A set of devices for improving breathing quality during sleep and the methods for doing so.
Patent Information
- Application Number
- TH1701006098
- Authority / Receiving Office
- TH · TH
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2015-04-16
- Publication Date
- 2026-08-17
- Estimated Expiration
- 2035-04-15
AI Technical Summary
Existing negative pressure oral interface devices can easily cause saliva to accumulate during use, causing pipeline obstruction and difficulty in maintaining the negative pressure environment inside the oral cavity. They are also uncomfortable for teeth and soft tissues, and require special technology for customization.
A saliva processing system is designed that removes saliva by introducing air into the oral interface device and monitors the liquid volume by detecting the pressure in the reservoir to ensure normal operation of the system. The system includes a fluid diverter and a vacuum-activated pressure relief valve that collects saliva under negative pressure and maintains air circulation in the mouth.
It effectively avoids pipeline obstruction caused by saliva accumulation, maintains a negative pressure environment in the oral cavity, reduces damage to teeth and soft tissues, and simplifies the device adaptation process.
Abstract
Description
Saliva Processing System and Method for Oral Interface Device Technical Field The present invention relates to a medical device for improving the quality of sleep breathing and a method for using the same; specifically, the present invention relates to a saliva processing system and method for a negative pressure oral interface device that can reduce sleep apnea, snoring, etc., for removing saliva from the oral cavity and the system pipeline. Background Art Obstructive sleep apnea (OSA) is a condition in which the patient's airway repeatedly collapses during inspiration, resulting in apnea during sleep. During inspiration, the air pressure in the lungs and airway decreases. If at this moment the muscle activity in the upper airway decreases, the airway tends to collapse. Before apnea, the airway begins to close, and the patient often begins to snore. Snoring is a phenomenon in which the patient tries to fight against the collapsing airway. These disorders occur at different positions along the airway in different patients, but the throat and nasopharynx are two common positions. Patients with moderate to severe obstructive sleep apnea symptoms feel sleepy, tired, and unable to concentrate during the day. In addition to these immediate problems, studies have shown that patients with obstructive sleep apnea symptoms use more medical resources, have an increased risk of medical treatment failure, and ultimately result in a higher mortality rate. Considering all cases, it is estimated that the mortality rate of patients with severe obstructive sleep apnea symptoms will increase by three to six times. Obstructive sleep apnea symptoms are also hidden in many cardiovascular diseases, such as systemic hypertension and a certain degree of pulmonary hypertension. Obstructive sleep apnea symptoms increase the risk of myocardial infarction, cerebrovascular diseases, and arrhythmias. Patients with obstructive sleep apnea symptoms also experience excessive daytime sleep and inability to concentrate due to interrupted sleep at night. The patient's daytime daily function is impaired due to the compromise of the patient's neural recognition function. They are more likely to make mistakes and have accidents. Therefore, if obstructive sleep apnea symptoms are not treated, it will bring serious negative consequences. There are several treatment methods for patients with sleep apnea symptoms currently. Oral appliances are used to treat mild to moderate sleep apnea symptoms, but they often do not work well and can cause damage to the patient's gums and teeth. There are some surgeries used to treat sleep apnea symptoms. However, these surgical procedures are invasive, expensive, and painful, and the recovery period can be up to six months. The most common treatment method for moderate to severe sleep apnea symptoms in adults is to use a constant positive airway pressure (CPAP) machine. The CPAP machine consists of a mask, a pump, and a humidifier. The CPAP machine continuously blows high-pressure air into the patient's nasal passage to keep the airway unobstructed during sleep. The CPAP machine is quite effective, but it can cause uncomfortable side effects, such as dry throat and nasal congestion. Patients using the CPAP machine often feel swollen and have headaches in the morning. The CPAP machine also makes noise and is uncomfortable for the user and their family members. The CPAP machine is the current first-line and gold standard treatment method, but due to the serious side effects it causes, it has a low compliance rate. One current improved practice is to apply negative pressure in the patient's oral cavity to pull the patient's tongue and soft palate forward by the negative pressure to maintain the patency of the airway. For example, U.S. Patent No. 5,957,133, U.S. Published Patent Application No. 2005 / 0,166,928, and No. 2006 / 0,096,600. Although feasible in theory, these prior arts all use large structures to clamp the teeth and / or hold and position the tongue. Furthermore, the negative pressure is directly applied to the soft tissue of the tongue to keep the tongue positioned within the oral cavity. However, these practices will occupy a lot of space in the oral cavity, causing discomfort and damage to the teeth, gums, and soft tissues. At the same time, the presence of larger devices will cause excessive saliva secretion and nausea. Other major drawbacks of these practices still include that these oral devices involve surgical anatomy and they will require special technical personnel to provide customized oral interfaces for each patient. In addition, when using a negative pressure oral interface device, saliva will stay in the pipeline between the oral interface device and the negative pressure source, causing pipeline blockage and the pressure difference between the oral interface device and the negative pressure source, and even having an adverse impact on the maintenance of the negative pressure environment inside the oral cavity. Summary of the Invention In one aspect, the present invention provides a saliva treatment system for an oral interface device, which continuously or as needed introduces air into the system pipeline during the operation of the system while maintaining a negative pressure environment inside the user's oral cavity, so as to facilitate the removal of saliva in the oral interface device and the aforementioned pipeline. On the other hand, the present invention provides a method for monitoring whether the liquid volume in a liquid storage tank for collecting