WO2016165103A1 - 口部介面装置的唾液处理系统及其方法 - Google Patents

口部介面装置的唾液处理系统及其方法 Download PDF

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Publication number
WO2016165103A1
WO2016165103A1 PCT/CN2015/076748 CN2015076748W WO2016165103A1 WO 2016165103 A1 WO2016165103 A1 WO 2016165103A1 CN 2015076748 W CN2015076748 W CN 2015076748W WO 2016165103 A1 WO2016165103 A1 WO 2016165103A1
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WO
WIPO (PCT)
Prior art keywords
interface device
saliva
oral
user
pressure
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PCT/CN2015/076748
Other languages
English (en)
French (fr)
Inventor
陈仲竹
黄振宁
余东铭
陈殷瑞
游明谏
黄文彦
Original Assignee
莱镁医疗器材股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 莱镁医疗器材股份有限公司 filed Critical 莱镁医疗器材股份有限公司
Priority to PCT/CN2015/076748 priority Critical patent/WO2016165103A1/zh
Priority to SG11201708160QA priority patent/SG11201708160QA/en
Publication of WO2016165103A1 publication Critical patent/WO2016165103A1/zh
Priority to IL255021A priority patent/IL255021B/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/56—Devices for preventing snoring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C17/00—Devices for cleaning, polishing, rinsing or drying teeth, teeth cavities or prostheses; Saliva removers; Dental appliances for receiving spittle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C17/00—Devices for cleaning, polishing, rinsing or drying teeth, teeth cavities or prostheses; Saliva removers; Dental appliances for receiving spittle
    • A61C17/06—Saliva removers; Accessories therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/56—Devices for preventing snoring
    • A61F5/566—Intra-oral devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems

Definitions

  • the present invention relates to a medical device for improving sleep breathing quality and a method for using same; in particular, the present invention relates to a saliva treatment system and a method thereof for reducing a sleep breathing suspension phenomenon, snoring and the like having a negative pressure oral interface device Used to remove saliva from the mouth and system lines.
  • Sleep Respiratory Suspension is a symptom of repeated collapse of the respiratory tract during inhalation, which can cause apnea during sleep.
  • the air pressure in the lungs and respiratory tract is reduced during inhalation. If at this moment, the muscle activity of the upper respiratory tract is reduced, the respiratory tract will tend to collapse. Before the apnea, the airway will begin to close and the patient will often start snoring.
  • Snoring is a phenomenon in which a patient tries to fight a collapsed respiratory tract. These disorders occur in different locations along the respiratory tract in different patients, but there are two common locations in the throat and nasopharynx.
  • CPAP Constant Positive Airway Pressure
  • Positive pressure breathing apparatus is composed of a mask, a pump and a humidifier. The positive pressure respirator continuously blows high pressure air into the patient's nasal passages to keep the patient's airway clear during sleep.
  • Positive pressure breathing apparatus is quite effective, but it can cause unpleasant side effects, such as Dry throat and blocked nasal passages. Patients who use positive pressure respirators often experience swelling and headaches in the morning. Positive pressure breathing apparatus also makes users and their families feel noisy and uncomfortable. Positive pressure breathing apparatus is the first line and gold standard treatment method today, but it has low adaptability due to its serious side effects.
  • a current improvement is to apply a negative pressure in the patient's mouth and pull the patient's tongue and soft palate forward by negative pressure to maintain the airway.
  • U.S. Patent No. 5,957,133 U.S. Patent Application Serial No. 2005/0,166,928, and No. 2006/0,096,600.
  • these prior art techniques use large structures to clamp the teeth and/or hold and position the tongue.
  • the negative pressure is applied directly to the soft tissue of the tongue to keep the tongue positioned in the mouth.
  • these practices can take up a lot of space in the mouth, causing discomfort and damage to teeth, gums and soft tissues.
  • the presence of larger devices can cause excessive salivation and nausea.
  • Other major drawbacks of these practices still include that these oral devices involve surgical anatomy, which would require a special technician to provide a customized oral interface for each patient.
  • the present invention provides a saliva treatment system for an oral interface device that continuously or optionally introduces air into the system tubing while maintaining a negative pressure environment within the user's mouth during system operation. In order to facilitate the removal of saliva in the oral interface device and the aforementioned conduit.
  • the present invention provides a method for detecting the internal pressure of a liquid storage tank of a saliva to monitor whether the liquid capacity in the liquid storage tank is fully loaded, thereby effectively processing the oral interface device and the pipeline in the system of the present invention. saliva.
  • the present invention provides a ventilated oral interface that can be applied to the system of the present invention, through which the vented oral interface device facilitates venting air from the user's mouth to the surrounding environment. .
  • the present invention provides a method for measuring a liquid volume in a reservoir of a saliva processing system of the aforementioned oral interface device, comprising placing the oral interface device in a user's mouth and communicating a negative pressure through the system a source for forming a negative pressure path between the user's mouth and the source of negative pressure, and saliva in the oral cavity of the user is collected into the reservoir via the negative pressure path; continuously measuring the stock solution intermittently The pressure value in the tank; and determining the liquid capacity in the liquid storage tank according to the measured pressure value, so as to facilitate the user to determine whether the liquid storage tank needs to be replaced or cleaned.
  • the present invention provides a saliva treatment system for an oral interface device that includes an oral interface device for placement in a user's mouth to provide a user's mouth.
  • a fluid channeling device having a first interface end and a second interface end, the fluid diverter for restricting all fluids from flowing to the second interface end thereof, the first interface end being connected to the port interface The fluid passage of the device; and a communication tube having a first open end and a second open end, wherein the first open end is in communication with the second interface end of the fluid diverter, and the second open end Connected to a reservoir and a source of negative pressure to form a negative pressure path between the interior of the user's mouth and the source of negative pressure, wherein saliva in the oral cavity of the user is collected in the reservoir through the negative pressure path Liquid tank.
  • the present invention provides a saliva treatment system for an oral interface device, comprising: an oral interface device for placement in a user's mouth for in the user's mouth Providing at least one fluid passage, the oral interface device having an extension protruding from the outside of the user's mouth, the extension having a first flow passage and a second flow passage, all communicating with the inside of the user's mouth, the first flow a vacuum activated pressure release valve is disposed at one end of the outer portion of the oral cavity; and a communication tube having a first open end and a second open end, the first open end being connected to the second flow path of the oral interface device 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 interior of the user's mouth and the negative pressure source; wherein, in the case of a predetermined negative pressure value, the The vacuum activated pressure release valve is activated to allow ambient air to pass into the user's mouth via the first flow path, and to carry saliva in
  • the present invention provides a breathable oral interface comprising a flexible barrier for placement between a user's lips and teeth.
  • the flexible barrier has at least one one-way valve to limit the flow of air in the oral cavity of the user to the outside of the oral cavity via the one-way valve; an extension member formed on one side of the flexible barrier and protruding from the user An outer portion of the oral cavity; and a flexible airflow conduit through the flexible barrier and the extension member, the flexible airflow conduit having a first open end extending beyond the mouth of the user for communicating with a negative pressure
  • the source and the opposite second opening end are disposed between the user's tongue and the upper jaw.
  • the present invention further provides an oral interface device comprising a flexible barrier for being disposed between a user's lips and the teeth; and an extension member formed on the The flexible barrier protrudes from one side of the user's mouth; and a flexible airflow conduit through which the flexible airflow conduit has a first open end extending Externally connected to the outside of the user's mouth and connected to a negative pressure source, and a second open end is disposed between the user's tongue and the upper jaw; wherein the extension has a first flow path and a second Flow channels are formed on opposite sides of the flexible gas flow conduit and are in communication with the use Inside the oral cavity, a one-way valve is disposed at an end of at least one of the first flow path and the second flow path away from the user's mouth to restrict the flow of air in the oral cavity of the user to the oral cavity via the one-way valve outside.
  • Figure 1 is a first embodiment of a saliva treatment system for an oral interface device of the present invention.
  • FIG. 1A is a perspective structural view of the oral interface device of FIG. 1; and FIG. 1B is a plan view of the oral interface device of FIG. 1 placed in a user's mouth.
  • FIG. 2A and 2B are plan cross-sectional views showing a first modification and a second modification of the oral interface device of Fig. 1.
  • Figure 3 is a pressure-time diagram.
  • Figure 4 is a pressure-liquid capacity relationship diagram
  • Figure 5 is a second embodiment of the saliva treatment system of the oral interface device of the present invention.
  • Figure 5A is an enlarged cross-sectional view of the fluid director of the saliva processing system of Figure 5.
  • 5B-1 and 5B-2 are enlarged cross-sectional views showing an embodiment of the vacuum activated pressure release valve of Fig. 5 in a closed and open state, respectively.
  • 5C-1 and 5C-2 are enlarged cross-sectional views showing another embodiment of the vacuum activated pressure release valve of Fig. 5 in a closed and open state, respectively.
  • Figure 6 is a third embodiment of the saliva treatment system of the oral interface device of the present invention.
  • 6A-1 and 6A-2 are schematic cross-sectional views of the first variation of the saliva treatment system of Fig. 6 in different states of use.
  • 6B-1 and 6B-2 are schematic cross-sectional views of the second variation of the saliva treatment system of Fig. 6 in different states of use.
  • FIG. 1 is a first embodiment of a saliva treatment system for an oral interface device of the present invention.
  • the present invention provides a saliva treatment system 1 for an oral interface device that includes a mouth interface device 100, A fluid flow regulator, a communication tube 12, and a reservoir 14 formed by a tri-way connector 11 and a second one-way valve 13 A negative pressure source 15, a pressure sensor 16, a timer 17, a control unit 18 and a warning device 19.
  • the mouth interface device 100 is the same as the mouth device of Figs. 1A and 1B disclosed in Chinese Patent Application No. 103101121, the entire disclosure of which is incorporated herein by reference.
  • the specific three-dimensional structure of the oral interface device 100 is as shown in FIG.
  • FIG. 1A of the present application is a plan view of the oral interface device 100 placed in a user's mouth.
  • the oral interface device 100 is an integrally formed device, including a flexible barrier 150 and a flexible airflow conduit 110, wherein the flexible barrier 150 is disposed between a user's lips and teeth.
  • the flexible barrier 150 is placed between the user's lips and the front teeth, and the flexible barrier 150 has a flexible center portion 151 for conforming to the contour of the front and rear teeth of the user to fit different tooth configurations of different users;
  • the flexible airflow duct 110 is in the form of a hollow tube And passing through the flexible center portion 151 of the flexible barrier 150, the flexible airflow conduit 110 has a first open end 120 disposed outside the user's mouth for communicating with the three-way connector 11 a first interface end, the flexible airflow duct 110 further has an opposite second opening end 130 for being disposed between the user's tongue and the upper jaw; preferably, the flexible airflow Catheter 110 along the user tongue The center line of the head is placed.
  • the flexible airflow conduit 110 can be conformable to the upper jaw contour and the tongue contour of the user, and the flexible airflow conduit 110 has a flexible intermediate section 111 formed on the flexible barrier. Between the 150 and the second open end 130 and adjacent to the flexible barrier 150, the flexible intermediate section 111 has a narrower and thinner structure than other portions of the flexible airflow duct 110 to facilitate It conforms to the contour of the user's upper jaw and the contour of the tongue. In other words, the flexible intermediate section 111 can conform to the upper jaw profile of different users.
