 cmH2O is taken as the optimal CPAP pressure for long-term treatment. If the incidence of apnea events overnight is greater than 10 times / hour at CPAP 10 cmH2O, then CPAP 12 cmH2O is set as the treatment pressure for long-term treatment.
9. The device for precise detection and treatment of sleep apnea under continuous airflow support according to claim 1, characterized in that: An open-face mask covering the mouth and nose and a positive pressure nasal mask can be used interchangeably to determine whether sleep apnea events still exist and to treat them, enabling dynamic tracking of sleep apnea events during treatment.