saliva is full by detecting the internal pressure of the liquid storage tank, so as to effectively handle the saliva in the oral interface device and pipeline of the system of the present invention. In yet another aspect, the present invention provides a breathable oral interface that can be applied to the system of the present invention, and through which the air in the user's oral cavity is facilitated to be discharged to the surrounding environment. On the other hand, the present invention provides a method for measuring the liquid volume in the liquid storage tank of the saliva processing system of the aforementioned oral interface device, which includes placing the oral interface device in a user's oral cavity, connecting a negative pressure source through the system to form a negative pressure path between the user's oral cavity and the negative pressure source, and collecting the saliva in the user's oral cavity into the liquid storage tank through the negative pressure path; continuously and intermittently measuring the pressure value in the liquid storage tank; and determining the liquid volume in the liquid storage tank according to the measured pressure value to facilitate the user to judge whether it is necessary to replace or clean the liquid storage tank. In one aspect of the present invention, the present invention provides a saliva processing system for an oral interface device, which includes an oral interface device for placing in a user's oral cavity to provide a fluid passage in the user's oral cavity; a fluid diverter having a first interface end and a second interface end, the fluid diverter being used to restrict all fluids to flow to its second interface end, the first interface end being connected to the fluid passage of the oral interface device; and a connecting pipe having a first open end and a second open end, wherein the first open end is connected to the second interface end of the fluid diverter, and the second open end is connected to a liquid storage tank and a negative pressure source, thereby forming a negative pressure path between the inside of the user's oral cavity and the negative pressure source, and the saliva in the user's oral cavity is collected in the liquid storage tank through the negative pressure path. In another aspect of the present invention, the present invention provides a saliva treatment system for an oral interface device, comprising: an oral interface device for placement in a user's oral cavity to provide at least one fluid passage in the user's oral cavity, the oral interface device having an extension protruding outside the user's oral cavity, the extension having a first flow channel and a second flow channel, both communicating with the interior of the user's oral cavity, a vacuum-activated pressure relief valve being provided at one end of the first flow channel located outside the oral cavity; and a connecting pipe having a first open end and a second open end, the first open end communicating with the second flow channel of the oral interface device, and the second open end communicating with a liquid storage tank and a negative pressure source, thereby forming a negative pressure path between the interior of the user's oral cavity and the negative pressure source; wherein at a predetermined negative pressure value, the vacuum-activated pressure relief valve is activated to allow ambient air to enter the user's oral cavity through the first flow channel, and the saliva in the oral cavity and the saliva flow remaining in the connecting pipe are carried by the inflowing air stream to the liquid storage tank. In an aspect of the oral interface device of the present invention, the present invention provides a breathable oral interface, comprising a flexible barrier for placement between a user's lips and teeth, the flexible barrier having at least one one-way valve to restrict the flow of air in the user's oral cavity through the one-way valve to the outside of the oral cavity; an extension formed on one side of the flexible barrier and protruding outside the user's oral cavity; and a flexible air conduit passing through the flexible barrier and the extension, the flexible air conduit having a first open end extending outside the user's oral cavity for connection to a negative pressure source, and an opposite second open end for placement between the user's tongue and the palate. In an aspect of the oral interface device of the present invention, the present invention further provides an oral interface device, comprising a flexible barrier for placement between a user's lips and teeth; an extension formed on one side of the flexible barrier and protruding outside the user's oral cavity; and a flexible air conduit passing through the flexible barrier and the extension, the flexible air conduit having a first open end extending outside the user's oral cavity for connection to a negative pressure source, and an opposite second open end for placement between the user's tongue and the palate; wherein the extension has a first flow channel and a second flow channel formed on opposite sides of the flexible air conduit and communicating with the interior of the user's oral cavity. One of the first flow channel and the second flow channel, or both, has a one-way valve provided at an end remote from the user's oral cavity to restrict the flow of air in the user's oral cavity through the one-way valve to the outside of the oral cavity. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a first specific embodiment of the saliva treatment system of the oral interface device of the present invention. FIG. 1A is a perspective structural view of the oral interface device of FIG. 1; FIG. 1B is a top view of the oral interface device of FIG. 1 placed in a user's oral cavity. FIGS. 2A and 2B are top cross-sectional views of the first and second variants of the oral interface device of FIG. 1. FIG. 3 is a pressure-time graph. FIG. 4 is a pressure-liquid volume graph, FIG. 5 is a second specific embodiment of the saliva treatment system of the oral interface device of the present invention. FIG. 5A is an enlarged cross-sectional view of the fluid diverter of the saliva treatment system of FIG. 5. FIGS. 5B-1 and 5B-2 are enlarged cross-sectional views of an embodiment of the vacuum activation pressure release valve of FIG. 5 in the closed and open states, respectively. FIGS. 5C-1 and 5C-2 are enlarged cross-sectional views of another embodiment of the vacuum activation pressure release valve of FIG. 5 in the closed and open states, respectively. FIG. 6 is a third specific embodiment of the saliva treatment system of the oral interface device of the present invention. FIGS. 6A-1 and 6A-2 are top cross-sectional views of the first variant of the saliva treatment system of FIG. 6 in different usage states. FIGS. 6B-1 and 