  • the flexible airflow duct 110 further has at least one through hole 140 formed in the flexible intermediate section 111 near the central area of the flexible barrier 150, and the through hole 140 is connected to the flexible airflow duct 110. One side.
  • the through hole 140 is transversely communicated with the flexible air flow duct 110 with respect to the hollow tubular body direction of the flexible air flow duct 110.
  • the second open end 130 of the flexible airflow duct 110 has a wider structure 131 than the flexible intermediate section 111 to increase the structural strength of the flexible airflow duct 110.
  • the flexible airflow conduit 110 avoids collapse when pressed by the user's tongue and upper jaw.
  • the cross-sectional view of the three-way connector 11 is the same as that of the three-way connector 51 of Fig. 5A.
  • the first interface end of the three-way connector 11 communicating with the first open end 120 of the oral interface device 100 is provided with a first one-way valve (not shown in FIG. 1 ), the first check valve
  • the first check valve 511 shown in FIG. 5A is used to restrict the fluid in the oral cavity of the user from flowing to the three-way connector 11.
  • a first open end of the communication tube 12 is connected to the three-way connection
  • a second interface end of the connector 11 communicates with a second open end of the communication tube 12 to the reservoir 14.
  • the second one-way valve 13 is connected to a third interface end of the three-way connecting member 11 for restricting ambient air from flowing to the three connecting members 11 via the second one-way valve 13 .
  • the three-way connector 11 and the second one-way valve 13 constitute the fluid diverter for restricting all fluids through the second interface end of the three-way connector 11 Flows to the communication tube 12.
  • the negative pressure source 15 is connected to the liquid storage tank 14. The present invention can start/stop the negative pressure source 15 via the control unit 18 or manually, for example, after the negative pressure source 15 is activated, the mouth portion of the present invention.
  • the saliva treatment system 1 of the interface device forms a negative pressure path between the inside of the user's mouth and the negative pressure source 15 to facilitate the evacuation of air and saliva in the oral cavity of the user via the negative pressure path, and saliva. It can be collected in the liquid storage tank 14. Furthermore, during the activation of the saliva treatment system 1 of the oral interface device of the present invention, ambient air can be introduced into the communication tube 12 via the second check valve 13 and the three-way connector 11 during the start-up, as indicated by the arrows in FIG. In order to facilitate the collection of saliva remaining in the communication tube 12 to the liquid storage tank 14, the difference in pressure between the interior of the user's mouth and the negative pressure source 15 caused by the residual saliva may be avoided. It is even possible to prevent the communication tube 12 from being blocked by saliva, thereby maintaining the negative pressure path between the inside of the user's mouth and the negative pressure source 15.
  • the negative pressure source 15 of the saliva processing system 1 of the oral interface device of the present invention may also communicate with the communication tube 12 and the reservoir.
  • the liquid pressure source 15 can be started/stopped between the liquid tanks 14 via the control unit 18 or by an artificial means.
  • the saliva treatment system 1 of the oral interface device of the present invention can continuously measure the saliva capacity in the reservoir 14 intermittently to monitor whether the saliva capacity in the reservoir 14 is full, so as to maintain the entire system in a normal state. Under operating conditions.
  • the saliva processing system 1 of the oral interface device starts/stops the time calculation action of the timer 17 by the control unit 18, and the timer 17 can be intermittently started after being activated. After the counting time reaches a set time period t, a notification signal is sent to the control unit 18, and a pressure value measured by the pressure sensor 16 is read via the control unit 18.
  • the pressure sensor 16 is connected to the liquid storage tank 14 for measuring the pressure value inside the liquid storage tank 14.
  • a notification signal is sent to the control unit 18 every time t to notify the control unit 18 to read a pressure value measured by the pressure sensor 16.
  • the control unit 18 can continuously read the pressure value sensed by the pressure sensor 16 intermittently.
  • the control unit 18 determines the volume of liquid in the reservoir 14 based on the read pressure value.
  • the length of the set time period t can be adjusted as needed, for example, the control unit 18 can be periodically read the pressure value measured by the pressure sensor 16.
  • T 2 -T 1 t
  • the pressure value shown in the 14th line of the pressure value of Table 1 can be clearly seen that when the timer 17 is set to be separated by a set period of the same length of time (for example, T 14 ), the control unit 18 is notified to read the pressure sense.
  • the pressure value measured by the measuring device 16 increases with the increase of the liquid capacity inside the liquid storage tank 14 (0 ml to 80 ml), and the pressure value inside the liquid storage tank 14 also increases (-71.0922 mmHg to -33.7023 mmHg). ).
  • FIG. 3 it is a pressure-time relationship diagram, wherein the Y axis represents the pressure value inside the liquid storage tank 14, and the X axis represents the time zone t counted by the timer 17, curve a, curve b, curve c, curve d, curve e, curve f, curve g, curve h and curve i represent the liquid contents of the liquid storage tank 14 are 80 ml, 70 ml, 60 ml, 50 ml, 40 ml, 30 ml, 20 ml, 10 ml and 0 ml.
  • Figure 4 is a pressure-liquid capacity relationship diagram, which is converted from the pressure value and the liquid capacity listed in the 15th row of Table 1.
  • the control unit 18 reads the internal pressure value of the liquid storage tank 14 measured by the pressure sensor 16, when the liquid capacity inside the liquid storage tank 14 is different, the measured pressure value also changes.
  • the control unit 18 is built on a period T is set to the timer 17 counts the pressure should be 15 - the reservoir fluid volume correspondence table, for example, FIG. 4 come from the conversion.
  • the control unit 18 reads the pressure value of the liquid storage tank 14, the liquid capacity value inside the liquid storage tank 14 can be determined according to the pressure-storage liquid capacity correspondence table, and the liquid capacity value is transmitted.
  • the warning device 19 sends a warning signal via the warning device 19, thereby detecting whether the liquid capacity in the liquid storage tank 14 is full.
  • control unit 18 can also be built with multiple pressures corresponding to different set time periods t (eg T 2 , T 3 , T 4 , T 5 , . . . , T 10 , T 11 ...) of the timer 17 .
  • a liquid storage capacity correspondence table for adjusting the time during which the control unit 18 reads the internal pressure value of the liquid storage tank 14 as needed, and determining the liquid storage tank 14 according to the corresponding pressure-storage liquid capacity correspondence table. Liquid capacity.
  • the one-part interface device 200 of the present invention includes a flexible barrier 250 and a flexible airflow conduit 210.
  • the flexible airflow conduit 210 has a first open end 220 disposed outside the user's mouth for communicating with a first interface end of the three-way connector 11, the flexible airflow conduit 210 further having a relative A second open end portion 230 is provided for the space between the tongue and the upper jaw of the user.
  • the dotted line area indicated by the reference numeral 260 represents the oral region between the tongue and the soft/hard palate.
  • the flexible airflow conduit 210 further has at least one through hole 240 formed near a central region of the flexible barrier 250, and the through hole 240 communicates with the flexible airflow conduit 210.
  • the through hole 240 is transversely communicated with the flexible air flow conduit 210 with respect to the hollow tubular body direction of the flexible air flow conduit 210.
  • the body shape of the flexible airflow conduit 210 is the same as that of the flexible airflow conduit 110 and will not be repeated here.
  • the flexible barrier 250 has an extension extending toward the first open end 220 of the flexible airflow conduit 210 to protrude beyond the mouthpiece and the flexible airflow conduit 210 passes through the extension.
  • the flexible barrier 250 has at least one one-way valve 252 through which air in the oral cavity flows to the exterior of the oral cavity as the user opens his mouth to breathe, as indicated by the arrows.
  • the one-port interface of the present invention Device 202 includes a flexible barrier 250 and a flexible airflow conduit 212.
  • the flexible airflow conduit 212 has a first open end 222 disposed outside the user's mouth for communicating with a first interface end of the three-way connector 11, the flexible airflow conduit 212 further having a relative A second open end 232 is provided for the space between the tongue and the upper jaw of the user.
  • the dotted line area referred to by the component number 262 represents the oral region between the tongue and the soft/hard palate.
  • the flexible air flow conduit 212 further has at least one through hole 242 formed in the vicinity of a central region of the flexible barrier 250, and the through hole 242 is in communication with the flexible air flow conduit 212.
  • the through hole 242 is transversely communicated with the flexible air flow conduit 212 with respect to the hollow tubular body direction of the flexible air flow conduit 212.
  • the body shape of the flexible airflow conduit 212 is the same as that of the flexible airflow conduit 110 and will not be repeated here.
  • the flexible barrier 250 has an extension extending toward the first open end 222 of the flexible airflow conduit 212 to protrude beyond the user's mouth, and the flexible airflow conduit 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, wherein 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 are in communication with the inside of the user's mouth, and the ports of the first channel 214 and the third channel 216 are adjacent to the first opening end 222, respectively.
  • a one-way valve is provided to allow air within the user's mouth to flow to the exterior of the oral cavity via the one-way valve, as indicated by the arrows.
  • FIG. 5 is a second embodiment of the saliva treatment system of the oral interface device of the present invention.
  • the present invention provides a saliva treatment system 5 for an oral interface device comprising an oral interface device 500, a fluid flow regulator 50, a communication tube 52, and a The 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 embodiment shown in FIG. 1.
  • the oral interface device 500 is an integrally formed device including at least one flexible barrier 550 and a flexible device.
  • the fluid aligner 50 includes a three-way connector 51, a second one-way valve 53, and a vacuum-activated pressure relief valve 54.
  • FIG. 5A is an enlarged cross-sectional view of the fluid aligner 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 single
  • the valve 511 is connected to the first open end 520 of the flexible air flow conduit 510, and the fluid in the user's mouth flows to the three-way connector 51 via the first one-way valve 511, and the second interface end
  • a first open end of the connecting pipe 52 is connected, and a second open end of the connecting pipe 52 communicates with the liquid storage tank 55.
  • the reservoir 55 is in communication with the negative pressure source 56. When the negative pressure source 56 is activated, a vacuum path is formed between the interior of the user's mouth and the negative pressure source 56.
  • the A second check valve 53 is disposed at the third interface end of the three-way connector 51, and the vacuum activated pressure release valve 54 is coupled to one end of the second check valve 53 with respect to the three-way connector 51.
  • 5B-1 and 5B-2 are enlarged cross-sectional views showing an embodiment of the vacuum activated pressure release valve 54.
  • the vacuum activated pressure release valve 54a provided in the embodiment shown in Fig. 5B-1 is in a closed state, which includes a The body 540a, a push valve 546a, a spring 547a and a spring seat 548a.
  • a partition having a passage is defined in 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 Connected to the second one-way valve 53, the propulsion valve 546a is movably disposed in the first chamber 542a and passes through the passage.
  • the push valve 546a occupies the entire space of the passage, so that the fluid of the first chamber 542a is isolated from the second chamber 544a to prevent ambient air from entering the second chamber. Room 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 propulsion valve 546a and the spring seat 548a.
  • 5B-2 shows the vacuum activated pressure release valve 54a 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 start valve of the vacuum activated pressure release valve 54a.
  • the pressure difference between the first chamber 542a and the second chamber 544a causes ambient air to push the propulsion valve 546a forward, thereby forming an air flow path between the diaphragm passage and the propulsion valve 546a to surround the circumference.