6B-2 are top cross-sectional views of the second variant of the saliva treatment system of FIG. 6 in different usage states. Description of main component reference numerals: 1, 5, 6 ---- Saliva treatment systems of the oral interface device 11, 51 ---- Three-way connectors 12, 52, 62 ---- Connecting pipes 13, 53, 511, 252, 604 ---- Check valves 14, 55, 64 ---- Liquid storage tanks 15, 56, 65 ---- Negative pressure sources 17, 58, 67 ---- Timers 18, 59, 68 ---- Control units 19, 60, 69 ---- Warning devices 50 ---- Fluid diverter 54, 54a, 54b, 602 ---- Vacuum activation pressure release valves 100, 200, 202, 500, 600, 600a, 600b ---- Oral interface devices 110, 210, 212, 510, 610 ---- Flexible air ducts 120, 220, 222, 520, 620 ---- First opening end 130, 230, 232, 530, 630 ---- Second opening end 150, 250, 550, 650 ---- Flexible barrier 111 ---- Flexible intermediate section 131 ---- Thicker and wider structure 140, 240, 242, 640 ---- Through hole 151 ---- Flexible central part 214, 612 ---- First flow channel 215, 613 ---- Second flow channel 216, 614 ---- Third flow channel 260, 262 ---- Oral region between tongue and soft / hard palate 540a, 540b ---- Body 542a, 544a ---- First chamber 542b, 544b ---- Second chamber 546a, 546b ---- Propulsion valve 547a, 547b ---- Spring 548a, 548b ---- Spring seat 660 ---- Movable projection 680 ---- Rotatable hollow pipe fitting Detailed implementation mode The objectives, spirit and advantages of the present invention will become apparent through the following detailed description of specific embodiments in conjunction with the accompanying drawings. Figure 1 is a first specific embodiment of the saliva treatment system of the oral interface device of the present invention. In the first specific embodiment, the present invention provides a saliva treatment system 1 of an oral interface device, which includes an oral interface device 100, A fluid flow regulator composed of a tri-way connector 11 and a second one-way valve 13, a connecting pipe 12, a liquid storage tank 14, a negative pressure source 15, a pressure sensor 16, a timer 17, a control unit 18, and a warning device 19. The oral interface device 100 is the same as the oral device shown in FIGS. 1A and 1B disclosed in Taiwan Patent Application No. 103101121 of the applicant of the present invention, which claims priority from U.S. Provisional Application No. 61 / 751,559. The specific three-dimensional structure of the oral interface device 100 is shown in FIG. 1A of the present application, and FIG. 1B is a top view of the oral interface device 100 placed in a user's oral cavity. The oral interface device 100 is an integrally formed device, including a flexible barrier 150 and a flexible air flow conduit 110. The flexible barrier 150 is used to be disposed between a user's lips and teeth to facilitate firmly attaching the oral interface device 100 to the user's mouth. Preferably, the flexible barrier 150 is placed between the user's lips and front teeth, and the flexible barrier 150 has a flexible center portion 151 for conforming to the front surface contour of the user's upper and lower rows of teeth to suit different tooth structures of different users. The flexible air flow conduit 110 is in the shape of a hollow tube and passes through the flexible center portion 151 of the flexible barrier 150. The flexible air flow conduit 110 has a first open end 120 disposed outside the user's mouth and used to communicate with a first interface end of the three-way connector 11. The flexible air flow conduit 110 further has a relative second open end 130 for being disposed in the space between the user's tongue and the palate. Preferably, the flexible air flow conduit 110 is placed along the center line of the user's tongue. The flexible air flow conduit 110 is conformable to the contour of the user's palate and tongue, and the flexible air flow conduit 110 further has a flexible intermediate section 111 formed between the flexible barrier 150 and the second open end 130 and near the flexible barrier 150. The flexible intermediate section 111 has a narrower and thinner structure compared to other parts of the flexible air flow conduit 110 to facilitate conforming to the contour of the user's palate and tongue. In other words, the flexible intermediate section 111 can conform to the palate contour of different users. The flexible air flow conduit 110 further has at least one through hole 140 formed in the flexible intermediate section 111 near the center region of the flexible barrier 150, and the through hole 140 communicates with one side of the flexible air flow conduit 110. Preferably, the through hole 140 communicates with the flexible air flow conduit 110 laterally with respect to the direction of the hollow tube of the flexible air flow conduit 110.The second opening end 130 of the flexible air duct 110 has a thicker and wider structure 131 compared to the flexible intermediate section 111, so as to increase the structural strength of the flexible air duct 110 and prevent the flexible air duct 110 from collapsing when pressed by the user's tongue and palate. The cross-sectional schematic diagram of the three-way connector 11 is the same as that of the three-way connector 51 in FIG. 5A. A first one-way valve (not shown in FIG. 1) is provided at the first interface end of the first opening end 120 of the oral interface device 100 where the three-way connector 11 communicates. The first one-way valve is the same as the first one-way valve 511 shown in FIG. 5A and is used to restrict the flow of fluid in the user's oral cavity to the three-way connector 11. A first opening end of the connecting pipe 12 communicates with a second interface end of the three-way connector 11, and a second opening end of the connecting pipe 12 communicates with the liquid storage tank 14. The second one-way valve 13 communicates with a third interface end of the three-way connector 11 and is used to restrict the flow of ambient air through the second one-way valve 13 to the three-way connector 11. In the first specific embodiment of the present invention, the three-way connector 11 and the second one-way valve 13 constitute the aforementioned fluid diverter, which is used to restrict all fluids from flowing through the second interface end of the three-way connector 11 to the connecting pipe 12. In other words, after the saliva treatment system 1 of the oral interface device of the present invention is started, the fluid flow direction is as shown by the arrow in FIG. 1. The negative pressure source 15 communicates with the liquid storage tank 14. The present invention can start / stop the negative pressure source 15, for example, via the control unit 18 or manually. After the negative pressure source 15 is started, the saliva treatment system 1 of the oral interface device of the present invention forms a negative pressure path between the inside of the user's oral cavity and the negative pressure source 15, so as to facilitate the extraction of air and saliva in the user's oral cavity through the negative pressure path, and the saliva can be collected in the liquid storage tank 14. Furthermore, during the start-up of the saliva treatment system 1 of the oral interface device of the present invention, as shown by the arrow in FIG. 1, ambient air can pass through the second one-way valve 13 and the three-way connector 11 into the connecting pipe 12, so as to facilitate the collection of saliva remaining in the connecting pipe 12 into the liquid storage tank 14, thereby avoiding the pressure difference between the inside of the user's oral cavity and the negative pressure source 15 caused by the remaining saliva in the connecting pipe 12, and even avoiding the blockage of the connecting pipe 12 by saliva, and further maintaining the negative pressure path between the inside of the user's oral cavity and the negative pressure source 15. In addition, in a variant of the first specific embodiment (not shown in the figure), in the saliva treatment system 1 of the oral interface device of the present invention, the negative pressure source 15 can also communicate between the connecting pipe 12 and the liquid storage tank 14, and the negative pressure source 15 can be started / stopped via the control unit 18 or manually. On the other hand, the saliva processing system 1 of the oral interface device of the present invention can continuously and intermittently measure the saliva volume in the liquid storage tank 14 to monitor whether the saliva volume in the liquid storage tank 14 is full, so as to facilitate maintaining the normal operation of the entire system. In the first specific embodiment of the present invention, the saliva processing system 1 of the oral interface device starts / stops the time calculation operation of the timer 17 through the control unit 18. After the timer 17 is started, it can continuously and intermittently count time until a set time period t and then send a notification signal to the control unit 18, and then the control unit 18 reads a pressure value measured by the pressure sensor 16. The pressure sensor 16 is connected to the liquid storage tank 14 and is used to measure the pressure value inside the liquid storage tank 14. In short, after the timer 17 is started, it sends a notification signal to the control unit 18 every period of time t to notify the control unit 18 to read a pressure value measured by the pressure sensor 16. In this way, the control unit 18 can continuously and intermittently read the pressure value sensed by the pressure sensor 16. The control unit 18 then determines the liquid volume in the liquid storage tank 14 according to the read pressure value. In addition, the length of the set time period t can be adjusted as needed. For example, it can be set so that the control unit 18 periodically reads the pressure value measured by the pressure sensor 16. The method for measuring the liquid volume in the liquid storage tank 14 in the saliva processing system 1 of the oral interface device of the present invention is described in detail as follows. Please refer to Table 1 below. The first row of Table 1 shows the liquid volume inside the liquid storage tank 14. The value in each column represents the pressure value (the unit of the pressure value is mmHg) measured by the liquid storage tank 14 with the liquid volume shown in that column. And the time intervals between the upper and lower pressure values measured in the same column are of the same length, for example, T2 - T1 = t, and T3 - T2 = t. It can be seen from Table 1 that at a specific set time period t, when the liquid volume inside the liquid storage tank 14 is different, the measured pressure value inside the liquid storage tank 14 is also different. For example, the pressure value shown in the 14th row of the pressure value in Table 1. It can be clearly seen that when the timer 17 is set to notify the control unit 18 to read the pressure value measured by the pressure sensor 16 at the same time length interval (for example, T 14 ) as the liquid volume inside the liquid storage tank 14 increases (from 0 ml to 80 ml), the pressure value inside the liquid storage tank 14 also increases (from -71.0922 mmHg to -33.7023 mmHg). Table 1 Please refer to FIG. 3, which is a pressure-time relationship diagram. The Y-axis represents the pressure value inside the liquid storage tank 14, and the X-axis represents the time period t counted by the timer 17. Curves a, b, c, d, e, f, g, h, and i represent that the internal liquid volume of the liquid storage tank 14 is 80 ml, 70 ml, 60 ml, 50 ml, 40 ml, 30 ml, 20 ml, 10 ml, and 0 ml. FIG. 4 is a pressure-liquid volume relationship diagram, which is obtained by converting the pressure values and liquid volumes listed in row 15 of Table 1. It can be seen that when the timer 17 notifies the control unit 18 to read the pressure value inside the liquid storage tank 14 measured by the pressure sensor 16 every set time period T, when the internal liquid volume of the liquid storage tank 14 is different, the measured pressure value is also different. The control unit 18 has built-in a pressure-liquid storage tank liquid volume correspondence table corresponding to the set time period T counted by the timer 17 15 , for example, obtained by converting from FIG. 4. When the control unit 18 reads the pressure value of the liquid storage tank 14, it can determine the liquid volume value inside the liquid storage tank 14 according to the pressure-liquid storage tank liquid volume correspondence table, and transmit the liquid volume value to the warning device 19, and a prompt signal is issued through the warning device 19, so as to detect whether the liquid volume in the liquid storage tank 14 is full. In addition, the control unit 18 can also build multiple pressure-liquid storage tank liquid volume correspondence tables corresponding to different set time periods t (such as T2, T3, T4, T5,..., T 10 , T 11 ...) of the timer 17 to adjust the time for the control unit 18 to read the pressure value inside the liquid storage tank 14 as needed, and determine the liquid volume of the liquid storage tank 14 according to the corresponding pressure-liquid storage tank liquid volume correspondence table. Figures 2A and 2B are top cross-sectional views of a first variation and a second variation of the oral interface device 100 of the first specific embodiment. In the saliva processing system 1 of the oral interface device of the present invention, the oral interface devices of the first variation and the second variation can replace the oral interface device 100. In the first variation shown in Figure 2A, an oral interface