  • the air enters the second chamber 544a via the air flow passage, and then enters the communication tube 52 via the second one-way valve 53 and the second interface end of the three-way connecting member 51.
  • the surrounding air that is introduced can carry saliva remaining in the communication tube 52 to the reservoir 55.
  • the fluid directional device 50 formed by the three-way connecting member 51, the first one-way valve 511, the second one-way valve 53, and the vacuum-starting pressure release valve 54 can restrict all fluids. It flows to the communication pipe 52.
  • the fluid flow direction is as indicated by the arrow in FIG.
  • the negative pressure source 56 is connected to the liquid storage tank 55.
  • the present invention can start/stop the negative pressure source 56 via the control unit 59 or manually, for example, after the negative pressure source 56 is activated, the mouth portion of the present invention.
  • the saliva treatment system 5 of the interface device forms a negative pressure path between the interior of the user's mouth and the negative pressure source 56 to facilitate the evacuation of air and saliva in the oral cavity of the user via the negative pressure path, and saliva. It can be collected in the liquid storage tank 55. Furthermore, in the saliva processing system 5 of the oral interface device of the present invention, during startup, as shown by the arrow in FIG. 5, ambient air can pass through the second check valve 53 and the vacuum actuated pressure release valve 54 and the three-way connection. The member 51 is inserted into the communication tube 52 to facilitate the saliva staying in the communication tube 52 to be carried by the air and collected into the liquid storage tank 55, thereby preventing the communication tube 52 from being caused by residual saliva. The difference in pressure between the interior and the negative pressure source 56 prevents the communication tube 52 from being blocked by saliva, thereby maintaining a negative pressure path between the interior of the user's mouth and the negative pressure source 56.
  • the vacuum activated pressure release valve 54b provided in the embodiment shown in Fig. 5C-1 is in a closed state, and includes a body 540b, a push valve 546b, a spring 547b and a spring seat 548b.
  • the body 540b is internally provided with a partition having a passage to divide the body 540b into a first chamber 542b and a second chamber 544b.
  • the first chamber 542b is connected to the surrounding air, and the second chamber 544b Connected to the second one-way valve 53, the propulsion valve 546b is movably disposed in the first chamber 542b and passes through the passage.
  • the push valve 546b occupies the entire space of the passage, so that the fluid of the first chamber 542b is isolated from the second chamber 544b to prevent ambient air from entering the second chamber. Room 544a.
  • the spring seat 548b is disposed on a surface of the partition in the first chamber 542b, and the spring 547b abuts between the propulsion valve 546b and the spring seat 548b.
  • 5C-2 shows the vacuum activated pressure release valve 54b 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 start valve of the vacuum activated pressure release valve 54b.
  • the pressure difference between the first chamber 542b and the second chamber 544b causes ambient air to push the propulsion valve 546b forward, thereby forming an air flow path between the diaphragm passage and the propulsion valve 546b to surround the circumference.
  • the air enters the second chamber 544b via the air flow passage, and then enters the communication tube 52 via the second one-way valve 53 and the second interface end of the three-way connecting member 51.
  • the surrounding air that is introduced can carry saliva remaining in the communication tube 52 to the reservoir 55.
  • the negative pressure source 56 of the saliva processing system 5 of the oral interface device of the present invention may also communicate with the communication tube 52 and the reservoir.
  • the liquid pressure source 55 can be activated/stopped via the control unit 59 or by an artificial means.
  • the saliva processing system 5 of the oral interface device of the present invention can continuously measure the saliva capacity in the reservoir 55 intermittently to monitor whether the saliva capacity in the reservoir 55 is fully loaded to facilitate maintaining the entire system in a normal state. Under operating conditions.
  • the saliva processing system 5 of the oral interface device activates/stops the time calculation action of the timer 58 by the control unit 59, and the timer 58 can be intermittently started after being activated. After the counting time reaches a set time period t, a notification signal is sent to the control unit 59, and a pressure value measured by the pressure sensor 57 is read via the control unit 59.
  • the pressure sensor 57 is connected to the liquid storage tank 55 for measuring the pressure value inside the liquid storage tank 55.
  • a notification signal is sent to the control unit 59 every time t to notify the control unit 59 to read a pressure value measured by the pressure sensor 57.
  • the control unit 59 can continuously read the pressure value sensed by the pressure sensor 57 intermittently.
  • the control unit 59 determines the liquid volume in the reservoir 55 based on the read pressure value.
  • the length of the set time period t can be adjusted as needed, for example, the control unit 59 can periodically read the pressure value measured by the pressure sensor 57.
  • the method for measuring the liquid capacity in the liquid storage tank 55 in the saliva processing system 5 of the oral interface device of the present invention The method of the system 1 of the first specific example shown in FIG. 1 is the same and will not be repeated here.
  • FIG. 6 is a third embodiment of the saliva treatment system of the oral interface device of the present invention.
  • the present invention provides a saliva treatment system 6 for an oral interface device, which includes an oral interface device 600, a communication tube 62, a reservoir 64, a negative pressure source 65, and a The pressure sensor 66, a timer 67, a control unit 68 and a warning device 69.
  • the mouth interface device 600 is an integrally formed device, and includes at least a flexible barrier 650 and a flexible airflow conduit 610 having a first open end 620 disposed at the user's mouth. The outside is connected to a first open end of the connecting pipe 62, and a second open end of the connecting pipe 62 communicates with the liquid storage tank 64.
  • the flexible air flow conduit 610 further has an opposite second opening end 630 for being disposed in a space between the user's tongue and the upper jaw.
  • the flexible airflow duct 610 further has a flexible intermediate section formed between the flexible barrier 650 and the second open end 630 and located adjacent to the flexible barrier 650.
  • the flexible intermediate section The segment has a narrower, thinner configuration than the other portions of the flexible airflow conduit 610 to facilitate conformance to the user's upper jaw contour and tongue contour. In other words, the flexible intermediate section can conform to the upper jaw contour of different users.
  • the flexible air flow conduit 610 further has at least one through hole 640 formed in the flexible intermediate portion near the central region of the flexible barrier 650. Preferably, the through hole 640 is opposite to the flexible airflow.
  • the hollow tube body of the conduit 610 is laterally communicated with the flexible gas flow conduit 610.
  • the second open end 630 of the flexible airflow conduit 610 has a wider structure than the flexible intermediate section to increase the structural strength of the flexible airflow conduit 610 to provide flexibility.
  • the airflow conduit 610 avoids collapse when pressed by the user's tongue and upper jaw.
  • the flexible barrier 650 has an extension extending toward the first open end 620 of the flexible airflow conduit 610 to protrude beyond the user's mouth, and the flexible airflow conduit 610 passes through the extension, and A first flow channel 612, a second flow channel 613 and a third flow channel 614 are formed in the extension member, wherein the first flow channel 612 and the third flow channel 614 are formed on opposite sides of the second flow channel 613.
  • the flexible airflow conduit 610 forms the second flow passage 613 through a portion of the extension.
  • the first flow channel 612, the second flow channel 613, and the third flow channel 614 are in communication with the inside of the user's mouth, and the first flow channel 612 is adjacent to the port of the first open end 620 to provide a vacuum activated pressure release valve.
  • the third flow channel 614 is adjacent to the port of the first open end 620 is provided with a one-way valve 604; when the user's oral internal negative pressure value reaches the activation threshold of the vacuum activated pressure release valve 602, the vacuum The valve that activates the pressure relief valve 602 is opened and ambient air is introduced into the interior of the user's mouth via the vacuum activated pressure relief valve 602.
  • the aforementioned ambient air that is introduced facilitates carrying saliva inside the user's mouth and saliva remaining in the communication tube 62 to the reservoir 64.
  • the one-way valve 604 is configured to restrict the flow of air inside the user's mouth through the one-way valve 604 to the surrounding environment.
  • the embodiment of the vacuum actuated pressure release valve 602 can adopt the specific embodiment shown in FIG. 5B-1 and FIG. 5B-2 and FIG. 5C-1 and FIG. 5C-2, and will not be repeated here.
  • the negative pressure source 65 In connection with the liquid storage tank 64, the present invention can start/stop the negative pressure source 65 via the control unit 68 or manually, for example, after the negative pressure source 65 is activated, the saliva treatment of the oral interface device of the present invention.
  • the system 6 forms a negative pressure path between the inside of the user's mouth and the negative pressure source 65 to facilitate the evacuation of air and saliva in the oral cavity of the user via the negative pressure path, and saliva can be collected in the reservoir.
  • Liquid tank 64 Furthermore, during the activation of the saliva treatment system 6 of the oral interface device of the present invention, ambient air can be introduced into the communication tube 62 via the vacuum activation pressure release valve 602 to facilitate the passage of saliva remaining in the communication tube 62 via the air.
  • the difference in pressure between the inside of the user's mouth and the negative pressure source 65 caused by the residual saliva can be avoided, and the communication tube 62 can be prevented from being The saliva is clogged, which in turn maintains a negative pressure path between the interior of the user's mouth and the source of negative pressure 65.
  • FIG. 6A-1 and 6A-2 are schematic cross-sectional views showing a first variation of the oral interface device 600.
  • the one-port interface device 600a shown in the first variation can be substituted for the oral interface device 600 of the saliva treatment system 6 of the oral interface device.
  • the mouth interface device 600a is different from the mouth interface device 600 in that the oral interface device 600a is provided with an adjustment type choke in the first flow channel 612 near the vacuum activation pressure release valve 602, which is a movable
  • the convex member 660 the remaining members are the same as the oral interface device 600, and will not be repeated here.
  • the movable protrusion 660 protrudes from the outside of the extension member for moving the movable protrusion 660 by hand, as shown in FIG. 6A-1 and FIG.
  • the activation threshold of the vacuum activation pressure release valve 602 is increased when the movable projection 660 moves toward the flexible airflow conduit 610 to reduce the internal space of the first flow passage 612.
  • the activation threshold value of the vacuum activation pressure release valve 602 in the use state of Fig. 6A-2 is higher than the activation threshold value of the vacuum activation pressure release valve 602 in the use state of Fig. 6A-1.
  • the vacuum activated pressure relief valve 602 in the use state of Figure 6A-2 requires a higher oral negative pressure value to be opened.
  • 6B-1 and 6B-2 are schematic cross-sectional views showing a second variation of the oral interface device 600.
  • the one-port interface device 600b shown in the second variation can be substituted for the oral interface device 600 of the saliva treatment system 6 of the oral interface device.
  • the mouth interface device 600b is different in structure from the mouth interface device 600 in that the mouth interface device 600b is provided with an adjustment type choke in the first flow channel 612 near the vacuum activation pressure release valve 602, which is a rotatable
  • the hollow tubular member 680 has the same components as the oral interface device 600 and will not be repeated here.
  • the rotatable hollow tubular member 680 has an open hollow conduit communicating with the first flow passage 612, and one end of the rotatable hollow tubular member 680 protrudes outside the extension member for manually rotating the rotatable hollow tubular member 680, as shown in FIG. 6B- 1 and FIG. 6B-2, thereby changing the flow resistance of the first flow path 612.
  • FIG. 6B-2 as the rotatable hollow tubular member 680 is rotated at a specific angle, the flow resistance of the first flow passage 612 can be changed, and the vacuum can be changed.