device 200 of the present invention includes a flexible barrier 250 and a flexible air duct 210. The flexible air duct 210 has a first open end 220 disposed outside the user's mouth and used to communicate with a first interface end of the three-way connector 11. The flexible air duct 210 further has a second open end 230 opposite thereto, which is used to be disposed in the space between the user's tongue and the upper jaw. The dashed area indicated by the reference numeral 260 represents the oral area between the tongue and the soft / hard palate. The flexible air duct 210 further has at least one through hole 240 formed near the central area of the flexible barrier 250, and the through hole 240 communicates with the flexible air duct 210. Preferably, the through hole 240 communicates with the flexible air duct 210 laterally with respect to the direction of the hollow tube body of the flexible air duct 210. The body shape of the flexible air duct 210 is the same as that of the flexible air duct 110 and will not be repeated here. The flexible barrier 250 has an extension extending towards the first open end 220 of the flexible air duct 210 and protruding outside the user's mouth, and the flexible air duct 210 passes through the extension. The flexible barrier 250 has at least one one-way valve 252. When the user opens the mouth to breathe, the air in the oral cavity flows out of the oral cavity through the one-way valve 252, as indicated by the arrow. In the second variation shown in Figure 2B, an oral interface of the present invention The device 202 includes a flexible barrier 250 and a flexible air duct 212. The flexible air duct 212 has a first open end 222 disposed outside the user's mouth and is used to communicate with a first interface end of the three-way connector 11. The flexible air duct 212 further has a relative second open end 232, which is used to be disposed in the space between the user's tongue and the upper jaw. The dotted area indicated by the reference numeral 262 represents the oral area between the tongue and the soft / hard palate. The flexible air duct 212 further has at least one through hole 242 formed near the central area of the flexible barrier 250, and the through hole 242 communicates with the flexible air duct 212. Preferably, the through hole 242 communicates with the flexible air duct 212 transversely with respect to the direction of the hollow tube body of the flexible air duct 212. The body shape of the flexible air duct 212 is the same as that of the flexible air duct 110 and will not be repeated here. The flexible barrier 250 has an extension extending toward the first open end 222 of the flexible air duct 212 and protruding outside the user's mouth. The flexible air duct 212 passes through the extension, and a first flow channel 214, a second flow channel 215, and a third flow channel 216 are formed in the extension. The first flow channel 214 and the third flow channel 216 are formed on opposite sides of the second flow channel 215. The first flow channel 214, the second flow channel 215, and the third flow channel 216 communicate with the interior of the user's oral cavity, and one-way valves are respectively provided at the ports of the first flow channel 214 and the third flow channel 216 near the first open end 222, so that the air in the user's oral cavity can flow out of the oral cavity through the one-way valves, as indicated by the arrows. Figure 5 is a second specific embodiment of the saliva processing system of the oral interface device of the present invention. In this second specific embodiment, the present invention provides a saliva processing system 5 of an oral interface device, which includes an oral interface device 500, a fluid flow regulator 50, a connecting pipe 52, a liquid storage tank 55, a negative pressure source 56, a pressure sensor 57, a timer 58, a control unit 59, and a warning device 60. The oral interface device 500 is the same as the oral interface device 100 of the first specific embodiment shown in FIG. 1. The oral interface device 500 is an integrally formed device, at least including a flexible barrier 550 and a flexible air duct 510. The flexible air duct 510 has a first opening end 520 disposed outside the user's mouth and used to communicate with the fluid flow regulator 50. The flexible air duct 510 further has a relative second opening end 530, which is used to be disposed in the space between the user's tongue and the upper jaw. The fluid flow regulator 50 includes a three-way connector 51, a second one-way valve 53, and a vacuum start pressure release valve 54. FIG. 5A is an enlarged cross-sectional schematic view of the fluid flow regulator 50. The three-way connector 51 has a first interface end, a second interface end, and a third interface end. The first interface end is provided with a first one-way valve 511 and communicates with the first opening end 520 of the flexible air duct 510. The fluid in the user's oral cavity flows through the first one-way valve 511 to the three-way connector 51. The second interface end communicates with a first opening end of the connecting pipe 52, and a second opening end of the connecting pipe 52 communicates with the liquid storage tank 55. The liquid storage tank 55 communicates with the negative pressure source 56. After the negative pressure source 56 is started, a negative pressure path is formed between the inside of the user's oral cavity and the negative pressure source 56. The The second one-way valve 53 is disposed at the third interface end of the three-way connector 51, and the vacuum start pressure release valve 54 is coupled to one end of the second one-way valve 53 relative to the three-way connector 51. FIGS. 5B-1 and 5B-2 are enlarged cross-sectional views of an embodiment of the vacuum start pressure release valve 54. The vacuum start pressure release valve 54a shown in FIG. 5B-1 is in a closed state and includes a body 540a, a push valve 546a, a spring 547a, and a spring seat 548a. A partition with a channel is disposed inside the body 540a to divide the body 540a into a first chamber 542a and a second chamber 544a. The first chamber 542a communicates with the surrounding air, and the second chamber 544a communicates with the second one-way valve 53. The push valve 546a is movably disposed in the first chamber 542a and passes through the channel. When the vacuum start pressure release valve 54a is not activated, the push valve 546a occupies the entire space of the channel, isolating the fluid in the first chamber 542a from the second chamber 544a to prevent the surrounding air from entering the second chamber 544a. The spring seat 548a is disposed on a surface of the partition in the first chamber 542a, and the spring 547a abuts between the push valve 546a and the spring seat 548a. FIG. 5B-2 shows the vacuum start pressure release valve 54a in an open state. When the negative pressure value in the negative pressure path between the user's oral cavity and the negative pressure source 56 reaches the activation threshold of the vacuum start pressure release valve 54a, the pressure difference between the first chamber 542a and the second chamber 544a causes the surrounding air to push the push valve 546a forward, thereby forming an air flow path between the partition channel and the push valve 546a, allowing the surrounding air to enter the second chamber 544a via the air flow path, and then passing through the second one-way valve 53 and the second interface end of the three-way connector 51 into the communication pipe 52. The introduced surrounding air can carry the saliva staying in the communication pipe 52 to the liquid storage tank 55. As can be seen from FIG. 5, the fluid diverter 50 composed of the three-way connector 51, the first one-way valve 511, the second one-way valve 53, and the vacuum start pressure release valve 54 can restrict all fluids from flowing to the communication pipe 52. In other words, after the saliva processing system 5 of the oral interface device of the present invention is activated, the fluid flow direction is as shown by the arrows in FIG. 5. The negative pressure source 56 is connected to the liquid storage tank 55. The present invention can start / stop the negative pressure source 56, for example, via the control unit 59 or manually. After the negative pressure source 56 is started, the saliva processing system 5 of the oral interface device of the present invention forms a negative pressure path between the user's oral cavity and the negative pressure source 56 to facilitate the extraction of the air and saliva in the user's oral cavity via the negative pressure path, and the saliva can be collected in the liquid storage tank 55.Furthermore, during the startup of the saliva treatment system 5 of the oral interface device of the present invention, as shown by the arrow in FIG. 5, ambient air can enter the communication pipe 52 through the second one-way valve 53, the vacuum startup pressure release valve 54, and the three-way connector 51, so as to facilitate carrying away the saliva staying in the communication pipe 52 by air and collecting it in the liquid storage tank 55. Furthermore, it is possible to avoid the pressure difference between the inside of the user's oral cavity and the negative pressure source 56 caused by the remaining saliva in the communication pipe 52, and even more, it is possible to avoid the communication pipe 52 being blocked by saliva, thereby maintaining the negative pressure path between the inside of the user's oral cavity and the negative pressure source 56. FIG. 5C-1 and FIG. 5C-2 are enlarged cross-sectional schematic views of another embodiment of the vacuum startup pressure release valve 54. In the embodiment shown in FIG. 5C-1, the vacuum startup pressure release valve 54b is in a closed state, which includes a body 540b, a push valve 546b, a spring 547b, and a spring seat 548b. A partition with a channel is provided inside the body 540b to divide the body 540b into a first chamber 542b and a second chamber 544b. The first chamber 542b communicates with ambient air, and the second chamber 544b communicates with the second one-way valve 53. The push valve 546b is movably arranged in the first chamber 542b and passes through the channel. When the vacuum startup pressure release valve 54b is not started, the push valve 546b occupies the entire space of the channel, isolating the fluid in the first chamber 542b from the second chamber 544b to prevent ambient air from entering the second chamber 544a. The spring seat 548b is arranged on a surface of the partition in the first chamber 542b, and the spring 547b abuts between the push valve 546b and the spring seat 548b. FIG. 5C-2 shows that the vacuum startup pressure release valve 54b is in an open state. When the negative pressure value of the negative pressure path between the user's oral cavity and the negative pressure source 56 reaches the startup threshold of the vacuum startup pressure release valve 54b, the pressure difference between the first chamber 542b and the second chamber 544b causes ambient air to push the push valve 546b forward, thereby forming an air flow path between the partition channel and the push valve 546b, enabling ambient air to enter the second chamber 544b through the air flow path, and then entering the communication pipe 52 through the second one-way valve 53 and the second interface end of the three-way connector 51. The introduced ambient air can carry the saliva staying in the communication pipe 52 to the liquid storage tank 55. In addition, in a variation of the second specific embodiment (not shown in the figure), in the saliva treatment system 5 of the oral interface device of the present invention, the negative pressure source 56 can also be connected between the communication pipe 52 and the liquid storage tank 55, and the negative pressure source 56 can be started / stopped via the control unit 59 or manually. On the other hand, the saliva processing system 5 of the oral interface device of the present invention can continuously and intermittently measure the saliva volume in the liquid storage tank 55 to monitor whether the liquid storage tank 55 is full of saliva, so as to facilitate maintaining the normal operation of the entire system. In the second specific embodiment of the present invention, the saliva processing system 5 of the oral interface device starts / stops the time calculation operation of the timer 58 through the control unit 59. After the timer 58 is started, it can continuously and intermittently count the time until a set time period t and then send a notification signal to the control unit 59, and then the control unit 59 reads a pressure value measured by the pressure sensor 57. The pressure sensor 57 is connected to the liquid storage tank 55 for measuring the pressure value inside the liquid storage tank 55. In short, after the timer 58 is started, it sends a notification signal to the control unit 59 every period of time t to notify the control unit 59 to read a pressure value measured by the pressure sensor 57. In this way, the control unit 59 can continuously and intermittently read the pressure value sensed by the pressure sensor 57. The control unit 59 then determines the liquid volume in the liquid storage tank 55 according to the read pressure value. In addition, the length of the set time period t can be adjusted as needed. For example, it can be set so that the control unit 59 periodically reads the pressure value measured by the pressure sensor 57. The method for measuring the liquid volume in the liquid storage tank 55 in the saliva processing system 5 of the oral interface device