  • the activation threshold of the pressure relief valve 602 is activated. In other words, the starting threshold value of the vacuum starting pressure release valve 602 in the use state of Fig. 6B-2 is higher than the starting threshold value of the vacuum starting pressure releasing valve 602 in the use state of Fig. 6B-1.
  • the vacuum activated pressure relief valve 602 of Figure 6B-2 in use requires a higher oral vacuum value to be opened.
  • the negative pressure source 65 of the saliva processing system 6 of the oral interface device of the present invention may also communicate with the communication tube 62 and the reservoir.
  • the liquid pressure source 65 can be started/stopped between the liquid tanks 64 via the control unit 68 or by an artificial means.
  • the saliva processing system 6 of the oral interface device of the present invention can continuously measure the saliva capacity in the reservoir 64 intermittently to monitor whether the saliva capacity in the reservoir 64 is fully loaded to facilitate maintaining the entire system in a normal state. Under operating conditions.
  • the saliva processing system 6 of the oral interface device activates/stops the time calculation action of the timer 67 by the control unit 68, and the timer 67 can be intermittently started after being activated. After the counting time reaches a set time period t, a notification signal is sent to the control unit 68, and a pressure value measured by the pressure sensor 66 is read via the control unit 68.
  • the pressure sensor 66 is in communication with the reservoir 64 for measuring the pressure value inside the reservoir 64.
  • a notification signal is sent to the control unit 68 every time t to notify the control unit 68 to read a pressure value measured by the pressure sensor 66.
  • the control unit 68 can continuously read the pressure value sensed by the pressure sensor 66 intermittently.
  • the control unit 68 determines the volume of liquid in the reservoir 64 based on the read pressure value.
  • the length of the set time period t can be adjusted as needed, for example, the control unit 68 can periodically read the pressure value measured by the pressure sensor 66.
  • the method for measuring the liquid capacity in the liquid storage tank 64 in the saliva processing system 6 of the oral interface device of the present invention is the same as the method of the system 1 of the first specific example shown in Fig. 1, and will not be repeated here.
  • the systems and methods of the present invention may further be used in conjunction with other devices for treating sleep disordered breathing.
  • the system of the present invention can be used in conjunction with a nasal check valve device, such as the device disclosed in U.S. Patent No. 8,061,357.
  • the nasal check valve device can be used to increase the positive pressure in the upper airway, and the present invention can generate an oral pressure and prevent the mouth from opening and leaking, and the pressure gradient between the oral cavity and the upper airway can be increased and maintained. This causes the soft palate to move toward the front of the mouth and the tongue to move up and the front of the mouth to ensure the smoothness of the upper airway.
  • the system and method of the present invention can be further used in conjunction with a positive pressure breathing apparatus (CPAP).
  • CPAP positive pressure breathing apparatus
  • the positive pressure breathing apparatus can be used to increase and maintain the positive pressure in the upper airway, and the pressure in the oral cavity can be increased and maintained by the present invention to generate negative pressure in the oral cavity and to prevent leakage of the mouth. Therefore, the soft palate is softly moved to the front of the mouth and the tongue is moved upwards and the front of the mouth to ensure the smoothness of the upper airway.
  • the set value required for the positive pressure breathing apparatus can be reduced; and the system of the invention can be used to further reduce the positive pressure value of the positive pressure breathing apparatus intermittently to reduce the breathing of the user due to continuous positive pressure. Discomfort to improve patient compliance.
  • the system and method of the present invention can be further utilized in conjunction with a respiratory detection device.
  • the respiratory detecting device detects the respiratory flow of the upper airway, and when the state of the breathing suspension or the weakened breathing is detected, the negative pressure value of the oral interface device of the present invention is turned on or increased to reduce the opening time of the negative pressure generating device, thereby achieving the province The purpose of being able to be quiet.

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Abstract

一种口部介面装置（100，200，202，500，600，600a，600b）的唾液处理系统（1，5，6）及唾液处理系统（1，5，6）的储液槽（14，55，64）中液体容量测量方法，唾液处理系统（1，5，6）包括一个口部介面装置（100，200，202，500，600，600a，600b）、一个流体调向器（50）及一个连通管（12，52，62）。口部介面装置（100，200，202，500，600，600a，600b）放置于使用者口腔内，流体调向器（50）连通于口部介面装置（100，200，202，500，600，600a，600b）与连通管（12，52，62）。连通管（12，52，62）连通于一个负压源（15，56，65），以在口部介面装置（100，200，202，500，600，600a，600b）与负压源（15，56，65）之间构成一个负压途径，使用者口腔内的唾液通过负压途径而收集于一个储液槽（14，55，64）。流体调向器（50）用以限制所有流体流向连通管（12，52，62），进而在保持使用者口腔内部负压环境的情况下持续地或视需要地通入空气于唾液处理系统（1，5，6）的管路中，以利于清除口部介面装置（100，200，202，500，600，600a，600b）与连通管（12，52，62）中的唾液。