of the present invention is the same as the method of the system 1 in the first specific example shown in FIG. 1 and will not be repeated here. Figure 6 is a third specific embodiment of the saliva processing system of the oral interface device of the present invention. In this third specific embodiment, the present invention provides a saliva processing system 6 of an oral interface device, which includes an oral interface device 600, a connecting pipe 62, a liquid storage tank 64, a negative pressure source 65, a pressure sensor 66, a timer 67, a control unit 68 and a warning device 69. The oral interface device 600 is an integrally formed device, at least including a flexible barrier 650 and a flexible air duct 610. The flexible air duct 610 has a first opening end 620 disposed outside the user's mouth and used to communicate with a first opening end of the connecting pipe 62, and a second opening end of the connecting pipe 62 communicates with the liquid storage tank 64. The flexible air duct 610 further has a relatively second opening end 630, which is used to be disposed in the space between the user's tongue and the upper jaw. The flexible air duct 610 further has a flexible intermediate section formed between the flexible barrier 650 and the second opening end 630 and near the flexible barrier 650. The flexible intermediate section has a narrower and thinner structure compared with other parts of the flexible air duct 610, so as to conform to the contour of the user's upper jaw and tongue contour. In other words, the flexible intermediate section can conform to the upper jaw contours of different users. The flexible air duct 610 further has at least one through hole 640 formed in the flexible intermediate section near the central area of the flexible barrier 650. Preferably, the through hole 640 is horizontally communicated with the flexible air duct 610 relative to the direction of the hollow tube body of the flexible air duct 610. The second opening end 630 of the flexible air duct 610 has a thicker and wider structure compared with the flexible intermediate section, so as to increase the structural strength of the flexible air duct 610, so that the flexible air duct 610 can avoid collapsing when being pressed by the user's tongue and upper jaw. The flexible barrier 650 has an extension extending towards the first opening end 620 of the flexible air duct 610 and protruding outside the user's mouth, and the flexible air duct 610 passes through the extension, so that a first flow channel 612, a second flow channel 613 and a third flow channel 614 are formed in the extension. Among them, the first flow channel 612 and the third flow channel 614 are formed on the opposite sides of the second flow channel 613, and the part of the flexible air duct 610 passing through the extension constitutes the second flow channel 613.The first flow channel 612, the second flow channel 613 and the third flow channel 614 communicate with the interior of the user's oral cavity. A vacuum start pressure release valve 602 is provided at the port of the first flow channel 612 close to the first opening end 620, and a check valve 604 is provided at the port of the third flow channel 614 close to the first opening end 620. When the negative pressure value inside the user's oral cavity reaches the start threshold of the vacuum start pressure release valve 602, the valve of the vacuum start pressure release valve 602 is opened, and surrounding air enters the user's oral cavity through the vacuum start pressure release valve 602. The introduced surrounding air is conducive to carrying the saliva in the user's oral cavity and the saliva staying in the connecting pipe 62 to the liquid storage tank 64. The check valve 604 is used to limit the air inside the user's oral cavity to flow to the surrounding environment through the check valve 604. The implementation manner of the vacuum start pressure release valve 602 can adopt the specific embodiments shown in FIGS. 5B-1, 5B-2, 5C-1 and 5C-2, which will not be repeated here. The negative pressure source 65. communicates with the liquid storage tank 64. In the present invention, the negative pressure source 65 can be started / stopped, for example, via the control unit 68 or manually by a person. After the negative pressure source 65 is started, the saliva treatment system 6 of the oral interface device of the present invention forms a negative pressure path between the interior of the user's oral cavity and the negative pressure source 65, so as to facilitate pumping out the air and saliva in the user's oral cavity through the negative pressure path, and the saliva can be collected in the liquid storage tank 64. Furthermore, during the start-up period of the saliva treatment system 6 of the oral interface device of the present invention, surrounding air can enter the connecting pipe 62 through the vacuum start pressure release valve 602, so as to facilitate carrying away the saliva staying in the connecting pipe 62 through the air and collecting it into the liquid storage tank 64, thereby avoiding the pressure difference between the interior of the user's oral cavity and the negative pressure source 65 caused by the remaining saliva in the connecting pipe 62, and even avoiding the connecting pipe 62 being blocked by saliva, and further maintaining the negative pressure path between the interior of the user's oral cavity and the negative pressure source 65. Figures 6A-1 and 6A-2 are schematic top cross-sectional views of a first variant of the oral interface device 600. An oral interface device 600a shown in the first variant can replace the oral interface device 600 of the saliva treatment system 6 of the oral interface device. The difference in structure between the oral interface device 600a and the oral interface device 600 is that the oral interface device 600a is provided with an adjustable flow restrictor, which is a movable convex member 660, in the first flow channel 612 near the vacuum start pressure release valve 602. The remaining components are the same as those of the oral interface device 600 and will not be repeated here. One side of the movable convex member 660 protrudes outside the extension for holding and moving the movable convex member 660, as shown in Figures 6A-1 and 6A-2, so as to adjust the size of the internal space of the first flow channel 612 and thus change its flow resistance. Referring to Figure 6A-2, when the movable convex member 660 moves towards the flexible air duct 610 to reduce the internal space of the first flow channel 612, the start threshold of the vacuum start pressure release valve 602 is increased. In other words, the start threshold of the vacuum start pressure release valve 602 in the usage state of Figure 6A-2 is higher than that in the usage state of Figure 6A-1. The vacuum start