Description

口部介面装置的唾液处理系统及其方法 技术领域
本发明关于一种改善睡眠呼吸品质的医疗装置及其使用方法；具体而言，本发明关于一种可以减少睡眠呼吸中止现象、打鼾等具有负压式口部介面装置的唾液处理系统及其方法，用以清除口腔及系统管路的唾液。
背景技术
睡眠呼吸中止(OSA)是一种患者在吸气期间呼吸道重复塌陷的症状，会造成睡眠时呼吸暂停。在吸气期间肺部及呼吸道的气压会降低。假若在此时刻，上呼吸道的肌肉活动降低，呼吸道就会倾向塌陷。在呼吸暂停之前，呼吸道会开始封闭，患者经常会开始打鼾。打鼾是患者试着对抗塌陷的呼吸道的一种现象。在不同患者身上这些障碍会发生在沿着呼吸道的不同位置，但咽喉处及鼻咽处是两种常见的位置。
中度至重度睡眠呼吸中止症状的患者会在白天感到嗜睡、疲倦及精神无法集中。除了这些立即性问题之外，研究显示睡眠呼吸中止症状的患者使用到较多的医疗资源，医疗行为失效的风险提高，最后会导致更高的死亡率。若考虑到所有例子，预估重度睡眠呼吸中止症状患者的死亡率会提高到三到六倍。睡眠呼吸中止症状亦隐藏在许多的心血管疾病中，例如体循环高血压(Systemic hypertension)及某程度的肺高血压。睡眠呼吸中止症状会增加得到心肌梗塞、脑血管疾病及心律不整的风险。睡眠呼吸中止症状患者由于夜间睡眠状态被打断亦会造成白天过多的睡眠并导致精神无法集中。由于患者的神经辨识功能妥协使得患者白天日常功能受损。他们更可能造成错误及发生车祸。因此，若睡眠呼吸中止症状未被治疗，它会带来严重的负面结果。
对于睡眠呼吸中止症状患者目前有几种治疗方式。口部装置(Oral appliance)是用来治疗轻度到中度睡眠呼吸中止症状，但它们经常无法良好作用且会对患者齿龈及牙齿造成损伤。有一些手术用来治疗睡眠呼吸中止症状，然而这些手术动作属于侵入式、昂贵及会疼痛，复原期长达六个月。对于成人中度至重度睡眠呼吸暂停症状的最普遍治疗方法是采用正压呼吸器(Constant Positive Airway Pressure(CPAP)Machine)。正压呼吸器是由面罩、泵及湿润机组成。正压呼吸器连续地将高压空气吹入患者鼻道，以使患者在睡眠期间保持呼吸道畅通。正压呼吸器相当有效，但它会引起令人不舒服的副作用，例如 喉咙干燥及鼻道阻塞。使用正压呼吸器的患者经常会在早晨感到肿胀及头疼。正压呼吸器亦让使用者及其家属感到吵杂与不舒服。正压呼吸器是当今第一线及黄金标准治疗方式，但由于它引起的严重副作用使得它具有低的适应性。
目前的一种改良的做法是在患者口腔内施予负压，通过负压将患者的舌头及软颚拉向前方以维持呼吸道的畅通。例如，美国专利第5,957,133号、美国公开专利申请案第2005/0,166,928号及第2006/0,096,600号。虽然理论上可行，但这些先前技术皆使用大型结构卡紧牙齿及/或保持、定位舌头。再者，负压是直接施予在舌头的软组织，以保持舌头定位于口腔内。然而，这些做法会在口腔内占据许多空间，引起牙齿、齿龈及软组织的不舒服及损伤。同时较大装置的存在会引起过多唾液分泌物及作呕。这些做法的其它主要缺点仍包括这些口腔装置涉及手术解剖，它们会需要特殊技术人员对于每一个患者提供客制化的口腔介面。
此外，采用负压式口部介面装置会面临唾液停留于前述口部介面装置与负压源之间的管路，造成管路阻塞及该口部介面装置与该负压源之间的压力差，甚至对于口腔内部负压环境的维持有不利影响。
发明内容
在一方面，本发明提供一种口部介面装置的唾液处理系统，是在系统运作期间，在保持使用者口腔内部负压环境的情况下持续地或视需要地通入空气于系统管路中，以利于清除该口部介面装置与前述管路中的唾液。
在另一方面，本发明提供一种通过检测收集唾液的储液槽内部压力以监控该储液槽内液体容量是否满载，进而可以有效地处理本发明系统的口部介面装置与管路中的唾液。
在又另一方面，本发明提供一种通气的口部介面装置(breathable oral interface)，可以应用于本发明系统，通过该通气的口部介面装置利于将使用者口腔内的空气排出至周围环境。
另一方面，本发明提供前述口部介面装置的唾液处理系统的储液槽中液体容量测量方法，其包括将该口部介面装置放置于一使用者口腔内，并通过该系统连通一负压源，以在该使用者口腔内与该负压源之间构成一负压途径，并且该使用者口腔内的唾液经由该负压途径收集至该储液槽；持续间歇地量测该储液槽内的压力值；以及根据量测的该压力值决定该储液槽内的液体容量，以利于使用者判断是否需要更换或清洗该储液槽。
在本发明的一个态样中，本发明提供一种口部介面装置的唾液处理系统，其包括一口部介面装置，用以放置于一使用者口腔内，以在该使用者的口腔内提供一流体通道；一流体调向器，具有一第一接口端及一第二接口端，该流体调向器用以限制所有流体是流向其第二接口端，该第一接口端连通于该口部介面装置的该流体通道；及一连通管，具有一第一开口端及一第二开口端，其中该第一开口端连通于该流体调向器的该第二接口端，以及该第二开口端连通于一储液槽与一负压源，借以在该使用者口腔内部与该负压源之间构成一负压途径，其中该使用者口腔内的唾液通过该负压途径而收集于该储液槽。
在本发明的另一个态样中，本发明提供一种口部介面装置的唾液处理系统，其包括：一口部介面装置，用以放置在一使用者口腔内，以在该使用者的口腔内提供至少一流体通道，该口部介面装置具有一延伸部突出于该使用者口腔外面，该延伸部具有一第一流道及一第二流道，皆连通于该使用者口腔内部，该第一流道位于口腔外面的一端设置有一真空启动压力释放阀；及一连通管，具有一第一开口端及一第二开口端，该第一开口端连通于该口部介面装置的该第二流道，及该第二开口端连通于一储液槽及一负压源，借以在该使用者口腔内部与该负压源之间构成一负压途径；其中在一预定负压值情况下，该真空启动压力释放阀被启动，使周围空气经由该第一流道通入该使用者口腔内，并通过通入的空气流携带口腔内的唾液及该连通管内停留的唾液流至该储液槽。
在本发明的口部介面装置态样中，本发明提供一种通气的口部介面装置(breathable oral interface)，其包括一可挠性屏障，用以设置于一使用者嘴唇与牙齿之间，该可挠性屏障具有至少一单向阀，以限制该使用者口腔内的空气经由该单向阀是流向口腔外面；一延伸件，形成于该可挠性屏障一侧并且突出于该使用者口腔外部；及一可挠性气流导管，通过该可挠性屏障及该延伸件，该可挠性气流导管具有一第一开口端部延伸突出于该使用者口腔外部并用以连通于一负压源，及相对的一第二开口端部用以设置于该使用者舌头与上颚之间。
在本发明的口部介面装置态样中，本发明另提供一种口部介面装置，其包括一可挠性屏障，用以设置于一使用者嘴唇与牙齿之间；一延伸件，形成于该可挠性屏障一侧并且突出于该使用者口腔外部；及一可挠性气流导管，通过该可挠性屏障及该延伸件，该可挠性气流导管具有一第一开口端部延伸突出于该使用者口腔外部并用以连通于一负压源，及相对的一第二开口端部用以设置于该使用者舌头与上颚之间；其中该延伸件具有一第一流道及一第二流道，分别形成于该可挠性气流导管的相对侧并且连通于该使用 者口腔内部，该第一流道及该第二流道至少其中之一的远离该使用者口腔的一端设置有一单向阀，用以限制该使用者口腔内的空气经由该单向阀是流向口腔外面。
附图说明
图1是本发明口部介面装置的唾液处理系统的一第一具体实施例。
图1A是图1的口部介面装置的立体结构图；图1B是图1的口部介面装置放置于一使用者口腔内的俯视图。
图2A及图2B是图1的口部介面装置的第一变化例与第二变化例的俯视剖面图。
图3是一压力-时间关系图。
图4是一压力-液体容量关系图，
图5是本发明口部介面装置的唾液处理系统的一第二具体实施例。
图5A是图5唾液处理系统的流体调向器的剖面放大示意图。
图5B-1及图5B-2是图5的真空启动压力释放阀的一实施例分别在关闭与开启状态下的剖面放大示意图。
图5C-1及图5C-2是图5的真空启动压力释放阀的另一实施例分别在关闭与开启状态下的剖面放大示意图。
图6是本发明口部介面装置的唾液处理系统的一第三具体实施例。
图6A-1及图6A-2是图6的唾液处理系统第一变化例在不同使用状态下的俯视剖面示意图。
图6B-1及图6B-2是图6的唾液处理系统第二变化例在不同使用状态下的俯视剖面示意图。
主要元件标号说明：
1、5、6----口部介面装置的唾液处理系统
11、51----三向连接件
12、52、62----连通管
13、53、511、252、604----单向阀
14、55、64----储液槽
15、56、65----负压源
17、58、67----计时器
18、59、68----控制单元
19、60、69----警示装置
50----流体调向器
54、54a、54b、602----真空启动压力释放阀
100、200、202、500、600、600a、600b----口部介面装置
110、210、212、510、610----可挠性气流导管
120、220、222、520、620----第一开口端部
130、230、232、530、630----第二开口端部
150、250、550、650----可挠性屏障
111----可挠折中间区段
131----较宽厚结构
140、240、242、640----通孔
151----可挠折中心部分
214、612----第一流道
215、613----第二流道
216、614----第三流道
260、262----舌头与软/硬颚之间的口腔区域
540a、540b----本体
542a、544a----第一容室
542b、544b----第二容室
546a、546b----推进阀
547a、547b----弹簧
548a、548b----弹簧座
660----可移动式凸件
680----可旋转中空管件
具体实施方式
本发明的目的、精神及优点通过以下具体实施例的详细描述配合所附附图将趋于明了。
图1是本发明口部介面装置的唾液处理系统的一第一具体实施例。在第一具体实施例中，本发明提供一种口部介面装置的唾液处理系统1，其包括一口部介面装置100、 由一三向连接件(tri-way connector)11及一第二单向阀(one-way valve)13构成的一流体调向器(fluid flow regulator)、一连通管12、一储液槽14、一负压源15、一压力感测器16、一计时器17、一控制单元18及一警示装置19。该口部介面装置100与本发明申请人主张美国临时申请案第61/751,559号优先权的中国台湾专利申请案第103101121号所揭露的图1A与图1B的口部装置相同。该口部介面装置100的具体立体结构如本申请案图1A所示，图1B是该口部介面装置100放置于一使用者口腔内的俯视图。该口部介面装置100为一体成型的装置，包括一可挠性屏障150及一可挠性气流导管110，其中该可挠性屏障150是用以设置于一使用者的嘴唇与牙齿之间，以利于将该口部介面装置100稳固地结合于该使用者嘴巴；较佳地，该可挠性屏障150放置于该使用者嘴唇与前方牙齿(front teeth)之间，并且该可挠性屏障150具有一可挠折中心部分151，用以顺形于该使用者上下排牙齿前表面轮廓，以适合于不同使用者不同的牙齿构造；该可挠性气流导管110呈一中空管体状并通过该可挠性屏障150的该可挠折中心部分151，该可挠性气流导管110具有一第一开口端部120设置于该使用者嘴巴外面并用以连通于该三向连接件11的一第一接口端，该可挠性气流导管110另具有一相对的一第二开口端部130，用以设置于该使用者的舌头与上颚之间空间；较佳地，该可挠性气流导管110沿着该使用者舌头中心线放置。该可挠性气流导管110可顺形(conformable to)于该使用者的上颚轮廓及舌头轮廓，并且该可挠性气流导管110更具有一可挠折中间区段111形成于该可挠性屏障150与该第二开口端部130之间并位于该可挠性屏障150附近，该可挠折中间区段111相较于该可挠性气流导管110其它部分具有一较窄薄结构，以利于顺形于该使用者上颚轮廓及舌头轮廓。换句话说，该可挠折中间区段111可顺应于不同使用者的上颚轮廓。该可挠性气流导管110更具有至少一通孔140形成于该可挠性屏障150的中心区域附近的该可挠折中间区段111中，并且该通孔140连通于该可挠性气流导管110一侧。较佳地，该通孔140相对于该可挠性气流导管110的中空管体方向横向地连通于该可挠性气流导管110。该可挠性气流导管110的该第二开口端部130相较于该可挠折中间区段111具有一较宽厚结构131，以增加该可挠性气流导管110的结构强度，以使该可挠性气流导管110在被该使用者舌头及上颚压迫时避免塌陷。
该三向连接件11的剖面示意图与图5A的三向连接件51相同。该三向连接件11连通于该口部介面装置100的该第一开口端部120的该第一接口端设置有一第一单向阀(图1中未示出)，该第一单向阀与图5A所示的第一单向阀511相同，用以限制该使用者口腔内的流体是流向该三向连接件11。该连通管12的一第一开口端连通于该三向连 接件11的一第二接口端，该连通管12的一第二开口端连通于该储液槽14。该第二单向阀13连通于该三向连接件11的一第三接口端，其用以限制周围空气(ambient air)经由该第二单向阀13流向该三连接件11。在本发明第一具体实施例中，该三向连接件11与该第二单向阀13构成前述流体调向器，用以限制所有流体是经由该三向连接件11的该第二接口端流向该连通管12。换句话说，本发明该口部介面装置的唾液处理系统1在启动之后，流体流动方向即如图1箭头所示。该负压源15连通于该储液槽14，本发明例如可以经由该控制单元18或者以人为手动方式启动/停止该负压源15，当该负压源15启动之后，本发明该口部介面装置的唾液处理系统1即在该使用者口腔内部与该负压源15之间构成一负压途径，以利于将该使用者口腔内的空气与唾液经由该负压途径抽离，并且唾液可收集于该储液槽14。再者，本发明该口部介面装置的唾液处理系统1在启动期间，如图1箭头所示，周围空气可经由该第二单向阀13及该三向连接件11通入该连通管12，以利于将停留在该连通管12的唾液收集至该储液槽14，进而可以避免该连通管12因残留有唾液而造成该使用者口腔内部与该负压源15之间压力的差异，甚者可以避免该连通管12被唾液阻塞，进而可以保持该使用者口腔内部与该负压源15之间的该负压途径。
此外，在该第一具体实施例的一变化例中(图未示出)，本发明该口部介面装置的唾液处理系统1中该负压源15也可以连通于该连通管12与该储液槽14之间，并可经由该控制单元18或人为方式启动/停止该负压源15。
另一方面，本发明该口部介面装置的唾液处理系统1可以持续间歇地测量该储液槽14中唾液容量，以监控该储液槽14中唾液容量是否满载，以利于维持整个系统在正常运作情况下。在本发明该第一具体实施例中，该口部介面装置的唾液处理系统1通过该控制单元18启动/停止该计时器17的时间计算动作，该计时器17经启动后即可以持续间歇地计数时间至一设定时间区段t后送出一通知信号至该控制单元18，再经由该控制单元18读取该压力感测器16所量测的一压力值。该压力感测器16连通于该储液槽14，是用以量测该储液槽14内部的压力值。简言之，该计时器17被启动后每隔一段时间t即送出一通知信号至该控制单元18，以通知该控制单元18读取该压力感测器16测量到的一压力值。如此一来，该控制单元18可以持续间歇地读取该压力感测器16感测的压力值。该控制单元18再根据读取的压力值决定该储液槽14中的液体容量。此外，该设定时间区段t的长短可以视需要加以调整，例如可以设定成使该控制单元18周期性地读取该压力感测器16量测的压力值。
本发明该口部介面装置的唾液处理系统1中测量该储液槽14中液体容量的方法详述如下。
请参下文表一，表一的第一行显示该储液槽14内部的液体容量，每一列的数值代表该列所示液体容量的储液槽14所测量的压力值(压力值单位为mmHg)，且同一列所显示上下两压力值测量的时间间隔都是相同长度的，例如是T2-T1＝t，而且T3-T2＝t。从表一可看出，在一特定设定时间区段t下，该储液槽14内部的液体容量不同时，测量到的该储液槽14内部的压力值也会不同。例如表一压力值第14行所显示的压力值，可明显看出，当设定该计时器17间隔一段相同时间长度的设定时段(例如T14)通知该控制单元18读取该压力感测器16量测的压力值，随着该储液槽14内部液体容量的增加(0ml递增至80ml)，该储液槽14内部的压力值也随着增加(-71.0922mmHg递增至-33.7023mmHg)。
表一
Figure PCTCN2015076748-appb-000001
Figure PCTCN2015076748-appb-000002
请参图3，为压力-时间关系图，其中Y轴代表该储液槽14内部的压力值，X轴代表该计时器17计数的时间区段t，曲线a、曲线b、曲线c、曲线d、曲线e、曲线f、曲线g、曲线h及曲线i代表该储液槽14内部液体容量为80ml、70ml、60ml、50ml、40ml、30ml、20ml、10ml及0ml。图4是一压力-液体容量关系图，该图是经由表一第15行所列压力值与液体容量转换得来，可以看出，当该计时器17每隔该设定时段T即通知该控制单元18读取该压力感测器16测量到的该储液槽14内部压力值时，当该储液槽14内部液体容量不同时，测量到的该压力值也随之不同。该控制单元18内建有对应该计时器17计数的该设定时段T15的一压力-储液槽液体容量对应表，例如是由图4转换得来。当该控制单元18读取到该储液槽14的压力值时，即可根据该压力-储液槽液体容量对应表决定该储液槽14内部的液体容量值，并且将该液体容量值传送至该警示装置19，经由该警示装置19发出一提示信号，进而可以检测该储液槽14内液体容量是否满载。此外，该控制单元18亦可以内建对应该计时器17不同设定时间区段t(例如T2,T3,T4,T5,……,T10,T11…)的多个压力-储液槽液体容量对应表，以视需要调整该控制单元18读取该储液槽14内部压力值的时间，并根据对应的该压力-储液槽液体容量对应表决定该储液槽14液体容量。
图2A及图2B是该第一具体实施例的该口部介面装置100的第一变化例与第二变化例的俯视剖面图。在本发明的该口部介面装置的唾液处理系统1中可以该第一变化例及第二变化例的口部介面装置代替该口部介面装置100。在图2A所示该第一变化例中，本发明的一口部介面装置200包括一可挠性屏障250及一可挠性气流导管210。该可挠性气流导管210具有一第一开口端部220设置于该使用者嘴巴外面并用以连通于该三向连接件11的一第一接口端，该可挠性气流导管210另具有一相对的一第二开口端部230，用以设置于该使用者的舌头与上颚之间空间。元件标号260所指虚线区域代表舌头与软/硬颚之间的口腔区域。该可挠性气流导管210更具有至少一通孔240形成于该可挠性屏障250的中心区域附近，并且该通孔240连通于该可挠性气流导管210。较佳地，该通孔240相对于该可挠性气流导管210的中空管体方向横向地连通于该可挠性气流导管210。该可挠性气流导管210的本体形状与该可挠性气流导管110相同，在此就不再重述。该可挠性屏障250具有一延伸件朝该可挠性气流导管210的该第一开口端部220延伸而突出于该使用嘴巴外面，并且该可挠性气流导管210通过该延伸件。该可挠性屏障250具有至少一单向阀252，当该使用者张开嘴巴呼吸时，口腔内的空气经由该单向阀252流向口腔外部，如箭头所示。在图2B所示该第二变化例中，本发明的一口部介面 装置202包括一可挠性屏障250及一可挠性气流导管212。该可挠性气流导管212具有一第一开口端部222设置于该使用者嘴巴外面并用以连通于该三向连接件11的一第一接口端，该可挠性气流导管212另具有一相对的一第二开口端部232，用以设置于该使用者的舌头与上颚之间空间。元件标号262所指虚线区域代表舌头与软/硬颚之间的口腔区域。该可挠性气流导管212更具有至少一通孔242形成于该可挠性屏障250的中心区域附近，并且该通孔242连通于该可挠性气流导管212。较佳地，该通孔242相对于该可挠性气流导管212的中空管体方向横向地连通于该可挠性气流导管212。该可挠性气流导管212的本体形状与该可挠性气流导管110相同，在此就不再重述。该可挠性屏障250具有一延伸件朝该可挠性气流导管212的该第一开口端部222延伸而突出于该使用者嘴巴外面，并且该可挠性气流导管212通过该延伸件，而使该延伸件内形成一第一流道214、一第二流道215及一第三流道216，其中该第一流道214与该第三流道216形成于该第二流道215的相对侧。该第一流道214、第二流道215及该第三流道216连通于该使用者的口腔内部，并且该第一流道214与第三流道216靠近该第一开口端部222的端口分别设置一单向阀，以使该使用者口腔内的空气可经由所述单向阀流向口腔外部，如箭头所示。
图5是本发明口部介面装置的唾液处理系统的一第二具体实施例。在该第二具体实施例中，本发明提供一种口部介面装置的唾液处理系统5，其包括一口部介面装置500、一流体调向器(fluid flow regulator)50、一连通管52、一储液槽55、一负压源56、一压力感测器57、一计时器58、一控制单元59及一警示装置60。该口部介面装置500与图1所示第一具体实施例的该口部介面装置100相同，该口部介面装置500为一体成型的装置，至少包括一可挠性屏障550及一可挠性气流导管510，该可挠性气流导管510具有一第一开口端部520设置于该使用者嘴巴外面并用以连通于该流体调向器50，该可挠性气流导管510另具有一相对的一第二开口端部530，用以设置于该使用者的舌头与上颚之间空间。该流体调向器50包含一三向连接件51、一第二单向阀53及一真空启动压力释放阀54。图5A是该流体调向器50的放大剖面示意图，该三向连接件51具有一第一接口端、一第二接口端及一第三接口端，其中该第一接口端设置有一第一单向阀511并连通于该可挠性气流导管510的该第一开口端部520，该使用者口腔内的流体经由该第一单向阀511流向该三向连接件51，该第二接口端连通于该连通管52的一第一开口端，而该连通管52的一第二开口端连通于该储液槽55。该储液槽55连通于该负压源56。当该负压源56启动之后，该使用者口腔内部与该负压源56之间即构成一负压途径。该 第二单向阀53设置于该三向连接件51的该第三接口端，并且该真空启动压力释放阀54结合于该第二单向阀53相对于该三向连接件51的一端。图5B-1及图5B-2是该真空启动压力释放阀54的一种实施例的剖面放大示意图，图5B-1所示实施例提供的真空启动压力释放阀54a呈关闭状态，其包含一本体540a、一推进阀546a、一弹簧547a及一弹簧座548a。该本体540a内部设置一具有一通道的隔板，以将该本体540a区分成一第一容室542a及一第二容室544a，该第一容室542a连通于周围空气，该第二容室544a连通于该第二单向阀53，该推进阀546a可以移动地设置于该第一容室542a中并通过该通道。在该真空启动压力释放阀54a未启动情况下，该推进阀546a占据该通道整个空间，使该第一容室542a的流体隔绝于该第二容室544a，以防止周围空气进入该第二容室544a。该弹簧座548a设置于该第一容室542a中该隔板的一表面上，该弹簧547a抵靠于该推进阀546a与该弹簧座548a之间。图5B-2显示该真空启动压力释放阀54a呈开启状态，当该使用者口腔内与该负压源56之间的该负压途径的负压值到达该真空启动压力释放阀54a的启动阀值时，该第一容室542a与该第二容室544a之间压力差造成周围空气推动该推进阀546a前进，进而在该隔板通道与该推进阀546a之间形成空气流道，使周围空气经由该空气流道进入该第二容室544a，再经由该第二单向阀53、该三向连接件51的该第二接口端通入该连通管52。通入的周围空气即可以将停留在该连通管52内的唾液携带至该储液槽55。从图5可看出，该三向连接件51、该第一单向阀511、该第二单向阀53及该真空启动压力释放阀54构成的该流体调向器50即可以限制所有流体是流向该连通管52。换句话说，本发明该口部介面装置的唾液处理系统5在启动之后，流体流动方向即如图5箭头所示。该负压源56连通于该储液槽55，本发明例如可以经由该控制单元59或者以人为手动方式启动/停止该负压源56，当该负压源56启动之后，本发明该口部介面装置的唾液处理系统5即在该使用者口腔内部与该负压源56之间构成一负压途径，以利于将该使用者口腔内的空气与唾液经由该负压途径抽离，并且唾液可收集于该储液槽55。再者，本发明该口部介面装置的唾液处理系统5在启动期间，如图5箭头所示，周围空气可经由该第二单向阀53及该真空启动压力释放阀54以及该三向连接件51通入该连通管52，以利于将停留在该连通管52的唾液经由空气携离并收集至该储液槽55，进而可以避免该连通管52因残留有唾液而造成该使用者口腔内部与该负压源56之间压力的差异，甚者可以避免该连通管52被唾液阻塞，进而可以保持该使用者口腔内部与该负压源56之间的负压途径。