pressure release valve 602 in the usage state of Figure 6A-2 requires a higher oral negative pressure value to be opened. Figures 6B-1 and 6B-2 are schematic top cross-sectional views of a second variant of the oral interface device 600. An oral interface device 600b shown in the second variant can replace the oral interface device 600 of the saliva treatment system 6 of the oral interface device. The difference in structure between the oral interface device 600b and the oral interface device 600 is that the oral interface device 600b is provided with an adjustable flow restrictor, which is a rotatable hollow pipe fitting 680, in the first flow channel 612 near the vacuum start pressure release valve 602. The remaining components are the same as those of the oral interface device 600 and will not be repeated here. The rotatable hollow pipe fitting 680 has an open hollow pipe communicating with the first flow channel 612, and one end of the rotatable hollow pipe fitting 680 protrudes outside the extension for holding and rotating the rotatable hollow pipe fitting 680, as shown in Figures 6B-1 and 6B-2, so as to change the flow resistance of the first flow channel 612. Referring to Figure 6B-2, by rotating the rotatable hollow pipe fitting 680 by a specific angle, the flow resistance of the first flow channel 612 can be changed, and thus the start threshold of the vacuum start pressure release valve 602 can be changed. In other words, the start threshold of the vacuum start pressure release valve 602 in the usage state of Figure 6B-2 is higher than that in the usage state of Figure 6B-1. The vacuum start pressure release valve 602 in the usage state of Figure 6B-2 requires a higher oral negative pressure value to be opened. In addition, in a variation of the third specific embodiment (not shown in the figure), the negative pressure source 65 in the saliva treatment system 6 of the oral interface device of the present invention can also be connected between the communication pipe 62 and the liquid storage tank 64, and the negative pressure source 65 can be started / stopped via the control unit 68 or manually. On the other hand, the saliva treatment system 6 of the oral interface device of the present invention can continuously and intermittently measure the saliva volume in the liquid storage tank 64 to monitor whether the liquid storage tank 64 is full of saliva, so as to facilitate maintaining the normal operation of the entire system. In the third specific embodiment of the present invention, the saliva treatment system 6 of the oral interface device starts / stops the time calculation operation of the timer 67 through the control unit 68. After the timer 67 is started, it can continuously and intermittently count the time until a set time period t and then send a notification signal to the control unit 68, and then the control unit 68 reads a pressure value measured by the pressure sensor 66. The pressure sensor 66 is connected to the liquid storage tank 64 for measuring the internal pressure value of the liquid storage tank 64. In short, after the timer 67 is started, it sends a notification signal to the control unit 68 every once in a while t to notify the control unit 68 to read a pressure value measured by the pressure sensor 66. In this way, the control unit 68 can continuously and intermittently read the pressure value sensed by the pressure sensor 66. The control unit 68 then determines the liquid volume in the liquid storage tank 64 according to the read pressure value. In addition, the length of the set time period t can be adjusted as needed. For example, it can be set so that the control unit 68 periodically reads the pressure value measured by the pressure sensor 66. The method for measuring the liquid volume in the liquid storage tank 64 in the saliva treatment system 6 of the oral interface device of the present invention is the same as that of the system 1 in the first specific example shown in FIG. 1, and will not be repeated here. The system and method of the present invention can also be further used in combination with other devices for treating sleep apnea. For example, the system of the present invention can be used in combination with a nasal one-way valve device. For example, the device disclosed in U.S. Patent No. 8,061,357. Using the nasal one-way valve device can increase the positive pressure in the upper respiratory tract. In cooperation with the present invention to generate negative pressure in the oral cavity and avoid air leakage through the open mouth, the pressure gradient between the oral cavity and the upper respiratory tract can be increased and maintained, thus prompting the soft palate to move forward into the oral cavity and the tongue to move upward to the hard palate and the front of the oral cavity to ensure the patency of the upper respiratory tract. The system and method of the present invention can be further used in conjunction with a continuous positive airway pressure (CPAP) device. By using the CPAP device, positive pressure in the upper respiratory tract can be increased and maintained. Combining with the present invention to generate negative pressure in the oral cavity and prevent air leakage through an open mouth, the pressure gradient between the oral cavity and the upper respiratory tract can be increased and maintained, thus promoting the soft palate to move forward into the oral cavity and the tongue to move upward towards the hard palate and the front of the oral cavity to ensure the patency of the upper respiratory tract. When using the system of the present invention simultaneously, the set value required for the CPAP device can be further reduced; when using the system of the present invention simultaneously, the positive pressure value of the CPAP device can be further reduced intermittently to be turned on or increased, so as to reduce the respiratory discomfort caused by continuous positive pressure to the user and improve the patient compliance. The system and method of the present invention can be further used in conjunction with a respiratory detection device. By using the respiratory detection device to detect the respiratory flow in the upper respiratory tract, when a state of apnea or hypopnea is detected, the negative pressure value of the oral interface device of the present invention is turned on or increased to reduce the activation time of the negative pressure generating device, achieving the purpose of energy saving and quietness. The above are only specific embodiments of the present invention and are not intended to limit the scope of the patent application of the present invention; all other equivalent changes or modifications made without departing from the spirit disclosed by the present invention shall be included in the scope of the patent application of the present invention.