图5C-1及图5C-2是该真空启动压力释放阀54的另一种实施例的剖面放大示意图， 图5C-1所示实施例提供的真空启动压力释放阀54b呈关闭状态，其包含一本体540b、一推进阀546b、一弹簧547b及一弹簧座548b。该本体540b内部设置一具有一通道的隔板，以将该本体540b区分成一第一容室542b及一第二容室544b，该第一容室542b连通于周围空气，该第二容室544b连通于该第二单向阀53，该推进阀546b可以移动地设置于该第一容室542b中并通过该通道。在该真空启动压力释放阀54b未启动情况下，该推进阀546b占据该通道整个空间，使该第一容室542b的流体隔绝于该第二容室544b，以防止周围空气进入该第二容室544a。该弹簧座548b设置于该第一容室542b中该隔板的一表面上，该弹簧547b抵靠于该推进阀546b与该弹簧座548b之间。图5C-2显示该真空启动压力释放阀54b呈开启状态，当该使用者口腔内与该负压源56之间的该负压途径的负压值到达该真空启动压力释放阀54b的启动阀值时，该第一容室542b与该第二容室544b之间压力差造成周围空气推动该推进阀546b前进，进而在该隔板通道与该推进阀546b之间形成空气流道，使周围空气经由该空气流道进入该第二容室544b，再经由该第二单向阀53、该三向连接件51的该第二接口端通入该连通管52。通入的周围空气即可以将停留在该连通管52内的唾液携带至该储液槽55。
此外，在该第二具体实施例的一变化例中(图未示出)，本发明该口部介面装置的唾液处理系统5中该负压源56也可以连通于该连通管52与该储液槽55之间，并可经由该控制单元59或人为方式启动/停止该负压源56。
另一方面，本发明该口部介面装置的唾液处理系统5可以持续间歇地测量该储液槽55中唾液容量，以监控该储液槽55中唾液容量是否满载，以利于维持整个系统在正常运作情况下。在本发明该第二具体实施例中，该口部介面装置的唾液处理系统5通过该控制单元59启动/停止该计时器58的时间计算动作，该计时器58经启动后即可以持续间歇地计数时间至一设定时间区段t后送出一通知信号至该控制单元59，再经由该控制单元59读取该压力感测器57所量测的一压力值。该压力感测器57连通于该储液槽55，用以量测该储液槽55内部的压力值。简言之，该计时器58被启动后每隔一段时间t即送出一通知信号至该控制单元59，以通知该控制单元59读取该压力感测器57测量到的一压力值。如此一来，该控制单元59可以持续间歇地读取该压力感测器57感测的压力值。该控制单元59再根据读取的压力值决定该储液槽55中的液体容量。此外，该设定时间区段t的长短可以视需要加以调整，例如可以设定成使该控制单元59周期性地读取该压力感测器57量测的压力值。
本发明该口部介面装置的唾液处理系统5中测量该储液槽55中液体容量的方法与 图1所示该第一具体实例的该系统1的方法相同，在此不再重述。
图6是本发明口部介面装置的唾液处理系统的一第三具体实施例。在该第三具体实施例中，本发明提供一种口部介面装置的唾液处理系统6，其包括一口部介面装置600、一连通管62、一储液槽64、一负压源65、一压力感测器66、一计时器67、一控制单元68及一警示装置69。该口部介面装置600为一体成型的装置，至少包括一可挠性屏障650及一可挠性气流导管610，该可挠性气流导管610具有一第一开口端部620设置于该使用者嘴巴外面并用以连通于该连通管62的一第一开口端，而该连通管62的一第二开口端连通于该储液槽64。该可挠性气流导管610另具有一相对的一第二开口端部630，用以设置于该使用者的舌头与上颚之间空间。该可挠性气流导管610更具有一可挠折中间区段形成于该可挠性屏障650与该第二开口端部630之间并位于该可挠性屏障650附近，该可挠折中间区段相较于该可挠性气流导管610其它部分具有一较窄薄结构，以利于顺形于该使用者上颚轮廓及舌头轮廓。换句话说，该可挠折中间区段可顺应于不同使用者的上颚轮廓。该可挠性气流导管610更具有至少一通孔640形成于该可挠性屏障650的中心区域附近的该可挠折中间区段中，较佳地，该通孔640相对于该可挠性气流导管610的中空管体方向横向地连通于该可挠性气流导管610。该可挠性气流导管610的该第二开口端部630相较于该可挠折中间区段具有一较宽厚结构，以增加该可挠性气流导管610的结构强度，以使该可挠性气流导管610在被该使用者舌头及上颚压迫时避免塌陷。该可挠性屏障650具有一延伸件朝该可挠性气流导管610的该第一开口端部620延伸而突出于该使用者嘴巴外面，并且该可挠性气流导管610通过该延伸件，而使该延伸件内形成一第一流道612、一第二流道613及一第三流道614，其中该第一流道612与该第三流道614形成于该第二流道613的相对侧，该可挠性气流导管610通过该延伸件的部分构成该第二流道613。该第一流道612、第二流道613及该第三流道614连通于该使用者的口腔内部，并且该第一流道612靠近该第一开口端部620的端口设置一真空启动压力释放阀602，该第三流道614靠近该第一开口端部620的端口设置一单向阀604；当该使用者口腔内部负压值达到该真空启动压力释放阀602的启动阀值时，该真空启动压力释放阀602阀门即被开启并使周围空气经由该真空启动压力释放阀602进入该使用者口腔内部。通入的前述周围空气则有利于将该使用者口腔内部的唾液及停留在该连通管62内的唾液携带至该储液槽64。该单向阀604则用以限制该使用者口腔内部的空气可经由该单向阀604流向周围环境。该真空启动压力释放阀602的实施方式可以采用图5B-1及图5B-2与图5C-1及图5C-2所示的具体实施例，在此不再重述。该负压源65 连通于该储液槽64，本发明例如可以经由该控制单元68或者以人为手动方式启动/停止该负压源65，当该负压源65启动之后，本发明该口部介面装置的唾液处理系统6即在该使用者口腔内部与该负压源65之间构成一负压途径，以利于将该使用者口腔内的空气与唾液经由该负压途径抽离，并且唾液可收集于该储液槽64。再者，本发明该口部介面装置的唾液处理系统6在启动期间，周围空气可经由该真空启动压力释放阀602通入该连通管62，以利于将停留在该连通管62的唾液经由空气携离并收集至该储液槽64，进而可以避免该连通管62因残留有唾液而造成该使用者口腔内部与该负压源65之间压力的差异，甚者可以避免该连通管62被唾液阻塞，进而可以保持该使用者口腔内部与该负压源65之间的负压途径。
图6A-1及图6A-2是该口部介面装置600的一第一变化例的俯视剖面示意图。该第一变化例所示的一口部介面装置600a可以代替该口部介面装置的唾液处理系统6的该口部介面装置600。该口部介面装置600a与该口部介面装置600结构不同处在于该口部介面装置600a在该真空启动压力释放阀602附近该第一流道612内设置一调整型阻流器，为一可移动式凸件660，其余构件则与该口部介面装置600相同，在此不再重述。该可移动式凸件660一侧突出于该延伸件外部，以供手持移动该可移动式凸件660，如图6A-1及图6A-2所示，借以调整该第一流道612内部空间大小，进而改变其流阻大小。参图6A-2所示，当该可移动式凸件660朝向该可挠性气流导管610移动而缩小该第一流道612内部空间时即提高该真空启动压力释放阀602的启动阀值。换句话说，在图6A-2使用状态下的该真空启动压力释放阀602的启动阀值高于图6A-1使用状态下的该真空启动压力释放阀602的启动阀值。图6A-2使用状态下的该真空启动压力释放阀602需要更高的口腔负压值才能被开启。
图6B-1及图6B-2是该口部介面装置600的一第二变化例的俯视剖面示意图。该第二变化例所示的一口部介面装置600b可以代替该口部介面装置的唾液处理系统6的该口部介面装置600。该口部介面装置600b与该口部介面装置600结构不同处在于该口部介面装置600b在该真空启动压力释放阀602附近该第一流道612内设置一调整型阻流器，为一可旋转中空管件680，其余构件则与该口部介面装置600相同，在此不再重述。该可旋转中空管件680具有一开放的中空管道连通于该第一流道612，并且该可旋转中空管件680一端突出于该延伸件外部，以供手持转动该可旋转中空管件680，如图6B-1及图6B-2所示，借以改变该第一流道612流阻大小。参图6B-2所示，随着转动该可旋转中空管件680一特定角度，可以改变该第一流道612流阻大小，进而可以改变该真空 启动压力释放阀602的启动阀值。换句话说，在图6B-2使用状态下的该真空启动压力释放阀602的启动阀值高于图6B-1使用状态下的该真空启动压力释放阀602的启动阀值。图6B-2使用状态下的该真空启动压力释放阀602需要更高的口腔负压值才能被开启。
此外，在该第三具体实施例的一变化例中(图未示出)，本发明该口部介面装置的唾液处理系统6中该负压源65也可以连通于该连通管62与该储液槽64之间，并可经由该控制单元68或人为方式启动/停止该负压源65。
另一方面，本发明该口部介面装置的唾液处理系统6可以持续间歇地测量该储液槽64中唾液容量，以监控该储液槽64中唾液容量是否满载，以利于维持整个系统在正常运作情况下。在本发明该第三具体实施例中，该口部介面装置的唾液处理系统6通过该控制单元68启动/停止该计时器67的时间计算动作，该计时器67经启动后即可以持续间歇地计数时间至一设定时间区段t后送出一通知信号至该控制单元68，再经由该控制单元68读取该压力感测器66所量测的一压力值。该压力感测器66连通于该储液槽64，用以量测该储液槽64内部的压力值。简言之，该计时器67被启动后每隔一段时间t即送出一通知信号至该控制单元68，以通知该控制单元68读取该压力感测器66测量到的一压力值。如此一来，该控制单元68可以持续间歇地读取该压力感测器66感测的压力值。该控制单元68再根据读取的压力值决定该储液槽64中的液体容量。此外，该设定时间区段t的长短可以视需要加以调整，例如可以设定成使该控制单元68周期性地读取该压力感测器66量测的压力值。
本发明该口部介面装置的唾液处理系统6中测量该储液槽64中液体容量的方法与图1所示该第一具体实例的该系统1的方法相同，在此不再重述。
本发明系统与方法还可进一步与其他治疗睡眠呼吸障碍的装置共同使用。例如本发明系统可与鼻腔单向阀装置共同使用，例如，美国专利第8,061,357号揭露的装置。利用该鼻腔单向阀装置可增加上呼吸道内正压，配合本发明产生口腔内负压与避免嘴巴张开漏气，口腔内和上呼吸道之间的压力梯度(pressure gradient)可以增加并维持，因而促使软颚向口腔前方移动和舌头向上硬颚和口腔前方移动，以确保上呼吸道的畅通。
本发明系统与方法可进一步与正压呼吸器(CPAP)共同使用。利用该正压呼吸器可增加并维持上呼吸道内正压，配合本发明产生口腔内负压与避免嘴巴张开漏气，口腔内和上呼吸道之间的压力梯度(pressure gradient)可以增加并维持，因而促使软颚软向口腔前方移动和舌头向上硬颚和口腔前方移动，以确保上呼吸道的畅通。同时使用本发明系统， 进一步可以降低正压呼吸器所需要的设定值；同时使用本发明系统，再进一步可以降低间歇性地开启或提高正压呼吸器的正压值，以减少使用者因连续正压造成的呼吸不适感，以提高病人的使用顺从度(patient compliance)。
本发明系统与方法可进一步与呼吸检测装置共同使用。利用该呼吸检测装置检测上呼吸道的呼吸流量，当检测到呼吸中止或呼吸减弱的状态时，再开启或提高本发明口部介面装置的负压值，以减少负压产生装置开启时间，达到省能及安静的目的。
以上所述仅为本发明的具体实施例而已，并非用以限定本发明的申请专利范围；凡其它未脱离本发明所揭示的精神下所完成的等效改变或修饰，均应包含在本发明的申请专利范围内。

Claims (34)

  1. 一种口部介面装置的唾液处理系统，其特征在于，所述口部介面装置的唾液处理系统包括：
    一口部介面装置，用以放置于一使用者口腔内，以在该使用者的口腔内提供一流体通道；
    一流体调向器，具有一第一接口端及一第二接口端，该流体调向器用以限制所有流体是流向其第二接口端，该第一接口端连通于该口部介面装置的该流体通道；及
    一连通管，具有一第一开口端及一第二开口端，其中该第一开口端连通于该流体调向器的该第二接口端，以及该第二开口端连通于一储液槽与一负压源，借以在该使用者口腔内部与该负压源之间构成一负压途径；
    其中该使用者口腔内的唾液通过该负压途径而收集于该储液槽。
  2. 如权利要求1所述的口部介面装置的唾液处理系统，其特征在于，该流体调向器包含一三向连接件、一第一单向阀及一第二单向阀，该三向连接件具有该第一接口端、该第二接口端及一第三接口端，并且该第一单向阀设置于该第一接口端处，以限制流体是流向该第二接口端，该第二单向阀设置于该第三接口端处，以限制周围空气是经由该第二单向阀及该第二接口端通入该连通管，以利于该连通管内停留的唾液流至该储液槽。
  3. 如权利要求1所述的口部介面装置的唾液处理系统，其特征在于，该流体调向器包含一三向连接件、一第一单向阀、一第二单向阀及一真空启动压力释放阀，该三向连接件具有该第一接口端、该第二接口端及一第三接口端，并且该第一单向阀设置于该第一接口端处，以限制流体是流向该第二接口端，该第二单向阀设置于该第三接口端处，及该真空启动压力释放阀结合该第二单向阀，以在一预定负压值下开启该真空启动压力释放阀通入周围空气，并限制周围空气是经由该第二单向阀及该第二接口端通入该连通管，以利于该连通管内停留的唾液流至该储液槽。
  4. 如权利要求3所述的口部介面装置的唾液处理系统，其特征在于，该真空启动压力释放阀包含一本体、一推进阀、一弹簧及一弹簧座，其中该本体内部设置一具有一通道的隔板，以将该本体区分成一第一容室及一第二容室，该第一容室连通于周围空气，该第二容室连通于该第二单向阀，该推进阀能移动地设置于该第一容室中并通过该通道，在该真空启动压力释放阀未启动情况下，该推进阀占据该通道整个空间，使该第一容室的流体隔离于该第二容室，该弹簧座设置于该第一容室中该隔板的一表面上，该弹 簧抵靠于该推进阀与该弹簧座之间。
  5. 如权利要求1所述的口部介面装置的唾液处理系统，其特征在于，该系统更包含该储液槽及该负压源，该储液槽连通于该连通管的该第二开口端，该负压源连通于该储液槽。
  6. 如权利要求1所述的口部介面装置的唾液处理系统，其特征在于，该系统更包含该储液槽及该负压源，该负压源连通于该连通管的该第二开口端，该储液槽连通于该负压源。
  7. 如权利要求5所述的口部介面装置的唾液处理系统，其特征在于，该口部介面装置的唾液处理系统进一步包含：
    一控制单元；
    一计时器，经由该控制单元启动/停止该计时器的时间计算动作；及
    一压力感测器，用以测量该储液槽内压力大小并将测量的一压力值传送至该控制单元；
    其中该计时器被启动后开始计算时间达一设定时段，该计时器即传送一通知信号至该控制单元，通知该控制单元读取该压力感测器传送的该压力值。
  8. 如权利要求6所述的口部介面装置的唾液处理系统，其特征在于，该口部介面装置的唾液处理系统进一步包含：
    一控制单元；
    一计时器，经由该控制单元启动/停止该计时器的时间计算动作；及
    一压力感测器，用以测量该储液槽内压力大小并将测量的一压力值传送至该控制单元；
    其中该计时器被启动后开始计算时间达一设定时段，该计时器即传送一通知信号至该控制单元，通知该控制单元读取该压力感测器传送的该压力值。
  9. 如权利要求7所述的口部介面装置的唾液处理系统，其特征在于，该控制单元内建对应该计时器计数的该设定时段的一压力-储液槽液体容量对应表，以根据该压力值及该压力-储液槽液体容量对应表，决定该储液槽中的液体容量。
  10. 如权利要求8所述的口部介面装置的唾液处理系统，其特征在于，该控制单元内建对应该计时器计数的该设定时段的一压力-储液槽液体容量对应表，以根据该压力值及该压力-储液槽液体容量对应表，决定该储液槽中的液体容量。
  11. 一种口部介面装置的唾液处理系统，其特征在于，所述口部介面装置的唾液处 理系统包括：
    一口部介面装置，用以放置在一使用者口腔内，以在该使用者的口腔内提供至少一流体通道，该口部介面装置具有一延伸部突出于该使用者口腔外面，该延伸部具有一第一流道及一第二流道，该第一流道及该第二流道皆连通于该使用者口腔内部，该第一流道位于口腔外面的一端设置有一真空启动压力释放阀；及
    一连通管，具有一第一开口端及一第二开口端，该第一开口端连通于该口部介面装置的该第二流道，及该第二开口端连通于一储液槽及一负压源，借以在该使用者口腔内部与该负压源之间构成一负压途径；
    其中在一预定负压值情况下，该真空启动压力释放阀被启动，使周围空气经由该第一流道通入该使用者口腔内，并通过通入的空气流携带口腔内的唾液及该连通管内停留的唾液流至该储液槽。
  12. 如权利要求11所述的口部介面装置的唾液处理系统，其特征在于，该口部介面装置的该延伸部更具有一第三流道连通于该使用者口腔内，该第三流道位于口腔外面的一端设置有一单向阀，用以限制口腔内的空气是流向口腔外面。
  13. 如权利要求11所述的口部介面装置的唾液处理系统，其特征在于，该真空启动压力释放阀包含一本体、一推进阀、一弹簧及一弹簧座，其中该本体内部设置一具有一通道的隔板，以将该本体区分成一第一容室及一第二容室，该第一容室连通于周围空气，该第二容室连通于该第一流道，该推进阀能移动地设置于该第一容室中并通过该通道，在该真空启动压力释放阀未启动情况下，该推进阀占据该通道整个空间，使该第一容室的流体隔绝于该第二容室，该弹簧座设置于该第一容室中该隔板的一表面上，该弹簧抵靠于该推进阀与该弹簧座之间。
  14. 如权利要求11所述的口部介面装置的唾液处理系统，其特征在于，所述口部介面装置的唾液处理系统更包含一调整型阻流器设置于该第一流道中，该调整型阻流器用以调整该第一流道的流阻大小。
  15. 如权利要求14所述的口部介面装置的唾液处理系统，其特征在于，该调整型阻流器为一可移动式凸件，该可移动式凸件一侧突出于该延伸件外部，以供手持移动该凸件，借以调整该第一流道的流阻大小。
  16. 如权利要求14所述的口部介面装置的唾液处理系统，其特征在于，该调整型阻流器为一可旋转中空管件，该可旋转中空管件具有一开放的中空管道连通于该第一流道，并且该可旋转中空管件一端突出于该延伸件外部，以供手持转动该中空管件，借以 调整该第一流道的流阻大小。
  17. 如权利要求11所述的口部介面装置的唾液处理系统，其特征在于，该系统更包含该储液槽及该负压源，该储液槽连通于该连通管的该第二开口端，该负压源连通于该储液槽。
  18. 如权利要求11所述的口部介面装置的唾液处理系统，其特征在于，该系统更包含该储液槽及该负压源，该负压源连通于该连通管的该第二开口端，该储液槽连通于该负压源。
  19. 如权利要求17所述的口部介面装置的唾液处理系统，其特征在于，该口部介面装置的唾液处理系统进一步包含：
    一控制单元；
    一计时器，经由该控制单元启动/停止该计时器的时间计算动作；及
    一压力感测器，用以测量该储液槽内压力大小并将测量的一压力值传送至该控制单元；
    其中该计时器被启动后开始计算时间达一设定时段，该计时器即传送一通知信号至该控制单元，通知该控制单元读取该压力感测器传送的该压力值。
  20. 如权利要求18所述的口部介面装置的唾液处理系统，其特征在于，该口部介面装置的唾液处理系统进一步包含：
    一控制单元；
    一计时器，经由该控制单元启动/停止该计时器的时间计算动作；及
    一压力感测器，用以测量该储液槽内压力大小并将测量的一压力值传送至该控制单元；
    其中该计时器被启动后开始计算时间达一设定时段，该计时器即传送一通知信号至该控制单元，通知该控制单元读取该压力感测器传送的该压力值。
  21. 如权利要求19所述的口部介面装置的唾液处理系统，其特征在于，该控制单元内建对应该计时器计数的该设定时段的一压力-储液槽液体容量对应表，以根据该压力值及该压力-储液槽液体容量对应表，决定该储液槽中的液体容量。
  22. 如权利要求20所述的口部介面装置的唾液处理系统，其特征在于，该控制单元内建对应该计时器计数的该设定时段的一压力-储液槽液体容量对应表，以根据该压力值及该压力-储液槽液体容量对应表，决定该储液槽中的液体容量。
  23. 一种口部介面装置，其特征在于，所述口部介面装置包括：
    一可挠性屏障，用以设置于一使用者嘴唇与牙齿之间，该可挠性屏障具有至少一单向阀，以限制该使用者口腔内的空气经由该单向阀是流向口腔外面；
    一延伸件，形成于该可挠性屏障一侧并且突出于该使用者口腔外部；及
    一可挠性气流导管，通过该可挠性屏障及该延伸件，该可挠性气流导管具有一第一开口端部及相对的一第二开口端部，该第一开口端部延伸突出于该使用者口腔外部并用以连通于一负压源，该第二开口端部用以设置于该使用者舌头与上颚之间。
  24. 如权利要求23所述的口部介面装置，其特征在于，该可挠性气流导管具有至少一通孔位于该可挠性屏障附近，并且该通孔连通于该可挠性气流导管一侧及用以连通于该使用者的口腔内部前端区域。
  25. 一种口部介面装置，其特征在于，所述口部介面装置包括：
    一可挠性屏障，用以设置于一使用者嘴唇与牙齿之间；
    一延伸件，形成于该可挠性屏障一侧并且突出于该使用者口腔外部；及
    一可挠性气流导管，通过该可挠性屏障及该延伸件，该可挠性气流导管具有一第一开口端部及相对的一第二开口端部，该第一开口端部延伸突出于该使用者口腔外部并用以连通于一负压源，该第二开口端部用以设置于该使用者舌头与上颚之间；
    其中该延伸件具有一第一流道及一第二流道，分别形成于该可挠性气流导管的相对侧并且连通于该使用者口腔内部，该第一流道及该第二流道至少其中之一的远离该使用者口腔的一端设置有一单向阀，用以限制该使用者口腔内的空气经由该单向阀是流向口腔外面。
  26. 如权利要求25所述的口部介面装置，其特征在于，该第一流道远离该使用者口腔的一端设置有一单向阀，并且该第二流道远离该使用者口腔的一端设置有一真空启动压力释放阀。
  27. 如权利要求26所述的口部介面装置，其特征在于，该真空启动压力释放阀包含一本体、一推进阀、一弹簧及一弹簧座，其中该本体内部设置一具有一通道的隔板，以将该本体区分成一第一容室及一第二容室，该第一容室连通于周围空气，该第二容室连通于该第二流道，该推进阀能移动地设置于该第一容室中并通过该通道，在该真空启动压力释放阀未启动情况下，该推进阀占据该通道整个空间，以使该第一容室的流体流向该第二容室，该弹簧座设置于该第一容室中该隔板的一表面上，该弹簧抵靠于该推进阀与该弹簧座之间。
  28. 如权利要求27所述的口部介面装置，其特征在于，该口部介面装置更包含一调 整型阻流器，设置于该第二流道中用以调整该第二流道的流阻大小。
  29. 如权利要求28所述的口部介面装置，其特征在于，该调整型阻流器为一可移动式凸件，该可移动式凸件一侧突出于该延伸件外部，以供手持移动该凸件，借以调整该第二流道的流阻大小。
  30. 如权利要求28所述的口部介面装置，其特征在于，该调整型阻流器为一可旋转中空管件，该可旋转中空管件一端突出于该延伸件外部，以供手持转动该中空管件，借以调整该第二流道的流阻大小。
  31. 一种口部介面装置的唾液处理系统的储液槽中液体容量测量方法，其特征在于，所述口部介面装置的唾液处理系统的储液槽中液体容量测量方法包括：
    将该口部介面装置放置于一使用者口腔内，并通过该系统连通一负压源，以在该使用者口腔内与该负压源之间构成一负压途径，其中该使用者口腔内的唾液经由该负压途径收集至该储液槽；
    持续间歇地量测该储液槽内的压力值；及
    根据量测的该压力值以决定该储液槽内的液体容量。
  32. 如权利要求31所述的口部介面装置的唾液处理系统的储液槽中液体容量测量方法，其特征在于，该持续间歇地量测该储液槽内的压力值的步骤包含周期性地量测该储液槽内的压力值。
  33. 如权利要求31所述的口部介面装置的唾液处理系统的储液槽中液体容量测量方法，其特征在于，所述系统是如权利要求7、8、19或20中所述的系统。
  34. 如权利要求31所述的口部介面装置的唾液处理系统的储液槽中液体容量测量方法，其特征在于，所述根据量测的该压力值以决定该储液槽内的液体容量的步骤是根据该压力值与一对应的压力-储液槽液体容量对应表，决定该储液槽中的液体容量。
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